# Medical Student COVID-19 Curriculum

Thank you for visiting the COVID-19 Medical Student Curriculum! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating these modules regularly.

## Introduction

One of the greatest difficulties facing everyone nowadays is a lack of clarity about what is going on and what lies ahead.  We students especially feel a need to deepen our knowledge of the situation, as we are often viewed as resources by our friends and family.  However, it soon became clear how challenging it was to process the wealth of information coming our way.  A team of us at Harvard Medical School set out to quickly collate and synthesize accurate information about the pandemic to share with those who do not have the time or resources to research it themselves.&#x20;

Please share these materials with anyone whom you believe may benefit from them.  **We invite you to sign the** [**guest book**](https://docs.google.com/forms/d/e/1FAIpQLSdDgCyBO-l7qsamNhbEPznxhaDetC-dFBd4W5Tu5WC4zBWC6g/viewform) **so we can track this material’s reach.**

![As of January 2021, visitors from over 100 countries have signed the guest book!](/files/-MRBBCIOrK-DYTq1XY0j)

This curriculum was written and compiled by Harvard Medical School students.  This document is not an official publication of the institution.  It is provided for educational purposes only and does not constitute medical advice.

The contents in each module were reviewed for accuracy by expert faculty members at the time of initial publication.  We thank them for their attention during this particularly demanding time. However, given our constantly changing understanding of SARS-CoV-2 and the pandemic’s spread in society, the material in this curriculum will need to be updated frequently, and we cannot guarantee the accuracy of the information at any given time.  We plan to update content every weekend.  Please share your [feedback](https://docs.google.com/forms/d/e/1FAIpQLSdZGYWkx5AVaYUIxCwvQmI75Vu6jVOHkinhDHr_XbrQq4WMTg/viewform).

Contact: [HMS Medical Student COVID-19 Curriculum Committee](mailto:medicalstudentcovidcurriculum@gmail.com)


# Curriculum Overview

Thank you for visiting the COVID-19 Medical Student Curriculum! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating these modules regularly.

## How To Use This Curriculum

We want these lessons to be as widely helpful as possible.  Given the range of circumstances in which medical students may find themselves right now, we do not have a single approach in mind.  For those with the time, we suggest you proceed through the modules start-to-finish. However, for those with more urgent needs, the modules are stand-alone, and you can selectively access content on an as-needed basis.  The subsequent learning objectives and table of contents at the left may help you locate content that is most important.&#x20;

Many modules reference supplemental resources that may be worth accessing in the future, either in anticipation of specific patient interactions or simply to find the most current statistics of the pandemic.  Also included on this website are one-page summaries of each module’s key takeaways.

## Learning goals

[**Module 1: From Bench to Bedside**](/module-1-from-bench-to-bedside)

Evaluate how the emerging understanding of COVID-19 pathophysiology translates to evolving diagnosis, treatment, and prevention efforts.

[**Module 2: Epidemiology Principles**](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles)

Introduce epidemiological principles underlying the current public health interventions regarding COVID-19, and evaluate how these interventions could influence the impact of the pandemic.

[**Module 3: Health Disparities, Policy Changes, and Socioeconomic Effects in the U.S.**](https://curriculum.covidstudentresponse.org/module-3-current-situation-and-healthcare-response)

Appreciate the complex and rapidly changing landscape of the COVID-19 pandemic as it stands in the U.S., as well as the adapting responses of the healthcare system and society as a whole.

[**Module 4: Mental Health in the Time of COVID-19**](https://curriculum.covidstudentresponse.org/module-4-mental-health-in-the-time-of-covid-19)

Assess how the COVID-19 pandemic affects the mental health of patients and identify basic tools for responding to these changes in the clinical setting.

[**Module 5: Communicating Information about COVID-19**](https://futuremdvscovid.gitbook.io/covid19-curriculum/module-4-communicating-information-about-covid-19)

Prepare to productively communicate information about COVID-19, especially with a non-medical audience who may have varying attitudes towards the pandemic.

[**Module 6: Training for Potential Clinical Roles**](https://curriculum.covidstudentresponse.org/module-5-training-for-medical-student-specific-roles)

Develop technical know-how in preparation for roles that medical students may play in the clinical setting.

[**Module 7: Global Innovation and Collaboration**](https://curriculum.covidstudentresponse.org/module-7-global-innovation-and-collaboration-in-response-to-the-pandemic)

Explore collaborative innovation and shared experiences regarding optimizing “staff, stuff, space, and systems” between countries of all income levels as they relate to COVID-19.

[**Module 8: Medical Ethics in Relation to COVID-19**](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19)

Discuss various ethical controversies related to COVID-19, and apply ethical frameworks to examine the impacts of personal, medical, and governmental decisions related to the pandemic.


# Cases

To help link this curriculum’s clinical, epidemiological, and social principles into real-world human narratives, the modules will repeatedly reference two characters. We’d like to introduce them now:

## Case 1: Brian

Brian is a healthy, 22 year-old college senior in Boston who just received a 5-day notice to pack up his dorm room belongings, say goodbye to his friends, and return home. He posts on Twitter about being mad at the administration for taking such “ridiculous measures” and “ruining his senior spring.” He has been looking forward to walking at graduation with his friends all year and now the school has made it “virtual.” To celebrate these last few days of school, he goes out to dinner with his roommates and is surprised when the restaurant is basically empty. He is convinced the chances he’ll get COVID-19 are miniscule--there’s only a few dozen cases in Boston--and even if he does, he’ll be asymptomatic. People are overreacting, he thinks to himself. It’s just a bad cold, right?

He puts on a brave face, but inside he is really concerned. He doesn’t have a place to live after graduation and was planning on staying with his grandmother, Diane, until he earned enough money to pay rent. Now he’s being told he can’t move in with her because of the dangers he may pose to her. On top of that, he has no earnings, student debt, and a post-grad job that is on indefinite hold.&#x20;

The next day, he notices that a few people have commented on his insta-story from last night at dinner with his friends, reprimanding him for being irresponsible and not “socially distancing.” Brian feels like they are acting holier-than-thou and is frustrated that they don’t understand everything he is going through right now.&#x20;

## Case 2: Diane

Diane is a 72 year-old woman who has COPD, heart failure, depression, and anxiety. She’s proud to live on her own in an independent living facility for the elderly in the middle of the city. She was planning on housing her grandson, Brian, after graduation from college until he could find a place to live but she doesn’t think that is a good idea anymore given everything that is going on with the coronavirus madness. Over the last few weeks, she’s watched the news carefully, becoming more and more alarmed as the case numbers are rising. In particular, she’s heard that people who are older and have other health conditions are more at risk, and she is reminded of her late husband, who passed away last year of complications from the flu. Making things worse are her concerned children, who live across the country.  They call her and plead that she isolate herself at home. But she can’t--she doesn’t have any help, so Diane walks to her local supermarket to stock her pantry and purchase what she has heard to be necessities, including cleaning wipes, masks, and soap. At the store, her heart pounds. The home supply shelf is completely empty.


# One-Page Summaries

Click the links below to view downloadable one-page summaries of each module:

[**Module 1: From Bench to Bedside**](https://docs.google.com/document/d/1wf66ssePqEXIfnxUQ_wXs7kpVar4XufOkjO4wk-q9lU/edit?usp=sharing)

[**Module 2: Epidemiology Principles**](https://docs.google.com/document/d/1pmXGlyV5tl2Yp81bMPMk8S0wgVL1SM6p7wxqN6Pey1Q/edit?usp=sharing)

[**Module 3: Health Disparities, Policy Changes, and Socioeconomic Effects in the U.S.**](https://docs.google.com/document/d/1m9sB3OwzAE560a3GOL65RVfFR_gQu85ZpulziU1RCdc/edit#heading=h.9dyolvmurlmw)

[**Module 4: Mental Health in the Time of COVID-19**](https://docs.google.com/document/d/1jxKDUbcL1w-Tl9HaY2nYQDNx3XLaEhKjo0PtBBkCeNQ/edit)

[**Module 5: Communicating Information about COVID-19**](https://docs.google.com/document/d/1QM3Xr9yIl3k7thI4d7EnC4_5zGpwjRnJZj7gZBSJbPY/edit?usp=sharing)

[**Module 6: Training for Potential Clinical Roles**](https://docs.google.com/document/d/1H87Re6p_V7_sIyPZqTRYYJa5Bns-gptcyH4AvuXByqo/edit?usp=sharing)

[**Module 7: Global Innovation and Collaboration**](https://docs.google.com/document/d/1eHf-hKwMDfHbeYogaLEgRoVa6aJrpEagspV8PsIFwDQ/edit?usp=sharing)

[**Module 8: Medical Ethics in Relation to COVID-19**](https://docs.google.com/document/d/13LjR_iFNy1O2uL7w9zZNPrTseOkr9E62Gn83xBqSF7s/edit?usp=sharing)


# About Us

## Our Mission

We provide educational materials on the COVID-19 pandemic for medical students, by medical students, so that we and students around the world feel empowered to address the pandemic as budding clinicians, scientists, communicators, and human beings.

## Our Goals

To share accurate, cohesive and contextualized educational material about COVID-19 to medical students

To serve as a structured curriculum with objectives, thought questions, and assessments that can be used in educational settings&#x20;

To challenge medical students to identify and address gaps in knowledge, as well as think critically about difficult situations they may encounter

To provide an opportunity for medical students to engage in medical education and curriculum development.

## Our Values

* Innovation
* Communication
* Collaboration
* Lifelong Learning

## Curriculum Leadership

You can reach all three co-chairs at [medicalstudentcovidcurriculum@gmail.com](/). Feel free to address specific concerns to an individual co-chair as you would like.

Co-Chair for Content Creation: Kendall Carpenter

Co-Chair for Outreach: Abby Schiff

Co-Chair for Development: Katie Shaffer

Former Chair and Founder: Michael Kochis, MD, M.Ed.


# Translations

COVID-19 Curriculum has gone global!

## Introduction

Since the creation of the curriculum, we have been fortunate enough to receive numerous requests to translate it into other languages.  We are delighted to work with collaborators from different countries to expand our materials' educational reach.  We are especially grateful for our colleagues at [Oli Health Magazine](https://www.olihealthmagazine.com/covid19/homepage) who have contributed a number of these translations.

## Disclaimer

Please note that while all possible effort has been made to ensure the accuracy of the information on this page, we currently do not have the capacity to verify the reliability of the translations which are represented on this page. If you have any suggestions, comments, or concerns, please contact the page managers Sayo Eweje or Hemen Muleta at <medicalstudentcovidcurriculum@gmail.com>.

## Translation Requests

If you are interested in translating any aspect of the COVID curriculum into a specific language, please fill out the form below to expedite communication and process your request.

[**Translation request form**](https://docs.google.com/forms/d/e/1FAIpQLSebf7oDeLzp90TmtM6ZIqq_y0QQeXgX1gUC1joDh76QkNQ7qQ/viewform)


# Currently Available Languages

Listed here are links to curriculum materials that are currently available in various languages. This page will be updated as we continue to receive additional translated materials from our collaborators.

## [Amharic](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/amharic)

## [Arabic](/curriculum-translations/currently-available-languages/arabic)

## [Chichewa](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/chichewa)

## [Chinese](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/chinese)

## [Farsi](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/farsi)

## [French](/curriculum-translations/currently-available-languages/french)

## [Georgian](/curriculum-translations/currently-available-languages/georgian)

## [German](/curriculum-translations/currently-available-languages/german)

## [Greek](/curriculum-translations/currently-available-languages/greek)

## [Guinea Bissau-Creole](/curriculum-translations/currently-available-languages/creole)

## [Indonesian ](/curriculum-translations/currently-available-languages/indonesian)

## [Italian](/curriculum-translations/currently-available-languages/italian)

## [Kinyarwanda](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/kinyarwanda)

## [Krio](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/krio)

## [Nepali](/curriculum-translations/currently-available-languages/nepali)

## [Portuguese](/curriculum-translations/currently-available-languages/portuguese)&#x20;

## [Romanian](/curriculum-translations/currently-available-languages/romanian)

## [Russian](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/russian)

## [Serbian](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/serbian)

## [Spanish](/curriculum-translations/currently-available-languages/spanish)

## [Swahili](/curriculum-translations/currently-available-languages/kiswahili)

## [Tamil](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/tamil-1)

## [Thai](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/thai)

## [Tumbuka](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/tumbuka)

## [Turkish](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/turkish)

## [Urdu](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M9sB8RQ3YMI5-NrL5VM/curriculum-translations/currently-available-languages/urdu)

## [Vietnamese ](/curriculum-translations/currently-available-languages/vietnamese)


# Amharic

Translations courtesy of Aemon Berhane Fissha (<aemonberhane1@gmail.com>), Gebeyaw Addis Bezie (<gebeyawas2006@gmail.com>), Loza Admassu Kelemework (<lozaad2017@gmail.com>), Miraf Yeshaneh Tatere (<mirafmyyeshaneh@gmail.co>&#x6D;**),** and Yodit Yacob Arsano (<yodityacobarsano@gmail.com>) with Oli Health Magazine.

## [Module 1 Graphic Summary ](https://drive.google.com/file/d/11_A620OfL_Zays68PGroV1O8RPetzozi/view?usp=sharing)

## [Module 2 Graphic Summary ](https://drive.google.com/file/d/1GgUg_Z4wzBziOtbXG9E0JwOCW0Vocakq/view?usp=sharing)

## [Module 1 Summary ](https://drive.google.com/file/d/1H0fmnPXZQj9mQQ3Plw2ikutHUh2kKYad/view?usp=sharing)

## [Module 2 Summary ](https://drive.google.com/file/d/1H0fmnPXZQj9mQQ3Plw2ikutHUh2kKYad/view?usp=sharing)

## [Module 3 Summary ](https://drive.google.com/file/d/1jqRTa-WPlSQFuRPxoyv9S9K95G847v7g/view?usp=sharing)

## [Module 4 Summary ](https://drive.google.com/file/d/1TT2RYF-_vNhmYPrXo9LYXSD9FAWo1YAI/view?usp=sharing)

## [Module 5 Summary ](https://drive.google.com/file/d/11kyQKkFRMxDZyyDlBz-GNrHIoVtX2Wiq/view?usp=sharing)

## [Module 6 Summary ](https://drive.google.com/file/d/17ZUKf4nNNdYC9Fr2i5ysNJxHJYoS0fxy/view?usp=sharing)

## [Module 7 Summary ](https://drive.google.com/file/d/17ZUKf4nNNdYC9Fr2i5ysNJxHJYoS0fxy/view?usp=sharing)

## [Module 8 Summary](https://drive.google.com/file/d/1oSlJfyCUy2D1v7R3GoXB_Bxxu3KOnbAS/view?usp=sharing)


# Arabic

Translations courtesy of: Melissa Mhanna, Medical Student and Masters in Biological and Medical Sciences at Saint Joseph University of Beyrouth, Lebanon (<melissamhanna98@gmail.com>) with Oli Health Magazine -Updated 5/6/20-

## [Module 1 Summary ](https://docs.google.com/document/d/11q4gmPU1-R9LJgy7nU8nQLQPdzuhP7fx2GSXLGPKCdY/edit?usp=sharing)

## Module 1 Graphic Summary

![](/files/-M6fCjl5nekxotFnFc7-)

## [Module 2 Summary](https://docs.google.com/document/d/1VBJUoF2oHn-R3Y60H8v1rTXcKK7s66fNT9hszgI7j6k/edit?usp=sharing)

## Module 2 Graphic Summary

![](/files/-M6fCuxqKFcWhJZQWBl7)


# Chichewa

Translations courtesy of Kuleza John Lembi (johnlembi3\@gmail.com) with Oli Health Magazine.

## [Module 1 Summary ](https://drive.google.com/open?id=1pSBftqPHMe91yMGuRSAhSWyU-NR89kdR)

## [Module 2 Summary ](https://drive.google.com/open?id=1Ny_n8HkmnuoTG-dEy2HiW0TsouPm9RGj)

## [Module 3 Summary](https://drive.google.com/open?id=1h6oAMeZuX_HN3u9HlrNeMg-wZUWQ8Lt_)&#x20;

## [Module 4 Summary](https://drive.google.com/open?id=1PTFsnMOaJhBdhwKVX-1Nyr8B5W8qSa9Z)

## [Module 5 Summary ](https://drive.google.com/open?id=17ii4poThmbDnk0T2fJV0ioliVnzZCFuA)

## [Module 6 Summary](https://drive.google.com/open?id=1FoDTJ7frOOCVfWykjVK25xlhCJ6mHjdR)

## [Module 7 Summary ](https://drive.google.com/open?id=1SSyR0WJgMzvUGDl1ZSTdA4dcf0kWqfHI)


# Chinese

Translations courtesy of Chia Chi Chang (chichi-chang\@berkeley.edu) and George Ting (940322731\@qq.com) -Updated 5/20/20 -

## [Module 1](https://docs.google.com/document/d/1AXW14B4kC16OxqxrZidLof8wbGyMU9TVuW9CkFmwjes/edit?usp=sharing)

## [Module 2 ](https://docs.google.com/document/d/12i9JVOouHjg_Xa4X4ZRrKTSbFafglIAZUkDe_PNX9-E/edit?usp=sharing)

##


# Farsi

Translations courtesy of Katherine Bruch (katherine.bruch\@gmail.com).

## [Module 1 Graphic Summary](https://drive.google.com/open?id=1fpmLACYJ4w1ThR0FkxOQdtbD18xmTdwv)


# French

## [Module 1 Summary](https://docs.google.com/document/d/1bXq8N3CVxeqSie9j4GL8CChIbbtnlX95QZfiXmBNgYA/edit?usp=sharing)

Translation courtesy: Wendy Demouge, Medical Student Besançon's Medical University (<wendy.demouge@gmail.com>) -Updated 04/09/20-

## Module 2 Graphic Summary

![](/files/-M6fFlZ86M4VkdzZj07S)

Translations courtesy of: Wendy Demouge, Medical Student Besançon's Medical University (<wendy.demouge@gmail.com>) and Vincent Georges, SNIR student Jules Haag High School for Informatics and Networks Besançon, France (<georges.vincent4@laposte.net>) with Oli Health Magazine  -Updated 05/06/20-


# Georgian

## Module 1 Graphic Summary&#x20;

![Translations courtesy of: Tsotne Chitiashvili (tsotne@ucla.edu) -Updated 04/09/20-](/files/-M4a8b0K1L6_yMWa9BwH)


# German

Modules 1,3,5 translations courtesy of Katharine Baugmart (katharina.baumgart\@student.uni-tuebingen.de) -Updated 04/06/20-

## [Module 1 Summary ](https://docs.google.com/document/d/1q3p1THOSVLON8b7p4wTLIgPJ9J8m0BSo/edit#heading=h.gjdgxs)

Translations courtesy of Katharine Baugmart (<katharina.baumgart@student.uni-tuebingen.de>)

## [Module 2 Summary](https://docs.google.com/document/d/1xY503plnow7axD_HX7eFkuFx3PhtvGWia2jclynxxMk/edit?usp=sharing)

Translations courtesy of  Miriam Burger, MD,  Zurich Switzerland ([www.whis.uk](https://urldefense.proofpoint.com/v2/url?u=http-3A__www.whis.uk\&d=DwMFaQ\&c=WO-RGvefibhHBZq3fL85hQ\&r=1XAy0Fn4GMJc_8iApT9cDygkuWV_6aoDCrWrcgJ1BcI\&m=W4qgJhZsHB8veZBoAaIuQEy0biv9xIA0o2wYnkFszuU\&s=ePD_RIaZLbGCXWulUPVJuuXwE9xXCgmcimL9als-KD8\&e=) / <burger.miriam@icloud.com>) -Updated 05/02/20-

## Module 2 Graphic Summary

![Translations courtesy of  Miriam Burger, MD,  Zurich Switzerland](/files/-M6_Mv32QseKDs3EDaVP)

## [Module 3 Summary ](https://docs.google.com/document/d/145PnTqCj1cFBz_C9JPvubNGcR4WSTa22/edit?dls=true)

Translations courtesy of Katharine Baugmart (<katharina.baumgart@student.uni-tuebingen.de>)

## [Module 5 Summary ](https://docs.google.com/document/d/1il-KeG4mExUgzEMa-9nxPbEFispIqJY6/edit#heading=h.gjdgxs)

Translations courtesy of Katharine Baugmart (<katharina.baumgart@student.uni-tuebingen.de>)


# Greek

Translations courtesy of: Eirini Sapouni MD (iris13896\@gmail.com) and Efstathia Maria Sapouni,  University of Thessaly, Greece (efimarie\@gmail.com) with Oli Health Magazine -Updated 05/06/20-

## [Module 1 Summary ](https://drive.google.com/file/d/1i-xy7TrbMbtsl4kQPA4ijx1-BFF30_XD/view?usp=sharing)

## [Module 2 Summary](https://drive.google.com/file/d/1jj1T_aMUrwVodni6NNtw-9u0PYVJHvR4/view?usp=sharing)

## Module 1 Graphic Summary

![](/files/-M6fHuG7ezl_96y4JsSe)

## Module 2 Graphic Summary

![](/files/-M6fI3-rTUwTc0eH3KkW)


# Guinea Bissau - Creole

Translations on this page courtesy of Francisco José Lopes Júnior, Medical Student at Adnan Menderes University, Turkey (fcojoselopesjr1\@gmail.com) with Oli Health Magazine -Updated 5/6/20-

## Module 1 Graphic Summary

![](/files/-M6fE8z8kfIVC_nVjv6d)

## [Module 2 Summary](https://drive.google.com/file/d/19CbYCBmJT8iuyLhx-k9naN6Y2mCBu2OP/view?usp=sharing)

## Module 2 Graphic Summary

![](/files/-M6fEL73bjTlw3gHiKYd)


# Indonesian

All translations on this page courtesy of: Dr. Candrika Khairani (Candrika\_Khairani\@hms.harvard.edu) -Updated 04/09/20-

## [Module 1 Graphic Summary ](https://drive.google.com/drive/u/1/folders/1HmdxZX6IP0aLE8Yt96Fz2tcy4KCWqaXb)


# Italian

Translations on this page courtesy of: Eliana Cassano, Medical Student at the University of Salerno (elianacassano\@gmail.com) with Oli Health Magazine -Updates 05/06/20-

## [Module 1 Summary](https://drive.google.com/file/d/11-upmlJz6ympdDM6e1kabVtS3Cr1x5GO/view?usp=sharing)

## [Module 2 Summary](https://drive.google.com/file/d/1D1TUqXu_3-i-wZRwkXxRR-z4wxvF85yC/view?usp=sharing)

## Module 1 Graphic Summary

![](/files/-M6fJDpCjLMgOAcgGX8n)

## Module 2 Graphic Summary

![](/files/-M6fJPmvAKXkvrZdSWkP)


# Japanese

Japanese translation team leader: Ms. Akane Kajita, MPH, graduate student in health management at Keio University (<h18806ak@sfc.keio.ac.jp>)

Translators: Ms. Emi Hiraga, Dr. Takeshi Kimura, Ms. Kana Kawai.

Modules 1 and 2- translated by Ms. Akane Kajita

Module 4- translated by Ms.Emi Hiraga, undergraduate student at Keio University (<h.emi@keio.jp>)

Module 5- translated by Ms. Kana Kawai, undergraduate student at Keio University (<kana.kawai@keio.jp>)

Module 6-translated by Dr. Takeshi Kimura MD, DDS (<tkbrand@keio.jp>)

-Updated 08/30/20-

## Overview

![Module 1 Summary Japanese Translation](/files/-MFpHQ9an5atjA35OWGJ)

## Module 1

{% embed url="<https://drive.google.com/file/d/1_0lHr44sn8DUqp7WE8B7tF__UJMWxnuW/view>" %}

## Module 2

![Module 2 Summary Japanese Translation ](/files/-MFpI96agms4VKOUi8CQ)

## Module 4

{% embed url="<https://drive.google.com/file/d/1axW62VB3zS_QQpbgW5_jHItvboeSk7Td/view>" %}

{% embed url="<https://drive.google.com/file/d/1SgYFjneQMn7ddTt7u3UO2FdaTVXcanwD/view>" %}

{% embed url="<https://drive.google.com/file/d/1FY3-rKHJsTQ39gdo4_tO58ViD2Yn886K/view>" %}

{% embed url="<https://drive.google.com/file/d/1x8uN4J7hs7aSvX4gc7_RWJJy7o4ci67c/view>" %}

{% embed url="<https://drive.google.com/file/d/1TkT0QFJ9d5FtlWtwUHzVJYENVCm_RHY0/view>" %}

## Module 5

{% embed url="<https://drive.google.com/file/d/1I3_zfi5cHUpncmszigNhs7T9NK7ZomVf/view>" %}

## Module 6

{% embed url="<https://drive.google.com/file/d/1qe4dJB2HX9RIIQ6U2ZzAq3_ogzt3PGQD/view>" %}

{% embed url="<https://drive.google.com/file/d/1l588414UtU8hbsJ498znIVWjKUh2jCzg/view>" %}

{% embed url="<https://drive.google.com/file/d/1F6cv--TuK1zGE80dVeGJPtNjz9bJcTLr/view>" %}

{% embed url="<https://drive.google.com/file/d/1LgVSYuStevBmLwzfqq64alNTohHKUeTn/view>" %}

{% embed url="<https://drive.google.com/file/d/1v0emHeIvpkSnkmK3kPEaUcJvHeYstJ77/view>" %}

{% embed url="<https://drive.google.com/file/d/1PcFs0mu-1tkv7hMgCwcgQlz3QbxHQ0xT/view>" %}

{% embed url="<https://drive.google.com/file/d/1lqDQvuIFYgX-v_Mp2jNnH9D9L2BUCZYx/view>" %}

{% embed url="<https://drive.google.com/file/d/1V7rVArg0apzo3pukCGSWBjKOO4PlicND/view>" %}

{% embed url="<https://drive.google.com/file/d/1CFQMpfnBLFgD1wnlLTD4sdfXDVUdmIV6/view>" %}


# Kinyarwanda

Translations courtesy of Norbert Niyongira, RN (niyonorbert\@gmail.com) with Oli Health Magazine. -Updated 05/06/20-

## [Module 1](https://drive.google.com/file/d/1TsnbKa-hwSSNQLYh1fhGia26Hgtww2-l/view?usp=sharing)

## [Module 2](https://drive.google.com/file/d/1k3yFYbKTZHm06Xsihp5CZBxbfmYgDo0B/view?usp=sharing)


# Krio

Translations courtesy of Mohamed Lahai Samura Jr. (mosamura3\@gmail.com) with Oli Health Magazine.

## [Module 1 Graphic Summary ](https://drive.google.com/open?id=1WkRYrpDrVPC44toEP2n3kxG6YAngLimC)

## [Module 1 Summary ](https://drive.google.com/open?id=11JOV721hqjvZ-0XEPPbs1Hm1Pa9G9HJN)

## [Module 2 Graphic Summary ](https://drive.google.com/open?id=1yXbrvQNlWQcZnebLv5MuK16BObcm67We)

## [Module 2 Summary](https://drive.google.com/open?id=1TJHxOs2nViRORYeoHC3YvaqJioAO-u5t)&#x20;


# Nepali

All translations courtesy of Mandeep Guragai (mandeep.guragai\@gmail.com) Updated 04/16/20

## [Module 1 Graphic Summary](https://drive.google.com/file/d/1fxQyCulAMx7gB_9D45ig_4IVn7oDuQTD/view?usp=sharing)

## [Module 2 Graphic Summary](https://drive.google.com/drive/u/1/folders/1yjN8h_uwDkEzUzb8ToLteFzgXu86bGy1)

## [Module 1 Summary](https://docs.google.com/document/d/1qnSyYAyJXe1pTjbmkLN5ua7vNaD-ChmItgTXPp2t-ns/edit?usp=sharing)

## [Module 2 Summary](https://docs.google.com/document/d/1MvR5I51TywfqowgDIv1U7lFguHp1pnwIq7cvxFcrIro/edit)

##


# Portuguese

All translations on this page courtesy of: Luis Freitas (luiscardosofreitas\@gmail.com),  Paula Ando (paulakaoria\@gmail.com) and Jose Almeida (josegui05\@gmail.com) - Updated 04/28/20 -

## Module 1 Graphic Summary&#x20;

![](/files/-M66SH6CV3Mw2cbu-WMF)

## Module 2 Graphic Summary&#x20;

![](/files/-M66SNJnrCfdY1t2yvoe)

## [Module 1 Summary ](https://docs.google.com/document/d/1_g856Mou54cPFvj2aaQYugoDChB9nrNLgED3PtGs4KM/edit)

## [Module 2 Summary ](https://docs.google.com/document/d/1sBqOoX_JEEh9d9ODNX02mXUGRAy7bskm8DuCHFmkOuY/edit)

## [Module 3 Summary ](https://docs.google.com/document/d/1B6WSuHK-O9VhBfTAOq_rNuozugYDqNIzSGAfWEt1qX8/edit)

## [Module 4 Summary](https://docs.google.com/document/d/1_asOS7ReFUl7Yls72JET27pSZJvpMwd72xJSYMm38_U/edit)

## [Module 5 Summary ](https://docs.google.com/document/d/1eUkXU7U_-sW8a20a3ongZP3ACT3DyhoF_rXMWt9nGcI/edit)

## [Module 6 Summary](https://docs.google.com/document/d/1B3FECyswOUmpP4psnGd3xgjoPBQ5lrPRHG66EbWaWo0/edit)

## [Module 7 Summary](https://docs.google.com/document/d/1kGzUT5LL_aWh414KGFwNwWggebadaazQ_DxZyPPAS-g/edit)

## [Module 8 Summary](https://docs.google.com/document/d/1CFc24RdsSTVmB1f3TeaXel02yFzOHj_rI6xnkk5JSJ0/edit?usp=sharing)


# Romanian

Translations courtesy of: Alina Ioana Grosu(alinnagrosu\@gmail.com)             Updated 04/27/20

## Module 1 Graphic Summary

![](/files/-M661-kLBh9Ll9OYqsKY)

## Module 2 Graphic Summary

![](/files/-M661p_TP7OxX1m2Y_0i)


# Russian

Translations courtesy of Elina Rashitova (<elina.rashitova@gmail.com>); Anna Gerasimova (<Annager@inbox.ru>); Elnara Garaeva (<garaevaed@gmail.com>); Arina Zotova (<queenarin@yandex.ru>); Alfiia Zakirova (<azakirova@gmail.com>); Georgii Krivoshein (<g.kriwoshein@gmail.com>); Akhmadieva Liaisan (<lyaisan21099@gmail.com>); Arman Valitkhanov (<armanval7@gmail.com>);  Azam Lazizov (<azam.lazizov@gmail.com>) with Oli Health Maganize. -Updated 5/6/20-

## [Module 1 Summary](https://drive.google.com/file/d/1yAgDQpykytV9zDuHRoEM-B8zaVkZn1qc/view?usp=sharing)

## Module 1 Graphic Summary

![](/files/-M6ar51Ag-EzyT9T4tNk)

## [Module 2 Summary](https://drive.google.com/file/d/159KtIt3ljAUJ2sVkQVbKVL8xgD6N6wid/view?usp=sharing)

## Module 2 Graphic Summary

![](/files/-M6arB3aVwThqt32UVLR)

## [Module 3 Summary](https://drive.google.com/open?id=1p1FEah6fWmuqyyk9-ZOCgkAvVJJsKO4J)

## [Module 4 Summary](https://drive.google.com/open?id=1z8r_9CSzoQZ8nwj-HdbPv3TZq9_p2Stl)

## [Module 5 Summary](https://drive.google.com/open?id=1cjetrJLagfLb5tgIOCpEUBVjQb7RBkTY)

## [Module 6 Summary](https://drive.google.com/open?id=1gVQvjf66Mcioo21iSSs5W-hDyV7Tw3_9)

## [Module 7 Summary](https://drive.google.com/open?id=1TqfGMKfDq6ZNAIxa14E17QjSsREYkVVR)

## [Module 8 Summary](https://drive.google.com/open?id=1464xlZqfH0END3OoxAq13kunMFp72L1y)


# Serbian

Translations courtesy of Erna Topalović, Medical Student at Ankara Yıldırım Beyazit University (ernatopalovic\@gmail.com) with Oli Health Magazine. -Updated 5/6/20-

## Module 1 Graphic Summary

![](/files/-M6asUEQi6NUfUkEQUfL)

## [Module 1 Summary](https://drive.google.com/file/d/1LpURyFhzbWxrd9-YNZtuKUAQl1baALKt/view?usp=sharing)

## Module 2 Graphic Summary&#x20;

![](/files/-M6asaud4c7yf-dRn-bx)

## [Module 2 Summary](https://drive.google.com/file/d/1f5ndpD1M4ocdZ_GsU8E2DCDKKrPCxG2d/view?usp=sharing)


# Spanish

### Module 1 Graphic Summary

![Translations courtesy of: Vasti Thamara Juárez González (vasti.juarez.gonzalez@gmail.com) - Updated 04/10/20 - ](/files/-M4Wo1vDlJz_9VPrJU3J)

## Module 2 Graphic Summary

![Translations courtesy of: Vasti Thamara Juárez González (vasti.juarez.gonzalez@gmail.com) - Updated 04/10/20 - ](/files/-M4iiQk6XoVrXm9RAZOq)

## [Modules 1-2 ](https://drive.google.com/drive/u/3/folders/1I28wCuFsVDXmY8APdFlKLjl2G9NELQ1w)

Translations courtesy of : Lorena Tora, M.D., M. Fragoso, L. Salgado, & A. Cortés, Mitosis COVID19 response (<lorena@mitosishealth.org>)                                                  - Updated 05/3/20 -&#x20;

## [Module 6 Summary ](https://docs.google.com/document/d/1VLkEOt18zKEusdKWnzOgx7Mp17vb867Y5_W3qNNEip4/edit?usp=sharing)

Translations courtesy of: Eva Fuentes, MD & Jorge Buendia-Buendia, MPhil, MS (<eva.fuentes.terrazas@gmail.com> & <job496@mail.harvard.edu>)                                   - Updated 04/19/20 -&#x20;

####


# Swahili

Translations on this page courtesy of Kalipa Kisuse (<mesh.r@hotmail.com>), Joshua Tadayo (<joshuatadayo@gmail.com>) (with Oli Health Magazine) - Updated 05/06/20 -

## [Module 1 Summary](https://drive.google.com/file/d/1wnu7beKdXiYNkmmRdagzV7RdhMd1JXra/view?usp=sharing)

## Module 1 Graphic Summary&#x20;

![](/files/-M4g3D-pVoR8jbIygeHx)

## [Module 2 Summary](https://drive.google.com/file/d/1YNYevnzNWZbgQwJwOkAddU-u3tl0ZEZX/view?usp=sharing)

## Module 2 Graphic Summary

![](/files/-M73-g6JCk7ZkfLrGhca)


# Tamil

Translations courtesy of Shafeeq Ur Rahman (shafeeqdon20\@gmail.com).

## [Module 1 Summary ](https://docs.google.com/document/d/1pWZcRlrQwr-B10ynnGRNS-Jnz9SEYta1Sh7Zqafqtcc/edit?usp=sharing)

## [Module 2 Summary ](https://docs.google.com/document/d/1KZiUY337ZzqGFjuv8TG371T2qov7Pe0QwUQ66KriN40/edit?usp=sharing)

## [Module 3 Summary](https://docs.google.com/document/d/1lcgfFBnHsY4slvmpvypt-4Vh5wSG4aJ8J709efckKkQ/edit?usp=sharing)&#x20;


# Thai

Translations courtesy of Chayada Kasirawat (chayada.kas\@gmail.com) and Thachapon Thepchinda (Sthachapon\@gmail.com) with Oli Health Magazine. -Updated 5/6/20-

## Module 1 Graphic Summary

![](/files/-M6atfCCOieKkWtprKoH)

## [Module 1 Summary ](https://drive.google.com/file/d/1WnZnlWE9c0J-HFZTcL4cUvZMHplXBnB9/view?usp=sharing)

## Module 2 Graphic Summary&#x20;

![](/files/-M6atj50oSP4bS3MRaW7)

## [Module 2 Summary ](https://drive.google.com/file/d/1cAcp_kaUudv564qbXx8bcwj8rcz1213Y/view?usp=sharing)


# Tumbuka

Translations courtesy of Lubanga Focus Adriano (lubangafocusadriano\@gmail.com) with Oli Health Magazine.

## [Module 1 Graphic Summary ](https://drive.google.com/open?id=1JkrM6_Tr4msHbXKXLsAD_KjrbYQE8ogl)

## [Module 1 Summary](https://drive.google.com/open?id=1oQABVVJOLa0JwBwWrXA0M_xawX0XLsaE)&#x20;

## [Module 2 Graphic Summary ](https://drive.google.com/open?id=1u-M80gFy8J6z0jrJTimTq7w-S2eE_kP3)

## [Module 2 Summary](https://drive.google.com/open?id=1QkQn9FWf0rfAvJPCy-DoAcI8HiYUe3dn)&#x20;

## [Module 3 Summary](https://drive.google.com/open?id=1Necz3smt3Ke2a48bKaL8YqiVD3mX2PvN)&#x20;

## [Module 4 Summary](https://drive.google.com/open?id=1f_-Y1LU5rN911njTAog7BqPh-6Ylw7rU)

## [Module 5 Summary ](https://drive.google.com/open?id=13-o-X-M1ZYwzN--GUEVsf8TD8tblx9pY)

## [Module 6 Summary ](https://drive.google.com/open?id=1fTRCMMMmJFey4YV_khSiSazMCeR59Zhp)

## [Module 7 Summary](https://drive.google.com/open?id=1c0gfkZsvhnpcRY8BpvxaSNxX15N9gbUS)&#x20;


# Turkish

Translations courtesy of Uğurcan Özaydin (<ugurcan.ozaydin@gazi.edu.tr>), Esin SÜLÜN (<esin.sulun@gazi.edu.tr>), Hacer Alkan (<hacer.alkan@gazi.edu.tr>), and Cansu Tokat (<tokatcansu@outlook.com>) with Oli Health Magazine.

## Module 1 Graphic Summary

![](/files/-M6autZVCwhwYsi9g9Sk)

## [Module 1 Summary ](https://drive.google.com/file/d/1jXh6S9Jp_SxFu1eU5ad-sqTi-PyBqKET/view?usp=sharing)

## Module 2 Graphic Summary&#x20;

![](/files/-M6auvBlIxYEUmRym_dB)

## [Module 2 Summary](https://drive.google.com/open?id=1kreTNVbkz30D8njAdB0D-Zjqw5ASPYqX)&#x20;

## [Module 3 Summary](https://drive.google.com/open?id=1mkiYsoePrPqZEf_vmVA10Xaq81irnNaF)&#x20;

## [Module 4 Summary ](https://drive.google.com/open?id=1o1vmQ-cvTfQf0XtE58FGz082CjFl7Kxm)

## [Module 5 Summary ](https://drive.google.com/open?id=1c2QyzX-L8R5fQ38Xgnp08O1kOeV6AkGJ)

## [Module 6 Summary](https://drive.google.com/open?id=1YXq783USRaeP7h-ngUyGdELjV7RnhA3z)&#x20;

## [Module 7 Summary](https://drive.google.com/open?id=1URPmOCbqNdSSGTlpbttFEKdnm5TIQhJ9)&#x20;

## [Module 8 Summary ](https://drive.google.com/open?id=16fcjo1IC-hkBI6lxtMDOYwZAro6Oif9g)


# Urdu

Translations courtesy of Bilal Zafar, MD (zafarbilal575\@gmail.com) and Mishal Shan (mishalshansiddiqui\@gmail.com) with Oli Health Magazine. -Updated 5/6/20-

## Module 1 Graphic Summary&#x20;

![](/files/-M6aw4zUCp3capaU8a6k)

## [Module 1 Summary ](https://drive.google.com/file/d/1bS4dFDdT5XrUU1V10a_6Ujy6MQOn4gzs/view?usp=sharing)

## Module 2 Graphic Summary&#x20;

![](/files/-M6aw6u6_cdnjYxFGJEn)

## [Module 2 Summary](https://drive.google.com/file/d/1rNwwrMHjXDuvb7VamcalGlC2l4T5WbjO/view?usp=sharing)


# Vietnamese

> Tất cả các bản dịch trên trang này là đóng góp của một nhóm sinh viên Việt Nam. Vui lòng gửi các câu hỏi và đóng góp về dịch thuật tới <covid19-vn-translation-team@googlegroups.com>. Cho các vấn đề khác, vui lòng liên hệ Phương Phạm (<phuongpm241@gmail.com>) hoặc Trinh Nguyễn (<trinh.thd.nguyen@gmail.com>).                                                                                         - Updated 04/12/20 -&#x20;

## [Modules 1 - 4](https://docs.google.com/document/d/1xVI556Gb9hP94iAOOr0tMlJaq_wLGd3Z6E6sdtSNLkI/edit#)

## [Module 1](https://docs.google.com/document/d/1D1FcPXCFr0rZYVQKcRnvg3f0QBX4wyHCcqLf4mz5Pfo/edit)

## [Module 2](https://docs.google.com/document/d/1HpMj5NKkqwyiRs2m_W0zPW8QBnI4Hu-6Ga8OSB3z2wk/edit)

## [Module 3](https://docs.google.com/document/d/1RFvaxOaAAV_XvJ7oWCVihgJ6hAQ8x2rOVZ-902MUd-Q/edit)

## [Module 4](https://docs.google.com/document/d/12xKDXAuQMLIz6mp6k1-Qdi1xwTDt2wy8fvzbFo4PVcQ/edit)

## [Module 5](https://docs.google.com/document/d/12xKDXAuQMLIz6mp6k1-Qdi1xwTDt2wy8fvzbFo4PVcQ/edit?usp=sharing)

## [Module 6](https://docs.google.com/document/d/1Gf1hzCJx7ud83UDZVWaKk_hfnEXbD4d7PvUl9Du4AHo/edit?usp=sharing)

## [Module 7](https://docs.google.com/document/d/1OGVl0FBWIHlP5Z0pXLp0twGTMURc36AVr6RzV1JHN-Y/edit?usp=sharing)

## [Module 8](https://docs.google.com/document/d/1C0LFzRUwOL2Q5DJg7MpF6k8tkRmX9VSC3PekvHq3O3Q/edit?usp=sharing)


# Module 1: From Bench to Bedside

Evaluate how the emerging understanding of COVID-19 pathophysiology translates to evolving diagnosis, treatment, and prevention efforts

*Authors:* Adi Achanta; Stephanie Alden; Pamela Chen; Ziqi Chen; Sunny Chung; Ayooluwa Douglas; Jack Ghannam; Nicole M. Gilette; Jasmin Joseph-Chazan; Ashwini Joshi; Pinky Langat, PhD; Rebecca Larson; Yuzhong Jeff Meng, PhD; Adam Nitido; Blake Oberfeld; Jordan Said; Suparna Kumar; Rifat Rahman; Simone Sasse; Abigail Schiff, PhD; Allen Zhou

*Editor:* [Kendall Carpenter](mailto:kendall_carpenter@hms.harvard.edu)

*Reviewers:* Gaurav Gaiha, MD, PhD; Daniel Solomon, MD; Shiv Pillai, MD, PhD

**Update Disclaimer:** Thank you for visiting Module 1! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. Information on the last major update on 6/9/21 can be found below. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

**Highlight of Last Updates (6/9/21):**

* Discussion of therapeutic options for [ambulatory patients ](/module-1-from-bench-to-bedside/management-of-covid-19#if-mildly-ill)based on IDSA recommendations
* Updated [dexamethasone](/module-1-from-bench-to-bedside/management-of-covid-19#treatment) treatment data
* Discussion of [Baricitinib and Remdesivir](/module-1-from-bench-to-bedside/management-of-covid-19#treatment)
* Revamped [Investigational Therapeutics](/module-1-from-bench-to-bedside/investigational-therapeutics-and-vaccine-development#investigational-therapeutics) section with curated resources for up-to-date information about COVID-19 therapeutics

The Coronavirus Disease 2019 (COVID-19) pandemic has had massive, overarching ramifications for our global population. This is an unprecedented time for our healthcare system, and as medical trainees ourselves, we felt an obligation to synthesize the growing literature and educate our peers.&#x20;

This first module, written by students for students, is designed to walk you through the disease characteristics of COVID-19, including the basic virology of SARS-CoV-2 (the etiologic agent of COVID-19) and clinical knowledge to date. We hope that a deeper understanding of the pathophysiology of the virus, including its structure, transmission, and host immune defenses, will allow you to critically engage with evolving diagnosis, treatment, and prevention efforts. Throughout, we will highlight areas of ongoing investigation and innovation, from bench to bedside. We expect that this module will take 2.5-3 hours to complete.

## Learning Objectives

At the end of this module, medical students should be able to:

* Relate the basic virology of SARS-CoV-2 to evolving COVID-19 diagnosis and prevention approaches
* Translate knowledge of the host immune response against SARS-CoV-2 to COVID-19 risk stratification, treatment, and vaccine strategies
* Build a differential diagnosis for COVID-19 using its typical clinical manifestations, laboratory, and imaging findings&#x20;
* Evaluate current triage and treatment recommendations for COVID-19, stratified by disease severity
* Appreciate how COVID-19 pathophysiology underlies ongoing research into investigational therapeutics and vaccines


# Basic Virology and Immunology

## **Basic Virology**

### **Introduction**

In December 2019, a series of cases of pneumonia of unknown origin were [reported](https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/) in Wuhan, the capital city of Hubei province in China. The causative virus was isolated and characterized in January 2020 ([Zhou et al., Nature 2020](https://www.nature.com/articles/s41586-020-2012-7), [Zhu et al., NEJM 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001017?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)). On January 12, 2020, the World Health Organization (WHO) tentatively named the virus as the 2019 novel coronavirus (2019-nCoV). On January 30, 2020 WHO issued a public health emergency of international concern (PHEIC) and on February 11, 2020, the WHO formally named the disease caused by the novel coronavirus as coronavirus disease 2019 (COVID-19). At that time, based on its genetic relatedness to known coronaviruses and established classification system, the International Committee on Taxonomy of Viruses [classified and renamed](https://www.nature.com/articles/s41564-020-0695-z) 2019-nCoV as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On March 11, 2020, the [WHO formally characterized](https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen) the global spread of COVID-19 as a pandemic, the first to be caused by a coronavirus.&#x20;

![](https://lh6.googleusercontent.com/SO7HSWJKEv2AOcasEyXd-q8q8M8idevuSURG0ftz0AiMfPJGLt9M29sS_ScSGgqG7-Meh4Uo97Vh-wlapgdFgzdfE0sqgmyi8iz5eiy1l-hieb2jjy2p4MUpPD0uzeteEa3WY4XS)

Key events in the early COVID-19 pandemic, based on data from World Health Organization situation reports. From [Wiersinga et al., JAMA, 7/10/2020](https://jamanetwork.com/journals/jama/fullarticle/2768391).

### **Classification**

Coronaviruses are positive-sense, single-stranded enveloped RNA viruses with helical capsids that infect a wide range of hosts including humans, bats, other mammals, and birds. As shown in the schematic taxonomy below, coronaviruses are [classified](https://www.nature.com/articles/s41564-020-0695-z) within the order Nidovirales and are further subclassified into four genera: alpha, beta, delta, and gamma coronaviruses, of which alpha and beta coronaviruses are known to infect humans. As a family, coronaviruses most prominently include several human coronaviruses (HCoV) that are associated with lower pathogenicity (HCoV-229E, -NL63, -OC43, -HKU-1), contributing to seasonal cases of the ‘common cold’ and sometimes linked to more severe respiratory illness ([Bradburne et al., BMJ 1967](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1843247/?page=1); [Lieberman et al., Chest 2010](https://journal.chestnet.org/article/S0012-3692\(10\)60526-0/fulltext)). Two betacoronaviruses have previously been identified to cause more severe disease and outbreaks: severe acute respiratory syndrome coronavirus (SARS-CoV), responsible for the SARS worldwide outbreak in 2002-3 with 8,096 cases and 774 deaths [reported](https://www.who.int/csr/sars/country/table2004_04_21/en/), and Middle East respiratory syndrome coronavirus (MERS-CoV), responsible for 2,102 cases and 780 deaths [reported](https://www.who.int/emergencies/mers-cov/en/) during the 2012 MERS outbreak. SARS-CoV-2 falls within the Sarbecovirus subgenus of the Betacoronavirus genus along with SARS-CoV, and is the seventh coronavirus identified to infect humans ([Zhou et al., Nature 2020](https://www.nature.com/articles/s41586-020-2012-7), [Zhu et al., NEJM 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001017?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)).

![Schematic of the taxonomy of Coronaviridae family of viruses as per ICTV classification, highlighting coronaviruses known to infect humans. From Pillaiyar et al., Drug Discovery Today, 2020.](https://lh5.googleusercontent.com/WgOZJZPiTRXr0ScNg4mmP0_B9EMBeounaQDnj4Z6uiNJZNZduXs9epnlEoP_xWt8CFHzWsdnGuPWXKS_RR4dWX7_aE1dcYc4aZdiAfiTnLYNj4C0lSIaLbsWWgHcV0KeLKWEcjQn)

![Schematic of Baltimore classification scheme based on type of genome and replication for virus families (text in blue), highlighting SARS-CoV-2 and select virus families with viruses (influenza virus, rhinovirus) known to cause common human respiratory infections. Adapted from Collier, Oxford, Kellam, Human Virology 5e 2016. ](https://lh3.googleusercontent.com/sBThmvmgHvLBa1taTVxyJH3hZ8Jv8T8xnNIIxW2mI5zTbmag33wtVc7uRdpN9b8sqq2zpkjbPTKdudcmJTxfUOI35KmMwtzaqEH2SNHWhJlSNZxtPUk_tUcXXlIQE5ZmatkhpZNv)

### Genome

Coronaviruses have the largest genome of all ribonucleic acid (RNA) viruses infecting humans, consisting of a positive-sense single-stranded RNA roughly 30 kb in size that is 5’-capped and 3’-polyadenylated. Shown in the figure below, the virus genome is non-segmented with as many as 14 open reading frames ([Zhu et al., NEJM 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001017?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)). The genome is organized with non-structural polyproteins, which are then cleaved to be enzymes such as proteases and a RNA-dependent RNA polymerase, encoded at the 5’ end and structural proteins encoded toward the 3’ end.

![SARS-CoV-2 genomic organization and encoded proteins (Lu et al., Lancet 2020; genome assembly data). Figure from Gordon et al., Nature 2020. ](https://lh6.googleusercontent.com/-JqR2cdd3QBkm5FTYoSEF6DUW3UpiA6iE-JnpAJNvGERIyYtwR7mNWCu95gU37haRTHXHsL3YMoxyzSRRY3YbSHGqRqH2kv8ZcdS2bTFyAuqFzo_mqr8tGrBfTQouP58nHhebhyk)

### **Genetic analyses: relatedness to other viruses, suspected origins, and continued surveillance**

The majority of new coronaviruses have been isolated from bats, which serve as a natural reservoir, though other animal species have been linked as intermediate hosts in the transmission to humans, such as the palm civet and racoon dogs for SARS-CoV ([Guan et al., Science 2003](https://science.sciencemag.org/content/302/5643/276)) and dromedary camel for MERS-CoV ([Chu et al., Emerg Infect Dis 2014](https://wwwnc.cdc.gov/eid/article/20/6/14-0299_article)). Currently, the closest identified relative to SARS-CoV-2 is a virus isolated in bats with 96% sequence identity ([Zhou et al., Nature 2020](https://www.nature.com/articles/s41586-020-2012-7)). It is suspected that an intermediate host may have facilitated the zoonotic event, given both overall limited interactions between bats and humans and also the initial cluster of cases which were epidemiologically linked to a live animal and seafood market in Wuhan. Among a large variety of animals present, the pangolin, a scaly anteater and commonly trafficked mammal, has been implicated as a potential intermediate host, based on high levels of similarity of pangolin coronaviruses to SARS-CoV-2 at the protein level (Lam et al., [Nature 2020](https://www.nature.com/articles/s41586-020-2169-0)). However, full genome analysis of pangolin coronaviruses have appeared more distinct, suggesting that other market animals may have been the intermediate host between bats and humans ([Lu et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30251-8/fulltext); [Zhang et al. Clin Infect Dis 2020](https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa112/5721420)). High levels of recombination among Sarbecoviruses and the large, unsampled diversity of coronaviruses in bats and other animals contribute to the challenge of identifying the origins of SARS-CoV-2 ([Boni et al., Nature Microbiology 2020](https://www.nature.com/articles/s41564-020-0771-4)).\
\
Continued sequencing and real-time analysis of SARS-CoV-2 genomes from samples around the world have helped track global spread, monitor local outbreaks and transmission chains, and provide insights into the epidemiology of COVID-19 ([nextstrain.org](https://nextstrain.org/narratives/ncov/sit-rep/2020-03-20?n=1)).  For more information about how to read phylogenetic trees, see [here](https://nextstrain.org/narratives/trees-background/?n=1).<br>

![Phylogeny showing the genetic relationship of betacoronaviruses, including novel coronavirus SARS-CoV-2 isolates from Wuhan (red) to SARS-CoV and MERS-CoV (blue). The closest related virus to SARS-CoV-2 was isolated from bats (Lu et al., Lancet 2020).](https://lh5.googleusercontent.com/z6OF_354gRaUOjumotiZ94Jh3nCT4TYrDhMVqZ5v0l4ZHi91Gf5SCTi_fQVpmCNIjA3xoE87oIRG1fyv9R5oO1CHPABhyZGzB7cHr_8XMfHPcQeWr8pg3k2xaCU8dgRKwomJPr6t)

![Phylogeny showing relatedness of ‘SARS-like’ betacoronaviruses (‘Sarbecovirus’ subgenus from previous figure) to select SARS-CoV-2 samples isolated from China, USA, and Japan. Each circle ‘tip’ of the phylogenetic tree represents a virus sample, color coded by type of host. From nextstrain.](https://lh3.googleusercontent.com/Qq6oBB8jFOWxaJVia1WutqFP96pE8gNH0gsH2HZACeYvAb0XY6iiUgYPONnF7RseiooI1znQ6yHw2Z15dq9IHpgkliLddGSpvNLQviSlRscqpcFqud4tn_diaD8uoT00KuU891t-)

*Thought questions:*

* Based on the phylogeny, would you expect SARS-CoV-2 to behave more like SARS-CoV or MERS-CoV?
* What are some benefits and drawbacks of analyzing specific genes compared to the whole genome of a virus?
* How might understanding the origin and intermediate hosts of a virus influence human practices and policies to prevent zoonotic viruses from seeding new epidemics?

### Virus structure

Microscopically and as seen in the schematic figure below, coronaviruses have club-shaped trimeric surface spike glycoproteins that give the virions the appearance of a crown, hence their name (from the Latin corona meaning “crown”). Summarized in the table below, coronaviruses contain four major structural proteins: the spike (S), hemagglutinin-esterase (HE) in some betacoronaviruses, membrane (M), and envelope (E) all located on the membrane envelope, and the nucleocapsid (N) protein found in the core. The N proteins associate with the RNA genome to form a long helical ribonucleoprotein (RNP) packaged within the enveloped virus particle. The M protein, the most abundant of the structural proteins, is a transmembrane glycoprotein that gives the envelope its shape. The M protein embedded in the host membrane interacts with the N protein coating the viral RNA and thus helps assembly of enveloped virions. It serves as a “bridge” between the nucleocapsid and the other integral membrane proteins of the virus. The E protein is thought to be critical for coronavirus infectivity.

![Structural proteins of coronaviruses and their functions. Summarized from Fields, Knipe, Howley, Fields Virology 6e 2013.](https://lh3.googleusercontent.com/iORmhConwyP38xPQFE8kHJQ9FNYD8lVMq-qBPsJ-HjIvIuta7F6sjkthKgQsN1Wbps_LJC8PGcBxYSVghrKIUEAwExUflQsgMyagzP8ODko_C8cI0sH6NaszOEv5x1NHxaCK5GcA)

![Coronavirus structure. Schematic showing major structural proteins of the coronavirus virion. From AMBOSS.](https://lh5.googleusercontent.com/gv1AbsHNgLLI_3lQ_TwaCKj4RXI_3yABku8su04LXXiZ0vt7mnGJd0JbtUXyukZzlFhuJAZttygoPMyG2dJNxz5OmQxqT51O1ykxxErw7Qa360_e-2-OwQ0wJMz5tnxSlDZ--mXz)

The S surface protein plays key roles in the viral life cycle and in host defense: it is responsible for receptor binding, host range, membrane fusion, hemagglutinin activity, and is a target for eliciting host neutralizing antibodies ([Millet & Whittaker, Virus Res 2015](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4465284/)). SARS-CoV-2 has genetic polymorphisms in the S protein that distinguish it from SARS- and MERS-CoV. This different spike protein structure has been suggested to allow activation by furin, a host-cell enzyme found in many human tissues including lungs, liver, and small intestines ([Andersen et al., Nature 2020](https://www.nature.com/articles/s41591-020-0820-9)). Thus, the potential for furin activation in SARS-CoV-2 may explain its expanded cellular tropism ([Walls et al., Cell 2020](https://www.cell.com/cell/fulltext/S0092-8674\(20\)30262-2?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0092867420302622%3Fshowall%3Dtrue)), which may contribute to the manifestation of liver injury with COVID-19 ([Zhang et al., The Lancet 2020](https://www.thelancet.com/journals/langas/article/PIIS2468-1253\(20\)30057-1/fulltext)).

![](https://lh6.googleusercontent.com/2cNVGAAqj1nNtqPGz2fViD3p92bbXRuaYXwfiVCNXuYQWgAPzgproSkyFRczTY2D5SaRueuZluXWCHV56MnqaPfeyKrStxG8FQ58CYKmJAi5m6u0wgPQtPV0MGWlCAu4LuT4PBUn)

![Alignment of amino acid sequences highlights differences between SARS-CoV-2 to SARS-like coronaviruses and SARS-CoV in spike protein residues important for (a) receptor-binding and (b) polybasic cleavage site for potential furin activation. Figure modified from Andersen et al., Nature 2020.](https://lh3.googleusercontent.com/XFJ6bOvTF7p5mnvjdHs-UjTPM1xhuloFCd1fAGKkUxvtHQ3ZUSOVQfDmWeSy_gk7Stp6eUF8lo9_fk7Ttw8YshPI348TvG_yn7OYbmDa2nR4wOSMwdUReFsT1RdTRjbMu-vHz03N)

*Thought questions:*

* How could the specific proteins (S, E, M, and N) on SARS-CoV-2 be useful targets for diagnosis? For treatment? What technologies or molecular diagnostics/therapeutics would be useful?

## **Pathogenesis of COVID-19 Infection**&#x20;

Research is ongoing to characterize the pathogenesis of how SARS-CoV-2 results in COVID-19 disease in humans. Below is our current understanding of the literature.

**Viral entry**

SARS-CoV-2 enters host cells through interacting with ACE2, an interferon-induced gene expressed on type 2 pneumocytes, intestinal epithelial cells, nasal goblet secretory cells ([Ziegler et al., Cell 2020](https://www.sciencedirect.com/science/article/pii/S0092867420305006)), olfactory epithelial support cells and stem cells, and nasal respiratory epithelium ([Brann et al. Science Advances 2020](https://advances.sciencemag.org/content/6/31/eabc5801)). Although SARS-CoV-2 has been found inside GI epithelial cells ([Xiao et al., Gastroenterology 2020](https://www.gastrojournal.org/article/S0016-5085\(20\)30282-1/pdf)), the virus mainly infects type 2 pneumocytes in the lung ([Zhu et al., NEJM 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001017?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)). Comprising 3% of the alveolar epithelium, type 2 pneumocytes secrete pulmonary surfactant (dipalmitoyl phosphatidylcholine), which decreases the surface tension of the lungs, and also act as stem cells for the alveolar epithelium.\
\
ACE2 is a transmembrane protein implicated in the renin-angiotensin-aldosterone system (RAAS) and hypertension pathogenesis. Note that ACE2 is a distinct enzyme from ACE: ACE converts angiotensin I to angiotensin II, a potent vasoconstrictor that drives the synthesis of aldosterone, whereas ACE2 converts active angiotensin II to angiotensin 1-7, a primary vasodilatory agent. This functions as negative regulation of RAAS. ACE2 has a protective effect in mouse models of ARDS ([Imai et al., Nature, 2005](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7094998/)). ACE2 levels in the nasal epithelium increase with age ([Bunyavanich et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2766524)), which may contribute to the differential susceptibility of older individuals to COVID-19. Of note, large studies have not shown an association with drugs that block the RAAS, such as angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) with increased COVID-19 acquisition or mortality ([Fosbol et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2767669)).\
\
SARS-CoV-2 binds to ACE2 via its S protein. Binding triggers a conformational change in the S protein, allowing it to be cleaved by a host cell serine protease called TMPRSS2 ([Zhou et al., Nature 2020](https://www.nature.com/articles/s41586-020-2012-7)). Cleavage of the S protein between its S1 and S2 domains allows fusion of the viral and host cell membranes and viral entry to the cell.

SARS-CoV-2 can enter by two pathways: through endocytosis, and through non-endocytic cell surface entry ([Zumla et al., Nat Rev Drug Discovery 2016](https://www.nature.com/articles/nrd.2015.37)). The endocytic pathway is a potential target of drugs like chloroquine and hydroxychloroquine ([Liu et al., Cell Discovery 2020](https://www.nature.com/articles/s41421-020-0156-0)). Upon entering in a membrane vesicle, the virion fuses with the vesicle and releases its single-segmented RNA genome into the cytosol. Since the virus is positive-sense, it can serve as mRNA and be translated immediately into non-structural viral proteins by the endogenous cell machinery. Some of these proteins form a replication complex to produce more RNA with a viral RNA-based RNA polymerase, including subgenomic RNAs which are used to translate structural proteins, and full-length transcripts to be incorporated into SARS-CoV-2 virions. The nucleocapsid (N) protein binds to the full-length positive sense viral RNA and associates with the matrix glycoprotein in the ER-Golgi intermediate compartment (ERGIC) to form a virion.  The M protein associates with S and the virion virion buds into the Golgi lumen, thus gaining an envelope and exocytic vesicles from the Golgi containing the enveloped virus fuse with the cell membrane and releases viruses  to infect other cells (Masters and Perlman, “Chapter 28: Coronaviridae”, Fields Virology).<br>

![Demonstration of how SARS-CoV-2 infects type 2 pneumocytes, propagates its own mRNA and viral proteins with host machinery, and then releases newly formed SARS-CoV-2 virions. From The Economist.](https://lh4.googleusercontent.com/uQBQ2HQ8mIsT2mR3ca8fc3gLQIlYZIIyO72FYw990473c0KRzC7Iq67gpU0mOTO_ld773blGBurXgVDkdAPXIKFwtLfR4yU4E5i0gA-5fuLEnEFoN_xjzpy2yqY_bRaiheiKn4ND)

Systematic studies of possible interactions between SARS-CoV-2 and human proteins have been reported, with aims of investigating host factors mediating virus infection to identify new antiviral drug targets and repurposing of previous drugs ([Zhou et al., Cell Discovery 2020](https://www.nature.com/articles/s41421-020-0153-3); [Gordon et al., Nature 2020](https://www.nature.com/articles/s41586-020-2286-9)).

*Thought question:*

* What are the pros and cons of targeting human proteins compared to viral proteins to treat a viral disease?

**Transmission dynamics**

Transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets ([Aylward et al., Report of the WHO-China Joint Mission 2020](https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf)). Prolonged exposures to an asymptomatic infected person (within 6 feet for at least 15 minutes) and briefer exposures to symptomatic individuals (coughing) are associated with higher risk of transmission than shorter exposures to asymptomatic individuals ([Chu et al., Lancet 2020](https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736\(20\)31142-9.pdf)). Other routes of transmission such as virus contamination of common objects and aerosolization in a confined space have been suggested, though the significance of their role in contributing to overall transmission have yet to be fully elucidated ([Cai et al., Emerg Inf Dis 2020](https://wwwnc.cdc.gov/eid/article/26/6/20-0412_article); [Rothe et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMc2001468)). Respiratory droplets can be generated by sneezing (40,000 droplets), coughing (3,000 droplets), or talking (about 600 droplets per minute). They can also be produced by medical procedures like intubation and bronchoscopy or by use of oxygen masks and nebulizers ([Tang et al., Journal of Hospital Science 2006](https://www.sciencedirect.com/science/article/pii/S0195670106002866)). Larger droplets (>5 microns) tend to spread about 1-2 meters (3-6 feet) before the force of gravity causes them to drop to the ground and require droplet precautions. Aerosols are smaller and rapidly evaporate, leaving behind droplet nuclei that can spread further and remain suspended in the air for hours; these require stricter airborne precautions ([Klompas et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2768396)). While experimental data has shown that SARS-CoV-2 can remain suspended in the air and viable for many hours and that aerosolization can occur outside of aerosolizing procedures, epidemiological data and secondary attack rates support a primarily droplet based mode of transmission, although rare events of transmission via airborne routes have been documented in settings like choir practice and a call center ([Klompas et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2768396)). To reduce the risk of exposure, current guidelines recommend physical distancing and mask wearing. A systematic review and meta-analysis of studies on SARS, MERS and COVID-19 found that physical distancing of more than 3 feet from others had an adjusted odds ratio of coronavirus transmission of 0.18 ([Chu et al., Lancet 2020](https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736\(20\)31142-9.pdf)).  The CDC currently recommends staying at least 6 feet away from others who do not live in the same household (<https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html>). This topic remains an area of active investigation.

Reports indicate that SARS-CoV-2 has the potential to be transmitted through [fomites](https://en.wikipedia.org/wiki/Fomite), or objects with virus on their surface, although this route of transmission is less important compared to respiratory transmission. SARS-CoV-2 appears to have similar viability in aerosols and on surfaces when compared to that of SARS-CoV. When aerosolized, SARS-CoV-2 remains viable for up to 3 hours, a critical consideration for hospital infection control, particularly when undergoing aerosolizing procedures. Viable SARS-CoV-2 was measured from surfaces up to 4 hours on copper, 24 hours on cardboard, and 72 hours on plastic and stainless steel ([van Doremalen et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMc2004973)). While these results do not fully evaluate the infectivity of the virus on different surfaces, in general this data supports the notion that maintaining good hygiene (washing hands often, especially after touching public surfaces, and avoiding touching face and mouth) could help mitigate the spread of SARS-CoV-2. Moreover, this data suggests that other viral properties must explain the infectivity differences between SARS-CoV-2 and SARS-CoV. Previous work studying other coronaviruses have also suggested that surface disinfection such as with 62-71% ethanol or 0.5% hydrogen peroxide, commonly found in household cleaning products, can inactivate coronaviruses that persist on surfaces ([Kampf et al., J Hosp Infect 2020](https://www.journalofhospitalinfection.com/article/S0195-6701\(20\)30046-3/fulltext)).

Mask wearing is important to lessen transmission from asymptomatic, presymptomatic and symptomatic individuals alike, and helps protect both the mask wearer and those around them. A meta-analysis of studies on SARS, MERS and COVID-19 found that mask wearing resulted in an adjusted odds ratio of 0.15 (0.07-0.34) of infection (85% decreased risk with face masks compared to no face masks); N95 masks were associated with an adjusted odds ratio of 0.04, while surgical and cloth face masks had an adjusted odds ratio of 0.33 ([Chu et al., Lancet 2020](https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736\(20\)31142-9.pdf)).  In the same study, eye protection was associated with an adjusted odds ratio of 0.22 compared to no eye protection. Surgical masks have shown efficacy in hospitalized patients with seasonal coronaviruses ([Leung et al., Nat Med 2020](https://www.nature.com/articles/s41591-020-0843-2)), and homemade cloth masks can block large droplets produced during speech ([Anfinrud et al., MedRXiv 2020](https://www.medrxiv.org/content/10.1101/2020.04.02.20051177v1)). Current CDC recommendations are for the lay public to wear cloth masks in public settings and when around other people who don’t live in the same household and to reserve N95 masks for people with high levels of exposure ([cdc.gov](https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover.html)).

In concordance with the ability of SARS-CoV-2 to infect intestinal epithelial cells, viral RNA has been detected in 29–55% of stool samples from COVID-19 patients ([Xiao et al., Gastroenterology 2020](https://www.gastrojournal.org/article/S0016-5085\(20\)30282-1/pdf);[ Wang et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2762997); [Wu et al., Lancet Gastroenterol Hepatol 2020](https://www.thelancet.com/journals/langas/article/PIIS2468-1253\(20\)30083-2/fulltext)), as well as environmental samples from the toilet ([Ong et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2762692)).  Live virus has also been isolated from stool specimens ([Wang et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2762997); [Zhang et al., CCDC Weekly 2020](http://weekly.chinacdc.cn/en/article/id/ffa97a96-db2a-4715-9dfb-ef662660e89d)). Viral RNA can be detected in the stool or on rectal swabs even after oro-/nasopharyngeal swabs turn negative ([Xiao et al., Gastroenterology 2020](https://www.gastrojournal.org/article/S0016-5085\(20\)30282-1/pdf); [Xu et al., Nat Med 2020](https://www.nature.com/articles/s41591-020-0817-4)). These data raise the possibility of fecal–oral transmission of SARS-CoV-2 ([Yeo et al., Lancet Gastroenterol Hepatol 2020](https://www.thelancet.com/journals/langas/article/PIIS2468-1253\(20\)30048-0/fulltext)), as was suspected with the SARS outbreak of 2002–2003 ([Abdullah et al., Emerg Inf Dis 2003](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3016765/)). Live SARS-CoV-2 has also been isolated from blood but only from rare patients, and RNA has been isolated from the conjunctiva of the eyes and from urine samples ([Wang et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2762997);[ Liang & Wu, Acta Opthalm 2020](https://onlinelibrary.wiley.com/doi/full/10.1111/aos.14413); [Peng et al., J Med Virol 2020](https://pubmed.ncbi.nlm.nih.gov/32330305/)).

COVID-19 can be spread by vertical transmission, passed from mother to fetus or neonate during pregnancy or during the perinatal period, but this occurrence is very rare. A study of 31 deliveries in women with SARS-CoV-2 infection found evidence of infection in two newborn infants, with only one episode of confirmed congenital infection prior to delivery ([Fenizia et al., Nat Comm 2020](https://www.nature.com/articles/s41467-020-18933-4)).  In a number of limited case series of pregnant women with lab-confirmed COVID-19, none of the infants were found to have COVID-19, and SARS-CoV-2 was not detected in samples including amniotic fluid, cord blood, neonatal throat swab, or breastmilk ([Chen et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30360-3/fulltext#seccestitle130), [Li et al., Emerg Infect Dis 2020](https://wwwnc.cdc.gov/eid/article/26/6/20-0287_article), [Schwartz, Arch Path Lab Med 2020](https://www.archivesofpathology.org/doi/10.5858/arpa.2020-0901-SA)). Previous limited case series have found infants born to mothers with SARS were negative for SARS-CoV ([Wong et al., Am J Ob Gyn 2004](https://www-sciencedirect-com.ezp-prod1.hul.harvard.edu/science/article/pii/S0002937803020398); [Shek et al., Pediatrics 2003](https://pediatrics.aappublications.org/content/pediatrics/112/4/e254.full.pdf?ck=nck)) and vertical transmission with SARS or MERS infection have not been documented in the past ([Schwartz & Graham, Viruses 2020](https://www.mdpi.com/1999-4915/12/2/194/htm)). Cases of COVID-19 have been reported in neonates and infants; however, these were complicated by close contact history with confirmed infected persons following birth ([Qiao, Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30365-2/fulltext); [Wei et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2761659)). In contrast, neonates born to COVID-positive mothers can acquire IgG (transplacentally) and IgM (mechanism unknown, possibly imperfect assay) antibodies against the disease ([Zeng et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2763854)).

A feature of COVID-19 is its ability to be transmitted by asymptomatic individuals, whether before symptoms start or by individuals who do not have symptoms. Viral shedding appears to start 2 to 3 days prior to the onset of symptoms and peaks around the time of symptom onset ([Aylward et al., Report of the WHO-China Joint Mission 2020](https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf); [He et al., Nature Medicine 2020](https://www.nature.com/articles/s41591-020-0869-5)), and has been shown in asymptomatic individuals ([Zhou et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMc2001737)). Viral load can be positive multiple (1 to 7) days before symptom onset ([Wang et al., JID 2020](https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa119/5807958)), and peaks around the time of symptom onset, suggesting significant viral load before someone knows they may be infected ([To et al., Lancet ID 2020](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(20\)30196-1/fulltext)). Modeling of transmission events in China prior to the January 23rd travel restrictions estimated that undocumented cases, which experienced no to mild symptoms that did not warrant hospitalization, were responsible for 79% of new cases ([Li et al., Science 2020](https://science.sciencemag.org/content/early/2020/03/13/science.abb3221)); other studies  found that 12-62% of cases were transmitted from pre-symptomatic individuals ([Du et al., Emerging Inf Dis, 2020](https://wwwnc.cdc.gov/eid/article/26/6/20-0357_article); [Ganyani et al., Eurosurveillance 2020](https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.17.2000257)). Current estimates of the COVID-19 incubation period, which refers to the time period from initial exposure to symptom onset, range from 1-14 days with a median of 5 days and 95th percentile of 12 days, similar to SARS ([Lauer et al., Ann Intern Med 2020](https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported); [Li et al., NEJM 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001316?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)). The detection of SARS-CoV-2 RNA in patients at 20 days and as long as 37 days also suggests the potential of prolonged virus shedding ([Zhou et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30566-3/fulltext#seccestitle10); [He et al., Nature Medicine 2020](https://www.nature.com/articles/s41591-020-0869-5)). Increased severity of cases have been suggested to be associated with higher viral loads and longer duration of viral shedding ([Liu et al., Lancet Inf Dis 2020](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(20\)30232-2/fulltext)). Because they may shed virus for a period of time after symptoms have resolved, it is still unknown how long someone in remission from COVID-19 remains infectious. However, for people who become symptomatic, a recent study was not able to isolate infectious virus after 8 days after symptom onset, suggesting a limited time period for infectious viral shedding ([Bullard et al., Clin Inf Dis 2020](https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa638/5842165)). Truly asymptomatic cases are likely relatively rare, with rates of asymptomatic cases estimated to make up 15% of total cases overall, with more asymptomatic younger individuals than older ones ([Byambasuren et al., JAMMI Canada 2020](https://jammi.utpjournals.press/doi/10.3138/jammi-2020-0030)). The delay between exposure and showing symptoms combined with transmission from asymptomatic or presymptomatic hosts have made SARS-CoV-2 particularly difficult to contain.

**COVID-19 Variants**

Like all viruses, COVID-19 changes through mutation as it replicates through populations. Multiple COVID-19 variants have emerged, some more consequential than others. Notable variants include a new variant called B.1.1.7 that emerged in the U.K. and has been identified in numerous countries including the U.S. The mutation affects an amino acid in  the receptor binding domain of the  spike protein, the portion that physically interacts with ACE2.  This variant  is known to spread more easily than previous variants leading to projections that it will be the dominant strain in the US by March. The CDC has emphasized that while there is no evidence that this strain is more deadly than previous strains, increased transmission will equal more cases and subsequently more deaths ([MMWR CDC 1.15.21](https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e2.htm?s_cid=mm7003e2_w)). However the current vaccines will likely still be protective against this variant. Additional variants that have been identified in the US starting at the end of January 2021 include the 1.351 variant in South Africa and the P.1 variant in Brazil.\
\
Further discussion of COVID-19 variants to watch can be found on the regularly updated [CDC’s New Variants page](https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html).

*Thought questions:*

* How would you predict that a difference in infected cell types might change the presentation and transmission of COVID-19?
* Imagine a few real-life scenarios that you may soon encounter or may have already encountered:
  * [**Diane** ](https://curriculum.covidstudentresponse.org/curriculum-overview/cases)wants to order food from a delivery service, but is worried about getting sick. What advice would you give her about touching packages, meeting the delivery person, and ordering premade food?
  * [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases) has a friend who had low fevers, fatigue, and a dry cough, but was never tested for COVID-19. His friend self-quarantined at home and now has not had any symptoms for the past day. Brian wants to hang out with this friend today. What would you tell him about his risk of exposure? What precautions should he take if he decides to see his friend?
* How do estimates of incubation periods and viral shedding inform public health efforts?

**Pathogenesis of Organ Damage in COVID-19**

Like pulmonary epithelial cells, vascular endothelial cells express ACE2, and SARS-COV-2 has been found inside of endothelial cells in pulmonary capillaries, leading to inflammatory cytokine production, endothelial cell death, and endothelial barrier disruption ([Varga et al., Lancet 2020](https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736\(20\)30937-5.pdf)). This endotheliitis is associated with diffuse thickening of the alveolar wall and infiltration of mononuclear cells and macrophages into the airspaces, which collectively are seen as ground-glass opacities in the lungs on CT imaging ([Wiersinga et al., JAMA, 7/10/2020](https://jamanetwork.com/journals/jama/fullarticle/2768391)). As the inflammation progresses, pulmonary edema and hyaline membrane formation occur and cause acute respiratory distress syndrome (ARDS), which interferes with oxygen diffusion.

Activation of the coagulation cascade and consumption of clotting factors have been associated with severe COVID-19. In one study, 71% of patients who died of COVID-19 met criteria for disseminated intravascular coagulation (DIC) ([Tang et al., J Thrombosis Haemostasis 2020](https://onlinelibrary.wiley.com/doi/full/10.1111/jth.14768)); in another, 31% of COVID-19 patients admitted to ICUs had at least one thrombotic complication ([Klok et al., Thrombosis Res 2020](https://www.thrombosisresearch.com/article/S0049-3848\(20\)30120-1/pdf)). SARS-CoV-2 does not appear to have intrinsic procoagulant activity; instead, the increased coagulation is likely due to a combination of endothelial damage and procoagulopathic effects of the inflammatory response itself ([Connors and Levy, Blood 2020](https://ashpublications.org/blood/article/135/23/2033/454646/COVID-19-and-its-implications-for-thrombosis-and)).

Neurological symptoms such as myalgias, headaches, encephalopathy, dizziness, dysgeusia (loss of taste), and anosmia (loss of smell) are common in COVID-19 patients, affecting up to 82.3% of COVID-19 patients at some point in their disease course in one study ([Liotta et al., Annals of Clinical and Translational Neurology 2020](https://onlinelibrary.wiley.com/doi/full/10.1002/acn3.51210)).  So far, there are several theories proposed to explain the cause of COVID-associated neurological symptoms. The loss of smell and taste may be explained by infection of non-neuronal ACE2-positive cells in the nasal and oral mucosa, such as endothelial cells, oligodendrocytes, and astrocytes. This can alter axon conduction velocity, metabolic and neurotransmitter homeostasis, and/or cerebral perfusion ([Pan et al., Academic Radiology 2020](https://www.academicradiology.org/article/S1076-6332\(20\)30507-9/fulltext)). The SARS-CoV-2 mediated cytokine storm can injure the blood-brain barrier, which allows the entry of cytokines into the brain, resulting in seizures and encephalopathy. SARS-CoV-2 activated cytokines can also cause immune-mediated “molecular mimicry” which damages cranial nerves, peripheral nerves, and/or muscles ([Majid et al., Journal of Alzheimer’s Disease 2020](https://content.iospress.com/articles/journal-of-alzheimers-disease/jad200581)).

Lingering symptoms are common in people who have had COVID-19, even in those who had mild or asymptomatic disease. These symptoms have been described as “long COVID”, “post-COVID syndrome”, or “post-acute COVID-19 syndrome” ([IDSA 11/19/20](https://www.idsociety.org/covid-19-real-time-learning-network/disease-manifestations--complications/post-covid-syndrome/)); the lay press has called people with these symptoms “long haulers” ([Yong, Atlantic 8/19/20](https://www.theatlantic.com/health/archive/2020/08/long-haulers-covid-19-recognition-support-groups-symptoms/615382/)). Studies following up on patients weeks to months after diagnosis or hospitalization with COVID-19 have found that 35%-87% of patients had ongoing symptoms, with fatigue, dyspnea, anosmia, dysgeusia, and weakness frequently reported ([Tenforde et al., MMWR 2020](https://www.cdc.gov/mmwr/volumes/69/wr/mm6930e1.htm); [Halpin, J Med Virol 2020](https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.26368); [Carfi et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2768351); [Garrigues, J Infection 2020](https://www.journalofinfection.com/article/S0163-4453\(20\)30562-4/fulltext); [Carvalho-Schneider, Clin Micro Infection 2020)](https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X\(20\)30606-6/fulltext). In one study, 66% of adults with COVID-19 who had not been admitted to an ICU reported persistent symptoms at day 60 after first positive RT-PCR test ([Carvalho-Schneider, Clin Micro Infection 2020](https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X\(20\)30606-6/fulltext)). A recent study found a high prevalence of autoantibodies in people with both mild/moderate and severe COVID-19, including some that target immunological functions and can worsen severity of disease in a mouse model of COVID-19; other autoantibodies targeted proteins found in the central nervous system, vascular cells, and connective tissue ([Wang, MedRXiv 12/12/20](https://www.medrxiv.org/content/10.1101/2020.12.10.20247205v3)). These autoantibodies may provide a link between COVID-19 infection and the autoimmune-like symptoms found in some individuals.

## Immune Response in COVID-19

![(Prompetchara et al., APJAI 2020)](https://lh4.googleusercontent.com/6NE_4KBJyjAfeo3dmZLkR4l9eFiIZMQ3_GKC-VHvmDATibv0DJKiHcwHMJessVb6BTzZmfEXYSxgg3jzb0AKmYKrgvnVyrNGOjX9Mvyg2k-pp2pl3e_rW63KLiBcmZ-3jb_1AEP_)

### Innate immune response

In severe cases of COVID-19, decreased viral control of SARS-CoV-2 is associated with a delayed or absent type I interferon response ([Chu et al., Clin Inf Dis, 2020](https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa410/5818134)); instead, the initial response recruits neutrophils, monocytes and macrophages to the lung, which is associated with increased immunopathology ([Blanco-Melo et al., Cell 2020](https://www.cell.com/pb-assets/products/coronavirus/CELL_CELL-D-20-00985.pdf); [Hadjadj et al., MedRXiv preprint 2020](https://www.medrxiv.org/content/10.1101/2020.04.19.20068015v1)). Like many other RNA viruses, SARS-CoV-2 RNA is detected by cytosolic sensors including RIG-I and MDA-5, which then interact with MAVS on the mitochondrial surface; downstream signaling leads to transcription of type I interferon genes. IFN-I binds to the interferon alpha receptor (IFNAR), which leads to expression of interferon stimulated response genes that create an antiviral state. At least 10 SARS-CoV-2 viral proteins inhibit elements of the cellular type I interferon response, including modifying viral RNA to make it difficult to detect, leading to degradation of RIG-I and MAVS, blocking host translation, and promoting IFNAR1 degradation  ([Sa Ribero et al., PLoS Pathogens 2020](https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1008737)).  SARS-CoV-2 induces a less robust interferon response than SARS-CoV, which may explain the delay in symptom onset in COVID-19 compared to SARS. Additionally, two recent studies ([Bastard et al., Science 2020, Zhang et al., Science 2020](https://science.sciencemag.org/content/early/2020/09/23/science.abd4585)) show that some patients harbor neutralizing auto-antibodies against type I interferons or mutations in genes associated with type I interferon signaling, and are both overrepresented in about 14% of people who developed severe COVID-19 disease.&#x20;

The influx of myeloid cells into the lungs is accompanied by increases in levels of serum pro-inflammatory cytokines, such as IL-1, IL-6, IL-12 and TNFɑ, that increase vascular permeability and decrease lung function. IL-6 can signal through direct binding to the IL-6 receptor on lymphocytes; it can also bind to soluble IL-6 receptor and bind to endothelial cells to stimulate vascular effects of the disease, and finally it can change expression of inflammatory mediators in the liver ([Moore and June, Science 2020](https://science.sciencemag.org/content/368/6490/473/tab-pdf)). In COVID-19, both increases in monocytes and neutrophils in the lungs ([Prompetchara et al., Asian Pacific Journal of Allergy and Immunology 2020](http://apjai-journal.org/wp-content/uploads/2020/02/Covid_AP-200220-0772.pdf)) and higher serum pro-inflammatory responses are associated with severe disease ([Huang et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30183-5/fulltext)). However, when levels of these cytokines were compared between critically ill patients with COVID-19 and other conditions like septic shock with or without ARDS, the COVID patients had lower levels of TNFa, IL-6 and IL-8 than septic patients with ARDS and lower levels of IL-6 and IL-8 than septic patients without ARDS ([Kox et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2770484)), which calls into question the extent of a “cytokine storm” in COVID-19 compared to other critical illnesses. It is thought that glucocorticoids like dexamethasone, which has been found to protect against mortality in patients with severe COVID-19, act by dampening this over-exuberant immune response ([RECOVERY trial, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2021436)). Antibodies against the IL-6 receptor, such as tocilizumab and sarilumab were tested in clinical trials, but did not show efficacy (tocilizumab: [Stone et al., NEJM 2020](https://pubmed.ncbi.nlm.nih.gov/33085857/); sarilumab: [Sanofi press release 9/1/2020](https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-01-07-00-00)), suggesting that a more narrow inhibition of IL-6 is not sufficient to treat COVID-19.

*Thought question:*

* How might the integrity of the lung and ability of immune cells to migrate to the site of infection affect the immune response to SARS-CoV-2?

### Adaptive immune response

The adaptive immune response generally consists of humoral immunity, most prominently antibodies produced by B cells, and cellular immunity, including CD4+ and CD8+ T cells and NK cells. These cells are primed by antigen presentation from cells including dendritic cells, macrophages, and B cells. One study using serological methods found low to no detection of SARS-CoV-2 specific antibodies in samples banked prior to SARS-CoV-2 exposure with negligible cross-reactivity from other human coronaviruses, suggesting humans may be completely immunologically naive to SARS-CoV-2 prior to the emergence of COVID-19 ([Amanat et al. Nature Medicine 2020](https://www.nature.com/articles/s41591-020-0913-5)). Once exposed, people can form a detectable humoral immune response to SARS-CoV-2. IgM antibodies to SARS-CoV-2 were found at a median of 12 days after illness onset and IgG after a median of 14 days; the timing of antibody production was not associated with disease severity, but higher antibody titer was associated with worse disease ([Zhao et al., Clinical Infectious Diseases 2020](https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa344/5812996)). Antibody responses are often of low magnitude ([Robbiani et al., 2020](https://www.nature.com/articles/s41586-020-2456-9)) and appear to lack durability ([Long et al., 2020](https://www.nature.com/articles/s41591-020-0897-1)). Antibody somatic hypermutation levels are low in both mild and severe disease, and autopsy studies have revealed the absence of germinal centers in patients with severe disease ([Kaneko et al. Cell 2020](https://www.cell.com/cell/pdf/S0092-8674\(20\)31067-9.pdf)). These results may explain the  lack of durability of antibody responses in severely ill patients. The presence of an antibody and T cell response that protects from reinfection has been established in animal models ([Chandrashekar et al., Science, 2020](https://science.sciencemag.org/content/369/6505/812)). Data from a COVID-19 outbreak on a fishing boat found that the presence of neutralizing antibodies from a prior infection was protective against reinfection ([Addetia et al., J Clin Micro, 2020](https://jcm.asm.org/content/58/11/e02107-20)).&#x20;

Neutralizing monoclonal antibodies to SARS-CoV2 have been cloned from humanized mice and humans ([Hansen et al., Science 2020](https://science.sciencemag.org/content/369/6506/1010?ijkey=f5391435661ccffed6e3690ce2ec1b66c796f753\&keytype2=tf_ipsecsha); [Baum et al., Science 2020](https://science.sciencemag.org/content/369/6506/1014)). Monoclonal antibodies from Lilly and Regeneron have both received emergency use authorization from the FDA for outpatient use ([Lilly press release 11/9/20](https://www.lilly.com/news/media/media-kits/bamlanivimab-covid19); [Regeneron press release 11/21/20](https://newsroom.regeneron.com/news-releases/news-release-details/regenerons-regen-cov2-first-antibody-cocktail-covid-19-receive)). . The Lilly antibody, called bamlanivimab, consists of one monoclonal antibody, while the Regeneron cocktail, called casirivimab and imdevimab, has two antibodies which bind to separate sites on the Spike protein, a combination which prevented development of resistance in vitro ([Baum et al., Science 2020).](https://science.sciencemag.org/content/369/6506/1014) Both companies’ monoclonal antibodies showed preliminary efficacy in decreasing viral loads and follow-up visits in outpatient clinical trials ([Regeneron press release 10/28/20](https://investor.regeneron.com/news-releases/news-release-details/regenerons-covid-19-outpatient-trial-prospectively-demonstrates); [Chen et al. for the BLAZE-1 study, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2029849)). Lilly’s antibody, bamlanivimab, received an emergency use authorization for outpatient use from the FDA (). A parallel trial of bamlanivimab in hospitalized patients was halted for lack of efficacy ([New York Times 10/26/20](https://www.nytimes.com/live/2020/10/26/world/covid-19-coronavirus-updates/eli-lilly-said-its-antibody-treatment-does-not-work-on-patients-hospitalized-with-covid-19)), which suggests that the timing of antibody administration is important in efficacy. Immunologically, antiviral antibodies are most likely to be effective during earlier stages of infection where viral load is higher, rather than after critical illness sets in. However, it may be challenging to identify patients who would benefit most from these monoclonal antibodies, and the infusions are expensive and may be challenging to administer in the outpatient setting while maintaining infection precautions ([Sax, NEJM Journal Watch, 11/15/20](https://blogs.jwatch.org/hiv-id-observations/index.php/bamlanivimab-hard-to-pronounce-even-harder-to-give/2020/11/15/)).Convalescent plasma is another strategy for transferring protective antibodies to people with COVID-19. The FDA granted an emergency use authorization for convalescent plasma based on retrospective, indirect analyses of an open label protocol from the Mayo Clinic, which showed lower 7-day mortality in non-intubated patients who received high-titer plasma (11%) compared to low-titer plasma (14%) ([FDA EUA request](https://www.fda.gov/media/141481/download)). However, many other studies had equivocal results, and the NIH COVID-19 Treatment Guidelines currently state that there is insufficient data to recommend for or against use of convalescent plasma ([NIH COVID-19 Treatment Guidelines](https://www.covid19treatmentguidelines.nih.gov/immune-based-therapy/blood-derived-products/convalescent-plasma/)).

When it comes to T cells, CD4+ T cell responses against SARS-CoV-2 peptides are seen in 100% of COVID-19 patients, and CD8+ T cell responses are seen in 70% of these patients ([Grifoni et al., Cell 2020](https://www.cell.com/cell/pdf/S0092-8674\(20\)30610-3.pdf)). Interestingly, CD4+ T cells that react against SARS-CoV-2 were also seen in 40-60% of patient cells collected in 2015-2018, which correlated with the presence of antibodies against seasonal coronaviruses, suggesting pre-existing cross-immunity from other coronavirus infections ([Grifoni et al., Cell 2020](https://www.cell.com/cell/pdf/S0092-8674\(20\)30610-3.pdf)). However differentiation of T cells into Bcl-6+ T follicular helper cells is defective in severe COVID-19, and this likely compromises the quality of the humoral immune response ([Kaneko et al. Cell 2020](https://www.cell.com/cell/pdf/S0092-8674\(20\)31067-9.pdf)).  A Th1-type CD4+ T cell response is important in successful control of SARS-CoV and MERS-CoV ([Li et al., J Imm 2008](https://www.jimmunol.org/content/jimmunol/181/8/5490.full.pdf); [Shin et al., Clin Inf Dis 2019](https://academic.oup.com/cid/article/68/6/984/5060259)). In mouse models of SARS, loss of CD4+ T cells reduced viral clearance, decreased antibody responses and led to increased mortality, while depletion of CD8+ T cells had no effect ([Shen et al., J Virol 2009](https://jvi.asm.org/content/84/3/1289.short)). In mice, CD4+ T resident memory cells in the lung are particularly important for vaccine-mediated protection against SARS ([Zhao et al., Immunity 2016](https://www.sciencedirect.com/science/article/pii/S1074761316301601)). CD8+ T cell responses are also important to control infection, but may be associated with increased lung pathology in SARS and MERS when overabundant, making it difficult to discern cause from consequence ([Shin et al., Clin Inf Dis 2019](https://academic.oup.com/cid/article/68/6/984/5060259); [Prompetchara et al., As Pac J of All and Imm 2020](http://apjai-journal.org/wp-content/uploads/2020/02/Covid_AP-200220-0772.pdf)). MERS-CoV has been shown to decrease antigen presentation on dendritic cells and macrophages, delaying activation of the adaptive immune system ([Shokri et al., J Cell Physiol, 2019](https://onlinelibrary.wiley.com/doi/full/10.1002/jcp.27155)).&#x20;

Lymphopenia is a hallmark of in COVID-19, is associated with IL-6 and IL-8 levels ([Zhang et al., Nature 2020](https://www.nature.com/articles/s41586-020-2355-0)), and is a predictor of disease severity ([Tan et al., Signal Transduction and Targeted Therapy 2020](https://www.nature.com/articles/s41392-020-0148-4#MOESM1)). CD4+ and CD8+ T cells are depleted to a greater extent than B cells or NK cells ([Zhang et al., Nature 2020](https://www.nature.com/articles/s41586-020-2355-0)), which may be partially explained by recruitment to infected tissue. This may be due to bone marrow suppression by the antiviral response, destruction of lymphatic tissue ([Chen et al., MedRXiv 2020](https://www.medrxiv.org/content/10.1101/2020.03.27.20045427v1)), or perhaps by direct viral infection and depletion of lymphocytes ([Wang et al., Cellular and Mol Immunol, 2020](https://www.nature.com/articles/s41423-020-0424-9)). It is not yet known whether individuals with mild disease recover in part because of vigorous protective cytotoxic CD8+ T cell based elimination of infected cells, and whether the progression of illness in more seriously ill patients reflects a relative absence of such a response. These differences, if established, could in part help explain the clinical spectrum of the disease.\
\
A key question for understanding the dynamics of the pandemic is whether previously infected individuals can be re-infected. It appears that re-infection is possible but rare. In macaque models of infection, some monkeys become infected again after rechallenge, but this infection only lasted a short period of time and no infectious virus was recovered, suggesting that they had developed an effective immune response ([Chandrashekar et al., Science 2020](https://science.sciencemag.org/content/early/2020/05/19/science.abc4776.abstract)). A case of human reinfection 142 days after the initial infection with a genetically distinct viral strain has been reported; however, the patient was asymptomatic during the second episode ([To et al., Clin Inf Dis 2020](https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1275/5897019)). Cases of human reinfection (people testing positive for SARS-CoV-2 RNA after testing negative) are most likely rare; a study of 790 contacts of 285 re-positive cases in South Korea found no cases of transmission from re-positive individuals, so they are very unlikely to be infectious ([Korean CDC, 5/21/20](https://www.cdc.go.kr/board/board.es?mid=a30402000000\&bid=0030\&act=view\&list_no=367267\&nPage=1)). Immunity to seasonal coronaviruses wanes over several years, permitting reinfection with very similar strains of the same virus, and antibody titers to SARS and MERS decrease after infection, raising questions about the durability of protection against COVID-19 . Encouragingly, a study that sampled immune responses to SARS-CoV-2 in people with mild, moderate and severe COVID-19 over time with up to 8 months of follow-up found persistence of antibody, B cell and T cell responses ([Dan et al., BioRXiv 11/16/20](https://www.biorxiv.org/content/10.1101/2020.11.15.383323v1.full.pdf)). Data from phase 3 clinical trials from currently approved vaccine candidates show that antibody and T cell responses are durable and that protection can last for at least several months. The long-term duration of protection from previous infection and vaccines will become more apparent as time goes on.\
\
For more detailed information on vaccine development, see the below [section](https://docs.google.com/document/d/1wXMH05bfCrj4UFXtJ_DFZE9g_WrEjj7V7MB_Ur7l7m0/edit#bookmark=kix.th8bz2lrbutu). For more information about how this affects epidemiological modeling, see [Module 2](/module-2-epidemiology-principles#introduction).

*Thought question:*

* How might the initial mild presentation and later severe disease seen in COVID-19 be explained by the immune response to the virus?

Additional Readings:

[Prompetchara et al., Asian Pacific Journal of Allergy and Immunology, 2020](http://apjai-journal.org/wp-content/uploads/2020/02/Covid_AP-200220-0772.pdf)\
[de Wit et al., Nat Rev Microbiol 2016](https://www.nature.com/articles/nrmicro.2016.81.pdf)<br>


# Diagnosis of COVID-19

## Clinical Presentation

The most common presenting signs and symptoms of COVID-19 are fever, dry cough, and fatigue. Other common presenting symptoms are detailed below ([WHO-China Joint Commission Report, 2020](https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf)):&#x20;

![](https://lh6.googleusercontent.com/iYoshycgtX8qT5m6SvMv0MhhUeTyjfc6vOAqj9S-0qZ8yuUQAR2hfSIyk4uZXLMl8wtbICZHvkabBtBUTzoaJvaLAc5QIZf-3eMuQ62TTscNTq4EoutlgMVYyUpcxVg_Cn7lb6wi)

Of note, though a majority of patients have fever at some point in their disease course, a study of 1,099 patients (both hospitalized and outpatient) with laboratory-diagnosed COVID-19 from 522 hospitals in 30 provinces of China found that only 44% of patients were febrile at the time of diagnosis, which highlights some of the diagnostic challenges associated with variable clinical presentations ([Guan et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2002032)).

*Thought questions:*

* [**Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases) wakes up feeling “off,” and she calls her doctor to ask about the possibility of having coronavirus. If you were her doctor, what questions might you ask? What is on your differential alongside COVID-19? &#x20;
* Does the lack of a fever mean a patient is not infected with SARS-CoV-2? Why not? What about the presence of a sore throat or nasal congestion?
* So if [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases) is correct and the majority of people will have “just a bad cold” with fever, dry cough, and fatigue, why are we taking such drastic measures to contain this virus?

Another clinical feature of COVID-19 that has received considerable media attention is olfactory and taste disorders (OTDs), including anosmia ([NPR, 4.1.20](https://www.npr.org/2020/03/31/824712669/is-this-real-loss-of-smell-and-the-coronavirus)). Frequency of reported anosmia ranges from 22%-65% in the literature. Frequency of taste disorders depends on the definition (dysgeusia - 33% vs ageusia - 20%) ([Larco, et al., Wellcome Open Res 2020](https://pubmed.ncbi.nlm.nih.gov/32587902/)).

In summary, no ONE symptom or set of symptoms can reliably diagnose or exclude COVID-19 infection but it is clear that cough, fever, and fatigue are most commonly seen. As discussed in the basic virology section, it is also important to remember that a person begins shedding the virus (i.e. can transmit the virus to others) prior to symptom onset and some people will never develop symptoms and remain asymptomatic carriers ([Li et al., Science 2020](https://science.sciencemag.org/content/early/2020/03/13/science.abb3221); [Pan et al., Lancet 2020](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(20\)30114-6/fulltext); [Roth et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMc2001468?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dpubmed)).

Presenting symptoms in children are similar to those in adults (fever, dry cough, and fatigue) although often less severe and asymptomatic cases have also been reported ([Hoang et al., EClinicalMedicine 2020](https://www.thelancet.com/action/showPdf?pii=S2589-5370%2820%2930177-2)).

## Diagnostics

*Thought question:*

* Given that treatment for COVID-19 is primarily supportive, what are the benefits of testing for SARS-CoV-2?
* Based on what you have learned about the basic virology of SARS-CoV-2, how would you design a test to look for infection? From where would you collect samples?

### Molecular assays

Most tests for SARS-CoV-2 utilize RT-PCR against the RNA-dependent RNA polymerase (RdRp), E (envelope), N (nucleocapsid), S (spike protein), and/or ORF1b transcripts (video review of [RT-PCR](https://www.youtube.com/watch?v=0MJIbrS4fbQ)) (review: [Sheridan, Nature 2020](https://www.nature.com/articles/d41587-020-00002-2)). These PCR tests use respiratory specimens, primarily from nasopharyngeal, and sometimes oropharyngeal, swabs. RT-PCR is highly specific, and is therefore considered the gold standard diagnostic for confirming COVID-19 infection. Sensitivities across kits vary dramatically, however, and can be as low as 70% compared against clinical suspicion with positive CT findings, especially early in the disease course ([Fang et al., Rad 2020](https://pubs.rsna.org/doi/full/10.1148/radiol.2020200432); [Ai et al., Rad 2020](https://pubs.rsna.org/doi/10.1148/radiol.2020200642)). Given this higher likelihood for false negatives, if clinical suspicion remains for COVID-19 despite a negative initial test, the [WHO](https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/surveillance-and-case-definitions) recommends resampling and retesting from multiple sites. Though there has been new data in preprint suggesting saliva swabs may be more sensitive than nasopharyngeal swabs at least in inpatients, current clinical guidelines recommend nasopharyngeal swabbing only  ([Wyllie et al., medRxiv 2020](https://www.medrxiv.org/content/10.1101/2020.04.16.20067835v1.full.pdf+html)). Additional PCR testing can be done on stool samples, though whether this represents active infection or continued viral shedding is debated (see Pathogenesis).

