Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.

• Type of Material: Article
• Authors: Safia Kuriakose, Frederick National Laboratory for Cancer Research; Kanal Singh, National Institutes of Health; Alice K. Pau, National Institutes of Health; Eric Daar, University of California Los Angeles; Rajesh Gandhi, Massachusetts General Hospital; Pablo Tebas, University of Pennsylvania; Laura Evans, University of Washington; Roy M. Gulick, Weill Cornell Medicine; H. Clifford Lane, National Institutes of Health; Henry Masur, National Institutes of Health; Craig Coopersmith, Emory University; Gregory Martin, Emory University; Jeffrey L Lennox, Emory University; John T. Brooks, Emory University
• Language: English
• Date: 2021-08
• Publisher: American College of Physicians
• Publication Version: Final Published Version
• Copyright Statement: © 2020 American College of Physicians. Some rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.7326/M21-1647
• Title of Journal or Parent Work: Ann Intern Med
• Volume: 174
• Issue: 8
• Start Page: 1151
• End Page: 1158
• Grant/Funding Information: By NIH. This project has been funded in whole or in part with federal funds from the National Cancer Institute of the NIH under contract 75N91019D00024, task order 75N91020F00004.
• Keywords: Humans; SARS-CoV-2; Child; National Institutes of Health (U.S.); Practice Guidelines as Topic; United States; Drug Approval; Advisory Committees; Pandemics; Evidence-Based Medicine; Interprofessional Relations; Data Interpretation, Statistical; Pregnancy; COVID-19; Stakeholder Participation; Female
• Research Categories: Health Sciences, Obstetrics and Gynecology; Biology, Virology; Health Sciences, Health Care Management

Abstract

The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.