1. Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.
- Author
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Kuriakose S, Singh K, Pau AK, Daar E, Gandhi R, Tebas P, Evans L, Gulick RM, Lane HC, Masur H, Aberg JA, Adimora AA, Baker J, Kreuziger LB, Bedimo R, Belperio PS, Cantrill SV, Coopersmith CM, Davis SL, Dzierba AL, Gallagher JJ, Glidden DV, Grund B, Hardy EJ, Hinkson C, Hughes BL, Johnson S, Keller MJ, Kim AY, Lennox JL, Levy MM, Li JZ, Martin GS, Naggie S, Pavia AT, Seam N, Simpson SQ, Swindells S, Tien P, Waghmare AA, Wilson KC, Yazdany J, Zachariah P, Campbell DM, Harrison C, Burgess T, Francis J, Sheikh V, Uyeki TM, Walker R, Brooks JT, Ortiz LB, Davey RT Jr, Doepel LK, Eisinger RW, Han A, Higgs ES, Nason MC, Crew P, Lerner AM, Lund C, and Worthington C
- Subjects
- Advisory Committees, COVID-19 epidemiology, Child, Data Interpretation, Statistical, Drug Approval, Evidence-Based Medicine, Female, Humans, Interprofessional Relations, National Institutes of Health (U.S.), Pregnancy, SARS-CoV-2, Stakeholder Participation, United States, COVID-19 Drug Treatment, COVID-19 therapy, Pandemics, Practice Guidelines as Topic
- 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.
- Published
- 2021
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