Multiple companies have also developed isothermal nucleic acid amplification tests (NAAT)-- the same technology used for rapid influenza and strep tests-- against SARS-CoV-2 ([Cepheid](https://www.fda.gov/media/136314/download), [Abbott](https://www.fda.gov/media/136522/download)). By avoiding thermal cycling for denaturing and annealing, isothermal NAAT can amplify user-specified nucleic acid sequences at a much faster rate than conventional PCR. Notably, however, unlike other modalities, most isothermal strategies would only be able to run one test at a time. They may be better suited for outpatient clinic settings or point-of-care testing sites, rather than high-throughput clinical laboratories. Clinical sensitivity and specificity data for these tests have yet to be released.

Given the risk of inducing coughing and consequently aerosolizing droplets, the [CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html#collection) recommends healthcare workers wear N95 respirators, eye protection, gloves, and a gown for all lower respiratory tract specimen collection (e.g.: sputum induction, bronchoalveolar lavage), and, if resources allow, for nasopharyngeal swabbing as well.

### **CRISPR**

CRISPR-based technologies have also emerged as novel diagnostic strategies for COVID-19 (video review of [CRISPR)](https://www.youtube.com/watch?v=UKbrwPL3wXE). The Broad Institute is in the process of validating their CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter UnLOCKing) technique against the SARS-CoV-2 S and ORF1ab genes ([Zhang, Abudayyah, and Gootenberg, 2020, not peer-reviewed](https://www.broadinstitute.org/files/publications/special/COVID-19%20detection%20\(updated\).pdf)), while Mammoth Biosciences out of the University of California San Francisco simultaneously validated their DETECTR protocol, against a panel of N, E, and RdRP genes ([Broughton et al., Nature Biotechnology 2020](https://www.nature.com/articles/s41587-020-0513-4)). These tests are similar in design: after nucleic acid extraction from respiratory samples, both SHERLOCK and DETECTR make use of simultaneous reverse transcription and isothermal amplification. Guide RNAs paired with Cas enzymes first cleave these specific sequences, and then cut reporter substrates to generate a visual read-out. Using lateral flow (a technique used in commercial pregnancy tests, for a review: [Koczula & Gallota, Essays Biochem 2016](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4986465/)), results can then be read on a paper dipstick. Both would be rapid diagnostic tests that could turn around results in under an hour.

*Thought questions:*

* What are the limitations of testing via nasopharyngeal swab?
* What might be the benefits of testing for previous infection with SARS-CoV-2, rather than active infection?

### Immunoassays

Blood samples of patients with COVID-19 mount the expected dynamic pattern of IgM followed by sustained IgG antibody levels against SARS-CoV-2 within two weeks time ([Zhao et al., Clin Inf Dis 2020](https://watermark.silverchair.com/ciaa344.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAmMwggJfBgkqhkiG9w0BBwagggJQMIICTAIBADCCAkUGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQM1dHS6Io34MrzEhQMAgEQgIICFq7Qj6UZTPYiaM_dAanIEPypsuE1Obk2sy9gxfjlMYx4_K1Kn4JMA_H0RhY06IrHOsT9YCabdRX-LXmg59mUExtoTrXXRmUHIGqIFfXj3DlhFtRvKbk4yS2M9jPrHVPB1h7cSfz0BTtFCaQQk1k-F98rVU2qiZkVGy8NxVepEH0aK7bX2_jQUmN_3BizlWUidBOfiPavD_iQszfZnVPoyNV-dp2rSekamGNme8Njtc6TKBIqXhKq9l9tUdvpqxa1XRJyAaW25nnLMQEMJaHx5BcigQRN6JvxwmtLsxtuF49uoR_UmZfUUSpCn2aXzslRYem65wsjMFRACTYWJaTquQFK_w_tyfa40ebGnRABPv3jSkbGhlJPt7sRq1Wv6GVz-cERNmWcbJD7sMaj6gz9nXTtpaD9z5MsIta9Uni1x4PuTfAvL2ujocdB2A6zpyJqY2_FYqhG3VLmdjfUvxCQuddmVO5omM4VsQ4BsJ1fSjc_YKwtP95TU---qaZp4iALM7wljpNNDSUscuw2Wgt06cQvCyS_DMGqCS-LU3ONNnoAzNTaHez53NpjfVAceCxwiK49K0TogS1OypGvlHLk7QItex0XQ40xYmprsNqEDSEbP5EinKmqaO_4s7NN50puiyFcg0iymQ_LczBRnaKOgkh-aoxiLWlLLCxFv2JC98wGrVTeItZ0ktp_3vBGXkpx2Dt0kdc8Tw)) (video review of [ELISA](https://www.thermofisher.com/us/en/home/life-science/protein-biology/protein-biology-learning-center/protein-biology-resource-library/pierce-protein-methods/overview-elisa.html), the primary method of antibody/antigen detection). IgM/IgG testing could reveal not only those with active infection but also those with a missed previous infection. It is currently unknown whether the presence of these antibodies confers immunity, and if so, for how long.\
\
A rapid diagnostic antibody test against the SARS-CoV-2 spike protein (both the full length protein, and its smaller receptor binding domain) has recently been designed and validated against 3 samples from COVID-19+ patients ([Amanat et al., Nat Med 2020](https://www.nature.com/articles/s41591-020-0913-5)). Rapid point-of-care lateral flow immunoassay testing for an IgM/IgG panel was also validated in 397 PCR-confirmed positive patients and 128 negative patients, with 89% sensitivity and 91% specificity within 15 minutes ([Li et al., J Med Virol 2020](https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.25727)). Testing from venous blood and fingerstick were consistent across samples. Obtaining blood rather than respiratory samples, especially if blood is collected by fingerstick onto a paper strip, might also decrease risk of transmission to healthcare workers handling the specimens.

### United States Testing Capacity&#x20;

[Testing capacity](https://www.wcvb.com/article/massachusetts-coronavirus-covid-19-testing-update-march-15-2020/31630997#) in the United States initially lagged behind that of other countries due to regulatory requirements by the FDA, [faulty tests](https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html) provided by the CDC, and limitations in healthcare infrastructure such as not enough laboratory personnel, supplies, and/or testing facilities such as tents and drive-through centers. These policies resulted in “rationing” of tests, with eligibility based not only on viral pathophysiology and clinical judgment, but also on epidemiology and public safety. The limitations of testing in the U.S. prevented early contact tracing and individual isolation, as has been done in [South Korea](https://www.npr.org/sections/goatsandsoda/2020/03/13/815441078/south-koreas-drive-through-testing-for-coronavirus-is-fast-and-free) (discussed in [Module 2](/module-2-epidemiology-principles/case-study-south-korea-2020)).

Commercial lab tests and hospital-specific protocols were quickly developed based on CDC protocol, underwent FDA Emergency Use Authorization (EUA), and began to address the need for PCR gold standard diagnostics in the United States ([Roche](https://www.fiercebiotech.com/medtech/roche-begins-shipping-400-000-coronavirus-test-kits-per-week-u-s) EUA 3/16/20, [Thermo Fisher](https://www.fiercebiotech.com/medtech/fda-quickly-oks-its-second-commercial-covid-19-test-from-thermo-fisher) EUA 3/16/20, [Broad Institute](https://www.broadinstitute.org/news/broad-institute%E2%80%99s-clia-certified-testing-center-begins-processing-covid-19-patient-samples) for Massachusetts). Point-of-care tests using isothermal NAAT also dramatically increased outpatient testing capacity (Cepheid [Xpert Xpress SARS-CoV-2](https://www.fda.gov/media/136314/download) EUA 3/21/20, Abbott [ID NOW COVID-19](https://www.alere.com/en/home/product-details/id-now-covid-19.html) EUA 3/27/20). Rapid antibody testing has also been approved ([Cellex](https://www.fda.gov/media/136625/download) EUA 4/1/20). Though antibody testing is gaining attention, it is currently only used to support a diagnosis of SARS-CoV-2 infection rather than to guide practices such as use of PPE and return to work given that it is unknown if and for how long these antibodies confer immunity. As this is a rapidly changing area of diagnostics, the CDC has published [interim guidelines for serologic testing](https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html).

Given rapid development of EUA SARS-CoV-2 virology tests, with over 150 tests having undergone EUA to date, there has emerged a need to compare test performance (e.g., limit of detection, sensitivity, specificity) and scalability across the myriad assay and sample types in a standardized fashion. Doing so could better enable the selection of the most economically viable, scalable, and best-performing tests for the much needed global, ubiquitous temporal monitoring, involving diverse clinical settings and sample types. Recent efforts to perform such a standardized comparison of virology tests include the [Resilience Health online tool](https://www.resiliencehealth.com/tests.html), a continually updated comparative dataset of tests that have undergone EUA ([Mackay et al., Nat Biotechnol 2020](https://www-nature-com.ezp-prod1.hul.harvard.edu/articles/s41587-020-0655-4#citeas)).

Many strategies are being implemented to limit transmission of SARS-CoV-2 from those awaiting testing to other patients in healthcare waiting rooms or healthcare workers themselves. Often, patients are screened remotely via virtual visit or telephone. For those who are determined to require testing by institution-specific protocols, many institutions have developed  “[drive-through](https://www.nytimes.com/2020/03/17/nyregion/new-rochelle-coronavirus-testing.html)” testing capabilities to limit exposure. On April 21, the [FDA approved](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection) the first at-home RT-PCR nasal swab test kit for COVID-19 through LabCorp. On November 17th, the FDA approved the first home self-testing providing rapid at-home results, The Lucira COVID-19 All-In-ONe Test Kit ([FDA News Release, 11/20](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home)).

This is an active area of innovation, and tests are being developed at a rapid pace to meet need. Here is a frequently updated [list](https://www.finddx.org/covid-19/pipeline/) of what diagnostic tests for COVID-19 are being developed worldwide. For a complete list of FDA EUAs, please refer to the [COVID-19 Emergency Use Authorizations for Medical Devices](https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations).

*Thought questions:*

* For whom would you recommend PCR testing in an ideal resource situation? With limited testing resources, who should be tested?

### **Massachusetts Case Study: Testing on a State Level**

Massachusetts began to see COVID-19 cases in early March; case numbers and state and commercial testing capacity rapidly increased since then. Compare the following two testing algorithms, adapted from Massachusetts Department of Public Health (MA DPH) guidelines (version 1 published 3/13/20, version 2 published [4/2/20](https://www.mass.gov/doc/covid-19-pui-criteria/download)) (highest quality images [here](https://drive.google.com/file/d/1bEvsryaiYZv8q_0cqJp1db45xW0l8K-y/view?usp=sharing) and [here](https://drive.google.com/file/d/1UxsjI91Dc0Ndk0z6osjn5sekTFy5n6Kt/view?usp=sharing)).\
\
*Thought question:*

* What changes were made to the testing guidelines, and why?

![](https://lh5.googleusercontent.com/pa7gB9IXtpQ55uFg7nbDQiZpgGkfdaeFFtYMtlYpsaoyaFv0lP4c1JjhSUTUSsXkqRhlcmt7VnpeLuIh7ngAxu1eO86FcjIj4U8W9Qf-d2C_OPu5KWgDtfJPKS9Q03ccfZFerk2b)

Note that several eligibility categories in MA DPH’s guidelines in both versions query public safety factors, such as the individual’s risk of disease transmission to others, rather than the probability of an individual having COVID-19. Also note how epidemiological risk factors were adjusted (removal of recent travel categories, no requirement for “close contact” with known cases, expansion of testing to essential workers besides healthcare workers). Other institution-specific testing guidelines may approach eligibility from a purely clinical view, and may have a specific set of signs, laboratory findings, and/or imaging findings needed for inpatients, or telemedicine triage protocols to assess symptoms and signs for outpatients.  As testing capacity has increased, clinical sites are able to test asymptomatic individuals such as close contacts of known COVID-19 patients and people without symptoms of COVID-19 who are admitted to the hospital.

*Thought question:*

* What factors would be important to consider in implementing a testing protocol for asymptomatic individuals? How might you weigh test characteristics, clinical management strategies, risks of testing, and economic implications?

## Ancillary Studies

### Laboratory diagnostics

*Thought question:*

* Given what you know about laboratory values in viral infections in general, what would you predict the laboratory values to be in patients with COVID-19?

The hallmark laboratory findings in COVID-19 cases reported thus far is lymphocytopenia. In the Guan cohort of 1099 patients discussed above, these trends were seen: lymphocytopenia (83%), elevated CRP (61%), thrombocytopenia (36%), and leukopenia (33%). Less commonly, elevations were seen in ALT, AST, CK, and d-dimer ([Guan et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2002032)). These laboratory trends are represented below in the typical fishbone format but REMEMBER - a patient need not have all or any of these laboratory values to be infected:

![](https://lh6.googleusercontent.com/5DJZayagbzNSgXP0ogilJr062gzSzcMpQnjnd_zd4tDinJoNQ69L-MdSH0xWQZMriTPnC8gJq3fIdYVJrt4HTe78nNs71DpI-5qZZBwi8CXujYZlTdR5upSTaI3HcL68jdZ0tQ2o)

([Nick Mark, A Seattle intensivist’s one-pager on COVID-19](https://www.onepagericu.com/))

A strong push has been made for identifying laboratory markers that can be used as clinical predictors of disease severity. Unsurprisingly, patients with more severe disease have been seen to have more prominent laboratory abnormalities across the board than those with nonsevere disease ([Guan et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2002032)). Additionally, some inflammatory markers have been found to be significantly different between admitted patients that recover from COVID-19 compared to those who die. Specifically, those who died had higher levels of troponin, myoglobin, CRP, IL-6, ferritin, procalcitonin, LDH, creatine kinase, D-dimer, and lower lymphocyte counts, platelet counts and albumin ([Ruan et al., Intensive Care Med 2020](https://link.springer.com/article/10.1007/s00134-020-05991-x); [Zhou et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30566-3/fulltext)). These findings are detailed in the graph below. In a study that longitudinally monitored immunologic data from 326 COVID-19 patients, IL-6 kinetics were highly correlated with disease severity (i.e. if IL-6 increased over the course of a patient's disease, so too did their disease severity). Additionally, this study found that lymphocyte count on admission was associated with disease severity, with increased lymphopenia being associated with a more severe disease course ([Zhang et al, Nature 2020](https://www.nature.com/articles/s41586-020-2355-0)).

![Temporal changes in laboratory markers from illness onset in patients hospitalised with COVID-19 (Zhou et al., Lancet 2020).](https://lh6.googleusercontent.com/5usdcA5g880VnsyyHmPWPHo6RaUhJsxsikzyMiFngUXyZNPoIw2jHaOPYKrrm0JSRJ0s59h9XBBtiadfOPjLY5onkDXInT2CS9EHAgYXbIVWQlBpjjIq44RSKqz_UKGMEJxMwvUA)

Elevated procalcitonin has been shown to be associated with a higher risk of more severe SARS-CoV-2 infection. Whether this represents bacterial superinfection or an inherent feature of the immune system’s response to SARS-CoV-2 remains unclear ([Lippi et al., Clin Chim Acta 2020](https://www.sciencedirect.com/science/article/pii/S0009898120301066?via%3Dihub)).

Coagulation abnormalities in COVID-19 patients, notably elevated D-dimer and fibrinogen levels, increased Factor VIII activity, as well as the following abnormal thromboelastography (TEG) findings in a population of 24 selected intubated patients with COVID-19 pneumonia ([Panigada et al., J Thromb Haemost 2020](https://pubmed.ncbi.nlm.nih.gov/32302438/)):

* Reaction time (R) shortened (50%)
* Clot formation time (K) shortened (83%)
* Maximum amplitude (MA) increased (83%)
* Clot lysis at 30 minutes (LY30) reduced (100%)

While COVID-19 coagulation abnormalities are reminiscent of disseminated intravascular coagulation (DIC), a major distinction can be seen in the prominence of thrombosis in COVID-19 versus bleeding in DIC.

MGH’s [COVID-19 Management Guidelines](https://www.massgeneral.org/assets/MGH/pdf/news/coronavirus/mass-general-COVID-19-treatment-guidance.pdf) (7.1.20) recommend daily CBC, CMP, CPK, and Ferritin/CRP as well as PT/PTT/fibrinogen and d-dimer every other day for all patients admitted with confirmed or suspected COVID-19. Additionally they recommend LDH, troponin, and baseline ECG for risk stratification.

### Imaging

*Thought question:*

* What might be barriers to using imaging to routinely screen for COVID-19?

Studies have found that abnormal lung findings can be seen on chest CT for patients with COVID-19, even in asymptomatic cases ([Shi et al., Lancet Inf Dis 2020](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(20\)30086-4/fulltext)). Despite this, concerns over resource allocation, infection control, and the limited diagnostic specificity of chest imaging for COVID-19 have resulted in recommendations against using chest radiographs or CT as a first-line form of diagnosis ([American College of Radiology Position Statement, 3/11/20](https://www.acr.org/Advocacy-and-Economics/ACR-Position-Statements/Recommendations-for-Chest-Radiography-and-CT-for-Suspected-COVID19-Infection)).&#x20;

Chest CT may however be indicated for hospitalized patients with severe respiratory symptoms, and the most commonly seen findings for COVID-19 are described below.

*Thought questions:*

* What imaging findings would you expect to see in a viral pneumonia?
* Are the imaging findings for COVID-19 different from other viral pneumonias? How?

For a concise summary and multiple images of CT findings, please watch this [video](https://www.youtube.com/watch?v=g9jEk_gi__g).&#x20;

The majority of imaging findings for COVID-19 are consistent with a viral pneumonia, with diffuse, bilateral involvement of the lung. The most common patterns seen are [ground-glass opacities](https://radiopaedia.org/articles/ground-glass-opacification-3?lang=us) (GGOs), air-space consolidations, [crazy paving](https://radiopaedia.org/articles/crazy-paving?lang=us) (pattern of GGOs with inter/intra-lobular septal thickening), vascular enlargement, and traction bronchiectasis. Of note, GGOs, vascular thickening, and the peripheral distribution of these findings have been the most helpful in allowing radiologists to distinguish COVID-19 pneumonia from other viral pneumonias, but specificity remained quite variable across radiologists (24-100%) ([Bai et al., Rad 2020](https://pubs.rsna.org/doi/10.1148/radiol.2020200823)). Imaging findings evolve over time, with abnormalities peaking at 10 days post symptom onset ([Pan et al., Rad 2020](https://pubs.rsna.org/doi/10.1148/radiol.2020200370)), and fibrous stripes appearing with resolution ([Pan et al., Eur Rad 2020](https://link.springer.com/article/10.1007%2Fs00330-020-06731-x)). Imaging abnormalities, perhaps unsurprisingly, also correspond to disease severity, with dramatic increase in lung involvement correlating to rapid decline in patient prognosis ([Shi et al., Lancet Inf Dis 2020](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(20\)30086-4/fulltext)).

![Transverse thin-section CT scans in patients with COVID-19 pneumonia. (A) 56-year-old man, day 3 after symptom onset: focal ground-glass opacity associated with smooth interlobular and intralobular septal thickening in the right lower lobes. (B) 74-year-old woman, day 10 after symptom onset: bilateral, peripheral ground-glass opacity associated with smooth interlobular and intralobular septal thickening (crazy-paving pattern). (C) 61-year-old woman, day 20 after symptom onset: bilateral and peripheral predominant consolidation pattern with a round cystic change internally (arrow). (D) 63-year-old woman, day 17 after symptom onset: bilateral, peripheral mixed pattern associated with air bronchograms in both lower and upper lobes, with a small amount of pleural effusion (arrows). (Shi et al., Lancet Inf Dis 2020)](https://lh6.googleusercontent.com/15aXwVTcrfhEFn_TJPgEJupsdtti7NlDOWDy16v59jodZ9N8UVh3y0dLjB_F2IGXRRk94Rz3-o6DRoV2EU8sla1Uz9eTMjTWxNfpFprp6bwXZWj7WP_JUX_HjmlIEdgS6TibVu-E)

Lung ultrasound has also been used to evaluate critically ill COVID-19 patients; lung consolidation, B lines, septal thickening, and A lines may be seen during recovery (letter, [Peng et al., Intensive Care Med 2020](https://link.springer.com/article/10.1007%2Fs00134-020-05996-6)).


# Management of COVID-19

## Clinical Course

Once infected, the clinical course of COVID-19 in adults is variable, making both case identification and triage difficult. As discussed prior, both asymptomatic and presymptomatic transmission have been documented. For those who do become symptomatic, the incubation period (time from exposure to symptom onset) is 4-7 days on average ([Li et al. 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001316?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)). For a minority of patients, the disease worsens approximately 5-10 days after symptom onset resulting in complications such as acute respiratory distress syndrome (ARDS), heart failure, coagulopathy, sepsis, acute cardiac injury, acute kidney injury, secondary infections, hypoproteinemia, and acidosis ([Zhou et al., Lancet 2020](https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2930566-3); [Bhatraju et al., NEJM, 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2004500)). This progression is visually represented by the slide below from Partners ID Grand Rounds Presentation ([Richterman and Meyerowitz, Partners ID Grand Rounds 3/25/20](https://docs.google.com/presentation/d/1shQ8m7kX2qFyj6PByY_DxM37fcyxLjSBojmTpFJN4kU/edit?usp=sharing)). This demonstrates the late worsening that can be seen ([MGH Grand Rounds 3/12/20](https://externalmediasite.partners.org/Mediasite/Play/53a4003de5ab4b4da5902f078744435a1d); [Holshue et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2001191); [Huang et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30183-5/fulltext)).

![(Richterman and Meyerowitz, Partners ID Grand Rounds 3/25/20)](https://lh3.googleusercontent.com/jE86vXWXwE5_LDoXcQ3GVLfyYy1Kfz5gO6K5AWdQk8ESk6Cc-RUynbxQl1P1LJQesvOKiCYgUMR5lEmC9C4purBfY5w29VBox5kZYQWF2nd7wY4GkuC5XQfr5SYj4o8mRFPMFbV3)

While the respiratory system is the most frequently affected organ systems, other prominently infected organ systems include the gastrointestinal, neurologic, hematologic and cardiovascular systems. The role of cardiac injury in disease progression remains unclear at this time; however, acute cardiac injury and fast-onset heart failure with reduced ejection fraction (HFrEF) may be playing an important role in the death of certain patients ([Shi et al., JAMA 2020](https://jamanetwork.com/journals/jamacardiology/fullarticle/2763524)). The neurologic symptoms of COVID-19 that have been identified include dizziness, headache, altered mental status ([Mao, et al JAMA 2020](https://jamanetwork-com.ezp-prod1.hul.harvard.edu/journals/jamaneurology/fullarticle/2764549)). Ischemic stroke has been noted in severe disease ([Helms et al, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMc2008597); [Iaccarino, et al. Am J Phys Med Rehabil 2020](https://journals.lww.com/ajpmr/Citation/9000/Neurological_Manifestation_of_COVID_19_and_the.97963.aspx)). Whether these manifestations are a result of direct or indirect damage to the tissue remains to be elucidated.

A report from ambulatory clinics in Cambridge, MA suggests that in patients with mild disease being managed at home, dyspnea typically develops days after the onset of other symptoms and worsens with exertion. They highlight the 72 hours after the onset of dyspnea as a period for frequent check-in phone calls, as many patients will stay mildly dyspneic for 2 weeks and then recover but some will have a sudden worsening and require hospitalization ([Cohen et al, Mayo Clin Proc 2020](https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/jmcp/jmcp_ft95_4_8-1586804723267.pdf)).

While most patients will eventually recover, a minority of patients will pass away from disease complications. For an in-depth discussion of case fatality rate, please see [Module 2](/module-2-epidemiology-principles/where-are-we-now#case-fatality-rate).

As discussed in “Clinical Presentation,” COVID-19 in children often has a more benign disease course compared to adults. Children infected with COVID-19 are less likely to require hospitalization and ICU admission than their adult counterparts and have lower fatality rates ([CDC MMWR, 3.18.20](https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e2.htm#F2_down); [Hoang, EClinicalMedicine 2020; Castagnoli et al., JAMA Pediatrics 2020](https://www.thelancet.com/action/showPdf?pii=S2589-5370%2820%2930177-2)). However, one potential severe consequence of COVID-19 in pediatric patients is an entity called Multisystem Inflammatory Syndrome in children (MIS-C) ([Godfred et al, MMWR 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440126/)). This inflammatory disorder presents similarly to Kawasaki disease - although it does not meet all clinical criteria for Kawasaki Disease. The key differences between MIS-C and severe acute COVID-19 is cardiovascular and mucocutaneous involvement ([Feldstein et al., JAMA, 2020](https://jamanetwork.com/journals/jama/fullarticle/2777026?guestAccessKey=4541ac3f-66ee-432b-9048-373aadf886e6\&utm_source=silverchair\&utm_medium=email\&utm_campaign=article_alert-jamapediatrics\&utm_content=olf\&utm_term=032221)). Additionally, unlike acute SARS-CoV-2 infection, MIS-C often occurs *after* active infection with many MIS-C patients testing negative for SARS-CoV-2 PCR but with evidence of prior infection via serologic testing ([Jones et al, Hosp Pediatrics, 2020;](https://hosppeds.aappublications.org/content/hosppeds/early/2020/04/06/hpeds.2020-0123.full.pdf) [Riphagen et al, Lancet 2020](https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931094-1)). See [CDC Health Advisory](https://emergency.cdc.gov/han/2020/han00432.asp) for more background and information.

\*\*\*For help on talking to children about COVID-19, visit the [COVID-19 Health Literacy Project](https://covid19healthliteracyproject.com/#english) that provides a fact sheet about COVID-19 for 3-6 year olds, 6-12 year olds, and 13-18 year olds.

*Thought questions:*

* Given the variable clinical course and outcomes in patients with COVID-19, how do we predict who will have more severe disease?
* What criteria could we use to determine who to admit to the hospital? What about admission to the ICU?
* Why might infants and children infected with SARS-CoV-2 have more mild symptoms than in adults and be at a lower risk for progression to serious illness including pneumonia and acute respiratory distress syndrome (ARDS)?
  * (Note: there is no consensus on this topic with [many competing theories](https://pubmed.ncbi.nlm.nih.gov/33262177/))

## **Risk Stratification**&#x20;

Numerous large cohort studies from China, US, and Italy have shown several common chronic conditions have prognostic implications for patients with COVID-19, including hypertension, type II diabetes, and cardiovascular (as well as cerebrovascular) disease ([China CDC Weekly, 2.10.20](https://pubmed.ncbi.nlm.nih.gov/32064853/), [CDC COVID-19 Response Team, MMWR 4.3.20](https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm?s_cid=mm6913e2_w#F1_down), [Grasselli et al, JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2764365)). Numerous studies have shown that BMI, obesity are strongly correlated with increased risk of more serious COVID-19 infection outcomes; however, until recently, none have been able to establish a direct causative link between obesity and COVID-19 risk. Findings from a recent genetic analysis now show that people with genetic predisposition toward a higher BMI, LDL cholesterol, are significantly more likely to test positive for the virus [(Aung et al., 2020).](https://www.frontiersin.org/articles/10.3389/fgene.2020.586308/full) Additionally, NHS England formed a OpenSAFELY database containing information on 17.3 million citizens with a total of 10,926 deaths from COVID-19. Factors strongly associated with hospital related death confirmed some previous findings such as older age, male sex, uncontrolled diabetes, and severe asthma ([Williamson et al, Nature 2020](https://www.nature.com/articles/s41586-020-2521-4)).<br>

![CDC Weekly Summary 4.18.20](https://lh4.googleusercontent.com/KXqD4RXa_x4Hk_WAa4spG00IGkqgzcDP3nwBg1OVQa7lYdvXRnSrpMxa4VIzV4MQG4Lqzaa4y0JQ8_pNlomwShAXhzt2sZ0NGE6xViTBrglhb9OCX4xNr-lDIDIGzAnEv5Ah3LTf)

It has also been noted that there is a disproportionate risk for infection and severe disease in racial minorities in the US. For an in depth discussion of the health disparities in COVID-19 Outcomes, see [Module 3](/module-3-disparities-policy-socioeconomic-effects).\
\
“Elderly” age has been found to be an independent risk factor for both COVID-19 infection and a more serious disease course . While the precise age is up for debate, it is clear that the older a patient is (particularly above 65 years of age), the higher their mortality and ARDS risk is ([Wu et al, JAMA 2020](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2763184)). In addition to the increased mortality rate, older age has also been associated with increased need for hospitalization in the US ([COVID-NET CDC, 10.10.20](https://gis.cdc.gov/grasp/covidnet/COVID19_3.html)). The following graph shows the COVID-19 related hospitalization rates per 100,000 people delineated by age group through March 13th, 2021. The CDC continually updates this data [here](https://gis.cdc.gov/grasp/covidnet/COVID19_3.html). Some have suggested that a composite score that takes into account both age and medical comorbidities, such as the Clinical Frailty Score (CFS) may more appropriately predict risk of severe disease than either factor alone. Frailty, a cornerstone of geriatric medicine, may have a role in both risk stratification and resource allocation as the pandemic unfolds, although more research is required to correlate this measure with clinical outcomes ([Hubbard et al., Age and Aging 2020](https://academic.oup.com/ageing/advance-article/doi/10.1093/ageing/afaa095/5831147); [Andrew et al., J Infect Dev Countr 2020](https://jidc.org/index.php/journal/article/view/32525825/2244)).

![](/files/-MWX8wa9vEZIMcQo3ITb)

Patients can be immunosuppressed for a variety of reasons including genetic immunodeficiencies, malignancies, and immunosuppressive medications used to manage a variety of medical conditions including transplants and rheumatologic conditions.  Data from a heart transplant cohort in China (87 patients) and a liver transplant cohort in Italy (200 patients) showed no increased risk of infection in these populations ([Ren et al, J Heart Lung Transpl 2020](https://www.sciencedirect.com/science/article/pii/S1053249820314698); [D’Antiga et al, Liver Transpl 2020](https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/lt.25756)). A small study in France concluded that the type of immunosuppression may matter, with those who have hematologic malignancies being at highest risk for severe infection, although this trend did not reach statistical significance ([Razanamahery, J Infection 2020](https://www.journalofinfection.com/article/S0163-4453\(20\)30351-0/pdf)). Larger scale studies are needed to determine if this theoretical risk represents a true risk in order to better guide clinical management decisions for patients on immunosuppressive medications.&#x20;

Interestingly, a genomewide association study (GWAS) showed that blood type A was a risk factor for more severe infection and blood type O was a protective factor. While this is an exciting and interesting finding, it is important to remember that correlation does not equal causation and that the nature of the relationship is poorly understood at this time ([Ellinghaus, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2020283)). Another recent GWAS showed associations between multiple genes involved in immune signaling and development of critical illness in COVID-19 patients ([Pairo-Castineira, Nature 2020](https://www.nature.com/articles/s41586-020-03065-y)). These genes included antiviral restriction activators, tyrosine kinase 2, DPP9 (involved in pulmonary fibrosis), and the interferon receptor gene 2 (IFNAR2), and also included CCR2, which is associated with monocyte infiltration into the lung, pointing to the importance of the lung immune response in COVID clinical outcomes.

Risk factors for developing the neurologic complication of encephalopathy are being older, having severe COVID-19 disease, and having a prior history of any neurological disorder or chronic kidney disease ([Liotta et al, ACTN 2020](https://onlinelibrary.wiley.com/doi/epdf/10.1002/acn3.51210)).

Data on COVID-19 risk factors and treatments continue to modify our current understanding of the virus and illness trajectory. Given available data, physicians have been able to devise new COVID-19 patient assessment systems, including the Dublin-Boston score which enables clinicians to make better informed decisions about treatment plans ([McElvaney et al., 2020)](https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964\(20\)30402-3/fulltext) . The test is based on patients’ inflammatory cytokine markers (IL-6, IL-10) which are linked to changes in the body’s immune response. This measure underscores the idea that COVID-19’s most severe effects are mediated through the body’s own inflammatory response.

## Triage Guidelines

Your institution likely has their  own triage and treatment guidelines that should be used for clinical decision making. Therefore, this section is not designed to provide you with clinical guidance but rather give you a framework for which to think about COVID-19 triage decisions.

If a patient with risk of exposure to COVID-19 or confirmed COVID-19 calls phone triage, presents to urgent care, or to the ED, first identify whether they have no symptoms, mild symptoms, or moderate-severe symptoms:

* Mildly ill patients have subjective or low-grade fever, dry cough, aches and pains, nasal congestion, headache, sore throat ([Kirtz NPR 2020](https://www.npr.org/sections/goatsandsoda/2020/03/13/814691018/coronavirus-symptoms-defining-mild-moderate-and-severe); [WHO Department of Communication March 2020](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected)).
* Moderately ill patients have high-grade temperatures, shortness of breath/trouble breathing, chills, profound fatigue ([Kirtz NPR 2020](https://www.npr.org/sections/goatsandsoda/2020/03/13/814691018/coronavirus-symptoms-defining-mild-moderate-and-severe)), and may have signs of pneumonia on imaging ([China National Health Commission](http://kjfy.meetingchina.org/msite/news/show/cn/3337.html))
* Severely ill patients have symptoms including severe dyspnea, hypoxia, dehydration ([Kirtz NPR 2020](https://www.npr.org/sections/goatsandsoda/2020/03/13/814691018/coronavirus-symptoms-defining-mild-moderate-and-severe)). Signs include RR>30, PaO2/FiO2<300, imaging concerning for ARDS (bilateral lung infiltrates within the last 1-2 days) ([Casella et al. StatPearls March 2020](https://www.ncbi.nlm.nih.gov/books/NBK554776/))
* Critically ill patients will have frank respiratory failure, shock, and multiorgan failure ([Casella et al. StatPearls March 2020](https://www.ncbi.nlm.nih.gov/books/NBK554776/))

The categorization of mild, moderate, and severe symptoms of COVID-19 definitions may have overlap. The morbidity of disease should be considered on a case-by-base basis in the setting of the patient’s comorbidities and well-being as a whole.

Per the China CDC report of 72,314 cases, 81% of patients were mild/moderately ill, 14% were severely ill, and 5% were critically ill. There were no reports of deaths for patients who were mildly, moderately, or severely ill; there was a case fatality rate of 49% in critically ill patients ([Wu, McGoogan JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2762130)).&#x20;

*Thought question:*

* What questions would a clinician ask over the phone to get a sense of a patient's dyspnea or hypoxia?

### If Mildly Ill...

If a patient is calling on phone triage with only mild symptoms, try to assess if their symptoms can be managed with supportive care and self-isolation at home. A helpful tool for patients and providers for this determination is <https://c19check.com/>, an application made by providers at the Emory University School of Medicine.

Patients being evaluated in the ED with no symptoms or mild symptoms - who are not at risk of rapid decompensation and have reliable follow-up -  should be discharged from the ED with a set of careful return precautions, direction to self-quarantine, instruction for caregivers, and instruction for how to practice supportive care. A detailed guide by the CDC for COVID-19 triage, including a sample phone script for responders can be found using the [CDC Phone Advice Line Tool](https://www.cdc.gov/coronavirus/2019-ncov/hcp/phone-guide/index.html). Highlights of triage guidance are detailed below:

* Return precautions would be instruction to call a provider or 911 if they have trouble breathing, worsening symptoms, high fevers, etc. The patient should let the clinic or the 911 operator know about their current symptoms and their prior exposure to COVID-19 over telephone.
* Self-quarantine includes avoiding going to public places or events, staying at home (preferably in a private room with a private bathroom), wearing a face mask, and cleaning door knobs and other high touch household fixtures for at least 2 weeks after potential exposure; the decision to discontinue self-quarantine should be made with the help of healthcare providers ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html)). Per CDC guidelines, if patients had no symptoms but tested positive for COVID-19, they can end self-quarantine a week after their positive test - if they continue to be asymptomatic ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html)). For patients with mild symptoms, there are two strategies to discontinue self-quarantine, a test-based strategy (only realistic when enough testing resources are available) and non-test-based strategy (which still prevents most secondary spread):
  * Test-based strategy: All symptoms have resolved AND 2 confirmed negative results from nasopharyngeal swab molecular assays for COVID-19, collected 24 hours or more apart ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html))
  * Non-test-based strategy: Patients with mild symptoms who were taking care of themselves at home can end self-quarantine 3 days after resolution of all symptoms AND if it has been over 10 days since they first started having symptoms ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html))
* The only therapeutic option recommended by IDSA guidelines for ambulatory patients at risk of severe COVID-19 disease is treatment with monoclonal antibodies, including bamlanivimab + etesevimab or casirivimab + imdevimab. These antibodies act faster than vaccination, which takes at least 2 weeks to build high-quality antibodies, and are likely to be effective even in individuals who are immunosuppressed. They may have lower efficacy against certain variant strains. Bamlanivimab alone is not recommended ([IDSA Recommendation 14, April 2021](https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/)).
* Supportive care involves making sure the patient is eating and drinking well, and taking acetaminophen for comfort and fever reduction ([WHO Department of Communication March 2020](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected))
  * There was an initial theoretical risk that NSAIDs may worsen COVID-19 infection due to molecular interactions ([BMJ](https://www.bmj.com/content/368/bmj.m1086) News). This has not been borne out in the literature and there is currently no good evidence establishing a link between NSAIDs and worsening of COVID-19 severity ([WHO Scientific Brief, April 2020](https://www.who.int/news-room/commentaries/detail/the-use-of-non-steroidal-anti-inflammatory-drugs-\(nsaids\)-in-patients-with-covid-19)). A Danish nationwide study showed no association between NSAID use and adverse outcomes such as 30-day mortality, hospitalizations, ICU admissions, and mechanical ventilation among those who tested positive for COVID-19 ([Lund et al. Plos Medicine September 2020](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003308)). However, due to an abundance of caution, the easy availability of alternatives (ex. acetaminophen), and the theoretical risk that NSAIDs may pose ([Fang et al. Lancet March 2020](https://www.thelancet.com/journals/lanres/article/PIIS2213-2600%2820%2930116-8/fulltext)), many hospitals are minimizing  NSAID use as first line antipyretic therapy. If NSAIDs are used, the lowest effective dose is recommended ([MGH COVID-19 Treatment Guidance](https://www.massgeneral.org/assets/MGH/pdf/news/coronavirus/mass-general-COVID-19-treatment-guidance.pdf)).

Patients with a high risk of exposure to COVID-19 or confirmed COVID-19, but with only mild symptoms, should be admitted if there is risk they will decompensate or do not have reliable follow-up. Other considerations for admission are if there are others at the patient’s residence who are at high risk of complications from COVID-19, if your patient doesn’t have access to necessary resources and personal protective equipment at home, and if your patient is unable to self-quarantine ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html)).&#x20;

Thus far, there is very limited data for care for pregnant women with COVID-19 and for post-partum care. Routine antenatal care continues to be encouraged. Individuals with high suspicion of COVID-19 or confirmed disease who are breastfeeding or having skin-to-skin contact with their infants should wear masks as appropriate and wash their hands before and after touching the baby. Please see the WHO clinical treatment guidelines for further details: [WHO Dept of Communication March 2020](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected).

*PPE Guidelines by the CDC*

When caring for patients with a URI of unspecified etiology or with suspected COVID-19 infection in the ED, providers are recommended to use droplet precautions (face mask or respirator), contact precautions, and eye protection. Patients should also be given droplet masks to wear throughout their visit if possible ([CDC COVID-19 PPE guidelines](https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html)). If facemasks are not available for patients, homemade masks can also be used, although proper caution should be taken as these masks could also become contaminated and serve as a source of transmission to others ([CDC COVID-19 Standard of Procedure for Triage](https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/sop-triage-prevent-transmission.html#:~:text=A%20standardized%20triage%20algorithm%2Fquestionnaire,19%20given%20the%20global%20pandemic.)).

Airborne precautions (ex. N95 respirators) should be used if providers are planning to intubate, administer HFNO or CPAP/BiPAP, obtain a nasopharyngeal swab, or perform other procedures that may generate aerosols ([CDC COVID-19 PPE guidelines](https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html)). In settings of PPE scarcity, please follow your institution’s guidelines; these may involve using PPE for an entire shift or reusing it unless the PPE becomes wet or visibly soiled.

For more information on PPE, please see [Module 6](/module-6-training-for-clinical-roles/personal-protective-equipment).

### If Moderately, Severely, or Critically Ill...

It is important to admit patients who are moderately, severely, or critically ill. The decision about whether or not to manage patients on the floor versus admit patients to the ICU is ideally dependent on a patient’s medical stability. ICU level care is needed for patients who are at high risk of decompensation, who need advanced ventilatory support, or who need support for 2+ systems (neurologic, renal, respiratory, circulatory). For patients with COVID-19, the patients at most risk for needing ICU level care are older patients and patients with comorbid conditions such as COPD, hypertension, cardiovascular disease, and diabetes mellitus ([Smith, Nielsen BMJ 1999](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1115908/)). The most likely need for ICU admission in this patient population is advanced respiratory support ([Murthy et al. JAMA Insights 2020](https://jamanetwork.com/journals/jama/fullarticle/2762996)). Patients should be admitted if in or at risk for hypercarbic or hypoxic respiratory failure, are having or have had recent seizures, if they are at risk for losing their airway, or if they are in shock, etc. It is also important to note whether your patient had previously noted wishes about not receiving ICU level care in an advanced directive ([Smith, Nielsen BMJ 1999](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1115908/)).

## Treatment

[Infectious Disease Society of America (IDSA)](https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/) keeps an up-to-date list of complete treatment/management recommendations. The following is a summary of measures used for treatment of admitted patients who are moderately, severely, or critically ill but should not be used for direct patient management, please consult IDSA and hospital guidelines to inform clinical decisions:

* Hospitalization for routine monitoring of vitals
* Use National Early Warning Score ([Smith et al. Resuscitation 2013](https://www.resuscitationjournal.com/article/S0300-9572\(18\)30945-6/fulltext); [MDCALC](https://www.mdcalc.com/national-early-warning-score-news#evidence)), warning scores, to predict if a patient will decompensate
* If the patient is undergoing procedures that generate aerosols (sputum production, intubation, HFNO, BiPAP/CPAP, etc.), isolate the patient in a single private negative pressure isolation room with HEPA filter to minimize risk of airborne transmission
  * If unable to provide airborne infection isolation room, be extremely cautious in giving patient airway devices that deliver 6L/min or more of oxygen (if not intubated) as this may generate aerosols ([Cheung Lancet Respir Med 2020](https://www.ncbi.nlm.nih.gov/pubmed/32105633), [Brewster et al. Medical Journal of Australia 2020](https://onlinelibrary.wiley.com/doi/full/10.5694/mja2.50598))
  * High flow nasal oxygen can give fraction of inspired oxygen (FiO2) up to 100% and reduces the need for intubation, but should be used with airborne precautions as it may produce aerosols ([WHO Department of Communication March 2020](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected))
  * BiPAP and CPAP may also generate aerosols and should be avoided if possible, or used with caution if necessary ([WFSA Coronavirus Guidance](https://www.wfsahq.org/resources/coronavirus))
  * If a private room is not possible, keep 2+ feet distance between patients ([Murthy et al. JAMA Insights 2020](https://jamanetwork.com/journals/jama/fullarticle/2762996))
* If concomitant asthma or COPD, to give bronchodilators, use metered dose inhalers with a spacer instead of nebulizers due to risk of aerosolization ([Wax, Christian Can J Anesth 2020)](https://link.springer.com/article/10.1007%2Fs12630-020-01591-x#citeas)
  * If patient has severe asthma or COPD, consider epinephrine and early rapid sequence intubation
* Consult Infectious Disease and Pulmonology services early if not already involved
* Use standard DVT prophylaxis ([MGH COVID-19 Treatment Guidance](https://www.massgeneral.org/assets/MGH/pdf/news/coronavirus/mass-general-COVID-19-treatment-guidance.pdf))
* Conservative fluid management--defined as net fluid balance of 0mL over the first 7 days-- if patient has been diagnosed with ARDS and is not hypotensive or in shock ([FACT trial NEJM 2006](https://www.nejm.org/doi/full/10.1056/NEJMoa062200))
* If suspecting sepsis, give empiric antibiotics (for community acquired pneumonia vs healthcare associated pneumonia) within 1 hour of recognition of sepsis, and then work-up source of infection
* Consider oseltamivir in flu season or if you have a high suspicion that your patient has comorbid flu
* Strongly consider advanced ventilatory support/intubation if a patient is in respiratory failure (hypercarbic or hypoxic); for intubation specifics, please check out this [link](https://docs.google.com/document/d/1SsWujt6g1iNUAAPeOFjSP8YFaK_C48SSO_2iz0BcQi4/edit#bookmark=id.q0levkbf899a)
* For a quick summary review of ventilatory settings for ARDS treatment, please check out this [link](https://docs.google.com/document/d/1SsWujt6g1iNUAAPeOFjSP8YFaK_C48SSO_2iz0BcQi4/edit#bookmark=id.8ldb2jkztow5); for more detailed information about the pathophysiology of ARDS and instruction about the basic operations of ventilators, please read the relevant sections of [Module 6](/module-6-training-for-clinical-roles/mechanical-ventilation-the-basics).&#x20;
* If patients have refractory hypoxemia even with advanced ventilatory support, consider extracorporeal membrane oxygenation (ECMO) if available ([WHO Department of Communication March 2020](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected); [Ramanathan et al., Lancet Resp Med 2020](https://www.thelancet.com/journals/lanres/article/PIIS2213-2600\(20\)30121-1/fulltext); [Combes et al., NEJM 2018](https://www.nejm.org/doi/10.1056/NEJMoa1800385)**)**
* Treat shock with volume support and pressors - norepinephrine as a first-line agent, vasopressin as a second-line agent is recommended; dopamine is not recommended ([Poston, Patel, Davis JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2763879)).
* Dexamethasone is recommended for patients requiring supplemental oxygen or invasive mechanical ventilation. The RECOVERY trial showed 28-day mortality benefit among those receiving mechanical ventilation or supplemental O2 but did not show mortality benefit for those not requiring oxygen support ([RECOVERY trial, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2021436); [rebelEM summary](https://rebelem.com/the-recovery-trial-dexamethasone-for-covid-19/)). These findings were further corroborated by a meta-analysis of seven randomized trials analyzing the impact of steroid therapy on mortality in severely ill COVID-19 patients (REACT Working Group, [JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2770279)). Equivalent doses of alternative glucocorticoids may be used if dexamethasone is not available ([IDSA guidelines](https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/)).
* Multiple clinical trials have not found an impact of ACEi/ARB therapy on COVID-19 outcomes ([BRACE CORONA trial, JAMA 2021](https://jamanetwork.com/journals/jama/fullarticle/2775280); [REPLACE COVID trial, Lancet 2021](https://www.thelancet.com/journals/lanres/article/PIIS2213-2600\(20\)30558-0/fulltext#:~:text=The%20REPLACE%20COVID%20trial%20was,angiotensin%20system%20inhibitor%20before%20admission.)), and one meta-analysis found a lower rate of multivariable-adjusted mortality and severe adverse events in patients with hypertension on ACEi/ARBs ([Baral et al., JAMA Network Open 2021](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777978)). . The current recommendations are to continue ACEi/ARB therapy during treatment of COVID-19 unless there is a contraindication.
* The ACTT-1 study demonstrated that remdesivir was effective as compared to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection ([NEJM Oct 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2007764?query=featured_home)). The IDSA presently recommends the use of remdesivir for hospitalized COVID patients with SpO2 ≤94% on room air without critical disease ([IDSA COVID Treatment Guidelines](https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-8)). The FDA has [approved](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19) the use of remdesivir in COVID-19 cases requiring hospitalization. However, the use of remdesivir continues to be controversial with the WHO releasing [recommendations](https://www.who.int/publications/i/item/therapeutics-and-covid-19-living-guideline) against its use.
* The EMPACTA study demonstrated that in hospitalized patients with Covid-19 pneumonia who were not receiving mechanical ventilation, tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival ([NEJM Jan 2021](https://www.nejm.org/doi/full/10.1056/NEJMoa2030340)). Presently, IDSA recommends the use of tocilizumab in addition to standard of care among hospitalized adults with progressive severe or critical COVID-19 who have elevated markers of systemic inflammation ([IDSA COVID Treatment Guidelines](https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-8)).
* The ACTT-2 study demonstrated that baricitinib plus remdesivir were effective as compared to remdesivir alone in shortening the time to recovery, especially in patients receiving high-flow oxygen or non-invasive ventilation at baseline ([NEJM March 2021](https://www.nejm.org/doi/full/10.1056/NEJMoa2031994)). IDSA recommends use of baricitinib in hospitalized non-critically ill patients up to 14 days or until discharge ([IDSA COVID Treatment Guidelines](https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/)).

Please take a look at this link for up-to-date recommendations about how resources and space should be managed in ED and ICU settings: [University of Washington](https://em.uw.edu/faculty/uw-department-emergency-medicine-edicu-covid-19-preparedness?fbclid=IwAR1nn6Y0h_mQ22F7Bt0tZHnNoivvXNcJNdpyhVcB4C7aGOrRt-3YPMgWiOU)&#x20;

Continue reading “Investigational Therapeutics” for information on the scientific basis for many of these experimental therapies.&#x20;

*Thought questions:*

* How do you personally balance the benefits vs risks of high flow nasal oxygen delivery? Would you use this treatment modality? In which situations?
* What signs/symptoms/imaging findings would prompt you to think about giving empiric antibiotics?


# Investigational Therapeutics & Vaccine Development

## Investigational Therapeutics

In this section we will build off fundamental SARS-CoV-2 virology and COVID-19 pathogenesis discussed in section 1 to explore the scientific basis of therapeutics and vaccines. We will discuss general approaches to therapies and vaccines but we will not be providing most up-to-date information about specific therapies. For that level of information, we highly suggest referencing The New York Times COVID-19 [drug](https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html?fbclid=IwAR3XGClUpmmEJlrsNRkJMAEWll7WRHD_KvOSkVpk0icQiRY7dJ07xBF_zeM) and [vaccine](https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html?fbclid=IwAR2kYzypoNJaSpl8ef3GT_6OpJeNAr3eDAPFekatGW5c-R3EiLNbgSuyt3U) trackers which are updated daily.

*Thought Question:*

* Based on what you know about SARS-CoV-2 viral structure and pathogenesis, what kinds of drugs do we already have on the market that could have efficacy in treating COVID-19?

### **Drug approval process**

The FDA (US Food and Drug Administration) is responsible for approving new drugs. The Center for Drug Evaluation and Research (CDER) receives applications for new medications and evaluates the evidence that the new drug is safe and effective ([FDA website](https://www.fda.gov/drugs/development-approval-process-drugs)).

In order to test the new compound, the company or group developing the drug must perform preclinical studies, usually on cells and experimental animals, to understand how the drug is likely to work and the safety profile. They then submit data from preclinical studies to the FDA to obtain an investigational new drug (IND) approval. Next, they test the medication in phase 1, 2 and 3 studies. Phase 1 studies evaluate the drug’s safety in humans by giving a small dose to a small group of people, observing them for side effects, and then gradually scaling up the dose. Phase 2 studies look for efficacy based on markers of disease in a somewhat larger group of people. Phase 3 studies compare the medication to whatever is currently available, which may be the standard of care or placebo, and are done in a large enough group of people to statistically evaluate pre-determined outcomes ([Cancer.org, Types and Phases of Clinical Trials](https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html)). During the clinical trial phase, access to INDs is only available as part of a clinical trial, with exceptions noted below. Evidence from these studies is submitted to the FDA as part of a New Drug Application ([FDA website](https://www.fda.gov/drugs/types-applications/new-drug-application-nda)).

In states of emergency, the FDA can authorize treatments for life-threatening conditions when there are no adequate, approved and available alternatives using a method called Emergency Use Authorization (EUA). The secretary of Health and Human Services authorized EUAs for COVID-19 effective March 27, 2020 ([FDA website](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization)); these approvals will be valid until the state of emergency ends. The EUA is made given the best available evidence weighing risks and benefits in order to make products available to the public in a timely manner, and may be revoked as further evidence becomes available. Please see [this website](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization) for an updated list of EUAs for vaccines, therapeutics, and medical devices.

Other pathways for access to medications for a new condition like COVID-19 include expanded access and off-label use ([FDA website](https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19#:~:text=The%20EUA%20process%20is%20different,for%20FDA%20approval%20or%20clearance.)). Expanded access, also known as compassionate use, allows people with a serious or life-threatening condition to access investigational new drugs outside of a clinical trial. Expanded access has been used frequently for convalescent plasma, which made it harder to evaluate the efficacy of the treatment. Off-label use allows providers to prescribe an FDA-approved medication for another indication than the original one it was approved for. This mechanism has been used for many medications like hydroxychloroquine that were approved by the FDA for treatment and prevention of malaria and treatment of certain autoimmune diseases.&#x20;

*Thought Question:*

* What are the advantages and disadvantages to an individual patient to receiving a drug outside of a clinical trial through expanded access or off-label use? What about to society?

### **Approaches**

Some medications target the virus, while others target the immune response to the virus.

Of antivirals, some are small molecules which inhibit viral processes. For example, remdesivir is a nucleotide analog which interferes with replication of SARS-CoV-2 by causing premature termination of RNA made by the viral RNA-dependent RNA polymerase.  Other virally-directed medications are biologic drugs that use antibodies to block viral entry, like the monoclonal antibodies bamlanivimab, etesevimab, casirivimab and imdevimab. These types of medications can lose efficacy as SARS-CoV-2 evolves, but are less likely to interfere with other homeostatic processes.

Anti-inflammatory drugs include corticosteroid hormones like dexamethasone, small molecules like baricitinib, and larger proteins like tocilizumab. These medications inhibit the inflammatory response which is responsible for many of the symptoms of COVID-19 by targeting inflammatory signaling. The drugs that target the immune response to the virus are more useful later in the course of disease when more symptoms are due to the immune response rather than the virus itself.

For more information on particular medications, please visit these resources:

* The New York Times COVID-19 [drug](https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html?fbclid=IwAR3XGClUpmmEJlrsNRkJMAEWll7WRHD_KvOSkVpk0icQiRY7dJ07xBF_zeM) and [vaccine](https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html?fbclid=IwAR2kYzypoNJaSpl8ef3GT_6OpJeNAr3eDAPFekatGW5c-R3EiLNbgSuyt3U) trackers
* We have made concept videos for medical professionals on leading antiviral and immune therapies for COVID-19, including mechanism, trial data and outlook:
* * [Medications for COVID-19: Antivirals (Part 1)](https://tinyurl.com/COVID19MedsAntivirals)
  * [Medications for COVID-19: Immune Therapies (Part 2)](https://tinyurl.com/COVID19MedsImmuno)
  * [Therapeutic summary image](https://tinyurl.com/covid19therapeutics)

## Vaccines

*Thought Questions:*

* How do we balance the need to quickly develop and distribute existing vaccines vs. the ethical considerations of testing new vaccines to make sure they are safe and effective?

### Timing

Vaccines are used in healthy individuals to prevent the development of future illness, as well as to attenuate the duration and severity of symptoms in those who do develop illness in the future. \
\
Prior to a vaccine’s introduction on the market, scientists must go through the following steps: (Review: [Vaccine Testing and Approval Process](https://www.cdc.gov/vaccines/basics/test-approve.html) [(CDC)](https://paperpile.com/c/Z2EDp3/H2Iw) and [video](https://youtu.be/ek3T8xiu1Fw) [(CNBC](https://paperpile.com/c/Z2EDp3/32j0))&#x20;

* **Phase 1** trials with small numbers of healthy patients will first strive to demonstrate that the vaccine is safe, void of adverse side effects, and establish an acceptable dosage. This is especially important given that vaccines are given to healthy individuals, rather than sick individuals, and must reach a greater threshold for safety.&#x20;
* **Phase 2** trials enroll a larger group of individuals and aim to demonstrate the vaccine is effective in preventing the symptoms or disease under investigation. The subjects enrolled tend to be people that are considered to benefit most from a new treatment (i.e. elderly, persons with comorbid conditions).
* Upon successful completion of the prior stage, **phase 3** trials enrolling even more patients will seek to show continued safety and efficacy. Typically Phase 3 trials are conducted in an area where a pathogen is endemic and the frequency of infection in the vaccinated and control groups are compared and efficacy thus determined. However in this outbreak some ethicists have supported human challenge studies in well informed volunteers, in which one arm of the study will involve volunteers receiving a  deliberate vaccine challenge.This issue is currently being debated  with some civil society organizations pushing for this approach (<https://www.1daysooner.org/>).
* After a phase 3 trial, the vaccine is generally approved and available to the general public, though formal **phase 4 trials** are encouraged (but not usually formally required) to assess for longer-term safety and efficacy. The safety of the vaccine should continue to be surveilled after its rollout to the public as well. Two examples of this in the US include the [Vaccine Adverse Event Reporting System (VAERS)](https://vaers.hhs.gov/), which accepts reports of complications for any vaccine, and the opt-in [V-SAFE program](https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html), which surveys vaccine recipients multiple times after vaccination against SARS-CoV-2

### Approaches

As clinical trials for COVID-19 vaccines continue and multiple vaccines are administered, the choice of viral component to be used as a basis for developing immunity is an important consideration. In general, previous vaccine strategies for SARS & MERS have targeted the S protein, since it has been shown to play a role in inducing protective immunity by eliciting the production of neutralizing-antibodies and T-cell responses [(Keng et al. 2005; Zhou et al. 2004; Bukreyev et al. 2004)](https://paperpile.com/c/Z2EDp3/PhfX+RjCE+IKA9). Based on the function of this protein, it is also an attractive target because immunity against this protein could block virus binding, impair membrane fusion or neutralize infection.The use of an inactivated SARS-CoV-2 vaccine resulted in the generation of neutralizing antibodies and the protection of immunized macaques from SARS-CoC-2 rechallenge without any evidence of disease enhancement ([Gao et al., Science 2020](https://science.sciencemag.org/content/early/2020/05/06/science.abc1932)). There are many different types of vaccines in the modern era, including whole pathogen vaccines (either killed/inactivated or live attenuated), subunit vaccines, mRNA vaccines, and DNA vaccines [(Vaccine Types | NIH)](https://paperpile.com/c/Z2EDp3/lP3D).  Vaccines previously developed for SARS and MERS have informed the approach to SARS-CoV-2 vaccine development. Different approaches are detailed below and are also described more broadly in this [NYT article](https://www.nytimes.com/interactive/2020/05/20/science/coronavirus-vaccine-development.html):

**Whole pathogen vaccines** require the pathogen to be grown in the laboratory, where they can then either be killed with chemicals, heat, or radiation (to make a killed/inactivated vaccine) or weakened (to make a live attenuated vaccine), and then incorporated into the vaccine. Yet another approach that has been used for many live viral vaccines is codon deoptimisation of the genetic material of a virus to make it less virulent. The use of non-preferred codons can markedly reduce viral protein expression. This approach has been used for a SARS-CoV-2 vaccine as well.

**Hybrid vaccines** incorporate part of the pathogen of interest’s genetic material into that of a harmless pathogen, often an adenovirus, to create a “chimeric pathogen”, which can be used to stimulate the immune system. Adenoviruses like Adenovirus 26 can enter many different human cells at the site of infection and thus serve as potent immunogens.

**Subunit vaccines** utilize laboratory techniques to create the components (i.e. antigens) of the pathogen that best stimulate the immune system and incorporate these into a vaccine.

**mRNA vaccines** are developed by identifying the genetic sequence of the pathogen and then determining which sequences code important, unique components (antigens) of the pathogen. mRNAs for these genetic sequences are  synthesized, altered to enhance RNA stability and translatability by addition of a 5’cap and a long polyA tail, altering 5’ and 3’ UTRs and changing codon usage.  mRNA vaccines can be rapidly designed and manufactured and mRNAs for multiple antigens can be easily combined into a single vaccine.  mRNAs can be linked to alphavirus RNA sequences to make them self-replicating and this enhances the expression of the antigen/s encoded. Once the vaccine is introduced into a recipient, the recipient's cells will use the mRNAs to make the corresponding proteins, which will then stimulate the immune system. These designs have been shown to have greater stability and protein translation efficiency which translates into a more robust immune response.

**DNA vaccines** work similarly to RNA vaccines. Instead of RNA, a cDNA is injected usually into the vaccine recipient’s muscle tissue. Some of the recipient's dendritic cells likely take up the cDNA that is then transcribed and translated to generate the relevant antigen. These cells migrate to draining lymph nodes and thus initiate an immune response.

**Nanoparticle vaccines** utilize an understanding of synthetic biology to create nanoparticles out of proteins that are then studded with pathogenic components (antigens) for a pathogen. The idea is that while the underlying nanoparticle could stay consistent from vaccine to vaccine, the antigens could be switched out easily and interchangeably, allowing for rapid vaccine development. This could be especially important if the SARS-CoV-2 virus, as is feared, becomes a yearly illness like influenza [(Begley et al. 2020)](https://paperpile.com/c/Z2EDp3/TYLr) and if nanoparticle vaccines developed do not induce durable immune responses.

Vaccines also commonly have adjuvants, which are used in order to increase the immune system’s response to a vaccine and thus develop a more effective immunity to a pathogen in the future. They have been used safely in vaccines for decades [(CDC | Adjuvants help vaccines work better)](https://paperpile.com/c/Z2EDp3/LsNE).

### Clinical Vaccine Trials

Many pharmaceutical companies and governments are currently in the process of developing SARS-CoV-2 vaccines, and strategies with all of the above vaccine types are being utilized ([Pang et al., JCM 2020](https://www.mdpi.com/2077-0383/9/3/623/htm)). The speed at which each type of vaccine can be developed can vary, with mRNA/DNA vaccine development being more rapid and subunit development more slow (read [Lurie et al. NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2005630) to learn more). A list of vaccines under clinical and preclinical development is compiled and updated by [WHO](https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines). The NYT also has an easy to follow [vaccine tracker](https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html).&#x20;

## **Summary**

Knowledge of COVID-19 pathogenesis is emerging at a lightning pace, and the evidence-basis underpinning our diagnosis and treatment guidelines are constantly under review. We as medical students and global citizens are living and learning through a formative time. Now, more than ever, it is critical for the scientific and medical community to collaborate, to innovate, and to push the frontiers of our understanding.

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

We hope that this module highlighted the frontier of basic science and translational research on COVID-19. It provides a conceptual grounding on COVID-19 pathophysiology and how this relates to evolving diagnosis, treatment, and prevention efforts to prepare you for the impacts that this disease has on society, the government, and our healthcare systems.&#x20;

We welcome your feedback on this module and on the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).<br>


# Graphic Summary & Concept Videos

## Graphic Summary

For a graphic overview summary, we recommend reviewing the Cell [Snapshot: COVID-19](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7190493/pdf/main.pdf) article created by members of the Module 1 author team after the publication of this curriculum (preview inset below):

![](https://lh4.googleusercontent.com/unLQreQqlF6M1lA3Ng8OuU8HcCv_P7hDNIE4YgvEMRCyMegA8IxWBOPehj-9MLfQAuMcIIRLVf32TNXvJXddfsX-_ibX44U2HMKxZZpgYNfn4LYuzsvJWHZbX0n6UdM08c5MoBtV)

We have also continued to update our [original graphic summary](https://tinyurl.com/MedStudentCOVID19Graphic):

![](https://lh5.googleusercontent.com/YfLFok2upsJbqkivHkhbSVPbhP9seYLJN_FdL6PNu3_7_lFHusYwFZ0MNsxsLncwZQo32JDCYw0w2tl8dn4f1KRE0DWf_6qnYBkAF5cdSSJsuWOmdNsj1ITNmlSUKAAoDTu57uA5)

## **Concept Videos**

We have made concept videos for medical professionals on leading antiviral and immune therapies for COVID-19, including mechanism, trial data and outlook:

* [Medications for COVID-19: Antivirals (Part 1)](https://tinyurl.com/COVID19MedsAntivirals)&#x20;
* [Medications for COVID-19: Immune Therapies (Part 2)](https://tinyurl.com/COVID19MedsImmuno)&#x20;
* [Therapeutic summary image](https://tinyurl.com/covid19therapeutics) (preview inset below)

![](https://lh3.googleusercontent.com/y_9m3H-jcJyS_X9ksUoQHMLbnoDuwK_tNF_z1WCbG6G3_GLzA5diB8gbqIhTLJ6dSAj7Xs-uu-S4k9M2YPMlrErGdFgRcvijesJMh2zHUmQqwCrV4bc7wG8untnB78g57aEzWS6X)


# Module 2: Epidemiology Principles

Apply epidemiological principles to describe the spread of COVID-19, and evaluate the potential impact of public health interventions via modeling and historical and contemporary examples.

*Authors:* Vineet Desai; Jessie Duggan; Jakub Glowala; Manav Gupta; Kiryung Kim; Gina Liu; Katherine McDaniel, MSc; Katherine Nabel; Himaja Nagireddy; Deborah Plana; Emily Rencsok; Connor Verheyen; Lily Zhong

*Editor:* [Himaja Nagireddy](mailto:himaja_nagireddy@hsph.harvard.edu)

*Reviewers:* Wolfram Goessling, MD, PhD; Andrea Wershof Schwartz, MD, MPH; William Hanage, PhD; Rebecca Kahn, MS; James Hay, PhD

**Update Disclaimer:** Thank you for visiting Module 2! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. Information on the last major update on 1/3/21 can be found below. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

**Highlight of Updates (1/03/21):**&#x20;

* Clarified learning objectives in [Introduction](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles) and updated [author team](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles)
* [Glossary](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles): Added definition of presymptomatic vs. asymptomatic
* Added section on differential [disease and mortality burden by race](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/where-are-we-now#disease-burden-and-mortality-by-race)
* Included information on [super spreading events](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/where-are-we-now#risk-of-superspreading-events) in nursing homes&#x20;
* Updated [South Korea Case Study](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/case-study-south-korea-2020)&#x20;
* Created the [Re-opening](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/approaches-to-long-term-planning#reopening) Section
* Added section on [Mental Health Concerns](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/where-are-we-now#epidemiology-of-mental-health-concerns-during-the-covid-19-pandemic)
* Added section on [Equitable Vaccine Distribution](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/approaches-to-long-term-planning#equitable-vaccine-distribution)&#x20;

## Introduction

In this module, we move from the biology and pathophysiology of SARS-CoV-2 to its implications at a population level. We start with an introduction to epidemiological **terms**. To understand where the epidemic is **now**, we link a curated set of continuously updating resources. Current estimates for the U.S. indicate a caseload [10-50x](https://medium.com/@tomaspueyo/coronavirus-act-today-or-people-will-die-f4d3d9cd99ca) of what is currently recognized, with asymptomatic, presymptomatic, and mildly symptomatic people as a major contributor to transmission. Next, we give an overview of the factors used to **predict** where the epidemic is going in the U.S., focusing on the concept of [exponential growth](https://www.youtube.com/watch?v=Kas0tIxDvrg\&feature=youtu.be). Mathematically and empirically, small modifications to the parameters of this growth can “[flatten the curve](https://www.washingtonpost.com/graphics/2020/world/corona-simulator/)," which lengthens the time over which severely ill people present, providing the healthcare system more time to prepare to treat patients and scientists time to test and optimize new treatment strategies to reduce mortality. At this phase, the U.S. is primarily attempting to flatten the curve by “[social distancing](https://www.ariadnelabs.org/resources/articles/news/social-distancing-this-is-not-a-snow-day/).” Modeling from the UK indicates social distancing may be required for months.

We end with three **case studies** to contextualize these epidemiology principles. The **influenza pandemic of** [**1918**](https://www.nytimes.com/2020/03/17/opinion/coronavirus-1918-spanish-flu.html) prompted different responses from three U.S. cities, with three dramatically different outcomes for morbidity and mortality. The **2009 H1N1 pandemic**, a frequent foil to COVID-19, required less disruption to control due to a lower R0 and case fatality rate, as well as faster testing, prior population immunity and pre-existing antiviral treatments. In confronting COVID-19, **South Korea** presents a contemporary example of a country that rapidly scaled up testing, contact tracing, and social distancing without nationwide lockdown, and has brought new cases to a minimum.

## Learning Objectives

By the end of this module, medical students should be able to:

* Define R0, Re, incubation period, serial interval, epidemic curve, community transmission, social distancing, and flattening the curve as they pertain to COVID-19
* Access a reliable source of the latest epidemiologic information about COVID-19
* Describe how changing epidemiological parameters changes disease dynamics
* Contrast three cases that illustrate how nonpharmaceutical interventions save lives in a pandemic

## Core Materials

* Sanderson, G. [Exponential Growth and Epidemics](https://www.youtube.com/watch?v=Kas0tIxDvrg\&feature=youtu.be). Youtube, 3.8.20
* Stevens, H. [Why outbreaks like coronavirus spread exponentially, and how to “flatten the curve”](https://www.washingtonpost.com/graphics/2020/world/corona-simulator/). Washington Post, 3.14.20.
* Scott, D. [Flattening the Curve Worked- Until It Didn't](https://www.vox.com/22180261/covid-19-coronavirus-social-distancing-lockdowns-flatten-the-curve). Vox, 12.31.20
* Bitton, A. [Social Distancing: This Is Not a Snow Day](https://www.ariadnelabs.org/resources/articles/news/social-distancing-this-is-not-a-snow-day/). Ariadne Labs, 3.20.20
* Pueyo, T. [Coronavirus: The Hammer and the Dance](https://medium.com/@tomaspueyo/coronavirus-the-hammer-and-the-dance-be9337092b56). Medium, 3.19.2020.
* Scudellari, M. [How the Pandemic May Play Out in 2021 and Beyond](https://www.nature.com/articles/d41586-020-02278-5). Nature, 8.5.2020
* Baird, R. [What Went Wrong with Coronavirus Testing in the U.S.](https://www.newyorker.com/news/news-desk/what-went-wrong-with-coronavirus-testing-in-the-us) New Yorker, 3.16.20
* Barry, J. [The Single Most Important Lesson From the 1918 Influenza](https://www.nytimes.com/2020/03/17/opinion/coronavirus-1918-spanish-flu.html). New York Times, 3.17.20.


# Introduction to Epidemiological Terms

## Epidemic Parameters

**Attack rate/ratio:** Refers to the (number of new cases of disease)/(population at risk) during a specified time interval. Generally, the time interval here is defined as “the duration of the outbreak.” ([CDC](https://www.cdc.gov/csels/dsepd/ss1978/glossary.html))

**R0 (basic reproduction number or “R naught”):** Refers to the estimated contagiousness of an infectious agent and is affected by its biological features as well as human behaviors. Generally, it refers to the average number of people an infectious person is expected to infect in an entirely susceptible population (i.e., no immunity or vaccination). For this reason, R0 is by definition unaffected by vaccination but it can change over time and place and is not a constant of the disease (i.e., an outbreak of a disease can have a different R0 the second time there is an outbreak in the same place if population density is higher). R0 can also be mathematically defined as follows:

$$
R\_{0} = \beta \*  \kappa \* D
$$

in which **β** is the risk of transmission per contact, **κ** is the contact rate, and **D** is the duration of infectiousness. ([CDC](https://wwwnc.cdc.gov/eid/article/25/1/17-1901_article))

**Re (effective reproduction number):** The same as R0 without the assumption that everyone is susceptible. As a formula,

$$
R\_e = R\_o \* X
$$

where X is the proportion of the population susceptible. Therefore, vaccination would decrease X and correspondingly the Re value. Additionally, as more people are infected with a virus, more individuals become immune to reinfection from the virus, and X decreases. When Re < 1, the total number of infected persons declines, and the outbreak dies out. Re = 1 would keep numbers stable, and Re > 1 would lead to continued growth in the numbers of infected persons. Re gives an idea of transmission over time and is useful for monitoring during an outbreak, as compared to R0, which is most useful in forecasting potential severity and spread at the start of an outbreak. ([CDC](https://wwwnc.cdc.gov/eid/article/25/1/17-1901_article), [Giesecke 2002](https://books.google.com/books/about/Modern_Infectious_Disease_Epidemiology_S.html?id=lHSBQgAACAAJ))

**Doubling time:** The period of time required for the number of infected individuals in a population to double. ([Vynnycky and White, 2010](http://anintroductiontoinfectiousdiseasemodelling.com/))

**Epidemic curve:**  A graph of cases vs. time. Most graphs being used in articles are examples of this type of curve. Epidemic curves are most often presented as the number of new (incident) cases over time, though may also be presented as the cumulative number of cases. It can be used to make predictions about how well interventions are working and compare across different communities. Like any graph or curve, it is only as reliable as the data it is based on. ([CDC](https://www.cdc.gov/training/quicklearns/createepi/index.html))

**Community transmission:** Refers to transmission occurring between people within the same community. This phenomenon is separate from people acquiring the infection while traveling or due to close contact with someone who visited an area with the infection as it implies that there are unknown cases spreading the infection locally. ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/downloads/community-mitigation-strategy.pdf))

**Case-fatality rate (CFR):** The percentage of patients with the disease (cases) who die from the condition. This is sometimes referred to as the case-fatality ratio as it is strictly speaking a proportion, not a rate. This measure is often used as a proxy for the severity of a disease. Mathematically it can be defined as:

*Number of cause-specific deaths among incident cases* \
*\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_*\
&#x20;                  *Total number of incident cases*

Note that incomplete data can skew the CFR. For example, if severe cases are more likely to be diagnosed than milder cases, then the denominator would be artificially lowered relative to the numerator and CFR would be inflated. Conversely, if many people were dying of the cause without being diagnosed (e.g. at home without interfacing with the medical system), the CFR could be artificially lowered. ([CDC](https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section3.html))

**Mortality rate:** The number of people who died in a defined population for a given time interval. For this reason, it is often expressed as x deaths per 100,000 people. The denominator is the entire population at risk per time studied, and is generally multiplied by 10,000 or 100,000 to make the number comparable to other populations or diseases. Unlike case-fatality rate, this measure is not a proxy for severity, as it does not look only at infected persons, but rather estimates mortality attributable to the disease across the population. ([CDC](https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section3.html))&#x20;

**Asymptomatic vs Pre-symptomatic:** The term “asymptomatic” is a patient who will never develop symptoms but carries the infection. Patients who are not yet symptomatic but become symptomatic later were actually “pre-symptomatic” at the time they did not have symptoms ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html)). These two terms caused some confusion in the public sphere as the term asymptomatic is sometimes erroneously used to encompass both groups, but strictly speaking they are separate and likely have different likelihoods of infecting others ([Twitter](https://twitter.com/XihongLin/status/1270334436895264769)). Difficulty arises with distinguishing the two at the time they are diagnosed. The only way to know if a patient is pre-symptomatic is to follow-up with them and see if they develop symptoms. If they do, then they were pre-symptomatic; if not, they were asymptomatic. Importantly, both terms are dependent on what the case-defining symptoms are accepted to be. For example, once loss of smell was recognized as a COVID-19 symptom, many previously “asymptomatic” patients who only had this symptom would be better reclassified as symptomatic cases.

## Case Descriptors

**Incubation period:** The period of time between exposure to a pathogen and onset of first *symptoms*. ([CDC](https://www.cdc.gov/training/QuickLearns/exposure/2.html))

**Latent period:** The period of time between exposure to a pathogen and onset of *infectiousness*. Note that the latent period can be shorter than the incubation period, leaving a window of pre-symptomatic infectiousness. In addition, virus transmission can happen even with a person that ultimately does not develop symptoms, known as asymptomatic infectiousness.

**Serial interval:** The period of time between symptom onsets in an infector-infectee pair. This period is often used as a proxy for **generation interval**, which is the period of time between infection of an infector-infectee pair. The serial interval helps determine the speed with which an outbreak spreads, and along with Re is a key parameter for how “steep” or “flat” an epidemic curve will appear.

![Adapted from Giesecke, J. Modern Infectious Disease Epidemiology. 2002.](https://lh6.googleusercontent.com/JuXtFn-a7Bq8rz5QTO0taFwFNFbHKmHSDGwUm4ZWQu5OBytoraQTTQ_BwHOEp9x7lA5ePxJl5FwD7tY0TmHg3vCoozyQ7qj7eZkBmmMmYBuoDaSNIEwT9HsU3fsodKfUIaCLp3Wr)

## Non-Pharmaceutical Interventions

### Containment and Suppression

**Contact tracing:** An intervention in which close contacts of known cases are traced, notified of their potential exposure, and encouraged to self-quarantine. Relies on speedy testing and significant effort for each case.

**Quarantine:** An intervention that separates and restricts the movement of people who were exposed to a contagious disease to see if they become sick. Individuals can also choose to self-quarantine. ([CDC](https://www.cdc.gov/quarantine/index.html))&#x20;

**Isolation:** Separation of sick people with a contagious disease from those who are not sick. Individuals can also choose to self-isolate. ([CDC](https://www.cdc.gov/quarantine/index.html))

### Mitigation

**Social distancing:** A [public health practice](https://hub.jhu.edu/2020/03/13/what-is-social-distancing/) that aims to prevent sick people from coming in close physical contact with healthy people in order to reduce opportunities for disease transmission. It can include large-scale measures like canceling group events or closing public spaces, as well as [individual decisions](https://medium.com/@ariadnelabs/social-distancing-this-is-not-a-snow-day-ac21d7fa78b4), such as avoiding crowds. The goal of these interventions is to avoid infecting high-risk populations and “flatten the curve.”

**Peak:** The largest value reached on anthe epidemic curve of incident cases. This value generally refers to the maximal number of patients infected in a single short time period (e.g. day, week) in the course of an epidemic. Many mitigation strategies are aimed at reducing this peak in order to minimize the number of cases at any given time and reduce the strain on the healthcare system at any given time. ([CDC](https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section11.html))

**Medical surge capacity:** The ability of a medical system to provide medical care for an increased volume of patients or an increased medical demand of patients beyond the normal operating capacity. Therefore, when discussing trying to minimize the surge of the pandemic, we are referring to reducing the demand on the health care system. ([PHE.gov](https://www.phe.gov/Preparedness/planning/mscc/handbook/chapter1/Pages/whatismedicalsurge.aspx))

**Flattening the curve:** The concept is based on the reality that the healthcare system can only handle a limited number of sick patients at one time. Measures to “flatten the curve” attempt to slow the spread so that there are fewer cases at any one time (however, cases are spread out over a longer period of time) and the healthcare system is capable of providing appropriate care without being overwhelmed. Failing to do so increases the spread of the infection and the case fatality rate as the healthcare system is unable to provide appropriate care to every patient. Should improvements in treatment occur, a larger proportion of the infected population will have access to appropriate treatment. Should a vaccine be developed, more people will gain immunity that way rather than by getting sick.

*Note: flattening the curve does not necessarily mean that fewer people will become infected and require medical care in total - the area under the curve is not necessarily reduced (even though many graphs on the Internet might suggest otherwise)*

![](https://lh5.googleusercontent.com/p6vpfE1XTzmhdaALgyghn0X6vFAqaPcCn2wcOOwC6JADJD-YmUWXRXNbJF-zGtMcTV4_1Boe8wn-82gFNueIZi-65woTT4uvG2sZ6VnhzrpPwosaH9_7gMpdasKHnilo8Tb4fMUr)


# Where Are We Now?

The following is a set of basic figures about the epidemic as a snapshot, which will be updated in this document as we receive new information.

## Case Numbers

* Simple [map](https://www.cnn.com/2020/03/03/health/us-coronavirus-cases-state-by-state/index.html?utm_term=image\&utm_content=2020-03-16T18:50:07\&utm_medium=social\&utm_source=twCNN) of the US
* More complete global [map](https://coronavirus.jhu.edu/map.html) and associated [publication](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2820%2930120-1/fulltext) from Johns Hopkins, featuring data from a variety of sources.
* Additional [maps and resources](http://www.cidrap.umn.edu/covid-19/maps-visuals)

Reported cases *underestimate* the total number of cases due to the [incubation period](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#case-descriptors), [asymptomatic or presymptomatic carriers](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/where-are-we-now#asymptomatic-transmission), limited testing availability, and delays in receiving testing results after the initial onset of symptoms. The following resource is an excellent explanation of this phenomenon working from data publicly available in early March.

**CORE TEXT:** [**Pueyo - Coronavirus: Why You Must Act Now. 3/10/20. Medium.**](https://medium.com/@tomaspueyo/coronavirus-act-today-or-people-will-die-f4d3d9cd99ca)

Based on previous epidemics, it is estimated that for every 1 case that is reported, there may be as many as 10-50 other cases that we don’t know about. So when you hear “confirmed cases,” mentally multiply that number by 10 to have an idea of the disease incidence ([NYTimes U.S. Coronavirus Map](https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html), [Lipsitch M. Presentation 3.16.20](https://drive.google.com/file/d/1VvRoIRi8GjatUhlaWh0BAYRC-yemi3pv/view?usp=sharing)). One way to get a better estimate for the true prevalence of COVID-19 and future pandemics is ongoing surveillance testing ([Lipsitch et al. NEJM 3.26.20](https://www.nejm.org/doi/full/10.1056/NEJMp2002125)). For more on these principles, here is a supplementary [video](https://www.youtube.com/watch?v=mCa0JXEwDEk) on how to accurately estimate actual COVID-19 cases based on reported data.

{% embed url="<https://ourworldindata.org/grapher/total-cases-covid-19?yScale=log&country=OWID_WRL+KOR+USA+ITA>" %}
Continuously updating number of cases worldwide, with U.S., Italy and South Korea for comparison. From Our World in Data
{% endembed %}

## Case Fatality Rate

Patients diagnosed with SARS-CoV-2 worldwide have a widely variable chance of death. Initial estimates from U.S. cases are [1.8-3.4%](https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e2.htm?s_cid=mm6912e2_w) (see table below).&#x20;

**Overall case fatality rate (CFR)** is difficult to discern because we are, for the most part, testing patients with more severe disease. The oft-quoted 2% CFR primarily comes from the largest epidemiologic report out of China that showed an overall CFR of 2.3% (1023/44672) ([Zhang et al, CCDC 2020](http://weekly.chinacdc.cn/en/article/id/e53946e2-c6c4-41e9-9a9b-fea8db1a8f51)). The numerator here is the number of deaths in this cohort, which may be an underestimate because deaths lag behind new cases. The denominator is the number of CONFIRMED cases of COVID-19 in this cohort, which may also be an underestimate due to lack of testing of the general population and presence of asymptomatic cases. There is currently no way - particularly with how little surveillance screening is being performed - to determine the TRUE number of COVID-19 cases in this cohort or others like it, given that many patients are asymptomatic or mildly symptomatic and never present for care or testing.&#x20;

Of note, reports from Italy suggest a much higher CFR than seen in China, hovering around 8% ([Lazzerini et al., Lancet 2020](https://www.thelancet.com/journals/langlo/article/PIIS2214-109X\(20\)30110-8/fulltext)). It is possible that this too is due to the lack of surveillance testing, but it may be due to inadequate medical resources from a healthcare system overburdened by the fast expansion of the epidemic in the region. The high disparity between the CFRs in China and in Italy warrant further attention as the US continues to respond to the pandemic. An additional point from the Chinese data is that there was a large disparity between the CFR in Hubei province (2.9%), which includes Wuhan, and outside of Hubei province (0.4%), suggesting that healthcare capacity is likely playing a role in the lethality of COVID-19. and is a major driver behind the “flatten the curve” movement, as described in the remainder of the module ([Wu et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2762130)). It is important to note that since it takes 1-2 weeks for newly infected patients to develop symptoms, there is at least a corresponding 1-2 week delay to see the effect of new interventions on infection and mortality rates ([Fauci et. al., 2/2020](https://www.nejm.org/doi/full/10.1056/NEJMe2002387); [Lipsitch M., Presentation 3/2020](https://drive.google.com/file/d/1VvRoIRi8GjatUhlaWh0BAYRC-yemi3pv/view?usp=sharing)).

The CFR is widely variable along axes of age and race. Relatively low (0.01-0.02%) amongst youth and people in their 30’s and 40’s, case fatality rate begins to rise past age 50. By age 80 the case fatality rate is 15%, at least five times higher than the average ([WHO, 2020](https://www.who.int/docs/default-source/coronaviruse/covid-strategy-update-14april2020.pdf?sfvrsn=29da3ba0_19\&download=true)).

![Severe Outcomes among Patients with COVID-19, February 12-March 16, 2020](https://lh4.googleusercontent.com/mWi7QZk9OodAFs9vUT7X7Pq9_AxxoYS5I9Jdrd1F7StGWsMik179z7jfeZa-M-bVwa0AF2JwCLKRMDpqXseDsIbHlcrAzjxOdC_EuZB_HgVKWgJVXcjn-yCloZqeYFnUhC_Cb5eM)

## Disease Burden and Mortality by Race

\
Racial inequities that permeate the healthcare system have been brought to light, although they have existed long before the COVID-19 pandemic. Racial minorities, especially Black, Indigenous and Latinx populations are experiencing greater disease burden and mortality from COVID-19 pandemic. This is not a surprise - as early as March, epidemiologists [warned](https://www.nytimes.com/2020/03/01/upshot/coronavirus-sick-days-service-workers.html?smtyp=cur\&smid=fb-nytscience\&fbclid=IwAR15BgPKyZJq4TflltoMqiLU6D1XQA99Lvcv7FPSsSITo8grGr8jn4lXpUk) that differential access to precautionary measures will disproportionately impact low-income communities and racial minorities, which are closely related social factors in the United States, due to racist policies.<br>

If racial minority groups had died at the same rate of White Americans, at least 14,400 Black Americans, 1,200 Latino Americans and 200 Indigenous Americans would still be alive ([APM Research Lab 2020](https://www.apmresearchlab.org/covid/deaths-by-race)). Navajo Nation’s COVID-19 infection rate is 10 times higher than the general population of Arizona. The [Boston Globe](https://www.bostonglobe.com/2020/05/09/nation/disparities-push-coronavirus-death-rates-higher/) reported that compared to prior years, there was a surge of excess death rates in communities with higher percentages of populations of color, especially Black folks, and independently with higher poverty, and higher crowded housing. Millett et al., ([2020](https://dx.doi.org/10.1016%2Fj.annepidem.2020.05.003)) found that counties with a higher proportion of Black residents had more COVID-19 diagnoses and deaths, even after adjusting for age, poverty, comorbidities and epidemic duration. That said, controlling for race, race-based co-morbidities, and area of residence, Black patients are not inherently more predisposed to COVID-19 morbidity and mortality ([Boulware et al., JAMA, 2020](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2769381)).

[Ajilore and Thames](https://doi.org/10.1016/j.bbi.2020.06.003) explore the biological consequences of structural racism and discrimination in the COVID-19 era, building upon a large body of work examining biological stress effects of racism ([1](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6532404/),[2](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4580597/),[3](https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2018.304766)). Although more studies are being done to show and explain racial inequities in the COVID-19 pandemic, the evidence is already clear that Blacks, Indigenous and People of Color are experiencing disproportionate morbidity and mortality. It is important to note that the higher disease risk cannot only be explained by race and other co-morbidities. Varying risk of  exposure, for example, with a high percentage of Blacks and Latinos part of the essential work force, also exacerbates COVID-19 disease and mortality burden ([Boulware et al., JAMA, 2020](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2769381)).

## Epidemiology of Mental Health Concerns During the COVID-19 Pandemic

The COVID-19 pandemic has taken a severe toll on the physical health of populations around the world, and its effects on community mental and emotional health are also becoming increasingly clear. Mental health challenges can arise from both the disease itself (being ill or knowing others suffering from the disease) and from the risk-mitigation measures set in place to control the outbreak of the SARS-CoV-2 virus (ex. social distancing). The following study from the [CDC Morbidity and Mortality Weekly Report](https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm) (8.14.20) presents survey results from 5,412 adults in the U.S., looking at their mental health, substance abuse, and suicidal ideation.&#x20;

* 40.9% reported having at least “one adverse mental or behavioral health condition”.&#x20;
* 30.9% reported symptoms of an anxiety disorder or a depressive disorder, with these symptoms being 3.15 times and 3.74 times more prevalent, respectively, than seen for the same time period in 2019.&#x20;
* 26.3% reported symptoms of a “trauma and stressor-related disorder (TSRD) related to the pandemic”.&#x20;
* 13.3% reported increasing their substance use to cope with stressors of the pandemic. This finding was most common among Black individuals (18.4%).&#x20;
* 10.7% seriously considered committing suicide within the past 30 days. This finding was significantly higher among certain subsets of the population.
  * 18-24 year olds: 25.5% considered suicide
  * Hispanic people: 18.6% considered suicide
  * Black people: 15.1% considered suicide
  * Unpaid caregivers for adults: 30.7% considered suicide&#x20;
  * Essential workers: 21.7% considered suicide&#x20;

While this study did not directly identify factors responsible for changes in mental health, several proposals include: impacts of social isolation, lack of school/work structure, unemployment, financial concerns, and violence/abuse (physical, emotional, mental, or sexual). These factors and their influence on individuals’ mental health during the COVID-19 pandemic are areas for future research.&#x20;

Nearly everyone has been impacted by COVID-19 in some way, but certain populations of individuals in the U.S. have been disproportionately affected by adverse mental health conditions. These populations include young adults (ages 18-24), Hispanic people, Black people, unpaid caregivers for adults, and those who were receiving psychiatric treatment prior to the pandemic. Mental health thus provides a new lens through which health inequities in America can be identified and addressed. Several systemic approaches to reducing these disparities during the COVID-19 pandemic include providing increased financial support, address the impact of racism on peoples’ mental health, supporting those at risk for suicide, and providing services to those struggling with increased substance use.

## Asymptomatic Transmission

![A difference between latent period and incubation period can lead to a period of asymptomatic communicability. The period of communicability may also extend beyond the duration of symptoms. Figure from Wikimedia, contributor Patilsaurabhr.](https://lh5.googleusercontent.com/uc-9xhbQCaLFcv4TbrhLg3MQD98NDX6FH3fpQ779NCTQ6BgcZWVSN9ACpDp11orFcjndq9-eMFplm_ynPcp202nhH73Asa79JHVluGPv6Z7IHQfvACUzJag_B7cboXYEPy8vJGEJ)

Recall that the **latent (presymptomatic) period**, or time from exposure to transmissibility, can differ from the **incubation period,** or time from exposure to first symptoms (see figure above, from [Wikimedia](https://upload.wikimedia.org/wikipedia/commons/thumb/0/04/Concept_of_incubation_period.svg/330px-Concept_of_incubation_period.svg.png)). Several sources of evidence suggest SARS-CoV-2 has a shorter latent period than incubation period, opening the door for presymptomatic transmission. Current estimates of the SARS-CoV-2 incubation period, from initial exposure to symptom onset, range from 1-14 days with a median of 5 days, an interquartile range from 4.5 to 5.8 days ([Wiersinga et al., JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2768391)), and 95th percentile of 12 days ([Lauer et al., Ann Intern Med 2020](https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported); [Li et al., NEJM 2020](https://www.nejm.org/doi/10.1056/NEJMoa2001316?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov)). Meanwhile, analyses of infector-infectee pairs show a mean serial interval of 4.0 days \[95% CI 3.1, 4.9] ([Nishiura et al., March 2020](https://www.ncbi.nlm.nih.gov/pubmed/32145466)), though this varies by location; Shenzhen data, for example, had a serial interval of 6.3 days ([Bi et al., medRxiv March 2020](https://www.medrxiv.org/content/10.1101/2020.03.03.20028423v1.full.pdf)). Generation intervals in case clusters in Tianjin, China are estimated to be 3.95 \[95% CI 3.01-4.91] days and in Singapore to be 5.20 \[95% CI 3.68-6.78] days **(**[Ganyani et al., Euro Surveill. March 6 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201952/pdf/eurosurv-25-17-3.pdf)**).** Put together, these estimates imply a period of presymptomatic transmissibility. (For more on the basic biology of transmission, see [Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/basic-virology-and-immunology#transmission-dynamics).)

It is becoming increasingly clear that most new confirmed COVID-19 cases (an estimated 79%, from models based on data from Wuhan) are likely spread by people that show mild or no symptoms of the disease ([Ruiyan et al., Science 3/2020](https://science.sciencemag.org/content/early/2020/03/13/science.abb3221)). Similarly, data from case clusters in Tianjin, China and Singapore give rise to estimates of 48-77% asymptomatic transition ([Ganyani et al., Euro Surveill. March 6 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201952/pdf/eurosurv-25-17-3.pdf)). Social isolation, especially of young, healthy, asymptomatic people, will be critical to controlling disease spread.

Patients may be able to transmit the virus for a prolonged period of time, as SARS-CoV-2 RNA has been detected in patients for an average of 20 days, lasting as long as 37 days ([Zhou et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2820%2930566-3/fulltext#seccestitle10)). However, detection of RNA does not necessarily indicate the presence of live virus, and it is still unclear for how many days patients remain infectious.

## **Airborne vs. Droplet Transmission of SARS-CoV-2**

At the end of March 2020, the World Health Organization released a scientific brief detailing the main routes of transmission of COVID-19 ([WHO, 27 Mar 2020](https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations)). In the brief, there is a clear distinction made between large respiratory particles (>5-10 microns in diameter) and small respiratory particles (<5 microns in diameter) (**FIG. 1**). Large particles are often referred to as “respiratory droplets” while small particles are often referred to as “aerosols” or “droplet nuclei.” At the time, the WHO, along with the CDC, believed that COVID-19 was spread via large respiratory droplets (>5-10 microns) at a very close range (1-2 meters) ([Roberts, 6 Oct 2020](https://www.bbc.com/news/health-54435240)). Airborne transmission via small particles was considered highly unlikely except for a few specific circumstances (e.g. endotracheal intubation in the ICU). Given these assumptions, both organizations recommended 2-meter social distancing guidelines and frequent hand-washing in order to decrease the probability of infection from “large” respiratory droplets. The public health authorities hoped that these [non-pharmaceutical interventions would reduce community spreading events to help to flatten the curve](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#non-pharmaceutical-interventions).&#x20;

![](https://lh5.googleusercontent.com/dgjHmqf9m9Da-bJw0FEsoRQrwxIvZ3SISAxqM2KUGbochck04rpFgHyYMjML8e214wD9GsnlYgnOnVLl7iCHw3668RbV0Oc6V-X1RiJ4WxPtyYIUpFzF-lx5fZAvbKwL9gZm-9us)

**FIGURE 1.** Droplet Transmission vs Airborne Transmission Dichotomy (modified from [Roberts, 2020](https://www.bbc.com/news/health-54435240))

Though oft-repeated, the 5-10 micron cutoff between large and small particles is arbitrary. The large vs. small droplet dichotomy and the 2-meter social distancing rule are based on science from the 1950s and earlier ([Wilson et al., 20 Aug 2020](https://www.bmj.com/content/370/bmj.m3206)). In reality, respiratory particles occur along a wide continuum of sizes that depend strongly on both the particle generation procedure (e.g. sneezing, talking breathing) and on the ambient conditions (e.g. temperature, humidity, ventilation). In early July of 2020, a group of 239 scientists released an open letter requesting that public health organizations recognize the potential for airborne COVID-19 transmission ([Morawska and Milton, 6 Jul 2020](https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa939/5867798)). Most of the coronavirus prevention measures were focused on large droplet precautions, and the authors argued that although such measures were necessary, they would be insufficient if airborne transmission was also a possibility. Though our understanding of COVID-19 is still incomplete, laboratory studies, computational models, and retrospective case studies all suggest the potential for aerosol transmission of SARS-CoV-2 ([Stadnytskyi et al., 4 May 2020](https://www.pnas.org/content/117/22/11875?luicode=10000011\&lfid=231522type%3D1%26t%3D10%26q%3D%23%E6%A2%A6%E6%A2%A8%E8%8D%80%E7%BA%B3h88%23\&featurecode=20000320%E3%80%8A%E6%BA%AB%E6%9A%96%E7%9A%84%E5%BC%A6%E3%80%8B%E5%AE%98%E6%96%B9%E5%BE%AE%E5%8D%9A\&u=https%3A//www.pnas.org/content/early/2020/05/12/2006874117) and [Chen et al., 10 Apr 2020](https://www.sciencedirect.com/science/article/pii/S0360132320302183?casa_token=3Y-nsqyS3zwAAAAA:u2rDkbDBrqkpbwNnQKM01uwUkRSjtHAoz4wytQP06peCLXCvBbGYoGwwoj1TLqywxk71jSaIGUw) and [Miller et al., 26 Sep 2020](https://onlinelibrary.wiley.com/doi/full/10.1111/ina.12751?casa_token=xp-iyPAYVzsAAAAA%3AoL5au0jZ24jf_GPVjrmkHm3kicG3tCxYwsEEeyKMTKz9wRhB6hK-lZXm8VWIZ0gB305uKf0MzlPvox0g)).&#x20;

Eventually, the WHO and CDC recognized that airborne transmission was possible, but widespread support for and adoption of appropriate countermeasures has been lagging ([WHO, 09 Jul 2020](https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions) and [WHO, 23 Jul 2020](https://www.who.int/docs/default-source/coronaviruse/risk-comms-updates/update-33-trasmission.pdf?sfvrsn=9b1b10aa_2) and [CDC, 05 Oct 2020](https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html)). Airborne transmission naturally has a number of important implications for public health guidelines, particularly for indoor settings ([Morawska and Cao, Jun 2020](https://www.sciencedirect.com/science/article/pii/S016041202031254X)).  For example, [infectious individuals without symptoms](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#epidemic-parameters) may generate fewer large droplets if they aren’t sneezing and coughing, but they can still generate large volumes of small particles through normal breathing and speaking. Such aerosols can accumulate indoors and also spread well beyond the currently-prescribed 2-meter (6 feet) distancing guidelines. Factors like indoor occupancy, duration of contact, adherence to masking, adherence to distancing, mode of respiratory particle generation procedure, and level of indoor ventilation all substantially affect the probability of a successful transmission event (and therefore the [R0](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#epidemic-parameters) value as well).

![](https://lh4.googleusercontent.com/IF5h-bbpWS-geQ71XKcKd9HRm90hFpG9U82i1GFp5kY6xO8AJ0-o8X5oWFVlychWJzkMA8xEdvTnWlJ1JmBV2tvtRVYUrjddefIyEdze_SAvinSm5vXtPjYpKEQOyt2VCJH_Awbf)

**FIGURE 2.** Masks reduce droplet and airborne transmission (modified from [Prather et al., 6 Jun 2020](https://science.sciencemag.org/content/368/6498/1422))

Overall, appropriate mask-wearing has emerged as one of the most consistently-effective measures to reduce COVID-19 spread ([Prather et al., 6 Jun 2020](https://science.sciencemag.org/content/368/6498/1422) and [Peeples, 6 Oct 2020](https://www.nature.com/articles/d41586-020-02801-8)) (**FIG. 2**). Exposure is maximized when neither infectious nor susceptible individuals are wearing masks, while exposure is limited when both infectious and susceptible individuals are wearing correctly-fitted masks. Given the multi-faceted nature of the problem, some authors have argued for a more nuanced framework to describe COVID-19 [transmission risk](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#epidemic-parameters) ([Jones et al., 25 Aug 2020](https://www.bmj.com/content/370/bmj.m3223)). If we assume that symptomatic individuals (with high viral load and violent respiratory events) are appropriately self-isolating, the probability of transmission between asymptomatic/presymptomatic individuals and susceptible individuals will vary according to metrics like occupancy, ventilation, masking, and type of respiratory event (**FIG. 3**). Thus, universal adoption of masking, optimization of ventilation, and de-densification strategies should be combined with other [containment/mitigation strategies to reduce the spread of COVID-19](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#non-pharmaceutical-interventions). <br>

![](https://lh6.googleusercontent.com/JsrreA0b107v8fQ1TadIOPHnpCufrqzj9oPk2mRTL7DriTg0hpI3fp9eMiXVBis_tMVY-hegi3QG6bJ5EBwZrlFsB4my0PzXvFC6SiIwXAnvT0Ru7navgBJThDPJ1U3dZs8jwRlR)

**FIGURE 3**. COVID-19 Transmission Risk in Different Circumstances (modified from [Jones et al. 25 Aug 2020](https://www.bmj.com/content/370/bmj.m3223))

## **Risk of Superspreading Events**

In an epidemic, superspreaders are individuals who are more likely to infect other people, compared to the average infected person. The question is: how many individuals can a superspreader infect? Let’s first turn to how epidemiologists define superspreaders.&#x20;

While many loose definitions of super-spreading events (SSEs) exist, [Lloyd-Smith et al.](https://www.nature.com/articles/nature04153) published a protocol to identify superspreading events. According to this protocol, one needs to:

1. Estimate the R for the disease and population being studied
2. Construct a Poisson distribution with mean R and expected range Z due to stochasticity without individual variation
3. Define an SSE as any infected person who infects Z(n) others, where Z(n) is the nth percentile of the Poisson distribution.&#x20;

Thus, a 99th-percentile SSE would be a case that causes more infections than would occur in 99% of case histories in a homogeneous population.&#x20;

SSEs, therefore, depend on the disease and the population. During the 2003 SARS outbreak, epidemiologists defined a super-spreader as an individual that could transmit SARS to at least 8 other individuals ([Shen et al., Emerging Infectious Diseases 2004](https://wwwnc.cdc.gov/eid/article/10/2/03-0732_article)). In one of the most famous superspreading cases of the [SARS outbreak](https://www.cell.com/cell-host-microbe/fulltext/S1931-3128\(15\)00382-0?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1931312815003820%3Fshowall%3Dtrue#fig1), a physician who had treated SARS patients traveled to the Hotel Metropole in Hong Kong and infected at least 13 other people on his floor. These individuals left the country, spreading the disease to Canada, Vietnam, and Singapore. The single imported case to Canada resulted in 128 cases at a Toronto hospital. During the 2014-2015 Ebola outbreak, SSEs were also found to play a key role in sustaining the epidemic. One study by [Lau et al.](https://www.pnas.org/content/114/9/2337) found that 3% of cases were responsible for 61% of infections. SSEs were also reported in the 2015 [MERS outbreak](https://www.cell.com/cell-host-microbe/fulltext/S1931-3128\(15\)00382-0?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1931312815003820%3Fshowall%3Dtrue#fig1), when a 68-year-old male traveled to Bahrain, the United Arab Emirates, Saudi Arabia, and Qatar before returning to South Korea. This index patient led to 29 secondary infections. Two of these secondary cases were shown to be responsible for 106 subsequent infections, out of 166 cases known at the time. Approximately 75% of cases in the MERS-CoV outbreak in South Korea could be traced back to these three superspreaders.&#x20;

As SARS-CoV-2 continues to spread, several reports of SSEs have emerged. In South Korea, a cluster of cases was linked to a 61-year-old woman known as “Patient 31,” who attended church services in the city of Daegu. By [February 20, 2020](https://www.theguardian.com/world/2020/feb/20/south-korean-city-daegu-lockdown-coronavirus-outbreak-cases-soar-at-church-cult-cluster), South Korea reported a total of 82 infections, of which 37 cases were linked to her. The Korean Centre for Disease Control (KCDC) called this event a [super-spreader event](https://www.businessinsider.com/shincheonji-church-cult-south-korea-super-spreader-coronavirus-spike-2020-2). (Read more about this case in the [South Korea case study](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/case-study-south-korea-2020#strategy-for-mitigation-social-distancing).) Several other countries have also reported SSEs during the COVID-19 outbreak. According to the [WHO](https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200213-sitrep-24-covid-19.pdf?sfvrsn=9a7406a4_4), a British man who traveled from a conference in Singapore to a ski trip in the French Alps in late January reportedly infected 11 other people in the ski village. [The New York Times](https://www.nytimes.com/2020/03/23/us/coronavirus-westport-connecticut-party-zero.html) reported a case of super-spreading in the suburb of Westport, Connecticut, after 50 guests gathered on March 5 for a 50th birthday party. On the day of the party, Westport did not have a single known COVID-19 case. By March 23, Westport had 85 cases, reflecting a 40-fold change in cases in 11 days. In Massachusetts, the annual leadership meeting of the pharmaceutical company, Biogen, February 26-27th was found to be responsible for [99 in-state cases](https://www.nytimes.com/2020/04/12/us/coronavirus-biogen-boston-superspreader.html), as well as the first confirmed cases in several other states.

