학술논문

Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19
Document Type
article
Source
Annals of Internal Medicine. 174(8)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Health Services
Clinical Research
Generic health relevance
Good Health and Well Being
Advisory Committees
COVID-19
Child
Data Interpretation
Statistical
Drug Approval
Evidence-Based Medicine
Female
Humans
Interprofessional Relations
National Institutes of Health (U.S.)
Pandemics
Practice Guidelines as Topic
Pregnancy
SARS-CoV-2
Stakeholder Participation
United States
COVID-19 Drug Treatment
NIH COVID-19 Treatment Guidelines Panel
Medical and Health Sciences
General & Internal Medicine
Clinical sciences
Language
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.