One of the most significant SSEs in the US has been in nursing homes (see [Module 3](https://www.bostonglobe.com/2020/05/02/nation/rate-coronavirus-deaths-mass-long-term-care-facilities-among-highest-nation/) for more information on infection spread in nursing homes). The [New York Times](https://www.nytimes.com/2020/09/05/opinion/sunday/coronavirus-nursing-homes-deaths.html) reports that residents and staff of long-term care facilities account for almost 40 percent -- around 68,000 -- of all COVID-19-related deaths in the US as of September 5th. In Massachusetts, nursing home deaths account for over 60% of all deaths in the state, per the [Boston Herald](https://www.bostonherald.com/2020/08/08/massachusetts-senior-care-association-chief-worries-about-testing-ppe-as-coronavirus-creeps-back/) in August 2020. Data from the [CDC](https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#AgeAndSex) shows that over half of all COVID-19 fatalities in the US are in the over-75 population as of September 2020. Research suggests that older people have paid a higher toll in COVID-19-related mortality than other age groups due more severe clinical presentations caused by frailty ([Maltese et al., Journal of Clinical Medicine 2020](https://www.mdpi.com/2077-0383/9/7/2106/pdf)). To prevent further spreading of SARS-CoV-2 in long-term care facilities, states like Maryland, as highlighted by the [Washington Post](https://www.washingtonpost.com/local/coronavirus-dc-maryland-virginia/2020/09/10/880407c8-f36e-11ea-b796-2dd09962649c_story.html) in September 2020, are deploying thousands of rapid SARS-CoV-2 antigen tests to mass screen nursing home populations. This response is a part of a novel effort to adapt response models typically used for natural disasters and deploy teams of responders (including medical workers, emergency responders, etc.) to help nursing homes handle outbreaks in their facilities, according to the [New York Times in August 2020.](https://www.nytimes.com/2020/08/18/health/Covid-nursing-homes.html) Maryland is but one of several states such as Massachusetts, Florida, Texas, New Jersey, Ohio, Wisconsin, and Tennessee who are also adapting such large-scale epidemiological response methods.&#x20;

SSEs play a critical role in both the early explosive growth of epidemics and sustained transmission in later stages. SSEs are worrisome because they are inherently difficult to predict and therefore, even more difficult to prevent. The best prevention and mitigation strategies rely on quickly recognizing and studying SSEs. According to a study by [Frieden et al.](https://wwwnc.cdc.gov/eid/article/26/6/20-0495_article) (2020), **several actions can help to reduce the impact of SSEs to better control COVID-19**, including: 1) understanding their transmission dynamics, 2) identifying and mitigating high-risk settings for SSEs, 3) strictly adhering to protocols for infection prevention in healthcare settings, and 4) quickly implementing nonpharmaceutical interventions, such as closing schools, canceling public events, and imposing city lockdowns. Interventions such as these seek to reduce the impact of SSEs, as well as reduce the risk of future SSEs. \
\
*Thought Questions:*

1. How would you talk with [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian) about the importance of speedy social distancing, including with peers? (For a more extensive dive into this task, stay tuned for [Module 5](https://curriculum.covidstudentresponse.org/module-5-communicating-about-covid-19).)
2. Given what you already know about SARS-CoV-2, why might it be giving rise to so many super-spreading events? In your answer, incorporate epidemiological concepts defined at the beginning of the Module.


# Where Will We Be Next?

Many models for the expected impact and spread of the virus are being shared on social media and reported in popular news. Below, we hope to point you to a couple of such models and provide a basic introduction to the assumptions that they use and their key conclusions about what we can do to slow the spread of the virus.

## Common Assumptions about Virus Spread

* Almost everyone in a population is **susceptible** to be ill because our immune systems have not recognized an organism like this before.
* Current estimates for **R0** vary, considered to be somewhere between 2-4.  This means each infected person will transmit the virus to 2-4 other people during the course of their illness. Most models assume a value of around 2.3 ([Tuite et al. 2.5.20](https://annals.org/aim/fullarticle/2760912/reporting-epidemic-growth-reproduction-numbers-2019-novel-coronavirus-2019-ncov)), which is higher than the estimated R0 for the seasonal flu (\~1-2) ([Callaway et al. 3.18.20](https://www.nature.com/articles/d41586-020-00758-2)).&#x20;
* We can quantify how quickly a virus spreads by the virus **doubling time** (the time it takes for the number of cases to double). In the early days of the pandemic, the doubling time was estimated to be 5-7 days for the U.S. ([Lin, M. Lin Lab Presentation 3.13.20](https://drive.google.com/file/d/1DqfSnlaW6N3GBc5YKyBOCGPfdqOsqk1G/view)); the estimate as of 9.7.20 is **2 months** for the U.S., though it [varies](https://www.nytimes.com/interactive/2020/03/21/upshot/coronavirus-deaths-by-country.html) by stat&#x65;**.**
* We are assuming patients cannot be **re-infected** with the virus in the short-term (months-years). As discussed in [Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside), this is an open question, and will only be answered with data gathered over the coming weeks or months. It is important to note that some apparent reinfections reported in case studies may reflect deficiencies in test specificity. Apparent reinfections in South Korea, for example, were later [confirmed](https://www.livescience.com/coronavirus-reinfections-were-false-positives.html) to be false positives

## Models of Virus Spread

Creating a complete, accurate model for the spread of SARS-CoV-2 will require the expertise of multiple highly trained scientists and complex computational tools. We will not present such a model here. Instead, we hope to introduce an intuitive, simple model that helps explain the spread of the virus based on current data. Such a model is being used to make estimates about how many people will get sick from SARS-CoV-2.

This video describes what we can expect from the simplest model of virus spread, using real data. **If there is only one thing that you click on in this section, it should be this video**. It’s only 9 minutes long (4.5 if you watch at 2X speed). We will emphasize some key take-aways from the video below:

**CORE VIDEO:** [**Exponential Growth and Epidemics**](https://www.youtube.com/watch?v=Kas0tIxDvrg\&feature=youtu.be)

The epidemic spread is modeled by an exponential curve at the beginning, because most people have not been infected by the virus yet and are therefore susceptible to infection. This is what the spread of the virus looks like right now based on existing data; the scale on the y-axis is a log scale, so cases grow a lot quicker as time goes on in the x axis. (Note: a limitation of an exponential growth model is that it assumes homogeneous mixing of individuals in the population, which is not true, especially in the latter stages of an epidemic).

![](https://lh6.googleusercontent.com/BG0-Azf7hkmiepfnCwTBYEZC2NhPsVHSO6ijEVzZE9EifjeTsXyz3SqYILkv_nvRwDmWSxmKYR26ZunitJgrgZun2BVkLAB-j3k45a_PvWdghnlQ9C_ukslXQ2El9J9ljkpTKZKg)

As more people are infected, the spread of an epidemic slows down because there are fewer people who can still get sick from the virus. The spread of virus will eventually slow down and look logistic:

![](https://lh5.googleusercontent.com/6chbMUnZ0yQvpmTJOj97ZlhU1ExglupHBkbsL6ZoHRNyR8MYGf44Qo8HlDM8XteuGYNnun0zTOirdo1fAq7CSoKmNahTlxNGTjLxjasSiRObhgm2-nPfLREGcchKYkWQI1I_jHdB)

Without a vaccine, the majority of people in the entire world will eventually become infected by SARS-CoV-2. This is why the logistic curve flattens out: because there will be no one left to infect. **Our goal is for the spread of the virus to slow down, so that our healthcare system can provide the best possible clinical care for the critical cases of SARS-CoV-2 coming in every day**, along with the routine clinical cases that you would expect irrespective of the pandemic (heart attacks, cancer treatments, hip replacements, car accidents).&#x20;

In the worst case scenario, if we do nothing to change the disease doubling rate, the CDC estimates up to 214 million cumulative infections (⅔ of the American population), and 1.7 million deaths (assuming 1-2% case fatality rate) in the United States in the coming months ([NYTimes 3.13.20](https://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.html)).

## How Social Distancing Could Impact Spread in the Short Term

Our main strategy to stop these outcomes is **mitigation**: we cannot stop transmission completely, but we can reduce the pandemic’s impact on the healthcare system.&#x20;

**CORE TEXT (simple model to illustrate concept):** [**Stevens, H. Why outbreaks like coronavirus spread exponentially, and how to “flatten the curve.”**](https://www.washingtonpost.com/graphics/2020/world/corona-simulator/) **Washington Post, March 14th, 2020.**

Supplementary material: a [tunable model](https://art-bd.shinyapps.io/nCov_control/) that allows the user to change model parameters to visualize how they could affect virus spread.

There is a lot to be hopeful for. Regions that implement these mitigating interventions, which use social distancing to slow down and reduce the spread of the virus, may reduce the Re. If we can reduce the Re by half (from 2-3 new cases per infected person to \~1.2 per case), then the doubling time will be 4 times longer. Indeed, we are already seeing these effects in the U.S. Siedner et al. ([medRxiv, 4.8.2020](https://www.medrxiv.org/content/10.1101/2020.04.03.20052373v1)) calculated the daily epidemic growth rate by confirmed cases in all 50 U.S. states, before and after each state implemented its first mandatory social distancing measure in mid-late March. On the 4th day after implementation -- consistent with viral incubation period -- the mean daily COVID-19 growth rate dropped 0.8%, which corresponds to an increase of average doubling time from 3.3 days to 5 days nationwide.

The key take-away is that social distancing measures will have a profound effect in delaying the “peak” in the number of critical COVID-19 cases in the US. We buy the healthcare system valuable time to get ready for this crisis by increasing the personal protective equipment, beds, ventilators, and healthcare workers available to care for those critically ill from the virus and from causes other than the virus, decreasing overall mortality. This is why social distancing is critical.

Simulations show that slowing disease spread by a couple of months will dramatically affect the number of critically ill COVID-19 patients who can get hospital beds:

![](https://lh6.googleusercontent.com/54Mgr3WoJZT_h-l6MgdiF4867zs6FDyE_hjX2klK5eMZnmK2kqqPpzaINN_qpOzhK98JSqoRaQ3Dmm-jNwyqYhRV_16QC704WXBlRtabnIMPmDsTMdoXfre-wUUCYWrK0iaOVYeL)

In the figure above, each line describes the number of simulated COVID-19 cases under different assumptions about the total number of infected cases needed to establish herd immunity (20, 40, or 60%) and the success of social distancing. Successful social distancing is simulated, "flattening the curve," such that the spread of the virus lasts 6, 12, or 18 months respectively. Full [simulation](https://www.nytimes.com/interactive/2020/03/17/upshot/hospital-bed-shortages-coronavirus.html?auth=login-google) linked here.

Actually implementing social distancing requires fundamentally changing our habits and daily routines. Though all 50 states have adopted some form of social distancing measure as of March 27th, adherence varies city to city and even household to household. **The brief article below makes these recommendations concrete and clear, including reducing all public gatherings of any size, ceasing visits to others’ homes, and limiting trips.** We recommend reading it if you haven’t already, and sharing it with friends and family.

**CORE TEXT:** [**Bitton, A. Social Distancing: This Is Not a Snow Day**](https://www.ariadnelabs.org/resources/articles/news/social-distancing-this-is-not-a-snow-day/)**, Ariadne Labs, 3.13.20**


# Approaches to Long-Term Planning

Governments worldwide are trying to plan for the next 1-2 years before a vaccine is available (for the latest on vaccine development, see [Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/investigational-therapeutics-and-vaccine-development)). A number of models have emerged to help with this task - some focused just on resource demands in the next few months (e.g. [Murray, medRxiv 2020](https://www.medrxiv.org/content/10.1101/2020.03.27.20043752v1.full.pdf)), others aimed at the next 18-24 and incorporating consideration of a second wave in the fall-winter (e.g. [Kissler & Tedijanto et al, Science, 4.14.20](https://science.sciencemag.org/content/early/2020/04/14/science.abb5793)). Modeling on these timescales requires making a number of assumptions and is therefore fraught with uncertainty, as detailed in this [article](https://fivethirtyeight.com/features/why-its-so-freaking-hard-to-make-a-good-covid-19-model/) ([Koerth et al., 538 2020](https://fivethirtyeight.com/features/why-its-so-freaking-hard-to-make-a-good-covid-19-model/)). Nevertheless, modeling has helped the scientific community to explore two main long-term approaches, which we will call “**long-term mitigation**” and “**suppression**.” Long-term mitigation would involve sustained or intermittent social distancing until herd immunity is reached or a vaccine is available. Suppression would identify and isolate cases until a vaccine is available. Suppression requires bringing case numbers down in the short term, and then excellent testing and contact tracing infrastructure.

## **Long-Term Mitigation**

Many governors and mayors around the country have implemented policies in recent weeks promoting social distancing for their states/cities (closing bars and restaurants, moving schooling online, banning public gatherings, etc). As of March 16th, the CDC and the White House recommended canceling events expected to host at least [10 people](https://www.whitehouse.gov/wp-content/uploads/2020/03/03.16.20_coronavirus-guidance_8.5x11_315PM.pdf). As of April 3rd, the majority of states have already implemented or are strongly considering shelter-in-place precautions for their citizens, meaning that individuals must stay home except to conduct essential activities related to health, work, food and exercise. These initiatives help to flatten the curve, decreasing the peak number of COVID-19 cases and increasing the length of the pandemic. Yet they come at a substantial economic and social cost, including increased rates of unemployment, which will likely in themselves impact population health in the long term.&#x20;

If social distancing and lockdowns are our sole response to the pandemic, they will require many months of participation to be effective. An [Imperial College report](https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf) (analysis specific to the U.S. is found on page 19) suggests that social distancing needs to be maintained “until a vaccine becomes available (potentially 18 months or more)” in order to actually decrease deaths from COVID-19 in the long run. Furthermore, mortality rates will certainly be worsened if the healthcare system is overwhelmed and unable to provide appropriate care to all who need it. Lifting lockdowns and social distancing restrictions immediately once the curve is flattened will essentially release the virus back into a population without immunity; creative methods, such as stratified lockdowns or alternating open and closed periods (intermittent social distancing) to increase herd immunity would be necessary to ensure prevention of a second viral outbreak [(Hernán, 3.15.20)](https://twitter.com/_MiguelHernan/status/1239227279512829953).&#x20;

A recent Harvard study ([Kissler & Tedijanto et al, Science, 4.14.20](https://science.sciencemag.org/content/early/2020/04/14/science.abb5793)) modeled the effects of intermittent social distancing, periods of enforced social distancing with alternating periods of lifted restrictions, on the spread of COVID-19 and impact on hospital systems in the US. This analysis indicates that there will likely be recurrent outbreaks after the initial pandemic wave once social distancing measures are lifted. The authors aim to develop models to allow for maintenance of the flattening of the curve in addition to beginning to open the economy. The study finds that, given current US hospital capacity, intermittent social distancing could need to be prolonged to 2022, with social distancing restrictions in place between 25% and 75% of the time. The majority of the models in the analysis allow for 1-2 months of social distancing followed by 1-2 months of re-openings for the next 2 years.

It is important to note that the Imperial College model and the Harvard study mentioned above do not take into account the implementation of new therapeutic and vaccine options (such as remdesivir and other antivirals, viral proteins and mRNA vaccine approaches described in Module 1) that might become widely available to treat COVID-19 in the coming months. Nor do they account for expansion of health care facilities, for instance allowing time to make more ventilators to manage the surge. The Imperial College study acknowledges that as case numbers come down it will become easier to carry out expanded testing with robust contact tracing and isolation. These approaches form the foundation of the suppression approach as detailed in the next section.&#x20;

As we have discussed, social distancing, both prolonged one-time and intermittent, buys the healthcare system time to adapt to the outbreak. Importantly, social distancing also buys physicians and scientists time to test and optimize the efficacy of new therapies to treat COVID-19 patients, thereby reducing the percent of those patients requiring critical care and the disease mortality. As we face the long term, however, we may aim to target interventions more precisely - progressing from mitigation to suppression.&#x20;

## **Suppression**

Mitigation is a blunt tool: without knowledge of who has COVID-19 and who does not, everyone must adopt social distancing measures and society grinds to a halt. The suppression strategy, by contrast, identifies those who have or are at risk for having the virus and keeps them away from others while infectious. This fine targeting is meant to keep the Re below 1 while releasing the rest of society to resume activity, even without herd immunity.&#x20;

South Korea is the exemplar of this strategy, as detailed in the South Korea [case study](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/case-study-south-korea-2020). With massive testing, contact tracing, and strictly enforced quarantines and isolations they have been able to control their outbreak without resorting to mandatory shutdowns. As of April 10th they report [epidemiological links](https://www.cdc.go.kr/board/board.es?mid=a30402000000\&bid=0030) for over 80% of their confirmed cases, evidence that they have been able to track the extent of the outbreak closely. Using these strategies, as of April 10th, South Korea reports 0 new cases in Daegu, the region that was once the epicenter of South Korea’s COVID-19 outbreak. However, even with broad testing, contact tracing, and quarantine, South Korea continues to see a rise in their imported cases. This rise emphasizes the need for global cooperation in suppressing the outbreak.

As of April, other Asian countries that were successful in containment initially are similarly seeing a second wave of the outbreak due to imported cases. One example is Singapore, where the number of cases remained below 200 in mid-March despite being in close physical and social proximity to the center of the outbreak, China. Singapore was one of the first countries to ban travel from China, doing so at the end of January, and deployed strict contact tracing and quarantine of cases. However, as of April 23, their cases have spiked to greater than 10,000 cases, and are [spreading fast](https://www.nytimes.com/2020/04/20/world/asia/coronavirus-singapore.html?action=click\&module=Spotlight\&pgtype=Homepage) amongst the migrant foreign laborers who had been neglected. The exponential rise in cases amongst migrant workers has been compounded by the inability to quarantine effectively, as these workers live in cramped dormitory housing with more than 20 people per single room.

A number of public health advocates are pushing the U.S. to adopt the suppression approach ([Jha and Carroll, Atlantic 3.17.20](https://www.theatlantic.com/ideas/archive/2020/03/how-we-beat-coronavirus/608389/)). They turn to both federal and state policy-makers and are asking the [business community](https://www.forbes.com/sites/steveforbes/2020/04/08/to-get-our-economy-moving-focus-on-testing-for-coronavirus/) to support the same. We find the clearest explanation of what this strategy would require and why it matters in the following resource, working from data publicly available in mid-March. The main points are summarized below and the full text is linked here:

**CORE TEXT:** [**Pueyo, T. Coronavirus: The Hammer and the Dance.**](https://medium.com/@tomaspueyo/coronavirus-the-hammer-and-the-dance-be9337092b56) **Medium, 3.19.2020.**

### **Suppression Strategy: Hammer and the Dance**

The “**hammer**” is a short-term total mandatory shutdown of all activities such as schools, churches, social venues and other non-essential businesses, and instituting travel bans internationally and domestically with economic assistance to allow mandatory quarantine for all people. This is what Italy, Spain and France are currently doing to control their outbreaks. The goal is to reduce Re to below 1 as quickly as possible, stop infections from growing exponentially, and then transition to the “dance” phase.&#x20;

The hammer gives us time - to scale up testing and tracing capacities, increase healthcare capacities including increasing production of necessary PPE and equipment, improve treatments, understand the true number of cases and learn more about the virus and the disease.&#x20;

The severity of the hammer will depend on how long we waited to institute effective interventions to mobilize the government, educate the public, and detect and isolate cases. The bigger the outbreak is, the more severe the hammer needs to be to catch up. The lesson for countries who are just now seeing the rise in cases is to implement cheaper interventions early on, to avoid having to shut down with severe economic consequences. (See chart below for examples of cheaper and more expensive non-pharmaceutical interventions, with detail on various representative country responses.)

![](https://lh5.googleusercontent.com/LtgNuUDKn3auPgbY33ZukjIGnCs0OEIhPdHM1aw31d1GdRlWvC612DM358XZROHPsDkscstBRs8DsVi6V3A8gR5qq_Tco17OKvgI80NvXMa9jEsHrDwcU-Qd8189TySD55JSx-pQ)

After the initial intense effort to get Re below 1, the **dance** aims to keep Re below 1 with a combination of cheaper strategies while relaxing the severe restrictions. These strategies include:\
1\. Measures to detect the true extent of the outbreak including widespread testing, contact tracing, strict quarantining and isolating of detected cases.\
2\. Continuing public education on social distancing and hygiene.\
The restrictions can be tightened and loosened, based on how the outbreaks evolve. Transitioning to the dance requires that we have the capacity to support hospital systems in time of surge so that localized and concentrated efforts can be delivered when new outbreaks arise.

The question echoing in the media, “When can we reopen?” is another way of framing the safe transition from the “hammer” to the “dance.” One excellent response for U.S. states advises a series of pre-conditions for re-opening that reflect the strategies above. These are: 1) adequate hospital capacity to treat all patients requiring hospitalization without resorting to crisis standards of care; 2) ability to test at least everyone who has symptoms; 3) ability to conduct monitoring of confirmed cases and contacts; 4) sustained reduction in cases for at least 14 days ([Carroll, NY Times, 4.6.20](https://www.nytimes.com/2020/04/06/upshot/coronavirus-four-benchmarks-reopening.html)).

## Reopening

As all 50 states in the U.S. reopen and ease social distancing policies, the frequency, intensity and scope of human interaction will inevitably increase. The three major factors of the [basic reproduction number, R0](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms), are contact rate, transmission risk per contact, and duration of infectiousness. Reopening increases contact rate and hence increases the probability of the virus spreading.  Understanding the epidemiological principles behind the [transmission dynamics](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/basic-virology-and-immunology) of the virus allows us to use non-pharmaceutical interventions to reduce the risk of transmission. For example, transmission risk per contact could be reduced through proper use of [personal protective equipment](https://curriculum.covidstudentresponse.org/module-6-training-for-clinical-roles/personal-protective-equipment), avoiding close contact with others, or meeting outside where air circulation is better. Contact rate could be reduced by limiting gathering size or avoiding unnecessary in-person meetings. Reducing the duration of infectiousness can be accomplished by getting tested to receive an early diagnosis and self-quarantining. Detailed risk measurements vary by situations and activities, but the same principles and cautiousness should be consistently applied.

### **Testing to Determine Immune vs Susceptible Populations**&#x20;

Recall that there are two main tests available for COVID-19: serology and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Briefly, serology testing is used to determine whether an individual has had an active COVID-19 infection in the past, since it tests for antibodies against SARS-CoV-2, the virus that causes COVID-19. RT-PCR, on the other hand, is used to test for active infection of SARS-CoV-2. More information can be found in[ Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/clinical-presentation-of-covid-19#molecular-assays).

As states in the US continue to reopen, testing, especially RT-PCR, is being used to detect both asymptomatic and symptomatic cases with high accuracy. Many institutions are planning to reduce risk of transmission by providing [test kits](https://www.questdiagnostics.com/dms/Documents/covid-19/COVID19_Specimen_Collection_Device_Guidelines/COVID19%20Specimen%20Acceptability_LDT%20Roche%20Revised%20Version%20v4%2032020.pdf) on a regular basis that allow individuals to self-acquire samples via, for example, the anterior nares, to send to a high-throughput facility in a CLIA-certified lab to process the RT-PCR tests. More details can be found in[ Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/clinical-presentation-of-covid-19#united-states-testing-capacity). Some reopening institutions are also requiring individuals to [report symptoms](https://covid.joinzoe.com/us) of COVID-19 on a regular basis and have plans to implement [contact tracing](https://time.com/5825140/what-is-contact-tracing-coronavirus/) for rapid identification of those who might have been in contact with an infected person. All these efforts are important proactive and reactive measures to take to reduce the spread of the virus.

Testing, symptoms reporting, and contact tracing can all inform the behaviors of infected individuals and reduce the risk of transmission and contact rate, which decreases the estimated contagiousness (R0) of SARS-CoV-2. Testing for SARS-CoV-2 antibodies via serology can also help to identify individuals who have already acquired immunity to SARS-CoV-2. This decreases the estimated contagiousness of the virus factoring in the decreased size of susceptible  populations (Re). More information on R0 and Re can be found in the previous section [Introduction to Epidemiological Terms](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#epidemic-parameters).&#x20;

### Risk Stratification of Activities

Different activities and interactions have various levels of risk for infection. Risks for different activities can be accessed from: 1) Contact intensity; how close you are in contact with people for how long, 2) Number of contacts, and 3) Mitigation measurements; steps taken to minimize risk of exposure. Exposures to different social activities and environments carry varying relative levels of transmission risk (see figure below for more details). More detailed advice for different daily activities like commuting and going to restaurants can be found in the article [Safety Advice for Reopening: How to Reduce Your Risks as Coronavirus Lockdowns Ease](https://www.wsj.com/articles/safety-advice-for-reopening-how-to-reduce-your-risks-as-coronavirus-lockdowns-ease-11588510800).

![ ](/files/-MI5LUZeetN01O40caT_)

Risk benefit analysis of activities stratified on importance of location and risk of SARS-CoV-2 transmission, from [Benzel, et al., SSRN, 04/20/20](https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3579678).

These principles apply during public gatherings as well. In protests, for example, attendees should stay home if feeling sick and bring protective equipment for themselves (masks, hand sanitizer, eye protection). During the protest, attendees can reduce risk by masking, maintaining physical distance from others not in their pod, and minimizing additional aerosol production by avoiding shouting. They should avoid touching their faces. After returning home, they should wash their hands and sanitize all items with. The recommendation is to test or self-quarantine for 14 days afterward. Refer to [How to Protest Safely During the COVID-19 Pandemic](https://www1.nyc.gov/assets/doh/downloads/pdf/imm/covid-19-safe-protest.pdf) and [How to more safely protest in a pandemic](https://www.vox.com/2020/5/31/21276082/what-to-bring-to-a-protest-coronavirus-covid-19-risk-safety) for more detailed advice.

### Equitable Vaccine Distribution

With record-breaking progress being made in SARS-CoV-2 [vaccine development](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/investigational-therapeutics-and-vaccine-development#vaccines) (by Moderna, Pfizer, AstraZeneca, and more), the challenge of equitable vaccine distribution remains. Who will receive the vaccine and when? Will at-risk individuals in poorer countries have to wait longer than healthy individuals in wealthy countries? What will the financial burden be?&#x20;

In September 2020, the World Health Organization (WHO) developed a plan to distribute the SARS-CoV-2 vaccine to all countries via a “[fair allocation mechanism](https://www.sciencemag.org/news/2020/09/who-unveils-global-plan-fairly-distribute-covid-19-vaccine-challenges-await),” in hopes of ensuring access to the vaccine in lower income countries. Roughly $1.7 billion has been raised globally to support this program, named the COVID-19 Vaccines Global Access (COVAX) Facility. The WHO’s proposal is as follows:&#x20;

Phase 1: Baseline coverage for all participating countries&#x20;

* First, all countries receive vaccines “proportional to their population”
  * Sufficient vaccine to cover 3% of the population
  * Distribute first to front-line workers health care and social care
* Second, vaccine delivered until 20% of countries’ populations are immunized&#x20;
  * Prioritizing high-risk individuals, such as those who are elderly, immunocompromised, and/or have comorbidities&#x20;

Phase 2: Prioritized global distribution&#x20;

* Vaccine delivered based on its level of urgency in particular countries&#x20;
* Country priority will be determined by:
  * The [effective reproduction number](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/introduction-to-epidemiological-terms#epidemic-parameters) (Re) or rate, of COVID-19 spread&#x20;
  * Presence of other infectious pathogens (influenza, measles, TB)&#x20;
  * Vulnerabilities and limitations of health systems (ex. hospital and ICU capacities) &#x20;

As of late September 2020, over 170 countries, representing roughly ⅔ of the world’s population, have joined the COVAX Facility. Of important note, the United States and China have not partnered with the WHO in support of their COVAX Facility, highlighting the “deeply unequal power dynamics in global health and vaccine manufacturing capabilities that may still challenge equitable access to vaccines” ([Science Magazine](https://www.sciencemag.org/news/2020/09/who-unveils-global-plan-fairly-distribute-covid-19-vaccine-challenges-await), 21 Sept 2020). With both [Pfizer](https://www.nytimes.com/2020/12/23/us/politics/pfizer-vaccine-doses-virus.html) and [Moderna](https://www.nytimes.com/2020/12/18/health/covid-vaccine-fda-moderna.html) being U.S.-based pharmaceutical companies, the lack of U.S. participation in COVAX is likely to have a major impact on vaccine distribution globally.&#x20;

An additional challenge to the WHO’s plan of equitable distribution includes lack of knowledge regarding vaccine efficacy across certain groups of people (age groups, racial and ethnic minorities, those with underlying conditions). Given that COVID-19 has disproportionately impacted Black communities, [vaccine education](https://www.aamc.org/news-insights/saving-black-lives-during-covid-19-vaccines-matter) will be imperative in saving lives. Moreover, certain political agendas may prevent the WHO from obtaining sufficient vaccine supply. In order to make strides towards worldwide immunization, however, it is imperative that we prioritize equitable vaccine distribution in order to reduce the overall transmission and disease burden of COVID-19.

*Thought Questions:*

1. Current models estimate that social distancing measures might need to be implemented for years, not months, to slow the spread of the virus and its impact on our healthcare system. How will our society need to adapt to these long-term changes?
2. &#x20;How do we make sure vulnerable populations (including families dependent on jobs unable to be adapted to remote work) are adequately supported during this time?
3. How do you think the general public would respond to intermittent social distancing if it were implemented? Some ideas to consider: compliance with social distancing restrictions as time goes on, view of the importance of social distancing as restrictions are continually lifted and put back in place, effects on businesses needing to close and reopen, what messaging would need to come from the government/academic leaders, etc. <br>


# Case Study: 1918 Influenza Pandemic

![Image from Arnett, Boston Globe 3/2020 - print edition.](https://lh3.googleusercontent.com/jAEqPWzV1MqzAiA7fL6QYnLWRzpxvR4pZO83sXJ964eduG5RApqAkDlPRuSbHfvcAcbrx8HwcNgA2cB8cUOnVNK84qKOt6-lgJBPr5dMMmX20k6GUAcq6FnZtLLM0zX6e2MUA6Tn)

Prior to COVID-19, the 1918 influenza pandemic was the most severe pandemic in recent history. First identified in military personnel in the spring of 1918, the influenza was an H1N1 virus of avian origin. It is commonly referred to by scientists and historians as “the Mother of all Pandemics.” This pandemic is often referred to as the “Spanish Flu” in the lay press, though this name is a misnomer, and the virus likely originated elsewhere. Contemporary reporting focused heavily on Spain, as it was one of few places at the time that did not have restrictions on the press during World War I.

## **Fast Facts about the 1918 Flu**

* Infectivity: 500 million people, or ⅓ of the world’s population. Note that this is smaller than estimates for SARS-CoV-2, as the population had some pre-existing immunity from prior influenza exposure.
* Death rates: at least 50 million people worldwide, with 675,000 deaths in the United States.
* Mortality: highest in people age <5, 20-40, and 65+ years. It is thought that this unusual age-distribution of cases may be due to differences in prior influenza exposure across different age groups.
* More soldiers died from the 1918 flu pandemic than were killed in battle during World War I in 1918.
* In 1918, there were no flu vaccines, antiviral drugs, antibiotics, or mechanical ventilators. Treatment options were limited to supportive care and unproven remedies.&#x20;
* There were 3 waves of the epidemic, which lasted from January 1918 - December 1920 ([CDC](https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/three-waves.htm)):
  * First wave: March 1918 - Summer 1918
  * Second wave: Fall 1918 (peak of epidemic)
  * Third wave: Winter 1918 - Spring 1919
* According to a 2007 study in the *Internal Journal of Epidemiology* ([Vynnycky et al.](https://www.ncbi.nlm.nih.gov/pubmed/17517812)), the **Re** for the 1918 influenza virus was in the range of 1.2-3.0 for community-based settings.
  * The study estimates that, in a totally susceptible population, a single infectious case could have led to 2.4-4.3 cases in a community-based setting.&#x20;
* Link out: CDC’s [1918 Pandemic Influenza Historic Timeline](https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/pandemic-timeline-1918.htm)

## How Three US Cities Tried to Stop the Spread of the 1918 Flu

### Philadelphia held a parade

By mid-September 1918, the second wave of the flu epidemic was in full effect, spreading from Boston to New York and Philadelphia before traveling west to St. Louis and San Francisco. Without a vaccine or known cause for the outbreak, mayors and city health officials were grappling with how to implement **social distancing** and reduce **community transmission**. They asked themselves the following questions:

* Should they close schools and ban all public gatherings?&#x20;
* Should they require all citizens to wear a gauze face mask?
* Would shutting down financial centers during a time of war be unpatriotic?

Wilmer Krusen, Philadelphia’s public health director, advised citizens they could lower their risk for flu by: staying warm, keeping their feet dry, and “loosening their bowels.” Krusen refused to cancel the Liberty Loan parade on September 28, 1918, even as cases steadily increased up to this point. Infectious disease experts warned Krusen that the parade (likely to attract several hundred thousand people) would be a “ready-made inflammable mass for a conflagration.” Krusen kept the parade on because it would raise millions of dollars in war bonds. The parade took place: soldiers, Boy Scouts, marching bands, and local dignitaries processed two miles through downtown Philadelphia past sidewalks teeming with spectators. **Just 72 hours after the parade, all 31 of Philadelphia’s hospitals were full. By the end of the week, 2,600 people were dead.**

### St. Louis flattened the epidemic curve

Before the first case of 1918 flu appeared in the city, health commissioner Dr. Max Starkloff wrote an editorial about the importance of avoiding crowds in the *St. Louis Post-Dispatch*, putting local physicians on high alert. When a flu outbreak from nearby military barracks spread to St. Louis, Starkloff closed schools, movie theaters, and pool halls, and banned public gatherings. When infections surged, thousands of sick residents were treated at home by a network of volunteer nurses. George Dehner, author of *Global Flu and You: A History of Influenza*, writes that because of these precautions, St. Louis public officials **flattened the curve** and prevented the flu epidemic from exploding overnight like in Philadelphia. According to a 2007 NIH analysis in *PNAS* of 1918 flu death records ([Hatchett et al.](https://www.pnas.org/content/104/18/7582)), the **peak mortality rate in St. Louis was only ⅛ of Philadelphia’s death rate** at its worst.

### San Francisco required face masks

California governor William Stephens declared it the “patriotic duty of every American citizen” to wear a gauze face mask and eventually made it the law. Citizens found in public without a face mask or wearing it improperly were arrested, charged with disturbing the peace, and fined $5. San Francisco’s low infection rates were likely not due to the face masks, but instead due to:

* Well-organized campaigns to quarantine all naval institutions before the flu arrived
* Early efforts to close schools
* Bans on social gatherings
* Closing all places of “public amusement”

San Francisco did well in the second wave of the epidemic through the fall of 1918. When the third wave struck in January 1919, businesses and theater owners fought back against closings, as they believed masks were what saved them the first time. The 2007 NIH analysis found that **if San Francisco had kept up the same flu protections in the third wave as it did in the second wave, it could have reduced deaths by 90%.**

**CORE TEXT: Barry, J.** [**The Single Most Important Lesson From the 1918 Influenza**](https://www.nytimes.com/2020/03/17/opinion/coronavirus-1918-spanish-flu.html)**. New York Times, (March 17, 2020).**

Supplementary reading:

* “[How U.S. Cities Tried to Halt the Spread of the 1918 Spanish Flu](https://www.history.com/news/spanish-flu-pandemic-response-cities),” Dave Roos. History.com (March 11, 2020)
* “[The effect of public health measures on the 1918 influenza pandemic in U.S. cities](https://www.pnas.org/content/104/18/7588),” M. C. J. Bootsma and N. M. Ferguson. PNAS (May 1, 2007).&#x20;
* *The Great Influenza: The Story of the Deadliest Pandemic in History*, John Barry (2004).&#x20;
* *Global Flu and You: A History of Influenza*, George Dehner (2012).&#x20;

*Thought Questions:*

* If you were a public health official in the early 1900s trying to determine the cause of the outbreak, what methods would you use to find the answer? (Assume you can only use resources available from the early 1900s.)
* How could public health officials in San Francisco have probed deeper into whether it was gauze face masks that reduced transmission or closing of public spaces?
* What are the challenges for trying to determine R0 and Re values for the 1918 flu epidemic? What assumptions can be made in modeling? What challenges do these assumptions bring?


# Case Study: 2009 H1N1 Pandemic

While certain comparisons can be drawn to the H1N1 outbreak in 2009, it is important to remember key distinctions between H1N1 and SARS-CoV-2. Certainly, the public health measures implemented to prevent COVID-19 have been far more widespread and disruptive to normal life than the H1N1 outbreak. To understand why these measures have been different, a short background on H1N1 is needed.&#x20;

### **Fast Facts about the 2009 Flu**

A novel influenza A (H1N1) virus emerged in the spring of 2009. This virus, designated as (H1N1)pdm09 (colloquially called the 2009 swine flu), was very different from other H1N1 strains circulating at the time. Very few young people had pre-existing immunity to the virus, but nearly ⅓ of people over age 60 had antibodies against (H1N1)pdm09, suggesting exposure to an older H1N1 earlier in their lives. The [CDC estimates](https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html) that, in the United States, from April 12, 2009 to April 10, 2010, the (H1N1)pdm09 virus led to:&#x20;

* 60.8 million cases
* 274,304 hospitalizations
* 12,469 deaths

### **Mortality Rate and Case Fatality Rate**

The [CDC estimates](https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html) that 151,700 to 575,400 people around the globe died from infection in its first year of circulation (0.001-0.007% of the world’s population). While these numbers are staggering, **the impact of the (H1N1)pdm09 virus on the global population was less severe than previous influenza pandemics.** In comparison, pandemic influenza mortality rate was estimated to be 0.03% of the world’s population during the 1968 H2N2 pandemic, while the mortality rate for the 1918 H1N1 pandemic was estimated to be 1-3% of the world’s population.

The **case fatality rate for (H1N1)pdm09 was approximately 0.02%** in the U.S. from April 2009-April 2010. A monovalent (H1N1)pdm09 [vaccine](https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5839a3.htm) was produced and available in large quantities in November 2009.  This rapid response was possible because the similarity to other influenza strains allowed the use of established biological and regulatory practices. In August 2010, the WHO declared the end of the global 2009 H1N1 influenza pandemic. While the numbers are still evolving for the COVID-19 outbreak, according to the CDC’s initial report on the first COVID-19 cases in the United States, the **case fatality rate for COVID-19 is estimated to be** [**1.8-3.4%**](https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e2.htm?s_cid=mm6912e2_w) in the U.S.

### **Transmissibility and Prior Immunity**

The H1N1 flu was also less contagious than COVID-19. In a 2014 BMC Infectious Diseases article, [Biggerstaff et al.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4169819/) estimated the R0 value for (H1N1)pdm09 to be 1.46. As of March 25th, the R0 for COVID-19 is considered to be between 2-4, as discussed earlier in the module. Finally, while people over age 60 did have some immune protection against the (H1N1)pdm09 virus, there is no pre-existing immunity to SARS-CoV-2, as this virus has never been experienced before by a global population.

### Initial Responses

The beginning of both the H1N1 and COVID-19 outbreaks appeared similar in terms of major turning points. At the beginning of both H1N1 and COVID-19 pandemics, the genetic sequences of both viruses were released online to enable scientists to begin development of diagnostic tests, vaccines, and antiviral treatments. Just nine days after (H1N1)pdm09 was detected, on April 24, 2009, the CDC uploaded genetic sequences of the virus to a public database and work began on developing a vaccine. Five days after SARS-CoV-2 was detected, on January 12, 2020, Chinese scientists published the viral genetic sequence, and scientists around the globe catapulted into action. The U.S. declared H1N1 to be a public health emergency just 11 days after the first confirmed U.S. case in 2009. The U.S. Department of Health and Human Services also declared COVID-19 a public health emergency 11 days after the first U.S. case was detected.

### **Testing and Treatment**

Despite these initial similarities, the response to COVID-19 has not been as smooth as it was to H1N1 following the initial weeks of detection. **Four weeks after H1N1 was detected,** the CDC released **health supplies from their stockpiles** that could prevent and treat influenza. By this time, most U.S. labs had **diagnostic tests that could detect H1N1** without verification by the CDC.

In contrast, the CDC began sending diagnostic kits for SARS-CoV-2 to 100 public health laboratories around the U.S. on February 5, 2020. However, most of the labs received defective kits, which caused [significant delays](https://www.newyorker.com/news/news-desk/what-went-wrong-with-coronavirus-testing-in-the-us) in detecting and combating the virus. Testing could only be performed at the CDC headquarters until they could send replacement kits. This constraint allowed the virus to spread undetected for weeks. By March 10, **seven weeks after the first U.S. confirmed case, only 79 state and local health labs could test for COVID-19**--many of whom were already running out of supplies to run the tests. Moreover, since SARS-CoV-2 was a novel virus, there were **no medications, let alone stockpiles** that could be used to prevent or treat COVID-19. (For the latest on testing and treatment, see (For the latest on testing and treatment, see Module 1, sections on [Diagnostics](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/clinical-presentation-of-covid-19#diagnostics) and [Investigational Therapeutics and Vaccine Development](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/investigational-therapeutics-and-vaccine-development).)

According to Dr. Steffanie Strathdee, the Associate Dean of Global Health Sciences at the University of California San Diego’s Department of Medicine, “The 2009 H1N1 pandemic should have been a warning sign. It didn’t end up being a pandemic that killed millions of people as we feared it would, but it should have been a wake-up call. By all serious estimates, COVID-19 is going to be a [major killer](https://www.livescience.com/covid-19-pandemic-vs-swine-flu.html).”

### Summary

**The key differences between the H1N1 and COVID-19 outbreaks include case fatality rate, R0, pre-existing immunity in the population, testing capability, and preexistence of antiviral treatments.** The response to the COVID-19 outbreak has been unprecedented in this century because of the cumulative impact of many of these factors.&#x20;

**CORE TEXT: Baird, R.** [**What Went Wrong with Coronavirus Testing in the U.S.**](https://www.newyorker.com/news/news-desk/what-went-wrong-with-coronavirus-testing-in-the-us) **New Yorker, 3.16.20**

*Thought Question:*

* \[5.1.20] [**Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-2-diane) posts a wistful thought on Twitter: “6 wks since I last hugged my friends at church. The H1N1 pandemic didn't seem like such a big deal. How did COVID get to be so much worse?” What might you tweet back?
* \[3.27.20] [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian) has just posted on Facebook: “Swine flu was a pandemic, but no one called for us to turn our lives upside down. Why are we freaking out about COVID-19?” What would you write?


# Case Study: South Korea 2020

As COVID-19 cases in the US continue to rise, we can look to other countries that are farther ahead in their epidemics as sources of instruction. Of particular interest is the case of South Korea. SK is a democratic country, with largely privatized healthcare and strong corporate research presence, much like the US. Cases in SK initially grew exponentially but have flattened in recent days with extensive efforts to scale up testing, perform contact tracing, and promote social distancing, [without nationwide lockdown.](https://www.scmp.com/week-asia/health-environment/article/3075164/south-koreas-coronavirus-response-opposite-china-and) Here we present an overview of SK’s interventions.

{% embed url="<https://ourworldindata.org/grapher/covid-confirmed-cases-since-100th-case?country=USA+KOR+ITA>" %}

Italy and SK had initially shown similar trajectory in the rise of cases, however, SK in recent days has plateaue&#x64;**.** The US is about 1-2 weeks behind SK and Italy (fact and figure [source](https://www.vox.com/policy-and-politics/2020/3/13/21178289/confirmed-coronavirus-cases-us-countries-italy-iran-singapore-hong-kong)).

## Strategies for Testing

Both the US and SK detected their first case of COVID-19 on January 20. In response, the SK government [urged](https://www.reuters.com/article/us-health-coronavirus-testing-specialrep/special-report-how-korea-trounced-u-s-in-race-to-test-people-for-coronavirus-idUSKBN2153BW) SK medical companies to immediately develop a testing kit. [By February 4,](https://www.reuters.com/article/us-health-coronavirus-testing-specialrep/special-report-how-korea-trounced-u-s-in-race-to-test-people-for-coronavirus-idUSKBN2153BW) SK approved the first testing kit, when only 16 cases had been confirmed in SK. [Rapid approval](https://www.wsj.com/articles/inside-the-south-korean-labs-churning-out-coronavirus-tests-11584610667) was possible because of the emergency use authorization policy enacted after the MERS outbreak in 2015. This cooperation between the private biotechnology sector and government led to efficient roll out of its extensive [testing capacity](https://www.washingtonpost.com/world/asia_pacific/coronavirus-test-kits-south-korea-us/2020/03/13/007f14fc-64a1-11ea-8a8e-5c5336b32760_story.html). As of mid-March, four biotech companies are producing testing kits around the clock to meet the demand, distributed to over 600 testing centers. All labs upload their results to the shared database and are reported to KCDC, which then releases daily reports detailing the epidemiologic data to the public. SK’s maximal testing capacity is \~22,000 tests per day. Why is extensive testing so important? It means that infected individuals and contacts of those individuals can be isolated and/or treated with minimal delay. This drastically reduces opportunity for transmission, thereby decreasing Re.

In addition to scaling up testing capacity, SK has come up with creative testing strategies to *reduce risk of contamination, reduce risk of cross transmission, increase efficiency, and prioritize safety of healthcare workers.*

* **Automatic testing:** Done by a diagnostic machine, rather than by a lab technician. This decreases risk of contamination, risk of transmission to healthcare workers, and allows for faster turnaround of results.
* **Drive-through testing:** Patient stays in their vehicle with recirculating air turned on to minimize risk of transmission to healthcare workers. (Think of it as a makeshift negative pressure vehicle.) This method is much faster than point of care testing, because time is not wasted in disinfecting the facility and reduces risk of cross transmission. The results are texted to patients the next day. As of mid-March, SK has 43 [drive-through testing centers](<https://doi.org/10.3346/jkms.2020.35.e123 >), part of more than 600 testing sites.
* **Telephone booth testing**: For those without access to vehicles. Nasopharynx and oropharynx swabs are collected while the patient is in a negative-pressure telephone booth sized room, which takes only two minutes to disinfect. This methods has the same advantages as drive-through testing. Link to a [video](<http://www.arirang.com/News/News_View.asp?sys_lang=Eng\&nseq=254358 >).

![Image Source: AFP                                                          Image Source: CGTN](/files/-M3Oy2MNSPNG_iT00eL2)

## **Strategies for Containment: Contact Tracing, Quarantine, and Treatment**

With a large capacity to test individuals, SK can offer testing to individuals who have been in contact with a confirmed case, [even if asymptomatic.](https://www.nytimes.com/2020/03/11/opinion/letters/south-korea-coronavirus.html) When an individual tests positive, thorough [contact and location tracing](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045882/) is done through patient interview, credit card use history, CCTV (surveillance camera), and [mobile phone location](https://www.sciencemag.org/news/2020/03/cellphone-tracking-could-help-stem-spread-coronavirus-privacy-price). These locations are disclosed to the public and emergency [text alerts](https://www.nature.com/articles/d41586-020-00740-y) are sent to those in the region, so that people can learn whether they came in contact with a confirmed case. All identified close contacts are put under quarantine and monitored daily for developing symptoms. Those who are required to self-quarantine or self-isolate are required to download [an app](https://www.nytimes.com/2020/03/23/world/asia/coronavirus-south-korea-flatten-curve.html) that tracks their location to ensure adherence. Those violating self-isolation can be [fined](http://ncov.mohw.go.kr/en/baroView.do?brdId=11\&brdGubun=111\&dataGubun=\&ncvContSeq=\&contSeq=\&board_id=\&gubun=) up to 10 million won (\~$8,000 USD) and up to one year of imprisonment.&#x20;

These interventions have allowed for detection of mildly symptomatic to asymptomatic cases, which have contributed to a low case fatality rate of [1.3%](https://ourworldindata.org/grapher/coronavirus-cfr) in SK in comparison to the 4.8% global average as of March 31st. CFR should not be used to estimate risk of death during an outbreak due to the propensity to underestimate, given the time delay from case confirmed to death confirmed. However, the low CFR in SK may reflect the success of their extensive testing regimen that can detect cases that are missed in other countries without the same testing capacity. Determining asymptomatic carriers and isolating those individuals may be of great importance as increasing evidence ([1](https://www.nejm.org/doi/full/10.1056/NEJMc2001468?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dpubmed),[2](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(20\)30114-6/fulltext),[3](https://science.sciencemag.org/content/early/2020/03/13/science.abb3221),[4](https://www.nytimes.com/2020/03/31/health/coronavirus-asymptomatic-transmission.html)) suggests that asymptomatic carriers may be a significant vector for transmission. Furthermore, the South Korean health officials recommend wearing masks to all citizens to prevent the spread of COVID-19, and the public embraces mask-wearing. To prevent shortage, the government has taken over the production, distribution and sales and began [rationing the masks](https://www.wsj.com/articles/south-korea-rations-face-masks-in-coronavirus-fight-11584283720).

In addition, the government bears the cost of testing and medical care received for COVID-19. It is free regardless of immigration status for anyone with doctor’s referral or contact with an infected person. Those required to quarantine are provided [food and other essentials](https://observers.france24.com/en/20200305-south-korea-coronavirus-COVID-19-kits-masks) via package deliveries, paid for by the government. This decreases barriers for those of low socioeconomic status, helps curb the panic, and allows for individuals to adhere to strict quarantine.

South Korea’s extensive testing and contact tracing means that areas of outbreak can be recognized early and efforts can be deployed and concentrated to those hotspots to contain the spread. This minimizes the economic and social disruption of nationwide lockdown.

*Thought question:*

* What factor(s) may contribute to differences in case fatality rates between countries?&#x20;

## Strategy for Mitigation: Social Distancing

Using aggressive testing and contact tracing measures, SK had been controlling COVID-19 cases since their first reported case on 1/20/2020 until patient 31, deemed a “super spreader,” who tested positive on 2/18/2020. As shown in the figure below, South Korean cases spiked after the [31st patient](https://graphics.reuters.com/CHINA-HEALTH-SOUTHKOREA-CLUSTERS/0100B5G33SB/index.html) who had attended mass religious gatherings, coming into contact with more than a thousand people. As of March 25th, this cluster accounts for 55.6% of the confirmed cases in SK. Large mass gatherings in closed, confined spaces have led to massive increases in cases. This stresses that public participation in social distancing is critical for reducing Re, lengthening doubling time, and, thereby, flattening the curve.

Unlike China, SK has not implemented domestic travel bans and did not immediately ban travel from China at the beginning of the outbreak. Instead of a lockdown, South Korea has focused on engaging the public to practice social distancing in addition to cancelling large events, school openings and religious gatherings. While the number of new cases have decreased consistently, there are still clusters of new cases reported. These [clusters](https://www.ijidonline.com/article/S1201-9712\(20\)30150-8/fulltext) have been attributed to large gatherings in confined rooms such as churches, call-centers (where large groups of people work in close proximity without wearing masks so they can speak clearly on the phone), internet cafes, hospitals, and gym facilities.

## Situation in South Korea as of 4.16.20

![Green bars: number of new cases per day; Blue curve: cumulative cases.](https://lh3.googleusercontent.com/PeB47-sDkmreDSi3wvuFAlV9EsEPzkZVHxjmfZhaOtUvAkk6l76bYR5KarY8kBZmPtLXC3BwW7MO_5msOJ00uzr4wnMPYeEOQT4GRuSo1YcdCOPdw76bcEZ00TrBwkpEMLV67H7a)

**As of April 16th 2020** (source: [KCDC](https://www.cdc.go.kr/board/board.es?mid=\&bid=0030))

As evidenced by the figure above, numbers of new cases per day have been consistently declining and stabilizing. The slope of the cumulative curve has been decreasing, no longer showing an exponential growth pattern, suggesting that SK may have been successful in reducing Re. While SK's health minister has said he is hopeful that SK has passed the ‘[peak](https://www.cnn.com/2020/03/09/asia/south-korea-coronavirus-intl-hnk/index.html)’ of the outbreak, it remains to be seen whether this depression is temporary. As stated earlier, the majority of the population has not been infected and therefore remains susceptible. This is particularly challenging given [differences](https://www.sciencemag.org/news/2020/03/mass-testing-school-closings-lockdowns-countries-pick-tactics-war-against-coronavirus) in intervention across countries responding to this pandemic, such that the risk of reintroduction from different locations persists. As of April 1st, SK imposed a mandatory [14-day quarantine](https://www.cdc.go.kr/board/board.es?mid=a30402000000\&bid=0030) to all (Koreans and Foreigners) arriving from overseas in an attempt to curb the rise of imported cases. As of April 4th, SK has extended the social distancing campaign to April 19th. Given the long tail of the cases that have followed the peak, the period for contact tracing has also been extended to 2 days before onset of symptoms from 1 day. How SK continuously adapts its control measures to respond to new infections will be a useful case study for other countries.

On April 15th, South Korea held their National Assembly election as scheduled. SK was the first country to hold a nationwide election during the coronavirus pandemic. Extensive safety measures were put into place to prevent another outbreak. All polling stations, which were disinfected regularly, were equipped with hand sanitizers, plastic gloves, non-contact thermometer, and separate polling stations designated for those with elevated temperatures. In order to vote, one had to wear a mask, stand at least 3ft away from others, have their temperature taken, sanitize their hand, and wear the provided plastic gloves. Even those in mandatory quarantine were able to cast their ballots at a restricted time when polling centers were closed to the general public. In addition, SK expanded early in-person and mail-in voting options to reduce crowding. SK had a record turnout of 66.2%, meaning more than 29 million people casted their ballots. Yet, their new cases per day have remained under 20, giving hope to other countries considering elections that democratic right to vote does not have to be compromised during the pandemic if protective measures are taken along with baseline of widespread testing, contact tracing and strict isolation of suspected cases.

As of April 30th, SK reports 4 new cases, all of them being imported cases. This is the first day since January 20th, where SK reports 0 infections acquired within the country.

## Situation in South Korea as of June 16th 2020

![South Korea Daily Cases 4/1/2020 - 6/15/2020](https://lh6.googleusercontent.com/1LWmVKpttSsy8X1hOdDGQCDUnMMm7NY1zRnK5pcgtrlkrUh64P7AHam0uQb2ks88lzZ4_qLPJjG9CDCaJyy85zOWATTlg3FcZNHYWdAnIwb_kPp5J6Jh3yYQqPBrrMa9VwWrcEde)

**As of June 16th 2020** (source: [KCDC](https://www.cdc.go.kr/board/board.es?mid=\&bid=0030))

With decline in daily domestic cases and stabilization at the end of April and early May, schools have begun to reopen in South Korea as of mid-May with supports such as daily temperature checks, partition on desks and cafeteria, mandatory mask wearing, and regular disinfection. Although South Korea was never under lockdown, social distancing guidelines were also loosened. Despite measures such as regular temperature checks to enter public places, considerable rise in cases were detected starting with a cluster in night clubs of Itaewon district. With SK’s stance on public transparency, data regarding specific clubs where people have tested positive were made public which were prominent LGBTQ establishments. Local [media](https://www.cnn.com/2020/05/12/asia/south-korea-club-outbreak-intl-hnk/index.html) erupted with anti-LGBTQ rhetoric, and in response the Korean government asked everyone who visited Itaewon district, whether they had visited any clubs or not to come forward to test, anonymously, in order to reduce stigma and barrier to testing for people who feared being outed.

Several clusters have spread through schools, and other public spaces but immediate testing, contact tracing and isolation has continued, with institutional protocols such as prompt closing and disinfection of spaces that were visited by those who tested positive.&#x20;

While resurgence in cases have stayed below 100 new cases per day, compared to over 900 at its earlier peak in February, KCDC officials warn of the possibility of greater resurgence especially with the new clusters of cases concentrated in Seoul, the capital and most densely populated city in SK.<br>

## Summary

South Korea and other Asian countries experienced the [MERS outbreak in 2015](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840604/), which contributed to increased [preparedness](https://www.lawfareblog.com/lessons-america-how-south-korean-authorities-used-law-fight-coronavirus) for this pandemic. Although more time and monitoring is needed to determine whether SK has been able to suppress the COVID-19 outbreak, current trends suggest that their strategies of public transparency, civic awareness and responsibility, cooperation between the private sector and the government, decreasing barriers, and widespread testing has led to slowing the outbreak.

*Thought Questions:*

* What strategies to reduce disease spread and case fatality rates can we implement in the US?
* As future physicians, how could we advocate to increase preparedness for the next pandemic? &#x20;

Supplementary Reading:

* [Effective reproduction number, transmission dynamics in South Korea](https://www.ijidonline.com/article/S1201-9712\(20\)30150-8/fulltext), 1/20/20-2/26/20
* [Continuously updated effective reproduction number in South Korea](http://covid19.mi2rl.co)
* [KCDC daily COVID-19 updates](https://www.cdc.go.kr/board/board.es?mid=a30402000000\&bid=0030)
* Interview of SK Foreign Minister - [Coronavirus: South Korea Seeing a ‘stabilizing’ trend](https://www.bbc.com/news/av/world-asia-51897979/coronavirus-south-korea-seeing-a-stabilising-trend)


# Graphic Summary

We hope this module helped you apply epidemiological principles to describe the spread of COVID-19, and evaluate the potential impact of public health interventions via modeling and historical and contemporary examples. Please see below for the graphic summary. Highest quality available [here](https://drive.google.com/open?id=1YsyI6-nBOHNvLPFtwL1vIerllRHuTs5u).

![](/files/-M45OOnrNmGiGdpxWxh4)

To continue in our COVID-19 curriculum, please click here: [Module 3: Health Disparities, Policy Changes, and Socioeconomic Effects in the U.S.](https://curriculum.covidstudentresponse.org/module-3-disparities-policy-socioeconomic-effects). Click here to return to our [Overview](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles).

We welcome your feedback on this module and on the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).

We also invite you to sign the [guest book](https://docs.google.com/forms/d/e/1FAIpQLSdDgCyBO-l7qsamNhbEPznxhaDetC-dFBd4W5Tu5WC4zBWC6g/viewform) so we can track this material’s reach.


# Module 3: Health Disparities, Policy Changes, and Socioeconomic Effects in the U.S.

Appreciate the complex and rapidly changing landscape of the COVID-19 pandemic as it stands in the U.S., as well as the adapting responses of the healthcare system and society as a whole.

*Authors:* Stephanie Alden, Lucy Chen, Jennifer Cruz, MPH, Chuma Eruchalu, Michael Fuchs, Melody Huang, Ashwini Joshi, Ben Landwersiek, Hemen Muleta, Fejiro Okifo, Hema Pingali, Morgan Sehdev, Emily Witt

*Editor:* [Katie Shaffer](mailto:katherine_shaffer@hms.harvard.edu)

*Reviewers:* Brian Chan, MD, MPH; Jennifer Kasper, MD, MPH; Camila M. Mateo, MD, MPH

*Past Reviewers:* Holly Rawizza, MD; Michael Dougan, MD, PhD

In Module 3 of this curriculum, students will begin to consider the broader implications of the COVID-19 pandemic. In the first section of this module, students will discuss health disparities and how the pandemic has lifted the curtain on these disparities. In the next section, students will learn how state and federal governments, in addition to insurers, are able to respond to public health crises and the actions they have taken thus far in addressing the COVID-19 pandemic. We provide state-by-state case studies to allow students to compare and contrast the various responses across the country. Finally, students will receive a general overview of how the pandemic impacts healthcare that is not associated with COVID-19, in addition to many social and economic aspects of daily life. While these sections are by no means complete reviews, we hope that they will invite further consideration of the broader scope of the pandemic. We expect that this module will take **3 hours** to complete.

**Update Disclaimer:** Thank you for visiting Module 3! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. Information on the last major update on 12/20 can be found below. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

**Highlight of Updates December 2020:**

* ICU capacity and elective procedures in current surge
* Rates of infection in ICE detention centers
* Potential long-term impacts of food insecurity
* Complexity surrounding K-12 school planning
* Unemployment and union representation for essential workers

## Overarching Learning Goal:

Appreciate the complex and rapidly changing landscape of the COVID-19 pandemic as it stands in the U.S., as well as the adapting responses of the healthcare system and society as a whole.

## Learning Objectives:

At the end of this module, medical students should be able to:

* Elucidate how pre-existing and ongoing health and other disparities contribute to COVID-19 health outcomes
* Identify three major federal health policy stakeholders and federal legislation that has been implemented to address the COVID-19 pandemic
* Assess strengths and weaknesses of state and local responses to the pandemic, identifying attributes associated with “hotspots”
* Explain how the pandemic is impacting care in other areas of the U.S. healthcare system, including routine and chronic care&#x20;
* Identify at least three different ways in which the pandemic has impacted our economic and social climate


# Social-Ecological Model for Understanding Differential Impact of COVID-19

![Adapted from McLeroy, K. R., Steckler, A. and Bibeau, D. (Eds.) (1988). The social ecology of health promotion interventions. Health Education Quarterly, 15(4):351-377.](https://lh6.googleusercontent.com/NpQLeEP9D5IlCeBnFGa5mNbag8hlOMvemKHrjV8sMddSsb3Yu9iwr5MapPCw2vRKbPqH3VZ4SA4PtF0a0HWl5ZqJg_aFFYuA6LA3Hw40XGUlSmFF5Fe9vpsfF7csDSuvxj_wsRlU)

## Social-Ecological Model Background

As first proposed by [McLeroy and colleagues in 1988](https://journals.sagepub.com/doi/10.1177/109019818801500401), the Social-Ecological Model posits  that health is not solely determined by biological factors, but instead is influenced by a collection of subsystems that occur at various levels. Mainly, these levels include individual, interpersonal, institutional, community, and public policy. By taking an Ecological approach to understanding COVID-19 we are able to account for both the population- and individual-level determinants of health that are at play. This framework also affords us with the ability to think, design, and implement effective interventions while fully acknowledging the complex systems that lead to differential risk of disease. Understanding how multi-level social factors and systems not only produce inequities, but sustain them, is imperative to understanding health disparities both pre-COVID-19 and presently.

## Determinants of Health at Various Levels

### Individual

The characteristics of the individual which may include gender, religion, race, ethnicity, age, socioeconomic status, or sexual orientation as well as the attitudes, behaviors, and knowledge that influence health are shaped by such characteristics.&#x20;

### Interpersonal&#x20;

Formal and informal relationships with other individuals that may shape social identities or serve different roles in an individual’s life. These relationships may be familial or peer, may be serving as social or emotional support, and may span generations.&#x20;

### Institutional&#x20;

Institutions that shape behaviors and attitudes due to their organizational characteristics, regulations, rules (formal and informal), and cultural expectations. This may include safety, social stigma, or health initiatives.&#x20;

### Community&#x20;

The environment within defined boundaries an individual lives in that may promote certain social norms, provide access to resources, and offer social networks. Built environment, location of community, housing, transportations, community engagement, income level, health and educational facilities are components of communities. &#x20;

### Public Policy&#x20;

Laws and policies may be at the local, state or federal level may be influential in determining health outcomes. Allocation of funds, policy initiatives that aim to address health behaviors, social equity, and overall infrastructure all are integral in shaping health outcomes.&#x20;


# Health Disparities in COVID Outcomes

## Racial Health Disparities Background

### *Race as a social construct*&#x20;

The discussion on racial disparities in COVID-19 outcomes should begin with the fundamental understanding that race is a social construct rather than a biological factor ([Smedley et al, American Psychologist, 2005](https://psycnet.apa.org/record/2005-00117-003)). The [American Anthropological Association](https://www.americananthro.org/ConnectWithAAA/Content.aspx?ItemNumber=2583) upholds that “‘race’ evolved as a worldview” from “a body of prejudgements” that came together to form a myth that today impedes “our comprehension of both biological variations and cultural behavior, implying that both are genetically determined” (see AAA statement for more details and background).

### *Racial Disparities in Health Outcomes before COVID*&#x20;

Racial disparities in access to health care, health outcomes, and collection of race-based data predate the COVID pandemic. For an in-depth discussion of racial disparities prior to COVID, please refer to the [supplemental material](https://docs.google.com/document/d/1weLnZQE7LxS_Gm9pyX4Ba7ViH_7rQNH56T-1GT5dRp8/edit?usp=sharing).

## Racial Disparities in COVID-Specific Outcomes

Health disparities have been known to worsen health outcomes in African American and Hispanic populations. The spread of COVID-19 in the U.S. has exacerbated these racial disparities--data released from the [CDC](https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm) demonstrated that African American and Hispanic patients are much more likely to contract coronavirus and die from the disease. States and counties began to release racial data pertaining to COVID-19, and a [pattern](https://www.theatlantic.com/ideas/archive/2020/04/coronavirus-exposing-our-racial-divides/609526/) emerged showing that African Americans and Latinos were overrepresented among the infected and the dead. News articles abounded, illuminating the tragedy that the most vulnerable populations in America would inevitably be hit the hardest by this pandemic. Even without all states and localities reporting outcomes by race, [preliminary analyses](https://www.medrxiv.org/content/10.1101/2020.05.07.20094250v1.full.pdf) have found a relative risk of COVID-19 associated mortality of 3.57 for Black individuals compared to their White counterparts, and 1.88 for Latinx individuals compared to White individuals.

The statistics are especially alarming in cities like Chicago and Detroit, which have predominantly African American populations. In Chicago, which is 30% African American, deaths amongst this population represent 65% of the total deaths from COVID-19 and deaths amongst the Latinx community represent [11%](https://www.chicago.gov/city/en/sites/covid-19/home/latest-data.html) of COVID-19 deaths. In Michigan, which is 14% African American, the number of African American deaths constitute [39%](https://www.michigan.gov/coronavirus/0,9753,7-406-98163_98173---,00.html) of fatalities. Detroit, Michigan, a city with the highest percentage of African Americans compared to any other large U.S. city, has emerged as a hotspot for COVID-19. Detroit is located within Wayne County, which has [47%](https://www.detroitnews.com/story/news/local/michigan/2020/04/02/michigans-covid-19-deaths-hit-417-cases-exceed-10-700/5113221002/) of Michigan's COVID-19 cases.

With over 408,000 [confirmed cases and 25,000 COVID-related deaths as of](https://covid19tracker.health.ny.gov/views/NYS-COVID19-Tracker/NYSDOHCOVID-19Tracker-Fatalities?%3Aembed=yes&%3Atoolbar=no&%3Atabs=n#/views/NYS%2dCOVID19%2dTracker/NYSDOHCOVID%2d19Tracker%2dMap?%253Aembed=yes&%253Atoolbar=no.) mid-July, New York State continues to represent the epicenter of the COVID-19 pandemic in the U.S. The disparate effects of COVID are particularly evident in New York City, where African Americans account for [28%](https://www.nytimes.com/2020/04/08/opinion/coronavirus-black-cities.html) of fatalities, while composing only 22% of the total population. Furthermore, significant neighborhood-level disparities have been observed in New York City during the pandemic. Communities of color within New York City are disproportionately impacted , with neighborhoods such as Corona, Elmhurst, East Elmhurst, and Jackson Heights recording more than 7,260 coronavirus [cases](https://www.nytimes.com/2020/04/09/nyregion/coronavirus-queens-corona-jackson-heights-elmhurst.html) as of April 8th, out of a population of 600,000. Elmhurst, a neighborhood in Queens, has been described as the epicenter of the epicenter in New York. The[ preliminary death rate](https://www.nytimes.com/2020/04/08/nyregion/coronavirus-race-deaths.html?) for Latinx people in New York City is 22 people per 100,000, and, for African Americans, the rate is 20 per 100,000. In comparison, the rate is 10 per 100,000 for white people and 8 per 100,000 for Asian people.&#x20;

Moreover, significant disparities have been noted in the impact of COVID within different NYC boroughs. In early April, [COVID incidence was highest in Brooklyn, Queens, and the Bronx](https://covid19tracker.health.ny.gov/views/NYS-COVID19-Tracker/NYSDOHCOVID-19Tracker-Fatalities?%3Aembed=yes&%3Atoolbar=no&%3Atabs=n#/views/NYS%2dCOVID19%2dTracker/NYSDOHCOVID%2d19Tracker%2dMap?%253Aembed=yes&%253Atoolbar=no.), which have [higher poverty rates and a larger proportion of minorities](https://time.com/5815820/data-new-york-low-income-neighborhoods-coronavirus/). By mid-May, the Bronx had emerged as the leader in COVID prevalence, hospitalization, and mortality. When compared to Manhattan, the Bronx has more than twice the number of COVID cases and nearly two times the number of hospitalizations and deaths. The Bronx, in contrast to predominantly White and affluent Manhattan, has the [lowest median household income and the smallest proportion of residents holding a bachelor’s degree](https://jamanetwork.com/journals/jama/fullarticle/2765524) of the five NYC boroughs Furthermore, the Bronx has the [highest prevalence of diabetes, asthma, and other comorbidities](https://www.countyhealthrankings.org/sites/default/files/media/document/CHR2020_NY_0.pdf), the result of decades of structural racism.  In response to the data being released from New York, Governor Cuomo committed more testing resources to minority and low-income communities, as well as additional funding for research efforts to determine why these disparities exist.

In Boston, MA where African American residents account for 25% of the population, more than [40% of COVID infected residents were reported as Black](https://www.bostonglobe.com/2020/04/09/nation/boston-releases-coronavirus-data-that-point-stark-racial-disparities-among-those-infected/?event=event12). On the other hand, the number of White and Asian residents infected with COVID-19 was lower than expected for the proportion of the population they compose. Though current aggregated data does not yet reflect a higher rate of infection among Latinos in Boston, medical providers in hospitals are [reporting higher rates of hospitalization among Latinos](https://www.bostonglobe.com/2020/04/07/nation/coronavirus-may-be-hitting-hard-black-latino-communities/?p1=Article_Inline_Text_Link). While Governor Baker’s administration has made race-based outcomes public, only 62% of the data has race information. As a response to these statistics and the need to protect minority populations in Boston, Mayor Martin Walsh has created the [COVID-19 Health Inequities Task Force](https://www.boston.gov/news/covid-19-health-inequities-task-force-created).&#x20;

An important aspect to take into consideration when evaluating the racial disparities in COVID-19 outcomes is the age differences in each group. The White population has a [large proportion of older individuals](https://www.statnews.com/2020/07/10/covid-19-disparity-black-hispanic-americans-deaths-under-65/) (median age 44) compared to non-White populations (median age 31). Given the relationship between age and risk of poor COVID-related outcomes, not adjusting for age in analyses of racial disparities could lead to [significant underestimates of the disparities](https://www.medrxiv.org/content/10.1101/2020.05.07.20094250v1.full.pdf+html). When age is taken into account, the disparities in COVID-19 mortality are even more stark. In [one analysis](https://cdn1.sph.harvard.edu/wp-content/uploads/sites/1266/2020/06/20_Bassett-Chen-Krieger_COVID-19_plus_age_working-paper_0612_Vol-19_No-3_with-cover.pdf), age-standardized risk ratios relative to White individuals were 3.6 for Black individuals, 2.6 for Hispanics, and 1.7 for Asian Pacific Islanders people and 1.2 for American Indian/Alaska Natives.  However, when examining age groups individually, the risk ratios compared to white individuals were much higher (see image below). Thus, it appears that younger non-White populations are dying at significantly higher rates than their White counterparts.

![](https://lh6.googleusercontent.com/uPBtkpjL9CGfI8N2Q29c-WoOK9mWiyGKtbXgrVFAkB9xsIyDp1oioXiiOW6tOk_Y1zYJK1_78lThXrwULKyCy9wlAR1Z7faVxJ6nDNXFBQHtGAw_Rw7ULFSezjB_u-K8EAK8cHh6)

As more race-based data is collected and reported, as shown above, the information on many minority communities, especially American Indian/Alaska Natives, remains incredibly limited. While tribes like the Navajo Nation have been recognized in the media for having [rates of COVID-19 higher than New York and New Jersey](https://www.cnn.com/2020/05/18/us/navajo-nation-infection-rate-trnd/index.html), data from smaller tribes or urban dwelling American Indian/Alaska Natives are not being captured. Several states have released COVID-19 racial demographic data, which has been instrumental in highlighting differential impacts across African American and Latino populations. However, a large proportion of these states intentionally [omitted an American Indian/Alaska Native racial category and opted to label such individuals as “other”](https://www.theguardian.com/us-news/2020/apr/24/us-native-americans-left-out-coronavirus-data) making it difficult to describe the impact COVID-19 is having on many of these communities.&#x20;

Further, [state and federal agencies that have disaggregated racial data are withholding access](https://www.politico.com/news/2020/06/11/native-american-coronavirus-data-314527) from tribal epidemiology centers which is imperative to understanding risk factors that are unique to American Indian/Alaska Natives that may be putting them at higher risk for COVID-19. As a result of this neglect, [ the Indian Health Services](https://www.ihs.gov/coronavirus/) has started an initiative to centralize aggregate data  on the infection rate among American Indian/Alaska Natives [despite being severely underfunded](https://www.npr.org/sections/health-shots/2017/12/12/569910574/native-americans-feel-invisible-in-u-s-health-care-system)  . This data collection relies on volunteer release of data from various organizations, health centers, and programs across the country. The[ call for more accurate collection and reporting of data](https://www.healthaffairs.org/do/10.1377/hblog20200414.238084/full/) on the health and outcomes of minority populations during COVID-19 is being echoed by leaders in medicine, public health, and policy.

## A Modern Day Gardener's Tale

### *Framework for race, disparities, and health*&#x20;

Racial disparities in health outcomes are not new to the COVID-19 pandemic, but rather are intertwined within the historical, structural, and economic disadvantages afforded to communities of color throughout U.S. history. Research shows that African Americans, Native Americans, Latinos, Native Hawaiians, Pacific Islanders, and Asian Americans have disproportionately worse outcomes compared to their White counterparts ([Williams, J Health Soc Behav 2012](https://journals.sagepub.com/doi/10.1177/0022146512455804)).  The relationship between race and health has been explained in various frameworks; one nationally recognized framework is Dr. Camara Jones’s Gardener’s Tale, in which three levels of racism are described: institutionalized, personally mediated, and internalized ([Jones, Am J Pub Health 2000](https://ajph.aphapublications.org/doi/10.2105/AJPH.90.8.1212)).  For a more in-depth discussion of racism through the lens of the Gardener’s Tale, please see the [supplemental material](https://docs.google.com/document/d/1weLnZQE7LxS_Gm9pyX4Ba7ViH_7rQNH56T-1GT5dRp8/edit?usp=sharing).

### Institutional Racism

Institutionalized, or structural racism, can be succinctly defined as the “differential access to goods, services and opportunities of society by race” ([Jones, Am J Pub Health 2000](https://ajph.aphapublications.org/doi/10.2105/AJPH.90.8.1212)).  This form of racism has manifested in the current pandemic in a number of ways. , African American and Hispanic people are less able to socially isolate, as they make up a large portion of the essential workforce, particularly portions of the [essential workforce](https://whyy.org/articles/essential-and-unsafe-frontline-workers-of-color-face-compounded-risks/) with [less representation in management](https://www.buzzfeednews.com/article/kadiagoba/coronavirus-new-york-brooklyn-essential-workers-black-poc), such as grocery, maintenance, and housekeeping workers. They also face reduced access to testing, inadequate treatment upon contracting the virus, and increased risk of developing serious illness due to a higher prevalence of underlying health conditions.‌

Data from the [U.S Bureau of Labor Statistics](https://www.bls.gov/news.release/flex2.t01.htm) in 2018 showed that less than 30% of workers in the U.S. are able to work from home, falling to lower numbers in minority populations, at 20% amongst African American and 16% amongst Hispanic workers. In New York City, [city comptroller Scott M. Stringer](https://www.nytimes.com/2020/04/08/nyregion/coronavirus-race-deaths.html?) noted that 75% of frontline workers, including grocery clerks, bus and train operators, janitors, and child care staff, were in minority groups. He also reported that 60% of people who worked as cleaners were Latino, and more than 40% of transit employees were African American. The overrepresentation of racial and ethnic minorities in the essential workforce is not a coincidence. Rather, it is the result of [decades of intentional policies](https://www.americanprogress.org/issues/race/reports/2019/08/07/472910/systematic-inequality-economic-opportunity/) that confined racial and ethnic minorities to low-wage occupations, devalued agricultural, domestic and service vocations and excluded these occupations from legislation that boosted wages and improved working conditions. &#x20;

Essential workers are more restricted in their ability to participate in social distancing. Most workers that have been deemed essential, including many that are not in the healthcare industry, occupy front-facing roles as grocery store workers, first-responders, and public transport workers, where they are at increased risk of exposure to COVID-19.  Many essential workers depend on their jobs financially and do not have access to paid sick leave and health insurance if they do not go to work. The risk is further compounded by insufficient personal protective equipment (PPE) amongst essential workers who are not in the healthcare system. This has led to [strikes](https://www.npr.org/2020/03/30/823767492/amazon-instacart-grocery-delivery-workers-strike-for-coronavirus-protection-and-) to protest unsafe working conditions, insufficient testing, and insufficient PPE while on the job.&#x20;

Once these workers return home, they are more likely to live in crowded households, with increased risk of exposure to family members living in the same household ([New Yorker, April 2020](https://www.newyorker.com/news/q-and-a/the-coronavirus-and-the-interwoven-threads-of-inequality-and-health)).  While there are many [sociocultural reasons](http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.853.3972\&rep=rep1\&type=pdf) why people choose to live in multigenerational housing, the increased proportion of racial and ethnic minorities living with a large number of other family members is predominantly due to [economic inequality and exclusionary housing policies](https://www.newyorker.com/news/q-and-a/the-coronavirus-and-the-interwoven-threads-of-inequality-and-health) that prevent individuals in these populations from accessing affordable housing.  These exclusionary housing policies have not only resulted in crowded housing, but are the cause of [the significant residential segregation by race](https://www.washingtonpost.com/graphics/2018/national/segregation-us-cities/) that exists throughout the US to this day.&#x20;

Racial residential segregation is one component of systemic racism that has been a [known contributor to poor health and racial health disparities](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497358/pdf/12042604.pdf) for decades.  It has also been [linked to an increased risk](https://www.sciencedirect.com/science/article/abs/pii/S0277953600000162) of spread of infectious diseases. Lack of access to clean water, poor access to healthcare and increased exposure to air pollution are all underlying causes of racial health disparities that are deeply intertwined with residential segregation. Each of these factors has also fueled the racial disparities in COVID-19 outcomes.  For instance, communities of color are known to have [worse access to clean water](https://www.nbcnews.com/news/nbcblk/unsafe-water-more-prevalent-communities-color-study-finds-n1060366), which has been exacerbated in recent months as some low-income residents have [had their water shut off](https://www.metrotimes.com/news-hits/archives/2020/03/23/detroit-water-activists-urge-gov-whitmer-to-provide-free-water-stations-during-the-coronavirus-pandemic) due to inability to pay rising bills. It is difficult to promote hand-washing without access to clean, affordable water, which can increase the risk of contracting infectious diseases. This problem has been particularly acute for [Native American communities](https://www.healthaffairs.org/do/10.1377/hblog20200331.659944/full/) that have faced severe barriers to accessing clean water for many years. Additionally, [it has been reported](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7277007/) that greater chronic exposure to air pollution is associated with higher death rates of COVID-19, making communities of color who have disproportionately high exposure to toxic pollutants more likely to suffer severe consequences from the SARS-CoV2.&#x20;

The [CDC](https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html) also states that people of any age who have serious underlying conditions are at higher risk for severe illness from COVID-19 compared to people without these conditions. African American and Hispanic communities are at increased risk of developing health conditions such as hypertension, cardiovascular disease, diabetes, obesity, and lung disease due to poor access to healthcare, increased exposure to air pollution, and insufficient public health support systems in segregated communities. In particular, cardiovascular disease starts at earlier ages in people subjected to discrimination and economic deprivation compared to people in more privileged groups ([New Yorker, April 2020](https://www.newyorker.com/news/q-and-a/the-coronavirus-and-the-interwoven-threads-of-inequality-and-health)). Furthermore, Black people are known to have higher all-cause mortality, including mortality related to chronic cardiovascular and respiratory diseases, as well as poorer self-reported health behaviors and higher reported mental and physical stress. As indicated above, these pre-existing disparities in chronic disease prevalence arise from interconnected individual and structural forces such as poor health literacy, inadequate access to care, residential segregation, and overrepresentation in essential industries without paid sick leave.

Compounding the inability to have adequate social distancing due to financial and systemic constraints, COVID-19 testing is limited in availability to minority communities. Although the [Families First Coronavirus Response Act](https://www.natlawreview.com/article/emergency-legislation-families-first-coronavirus-response-act-updated-march-26-2020) provides funding for free COVID-19 testing, tests remain limited to those deemed to have serious symptoms and, in some cases, patients have been asked to cover the cost of testing ([Time, Mar 2020](https://time.com/5806724/coronavirus-testing-costs/)). In some areas of the country, [testing sites](https://www.npr.org/sections/health-shots/2020/05/27/862215848/across-texas-black-and-hispanic-neighborhoods-have-fewer-coronavirus-testing-sit) have been found to be concentrated in majority White neighborhoods, with fewer testing sites operating in majority non-White neighborhoods. In addition, the stimulus package does not cover all expenses related to hospitalization for COVID-19, meaning significant financial ramifications for under- or uninsured Americans if they present for care. These factors may dissuade people from going to the hospital for testing and seeking help before symptoms worsen.&#x20;

Hospitals in historically low-income communities, often referred to as “safety-net hospitals,” predominantly serve patients who are uninsured or on Medicaid and have been [hit particularly hard by the pandemic](https://www.bostonglobe.com/2020/04/18/metro/inside-boston-medical-center-heart-coronavirus-storm/).  They have been [ overwhelmed](https://www.cnn.com/2020/04/13/health/detroit-hospital-bodies-coronavirus-trnd/index.html) by the volume of patients and staffing shortages. Due to [years of disinvestment](https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2019/10/31/rural-and-safety-net-hospitals-prepare-for-cut-in-federal-support) in these hospitals, many were in tenuous financial situations prior to the pandemic. Moreover, they [received less relief funding](https://www.wsj.com/articles/coronavirus-takes-financial-toll-on-new-york-citys-safety-net-hospitals-11591904490) early in the pandemic because the initial funding allocation was based on Medicare volume, disadvantaging hospitals that service mostly Medicaid patients.   The lack of funding has resulted in [less PPE for frontline staff](https://www.nytimes.com/2020/04/26/nyregion/coronavirus-new-york-university-hospital.html), lower availability of medications and ventilators, and worse outcomes for patients presenting to these hospitals in serious condition. These manifestations of institutional racism increase the risk of exposure amongst minority patients, limit their access to testing, and disadvantage them when they present to care.

### Personally-mediated racism&#x20;

Personally-mediated racism, which refers to differential assumptions about or actions toward individuals based on their race, can also lead to poor COVID-19 health outcomes. Tests are given at the discretion of physicians, which can introduce implicit bias, unless policies are enacted and resources devoted to testing in hard-hit areas, a practice implemented at [MGH Chelsea](https://www.boston.com/news/local-news/2020/04/13/live-updates-latest-news-covid-19-outbreak-massachusetts-new-england). Individual bias can also mean that some physicians may not accurately calculate the risk to minority patients in deciding whether a test is warranted. African American and Hispanic patients have cited difficulty obtaining COVID-19 testing. There have been [cases](https://www.usatoday.com/story/news/nation/2020/04/20/coronavirus-racial-disparity-denied-tests-hospitalization/5163056002/) of minority patients being turned away from testing sites and emergency rooms, only to decompensate later without receiving adequate treatment. See module 8 for more discussion of the potential for bias in rationing scarce resources and in which groups have access to experimental treatments.

### Internalized Racism&#x20;

Finally, internalized racism, [defined as](https://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.90.8.1212) “acceptance by members of the stigmatized races of negative messages about their own abilities and intrinsic worth,” can present a challenge to battling COVID-19 in minority communities. Due to repeated examples of racism throughout history, such as the Tuskegee trials and the unpermitted use of Henrietta Lacks’ cells, African American and Hispanic patients may harbor distrust towards the healthcare system and its policies. This distrust can manifest as [reluctance to present for care](https://abcnews.go.com/US/wireStory/amid-coronavirus-pandemic-black-mistrust-medicine-looms-69983726) due to [fear of discrimination](https://www.npr.org/sections/coronavirus-live-updates/2020/04/10/832039813/why-misinformation-and-distrust-is-making-covid-19-more-dangerous-for-black-amer) or hesitancy to recieve a COVID-19 vaccine, as distrust is a [known barrier to vaccination](https://www.sciencedirect.com/science/article/pii/S0264410X16312713?casa_token=l9Z6zD0sPSgAAAAA:Sr8pbezxOD1JpnrQjqAitx0MsoDcGNSDi4JeiOkMAdo41h-jF-g2JP1exFlcpHB4OPH6WEpI_qc) for other infectious diseases in communities of color. Feeling reduced self-worth due to internalized racism could also lead to delaying or avoiding care altogether. As individuals and communities take on the negative perceptions of dominant culture that label them as “unhealthy,” they may in turn feel less inclined to seek care when they need it.&#x20;

## **COVID-19 among Populations with Limited English Proficiency**

Another group of people that has been disproportionately affected by the pandemic are those with limited English proficiency (LEP).[ 1 in 5 people](https://data.census.gov/cedsci/table?q=B16001\&tid=ACSDT1Y2018.B16001\&vintage=2018\&cid=B16001_001E) in the US speak a language other than English at home and[ 1 in 12](https://data.census.gov/cedsci/table?q=B16001\&tid=ACSDT1Y2018.B16001\&vintage=2018\&cid=B16001_001E) report speaking English “less than well” (i.e. categorized as LEP). Reports from both[ New York](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2765826) and[ Boston](https://static1.squarespace.com/static/57e2cad437c58171a3339b66/t/5e90ce79248335671458d531/1586548347509/04072020_Globe_ChelseaCovidHotspot.pdf) in the early stages of the pandemic indicated that immigrant working class communities, in which a large proportion of people have LEP, were being hit particularly hard. At the beginning of April,[ officials from Massachusetts General Hospital](https://static1.squarespace.com/static/57e2cad437c58171a3339b66/t/5e90ce79248335671458d531/1586548347509/04072020_Globe_ChelseaCovidHotspot.pdf) reported that 35-40 % of the COVID-19 patients in the hospital were Latino, 40% of whom had LEP.  This population is particularly vulnerable to contracting the virus and developing advanced disease due to the lack of high-quality translated information, inability to access care because of lack of insurance and immigration concerns and a high proportion of people in essential workers.

The lack of available translated materials about COVID-19 has forced people with LEP to rely on other sources of information, such as social media, that can be erroneous and misleading. For example,[ one article](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2765826) describes a man who believed he could not be infected with SARS-CoV-2 because he held his breath for 10 seconds without coughing. This[ myth](https://apnews.com/afs:Content:8635070312), which had apparently circulated online in many languages, illustrates the danger of failing to disseminate public health information widely in forms that all communities can comprehend.

This problem is especially serious for the LEP population as many individuals with LEP have occupations classified as essential and, thus, are in need of reliable, accurate information about how to avoid contracting SARS-CoV-2. Hispanic populations, for example, are disproportionately represented in[ service and janitorial occupations](https://www.bls.gov/opub/ted/2015/hispanics-and-latinos-in-industries-and-occupations.htm) and[ home health care occupations](https://ajph.aphapublications.org/doi/10.2105/AJPH.2018.304801). This puts them at high risk not only of becoming infected, but also of suffering greatly from the financial devastation of the pandemic due to the low compensation of these positions.  Moreover, as many people with LEP are immigrants with various levels of citizenship status, they often lack health insurance and are also frequently afraid to seek care for fear of the immigration-related consequences. (See section on [Insecure Immigration Status](https://curriculum.covidstudentresponse.org/module-3-disparities-policy-socioeconomic-effects/socioeconomic-ramifications#insecure-immigration-status))

For the LEP population that can access healthcare, they face additional barriers in both the outpatient and inpatient setting. In the[ outpatient setting](https://www.theverge.com/21277936/telehealth-english-systems-disparities-interpreters-online-doctor-appointments), the shift to telemedicine has created additional hurdles for accessing care and for having high-quality interpretation services available for virtual care. In the[ inpatient setting](https://www.bmc.org/healthcity/population-health/urgent-need-multilingual-providers-interpreters-COVID-LEP), PPE shortages and the restriction of visitors and hospital personnel to the minimum necessary have created a scarcity of in-person interpretation that threatens to undermine the quality of care provided to these individuals.

As the pandemic continues and cases begin to rise in areas of the U.S. with very large LEP populations, such as Arizona, Texas, Florida and California, the vulnerability of this population remains a significant concern.

Further Reading:&#x20;

* [Providing equitable care to patients with limited dominant language proficiency amid the COVID-19 pandemic](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304953/)
* [More than a third of Texans speak a language other than English. That means key coronavirus updates aren’t accessible to them](https://www.texastribune.org/2020/06/02/texas-coronavirus-language-spanish/)

## **Lessons for the Future**

Dr. Camara Jones proposes three principles for achieving health equity during the fight against COVID-19, which include “valuing all individuals and populations equally, recognizing and rectifying historical injustices, and providing resources according to need” ([Newsweek, April 2020](https://www.newsweek.com/2020/04/24/coronavirus-disease-discriminates-our-health-care-doesnt-have-opinion-1496405.html)). Dr. Jones emphasizes the importance of enabling all communities to participate in social distancing, stay-at-home orders, and frequent hand-washing, which means providing housing for the homeless, hand-washing stations, and reaching out to communities of color to emphasize the importance of social distancing. It is necessary to collect and disaggregate data on “coronavirus testing, diagnosis, treatment, and outcome by ‘race’ and ethnicity so that the impacts of these historical injustices can be recognized and addressed.” Finally, it is important to agree upon a metric of need in a particular community, such as the number of diagnosed cases or indicators of the trajectory of the epidemic, to allocate and distribute resources according to that metric of need. Dr. Valerie Montgomery Rice urges the importance of[ concentrating resources in communities of color,](https://www.youtube.com/watch?v=PWGXmuDcAFA) commenting that, “At a federal level, we want to see resources deployed to the hardest hit communities, and, based on the data we are seeing, these are African American communities, Hispanic communities, poor communities.” In addition to [petitioning for national standards](https://www.ama-assn.org/press-center/press-releases/top-physician-orgs-urge-covid-19-mortality-data-race-ethnicity?utm_source=Selligent\&utm_medium=email\&utm_term=%25m%25d%25y\&utm_content=OTHER_PE_COVID19_MEM_041620\&utm_campaign=PPOS_Lifestyle_020920\&utm_uid=10939166\&utm_effort=\&utm_h=) for reporting race outcomes in COVID, medical organizations such as the American Medical Association (AMA) have responded by creating a [Health Equity Resource](https://www.ama-assn.org/delivering-care/health-equity/covid-19-health-equity-resources) website.&#x20;

The data has drawn national attention. Dr. Fauci, immunologist and director of the National Institute of Allergy and Infectious Diseases (NIAID),[ reflected](https://www.businessinsider.com/fauci-covid-19-shows-unacceptable-disparities-for-african-americans-2020-4) “...sometimes when you're in the middle of a crisis, like we are now with the coronavirus, it really does, ultimately, shine a very bright light on some of the real weaknesses and foibles in our society.” COVID-19 has already taken a devastating toll on American society and communities of color, in particular.  It is critical that society recognizes and addresses the causes of these racial health disparities before they claim more lives.

## Emerging Equity Based Efforts

Recognizing these disparities as the result of racism within our society and our healthcare system is only the first step. Over the course of the past several weeks, several initiatives have emerged as a means to address some of these disparities. While there is still much to do, we believe that there is merit in learning from examples set by other groups, organizations, and individuals who have attempted to combat disparities in the moment. For a growing list of efforts see the [NAACP’s Equity Implications report](https://naacp.org/wp-content/uploads/2020/03/Ten-Equity-Considerations-of-the-Coronavirus-COVID-19-Outbreak-in-the-United-States_Version-2.pdf).

Examples of emerging efforts include:

* Demands to release of residents from jails and prisons. See [Humanity Not Cages](https://humaneoutbreakresponse.org/) and reporting on efforts by public defenders in [Louisiana](https://thelensnola.org/2020/03/12/public-defenders-request-the-release-of-all-non-violent-offenders-in-jail-due-to-coronavirus/).
* Successful implementation of similar demands to address mass incarceration in [Ohio](https://www.commondreams.org/news/2020/03/16/applauding-release-prisoners-ohio-due-coronavirus-threat-aclu-calls-officials).
* [Guidance](https://www.shrm.org/resourcesandtools/hr-topics/behavioral-competencies/global-and-cultural-effectiveness/pages/coronavirus-and-racism-take-precautions-to-fight-discrimination.aspx) made for employers whose employees may be subject to racism.&#x20;
* Multiple cities choose to [suspend evictions](https://thehill.com/policy/healthcare/public-global-health/487877-multiple-cities-suspend-evictions-during-coronavirus) during the pandemic.
* [Nonprofit](https://marthastable.org/wp-content/uploads/2020/03/Local-Nonprofit-Martha%E2%80%99s-Table-Rolls-Out-Unprecedented-Level-of-Support-for-D.C.-Communities-Amid-Coronavirus-Outbreak.pdf?fbclid=IwAR1_3XDk0Uf0uBBOsN0XE_aOV0BzPGBIwQKBLF_ngULirk9uRfuHqK2nno0) initiatives to feed those who may be disadvantaged by this situation.
* [ACLU](https://www.aclu.org/press-releases/aclu-sues-ice-release-immigrants-especially-vulnerable-covid-19) sues for ICE detention centers to release residents. ACLU has ongoing initiatives to also ensure that reproductive health is open to and accessible by all.

## Racism as a Public Health Crisis

In the wake of COVID-19’s disproportionate burden on communities of color, continued acts of police violence, and countless additional injustices, the [American Public Health Association](https://www.apha.org/topics-and-issues/health-equity/racism-and-health) has declared racism a public health crisis. Physician Assistant and advocate [Leslie Gregory](https://www.right2healthus.org/about-us) has [long argued](https://www.rollingstone.com/culture/culture-news/racism-public-health-crisis-1014162/) that racism is a public health crisis, rather than an “issue,” as it meets the four criteria of crises the CDC has [previously cited](https://www.cdc.gov/pcd/issues/2006/apr/05_0105.htm):

1. It places a significant burden on society that is increasing
2. This burden is unevenly distributed throughout society (some groups are affected more than others)
3. Preventative strategies have the potential to reduce the burden
4. These strategies are not yet in place

While this crisis is not new, COVID-19 has made even more clear many of the inequities that have been harming health in communities of color for years, as discussed above. The [same structures](https://www.washingtonpost.com/opinions/racism-is-killing-black-people-its-sickening-them-too/2020/06/04/fe004cc8-a681-11ea-b619-3f9133bbb482_story.html) of oppression that create over-policing and violence toward communities of color result in disparities that make these communities the most susceptible to the worst COVID-19 outcomes. Acknowledgement of racism as a public health crisis pushes us to see [racism, rather than race](https://www.wbur.org/cognoscenti/2020/06/12/anti-racism-in-medicine-hospitals-ayotomiwa-ojo), as the risk factor for morbidity and mortality.&#x20;

Cities and counties across the country have joined in this declaration, but the meaning of an official declaration remains unclear. In this national moment of focus on public health, a public health crisis may provide a useful framework for action around racial inequities. At the same time, public health itself has a racist history, and practitioners will need to remain vigilant that the voices and needs of communities of color are prioritized in future directions. While some declarations may remain symbolic with little policy or funding tied to them, others may gain support that was not previously accessible without the label of “crisis.”

While a full review of racism and antiracist education is beyond the scope of our curriculum, we feel this is something vital for future medical professionals to understand, and direct readers to resources listed at [Med-Ed Portal's Antiracism Page](https://www.mededportal.org/anti-racism). Please also see Module 6, Training for Clinical Roles, for additional information.

## **Further Reading and Resources**

Our understanding of racial disparities in COVID infection, access to quality care, and outcomes will continue to evolve over the coming months. These racial disparities are closely intertwined with other social determinants of health, such as housing, employment, and immigration status. See the final section of this module for more discussion of these issues. With the framework provided above, we hope the below articles and resources help you to assess the constantly changing situation and potential solutions to mitigate these disparities.

* [Racial Disparities in Age-Specific Mortality Among Blacks or African Americans](https://www.cdc.gov/mmwr/volumes/66/wr/mm6617e1.htm)
* [COVID-19 in Racial and Ethnic Minority Groups](https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/racial-ethnic-minorities.html)
* [COVID-19 and African Americans | Health Disparities | JAMA](https://jamanetwork.com/journals/jama/fullarticle/2764789)
* [Racial Health Disparities and Covid-19 — Caution and Context | NEJM](https://www.nejm.org/doi/full/10.1056/NEJMp2012910?query=featured_coronavirus)
* [The COVID Racial Data Tracker](https://covidtracking.com/race) from the COVID Tracking Project
* [The Coronavirus Is Exposing Our Racial Divides](https://www.theatlantic.com/ideas/archive/2020/04/coronavirus-exposing-our-racial-divides/609526/)
* [Health Equity—A New Kind of “Herd Immunity”](https://jamanetwork.com/journals/jama/fullarticle/2766096)
* [Why is COVID-19 hitting Black communities harder? Residential Segregation is a Key Factor.](https://theappeal.org/coronavirus-racial-disparities-residential-segregation/)

### **Thought Questions:**

* What are immediate and long term policies that are necessary to curb the devastation that COVID-19 is having on minority communities?
* What lessons can we learn from COVID regarding disparities in health care which can help us improve outcomes of minority populations in the long run?
* What are data points that are still lacking in the race based COVID outcome reports?&#x20;
* If you were to identify a disparity or social need mentioned above (or one you have noticed, learned about, recognized yourself), what actionable steps could you take now to help contribute to emerging efforts? Change is incremental, disparities won’t disappear overnight, but they can be combated one action at a time.


# COVID-19 among Populations in Correctional Facilities

## Health and Health Care in Correctional Facilities Prior to COVID-19

Given the United States has one of the highest incarceration rates in the world, the health and wellbeing of this population during the COVID pandemic warrants discussion. It is estimated that[ nearly 2.3 million](https://www.prisonpolicy.org/reports/pie2020.html) individuals in the United States are currently incarcerated.  For a discussion on the state of health and healthcare in correctional facilities prior to COVID, please refer to the [supplemental reading](https://docs.google.com/document/d/1weLnZQE7LxS_Gm9pyX4Ba7ViH_7rQNH56T-1GT5dRp8/edit?usp=sharing).&#x20;

## Incarceration During the COVID-19 Pandemic

[At least 25,000 incarcerated individuals](https://covidprisondata.com) have tested positive for COVID-19, along with more than 7,000 correctional facility staff. At one point during the pandemic, an Ohio state prison was the largest known source of COVID-19 cases in the U.S., with at least 1,937 confirmed cases (73% of the population in that prison).&#x20;

Correctional facilities are a particularly dangerous site for viral spread. First, social distancing is difficult to implement in forced confinement. Second, given the predilection of COVID-19 for older adults with pre-existing conditions, the fact that nearly [20% of incarcerated individuals are over the age of 50, and more than a third](https://www.bop.gov/about/statistics/statistics_inmate_age.jsp) have pre-existing health conditions puts them in a vulnerable position for serious illness from COVID-19. Reports also show that, in some prisons, the [response to provide medical care](https://www.buzzfeednews.com/article/melissasegura/prison-inmates-covid-19-coronavirus) for incarcerated individuals with COVID-19 symptoms is slow. In Kansas, [the outcry to receive medical attention](https://www.theguardian.com/us-news/2020/apr/10/us-prisons-coronavirus-uprising-riot) resulted in an uprising within a correctional facility. In addition to the direct health effects of COVID, incarcerated individuals face additional health risks from isolation as a result of loss of privileges and visitation rights.

### Federal response&#x20;

Several human rights organizations and initiatives have pleaded with the federal government to take immediate action to reduce the spread of COVID-19 in prisons and jails. For example, the [Prison Policy Initiative](https://www.prisonpolicy.org/virus/virusresponse.html) has released a five point list of immediate actions, which include the following:

1\. Releasing incarcerated individuals from jails and prisons ([an initiative now in action](https://www.bbc.com/news/world-us-canada-51947802) in several states)

2\. Reducing admissions to correctional facilities&#x20;

3\. Reducing check-ins, such as parole visits

4\. Eliminating co-pays for medical care

5\. Providing telephone and video calls at a lower cost

While U.S. Attorney General William Barr has [taken some initiatives to address](https://www.themarshallproject.org/2020/03/28/how-bill-barr-s-covid-19-prisoner-release-plan-could-favor-white-people) the spread of COVID-19 in federal correctional facilities, such as ordering the use of home confinement and early release, many biases plague the current system that determines which individuals qualify for these initiatives. This is an area of much debate during the pandemic, and we recommend you visit the [Prison Policy Initiative's COVID-19 Resources page](https://www.prisonpolicy.org/virus/index.html) for further exploration of this issue.


# Overview of U.S. Health Policy Responses to COVID-19

COVID-19 is a test of the U.S. healthcare system that has highlighted its weaknesses and fragmentation, necessitating quick and decisive action from policymakers. One key reason for government intervention during an infectious disease pandemic is externalities, a phenomenon that occurs when individual decision-makers do not face the full social consequences of their actions. Which government intervenes is rooted in another key theme: federalism, or the constitutional distribution of powers among federal, state, tribal, and local (city/county) governments. This section will provide an overarching framework of COVID-19 responses at each level of government, and later sections will dive into specifics.

## Health Policy Stakeholders & Levers

**President:** The president has many executive powers and large discretion over how to use them. The president has the authority to declare a national emergency, as President Trump did on March 13. This emergency declaration permits the use of designated emergency funds to aid state and local governments and allows the Federal Emergency Management Agency (FEMA) to coordinate a response. The president can also issue executive orders, as was done March 18, 23, and 27, to allow the Department of Health and Human Services to prioritize and allocate health and medical resources, regulate hoarding and price gouging, and activate the Defense Production Act (DPA) to increase production of essential supplies. On April 22, President Trump also issued an executive [order](https://www.whitehouse.gov/presidential-actions/proclamation-suspending-entry-immigrants-present-risk-u-s-labor-market-economic-recovery-following-covid-19-outbreak/) limiting most legal immigration into the U.S. for 60 days for anyone currently outside the U.S., including green card holders but exempting healthcare workers or other temporary workers on nonimmigrant visas. On April 27, President Trump issued more details on a federal [plan](https://www.nytimes.com/2020/04/27/us/politics/trump-coronavirus-testing.html) to increase diagnostic COVID-19 testing. See [Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/clinical-presentation-of-covid-19#united-states-testing-capacity) for more details on testing.

**Department of Health and Human Services:** This is the executive branch’s cabinet-level department that houses many of the agencies responsible for policy related to COVID-19.

1. Centers for Disease Control and Prevention (CDC): The CDC issues public health guidance, such as travel warnings and recommendations to wear cloth face coverings outdoors. Importantly, it also tracks COVID-19 cases and releases data to the public.
2. Center for Medicare and Medicaid Services (CMS): CMS is responsible for setting reimbursement rates and rules for hospitals and physicians, including what telehealth visits are reimbursable and what qualifies as a hospital. More discussion below under “Insurance.”
3. Food and Drug Administration (FDA): regulates COVID-19 tests and approves any drugs or vaccines before public use.
4. National Institutes of Health (NIH): funds COVID-19 research and clinical trials. Dr. Anthony Fauci is the director of the National Institute of Allergy and Infectious Diseases (NIAID), an NIH division.
5. Strategic National Stockpile: limited inventory of essential medical supplies and equipment to be used during disease outbreaks or bioterrorism attacks.

**Congress:** Congress is broadly in charge of federal spending. As was done, Congress can pass stimulus bills that provide direct funding to low/middle-income Americans, funding for hospitals, expand unemployment benefits, increase testing capacity, and provide loans for small businesses, among other policy actions. More detail below on the stimulus bill.

## State governments

**Governors:** Governors have become a large part of the policy response to the pandemic in the U.S., as states have been differentially affected. They can also declare state emergencies and state orders, including stay-at-home policies, mandatory quarantine for travelers, non-essential business closures, and bans on large gatherings.[ Here](https://www.kff.org/health-costs/issue-brief/state-data-and-policy-actions-to-address-coronavirus/#policyactions) is a useful map of what states have done.

**Budgets:** States have to balance their budget at the end of each fiscal year. Unlike the federal government, they cannot run a deficit. This means that states can have limited capacities to pay large amounts of money to secure personal protective equipment (PPE), fund contact tracing, or support local businesses.

**Medicaid:** As a joint federal-state program, states have much control over their own Medicaid program. Some states have paused any Medicaid disenrollments or cost-sharing for beneficiaries (details[ here](https://www.kff.org/medicaid/issue-brief/medicaid-emergency-authority-tracker-approved-state-actions-to-address-covid-19/)). Importantly, some states’ Medicaid programs are less suited to respond to a recession, such as in states that have not expanded Medicaid. Medicaid eligibility is determined on a monthly basis, so if someone’s income in April dropped to $0, then he or she would be eligible in all expansion states. Medicaid often has increased enrollment during recessions, which is also when funding for Medicaid is lowest due to decreased tax revenue. The pandemic also highlights that some states’ proposals to reform Medicaid, such as block grants (moving from the federal government paying a set percentage of states’ Medicaid costs to a set amount) or per capita caps (moving to a set amount per beneficiary), may reduce states’ Medicaid funding, and thus the number of enrollees or benefits per enrollee, which may not be flexible enough to account for increased enrollment during a recession ([Sommers and Gruber, 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2007124)).

## Insurance

**Cost-sharing:** Federal and state regulations can require insurers to eliminate cost-sharing (e.g. copayments) for COVID-19 testing and/or care. Note that state regulations do not apply to self-insured employers, who are responsible for all their employees’ health costs and employ over half of all private employees nationwide. While we typically worry about moral hazard, or the increased use of care when consumers face a subsidized price, that is less important in the setting of care for a pandemic.

**Reimbursement for testing:** CMS announced on[ April 15](https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-high-production-coronavirus-lab-tests-0) that it would increase how much it would pay for COVID-19 tests to $100/test.

**Reimbursement for telehealth:** CMS has significantly eased restrictions on reimbursements for[ telehealth](https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet) to promote its use and to fund providers.

**Employer-sponsored insurance:** The U.S. healthcare system is unique in that half of the population has employer-sponsored insurance. This is especially problematic now that many individuals are losing their jobs and, thus, their insurance coverage. If a worker is furloughed, his or her salary is withheld, but benefits like health insurance may continue for a limited duration, depending on the details of the insurance plan (which vary greatly between states and insurers).

**Individual marketplaces:** Typically, open enrollment for plans on the marketplaces is only in the fall. A special enrollment period would allow individuals who have newly lost their jobs, and thus their health insurance, to sign up for new coverage on the marketplaces. While losing one’s insurance is a “qualifying event” that permits you to enroll, significant paperwork is required to demonstrate your case; thus, advocates argue that a special enrollment period would still be preferable and would also allow those who didn’t sign up earlier to enroll. Of note, some states use state-based exchanges, and some of those exchanges have opened enrollment (map[ here](https://www.kff.org/health-costs/issue-brief/state-data-and-policy-actions-to-address-coronavirus/)). One policy tool to combat adverse selection, where only the sickest and highest-cost individuals sign up for coverage, is to establish a federal reinsurance program that helps to cover some of the high costs that individual insurers may struggle to pay on their own ([Glied and Swartz, 2020](https://www-healthaffairs-org.ezp-prod1.hul.harvard.edu/do/10.1377/hblog20200401.505998/full/)).


# United States Federal Health Policy Response Details

President Donald Trump enacted the C[oronavirus Guidelines for America on](https://www.whitehouse.gov/briefings-statements/coronavirus-guidelines-america/) March 16, 2020, which include avoiding gatherings of more than 10 people, working from home when possible, closing schools, and avoiding unnecessary travel, among other requirements. On March 29, 2020, in light of recommendations from multiple public health advisors, President Trump extended these guidelines from April 12 to [April 30](https://www.nytimes.com/2020/03/29/us/politics/trump-coronavirus-guidelines.html). On April 16, 2010, President Trump announced new guidelines for re-opening parts of the country.&#x20;

Congress began addressing the social and economic impacts caused by COVID-19 and its resulting guidelines with the Families First Coronavirus Response Act, passed March 18. This bill includes the following (read the full text [here](https://www.congress.gov/bill/116th-congress/house-bill/6201/text)):

* Expands paid sick leave
* Provides additional funding to WIC and other supplemental nutrition programs
* Mandates that COVID-19 testing be of no cost to patients
* Expands requirements around employers’ infectious disease control plans

Senate Republicans and Democrats also constructed and passed the Coronavirus Aid, Relief, and Economic Security Act (CARES), a [$2 trillion stimulus package](https://www.nytimes.com/2020/03/25/us/politics/whats-in-coronavirus-stimulus-bill.html), which was enacted at the end of March 2020. This package includes (read the most recent text [here](https://www.congress.gov/bill/116th-congress/senate-bill/3548/text)):

* Direct payments to taxpayers, with the IRS disbursing up to $1,200 per taxpayer based on 2018 and 2019 tax returns, with an additional $500 per child
* Extension of unemployment benefits
* Loans to small businesses
* Bailouts for larger businesses
* Increased funding and Medicare payments to hospitals, including:
  * $100 billion for hospitals and other entities to cover unreimbursed health care related expenses or lost revenues attributable to COVID-19
* Increased Medicare payments by 20% for patients with COVID-19
* $945 million for the National Institutes of Health to support research, including developing an improved understanding of the prevalence of COVID-19
* $200 million for Centers for Medicare and Medicaid to assist nursing homes with infection control
* $425 million for Substance Abuse and Mental Health Services Administration to increase access to mental health services

&#x20;Another interim coronavirus funding bill worth $484 billion provides more funding for small businesses, hospitals, and testing.  A majority of the bill is designated towards replenishing the [Paycheck Protection Program (PPP)](https://www.sba.gov/funding-programs/loans/coronavirus-relief-options/paycheck-protection-program-ppp). This bill was signed by the President April 24, 2020.

* The PPP provides government-guaranteed loans to small businesses through the CARES Act.  The loan amount is forgiven if “all employees are kept on the payroll for eight weeks and the money is used for payroll, rent, mortgage interest, or utilities.”

On May 15th, the House passed the [HEROES Act](https://docs.house.gov/billsthisweek/20200511/BILLS-116hr6800ih.pdf), a $3 trillion stimulus package.  Discussion of a second relief bill will resume in the Senate after the congressional Memorial Day Recess.  [Notable provisions](https://www.vox.com/2020/5/15/21258854/house-three-trillion-stimulus-bill) of the House bill include:

1\.     Nearly $900 billion for states and local governments

2\.     A second round of $1,200 stimulus checks, with a new provision granting filers an additional $1200 per dependent (for up to three dependents). &#x20;

3\.     Funding to expand testing and tracing programs&#x20;

4\.     Extension of unemployment insurance, increased SNAP benefits, COBRA subsidies for health insurance, and support for small business

5\.     Expansion of vote-by-mail access and early voting<br>

Despite the passage of the HEROES Act in the House, discussion of a second stimulus package remains ongoing at all levels of government.  Compared to its predecessor, the HEROES act would expand the number of adults and dependents eligible for a stimulus check, but it remains unclear if this act will pass as written in the Senate.  With record unemployment and a worsening economic situation, members of the executive administration have also signaled their interest in a [second stimulus package](https://www.cbsnews.com/news/second-stimulus-check-round-2-how-much/)  but have not specified their plan for recovery. &#x20;

As many states struggle to deal with the economic ramifications of the COVID-19 pandemic (discussed below), each state, and, in many areas, each county, is enacting regulations in an attempt to ensure a safe reopening. The [CDC](https://www.cdc.gov/coronavirus/2019-ncov/community/index.html) has provided recommendations for communities, schools, workplaces, and events as they begin to reopen, and the White House has established broader guidelines for [Opening Up America Again](https://www.whitehouse.gov/openingamerica/). Despite these recommendations, [over 30 states](https://www.healthline.com/health-news/covid19-cases-rising-states-reopened#Some-states-are-doing-better) were seeing a daily rise in confirmed cases at the end of June, causing 12 states, including [California, Texas, and Florida,](https://www.cnn.com/2020/06/29/health/us-coronavirus-monday/index.html) to pause or move backwards in their reopening plans. To read more about individual state responses, please see our section on [State Responses to COVID-19](https://curriculum.covidstudentresponse.org/module-3-disparities-policy-socioeconomic-effects/state-responses-to-covid-19-selected-case-studies), as well as state policy maps from the [Washington Post](https://www.washingtonpost.com/graphics/2020/national/states-reopening-coronavirus-map/) and [CNN](https://www.cnn.com/interactive/2020/us/states-reopen-coronavirus-trnd/).

### Thought questions:

* $1,200 is approximately how much an American minimum-wage worker being paid $7.25/hour for 40 hours would make for 4 weeks of work. How does this change your thoughts on the above discussion? Does this change how you think about the American minimum wage?
* What areas of healthcare, if any, are not receiving support from the CARES Act?
* Large companies and institutions have received millions in relief funding through the CARES Act.  After facing criticism, Shake Shack returned $10 million in federal loans.  Should companies and institutions qualify for the same relief as small businesses?

## Federal Response Case Study: Understanding the Medical Supply Shortage

After the 2014-2016 Ebola outbreak, the White House issued a [memorandum](https://int.nyt.com/data/documenthelper/6823-national-security-counci-ebola/05bd797500ea55be0724/optimized/full.pdf) explaining how “gaps in preparedness and capacity surfaced in every major agency tasked with health and security in the U.S. government.” The report asserted that “the current scale of response activities… is likely not sufficient,” and that future infectious disease threats, “especially those that are airborne and transmissible before symptoms appear” are “ among the most serious threats to our homeland and to international security.” An office was created within the National Security Council to manage potential pandemic responses, and an [“H9N2 simulation”](https://www.politico.com/news/2020/03/16/trump-inauguration-warning-scenario-pandemic-132797) of a global influenza pandemic took place in early 2017. Unfortunately, many of the White House staff present for that simulation were no longer in office at the time of the COVID-19 outbreak, and the office dedicated to managing the U.S. response to a global pandemic was dismantled in 2018.&#x20;

In a later influenza pandemic simulation called [Crimson Contagion 2019](https://int.nyt.com/data/documenthelper/6824-2019-10-key-findings-and-after/05bd797500ea55be0724/optimized/full.pdf), it was noted that the “current medical countermeasure supply chain and production capacity \[could] not meet the demands” of nations in the scenario, and that officials were unsure of how the Defense Production Act could be implemented. This latter simulation brought to light the [inability of the U.S](http://nytimes.com/2020/03/19/us/politics/trump-coronavirus-outbreak.html). to manufacture PPE, medication, and ventilators, among other medical supplies in the setting of a global pandemic. Adding to the potential for a medical supply shortage, the national stockpile of face masks [was not fully replenished](https://www.washingtonpost.com/investigations/face-masks-in-national-stockpile-have-not-been-substantially-replenished-since-2009/2020/03/10/57e57316-60c9-11ea-8baf-519cedb6ccd9_story.html) after H1N1 in 2009. On March 4, 2020, the HHS released a [statement](https://www.cnbc.com/2020/03/04/hhs-clarifies-us-has-about-1percent-of-face-masks-needed-for-full-blown-pandemic.html) that the U.S. had 1% of the respirator masks needed in the event of COVID-19 becoming a pandemic, with a Strategic National Stockpile containing only 12 million medical-grade N95 masks and 30 million surgical face masks.&#x20;

Two weeks later, on March 18, 2020, the White House invoked but did not activate the [DPA](https://www.vox.com/2020/3/18/21185333/coronavirus-defense-production-act-trump), which gives the President the authority to order manufacturers to increase their production of needed supplies (such as masks, respirators, and ventilators) in times of emergency. Once the act has been invoked, industries are obligated to fill orders coming from the federal government before any others, and the federal government can distribute medical supplies according to need instead of ability to pay. Without the DPA, [state governors were forced to compete with one another and the federal government](https://www.washingtonpost.com/business/2020/03/26/gouged-prices-middlemen-medical-supply-chaos-why-governors-are-so-upset-with-trump/) to purchase medical supplies, leading to increases in medical supply cost and counterfeit sales. President Trump issued an [executive order](https://www.hhs.gov/about/news/2020/03/25/hhs-implements-president-trumps-hoarding-prevention-executive-order.html) under the DPA on March 23, 2020 “preventing hoarding of health and medical resources necessary to respond to COVID-19” by “business, personal, and home” interests.&#x20;

The President went further on March 27, 2020, [activating the DPA](https://www.washingtonpost.com/politics/2020/03/25/is-trump-using-defense-production-act/) to force ventilator production by General Motors. He took a similar measure on April 2 with two memorandums, the [first](https://www.whitehouse.gov/presidential-actions/memorandum-order-defense-production-act-regarding-3m-company/) instructing 3M Company to increase production of N95 masks and a [second](https://www.whitehouse.gov/briefings-statements/statement-president-regarding-defense-production-act-3/) to facilitate the supply of manufacturing products to [General Electric Company, Hill-Rom Holdings Inc., Medtronic Public Limited Company, ResMed Inc., Royal Philips N.V., and Vyaire Medical Inc. to accelerate ventilator production](https://www.aha.org/news/headline/2020-04-02-president-uses-dpa-facilitate-production-ventilators). The U.S. government and 3M reached an agreement four days later, with 3M providing an additional [55.5 million N95 masks each month](https://www.cnn.com/2020/04/06/politics/trump-3m-defense-production-act-masks/index.html).

For more information on optimizing PPE use in our current shortage, please see [Module 6: Personal Protective Equipment](https://curriculum.covidstudentresponse.org/module-5-training-for-medical-student-specific-roles/personal-protective-equipment). For more information regarding the ethical considerations surrounding PPE allocation and lifesaving interventions, such as CPR, please see [Module 8: Resource Distribution](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19/untitled-1#microallocation).<br>


# State Responses to COVID-19: Selected Case Studies

\***Page Currently Under Construction!**\*

Case Study Student Authors: Andrew Foley MPH, Michael Fuchs, Mugdha Mokashi, Sarah Onorato, Hema Pingali, Simone Sasse, Katie Shaffer

***Please Note:** While our curriculum is reviewed by expert faculty, this section focuses on specific state responses with which faculty in Boston may not be familiar. As such, faculty review may not apply to this entire section.*

The U.S. has been unique in its response to COVID-19. Despite now having the [highest number of cases](https://www.sciencemag.org/news/2020/04/united-states-leads-coronavirus-cases-not-pandemic-response#) in the world, relatively little action has taken place at the level of the national government. The U.S. has historically utilized a decentralized approach to public health, and the resulting [patchwork](https://www.nytimes.com/2020/03/15/us/united-states-coronavirus-response.html) of approaches by states, cities, and counties has become apparent in the past weeks. Preparedness plans, and the information used to create them, vary widely by state and region, and experts warn that these [disparities in preparation](https://khn.org/news/during-a-pandemic-states-patchwork-of-crisis-plans-could-mean-uneven-care/) may lead to disparities in outcomes. Others caution that small-scale mobilization is [insufficient](https://www.nejm.org/doi/full/10.1056/NEJMp2006740) to overcome the demands of COVID-19. With states at the leading edge of the COVID-19 response, it is important for medical students and other health profession trainees to have the skills to critically examine state and local public health responses.

While we are not able to cover every state, we’ve highlighted a few that are distinct in their approaches. California’s population is the largest in the country, and leaders have had to consider a diverse population across a large geographic span. Ohio acted early on many social distancing measures, despite relatively few early cases. Texas has relied on actions from local and county officials, with state action coming later. Pennsylvania has taken a county-by-county approach, rather than enacting statewide measures. Alabama serves as an example of a response in a state with more rural populations and a historically politically conservative government; responses were initially led by county, but are now being coordinated statewide by the governor. Massachusetts is a densely populated state with a large healthcare infrastructure. We plan to profile additional states in the coming weeks.

![COVID-19 Cases, selected states, as of May 17, 2020](/files/-M7c-Leqqzrvy1-GCGXP)

![COVID-19 Deaths, selected states, as of May 17, 2020](/files/-M7c-cOPCGebQhL3WHp8)

*Graphics by Jennifer Ge, HMS Student; data from* [*The COVID Tracking Project*](https://covidtracking.com/)

## Helpful Resources in Understanding State Responses:

* Kaiser Family Foundation: [State Data and Policy Actions to Address Coronavirus](https://www.kff.org/health-costs/issue-brief/state-data-and-policy-actions-to-address-coronavirus/)
* National Conference of State Legislatures: [State Action on Coronavirus](https://www.ncsl.org/research/health/state-action-on-coronavirus-covid-19.aspx)
* Institute for Health Metrics and Evaluation: [COVID-19 Projections](https://covid19.healthdata.org/united-states-of-america)

## Thought Questions for Understanding Your Own State’s Response

While we have highlighted states that have taken a unique approach to managing the pandemic or have been particularly hard-hit, each state (and city and town!) has its own approach. We encourage you to think critically about these responses and use some of the themes discussed in this section to inform your evaluation of local and state public health responses around the country.

* Who lives and works in the state, and how do their lives impact how the virus spreads?
* Who orchestrates the response within the state? How does their background and expertise affect their leadership?
* What does public health look like at baseline? How has the safety net (or lack thereof) affected the trajectory of the virus?
* How did the state fare during the 1918 Influenza epidemic? Check out [this site](https://www.influenzaarchive.org/index.html) from the University of Michigan Center for the History of Medicine for more information.
* How has the state handled testing? Who has access and why? How might you redesign testing access if you were tasked to do so?&#x20;
* What kinds of social distancing and non-pharmacologic measures were put in place and when? How do these measures and timing impact the spread of the virus? Why might these measures be important during a pandemic and how could you evaluate whether or not these measures were successful?
* How have leaders communicated important information to the public? How might this communication be continued or modified?

## Selected Case Studies

To view the cases, click [HERE](https://docs.google.com/document/d/17dUmXrdfCQtDYfNH4aQfX4pdY9mEpOqqBFeB1KLcC5M/edit?usp=sharing).

![States with a case study are highlighted in orange.](/files/-M8g38KJhatJ4pCPM1hB)


# Implications for the Healthcare System Beyond COVID-19 Patients

## A New Landscape for Routine Medical Care

Routine care has shifted towards telemedicine, which both reduces the risk of viral transmission and preserves the healthcare workforce. In addition to audio and visual virtual visits for established outpatients, telemedicine can be used in triage for patients exhibiting COVID-19 symptoms and monitoring in the ICU setting ([Hollander and Carr, 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2003539)). Prior to March 2020, reimbursement for telehealth services was limited. In light of the COVID-19 public health emergency and urgent need for social distancing, on March 6, 2020, CMS expanded telehealth coverage to “[office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence.](https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet)” While this expansion in coverage is temporary, the widespread implementation of telehealth during this crisis will likely change the landscape of telemedicine in the future.[ Module 6](https://curriculum.covidstudentresponse.org/module-6-training-for-clinical-roles/telehealth) describes best practices in conducting telehealth encounters.

Because patients with chronic conditions are more likely to develop complications, they are advised to be especially prudent in taking necessary precautions such as social distancing and handwashing. In one example,[ Fenway Health](https://fenwayhealth.org/fenway-health-policy-brief-outlines-impact-of-covid-19-on-people-living-with-hiv-and-lgbtqia-people/), a Boston health center serving LGBTQ patients, advised patients with HIV to confirm that their flu and pneumonia vaccines are up to date, that a 30-day (or more) supply of their medication is available on hand, and that they pay special attention to treatment adherence. In another example, oncologists carefully balance the timing and benefit of various cancer treatments with the risk of infection and hospital admission ([Shrag et al, 2020](https://jamanetwork.com/journals/jama/fullarticle/2764728)).

Many non-urgent procedures have been postponed. On April 19, CMS released guidelines for re-opening certain non-essential procedures, a process that has started with caution where hospital capacity and infection control are thought to be adequate. However, as COVID-19 cases have surged across the country in the fall, threatening ICU capacity in some states, [restrictions](https://www.mass.gov/doc/dph-elective-surgery-order/download) on elective procedures have been put in place again. The impact of delaying a procedure is balanced with the risk of hospital admission, both to individual patients and to a hospital’s capacity, though in-hospital transmission of COVID-19 is rare. Other impacts of COVID-19 on non-COVID-19 care include deferred dental care, postponed[ preventive care](https://www.reuters.com/article/us-health-coronavirus-usa-screenings-exc/exclusive-us-medical-testing-cancer-screenings-plunge-during-coronavirus-outbreak-data-firm-analysis-idUSKCN22A0DY), and relocation of ambulatory and specialty staff to the inpatient setting. Surprisingly,[ emergency room visits](https://www.cnbc.com/2020/04/14/doctors-worry-the-coronavirus-is-keeping-patients-away-from-us-hospitals-as-er-visits-drop-heart-attacks-dont-stop.html) for symptoms such as chest pain and weakness had also dropped. There is growing concern that this decline reflects patients avoiding seeking necessary and timely emergency care due to concern about exposure to COVID-19 rather than a true absence of patients with emergencies such as heart attacks, strokes, and appendicitis. There has been an[ increase in all-cause mortality](https://www.nytimes.com/interactive/2020/04/21/world/coronavirus-missing-deaths.html) thus far in 2020, with excess deaths including both deaths directly due to COVID-19 infection and other causes that were not able to be treated at hospitals such as heart disease and diabetes ([Woolf et al, 2020](https://jamanetwork.com/journals/jama/fullarticle/2768086?guestAccessKey=a41c1ad0-ef8f-41aa-b478-e3eff3f1e566\&utm_source=silverchair\&utm_campaign=jama_network\&utm_content=covid_weekly_highlights\&utm_medium=email)).

The rapid rise of telemedicine has been regarded by some as an innovative transformation in healthcare delivery with the potential to reduce disparities in healthcare access among vulnerable populations. Nevertheless, the benefits of telehealth have not been equally shared. In the new era of telemedicine, the concept of healthcare access has changed - digital literacy, access to technology, and the ability to effectively communicate with providers through virtual platforms have become[ important determinants of acces](https://www.healthaffairs.org/do/10.1377/hblog20200505.591306/full/)s. Digital literacy in particular now plays a critical role in the ability of patients to access and fully engage with telehealth platforms. Of note,[ digital literacy is lower](https://nces.ed.gov/pubs2018/2018161.pdf) in individuals who are older, less educated, and Black or Hispanic. Accordingly, minority and low-income patients are[ less likely to utilize the internet to obtain health information](https://pubmed.ncbi.nlm.nih.gov/29661052/).

Furthermore,[ over 21 million individuals in the US lack broadband internet access](https://docs.fcc.gov/public/attachments/FCC-19-44A1.pdf). Importantly, patients who lack broadband internet tend to have[ fewer telehealth visits](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2739054) and are[ less likely to utilize patient portals](https://link.springer.com/article/10.1007/s11606-020-05633-4) to communicate with providers. Even if patients are able to obtain a virtual visit,[ language or other cultural barriers may impair the quality of care](https://pubmed.ncbi.nlm.nih.gov/20223615/). Certain primary care health systems have already encountered challenges regarding the equitable implementation of telemedicine, noting[ disproportionate decreases in visits](https://catalyst.nejm.org/doi/abs/10.1056/CAT.20.0123) by patients from racial/ethnic minority groups, patients over age 65, and patients with non-English language preference after the implementation of telemedicine. Poor management of chronic medical conditions in vulnerable communities due to inability to access primary care providers during the pandemic may result in downstream increases in acute medical conditions, including those unrelated to COVID-19. In this way, individual and structural factors that impair access to telemedicine may continue to impair access to COVID-related and non-COVID care during the pandemic despite the transition to virtual care platforms. As a result, the widespread implementation of telemedicine may contribute to COVID-related and other disparities in vulnerable communities if not performed with a keen focus on equitable access.

## The Role of Skilled Nursing Facilities and Nursing Homes

Nursing homes became an [area of focus](https://jamanetwork.com/channels/health-forum/fullarticle/2763666) in the COVID-19 pandemic following the initial outbreak at a Seattle-area nursing home in late February and early March. Nursing homes and skilled nursing facilities (SNFs) present a unique combination of factors that predispose them to widespread outbreaks of severe disease, including population density, elderly and frail residents with multiple comorbidities, and staff that travels among rooms to care for residents. If staff fall ill, they can easily transmit the virus from resident to resident and often feel pressure to continue working due to short staffing and/or lack of paid sick leave.&#x20;

Infection control is the most common [area of deficiency](https://www.kff.org/medicaid/issue-brief/data-note-how-might-coronavirus-affect-residents-in-nursing-facilities/) reported in nursing facilities. The [CDC](https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/prevent-spread-in-long-term-care-facilities.html) has concluded that most nursing home outbreaks are the result of visitors, staff, or healthcare providers importing the virus before it spreads between residents. As a result, CMS has instituted a nationwide no-visitor policy across nursing homes and SNFs. It has also restricted the presence of non-essential staff and volunteers and cancelled all communal and group activities, including meals.&#x20;

As hospitals reach capacity, some are looking to nursing homes and SNFs as potential sites for patient overflow or patients with COVID-19 requiring [post-acute care](https://jamanetwork.com/journals/jama/fullarticle/2763818). States have taken [different approaches](https://www.forbes.com/sites/howardgleckman/2020/03/31/states-are-beginning-to-move-covid-19-patients-from-hospitals-to-nursing-facilities/#158c53994401), with New York ordering all nursing homes to accept patients regardless of COVID-19 status, and Massachusetts designating specific facilities for patients recovering from COVID-19 and relocating patients without COVID-19 to other facilities. CMS has temporarily lifted the requirement that patients be hospitalized for three days before returning to a SNF in order for hospitals to be reimbursed (the “three day rule”), allowing patients to move more quickly between hospitals and SNFs. In addition, the suspension of elective surgeries has freed space in SNFs usually occupied by patients recovering from elective orthopedic procedures. Moving patients from the acute care setting provides needed beds but may expose the densely populated and highly vulnerable residents of the facilities into which they move. Strategies requiring separation of COVID-19 and non-COVID-19 populations rely on widespread testing availability, which remains a challenge in most of the U.S. [Additional solutions](https://khn.org/news/coronavirus-patients-caught-in-conflict-between-hospital-and-nursing-homes/) for temporary post-acute care settings are surfacing around the country, with many focusing on currently unused buildings such as previously closed hospitals and nursing homes, college dorms, and even summer camps.

## Healthcare Workers Falling Ill

COVID-19 has affected a high proportion of healthcare workers. In Italy’s Lombardy region, at one point [9%](https://www.icn.ch/news/high-proportion-healthcare-workers-covid-19-italy-stark-warning-world-protecting-nurses-and) of COVID-19 cases were healthcare workers. Academic articles studying infections in China have proposed a number of reasons for these increased infections: lack of knowledge about the virus and inadequate personal protection at the beginning of the outbreak, subsequent PPE shortage, suboptimal hand hygiene after exposure to infected patients, high exposure to the virus, and long work hours in high-risk environments ([Wang et al, 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7134479/#__ffn_sectitle) and [Ran et al, 2020](https://www.ncbi.nlm.nih.gov/pubmed/32179890)). Many of these issues apply to the United States. [Thousands](https://www.buzzfeednews.com/article/zahrahirji/us-health-care-workers-coronavirus) of healthcare workers in the U.S. have tested positive for COVID-19, and many have already died. Thus far, it is unknown whether the mortality rate is higher for healthcare workers than for the general population. Some steps that U.S. hospitals have taken to reduce transmission risk both for staff and patients are universal masking, daily symptom monitoring for staff, and COVID-19 testing of all admitted or procedural patients.

As healthcare workers become ill or are required to self-quarantine, systems have been forced to consider creative solutions to alleviate healthcare worker shortages. In the spring of 2020 medical schools in several states  graduated their fourth year students early to augment this workforce. The healthcare workforce in “hot spots” is also supplemented by workers coming in from other states. It  is important to consider the implications of the COVID-19 outbreak on the physical and mental health of these frontline workers. Physical exhaustion, increased workplace demands, anxiety over personal illness or viral transmission, viral infection, and ethical dilemmas are just some of the stressors outlined by the [U.S. Department of Veterans Affairs.](https://www.ptsd.va.gov/covid/COVID_healthcare_workers.asp) Please see [Module 4](https://curriculum.covidstudentresponse.org/module-4-mental-health-in-the-time-of-covid-19), [Module 6](https://curriculum.covidstudentresponse.org/module-6-training-for-clinical-roles/care-for-self-and-others-during-crisis), and [Module 8](https://curriculum.covidstudentresponse.org/module-8-medical-ethics) for a more in-depth discussion of the impact of COVID-19 on mental health overall, support for healthcare providers, and ethical considerations, respectively.

## Health Care for Housing-Unstable and Homeless Communities

The housing-unstable and homeless populations are [uniquely vulnerable](https://www.cdc.gov/coronavirus/2019-ncov/community/homeless-shelters/faqs.html) during this pandemic. For this population, implementation of many of the social distancing practices recommended by the WHO and CDC, including frequent handwashing, disinfection of commonly used surfaces, and quarantining if necessary, is difficult given the lack of stable housing. Shelters may further increase the risk of infection, given the close quarters in which shelter residents must stay. As public bathrooms shut and soup kitchens close due to lack of volunteers, individuals with housing instability are increasingly turning to shelters for respite, increasing the density of shelter residents. As a result, shelters are unfortunately becoming some of the many [epicenters of disease transmission](https://www.nytimes.com/2020/04/13/nyregion/new-york-coronavirus-homeless.html). In Boston, more than one-third of the residents at a local shelter tested positive for the virus in [one prevalence survey](https://jamanetwork.com/journals/jama/fullarticle/2765378), confirming that the housing-unstable population is highly susceptible to the disease.           &#x20;

To combat disease transmission within the homeless and housing-unstable community, states have implemented a number of unprecedented health delivery systems. These have the potential to persist and meaningfully improve delivery of health care for this population even after the pandemic. In New York City, for example, Mayor Bill de Blasio called for 6,000 homeless individuals to be [housed in empty hotel rooms](https://ny.curbed.com/2020/4/13/21218888/nyc-coronavirus-homeless-hotel-rooms-shelters) to prevent transmission of COVID-19. In Massachusetts, 5 hotels across the state (including [Lexington, Massachusetts](https://lexington.wickedlocal.com/news/20200407/lexington-hotel-to-host-homeless-coronavirus-patients)) are being used to care for homeless patients with COVID-19. These efforts are aided by a [federal aid bill](https://nlihc.org/resource/congressional-leaders-agree-coronavirus-response-package-funding-homelessness-and-housing) passed in late March, which provided funding for homelessness assistance and public housing, among other needs. It is still unclear if these innovations to healthcare delivery for homeless populations will be useful and permanent after the pandemic. Please see Module 4 for more discussion of patients experiencing homelessness.

### Further Reading

* Crowding and unstable housing conditions in Chelsea, Massachusetts: [In a crowded city, leaders struggle to separate the sick from the well](https://www.nytimes.com/2020/04/25/us/coronavirus-chelsea-massachusetts.html)
* Resources for preventing spread of infectious disease among those with unstable housing: [Infectious Disease Toolkit for CoCs](https://www.hudexchange.info/resource/5985/infectious-disease-toolkit-for-cocs/?utm_source=HUD+Exchange+Mailing+List\&utm_campaign=453c25fdc2-Health+Prepare+CoC+3.2.20\&utm_medium=email\&utm_term=0_f32b935a5f-453c25fdc2-19540589)
* Insight on why housing the homeless will be critical: [Why housing the homeless in the age of COVID-19 will be essential](https://www.forbes.com/sites/anitabartholomew/2020/04/03/why-housing-the-homeless-in-the-age-of-covid-19-is-essential/#334040123284)

### Thought question:

* What types of public health and health care delivery interventions introduced during this crisis have staying power (e.g. telemedicine, expansion of sick leave, respite care for persons experiencing homelessness), and why?


# Socioeconomic Ramifications in the United States

Illness and health have an impact on our lives and communities, and vice versa. COVID-19 is no exception--the ways we gather and interact with one another directly enable transmission of this disease, and steps to mitigate disease spread have ripple effects in our lives. Earlier in this module, you read about the disproportionate impact of the pandemic on communities of color and incarcerated persons, as well as the interventions being undertaken to address housing insecurity. Race, incarceration, and housing are just three of the many social determinants of health, and we encourage you to continue to explore the role of social determinants of health in this pandemic in this section. In particular, we encourage you to consider how infectious diseases and societal responses to them disproportionately impact those experiencing:

* Social isolation
* Housing insecurity
* Incarceration
* Insecure immigration status
* Lack of paid sick leave/ability to take time off from work
* Financial instability
* Lack of childcare and disparities in education in light of school closings

## Social Isolation

Social distancing asks us to stay physically separated from one another, posing the risk of increasing social isolation and loneliness (social distancing still allows for other forms of social connection, mostly through technology, that can help decrease social isolation and loneliness). This risk is particularly high for elderly individuals and those already isolated. While the relationship between isolation caused by social distancing and mental health has not been studied prior to the pandemic, [this meta-analysis](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2910600/) explores the effect of social relationships on morbidity and mortality. [Module 4](https://curriculum.covidstudentresponse.org/module-4-mental-health-in-the-time-of-covid-19), Mental Health in COVID-19, explores isolation and other mental health impacts of the pandemic.

## Social Stigma and Racism

As rates of COVID-19 infection have increased across the United States, so too have racist and xenophobic sentiments toward Chinese and Chinese-American people, or, more broadly, people who appear East Asian. A[ report from San Francisco State University](https://drive.google.com/file/d/1mzNEU2ebTF_5OZUon-ovrt36x22nXcuE/view) demonstrated that news coverage of anti-Asian discrimination increased by 50% in February. These reports cited acts against Asian-American individuals and the community at large, as well as xenophobic labels employed by the media and political leaders. Asian-American establishments have seen a particular decline in business. Between January and February, Manhattan’s Chinatown sales[ dropped between 40-80%](https://www.mercurynews.com/2020/02/18/asian-american-businesses-suffer-during-virus-fears/), as news of the virus spread in the U.S., even before there were any confirmed cases of COVID-19 in New York City itself. On multiple occasions, President Trump called the virus[ "The Chinese Virus,"](https://www.nytimes.com/2020/03/18/us/politics/china-virus.html) despite recommendations from the[ WHO](https://www.who.int/mediacentre/news/notes/2015/naming-new-diseases/en/) to avoid geographical descriptors, because prior nomenclature, such as the Middle East Respiratory Syndrome, resulted in stigmatization of particular communities. Amidst these large-scale acts of discrimination, interpersonal attacks have escalated, ranging from accounts of school bullying and verbal harassment to[ physical assault](https://www.nytimes.com/2020/03/23/us/chinese-coronavirus-racist-attacks.html).‌

Perhaps it is the uncertainty of pandemics or the intangibility of a virus, but scapegoating, as we are seeing with the coronavirus, has historically been common practice in the face of global pandemic. For instance,[ Europeans blamed Jews for the spread of the Black Death (1348) and North and South Americans blamed those in Mexico for the spread of the Swine Flu (2009)](https://www.nytimes.com/2009/09/01/health/01plague.html). Unfortunately, those of Asian descent have often been the target of the pandemic-related scapegoating. In the mid-19th century, anti-Asian sentiments were on the rise in the United States, especially in California where the highest numbers of Asian immigrants settled. Already relegated to the lower tiers of society, Asian Americans[ were blamed for the smallpox, malaria, and leprosy that plagued cities like San Francisco](https://www.jstor.org/stable/25157817?seq=2#metadata_info_tab_contents). As a result, the United States government enacted overtly anti-Asian legislation in the[ Chinese Exclusion Act of 1882](https://watermark.silverchair.com/phr_2007_76_4_537.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAnQwggJwBgkqhkiG9w0BBwagggJhMIICXQIBADCCAlYGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQM6Lye7OO4NuMBs5a3AgEQgIICJ4uiF4SKvyd_oKbYPclrQzQEuj520mv3c7-7c9Dm88cyZiADZneiyHWIuHVqAnVVxR7-Y-6_02dYouKFyfT-nyr3gHO2nwZriGUb4BhSgjlOdSoLVONUSYC4it8AIKj_ZtlHlivD2Oss-dC8eydoLfLCLh3Tx-D_o6AExH9bDXmFqwuD2ULB6lBHem5sAqUggj7M5sZ2opVjWB0qHPrudSWp3O3tZO3EXIvW126bFDm0PdFC5gb3FAhx1eISG1h2solN63e-DD_FRaEleSDJQxMN9D18P7K2hdToienY2us-MoQmC9CXAyPd-Y1t1QJoIR8onLroGs_uK7-OxQSZzPOmHXjG2liu26HP-fhjM67CSLw7xYEy-I4irzK40z1M-4d4J-gzhe0lalp07yEupGQZRuuBYcm328nMMfaFVA4u0ZO8B9J9cywyKatIcJx1l3pin6N6W0p60MdwjATTpbhVtO8mptNBT55F99IvuSbg9Dx7-k2ILikwEeu9V8YeUiuj-2z7foSUmJYm8qBRixqhTwEHtFbPEmEwrQTNDdeaDXehio5JmzLRc2IRWhzNS1ieyO_JzRV0DWU5f30KX4FbU1K7pSTsde9vpeZJyEtAbVJ6NWbdEV3Q8SOO9Uq3YfbIfhgKcR8nabMQ2esQTRk4HY3R_MT5vceZUMYmXtmVC8_qHfTVhdrezQvNSV5AaWxAvFwkhv23OAbrUPxQqM3p1K-966wd) which banned the immigration of Chinese laborers to the United States. Eventually repealed in 1943, the Chinese Exclusion Act, among many other anti-Asian actions and sentiments, have perpetuated stigma and “otherness” among the Asian American population. In turn, this population has often become the[ target of unfounded and unfair treatment](https://www.washingtonpost.com/outlook/2020/02/04/2003-sars-outbreak-fueled-anti-asian-racism-this-pandemic-doesnt-have/) secondary to the blame imposed upon this population by the larger population.

Fear may amplify implicit bias, which fuels stigmatizing misconceptions that entire cultural communities are innately more likely to have or spread disease. The[ CDC affirms](https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/reducing-stigma.html) that people of Asian heritage are not at greater risk of spreading COVID-19 than other Americans. They recommend educating people on factual evidence and speaking out against discriminatory behaviors. The WHO has cautioned against language that promotes social stigma or attaches locations to the illness. Further guidance from the WHO in preventing social stigma and the spread of inaccurate information can be found[ here](https://www.who.int/docs/default-source/coronaviruse/covid19-stigma-guide.pdf).

### **Thought Question:**

* What role do healthcare workers play in mitigating acts of discrimination?

## Insecure Immigration Status

Restrictions on land and air travel to limit viral spread, while necessary from a public health standpoint, have placed significant stress on immigrants, recent migrants, asylum seekers, and those in immigration detention. These populations are at increased risk for COVID exposure and associated socioeconomic hardship as “immigrants on average have less access to safety-net benefits, are more likely to lack health insurance coverage, and have lower median incomes than the U.S. born” ([Chisti & Pierce, MPI](https://www.migrationpolicy.org/article/crisis-within-crisis-immigration-time-covid-19)). Various policies enacted in response to the pandemic, including the CARES Act mentioned above, exclude immigrants and fail to recognize that “every person’s health and financial stability are critical” ([ACLU](https://www.aclu.org/news/immigrants-rights/covid-19-doesnt-discriminate-neither-should-congress-response/)). Additionally, the public charge rule introduced just months before the start of the pandemic has introduced a “chilling effect,” with many eligible families forgoing public benefits such as WIC, SNAP, and housing assistance, which have become all the more necessary with the [unique pressures facing immigrant families during the pandemic](https://pediatrics-aappublications-org.ezp-prod1.hul.harvard.edu/content/146/1/e20201094).&#x20;

While legislative policies have neglected to protect these populations, many of them find themselves labeled as “essential”, whether they are working within the hospital systems, in the service industry, or in the food industry. Additionally, the essential workforce is greatly supported by DACA ([deferred action for childhood arrivals](https://www.nilc.org/issues/daca/)) recipients, for instance upwards of 43,000 DACA recipients work in health care and 76,000 work in the food and service industry. In the face of COVID-19 related anxieties, DACA recipients find themselves concerned about the[ future of DACA](https://cmsny.org/daca-essential-workers-covid/) and how renewal offices may be delayed/shut down or the protection they receive may be repealed.&#x20;

Certain considerations will also need to be made about legal immigration status and visas that are essential to the farm industry -- the Trump administration extended eligibility for H2A visas that allow migrant farmworkers to enter the country each growing season in order to preserve the U.S. food supply. However, these [workers have been overlooked](https://www.chlpi.org/covid-19-highlights-systemic-flaws-in-h-2a-visa-program/) in relief packages and remain at increased risk for severe disease due to crowded conditions at work and home, as well as lack of access to medical care. See more[ here](https://www.epi.org/publication/coronavirus-and-farmworkers-h-2a/) on farmworker visas. Additionally, there have been[ several efforts](https://www.npr.org/sections/coronavirus-live-updates/2020/04/21/839470122/federal-judge-orders-ice-to-consider-releasing-detainees-at-high-risk-for-covid) to protect those in ICE detention centers, with several legal advocates and judges calling on the detention centers to release residents to mitigate the spread of COVID. Despite these efforts, COVID infection rates inside ICE detention centers continue to [rise at a rate greater](https://jamanetwork.com/journals/jama/article-abstract/2772627) than that of the general U.S. population. These are some of the myriad issues facing this at risk population in the face of the pandemic, but certainly not a complete picture.

### Further Reading

* Perspective piece on undocumented immigrants from [NEJM.](https://www.nejm.org/doi/full/10.1056/NEJMp2005953)
* [Immigrant Resources Portal](https://www.gcir.org/covid19)
* [Undocumented immigrants among the first hit](https://www.washingtonpost.com/business/2020/04/05/undocumented-immigrants-coronavirus/).
* Work done in [Chicago](https://thehill.com/homenews/state-watch/491572-chicago-mayor-signs-order-ensuring-immigrants-and-refugees-have-access) to protect this population.&#x20;

## Food Security and Hunger

Lack of income due to job loss, stay at home orders, and “panic buying” have made it difficult for many Americans to find and purchase needed food. Food insecurity has the potential to rise by over[ 10 million individuals](https://hungerandhealth.feedingamerica.org/wp-content/uploads/2020/03/Brief_Covid-and-Food-Insecurity-3.30.pdf) in the coming months, similar to levels seen during the Great Recession. Record numbers of families are relying on[ food banks](https://www.nytimes.com/2020/04/08/business/economy/coronavirus-food-banks.html?searchResultPosition=2) and other emergency food resources at the same time that these organizations are seeing fewer donations from the hospitality industry. Food insecurity and social isolation are[ compounded](https://www.chicagotribune.com/opinion/commentary/ct-opinion-coronavirus-food-insecurity-snap-meals-20200406-xal2ojigbjbh3afegihtowqwri-story.html) within communities at the highest risk for COVID-related complications, as food deserts overlap with areas of high unemployment and rates of comorbid conditions. As food insecurity worsens with job losses and economic downturns associated with COVID, it also acts as a [risk factor](https://academic.oup.com/ajcn/article/112/5/1162/5882672) for many of the comorbid conditions associated with increased COVID disease severity, including heart disease and diabetes (see figure). [One study](https://www-ncbi-nlm-nih-gov.ezp-prod1.hul.harvard.edu/pmc/articles/PMC7402065/) found that a third of individuals who lost their jobs during the pandemic reported eating less due to inability to pay for food. Temporary measures to aid low-income families and increase SNAP (formerly known as food stamps) benefits have not been extended, which [experts argue](https://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.2020.305953) could lead to long term health effects of hunger for children and adults.  COVID and food insecurity represent a complex interplay of cause and effect, and illustrate one of the many ways social conditions become experienced as health conditions.

Social and Structural Impacts of COVID-19 on Food Insecurity and Health Outcomes

![from Leddy et al., 2020](https://lh4.googleusercontent.com/90zIqA3daINYzToCs0Y-0HiSWrAk-hpIFxxxUQ6a-Btk1MN1yPuSA7TRocTW6FPCoDrcEew11fjsd5Y1Fo-lc5fWdFv9uD98ZaTyT714di_mjiC__kidNDqpPOgDVDFKAJak3CfY)

### **Further Reading**

* [Feeding Low-Income Children during the Covid-19 Pandemic | NEJM](https://www.nejm.org/doi/full/10.1056/NEJMp2005638?query=featured_coronavirus)
* [Health Justice Strategies To Combat COVID-19: Protecting Vulnerable Communities During A Pandemic](https://www.healthaffairs.org/do/10.1377/hblog20200319.757883/full/)

## **Impact on K-12 Education**

Early in the pandemic, schools closed their facilities and switched to virtual learning to avoid transmission of disease. Prior to the pandemic, there were[ clear disparities in the quality of education](https://nces.ed.gov/nationsreportcard/studies/gaps/) in lower income districts nationwide. The closure of in-person school has only furthered these disparities, as students have begun engaging in virtual learning. The etiologies of these disparities have been studied and[ described well](https://www.washingtonpost.com/education/2020/04/14/how-covid-19-has-laid-bare-vast-inequities-us-public-education/). Schools in poorly resourced settings have[ less access to technology](https://www.edweek.org/ew/articles/2020/04/10/the-disparities-in-remote-learning-under-coronavirus.html),[ making the transition to virtual learning more difficult](https://hub.jhu.edu/2020/05/04/school-closures-inequality/). In addition, these schools are having to invest more in training their teachers on the inclusion of technology in the classroom, as this type of professional development was not previously made available. For a number of reasons, including disparate access to technology, rates of virtual drop out are high in cities, as[ one study in Boston](https://www.bostonglobe.com/2020/05/23/metro/more-than-one-five-boston-public-school-children-may-be-virtual-dropouts/) showed. For many children, schools serve as an [important access point](https://jamanetwork.com/channels/health-forum/fullarticle/2767411?utm_source=ground.news\&utm_medium=referral) for a variety of services, including physical and behavioral health, nutrition, and developmental services. With physical access to schools cut off, many children are experiencing new barriers to these essential services. Schools where children depend on their school for 1-2 meals everyday quickly set up methods to[ deliver food to students](https://www.nejm.org/doi/full/10.1056/NEJMp2005638) in the midst of the pandemic. This meant, however, that these already low resourced institutions had even fewer funds to devote to education.

Students who live in well-resourced districts are also likely to benefit from several factors in their home that improve their education. They are more likely to[ have more books at home](https://www.slj.com/?detailStory=2017-scholastic-reading-report-reveals-extent-of-book-ownership-divide), which they can use to supplement their education. They also are more likely to have parents at home who attended higher education themselves and have[ developed the skills necessary](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853053/) to teach their kids.

Debates over whether to keep schools physically closed or restart in-person learning balance social, behavioral, and educational needs with physical safety and transmission risk. The [American Academy of Pediatrics](https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/covid-19-planning-considerations-return-to-in-person-education-in-schools/) has recommended that the goal of in-person K-12 schooling should be at the forefront of policy plans regarding re-opening, as soon as it is safe to do so. Other [experts](https://jamanetwork.com/journals/jama/article-abstract/2769036) have recommended prioritization of children in grades K-5 for in-person learning, as well as students with special needs. They acknowledge, however, the differing circumstances and values for communities around the country. Initial reports from virtual learning in the first months of the pandemic have shown [mixed results](https://www.brookings.edu/blog/brown-center-chalkboard/2020/12/03/how-is-covid-19-affecting-student-learning/), and come with the warning that long-term educational impacts of the pandemic will not be known for years to come.Educational disparities created and exacerbated by the pandemic will likely have severe ramifications on the education of kids living in low-resourced settings. For more resources to teach kids about COVID-19 at home, please see the[ COVID-19 Classroom curriculum](https://kids.covidstudentresponse.org/).

### Thought Questions:&#x20;

* What are some important considerations for designing in-person, virtual, or blended learning plans for schools in your community? Which approach would you recommend, and why?

## Impact on Work: Small Businesses, Essential Workers, and Unemployment

Social distancing has become an important strategy for slowing viral spread and flattening the curve. Nevertheless, it has had dramatic impacts for those unable to work from home, as well as businesses that rely on in-person interactions, such as brick and mortar stores, restaurants, museums, and theaters.[ Early research](https://hbswk.hbs.edu/item/how-are-small-businesses-adjusting-to-covid-19-early-evidence-from-a-survey) has shown that nearly half of small businesses have temporarily closed, and large numbers of small business employees have been furloughed or permanently let go. Compounding the current crisis, financial fragility is the norm for these businesses, with many unable to sustain even one month of expenses without their typical cash flow. Many businesses are seeking support through the CARES act and[ additional loan and grant programs](https://www.forbes.com/sites/advisor/2020/04/10/list-of-coronavirus-covid-19-small-business-loan-and-grant-programs/#4a92c597cc4b), though many of these are plagued with bureaucratic hoops.[ This article](https://www.vox.com/the-goods/2020/3/13/21178879/coronavirus-covid-19-restaurant-workers-sick-leave-chipotle-mcdonalds) describes the struggle of food service workers whose work requires them to be public-facing, often without the option for paid sick leave.

Essential workers, including grocery workers, food service workers, public transit drivers, and many more, are exposed to the public on a daily basis,[ often without the protection they need](https://doi.org/10.1016/S0140-6736\(20\)31200-9). In response to lack of protections and continued low wages despite increasingly hazardous working conditions, workers from[ Instacart, Amazon](https://www.washingtonpost.com/technology/2020/03/30/worker-strike-instacart-amazon-whole-foods/), and[ Whole Foods](https://www.vice.com/en_us/article/5dmeka/whole-foods-employees-are-staging-a-nationwide-sick-out)[ have organized around](https://www.vox.com/recode/2020/3/30/21200495/instacart-strike-coronavirus-covid-19-working-conditions-amazon-whole-foods-gig-economy) increased health precautions, hazard pay, and free COVID-19 testing, among other protections. Additional smaller-scale strikes have occurred at restaurants, packaging facilities, and manufacturing plants around the world, often without the structure and protection offered by [union representation](https://www.brookings.edu/blog/up-front/2020/09/03/essential-workers-during-covid-19-at-risk-and-lacking-union-representation/).&#x20;

As the pandemic progresses, evidence is emerging that these workers are[ getting sick](https://www.washingtonpost.com/business/2020/04/06/supermarket-workers-deaths-coronavirus-/) and[ dying](https://slate.com/news-and-politics/2020/04/essential-workers-deaths-underclass.html) at disproportionate rates. Many of these workers also live in [“high risk” households](https://jamanetwork.com/journals/jama/article-abstract/2767630), with low household income, uninsured household members, or elderly individuals living at home. With lack of sick leave and low pay rates, these employees often feel forced to continue working to provide for their families, even if they feel unsafe or unwell. Many have called for essential workers to be [first to receive](https://www.statnews.com/2020/11/23/essential-workers-likely-to-get-earlier-access-to-covid-19-vaccine/) a newly-approved COVID vaccine, though this is complicated by varying definitions of who is an essential worker.As the pandemic escalated, unemployment rates in the U.S.have soared. Between March 15 and June 6, over 44.2 million individuals[ filed for unemployment](https://tradingeconomics.com/united-states/jobless-claims), reaching a peak of 6.9 million claims in one week on March 28, nearly ten times the[ previous record](https://www.vox.com/2020/4/9/21213449/unemployment-initial-claims-us-april-4). Updated data released December 4 by the [Bureau of Labor Statistics](https://www.bls.gov/news.release/pdf/empsit.pdf) confirmed that the unemployment rate has reached 6.7%, improving from May 8’s estimate of 14.7%, which was higher than it had been since the Great Depression. The increase in unemployment claims has[ overwhelmed the system](https://time.com/5816775/coronavirus-unemployment-stimulus/), leading to long waits on the phone, crashing websites, and, ultimately, delays in accessing essential benefits. Notably, though other countries have implemented similarly restrictive social distancing policies, they have not triggered similar massive unemployment claims. Instead,[ many countries have enacted policies](https://www.nytimes.com/2020/03/30/opinion/coronavirus-economy-saez-zucman.html) that require employers to pay a certain percentage of an employee’s salary during this time and guarantee employment once the pandemic has passed. How quickly and effectively a nation’s economy recovers from this pandemic may rely on creative strategies implemented now.

### Further Reading:

* Details and loopholes on paid sick leave as proposed in Families First bill: [Paid sick leave: Who gets it during the coronavirus outbreak](https://www.washingtonpost.com/business/2020/03/16/paid-sick-leave-coronavirus-house-bill/)
* Grocery shopping and risks to grocery store workers: [Coronavirus Panic Buying Puts Grocery Workers and Shoppers at Risk of Infection](https://www.propublica.org/article/coronavirus-grocery-shopping-risk-workers-shoppers-covid-19)
* Which workers are most at risk? [The Workers Who Face the Greatest Coronavirus Risk](https://www.nytimes.com/interactive/2020/03/15/business/economy/coronavirus-worker-risk.html?referringSource=articleShare\&fbclid=IwAR2lKU6eSRsoGo9WO9ScKN5Jt5LpqRfYO-cd0SLm4z1x73W2gqhP8palfMc)
* Essential Workers and Reopening: [Listen To Essential Workers First. Then, We Can Consider Reopening The Economy](https://www.wbur.org/cognoscenti/2020/05/07/essential-workers-opening-economy-massachusetts)

## Economic Implications of the Pandemic

The economic effects of the pandemic are many and will likely continue to become evident in months and years to come. It is probable that we will enter a recession, and unlike some prior recessions, this one is abrupt and global. Some overarching themes to understand these effects include a decrease in labor, supply chain disruptions, and a decrease in demand for many consumer goods.

First, there is certainly a decrease in labor. This decrease in labor is exacerbated by poor working conditions, limited worker protection, and decreased compensation, prompting worker strikes as outlined above. Many production centers work at a stable basal rate and are not equipped to operate under conditions that result from a surge in demand, such as that for medical masks. In order to accommodate an increase in demand for one good and a decrease in demand for another, some production centers are able to contribute to the dwindling supply by modifying their efforts, however, this modification is more feasible if the demanded good is easier to produce. Consider distilleries modifying their production lines to produce hand sanitizer, a manufacturing adjustment that is much easier to accommodate than the demand for ventilators, which requires more specialized production.&#x20;

This issue highlights another shock introduced -- a precipitous decline in demand for many goods, meaning production must halt entirely and, at times, results in the [wasting of goods](https://www.nytimes.com/2020/04/11/business/coronavirus-destroying-food.html?searchResultPosition=1). Decreases in travel and tourism are revealing balances that exist within the supply-demand chain as a result of global interconnectedness (for more details, see the [OECD report](https://www.oecd.org/economic-outlook/#resources)).&#x20;

Some have proposed that disruption to the global food system will be the [third shock](https://www.thenation.com/article/society/coronavirus-global-food-crisis/) our world experiences from the pandemic, with supply-demand mismatch and resultant hunger possible worldwide. While supermarket sales have increased, demand from restaurants and schools has steeply declined, a shift felt particularly by the [seafood industry](http://www.fao.org/2019-ncov/q-and-a/impact-on-fisheries-and-aquaculture/en/). Inability to quickly change packaging and distribution practices on US farms has resulted in [wasting](https://www.nytimes.com/2020/04/11/business/coronavirus-destroying-food.html?searchResultPosition=1) large volumes of food, all while food insecurity increases. Agriculture and the food industry are not exempt from the same labor shortages experienced in other sectors of the economy, and many workers within the food system face poor working conditions, as described above. Their absence from work not only decreases the availability of food products, but also increases the workers’ own likelihood of becoming food insecure.&#x20;

The [World Bank](https://www.worldbank.org/en/topic/agriculture/brief/food-security-and-covid-19) is working to maintain import/export agreements that typically create stability within the global food market, but this has been complicated by countries that rely on income from other commodities, such as oil, to purchase and import food. Faced with less demand for these other commodities, these countries are less able to import the food they need. While large-scale global supply chains risk disruption, [small scale farmers](http://www.fao.org/2019-ncov/q-and-a/impact-on-food-and-agriculture/en/) around the world will also lose access to their regular markets. Both large and small scale agriculture and food production take place in predominantly [rural settings](http://www.fao.org/2019-ncov/q-and-a/impact-on-food-and-agriculture/en/) globally, leaving rural economies with the brunt of this economic burden. In many rural communities in the Horn of Africa, the Middle East, and South Asia, farmers are also facing one of the worst [locust resurgences](https://www.vox.com/2020/5/20/21158283/locust-plague-swarm-outbreak-africa-asia-2020) in years. Around the world, hunger and alteration in food supply have the potential to impact a number of health problems not otherwise directly related to COVID-19, including nutritional deficiency, growth and development problems, and metabolic diseases such as diabetes.

Structural and political mismanagement of the situation can worsen an economic downturn. These and other economic principles, in addition to GDP trends during other pandemics in history, are reviewed [here](https://hbr.org/2020/03/what-coronavirus-could-mean-for-the-global-economy).&#x20;

Some economists have called for [increased guidance](https://www.npr.org/sections/money/2020/03/31/824103765/the-case-for-more-federal-action-to-combat-covid-19) from the federal government in directing industry to produce supplies, as well as a more consolidated response unifying economic and public health responses. Initially, many analyses put these two realms in opposition to one another, implying that either public health or a robust economy must be sacrificed at the others’ expense. However, [a panel of top economists](http://www.igmchicago.org/surveys/policy-for-the-covid-19-crisis/) overwhelmingly disagrees with this dichotomy, supporting public health measures as tools for economic recovery. A [letter to the editor](https://www.nytimes.com/2020/03/23/opinion/coronavirus-depression.html?utm_source=npr_newsletter\&utm_medium=email\&utm_content=20200330\&utm_term=4491715\&utm_campaign=money\&utm_id=4456219\&orgid=305) challenges policy makers to think outside of this dichotomy, suggesting that we pursue aggressive testing and precautions that allow our economy and world to return to normal more quickly.

### Further Reading:

* [5 of the World's Smartest Economists Share Ideas on Saving the Economy](https://www.npr.org/2020/03/24/820638577/how-to-save-us-from-a-recession-ideas-from-5-of-the-worlds-smartest-economists?utm_medium=social\&utm_term=nprnews\&utm_campaign=npr\&utm_source=facebook.com\&fbclid=IwAR0dSFMmnX7AAfHWkoo2w7rDllzleLjhPUgXF_Lcmr6d6qtUU9AeOdcjOvo\&fbclid=IwAR1fMhMs_ViqxHcPvojf5aGe6cXDFvE8W0Z3qboVAq9qUx3V68CTzzt3VcU)
* Response to current debate weighing economic consequences of continuing social distancing: [Can We Put a Pricetag on Life? The Shutdown Forces a New Look](https://www.nytimes.com/2020/03/24/business/economy/coronavirus-economy.html?campaign_id=9\&emc=edit_NN_p_20200325\&instance_id=17048\&nl=morning-briefing\&regi_id=116828747\&section=topNews\&segment_id=22795\&te=1\&user_id=1666f006ab8599b38933d2552d9f778b)
* Deep dive into [the macroeconomics of epidemics](https://fb8280a8-a-62cb3a1a-s-sites.googlegroups.com/site/mathiastrabandt/home/downloads/EichenbaumRebeloTrabandt_EpidemicsMacro.pdf?attachauth=ANoY7coDbQyJzHEuO9srNqn0MeHoSy0vwotGamHOog4lY20v0szBcGMafJjTMWe9ZVYoAIJ8ve--nJpfQWnj1pBhiVI6HUak2--9nqp_jrfmW-AyJ9e7GybnaFHOJ7L1mUorQsP4O29BClJTjTZIH8zKIhdG4-gfx8mJuehd_dwlGgp8fO0I9bxEDeF7Qp-aUA75ckJX4VbgPvxc7DIeOvPN-W40yIEmC1HRZeIDvKsGSFVdwgaWNCIKJyegbMYJq64hpl5-oyJLv-VZx4Zvc_Pn_qw7L3WMLg%3D%3D\&attredirects=2)
* Read more about the UN plan to prevent a global food crisis [here](http://www.fao.org/news/story/en/item/1268059/icode/)

### Thought Questions:

* What is the role of the federal government in public health and economic responses to COVID?
* How can public health and economic responses work synergistically?
* The pandemic has been described as a global phenomenon that has exposed the “Achilles’ heel” of many social and structural shortcomings. What shortcomings have you identified during this pandemic and, if given the chance, how would you propose we address them after the pandemic ends?


# Summary

The situation around the world is rapidly evolving, as we quickly moved from imported cases to community spread. For individuals like [**Brian and Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases), significant changes in day-to-day routines and long-term plans have to take place in order to protect the community as a whole. Both Brian and Diane will have to minimize trips outside their homes. Brian is disappointed he will no longer be able to eat out at restaurants with his friends, while Diane is disappointed her grandkids from across the country will no longer be visiting due to decreased air travel. Both are trying to wash their hands more often.&#x20;

Diane worries what will happen if she has a COPD or heart failure exacerbation, as her local hospital is full with COVID-19 patients. She is also aware that the providers at her healthcare centers are facing a PPE shortage, meaning that they would have inadequate protection when working with her and other patients and adding to her fear of presenting for care. How could Diane obtain care for her chronic conditions without seeing a physician in person?&#x20;

Brian was introduced to us at the beginning of this curriculum as a young adult male graduating from a university in Boston. When you read this vignette, how did you envision Brian? What was his socioeconomic status? What was his race? How would these factors affect his risk of contracting COVID-19 and his likelihood of obtaining adequate testing and care if he were to fall ill?

Brian is worried about how the changing economy will impact the job he has lined up for after graduation. What are other ways Brian’s life might be impacted in the coming months?

Diane is worried about leaving her home for her usual book club and to volunteer at the library. How can Diane stay connected to her community? Are there programs or interventions you could imagine setting up to help her stay connected?

We hope this module captured the broader implications of the COVID-19 pandemic  for health disparities, government policy, and U.S. socioeconomic well-being, as well as the adapting responses of the healthcare system and society as a whole.

We welcome your feedback on this module and the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).


# Module 4: Mental Health in the Time of COVID-19

Assess how the COVID-19 pandemic affects the mental health of patients and identify basic tools for responding to these changes in the clinical setting.

*Authors:* Anthony Almazan; Okechi Boms; Maggie Beazer; Taylor Brown; Andrew Chun, Sun Fletcher; Colby Hyland; Katie Kester; Danny Linggonegoro; Catherine Mankiw; Katherine McDaniel, MSc; Larisa Shagababayeva; Miriam Zawadzki

*Editor:* [Catherine Mankiw](mailto:catherine_mankiw@hms.harvard.edu)

*Reviewers:* Jennifer Potter, MD; Fernando Rodriguez-Villa, MD; Nhi-Ha Trinh, MD, MPH; Aliya Feroe; King Fok, MSc; Sabra Katz-Wise, PhD

**Update Disclaimer:** Thank you for visiting Module 4! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. This module last underwent major updates in **December 2020**. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

## Introduction

The COVID-19 pandemic has already caused a significant psychological impact across the globe, and patients are now experiencing many new stressors that may negatively affect their overall mental health status.([Galea et al., JAMA 2020](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2764404)). The[ World Health Organization](https://www.who.int/docs/default-source/coronaviruse/mental-health-considerations.pdf),[ National Alliance on Mental Illness](https://www.nami.org/covid-19-guide), [Centers for Disease Control and Prevention](https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/managing-stress-anxiety.html) (CDC), and[ Substance Abuse and Mental Health Service Administration](https://www.samhsa.gov/coronavirus) (SAMHSA) have all released guidelines for individuals to address the mental health consequences of the pandemic.

Multiple surveys and epidemiologic studies have attempted to capture the effect of the pandemic on mental health. When compared to April 2018, an increased number of US adults reported symptoms of serious psychological distress in April 2020 (13.6% versus 3.9%) ([McGinty et al. JAMA 2020](https://jamanetwork.com/journals/jama/article-abstract/2766941)). Perhaps most concerningly, one nationwide study in June 2020 found that approximately 10% of respondents reported serious consideration of suicide in that past 30 days (up from 4.3% in the previous 12 months) ([Czeisler et al. MMWR 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440121/#R6)). These psychiatric sequelae fall disproportionately on specific patient populations, including black and Hispanic patients, essential workers, unpaid caregivers, patients with less than $5,000 in savings, and those with pre-existing mental healthcare conditions ([Ettman et al. JAMA Netw Open 2020](https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2770146), [Czeisler et al. MMWR 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440121/#R6)). Unfortunately, these mental health consequences may be increasing over time: in a [tracking poll](https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/) conducted by the Kaiser Family Foundation (KFF) in July 2020, 53% of adults reported that their mental status had been negatively impacted as a result of the pandemic, up from 32% during a similar survey in March 2020.&#x20;

How we as medical providers can respond to these increased mental healthcare needs during this time of crisis is an open question ([Pfefferbaum & North, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2008017?query=recirc_top_ribbon_article_3)). As medical students, we too can have an important role in the mental health response.&#x20;

Module 4 of the curriculum will teach students about the mental health ramifications of the COVID-19 pandemic. We will first utilize two cases to demonstrate how the biopsychosocial framework can illuminate the many stressors COVID-19 is currently inflicting on our patients. Second, we will address populations that may be particularly vulnerable to mental health sequelae and special considerations we must take when working with these patients. These include healthcare workers, elderly patients, pregnant women, patients with pre-existing mental health conditions, patients experiencing homelessness, individuals experiencing intimate partner violence, and several minority communities. And finally, we will outline the ways we can expect clinical care and mental healthcare delivery to change as a result of COVID-19. This section introduces a framework to help us evaluate the mental health resources available for our patients, an update on the use of telehealth during the crisis, and a set of trauma-informed precautions that should guide our patient encounters in the months ahead.

## Learning Objectives

At the end of this module, medical students should be able to:&#x20;

* Describe the multidimensional factors that impact mental health during the COVID-19 pandemic.
* Identify vulnerable patient populations, and critically evaluate and describe how to respond to the unique needs of each one.&#x20;
* Identify both health systems and community resources for individuals requiring mental health support.
* Evaluate the current state of telehealth in the context of mental health delivery and describe barriers to its dissemination.
* Practice trauma-informed care with patients as a universal precaution.

Note: This module is primarily aimed to help us as medical providers and future physicians understand the impact of the COVID-19 pandemic on the mental health of our patients. Our goal is to help you identify the complex ways that the crisis contributes to our population’s mental health and how your role in clinical settings may evolve to respond to these new mental health challenges. But before we can take care of our patients, it is important that we first take care of ourselves. Your own mental health and well-being as a trainee and medical provider are incredibly important in this time. For information on care of self and others, and tools to protect your own mental health in the setting of this traumatic exposure, please refer to [Module 6](https://curriculum.covidstudentresponse.org/module-6-training-for-clinical-roles/care-for-self-and-others-during-crisis).


# The Biopsychosocial Framework

A Tool To Understand the Mental Health Impact of COVID-19

To better understand how the pandemic may be causing this spike in mental health concerns, we are going to consider the cases of a new patient Adam as well as [Diane](https://curriculum.covidstudentresponse.org/curriculum-overview/cases) through the lens of the biopsychosocial (BPS) framework as well as the physiology of the trauma response. You’ve likely learned the BPS model in your past medical training, but if you want a refresher on the topic, you can review it [here](https://ajp.psychiatryonline.org/doi/abs/10.1176/ajp.137.5.535).

These cases capture some of the ways the pandemic may impact the mental health of our patients; we appreciate that there may be numerous factors that affect their health.  Our goal is to demonstrate some of the prevalent stressors that we are seeing in our patients right now and provide examples of how to pull together the many interwoven life events that contribute to our patients' mental health.

## Adam’s Case

Let’s begin with Adam. Adam is a healthy, 20-year-old college student in Boston who has just returned to campus for his junior year.&#x20;

Adam grew up outside of Seattle with his parents and older brother. He reports that he had a “happy childhood”, but that his high school years were challenging due to a tense relationship with his father. This relationship has further deteriorated during college because his father is constantly upset with Adam for spending his free time at parties with his friends from the soccer team, rather than focusing on his studies. Hanging out with his teammates both in practice and on the weekends has been Adam’s favorite part of college. Over the summer, Adam planned to live with friends while completing a prestigious summer internship. Within the space of a week in March, Adam’s second year of college came to an abrupt end and his plans for the summer were canceled. He had no other choice but to move back home to his childhood room and a tense environment with his father. In May, one of Adam’s grandmothers, a resident at an assisted care facility, passed away due to COVID. The family was unable to hold a funeral for her, and Adam feels like he was unable to adequately process his grief. The experience of losing his grandmother was a painful reckoning with the pandemic’s severity.

After five difficult months at home, Adam was eager to return to college for the fall term. Taking online classes at home in Seattle had proved difficult in the spring, and he felt that a return to campus would provide him with a more structured learning environment. He took difficult computer science classes and found himself struggling to learn the material without robust academic support.  Even though his college mandated strict requirements about twice weekly COVID testing, and extracurricular activities (including his club soccer team) were limited, he was excited to spend time with his friends again in small groups.&#x20;

Once Adam has arrived in his dorm, as he’s completing his mandated two-week quarantine, he sees on social media that a few of his friends living in off-campus housing have started to throw parties that are prohibited by university regulations. It all looks like a lot of fun--exactly what he had missed in all his months at home. No one else seems to be as isolated as he feels. Adam wants to complete his quarantine and be responsible about social distancing, but he feels frustrated that after his terrible summer, he could face administrative consequences for trying to blow off a little steam. He knows that even if he contracts COVID-19 and develops symptoms, they are likely to be mild. At the same time, he is keenly aware of the risks of spending time indoors with a large group of people. He can’t help but think of his grandmother. Still, the challenges of remote learning and lost socialization weigh heavily on him. Even once he completes quarantine, Adam is worried that he does not have much to look forward to. He ultimately decides to reach out for care via a telehealth provider.

Adam has a past psychiatric history of depression and was prescribed SSRIs for a year during high school. His family mental health history is notable for depression in his maternal grandmother, as well as anxiety and panic disorder in his mother. He denies tobacco or drug use.

*Thought Question:*&#x20;

* What additional information have we missed here that you might want to help evaluate Adam’s current presentation?&#x20;

## Adam's Biopsychosocial Formulation

What ***biological factors*** are contributing to Adam’s current presentation? In addition to his family history, which may genetically load him for mental illness, he has a personal history of depression. The COVID-19 pandemic has deeply affected many individuals, and young people seem to be at particular risk. One study found that while overall depression rates in the US rose from 8.7% the year of 2017-2018 to 10.6% by April 2020, the rates of depression in those aged 18-34 years old increased from 7.8% to 21.2% ([Daly et al., Journal of Affective Disorders 2020](https://www.sciencedirect.com/science/article/pii/S0165032720327609?via%3Dihub)). Of note, individuals with pre-existing substance use disorders may face additional burdens during this crisis. We will outline specific challenges that these individuals face in our at-risk populations sections.&#x20;

Now, what ***psychological factors*** are contributing to Adam’s current presentation? There are many psychological factors and underlying personality vulnerabilities that could contribute to Adam’s current mental health status. One that is particularly relevant to the COVID-19 pandemic may be barriers to using previously formed **coping mechanisms**. Some of Adam’s existing coping mechanisms, such as playing soccer or spending time with friends, are now no longer available to him. Like Adam, many of our patients must now identify new coping mechanisms to help them deal with their day-to-day-stressors. Mental health can also affect one’s access to coping strategies: one survey conducted showed that those who self-identify as having depression also tend to report that they are less connected with family during the pandemic ([Costa et al., Psychiatric Services 2020](https://ps.psychiatryonline.org/doi/10.1176/appi.ps.202000245?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%20%200pubmed)).

*Thought Question:*&#x20;

* How would you coach Adam to consider additional coping mechanisms during the pandemic? If you want to learn more about a framework for thinking about coping mechanisms and stress during the pandemic, [here](http://researchgate.net/profile/Craig_Polizzi/publication/340515703_Stress_and_Coping_in_the_Time_of_COVID-19_Pathways_to_Resilience_and_Recovery/links/5e8e5acda6fdcca78901efbe/Stress-and-Coping-in-the-Time-of-COVID-19-Pathways-to-Resilience-and-Recovery.pdf) is a perspective piece that delves further into the issue.

In addition, Adam is now facing the psychological effects of **quarantine**, which are likely further exacerbating his presentation. A recent review of the mental health impact of quarantine during prior infectious disease outbreaks—including the 2003 SARS, 2010 H1N1, and 2014 Ebola outbreaks—suggested that individuals undergoing quarantine reported increased post-traumatic stress symptoms, confusion, and anger. Some of these effects may even be long lasting ([Brooks et al., Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30460-8/fulltext#bib5)). There were also social effects of quarantine. Quarantined healthcare workers continued to engage in avoidance behaviors following quarantine, including minimizing contact with patients ([Marjanovic et al., IJNS 2007](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7094220/)). All of these sequelae are important to consider when caring for Adam both now and once the COVID-19 pandemic resolves.

What are the ***social contributors*** to Adam’s current presentation? From the vignette, it appears there are several. Like many individuals, he is facing increased tension with his family, particularly his father, with whom he was suddenly forced to live with again following the move to remote learning by colleges in the spring. He is also still processing the loss of his grandmother without the space to fully grieve, and is struggling with his own personal role in preventing the spread of COVID-19. Due to social distancing guidelines, in-person funerals and religious assemblies have been limited, which detracts from many people’s mourning process. Now, he is back on campus, which has unexpectedly exacerbated his feelings of isolation. Adam is conflicted as he chooses between safe quarantine protocols in his dorm and social connection through off-campus parties.

There are many changes in Adam’s life that threaten his mental health. However, as healthcare providers, we work with all patients - both with and without mental illness diagnoses - to support their own mental health. Telepsychiatry has blossomed during this pandemic, and work in this field may greatly increase accessibility to care ([Di Carlo et al, Int J of Clin Prac 2020](https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13716)).&#x20;

\
It will also be important to assess Adam’s risk for **self harm and suicidality**. During the pandemic, many risk factors for suicide have been increased, including social isolation, unemployment, and financial difficulty. Encouragingly, Google searches for phrases related to suicide are down, and those seeking mental health care are up ([Halford et al., PLoS One 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380602/)). However, gun sales and background checks have greatly increased during the pandemic ([Mannix et al., Annals of Int Med 2020](https://annals.org/aim/fullarticle/2765237/coronavirus-disease-2019-covid-19-firearms-united-states-epidemic-suicide), [Lang and Lang, SSRN 2020](https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3593956)). Given the known risk gun ownership on suicide and ongoing mental health stressors experienced by patients at this time, risk assessment is going to be of utmost importance in the months ahead. &#x20;

## Diane’s Case

Now let’s start thinking about [Diane](https://curriculum.covidstudentresponse.org/curriculum-overview/cases). Remember, Diane is a 72-year-old woman who has COPD, heart failure, depression, and anxiety. She’s proud to live on her own in an independent living facility for the elderly in the middle of the city, and doesn’t like to ask other people for help. Early in the spring, she was cautiously running errands herself with a mask and a pair of gloves. As the summer starts, Diane is increasingly worn down from isolation. She finds herself frequently tearful, and has difficulty sleeping. Although she keeps in touch with her children via daily phone or video calls, it isn’t enough to ease her loneliness. At a friend’s suggestion, she meets up for “distanced” coffee at an outdoor restaurant. Feeling comfortable with how careful the servers seem to be, she starts to make plans to carefully resume some of her usual activities. Her children worry about her out in public--she lives in an area where COVID cases are rising-- and they tell her to isolate herself at home. However, Diane feels much less anxiety while interacting with her friends, and she tells her children that she’s taking adequate precautions.

In late June, Diane wakes up with a dry cough. She calls her PCP for a COVID test, which comes back positive. She becomes very worried about this diagnosis, and can’t tell when her breathlessness is due to COVID or a possible panic attack. Her anxiety is exacerbated by her children, who call incessantly to check in on her because she lives alone. After one phone call in which she was short of breath and dizzy while trying to talk, her daughter calls 911 and Diane is taken by ambulance to the hospital. On admission, Diane is found to have an oxygen saturation of 78 and a fever of 101.2. She’s placed on supplemental oxygen and is moved from the ED to a COVID unit. Her family video chats and calls her while she’s in the hospital, but Diane is often confused as to who they are and where she is. Her breathing becomes increasingly labored over the course of a week, and she is sedated and intubated.

The rest of her hospital stay is a blur. She does not remember being weaned off the ventilator a month later, nor does she remember the transfer to rehab. Diane is at the rehabilitation center for about two weeks before returning home. However, as September starts, Diane still doesn’t feel like herself. Besides her physical weakness, residual dry cough, and easily-induced shortness of breath, she finds non-physical tasks also difficult. She finds it hard to think through steps for simple things she used to do without issue, like making breakfast. Diane suspects it could be her lack of good sleep. Her family continues to call, but she hardly has the energy for more than a 2 minute conversation. This is a large change from how she felt in June, when she felt very energetic and enthused to see friends. Diane has also stopped returning her friends’ calls. This is in part due to fatigue but also because she has heard that another friend in her circle also contracted COVID, and she feels guilty that she didn’t take the pandemic as seriously as she should have. Diane finds herself waking up in the middle of the night with her heart racing, and has a hard time recognizing her room for about a minute once she wakes up. In addition, she is unusually tired during the day. Napping doesn’t provide her the rest she thinks it should. Recently, she received a large medical bill for her time in the ICU and her rehab center, which is much more than what she feels she can afford, particularly right now. Even though money is tight, she still relies on delivery services for her groceries when she cannot get out of bed. It’s now been about 10 weeks since her hospitalization. She has stopped trying to guess when she will feel better again.&#x20;

She presents to her PCP for “exhaustion.” Notes from her two follow-up appointments after her discharge from rehab focus on her residual dry cough and fatigue; she missed her third follow-up appointment altogether. Today, when she comes to the office, Diane’s hair and clothing are disheveled. She has been using a walker since her hospitalization and moves very slowly. Diane reports that she has been taking her SSRI, but that it doesn’t “seem to be helping at all.” She feels as though she is still sick and that she has not yet recovered.&#x20;

## Diane’s Biopsychosocial Formulation

What ***biological factors*** are contributing to Diane’s current presentation? Diane’s age, coupled with additional risk factors such as COPD and heart failure, place her in a high risk category for a protracted disease course following exposure to COVID-19. Unfortunately, she experienced severe symptoms of COVID-19, including fever and shortness of breath, and required **intubation**. Fatigue and continued shortness of breath were demonstrated by 72% and 65% of COVID-19 survivors respectively 29-70 days after ICU discharge ([Halpin et al., Journal of Medical Virology 2020](https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.26368)). Physical difficulties, such as weakness, can also persist long after ICU stays. A cluster of physical, psychological and cognitive symptoms known as **post-intensive care syndrome (PICS)** could also be contributing to Diane’s exhaustion. Physically, this could include weakness and reduced exercise tolerance, although this could be confounded in Diane’s case with long-lasting symptoms of COVID-19. A small study of about 150 patients in Rome surveyed an average of about 60 days following onset of COVID-19 symptoms found that only 12.6% of patients were free of symptomatology. Even those that did not require hospitalization reported continued fatigue, dyspnea, and chest pain ([Carfi et al,JAMA 2020](https://jamanetwork.com/journals/jama/fullarticle/2768351)).&#x20;

What psychological factors are contributing to Diane’s current presentation? In addition to the physical contribution of PICS, many of the symptoms patients experience after a long course in the ICU are psychiatric in nature. PICS, on top of her current fatigue and uncertainty of when or if she will ever feel better, may have contributed to the worsening of her **depression**. There are elements of her nightmares that could indicate development of **PTSD**, another common finding in patients with PICS ([Lane-Fall et al,. Anesthesiology Clin 2019](https://www.anesthesiology.theclinics.com/article/S1932-2275\(18\)30099-5/fulltext)). As many as 80% of patients with PICS also have some amount of **cognitive impairment**. Diane’s stay in the hospital introduced a number of risk factors for the psychological sequelae of PICS, including a poor recollection of events in the ICU, delirium (could not recognize her family over video, nor remember where she was), and a long period of ICU sedation ([Biehl and Sese, Clev Clin J Med 2020](https://www.ccjm.org/content/early/2020/07/29/ccjm.87a.ccc055.long)).&#x20;

Lastly, what ***social factors*** are contributing to Diane’s current presentation? Early in the pandemic’s course, Diane was isolated from her support network, and found herself tearful and frustrated at simple tasks. She had great anxiety surrounding her errands for which she had to leave the house. However, as restaurants started opening their doors for customers, Diane found that seeing her friends for lunch contributed a great deal to her mental health and life satisfaction. She prioritized this in the wake of her intense loneliness. Following her COVID-19 infection, Diane blames herself for getting sick and possibly exposing others. In part, this **guilt** prevents her from reaching out and developing her social support from afar. Support from her family is also limited, as they live far away and cannot contribute to physical errands. Compounding her isolation, guilt, and anxiety are the medical bills for a hospital stay she does not remember. Her **financial obligations** add to her anxiety, as she is retired with limited savings. Financial strain and employment status have been shown to worsen depression ([Zimmerman & Katon, Health Econ 2005](https://onlinelibrary.wiley.com/doi/abs/10.1002/hec.1011)). Any prospect of working to help pay off her medical debt is out of the question: her fatigue and cognitive impairment prevent her from doing anything more than the bare minimum to maintain herself.&#x20;

*Thought questions:*

* &#x20;Thinking specifically about Diane’s cognitive impairments, what factors besides those above could be contributing? Fit these factors into your own biopsychosocial framework.&#x20;
* In what ways has Diane’s hospitalization changed her independence at home?<br>

### COVID-19 as Traumatic Exposure

Above, we discussed how COVID-19 dramatically changed Adam and Diane’s daily lives. For them and for many patients, the pandemic and its consequences may represent significant traumatic exposures. Trauma is defined by the Substance Abuse and Mental Health Services Administration (SAMHSA) as “an event, series of events, or set of circumstances that is experienced by an individual as physically or emotionally harmful or life threatening and that has lasting adverse effects on the individual’s functioning and mental, physical, social, emotional, or spiritual well-being” ([SAMHSA 2014](https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf))

Traumatic exposures may occur at an individual, interpersonal, or collective level, as shown in the figure below. The pandemic may affect individuals at any or all three levels. At the individual level, for example, Diane is suffering from a long and protracted hospital course, as well as perhaps long-term COVID-19 symptoms, and has lost the independence she so valued. At the interpersonal level, Adam experiences a deterioration of his relationships with friends and family. At the collective level, Adam and Diane are constantly exposed to the illnesses of those around them as well as a societal grappling with deaths and other losses.

![](https://lh5.googleusercontent.com/5XhHuduUT0jNclWedzCvTIWufmGcIf01QrJQepHqSg2obo0_c3WKjZ2m8VbbiQQ3BZIMTETj8ltHaVXSoVqaQUXFFqsq9JRtx9Y9wRO7kNIBwRStsxD6Ndp4paeQ4VtwlgLqmNYb)

The experience of trauma has been documented to impact mental and physical health across the life-course. In the landmark [Adverse Childhood Experiences study](https://www.ajpmonline.org/action/showPdf?pii=S0749-3797%2898%2900017-8), childhood exposures to trauma were linked with adult health outcomes such as depression, substance use disorders, and cardiovascular disease in a dose-dependent fashion. The mechanism by which trauma leads to poorer health outcomes is still under investigation, but is thought to be mediated by neurohormonal and metabolic adaptations to stress that change both physiology and behaviors ([McEwen, JAMA 2017](https://jamanetwork-com.ezp-prod1.hul.harvard.edu/journals/jamapsychiatry/fullarticle/2619523)).

Module 6 addresses how the traumatic exposure of COVID-19 is doubly burdensome for healthcare providers, as well as approaches to mitigate those impacts and skills to care for yourself and those around you.

## **Review**

To review, in this section we have discussed the biological, psychological, and social forces that contribute to worsening mental health outcomes during the COVID-19 pandemic. They include:&#x20;

* Biological: age, heightened stress response, coexisting medical and psychiatric comorbidities, prolonged ICU stays and personal illness due to COVID-19
* Psychological: changes in available coping skills, quarantine increasing feelings of anger and confusion, anxiety and guilt of contracting the illness, traumatic exposures
* Social: financial insecurity, changes to family dynamics, loss of social networks and community supports, additional weight of caring for others who are suffering.

*Thought Questions:*

* This list is far from complete. What other factors do you think are playing a role at this time?
* How might a personal history of trauma impact the mental health needs of our patients now and the health needs of our population in the long term?


# Special Considerations for At-Risk Populations

As society reels from the disruptions and losses resulting from the pandemic, some communities and populations may be particularly vulnerable. This added distress may increase mental health concerns in these populations. Below, we highlight several of these populations, keeping in mind that this is not an exhaustive list, and these principles may be applied to other at-risk populations.

## Healthcare Workers and Frontline Providers&#x20;

Healthcare workers represent a particularly vulnerable population in the pandemic. Early studies from the COVID-19 pandemic have documented adverse mental health effects of COVID-19 among frontline caregivers. Experiences from China suggest high rates of depression (50.4%), anxiety (44.6%), insomnia (34.0%), and emotional distress (71.5%) ([Lai et al., JAMA 2020](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2763229?guestAccessKey=01bafe6d-fdaa-4fb2-9401-a2ed096c1284\&utm_content=weekly_highlights\&utm_term=032820\&utm_source=silverchair\&utm_campaign=jama_network\&cmp=1\&utm_medium=email)). These effects were more pronounced in frontline healthcare workers directly engaged in the triage, diagnosis, and treatment of COVID-19 patients. Even prior to the COVID-19 pandemic, anyone involved in patient care (CNAs, interpreters, nurses, physicians, trainees, transport staff) was susceptible to secondary traumatization—a potential consequence of caring for patients in extreme suffering ([Guitar & Molinaro, AWOMJ 2017](https://ojs.lib.uwo.ca/index.php/uwomj/article/view/2021)). The broadened suffering during a pandemic can intensify the existing burden of secondary traumatization, perpetuating a serious acute-on-chronic condition for many healthcare workers ([CDC 2020](https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/managing-stress-anxiety.html)). For example, PPEs shortages have caused healthcare workers  to feel abandoned by their institutions and insufficiently protected at work. In addition to frontline caregiving roles, many healthcare workers also care for loved ones at home. The demands from increased clinical duties amidst a pandemic may complicate these caregiving roles and further exacerbate healthcare worker distress. Beyond this, there is the added stress of worrying about bringing the virus home and infecting one's loved ones.

We realize many of our readers fall into this category and are at risk for the concerns enumerated above. For strategies to maintain well-being both at work in clinical roles, as well as in caregiving roles at home with loved ones, please reference [Module 6: Care for Self and Others During Crisis](https://curriculum.covidstudentresponse.org/module-5-training-for-medical-student-specific-roles/managing-anxiety-and-stress-and-promoting-self-care). This module reviews trauma reactions of caregivers including medical trainees and physicians, details practical strategies for staying well, and highlights institutional strategies to support provider wellbeing.

## Elderly Patients

Risk-mitigating measures, such as physical distancing, are geared to protect everyone, but especially the populations at-risk for much more serious presentations of COVID-19. One such population is the elderly (over 60 years in age), a group that also has a higher prevalence of comorbid chronic conditions (see [Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/clinical-presentation-of-covid-19)). At baseline, it is estimated that 20% of adults older than 60 years old suffer from a neurologic or mental disorder ([WHO 2017](https://www.who.int/news-room/fact-sheets/detail/mental-health-of-older-adults)). Given that an estimated 43% of elderly people report feeling socially isolated with few relationships and infrequent social contact, many lack a vital social safety net to cope with stress ([NAP 2020](https://www.nap.edu/resource/25663/Social%20Isolation%20and%20Loneliness%20Report%20Highlights.pdf)).

The COVID-19 pandemic further amplifies underlying psychosocial stressors for elderly patients, including limited mobility, unease with technology, smaller social circles, and managing the burden of comorbid conditions. These issues frequently impact the ability of elderly people to care for their daily needs and feel connected to family and friends. As a result, reports suggest that many older people are foregoing physical distancing to maintain any degree of normalcy and social connectedness ([CNN 2020](https://www.cnn.com/2020/04/06/us/older-people-coronavirus-invincible-high-risk-wellness-trnd/index.html)).&#x20;

Therefore, as we advocate for risk-mitigation strategies like physical distancing to limit viral transmission, we must also account for the toll that pandemic-associated social isolation and psychosocial stressors have on the mental and emotional health of elderly patients ([ScienceNews 2020](https://www.sciencenews.org/article/coronavirus-pandemic-limit-spread-social-distancing-travel-bans)). One strategy to respond to these challenges is by establishing [virtual communities](https://eldersaction.org/community-conversations/) using telecommunication services. Such efforts to improve the accessibility of such technologies already exist, including: clear and illustrative [instructions](https://www.arrowseniorliving.com/coronavirus/using-zoom/) for setting up devices, and accessible [applications](https://www.seniorliving.org/cell-phone/apps/) that have functionality for patients with visual or auditory limitations. With adequate technological support, telecommunication services can help elderly individuals—or anybody, for that matter—-adhere to necessary physical distancing while maintaining social connectedness.

## Patients with Housing Insecurities&#x20;

The COVID pandemic poses a large burden both on patients experiencing homelessness as well as on the institutions that serve them. Patients experiencing housing insecurity/homelessness often report higher levels of stress, which negatively impacts their physical and mental health ([Stahre et al., CDC 2015](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4509099/pdf/PCD-12-E109.pdf)). There is a two-way relationship between homelessness and mental illness ([Patten, Can J Psychiatry 2017](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5528993/)). A patient’s pre-existing mental illness might make it difficult to maintain stable housing or get a job; in turn, a patient suffering from homelessness is at risk for developing a mental health illness. This cycle also highlights how housing serves as more than a protective physical barrier providing  an intimate environment for personal growth, relationships, and security ([Robinson & Adams, AFRC 2008](https://aifs.gov.au/cfca/sites/default/files/publication-documents/b12.pdf)). Therefore, people experiencing homelessness are at risk for mental health diseases including affective disorders, such as major depressive, bipolar disorder, schizophrenia, and substance use disorder.&#x20;

In addition to its effect on individuals, there are institutional ramifications from  the pandemic. Patients experiencing homeless often have limited access to healthcare due to various socio-economic factors including finances, institutional policies, lack of insurance, and more ([Robertson & Cousineau, AJPH 1986](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1646594/pdf/amjph00268-0083.pdf)). The COVID-19 pandemic will, unfortunately, exacerbate the health disparities caused by these determinants. [Baggett et al.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882397/pdf/1326.pdf) (2010) demonstrate that mental health services remain a major area of need for patients suffering from homelessness (refer to the figure below). Emergency departments provide a bulk of primary care for homeless patients but are currently running at the limit of personnel and therapeutic limits ([Feldman et al., WestJEM 2017](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5391885/pdf/wjem-18-366.pdf)). Therefore, it is crucial to expand on our current health infrastructure to accommodate homeless patients.

![](https://lh4.googleusercontent.com/0YLxsomz6hXUlyyEP2G_n3AT7J3dIuCwP00xanE52FsEeQnDb2OZEuBrOOsjA71o-8M9Bra1LYvNqMQaeMVqLtqWvp7cUFMC_MOCcuz9uEADQ0U8Grdz-tpYtJTIczUvQb1nRUiT)

Beyond the healthcare system, patients experiencing homelessness may have limited options in seeking safe, clean shelters and housing options. However, they might be at risk for contracting COVID-19 if they lack access to uncrowded, sanitary housing or personal sanitary products ([Tsai & Wilson, Lancet 2020](https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667\(20\)30053-0/fulltext)). There have been several measures to combat these issues including [renting hotel rooms](https://www.ktvu.com/news/newsom-announces-procurement-of-10974-hotel-rooms-to-house-california-homeless-during-pandemic), but these traditional resources including meals, and housing are [rapidly becoming unavailable](https://www.wired.com/story/coronavirus-covid-19-homeless/). As such, it is imperative to address these issues with holistic solutions; various organizations such as [Boston Healthcare for the Homeless](https://www.bhchp.org/covid-19-response-efforts) provide health resources targeted at the homeless population and provide a model for reaching out to this disadvantaged population. For more information on the ethical considerations surrounding this population, check out  [Module 7](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19/vulnerable-populations).&#x20;

## Individuals Suffering from Domestic Violence&#x20;

Another vulnerable group of patients are individuals suffering from domestic and intimate partner violence (IPV). According to the WHO, one out of three women will experience physical or sexual violence in her lifetime ([WHO 2018](https://www.who.int/news-room/feature-stories/detail/violence-against-women)). In the United States, according to data collected by the Williams Institute, 32.9% of females and 28.1% of males have been exposed to intimate partner violence in their lifetimes, with higher rates of violence for sexual and gender minorities ([Brown & Herman, The Williams Institute 2015](https://static1.squarespace.com/static/5696af9d57eb8d591d043e3d/t/5daecf508adb67266ad91b92/1571737429637/Taylor+N.T.+Brown+and+Jody+L.+Herman+-+Intimate+partner+violence+and+sexual+abuse+among+LGBT+people%3A+a+review+of+existing+research+%282015%29.pdf)). Survivors of domestic violence, regardless of gender identity, are at increased risk of depression, anxiety, and PTSD ([Warshaw et al., NCDVTMH 2009](http://www.nationalcenterdvtraumamh.org/wp-content/uploads/2015/10/Mitchell-Chapter-12.pdf)).

For vulnerable individuals, stay-at-home orders and quarantine may place them at greater risk, as it effectively traps them in a home with their abusive partner. As the United Nations Secretary-General Antonio Guterres [stated](https://www.npr.org/sections/coronavirus-live-updates/2020/04/06/827908402/global-lockdowns-resulting-in-horrifying-surge-in-domestic-violence-u-n-warns) on April 6th, “For many \[individuals], the threat looms largest where they should be safest — in their own homes...We know lockdowns and quarantines are essential to suppressing COVID-19, but they can trap \[individuals] with abusive partners. Over the past weeks, as the economic and social pressures and fear have grown, we have seen a horrifying surge in domestic violence.”

Some countries have already seen an increase in domestic violence cases and need for services. According to an April 6th NYT [article](https://www.nytimes.com/2020/04/06/world/coronavirus-domestic-violence.html), Spain has seen an 18% increase of domestic violence calls during the first two weeks of lockdown. Beijing-based NGO Equality reports it has seen a surge of hotline calls since early February.&#x20;

Medical care for these patients will have to change in order to accommodate the new challenges they face. Many mental health and primary care visits are now conducted via telehealth. Privacy in these settings cannot be guaranteed, so providers will need to take extra precautions when performing IPV screening. In addition, individuals may now be unable to carry out existing safety plans. For example, a patient who spends select nights with family or friends to protect themselves from abuse may feel unable to do so, due to fear of infecting loved ones with COVID-19, limited public transportation, and quarentines. We may need to reassess safety plans for feasibility and adjust them as necessary. Here is a [resource](https://drive.google.com/file/d/1Ax1dgWD7AISpqcm6Pq0Wg1R2dR_qtvqr/view) to assist us in developing safety plans for our patients.

Further resources for individuals experiencing domestic abuse during the COVID-19 pandemic can be found at the [National Domestic Violence Hotline](https://www.thehotline.org/2020/03/13/staying-safe-during-covid-19/).

*Thought Questions:*&#x20;

* If you were a PCP at this time conducting telehealth visits, how might you bring up IPV with your patients?&#x20;
* Assume you have a patient who you know is currently experiencing IPV, how might you structure a new safety plan for them?

## **Sexual and Gender Minority (SGM) Populations**

“Sexual and gender minority” ([SGM](https://www.nimh.nih.gov/about/organization/od/odwd/coordination-of-sexual-and-gender-minority-mental-health-research-at-nimh.shtml)) is an umbrella term that encompasses individuals whose sexual orientation, gender identity/expression, or reproductive development varies from societal, cultural, or physiological norms. This includes the lesbian, gay, bisexual, transgender, and queer communities, as well as individuals with differences of sex development (DSD), sometimes known as intersex.

It is well-established that SGM populations experience mood disorders, substance use disorders, and suicidality at rates higher than the general population ([Luk et al., 2018](https://pediatrics.aappublications.org/content/141/5/e20173309); [Reisner et al., 201](https://www.sciencedirect.com/science/article/pii/S014067361600684X?casa_token=fO_BP6Tz3kwAAAAA:6sfsF1u_J5SF4TSU4ZECAHlZXrqEAqL0QoEgO-M0H7V7-yRoGUWtYZG-gleZukEXqugPF9ePTA)6; [King et al., 2008](https://link.springer.com/article/10.1186/1471-244X-8-70); [Daniel & Butkus, 2015](https://www.acpjournals.org/doi/10.7326/M14-2482)). The prevailing explanatory model for these mental health disparities is the minority stress model, which posits that stigma, prejudice, and discrimination place SGM individuals at higher risk of experiencing mental illness ([Meyer, 2003](https://psycnet.apa.org/buy/2003-99991-002); [Hendricks and Testa, 2012](https://psycnet.apa.org/record/2012-21304-001)). The impact of minority stress is compounded in individuals with multiple minority stressors, including SGM people of color ([Balsam et al., 2011](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4059824/)).

The COVID-19 pandemic may exacerbate existing mental health disparities affecting SGM populations due to several socio-structural factors. First, stay-at-home mandates and school closures may be particularly harmful for SGM youth who may be forced to remain in non-affirming and potentially abusive environments. One-third of SGM individuals experience parental rejection, a significant risk factor for suicidality ([Rosario & Schrimshaw, 2013](https://psycnet.apa.org/record/2012-32754-007); [Ryan et al., 2009](https://pediatrics.aappublications.org/content/123/1/346?sso=1\&sso_redirect_count=2\&nfstatus=401\&nftoken=00000000-0000-0000-0000-000000000000\&nfstatusdescription=ERROR:%20No%20local%20token\&nfstatus=401\&nftoken=00000000-0000-0000-0000-000000000000\&nfstatusdescription=ERROR:+No+local+token); [Katz-Wise et al., 2016](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5127283/)). SGM youth are also more likely than the general population to experience physical and sexual abuse ([Baams, 2018](https://pediatrics.aappublications.org/content/141/5/e20173004?utm_source=TrendMD\&utm_medium=TrendMD\&utm_campaign=Pediatrics_TrendMD_1)). Second, the financial repercussions of the pandemic are more likely to be felt by SGM individuals due to disproportionate experiences of poverty, lack of insurance, and unemployment ([Crissman et al., 2017](https://ajph.aphapublications.org/doi/pdfplus/10.2105/AJPH.2016.303571)). Recent surveys have demonstrated that during the first months of the pandemic, SGM communities reported more significant reductions in work hours and endorsed greater financial strain than the general population ([Human Rights Campaign, 2020](https://assets2.hrc.org/files/assets/resources/COVID19-EconomicImpact-IssueBrief-042220.pdf?_ga=2.172155179.964127033.1598298646-1014056671.1598298646)). Third, shifting clinical priorities in the context of COVID-19 may lead to decreased access to gender-affirming medical and surgical procedures, which may exacerbate mental health disparities affecting transgender and gender-diverse communities ([Streed & Siegel, 2020](https://www.hrc.org/news/an-update-on-gender-affirming-care-during-the-covid-19-pandemic); [van der Miesen et al., 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7282831/)).

SGM individuals are more likely than the general population to experience challenges accessing medical care, a historical trend that renders this population more vulnerable in the COVID-19 era. The cause of this limited healthcare access is multifactorial. As mentioned previously, SGM populations are disproportionately impacted by poverty and unemployment, and medical care may therefore be cost-prohibitive. Furthermore, some subpopulations of the SGM community are more likely to be uninsured or underinsured than the general population ([Kates et al., 2018](http://lgbtbar.org/annual/wp-content/uploads/sites/6/sites/9/2019/03/20190301_123314_26384.pdf)). There is also a significant body of literature documenting experiences of healthcare-related discrimination among SGM patients ([Macapagal et al., 2016](https://pubmed.ncbi.nlm.nih.gov/27726496/); [Romanelli et al., 2020](https://pubmed.ncbi.nlm.nih.gov/32001051/); [Safer et al., 2016](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4802845/)). Notably, fear of mistreatment in medical settings is associated with reduced healthcare-seeking behavior ([2015 U.S. Transgender Survey](https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf)). Given that SGM patients may be dissuaded from seeking care for COVID-19 symptoms, the practice of SGM-inclusive care will be essential. Resources, strategies, and recommendations for the care of SGM patients in the COVID-19 era have been developed by clinicians ([Rosa et al., 2020](https://www.jpsmjournal.com/article/S0885-3924\(20\)30373-0/fulltext)) and community organizations ([Fenway Community Health, 2020](https://fenwayhealth.org/gender-affirming-care-in-the-time-of-covid-19/); [Massachusetts Transgender Political Coalition, 2020](https://www.masstpc.org/guiding-principles-for-gender-affirming-care-during-covid-19/)).

Many writers have drawn parallels between HIV and SARS-CoV-2; both viruses have disproportionately impacted SGM populations, and both diseases have disrupted norms regarding abstinence, social distancing, and personal autonomy. Abstinence-only approaches to social interaction and sexual activity remain commonplace. While such policies may be crucial for controlling viral transmission, they may also exacerbate psychologically harmful sexual stigma that currently exists among SGM communities ([Turban et al., 2020](https://pubmed.ncbi.nlm.nih.gov/32384139/)). There is currently no evidence that SARS-CoV-2 can be sexually transmitted, and a recent case series demonstrated that the virus is not detectable in the semen or testes of COVID-19 patients ([Song et al., 2020](https://academic.oup.com/biolreprod/article/103/1/4/5820830)). Some providers have therefore called for a harm reduction approach to minimize COVID-19 transmission risk while acknowledging that abstinence is not always possible ([Kutscher & Greene, 2020](https://jamanetwork.com/channels/health-forum/fullarticle/2766837)). Recommendations for safe sexual practices in the context of COVID-19 have been developed ([Turban et al., 2020](https://pubmed.ncbi.nlm.nih.gov/32384139/)).

A list of financial, legal, and mental health resources for SGM individuals has been curated by Dr. Sabra Katz-Wise at the [Harvard Health Blog](https://www.health.harvard.edu/blog/covid-19-and-the-lgbtq-community-rising-to-unique-challenges-2020043019721).

## Individuals with Pre-existing Mental Health Conditions

Individuals with pre-existing mental health conditions may be particularly vulnerable to the physical health impacts of COVID-19. It is well-established that this population has lower life expectancy than the general population. Most of this excess mortality is attributable to higher rates of low socioeconomic status, lack of health insurance, and poor physical health ([Druss et al., 2011](https://ovidsp-dc2-ovid-com.ezp-prod1.hul.harvard.edu/ovid-b/ovidweb.cgi?WebLinkFrameset=1\&S=IAKLFPHELAEBJLEJIPAKMEOGJCADAA00\&returnUrl=ovidweb.cgi%3fMain%2bSearch%2bPage%3d1%26S%3dIAKLFPHELAEBJLEJIPAKMEOGJCADAA00\&fromjumpstart=1\&directlink=https%3a%2f%2fovidsp.dc2.ovid.com%2fovftpdfs%2fFPEBIPOGMEEJLA00%2ffs046%2fovft%2flive%2fgv023%2f00005650%2f00005650-201106000-00011.pdf\&filename=Understanding+Excess+Mortality+in+Persons+With+Mental+Illness%3a+17-Year+Follow+Up+of+a+Nationally+Representative+US+Survey.\&link_from=S.sh.22%7c1\&pdf_key=FPEBIPOGMEEJLA00\&pdf_index=/fs046/ovft/live/gv023/00005650/00005650-201106000-00011\&D=ovft)). These factors likely contribute to higher risk of pneumococcal pneumonia in people with severe mental illness ([Seminog & Goldacre, 2012](https://thorax.bmj.com/content/68/2/171)). Given this predisposition to respiratory infection, people with mental illness may also be more susceptible to SARS-CoV-2. Higher rates of homelessness in people with mental illness may predispose this population to developing COVID-19 and experiencing barriers to treatment ([Tsai & Wilson, 2020](https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667\(20\)30053-0/fulltext)). Furthermore, people with mental illness are more likely than the general population to smoke tobacco ([Lasser et al., 2000](https://jamanetwork.com/journals/jama/fullarticle/193305)), a practice that may be associated with worse outcomes from COVID-19 ([Vardavas & Nikitara, 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7083240/)). Notably, at least one outbreak of nosocomial COVID-19 has been reported in a psychiatric hospital, likely due to a combination of overcrowding and the inability of some psychiatric patients to comply with physical distancing measures ([Zhu et al., 2020](https://pubmed.ncbi.nlm.nih.gov/32096116/)).

There is evidence that disaster events disproportionately impact the mental health of individuals already living with mental illness. Following Hurricane Katrina, subjects with prior psychiatric diagnoses were 6.8 times more likely than the general population to screen positive for a new mental illness ([Greer et al., 2013](https://journals.lww.com/jonmd/Abstract/2013/02000/Preexisting_Mental_Illness_and_Risk_for_Developing.15.aspx)). Similarly, in the aftermath of 9/11, pre-event psychopathology was a risk factor for the development of PTSD ([Cohen et al., 2005](https://link-springer-com.ezp-prod1.hul.harvard.edu/content/pdf/10.1007/s00127-006-0033-7.pdf)). These findings suggest that individuals with mental illness predating COVID-19 may be at risk for the most significant mental health consequences of the pandemic.

In the COVID-19 era, individuals with pre-existing mental illness may experience relapses or worsening of mental health conditions due to higher baseline psychosocial vulnerability ([Yao et al., 2020](https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366\(20\)30090-0/fulltext?fbclid=IwAR1SZKyMFNC4ngsiAq7v_JMx09wwwqPPDuaU8sgK47ryBXedW120fpHk5w8)). COVID-19 has given rise to many new stressors: threat of infection, financial strain, social isolation, and loss of in-person psychiatric supports. The pandemic may also disrupt the pharmacologic management of mental illness. Physical distancing measures may preclude the regular blood testing required for psychotropic agents such as clozapine. Consequently, the [FDA](https://www.fda.gov/media/136317/download) has advised prescribers to reassess the individual risks/benefits of prescribing such agents.

Mental health conditions encompass a broad range of disorders, and COVID-19 has impacted the management of these conditions in distinct ways. We provide an overview of the impact of COVID-19 on patients with two types of psychiatric disorders that have gained increasing attention: substance use disorders and anxiety disorders.

#### **Substance Use Disorders**

Physical distancing measures have produced conditions that increase the risk of new or worsening substance use disorders. Social isolation, loss of psychosocial support, and loss of structure are significant risk factors for high-risk substance use ([Volkow, 2020](https://annals.org/aim/fullarticle/2764313/collision-covid-19-addiction-epidemics)). A survey of addictive behaviors in a Chinese population at the onset of the COVID-19 pandemic demonstrated increases in relapses to alcohol and tobacco use, as well as increases in problematic internet consumption ([Sun et al., 2020](https://onlinelibrary.wiley.com/doi/pdf/10.1111/ajad.13066)). Furthermore, a Canadian study of adolescent substance use behaviors during the pandemic demonstrated increases in their frequency of alcohol and cannabis use ([Dumas et al., 2020](https://www.sciencedirect.com/science/article/pii/S1054139X20303311?casa_token=xjU6zILujVcAAAAA:ClLXC4ERjn8hRqvIdV5zwmB_8-KF-HfxME8YIxNukNFEk5gGliCP4Abzk-_4mREalz9LCwZofQ))

As the burden of substance use disorders has increased, physical distancing measures have concurrently disrupted existing treatment approaches. Group counseling is a cornerstone of therapy for many relapse prevention programs, but support structures such as Alcoholics Anonymous are no longer available in-person. Patients with lower socioeconomic status who lack the means to attend digital support groups will be disproportionately impacted ([Da & Im, 2020](https://www.researchgate.net/profile/Ben_Da/publication/341166217_COVID-19_Hangover_A_Rising_Tide_of_Alcohol_Use_Disorder_and_Alcohol-Associated_Liver_Disease/links/5eb6d9d34585152169c1229d/COVID-19-Hangover-A-Rising-Tide-of-Alcohol-Use-Disorder-and-Alcohol-Associated-Liver-Disease.pdf)). Pharmacologic management of substance use disorder is also complicated by COVID-19. Methadone maintenance therapy for opioid use disorder is tightly regulated, with most patients receiving one directly observed daily dose at a time. However, physical distancing measures have necessitated new treatment strategies ([Alexander et al., 2020](https://www.acpjournals.org/doi/full/10.7326/M20-1141)). Guidelines from the [Substance Abuse and Mental Health Services Administration](https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf) and the [Drug Enforcement Agency](https://www.deadiversion.usdoj.gov/coronavirus.html) have been released to promote take-home maintenance therapy and more flexible prescribing of controlled substances.

Online resources to support individuals with substance use disorders are available [here](https://drive.google.com/file/d/1VV4kgPPqCR3HLH2bPIhPL1sWaPhuGZsk/view?usp=sharing).

#### **Anxiety Disorders**

The new psychosocial stressors generated by the COVID-19 pandemic may exacerbate existing anxiety symptoms in people with mental illness ([Druss, 2020](https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2764227)). In one survey of U.S. and Canadian respondents, individuals with pre-existing anxiety disorders exhibited more COVID-related distress, were more likely to self-isolate, and were more likely to experience isolation-related stressors than those without a mental health disorder ([Asmundson et al., 2020](https://www.sciencedirect.com/science/article/pii/S0887618520300852?casa_token=vExWqPkCeR8AAAAA:TsKxciQmcN0zj4GdkLph1_wm4DJzONQeWtTh0Qy40zUdqqSsVjrm3bRp25hNmaOx_Ku6h-e1qQ))

Individuals with obsessive-compulsive disorder (OCD) are particularly prone to exacerbations of their symptoms in the COVID-19 era. Health-related dangers such as HIV/AIDS are a known precipitant of new or worsening OCD symptoms ([Fisman & Walsh, 1993](https://www.sciencedirect.com/science/article/abs/pii/S0890856709641769)). COVID-19 may pose similar challenges. Individuals with pre-existing OCD characterized by contamination obsessions may be particularly high-risk. The extant literature now has several case reports of acute exacerbations of previously well-controlled OCD symptoms following exposure to media about COVID-19 ([French & Lyne, 2020](https://www.cambridge.org/core/services/aop-cambridge-core/content/view/1B6810E7AC8CB708B8C0D27242D22A82/S0790966720000610a.pdf/div-class-title-acute-exacerbation-of-ocd-symptoms-precipitated-by-media-reports-of-covid-19-div.pdf); [Kumar & Somani, 2020](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151537/)). The experiences of individuals with OCD have also been highlighted in the lay press ([Rosman, 2020](https://www.nytimes.com/2020/04/03/style/ocd-coronavirus-challenges.html)). Clinicians should be prepared to offer counseling that supports observation of CDC sanitation recommendations while also managing contamination fears. Effective language for counseling patients with contamination OCD regarding COVID-related hygiene has been developed ([Shafran & Whittal, 2020](https://www.thelancet.com/pdfs/journals/lanpsy/PIIS2215-0366\(20\)30222-4.pdf)).&#x20;

Resources for individuals living with OCD in the COVID-19 era are available from the [International OCD Foundation](https://iocdf.org/covid19/covid-19-vs-your-ocd-symptoms/).

Additional resources for people with other mental health conditions are available at the Massachusetts General Hospital’s guide to [COVID-19 Mental Health Resources](https://www.massgeneral.org/psychiatry/guide-to-mental-health-resources/specific-mental-health).

## People Living with Disabilities&#x20;

With the advent of strict COVID-19 prevention policies, many people living with disabilities (PLWD) face additional challenges. Some of the practices and policies currently in place have often been abruptly instituted and can lead to disruptions in daily life and access to regular care for those living with disabilities.

For example, with new physical distancing measures, PLWD experience limited access to support, care and therapy (speech, physical, occupational, etc) that they may regularly use. While some clinical practices are transitioning to telehealth, specific services such as [physical therapy and audiology testing](https://www.asha.org/Practice/Telepractice-Services-and-Coronavirus) may be more difficult to translate virtually. Physical distancing has also caused widespread closure of day rehabilitation programs that PLWD utilize to thrive. These [closures](https://www.latimes.com/california/story/2020-04-05/coronavirus-services-disabled-families-california) have caused severe disruption to the structure of these individuals’ lives which can result in increased psychological distress for those living with developmental disabilities, such as individuals on the autism spectrum, as well as their caregivers.

In addition, for PLWD, medical resource allocation may also be a particular concern and source of anxiety. States such as Kansas and Tennessee have issued [emergency guidelines](https://www.theatlantic.com/politics/archive/2020/04/people-disabilities-worry-they-wont-get-treatment/609355/) suggesting that people with “advanced neuromuscular disease” might be excluded from receiving critical care. Until [recently](https://thehill.com/policy/healthcare/491896-alabama-removes-controversial-ventilator-guidelines-that-denied-coronavirus), Alabama had a proposed [emergency plan](https://www.theatlantic.com/politics/archive/2020/04/people-disabilities-worry-they-wont-get-treatment/609355/) that deemed people living with intellectual disabilities among those who “may be poor candidates” for lifesaving therapy. These guidelines and others have caused concern for [disability rights advocacy groups](http://www.survivalcoalitionwi.org/wp-content/uploads/2020/03/Survival-Coalition-letter-to-Governor-Evers-Lifesaving-Protocol_BLS.pdf) since they legitimize the ability of doctors to withhold care or to deliver lesser priority treatment. Individuals, such as [Rabbi Elliot Kukla](https://www.nytimes.com/2020/03/19/opinion/coronavirus-disabled-health-care.html?fbclid=IwAR2yWVNxz0I1-qZhtS5IWXP98KyD85P0yFC72WYio-SIN6zmGcXRHlKlZFU) who lives with a disability, have written Op-Ed pieces to describe their fears of being dismissed during this pandemic; Kukla describes worry over physicians and policymakers regarding his body as “simply worth less than others’ bodies.” For a longer discussion on the ethical considerations in this debate, check out [Module 7](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19/vulnerable-populations)’s section on vulnerable populations.

*Thought Questions:*&#x20;

* Imagine you are a pediatrician caring for a 13-year-old boy with autism spectrum disorder. How would you explain the current situation to your patient?
* His parents have heard about the recent rationing measures in other states and are worried their son won’t receive the care he needs, were he to get sick. How would you address and alleviate their anxieties?

## Racial and Ethnic Minority Communities&#x20;

The disproportionate impact of COVID-19 on racial/ethnic minority communities remains a key shortcoming of the pandemic response. The CDC’s surveillance efforts have demonstrated higher rates of COVID-19 in racial/ethnic minority individuals compared to their White counterparts ([Moore et al., 2020](https://www.cdc.gov/mmwr/volumes/69/wr/mm6933e1.htm#suggestedcitation)). Furthermore, mortality rates from COVID-19 are demonstrably higher in regions with higher proportions of racial/ethnic minorities ([Wadhera et al., 2020](https://jamanetwork.com/journals/jama/fullarticle/2765524)). The social-ecological model presented in [Module 3](https://curriculum.covidstudentresponse.org/module-3-disparities-policy-socioeconomic-effects/social-ecological-model-for-understanding-differential-impact-of-covid-19) offers a framework for understanding inequities in the distribution of COVID-19. These populations have historically experienced discrimination at individual, interpersonal, institutional, community, and public policy levels, and those experiences conspire to produce enduring health disparities.&#x20;

The same forces that give rise to general health inequities also contribute to well-established racial/ethnic disparities in mental health. While most racial/ethnic minority subgroups have a lower lifetime risk of psychiatric disorders than White individuals, there is evidence that racial/ethnic minorities tend to have more persistent and debilitating mental illness ([McGuire & Miranda, 2014](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3928067/)). The cause of these disparities is likely multifactorial. Notably, racial discrimination is associated with psychological distress and psychiatric disorders ([Todd et al., 2012](https://psycnet.apa.org/doiLanding?doi=10.1037%2Fa0026208); [Rodriguez-Seijas et al., 2015](https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2278024)). Furthermore, racial/ethnic minority patients are much less likely than their White counterparts to utilize mental health services ([Smith & Trimble, 2016](https://psycnet.apa.org/record/2015-20321-000)).

The increasing burden of mental illness attributable to COVID-19 has disproportionately affected racial/ethnic minority communities. One survey examining mental health at the height of the pandemic demonstrated that Black and Hispanic participants reported a “major impact” on their mental health at rates higher than their White counterparts ([Kirzinger et al., 2020](https://www.kff.org/health-reform/report/kff-health-tracking-poll-early-april-2020/)). Unfortunately, the resources to engage in mental health care are not equitably distributed. Black and Hispanic individuals have experienced pandemic-related unemployment and financial strain at rates that are much higher than White individuals ([Fairlie et al., 2020](https://www.nber.org/papers/w27246.pdf)). Furthermore, as the shift to teletherapy and telepsychiatry continues, new care delivery structures may exacerbate existing racial/ethnic disparities, as Black and Hispanic patients are less likely than their White counterparts to own computers, use smartphones, or have home internet access ([Perrin & Turner, 2019](https://www.pewresearch.org/fact-tank/2019/08/20/smartphones-help-blacks-hispanics-bridge-some-but-not-all-digital-gaps-with-whites/)).

Although research on racial/ethnic disparities in COVID-19 distribution is still developing, the mainstream discourse concerning the disease has been racialized since the onset of the pandemic. The initial spread of COVID-19 beyond the borders of Wuhan, China led to a surge of anti-Asian discrimination. In March 2020, the U.S. FBI and Department of Homeland Security issued alerts regarding the potential for a rise in hate crimes and terrorist events targeting Asian-American and Pacific Islander (AAPI) communities ([Mallin & Margolin, 2020](https://abcnews.go.com/Politics/homeland-security-warns-terrorists-exploit-covid-19-pandemic/story?id=69770582)). A surveillance study of anti-Asian discrimination related to COVID-19 yielded 1,843 incident reports from March to May 2020 ([STOP AAPI Hate Report, 2020](https://abcnews.go.com/Politics/homeland-security-warns-terrorists-exploit-covid-19-pandemic/story?id=69770582)). It is broadly understood that this escalation of interpersonal racism has placed AAPI individuals at increased risk of adverse mental health experiences ([Zhai & Du, 2020](https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366\(20\)30089-4/fulltext); [Zheng & Goh, 2020](https://www-tandfonline-com.ezp-prod1.hul.harvard.edu/doi/full/10.1080/13032917.2020.1747208)). Early studies have demonstrated a disproportionate impact of COVID-19 on AAPI mental health. Crisis Text Line, a crisis intervention service, released data demonstrating that AAPI individuals made up 16% of users seeking support for COVID-related mental distress, despite making up only 5% of the U.S. population ([Filbin, 2020](https://www.crisistextline.org/data/bobs-notes-on-covid-19-mental-health-data-on-the-pandemic/)). Mental Health America, an online mental health screening service, examined screening data following the first month of the U.S. COVID-19 surge; the data revealed that AAPI individuals exhibited the sharpest increase in severe anxiety (measured by the GAD-7 screen) of any racial/ethnic subgroup ([Gionfriddo et al., 2020](https://www.mhanational.org/blog/asian-americans-experience-sharp-increase-percentages-screening-severe-anxiety-why)). Given the psychological impact of COVID-related racial discrimination, evidence-based stigma reduction initiatives and policy responses to combat anti-Asian racism have been suggested ([Misra et al., 2020](https://psycnet.apa.org/fulltext/2020-41444-001.pdf)).

Additional resources for racial/ethnic minority communities are available at the Massachusetts General Hospital’s guide to [Mental Health Resources for BIPOC](https://www.massgeneral.org/psychiatry/guide-to-mental-health-resources/for-bipoc-mental-health).


# Evolving Clinical Practices in Mental Healthcare

As we have shown throughout the module, many individuals are at risk for worsening mental health outcomes as a result of the pandemic. Given the existing [shortage](https://bhw.hrsa.gov/sites/default/files/bhw/nchwa/projections/state-level-estimates-report-2018.pdf) of mental healthcare providers in our country and the increasing demand, we can expect increasing strain on mental healthcare services in the future.

Here, we describe how the ways in clinicians support patients and provide clinical care may evolve as a consequence of the COVID-19 pandemic. How mental health care systems will continue to evolve over time is not possible to predict, but we can expect changes at all levels of psychiatric care and a move towards increased telehealth services. In addition, we can expect a significant rise in post-traumatic stress symptoms among our patients making trauma-informed approaches to clinical care essential.&#x20;

## Escalation of Psychiatric Care and Mental Health Resources

Resources for mental health support are, at baseline, often confusing given different types of providers (ie., MDs, PhDs, PsyDs, social workers) and care settings (community organizations, peer groups, hospitals, clinics). In addition, gaps in mental healthcare insurance coverage and high out of pocket costs often limit patients from obtaining the care they need.  As mental healthcare resources in our country become increasingly strained by the demand for services, it will come increasingly important to recognize and recommend clinically appropriate care for our patients. One model to think through this decision is a system of care approach, that has been previously utilized in many global health settings, shown below:

![](https://lh6.googleusercontent.com/c9QQ6NPJhwmeC7kSh2HN_eHkfCZtht90ZovJmnnI1JM4fHA8ukw6sh0jvFmB3ZFKMAXw_YN8A3jHXEQK2apdnlQPwgDepX-TGCRy-8P_hlyaricxxfthQ4x_JO0AoUSUMJCDv7I4)

([“Organization of Services for Mental Health,” World Health Organization, 2003](https://www.who.int/mental_health/policy/services/4_organisation%20services_WEB_07.pdf?ua=1))

This model compares various options for psychiatric support based on cost and frequency of need. Here, lower cost resources, such as self care, should be used broadly by the population while higher cost ones such as psychiatric hospital services are used less frequently.&#x20;

This framework helps us think through which level of care is appropriate for our patients. For example, Brian may benefit most from self-care techniques and connection to community resources. For Diane, on the other hand, these techniques may be insufficient. Patients may need to move up the pyramid to a more intensive system of care. Of note, this approach is not advocating for a rationing of care, as discussed in [Module 7](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19/untitled-1). Rather, it emphasizes directing patients to the appropriate level of care for their current psychiatric presentation. So what could this look like practically?

Let’s discuss how to conceptualize each bucket, resources you may be able to recommend to your patients within each, and how each might be impacted by COVID-19:

#### Self Care

Self care resources are important for maintaining day-to-day mental health and should be made available to all patients during this stressful time. Self care can come in many forms. It can include tips for stress management, advice on generating routine and setting realistic expectations during physical distancing, tools for good sleep or hygiene, and many others. Many are also turning to apps, such as Headspace and Evermind, to augment their self care, which may be appropriate to suggest to some of your patients.&#x20;

For even more information, there is a handout from Massachusetts General Hospital on [Tips for Coping with the Stress of COVID-19](https://www.massgeneral.org/assets/MGH/pdf/psychiatry/HSPH-COVID-19-mental-health-tips-3-11-20_kk.pdf) and the [COVID Mental Health Initiative](https://covidstudentresponse.org/campaigns/mental-health-initiative/).&#x20;

Thought Question: If you were seeing Brian in your primary care clinic, what three tools to manage stress would you first recommend?

#### Community Support&#x20;

It might be challenging for patients to deal with the fear and uncertainty of COVID-19 on their own. As we have seen with Diane, many of our patients will have their existing community support greatly disrupted throughout the pandemic. Schools, workplaces, community centers, and religious organizations have all suspended their current activities. Informal community support can come through family, friends, and other organizations.&#x20;

While some patients will be able to lean on friends and family to fill in the gaps lost by other social support mechanisms, others will not be able to do so. These patients may benefit greatly from connection to community resources.

Tips for talking to your patients about community resources:&#x20;

* As much as possible, try to keep individuals connected to their existing community support and care organizations. For example, work to connect individuals with online versions of their recovery groups or help your patients set up streaming of their religious services;
* Do your research before recommending resources! Some community groups that you’ve worked with in the past may not be operating at this time.

#### Primary-Care Mental Health Services

If self care and community support are not sufficient, the first touch point with the health system is generally through a patient’s primary care provider. This should not change during the pandemic, although the appointments themselves may be virtual. PCPs are appropriate providers to perform mental health screening, refer interested patients to therapy, and often offer initial medical management. These core roles should not change due to COVID-19. As medical students, you may be assisting with these tasks more frequently in your primary care clinics over the next few months.&#x20;

#### Psychiatric Specialist Care &#x20;

The most resource-intensive mental health care is psychiatric specialist care. This includes psychiatric specialty clinics, emergency room care, and psychiatric hospital care. Given the prevalence of COVID-19 positive patients in emergency rooms, beds and personnel resources might be shifted to accommodate individuals with emergent presentations of COVID-19. Additionally, patients may not feel safe presenting to emergency rooms given their fears of contracting the infection. In the midst of these limitations, there will still be a need for providing emergency psychiatric care to patients with pre-existing mental health conditions and new patients.

In general, decisions to escalate care are complex and grounded extensively in past experience and risk assessment training. You should not be making these decisions alone. If you are worried that your patient may be unsafe in the home environment or might require inpatient or specialty psychiatric care, please consult your professor or supervisor.&#x20;

*Thought Question:*&#x20;

* What are three available community resources available in your area that are currently operating and that you would recommend to a patient who needed additional support?<br>

## The Rise of Telehealth&#x20;

One major change we are seeing across mental healthcare providers is an increase in telehealth utilization (for a more detailed explanation about telehealth, including practical skills about conducting an effective visit, please see Module 6).  Evidence suggests that psychotherapy via teleconference shows promising results for anxiety and mood disorders ([Berryhill et al., Telemed J E Health 2018](https://www.ncbi.nlm.nih.gov/pubmed/30048211)). Despite these advantages, telemedicine has been slow to gain traction in some areas of healthcare due to policy limitations, insurance companies being reluctant to sign onto telehealth, and a slowed acceptance by healthcare professionals ([Topooco et al., Internet Interventions 2017](https://www.sciencedirect.com/science/article/pii/S2214782916300446)).

In China, as a result of the large numbers of confirmed cases and deaths, both medical staff and the public have been experiencing psychological problems ([Kang et al., Lancet Psychiatry 2020](https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366\(20\)30047-X/fulltext)). In response to this mental health crisis, online mental health education with communication companies, such as WeChat, Weibo, and TikTok, has been widely used ([Liu et al., Lancet Psychiatry 2020](https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366\(20\)30077-8/fulltext)). Throughout all 31 provinces and municipalities in mainland China, mental health professionals have established free, online psychological counselling services that are available 24 hours on all days of the week. Online psychological self-help intervention systems, including online CBT for depression, anxiety, and insomnia, have also been developed. In addition, several artificial intelligence (AI) programs have been put in use to detect potential suicidality during the pandemic.&#x20;

*Thought question:*&#x20;

* If a patient in Iowa has no local psychiatrists to reach out to for his mental health, would they be able to establish care with psychiatrists offering telehealth across state lines?

## Trauma-Informed Care and Universal Precautions&#x20;

As the pandemic unfolds and we collectively experience this ongoing trauma as a society, our patients may feel increasingly vulnerable. This is important to keep in mind as all medical care requires a degree of vulnerability, even routine annual wellness visits. In such challenging times, we must actively seek to avoid re-traumatizing our patients.

The response to traumatic exposure may manifest in many ways. Common responses are to feel overwhelmed, unsafe, or triggered. Activation of a trauma response may manifest as a fight or flight (hyperarousal), or freeze (hypoarousal) reaction, as illustrated in the figure below. These reactions may cause an individual to move outside the “window of tolerance” within which they are able to emotionally regulate. \ <br>

![](https://lh4.googleusercontent.com/9900UzwiJFpXLst48pLz1IW-0Ejsjw4n3oxLTFH2qjnt2k0ffnX__Noih4EwJMfggMRENA89IR4ukg9EAvk78i6Pxn6q6TXfaXOMzc6XRpta-YcGNWPf_1RtFoItip0bwrbsN6Wv)

([Brickel and Associates Counseling](https://brickelandassociates.com/how-to-grow-change-after-trauma/))

It is important to recognize that everyone (providers, patients, friends, family) may experience a trauma response at any time, both during and after the pandemic. These reactions may not be linear: you may feel better one day and then worse the next. If you are feeling overwhelmed right now, some grounding techniques are included in [Module 6](https://curriculum.covidstudentresponse.org/module-6-training-for-clinical-roles/care-for-self-and-others-during-crisis) to help you through the moment; these are also useful to share with patients.

A trauma-informed care approach to patient care can actively avoid re-traumatization and also encourage our patients to develop their own strengths and resilience ([SAMHSA 2014](https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf)). It is based on the six principles outlined in the figure below. As we cannot predict what clinical settings or exam maneuvers may be triggering to each individual patient, TIC should be used as a universal precaution with all patients ([Raja et al., Fam Community Health 2016)](https://www.brighamandwomens.org/assets/BWH/womens-health/connors-center/pdfs/tic-in-medicine-raja-2015.pdf). When taking a trauma-informed approach to patient care, remember that care is something you do with your patients and not something you do to your patients. <br>

![](https://lh4.googleusercontent.com/cN4xfsjFJNRWlnvl7Ly1Wito6Kv4mMnAZZ9IrRGrmjgXd7B2-Nw5Gm3MxIeqZWE3jBG6D5HSBEzgvYMIs7Hb3n9rUKD3Y-t1je3A3Vn4PoqbqZ8id0ibQlqkIMdL9N1KApkjR-5N)

Below we’ve included some practical tips for applying the six principles of TIC to patient care. For more detailed learning, educators at Warren Alpert School of Medicine have published a course on trauma-informed physical exam ([Elisseou et al., AAMC 2019](https://www.mededportal.org/publication/10799/)). SAMHSA is another great resource ([SAMHSA 2014](https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf)). Many healthcare interactions have migrated to telehealth, which warrant additional considerations for patient safety.&#x20;

Here are some specific communication & physical exam tips that will help you apply the principles of trauma informed care to your future patient interactions:&#x20;

1. Safety: Be aware of your physical positioning in the room, do not stand between the patient and the door, and always stay within eyesight of the patient. In a telehealth encounter, ensure the patient is somewhere they feel safe before starting the visit.&#x20;
2. Trust and transparency: Offer anticipatory guidance and obtain consent for each step of the interview and before you perform any exam maneuvers.&#x20;
3. Peer support: Ask the patient whether having a friend or family member present would facilitate care.&#x20;
4. Empowerment, voice & choice: Reaffirm your patient’s authority to stop the exam at any time if they become uncomfortable.
5. Collaboration and mutuality: Introduce yourself and ask for the  patient’s name and pronouns, and ask for and use the patient’s own terms for body parts.
6. Gender, historical, and cultural issues: Acknowledge that patients may have had negative personal or historical interactions with the healthcare system in the past, do not blame patients for their distrust of the system.&#x20;


# Summary

We hope this module helped you understand the mental health consequences of the pandemic and tools for treating mental health conditions during this challenging time.&#x20;

We welcome your feedback on this module, and on the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).


# Module 5: Communicating Information about COVID-19

Prepare to effectively communicate information about COVID-19, especially with a non-medical audience who may have various attitudes towards the pandemic.

*Authors:* Isaac Alty, MD; Luis Guilherme Cardoso; Michael Kochis, MD, EdM; Ashwini Joshi

*Editors:* [Wesley Chou](mailto:wesley_chou@hms.harvard.edu); [Andrew Foley](mailto:andrew_folely@hms.harvard.edu), MD, MPH; [Joyce Zhou](mailto:joyce_zhou@hms.harvard.edu)

*Reviewers:* Aliya Feroe; Andrea Wershof Schwartz, MD, MPH; Catherine Mankiw; Jocelyn Streid, MD, MPP; Kate Treadway, MD; Katie Greenzang, MD, EdM

**Update Disclaimer:** Thank you for visiting Module 5! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

## Introduction

As future physicians, we must master not only the science of medicine but also its art. Module 4 discusses the pandemic's tremendous [psychological trauma](https://curriculum.covidstudentresponse.org/module-4-mental-health-in-the-time-of-covid-19/evolving-clinical-practices-in-mental-healthcare#trauma-informed-care-and-universal-precautions) on society: while not everyone will become infected with SARS-CoV-2, during a pandemic, everyone is affected in some way. The art of medicine involves bringing that recognition to our encounters with friends and family, as well as to patients in direct clinical settings. Physical distancing measures impose new realities on what interacts look like. Furthermore, misinformation surrounding this pandemic has promulgated rapidly and guidelines have changed dramatically over the span of months. Adapting to these changes presents the perfect opportunity to review communication skills that will serve us well in this uncertain time.

Additionally, there is a renewed sense of urgency surrounding conversations on advance care planning (ACP), given the disproportionate burden of COVID-19 on the elderly and those with serious illness. While medical students may not always spearhead these challenging conversations, they can play a critical role in prompting busy care teams to discuss ACP with patients. Thus, familiarizing themselves with what ACP entails and frameworks for approaching it are certainly relevant to every medical student’s education.

We’ve now discussed [**Brian and Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases) in the context of their medical and mental health risk and why our community benefits from collective physical distancing. But knowing the facts is only a small part of effective engagement. In this module, we pivot to developing concrete tools that can help us communicate effectively with individuals like Brian and Diane.

Think of the people in your own life who may be struggling in similar ways to Brian and Diane. What makes communicating with them challenging, and how may you try to understand or support them differently?

## &#x20;**Learning Objectives**

At the end of this module, medical students should be able to:

* Revisit 3 key conceptual frameworks for communication skills and recognize the tool that would be most appropriate for a given situation
* Review methods through which to manage patient's questions about the COVID-19 and the reliability of information around the disease, as well as large divergences in opinion&#x20;
* Rehearse serious conversations with patients pertaining to bad news, misinformation, and advanced care planning.
* Identify ways in which a person's lived experiences may shape their current views towards the pandemic and use that to better inform methods by which to motivate them to modify behaviors.

## Core Materials

* Stone, Patton, and Heen, “Difficult Conversations,” [Introduction and Chapter 1](https://drive.google.com/file/d/1S-R5-b5lSgOvQqO4OJqCWMrEHFzPKZzS/view?usp=sharing).
* VitalTalk, [COVID-ready communication skills](https://docs.google.com/document/d/1uSh0FeYdkGgHsZqem552iC0KmXIgaGKohl7SoeY2UXQ/mobilebasic).
* Recommended Activity: Tamerius and Campt, “[Your Angry Uncle Wants to Talk About Politics. What Do You Do?](https://www.nytimes.com/interactive/2019/11/26/opinion/family-holiday-talk-impeachment.html)” *New York Times Opinion*.
* Patient-friendly infographic: [COVID-19: What you need to know: a 1-page guide](https://clinicalproblemsolving.com/wp-content/uploads/2020/04/4-5-20_COVID19-Patient-Communication-Tool.pdf) (last updated April 2020)
  * Patient-friendly resource from [UpToDate](https://www.uptodate.com/contents/126678#H2375421419) (last updated May 2021)


# Skillset Review

Let’s review some critical communication skills in the context of this pandemic. First, recall the overarching principles of communication with patients ([Makoul, Acad Med 2001](https://www.ncbi.nlm.nih.gov/pubmed/11299158)):

1. Build a relationship
2. Open the discussion
3. Gather information
4. Understand the person’s perspective
5. Share information
6. Reach agreement on problems and plans
7. Provide closure&#x20;

Depending on the scenario (talking one-on-one or in a group), you may also find the [CDC Crisis + Emergency Risk Communication](https://www.cdc.gov/coronavirus/2019-ncov/downloads/fs-CERC-Infectious-Disease.pdf) (CERC) in an Infectious Disease Outbreak principles helpful as well:

1. Build rapport by expressing empathy and respect, competence and expertise, honesty and openness, as well as commitment and dedication
2. Acknowledge uncertainty, validate concerns, and explain the processes in place to find answers
3. Be prepared to answer questions about safety and expectations moving forward.&#x20;

With these principles in mind, let’s take a deeper dive into communication frameworks for **having difficult conversations** and **giving bad news** in the context of this pandemic.

## **Difficult Conversations**

A useful paradigm to keep in mind during these interactions is set forth by Harvard Law School Professors Douglas Stone, Bruce Patton, and Sheila Heen in their *New York Times*-bestselling book *Difficult Conversations*.

In studying a variety of conversations, they found:&#x20;

> > ***An underlying structure to what’s going on, and understanding this structure, in itself, is a powerful first step in improving how we deal with these conversations. It turns out that no matter what the subject, our thoughts and feelings fall into the same three categories, or ‘conversations.’ And in each of these conversations we make predictable errors that distort our thoughts and feelings, and get us into trouble.***

The three conversations can be summarized as:

**1. The Facts Conversation.** In discussions about COVID-19, this would encapsulate concepts like R0 or the anticipated impact of physical distancing on reducing transmission. This knowledge is critical for us as future physicians. Given our own biases as physicians-in-training (perhaps including, among other things, our personality types, coping styles, and our training), our go-to approach to uncertain or challenging situations is often to return to the facts. However, no matter how convincing the evidence, facts alone are not enough to fully connect with listeners.

Psychologist Jonathan Haidt describes this idea in his metaphor of the [Elephant and the Rider](https://www.creativehuddle.co.uk/the-elephant-and-the-rider). Although it may seem like the Rider, representing logic and reason, can control where the two end up, the Rider’s commands are worthless unless they’re directing the Elephant (representing our emotions). If they are in opposition, the Elephant always wins out.

**2. The Feelings Conversation.** More often than not, emotions are at the heart of difficult conversations and should not be excluded from the problem; if our partners’ feelings are negative or different from ours, we should not view them as barriers or as issues to resolve. Making space for and acknowledging emotions is [critical to building a relationship](https://eprognosis.ucsf.edu/communication/video-emotions.php) that allows more meaningful connections.

The first step is to recognize those emotions; we can make that easier by anticipating them ahead of time. The exact emotions evoked in a given situation depend on how that situation relates to the values we hold most dear. Sometimes what sounds like a factual question is actually an expression of emotion. For example, “How can this be happening?” may not necessarily be a question about coronavirus epidemiology, but rather an expression of worry or fear.

**3. The Identity Conversation.** At the core of every difficult conversation is what this situation means to us. The authors explain: “We conduct an internal debate over whether this means we are competent or incompetent, a good person or bad, worthy of love or unlovable. What impact might it have on our self-image and self-esteem, our future, and our well-being?”

And all this cuts both ways: the conversation involves both your identity as well as your conversation partner’s. What does the outcome of the conversation mean to you? Taking stock of this ahead of time will prevent you from getting caught up and acting against your best judgment.

In short, focusing on facts without feelings will only make the conversation worse. To best anticipate your partner’s feelings, it helps to think about their identity and how the situation may relate to their most important values. The subsequent sections review specific communication techniques that have been proven to help clinicians provide facts about challenging situations in a way that also addresses underlying emotions.

*Thought Question:*&#x20;

* Look at some of the dialogues in the resource, [COVID-ready communication](https://docs.google.com/document/d/1uSh0FeYdkGgHsZqem552iC0KmXIgaGKohl7SoeY2UXQ/mobilebasic). How do the three conversations surface?

It is equally important that you take stock of your own reactions in preparing for potentially difficult encounters with patients. Anticipating your own negative feelings may help you recognize these emotions and let them go to have more productive interactions. For example, you may find that the anxiety of patients who are not sick or are mildly ill evokes feelings of annoyance, and even anger when you are simultaneously caring for severely ill patients. These are perfectly normal reactions, but they will not lead to productive encounters. The important thing is to accept your feelings and try to let them go as you turn your attention to each particular patient.

## **Giving Serious News**

Many conversations around the coronavirus pandemic will involve delivering difficult or serious news. Here, we can apply several frameworks to the conversations we have with patients, as well as in the community in a non-clinical setting.

### SPIKES

SPIKES is a [mnemonic developed](https://theoncologist.onlinelibrary.wiley.com/doi/full/10.1634/theoncologist.5-4-302) by oncologists for delivering bad or serious news. The pandemic has obviously evoked a wide range of emotions, including denial, fear, and altruism, for which this framework is relevant.

![](/files/-M3MsfymAIX8lmhCvelt)

### REMAP

REMAP is a [mnemonic developed](https://www.ncbi.nlm.nih.gov/pubmed/28445100) to guide Goals of Care discussions. As medical students, we may be asked to care for patients with COVID-19 or to talk with family members of these patients, where REMAP would be highly applicable. REMAP can also be used outside of clinical settings to guide challenging conversations when expectations between two parties do not align. Can you envision a scenario where you could apply the REMAP framework?

![](/files/-M3MsjCYpF5cmKUzpk0W)

### NURSE

Regardless of the framework used, giving bad news is challenging for both the person delivering the news and the person receiving such news. Sometimes, a person receiving the news may react with anger, frustration, heightened anxiety, sadness, or another similarly intense emotion. Having a framework for your response in this moment can be helpful for demonstrating how much you care. The [NURSE framework ](https://www.vitaltalk.org/guides/responding-to-emotion-respecting/)is one example; examples I provided below. Brainstorm 1-2 scenarios where you would use the NURSE framework in the context of COVID-19.

![](/files/-M404QgGvwjRqjEw-Gek)

*Thought questions:*&#x20;

* How might you apply these frameworks differently when talking to [**Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-2-diane) and [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian)?
* [This activity](https://www.nytimes.com/interactive/2019/11/26/opinion/family-holiday-talk-impeachment.html) from the NYT is an opportunity to play out a conversation with someone who holds different political views. How might our frameworks complement their approaches to conflict resolution?


# Science Communication and Misinformation

## Misconceptions about science

For a layperson with lower health literacy or a non-scientific background, principles of research can be challenging to understand. Furthermore, with various sources from the Internet and its virtual forums, takeaways that reach the public through the media can be misleading. The next section addresses some common misconceptions that patients might have about science--for example, that masks cause illness--and suggestions on how to frame a response that is grounded in fundamental principles of the scientific method.

**Q: Is science just an opinion?**

A: Good science comes from well-defined research questions that arrive at objective facts, while opinions are beliefs or feelings that cannot be proven through the scientific method. However, as humans, researchers can have biases because of past experiences, assumptions, and goals. To minimize the effects of human bias, scientific research needs to be well-designed, which can involve double blinding (where neither researchers nor participants know who received experimental treatment) and randomization (the chance assignment of intervention or placebo). It is important to note, however, that the media can present biased interpretations of scientific facts and outcomes. Thus, it is helpful to read the scientific literature itself, known as the primary source.

**Q: Why does scientific understanding seem to constantly evolve?**

A: Knowledge is generated through iterations of the scientific method, which involves asking the right questions, using appropriate and robust methods, conducting detailed analyses, and publishing studies that can be reproduced. Thus, science is self-improving: it continuously changes and expands, and additional insights, different contexts, or new ways to analyze information can suggest new conclusions. Also, not all current practices in medicine are based on the highest levels of evidence (e.g. randomized controlled trials and meta-analyses), so more robust and recent research can challenge previously held assumptions that were made through expert consensus. This does not detract from the impact of scientific research. Rather, scientists work to get closer to the truth behind real-life phenomena.

**Q: Why do different scientific models for COVID-19 produce such different predictions?**

A: The results of models that try to forecast future COVID cases, hospitalizations, and deaths are often offered without context about underlying assumptions that are necessary to build them. For example, take the epidemiological models that suggest widely varying case and death numbers despite extrapolating from similar datasets. Even small variations in R0 or the percentage of community members adhering to physical distancing policies, can vastly affect model outcomes. Additionally, the farther into the future the model forecasts, the greater the degree of uncertainty and wider the range of inaccuracy. Finally, real-life responses to models, such as the implementation of social distancing policies or opening of economies, can cause a divergence from a model’s predictions--as the baseline assumptions have now changed.

## Communicating data

Comprehending, interpreting, and communicating primary science literature can be overwhelming due to unfamiliar terms involving test statistics (e.g. sensitivity/specificity, positive/negative predictive values) and results (e.g. odds ratio, risk reductions). In this section, we offer suggestions on [how to most effectively communicate about data](https://www.nedarc.org/tutorials/utilizingdata/communicateNumbersEffectively/communicatingStatistics.html).

* **Ask yourself if specific numbers might be helpful.** In general, use numbers sparingly. If you are trying to motivate behavioral change or convey risk, a relative rather than absolute sense of scale may be sufficient. However, they may be helpful for concepts that require precision or when you are prompted for details.
* **Ask your patient if data would be helpful.** Perhaps more importantly, consider your patient’s perspective. Based on your experience with them, are they an individual who is interested in interpreting the data, or do they prefer if you summarized? Oftentimes, you can directly ask about their style if you are not sure--it can help you discern how much and how best to convey data to them.
* **Avoid statistical jargon.** Preferentially use qualitative descriptors, as they are more intuitive than fractions, statistics, and percentages. These descriptors can include terms such as “equally as likely” or “double as likely” to compare rates. In addition, describing probability as “one in four” rather than 25% is likely to be more informative. Try to translate test characteristics into more intuitive meaning--for instance, describe 60% sensitivity as a test that will have nearly as many false negatives (40%) as true positives (60%) and thus has a poor ability to accurately detect positive cases. Utilize analogies and comparisons to commonplace situations when applicable.
* **Use intuitive visual aids.** Pie charts can help effectively illustrate fractions and line graphs can easily demonstrate trends, such as COVID-19 cases or deaths. However, if using illustrations from outside sources, try to assess whether it is based on robust data.

## Navigating misinformation with patients

With patients increasingly spending time on the Internet and connecting with others through social media, they may receive medical information through not just traditional sources such as doctors but also from peers and online platforms. These technologies undoubtedly have positive effects, such as offering support networks for patients and providing more information to patients. But online platforms for knowledge can also be dangerous. When opinion pieces masquerade as fact, or when authors outright claim authority to “facts” that are in reality sown from prejudice or bias, the Internet can disseminate and propagate misinformation that can be harmful to medicine and society.&#x20;

Misinformation has proliferated during the pandemic, ranging from unfounded statements about the origins of COVID-19 to spurious links between 5G and COVID-19. In this section on navigating misinformation, our aim is not to make you an expert on how to dismantle every false belief, but rather to provide communication tools that build off previously described frameworks to speak with patients about misinformation. Thus, we want to address: how do you, as a trainee or clinician, communicate effectively with someone whose beliefs about COVID-19 may be grounded in false information? How might you navigate gulfs between a wide scientific consensus and an individual’s beliefs? To illustrate this, we have included a table below on another divisive issue: childhood vaccinations, an area that taps into similar fears and concerns that patients may have.

## Conversations on COVID vaccines

{% tabs %}
{% tab title="Background" %}
Vaccine hesitancy is a complex issue. Rampant misinformation, the novelty of these medications, and polarized discourse have all contributed to reluctance towards vaccine uptake. Longstanding medical racism is also inextricably linked with potential skepticism for BIPOC communities that have suffered disproportionately from COVID-19. From a medical perspective though, mass vaccination efforts sufficient to reach herd immunity are critical for addressing the pandemic. These differing perspectives have inevitably led to tensions and disagreement between healthcare providers and patients. However, while the vaccines themselves may be novel, many of the same principles previously covered in this module are relevant in such conversations with patients.
{% endtab %}

{% tab title="Approaching these conversations and resources" %}
Providers should learn more about where patients are receiving the information and what is driving their concerns regarding vaccines. It is critical not to anchor onto assumptions when broaching these conversations, such as who is more or less willing to be vaccinated. While it is of course important to be cognizant of these factors, this should not result in premature conclusions that a certain patient will be unreceptive to vaccination, and as a result, prevent such conversations from even being broached. For example, overemphasizing hesitancy in black communities glosses over[ inadequate access to vaccines](https://www.washingtonexaminer.com/news/covid-vaccine-hesitancy-exaggerated) and other health services for the many black individuals who wish to receive them.

&#x20;Answering patients’ questions does require keeping up to date on a rapidly changing topic; common questions with potential responses are displayed in this[ NEJM article](https://www.nejm.org/doi/full/10.1056/NEJMp2103104), and other sources are available in Table 2 of this[ article](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772995/). Healthcare workers should be upfront about what is and is not known about the vaccines. For example, while we have strong evidence of severe COVID-19 being prevented in vaccinated individuals, long-term data directly showing duration of immunity are not yet available. Together, healthcare providers should have strong, clear recommendations. In addition to directly addressing patient misgivings,[ other strategies such as framing the vaccine from a positive perspective and appealing to protecting patients’ loved ones](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772995/) have been shown to be helpful.
{% endtab %}
{% endtabs %}

First, it is important to have the [“facts” conversation](/module-5-communicating-about-covid-19/skillset-review#difficult-conversations). As in any disagreement, when speaking with a patient who holds a belief that diverges from general scientific understanding, it is important to explore the patient’s perspective. For example, where are they getting their information from? What evidence or principles are they using to support their conclusions? A patient who says that they do not wish to wear a mask in most settings could potentially expand on concerns about hypercapnia that they have seen in videos.

Intricately connected to the facts is the [“feelings” conversation](/module-5-communicating-about-covid-19/skillset-review#difficult-conversations). Rather than making assumptions about patients’ intentions, we should consider probing those experiences. Also, by exploring our patients’ perspectives, we may be able to better manage our own initial emotions, evoke empathy, and have a more balanced, productive conversation that allows them to feel heard. The above patient with concerns about masks may come in expecting to be judged or not feel heard for harboring that view.&#x20;

Finally, the [“identity” conversation](/module-5-communicating-about-covid-19/skillset-review#difficult-conversations) further explores patient priorities, and is key for creating common ground. As a provider, reflect on what deeper values or identities the patient holds. In the case of the patient who is reluctant to wear masks, anchoring recommendations on shared territory, such as concern for vulnerable family members or neighbors in the setting of COVID-19, may be more effective than listing specific numbers from recent studies.

From this framework of recognizing conversations on facts, feelings, and identity, healthcare providers can better validate and empathize with patient concerns while also providing clear recommendations and evidence for them. While this section focuses on communication with our patients, the strategies discussed also apply to other people in our life. As medical students, we will frequently field questions from friends and family that may seem uninformed or ignorant. We have a responsibility to probe further and address these misconceptions.

A strategy by which to structure this conversation is[ CASE](https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/immunizations/Pages/vaccine-hesitant-parents.aspx). The steps are as follows:

![](/files/-MJOE4c6bLAK6AXI1pSq)

Lastly, remember that while the goal is to help align a patient’s understanding with the greater scientific community’s consensus, the expectation is not necessarily to be able to change patients’ mind about a particular therapeutic that has been discredited or the value of wearing masks within the course of a single clinical interaction. Rather, it is important to continue to build and maintain the patient-physician relationship by making space for perspectives to be mutually heard.

*Thought question:*

* Say that a patient you are seeing via telehealth makes a comment that masks don’t work and that social distancing measures are overblown. How might you respond?


# Advance Care Planning

## Why Care About Advance Care Planning (ACP)?

ACP is a process by which patients communicate their goals of care, which can entail the assignment of healthcare proxies (HCPs), preferencing end-of-life treatments (e.g. CPR and/or intubation) and their location (e.g. home versus hospital), and completing advance directives (ADs), among other actions. ACP emphasizes patient autonomy, and is associated with[ end-of-life care that is better aligned with patient preference](https://www.nejm.org/doi/10.1056/NEJMsa0907901?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%20%200www.ncbi.nlm.nih.gov) and[ improved patient and family satisfaction](https://www.bmj.com/content/340/bmj.c1345). However, ACP is underutilized; a[ 2017 report](https://www.kff.org/other/report/views-and-experiences-with-end-of-life-medical-care-in-the-u-s/) found that while a little over half of Americans had had conversations on end-of-life care with a loved one, <20% had done so with providers, and only about a quarter had documented their wishes.

Those who wish to learn more about terms pertaining to ACP can find a glossary [here](https://docs.google.com/document/d/1RL7For_hKQzxfdZxahzYE_bLB1nXCYzQ7akTtdXcYiU/edit).

### Why is ACP particularly relevant now?&#x20;

* COVID-19 can have an unpredictable and precipitous clinical course. Initially stable patients can rapidly progress to respiratory failure. Such situations severely limit the ability for patients to express treatment preferences, which is further compounded by restrictions on visitation by loved ones.
* COVID-19 imposes a[ disproportionate burden on the elderly and those with serious comorbidities](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/where-are-we-now). ACP is especially crucial for these vulnerable patients, and as with ACP in any context, should begin prior to acute illness when discussions and decisions can take place in a calm, supportive, and unhurried atmosphere.
* COVID-19’s infectious nature and strain on PPE mean that resuscitation (e.g. CPR and defibrillation) of affected patients exposes healthcare workers to greater risk. By engaging in ACP with patients about resuscitation, healthcare workers can ensure care that aligns with patient preferences, and may also avoid unnecessarily risky care that is undesired.&#x20;
  * These issues have sparked discussions in hospitals on potentially limiting or foregoing resuscitation in patients with COVID-19. How patient preferences should intersect with these potential policies is beyond this module's scope, but you can read more about this [here](https://www.washingtonpost.com/health/2020/03/25/coronavirus-patients-do-not-resucitate/).

### Frameworks for ACP

These are difficult conversations. Thus, it can be helpful to have a framework for approaching this topic. While various frameworks exist (such as the previously described REMAP mnemonic for goals of care), they share many common characteristics. Here, we will focus on Ariadne Labs’s[ COVID-19 conversation guide for outpatient care](https://www.ariadnelabs.org/wp-content/uploads/sites/2/2020/04/2.-COVID-19-Conversation-Guide-for-Outpatient-Care-1.pdf), for which there is also a[ video](https://www.youtube.com/watch?v=Va6lTUcm85M\&feature=youtu.be) demonstration.

Process

1. Set up the conversation: ascertain whom to speak to (e.g. patient and/or family), acknowledge uncertain times, and normalize topics being discussed.
2. Assess patient understanding: gather information on patient’s awareness of their condition and how coronavirus could affect their health.
3. Share information: explain patient’s likely prognosis if they were to become sick and require more intensive treatment.
4. Explore priorities: ask patient about hopes and worries, their thoughts on different medical treatments they may want, and whether they have discussed such topics with their loved ones.
5. Review conversation: reflect on what the patient has discussed, provide recommendations on completing a health care proxy, advanced directive, and/or Physicians Orders for Life-Sustaining Treatment (POLST) as appropriate, and provide reassurance.
   1. ACP is a process. Multiple conversations focusing on different aspects may be ideal, especially in the outpatient setting.

This is not a one-size-fits-all approach, but it contains themes that are useful for medical students even if they may not typically lead such conversations. For example, during an admission interview, a student could segue into components of ACP by asking a patient if they have a health care proxy. Regardless of the answer, the student can then explore patient hopes and worries (e.g. “have you spoken to your proxy about your priorities?” or “if your health worsens, have you ever thought about what your priorities would be for treatment?”), as well as thoughts on desired treatments in relation to code status.

*Thought questions:*

* Imagine that you are Diane’s new PCP who has seen her once before. You are about to conduct a telehealth follow-up for her comorbidities (i.e. COPD, heart failure, depression, and anxiety). How might you broach ACP, and what wording might you use? How would you explain the [differences between advance directives and POLSTs](https://polst.org/wp-content/uploads/2019/05/2019.04.30-POLST-vs-ADs-chart.pdf) if she asks if she needs them?


# Cultural Humility & Meeting People Where They Are

Recognizing the disparate impact that COVID-19 has on people based on their past experiences or their current circumstances is foundational for effective communication. Practicing cultural humility as you approach conversations around COVID-19 includes bearing witness to a person's lived experience, recognizing the unique elements of someone’s personal experiences based on their background and culture, and acknowledging the authority that each person has over their experiences and story. Practicing cultural humility requires looking beyond one’s own experience and approaching the experiences of others without judgment.

*Thought Question:*&#x20;

* Think of 2-3 ways in which someone’s past experiences could impact their receptiveness or response to a conversation about COVID-19.

If you need help brainstorming, consider the following circumstances or review the ways in which this pandemic may further inequity from [this summary by the NAACP](https://naacp.org/wp-content/uploads/2020/04/Coronavirus-Equity-Considerations.pdf) (published April 2020):

* A person who has previously been quarantined for a prior outbreak (e.g. SARS, Ebola).
* A person who has been the [target of racism related to the pandemic](https://www.cbsnews.com/news/coronavirus-panic-fear-racism-attacks-against-asian-americans-world-us-restaurant-jing-fong/).&#x20;
* A person who is incarcerated and concerned about their risk of exposure.
* A person without health insurance who is [concerned about the cost of potential healthcare needs](https://www.kff.org/uninsured/fact-sheet/what-issues-will-uninsured-people-face-with-testing-and-treatment-for-covid-19/).&#x20;
* A person who [lives paycheck-to-paycheck](https://www.wbur.org/onpoint/2020/03/12/the-economic-impact-of-coronavirus) who is concerned about their inability to work during mandatory quarantine and ability to buy basic needs. &#x20;
* A person who distrusts the medical establishment because of prior experiences.&#x20;
* Persons with disabilities who rely on personal care assistants to do their grocery shopping and to pick up their medications.

In recent months, fear has bred more [xenophobia and racism](https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2020.305858). How can you respond when you see these remarks waged against others or yourself? We can look towards research on microaggressions–defined as verbal, behavioral, or institutional actions that communicate hostility or prejudice towards marginalized groups–for suggestions on how to react. One framework on how to respond to perpetrators of microaggressions (or macroaggressions) is modified from ([Sue et al., Am Psych 2019](https://www.ncbi.nlm.nih.gov/pubmed/30652905)):

* **Make the invisible visible.** Ask for clarification. Try to see where they’re coming from.
* **Disarm the microaggression.** Express disagreement, state your limit, or redirect the conversation.
* **Educate the offender.** Point out bias, discuss the impact of their statements, and promote empathy.
* **Seek external support.** Reach out to sources of support, discuss experiences with others, and report the statements if appropriate.


# Sustaining Constructive Behaviors Over Time

As you have learned in previous modules, public health measures like physical distancing are necessary to reduce disease transmission. Because the efficacy of these measures depends on high rates of compliance in the general population, COVID-19 can be seen as a behavior-related illness. We must equip ourselves with the tools to best ensure adherence to recommended practices.

**Prochaska’s Stages of Change Model**

This is an appropriate time to review the six stages of change ([Levinson et al., Ann Intern Med 2001](https://annals.org/aim/article-abstract/714741/change-change-sounds-like-you-have-dilemma)). The most effective approach to addressing a change in behavior should take into account the person’s willingness to change, motivating factors towards change, and barriers standing in the way. This framework is helpful as a roadmap for the process of behavior change, and it aids in engaging individuals in the process of change.

![Graphic adopted from Levinson et al., Ann Intern Med 2001](/files/-M3NYEafMCw1Zny1dWWy)

*Thought Question*:&#x20;

* With this framework in mind, how would you start a conversation with [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian) about physical distancing? How would you start a conversation with [**Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-2-diane) about physical distancing?

## Motivational Interviewing

This section will provide a refresher course on the principles of motivational interviewing. When engaging people in conversations about behavior changes, the four processes central to the approach are as follows:

![Graphic from the IFIOC Course: Introduction to Motivational Interviewing, Kelly Franklin](/files/-M3NYKPk7OpgAYJo55_I)

1. &#x20;**Engaging** the person in a high-quality, supportive relationship by:

* Expressing appreciation of the person’s main concern, even if they disagree with you. Acknowledge their efforts to change and willingness to engage in discussion.
* Building affiliation by partnering with the person. Collaborate on defining goals and agreeing on strategies, try to face the problem from shared goals (e.g. reducing spread of disease to loved ones who are at high risk of severe illness)
* Minimizing status differentials. Acknowledge that this person is the expert on their life. Convey information in a straightforward fashion and listen actively.
* Choosing a role that you feel is appropriate for the situation: cheerleader, coach, teacher, monitor, disciplinarian, friend, confessor, etc.
* Emphasizing autonomy, above all. People are much more likely to change if they feel they have the power to choose whether and how to proceed. Emphasize that any next steps are completely up to them. Affirm their strengths and self-efficacy. Point them towards helpful resources that they can consult on their own time.&#x20;

2\. **Focusing** on one specific behavior can help improve the chances of successfully changing it. This is where the “Ask-Tell-Ask” framework comes into play–when one informs people about risks and benefits of various behaviors (see figure below). Help them identify what matters most to them and which behaviors they want to change.

![](/files/-M3NYUCrTFv4cpzi7z-Q)

3\. **Planning** and evoking “change talk” in which patients express their **D**esires, **A**bilities, **R**easons, **N**eeds, and **C**ommitment to change (DARN-C). This can be done by:

* Summarizing/Reflecting as a part of active listening. You don’t have to use the person’s exact words, but the purpose is to show the patient you are listening.
* “On a Scale from 1 to 10, how likely are you to change X?” Then ask, “Why not a lower number?” This will get them to express motivations for change.
* Ask-tell-ask can also play a role here. Ask the person what they understand about the risks of their behavior. Tell the patient how that relates to what you know. Then ask how this new information might apply to their situation.&#x20;

4\. Pursuing and executing next steps that are **S**pecific, **M**easurable, **A**chievable, **R**elevant, and **T**ime-bound (**SMART**). Remember, this person has the autonomy to execute the plan. All your efforts to this point to reinforce that should enable them to feel motivated to execute it!


# Activity: Putting it to Practice

Now that we’ve reviewed several approaches to empathetically communicate across differences and share difficult information in the context of [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian) and [**Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-2-diane), identify a real person in your life whom you’ve noticed may benefit from a conversation about COVID-19. Reach out.

Remember that in today’s world, there are many ways to do so. Some ideas:

* Direct message someone who has posted something on social media about COVID-19 that you disagree with. Start exploratively: “I saw your post yesterday and was curious about what you meant by…”&#x20;
* Call a friend or family member who may be overwhelmed by the facts around COVID-19 and communicate such information while being attentive to their emotions and concerns.&#x20;

During that conversation, consider your new frameworks. Reflect on the “identity conversation” from the Difficult Conversations formulation. Think about where they are coming from–what factors might affect why they are behaving or speaking the way they are? Consider the Prochaska’s Stages of Change model and personalize your approach when encouraging them to make changes to their daily life, such as cancelling social gatherings (as you would for [**Brian**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian)) or accepting temporary help with daily activities (like for [**Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-2-diane)).

Let’s imagine that you have a chance to speak with Brian and engage in some motivational interviewing. Together, you explore ways for him to spend his time besides going out with friends. He mentions his grandmother, and, in time, makes a habit of talking with her every couple days. She, in turn, begins to feel comfortable with Brian and even asks if he would be willing to go out and shop for her groceries next week. Thanks to your empathetic counseling, both our characters find ways to make important changes to their lives, while staying in touch with one another via FaceTime and supporting each other through this difficult time.

To help you with these conversations, our classmates have compiled a number of resources intended for public audiences without medical training, provided below for reference.&#x20;

* FAQ documents: [CDC FAQ section](https://www.cdc.gov/coronavirus/2019-ncov/faq.html) (updated September 2020)
* One-page guides: ["What you should know about COVID-19 to protect yourself and others"](https://www.cdc.gov/coronavirus/2019-ncov/downloads/2019-ncov-factsheet.pdf) (updated June 2020)&#x20;


# Summary

We hope this module prepared you to have productive conversations about a complex and rapidly evolving topic.

We welcome your feedback on this module, and on the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).


# Module 6: Training for Potential Clinical Roles

Develop technical know-how in preparation for roles that medical students may play in the clinical setting.

*Authors:* James Agolia; Taylor Brown; Fang Cao; Ashwini Joshi; Soumyaa Mazumder; Katherine McDaniel, MSc; Niyi Odewade; Sarah Onorato; Alexander Ordoobadi; Simone Sasse; Sanjana Srinivasan; Rachel Weitzman; Denston Carey, Jr.&#x20;

*Editor:* [Bina Kassamali](mailto:bina_kassamali@hms.harvard.edu)

*Reviewers:* Jeremy B. Richards, MD; Harvey Simon, MD; Clyde Crumpacker, MD; Christian Larsen, MD; Jennifer Potter, MD; Eve Rittenberg, MD; Nhi-Ha Trinh, MD, MPH; Andrea Wershof Schwartz, MD, MPH

**Update Disclaimer:** Thank you for visiting Module 6! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

The COVID-19 pandemic has prompted numerous questions as to how best to prepare medical students to engage in efforts to stop the disease. This sixth module guides the reader through relevant information to smooth the transition onto hospital floors and play important roles in the clinic. Protocols regarding testing, triage, and PPE use for managing COVID-19 are constantly evolving at an institutional, state, and federal level.

In short, PPE minimizes exposures to hazards that result in serious infectious illnesses by creating a barrier between the healthcare worker and the infectious agent. For COVID-19, gloves protect the hands, gowns protect skin and clothing, masks and respirators protect nose and mouth, and goggles and face shields protect eyes and the entire face.  It is important to develop an understanding of how to safely put on, take off, and, at least currently, re-use such equipment to minimize the contraction and continued spread of the virus.&#x20;

The next section covers basic mechanical ventilator settings and modes, with an emphasis on ARDS. While students are unlikely to be directly involved in mechanical ventilator management of patients, a fundamental understanding of mechanical ventilator function may be useful for communicating with healthcare providers and as a foundation for further patient care.&#x20;

In addition to providing relevant information regarding PPE use, triaging, and mechanical ventilator function, this module aims to inform medical students about ways to support healthcare workers. Examples of clinical and non-clinical opportunities include phone triage for patient care and community initiatives to donate PPE. Furthermore, we discuss the importance of hygiene while serving in clinical settings to ensure the safety of yourself and those with whom you live.&#x20;

Finally, these are stressful, even traumatic times. Just as you protect your physical health, protecting your mental health and wellbeing is equally as important. This final section of this module instructs on ways to protect your own wellbeing and that of loved ones and colleagues using the principles of trauma-informed care.

## Learning Objectives

By the end of this module, medical students should be able to:

* Be able to choose appropriate form of PPE and become confident in its usage. Describe an algorithm by which patients with suspected COVID-19 should be tested
* Appreciate the many ways that you may be exposed to COVID19 and how to maintain proper hygiene behaviors and practices to minimize this risk to yourself and others
* Explain how mechanical ventilation is managed in patients with ARDS
* Appreciate the wide variety of student roles in clinical and non-clinical settings during this pandemic
* Describe how pandemic conditions, as a traumatic exposure, may affect the mental and physical health of healthcare workers and trainees
* Using principles of trauma-informed care, develop a personalized [action plan](https://docs.google.com/document/d/1hiPP2grRxesodCOXxwfxNejopEjelSKR2Xb9s-ZJBrQ/edit) to stay well and work effectively in clinical settings and at home


# Current Medical Student Involvement

Given the enormous toll that COVID-19 has taken on medical professionals working in hospitals, there has been a tremendous push by medical students to support health care workers in both clinical and non-clinical capacities.  Students from medical schools across the country have been organizing themselves to aid in roles ranging from collecting excess PPE from the general public to staffing phone hotlines for virtual triage.  Harvard Medical School students have coordinated a number of initiatives to aid medical staff.  Here, we will discuss examples of roles currently being filled by medical student volunteers.&#x20;

## Clinical support activities

In terms of clinical support, HMS teaching hospitals have recently begun approving opportunities for which medical students may volunteer.  These have included:

* training health care workers on proper PPE use and re-use
* creating and editing videos on proper PPE usage
* distributing appropriate PPE on hospital floors
* conducting telephone calls with patients during remote appointments
* screening patients who arrive at the hospital for necessary procedures
* workforce mapping (i.e. identifying what clinical spots need to be filled in various departments and by which personnel).

It should be noted that the guidelines regarding the extent of medical student involvement in clinical care are rapidly evolving, especially given the shortage of PPE.  The most recent set of [guidelines](https://www.aamc.org/system/files/2020-03/Interim%20Guidance%20on%20medical%20students%20voluntary%20participation%203.23%20Final.pdf) issued by the Association of American Medical Colleges (AAMC) has stated that while it is not recommended for medical students to be involved in any direct patient care activities in order to conserve PPE, if there is a critical healthcare workforce need locally, any medical student involvement at teaching hospitals must be voluntary and not compensated. Thus, the roles that are listed above may change as the safety guidelines regarding medical student involvement evolve and as the shortage of available PPE for health care workers increases.  Students may be required to shift to remote or low-risk roles (such as scribing or calling consults) in order to minimize usage of PPE by students.

## Non-clinical involvement

In addition to clinical roles, there is a wide range of efforts targeted towards supporting health care workers in other capacities. For example, one initiative at HMS has focused on collecting excess PPE donations from the general public for donation to hospitals. This group, the PPE Shortage Initiative, has used outreach (contacting businesses, organizations, friends, and family for donation) and advocacy (helping with ongoing legislation and petitions) to obtain much-needed PPE for health care workers. MD/PhD students, especially those with engineering backgrounds, are organizing projects to design new mechanical ventilators and 3D-printed masks. Other efforts include:

* volunteering to assist health care workers with child care
* picking up and delivering groceries and prescriptions
* helping with preparing meals

Regardless of the level of medical training, many students may be able to help with blood donation. Blood centers across the country are experiencing a significant drop in donations amid COVID-19 fears, and the FDA is [urgently asking healthy adults to consider donating](https://abcnews.go.com/Politics/fda-worried-blood-shortage-donation-drives-canceled-amid/story?id=69581026). This is a helpful way to add tangible resources to our health system.

*Thought question:*

* What are some clinical and non-clinical roles that you envision medical students performing to aid the response to the COVID-19 pandemic?<br>


# Personal Protective Equipment

## ![https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/MSHS-COVID-19-PPE-Practices.pdf](https://lh5.googleusercontent.com/sdglDOk9bYuKpPA5oJz4JvNU5Xfpo8PiL4vn5Bj9Xd0UP36635wyzKzhhkwtF3zwZ14q-s7OurYSUJC7EM9gLwDAkk_2XiZ_hf0fIvUtj8ETjf1hwuuk5b5-kGCBwhwLdlyswGfY)What is PPE?

![](https://lh4.googleusercontent.com/yMx8VQHFuBLTHjkdTJyAHzqpf_luxpWobqgoSO307Bo7nxRJVYKGByidyMPKHofIY8pLfwF_eT9qPzafT0yisbGI0VPNPtzBWbxciyOQH58kWAw_1PE-ENuCWtzN0kKYeGJVGv3H)

Personal protective equipment (PPE) is designed to protect the wearer from illness or injury due to contact with occupational hazards, such as dangerous chemicals, radioactive materials, or infectious biological agents. PPE may include items such as gloves, goggles, shoe covers, helmets, respirators, masks, gowns, or full body suits ([Occupational Safety and Health Administration](https://www.osha.gov/SLTC/personalprotectiveequipment/)).

## Importance of PPE

Medical professionals commonly use PPE in the inpatient and outpatient settings, as well as in clinical laboratories. Correct use successfully creates a barrier between the wearer’s skin and potentially infectious materials such as patients’ bodily fluids, thereby stopping transmission of bacterial or viral pathogens. Patients at high risk for contracting infections, such as those with significant cardiopulmonary comorbidities or an immunodeficiency, can also use PPE to protect themselves from exposure to infectious agents brought in by visitors or healthcare workers. Correct use of PPE, in combination with other infection control practices (e.g. washing hands, using alcohol-based hand sanitizers, covering coughs and sneezes), reduces the spread of infection ([FDA](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/personal-protective-equipment-infection-control)).

The [CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html) provides clear guidelines concerning the selection and use of PPE in healthcare settings for both patients and healthcare personnel. Significantly, staff caring for patients with confirmed or suspected COVID-19 should wear a gown, gloves, eye protection, and a mask. Currently, many institutions are reserving   N95 masks for aerosolizing procedures due to the limited stock.&#x20;

![https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/MSHS-COVID-19-PPE-Practices.pdf](https://lh6.googleusercontent.com/_6Mfa87rbMgfESFKkzUyDCJ50yG2FyMZgwMPGqw64Nxv7U3oXwLv5bbOjXHS4JgGZ3aWZbbax_1LMZttXxCdSUkuGuJqa7gNc4X9Qayvjg1jR5tRhOL35Z00G2HSmMhNHfaxDnN3)

Healthcare organizations may further delineate the circumstances as to when which PPE is required. As an example of recommendations as of March 23 from [BILH Website](https://static1.squarespace.com/static/5c5b3374ca525b57bb9b3e4d/t/5e6992213d430e6e35aa5b99/1583976993771/BILH+COVID-19+PPE+Grid+by+Location.pdf) (with the important note that protocols are evolving rapidly), see chart below:

![](https://lh4.googleusercontent.com/_1Kw0lsUJLwWys7VSOAbYE5MzU5ge-9N3NGN8kSak_SjSnVGa09rep9Z8oXa2VAcFeNEmMAuK5Cxypn1Tti28HH8akQKmLfzBEC0zGraTeteGcc7MZI9fSGoIpN6ksR7YsPIs8xf)

## Current Status/Shortage

As the COVID-19 outbreak continues to expand globally, the supply chain for PPE will continue to be stressed if demand exceeds available supplies ([FDA](http://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns)). &#x20;

The FDA [recommends strategies](https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-healthcare-providers) for use by healthcare organizations and personnel—categorized for a range of clinical needs and supply levels—to help determine conservation procedures during this time period. These strategies aim to augment, not necessarily replace, specific controls and procedures developed by health care organizations.

Due to shortages, new terminology is arising regarding extension or re-use of PPE:&#x20;

**Extended Use:** wearing PPE without removal or redonning between patients.&#x20;

**Re-Use:** removal and reuse of PPE between patients.&#x20;

The current shortage has led many healthcare organizations to consider different avenues of conserving supplies to meet the needs of their staff, such as community donations. Furthermore, hospitals including Massachusetts General Hospital, Brigham and Women’s Hospital, and Beth Israel Deaconess Medical Center have instituted new policies, such as requiring universal face masks for all workers to be worn throughout the day for all cases, as the situation continues to evolve. See [current FDA recommendations](https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-healthcare-providers) for conservation recommendations for crisis situations.&#x20;

*Thought questions:*

Your community hospital has been experiencing greater pressures on conserving the necessary protective equipment as well as personnel to help combat the virus. You receive an email requesting opportunities to help. Which PPE would the hospital need? What are some strategies to help provide enough protective attire to healthcare workers? What are some FDA approved alternatives/options?<br>

## PPE Training

### Donning/Doffing PPE

These diagrams describe the application and removal of PPE. For a more comprehensive description and images of the types of PPE, please refer to Module 5 [Supplemental Material](https://docs.google.com/document/d/1bCEmruPePVoAe1CzY-g4Uuky-e5lOiCVJ4ywWL-X0jQ/edit): PPE.  Note that in many hospitals, due to PPE shortage, masks, respirators, and eyewear are not discarded after single use (as shown in the figure), but are reused or used for an extended period of time. For example, partners' employees must wear face masks (surgical or procedural) at all times while in clinical care settings. In order to support the new policy, one surgical or procedural face mask will be issued at the start of each shift and will be used throughout the shift except in circumstances in which they become visible soiled or damaged (see next section for an example of reuse guidelines).  Nonetheless, policies involving mask usage are constantly changing. A [new system](https://www.massgeneral.org/news/coronavirus/research/partners-healthcare-mask-sterilizing-facility) to sanitize up to 80,000 masks a day is currently underway and policies regarding its use are in development.

![](https://lh3.googleusercontent.com/4G9_IO2HCJhajODgIabj4FJt8YZEPw0528rbTNgXCfZHD4X2J61n4T98mdcb5JP4x7DVqD92bAHRWupIzdxLCah8t8wciUCGv0cMl_H14W897HeYwGCQ5Bud66NhNWbKaQxkCpqL)

![](https://lh4.googleusercontent.com/ToTC73mF3KO5C5hTs4y5LEw9y2H3fKTtgexBfDjx7TZqekZNdplF1RNecGRgWR3OKaODQeCsRkEsHgEA-plwAJ6nWdP-_u3LKKEhjs-bQvXJhH_d4X2dw0wGMHSsP5XtQcTc-FgG)

### Reusing PPE

Due to the limitations in supplies, many hospitals are creating new trainings concerning the reuse of PPE. PPE that was previously single-use only is now being reused. Contrary to the guidance from the above ‘doffing’ figures, surgical masks, N95 masks and eye protection are currently being reused to preserve hospital supplies.

The following is taught at the HMS/MGH PPE training session:&#x20;

![](https://lh6.googleusercontent.com/0dqYH2MJwmoJ4FrsjzcpgUwhlyjBT4pLPq6lTpCgSJ4IB1Sv-EeeAQxYicMZzeYCOty_K1ZAFmdeHbC4ysjMpH0x6-npGiI9z8TGtvU0TU5mvgLlTzYwKCRs9SgzI_IPdI_s-Ctm)

**Reuse of Face Shield**

The face shield is a good option for eye protection if you wear glasses. The exterior surface of the face shield is always considered contaminated. The interior surface is considered contaminated if it is worn over a mask or respirator that has been reused or is being worn under extended use.

1. Perform hand hygiene and don gloves.
2. With “clean hand,” hold mask by inside foam.
3. With “dirty hand,” clean interior and exterior surface of face shield using alcohol wipes or an alcohol prep. Do NOT use bleach wipes or Sani-Cloth, Virex, or other similar cleaners as these will cloud the clear plastic and make it difficult to see.&#x20;
4. Remove gloves and perform hand hygiene.

**Reuse of Disposable Safety Glasses**

Disposable safety glasses consist of a plastic frame (blue section in picture) and an eye shield lens. The lens must be removed from the frame to adequately clean the glasses. This type of safety glasses can be worn over personal prescription glasses.<br>

![](https://lh5.googleusercontent.com/tZyqH2kJIj_wfbOA4klRgBLds5tmlEfC4dzFlEEyOo4ZmEHpwYcmcE7vgryz_EkPV3VRAgfArlkdWem0Yh2pO_kq9axNg9n5seqSWRvMAoOM54Jm-A9FY0v3mW8hFWUd9P2hfB8R)

*Option 1: if replacement eye shields are NOT available*

1. Perform hand hygiene and don gloves.
2. Remove the eye shield lens from the frame.
3. Clean the eye shield with standard disinfectants and place in a clean area to dry.
4. Clean the frame with disinfectant wipes and place in a clean area to dry.
5. Remove gloves and perform hand hygiene.
6. Once dry, place the eye shield lens back onto the frame. Note: the eye shield must be inserted so that it lies behind the front of the frame.

*Option 2: If replacement lenses are available (currently NOT the case in most hospitals)*

1. Perform hand hygiene and don gloves.
2. Remove the eye shield lens from the frame and dispose of the eye shield.
3. Clean the frame with standard disinfectants. Allow the frame to dry following instructions on disinfectant wipe package.
4. Remove gloves and perform hand hygiene.
5. Obtain a new eye shield for the glasses and insert it onto the frame. Note: the eye shield must be inserted so that it lies behind the front of the frame.&#x20;

**Reuse of Non-Disposable Safety Glasses**

Non-disposable safety glasses are meant to be reused. They cannot be worn over prescription glasses.&#x20;

![](https://lh5.googleusercontent.com/rh9pGvjdot8vmjBF7OJ7ltEFHn3PI3o9DFnVNrwYYR8Mtmnsbaqyw1hULHKLCqr3tMsgkB7l4c5hpZX2ppMkmFQTmrRjKhcB_cPrtXGq7bPQxUPVzZQdkRYKscjPrc889XtkZ7WP)

1. Remove eye protection by holding the the most posterior portion of the frames and lifting forward.
2. Wipe both surfaces of lenses with alcohol wipes or alcohol prep.
3. Wipe all other surfaces of the glasses with alcohol wipes or alcohol prep.
4. Perform hand hygiene upon exiting patient room
5. Glasses can be placed in any clean location for storage.

**Reuse of Surgical and N95 Masks**

1. Perform hand hygiene.
2. Carefully remove the mask from the face. Do NOT touch the exterior surface of the mask.
3. Place the mask in a container, such as a paper bag or plastic container, so that only the exterior surface of the mask is in contact with the container. Ensure that the elastic strap is placed to the side of the mask rather than lying inside the bag.
4. Perform hand hygiene.

**Donning a Reused Surgical or N95 Mask**

1. Perform hand hygiene and don gloves and gown.
2. Place the mask on the face, ensuring to only touch the outside of the mask and not your face with your hand.
3. Perform seal check (if using N95 mask).
4. Remove gloves and perform hand hygiene.
5. Don clean pair of gloves.
6. Don eye protection.

*Thought question:*

You volunteer at your medical school’s hospital and are asked to help train staff on how to reuse PPE. Think of up to five critical practices that all medical students need to know about reusing PPE.

## Frequently Asked Questions&#x20;

**Which PPE should healthcare personnel wear when working with COVID-19 positive patients?**&#x20;

As of April 25, 2019, the [CDC](https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html) recommends the following: As part of source control efforts, HCP should wear a facemask at all times while they are in the healthcare facility. When available, facemasks are generally preferred over cloth face coverings for HCP as facemasks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others. If there are anticipated shortages of facemasks, facemasks should be prioritized for HCP and then for patients with symptoms of COVID-19 (as supply allows). Cloth face coverings should NOT be worn instead of a respirator or facemask if more than source control is required. Nonetheless, any HCP who enter the room of a patient with known or suspected COVID-19 should adhere to Standard Precautions and use a respirator (or facemask if a respirator is not available), gown, gloves, and eye protection

**What PPE should patients with confirmed or suspected COVID-19 wear?**

Patients should wear nonsterile, disposable patient isolation gowns and should wear a facemask until they are isolated, whether that be in a hospital or at home. Once isolated, patients do not need to wear facemasks ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html)).

**What is the difference between an N95 respirator and a surgical facemask?**

An N95 respirator, which fits tightly to the face, filters at least 95% of small and large particles from the air, thus protecting users from airborne viruses.  A surgical facemask, which fits loosely to the face, protects the user from large airborne droplets and splashes but does not prevent the inhalation of aerosolized virus particles ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html#respirators)).  See the figure below from the CDC: [Infographic - Understanding the Difference, Surgical Mask, N95 Respirator](https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf).

**Which PPE is used in the following: Airborne Isolation/Droplet Isolation/Strict Isolation?**

Airborne Infection Isolation (“negative pressure”): N95 respirators.&#x20;

Droplet Isolation: surgical and procedural masks

Droplet Isolation and Strict Isolation: Eye protection (face-shields and goggles)

**Who should be using PPE?**

According to the CDC:

* Patients with confirmed or possible SARS-CoV-2 infection should wear a facemask when being evaluated medically.
* Healthcare personnel should adhere to [Standard and Transmission-based Precautions](https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html) when caring for patients with SARS-CoV-2 infection.&#x20;
* In light of new data about how COVID-19 spreads, along with evidence of widespread COVID-19 illness in communities across the country, CDC recommends that people wear a cloth face covering to cover their nose and mouth in the community setting. This is to protect people around you if you are infected but do not have symptoms.

**When should I use an N95 respirator vs. a facemask?**

![](https://lh5.googleusercontent.com/3cYhaZTa6N6G_BX2ID_DLBmYPmoFC5eLXNGD8Z-1uUQVjUvCbf0lZTJ5FeUipNjgYTgb3_8NPAiitAVrLQ42doUzebTbC9Qa-dtZ2vrZp-1HFS1vqA0tu__VUqErTA49Am0mt_VW)

Facemasks should be worn by patients with confirmed or suspected COVID-19 to prevent contamination when the patient coughs or sneezes. A facemask provides protection by containing droplets if someone has the virus and by preventing exposure to the virus if someone has close contact with another person who is infected. For healthcare personnel interacting with a patient with known or suspected COVID-19, the [CDC](https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html#adhere) recommends using an N95 respirator or a facemask if a respirator is unavailable. In addition, N95 respirators may be needed for clinical situations in which infectious droplets could become aerosolized, which occurs only in specific clinical situations such as when a patient is intubated. ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html)). Practically, there is currently a shortage of N95 respirators, so many hospitals are recommending that healthcare personnel use regular facemasks, reserving N95 use for procedures in which aerosols could be generated. CDC provides guidelines for optimizing the supply of N95, which can be found [here](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html).

**How do I make sure that my N95 respirator fits me correctly?**

All healthcare personnel should undergo formal mask fit testing prior to using an N95 respirator ([NIOSH](https://www.osha.gov/SLTC/etools/respiratory/respirator_basics.html#fit_testing)).  This ensures there is an airtight seal between the healthcare worker’s face and the respirator.  In addition, each time healthcare workers don an N95 respirator, they should perform a [user seal check](https://www.cdc.gov/niosh/docs/2018-130/pdfs/2018-130.pdf?id=10.26616/NIOSHPUB2018130) ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html#respirators)).

**Does the universal mask policy apply to every member of the workforce working anywhere at Partners HealthCare and Beth Israel Deaconess Medical Center?**

The universal mask policy applies to employees working in buildings or areas (i.e., home care) where clinical care is provided or when walking through common areas in those same buildings.

* Workers in private individual offices or in nonclinical settings where individuals are reliably separated by more than 6 feet, do not need to wear the mask in those settings. When walking through common areas in buildings where care is delivered, however, the mask policy applies.

Workers that work in nonclinical buildings (i.e., Assembly Row) are excluded.

* These employees should practice principles of social distancing, respiratory etiquette and frequent hand hygiene.
* If these workers visit buildings where clinical care is provided, the mask policy applies as above.

**In procedural areas, can a single face mask be worn continuously, including across different cases?**

Yes, a single mask can be worn across different cases. Masks must be changed, however, if they become wet or contaminated during a case or a shift.

**I work in a clinical setting. How can I eat when I am supposed to wear a face mask (surgical or procedural)?**&#x20;

Eating is not permitted in clinical areas. If you are working in a clinical setting, follow the removal and reuse instructions as is outlined in Partners Infection Control Guidance on Extended Use and Reuse.

**I work in a clinical setting. How can I drink when I am supposed to wear a face mask (surgical or procedural)?**&#x20;

Drinking is permitted in designated locations in clinical areas. If you need to drink, ensure you are 6 feet away from others, perform hand hygiene, remove the mask, drink, and then replace your face mask.&#x20;

**I work in a nonclinical setting. How can I eat and drink when I am supposed to wear a face mask (surgical or procedural)?**&#x20;

Steps to remove mask in nonclinical settings, where eating/drinking is not restricted:

1. Perform hand hygiene with soap and water or an alcohol-based hand rub
2. Remove the face mask and place it on a clean surface such as a paper towel, paper bag or paper tray
3. Perform hand hygiene with soap and water or an alcohol-based hand rub before eating

Steps to replace mask after eating or drinking:

1. Put on face mask, taking care to avoid touching face or eyes
2. Perform hand hygiene with soap and water or an alcohol-based hand rub

**If I need to leave the facility and come back later in my shift, what should I do?**

Every effort should be made to limit exit and entry to the facility during your shift to preserve supplies of face masks. If you leave the facility, the face mask must be discarded and a new one obtained upon re-entry.

**Can I use my face mask between patients, including those with confirmed COVID-19, suspect COVID-19, other respiratory viruses or patients in whom none of these apply?**&#x20;

Yes. Your face mask should be used according to the BIDMC guidelines and Partners Infection Control Guidance on Extended Use and Reuse, which ensures careful and deliberate handling of the mask to prevent both self-contamination and cross-contamination. Under conditions of extended use or reuse, a face shield is preferentially worn over the face mask as the form of eye protection.&#x20;

**Should employees be wearing the mask at home and should their families wear masks?**&#x20;

Employees should throw away their masks when leaving the hospital. They should not wear them home. There is generally no reason for employees and their families to wear masks at home. Social distancing and taking precautions like washing your hands, using hand sanitizer, and cleaning surfaces frequently should be appropriate for home. The Centers for Disease Control and Prevention (CDC) has provided this [guidance](https://www.cdc.gov/coronavirus/2019-ncov/prepare/prevention.html).

## Hospital-specific Policies

### Partners (BWH/MGH) Guidelines&#x20;

MGH has published videos outlining and modeling the use reuse of [N95 respirators](https://youtu.be/IfTVPCDami4) and [surgical masks](https://youtu.be/JBq7TjIM5k0).  For specific Partners guidelines, please follow [this link](https://pulse.partners.org/hub/departments/emergency_preparedness/coronavirus) (note: requires Partners credentials). These include recommendations for N95 respirators, surgical masks, and procedural masks, as well as eye protection.&#x20;

### Beth Israel (BILH) Guidelines&#x20;

Beth Israel has provided all guidelines under a [COVID-19 Information and Materials](https://www.bilh.org/covid19-information-assets) section of their website, updated frequently. Guidelines include [PPE recommendations](https://static1.squarespace.com/static/5c5b3374ca525b57bb9b3e4d/t/5e6992213d430e6e35aa5b99/1583976993771/BILH+COVID-19+PPE+Grid+by+Location.pdf) for providers and patients depending on location (inpatient vs ambulatory setting)

### Cambridge Health Alliance (CHA) Guidelines

CHA has provided all guidelines under a frequently updated [COVID-19 Quick Guide](https://sites.google.com/challiance.org/ncov-quick-guide/home), accessible with CHA credentials.

[Reuse policies](https://static1.squarespace.com/static/5c5b3374ca525b57bb9b3e4d/t/5e6da511ea160c0c82a63970/1584243985185/BILH+PPE+Reuse+Procedure+for+Respiratory+Evaluation+Units_Urgent+Care_Emergency+Department.pdf) for gowns, surgical masks, and eye protection. [Reuse instructions](https://covid-19.bilh.org/wp-content/uploads/2020/03/BILH-N95-Reuse-Procedure_3.18.20-2.pdf) for N95 respirators. [Reuse instructions](https://covid-19.bilh.org/wp-content/uploads/2020/03/BILH-Eye-Protection-Reuse-Guideline_3.20.20.pdf) for eye protection.

*Thought questions:*

* There is currently a supply shortage of many forms of PPE.  How are CDC and hospital guidelines attempting to address this issue?
* Your family member asks you whether they should be wearing a mask to protect against coronavirus.  How do you respond?
* You notice that members of the medical team in the hospital are not following hospital guidelines on appropriate use of PPE.  As a medical student, what do you do?<br>


# Telehealth

## Introduction

[Telehealth](https://www.nejm.org/doi/full/10.1056/NEJMsr1503323) is the distribution of health-related services via electronic information and telecommunication technologies. In the light of the COVID-19 pandemic and recommendations for physical distancing, live video telehealth allows for continued, albeit virtual, patient and clinician contact in a variety of settings including home health, outpatient appointments, the emergency department, and remote ICU monitoring ([Hollander and Carr, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2003539)).  Acknowledging the value of virtual visits in the COVID-19 era, [Medicare](https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet) and other insurers have committed to providing reimbursement to providers for telehealth video visits.&#x20;

Although the advantages of live video telehealth are numerous, there are several challenges for ensuring equity and privacy for its users. Clinicians must be sensitive to the barriers that may prevent some patients from owning basic technology such as digital mobile technology that is required for participation in virtual visits. Furthermore, certain individuals' home lives or inpatient shared rooms may not allow patients enough privacy to feel comfortable speaking about their health concerns.&#x20;

Despite these limitations, telehealth holds great promise for increasing our health care system’s capacity for providing care to patients while reducing the risk of viral exposure for both patients and healthcare workers and reducing the use of limited personal protective equipment. Although telehealth has been increasingly used in the past several years, its use has been largely limited to rural and other [access-poor settings](https://jamanetwork.com/journals/jama/fullarticle/2716547). Experience with telehealth in these settings suggests high patient and provider [satisfaction](https://www.nejm.org/doi/full/10.1056/NEJMra1601705), owing largely to the flexibility and convenience offered by this modality.&#x20;

However, despite recent increases in telehealth, many clinicians and students will have never used this mode of care delivery before and even fewer will have received telehealth-specific training. It is important to consider best practices for telehealth visits, including how to translate in-person clinical skills to the virtual settings. Telehealth promises to become increasingly integrated into our routine care delivery system, and it is thus important for clinicians and students to gain familiarity with this model of care delivery.&#x20;

## Components of Telehealth Visits&#x20;

In this section, we will focus on live video telehealth as part of outpatient visits, though the best practices highlighted here may be applicable to other clinical settings as well. Similar to in-person clinical visits, telehealth visits include distinct components.&#x20;

### Before the visit

Much like in-person visits, telehealth visits rely on appropriate preparation and rapport building to help set the stage for a successful encounter. The [American Medical Association’s Telehealth Visit Etiquette Checklist](https://www.ama-assn.org/system/files/2020-04/telehealth-appendix-g4-telehealth-visit-etiquette-checklist.pdf) summarizes some of the key considerations in setting up a telehealth video visit.

Preparation includes gathering the necessary personnel, technology, and materials. All relevant members of the interprofessional care team, including trainees and an interpreter if needed, should be present either physically or virtually before the visit begins. A caregiver may also need to be with the patient for the visit. Many of the interpersonal skills that clinicians rely on in the in-person setting to communicate warmth and attention can still be used over video visit. To communicate eye contact specifically, clinicians should make sure that they are **looking directly at the camera** rather than at the screen or their notes.

In terms of technology, both audio and visual elements should be optimized. Visually, the lights must be bright enough for the patient to see well, and a neutral, professional dress and background are preferred. Clinicians and students should check  for internet and microphone quality, and be prepared to adjust the brightness or volume for patients with visual or hearing impairment.  It is also important to have a backup plan if problems with connectivity arise during the visit. Lastly, because the screen provides a limited view of the clinician, the team should ensure that all equipment and materials are within reach to avoid the need to move off screen during the visit.&#x20;

### During the visit&#x20;

The visit begins by obtaining informed consent to conduct a virtual visit, orienting the patient to the video environment, and establishing a patient’s location and contact information in case of an emergency. If the telehealth encounter occurs in the inpatient setting, where the team may be large and may change from day to day, introductions and clarification of the clinician’s role is critical as well. Involving caregivers may be helpful, especially if a patient is unable to provide a history themselves.

Next, the same skills for taking a history in an in-person visit should be used during a virtual visit, using clinical judgment for which questions to ask and prioritize. In [geriatrics](https://patientprioritiescare.org/wp-content/uploads/2020/04/Patient-Priorities-Care-in-an-Age-Friendly-Health-System-Telehealth-to-Address-COVID-19_PPCJF04172020.pdf), for example, specialty-specific best practices used in in-person settings can be applied to telehealth. In addition to the usual information gathered during an in-person visit, outpatient telehealth visits can allow clinicians to observe patients in their home, which can help them better understand the physical and social environment  in which patients manage their medical conditions. Other novel strategies can be used during this part of the encounter to gather information from patients. For example, when reconciling medications, clinicians can ask patients to show their medications on camera and double check their supply. Additionally, some aspects such as [advance care planning](https://jamanetwork.com/journals/jama/fullarticle/2763952) may be even more important during the current pandemic. Clinicians should take extra care to speak loudly and slowly and to make time for questions.&#x20;

The [physical examination](https://www.aaaai.org/practice-resources/running-your-practice/practice-management-resources/telemedicine) remains an important component of virtual visits. Observation is a critical part of the virtual exam, as clinicians can gain valuable information by, for example, observing a patient’s environment, general appearance, and effort of breathing. More detailed elements of the exam, such as a focused [joint exam](https://www.ncbi.nlm.nih.gov/pubmed/32341311) or [neurologic exam](https://www.ncbi.nlm.nih.gov/pubmed/28768842), may require participation of the patient and can also be conducted. Vital sign measurement can be accomplished if the patient has the proper tools at home or if monitors are attached in the inpatient setting. A caregiver or nurse can also be involved to help conduct certain maneuvers, such as measurement of orthostatic vital signs. Creative approaches like these allow for the physical exam to be translated to the virtual setting. However, it is important to recognize that some maneuvers--such as auscultation of the heart or lungs--may be more difficult to adopt and may require in-person evaluation. As such, one important function of the televisit is to assess if a patient requires a higher level of care.

### Ending the visit

Much like in-person visits, telehealth encounters conclude with a discussion of the  assessment and plan. During this part of the visit, clinicians can provide education to patients, answer any remaining questions, and set expectations for follow up. For example, a patient may need labs, imaging, or consultation with a specialist. In the outpatient setting, a patient can make a follow up appointment as well. Written materials can be shared with patients through secure electronic message, mail, or fax. Finally, it is important to allow the patient to conclude the visit.&#x20;

Like for in-person visits, the team should then determine any remaining “to-do” items associated with the encounter. In the inpatient setting, this could include [virtual consultations](https://echo.unm.edu) or updating family members. If necessary, the team can review their telehealth process and make changes for continuous improvement of this rapidly evolving modality.

This module was written based on work originally created by Dr. Andrea Schwartz. For more information about telehealth in the geriatrics setting, please see her recorded presentation [here](https://ihi.webex.com/mw3300/mywebex/nbrshared.do?siteurl=ihi\&recordID=182224307\&serviceRecordID=182224312\&homepageurl=\&action=playback\&recordKey=4832534b000000049ecfa81a96025b001f477d71977ca055446d6335b920a9ded4237617df826de2).

*Thought questions:*

* Imagine you are working in clinic and see both Brian and Diane on your schedule as televisits.
  * [Brian](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian) has developed a cough and scheduled an urgent televisit. How will you orient Brian to this new format? How might you decide whether he needs to be seen in person?
  * [Diane](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-2-diane) has scheduled a routine telemedicine appointment with you for follow-up of her COPD, heart failure, depression, and anxiety. What would you look for during a virtual visit physical exam?


# Being Mindfully Hygienic

## **Introduction**

There is good scientific evidence that the virus responsible for causing COVID-19 can survive on various surfaces for quite some time. A study published in the [New England Journal Of Medicine](https://www.nejm.org/doi/full/10.1056/NEJMc2004973) found SARS-CoV-2 could survive for up to three days on plastics, two days on stainless steel, 24 hours on cardboard, and four hours on copper.&#x20;

Given this information, we must be keenly aware of the surfaces that we come into contact with as well as those carried with us while serving in the healthcare setting. Think of how many items we carry with us every day in the hospital: white coats, stethoscopes, shoes, badges, glasses, pens, pagers, cell phones--the list goes on. One way we can help ourselves, our patients, and those who live with us stay safe is by remaining diligent in reducing our exposure to contaminated surfaces through mindful hygiene practices. Many of the suggestions made below may require some difficult changes in behaviors, but keep in mind the substantial impact that these small changes in your behavior can have on the safety of those around you and ultimately in reducing the spread of COVID19.&#x20;

*Thought question*

* What are some surfaces with which you often come into contact (or carry with you) in the clinical setting?

## **The Many Potential Surfaces for Exposure**

ID Badge, Stethoscope, White coat (other clothes), Pens/Pencils- Pager/Phone, Glasses, Watches, Rings, Shoes, Hands, Hair&#x20;

## **Upon Arrival to Your Workspace (Every time)**

As a student serving during this time, your workspace will certainly vary and you must take the nuances of your specific environment into account. This section will provide you with some essential tips for properly preparing your new workspace.&#x20;

### **Plan ahead**

Before coming to work, there are a few things you can do to limit the unnecessary exposure of the surfaces you carry with you.&#x20;

* Leave accessories at home (jewelry, unneeded sun or reading glasses, etc.)
* Keep all essential items in a designated bag (hospital badge, stethoscope, hand sanitizer, etc.)
* Other: keep your designated pair of shoes in one area, limit hair exposure, cut nails short&#x20;

### **Clean, clean, clean!**

When first arriving at your new workspace, take the opportunity to disinfect all the surfaces that you will come into contact with. Wash your hands and don a pair of gloves before grabbing an [EPA approved disinfectant](https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2) and disinfecting your workspace. For a typical clinical workspace, this may include your: desk, badge, printer, phones, pager, and chair. See the infographic from BWH ED hygiene initiatives below:<br>

![](https://lh6.googleusercontent.com/zPvDlYDkuSJJ2iQXZFzNBIjAT02BO-oo1kFdFY3RT69YKvWRO4dt3Ijk6fD9XqJGmu2AQy0zHHnjZxbcvVMpVGj-m-vt8jHJQvicfifNZmrHPvuTXka-6v53JS_tU_yylJMI2EG2)

(Adapted directly from BWH ED Infographic Protocol)

### **Continuous caution & avoiding old bad habits**

As you progress through your workday, you will also come into contact with various surfaces outside of your workspace.  In addition to the previously discussed importance of wearing appropriate PPE and regular hand washing, work to avoid the following habits that could put yourself and others at risk of exposure.&#x20;

* Shaking hands (or anything that breaks social distancing rules discussed above)
* Touching your face
* Touching your cell phone with PPE

**Some tips for breaking these habits/avoiding inadvertent exposure in this way are:**

* Keep your phone and other items in a ziplock bag
* Put a sticker over your phone screen to remind you to remove PPE/disinfect hands prior to use

**Contaminated surfaces to be cognizant of:**

* Doors/door handles
* Patient beds
* IV poles
* Supplies carts
* Over bed tables
* Patient gowns, other linens

**Hand Washing/Sanitizing**

As you are well aware by now, hand washing or sanitizing is essential, especially with the following instances:&#x20;

* Before and after donning/removing any PPE
* Blowing nose, coughing, sneezing,&#x20;
* Before/after eating
* With visibly dirty hands

**According to the CDC, the most effective way to do this is:**

* Soap-Based: Lather hands with soap and scrub for 20 seconds before rinsing
* Hand Sanitizers: Spread sanitizer over all surfaces of of hand and allow to dry completely (effective alcohol-based hand sanitizers must have greater than or equal to 60% alcohol)

*Thought question:*

* What are the unique surfaces you may come into contact with in your clinical setting and how will you reduce your risk of contact/exposure?

## **Hygiene At Home**

One of the most important times to be aware of your hygiene is when returning back to your home from the clinical setting. This is especially important for those who live with others, as we certainly do not want to expose others, but it is also key in limiting exposure for ourselves.&#x20;

**The basics**

When it comes to keeping our living environments safe and clean, there are two key points to keep in mind: cleaning and disinfecting. Cleaning refers to the removal of microbes, while disinfecting refers to the killing of microbes. With awareness that a specific concentration of viral particles (IC50) is required to cause infection, both of these methods are essential in reducing that risk. When you clean a surface (use a non-microbe killing solution) you are reducing the amount of microbes but not killing them. The key is to do both! In general, soap, detergent, bleach, or >70% alcohol based cleaner will cause enough damage to the viral membrane to kill it--though it is preferred to clean the surface first with soap or detergent and then disinfect with bleach or >70% alcohol based solutions (or other approved disinfecting agents). To be sure you have products that are recognized by the CDC to be effective at killing COVID19, see the [EPA-registered disinfectants](https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2) webpage. All surfaces you come into contact with after returning from the hospital could potentially be exposed, so follow these brief guidelines to ensure the safety of yourself and those who live with you.&#x20;

**Cleaning Hard (nonporous) Surfaces**

Start by washing your hands and donning gloves if you can. The CDC recommends that any surface should first be cleaned (detergent/soap) prior to disinfecting, so clean exposed hard surfaces before disinfecting with bleach, >70% alcohol-based or other EPA-approved products. Be sure to let bleach solutions sit for at least one minute and ensure adequate ventilation and take note of manufacturing directions and precautions.&#x20;

**Soft (Porous) Surfaces**

When it comes to soft surfaces like rugs and carpets, the recommendation from the CDC is to follow manufacturers’ instructions while using the warmest possible water setting. &#x20;

**Laundry**&#x20;

It is recommended that you keep a separate hamper (preferably with a disposable or washable liner) for your work clothes and wash them in detergent on the warmest possible setting. Try keeping this in an area close to the entrance you come in at so you can reduce the areas exposed. Remember that the virus can survive in the air for hours, so be careful not to shake the bag. Be sure to wash your hands before and after (as you should with all of these cleaning methods).

**Electronics**&#x20;

The main item here to be cognizant of is your cell phone. It is preferred that you buy a wipeable case or covering that can be safely cleaned and disinfected in advance, so you don't risk damaging your phone with repeated cleanings. For any electronic, start with following manufacturer directions if available. For most electronic and touchable screens, >70% alcohol wipes or sprays are sufficient. Ensure that you allow all surfaces to dry or manually dry to avoid pooling.&#x20;

**Other General Tips**

* If possible, use a separate, low traffic door for going to and from the clinical setting
* Have a designated area wear you keep your shoes, dirty clothes and other items for cleaning/disinfecting after working
* Designated trash and laundry bin in isolated location if possible
* If possible/applicable, put on and remove scrubs in the clinical setting (in designated locker/changing room)

*Thought question:*

* What can you do to protect the people you live with from being exposed to COVID19?


# Triage

**Criteria for Testing**

Testing capacity has been in flux (see [Module 3: Testing Capacity](https://curriculum.covidstudentresponse.org/module-3-current-situation-and-healthcare-response/testing-capacity-and-eligibility) for updates), with resultant changes in testing eligibility protocols. The Massachusetts Department of Public Health (MA DPH) publishes  updated guidelines with criteria for COVID-19 testing (see below for version as of 4/2/2020). It differentiates between populations recommended to be tested at state versus commercial laboratories. <br>

![](https://lh5.googleusercontent.com/d4jXwjOBWVwfVXiDR8diymduVWA0Uuo2ciwNLHqdeyGTmevt1qYT2yQa22b6l_VpvO65RYCRBx31QqQ6lcn2q1IxB5QkmOi0bCQkCgBlEnOzVt77JyvzdblbptZnxGY8ikKLg2Fd)

### **Remote Screening**

Screening can occur remotely through a telephone/virtual visit by guidelines similar to above. Drive-through testing sites are expanding across the country, [including Massachusetts](https://cvshealth.com/newsroom/press-releases/cvs-health-expands-rapid-covid-19-drive-through-testing-sites-massachusetts), and often require that patients fill out [an online screening assessment](https://www.cvs.com/minuteclinic/covid-19-testing) to determine eligibility. With in-house testing increasing at hospitals, institutions are developing their own testing eligibility protocols (see below). The Cleveland Clinic has produced [an online tool](https://my.clevelandclinic.org/landing/preparing-for-coronavirus?utm_campaign=coronavirus-url\&utm_medium=offline\&utm_source=redirect\&utm_content=coronavirus-url&_ga=2.212126743.2068788212.1584840182-1300742023.1582059042)  allowing patients to self-assess for infection risk, with care recommendations based on risk level.

### Triage Guidelines by Hospital

Testing: Hospitals have generally been outlining testing criteria for ambulatory vs emergency department or inpatient settings. Partners-specific guidelines are available [here](https://pulse.partners.org/hub/departments/emergency_preparedness/coronavirus) (note: requires Partners credentials). BILH [provides guidelines on their website.](https://covid-19.bilh.org/covid-19-materials/) Cambridge Health Alliance guidelines are available [here](https://sites.google.com/challiance.org/ncov-quick-guide/home) (note: requires CHA credentials). Of note, most protocols are initially symptom-based (except for select populations such as transplant patients or requiring urgent airway surgery), followed by a prioritization list for symptomatic patients or staff. These reflect a balance of clinical/operational needs for testing and resource availability.&#x20;

Clinical Triage: For a discussion of clinical triage guidelines, see [Module 1: Triage Guidelines. ](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/management-of-covid-19#triage-guidelines)

*Thought question:*

For a low-risk patient who may not fall under the recommendations to get tested for COVID-19, but who does want to get tested, how might a healthcare worker navigate the conversation about the utility of testing amongst those at highest risk?&#x20;

##


# Mechanical Ventilation: The Basics

## Introduction

Patients with severe SARS-CoV-2 may require mechanical ventilation, currently in an intensive care unit (ICU). However, they may require ventilation in non-ICU settings as well. Sole management of a mechanical ventilator may not currently be a medical student’s responsibility, given recent changes regarding graduating 4th year medical students into early interns, this section is included to familiarize medical students with the terminology of mechanical ventilation. The hope is to educate medical students on the basics of mechanical ventilation in preparation for their future roles as physicians. As this section provides only a basic introduction, please refer to the linked resources for details.

Acute respiratory distress syndrome (ARDS) is a recognized complication of severe COVID-19 infection ([Zhou et al. Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30566-3/fulltext); [Wu et al. JAMA Intern Med. 2020](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2763184)).  In ARDS, a dysregulated immune response leads to pulmonary edema, making oxygenation difficult ([Mora Carpio and Mora StatPearls](https://www.ncbi.nlm.nih.gov/books/NBK448186/); [AMBOSS](https://www.amboss.com/us/knowledge/Acute_respiratory_distress_syndrome)).  Mechanical ventilation is usually required to maintain adequate arterial oxygen levels ([AMBOSS](https://www.amboss.com/us/knowledge/Acute_respiratory_distress_syndrome)).  In the sections below, look out for references to mechanical ventilator management in ARDS.

## Review of Essential Concepts and Definitions

### The three parts of the respiratory system

The respiratory system can be conceptually separated into three parts: the **controller**, the ventilatory **pump**, and the gas **exchanger** ([Schwartzstein and Parker, Respiratory Physiology: A Clinical Approach](https://www.amazon.com/Respiratory-Physiology-Clinical-Approach-Integrated/dp/0781757487/)).  The controller regulates the respiratory rate (RR) and the depth (tidal volume) of breathing.  The ventilatory pump includes the neuromuscular apparatus for breathing as well as the airways, and serves to move air from the mouth to the alveoli and back.  The gas exchanger describes the alveolar-capillary interface, and allows for the diffusion of oxygen into the blood and carbon dioxide out of the blood. Together, the three parts of the respiratory system perform the two main functions of oxygenation and mechanical ventilation ([UC Denver](http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/intmed/imrp/CURRICULUM/Documents/Mechanical%20ventilation%20review.pdf)).

* Oxygenation: getting O2 into the body
* Ventilation: getting CO2 out of the body

### Who requires mechanical ventilation?

There are several indications for mechanical ventilation ([Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation)).  In general, patients who cannot perform adequate oxygenation or ventilation on their own (respiratory failure from conditions such as ARDS, pneumonia, pulmonary edema, COPD, asthma), as well as patients who cannot maintain a patent airway, should be considered for mechanical ventilation ([Lippincott](https://www.nursingcenter.com/getattachment/Clinical-Resources/nursing-pocket-cards/Mechanical-Ventilation-Settings-and-Basic-Modes/Mechanical-Ventilation-Settings-and-Basic-Modes-Tip-Card_January-2019.pdf.aspx); [Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation)).  Ventilatory assistance can be provided using either a non-invasive route (e.g. CPAP, NIPPV) or an invasive route requiring endotracheal intubation (mechanical ventilation) depending on the clinical situation ([Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation)).

### Oxygenation and ventilation in a mechanically ventilated patient

Here’s how a mechanical ventilator accomplishes these two functions for a patient ([Mora Carpio and Mora, StatPearls](https://www.ncbi.nlm.nih.gov/books/NBK448186/)):

* **Oxygenation:** controlled by adjusting the fraction of inspired oxygen (FiO2) and the positive end-expiratory pressure (PEEP).  Oxygenation can be conveniently measured by pulse oximetry (SpO2).
  * **FiO2:** the fraction of air entering the airway of a patient that is made up of oxygen.  This can be anywhere between 21% (ambient air) and 100%. Increasing the FiO2 can increase the PaO2, depending on the patient’s clinical circumstances and pathophysiology.&#x20;
  * **PEEP:** air pressure remaining in the airways at the end of expiration.  In mechanically ventilated patients, PEEP is provided by the mechanical ventilator and is a positive pressure that is greater than the atmospheric pressure.  Increasing the PEEP may increase PaO2, depending on the patient’s clinical status and pathophysiology.&#x20;
* **Ventilation:** controlled by adjusting the minute ventilation.
  * **Minute ventilation:** the volume of air moved into and out of the lungs per unit time, measured in L/min.  Minute ventilation = RR x VT.
  * **Tidal volume (VT):** volume of air moved into and out of the lungs in one breath.

### Pressure and compliance in a mechanically ventilated patient

When mechanically ventilating a patient, there are two pressure parameters that are important to keep in mind ([Mora Carpio and Mora, StatPearls](https://www.ncbi.nlm.nih.gov/books/NBK448186/); [UC Denver](http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/intmed/imrp/CURRICULUM/Documents/Mechanical%20ventilation%20review.pdf)):

* **Peak pressure:** the maximum pressure created by forcing the programmed tidal volume through a patient’s airways during inspiration.  This parameter reflects airway resistance.
* **Plateau pressure:** equilibrium pressure in the respiratory system at the end of inspiration.  This parameter reflects the compliance of the respiratory system (chest wall and lungs).  You can measure the plateau pressure by conducting an inspiratory hold, which lets the pressure in the respiratory system equilibrate at the end of inspiration, such that the lower pressures in the alveoli and respiratory bronchioles (in which are generated by the compliance of the respiratory system) equilibrate with the larger airway (in which the pressures measured during the inspiratory phase of mechanical ventilation are generated by airways resistance).  This allows one to measure the pressure in the lower respiratory tree and approximate the respiratory system compliance.  Plateau pressure should be kept under 30cm H2O; higher plateau pressure may indicate low compliance, may result in trauma to the lungs, [and have been shown to result in increased mortality for patients with ARDS.](https://www.nejm.org/doi/full/10.1056/NEJM200005043421801)

**Compliance** is a fundamental concept in respiratory physiology.  Compliance is equal to the change in volume over the change in pressure (C = ΔV/ΔP) ([Mora Carpio and Mora, StatPearls](https://www.ncbi.nlm.nih.gov/books/NBK448186/)).  Some conditions, such as ARDS, may cause a patient’s lungs to be less compliant (stiffer); this means that for a given tidal volume, there is a greater than normal change in pressure.

### Additional definitions

Please see this chart for additional definitions ([Lippincott Ventilator Guide](https://www.nursingcenter.com/getattachment/Clinical-Resources/nursing-pocket-cards/Mechanical-Ventilation-Settings-and-Basic-Modes/Mechanical-Ventilation-Settings-and-Basic-Modes-Tip-Card_January-2019.pdf.aspx)).

*Thought questions:*

Which mechanical ventilator measure might suggest a state of low compliance in a patient with ARDS?

You are taking care of a patient with ARDS on a mechanical ventilator.  You draw an arterial blood gas (good job!) and you note that the PaO2 is worrisome. Which mechanical ventilator settings could you change to improve oxygenation?

## Fundamentals of Mechanical Ventilator Settings

The following information is sourced from [Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation) and [Mora Carpio and Mora, StatPearls](https://www.ncbi.nlm.nih.gov/books/NBK448186/).

Your first choice in operating a mechanical ventilator is to provide the patient with either a specified **volume** of air (volume control or volume-cycled ventilation) or a specified **pressure** of air (pressure control or pressure-cycled ventilation).  Remember that pressure and volume have an inverse relationship.  In volume control, when you set a volume and a respiratory rate, pressure will vary based on the patient’s respiratory system compliance.  In pressure control, when you specify a pressure, volume will vary, based on the patient’s respiratory system compliance.  In general, volume control is used more often than pressure control.

PEEP will be used in either pressure or volume control.  PEEP is used to, essentially, stent open alveoli that might otherwise collapse at the end of expiration.  More open alveoli can improve gas exchange, leading to better oxygenation.  As discussed above, another way of improving oxygenation would be to increase the FiO2.

Another important decision point in mechanical ventilator settings involves the control of the **initiation** of a breath.  Either the vent or the patient can initiate a breath.  In other words, either the machine can automatically begin a breath by pushing air into the lungs, or the machine can wait until the patient starts to take a breath before pushing air into the lungs.

### Noninvasive Positive Pressure Ventilation

Noninvasive positive pressure ventilation (NIPPV) is provided through a facemask that fits snugly over the patient’s face.  An endotracheal tube is not required.  As a broad generalization, NIPPV is used to try to improve oxygenation and ventilation in patients who are not yet sick enough for endotracheal intubation.  The two most common forms of NIPPV are:&#x20;

* **Continuous positive airway pressure (CPAP)**: machine delivers a constant positive pressure through the airways throughout inspiration and expiration.  The same pressure is delivered by the machine during inspiration and expiration.
* **Bi-level ventilation**: machine delivers a set pressure through the airways during inspiration and a different set pressure through the airways during expiration.  In other words, different pressures can be specified in inspiration and expiration ([Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation)).

Current [WHO treatment guidelines](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected) are equivocal as to whether NIPPV should be used in SARS-CoV-2, but they do cite a study suggesting that NIPPV was generally ineffective in patients with ARDS due to MERS infection ([Arabi et al., Ann Intern Med 2014](http://ncbi.nlm.nih.gov/pubmed/24474051)).  Their guidelines state that NIPPV “should only be used in selected patients with hypoxemic respiratory failure.”&#x20;

Informal guidance ([ICU one pager](https://www.onepagericu.com/)) has noted that CPAP and NIPPV should generally be avoided in patients with COVID-19, as these methods might potentially aerosolize virus particles.

### Modes of mechanical ventilation

Here are three common types of mechanical ventilator configuration, often referred to as “modes.”  You might see the abbreviations listed on patient lists during rounds.

The following information is sourced from [Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation), [Mora Carpio and Mora, StatPearls](https://www.ncbi.nlm.nih.gov/books/NBK448186/), and [UC Denver](http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/intmed/imrp/CURRICULUM/Documents/Mechanical%20ventilation%20review.pdf) and [SOCCA ICU Residents’ Guide](https://www.umassmed.edu/globalassets/anesthesiology/files/resources/2016-resources/2014-socca-residents-guide.pdf).

#### AC (Assist control) = CMV = Continuous Mandatory Ventilation

* “Assist”: If the patient is at or above the set RR.  When the patient tries to inspire, the mechanical ventilator pushes in air.
* “Control”: If the patient is below the set RR.  The mechanical ventilator will deliver air at the set RR regardless of the patient’s efforts at inspiration.
* So the vent delivers air at or above a minimum RR, and all breaths are assisted.

#### Pressure support ventilation (PSV)

* Breaths triggered by the patient only (not set respiratory rate from the mechanical ventilator)&#x20;
* Delivers a baseline PEEP, and an additional pressure of air above this PEEP during each patient-initiated inspiration
* Frequently used for weaning patients from the vent

There are many additional modes which are omitted here for brevity.  Some are described in a handy chart in the [Lippincott Ventilator Guide](https://www.nursingcenter.com/getattachment/Clinical-Resources/nursing-pocket-cards/Mechanical-Ventilation-Settings-and-Basic-Modes/Mechanical-Ventilation-Settings-and-Basic-Modes-Tip-Card_January-2019.pdf.aspx).

### How do I set a mechanical ventilator? ([Merck Manuals](https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and-mechanical-ventilation/overview-of-mechanical-ventilation))

1\) Mode: AC, PC, PSV, etc.

2\) Rate: Minimum breaths/minute (if indicated - not appropriate for PSV)&#x20;

3\) Tidal Volume: always target 6cc per kilogram of ideal body weight (based on the patient's height, not their actual weight) for assist-control ventilation.  This is not applicable for PSV.

4\) FiO2 = start at 100% and titrate down as you are able based on the patient’s SpO2

5\) PEEP = it is generally OK to start with 5 mmHg (but have a low threshold to increase up to 10-15mm Hg in hypoxemic patients)<br>

Note that (1), (2), (3) are all related to CO2, whereas (4) and (5) refer primarily to O2.

Sample Mechanical Ventilator Settings (Source: [Johns Hopkins Ventilator Guide](https://www.johnshopkinssolutions.com/wp-content/uploads/2017/10/4-Understanding-Mechanical-Ventilation.pdf))

![](https://lh5.googleusercontent.com/oSMhXBh8V7WopxKf5SM5vz9iAmUplCuHyNDZofXXp5XKhsbrVxFWWo3OYlUFhRfU_cnGusg8AgLruZPgx72mB70TFkm9m68ZXrYWSwUKffdgVnM5nKukfUUmVM8dN4M92Jb-gbgW)

![](https://lh3.googleusercontent.com/9jnNMVbSugatRJq3b7nKT02EZh8x6sc0OLcT7QiuFCblvqy8m_Jc8nhjCLINZaXCX2pK_HN229QJhSGZvKGjDFqjmWRMH8y6WIc76RMFnc4eSo-4IPwPOTDX8-65aPqjKsuOToU-)

### How is a mechanical ventilator used for ARDS?

Acute respiratory distress syndrome (ARDS) is a complication of many different pulmonary and systemic processes, including severe SARS-CoV-2 ([Zhou et al. Lancet 2020](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30566-3/fulltext); [Wu et al. JAMA Intern Med. 2020](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2763184)).  In ARDS, an explosive pulmonary or systemic inflammatory response damages pulmonary vasculature, resulting in non-cardiogenic pulmonary edema that can trigger hypoxemic respiratory failure.  Patients with ARDS often need ICU-level care and mechanical ventilation ([AMBOSS](https://www.amboss.com/us/knowledge/Acute_respiratory_distress_syndrome)).

In mechanical ventilation of ARDS patients, including patients with ARDS from COVID-19, the goal is to provide low tidal volumes and low inspiratory pressures.  This approach, known as **lung-protective ventilation (LPV)**, can help avoid mechanical ventilator-associated lung injury ([AMBOSS](https://www.amboss.com/us/knowledge/Acute_respiratory_distress_syndrome); [ARDSnet](http://www.ardsnet.org/files/ventilator_protocol_2008-07.pdf); [WHO](https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-\(ncov\)-infection-is-suspected)).

**Inclusion Criteria for Mechanical Ventilator Use in ARDS (**[**ARDSnet**](http://www.ardsnet.org/files/ventilator_protocol_2008-07.pdf)**):**

Acute onset of&#x20;

1. PaO2/FiO2 ≤300
2. Pulmonary edema (bilateral pulmonary infiltrates on CXR) not thought to be due to left-sided heart failure&#x20;
3. Bilateral alveolar infiltrates on chest x-ray&#x20;

**Mechanical Ventilation Protocol (**[**ARDSnet**](http://www.ardsnet.org/files/ventilator_protocol_2008-07.pdf)**):**

Mechanical Ventilator goals:

* Oxygenation: PaO2 55-80 mmHg or SpO2 88-95%
* Plateau pressure: ≤30 cm H2O
* pH: 7.30-7.45
* I:E ratio: inspiration ≤ expiration

**Weaning:** when patient improves and meets [criteria](http://www.ardsnet.org/files/ventilator_protocol_2008-07.pdf), conduct a daily **spontaneous breathing trial (SBT)**&#x20;

* Assess the ability of the patient to breathe with minimal or no mechanical ventilator support
* If trial is unsuccessful, resume pre-weaning settings

For a quick guide to extubating a patient ([click here](https://twitter.com/nickmmark/status/1242574416166277121)).

For more detailed information on mechanical ventilator settings for ARDS ([click here](http://www.ardsnet.org/files/ventilator_protocol_2008-07.pdf)).

For quick ICU guidelines for COVID ([click here](https://www.onepagericu.com/)).

For more information on clinical trials regarding mechanical ventilation, refer to supplementary material in Module 1 ([click here](https://docs.google.com/document/d/1SsWujt6g1iNUAAPeOFjSP8YFaK_C48SSO_2iz0BcQi4/edit#bookmark=id.8ldb2jkztow5)).

*Thought question:*

* Why might a slight respiratory acidosis be tolerated in a patient with ARDS?  In other words, if you are taking care of a patient with ARDS whose PaCO2 is above normal, why would you not increase the tidal volume to increase the minute ventilation?<br>

## Simulator

For an opportunity to apply these concepts while interacting with a ventilator control panel, please work through this [Ventilator Simulator](https://www.openpediatrics.org/assets/simulator/ventilator-simulator) created by OpenPediatrics.


# Care for Self and Others During Crisis

## Introduction

This is a time of high risk for our patients, colleagues, families, and selves. Previously in this module we’ve discussed how to mitigate the risk of pathogen exposure; here we discuss how to mitigate the risk of traumatic exposure. Just as in previous sections, we will discuss individual actions and structural interventions that support this mitigation and celebrate the strength of healthcare workers.

**COVID-19 as traumatic exposure**

We are in a time of dramatic changes to our daily lives and reevaluation of our collective sense of safety and control. Module 5 introduced the idea that this time may represent a traumatic exposure. As caregivers, we are vulnerable both to direct effects of trauma or primary traumatization, based on our own experience of the event and secondary traumatization, in which we are affected by the suffering of those we care for. This double burden is a chronic problem for healthcare workers, and will only be magnified during the pandemic. &#x20;

**How do caregivers respond to  traumatic exposures?** \
\
Early studies from the COVID pandemic have already documented adverse mental health effects of COVID-19 among frontline caregivers. Experiences from China suggest high rates of depression (50.4%), anxiety (44.6%), insomnia (34.0%), and emotional distress (71.5%) ([Lai et al. JAMA 2020](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2763229?guestAccessKey=01bafe6d-fdaa-4fb2-9401-a2ed096c1284\&utm_content=weekly_highlights\&utm_term=032820\&utm_source=silverchair\&utm_campaign=jama_network\&cmp=1\&utm_medium=email)). These effects were more pronounced in frontline healthcare workers directly engaged in triage, diagnosis, and treatment of COVID-19 patients. We share these data not to distress you, but to normalize a range of reactions that is normal for caregivers to experience during the stress of the pandemic.&#x20;

Caregivers (CNAs, interpreters, nurses, providers, trainees, transport staff - everyone who touches patient care) may experience an accumulating burden of secondary trauma. In her book, [Trauma Stewardship: An Everyday Guide to Caring for Self While Caring for Others](https://traumastewardship.com/), LICSW Laura van Dernoot Lipsky lays out common elements of a trauma response. These are demonstrated in the graphic below, and animated in her [TED talk](https://www.youtube.com/watch?v=uOzDGrcvmus). You may feel several or all of these reactions.&#x20;

![](https://lh3.googleusercontent.com/gIXLnZPzc4yAQb0qt44DtInMGugUQGs9NQzUCPYASYUVVShraH_mp5227YoQW-J0ofBEhQGQxKnmtUuO96Dvhl-KWMGX6nvF-o5qk3mjo42ju42kualeupCmpBf0b8yPnQwHHU-u)

**(**[**Laura van Dernoot Lipsky, 2009**](https://traumastewardship.com/)**)**

Another common reaction to trauma, is that the reactions such as those outlined above, may feel similar to reactions you’ve had in the past, and may cause you to think about other times in which you felt overwhelmed or unsafe. You may feel triggered. You may fight, flight or freeze. These reactions refer to your “window of tolerance” within which you can emotionally regulate. Trauma exposure may cause you to fight or flight (hyperarousal) or freeze (hypoarousal). This concept is illustrated by the figure below. It is important to recognize when you might be feeling this way. We have included some grounding techniques in the next section to help get you through the moment. <br>

![](https://lh5.googleusercontent.com/ijY6gacEluc9RyjqX-t47fWc96fU209j6xnBqUekzgc_y5c6PgBf9DBfvUExN5SSFlyOzXunnoRvYx8EPh8eYpGaTPxHivynEIlI4IFiLHTBnBRz7QJOUcWHQYascqQTKdOdJl3z)

**(**[**Brickel and Associates Counseling**](https://brickelandassociates.com/how-to-grow-change-after-trauma/)**)**

Equally as important as acknowledging the losses associated with the pandemic, is highlighting the opportunities it provides for strength and growth. The figure below from the [ECHO Project](https://www.echotraining.org/trauma-trainings/) highlights 5 domains of post-traumatic growth: personal growth, closer relationships, greater appreciation for life, new possibilities, and spiritual development.&#x20;

![](https://lh3.googleusercontent.com/r6Dp17is6fASuepoFiJQZhU9EiWcoMjCWf0mEc5fXBk_RfZhJ6wUNpLytiLyWuqiT3sgBpg84670F53pWrpqHvVbU-6feo5MQM4rXvtNRT3FLYBGeUWa3nYym4OdUzVZ0-WlLGP9)

**(**[**Project ECHO**](https://www.echoparenting.org/dev/wp-content/uploads/2018/07/Post-Traumatic-Growth-Web-8x11.pdf)**)**

It is important to call out the fear and anxiety we are experiencing collectively, while also celebrating our strength as a helping profession.  Even the simple act of reading through this module demonstrates your strength and commitment to staying well. By labeling the experience as traumatic, we are able to draw on the trauma-informed care (TIC) literature for guidance on how to care for ourselves.

**What can we do to mitigate the adverse impact of trauma on ourselves, our colleagues, and our patients?** \
Trauma-informed care (TIC) is a strengths-based model developed to mitigate the health effects of trauma and is based on the Substance Abuse and Mental Health Services Administration’s (SAMHSA) six principles (see figure below) including: safety; trustworthiness and transparency; peer support; collaboration and mutuality; empowerment, voice, and choice; and attention to cultural, historical, and gender issues ([SAMHSA 2014](https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf)). You may be familiar with trauma-informed care as a clinical model. The six principles you apply to patient care can also be used reflectively, for self-care, a practice referred to as trauma-informed self care (TISC). Here we apply the 6 principles to ourselves, our colleagues, and our institutions. The principles will be bolded throughout to highlight this framework. As you read, consider creating your own trauma-informed self care[ action plan](https://docs.google.com/document/d/1hiPP2grRxesodCOXxwfxNejopEjelSKR2Xb9s-ZJBrQ/edit).<br>

![](https://lh5.googleusercontent.com/LnNj_OA_jAXlNuHWnZZE68vXHtesjioVtHXA3fXX120DgAp40QW0Q2ljbWVW51pWXvcsvodzurUYqJHjvK_vsn3hVfyeTV__pQCezgi2P35j10QZ_Vr8KfyCt4uveAJwdUlm-9m0)

*Thought Question:*&#x20;

Think about a time you felt overwhelmed. What were some of your strengths in dealing with the situation?

### **How do we care for ourselves while performing clinical duties?**

Culturally, many healthcare providers are used to ignoring their own needs, and this is sometimes even celebrated ([Gazelle et al, 2015](https://www-ncbi-nlm-nih-gov.ezp-prod1.hul.harvard.edu/pmc/articles/PMC4371007/#CR20), [Salles and Gold, 2020](https://www.vox.com/2020/4/2/21204402/coronavirus-covid-19-doctors-nurses-health-care-workers)). However, your physical safety is critical to your psychological well-being and ability to provide care. In addition to PPE, proper meals, rest breaks throughout the day, decompression time and sufficient time off are equally as important ([Adams et al. 2020](https://jamanetwork.com/journals/jama/fullarticle/2763136), [National Center for PTSD](https://www.ptsd.va.gov/covid/COVID19ManagingStressHCW032020.pdf)). Consider high-calorie, low-volume foods such as protein bars if you anticipate you will have little time to eat during clinical care ([ACEP 2020](https://www.acep.org/corona/covid-19-field-guide/home-safety/preparing-for-work/)). Tuning in to your needs and attending to them is key to working sustainability during the pandemic.

During your clinical duties, you may notice yourself reacting to trauma such as in the reactions described above and reaching the limits of your “window of tolerance”. You might find the following framework helpful to address the emotions in the moment: Calm, Contain, Care, Cope ([Kimberg and Wheeler, 2019](https://www.springer.com/gp/book/9783030043414)).

* Calm: Do your best to remain calm in your professional environment, you may find grounding techniques particularly helpful (more below)
* Contain: Try and limit your traumatic exposure as you are able. If you are able to remove yourself from the room, do so. If a patient is disclosing traumatic events, you may remind them they do not have to share all of the details.
* Care: Be kind to yourself. Your reaction is normal.
* Cope: Reflect on positive coping strategies that have worked for you in the past- which ones are feasible in a clinical setting?

You may find grounding exercises particularly useful in the moment such as “square breathing” (inhale 4 seconds, hold 4 seconds, exhale 4 seconds, hold 4 seconds, repeat) or distraction (focus on the external environment, name all of the colors you see). More grounding techniques can be found in [SAMHSA’s Tip 57](https://www-ncbi-nlm-nih-gov.ezp-prod1.hul.harvard.edu/books/NBK207188/box/part1_ch4.box5/?report=objectonly).

You should feel empowered to advocate for your own health needs. Whether you are immunocompromised, have an underlying health condition, may be pregnant, or someone in your household has one of these conditions, you may be at higher risk for COVID complications.  As a student, you do not have to act clinically if this is the right decision for your health and safety. If you do want to be involved clinically, consider lower exposure risk clinical duties, such as working from home or seeing patients virtually.

You may also find it helpful to center on the language of resilience: what allows us to bend, not break, in the face of this collective challenge? Expert clinician Nomi Levy-Carrick emphasizes three strategies for individuals and front-line health care workers alike ([Levy-Carrick 2020](https://medium.com/@ariadnelabs/the-covid-resilience-marathon-4dee79f35a51)):

1. Be able to name what is distressing in real time.
2. Insist that you should never worry alone.
3. Maintain a sense of purpose.

*Thought questions:*

What are some ways you have forgotten to prioritize your own needs in the past while working clinically?&#x20;

What is one step you can take to prevent this? Consider entering it on your [action plan](https://docs.google.com/document/d/1hiPP2grRxesodCOXxwfxNejopEjelSKR2Xb9s-ZJBrQ/edit).

### **How do we care for ourselves and our loved ones at home?**&#x20;

In addition to the stressors of clinical work, many healthcare workers also play an important caregiving role at home. You may worry about transmitting the virus to family or loved ones. You may face additional stressors in your home life from the disruptions caused by the virus including lack of childcare, unemployment, financial concerns, and new difficulties obtaining basic groceries and cleaning supplies. We recognize that as medical students, you may play a variety of different social roles outside of the hospital. You may be responsible for translating medical information for friends and family. Due to cultural, historical, or gender issues, you may be called on to represent a community. In this section, we will outline strategies to care for yourself and loved ones in an ongoing disaster situation. <br>

As a first step to maintain your safety and the safety of those in your home, have a transparent conversation with your household about what to expect. What will your new clinical roles look like? How much will you be able to contribute to household activities? What will you need in terms of support? What will your household need from you in terms of support? This collaboration and anticipatory guidance can help make concrete plans for how to manage the upcoming challenges.

Consider making plans for separation of living spaces as needed to reduce the risk of transmission and home arrival routines (i.e. removing shoes and clothing, showering immediately) ([Adams et al. 2020](https://jamanetwork.com/journals/jama/fullarticle/2763136)). In addition to infection control, you may find the home arrival routine beneficial in helping you to disconnect from the clinical environment and be present in your home environment ([ACEP 2020)](https://www.acep.org/corona/covid-19-field-guide/home-safety/preparing-for-work/).&#x20;

[The National Child Traumatic Stress Network](https://www.nctsn.org/sites/default/files/resources/fact-sheet/outbreak_factsheet_1.pdf) has released powerful and succinct guidelines on managing the stress of the pandemic within our household and family units. These guidelines include:

* Stay informed with media that offers transparent information while minimizing exposure to media and social media that may promote panic
* Prioritize social connection and peer support through virtual platforms such as phone calls, text, email, and video calls; or [virtual game nights](https://www.marthastewart.com/7735817/how-host-virtual-game-night) and [watching parties](https://www.netflixparty.com)
* Adhere to a consistent schedule to emphasize your choice and control, but modify to reflect current realities and limitations&#x20;
* Prioritize activities that give you a sense of meaning and purpose, while still allowing yourself time to step back and take breaks as needed&#x20;
* Attempt to control negative self-talk and self-defeating statements (for more information on identifying cognitive distortions and re-framing them, read [this](https://arfamiliesfirst.com/wp-content/uploads/2013/05/Cognitive-Distortions.pdf))
* Draw on your strengths; engage in activities that bring you joy and positive coping mechanisms that have worked in the past (e.g. [music](https://www.npr.org/2020/03/13/815457669/isle-of-calm-stream-6-hours-of-soothing-music), [physical activity](https://medmotion.org/covid-19-workouts/), [yoga](http://downdogapp.com/schools%20or%20downdogapp.com/healthcare))&#x20;

This is a time of loss. Many trainees have lost clinical opportunities, graduation celebrations, and control of their medical education. You may have loved ones that lost a job or that have lost their lives during the pandemic. It is also a time of great uncertainty. We are not sure how long these disruptions will last and what that means for our medical training. The [National Center for PTSD](https://www.ptsd.va.gov/understand/types/disaster_help.asp) is a great resource on how to manage ongoing stress and trauma from disasters. The guidelines are similar to those above. Additionally, they emphasize reflecting positively on your losses and trying to make meaning of them either by yourself or through connection with others. For example, many of your social plans may have been canceled, but this time could allow you to reconnect with old friends or deepen existing friendships. &#x20;

\
*Thought Question:*&#x20;

What is one step you will take in your home life to keep yourself/loved ones well? Consider entering it on your[ action plan](https://docs.google.com/document/d/1hiPP2grRxesodCOXxwfxNejopEjelSKR2Xb9s-ZJBrQ/edit).

### **How do we care for and support our colleagues?**

For everyone, daily life has changed: first year students have been asked to leave their dormitories, clerkship students have been removed from clinical duties, healthcare workers have had to adapt to telehealth platforms or deployment to unfamiliar clinical settings overnight. Everyone is likely to have a keener sense of their own and their colleagues’ vulnerabilities. These stresses are compounded by the fact that everyone is weathering them at once. At the same time, the fact that we are all in it together enables us to offer and receive **peer support.**&#x20;

**Peer support** is one of the core principles of trauma-informed care. For those who are experiencing or have experienced trauma, it can be a source of healing to connect meaningfully with others who have been in a similar situation ([Blanch et al 2012](http://www.theannainstitute.org/Andrea%20Blanch%20TIWA/EngagingWomeninTIPeerSupportGuidebook.pdf)). In this section, we define your peers as anyone who is working to support patients and their families - from those fielding triage calls to those interpreting for patients and providers; from those synthesizing [information for patients](https://covid19healthliteracyproject.com/#) to those evaluating newcomers to the ED; and from those who keep our EMRs running to those who do the critical work of [disinfecting the hospital](https://www-acpjournals-org.ezp-prod1.hul.harvard.edu/doi/10.7326/M20-2237). If you are currently in training, your peers also include trainees across your country and across the world.

Each of us who is working and learning in the context of this pandemic may switch between giving support and opening ourselves to receive it. That’s okay. When we feel up to it, what are some things we can do to support one another?

* Recognize that the ways in which people (including supervisors and teachers) respond to you may be influenced by their own trauma responses; go easy on others as you are encouraged to go easy on yourself
* When someone is feeling isolated or overwhelmed, your presence and active listening represent a source of healing. Set an intention to reach out regularly to those in your immediate environment and those who cross your mind.
  * *I’ve been thinking about you and hope you’re okay. I’m happy to talk or listen or help in other ways.*
* When someone discloses an area of particular challenge, it can be helpful to express empathy, validate their experience, and offer assistance as appropriate. It is also okay to ask for this kind of support from your peers and mentors.&#x20;
  * *That’s so hard. I can see why you’re struggling with that. How can I help? Would you like me to help you brainstorm solutions?*
  * *\[To a mentor] I am particularly worried about this person for \_\_\_ reason. What would you recommend as a next step?*
  * *\[To a peer] I’m having a really hard time right now. Could we talk? / Are you in a space to help me think some things through?*
* When you are working directly with another person, being **transparent** about your limitations can **empower** both of you to fulfill your roles while respecting each other’s needs.
  * *I am trained in this procedure but have never done \_\_\_ before.*
  * *My housemate is high-risk; I can support virtually in any way, but not in person at this time.*
* Honor the impacts of others’ **voice and choice** with an explicit acknowledgment. One example is below.
  * *\[I] just wanted to say thank you, as a fellow med student, for putting together the module… \[I] felt really validated that compassion toward patients’ and our own pasts was being incorporated explicitly.*
* **Collaboration and mutuality** come in many forms, from contributing to clinical teams in person or afar, to helping colleagues on the front lines stay afloat with childcare, groceries, and other responsibilities.
* Attend to **gender, historical, and cultural issues**. You or your colleagues may have additional responsibility as trusted sources for your communities. You or your colleagues may face an additional burden from experiencing racism or xenophobia. Acknowledge these disparities and consider what you could do as an ally.
  * One primer on responding to microaggressions can be found in [Module 4](https://curriculum.covidstudentresponse.org/module-4-communicating-information-about-covid-19/cultural-humility).

*Thought question:*

* What is one action you might take to support one of your peers? (at work, at home, in community) Consider entering it on your [action plan](https://docs.google.com/document/d/1hiPP2grRxesodCOXxwfxNejopEjelSKR2Xb9s-ZJBrQ/edit).

### What can our institutions do to support us during the pandemic?

Individual and interpersonal approaches to weathering this crisis become much more effective when undergirded by institutional and structural efforts. Here we present several examples of what Boston-based medical schools and hospitals are doing to support the wellbeing of their trainees and staff, highlighting the principles of trauma-informed care.&#x20;

**Medical Schools:**

* **Safety:** Pausing mandatory in-person clinical work, making virtual courses available across the full curriculum, offering clinical volunteer opportunities with safeguards to ensure students do not feel pressured
* **Trust and transparency:** Nightly Zoom calls with medical school leadership and advisors, open to the entire student body, with a centrally accessible place to submit questions and proposals
* **Peer support:** Holding digital space for written student reflections, with the option to share anonymously; organizing groups of students for weekly hang-out calls; regular student-led collective “breathing space” on Zoom
* **Empowerment, voice & choice:** Establishing faculty-mentored student task forces to allow students to act collectively in a way that is meaningful to them; one of these task forces gave rise to this curriculum
* **Collaboration and mutuality:** Faculty taking time to review student-created [educational](https://covid19healthliteracyproject.com/#) [materials](https://curriculum.covidstudentresponse.org/); faculty and staff co-authoring [articles](https://www-nejm-org.ezp-prod1.hul.harvard.edu/doi/full/10.1056/NEJMp2008006) with students; faculty and staff working to continue clinical and preclinical teaching online
* **Gender, historical, and cultural issues:** Recognizing students may have care duties within their own families and home communities, and enacting travel and attendance policies that accomodate for these duties; teaching about historical injustices laid bare by the pandemic

**Hospitals:**

* **Safety:** PPE procurement and policies - from procurement at the [national](https://www.projectn95.org/) level; to working with engineers to solve problems [locally](https://www.panfab.org/); to soliciting [donations](https://www.challiance.org/about/newsroom/personal_protective_equipment_ppe_donations_includ_1179) from the community (see [Module 5](https://curriculum.covidstudentresponse.org/module-5-training-for-medical-student-specific-roles/personal-protective-equipment) for latest institutional policies on PPE, and [Module 3](https://curriculum.covidstudentresponse.org/module-3-current-situation-and-healthcare-response/socioeconomic-ramifications#understanding-the-medical-supply-shortage) for understanding the shortages)
* **Transparency:** Daily town halls with transparent data (# COVID patients admitted, days of PPE left); dedicated internal pages maintained by hospitals to share data and the latest policies
* **Peer support:** Workers and trainees taking time to listen to one another and channel existing learning groups into peer support groups
* **Empowerment, voice, and choice:** Empowering residents to re-organize schedules to keep as many residents home and minimize back and forth to hospitals; listening to residents as they identify what they need as in-hospital support and making that happen.
* **Collaboration and mutuality:** Collaboration across specialties and professions, including “gratitude baskets” for health care workers in various roles
* **Cultural, historical, and gender issues:** Institutions need to address disparities in who is getting sickest ([Kendi, 2020](https://www.theatlantic.com/ideas/archive/2020/04/stop-looking-away-race-covid-19-victims/609250/)) and recognize that clinicians and trainees are also impacted by the world outside the hospital - that they are part of communities that may be particularly hard-hit.

This article from [Shanafelt et al.](https://jamanetwork-com.ezp-prod1.hul.harvard.edu/journals/jama/fullarticle/2764380?guestAccessKey=01a73ac6-e78a-43e9-8ad2-6019b60b5dcb\&utm_source=silverchair\&utm_medium=email\&utm_campaign=article_alert-jama\&utm_content=olf\&utm_term=040720) (2020) collects front-line clinicians’ concerns about COVID-19 from listening sessions, exemplifying **empowerment, voice and choice**. They distill concerns into 5 “asks” from healthcare professionals to their institutions: “hear me - protect me - prepare me - support me - care for me.” Their suggestions to institutions address the need for **voice and choice** for healthcare professionals in institutional plans and **transparency** about how the situation is unfolding; attention to physical **safety; empowerment** through training for new roles; **collaboration and mutuality** across roles; and attention to the cultural issue that healthcare professionals tend to strive for self-reliance and not ask for help. Additionally they make excellent concrete suggestions for how to support health care professionals both physically and emotionally. See the full table below.

![](https://lh4.googleusercontent.com/KAb-0J6CTHW5Ab08UEsCuat72Adc_gpLnTEbd97kQK8FxSdk-Qlf633wWAS9S5Qz3BkS0P4iZVQPsa95EMsn4nwP_VAcYMGz39oIVGZE5clB59HnBwsfdXbmAeyrvRvFa4BnnAtH)

*Thought questions:*&#x20;

What do you need from your institution to feel able to contribute in a sustainable way to the pandemic response? Consider noting it on your [action plan](https://docs.google.com/document/d/1hiPP2grRxesodCOXxwfxNejopEjelSKR2Xb9s-ZJBrQ/edit).

What is the role of these recommendations even in non-crisis times?

**Where can I find additional resources to stay well in close contact with trauma?**<br>

[Self-Care When Working With Patients With Histories of Trauma](https://drive.google.com/open?id=1ZeMDwXKjSYEV_8-3W5YjcbwiQsCclXxK) (Samara Grossman, LICSW)

* [Grounding Exercises ](https://www-ncbi-nlm-nih-gov.ezp-prod1.hul.harvard.edu/books/NBK207188/box/part1_ch4.box5/?report=objectonly)
* [MGH Psychiatry Guide to Mental Health Resources for COVID-19](https://docs.google.com/document/d/11ZgNncZzNUEm24Z-Rej0g0ESGbRnd5u3cHSXTDpR5Sg/edit)
* Click [here](https://forms.gle/GaeUHAhZPGq9S2fu8) to sign up with a national network of allied health professional students.
* [Domestic Violence and Sexual Assault Resources](https://drive.google.com/open?id=1syr38-h9TEUuwCOMcB-tLvMMbReE9tVJ)
* [Safety Planning with Stay-At-Home Advisories ](https://drive.google.com/open?id=1Ax1dgWD7AISpqcm6Pq0Wg1R2dR_qtvqr)
* [Online Resources to Support Substance Use Disorder Recovery](https://drive.google.com/file/d/1VV4kgPPqCR3HLH2bPIhPL1sWaPhuGZsk/view?usp=sharing)
* Self-Service Apps: These apps, which have been clinically vetted by Partners mental health experts, are available and offer a range of support.
  * [The Headspace app](https://www.headspace.com/headspace-meditation-app), available via iOS, Android or desktop, offers sets of guided meditations aimed at tackling problems related to anxiety, sleeplessness and relationships.
  * [The Evermind app](https://apps.apple.com/us/app/evermind/id1485424497), available via iOS and Android, can help you build resilience and handle stress using cognitive behavioral therapy techniques. In the app, you can access guided programs on improving sleep, disconnecting, challenging negative thought patterns and more.


# Summary

We hope this module prepared you to understand PPE practice, sanitation, triaging, mechanical ventilator function,  ways to help out in clinical and non-clinical roles, and care for self and others during crisis. We recognize that this is an unsettling and stressful period of time for a duration that is uncertain. While it is important to stay informed about the pandemic, try to limit its spread, and help in ways that we can, it’s also of great importance not to disregard our own wellbeing. We hope our suggestions on how to manage anxiety and promote self-care during this pandemic are helpful.

For those of you who may soon be caring for COVID patients directly, we encourage you to try out this [Virtual Patient Simulation](https://interactives.nejm.org/external/covid_simulation/index.html).

We welcome your feedback on this module, and on the curriculum overall.  Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).<br>


# Module 7: Global Innovation and Collaboration

Explore collaborative innovation and shared experiences regarding optimizing “staff, stuff, space, and systems” between countries of all income levels as they relate to COVID-19.

*Authors:* Aditya Achanta¹, George Agyapong¹, Isaac Alty¹, Jeremie Kyle Angeles², Kathryn Ellyse Burgonio², Noelle Castilla-Ojo¹, Hassan Ali Daoud³, Parisa Fallah¹, Luis Freitas⁴, Philippe Jefferson Galban², Jessica Laird¹, Jean Wilguens Lartigue⁵, Jonathan Niyotwambaza⁶, Gavin Ovsak¹, Kirstin Woody Scott¹, Ulrick Sidney⁷, Julius Nico Valdez², Angela Zou¹, Jorge A. Abello Vaamonde⁸, Desireé Franco⁸, Alicia Amairan Gutiérrez⁸, Alejandra Cortés⁸, Melissa Fragoso⁸, Juan José Menéndez⁸, Liliana Salgado⁸, Michelle Guinand Reiners⁸, Daniela Arreola Barrios⁸

*Editors:* [Michael Dykstra](mailto:michael_dykstra@hms.harvard.edu)¹, [Jean Wilguens Lartigue](mailto:drlartigue@gmail.com)⁵, [Jorge A. Abello Vaamonde](mailto:abelloj.mitosis@gmail.com)⁸

¹ Harvard Medical School, Boston, MA, USA\
² Ateneo School of Medicine and Public Health, Pasig City, Philippines\
³ Amoud School of Medicine and Surgery, Somaliland\
⁴ Federal University of Parana, Curitiba, Brazil \
⁵ Faculté de Médecine et de Pharmacie, Université d'État d'Haïti, Port-au-Prince, Haiti\
⁶ University of Rwanda, College of Medicine and Health Sciences, Kigali, Rwanda\
⁷ Faculty of Medicine, Bel Campus University of Technology, Kinshasa, Democratic Republic of Congo\
⁸ [Mitosis Health Initiative](mailto:info@mitosishealth.org), Anahuac Mexico University. Mexico.&#x20;

*Reviewers:* [Agne](https://ughe.org/meet-the-team/agnes-binagwaho/)[s Binagwaho](https://ughe.org/meet-the-team/agnes-binagwaho/), MD, PhD¹; [Cameron Nutt](https://connects.catalyst.harvard.edu/Profiles/display/Person/122757), MD²; [Leonard Kabongo](https://www.linkedin.com/in/leonard-kabongo-3b82b247/), MD, MSc³; [Brett D. Nelson](mailto:%20bnelson1@mgh.harvard.edu), MD, MPH, DTM\&H⁴\
\
¹ University of Global Health Equity, Butaro, Rwanda\
² Brigham and Women’s Hospital, Boston, MA, USA\
³ Ministry of Health and Social Services, Gobabis, Namibia\
⁴ MassGeneral Hospital for Children, Boston, MA, USA

**Update Disclaimer:** Thank you for visiting Module 7! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. Information on the last major update on 5/9/21 can be found below. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

#### Highlight of updates (05/09/21)&#x20;

* Stuff: optimizing face mask usage.&#x20;
* Systems: effective vaccination protocol in high income countries (Israel).&#x20;

## **Introduction**

As of early April 2020, the reported morbidity and mortality from COVID-19 in low- and middle-income countries (LMICs) has been [relatively limited](https://www.bbc.com/news/world-africa-52058717) but is [increasing](https://qz.com/africa/1827789/coronavirus-ghana-senegal-burkina-faso-shut-down/). Due to a variety of historical injustices and chronic lack of investments into robust health systems, many LMICs lack the essential resources to prevent, diagnose, and treat COVID-19. These resources include social support systems for impoverished daily wage-earners without income during social distancing, capacity to feed citizens during lockdown, and health care resources to isolate, test  and treat critically ill patients. \
This module features a set of case studies that illustrate a range of responses to the COVID-19 pandemic, while also featuring examples of innovations that are being utilized in resource-limited settings. This material is organized by the [“4 S” analysis framework](https://www.globalhealthnow.org/2017-11/paul-farmer-remember-4-ss), advanced by Dr. Fernet Leandre and Dr. Paul Farmer of the global health non-profit Partners In Health:

* **Staff**: Doctors, nurses, community health workers (CHWs), respiratory therapists, environmental health practitioners, custodial staff, and other medical professionals
* **Stuff**: Essential medical equipment, both for treating patients and protecting healthcare workers
* **Space:** Availability of and access to clean and sanitary environments to test, treat, and isolate patients as well as living spaces conducive to limiting disease spread
* **Systems:** Infrastructure, logistical organization, and governance required to ensure the effective delivery of quality health care

This module will explore collaborative innovations of each component of the 4 S model, including interventions developed in LMICs that could be implemented in high-income countries (HICs), and innovations developed in HICs that could be adapted for LMICs. We then conclude the module with a final integrated case study on refugee and migrant health.

Although this module covers a number of examples from various settings on how COVID-19 is being addressed, it is by no means a comprehensive analysis of best practices and is unable to feature all innovations from all settings. We encourage you to consider how the 4 S framework may apply to where you train or practice in the setting of COVID-19 (or any health threat) as you progress through the module. Indeed, a core value of our group is that we believe those who are closest to the problem are the best people to design the solutions. For this reason, you will see that our authors and faculty reviewers span many parts of the globe. **We also want to invite you, our readers, to participate by sharing innovations which you have developed or witnessed on a website made for this purpose called** [**LeadChange**](http://leadchange.herokuapp.com/c1289?tab=activity#)**.** We hope that this platform will help to facilitate multi-directional communication directly across diverse contexts about innovations that are contributing to the COVID-19 response. Via LeadChange, you are able to discuss problems, propose solutions, or ask questions, all while interacting with existing posts and sharing pictures.&#x20;

## **Learning Objectives**

At the end of this module, medical students should be able to:

* Design two ways to redistribute clinician responsibilities through task shifting/sharing that can be applied to surges in demand for triage or critical care during the COVID-19 pandemic.
* Articulate how CHWs constitute an essential component of the healthcare system in some LMICs and how their role could be translated into other contexts.
* Consider innovative approaches to designing personal protective equipment (PPE), treatment resources such as oxygen therapy and ventilator use, and facility design to decrease cost without sacrificing effectiveness.
* Assess how structural violence may help explain why essential social supports required for people to adhere to public health requests like ‘shelter-in-place’ are not equitably distributed, and the importance of considering those who are most vulnerable in society when making policy recommendations.
* Describe the challenges and strengths regarding quarantine and contact tracing of positive cases in diverse contexts.
* Apply lessons from past infectious disease outbreaks in lower-resourced settings to the COVID-19 pandemic and how the lessons from the current COVID-19 pandemic in high-income countries can be translated in other settings.


# Staff

Doctors, nurses, community health workers, respiratory therapy, environmental services, custodial staff, and other medical professionals.

## **Overview**

The first component of the 4 S framework relates to “staff”. Here we discuss task shifting, community health workers, and telemedicine as interventions to alleviate human resource constraints during the pandemic. These and other solutions to expand the pandemic healthcare workforce are being actively investigated.

## **Task Shifting**

Task shifting is a mechanism employed in resource-constrained settings around the world to increase the effective number of clinical staff available to meet a population’s health demands. During the COVID-19 pandemic, systems from all income levels have strained to maintain an adequate healthcare worker capacity to treat the surge of COVID-19 patients in addition to all other patients.&#x20;

The [World Health Organization](https://www.who.int/healthsystems/TTR-TaskShifting.pdf?ua=1) defines task shifting as “the rational redistribution of tasks among health workforce teams…from highly qualified health workers to health workers with shorter training and fewer qualifications in order to make more efficient use of the available human resources for health.” The WHO recommends that task shifting be undertaken in parallel with efforts to strengthen the healthcare workforce capacity and only after consultation with relevant stakeholders, including patients, to ensure needs are appropriately met. Per [WHO guidelines](https://www.who.int/healthsystems/TTR-TaskShifting.pdf?ua=1), successful implementation of task shifting requires knowledge of:

1. the available human resources for healthcare;
2. the gaps in care provision;
3. the extent to which task shifting is already taking place;
4. the quality assurance mechanisms that already exist.

Task shifting is typically regulated by existing institutions (e.g., licensing boards, professional societies, as well as local, state, and national governments). Regulations can be modified – especially during times of crisis – to allow extension of the scope of practice or creation of new cadres within the healthcare system. Existing training and quality assurance programs may be modified to ensure that roles and core competencies are clearly defined for new or expanded positions. Furthermore, supervision by healthcare workers with higher levels of qualification is essential (e.g., an anesthesiologist supervises multiple nurse anesthetists). In this way, more highly qualified healthcare workers are available for cases requiring a higher level of skill or expertise. Finally, essential health services cannot be sustainably provided on a voluntary basis, so it is [important to ensure workers are compensated](https://www.who.int/healthsystems/TTR-TaskShifting.pdf?ua=1) and programs are adequately financed.

### **Examples of task shifting in COVID-19**

By mid-March, Italian hospitals were witnessing surges of COVID-19 patients that overwhelmed their existing capacity. As one mechanism to address the insufficient supply of care providers, Italy [expedited graduation for senior medical students](https://www.cnn.com/2020/03/30/europe/italy-young-doctors-coronavirus-intl/index.html) so that they could serve where need was greatest. Italy also requested that all Italian doctors who had completed their education in Italy and were practicing abroad return to Italy to work.

*Thought Question:*&#x20;

* Which of these policies from Italy incorporated task shifting? What tasks were shifted, and what qualifications were waived?

As the COVID-19 burden grows exponentially in the U.S., multiple task-shifting measures have been enacted to boost the numbers of healthcare workers and expand their scope of practice. In New York, the U.S. epicenter as of April, an Executive Order from the Governor [relaxed a number of restrictions](https://www.governor.ny.gov/news/no-20210-continuing-temporary-suspension-and-modification-laws-relating-disaster-emergency) on health professionals’ scope of practice. This order allows nurse anesthetists, physician assistants, specialist assistants, and nurse practitioners to practice without the supervision of a physician. In addition, the state has allowed nurses to order testing for COVID-19 without the need for a signed order from a physician. Plans have also been developed to [create ICU teams from non-critical care attending physicians and housestaff](https://www1.nyc.gov/assets/doh/downloads/pdf/em/icuce-tool.pdf) to meet surge demand. Attending physicians and residents at high risk for severe COVID-19 have been furloughed and serve as “virtual rounders” who assist with hospital documentation tasks including progress notes and discharge summaries. Medical schools in New York and Massachusetts have [accelerated graduation of fourth-year medical students](https://www.nytimes.com/2020/03/26/health/coronavirus-medical-students-graduation.html) and distributed emergency 90-day limited licenses to increase the number of licensed providers available to care for COVID-19 patients. Early graduation in the U.S. [has been implemented in the past](https://www.aamc.org/news-insights/itching-get-back-medical-students-graduate-early-join-fight): during the 1918 Influenza pandemic, and during World War II.&#x20;

*Thought Question:*&#x20;

* How would you organize an ICU team from a group of doctors, nurses, mid-level providers, clinical assistants, and technicians who have not worked in an ICU before? Who would provide immediate and ultimate supervision of each member of the team?

#### *Case Study: Mexico*

Mexico´s fifth-year medical school students are called “medical interns”. According to [Mexican Health Regulations](http://www.salud.gob.mx/unidades/cdi/nom/compi/r091283.html), an intern is considered a student who, after finishing the first years four years of medical school, is assigned to study and assist other HCWs in medical institutions as a scholarship holder. Most Mexican public hospitals rely on the workforce these students provide in order to satisfy daily patient demand. As these students are considered nonessential personnel, medical institutions facing shortages of PPE during the first weeks of the COVID-19 public health crisis decided to reserve available equipment; only essential personnel were granted with such resources, forcing medical interns to study and work without adequate protection. As COVID-19 incidence increased, educational authorities decided to withdraw all medical and nursing students from hospital settings, from April 6 to April 30, 2020.

Virtual medical education persisted for these students until public health authorities issued a [statement](http://www.calidad.salud.gob.mx/site/docs/Comunicado_personal_en_formacion_F3.pdf) announcing the following: “Undergraduate internal physicians and social service interns from all health careers without risk factors for serious illness due to COVID-19 must rejoin regular activities from May 1, 2020. In the event that its units have been designated for the care of COVID-19 patients, they will be relocated to lower risk areas, determined by health authorities in agreement with the educational institutions of origin, where they continue to support healthcare services or participate in health promotion and prevention tasks.” Risk factors for severe illness due to COVID-19 included in the official list were: pregnancy or lactation, chronic non-communicable diseases (lung, heart, liver, metabolic, morbid obesity, kidney failure, lupus, cancer, diabetes, hypertension) or acquired or drug-induced immunosuppression. Students with any of these risk factors were permanently withdrawn from in-hospital service “during the time of contingency due to the pandemic or until the end of their undergraduate medical internship.” Night shifts were limited by official policies to every third or fourth day.&#x20;

As the rate of medical interns attending non-COVID medical departments increased, by June 2020, almost every fifth-year medical student had partially or completely resumed their clinical rotations. The decisions taken by the government previously described are evidence of how to ensure the continuity of face-to-face medical education, minimizing the risk of contagion and viral transmission, and how to mitigate the shortage of medical personnel, maintaining quality standards in patient care. The latter was not completely achieved, as the Health Institute for Wellbeing (INSABI, according to its acronym in Spanish) hired 585 Cuban physicians and nurses to help combat COVID-19 in several federal entities. It must be noted that 12 of the most recognized medical associations of the country [publicly condemned](https://espanol.medscape.com/verarticulo/5905579) this decision, arguing that these foreign doctors “transgress the functionality in the assigned hospitals, relegate national healthcare professionals, receive excessive economic remuneration in comparison to better prepared Mexican doctors and disrupt the assignment of limited PPE."

Another important aspect of the urgent plan issued by the Mexican government is the “[Hospital Reconversion Guideline](https://coronavirus.gob.mx/wp-content/uploads/2020/04/Documentos-Lineamientos-Reconversion-Hospitalaria.pdf).” It was issued in April 2020, seeking to “guarantee that the organization of health care services is executed under the principles of timeliness, quality and efficiency of human, material and financial resources for the benefit of the population and thereby influence the prevention and control of the pandemic caused by the SARS-CoV2 virus disease in Mexico.” It highlights an algorithm created to reduce staff occupation in intensive care units and emergency departments; specifically, it aims to ensure one pulmonologist or internal medicine physician as head of the medical team for every 25 ICU beds, and one emergency physician, general physician, or any other physician not directly trained to be on an ICU for every five beds.&#x20;

There is no doubt that Mexico has most of the necessary tools to respond to the pandemic, but **the lack of prioritization has led to professional burnout and misuse of human resources.**&#x20;

*How did the US and Spain manage such situation? Could have Mexico chosen an alternate path?*\
\
In comparison, the US issued immediate provisional practitioner licenses for fourth-year medical students to assist hospital staff and serve as first-contact doctors during the pandemic. As for January 5, 2021, the [Federation of State Medical Boards](https://www.fsmb.org/siteassets/advocacy/pdf/state-emergency-declarations-licensures-requirementscovid-19.pdf) has 43 States in addition to DC, Guam (GU), Central Northern Mariana Islands (CNMI), United States Virgin Islands (USVI) and Puerto Rico (PR) with medical licenses waivers. On the other hand, in Spain, the second most affected European country at the beginning of the pandemic, a national call was made to all recently graduated physicians and last year medical students to join first response teams. “There was a national call to be on a national roster of healthcare personnel ready to lend a hand when needed, and that was what many peers did and most ended up in community health centers, nursing homes and "COVID hotels,” said Ruben Moreno MD. This strategy optimized triage services and medical attention for hospitalized COVID-19 patients.

## **Community Health Workers**

A CHW is a community member identified as a point of contact for health needs at the local level, helping to provide basic health and medical care within their own community. Although the terminology of a CHW varies by context (e.g., health worker, community health promoter, etc.) and [scopes of practice differ across settings](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3260896), they are typically capable of providing preventive care, health promotion, and rehabilitative care within their own community.&#x20;

\
In many LMIC settings that have historically lacked sufficient medical personnel to meet population health demands, CHWs have helped to fill a crucial gap. Compensation for CHWs varies by context. Some countries provide a salary. Other countries provide recognition for CHWs’ service and offer certain incentives such as access to health insurance or mobile phones. Some level of standardized training is generally offered to equip CHWs to perform their expected duties.

### **CHWs in the COVID-19 response: Rwanda case study**

Rwanda, a country of 12 million people in Sub-Saharan Africa, illustrates how a CHW network can be effectively deployed for the COVID-19 response. Much has been written about the growth of Rwanda’s [CHW program](http://www.chwcentral.org/sites/default/files/Rwanda%20-%20Rwanda%27s%20Community%20Health%20Worker%20Program.pdf) in light of the gaps it helped to fill following the devastating 1994 Genocide against the Tutsis. As of 2020, there are more than 45,000 village-level CHWs operating who provide the first line of health service delivery. In Rwanda, villages comprise between 100 and 200 households. There are [three CHWs in each village](https://dash.harvard.edu/bitstream/handle/1/14065527/4320528.pdf?sequence=1\&isAllowed=y): a male-female CHW pair (called binômes) providing basic care and integrated community case management (iCCM) of childhood illness and a CHW in charge of maternal health, called an Agent de Santé Maternelle (ASM). While CHWs are elected  by the members of their village, this position is voluntary and considered an honor in Rwanda. CHWs are also provided a series of incentives, including access to the national community-based insurance scheme (Mutuelles de Santé), tools such as a mobile phone with airtime for communication, access to CHW co-operatives, and training by the Ministry of Health. Finally, CHWs receive a nominal amount of financial support through the country’s performance-based financing program.&#x20;

Due to the distribution of CHWs throughout Rwanda, they are the first contacted at the local level by any person with suspected symptoms of COVID-19. Once a CHW is made aware of a suspected case, they contact coordinating health officials via SMS (with the phones they are provided), who then alert those responsible for contact tracing so that containment efforts are optimized. Also, SMS alerts sent by CHWs are integrated into a national health information technology (HIT) system that allows for real-time national information sharing, which in turn allows smooth coordination by regional and national authorities. The advantage of an SMS-based system is that it is a practical, rapid method for CHWs to notify health officials of emerging cases in real time. Because the Ministry of Health pays the cost linked to the telephone communications, there are no financial charges incurred by the CHWs. Further, the system is not reliant on having a stable internet connection in remote areas, thereby helping to ensure a rapid notification system across the entire country.&#x20;

### **Leveraging the CHW model to expand capacity in COVID-19 response**

Rwanda and many other countries have robust CHW programs that existed prior to the COVID-19 pandemic and are ready to integrate any new threat at the community level. Countries that have not historically relied on a cohesive CHW structure can draw important lessons from these systems as they recruit community members for their own COVID-19 responses. The health network that emerges may be worth sustaining well beyond the current crisis.

As seen in [Table 1](http://lastmilehealth.org/wp-content/uploads/2020/03/Prevent-Detect-Respond-Rapidly-expanding-healthcare-teams-through-community-health-workers-in-the-fight-against-COVID-19.pdf), CHWs can contribute to the COVID-19 response in a variety of ways, building on their previous tasks in their community. They may be particularly helpful in detecting and tracing suspected cases; educating peers about prevention, quarantine, isolation, and lockdown protocols put in place by public health officials; and continuing chronic disease care. In the U.S., community health care centers have drastically reduced in-person appointments to adhere to social distancing and stay-at-home orders. In some settings, these staff have been redirected to COVID-19 clinical teams, responding to high-risk patients over the phone. CHWs can assess risk for patients and provide appropriate escalation of care. As an example, a partnership between the Massachusetts government and [Partners in Health](https://www.pih.org/article/pih-partners-mass-governors-office-covid-19-response)  developed a CHW workforce capable of scaling up [contact tracing](https://www.wbur.org/npr/845026655/what-it-takes-to-be-a-contact-tracer). In the United Kingdom, a model has been proposed to [train CHWs to support people in their homes or virtually](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30735-2/fulltext) by assessing food and medication supplies and other needs for vulnerable people. In summary, a novel CHW program serves as a promising method to redistribute human resources in strained healthcare systems that lack adequate capacity for the surge in demand.

|             | **Table 1: Potential Roles of Community Health Workers in the COVID-19 Pandemic**                                                                  |
| ----------- | -------------------------------------------------------------------------------------------------------------------------------------------------- |
| **Prevent** | Educate communities regarding signs, symptoms, and transmission routes and  promote personal protective measures.                                  |
|             | Organize hand hygiene stations in communities and health facilities.                                                                               |
|             | Support facility-based infection prevention through triage areas and PPE use.                                                                      |
|             | Support preparation for future interventions like vaccines through outreach.                                                                       |
| **Detect**  | Identify signs and symptoms in community members and support safe sample collection and rapid transport to reduce risk of nosocomial transmission. |
| **Respond** | Communicate rapidly and effectively to residents.                                                                                                  |
|             | Support self-isolation while ensuring critical food, medical, and social support.                                                                  |
|             | Monitor patients for clinical deterioration and rapidly refer when needed.                                                                         |
|             | Support contact tracing, symptom reporting, and access to testing and treatment.                                                                   |
|             | Implement disinfection of high-risk surfaces.                                                                                                      |
|             | Sustain routine primary healthcare services (vaccines, diarrhea management, malaria management, etc.).                                             |

## **Telemedicine**

As a final example of how to increase staff availability in the setting of COVID-19, we focus this section on telemedicine. This mechanism for interacting with patients virtually is not a new technology, but its implementation has been variable for multifaceted reasons. Below, we provide an overview of telemedicine, evaluate advantages and disadvantages of this technology, and detail how regulations have been relaxed to promote its use in the COVID-19 response.

### **Providing care or triage without increasing transmission risk**

Prior to COVID-19, the U.S. had witnessed [varying degrees of telemedicine utilization](https://aspe.hhs.gov/system/files/pdf/206751/TelemedicineE-HealthReport.pdf) due to complex regulatory, policy, and reimbursement challenges. As discussed in [Module 3](https://curriculum.covidstudentresponse.org/module-3-disparities-policy-socioeconomic-effects/implication-for-the-healthcare-system-beyond-covid-19-patients#routine-chronic-and-non-essential-care-and-telemedicine), in the setting of the pandemic, federal and state policy [increased reimbursement mechanisms](https://www.ajmc.com/journals/issue/2020/2020-vol26-n4/incorporating-telemedicine-as-part-of-covid19-outbreak-response-systems) to ensure that telemedicine could be employed as a mechanism for patients to continue seeking care without having to physically attend appointments. For instance, [Jefferson Health](https://www.aamc.org/news-insights/delivering-more-care-remotely-will-be-critical-covid-19-races-through-communities) in the U.S. has increased their telemedicine visits from a few dozen per week to 500-600 visits per day - a tenfold surge in demand. The U.S. Congress recently passed the [CARES Act](https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf), which allows Medicare reimbursement for health centers and rural health clinics for the remainder of the crisis and for expansion of telemedicine. In the U.S., HIPAA (a law that provides protections for personal health information among many other things) compliance guidelines for telemedicine have been relaxed. It is now possible to use free or low-cost video communication tools such as Apple FaceTime, Facebook Messenger, Skype, and Zoom. Another example discussed in [Module 4](https://curriculum.covidstudentresponse.org/module-4-mental-health-in-the-time-of-covid-19/evolving-clinical-practices-in-mental-healthcare#the-rise-of-telehealth) is the use of telemedicine for mental healthcare in China. Major limitations include access to a device with audio and camera, and education in using electronic platforms, which may disproportionately affect patients who lack access to this technology. Additionally, development of guidelines on what will require an in-person visit must be set – for example, a change in condition, requiring a physical exam, or lack of interpreters (although remote phone interpreters have helped to fill this last gap). While there are logistical concerns, patients with difficulty in transportation or accessibility to attend in-person visits may benefit from this rise in telemedicine.

To provide an example from another context of how telemedicine has been utilized in the face of the COVID-19 pandemic, we provide a case study from the Philippines.

![Lung Center COVID Ask Force online consultations](/files/-M4_0BuxeFzDWdgp4XVo)

As the number of COVID-19 cases grows in the Philippines and strains its health sector, several medical groups and physicians have created a [Facebook-based platform for online consultation](https://www.facebook.com/COVIDAskForce/) services called the “Lung Center COVID Ask Force.” It primarily aims to triage patients with possible COVID-19-related complaints. Every Monday to Saturday, around 625 volunteer doctors – with the help of student volunteers from the Ateneo School of Medicine and Public Health – provide online consultation services to the first 1,000 patients who message the Facebook page that day. Additionally, the Lung Center COVID Ask Force also posts infographics based on frequently asked questions. These serve as educational materials that people can easily access without needing to consult a doctor.


# Stuff

Essential medical equipment, both for treating patients and protecting healthcare workers.

In this section, we explore the second component of the 4 S framework: stuff. Healthcare systems including China, Italy, and the U.S. have struggled to maintain sufficient medical supplies during peak need of the pandemic. We describe a few examples that illuminate the importance of having the appropriate materials to respond to emerging health needs. In addition to those discussed below, testing is a critical need as well; it is discussed in detail in [Module 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside). The inclusion of point-of-care ultrasound testing, which can used to identify characteristic COVID-related lung findings, may be critical particularly in lower-resourced settings where widespread PCR-based testing may not be feasible.

## **Focus #1: Personal Protective Equipment**

As discussed in [Module 6](https://curriculum.covidstudentresponse.org/module-5-training-for-medical-student-specific-roles), personal protective equipment (PPE) is essential to the safety of healthcare professionals and prevention of virus spread in clinical environments. The Centers for Disease Control and Prevention (CDC), anticipating critical shortages, [issued recommendations](https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html#crisis-capacity) for prolonged use and re-use of masks and face shields, use after expiration dates, and alternatives like cloth masks or bandanas when no masks are available. However, they acknowledge that some of these practices are less effective than conventional PPE. In LMICs where such shortages are more common at baseline, the pandemic makes adequate protection for providers and patients difficult. Innovators have been considering how to address this need. Here we summarize examples of such potential innovations.

### PPE innovations from the Philippines: “Do it yourself” (DIY) face shields

![DIY face shields, Philippines.](/files/-M4_GHiIBMPm1_byoWfG)

Due to an inadequate supply of PPE in the Philippines, student organizations and youth groups have created alternative means to procure them. This has led to DIY face shields designed and produced by graduating medical interns from the [Ateneo School of Medicine & Public Health](https://www.facebook.com/asmph2020/posts/636928666883996).

This initiative has been adopted by other institutions under the umbrella of Ateneo Professional Schools (APS), including law and business schools. Its rising popularity has prompted many independent groups to create their own versions of the face shields in order to aid in the procurement of much-needed PPE in their respective localities. Through this widespread initiative, thousands of face shields have been donated to local medical systems. These DIY face shields can be made using recycled [plastic bottles](https://m.youtube.com/watch?v=1S83fjKY19w\&t=16s) or sheets of acetate, recycled bubble wrap or strips of foam, garter, and common office supplies. A tutorial video can be accessed [here](http://tinyurl.com/ASMPH-DIY-FaceShields).

### Acrylic aerosol box

![Dr. Lai Hsien-yung (賴賢勇), Central News Agency](/files/-M4_0Bv-Hy83ZoWi4x7l)

The aerosol box, [originally designed by Taiwan-based anesthesiologist Dr. Lai Hsien-yung](https://www.taiwannews.com.tw/en/news/3902435), was developed to provide additional protection during aerosol-generating procedures (AGPs) like endotracheal intubation. This is of particular importance in COVID-19, as rapid clinical deterioration often necessitates rapid intubation. Performing AGPs places practitioners at higher risk of viral exposure and thus requires use of additional barriers for protection.

The protective tool is designed to be placed over the patient’s head with two holes to allow a physician’s hands to be inserted to perform procedures. The clear acrylic or poly-carbonate material makes for an inexpensive but effective barrier without interfering with visibility.

Anton Legaspi, a designer, and his sister, Frances Legaspi, an emergency room physician at Antipolo Doctors Hospital, spotted the device on social media and sought permission to [replicate it in the Philippines.](https://www.taiwannews.com.tw/en/news/3903467) Many independent groups in the country began mass-producing the aerosol box to meet PPE demands for critical care settings. The design continues to be improved, including [modified dimensions](https://www.facebook.com/anton.legaspi/posts/10158096249334861) to bring costs down from US$66 to US$29 per unit, larger holes to facilitate easier arm movement, and [adjusting dimensions to add a slanted viewing pane](https://www.facebook.com/everythingacrylic.ph/posts/1293347680850964).

The [original blueprint](https://sites.google.com/view/aerosolbox/design) by Dr. Hsien-yung is free for non-commercial purposes with proper attribution. Demonstration videos can be found here:

* [Aerosol Box for Use During Intubation & Extubation of COVID-19 Patients](https://www.youtube.com/watch?v=0tjtN_9HwLI)
* [Simulation Using Aerosol Box – Video Laryngoscopy](https://www.facebook.com/NeyNeyDMMD/videos/3119422944748819)
* [Modified aerosol box by Everything Acrylic](https://www.facebook.com/watch/?v=1059761341046808)

### Addressing PPE shortages in the United States

**Mask decontamination and re-use** has been considered in the U.S. for past infectious outbreaks. Two important questions that must be addressed with this process include: \
\
1\) Does decontamination impair the integrity of masks?\
2\) Is the effectiveness for eliminating viruses high enough?&#x20;

First, the maximum survival time of about 72 hours of SARS-CoV-2 means that masks could be re-used without sterilization. For unsoiled masks, the CDC suggests a [daily rotation of five masks](https://www.sages.org/n-95-re-use-instructions/), either hanging masks between use or placing them in breathable paper bags between uses, such that any virus would decompose before re-use.&#x20;

A number of other decontamination methods have been explored with [varied success](https://doi.org/10.1093/annhyg/mep070). Microwave oven irradiation, in some cases, melts materials following prolonged exposure, while bleach damages filtration efficacy and leaves a toxic scent which detracts from the user experience, making neither a robust option for widespread decontamination. Ultraviolet germicidal irradiation (UVGI), ethylene oxide, and vaporized hydrogen peroxide (VHP) all preserve the integrity of mask filtration. However, UVGI  [decreases the structural integrity](https://www.tandfonline.com/doi/full/10.1080/15459624.2015.1018518) of masks over time which will limit the number of disinfection cycles per mask.

The U.S. Environmental Protection Agency includes hydrogen peroxide in a [list of disinfectants](https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2) effective against SARS-CoV-2. A group at [Duke University](https://corporate.dukehealth.org/news-listing/duke-starts-innovative-decontamination-n95-masks-help-relieve-shortages?h=nl) developed a method to disinfect masks using a vaporized hydrogen peroxide solution in a room with masks hanging on clothes-lines to be fully exposed.&#x20;

High energy [UV-C radiation](https://www.sciencedirect.com/science/article/pii/S016609340400179X) has been shown to kill SARS-CoV and MERS, and it is expected to work in SARS-CoV-2 as well given their structural similarity. A group at the [University of Nebraska](https://www.nebraskamed.com/sites/default/files/documents/covid-19/n-95-decon-process.pdf) developed a decontamination method by hanging up masks between two large UV-C sources with good results (see image below). There are also some industrial approaches to mask sterilization, like those currently being used in [Boston hospitals](https://www.bostonglobe.com/2020/04/02/metro/boston-hospitals-getting-game-changer-machine-that-sterilizes-80000-protective-masks-day/).

![Mask sterilization at the University of Nebraska using UV-C light.](/files/-M4_0Bv0TRZJi_UKVqhl)

It is woth mentioning a novel strategy: microwaving. [Zulauf et al.](https://mbio.asm.org/content/11/3/e00997-20) were pioneers in the use of this approach. They used a rubber band, a glass container, mesh from a commercial produce bag, and a 1,000-watt microwave to decontaminate an N95 respirator from MS2 phages (surrogates for SARS-CoV-2). After a single use for 3 minutes, they found that there was a greater than 99.99% reduction of plaque-forming units (PFU) (a PFU is a measure of concentration used in virology). Even after 20 sequential cycles, fit and function of the respirator were preserved. Discoveries like these are essential because **advancement is not always within the creation of new things, but in taking what is and transforming it.**&#x20;

![N95 respirator microwave steam decontamination. PFU: plaque-forming units.](https://lh3.googleusercontent.com/CToGfUoInvLDL-J09UjFCoFNyv2v7GuHdXuzGypvzJ-Hz0WfiEmJC8ZZD5q_Oyv_8093X1-5Fp2ftW4M3NF95wnmhfL0V_PkWUKqtWYCQg6jevf5AANm93sgDvTesBw7L_c3mrVn)

Given the shortages of conventional N-95 respirators and surgical masks, **unconventional mask alternatives** are being widely made. **I**n 2015, [McIntyre et al.](https://bmjopen.bmj.com/content/bmjopen/5/4/e006577.full.pdf) showed in a large-scale randomized clinical trial that cloth face masks were inferior to medical ones in preventing influenza transmission among healthcare workers, mainly because the latter have larger number of layers, a finer weave and a better fit. Four years later, the N95 masks were assessed against medical masks [in a cluster randomized clinical trial](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724169/), evaluating their effectiveness in a clinical setting; it was found that N95 respirators are better in preventing aerosols, although no difference was found in preventing influenza infection. In other words, N95 respirators are clinically similar to wearing medical masks, which in turn are superior preventing the transmission of different virus.&#x20;

**Different materials; different levels of protection**

Cloth can be expected to block droplets and aerosols, even if it does not stop isolated virions. In comparison, the filtration efficiency in a single layer of different types of cotton in bioaerosols (0.2 μm) was 43-94% compared to 98-99% in disposable medical masks. [Davies et al.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7108646/pdf/S1935789313000438a.pdf) delved into this topic comparing the filtering efficiency of different materials. They concluded that despite the overall superiority in preventing bacterial and viral infections of the surgical masks, when it came to homemade textiles, pillowcases and 100% cotton fabrics were sufficient enough for their purpose. These experiments, useful as they are, are not geared towards COVID-19. For this reason, [Rodríguez-Palacios et al.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267001/pdf/fmed-07-00260.pdf) assessed household textiles to quantify effective environmental droplet barriers. After spraying microorganisms at six types of fabrics, they found that when using two-layered textiles as much as 99.7% of the ejection of micro droplets could be retained, leaving a circumferential contamination of approximately 0.3%.&#x20;

![Droplet retention potential of different textile barriers. ](/files/-MScr-DN1-h6B9tPNUlX)

Another approach, led by [University of Florida Anesthesiology](https://m.ufhealth.org/news/2020/uf-health-anesthesiology-team-devises-respirator-mask-made-existing-hospital-materials?fbclid=IwAR0-w6cmc8EcczT-Inkd0zL7KP8msEbQDEYJh_hITMD8UWBxL4N5wO0kDyA), is encouraging the use of Halyard H600 two-ply spun polypropylene to make masks with minimal particulate penetration. Researchers at Boston Children’s Hospital also produced a washable, inexpensive mask from available hospital materials, as seen [below](https://www.forbes.com/sites/jacquelyncorley/2020/03/23/researchers-devise-new-breakthrough-to-protect-healthcare-workers-from-coronavirus/#3c2ced712102) or at this [link for a video description](https://www.youtube.com/watch?v=Es_iY5WJdmI).

![Boston Children’s Hospital mask solution](/files/-M4_0Bv1muKqchUlHuD9)

When it comes to giving advice, healthcare workers should make [training](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7108646/pdf/S1935789313000438a.pdf) in usage and correct fitting of masks a priority. [Inclining the head and body downward during sneezing](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267001/pdf/fmed-07-00260.pdf), in addition to having a face mask, could help contain the droplet contamination’s trajectory due to a sneeze’s dispersion dynamics. [Ironing masks ](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267001/pdf/fmed-07-00260.pdf)be beneficial as well, because humid and dry heat produced by an iron destroy viruses and spore producing bacteria withouth affecting the textile integrity of face covers. Finally, [washing textiles](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267001/pdf/fmed-07-00260.pdf) between uses could eliminate COVID-19 from face masks and other coverings; it has been shown that SARS-CoV-2 can be denaturalized by heat when exposed to 70°C for 5 minutes, bleach, when exposed at a concentration of 1:49 for 5 minutes, or detergents when exposed for 20 minutes.

*Thought Questions:*&#x20;

* How could cloth masks be improved to be equivalent to medical-grade masks? What would you do to mass-produce them during a shortage?
* Thought question: What can you teach your family members and friends about homemade Personal Protective Equipment? Is there something you can improve at home to keep everyone safer?

### Optimizing face mask usage

Face masks are both effective in preventing transmission and preventing infection with SARS-CoV-2. An uncovered cough, for example, can cause droplets to travel 12 feet within approximately 50 seconds. However, according to [Verma, et al. (2020)](https://aip.scitation.org/doi/10.1063/5.0016018), with even just a properly fitting homemade cotton mask made of multiple layers, droplets only travel about 2.5 inches.&#x20;

Evidence has shown the use of face masks is associated with a 70% risk reduction of acquiring COVID-19 infection. The effectiveness of any given mask is, in large part, based on its filtration material. The US National Institute for Occupational Safety and Health (NIOSH) N95 classification established the “95” because, when subjected to testing, the respirator blocked 95% of small (0.3μm) test particles. Meanwhile, a [publication by the WHO](https://apps.who.int/iris/bitstream/handle/10665/332293/WHO-2019-nCov-IPC_Masks-2020.4-eng.pdf) on the use of masks in the context of COVID-19 highlights that the filtration of cloth fabrics –also referred to as “non-medical masks” – varies between 0.7% and 60%, depending on the type of material, the number of layers, maintenance and fit, while the filtration of surgical masks – also referred to as “medical masks” – is at least 95%. Considering the lower performance of non-medical masks, the WHO emphasizes that these “should only be considered for source control (used by infected persons) in community settings and not for prevention”, and that their use “should always be accompanied by frequent hand hygiene and physical distancing.”&#x20;

In January 2021, the CDC conducted [experimental simulations](https://www.cdc.gov/mmwr/volumes/70/wr/mm7007e1.htm?s_cid=mm7007e1_x#F1_down) on the efficacy of double-masking against SARS-CoV-2 transmission. These assessed the extent to which two simple modifications to medical masks could reduce risks of exposure to SARS CoV-2 droplet particles by individuals wearing the PPE in their daily lives.&#x20;

1. **Double-masking**: wearing a cloth mask tightly on top of a surgical mask; the surgical mask acts as a filter and the cloth mask provides an additional layer of filtration while improving the fit.
2. **Knotted-and-tucked masks:** knotting the ear loops of a medical-procedure mask where the loops attach to the mask’s edges and then tucking in and flattening the extra material close to the face.&#x20;

![Masks tested by the CDC: A. Unknotted medical mask; B. Double-masking; C. Knotting and tucking of medical mask.](/files/-M_IuRc3J_1tEKNMprs_)

[Pan et al. (2020)](https://www.medrxiv.org/content/10.1101/2020.11.18.20233353v1), after summarizing available [evidence](https://www.cell.com/med/pdf/S2666-6340\(20\)30072-6.pdf) on face masks used by the public for coronavirus prevention, introduced a third variation of face mask usage that helps achieve >90% protection against >1 μm particles: wearing a **three-layer mask** with outer layers consisting of a flexible, tightly woven fabric that can conform well to the face and a middle layer consisting of a non-woven, high-efficiency filter material (e.g., vacuum bag material).

![Left: double-masking; Right: three-layer mask. ](/files/-M_ItyaRwpCjeBrjEuAi)

The [CDC concluded ](https://www.cdc.gov/mmwr/volumes/70/wr/mm7007e1.htm?s_cid=mm7007e1_x#F1_down)that the wearer’s exposure was maximally reduced (>95%) when both the source and wearer used the modified medical-procedure masks. Other recent studies conducted similar protocols to evaluate the use of a cloth mask over a medical-procedure mask, the use of knotting and tucking the medical-procedure mask, and the use of mask filters to improve the fit. Results were similar throughout experiments and concluded that filtration efficacy (>90%) was better achieved applying all methods. A study by the CDC aimed to quantify aerosol penetration during breathing under the following scenarios: use of a medical mask alone, a cloth mask alone, a cloth over a medical-procedure mask (double-masking) and knotting and tucking a mask. They found that a unknotted medical mask alone blocked 56.1% of particles from a simulated cough, and a cloth mask alone blocked 51.4%. The double-masking method blocked 85.4% of cough particles, while the knotted-and-tucked method blocked 77.0%.&#x20;

## **Focus #2: Oxygen Administration**

Another example of the “stuff” that is required to care for COVID-19  patients is oxygen and the means to deliver it. Oxygen delivery is a critical need given that the cardinal manifestation of COVID-19 prompting hospitalization is hypoxemic respiratory failure progressing to acute respiratory distress syndrome (ARDS). As global reports suggest, approximately 15% of patients with COVID-19 have severe illness requiring oxygen therapy, and 5% of them will develop critical illness requiring intensive care unit (ICU) treatment. Furthermore, most critically ill patients with COVID-19 require mechanical ventilation. Healthcare facilities are required to be equipped with pulse oximeters and operating oxygen systems that include single-use oxygen supply interfaces (nasal cannulas, nasal prongs, simple face masks, and masks with reservoir bag), highlighting that only [medical-grade, high-quality oxygen](https://www.who.int/publications/i/item/oxygen-sources-and-distribution-for-covid-19-treatment-centres) should be administered to patients. Supplemental oxygen therapy must be applied immediately to patients with[ Severe Acute Respiratory Infections (SARI)](https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf) and respiratory distress, hypoxemia, or shock, for a target [SpO2 of > 94%](https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/specialty-guide-NIV-respiratory-support-and-coronavirus-v3.pdf).&#x20;

![Oxygen system. Technical specifications and guidance for oxygen therapy devices (WHO, 2019) ](/files/-MSd-VYUmNB_Gjd63fqy)

Successful oxygen treatment requires an **oxygen source**, either from oxygen cylinders, oxygen concentrators, or liquid oxygen. Choosing the [appropriate oxygen source](https://apps.who.int/iris/bitstream/handle/10665/329874/9789241516914-eng.pdf?ua=1) depends on many factors, for example: the amount of oxygen needed, the available infrastructure, electricity availability, cost, capacity, and supply chain for local production of medicinal gases, as well as access to maintenance services and spare parts, to name a few. A possible [decision tree](https://pubmed.ncbi.nlm.nih.gov/19876543/) for deciding between the use of oxygen cylinders and oxygen concentrators in resource-limited settings based on a cost-effectiveness analysis done in Gambia is shown below.

![Oxygen decision tree (Howie et al., 2009)](/files/-MScu5KxUk-xVKQGB0-S)

Most hospitals and healthcare facilities in high-income countries (HICs) use [liquid oxygen](https://www.chthealthcare.com/blog/medical-gas-systems). Two major medical gas companies that provide liquid oxygen and oxygen cylinders in the U.S. and around the globe are facing increasing demand for their products. These global medical gas companies are currently able to manage this demand and have started [preparing their supply chain](https://www.wsj.com/articles/gas-suppliers-face-soaring-demand-for-oxygen-to-treat-coronavirus-patients-11585223338) to address potential future bottlenecks. Nevertheless, the most popular source of oxygen storage used in healthcare facilities are oxygen [cylinders](https://apps.who.int/iris/bitstream/handle/10665/329874/9789241516914-eng.pdf?ua=1). A [medical oxygen cylinder](https://apps.who.int/iris/bitstream/handle/10665/329874/9789241516914-eng.pdf?ua=1) is a refillable cylindrical storage vessel used to store and transport oxygen in the compressed gas form.&#x20;

Healthcare facilities in resource-limited settings have many barriers to delivering oxygen to patients. According to a 2010 survey of health care facilities in 12 African countries, less than half reported uninterrupted oxygen access, and less than a quarter had an oxygen concentrator. Only 35% of these health care facilities have [access](https://www.ncbi.nlm.nih.gov/pubmed/20818088) to electricity. In another study in the [*Lancet* from 2010](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(10\)60392-3/fulltext), 19% of 77,700 surveyed surgical rooms, with a geographically and demographically diverse representation from over 50 countries, did not have access to pulse oximetry. In these settings, an advantage of oxygen cylinders is that they **fit perfectly within low-income countries (LICs) facilities, where power supply is intermittent or unreliable**, mainly because it doesn’t require electricity. Reported disadvantages of such oxygen source are:&#x20;

* Require a supply chain and transportation for refilling.&#x20;
* Require functional flow meters.
* May have [leakages](https://www.researchgate.net/publication/273256731_The_maintenance_needs_of_oxygen_concentrators_in_low-resource_settings_and_implications_for_technician_training_Experience_from_The_Gambia).&#x20;

An additional alternative for LICs are oxygen concentrators. However, they require electricity to operate and [technicians](https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-4129-7) to repair them. If electricity is reliable, oxygen concentrators are more cost-effective than oxygen cylinders. In settings with unreliable electricity, oxygen cylinders may be [preferred](https://www.ncbi.nlm.nih.gov/pubmed/19876543).&#x20;

*Thought Questions:*

* Should governments of HICs start to prepare for oxygen shortages? How should they do so? Should they favor oxygen concentrators or cylinders?
* What about LICs that don’t have access to all the complete oxygen systems? How should they compensate for this deficiency?

## **Focus #3: Respiratory Support**

Along the lines of oxygen, respiratory support is also a critical need for COVID-19. Here we summarize well-known estimates of ventilator shortages in HICs, explore implications for LMICs, and provide examples of innovations being explored to address this gap in supply versus demand.

### Mechanical ventilators

Currently there are an estimated [60,000 to 160,000 ventilators](https://www.nejm.org/doi/full/10.1056/NEJMp2006141) in the U.S. However, it is estimated that the COVID-19 pandemic may require up to [1 million ventilators](https://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.html). In addition to the shortage of ventilator equipment and insufficient production of [ventilator parts and consumables](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319564/), the U.S. may face other challenges relating to “Staff” who can operate ventilators, including a lack of skilled respiratory therapists and biomedical engineers to support ventilator use and function. Furthermore, currently, procedures that could decrease the need for intubation and increase the [safety of extubation](https://erj.ersjournals.com/content/50/2/1602426), such as high-flow nasal cannula (HFNC), CPAP, and BiPAP, are relatively contraindicated due to the [risk of aerosolization of](https://www.wfsahq.org/resources/coronavirus) [SARS-CoV-2](https://www.wfsahq.org/resources/coronavirus).

Resource-limited settings, such as rural areas in LMICs, have long struggled with the emerging scarcity that HICs are just now facing due to the surge of critically ill COVID-19 patients, including lack of [ICU beds](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0116949), lack of ventilatory equipment, lack of skilled technicians to operate ventilators, and an inability to repair ventilators. Healthcare facilities in LMICs may face additional challenges such as inability to monitor patients’ oxygen saturations or arterial blood gas readings, lack of portable x-rays, inconsistent access to electricity, and the aforementioned challenges with [oxygen delivery](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319564/). Some studies have shown evidence of high mortality rates even among the relatively few patients who are able to access invasive [mechanical ventilation](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319564/). This is often due to a lack of or inadequate access to ancillary support services, such as [portable x-rays, sedation](https://www.apsf.org/article/improving-anesthetic-safety-in-low-middle-income-countries-a-different-challenge/), and [suction devices](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5469676/).

Given this problem, experts explored a range of frameworks for practical guidance on administering respiratory support for those who are critically ill in resource-limited settings. One such framework proposed by [Inglis, Ayebale, and Sch](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319564/)[ultz](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319564/) is found in the figure below.

![Proposed interventions to improve outcomes in LMICs. ](/files/-M4_0Bv3n7J0wfIjjui-)

#### *Case study #1: Reconfiguring machines for sleep apnea into hospital ventilators*

A team of physicians at the[ Mount Sinai Health System](https://health.mountsinai.org/blog/mount-sinai-turns-hundreds-of-machines-for-sleep-apnea-into-hospital-ventilators-shares-instructions-worldwide/) have reconfigured hundreds of donated machines (200 ResMed VPAP ST machines) typically used at home for sleep apnea, with the purpose of deploying them as ventilators to be used for severely ill patients who are hospitalized with COVID-19. The Mount Sinai team made three important modifications to the VPAP ST machines: 1) connection to an endotracheal tube replaced the typical mask that can present a risk of COVID-19 aerosolization, 2) alarms were installed that can alert clinicians if there is a problem with air flow, 3) doctors and respiratory therapists were enabled to view and control the machine’s settings from outside the patient's room, so they do not need to enter to make minor adjustments. According to Drew Copeland, Director of Operations for the Sleep Program at the Mount Sinai Health System, “any type of high-performing sleep device that delivers a comparable level of pressure to the ResMed VPAP ST model can work as a repurposed ventilator.”

Mount Sinai has shared the protocols and instructions with the greater New York Hospital Association and the American Thoracic Society, as well as with other hospitals that are dealing with a national shortage of invasive ventilators during this pandemic.

![Members of the Mount Sinai team that created the ventilator prototype seen in the picture. ](/files/-MSczrRtkkAF9g7S_9Z2)

*Thought Question:*

* Mount Sinai has had a donation of VPAP machines, which are expensive. The reconfiguration of VPAP machines is showing good results as an option for other hospitals all over the world to reconfigure these machines into ventilators. However, what should the LMIC's without donations do given the cost of these VPAP machines? How could they have access to this solution?

#### *Case study #2: Friendly ventilador*

As another example of innovation to address the shortage of ventiladors, the israeli government took advantage of Israel Aerospace Industries as a place to design, manufacture and mass produce the [portable ventilators](https://www.israel21c.org/israel-fast-tracks-ventilator-innovations-for-covid-19-care/) shown in the image. Their main advantage is that they can be used outside the hospital setting and are suitable for chronic life support ventilation in COVID-19 patients. [This user-friendly ventilator](https://www.inovytec.com/wp-content/uploads/2018/01/BrochureVentwayWeb.pdf) has two possible weights: 1.0 kg or 1.15 kg, and both of them include different ventilation modes, tidal volumes, breath rates, peak inspiratory pressures, peak inspiratory flows, among other variables. This allows the patient to have specific information about some essential physiological parameters despite being outside a hospital setting.&#x20;

![Inovytec’s Ventway Sparrow portable turbine-powered ventilator.](/files/-MSd-JoBnO08VVkF7VJ5)

*Thought Question:*&#x20;

* How should LMICs elaborate these kinds of ventilators or acquire access to them?&#x20;

[**Optimizing Respiratory Management in Resource-Limited Settings**](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319564/)

For those patients who require ventilatory support, the following points have been recommended in the past for advanced ventilatory support and management, [especially in resource-limited settings](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4751193/):

* Follow ARDSnet protocol to prevent barotrauma (as described in [Module 1 supplement](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside) and [Module 6](https://curriculum.covidstudentresponse.org/module-5-training-for-medical-student-specific-roles)).&#x20;
* Elevate the head of the bed to a semi-upright position to prevent ventilator-associated pneumonia.&#x20;
* Use volume-control modes instead of pressure control.
* Monitor end-tidal carbon dioxide (ETCO2) if possible.
* Perform spontaneous breathing trials daily to see if a patient can be weaned off of the ventilator and use low level of pressure support during spontaneous breathing trials
* Before extubation, make sure to have staff, PPE, and resources to re-intubate if necessary

Despite established guidelines for managing complications of COVID-19 such as ARDS, best practices cannot be adopted globally due to resource constraints. In the following sections, we explore alternative options that frontline healthcare workers may consider when caring for COVID-19 patients in settings with limited access to ventilators. These include noninvasive ventilatory support, placing non-ventilated patients in the prone position, sharing a single ventilator amongst multiple patients, and bag-valve masking. All these options are discussed in the setting of a limited number of ventilators and skilled technicians to run and maintain ventilators.

### **Noninvasive ventilatory support**

One possible but tipically ill-advised option for respiratory support in the case of treating potential ARDS in COVID-19 patients is the use of noninvasive ventilatory support (such as CPAP or BiPAP). There is strong evidence for the use of noninvasive ventilation (NIV) in the treatment of chronic obstructive pulmonary disease (COPD) and heart failure exacerbations; NIV has even been shown to be effective in [reducing mortality in LMICs for these indications](https://www.ncbi.nlm.nih.gov/pubmed/29426584). However, ARDS has been shown to be a strong predictor of [BiPAP/CPAP failure](https://www.ncbi.nlm.nih.gov/pubmed/16696863). One possible use for NIV in the setting of ARDS is a 1-hour trial in patients with mild/moderate disease, with close monitoring, and prompt intubation after this one-hour period if the patient’s clinical status has deteriorated or not [improved](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066037/). Another potential use is to help wean patients who have passed spontaneous breathing trials and are no longer hypoxemic off of [mechanical ventilation](https://erj.ersjournals.com/content/50/2/1602426). The main risk of noninvasive ventilation use in the setting of ARDS is a delay in the time to a needed [endotracheal intubation](https://www.ncbi.nlm.nih.gov/pubmed/25111645). Furthermore, in COVID-19 patients, BiPAP/CPAP/HFNC also carry a risk of aerosolization and further spread of the virus and should be [avoided for this reason](https://www.wfsahq.org/resources/coronavirus) if possible. Therefore, while this is clearly an insufficient long-term option with an undesirable risk profile, NIV might play a temporary role when ventilators are not readily available.

### **Proning non-ventilated patients**

There is good evidence that laying ventilated ARDS patients on their abdomens (proning) [improves outcomes](https://www.nejm.org/doi/10.1056/NEJMoa1214103?url_ver=Z39.88-2003\&rfr_id=ori:rid:crossref.org\&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov). There are physiological reasons for the benefits of proning, such as improving ventilation perfusion (VQ) matching by reducing the dorsal ventral transpulmonary [pressure difference and improving perfusion](https://www.atsjournals.org/doi/pdf/10.1164/rccm.201308-1532CI). This has prompted some providers to attempt proning non-ventilated patients. In a retrospective analysis, prone positioning for nonintubated patients with hypoxemic respiratory failure has been [shown to improve oxygenation](https://www.sciencedirect.com/science/article/abs/pii/S0883944115003755?via%3Dihub). Therefore, it may be helpful to consider placing ventilated and non-ventilated patients with ARDS due to COVID-19 in the prone position to improve oxygenation, especially in the setting of limited resources for ventilation. Proning patients does, however, [carry risks](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4173887/), such as unintentional extubation, arrhythmias, falls, loss of a central venous line or peripheral venous line, and airway edema. To try to mitigate these risks, some checklists have been published to improve safety prior to and during prone maneuvers: [Oliveira et al. *Rev Bras Ter Intensiva*. 2017](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5496747/).

### **Multiple patients on one ventilator**

Many critical care or anesthesia physician, nursing, and allied health professional organizations have released a joint statement to advise against sharing one ventilator amongst multiple patients due to the current technological limitations in being able to do so [safely](https://www.apsf.org/news-updates/joint-statement-on-multiple-patients-per-ventilator/?utm_source=facebook\&utm_medium=paidsocial\&utm_campaign=2020+Automated+Promoted+Posts\&fbclid=IwAR2acGhsp4TvtBAjMbhJMfMAwOSDBzYehocxCZje6YJZ9trwRdN6iSxB50s). This joint statement outlines many issues with ventilator sharing, including the need for external monitoring of patients, difficulty managing PEEP levels in multiple patients at once, difficulty with alarm management, ethical issues, and more. The societies that authored this joint statement believe that it would be [dangerous to consider ventilating multiple patients](https://www.apsf.org/news-updates/joint-statement-on-multiple-patients-per-ventilator/?utm_source=facebook\&utm_medium=paidsocial\&utm_campaign=2020+Automated+Promoted+Posts\&fbclid=IwAR2acGhsp4TvtBAjMbhJMfMAwOSDBzYehocxCZje6YJZ9trwRdN6iSxB50s) on the same ventilator settings, as this would increase the risk for all patients involved when there is an already 40-60% mortality rate for an ARDS patient on a single ventilator in an ideal setting. However, in light of resource limitations seen during the COVID-19 pandemic, some have opted for this controversial and non-evidence-based practice; physicians have already initiated ventilator sharing between two patients with similar ventilatory requirements at [New York](https://www.nytimes.com/2020/03/26/health/coronavirus-ventilator-sharing.html) [Presbyterian](https://www.nytimes.com/2020/03/26/health/coronavirus-ventilator-sharing.html) [Hospital](https://www.nytimes.com/2020/03/26/health/coronavirus-ventilator-sharing.html). On March 31, 2020, the U.S. Surgeon General issued [technical guidance](https://www.hhs.gov/sites/default/files/optimizing-ventilator-use-during-covid19-pandemic.pdf) on co-ventilating two patients but endorsed this only as the absolute last resort, when the alternatives are either death or manual long-term bag-valve mask ventilation for patients.

### **Bag-valve mask**

In some resource-limited settings or disaster resource settings, long-term “hand bagging” or manual bag-valve-masking may be the only option. [Medical students](https://www.ncbi.nlm.nih.gov/pubmed/20066642), [nurses](https://www.ncbi.nlm.nih.gov/pubmed/30640219), or even non-medical professionals such as family members or the [National Guard](https://www.cnbc.com/2020/03/28/coronavirus-new-york-orders-thousands-of-manually-operated-pump-ventilators.html) may be required to bag-valve mask patients for extended periods of time if there is a shortage of ventilators. There is an increasing likelihood of needing to bag-valve-mask ventilate patients for extended periods of time during the COVID-19 pandemic. However, bag-valve-mask ventilation is considered an aerosolizing procedure and should ideally be done by providers who are wearing PPE that provides protection against [aerosol transmission](https://www.ncbi.nlm.nih.gov/books/NBK174441/) of COVID-19 ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html)).

### **Rationing and resource allocation**

The ethics of rationing and resource allocation are further discussed in [Mod](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19)[ule 8](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19).

*Thought Questions:*

* If you were a country with a low current burden of COVID-19, how would you make the decision to regulate trade of importing/exporting ventilators?
  * Helpful resources: [India’s response](https://www.indiatoday.in/india/story/coronavirus-in-india-government-bans-export-of-ventilators-and-sanitizer-1659203-2020-03-24), [brief description of responses of other European countries](https://www.politico.com/newsletters/morning-trade/2020/03/24/export-restrictions-threaten-ventilator-availability-786327), [China’s response](https://global.chinadaily.com.cn/a/202003/27/WS5e7d50cea3101282172825f2.html)
* What are possible innovations that could make extended use of the bag valve mask a more feasible alternative to ventilators?
  * Helpful resources: [Technology from Rice University and Metric Technologies](https://news.rice.edu/2020/03/27/ventilator-costing-less-than-300-developed-by-rice-university-and-metric-technologies-2/), [MIT E-vent](https://e-vent.mit.edu/), [Umbulizer](https://innovationlabs.harvard.edu/current-team/umbulizer/) (low cost ventilators)


# Space

Availability of and access to clean and sanitary environments to test, treat, and isolate patients as well as living spaces conducive to limiting disease spread.

In this section, we focus on the third component of the 4 S framework: “space.” This component relates to the presence or absence of physical structures or constraints that can affect health outcomes. Space presents a double challenge in COVID-19. First, spaces that facilitate social distancing or shelter-in-place are needed, a challenging prospect in some densely populated, lower-income communities. Second, for positive or suspected cases of COVID-19, there must be a dedicated safe facility for diagnosis, treatment, and isolation. These facilities will prevent further community spread and keep providers safe from acquiring or transmitting the infection.

## Challenges Following Public Health Recommendations in LMIC Communities

As discussed in [Module 2](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles) and [Module 3](https://curriculum.covidstudentresponse.org/module-3-current-situation-and-healthcare-response), the most widely-used interventions to reduce the spread of COVID-19 are social distancing among asymptomatic individuals and quarantine for those with confirmed or suspected infection. Implementing these interventions is particularly challenging in countries where the economy and governmental social supports are less robust. Due to a long history of colonialism and chronic lack of investments in poor communities, many remain economically vulnerable. This concept can be described as [structural violence](https://pdfs.semanticscholar.org/048d/d6fa65e90f610d24ba604f2c97f752d9f5c2.pdf), a systemic form of indirect oppression which creates poverty and steep grades of persistent inequity that are very challenging to escape. The economic effects of social distancing or shelter-in-place directly [affect the income of economically vulnerable populations](https://www.undp.org/content/undp/en/home/news-centre/news/2020/COVID19_Crisis_in_developing_countries_threatens_devastate_economies.html) and decrease government budgets through decreased tax revenue.

Well-resourced individuals in a given society may have larger homes or options to more easily self-isolate and, thus, prevent transmission even within the same household. In contrast, for those disproportionately living in crowded environments or impoverished areas, it may be more common to live in smaller dwellings with poor ventilation and many people, including extended family. These close-living conditions in densely populated areas are a risk factor for respiratory diseases like COVID-19 that are [transmitted ](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/basic-virology-and-immunology#transmission-dynamics)by respiratory droplets and contact with contaminated surfaces. In camps of asylum-seekers near the U.S.-Mexico border, residents in the tight living conditions have been encouraged to adopt [“head-to-toe” sleeping arrangements](https://www.dropbox.com/s/nviaa1sn752psqs/DurantPanel3.mp4?dl=0) to avoid transmission during sleep. In India, those living in crowded urban settlements [do not have anywhere to go](http://theconversation.com/indias-stark-inequalities-make-social-distancing-much-easier-for-some-than-others-134864) that would enable them to socially distance. In a [densely populated favela in Brazil](https://www.dw.com/pt-br/em-parais%C3%B3polis-moradores-ignoram-pandemia/a-53047778), Paraisopolis, with 45,000 people/km², 8 in 10 residents need to leave the favela to buy food or hygiene products and most share tight living spaces with many other people. As an additional complication, the WHO estimates that 40% of the global population [(3 billion people) do not have access to soap and water](https://www.who.int/water_sanitation_health/monitoring/coverage/en/) for hand-washing, a critical preventive measure against COVID-19.

![Paraisopolis favela (left) and Morumbi district (right). Source: Jornal de Brasilia](/files/-M4_0Bv4ySCkO8DnM9IL)

For individuals living in poverty or those who have no financial buffer, quarantine adds to the [toll ](https://curriculum.covidstudentresponse.org/module-3-disparities-policy-socioeconomic-effects/socioeconomic-ramifications#impact-on-work-small-businesses-essential-workers-and-unemployment)that COVID-19 and other pandemics can take. With many workers in service industries, including street vendors or food workers, social distancing or quarantine makes it impossible to earn their living. In Paraisopolis, Brazil, 56% of residents [only have enough resources for food for one week](https://www.dw.com/pt-br/em-parais%C3%B3polis-moradores-ignoram-pandemia/a-53047778) without donations or returning to work. Basic living requirements like food, water, and rent can lead service workers to come to work despite public health recommendations and risk of infectious transmission. After learning of the government's proclamation that they will be forcing people to stay at home, one resident of Somaliland said, “Hunger can kill me first before COVID-19.” Residents in India are making similar decisions as well as attempting to [avoid police brutality](https://www.pbs.org/newshour/world/police-struggle-to-enforce-indias-sweeping-virus-lockdown). These examples illustrate the impossible decisions being weighed by those affected by the COVID-19 pandemic around the world.

In addition to these economic drivers, cultural and religious factors also influence the response to public health measures. For example, in countries with strong and widespread religious beliefs, there are often daily or weekly gatherings in [churches](https://www.npr.org/2020/03/13/815502396/churches-grapple-with-whether-to-suspend-worship-services), [mosques](https://www.theguardian.com/world/2020/mar/17/iranian-police-shrines-coronavirus), and prayer centers that are disrupted by these public health measures.

LMICs are at particularly high risk for severe social unrest during the COVID-19 pandemic as people struggle to fulfill their essential needs and then find themselves in conflict with local authorities who are enforcing lock-down measures. These conflicts have already arisen in some places including [Kenya](https://www.hrw.org/news/2020/03/31/kenya-police-abuses-could-undermine-coronavirus-fight#) and [South Africa](https://www.bbc.com/news/world-africa-52125713). Such unrest could undermine public trust and complicate future public health measures that may be required to combat COVID-19 in these settings. In order to coordinate an effective response to COVID-19, addressing the challenges of living spaces and basic needs of citizens will be critical to enable individuals to follow public health recommendations.

*Thought Question:*&#x20;

* What essential community locations would be highest risk for COVID-19 transmission and how could those be changed to support public health recommendations?

### Mobile food markets

To highlight how one country has responded to this emerging tension between essential needs and national quarantines, we turn to the example of decentralizing the traditional Palengke market model in the Philippines. Palengke is a Filipino term referring to a market that sells essential produce and other groceries at cheaper price points compared to supermarkets across the country. These markets are frequented mostly by low-to-middle-income households, regularly leading to crowding that undermines physical distancing measures.

![Mobile Palengke (Mobile Wet Market), Philippines.  From Mayor of Pasig City @VicoSotto](/files/-M4_0Bv5Mu2KlLDZRKmX)

The **mobile markets** initiative was created by a local government unit wherein multiple trucks make daily rounds around neighborhoods and cities to sell essential goods. With items such as fruits, vegetables, meat, and poultry available closer to homes, crowding is reduced. The [decentralization of the *palengke* ](https://www.rappler.com/nation/255710-pasig-launches-mobile-palengke-coronavirus-lockdown-march-2020)ensures both social distancing and food security.

Other municipalities in the region have begun adopting unique versions of this initiative, helping citizens adapt to social distancing regulations. An example is [Valenzuela City](https://www.rappler.com/nation/256255-valenzuela-replicates-pasig-mobile-palengke) which, instead of trucks, made use of e-*tricycle*s (motorbikes fabricated with passenger carts) to cater to residents in regions of town not accessible to large vehicles. Local government efforts and other so-called “emergency trading centers” are now being recommended by industry groups that seek protection for farmers who need to sell their harvest.

## ‘Space’ Challenges in Diagnosis and Treatment

**Diagnostic testing facilities** are a critical part of the response to COVID-19. They must protect the healthcare professionals who are performing the testing, prevent transmission to uninfected people coming to be tested, and manage sufficiently high throughput to keep up with testing needs.

*Thought Questions:*&#x20;

* What types of testing facilities have you heard used in high income countries? What unique challenges might LMICs be likely to encounter?

### **Testing innovations**

**Drive-through testing centers** were made popular in [South Korea](https://www.cnn.com/2020/03/02/asia/coronavirus-drive-through-south-korea-hnk-intl/index.html) and are now being used across the [U.S.](https://time.com/5811061/drive-thru-coronavirus-testing-workers/) and Europe. There are many advantages to this approach. First, patients can use the air recirculation within the car, so even in close proximity there is minimal exposure for healthcare workers and other poeple being tested in their own automobiles. Additionally, there is no possible interaction with others in parking lots or hallways where transmission could occur. The throughput is high, since no cleaning of surfaces or air space is needed between patients; new patients are evaluated every 2-5 minutes. However, a major disadvantage of drive-through testing is that it requires participants to have cars. In heavily-affected urban centers, many people rely on public transit. Lower-resourced communities in the U.S. or internationally are also less likely to have vehicle access. To serve the needs of these communities, an alternative testing strategy is required.

**Walk-in testing centers** were also developed in South Korea using an innovative [phone-booth method](https://www.youtube.com/watch?v=A-33i9B8m6E). The patient and provider are on opposite sides of a transparent barrier. Using reusable gloves, the provider swabs the patient’s oropharynx and nasopharynx, then the provider transports the sample to the lab nearby. These booths are much easier and faster to clean than a conventional room, with a turn-around time of only 10 minutes per patient. Similar methods are being considered in other HICs and may have a role to play in LMICs as well. For more detail on South Korea’s innovations, see [Module 2](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/case-study-south-korea-2020).

![“Phone-booth” testing method, South Korea.](/files/-M4_0Bv6asw_CuhCSR0Z)

### **Treatment center innovations**

Based on optimal infection prevention and control (IPC) measures, every patient exhibiting COVID-19 symptoms should be isolated in a single-occupancy, negative-pressured room. However, this ideal has become unattainable as the pandemic has begun to overwhelm healthcare facilities worldwide. Cases requiring screening, hospitalization, and critical care are projected to far exceed existing capacity in LMICs and HICs alike. Low-income countries may be especially hard-hit, as they are estimated to have both significantly [fewer hospital beds and ICU beds per](https://www.preventionweb.net/publications/view/71077) [capita](https://www.preventionweb.net/publications/view/71077). Given these critical shortages in hospital space and beds, alternative strategies must be pursued to physically isolate, test, and treat patients with COVID-19. Several innovations are presented below for possible adaptation in a resource-limited setting.

[Build Health International](https://www.buildhealthinternational.org/) (BHI), a nonprofit developing sustainable health infrastructure in multiple LMICs, has generated [site plans, design drawings](https://www.buildhealthinternational.org/covid-infrastructure-resources/), and [blueprints](https://drive.google.com/file/d/1vZD3cSuUuOERhqlNn9koFPiuU1FgGuDo/view) for a COVID-19-focused screening and treatment center potentially deployable in many resource-limited communities. The center would be dedicated to triaging and treating patients with COVID-19 symptoms and would be built as either a standalone facility or an adjunct to current medical facilities (Walton, [MGH Durant Technical Panel](https://bit.ly/durantsession2)).

![BHI COVID-19 testing and treatment center prototype for resource-limited settings.](/files/-M4_0Bv7S8MinfCjTOWF)

Many features of this center balance IPC and patient care with space and resource constraints. Patient wards would contain beds spaced 0.9-1.8 m (3-6 ft) apart, separated by partitions to limit cross-transmission. Windows installed above beds would provide natural ventilation and airflow–a practical alternative to negative-pressure wards. Oxygen would be delivered via cylinders or concentrators if power is available. Overall, this center could enable large-scale cohorting, isolation, and treatment of patients with COVID-19. Located beyond the confines of existing clinics and hospitals, it would not only relieve overcrowding at those facilities but also minimize exposure of non-COVID-19 patients and healthcare personnel to the virus.

Similarly, in Metro Manila, the [most densely populated](https://psa.gov.ph/content/philippine-population-density-based-2015-census-population) region in the Philippines, community volunteers and local architects have mobilized to design and build [emergency quarantine facilities](https://bluprint.onemega.com/covid-19-emergency-quarantine-facility-filipino-architects/). These will house patients with presumptive COVID-19 who cannot be accommodated in area hospitals, several of which have already reached capacity. Critically, these facilities enable patients to self-isolate away from family and crowded living quarters at home. The project team has also provided [blueprints](https://drive.google.com/drive/u/0/folders/1VKTAs6Ly2Hz9MyVrAPVOZUmumvWZBsXT) for building these facilities from plastic sheeting and wood frames.

![Emergency quarantine facility designed for the Philippines (WTA Architecture and Design Studio)](/files/-M4_Fyzg6FrGHi8-RGgZ)

A number of other countries have begun adopting similar practices, with temporary triage and treatment facilities emerging, for example, in [Italy](https://www.pbs.org/newshour/health/not-a-wave-a-tsunami-italy-hospitals-at-virus-limit), the [U.S](https://www.cbsnews.com/news/coronavirus-central-park-ny-field-hospital-covid-19/)[.](https://www.cbsnews.com/news/coronavirus-central-park-ny-field-hospital-covid-19/), the [Gaza Strip](https://www.bbc.com/news/world-52089337), and [Haiti](https://externalmediasite.partners.org/Mediasite/Play/32e533c7740f45e99c97eaad74c319d71d). Countries are also converting existing large-capacity buildings into temporary hospitals. Convention centers and stadiums in [New York](https://www.governor.ny.gov/news/amid-ongoing-covid-19-pandemic-governor-cuomo-announces-completion-first-1000-bed-temporary), [Tehran](https://www.bbc.com/news/world-52089337), [London](https://www.wired.co.uk/article/nhs-nightingale-excel-centre-hospital-london), and [Sao Paulo](https://www.bbc.com/news/world-52089337), among other cities, have been fitted with thousands of beds in anticipation of accommodating dramatic surges in COVID-19 patient cases. Other facilities, including a [stadium](https://www.youtube.com/watch?v=r9eMuNgXvhU) in Lagos, Nigeria, [hotel rooms](https://ktla.com/news/coronavirus/l-a-county-officials-provide-update-on-covid-19-cases/) in Los Angeles, and [train coaches](https://www.aljazeera.com/news/2020/04/india-turns-trains-isolation-wards-covid-19-cases-rise-200402071515155.html) in India, are being converted into large-scale isolation wards for patients being evaluated for COVID-19 or for healthcare workers undergoing self-quarantine after potential exposure to the virus.

The approaches above still have multiple potential limitations. Building field hospitals or retrofitting existing buildings requires intense mobilization of labor, construction materials, funding and engineering expertise. In order to access these resources on short notice, communities must often secure considerable support from local and national governments, or partner extensively with nonprofits/NGOs. Additionally, while these solutions significantly increase isolation and treatment capacity, they do not directly address how to adequately staff and equip these facilities. This in itself poses a considerable challenge, given that medical personnel and supplies are already scarce in most resource-constrained settings. Finally, given ongoing presymptomatic (or asymptomatic) viral transmission (see [Module 2](https://curriculum.covidstudentresponse.org/module-2-epidemiology-principles/where-are-we-now#asymptomatic-transmission)), coupled with continued limitations in testing availability (see [Module 3](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/clinical-presentation-of-covid-19#united-states-testing-capacity) for U.S. example), it has proven difficult to effectively isolate all true COVID-19 cases from the general population or from other patients. As a result, even if triage and treatment centers are designed as dedicated COVID-19 facilities, there can still be a significant risk of disease cross-transmission within these centers and in the community at large.


# Systems

Infrastructure, logistical organization, and governance required to ensure the effective delivery of quality health care.

The final component of the 4 S framework focuses on “systems,” or the infrastructural and logistical organization required to ensure the effective delivery of high-quality health care. Much has been written regarding the importance of [health systems strengthening](https://www.who.int/healthsystems/strategy/en/), especially in resource-limited settings that have been disproportionately neglected historically. Prior outbreaks, including the 2014 Ebola epidemic in West Africa, have also demonstrated the acute importance of [prioritizing](https://www.ncbi.nlm.nih.gov/pubmed/27688219) health system strengthening in the most vulnerable and resource-constrained communities.

Thus far, the COVID-19 pandemic has already placed HICs under [unprecedented strain](https://www.politico.com/states/new-york/albany/story/2020/03/31/everybodys-in-the-same-boat-coronavirus-drives-new-yorks-hospitals-to-breaking-point-1269943). This has only elevated [concerns](https://jamanetwork.com/journals/jama/fullarticle/2763372) about the [potentially catastrophic effects](https://www.pih.org/article/dr-paul-farmer-axios-remember-caregivers-amid-coronavirus-response) that COVID-19 could have on LMICs, which are already resource-limited at baseline. The acute threat that COVID-19 poses for chronically underfunded and fragile health systems could exacerbate the vulnerabilities faced in these settings. Nonetheless, the broader systems in place in these settings that have prioritized effective “containment” strategies have shown some promise, implementing lockdowns from [Nigeria](https://www.reuters.com/article/us-health-coronavirus-nigeria/africas-biggest-city-lagos-locks-down-to-defend-against-coronavirus-idUSKBN21I1Z9) to [Rwanda](https://www.usnews.com/news/world/articles/2020-03-11/rwanda-keeping-coronavirus-at-bay-with-campaign-of-public-handwashing) to [South Africa](https://www.bbc.com/news/world-africa-52058717). Further, initiatives such as the [African Task Force for Coronavirus Preparedness and Response](https://www.un.org/en/africa/osaa/statements/statement1.shtml) model have been adopted to provide a continental response to COVID-19, demonstrating the potential that a united front can improve collective capacity for diagnostics, cross-border activity policy, supply-chain management, and effective social distancing measures. Nonetheless, there is concerning evidence from a recent [182-country analysis](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30553-5/fulltext) that there is great variability in each country’s capacity and preparedness to prevent, detect, and respond to outbreaks in general, which something as acute and pervasive as COVID-19 will likely further unveil.

The following five cases help to elucidate lessons learned from prior public health crises, underscoring the need for continual investment in health system strengthening; unique adaptation of interventions into different social, cultural, and political environments; and prospects for stronger international collaborations to assure improved global readiness for pandemic threats such as COVID-19 and those to come.

## *Case Study #1: Cholera epidemic in Haiti*

Haiti is [the poorest country in the Western Hemisphere](https://data.worldbank.org/indicator/NY.GDP.PCAP.CD?locations=ZJ-CL). It has the highest population density in the region and insufficient sanitation for many of its citizens. In 2010, this situation was exacerbated by the catastrophic earthquake and subsequent political crises. Consequently, the country’s health and economic infrastructures were devastated. One and a half million people lost their homes, leading to the construction of temporary sheltered camps with poor or no access to clean water. This is the context in which, nine months later, the cholera epidemic emerged.

On October 18, 2010, the Haitian Ministry of Health (MSPP) was notified of an alarmingly high number of cases of individuals with watery diarrhea. Fearing a cholera epidemic, Haitian investigators were sent to the area where they identified the first families affected, performed laboratory tests, and [confirmed the causal agent to be a serotype of *Vibrio cholerae*.](https://wwwnc.cdc.gov/eid/article/17/7/11-0059_article#r3)

The MSPP responded immediately to the situation. A surveillance system and other public health measures were established early on. New emergency treatment centers were established, with 95% testing rates resulting in a [flattening of the mortality curve within 3 months of the first reported case](https://www.nejm.org/doi/full/10.1056/nejmoa1204927). The last cholera case was reported in January 2019. The elimination of cholera in Haiti will be officially recognized by the World Health Organization [if no new cases are declared within two more years](https://news.un.org/en/story/2020/01/1056021). The lessons learnt during this cholera outbreak offer some guidance into public health interventions utilized during an epidemic in low-resource settings and may assist in the fight against COVID-19.

Battling cholera in Haiti was a significant public health challenge due to a variety of contextual constraints. Clean drinking water, proper handwashing and practicing hygienic defecation were [key to stopping the spread of the disease.](https://www.cdc.gov/cholera/prevention.html) However, [approximately half of the Haitian population did not have access to clean water or proper sanitary installations.](https://openknowledge.worldbank.org/handle/10986/28997) The Haitian government and partners understood that it would be ineffective to ask the population to use resources they were unable to access and that providing access to these basic services was an essential component of the overall response to the epidemic. They organized an education campaign on water and sanitation coupled with distribution of chlorine water purification tablets. In addition, a task force including NGOs and government, under the leadership of the local National Department of Drinking Water and Sanitation, [was established to increase access to clean water and sanitation](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3310587/). Although numerous international investments were pledged, [many did not come to fruition](https://www.lessonsfromhaiti.org/assistance-tracker/) which further complicated efforts to combat the spread.

The cholera epidemic in Haiti highlights the necessity for governments and partners to provide investments during this time of COVID-19 and beyond that assure essential, basic needs are met and individuals have improved agency to follow public health recommendations. As was highlighted in this cholera case study, each country must take into consideration specific challenges related to the local context, which may require going beyond the standard recommendations and the need for adaptation.

## *Case Study #2: HIV in Malawi*

Malawi is one of the 25 poorest countries in the world and has [high HIV seroprevalence](http://f1000.com/work/citation?ids=8565524,8558279\&pre=\&pre=\&suf=\&suf=\&sa=0,0) (9.2% in 2018). In the 30 years following the first case of HIV confirmed in 1985, nearly [850,000 Malawians died of AIDS](https://paperpile.com/c/smTqeN/BJ7u). At the peak of the epidemic in the 1990s and early 2000s, the government of Malawi mobilized domestic and international partnerships and implemented its first National HIV and AIDS Policy in 2003, which mandated its National AIDS Commission to administer a multisectoral “public health-based response that integrates principles of prevention, treatment, care, support, and impact mitigation as mutually reinforcing elements of a comprehensive response to HIV/AIDS."

Despite these commitments, the epidemic claimed many lives, hampering human capacity, agricultural productivity, and economic development in the country. Consequently, the national HIV response in Malawi was crippled by critical workforce shortages, inadequate health facilities, and poverty. With fewer than [200 physicians nationwide](https://www.who.int/workforcealliance/knowledge/resources/hrh_profile_malawi/en/), the health system relied heavily on non-physician cadres like Health Surveillance Assistants (HSAs, similar to CHWs), Nurses and Midwives, and Clinical Officers. Thus, the national program remained predominantly donor-funded.

Through incremental policies to strengthen its public health infrastructure, Malawi's Ministry of Health began to decentralize its antiretroviral treatment (ART) programs in 2004 and scale up into a coordinated national response, which enabled more efficient HIV testing, counseling, and treatment in accordance with World Health Organization (WHO) guidelines. These initiatives [reduced and stabilized](https://www.who.int/workforcealliance/knowledge/resources/hrh_profile_malawi/en/) adult HIV prevalence (16% at peak and 10.6% in 2010), although disease burden remained higher in women (13%) than in men (8%).

Still, Malawi operated an independent prevention of mother-to-child transmission (PMTCT) program, which objectively lagged far behind the ART program. PMTCT in Malawi and many high-burden LMICs suffered poor patient enrollment, high attrition rates, and logistical inefficiencies despite increased resource allocations. Complex WHO guidelines made PMTCT much more challenging compared to the simplified regimens available in HICs. Acknowledging the realities of its failing PMTCT program and incorporating lessons from the relative success of the ART program, Malawi pioneered a pragmatic and progressive modification to the WHO guideline for PMTCT in 2010 by recommending voluntary lifelong HIV treatment for all HIV-positive pregnant and breastfeeding women as a means to prevent new infections in a high-fertility LMIC (Option B+). They integrated PMTCT into the ART program, integrated antenatal and ART data into a unified registry, and scaled up logistics and supply chain systems to allow access in remote communities. To address human resource needs, the new Option B+ PMTCT/ART program adopted task-shifting initiatives, which trained and allowed HSAs to perform testing and simple laboratory testing in antenatal clinics. Additionally, the Ministry of Health formulated new national HIV treatment guidelines to integrate all aspects of testing, treatment, counseling, and mental health services. This new regimen was highly successful, leading the WHO to recommend Malawi’s Option B+ in their subsequent guidelines.

While HIV remains highly prevalent in Malawi, this feat in the global HIV narrative highlights several systems-level health delivery lessons for today’s COVID-19 and other emerging public health threats. The challenges revealed by the global COVID-19 pandemic, like availability of test kits, PPE, staff shortages, and economic disruptions, have the potential to be exacerbated in resource-limited settings such as Malawi. However, the HIV response in Malawi serves as a concrete reminder for how public health strengthening with data-driven initiatives, flexible human resource management and task shifting, and coordinated and decentralized logistics can help to mitigate the burden of suffering.

## *Case Study #3: Ebola in the Democratic Republic of Congo*

The Democratic Republic of Congo (DRC) is a large African state bordered by central, eastern, and southern African states. [Although the DRC is home to vast arable lands and numerous minerals, it ranks among the poorest countries in the world](https://www.worldbank.org/en/country/drc). The roots of this incongruence can be traced back to its colonial history. The DRC was first colonized as a personal estate of the Belgian crown, King Leopold, among the starkest examples of [colonial extraction](https://www.youtube.com/watch?v=alg33ey4ejo). Despite achieving independence in 1960, the DRC had never known a democratic transition until 2019. [The Congolese people had grown up in a country with USD $24 trillion worth of untapped resources](https://en.wikipedia.org/wiki/Mining_industry_of_the_Democratic_Republic_of_the_Congo) but with most of them living on less than USD $2 per day. There was optimism within the country about the anticipated democratic transition. However, in 2018, an Ebola outbreak began in the eastern regions of the DRC. After consulting with international partners and public health experts, the government decided against including the regions affected by Ebola in the much-anticipated nationwide vote. This decision, although reasonable from a public health standpoint, meant that over one million Congolese could not participate in choosing their president. Importantly, these regions were loyal to one of the opposition candidates, Martin Fayulu. When Martin Fayulu lost the election, as expected, people cried foul play. What ensued was political and medical anarchy. [Locals accused Ebola response teams](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(19\)30002-9/fulltext) of being part of a conspiracy. The [instability laid the ground for attacks](https://www.nejm.org/doi/full/10.1056/NEJMsr1904253) on Ebola outposts and members of the response team.

As a lesson for the current COVID-19 outbreak, it is imperative to take into consideration the social, economic, and political reasons for which some members of the public might not be [willing nor able](https://www.npr.org/sections/coronavirus-live-updates/2020/03/27/822559830/in-kenya-security-forces-attack-ferry-passengers-trying-to-make-coronavirus-curf) to abide by national public health recommendations. At the same time, it is important to uphold the public’s ability to continue to participate in political decision-making. Government policies related to the pandemic must be informed by the socioeconomic, political, and cultural context in which they are implemented.

## *Case Study #4: Diversion of Health System Resources, Ebola in West Africa*

It is important to also consider the downstream health effects of social distancing efforts during a pandemic. One poignant example is the increase in maternal mortality that was seen both during and after the 2014 Ebola crisis that promulgated throughout West Africa. A [study in Liberia](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515570/) found a 50% decrease in antenatal care access and a 33% decrease in reported deliveries, as well as a significant decrease in deliveries and Cesarean sections done by skilled birth attendants. Healthcare facilities diverted resources to fighting Ebola and women avoided them due to the Ebola risk. A similar [study in Sierra Leone](https://gh.bmj.com/content/1/3/e000065), a country with the world’s highest maternal mortality ratio, also showed decreases in antenatal services, postnatal visits, and healthcare facility-based births, along with a 34% increase in maternal mortality for those who gave birth at healthcare facilities. Overall, throughout the Ebola epidemic, fewer women accessed healthcare facilities, and the women who did also experienced higher rates of mortality. This does not account for the increase in maternal mortality due to the increase in home births. Countries with high baseline maternal mortality ratios also experienced some of the worst increases in maternal mortality, perpetuating existing patterns of systemic injustice.

In HICs, where a high proportion of deliveries are conducted at healthcare facilities, the COVID-19 pandemic is likely to lead to an unprecedented shift in presentations. With emerging hospital policies preventing partners from attending births and the significant fear around being at healthcare facilities, we may see a rise in home births, including amongst women who may live too far from a healthcare facility should they encounter an emergency at home. It is important that we learn from the challenges faced by women and the healthcare system during the Ebola crisis and work to prevent a devastating increase in maternal mortality during the COVID-19 pandemic. Additionally, we must think creatively about the challenges the many overburdened healthcare systems around the world are encountering, not just in caring for COVID-19 patients, but all patients.

## *Case Study #5: Supply Chains*

As has been suggested throughout this curriculum, there is a wealth of media coverage, hospital policy changes, and national debate regarding the [lack of the medical necessities](https://www.cnn.com/2020/03/21/politics/supply-chain-issues-fema-hhs/index.html) (e.g. PPE, tests, hospital beds, ventilators) required to combat a pandemic of this nature. While many of these reports focus on the “stuff” in the 4 S framework, the supply chain required to produce and distribute this “stuff” requires a “systems”-level focus. Why are medical systems not able to get the “stuff” that they need? The root of the problem is often a weakness in the **supply chain**, or the sequence of processes involved in the production and distribution of a commodity.

In the US, supply chain weaknesses have manifested in a number of ways; masks and hospital beds are two examples. [With masks](https://www.nytimes.com/2020/03/31/podcasts/the-daily/coronavirus-medical-supplies-shortages.html?showTranscript=1), most manufacturing was moved abroad, largely to China, over two decades ago to decrease costs of production. As long as predictions for demand were accurate (e.g., projections on cases of influenza per year, number of procedures over a specific time frame) this move appeared to be a prudent business decision. However, such a supply chain has broken down in crisis. In China, where the pandemic hit first, mask production was slowed, and they also needed to preserve more of this locally-produced supply amidst the crisis. There were additional [political tensions](https://www.nytimes.com/2020/03/23/business/coronavirus-china-masks.html) surrounding trade that further complicated the supply chain of masks. [Factories in the US](https://www.wsj.com/articles/clothing-brands-are-now-producing-medical-gear-but-does-it-work-11585915251) are being converted to mask production, but there will be a delay to convert operations before mass production is possible.&#x20;

The shortfall in surge capacity arises not only from spread-out manufacturing but also from deliberate limitations to hospital capacity. The number of hospital beds in the U.S. has [decreased](https://www.nytimes.com/2020/03/31/podcasts/the-daily/coronavirus-medical-supplies-shortages.html?showTranscript=1) by about half a million over the last 50 years. One aspect leading to decreasing beds has been medical or surgical improvements that shortened hospital stays, but it also involved regulations on the ‘business of healthcare.’ More beds usually meant more income for hospitals, so there was increasing governmental regulation. Hospitals now often function at \~95% capacity, especially during influenza season. While decreasing beds may help to decrease costs, it can also negatively impact the ability of a city, state, or country to respond, especially when local surge capacity plans fail to adequately estimate the demand that a pandemic of this nature may require. \
\
In Brazil, for example, the medical supply chain is facing significant challenges during this pandemic. Initially, according to the Health Minister, some state-imposed quarantine measurements [prevented transportation of essential medical supplies](https://www.poder360.com.br/governo/mandetta-critica-governadores-que-decidiram-fechar-rodovias-e-aeroportos/), including oxygen. Subsequently, the government ensured that airports and main highways remained open to deliver and distribute medications, products, and supplies. Like most countries, Brazil is also facing high demand for PPE and other products, and international supply chains are becoming more expensive given high global demand. Thus, many national industries are changing their production lines to make PPE and medical products. For example, [a Brazilian brewing company](https://economia.uol.com.br/noticias/estadao-conteudo/2020/04/07/ambev-fabricara-e-doara-3-milhoes-de-mascaras-de-protecao-facial-feitas-com-pet.htm) will make more than 3 million face shields and 1 million units of alcohol gel. [Vehicle or plane assembly companies, paper companies, and a technology company](https://www.reuters.com/article/us-health-coronavirus-brazil/brazil-turns-to-local-industry-to-build-ventilators-as-china-supplies-fail-idUSKCN21Q393) organized themselves to produce ventilators in a large-scale collaboration project. Hospitals are creating [crowdfunding](https://www.charidy.com/vempraguerra) to buy the appropriate materials and products. Also, universities are working together to produce better, fast, and/or low-cost [tests, masks, and ventilators](https://www.dw.com/pt-br/universidades-brasileiras-se-adaptam-para-responder-%C3%A0-pandemia/a-53073888). At the same time, they are producing alcohol gel and test kits. Makerspaces and engineers are working together to print 3D materials to [fix hospital equipment](https://docs.google.com/forms/d/e/1FAIpQLScfUj-bM_PQ1KI4FIFcsvy4bgYMYpnYRShfCECmjsQ4qywr5A/viewform). Companies, investors and associations also united to congregate [different solutions](http://www.sos-covid19.com/) in one place and to make it easy to donate, help, ask for help, and share on social media.

Supply chain challenges are likely to continue for the duration of the pandemic. While they have affected HICs profoundly, LMICs are likely to face equal or greater challenges. When bidding becomes internationally competitive, those with the most money are likely to win the needed supplies. Internationally, the U.S. has already been accused of [out-bidding its allies](https://www.vox.com/2020/4/4/21208250/coronavirus-trump-canada-germany-spain-brazil), including Brazil, France, and Germany. This bidding war is also happening [inside the U.S.](https://www.usnews.com/news/best-states/articles/2020-04-07/states-compete-in-global-jungle-for-personal-protective-equipment-amid-coronavirus) as states compete against each other and the federal government for the same PPE supplies, raising concerns that wealthier states will fare better than smaller, poorer states. Challenges with supply chains are likely to continue for months and will encompass the availability of PPE, ventilators, test kits, and vaccines. They will continue to play a key role in the COVID-19 pandemic, and will likely determine who gets essential resources and who does not.

*Thought Questions:*&#x20;

* How could the U.S. and Brazil change their supply chains to be better prepared for a pandemic in the future?
* If you were in the government, what regulations would you put on the make-shift supply chains of essential medical supplies to ensure their quality?

In summary, these diverse systems-level case studies illuminate lessons from prior epidemics. They emphasize the importance of considering the political, economic, and social history within a setting that affects a health system’s ability to function and a government’s ability to govern in the setting of an outbreak. They further provide examples of how systems – such as robust supply chains – are needed for the current crisis and beyond. Looking ahead, it is promising that innovations exist not only to educate individuals, but also to provide the support needed to implement acquired knowledge. As COVID-19 continues to evolve, there will be important systems-level lessons to learn, including the tradeoffs between a more centralized versus decentralized approach to implementation and the tradeoff between individual rights and public health measures.&#x20;


# Risk Communication Strategies

Effective communication between national authorities, scientific communities, and the general public is an essential factor countries must take into consideration when handling sanitary emergencies.

A country's outbreak response has to meet certain standards in order to limit prejudicial consequences over its population, institutions and economy. For this purpose, [the World Health Organization (WHO)](https://www.who.int/emergencies/diseases/managing-epidemics-interactive.pdf)[ recommends focusing strategies upon four coordinated blocks](https://www.who.int/emergencies/diseases/managing-epidemics-interactive.pdf), each with particular elements: 1) responders, 2) health information, 3) health interventions, and 4) risk communication.

During COVID-19 pandemic times, risk communication is particularly relevant, as health information of all kinds, including unverified and/or biased data, is rapidly spreading through non-supervised channels, such as social networks or public online sources – a phenomenon described as “infodemic.” This situation is worsened by the fact that multiple third parties compete for communicational authority on health matters, and communication response systems are under-resourced with a lack of investment and expertise. These natural but detrimental reactions of our modern communication systems progressively “raise public panic, financial market hysteria, and unintended misunderstandings of the science and epidemiology of SARS-CoV-2.” For this reason, authorities must prioritize “agile, accurate, worldwide-available counter-information that takes [the high moral ground and conveys a consistently science-driven narrative](https://pubmed.ncbi.nlm.nih.gov/32171075/).”&#x20;

Risk communication refers to “[the real-time exchange of information, advice, and opinions between health experts or officials and people who face a threat to their survival, health, or economic or social well-being](https://www.who.int/emergencies/diseases/managing-epidemics-interactive.pdf).” While facing emergencies, this dynamic process ensures the population at risk is able to make informed decisions, take protective and preventive actions, and maintain its social, economic and political stability. Developing a timely and sufficient risk communication strategy is an essential need when looking for urgent adherence of public health recommendations from the general population. Its degree of success mainly depends on guaranteeing that specific fundamentals are met and integrated into its work structure. The following characteristics of an effective communication strategy represent these concepts, as suggested by the WHO, the [Pan American Health Organization (PAHO)](https://www.paho.org/en/documents/covid-19-guidelines-communicating-about-coronavirus-disease-2019-guide-leaders), and the[ Inter American Development Bank.](https://blogs.iadb.org/gestion-fiscal/en/coronavirus-crisis-communications-recommendations-for-local-governments/)

#### 1. **Trustworthy**

Public confidence in government may enhance adherence with public health recommendations; without trust, people are unlikely to follow official provisions. Risk communication requires a three-way channel of reliability, which involves the government, the health experts, and the general population. Communicators must demonstrate they are accountable for what they say, promise, and do, as well as be both, consistent and transparent with the information they share. The strategy must be linked to functioning and accessible services, easy to understand, and accessible to different population subgroups. Moreover, any given intervention must empathically acknowledge how the [people's](https://www.who.int/emergencies/diseases/managing-epidemics-interactive.pdf)[ perception of risk is influenced by their beliefs, culture, education, political viewpoints, social norms, and prior experience.](https://www.who.int/emergencies/diseases/managing-epidemics-interactive.pdf)

#### **2. Proportional to demand**

Government and health officials must address people's expectations and anxiety at any given moment. Urgent concerns on health matters may evolve to potentially harmful panic given that [public perception of risk often does not match the science-based reality](https://www.paho.org/en/documents/covid-19-guidelines-communicating-about-coronavirus-disease-2019-guide-leaders). Providing frequent updates – including explicit information about uncertainties associated with risks, events, and interventions  – and indicating what is known and not known at a given time regarding emergency health matters in a calm, reassuring, and confident tone may keep the public from turning against public health or national security measures. Adapting the language through which official recommendations are communicated is [key to guarantee effective adherence.](https://blogs.iadb.org/gestion-fiscal/en/coronavirus-crisis-communications-recommendations-for-local-governments/)

The WHO and the PAHO have insisted on avoiding over-reassurance as it could be counterproductive. Taking this into consideration, health authorities must rely on updated information and, if possible, accurate statistical forecasting when addressing the population. Doing so will guarantee transparency within the communicative process as well as a message that does not underestimate the seriousness of any situation. In other words, reassurance is a useful strategy to promote conscious adherence with preventive measures but must accurately reflect current circumstances.&#x20;

#### 3. Timely

A critical moment for tackling misguiding rumors is just before they arise from knowledge gaps or concerns on the audience. Delayed delivery of information naturally sparks speculation and skepticism; therefore, it is crucial for governmental authorities to launch the first phases of their risk communication strategies even when the health hazard develops exclusively abroad. Defining the degree of risk, describing possible action plans, and justifying with evidence the need for immediate public cooperation prior to facing the threat within national borders helps guarantee credibility over any third parties divulging dubious information on the matter. Making clear the structure and work mechanism of the channel through which recommendations will be published [and acknowledging that updates will be provided as soon as the situation changes](https://www.paho.org/en/documents/covid-19-guidelines-communicating-about-coronavirus-disease-2019-guide-leaders) are also essential.&#x20;

#### 4. Transparent

As events unravel, all disclosed data and recommendations must be backed up by statistical analysis and expert opinion in order to limit the spread of misinformation. The final objective of this process also includes [reflecting empiricism and avoiding institutional or political biases](https://pubmed.ncbi.nlm.nih.gov/32171075/). Official communication teams must follow rigorous criteria when [selecting sources that will be used for creating, reviewing, and approving accurate content](https://blogs.iadb.org/gestion-fiscal/en/coronavirus-crisis-communications-recommendations-for-local-governments/). “For an unknown disease, communication should avoid using certain conclusions or expressions when clinical and epidemiological investigations are ongoing. Once an updated investigation is available, the information ought to be disclosed immediately. [Any delay will likely lead to unexpected consequences](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151105/).” Additionally, explaining how the designated decision-making process works is important [to strengthen credibility and increase citizen adherence with public health](https://www.paho.org/en/documents/covid-19-guidelines-communicating-about-coronavirus-disease-2019-guide-leaders) recommendations. Openly explaining what is yet unknown and what is being done about it – without jeopardizing national security – further increases public confidence in the risk communication strategy.&#x20;

#### 5. Structured

Risk communication strategies should be coordinated at the local, state, and federal levels across different agencies, [avoiding responsibility to be too centralized or decentralized](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151105/). Nevertheless, the government must play the leading role. In this manner, when executing a given risk communication strategy, essential partners to government leadership include civil society organizations, businesses, social entrepreneurs, and the general public.&#x20;

[Liwi Z, et al.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151105/) (2020) described a model that includes three components of communicative interaction for risk management. The first, government-public communication, refers to the external process of providing accurate updates, warnings, and recommendations to the population through mass media or other external communication channels; analyzing public feedback “enables the government to adjust its emphasis of information delivery and provide information in relation to the public´s own interests and values.” The second, government-expert communication, refers to the internal process of evidence evaluation for risk assessment and decision making; for this purpose, researchers and analysts must be empowered with access to enough resources for data collection and study. The author of this model emphasizes that “the very essence of responsible and rational action is to make viable and morally justified decisions in the face of uncertainty based on a range of expert judgments and assessments.” The third, expert-public communication, refers to the process of filling the gap between expert and public views on public health issues through strategic communication, by translating technical facts into understandable content for the general population. \
\
Particularly, partnering directly with community associations may accelerate policy-making processes, facilitate monitorization of adherence with public health measures, create accurate situational awareness, reinforce local responses, and establish dynamic feedback systems. Useful feedback approaches include social media, surveys, focus group discussions, community walk-throughs, and key informant interviews with front-line responders, partners, and stakeholders, [among other approaches](https://www.who.int/emergencies/diseases/managing-epidemics-interactive.pdf). The United Nations Department of Economic and Social Affairs (UN/DESA) highlights that an inclusive, multidisciplinary approach to risk communication may help tackle socio-economic challenges without leaving anyone behind. Partnerships with private companies or social entrepreneurs have multiple ways of addressing local and regional necessities during a critical situation; for example, government-organized hackathons may [encourage innovative solutions to economic, social, and technological challenges during the COVID-19 pandemic.](https://www.un.org/development/desa/dpad/publication/un-desa-policy-brief-61-covid-19-embracing-digital-government-during-the-pandemic-and-beyond/)

#### 6. Adequate

National risk communication strategies must encompass all items of the current social, economic, structural, and political context, as ignoring vulnerabilities within them results in diminished impact of containment measures. During emergencies, disrupted supply chains, insufficient monetary liquidity, volatile demand and pricing, international trade restrictions, among other phenomena, pose a prejudicial impact on the population´s financial security and food safety, particularly in LMICs. When facing insufficient income or basic life resources under critical national circumstances, containment measures considered in governmental risk communication strategies are expected to fail. For this reason, simultaneous strategies must identify and attenuate all possible vulnerabilities.&#x20;

Experts of the Organization for Economic Co-operation and Development (OECD) have created a centralized database of government responses to the different dimensions of the COVID-19 crisis, which includes insights into how OECD and G20 countries have responded to it. Regarding fiscal and monetary policy responses, they emphasize expansionary fiscal policies, among which “the most common schemes are deferral mechanisms for tax or social security contribution payments, credit subsidies for firms, and expanded unemployment income support programs for households.” Additionally, the latter includes “[targeted](https://oecdecoscope.blog/2020/05/15/the-oecd-covid-19-policy-tracker-what-are-governments-doing-to-deal-with-the-covid-19-pandemic/) [support ](https://oecdecoscope.blog/2020/05/15/the-oecd-covid-19-policy-tracker-what-are-governments-doing-to-deal-with-the-covid-19-pandemic/)[–](https://oecdecoscope.blog/2020/05/15/the-oecd-covid-19-policy-tracker-what-are-governments-doing-to-deal-with-the-covid-19-pandemic/)[ financial and otherwise ](https://oecdecoscope.blog/2020/05/15/the-oecd-covid-19-policy-tracker-what-are-governments-doing-to-deal-with-the-covid-19-pandemic/)[–](https://oecdecoscope.blog/2020/05/15/the-oecd-covid-19-policy-tracker-what-are-governments-doing-to-deal-with-the-covid-19-pandemic/)[ for vulnerable segments of their population](https://oecdecoscope.blog/2020/05/15/the-oecd-covid-19-policy-tracker-what-are-governments-doing-to-deal-with-the-covid-19-pandemic/).”

#### 7. Sufficient

Executing an effective risk communication response also depends on sufficient, sustained funding that meets the magnitude of current needs. Broadcasting networks, partnerships, infrastructure and human resources are essential elements for an effective strategy. Unfortunately, these are commonly underfunded to carry out their designated roles on urgent matters. LMICs are at higher risk of suffering communicational gaps due to weak, poor, or fragmented risk communication systems; it is unlikely that a message will reach its recipient without robust transmission channels.&#x20;

Regarding COVID-19, [Laurie ](https://pubmed.ncbi.nlm.nih.gov/32171075/)[Garret](https://pubmed.ncbi.nlm.nih.gov/32171075/) considers that governments, agencies and health organizations must urgently fund their messengers at an “unprecedented scale” if they want people at risk of infection to appropriately respond and cooperate with health authorities during the pandemic.&#x20;

## **Strategy development (**[**Peter Sandman, 2013**](https://www.psandman.com/index-intro.htm)**)**

After considering the seven fundamental characteristics described above, we recommend following Peter Sandman’s´ useful four-step process to develop an effective risk communication strategy. According to Sandman, the degree of risk and its perception on people´s mind determine the entire focus of operation. First, the degree of risk depends on multiple variables, which include hazard (“the technical component of risk”), time and resources available, exposure, and vulnerability of the population as compared to its response capacity. In turn, perception, which completely detaches from scientific evidence referring to the degree of risk, depends exclusively on culture and emotions. The latter conditions outrage or “the non-technical component of risk.”

The link between hazard and outrage is that outrage is the principal determinant of perceived hazard. Following this idea, Sandman comes up with four categories of risk communication strategies, one for a specific scenario: intermediate hazard – intermediate outrage; low hazard – high outrage; high hazard – low outrage; high hazard – high outrage. It must be noted that, as events unravel, hazard and outrage degrees must be reevaluated in order to change the risk communication strategy as needed.&#x20;

* **Intermediate hazard** – **Intermediate outrage**: the main task is to provide health education, open and rationally discussing the developing situation, answering questions of the public, and guaranteeing accessibility to technical information. Sandman emphasizes on the importance of “interpersonal dialogue, supplemented by specialized media.”
* **Low hazard** – **High outrage**: when the population is disproportionately responding to a low–hazard situation, the main task is to manage it. Sandman recommends directly listening, acknowledging, apologizing, and/or excessively reassuring, among other actions, to let outrage fanatics, which generally represent a minority of the population, celebrate victory over their claims, thus easing tension towards authorities.&#x20;
* **High hazard – Low outrage**: when the population is apathetic about a serious, urgent hazard, the main task is to intentionally provoke more outrage. Mass media may be helpful to get the attention of uninterested people, which generally represent a majority of the population. Sandman recommends being ready to change tactics when the audience starts to become more attentive.
* **High hazard – high outrage:** when facing this scenario, the main task is to help people cope with serious risk and bear with fear and/or misery. Taking advantage of mass media communication and in–person dialogue, as the situation allows, Sandman suggests being empathic and acknowledging uncertainty, among other actions, while avoiding over-reassurance.&#x20;

##

### &#x20;<br>


# Effective Vaccination Protocols

Organized, safe and effective vaccination campaigns are essential to reduce SARS-CoV-2 transmission and achieve economic reactivation in the context of the COVID-19 pandemic.

## Focus #1: High-income countries (Israel)

As of March 2021, Israel has been recognized as one of the most efficient infrastructure models for large-scale vaccination against COVID-19. However, before exploring this in more detail, we must emphasize that most of the strengths of the Israeli model are primarily found in high-income countries, so further research is needed to assess the fundamentals of effective vaccination protocols in LMICs.

In less than a month, over 80% of Israel's adult population >60 years received the first dose, outpacing every other country in the world. Through thoughtful planning, efficient use of available resources (including technical, institutional, and human resources), and investment in effective risk communication strategies, Israel went from having the highest per capita COVID-19 infection rate to [having herd immunity within its reach](https://theconversation.com/vital-signs-israel-shows-how-to-do-vaccinations-right-its-a-race-and-were-behind-157242). [Rosen et al. (2021)](https://ijhpr.biomedcentral.com/track/pdf/10.1186/s13584-021-00440-6.pdf) described the reasons for Israel’s success, organizing these factors into three main categories: 1) extrinsic to healthcare (e.g., small size of territory, young population, developed infrastructure), 2) healthcare-specific (e.g., systematic organization, cooperation, information technologies, training, and preparedness), and 3) vaccination-specific (e.g., timely decision-making, responsible resource allocation, clear eligibility criteria, effective communication strategies, and technical infrastructure, such as addressing the demanding cold storage requirements of the Pfizer-BioNTech COVID-19 vaccine).&#x20;

Taking these into consideration, we highlight the following [factors](https://ijhpr.biomedcentral.com/track/pdf/10.1186/s13584-021-00440-6.pdf) as key components of Israel´s exemplary vaccination roll-out:&#x20;

1. **Strategic planning**: Israel signed an early contract for Moderna´s mRNA vaccine in June 2020 and later with Pfizer-BioNTech and AstraZeneca in exchange for providing the companies with anonymous immunization data of its population. It must be noted that, according to these agreements, Israel [paid significantly more](https://www.dw.com/en/israels-clever-coronavirus-vaccination-strategy/a-56586888) than the European Union (EU) for each vaccine dose (e.g., for the BioNTech-Pfizer vaccine, the per-dose cost to Israel was reportedly about $28 compared with $14 paid by the EU).
2. **Universal healthcare system**: Israel has a community-based universal healthcare system, with four public health management organizations competing for members’ and government funding. When the national vaccination campaign began, these four entities were assigned the primary responsibility of vaccinating all specific subgroups of the population >60 years old and with preexisting medical conditions. For example: The National Medical Emergency Services Organization, “Magen David Adom,” was responsible for the vaccination of nursing home residents, while hospitals oversaw vaccination of their own front-line health responders. For this reason, everyone in the target groups [knew exactly where to obtain vaccination](https://www.healthaffairs.org/do/10.1377/hblog20210315.476220/full/).&#x20;
3. **Centralized national system of government:** a centralized government guaranteed a single authority responsible for planning, financing, and implementing the vaccine campaign. When comparing the centralized with a federal government system, [Rosen et al. (2021)](https://ijhpr.biomedcentral.com/track/pdf/10.1186/s13584-021-00440-6.pdf) wrote: “In contrast, several high-income countries have federal systems, with significant implications for how public health efforts are organized. For example, in the US, public health is administered and regulated primarily at the state level... This has led to some ambiguity regarding who is responsible and accountable for the success of the vaccination effort.”
4. **Efficiency**: Israel has achieved the highest vaccination rate per capita of any country. As of [March 15](https://ourworldindata.org/covid-vaccinations), 2021, 50% of its population had been fully vaccinated, and 60% had at least one dose. The [comparable figures](https://www.healthaffairs.org/do/10.1377/hblog20210315.476220/full/) for the United States were 12% and 21%, respectively. Digitalization of health management organizations was also critical as it made it possible to generate secure vaccination records, make online appointments, and keep communication channels open for instructions.
5. **Sufficient investment**: central authorities assigned adequate financial resources for vaccine acquisition and distribution throughout the nation. Policymakers began planning these efforts by as early as mid-2020, just a few months after the WHO declared COVID-19 infection a pandemic.&#x20;

As mentioned earlier, LMICs – in most cases – lack sufficient resources and infrastructure to organize a national vaccination program such as Israel´s. Further research is required to better understand effective vaccination strategies in resource-limited settings.


# Refugee and Migrant Health Case Study

Here we apply the 4S Framework to a case study about refugee and migrant health.

The case of [refugee health in the context of COVID-19](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30791-1/fulltext) is a global question that is yet to be fully addressed. The unique needs of this population and the innovative solutions being piloted will illustrate the 4 S model during the remainder of this module. **Staff** includes organizing medical professionals to care for patients in refugee camps and efforts to mobilize the refugee workforce to help out in the pandemic. **Stuff** includes providing basic resources such as soap, water, and basic medical equipment to refugee camps and settlements in LMICs. **Space** is a key issue in refugee camps, where thousands are cramped in close proximity without the ability to socially distance and often without space for medical facilities. Space is also a common concern among refugees and migrants in HICs who are marginally housed or homeless. **Systems** are what need to be put into place to address many of these issues, including de-densifying camps; improving access to medical care, food, water, and hygiene supplies; and creating government-level contingency plans that take refugee health into account.

## *Housing and Resources*

![Refugee Camp, Democratic Republic of Congo. Image via Wikipedia.](/files/-M4_0BvA0TbT31e_SfRc)

Populations without access to [stable, safe housing](https://en.wikipedia.org/wiki/Refugee_camp) are at increased risk of COVID-19, and special attention must be paid to supporting these populations. There are 70 million refugees and displaced people around the world according to the [UN Refugee Agency](https://www.unhcr.org/en-us/news/stories/2019/6/5d08b6614/global-forced-displacement-tops-70-million.html), and the vast majority of them live in LMICs. The refugees and migrants who are living in informal (e.g. tents, abandoned buildings) or formal settlements (e.g. refugee camps) are particularly susceptible to COVID-19 given their inability to access essential resources like [food](https://www.nytimes.com/2020/03/26/world/asia/coronavirus-refugees-camps-bangladesh.html), [soap, and water](https://www.npr.org/sections/goatsandsoda/2020/03/11/814473308/opinion-refugees-are-especially-vulnerable-to-covid-19-dont-ignore-their-needs); obtain medical care; and practice [social distancing](https://blogs.msf.org/bloggers/blogs-team/five-eye-opening-blogs-doctors-without-borders-march-2020). While there are not currently any reports of widespread transmission within refugee camps, experts are concerned about the devastating toll it would take upon this uniquely vulnerable population if containment efforts are unsuccessful. “It would be a disaster. It would be more devastating than the insurgency \[by Boko Haram] that brought them here,” said [Ahmadu Yusuf](https://www.nytimes.com/2020/03/26/world/asia/coronavirus-refugees-camps-bangladesh.html), a community leader in the Bakassi refugee camp in Nigeria. Few governments have put special attention towards the health needs of refugees and migrants that live within their country, despite the unique needs of this population.

## *Medical Care in Refugee Camps*

![Refugee Camp in Jordan. Image via DailyMail.](/files/-M4_0BvB7c-q3YsaU306)

Refugee camps perpetually face challenges in providing even [basic medical care](https://www.dailymail.co.uk/news/article-3367674/Born-refugee-Syrian-babies-welcomed-world-80-000-strong-camp-one-Jordan-s-largest-cities.html) given lack of medical personnel and health facilities. While no positive cases have yet been discovered at refugee camps, this is likely due to [lack of testing](https://www.nytimes.com/2020/03/19/world/middleeast/syria-coronavirus-idlib-tents.html). Some camps are preparing for what seems to be an inevitable arrival of COVID-19, such as the Dadaab refugee camp in Kenya that has [90 beds within the refugee camp](https://www.aljazeera.com/news/2020/03/front-worry-covid-19-spreading-african-refugee-camps-200329054029304.html) set up for COVID-19 isolation, as well as a partnership with the local community isolation facilities.

However, while many camps do not currently have the infrastructure, examples show it is possible to set up robust medical care in refugee camps. One promising model, led by Médecins Sans Frontières (MSF or Doctors Without Borders), established a [primary care clinic](https://www.ncbi.nlm.nih.gov/pubmed/30976298) in the Shatila refugee camp in Beirut, Lebanon in 2013 with four main components: case management, patient support and education counseling (PSEC), integrated mental health, and health promotion. Using their integrated team of doctors, nurses, and other medical personnel, they were able to nearly double the number of patients with diabetes and hypertension who were at goal for hemoglobin A1C levels or blood pressure within 6 months of care. Utilizing team-based care with a patient-centered approach to identify, closely follow up with, and support patients could be a transferable model to help with the pandemic.

## *Dissemination of Accurate, Timely Information*

Information dissemination is particularly challenging for refugee populations who do not speak the majority language of the country they are in and do not have access to news or internet. In Bangladesh, limited internet access for the Rohingya has caused [false information to circulate](https://www.nytimes.com/2020/03/26/world/asia/coronavirus-refugees-camps-bangladesh.html) and panic to spread. Organizations such as the UN refugee agency, UNHCR, have been running massive public awareness campaigns using text messages, sending [15,000 informational texts](https://reliefweb.int/report/world/unhcr-staying-and-delivering-refugees-amid-covid-19-crisis) about the disease and its prevention to urban refugees living in Khartoum, Sudan. Other solutions include setting up [language lines](https://www.nrc.no/news/2020/march/10-things-you-should-know-about-coronavirus-and-refugees/) with accurate and relevant information on a countrywide level in the language of the refugee population. Vetted fact sheets about COVID-19 and the basics of prevention and response to symptoms are available in over 35 languages [here](https://covid19healthliteracyproject.com/#languages).

## *Care for Refugees in High-Income Countries*

Refugees in HICs also face [substantial barriers to accessing care](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603273/). When a refugee arrives in a new country, efforts to connect them to stable care pathways in the health system are lacking. Many countries have [legal restrictions](https://www.ncbi.nlm.nih.gov/pubmed/16230318/) on access to care for asylum seekers, limiting them only to emergency care. Consequently, refugees and asylum seekers face significant financial barriers if the host country does not guarantee them free health care. Additionally, they often receive culturally insensitive care or inadequate interpreter services.

However, some countries are proactive and inclusive in their health care system, such as [France](https://www.who.int/migrants/publications/EURO-report.pdf), which gives its universal free health insurance to low-income irregular migrants and people seeking asylum. Orientation is offered in 23 languages. Another innovative program is the [Together Against Tuberculosis project in Germany](https://www.who.int/migrants/publications/EURO-report.pdf) that pairs medical students with patients with tuberculosis to provide support through the directly observed therapy strategy.

As refugees are generally viewed only as consumers of healthcare services, their ability to contribute to the health system is often undervalued or rarely recognized. Many refugees were working as physicians or other health care professionals previously but, due to extensive regulatory barriers and costs, are unable to work in the new setting/country where they live as a refugee. They are particularly well equipped to help given their experience working in high-pressure, low-resource settings. For example, during the [Ebola epidemic](https://www.unhcr.org/en-us/news/latest/2016/6/5750093e4/ebola-hit-liberia-refugees-took-frontline-health-role.html), refugee medics were key in providing care in the frontlines and limiting the spread of the epidemic in Guinea, Liberia and Sierra Leone, among others. In the current COVID-19 crisis, [Germany](https://uk.reuters.com/article/uk-health-coronavirus-germany-refugees/refugees-to-the-rescue-germany-taps-migrant-medics-to-battle-virus-idUKKBN21C2I%20https://www.infomigrants.net/en/post/23690/germany-migrants-and-refugees-may-fill-labor-gaps) and the [UK](https://www.theguardian.com/world/2020/mar/25/covid-19-call-for-fast-track-registration-of-refugee-doctors-in-uk) are in the process of fast-tracking applications from refugee medics, many of whom are physicians, and have each received hundreds of applications. A group of [Syrian refugees in Switzerland](https://www.unhcr.org/en-us/news/stories/2020/3/5e7878d94.html) set up a network of young, healthy volunteers to assist the elderly with grocery shopping and other necessary errands, while maintaining social distancing and proper hygiene practices. One of the volunteers said that her experience as a refugee makes her better equipped to respond to the pandemic: “We lived, and we are still living, a crisis as refugees. That makes us probably in a better position to understand that there is a crisis and how to help.” So far, the volunteer network has shopped for 200 elderly people in need.

## *Policy Implications and Takeaways*

![Kutupalong refugee camp, Bangladesh. Image via Medium.](/files/-M4_0BvCXCXH5hQkT5Lb)

As the world grapples with COVID-19, the [refugee population](https://medium.com/@UNmigration/iom-new-diphtheria-wards-saving-lives-and-calming-fears-of-rohingya-refugees-b796902704a6), which is historically marginalized and stigmatized, is both extremely vulnerable to the consequences of this health threat and neglected by policy makers. It is essential for governments to work with health authorities and experts on refugee health to include refugees in national preparedness plans to contain the spread of the virus while providing adequate protections for this vulnerable population.

Lessons from refugee health will also be relevant for caring for individuals who are homeless or marginally housed in the midst of this crisis. They are also among our world’s most vulnerable people and are being left behind in the epidemic, which endangers their health and the health of the public at large. Particularly in the U.S., this is relevant to three vulnerable populations: asylum seekers at the U.S. border, people who are homeless, and people who are incarcerated. It must be noted that during 2020, the U.S. closed its border to asylum seekers and expelled people seeking safety to their home countries, endangering their health and the health of the populations with whom they interact. It is imperative that the U.S. makes a [comprehensive plan](https://www.msf.org/us-must-include-asylum-seekers-covid-19-response) to address the needs of migrants and asylum seekers in the pandemic, with the health and dignity of these people being a top priority. The U.S. also needs to make a plan on how to assist people who are homeless. While the CDC has issued [guidelines](https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/unsheltered-homelessness.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcommunity%2Fhomeless-shelters%2Funsheltered-homelessness.html) specifically for homeless populations, these are difficult to implement. There are many innovative approaches being suggested, such as relocating homeless people to [empty dorm housing](https://www.statnews.com/2020/03/31/a-radical-approach-to-preventing-covid-19-infection-in-the-homeless/). In terms of individuals who are incarcerated, many states have begun efforts to [minimize their jail and prison populations](https://www.prisonpolicy.org/virus/virusresponse.html) to prevent the spread of the virus, however, there has not been widespread policy on how to support these people after release. Taken together, this case study underscores the utmost importance that policymakers develop and implement smart policies on housing, food security, employment, and access to health care for our world’s most vulnerable populations in the face of COVID-19. Although ignoring the most vulnerable is never just, these injustices are unveiled in the face of a pandemic that shows how interconnected we are.

*Thought Questions*: *Staff*

* How can we increase the medical workforce in refugee camps during a pandemic? What role could task shifting play in meeting healthcare demands in refugee camps? How could members of the community directly contribute to the care of patients?
* What would be the opportunities and challenges in introducing refugee or otherwise internationally-trained doctors into the American health care system for the first time during a pandemic?

*Thought Questions*: *Stuff*

* How can food and water supplies to refugee camps be guaranteed with the impending challenges to the global supply chain?
* Is deploying proper personal protective equipment to refugee camps feasible? How should it be prioritized against other competing needs? How can materials that are available within refugee camps or the local community be used to make PPE?

*Thought Questions*: *Space*

* If you could redesign refugee camps, given limited resources and space, how would you create them?
* What housing resources can be mobilized in HICs to improve the health of people who are homeless?
* How can treatment facilities be created or renovated to meet the needs of the population at the U.S.-Mexico border?

*Thought Questions: Systems*

* If you are in the ministry of health for a low-, middle-, or high-income country, what recommendations would you make to the government about effective ways to address refugee health in pandemic contingency planning?

We welcome your feedback on this module and on the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).


# Module 8: Medical Ethics in Relation to COVID-19

Discuss various ethical controversies related to COVID-19 and apply ethical frameworks to examine the impacts of personal, medical, and governmental decisions related to the pandemic.

*Authors*: James Agolia, Michelle Bayefsky, Maheetha Bharadwaj, Samuel Doernberg, Sun Fletcher, Melody Huang, Margaret Irwin, Maud Jansen, Bina Kassamali, Katie Kester, Benjamin Landwersiek, Chen Lu, Soumyaa Mazumder, Joe Montesano, Niyi Odewade, Phani Paladugu, Larisa Shagabayeva, Derek Soled, Sanjana Srinivasan, Tarika Srinivasan, Maria Thomas, Samson Yu, Allen Zhou, Angela Zou

*Editor:* [Derek Soled](mailto:derek_soled@hms.harvard.edu), MSc

*Reviewers*: Edward Hundert, MD; David S. Jones, MD, PhD; Louise King, MD, JD; Christine Mitchell, RN, MS, MTS, FAAN; Robert D. Truog, MD; David Urion, MD; Matthew Baum, PhD, DPhil; Pamela Chen; Rahul Nayak, MD; Sophia Yin

**Update Disclaimer:** Thank you for visiting Module 8! Due to the wide availability of high-quality resources at the medical student level, we are no longer updating this module regularly. We hope that the material, including our learning objectives, cases, and thought questions can still be useful as an educational resource. If you find that material is incorrect or that a link is broken, please do let us know by emailing <medicalstudentcovidcurriculum@gmail.com>.&#x20;

## Introduction

In Module 8 of this curriculum, students will begin to consider the ethical discussion surrounding the COVID-19 pandemic. The first section will give an overview of U.S. ethics and principles of allocation. The second section will focus on the ethics of resource distribution, particularly when supplies are limited. The third section will delve into the ethics regarding treatment and care of vulnerable populations, such as homeless individuals or children. The fourth section will center on the commitments and obligations of medical providers and trainees during public health crises. The fifth section will discuss the ethics of clinical trials, research, and treatment, especially when time is of the essence. The final section will analyze the ethics of public health interventions, particularly those that restrict individual liberties. As you work through this section, we encourage you to think critically about how these ethical debates affect your life, and how these conversations may change based on the context you are in. Please note that this module is not meant to be a comprehensive review of all ethical issues related to COVID-19, but rather provide a framework and highlight several salient topics. In addition, this module has a centrality of post-Scottish enlightenment thinking, which is the dominant framework in U.S. biomedical ethics. We recognize this bias and are working on subsequent sections that will include alternative models used throughout the world.

This module is different from the other modules; we recognize there are principles and terms with which you might not be familiar.  Rather than providing facts and answers to your questions, the goal of this module is to equip our readers with a philosophical foundation for approaching ethical issues in healthcare, especially as they pertain to COVID-19.  We expect that this module will take **2 hours** to complete.&#x20;

## Learning Objectives

At the end of this module, medical students should be able to:&#x20;

* Compare the rudimentary schools, frameworks, and principles to approach ethical issues in healthcare
* Apply ethical frameworks to debate how healthcare resources should be distributed during a pandemic
* Describe how COVID-19 differentially impacts populations that are already vulnerable
* Debate the boundaries of obligation for healthcare workers and medical students during a pandemic&#x20;
* Discuss the ethical principles of clinical research design and vaccine development during times of crises
* Discuss the tension between autonomy and collectivism in relation to public health measures


# Overview of U.S. Medical Ethics

## Overview

This section provides an overview of the major schools of thought in Western ethics: consequentialism, deontology, virtue ethics, natural law, and moral relativism. It then highlights principlism, a useful approach to medical ethics that breaks down issues into four major principles: respect for autonomy, beneficence, nonmaleficence, and justice. Moreover, it mentions the themes of negligence and reasonable care, which are often discussed in conjunction with beneficence and nonmaleficence. Finally, this section discusses the ethical principles of allocation of resources.

## Schools of Ethics from Western Philosophy

Centuries of scholarship have resulted in a variety of frameworks for making ethical decisions.  Selected frameworks are introduced briefly below, notably biased toward Western ethical approaches from the Scottish and English enlightenment.  Please refer to linked resources for more details. Notable proponents of each of these schools are also listed in our supplemental section, located [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

Please note: Noting our Western bias in this discussion, we briefly highlight a select few of the many schools of ethical thought and philosophy that did not originate in Europe in our supplemental section, located [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

Sources: [Dobrin 2012](https://www.psychologytoday.com/us/blog/am-i-right/201205/3-approaches-ethics-principles-outcomes-and-integrity), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/), [Barnhill 2010](https://www.uwosh.edu/facstaff/barnhill/490-docs/thinking/env-ethics), [Page Center](https://pagecentertraining.psu.edu/public-relations-ethics/introduction-to-public-relations-ethics/lesson-1/ethical-theories/)

* **Consequentialism:** the idea that the morality of an act depends on its consequences.  To decide whether an act would be right or wrong, one should examine the possible results of the act and ask whether the good effects would outweigh the bad effects.  As consequentialist ethics is focused on the ends rather than the means, it is also known as teleological ethics (from the Greek word telos, which means “end”).  Two forms of consequentialism are utilitarianism and prioritarianism.\
  Sources: [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/consequentialism/), [Dobrin 2012](https://www.psychologytoday.com/us/blog/am-i-right/201205/3-approaches-ethics-principles-outcomes-and-integrity), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/), [The Ethics Centre](https://ethics.org.au/ethics-explainer-consequentialism/), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/conseque/)
  * **Utilitarianism:** the most well-known theory of ethics within consequentialism.  Utilitarianism states that one should choose the act that **results in the most good** - the act that maximizes the good of all parties involved.  In other words, the most ethical action is the one that leads to “the greatest amount of good for the greatest number of people” (quoted in [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/utilitarianism-history/)).\
    Sources: [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/consequentialism/), [Dobrin 2012](https://www.psychologytoday.com/us/blog/am-i-right/201205/3-approaches-ethics-principles-outcomes-and-integrity), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/), [The Ethics Centre](https://ethics.org.au/ethics-explainer-consequentialism/), [Barnhill 2010](https://www.uwosh.edu/facstaff/barnhill/490-docs/thinking/env-ethics), [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/utilitarianism-history/)
  * **Prioritarianism:** a theory that, along with utilitarianism, falls under consequentialism. Prioritarianism proposes that priority should be given to those who are worse off because benefits have greater moral weight when given to those who are worse off. In contrast to the utilitarian perspective of maximizing good for all parties involved, prioritarianism **favors assisting those who are worse off**, even if this results in a diminished maximal overall good. Prioritarianism can also be distinguished from egalitarianism. Whereas egalitarianism proposes equality (i.e. treating all equally because all humans are equal in worth and moral status), prioritarianism suggests an approach more similar to equity (i.e. providing a good unequally to those who are worse off rather than those who are better off so that there is greater equality in the end). This is an important distinction to make, and instances may arise where this may be the case. For example, suppose that a government could choose to fund a cure for canker sores (i.e. aphthous ulcers) for everyone versus a cure for an orphan disease that kills a very small number of people. An egalitarian approach would suggest that funding a cure for canker sores as the correct choice, as this may benefit everyone equally, while prioritarianism would favor curing the rare deadly disease instead to help the few who suffer from it.

    Sources: [Oxford Research Encyclopedia](https://oxfordre.com/politics/view/10.1093/acrefore/9780190228637.001.0001/acrefore-9780190228637-e-232), [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/egalitarianism/)
* **Deontology:** The word “deontology” comes from the Greek word deon, which means “duty.”  Thus, deontological ethics is also known as duty-based ethics. In deontological ethics, one uses reason to arrive at a foundational ethical standard or standards, and one has a duty to act according to those principles. Deontological ethics is also called non-consequentialist ethics because one judges the morality of an act based on **how that act conforms to ethical principles**, not based on the result of the act. In one version of deontological ethics established by Kant, the basic ethical principle (“categorical imperative”) to which all right acts should conform is to “treat people as an end, and never as a means to an end” ([Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/)). In another statement of the categorical imperative, Kant explains that we should always act according to principles which we, as rational agents, would want to be a universal law for all people. The essence of morality is in these principles, not in the results of the acts themselves.

  Sources: [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/), [Dobrin 2012](https://www.psychologytoday.com/us/blog/am-i-right/201205/3-approaches-ethics-principles-outcomes-and-integrity), [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/kant-moral/#ForUniLawNat), [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/ethics-deontological/#DeoTheKan)
* **Virtue Ethics:** This is one of the oldest schools of ethics, as it is founded on the ideas of Plato and Aristotle. A virtue is “an excellent trait of character,” a fundamental principle that is deeply held within a person and causes that person to act habitually in a certain way ([Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/ethics-virtue/)). According to Plato, examples of virtues are wisdom, courage, temperance, and justice ([Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/)). Virtue ethics is concerned with forming the good character of a person, that is, becoming a person who embodies the virtues. If one acquires these fundamental dispositions, then making ethical decisions will naturally follow from them. In other words, in virtue ethics, the primary emphasis is **on what kind of people we are**, not on what decisions we make.  The decisions that we make are a result of the virtuous character we have developed.

  Sources: [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/ethics-virtue/), [Page Center](https://pagecentertraining.psu.edu/public-relations-ethics/introduction-to-public-relations-ethics/lesson-1/ethical-theories/), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/ethics/), [Dobrin 2012](https://www.psychologytoday.com/us/blog/am-i-right/201205/3-approaches-ethics-principles-outcomes-and-integrity)

## One Level Higher: Meta-Ethics

As discussed above, consequentialism, deontology, and virtue ethics are three methods that we can use to decide how to act ethically.  But how do we decide which framework to use? Where do ethical standards come from? Although these questions, which fall under the purview of meta-ethics, are largely beyond the scope of this module, two important answers are highlighted below.

* **Natural Law:** Natural law moral theory holds that humans can use reason to find basic moral principles that are central to human nature and that orient us toward the flourishing of all human beings.  In other words, human nature tells us something about morality. Using human nature (the way humans are) as a starting point, we can reason toward moral standards. Because moral norms are grounded in human nature, they are **objectively right or wrong**, and all human beings can have a basic understanding of them. Thomas Aquinas and many other natural law proponents operate from a theistic perspective; the natural law is given by God who created human nature, and humans can use reason to decide whether acts are in accord with the natural law.

  Sources: [International Encyclopedia of the Social & Behavioral Sciences](https://doi.org/10.1016/B978-0-08-097086-8.86084-5), [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/natural-law-ethics/), [Barnhill 2010](https://www.uwosh.edu/facstaff/barnhill/490-docs/thinking/env-ethics), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/natlaw/), [Britannica](https://www.britannica.com/topic/natural-law), [Soper 1992](http://www.jstor.org/stable/1289576), [Queensborough Community College](https://www.qcc.cuny.edu/SocialSciences/ppecorino/ETHICS_TEXT/Chapter_7_Deontological_Theories_Natural_Law/Natural_Law_Theory.htm)
* **Moral Relativism:** Moral relativism states that moral norms are not universal; rather, they are relative to a **particular time, place, or culture**.  Because moral norms are relative, it is not possible to prove that one moral stance is generally better or truer than another.  Unlike moral objectivists, moral relativists do not believe that any ethical standard is universally or absolutely true in all cases.  Different societies have different standards in evaluating a moral judgment (that an act is right or wrong), and these standards may be true for one society but false for another society.  Because the truth of moral standards between societies cannot be rationally debated, moral judgments cannot be absolutely true for all people. All prior theories that have been discussed in this section would be considered moral objectivist theories, as a right answer can be discerned based on certain principles.

  Sources: [Stanford Encyclopedia of Philosophy](https://plato.stanford.edu/entries/moral-relativism/), [Internet Encyclopedia of Philosophy](https://www.iep.utm.edu/moral-re/)

*Thought questions:*

* How would you describe, in your own words, the difference between consequentialism and deontology?
* What potential objections can be raised against moral relativism?  Against natural law theory?
* In a recent article, [Emanuel et al.](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114) argue that, in a situation of scarce resources, such as a limited number of ventilators during the COVID-19 pandemic, the limited resources should be allocated first to healthcare workers and other workers who maintain and operate critical infrastructure (see “Recommendation 2”).  Which ethical framework(s) do they use in arriving at this recommendation?

## Basic Principles of Medical Ethics

The four basic principles outlined by Beauchamp and Childress in Principles of Biomedical Ethics provide the foundation for modern American biomedical ethics. These principles are:

1\) respect for autonomy\
2\) justice\
3\) beneficence\
4\) nonmaleficence.&#x20;

These principles provide a practical but reductionist framework to approach biomedical ethics and draw on elements of each of the above schools of ethics. For example, deontologists could argue that the morality of an act in medicine could be based on how that act conforms to these principles, rather than on the result of the act. Consequentialists could instead argue that these principles are heuristic ways to have the best likelihood of maximizing the good effects of an act.&#x20;

Each of these four principles are considered and may be weighed against one another in the process of ethical decision-making in a given scenario.

* **Respect for Autonomy:** The principle of respect for autonomy originated in the Belmont Report - which summarized ethical principles for research involving human subjects - as **“respect for persons.”** Under this principle, patients must be given the opportunity to think, decide, and act independently and without coercion. One key way that this principle is seen in everyday medical practice is through the process of informed consent, in which patients must be informed of the relevant information and given the opportunity to evaluate, consider, and agree to a treatment modality prior to initiating a treatment.&#x20;
* **Justice:** The principle of justice is founded upon the idea of **fairness**. As such, the concept of equality - that all should be treated the same - plays an important role in justice. However, equality can also lead to unfairness because giving the same thing to those who are already better off may not promote justice. Some have argued that justice should actually be based on **equity**, which is the idea of providing a good un-equally between those who are better and worse off so that there is greater equality in the end. In medicine, the principle of justice has been used to argue that the burdens and benefits of advances in medical treatment and technology should be distributed fairly across all groups of people. Key areas of medical ethics in which justice is often considered are: fair distribution of scarce resources, balancing competing needs, and fulfilling obligations to different communities.
* **Beneficence:** The principle of beneficence describes the duty to **do good** for patients. It requires that all interactions, treatments, and decisions have the goal of increasing the well-being of the patient involved. This principle asks that providers develop and maintain their knowledge and skillsets, consider the individual circumstances of their patients, and strive for net benefit. It requires providers to take active steps to help their patients, as opposed to merely avoiding harm. Typically, when patient autonomy is compromised (e.g., incapacity), beneficence is the guiding ethic for decision-making on behalf of the patient’s best interests.
* **Nonmaleficence:** This requires that providers **do not inflict harm** on other persons, and that harm is to be avoided or minimized in pursuit of the greater good. This principle is the underlying tenet of the Hippocratic Oath (“Primum non nocere” - “First, do no harm”). Avoiding harm can sometimes be difficult because many beneficial therapies also have serious risks; the pertinent ethical issue is whether the benefits outweigh the burdens. In contrast to beneficence, the core of this principle is avoiding avoidable or unacceptable risks/harm. For instance, nonmaleficence describes avoiding unnecessary pain related to a surgery even if the benefits of having the surgery still outweigh the unnecessary pain (i.e., making sure to give good rather than minimal post-surgical pain control).

So far, we have discussed the rightness of acts, but these principles are also relevant to failures to act, as is illustrated by negligence and reasonable care - legal principles with ethical implications. **Negligence** is when an unintentional injury results from actions that were not intended to do harm. It requires that a provider have a duty, that he or she breach that duty, and that an injury results that was caused by the breach of duty. **Reasonable care** describes the degree of care that a reasonable person in a similar situation would use, and it depends on the standard of care for the procedure being performed.

* Negligence occurs in situations in which a duty to use reasonable care is owed to another person. An injury results from a failure to use reasonable care.
* Reasonable care may be determined by the applicable standards of care, by statute, or by previous judicial decisions known as precedents. If a duty is not performed with reasonable care, a physician may be held responsible.

*Thought questions*:

* How can physicians and healthcare providers balance respect for the autonomy of patients while providing their own medical opinions/recommendations? For example, how can we balance a patient’s refusal to quarantine after a positive test for COVID-19 versus a public health requirement to quarantine?
* Should the fundamental principle of justice be based upon equality or equity? For example, should everyone with COVID-19 be given equal access to ventilators, no matter how sick, or should those who are sickest be favored?

References:&#x20;

* Beauchamp TL and Childress JF. Principles of biomedical ethics. Oxford University Press, USA, 2001.
* [Gillon R. "Medical ethics: four principles plus attention to scope." BMJ 309.6948 (1994): 184. ](https://web.stanford.edu/class/siw198q/websites/reprotech/New%20Ways%20of%20Making%20Babies/EthicVoc.htm)
* Miles SH. The Hippocratic Oath and the ethics of medicine. 2004. Oxford; New York: Oxford University Press.


# Principles of Allocation

## Overview

Our modern societies have chosen to develop medical systems in which only a limited amount of resources - such as nurses and physicians, treatment, equipment, and money - are available. Even in seemingly normal times, patients are triaged in the emergency room based on the urgency of their complaint and the availability of clinicians. In the current COVID-19 pandemic, the limitations in our medical resources as a nation and globally have become increasingly apparent, as we hear about shortages of essential equipment for patients and providers such as surgical and N95 masks, beds, and ventilators. As such, determining the allocation of medical resources has become a pressing topic for all. We provide a framework that incorporates basic principles of medical ethics (autonomy, justice, beneficence, and nonmaleficence) and guides decision-making regarding resource allocation (i.e. “rationing”).

## Framework

Based on the principles of autonomy, justice, beneficence, and nonmaleficence, [Persad et al. (2009)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(09\)60137-9/fulltext) propose four categories of ethical values to guide the allocation of scarce medical resources:&#x20;

1\) treating people equally\
2\) giving priority to the worst off\
3\) maximizing benefits\
4\) promoting and rewarding social usefulness ([Persad et al. Lancet 2009](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(09\)60137-9/fulltext)).&#x20;

Within each category of ethical value, there are two competing ethical principles (for a total of eight sub-principles) that are competing specifications of the higher-order ethical value.

* **Treating people equally:** Allowing people to have equal opportunity to receive a medical intervention underlies this ethical value. This ethical value forms the basis for the following two principles, though they reach different conclusions:
  * **Lottery (Random Selection):** This ethical principle uses a lottery to provide people with an equal probability of obtaining a given medical resource, regardless of other circumstances.
  * **First-come, first-served:** Under this ethical principle, people who require a limited resource first receive it, without regard to differences between people. For example, during non-pandemic times, patients are allotted hospital beds on a first-come, first-served basis.&#x20;
* **Giving priority to the worst off:** This ethical value embodies prioritarianism (see above), in which individuals who are worse off are given priority access to needed medical resources. Below, we discuss ethical principles that incorporate this ethical value, though they differ in their definition of who is considered worst off. While these principles are among the most discussed, they are not the only ones. There are multiple other ways of defining who is “worse off.”
  * **Sickest first:** In this ethical principle, those with the worst chance of survival without a given scarce medical intervention are prioritized, as they are considered to be “worst off.”
  * **Youngest first:** This ethical principle prioritizes the distribution of resources to those who have lived fewer life years - thus defining those who are “worst off” as those who have yet to benefit from having lived longer.&#x20;
* **Maximizing benefits:** This ethical value is based upon utilitarianism (see above for detailed background on utilitarianism) and, at its core, aims to maximize the possible good that can be done. There are multiple ways, however, to define a “benefit,” and different ethical principles differ in the “benefit” that they promote. Two ethical principles falling under this ethical value are described below.
  * **Saving the most lives:** This ethical principle prioritizes saving the most individual lives. It treats each life as holding equal value and does not compare the worth of each individual life - for example, the lives of a 20-year-old and 70-year-old are weighed equally.
  * **Saving the most life-years:** In this ethical principle, saving the most life-years is preferred over saving the most lives, regardless of how this distribution is concentrated or spread. For example, this ethical principle would favor saving one person who goes on to live an additional 21 years rather than 20 people who each go on to live one additional year (20 life-years). There are multiple ways in which life years are quantified (see below).
* **Promoting and rewarding social usefulness:** This ethical value prioritizes people who have previously provided or will provide, in the future, benefit to society. It is important to recognize the effect that culture and societal norms have on defining these benefits to society and, thus, who would be prioritized.&#x20;
  * **Instrumental value:** In this ethical principle, people who have future usefulness are prioritized. For example, a system valuing instrumental value could focus on treating healthcare workers in the current COVID-19 pandemic because of the added value they may have for treating others in the future.&#x20;
  * **Reciprocity:** This ethical principle prioritizes and rewards people who previously were useful or had to sacrifice. In this system, a person who previously volunteered to test a new COVID-19 vaccine in a clinical trial would be prioritized if they were to require treatment in the future.

An important concept to understand within the context of the allocation of scarce resources (i.e. rationing) is the “life-year,” as it underlies the ethical principle of “saving the most life-years” in order to maximize benefits. There are [two general systems](https://nccid.ca/publications/understanding-summary-measures-used-to-estimate-the-burden-of-disease/) used to quantify life-years.

* **Quality-adjusted life-year:** Quality-adjusted life-year systems measure the gain of equivalent healthy years. In this system, a quality-adjusted life-year (QALY) is defined as one year of perfect health. A year of life with a specific illness or disability (i.e. health-related quality-of-life; HRQOL) is then normalized relative to this year of perfect health. Specific criteria for determining this normalized value vary, especially given the subjective nature of the “value” of a specific condition. For example, in the UK’s National Health Service, a year of life with a moderate mobility impairment is defined as 0.85 QALYs.&#x20;
  * **QALYs formula: QALYs = additional years of life x health-related quality-of-life (HRQOL)**<br>
* **Disability-adjusted life-year:** Disability-adjusted life-year systems measure the loss of health. This system measures the total length of time that a specific illness is disabling to an individual over their lifetime. Similar to a QALY, it incorporates quality-of-life factors to normalize a year of living with a specific condition/illness to a year of perfect health. Prior DALY systems included an age-weighting such that a year for a younger person was weighed as more valuable than that for an older person, but these weightings have generally since been removed.
  * **DALYs formula: DALYs = years of life lost to premature mortality (YLL) + years lived with disability (YLD)**

Each of these ethical values and principles has advantages and disadvantages (summarized in Table 1 below). [Persad et al. (2009)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(09\)60137-9/fulltext) have also developed a recommendation as to whether each ethical principle should be included or excluded when developing guidelines for allocation.

When developing a framework for allocation of scarce resources, it is important to recognize that no single value or principle is sufficient in determining whether a given individual receives the resource. Ultimately, a multi-value and multi-principle framework is necessary to facilitate such decision-making ([Emanuel et al. NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114)).

![Table 1: Simple principles and their core ethical values (Persad et al. 2009)](https://lh3.googleusercontent.com/-u9LHZ_nQWGE1MeJ0zaHvtevXt8MVaR4yTHN38IS8lFuGS80AOxTDBo--Dx72DZC8TUSEZ5qCuWXEt5RSfYYl7uW9hlMcp3878pfPvGwwivi5U9rJ7u5vPK9WQI_SalHv49kaeXD)

Similar to [Persad et al. (2009)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(09\)60137-9/fulltext), [White and colleagues (2009)](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2629638/) suggest a framework for the allocation of scarce medical resources that include maximizing life-years, broad social value, instrumental value, and the life-cycle principle (i.e. providing each individual with an equal opportunity to live through various stages of life). ([Who Should Receive Life Support During a Public Health Emergency? Using Ethical Principles to Improve Allocation Decisions](https://annals.org/aim/article-abstract/744219/who-should-receive-life-support-during-public-health-emergency-using)). However, they caution against over-reliance on maximizing life-years, as this practice may selectively discriminate against groups with certain conditions. For example, maximizing life-years could lead to favoring the lives of those who are younger and able-bodied, while disadvantaging those who are older and have disability. Please see [vulnerable populations below](https://docs.google.com/document/d/1eqtWy5fS_qd_e8jM58ii9wUr8_npHaVLPF-mHmqFvsg/edit#bookmark=id.lkprh7i1862w) for further discussion.

Although the above ethical values and principles for medical resource allocation suggested by [Persad et al. (2009)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(09\)60137-9/fulltext) are well-known, there are others as well. Some advocate for the interrelated concepts of cost, opportunity costs, and cost effectiveness to be considered within the principles of allocation. [Sheehan and Hope (2002)](https://books.google.com/books?hl=en\&lr=\&id=YsQIbtX2GXsC\&oi=fnd\&pg=PP1\&ots=BTE5i-2BrB\&sig=1tYGM2hagkyrf_joKZ7C0wF2mDE#v=onepage\&q\&f=false) in Allocating Health Care Resources in the UK promote this approach. Because cost is a limiting factor in medical budgets, they argue that it is important to assess the relative opportunity costs of approaches to allocation, as funding one area means another area will not receive funding. As such, cost effectiveness can be an essential consideration in deciding medical resource allocation. This approach to cost effectiveness is not solely limited to the hospital or medical center setting, but instead applies to society more broadly. For instance, during an economic downturn, we use cost effectiveness when deciding where to direct stimulus money (hospital vs. industry vs. directly to families).

*Thought Questions:*

* If you were developing a system of allocation for your country, which principles would you weigh most heavily and/or least heavily, and why?
* What role should monetary cost have in guiding decisions within an allocation system?
* What decisions (societal, governmental, personal, etc.) have been made in the past that have now caused rationing to be necessary in the setting of scarcity?
* Are there solutions outside of rationing that can solve the scarcity of medical resources?

**References:**

* [Emanuel, Ezekiel J., et al. "Fair allocation of scarce medical resources in the time of Covid-19." (2020).](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114)
* [Persad, Govind, Alan Wertheimer, and Ezekiel J. Emanuel. "Principles for allocation of scarce medical interventions." The Lancet 373.9661 (2009): 423-431.](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(09\)60137-9/fulltext)
* NCCID. “Understanding Summary Measures Used to Estimate the Burden of Disease: All about HALYs, DALYs and QALYs”. (2015)
* [Sheehan, M., and T. Hope. "Allocating healthcare resources in the UK: putting principles into practice." Medicine and social justice: essays on the distribution of healthcare (2002): 219-230.](https://books.google.com/books?hl=en\&lr=\&id=YsQIbtX2GXsC\&oi=fnd\&pg=PP1\&ots=BTE5i-2BrB\&sig=1tYGM2hagkyrf_joKZ7C0wF2mDE#v=onepage\&q\&f=false)
* [White, Douglas B., et al. "Who should receive life support during a public health emergency? Using ethical principles to improve allocation decisions." Annals of Internal Medicine 150.2 (2009): 132-138.](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2629638/)


# Resource Distribution

## **Overview**

This section will discuss the ethical arguments around scarce resource distribution with a focus on various scenarios that may arise in the COVID-19 pandemic. Briefly, we consider two broad forms of resource allocation: macroallocation and microallocation. Macroallocation determine how a particular society allocates funding and issues policies across areas such as defense, education, infrastructure, public health, and health care. It focuses on the healthcare needs of a population as an aggregate, with distributive justice as the underlying principle. In contrast, microallocation relies on context and individual judgment in the distribution of scarce supplies, such as ventilators and face masks. It uses ethical principles such as those discussed in [Principles of Allocation](https://app.gitbook.com/@futuremdvscovid/s/covid19-curriculum/~/drafts/-M4ykRcFd6O6ulGB4y0r/module-6-medical-ethics-in-relation-to-covid-19/principles-of-allocation) to make decisions among individual cases. In short, macroallocation decisions affect statistical and hypothetical lives, while microallocation decisions affect identified lives.

In this section, we first consider issues of macroallocation involving resource distribution between hospitals, states, and nations that may have differential access to resources or ability to produce them independently. We then turn to various scenarios involving microallocation of personal protective equipment (PPE), testing for SARS-CoV-2, and ventilators, all of which may be preferentially directed to certain individuals. &#x20;

It is never easy for clinicians to allocate resources, yet we do it all the time. We make choices as to how we spend our time, attention, and energy, the expertise of our specialists and subspecialists, and who we believe can be saved with or without heroic measures. The unfortunate reality is that any scarcity of resources is exacerbated in a time of crisis. Resources are more limited in a time of crisis, requiring decisions that would not ordinarily be made. The scarcity questions that arise in a crisis may be the same as in non-crisis situations but to a greater degree (e.g. patients competing for limited clinician attention), or they may be different in kind (e.g. ventilators supply for sick patients is not entertained in normal times). Furthermore, there are unique features of the COVID-19 pandemic that exacerbate resource shortages. Many of the masks, testing kits, and ventilators in short supply are produced on a regional or even global scale and are affected by stockpiling, supply chain issues, and politics. Since the pandemic is predicted to be limited to a relatively short time period, governments and suppliers face the economic question of whether it is worthwhile to buy or produce more resources if the investment or infrastructure will not be needed in the future.

It is important to note that any discussion of resource allocation is incomplete without the appropriate historical, political, and geographical context. A truly just distribution would allocate resources according to some agreed-upon criterion, such as need or potential improvement in well-being and would strike a fair bargain between various countries and regions. In reality, resources are not distributed this way. Economic and political interests, in the context of long-standing imbalances of power, drive preferential access in times of scarcity. We therefore concern ourselves here with the non- ideal world in which we live; this is the world in which allocation decisions operate in times of crisis.

## Macroallocation of Scarce Resources

Macroallocation centers on the larger dimension of healthcare needs across a society or multiple societies. Disparities in critical infrastructure and government functions are exacerbated in a pandemic in a way that raises questions of key moral importance. For instance, the rapidly increasing number of confirmed COVID-19 cases in countries like Morocco, Nigeria, and Armenia raises concerns about how each country will manage the impact COVID-19 will have on its health systems. Because the COVID-19 pandemic has already demonstrated the need for a [highly interdependent global response](/module-7-global-innovation-and-collaboration), a widespread outbreak in low-to-middle income countries (LMIC) will not only impact their populations and health systems, but will also exacerbate problems with the interdigitated health and economic systems of the world. Thus, macroallocation considers how scarce resources can be provided to safeguard the well-being of countries with more constraints and fewer resources.

Macroallocation places particular emphasis on priority setting across a population, with a focus on **distributive justice** as the underlying moral aim. Distributive justice is concerned with the equal distribution of goods across or between societies. Principles of distributive justice, such as various forms of Egalitarianism, are “therefore best thought of as providing moral guidance for the political processes and structures that affect the distribution of benefits and burdens in societies” ([SEP](https://plato.stanford.edu/entries/justice-distributive/)). In practice, these processes are operationalized by governments or the relevant authorities in the hopes of achieving the statistically best outcome with the underlying principles as guidance. It is critical to note that these principles do not exist on their own but should be consistent with societal norms and values to be effective.

In response to COVID-19, a number of organizations and institutions have established recommendations about priority-setting in various contexts. Some of these focus on the international setting. The Center for Disaster Philanthropy ([CDP](https://disasterphilanthropy.org/cdp-fund/cdp-covid-19-response-fund/)) addresses questions regarding the distribution of general funding, such as philanthropic and high-GDP country support for low- and middle-income countries (LMICs) as they try to afford critical treatments. [USAid](https://www.usaid.gov/coronavirus) states that funds directed to the WHO will help governments in developing countries prepare for large-scale testing, implement public health emergency plans, and equip rapid response teams. What are the roles of high-income governments in supporting LMICs during a global pandemic, if the outcome would be orders of magnitude worse in LMICs? How much funding should well-off countries divert from their own domestic efforts to fight the spread of disease overseas?

There are also questions of differential access. The [WHO](https://www.who.int/influenza/preparedness/pandemic-vaccine-products/en/) has explored the question of whether countries will have differential access to a vaccine in the early days after development, before it is made in large enough quantities for all. Such actions can spark global controversies, as evidenced by reports of President Donald Trump’s attempt to buy exclusive rights to a German vaccine ([BMJ](https://www.bmj.com/content/368/bmj.m1100)). Thus, we must question: Who will receive vaccines first? Does that distributive strategy prioritize fairness or power differentials?&#x20;

Domestically, the [United States Congress](https://www.npr.org/sections/health-shots/2020/03/06/812964894/where-that-8-3-billion-in-u-s-coronavirus-funding-will-and-wont-go) passed legislation that allocates funding for state and local health departments, pharmaceutical interventions, the NIH, and hospital reimbursement, as well as non-health needs such as educational and economic stabilization. These relative contributions to various sectors entail value-laden choices about how to prioritize, for instance, economic recovery or early disease control.

Individual values can influence how participants in macroallocation agreements view proceedings. The relative prioritization of values differs around the world. Unaddressed differences in ethical perspectives amongst participants can cause conflict and a failure to successfully implement policies. Macroallocation and the equitable distribution of resources therefore depends on a contract between stakeholders - to negotiate in good faith and seek to understand each other’s priorities and perspectives - in agree on fair resource allocation resources.

*Thought Question:*

* What are our responsibilities within our own country?  Should we feel responsible for the rest of the world? If so, how could we be of assistance?&#x20;

**Additional Resources:**

* [Fair Allocation of Scarce Medical Resources in the Time of Covid-19](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114?query=featured_home)
* [The Toughest Triage — Allocating Ventilators in a Pandemic](https://www.nejm.org/doi/full/10.1056/NEJMp2005689)
* [Medicine and Social Justice: Essays on the Distribution of Health Care](https://books.google.com/books?hl=en\&lr=\&id=YsQIbtX2GXsC\&oi=fnd\&pg=PP1\&dq=resource+allocation+rosamond+rhodes\&ots=BTE3dX4Drx\&sig=pPsHjj4hZHszVYiwWwR0jaX2YNY#v=onepage\&q=resource%20allocation%20rosamond%20rhodes\&f=false)
* [COVID-19: Supporting Ethical Care and Responding to Moral Distress in a Public Health Emergency](https://www.thehastingscenter.org/guidancetoolsresourcescovid19/?fbclid=IwAR2pj-QOWqg8v-e4msxGXnSvcwKE6ymz4LmDLkv3r_llorQT5gKNhHnbrNM)
* [Stanford Encyclopedia of Philosophy - Distributive Justice](https://plato.stanford.edu/entries/justice-distributive/)
* [Stanford Encyclopedia of Philosophy - Moral Particularism](https://plato.stanford.edu/entries/moral-particularism/)

## Microallocation

Here we present three situations necessitating microallocation, all of which seek to obtain more of the resource, use less of it, or stretch available resources further. These allocation questions involve direct trade-offs and require choosing who from among various identifiable individuals will receive scarce resources. At a certain point, the available resources, no matter how agilely managed, will dissipate. How should these cases be managed? In much of the conversation here, we draw from the [Principles of Allocation](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19/overview-of-u.s.-medical-ethics#principles-of-allocation).

### **Allocating Personal Protective Equipment (PPE)**

As the case burden of COVID-19 continues to grow, supply shortages of PPE such as gowns, gloves, and masks have become increasingly acute. Governments and hospitals worldwide must ration scarce PPE reserves. In some cases, healthcare workers are being trained to [reuse PPE](https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/contingency-capacity-strategies.html), [improvise their own gear](https://www.pbs.org/newshour/nation/what-are-surgical-masks-and-respirators-and-why-are-they-important-in-the-fight-against-covid-19), and sterilize or re-sanitize masks after completing shifts. If resource shortages continue to worsen, these individuals may be faced with a harrowing decision - do they work with substandard PPE, without PPE, or not at all? These decisions directly impact their own well-being as well as that of their patients.<br>

Where there is still adequate PPE, who should have priority access? Many sources, including [WHO](https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/infection-prevention-and-control), [Strategic National Stockpile](https://www.esrdnetwork.org/sites/default/files/COVID-19%20Strategic%20National%20Stockpile%20PPE%20Distribution%20Information.pdf), [Ranney et al., 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2006141) believe that frontline healthcare workers and first responders should have priority . These individuals assume the critical mantle of treating patients and keeping the medical infrastructure intact and arguably the most instrumental value during a pandemic ([Emanuel et al. 2020](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114)). A utilitarian approach also supports conservation of PPE for these personnel. Medical personnel, if infected, may transmit the virus and infect others. If they fall ill or succumb to the disease, many patients - both with and without COVID-19 - will receive insufficient care with increases in morbidity and mortality. Prioritizing PPE for frontline workers mitigates their own health risks and avoids asking them to treat patients with COVID-19 at a potentially tremendous personal cost.&#x20;

There is some debate over how far the definition of “frontline” worker should extend. For example, [Partners Healthcare](https://pulse.partners.org/hub/departments/emergency_preparedness/coronavirus/surgical_mask_policy) and Beth Israel Lahey Health, both in Boston, have mandated that all hospital personnel wear surgical masks on the premises, regardless of whether they directly interact with COVID-19 patients. One argument in support of this approach is that various staff who do not have direct patient care responsibilities (e.g. hospital cleaning staff) perform vital services in a pandemic by keeping hospitals running smoothly. Outside of the hospital, there is disagreement over whether “essential” workers such as [grocery store employees](https://www.brookings.edu/blog/the-avenue/2020/03/25/grocery-workers-are-keeping-americans-alive-during-the-covid-19-pandemic-heres-what-they-need/) should wear PPE. The CDC has stated that the general public, including supermarket employees, [do not](https://www.grocerydive.com/news/grocers-give-workers-the-ok-to-wear-masks-gloves/574897/) need to wear masks, though various locales in Massachusetts and elsewhere have [encouraged](https://necsi.edu/coronavirus-guide-for-supermarkets-grocery-stores-and-pharmacies) all grocery store workers to do so. This is in part a disagreement over who constitutes “essential” personnel and how far available resources can be stretched.

More on the allocation of PPE can be found in the supplemental materials [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

*Thought questions:*

* Do healthcare providers who lack adequate access to PPE have an obligation to care for patients?
* Should governments compel individuals and businesses to donate PPE to “frontline” efforts? What ethical principles or other circumstances might factor into that decision?

### **Allocating COVID-19 testing kits**

Demand for COVID-19 diagnostic testing outpaces supply in many countries. Worldwide, efforts to mass-produce test kits and augment testing volume have been stymied by shortages in [collection swabs](https://khn.org/news/as-coronavirus-testing-gears-up-specialized-swabs-running-out/) and [testing reagents](https://www.ecdc.europa.eu/sites/default/files/documents/RRA-seventh-update-Outbreak-of-coronavirus-disease-COVID-19.pdf), as well as [limitations](https://www.npr.org/sections/health-shots/2020/03/28/822869504/why-it-takes-so-long-to-get-most-covid-19-test-results) in laboratory processing capabilities. In the U.S., testing has also been handicapped by [multiple missteps](https://www.nytimes.com/2020/03/28/us/testing-coronavirus-pandemic.html) in the initial government response, including costly technical and regulatory delays in deploying working tests. Confronted with significant testing shortages, hospitals and public health agencies have devised guidelines stipulating which individuals merit access to testing over others (examples: [WHO](https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance), [CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html), [Beth Israel Lahey Health](https://www.bilh.org/covid19-information-assets), [Brigham/Mass General](https://pulse.partners.org/hub/departments/emergency_preparedness/coronavirus/covid19_testing_criteria) - access credentials required). These guidelines aim to use available testing kits in the most efficacious manner by triaging testing.&#x20;

Two groups consistently emerge as top priorities for testing: **patients** with COVID-19 symptoms who require hospitalization and **healthcare workers** who are directly caring for them. Patients hospitalized for presumptive COVID-19 tend to be the sickest and often have significant medical comorbidities. From a prioritarian perspective, these individuals should be tested first because they face the highest risk of morbidity and mortality from the disease and are thus considered to be the worst off ([Emanuel et al. 2020](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114)). Ascertaining a diagnosis is paramount in guiding the next steps of care, whereas it is far less critical for someone with mild disease recovering at home. According to many guidelines, members of the general public who are asymptomatic or who exhibit mild symptoms are lower priority for testing ([CDC](https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html)), particularly in areas where existing testing capacity is inundated by cases from hospitalized patients. In these settings, it has become difficult to test suspected cases of mild community-acquired COVID-19, to preemptively test close contacts, or to monitor local spread of the virus, all of which are important public health goals ([Emanuel et al., 2020](https://www.nejm.org/doi/full/10.1056/NEJMsb2005114)). The current approach to prioritize testing of high-acuity patients over lower-acuity ones achieves certain valuable goals at the expense of others. These tradeoffs are inherent in resource allocation and highlight the importance of developing broad testing.&#x20;

A different rationale guides preferential testing of frontline healthcare workers, who are at elevated risk of contracting and transmitting the virus yet have instrumental value in the response to a pandemic. Therefore, they require frequent testing in order to function effectively and avoid viral spread. Some have argued that this approach should extend personnel such as [first responders](https://www.chicagotribune.com/suburbs/aurora-beacon-news/ct-abn-aurora-first-responders-covid-19-testing-st-0327-20200326-64kn7zcykje4zoeglvcug7orxq-story.html), who have assumed similarly indispensable duties and risks during the pandemic. It is less clear how to optimally balance the testing of hospitalized patients with that of essential personnel in the setting of test kit shortages. If many hospitalized patients remain untested, this may affect appropriate triaging of care and cause unnecessary PPE use. Alternatively, if many essential personnel remain untested, they may be unnecessarily sidelined by mandatory quarantining or serve as vectors for infection, exacerbating healthcare and first responder staffing shortages.

It is unclear how consistently testing allocation schemes are being observed. In the U.S., a number of prominent figures, including [members of Congress](https://www.nytimes.com/2020/03/22/us/politics/coronavirus-rand-paul.html) and [NBA players](https://www.nytimes.com/2020/03/17/sports/brooklyn-nets-coronavirus.html), have been tested for COVID-19 despite being asymptomatic. One could argue that these individuals possess instrumental value (such as leadership or media influence during a pandemic) or associated risk factors (such as essential travel and extensive close contacts) that necessitate testing. However, if “instrumental value” is broadened to this extent, this could privilege the interests of the powerful and well-connected over those of the general public.&#x20;

*Thought question:*

* Given the current scarcity of diagnostic tests, communities will likely have differential access to early testing. How might disparities in access to early tests shape how the pandemic affects these communities in the long run?

### **Lifesaving interventions**

At the crux of resource allocation in a pandemic is who has access to lifesaving interventions when they are in limited supply. This reality is most acute when it comes to life-saving interventions such as ventilators and extra-corporeal membrane oxygenation (ECMO), as allocation decisions directly save certain lives at the expense of others. The current pandemic casts these choices into the sharpest relief. In what follows, we review several situations that could conceivably arise during the current pandemic, in which the allocation of life-saving interventions is necessary. Our goal is not to reach conclusions about the “right” choices to make in these cases. Rather, by highlighting various allocation issues that may arise, we hope to prepare readers for the possibility that they will be called on to make those decisions.&#x20;

There is a critical need for ventilators in the current pandemic. Why is that the case? It is a result of two key features of the disease: patients with COVID-19 require intubation early and for long periods of time. Usually, when a patient’s respiratory status is declining, there is a stepwise approach that gradually increases the invasiveness of the interventions used. Several intermediate steps in that pathway - the use of nebulizer treatments, humidified oxygen therapy (e.g., high-flow nasal cannula) and BIPAP machines - are felt to be unsafe, as they are aerosolize SARS-CoV-2 particles, placing healthcare workers at risk. Many hospitals therefore skip directly to intubation of any and all patients with COVID-19 in respiratory distress. Patients requiring mechanical ventilation need that support for an unusually long period of time - an average of two weeks, in contrast to the clinical course for most, in which many patients’ clinical status improves after several days. Thus, ventilators cannot be repurposed easily or after short periods.&#x20;

A number of important ethical questions arise around the question of who receives a ventilator. First, should ventilators be shared? New York has started to [share](https://www.nytimes.com/2020/03/26/health/coronavirus-ventilator-sharing.html?action=click\&module=Top%20Stories\&pgtype=Homepage) or ‘split’ ventilators between patients. The downside to this approach is that a ventilator can only be set to one setting, whereas patients usually require highly individualized settings fine-tuned by trial-and-error in the ICU to deliver optimal pulmonary support. The aim is to find patients who require similar settings, so both receive appropriate car, however, this practice has not been rigorously tested in humans and is primarily a theoretical idea. The advantage of this approach is that it may save more lives. The disadvantage is that a larger number of patients may have worse outcomes if they all receive treatments that are less efficacious compared to typical standard of care. Do the benefits of this approach outweigh the risks? The principle of non-maleficence suggests that clinicians should avoid harming patients. A corollary is that care is inappropriate if provided below a certain accepted standard. Non-maleficence opposes the splitting of ventilators, as it means that some patients - who might survive if they were the only one on a ventilator - might experience worse outcomes. This value is in tension with the idea of beneficence, which supports any attempt to save more lives. How should this tension be resolved? A common strategy is to turn to consequentialist approaches such as QALYs or DALYs to see which strategy has the greater expected net benefit. Other approaches argue that certain moral principles, such as nonmaleficence, carry greater moral weight given their relative centrality in the medical profession’s canon (e.g. ‘do no harm’ supersedes an affirmative obligation to heal).&#x20;

Second, should some patients not be considered for a ventilator? Some patients may arrive extremely sick, and a triage decision is made that they have a low likelihood of survival due to comorbidities or clinical status. Once ICU-level care with a ventilator is offered, it is difficult to revoke. Withdrawing life-sustaining care is typically done at a patient or family’s request, or for medical futility. In contrast, during a pandemic, rationing may require withdrawal of care in order to provide ventilators to patients who are given higher priority, a reason foreign to many front-line clinicians ([Truog et al, NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2005689)) This raises the question of when to initiate that decision. If it is apparent to ED clinicians that a particular patient, if intubated, would be removed from a ventilator in the near future because they are of lower priority, should they offer mechanical ventilation? If some patients will not be offered the option of aggressive care, when is that decision made, and who conveys it? These questions are likely to arise as an increasing number of precipitously ill patients arrive at the hospital.&#x20;

Third, who gets a ventilator? If there are not enough ventilators for all patients, some patients will receive them, while others will not. This will require tough decisions as to which patients may be saved. These allocation decisions can be made with a variety of ethical frameworks and principles. An excellent approach to thinking through allocation decisions is provided above ([Principles of Allocation](https://curriculum.covidstudentresponse.org/module-6-medical-ethics-in-relation-to-covid-19/overview-of-u.s.-medical-ethics#principles-of-allocation)). While these decisions are often not standardized across institutions and may reflect local context, the principles on which these decisions are based are felt to be universal.&#x20;

Finally, who decides who gets a ventilator? There are various options. Some have suggested that clinicians intimately involved in the care of the patients in question should make those decisions - an approach known as ‘bedside rationing.’ Such decisions can be fraught with bias and emotional entanglements with patients (e.g. ‘this patient reminds me of so-and-so’), and can inflict a toll on clinical staff. In an effort to standardize allocation decisions and obviate the distress to frontline staff, there is a move for hospital committees to make allocation decisions ([Truog, et al NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2005689)). Hospital committees consisting of doctors, various other clinical staff, and administrator, would meet and review cases. One clear advantage of this approach is that it allows for involvement of various stakeholder views including that of ‘community representatives.’ It may obviate the distress of bedside clinicians but may also make them feel that life-or- death decisions about their patients have been taken out of their hands.&#x20;

*Thought questions:*

* If you had to allocate ventilator spots to a panel of patients, how would you decide? What criteria would you consider important, and why?&#x20;
* When have you seen life-saving care rationed in the hospital on clinical rotations?&#x20;

## Real-World Example

On April 7, 2020, the Commonwealth of Massachusetts released Crisis Standards of Care [recommendations](https://d279m997dpfwgl.cloudfront.net/wp/2020/04/CSC_April-7_2020.pdf). These guidelines are primarily grounded in **utilitarian** principles: they seek to save the most lives and life-years.  They do so by using clinical scoring criteria to identify patients most likely to benefit from critical care services. &#x20;

In the days after the release of these recommendations, [public servants](https://www.wbur.org/commonhealth/2020/04/14/ayanna-pressley-critical-care-state-guidance-governor-letter) and [providers](https://docs.google.com/forms/d/e/1FAIpQLScxjXDKBrI8K2PC4eApInU-g8z9OIDcx4mexsmNeFhbTuX7Qg/viewform) taking a more **prioritarian** view pushed back, arguing that, "giving priority to those without serious comorbid illness, will disproportionately discriminate against vulnerable populations by serving as a proxy for race, ethnicity, immigration status, serious mental illness, and other sociodemographic characteristics." &#x20;

*Thought question:*

* Some of these concerns are addressed in this [video](https://harvard.zoom.us/rec/play/78cuJr-oqT83HYaSsgSDAvV5W420J6yshycd_qcPnRrkUnICZ1P0MOcXa-dpX6Ohuuv_iCFOEnq51ifk?continueMode=true&_x_zm_rtaid=mr94-yfqRBeuOPt2jGvdQw.1586961053268.f2d6f3952872cdf123b2a8b1b2482f1f&_x_zm_rhtaid=839) recording of Surgical Grand Rounds at April 15, 2020, at the Beth Israel Deaconess Medical Center.  What do you make of Dr. Kristin Raven’s assessment at 44:16 that “unfortunately in a time of crisis, we can’t also make up for those longstanding disparities in care... certainly an important thing that needs to be taken into consideration after crisis standards”?

In addition to Massachusetts, several other states. have released Crisis Standards of Care (CSC) guidelines for the allocation of scarce critical care resources. Most guidelines use the Sequential Organ Failure Assessment (SOFA) scores to predict short-term survival and maximize lives saved. However, different states have adopted different stances on whether to account for patient co-morbidities as a measurement of incorporating long-term survival into the consideration. In the future, it is important that physicians, wherever they practice, have an easy way to access and understand their own state guidelines, since another surge could arise before a vaccine is found. This information will also be useful for future pandemics. A table in our [supplementary section](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit#heading=h.heut4o36m2np) compares and contrasts four state guidelines: Maryland, Pennsylvania, New York, and Colorado. For more information about how these state guidelines compare in terms of outcomes, please visit the paper published in medRXiv: <https://www.medrxiv.org/content/10.1101/2020.05.16.20098657v1>. Of note, Massachussetts's guidelines was originally similar to that of Pennsylvania, but has now been addended extensively.


# Vulnerable Populations

## Overview

This section will discuss ethical questions that are particularly relevant to a range of vulnerable patient populations. By “vulnerable,” we mean patients who may be at particular risk of suffering physical or mental health consequences, financial hardship, or discrimination. Vulnerable populations may require additional aid and protection during a time of crisis, and, yet, can often be forgotten when public health measures are enacted for the population as a whole. This section will remind us of crucial issues and concerns affecting vulnerable groups.

Please note that the ethics relating to homeless, low-income populations, and communities facing racism and xenophobia can be found in [Module 3](/module-3-disparities-policy-socioeconomic-effects), as well as in the supplemental material [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

## **Children**&#x20;

While it is predicted that, from a disease morbidity standpoint, children will be less affected by COVID-19, the downstream implications on this  population should not be forgotten. The most obvious impact may be on educational progress. According to [UNESCO](https://en.unesco.org/themes/education-emergencies/coronavirus-school-closures), as of March 23rd, 2020, more than 1.3 billion learners were out of school due to COVID-19. While teachers and school boards are dedicated to continuing a child’s educational year, digital learning is an imperfect system, especially for children that do not have access to internet or have had to step into new roles (childcare, cooking, etc.) due to the pressures on the adult population. [Wang et al. (2020)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)30547-X/fulltext) stress that, when kids are out of school, they are less active, have longer screen time, and have irregular sleep patterns.  Moreover, the article points out that the psychological impact of such prolonged isolation must not be forgotten. [Sprang and Silman (2013)](https://www.cambridge.org/core/journals/disaster-medicine-and-public-health-preparedness/article/posttraumatic-stress-disorder-in-parents-and-youth-after-healthrelated-disasters/4F3E4300F74CEEAFA8EE95E490944888) showed that the mean posttraumatic stress scores were four times higher in children that had been quarantined than in those who had not. Lastly, the livelihood of children is closely connected to that of the adult population, which is being severely affected by the pandemic. For instance, parents who continue to work outside of the home may have difficulty finding childcare, as schools and daycare centers remain closed.

The pediatric population is a dependent, and thus vulnerable, population. The ethical discussion then becomes how one thinks through the allocation of resources to a population that will experience profound repercussions from the pandemic but 1) will be less affected from a purely health standpoint and 2) does not directly contribute to the economy.  While many argue that there will be a substantial trickle-down effect of supporting the caregivers of children, and thus, this should be the population targeted with funding and resources, it could be argued that failure to address the specific pediatric repercussions of COVID-19 will have substantial impact, which will continue to be felt far into the future.&#x20;

*Thought Questions:*

* Once things return to the status quo, how do we best repair the educational and psychological stressors that children face during this period?
* Is a dependent population that is not directly linked to economic productivity inherently less deserving of resources during a pandemic?

## **People with Physical and Developmental Disabilities**&#x20;

Societal responsibility towards people with disabilities has been a focus of discussion when situations such as pandemics or mass disasters arise and forces us to decide the most efficient and moral ways to distribute help. Experiences from [Hurricane Katrina](https://ncd.gov/publications/2006/Aug072006) have highlighted a disproportionate effect on people with disabilities in dire circumstances. Several U.S. states have proposed guidelines for resource allocation during crises with limitations for certain groups; most notably, [Alabama](http://www.adph.org/CEP/assets/VENTTRIAGE.pdf) has outlined an emergency allocation plan that deems people with severe intellectual disability as “unlikely candidates” for ventilators. [Several arguments](https://scholarship.law.ufl.edu/cgi/viewcontent.cgi?article=1110\&context=flr) have been made against the allocation of scarce resources to the disabled. These arguments propose that people with disabilities require extended time of resource use, “have a limited long-term prognosis as a result of their disabilities,” and, in some cases, might have limited benefit from the medical intervention due to a pre-existing disability. &#x20;

People with disabilities may not always require additional resources, however, and we must be careful not to let unconscious bias prevent us from prioritizing this population. As Edmund G. Howe discusses in [A Possible Application of Care-Based Ethics to People with Disabilities during a Pandemic,](http://www.clinicalethics.com.ezp-prod1.hul.harvard.edu/archives/201021401.pdf) care-providers experience “unwarranted pessimism” in seeing people with disabilities as “less likely to be happy with their life than is the case.” He also argues that non-disabled persons may have a tendency to “reflexively want to distance themselves from people with particularly visible and evident disabilities. *Thus, a policy regarding equality of access to treatment during a pandemic may be particularly warranted.”*&#x20;

In his [New York Times Op-Ed](https://www.nytimes.com/2020/03/23/opinion/coronavirus-ventilators-triage-disability.html), Ari Ne’eman, a disability rights activist, advocates for a “first come first served” approach in efforts to avoid discriminatory behavior in healthcare delivery, especially during the COVID-19 crisis. Although he recognizes the sacrifice imposed by this approach, he argues that there is value in maintaining certain moral principles, explaining, *“I believe that nondiscrimination is not just a tool to accomplish an end — it also is an end in and of itself.”*

*Thought questions:*&#x20;

* Do you agree with Howe’s argument that care-providers may incorrectly assume that those with disabilities live less happy lives? If so, how do you think this affects their healthcare management?&#x20;
* What ethical approach would you implement in your policy and action to avoid discriminatory behaviors against those with disabilities?

## **Pregnant Women Seeking Abortion**

As many states have called for "elective" or non-essential surgeries to halt, some states’ governments have argued that surgical abortions are non-essential and should be stopped to allow personnel and PPE to be re-allocated to the fight against COVID-19. The issue of whether surgical abortions should continue during this crisis strikes at a familiar and important question: is abortion an essential part of women’s healthcare, or is it something that women ‘elect’ to pursue but is not crucial to their health and well-being?

The American College of Obstetricians and Gynecologists, along with other medical professional organizations representing OB/GYNs, published a statement that calls for surgical abortions to continue, as they are a time-sensitive and essential part of women’s healthcare. Governors from conservative states disagree, and a handful of governors have ordered surgical abortions to stop. Others are considering similar action.

In addition to the question of what constitutes "essential care," it is important to consider reasons abortions may be in higher demand during this pandemic. First, women may have difficulty accessing contraception if in quarantine, they have no safe way to travel to a pharmacy, or their pharmacy may have a shortage of their contraceptive medications. Second, [intimate partner violence often increases during disasters](https://www.unwomen.org/en/news/in-focus/in-focus-gender-equality-in-covid-19-response), and there may be higher rate of sexual assault and resulting pregnancies. Third, China has seen an increase in divorce rates after COVID-19, and times of marital instability and financial distress have been linked to greater demand for abortion. If demand for abortion increases while the availability of abortion decreases, many pregnant women seeking abortion will be unable to obtain one during this pandemic.

*Thought questions:*

* Do you agree that abortion is an essential part of women’s healthcare? Why or why not?
* How should we think about the use of PPE for surgical abortions as compared to other uses during this pandemic? What kind of demand for PPE is posed by an ongoing pregnancy and delivery?

**References:**

* [Joint Statement on Abortion Access During the COVID-19 Outbreak](https://www.acog.org/en/News/News%20Releases/2020/03/Joint%20Statement%20on%20Abortion%20Access%20During%20the%20COVID%2019%20Outbreak)
* [The coronavirus may be driving up divorce rates in a Chinese city, officials say](https://www.businessinsider.com/covid-19-peak-divorce-rate-chinese-cities-2020-3)
* Finer LB, Frohwirth LF, Dauphinee LA, Singh S, Moore AM. Reasons U.S. Women Have Abortions: Quantitative and Qualitative Perspectives. Perspectives on Sexual and Reproductive Health 2005;37(3):110-8.


# Commitment of Healthcare Professionals and Trainees During Crisis

## Overview

This section will discuss the responsibility of clinicians to patients, and by extension, the responsibility of medical trainees to patients, during this pandemic. In addition to clinical responsibilities, we discuss the importance of maintaining individual patient rights and humanity and any responsibilities toward broader advocacy efforts.

## **Duty of Clinicians to Treat Patients Despite Personal Risk**&#x20;

The COVID-19 outbreak poses a very real ethical dilemma: what is a physician’s responsibility to serve patients despite personal risk? Responses during the 2003 SARS epidemic and previous influenza pandemics raise complex and conflicting issues that can guide our present thinking.

In addition to the principles of beneficence and altruism, there are several [arguments](https://bmcmedethics.biomedcentral.com/articles/10.1186/1472-6939-7-5?optIn=true) in favor of the duty to care for patients. First, healthcare professionals have a unique expertise and ability to serve. We have a monopoly on the right to practice medicine, and this right comes with a moral obligation to practice in emergencies when society needs us the most. Second, some might argue that we freely choose a profession that assumes a level of risk. Third, if a physician refuses to work because of personal risk, some might argue that the risk will be [passed onto a colleague](https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1467-8519.2005.00448.x), and the already significant burden on the healthcare system will increase. The [AMA Code of Ethics](https://www.ama-assn.org/delivering-care/public-health/ama-code-medical-ethics-guidance-pandemic) states that a physician’s responsibility to provide urgent care during disaster situations holds “even in the face of greater than usual risk to the physicians’ own safety, health or life.”&#x20;

However, is there a certain [level of acceptable risk](https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1467-8519.2005.00448.x) beyond which this duty no longer holds? Some physicians might have comorbidities themselves or live with elderly or immunocompromised individuals, where the consequence of transmitting COVID-19 would be serious. In addition to a duty to their COVID-19 patients, clinicians have a duty to themselves, their loved ones, and their non-COVID-19 patients, both present and future. The duty to serve typically implies[ reciprocity](https://erj.ersjournals.com/content/34/2/303.short) from the hospital system, including adequate training, support, and PPE to minimize risk of harm, which is not holding true in this pandemic in some areas. In fact, a [Seattle ED physician](https://www.seattletimes.com/seattle-news/health/er-doctor-who-criticized-bellingham-hospitals-coronavirus-protections-has-been-fired/) was recently fired, presumably in retaliation for speaking out about lack of PPE and infection control practices in his hospital. Overall, it is important to acknowledge that physicians and other healthcare workers are quite vulnerable to coercion during this pandemic. In a culture that expects selflessness and heroism from physicians, anyone who is hesitant to continue working based on personal risk might worry about openly expressing their opinion for fear of damaging their professional reputation, risking their job, and appearing selfish.&#x20;

In addition to providing PPE, there are ongoing discussions regarding ways to support healthcare workers during this time. The current stance of the [Accreditation Council for Graduate Medical Education (ACGME)](https://www.acgme.org/Newsroom/Newsroom-Details/ArticleID/10085/ACGME-Resident-Fellow-Education-and-Training-Considerations-related-to-Coronavirus-COVID-19) is to maintain normal work hour restrictions for residents and fellows, although there are growing concerns that this might not hold true as the number of patients rises. Breaking work hours would increase the number of available staff, although, per the ACGME, likely at the cost of more medical errors and lapses in infection control, which would adversely affect residents, fellows, and patients. Recently, some hospitals have started to consider [universal do-not-resuscitate (DNR) orders for COVID-19](https://www.washingtonpost.com/health/2020/03/25/coronavirus-patients-do-not-resucitate/) patients in the setting of limited PPE and significant risk of exposing multiple healthcare workers during a code. If infected, these healthcare workers would be unable to care for other patients. While instituting a universal DNR for COVID-19 patients would be consistent with the utilitarian approach of placing the needs of many over the needs of an individual patient, it violates a patient’s autonomy when he or she is most vulnerable. Finally, there are [online](https://www.change.org/p/united-states-department-of-health-and-human-services-hazard-pay-for-healthcare-workers-dealing-with-coronavirus?source_location=topic_page) [petitions](https://www.change.org/p/hazard-pay-for-nurses-doctors-and-healthcare-professionals) to provide hazard pay for frontline healthcare workers at increased risk of exposure, but it is unclear whether these will lead to change within hospital systems. A case could be made that the high salaries physicians enjoy at baseline are pre-payment for taking on risk when needed, but that is not the case for residents, fellows, nurses, and other hospital staff.

Ultimately, it is important to acknowledge that we have a professional obligation as healthcare workers to put our patients first, but we are also human beings with legitimate concerns about our own safety and that of our loved ones. In return, we expect our hospital systems to value our expertise, time, and lives, and adequately train, support, and protect us. These conflicting priorities are well summarized in the words of an [Ohio intern](https://www.aamc.org/news-insights/terrifying-privilege-residency-during-covid-19-outbreak) who describes her work in the current pandemic as “a terrifying privilege.”

*Thought Questions:*

* Are the standards set by the AMA Code of Ethics too much to ask of clinicians when there is insufficient PPE and support? How should healthcare workers combat feelings of guilt or shame if they find themselves unable or hesitant to fulfill this professional obligation?
* If a critical care physician’s child has recently had organ transplantation and is immunocompromised, is it acceptable for this physician to not come to work during this pandemic, or should he/she be held to the same standards as everyone else?
* How can we ensure that hospital administration holds up their end of this social contract? How do we protect healthcare workers, who often are intrinsically altruistic, from administrative exploitation during a pandemic?&#x20;

## **Role of Healthcare Workers in Supporting Patients’ Individual Rights and Humanity in a Crisis**&#x20;

One of the foundational ethical principles of doctoring involves balancing respect for patients’ wishes with concern for their welfare. Most of the time, when patients seek care from healthcare professionals, their wishes are aligned with what would be in the best interest for their welfare. However, we now face a pandemic where patients with COVID-19 could infect others and pose a risk to public health. Even people who are asymptomatic may be possible vectors for disease. Autonomy can be overridden in circumstances such as these in the interests of protecting the health of the community. Many hospitals are, therefore, enforcing strict visitor policy guidelines for greater infection control. At Brigham and Women’s Hospital in Boston MA, for example, [routine visitors are currently being restricted](https://www.brighamandwomens.org/patients-and-families/visitors/visitor-policies). Other visitors must be screened for risk of COVID-19 and are only allowed in during special circumstances outlined in their policy, such as a partner to a mother in labor or a parent of a child under 18.

These policies protect the safety of patients and our communities, but they come at a serious cost. Researchers have found many positive patient outcomes related to having visitors in the hospital, [including faster recovery times, reduced length of stay](https://www.clinicalcorrelations.org/2018/08/03/do-hospital-visitors-impact-patient-outcomes/), and [decreased anxiety and delirium in the ICU](https://www.ncbi.nlm.nih.gov/pubmed/10401338). Families serve as [key advocates](https://www.clinicalcorrelations.org/2018/08/03/do-hospital-visitors-impact-patient-outcomes/) for their loved ones and can help with transitions between care teams and [reduce medical errors.](https://www.clinicalcorrelations.org/2018/08/03/do-hospital-visitors-impact-patient-outcomes/) The power of emotional support from loved ones is incredibly healing and important in supporting a patient’s sense of humanity. With healthcare workers pressed for time and adhering to strict infection control guidelines, there is little time to spend with patients. The difficult choices we make during this outbreak go against our desire to deliver compassionate, patient-centered care. Are there other alternatives? Perhaps we can imagine an informed consent process so that visitors to dying patients acknowledge the risk and then self-quarantine afterwards.

*Thought Questions:*

* How do we maintain a patient’s humanity during pandemics? When should we consider policies that protect the health of the population but might sacrifice the individual healing and dignity of patients?
* What is the role of a physician during an overwhelming pandemic with limited resources and time?
* Is what it means to deliver "empathetic care" redefined under the current circumstances, and, if so, what does that look like?

## **Role of Medical Students**

In response to the COVID-19 crisis, American hospitals and medical schools have opted to temporarily halt student clinical involvement. As per [guidelines](https://www.aamc.org/system/files/2020-03/Guidance%20on%20Student%20Clinical%20Participation%203.17.20%20Final.pdf) of the Association of American Medical Colleges (AAMC), this suspension has been deemed necessary to allow medical schools “a window of opportunity” to educate students on safety precautions for return to the wards and to also reserve PPE for licensed hospital staff. Given previous cases of [medical student exposure](https://www.unionleader.com/news/health/coronavirus/four-dartmouth-medical-students-exposed-to-coronavirus/article_b803eac1-36db-548d-a073-94936be04f40.html) to COVID-19, these restrictions also help limit risk of infection and spread to students. With their clinical education and training set to pause, students are left questioning their roles and responsibilities during the pandemic.&#x20;

Many students are mobilizing efforts to participate in non-clinical ways, including spreading COVID-19 information (such as this curriculum), supporting healthcare workers with non- clinical work, and helping community organizations. As students continue to remain outside of the clinical arena, however, it becomes necessary to consider the consequences of lost educational experiences in the clinic on the quality of medical training for future physicians versus the risk of infection for students and necessary PPE conservation. As hospital staff struggle with increasing patient cases, should medical students be re-introduced to the hospitals to offset some of the workload? [Medical schools in Massachusetts and New York City](https://www.nytimes.com/2020/03/26/health/coronavirus-medical-students-graduation.html) have responded and graduated fourth year students early to immediately increase the pool of healthcare workers. [European medical schools](https://www.cnn.com/2020/03/19/europe/medical-students-coronavirus-intl/index.html) have taken similar measures. Historical examples exist from the 1918 Spanish Flu, during which [volunteer medical students in Spain](https://www.statnews.com/2020/03/14/medical-students-can-help-combat-covid-19/) were sent to villages with limited oversight.&#x20;

*Thought Questions:*&#x20;

* At what point would it truly be ethically appropriate to allow medical students to practice medicine independently with limited oversight?
* What if early graduation and starting on a COVID-19 floor during the peak of the epidemic was mandatory? What are the ethical implications of such a change?

## **Responsibilities of Physicians in Broader Advocacy Efforts**

With the current surge of COVID-19 cases and need for care, the chief of staff for MassHealth catalyzed policy changes in telemedicine to triage COVID-19 cases. At the same time, a dermatologist noted a 50% follow-up absentee rate in her clinic and advocated for expansion of telehealth to include specialists, allowing many physicians to continue monitoring patients with chronic conditions. If she had not advocated for expanded telehealth coverage during these extenuating circumstances, specialty care likely would have been compromised. &#x20;

Physicians have begun to collaborate to advocate for policy changes in the wake of this pandemic. States have been encouraged to waive the Medicare telemedicine requirement that a provider be licensed in the state where care is delivered. In doing so, physicians can enhance national telehealth triage efforts to identify COVID-19 cases and refer for testing. The obligation of healthcare workers to not only educate their patient population, but also share information with one another on best practices, is critical for tackling this crisis. If healthcare workers are given access to multimedia resources to share learned practices, such as how to efficiently arrange COVID-19 wards, adopt alternate staffing models, and facilitate screening, we can help save lives. With additional multimedia resources, however, we need to adopt policy changes to maintain patient privacy.&#x20;

While the virtual world evolves to meet emerging healthcare demands, the physical needs of hospital facilities continue to grow, necessitating policy change. [Physicians have pointed out](https://www.healthaffairs.org/do/10.1377/hblog20200312.363618/full/) that establishing remote facilities, such as [drive-through testing centers](https://synapse.koreamed.org/search.php?where=aview\&id=10.3346/jkms.2020.35.e123\&code=0063JKMS\&vmode=FULL) and temporary COVID-19-specific wards, would help mitigate the burden on hospitals, especially when capacity is reached. Licensure for such facilities, however, is a lengthy process, and triaging of COVID-19 patients who present to the ED with mild symptoms may be considered an EMTALA violation.&#x20;

One way in which healthcare workers are responding to the national shortage of PPE is by advocating for and engaging in its acquisition. [#GetUsPPE](https://getusppe.org/) is a grassroots movement initiated by leaders in the healthcare field to organize and distribute donated PPE to those on the front lines. The organization is also pioneering 3D printed mask designs to help meet high demand.

*Thought Questions:*

* Do we, as healthcare workers, have an ethical obligation to advocate for policy changes on behalf of our patients? What policies might you advocate for?
* Within the limitations of federal policies and national shortages of human and material resources, what is the most efficient and ethical way to triage and treat such patients?


# Clinical Trials, Research, and Treatments

## Overview

As COVID-19 spreads, scientists are developing pharmaceuticals and vaccines that might treat the disease. While everyone hopes for a rapid discovery, the quest to identify therapeutics and prove their efficacy raises important ethical considerations. Furthermore, the interests of patients, the scientific community, the general public, and government officials may conflict.

*Thought questions:*

* What are the main ethical considerations in carrying out medical research on human populations?&#x20;
* How are these considerations challenged in times of crisis, and how does a society balance the needs of the population while maintaining core ethical principles that protect human study subjects?

To learn more about what makes a research trial design "ethical" according to the [Belmont Report](https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html), please look at the supplemental material [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

## Challenges to the Principle of Respect for Persons

### **Providing informed consent:**&#x20;

Even under ordinary circumstances, ensuring proper informed consent can be difficult, as the term may be interpreted in different ways. In 1979, American philosophers Beauchamp and Childress offered one definition of informed consent that is still referenced: “an individual’s autonomous authorization of a medical intervention or of participation in research.” According to these philosophers, informed consent entails more than agreeing to a study. It must involve authorizing an act through the act of voluntary consent. In particular, Beauchamp and Childress stated that the following seven elements are thought to capture informed consent:&#x20;

1. **Threshold Elements (Preconditions)**
   1. Competence (to understand and decide)
   2. Voluntariness (in deciding)
2. **Information Elements**
   1. Disclosure (of material information)
   2. Recommendation (of a plan)
   3. Understanding (of Disclosure and Recommendation)
3. **Consent Elements**
   1. Decision (in favor of a plan)
   2. Authorization (of the chosen plan)

As we understand these elements that comprise informed consent, it begins to become clear how conditions of crisis may place constraints on these principles. In the context of the current COVID-19 pandemic, there are already a number of clinical trials underway, from testing antiviral drugs to vaccine trials to evaluating passive antibody transfer (see [Modules 1](https://curriculum.covidstudentresponse.org/module-1-from-bench-to-bedside/investigational-therapeutics-and-vaccine-development) for more information regarding ongoing trials). Given the rapid spread of COVID-19, many of these trials do not have preliminary data on the risks of treatments for human subjects. While some therapeutics, such as the anti-malarial drug hydroxychloroquine, have been FDA-approved and are being [tested on COVID-19 patients](https://www.washingtonpost.com/business/2020/03/30/coronavirus-drugs-hydroxychloroquin-chloroquine/), these medications may have significant toxic side effects. Given the unknown risks of new or unproven treatments for COVID-19, how does a researcher ensure that a potential study participant has received appropriate disclosure, and how does a researcher assess a potential study participant’s understanding of the risks of participating?&#x20;

Another ethical challenge that surrounds the issue of informed consent is determining whether severely ill COVID-19 patients may have the capacity to agree to clinical trials or experimental therapies. It has been reported that, after the initial onset of dyspnea, many [COVID-19 patients rapidly deteriorate](https://www.uptodate.com/contents/coronavirus-disease-2019-covid-19) and develop Acute Respiratory Distress Syndrome (ARDS). Given the possible sudden decline in respiratory function in this subset of patients, many individuals may not have the opportunity to designate a health care proxy (if they had none prior). Thus for recent, expedited trials such as the [convalescent plasma study](https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds), it may be difficult to determine whether patients who are severely sick would agree to be part of the research trial.

## **Challenges to the Principle of Beneficence**

One of the key questions raised by COVID-19 research trials is the balance between risks to human subjects and potentially life-saving treatments that can help the rest of society? This is not the first disease in recent history for which this ethical question has been posed. During the AIDS crisis in the 1980s, as well as Ebola and Zika epidemics of the past decade, there were similar pressures to expedite research studies to find vaccines or therapeutics. Even in non-pandemic scenarios, experimental drugs developed for terminal illnesses may be fast-tracked to help critically ill patients. Here, we will discuss some of the adaptations in research guidelines that are made in situations where time is even more limited, as well as the risks and benefits of these different standards.

To learn more about the four phases of clinical trials, please read the supplemental materials [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

### **Approving off-label treatments**

Even after a therapeutic is FDA-approved, the treatment cannot be used to treat any medical condition. According to the FDA, [“off-label”](https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label) refers to the unapproved use of a drug or treatment approved for a different use. During times of crisis, there is often an increased impetus to use medications approved for similar illnesses in the hopes that this previously FDA-approved therapeutic may be beneficial. In the context of the COVID-19 pandemic, the antimalarial agent hydroxychloroquine provides an example of an off-label drug being tested.

The FDA guidelines for “off-label” use of drugs approved for another purpose leave discretion to the individual treating physician, with oversight by local institutions, including its Institutional Review Boards (IRBs). The FDA [explains](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices), *“Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement.”* A physician’s responsibilities in using an approved product in such a way are three-fold:

1\) awareness of the product and its effects\
2\) use based on “firm scientific rationale and sound medical evidence"\
3\) keeping a record of the drug’s usage and its effects.&#x20;

While the off-label use of FDA-approved drugs and therapies is less stringently regulated, the testing of experimental drugs, therapies, and devices currently in the U.S. is bound by the Health and Human Service (HHS) Common Rule and FDA guidelines to ensure proper beneficence of any new drug or therapy. While a harmonized ruleset is currently expected, the expectation is that the more stringent and protective ruleset be followed by investigators.

To learn more about expedited FDA approval of treatments for experimental use, please read the supplemental materials [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

### **Ethics of vaccine development**

We will now focus on ethical questions specific to vaccine development. Below is a comparison of traditional vaccine development timelines versus that in a pandemic. Some of the main differences involve the parallelization of the steps seen normally, which reduces time while increasing risk for developers ([Lurie et al., 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2005630)). Despite the condensed timelines, many of the recent vaccine development efforts for outbreaks such as Ebola, Zika, and MERS were not completed in a time frame relevant for intervention in their respective epidemics.&#x20;

![Difference between Traditional Vaccine Development and Development Using a Pandemic Paradigm](https://lh4.googleusercontent.com/vgMk-3dGYLh5BHoFX5y2jRI355uz-sWG9a4S85aaAD3ZD9DVG7ilehwaw5puvLr2W-C5KImK-cglzO-W2XwIYQqebzJgiw0gGmsyDYKpP9hhrO44Q2rkihRp5-XdXVhFOBPVh1Mn)

To achieve optimally time efficient vaccine development, intentional infectious inoculation of human subjects is one of many methods to obtain efficacy data. These studies, known as **vaccine challenge experiments**, are substantially more expedient compared to natural infection studies, making them useful during time-sensitive pandemics. However, given that these trials require deliberate inoculation of healthy volunteers, thorough and careful ethical consideration is warranted, particularly when exposing subjects to diseases with significant risk of morbidity and mortality, and in scenarios with no treatment options.

For these human challenge trials, an ethical review is deemed essential, particularly to assess the risks of exposure versus the benefit of data, as well as the robustness of informed consent. These trials are truly an arena in which the considerations of beneficence (risk versus benefit), respect for persons (informed consent and true understanding of potential risks by studied individuals), and justice (ensuring fair population recruitment for risk burden) must be carefully balanced. For this reason, human challenge trials are not acceptable in vulnerable populations, particularly those that cannot give clear informed consent ([WHO, 2016](https://www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf)). However, these trials have been performed in specific circumstances. For example, in a recent NIH [malaria vaccine trial](https://clinicaltrials.gov/ct2/show/NCT02015091), the benefits of the study were determined acceptable relative to the risk of infection, particularly allowing for treatment and monitoring of the exposed group. As a counterexample, a human challenge study for a Zika vaccine was not conducted due to increased risk to potential non-consenting individuals (i.e., sexual partners of participants, fetuses) ([Callaway, 2020](https://www.nature.com/articles/d41586-020-00927-3#ref-CR1)).&#x20;

Given that no treatments for COVID-19 exist, in addition to chance of morbidity and non-negligible chance of mortality, the discussion around a potential human challenge trial, which would expedite efficacy data collection, has only just begun to weigh the risks to the experimental population versus the benefits of the population as a whole ([Callaway, 2020](https://www.nature.com/articles/d41586-020-00927-3#ref-CR1), [Eyal et al., 2020](https://dash.harvard.edu/handle/1/42639016)). Further, even the fundamental design of a randomized clinical trial can be problematic in diseases with significant morbidity and mortality with regards to the placebo control arm. For example, during the Ebola vaccine efficacy trials, it was deemed unethical to employ placebo for control. Alternative methods were sought, including the use of early and delayed phase vaccination groups to determine efficacy. Design of efficacy trials for SARS-CoV-2 are currently being discussed ([Lurie et al., 2020](https://www.nejm.org/doi/full/10.1056/NEJMp2005630)).

## **Challenges to the Principle of Justice**

The principle of justice is to ensure that those who bear the risks of research benefit from it and, correspondingly, those who benefit from research should bear some risk. Vulnerable and stigmatized populations should be protected from exploitation, and privileged groups should not be favored. To learn some examples from U.S. history that illustrate threats to this ethical principle during wartime and in epidemics, please read the supplemental materials [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

It is crucial to ensure that vulnerable populations are not targeted at the expense of rapid scientific discoveries, as has occurred in the past. While many of these clinical trials are recruiting volunteers, this practice may not be as equitable as it sounds. For example, in passive antibody transfer studies, even though antibodies are being isolated from the plasma of patients who volunteer for the study, COVID-19 does not affect individuals equally. Patients from more vulnerable populations, such as the elderly living in crowded nursing homes or the homeless, are at greater risk of COVID-19 exposure and infection, and as such may represent a greater proportion of study participants. As [the Atlantic](https://www.theatlantic.com/ideas/archive/2020/03/two-extreme-long-shots-could-save-us-coronavirus/608539/) pointed out in a recent article, there are no guidelines on who would own potentially therapeutic antibodies -- will the patients from whom these antibodies were obtained be able to choose to immunize loved ones, or might the rich be able to buy the plasma of the poor who were previously infected? If compensation is offered to increase the participation, particularly for vaccine trials, which typically require a large number of participants, this may bias for subjects of lower socio-economic background. People in the U.S. cannot receive financial compensation for donating blood or organs, but they can be compensated for plasma harvested eggs, and harvested sperm. When might compensation be considered coercive, limiting an individual’s ability to make a voluntary choice?


# Public Health

## Overview

This section will discuss public health ethics, which explores the tension between individual rights and the public good. During a public health crisis, there is typically a shift between care of individuals and care of the entire population. The new moral calculus introduces many issues, including: how do we weigh the interests of the few against those of the many? What do we owe each other, and what can our government ask of us?

To learn more about legal authority during a pandemic to enforce isolation and quarantine, please read the supplemental materials [here](https://docs.google.com/document/d/1knR5wday0HM4rb5ic2fV0qRpVIEgn-OGHk8Q8RCHcR0/edit?usp=sharing).

## What are Public Health Ethics?

Public Health Scholar John Last defines public health as “an organized activity of society to promote, protect, improve and when necessary, restore the health of individuals, specified groups, or the entire population” \[1]. However, no consensus exists about the precise scope and meaning of public health \[2]. In general, we can consider  the primary focus of public health is the well-being of the whole population, rather than the  individual patient, and often involves a government that develops or carries out public health tasks. As a result, individuals are treated as a member of a larger population impacted by the health care system, as opposed to the individual implicated in a clinical setting.&#x20;

When it comes to guiding public health officials in decision-making, the bioethics principles developed Beauchamp and Childress might not be as instructive. This is due to the fact that bioethics emerged as a field of study in the 20th century with a focus on the doctor-patient relationship, rather than the “doctor-population” relationship, the focus of public health. Beauchamp and Childress’s four  principles of autonomy, beneficence, non-maleficence and justice were taken from values considered important in the interaction between patients and physicians. The idea was that these principles represented a wide consensus about important values and driving forces for clinical interactions. The physician could use the principles as a framework and consider which prima facie obligation outweighs another in a situation. These principles are often useful for guiding clinical interactions, but, as we will see below, they often become insufficient when guiding choices in public health measures.

Public health focuses on creating the conditions in society that allow all persons to be healthy. Hence, principles cannot exclusively focus on the consequences of action for one individual, but rather must consider the consequences for many individuals. Policies or actions may also impact individuals in different ways, since each individual has unique characteristics and needs. In this way, the potential harm and benefit of actions must be considered not just in terms of the four principles, but also in terms of the overall needs of a society. Some ethicists therefore propose that consequentialism or utilitarianism is well-suited to public health. At the same time, other justice considerations such as ensuring equal opportunity to achieve health or rescuing those worse off—such as those with handicaps or severe illness—may outweigh the maximization of overall benefit.

**References:**

* \[1] Last, J. M. (2007). A dictionary of public health. Oxford University Press.
* \[2] Lee, L. M. (2012). Public Health Ethics Theory: Review and Path to Convergence. The Journal of Law, Medicine & Ethics, 40(1), 85–98. <https://doi.org/10.1111/j.1748-720X.2012.00648.x>

## **Overview of Selected Public Health Frameworks**

In what follows, we present a few ethical theories that are particularly relevant to modern public health frameworks. Although the overarching theories are more complex and nuanced than can be explored here, the overview below may help frame the key elements of the debate in public health.  For instance how do we balance respecting individual good and rights versus public interest?  How should public health act in the face of scientific uncertainty?  What constitutes appropriate government intervention? After explaining the underlying theories, we will illustrate how they are relevant to public health matters in the COVID-19 pandemic.

* **Paternalism:** The main principle of paternalism holds that those in charge of governing—whether it be at the local, state, national, or international level—are thought to know what is best for individual citizens. The paternalistic governing body then sets rules that serve to either protect the individuals, make them better off, or protect the public good of many individuals \[1]. Although paternalism commonly carries a negative connotation, proponents have justified the restriction of an individual or group’s liberty with the intent of promoting their good and the good of the many. Common paternalistic policies include laws that require those to wear seatbelts in order to protect individuals. Policies that seek to prevent individuals from driving while intoxicated protect both the individuals themselves and those that may be harmed by an intoxicated driver. In paternalistic systems, the government subverts individual freedoms in making rules that govern its individuals, sometimes in ways that those individuals may not consent to directly or may not prefer \[1]. In some cases, a level of deception, and often coercion, is used to prevent individuals from knowing or experiencing truths that may harm them. For example, a governing body may prevent the entry or exit from a hospital unit with a meningitis outbreak to prevent its spread to other individuals and communities. While infringing on the individuals’ rights to free movement through the unit within the unit, it protects the public from potential harm.
* **Libertarianism (Liberalism):** In contrast to paternalism, libertarianism (used interchangeably with liberalism here) holds that governing bodies ought to respect individual and personal freedoms. Therefore, policies must be made in such a way as to avoid subverting those individual freedoms. Libertarians assert that individual rights should supersede potential intervening policies from the government. However, individuals are required to not violate the rights of others, despite the lack of defined policies from a government as seen in paternalism \[2]. At the same time, individuals cannot be forced to serve the good of all of society, or even serve their own prudential good \[2]. This implies that the government must have an underlying trust that individuals will naturally tend to act in ways that benefit society. Importantly, individuals are seen as “right-holders” with “self-ownership,” and those rights are not to be infringed upon unless the individual is using freedoms under said rights to directly harm others in meaningful ways without retribution for the harm \[2]. For example, consider a painter who pours her excess paint thinner into a brook to avoid driving to the waste disposal plant, which incidentally poisons children playing in the water. To avoid harming the children, the painter could choose to pay the children’s family to take the paint thinner into the town when they go to buy groceries each week. By doing so, the two individual parties come to a mutual agreement in preventing harm without the need for governmental regulations that constrain their individual rights.
* **Libertarian Paternalism (“Nudging Theory”):** Libertarian Paternalism represents a combination of the two above frameworks, serving to assuage the negative connotations ascribed to pure paternalism and, to a lesser extent, libertarianism. As described by Thaler and Sunstein, this theory holds that in many cases individuals make choices that are irrational or against their own interests, and which they would not have made if they “had complete information, unlimited cognitive abilities, and no lack of willpower \[3].” Libertarian paternalism may rely on “opt-out” systems rather than “opt-in” ones; that is, the default is for an automatic agreement to a set of beneficial paternalistic policies by individuals, unless they actively choose to opt-out of being constrained by those rules \[3]. In the context of healthcare, vaccine administration for children in schools was proposed in 2019 as an application of the theory. Children were to be vaccinated by default without parental authorization (automatic “opt-in”), but parents had the right to complete paperwork that allowed them to “opt-out” their children \[4]. Filling out the paperwork to remove a child from the program may deter parents without significant anti-vaccination sentiments from removing their child, ultimately increasing the number of vaccinated children in the community.

**Acting in Uncertainty**

A feature of the epidemic is its dynamicity, with new, delayed and sometimes dubious  information from journals and media outlets every day. An ideal decision tool would be based on probability-weighted models of outcome distributions, with commonly agreed upon thresholds of risk-tolerance. But given the lack of evidence for interventions, how can decision-makers make choices about actions (or inactions) to best promote public health?

The oft-mentioned precautionary principle may provide guidance. One of its earliest formulations states that ”where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures.” However, how this translates into policies is unclear. Some interpret the principle as a decision-making algorithm (akin to Rawl’s minimax principle, where the policy that risks leading to the worst outcome should be avoided). Others invoke the principle in determining what we admit as evidence to favor the safer option, [for example, by accepting less statistically significant results](https://pubmed.ncbi.nlm.nih.gov/15512975/).&#x20;

The strongest versions of the principle, however, are prone to suffer from over-allocation of resources to prevent low-probability harms and decision [paralysis due to risks inherently incurred by](https://papers.ssrn.com/sol3/papers.cfm?abstract_id=307098#:~:text=The%20principle%20is%20literally%20paralyzing,regulation%2C%20and%20everything%20in%20between.\&text=Most%20often%2C%20those%20who%20use,the%20systemic%20effects%20of%20regulation.) all options. Additionally, alterations of our threshold for admitting studies as evidence for one conclusion but not another may fall prey to our biases as we selectively overlook outcomes.

**Limited Sympathies**

The issues become more complex when evaluating how communities may interact with another.  This is perhaps most obvious when countries hoard resources for the benefits of citizens. But the analysis need not be restricted to a mere matter of relations between nations, as humans tend to identify with communities at sub-national and international levels.&#x20;

Some question whether we should make distinctions between communities at all. Consider this thought experiment: if a child is at risk of death and saving him would require little effort, would your choice of whether to save him differ if he belonged to a different community? If you answer no, perhaps it implies that all humans ought to be treated as members of a single community, what some would call cosmopolitanism.

However, the hypothetical assumes that saving “strangers” requires little effort. Whereas a firm subscriber of cosmopolitanism would argue the effort required is irrelevant, many would struggle to answer the same question if saving strangers leads to risks to friends and families. While we typically assume that all individuals ought to be given equal moral consideration, it is perhaps unrealistic to expect us to be equally emotionally invested in all individuals. Here is where we hit the limitations of certain ethical theories: the idealized “moral saint,” who is never an egoist (who favors those we have personal ties to) and always treats all individuals equally, is likely an  unrealistic goal for most of us. Some may propose imagining a ring of concentric circles, where duties are stronger when one is closer to the individuals involved. Under such frameworks, some may modify tiers of responsibilities in relation to the communities we identify with.\
\
**References:**

* \[1] Dworkin, Gerald, "Paternalism", The Stanford Encyclopedia of Philosophy (Summer&#x20;

  2020 Edition), Edward N. Zalta (ed.), <https://plato.stanford.edu/archives/sum2020/entries/paternalism/>.
* \[2] van der Vossen, Bas, "Libertarianism", The Stanford Encyclopedia of Philosophy&#x20;

  (Spring 2019 Edition), Edward N. Zalta (ed.), <https://plato.stanford.edu/archives/spr2019/entries/libertarianism/>.
* \[3] Cass Sunstein & Richard Thaler, Libertarian Paternalism, 93 Am. Econ. Rev. 175&#x20;

  (2003).
* \[4] Giubilini, A., Caviola, L., Maslen, H., Douglas, T., Nussberger, A.-M., Faber, N.,&#x20;

  Vanderslott, S., Loving, S., Harrison, M., & Savulescu, J. (2019). Nudging&#x20;

  Immunity: The Case for Vaccinating Children in School and Day Care by Default. HEC Forum, 31(4), 325–344. <https://doi.org/10.1007/s10730-019-09383-7>.

## Case Studies: Public Health Ethics in COVID-19

**Face Mask Mandates and Social Distancing**

Starting in March of 2020, many states in the United States followed the example of countries around the world and began to implement stay-at-home orders, or social distancing for all individuals, and quarantine for exposed individuals. Historically, quarantines have been contested because of the severe restriction on individual liberty. In the HIV crisis of the 1980s, advocates argued that individuals with HIV should not be forced to isolate from society as it violated their human rights. We can imagine that a libertarian would also defend this position, as individual liberty trumps the public interest. &#x20;

The debate regarding the necessity of social distancing and face masks can be framed as a tension between those who believe the policy to be justified paternalism and those who prioritize individual rights. The defenders of face masks believe the government should impose these restrictions as it is in the individual and collective best interest. In many political theories, individual liberty is not absolute. As famously advanced by Rousseau, individuals accept the social contract, giving up individual liberties to the government to benefit from a stable social order. For example, in the U.S. constitution, the right to free speech is curtailed, as individuals are not allowed to endanger the public by shouting fire in a crowd. By contrast, the opponents of face masks and social distancing believe that governments and states do not have this authority—it infringes too much upon individual rights, and is therefore an illegitimate policy.&#x20;

However, when we frame this debate as a dichotomy between individual rights and paternalism, we may miss an important dimension—the mutual vulnerability of individuals and the right not to be harmed by others. Amy Fairchild, Lawrence O. Gostin and Ronald Bayer suggested that social distancing has not been opposed as fiercely as in the AIDS epidemic because of the severe contagiousness of COVID-19 \[1]. Since individuals who are asymptomatic or pre-symptomatic may spread COVID-19 to others, we depend on the actions of others in our community to keep us safe. Hence, some defenders of face masks and social distancing have started to argue that social distancing is a right itself \[1]. That is to say, individuals have a right to be protected against COVID-19 and not be harmed by others who put them at high risk by not social distancing. In this way, others have a duty to social distance to protect those who are vulnerable. This argument has been made especially for individuals in communities facing higher rates of COVID, as otherwise these communities will disproportionately bear the burden of disease (see module on Health Disparities).&#x20;

Still, considering what constitutes justified paternalism is important when defining the boundaries of social distancing and face masks. For instance, questions remain about the proper punishment for not following social distancing rules and the level of risk that is acceptable for businesses to re-open.

**Reopening Measures**

The dilemma of whether or not to reopen primary schools tests the extent to which we accept risks. [A survey](https://www.aei.org/wp-content/uploads/2020/06/COVID-19-Family-Impact-Survey-final-version-2.pdf) found that the majority of parents believed that “schools should remain closed until they are certain there is no health risk.” It is, however, unlikely that the statement is chosen following careful reflection. Risks represent a mere probability of a harm occurring; risks are inevitable in daily lives, even without epidemics. A more defensible version of the statement, therefore, is perhaps that a “minimal risk” is acceptable, where the risk is not in excess of what is encountered in daily lives. Even in considering the acceptance of a “minimal risk” threshold, we are no longer playing a game of minimax according to which even the infinitesimally small risk of the worst outcome is unacceptable.

As opposed to using the precautionary principle as an algorithm for making decisions, perhaps it should be utilized as a consideration for appraising scientific evidence. In other words, we need more robust, statistically significant evidence to warrant the reopening of schools than evidence to warrant continued closures, because we presume the harm potentially associated with reopening is greater than that of closure. Even if other [countries have successfully reopened schools](https://www.sciencemag.org/news/2020/07/school-openings-across-globe-suggest-ways-keep-coronavirus-bay-despite-outbreaks), the precautionary principle urges us to err on the side of avoiding risks and harms.

One counterargument is that such stances are based on our implicit biases. When we err on the side of precaution, which side are we talking about? When discussing the impact of reopening schools given the epidemic, many will jump to the conclusion that an increased number of interactions may facilitate transmission of the virus, which has frightening consequences of economic harm and longer periods of social distancing. Few will intuitively consider the other side of the equation—t[hat of reduced social-emotional learning for children,](https://www.nejm.org/doi/full/10.1056/NEJMms2024920) inability for students from lower--class families to access free or reduced-price meals, reduced provision of therapeutic services by schools, [limited physical activities](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/reopening-schools.html), etc. All of these variables may even exacerbate inequalities in our society, leading some to the conclusion that the reopening of school is essential, and that the “precautionary action” is to reopen schools.

It is also important to consider that consequences of policies interact with one another. If we are willing only to accept a small amount of risk, it may make policies mutually exclusive—it would, perhaps, go above the tolerable risk threshold to simultaneously open schools and restaurants, leaving us only the options of reopening one or the other.

The question is therefore misframed when we consider closure of schools to be “precautionary”, whereas reopening to be “risky”. All options have a risk, regardless of how small, to lead to the “worst outcome”. Both action and inaction entail risks of harm and potential for benefit. Instead, we should consider the maximal tolerable cumulative risk that we are willing to accept, and given risk tradeoffs, what we are willing to sacrifice for the reopening of schools.

**Herd Immunity and Vaccines**

In recent years, there has been resistance to mandatory vaccinations. While many of their concerns have little to no scientific credibility, these apprehensions are important to respond to in a global health crisis as they will affect public health outcomes. In many cases, unease over vaccinations may emerge from vaccine hesitancy rather than complete refusal (“anti-vaccination”) \[2]. Healthcare providers and physicians can play a critical role in supporting public health by reassuring, educating, and building trust with their patients.&#x20;

It has been incorrectly suggested that those who voluntarily get vaccinated represent a large enough fraction of the population to protect the remainder from infection, referred to as herd immunity. This status becomes incredibly important for protecting those that are unable to be vaccinated, such as the immunocompromised, newborns, etc. Unfortunately, herd immunity requires a much higher percentage of the population to be vaccinated. There is currently no consensus on the percentage required to achieve herd immunity against SARS-CoV-2, but other infectious diseases require vaccination rates upwards of 85% and 90% \[3]. These statistics do not consider isolated communities that choose not to be vaccinated, which would not be protected. Thus, determining how to set ethically sound policies for vaccination are critical for infectious disease containment.

Perhaps we should support a paternalistic policy in which all individuals that immunologically qualify are required to receive the vaccination. Or, instead, a libertarian framework may be more appropriate, where individuals should be able to decide whether they would like to get the vaccine. Yet, we may feel obligated to support a “nudging” stance, similar to that in the California school example, where everyone is required to be vaccinated unless they go through an “opt-out” process. This final framework may find the balance between the two more extreme stances.&#x20;

However, in a time of global health crisis, some may feel more obligated to support mandatory vaccination for all instead of a middle ground. For instance, policies may restrict the activities of those who choose not to get vaccinated. Individuals may not be allowed in certain public places (parks, pools, etc.) without proof of vaccination, and children may not be allowed to attend daycares or may have to remain virtual for school. In large part, these paternalistic policies would make a clear point: getting vaccinated is partially about protecting yourself, but also about protecting your community, especially those who are unable to be vaccinated.&#x20;

This decision illustrates the difficulty in determining what is ethical for the good of the public—should individual rights be curtailed for the good of the many (paternalism) or to protect the rights of others (rights-based argument), upheld for the good of the individuals regardless of the potential outcome (libertarianism), or somewhere in between to make individuals more likely to receive vaccinations (nudging theory)? Of course, these frameworks presuppose a “safe and efficacious” vaccine, which is the goal of the many Phase 3 trials being conducted currently. To protect patients’ bodily autonomy, healthcare providers must never force a patient to be vaccinated against their will—but, for the sake of promoting public health, we are obligated to educate patients and the public about the benefits and risks.

We must state outright: vaccinations are beneficial and, in most circumstances, should be administered to as many individuals as possible in situations where the benefits outweigh the risks. The dilemma lies, as described, in how to achieve that goal.

**References:**

* \[1] Fairchild, A., Gostin, L., & Bayer, R. (2020). Vexing, Veiled, and Inequitable: Social&#x20;

  Distancing and the “Rights” Divide in the Age of COVID-19. The American Journal of Bioethics, 20(7), 55–61. <https://doi.org/10.1080/15265161.2020.1764142>**.**
* \[2] Schwartz, J. L., & Caplan, A. L. (2011). Vaccination Refusal: Ethics, Individual Rights,&#x20;

  and the Common Good. Primary Care: Clinics in Office Practice, 38(4), 717–728. <https://doi.org/10.1016/j.pop.2011.07.009>.
* \[3] Omer, S. B., & Orenstein, W. A. (2009). Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases. The New England Journal of Medicine, 8.

## Public Health Ethics of Quarantine and "Typhoid Mary"

**History of Quarantines**&#x20;

Different from isolation, which is the restriction of movements of symptomatic individuals to prevent them from infecting the susceptible general public, [quarantine](https://www.cdc.gov/quarantine/index.html) is the restriction of movements of asymptomatic individuals exposed to the contagion but have not experienced symptoms. Individuals exposed to COVID-19 are mandated to quarantine for [14 days](https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html) at home and monitor their symptoms daily.

The English word quarantine was derived from the Italian words quaranta giorni, meaning 40 days, when [ships had to anchor for 40 days](https://www.cdc.gov/quarantine/historyquarantine.html) upon arrival in Venice due to concerns with the Black Death. Before [germ theory was widely accepted in the late 1800s](https://www.sciencemuseum.org.uk/objects-and-stories/medicine/listers-antisepsis-system#:~:text=By%20the%201890s%2C%20wider%20acceptance,only%20way%20to%20control%20infection.), quarantine practices were adopted worldwide to contain the spread of infectious diseases. The first recorded quarantine was mandated in the Byzantine Empire to handle the bubonic plague in [A.D. 549](https://www.pbs.org/wgbh/nova/article/short-history-of-quarantine/). The earliest quarantine law was established by [Massachusetts in 1647](https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1719144) to prevent the transmission of the plague from the West Indies. [The Pan American Sanitary Bureau](https://www.paho.org/en/who-we-are/history-paho) was created in 1902 as the first international effort to bring global collaboration of infectious disease control, which later led to the formation of the World Health Organization in 1948. The [Public Health Services Act](https://jamanetwork.com/journals/jama/fullarticle/2761556) in 1944 founded and authorized the Communicable Disease Center (CDC), which later became the Centers for Disease Control and Prevention, to detain, examine, and quarantine individuals suspected of transmitting infectious diseases.

![(Source: https://www.who.int/whr/2007/07\_chap1\_en.pdf)](https://lh5.googleusercontent.com/04YqXmP8CsmN8I1t_UlFdCz1rb7Mkhfd9acJwqpdf6yrMtDBzaNqNwCk4o30VpGSkbQAImcWwanVv1MzkhtlxlxHUUUzIxQNqSOnhcoTwO2THIrt7Xv_cXM2kp0CO-IHJc7Wq7aS)

In the US, quarantine restrictions are mostly regulated at the state level, but a federal court could overrule a state's decision, as evidenced by the case of [Jew Ho v. Williamson](https://jamanetwork.com/journals/jama/fullarticle/2761556#jvp200021r7) in 1900. In addition, tribal lands could [impose reservation-wide restrictions](https://www.nytimes.com/2020/04/09/us/coronavirus-navajo-nation.html), which are also subject to Congress [modification](https://www.theatlantic.com/ideas/archive/2020/07/tribes-coronavirus-enforcement/614242/) via the Indian-commerce clause. However, tribal autonomy has been well preserved historically.

**Rothstein’s Quarantine Justification Framework**

Quarantine is a public health measure used to slow down the spread and alleviate the negative consequences of a disease when uncertainties are abundant and therapeutics lacking. However, it can also lead to social harm, such as economic disruptions, social inequalities, and unrest. It infringes on individual liberty, and, if used too strictly, could erode public trust and be [counter-productive](https://jamanetwork.com/journals/jama/fullarticle/2761556). \
When discussing the ethics of quarantine, [Rothstein](https://www.researchgate.net/publication/282510790_From_SARS_to_Ebola_Legal_and_Ethical_Considerations_for_Modern_Quarantine) proposed a framework where these four aspects should be considered:

1. Necessity, effectiveness, and scientific rationale. Does an asymptomatic individual pose a threat to the public? Is separating them from the public efficacious enough to contain the spread? For example, during the Ebola outbreak, villagers in Sierra Leone were told to care for family members at home. Lack of proper training and limited resources led to [more infections to caregivers](https://www.nytimes.com/2014/11/08/world/europe/new-guidelines-for-burying-ebola-victims.html). Quarantine is one public health measure, but it is only useful if it is part of a comprehensive and effective plan.
2. Proportionality and least infringement. Proportionality assesses whether the level of restrictions is proportional to the severity and transmissibility of the infectious diseases of interest. During the early days of the Ebola outbreak in West Africa, a voluntary lockdown was enforced but was shown to be not effective at containing the spread. Least infringement discusses invasion of personal freedom. During the SARS outbreak, [Singaporeans were monitored](https://www.nytimes.com/2003/06/10/health/in-singapore-1970-s-law-becomes-weapon-against-sars.html) with video cameras at home to enforce quarantine. In addition, they would be electronically tagged if they violated their quarantine. Wuhan closed off travel of the entire city in the early days of COVID-19 outbreak. Depending on the prevailing culture in a region, the level of acceptable infringement on individual rights varies widely.
3. Humane supportive services. Quarantine limits social and economic activities, placing financial burden on the individuals in quarantine. For quarantines to be effective, supportive services need to be put in place to ensure the basic needs and dignity of quarantined individuals are met. If such services do not exist, families are forced to break quarantine and work to meet their basic needs, rendering the practice ineffective.
4. Public justification. Public compliance of quarantine and other public health measures relies on effective scientific communication and justification (See Module 5 for more information). Historically, xenophobia and panic have led to [discrimination against specific groups](https://www.hopkinsmedicine.org/news/articles/xenophobia-in-the-time-of-quarantines). Scientific communication and public health measures cannot be isolated from other current events, political or otherwise. For example, the 1918 Spanish flu occurred during World War I. Trying to boost wartime morale, President Woodrow Wilson downplayed its risks and disregarded quarantine as an essential disease prevention measure, leading to [675,000 deaths](https://time.com/5877129/1918-pandemic-white-house/).

**Quarantine Example: “Typhoid Mary”**

In this section, we will examine a highly controversial case of quarantine, “Typhoid Mary,” and use the framework proposed by Rothstein to discuss its relevant ethical considerations.

Mary Mallon, commonly known as “Typhoid Mary,” was an immigrant and cook in New York in the early 1900s. She unknowingly spread typhoid to her clients as she switched jobs from house to house, leading to [22 illnesses and 1 death of a young girl](https://medium.com/@kathycopelandpadden/typhoid-mary-and-the-ethics-of-forced-isolation-e59263ea74f6) in the families for which she worked. She was also reported to [serve ice cream](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1911442/pdf/bullnyacadmed00595-0063.pdf) in public on Sundays. In 1906, a sanitary engineer, George Soper, traced the infections back to Mary, who was somehow asymptomatic, uncommon in people with the ability to transmit typhoid. During a time when germ theory was not widely accepted and hand hygiene was not emphasized, Mary did not see the need to wash her hands before cooking. She was the first identified [asymptomatic carrier](https://www.history.com/news/10-things-you-may-not-know-about-typhoid-mary), though it was not known how she could infect others while being symptom-free. When asked by Soper to be tested, she did not see the need and resisted vehemently. Against her will, she was sent by the New York Department of Health to quarantine in a cottage on North Brother Island for two years. During that time, she was reported to be treated like a laboratory pet and repeatedly [tested and medically treated](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3959940/) without her consent. Having found high levels of Salmonella typhi in her gallbladder from the samples, authorities advised her to remove her gallbladder, to which she refused. After an unsuccessful lawsuit against the health department, she was released but told never to be a cook again.Upon her departure, Mary took a low paying job as a laundress. Seeing she could not make a living with that salary, and still not convinced she could infect others, Mary found her way back into cooking under a different name, leading to even more infections. She was eventually forced to quarantine again on North Brother Island for 26 years until she died in isolation. It was [reported](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1911442/pdf/bullnyacadmed00595-0063.pdf) that her autopsy showed high levels of bacterial infection in her gallstones, lending credence to the proposed medical procedure to remove her gallbladder. However, some questioned such a report and [suspected](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3959940/#ref5) it was used to calm the public amid controversial ethical debates. At the time of Mary’s death, 400 other asymptomatic carriers of typhoid were [found](https://www.nationalgeographic.com/history/2020/03/typhoid-mary-tragic-tale-exposed-health-impacts-super-spreaders/), but none were forced into solitary confinement.

*Thought questions using Rothstein's framework:*

* Was Mary’s quarantine necessary, effective, and scientifically sound? Keep in mind this was in the early 1900s, when many modern scientific discoveries were absent.
* Is Mary’s quarantine proportional to the threat she posed to the public? How was this infringing on her personal freedom?
* Was Mary provided with the necessary supportive services during her quarantine? What about after her first quarantine when the authorities told her not to be a cook again?
* How was Mary’s quarantine justified to her and to the public?

*Additional thought questions:*

* What ethical and legal responsibilities do the departments of public health, or other organizations have?
* What moral responsibilities and rights do germ carriers, symptomatic or asymptomatic, have?
* How would you weigh personal liberty against public health?
* What medical ethics principles are violated in Mary’s case?

## Vaccine Distribution for Public Health

Generally, resource allocation itself falls into two broad categories: micro allocation and macro allocation. Examples of macro allocation in medicine include widely used guidelines at the population level. Generally speaking, macro allocation principles are considered acceptable and ethical in the realms of public health ethics and policy \[1]. When considering the public health ethics informing vaccine allocation, it is necessary to consider the global distribution process as well as the national vaccine allocation protocol in the US.

Recently, a partnership between 156 countries and The World Health Organization (known as COVAX) formed the "COVID-19 vaccine allocation plan" to express the rules, regulations, and distribution plans to deliver "2 billion vaccine doses by the end of 2021" \[2]. The rationale of COVAX is to encourage collaboration rather than competition and prevent hoarding among member countries \[2]. According to the World Health Organization (WHO), there are two phases of vaccine allocation. Phase one will give each country an amount of vaccine proportional to their population. For instance, India, which has a population of 1 billion, will receive  30 million doses. In contrast, Australia, which has a population of 26 million, is allocated  780,000 doses. In both cases, the countries receive enough vaccine doses to cover 3% of their population. Later into phase one, the percentage may continue to rise to a 20% threshold.

Lastly, if the supply continues to remain limited after a 20% threshold is reached, COVAX will prioritize countries with higher incidences of infection. Regardless, the individual countries' policy on vaccine allocation within their population remains in the hands of their public health departments and governments \[2]. The USA is currently not part of COVAX. It is attempting to privately fund, develop, and distribute vaccines to its population.

Like the WHO, the American Center for Disease Control (CDC) has stated that the COVID-19 vaccine administration will require a phased approach. If the FDA approves a safe and effective vaccine, there are numerous considerations in the logistics and supply chain \[3]. Mass vaccination clinics are considered difficult centers for vaccine administration due to social distancing restrictions. Healthcare homes, PCP offices, and pharmacies are under consideration as potential sites for vaccine administration. It will be challenging to equitably distribute vaccines to low socioeconomic communities, racial and ethnic minorities, and rural populations in not just the US, but the world.

Because healthcare professionals working in hospitals are at the highest risk of contracting COVID-19, the CDC suggests administering vaccine doses to healthcare workers first. Specifically, healthcare workers who work in long-term healthcare facilities are the highest priority among other healthcare workers in the current CDC framework \[4]. Healthcare workers number 17 million to 20 million individuals within the overall US population.

Next, the CDC plans to distribute the vaccine to those classified as essential workers in non-clinical settings \[4]. Within this next group, some occupations' prioritization may have precedence over other essential occupations; however, this is up to local jurisdictions to decide. Population models indicate that the US has 60-80 million people in the essential worker category.

The next level of prioritization for the COVID-19 vaccine is for adults with medical conditions such as cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised state from solid organ transplant, obesity (BMI of 30 or greater), severe heart conditions (heart failure, coronary artery disease or cardiomyopathies), sickle cell disease and diabetes \[4]. There are over 100 million adults with these underlying conditions and are considered high risk.

COVID-19 is also a disease that has had more severe consequences in older adults, so the next priority group is adults over 65. The US has 53 million adults over the age of 65 \[4]. Once these four priority groups receive the vaccine, the government aims to distribute the vaccine to the remainder of the population as more doses become available.

The CDC's vaccine allocation checklist protects those most at risk of contracting COVID-19 first and foremost, followed by protecting the sickest and most vulnerable. Once these two populations (often, but not always overlapped) are vaccinated, the CDC plans mass distribution to the remaining population \[2,4]. As vaccine trials are ongoing, national and worldwide governments are working on storage and distribution protocols to ensure equitable vaccine allocation and distribution. The NIH and CDC recently refer to definite overlap within the four top priority groups \[4]. They suggest that the next steps towards a more equitable distribution plan are to create sub-groups within the priority groups for a more detailed allocation protocol. Therefore, the next steps are to overview epidemiological data and assess COVID-19 risk by demographic variables such as gender, race, and ethnicity.

**References**

* \[1] Truog, Robert. “Four Babies, Three Machines.” Center for Bioethics at Harvard Medical School Introduction to Clinical Ethics. Introduction to Clinical Ethics lecture on Rationing, 18 Nov. 2019, Boston, Tosteson Medical Education Center.
* \[2] Rauhala, Emily. “World Health Organization Unveils Plan for Distributing Coronavirus Vaccine, Urges Cooperation.” The Washington Post, WP Company, 21 Sept. 2020, [www.washingtonpost.com/world/coronavirus-vaccine-covax-who/2020/09/21/d21c7b4a-f9d3-11ea-a510-f57d8ce76e11\_story.html](https://curriculum.covidstudentresponse.org/module-8-medical-ethics/www.washingtonpost.com/world/coronavirus-vaccine-covax-who/2020/09/21/d21c7b4a-f9d3-11ea-a510-f57d8ce76e11_story.html).
* \[3] Irfan, Umair. “These COVID-19 Vaccine Candidates Could Change the Way We Make Vaccines - If They Work.” Vox, Vox, 13 Aug. 2020, [www.vox.com/2020/8/13/21359025/coronavirus-vaccine-covid-19-moderna-oxford-mrna-adenovirus](https://curriculum.covidstudentresponse.org/module-8-medical-ethics/www.vox.com/2020/8/13/21359025/coronavirus-vaccine-covid-19-moderna-oxford-mrna-adenovirus).
* \[4] Dooling, Kathleen. “COVID-19 Vaccine Prioritization: Work Group Considerations.” Cdc.gov, 26 Aug. 2020, [www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-08/COVID-08-Dooling.pdf](https://curriculum.covidstudentresponse.org/module-8-medical-ethics/www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-08/COVID-08-Dooling.pdf).

## COVID-19 Immunity-Based Licenses

**Immunity-Based Licenses**

Chile, Germany, China, the UK, and the US have indicated varying levels of interest in “immunity passports”, or more broadly “immunity-based licenses” – certifications that a person has contracted and recovered from COVID-19 or (foreseeably) has received a COVID-19 vaccine.\[1,2] Such licenses have mostly been proposed as an avenue to reopen international travel. However it has also been suggested as a checkpoint for employment (especially for essential work), housing, school, domestic travel, and entry into public spaces – including banks, government offices, or voting booths. This proposal has been met with controversy from scientists and ethicists alike.

First, the long-term immunity to COVID-19 is itself unclear. Reports of COVID-19 reinfection have been confirmed in Hong Kong, Belgium, the Netherlands, and even Nevada (USA).\[3] Even if the presence of detectable antibodies might be used as a proxy for immunity, there is not yet a consensus on what amount of antibody is sufficient for protection and how long this protection is conferred for.\[4] Data from seroprevalence studies will be needed to accurately inform policy based on key metrics such as sensitivity, specificity, precision, and false discovery rate.\[5] Thus, certifications of functional “immunity”, especially if deployed too early in the pandemic, may give false reassurance regarding the safety of public interaction and might even propagate more infection.

However, even if antibody testing is validated as a viable proxy for establishing immunity, immunity-based licenses raise several ethical concerns as to potential infringement on autonomy and civil liberty. A widely-circulated paper by medical ethicists Persad and Emanuel explored the ethical rationalization behind such licenses based on the public health principle of the “least restrictive alternative”, which forbids any measures more restrictive than necessary to achieve public health objectives.\[6] They argued that current liberty-limiting restrictions on social gathering, work, and travel are justified while COVID-19 poses significant harm; however, immunity-based licenses afford individuals a chance to demonstrate little to no risk of infection, deeming the aforementioned restrictions unjustified for licensed individuals. Persad and Emanuel compare immunity-based licenses to driver’s licenses (rather than passports), which do not entirely ban risky activities but instead licenses individuals to participate only after individual evidence of safety. The term “license” is intended to restrict the dichotomy of immune status is only relevant to the risky activities to which the license is applied - unlike that of “passport” which may create a stronger separation between groups.

**Biological Citizenship**

“Biological citizenship” (roughly equivalent to “biocitizenship” and “genetic citizenship”) is rooted in Foucaldian “biopower”, which asserts that the control and management of people is an innate aim of political governance. Petryna coined the term “biological citizenship” to apply to public movements of patient advocacy and civic engagement seeking welfare, reform, and remuneration among individuals who had been exposed to radiation from Chernobyl.\[7] Petryna’s definition of biological citizenship may be understood as a neoliberal expansion of patient rights that harnesses the political power of shared genetic status or disease state. Subsequent sociologists and anthropologists – notably Rose and Novas – have expanded “biological citizenship” to mean an active form of citizenship that produces new claims on belonging, expertise, and access to resources based on biological claims, entailing risk of surveillance, exclusion, and discrimination stemming from biological and genetic identities.\[8-10] Examples include the genetic burden of proof for immigrant family reunification (which foregrounds Western biological constructs of the family)\[11] and the lobbying power of disability rights movements for legislative accommodations and protections to ensure equal rights for people with disabilities.\[12] Essentially, biological information may be used by political entities to empower, affirm, disenfranchise, racialize, discriminate, stratify, and/or surveil citizens along with existing socioeconomic divisions as well as novel hierarchies based on biological condition or disease state.

We might use biological citizenship to understand the implications of immunity-based licenses on sociopolitical identity and civil liberties more broadly. We can imagine that the state-sanctioned utilization of immunity as a proxy for participation in civil activities might create two distinct classes of individuals: the immunolicensed and the immunorestricted. The former are those who are “immune” or vaccinated, and have been given full license to participate in civil life without restriction. The latter are those who have not yet contracted COVID-19 or do not have access to the vaccine, and thus continue to operate with restrictions on their civil liberties on the basis of protection given latent vulnerability. We will use these classes to explore a few of the emerging ethical dilemmas concerning immunity-based licenses:

* **Unfair access:** We can predict that separation into immunolicensed and immunorestricted subpopulations might track with existing socioeconomic stratifications in society. With a shortage of testing in several states, those who are wealthy and powerful in society have greater access to rapid COVID-19 testing at their convenience.\[13] On the other hand, those who would need licenses most urgently – such as those who are unemployed, uninsured, and financially underprivileged – might encounter the greatest difficulty in finding nearby testing centers and obtaining timely results. Similarly, driver’s license fees have been shown to unfairly burden low-income individuals.\[6] Disparities in access to testing and additional out-of-pocket costs of licensing may exacerbate existing inequalities. Depending on early vaccine administration procedures, it is possible that the wealthy may find ways to jump the line and ensure vaccination before other needy subpopulations, entrenching existing social powers in the immunity-based hierarchy.
* **Incentivizing infection:** Deploying immunity-based licenses as a restriction to work, travel, and civil participation may create a perverse incentive for individuals to willfully seek out infection.\[14] With prior efforts of willful infection in service of herd immunity having been unsuccessful,\[15] such efforts would pose a risk not only to individuals, but also those with whom they come into contact. Willful infection is especially a concern among those who are unable or hesitant to seek medical care due to out-of-pocket cost, inadequate insurance status, or discriminatory access. Often, these characteristics track with minority and immigrant communities, which also display elevated susceptibility and mortality to COVID-19 due to higher prevalence of comorbidities.\[16] Those who are most in need of licensing and a pathway to civil re-engagement may be deprioritized in access to medical care, serological testing, and (eventually) vaccine administration; they may be left with little practical alternative to actively seek infection. Without significant logistical amendments, immunity-based licenses may very well perpetuate existing racial and socioeconomic disparities in COVID-19 morbidity.
* **Potential for discrimination:** Linking immunity status to civil participation raises serious concerns as to the ability of citizens to exercise their constitutional rights. For example, the immunolicensed would be first in line to receive emerging offers of employment, especially in positions with high rates of interaction.\[2] While there are protections against discrimination based on medical condition, it is unclear as to whether COVID-19 immunity would fall under this category for the following few reasons. First, the population prone to discrimination are those without evidence of infection. Second, the transmissibility of COVID-19 might invoke restriction of anti-discriminatory clauses due to potential harm to others.\[17] The potential for discrimination is all the more troubling in relation to public rights such as suffrage. Let us imagine that prospective voters are barred from entering the voting booth without presenting a formal, state-approved immunity-based license (similar to current voter identification requirements) and are otherwise only left with mail-in ballots (the accessibility for which varies between states). This could result in a disenfranchised immunorestricted class, potentially compounding existing racial and socioeconomic disparities in voter participation.
* **Threats to privacy:** Immunity-based licensing does not only run the risk for discrimination along COVID-19 immunity status. Some Chinese provinces have utilized smartphone QR codes conveying COVID-19 exposure status to control entry into public spaces. First, these technologies may pose a barrier to older and poorer populations, who may not have the experience with or access to smartphone platforms. A more insidious concern is that apps have been found to track people’s locations, travel history, and other health information – providing a platform right for citizen surveillance.\[18] The convenience of electronic immunity-based licenses aside, increasing law enforcement encroachment into genetic databanks raises serious concerns as to long-term access to biological information.\[19] This sets an uneasy precedent of state-sanctioned collection of private health information, which may be expanded to mental health, chronic conditions, and genetic information from health records. States should exercise caution before deploying electronic immunity-based licenses to ensure encryption and/or destruction from access by private entities and law enforcement beyond the duration of the COVID-19 pandemic.

**References:**

* \[1] Bartlett J. Chile’s ‘immunity passport’ will allow recovered coronavirus patients to break free from lockdown, get back to work. The Washington Post. 2020. Published April 20, 2020. Accessed October 2, 2020.
* \[2] Phelan AL. COVID-19 immunity passports and vaccination certificates: scientific, equitable, and legal challenges. The Lancet. 2020;395(10237):1595-1598.
* \[3] Joseph A. Scientists are reporting several cases of Covid-19 reinfection — but the implications are complicated. STAT. 2020. Published August 28, 2020. Accessed October 2, 2020.
* \[4] Long Q-X, Liu B-Z, Deng H-J, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nature Medicine. 2020;26(6):845-848.
* \[5] Winter AK, Hegde ST. The important role of serology for COVID-19 control. The Lancet Infectious Diseases. 2020;20(7):758-759.
* \[6] Persad G, Emanuel EJ. The Ethics of COVID-19 Immunity-Based Licenses (“Immunity Passports”). JAMA. 2020.
* \[7] Petryna A. Biological Citizenship: The Science and Politics of Chernobyl-Exposed Populations. OSIRIS. 2004;19:250-265.
* \[8] Rose N, Novas C. Biological Citizenship. In: Ong A, Collier S, eds. Global Assemblages: Technology, Politics, and Ethics as Anthropological Problems. Oxford, UK: Blackwell; 2005.
* \[9] Raman S, Tutton R. Life, science, and biopower. Science, Technology, & Human Values. 2010;35(5):711-734.
* \[10] Wehling P. Biology, citizenship and the government of biomedicine: exploring the concept of biological citizenship. In: Brockling U, Krasmann S, Lemke T, eds. Governmentality: Current Issues and Future Challenges. New York: Routledge; 2010.
* \[11] Heinemann T, Lemke T. Biological citizenship reconsidered: the use of DNA analysis by immigration authorities in Germany. Science, Technology, & Human Values. 2014;39(4):488-510.
* \[12] Fitzgerald R. Biological citizenship at the periphery: parenting children with genetic disorders. New Genetics & Society. 2008;27(3):251-266.
* \[13] Lieberman-Cribbin W, Tuminello S, Flores RM, Taioli E. Disparities in COVID-19 Testing and Positivity in New York City. American Journal of Preventive Medicine. 2020;59(3):326-332.
* \[14] Kofler N, Baylis F. Ten reasons why immunity passports are a bad idea. Nature. 2020;581:379-381.
* \[15] Orlowski EJW, Goldsmith DJA. Four months into the COVID-19 pandemic, Sweden’s prized herd immunity is nowhere in sight. Journal of the Royal Society of Medicine. 2020;113(8):292-298.
* \[16] Evans MK. Covid’s Color Line — Infectious Disease, Inequity, and Racial Justice. New England Journal of Medicine. 2020;383(5):408-410.
* \[17] Mello MM, Persad G, White DB. Respecting Disability Rights — Toward Improved Crisis Standards of Care. New England Journal of Medicine. 2020;383(5):e26.
* \[18] Mozur P, Zhong R, Krolik A. In Coronavirus Fight, China Gives Citizens a Color Code, With Red Flags. The New York Times. 2020. Published March 1, 2020. Accessed October 2, 2020.
* \[19] Rothstein MA, Talbott MK. The Expanding Use of DNA in Law Enforcement: What Role for Privacy? Journal of Law, Medicine, and Ethics. 2006;34(2):153-164.

## **Is the Cure Worse Than the Disease?**

Some have suggested that we must be careful that the "cure" for COVID-19 is not worse than the disease itself. By this, they suggest that public health measures, including social distancing, are taking a dramatic toll on our economy, increasing unemployment, and bringing sectors of the economy to a halt. Many people fear that we are at the beginning of a serious recession that will cause untold hardship for millions of Americans over the course of months to years.

Considering the alternative, if we stop social distancing and allow viral spread, a large number of Americans are projected to die, primarily people older than 60 with pre-existing medical conditions, but also many younger people. In the process, hospitals around the country will be forced to make tragic choices regarding who should receive a ventilator, whether patients with COVID-19 should automatically be made DNR, and many other rationing issues raised earlier. Most likely, we will all know someone who has died of the virus if it continues to spread. However, Americans may develop herd immunity soon and be able to return to work and socialize as before. At the same time, it is important to remember that we do not know how long immunity lasts and if people can get re-infected.

It is hard to carefully consider such catastrophic consequences. Most individuals have never experienced a pandemic this severe, but perhaps the subsequent recession will be greater than any recession in American history. With a large portion of the population unemployed, suicide rates could increase, crime could rise, and many people could develop food insecurity. It is improbable that millions of Americans would die of suicide or starvation, but almost everyone’s lives will be affected for the worse, and those of us who are already the most vulnerable may find ourselves in dire straits.

We have to ask ourselves, are the lives of a smaller group of people, in this case, those who may die from COVID-19, worth immense hardship for a larger group of people? Do we value life above all other goods, or is it possible for quality of life considerations to outweigh life? A utilitarian, who values utility or happiness and aims to achieve the greatest utility for the greatest number of people, may prefer to end social distancing and open the economy. A deontologist, who supports the morally correct option over the option with the best results, may prefer to avoid allowing millions of Americans to die. Now approach the problem the other way: how could a utilitarian prefer social distancing and a deontologist prefer allowing viral spread?

**References:**

* [Yong, Ed. "How the Pandemic Will End." March 25, 2020. The Atlantic.](https://www.theatlantic.com/health/archive/2020/03/how-will-coronavirus-end/608719/)

## **What Do We Owe Each Other?**

While much of the debate surrounding the COVID-19 public health response centers on the use of government power, we can consider what we owe each other in a time of crisis. In particular, what do the healthiest among us owe to the most vulnerable?

The U.S. has [broken into two camps](https://www.vox.com/the-highlight/2020/3/24/21191184/coronavirus-social-distancing-pandemic-spring-break-keep-calm-carry-on): those that are observant of social distancing and hopeful of flattening the curve and those that have pushed back against public officials’ pleas to stay home. In China, social distancing policies were harder to evade, as officials [closed off apartment complexes](https://www.reuters.com/article/us-china-health-quarantine/sealed-in-chinese-trapped-at-home-by-coronavirus-feel-the-strain-idUSKCN20G0AY) and [screened millions for elevated temperatures](https://www.nytimes.com/2020/02/14/business/coronavirus-temperature-sensor-guns.html). Yet, in the U.S., there is a strong sense of letting individual liberties prevail in some parts of the country and “carrying on” despite the ongoing crisis. For example, the Washington Metro issued statements asking that people [not take the Metro](https://wjla.com/news/local/metro-cherry-blossoms-covid-19) to see the cherry blossoms this year, however, the [cherry blossoms continued to draw crowds of people](https://www.wsj.com/articles/washington-d-c-closes-streets-to-prevent-coronavirus-transmission-11584850717). There are countless examples in the news and media of people, including business owners and government officials, defying social distancing policies. These opposing views bring up a common debate in American politics: When do we sacrifice personal liberties to protect the safety of communities?

How we react to this crisis depends on our understanding of when individual rights must be limited in favor of supporting more vulnerable populations. We are social creatures that thrive in groups, meaning we must make certain sacrifices to be a part of that group. [Thomas Hobbes, for example, argues](https://www.tableaufit.com/ethics-and-what-we-owe-each-other/) that we intentionally surrender some of our rights to the government for security and other benefits. T.M. Scanlon, a moral philosopher, [states](https://www.tableaufit.com/ethics-and-what-we-owe-each-other/), “The idea is that actions are wrong if a principle that permitted the action couldn’t be justified to the affected people in the right way.” In other words, people that defy social distancing rules would have to justify their decisions to the community, particularly older and sicker individuals. Communitarianism is a emphasizes the connection between individuals and the community. The principle of “solidarity” asks that we act in a way that supports the most vulnerable members of our community and that we not abandon those in need in a time of crisis. A more personal perspective: we all have a friend or loved one who is vulnerable to COVID-19 - what would we want others to do to protect them?

*Thought questions:*

* What arguments do you see in favor of social distancing? What arguments do you see against those measures? What do we owe each other as members of a community during a crisis?


# Summary

## Cases

The situation around the world evolves rapidly. For individuals like [**Brian** and **Diane**](https://curriculum.covidstudentresponse.org/curriculum-overview/cases#case-1-brian)**,** the ethical questions and challenges are different and constantly change. For instance, given her older age and general condition, Diane worries that she will not have access to a ventilator if she needs one. Brian wonders if the government is ethically justified in imposing strict public health measures. Both understand how ethically complex many decisions around COVID-19 are and empathize with physicians and policymakers who grapple with these decisions daily. As the disease continues to spread, they wonder whether their perspectives will need to change and realize that the field of ethics constantly evolves based on context.

**Diane** is afraid about what will happen if she tests positive for COVID-19. Given her age and other health conditions, would she not receive a ventilator over someone younger and healthier? What ethical frameworks to approach resource allocation could be used, especially during a public health crisis?

**Brian** has many friends and family with pre-existing health conditions. In addition, as part of his community service work in college, he visited a prison and worked on a literacy project. He remembers one prisoner in particular named Dan. Dan was in his mid-20s and suffered from type I diabetes. Brian wonders how this pandemic affects Dan and his ability to obtain his medications.

**Diane's** daughter is a respiratory therapist at a New York hospital now recommending that its healthcare workers wear their face mask for one week at a time. Her daughter wants to "do the right thing" but is nervous she will not see Diane for months. Diane wonders how many other healthcare workers are in similar situations, and what the "right thing" to do is.

**Brian** thinks back to his canceled trip and plans for after graduation. While he understands the importance of social distancing, he is unsure whether the government is ethically justified to impose such stringent public health measures. What are the ethical considerations in the field of public health, especially as they relate to infectious disease outbreaks?

## Final Thoughts

We hope this module helped capture the ethical complexity of COVID-19. We recognize this module’s bias towards U.S. biomedical ethics and are working on additional supplemental materials that include additional frameworks prevalent throughout the world. Nonetheless, we think many of the ethical questions are universal, and we encourage you to think closely about the presented themes as the pandemic evolves.

We welcome your feedback on this module and on the curriculum overall. Please share it [here](https://docs.google.com/forms/d/e/1FAIpQLSc011UD-NF1WCvFHb7qWfluu4G9nxb6P4c9l3c8S3ZqxXxNOg/viewform).<br>


# Podcast: Antiviral

Listen to the curriculum in audio format, produced by our partners at the Philadelphia Organization of Health Professions Students.

This podcast is an audio translation of the Harvard Medical Student-developed COVID-19 curriculum supplemented with updated information and expert interviews. This podcast is designed for and by health professions students, in collaboration with members of the Carry the One Radio (Kanchi Mehta, Cindy Liu, Celia Ford and Nancy Cai). You can learn more about Carry the One Radio at <https://carrytheoneradio.com/>

[Google Podcasts](https://podcasts.google.com/feed/aHR0cHM6Ly9hbmNob3IuZm0vcy8xZGVmNGJlOC9wb2RjYXN0L3Jzcw==)

[Spotify](https://open.spotify.com/show/4sz4QB1FgLCofOKjF73voz?si=DnoDnTCaR-6rf4XRteE2gw)


