Kacew Alec J, Haslam Alyson, Prasad Vinay, Cifu Adam S
University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA
BMJ Open. 2024 Dec 20;14(12):e085210. doi: 10.1136/bmjopen-2024-085210.
The COVID-19 pandemic required the rapid and often widespread implementation of medical practices without robust data. Many of these practices have since been tested in large, randomised trials and were found to be in error. We sought to identify incorrect recommendations, or reversals, among National Institute of Health COVID-19 guidelines and Food and Drug Administration (FDA) approvals and authorisations.
Retrospective cross-sectional study.
Recommended medical practices and FDA authorisations or approvals for COVID-19 prevention, treatment and/or management.
The frequency and characteristics of COVID-19 medical reversals, defined as practices that were implemented and/or recommended during the pandemic, but were later tested in randomised trials that failed to find benefit.
We found 332 COVID-19 recommendations. 85 (25.6%) opposed a medical practice, 23 (6.9%) were to continue a pre-COVID standard of care without deviation and 224 (67.5%) reccommended a new medical practice. We found randomised trials assessing 72 of these practices (32.1%), among which 25 (35%) were found to be in error and deemed medical reversals. Among medical reversals, 21 (84%) were prescription medications and 1 (4%) was convalescent plasma. 17 (68%) were repurposed medications. Two (8%) were procedures or mechanical interventions and one (4%) was a device. 16 (64%) reversals pertained to the hospital setting (4 to intensive care units), 4 (16%) were non-specific (ie, applicable to any setting), 4 (16%) pertained to a non-hospital setting and 1 pertained to healthcare workers.
When faced with a novel pandemic, policymakers rapidly made hundreds of specific medical recommendations. More than two out of three were never robustly tested. Among practices tested in a randomised fashion, one in three was made in error. Pandemic recommendation errors were substantial. Early and coordinated efforts to initiate randomised trials, even during dire situations, may mitigate the perpetuation of ineffective practices.
新冠疫情要求在缺乏充分数据的情况下迅速且广泛地实施医疗措施。此后，其中许多措施已在大型随机试验中得到检验，结果发现存在错误。我们试图在国立卫生研究院的新冠指南以及食品药品监督管理局（FDA）的批准和授权中找出不正确的建议或反转。
回顾性横断面研究。
针对新冠预防、治疗和/或管理的推荐医疗措施以及FDA的批准或授权。
新冠医疗反转的频率和特征，定义为在疫情期间实施和/或推荐，但后来在随机试验中未发现益处的措施。
我们发现了332条新冠相关建议。其中85条（25.6%）反对某种医疗措施，23条（6.9%）是继续采用新冠疫情前的标准治疗方案且无偏差，224条（67.5%）推荐了新的医疗措施。我们发现有随机试验评估了其中72条措施（32.1%），其中25条（35%）被发现有误并被视为医疗反转。在医疗反转中，21条（84%）是处方药，1条（4%）是康复期血浆。17条（68%）是重新利用的药物。2条（8%）是手术或机械干预措施，1条（4%）是一种设备。16条（64%）反转涉及医院环境（4条针对重症监护病房），4条（16%）不具有特定性（即适用于任何环境），4条（16%）涉及非医院环境，1条涉及医护人员。
面对新型大流行时，政策制定者迅速提出了数百条具体的医疗建议。超过三分之二的建议从未得到充分检验。在以随机方式进行检验的措施中，三分之一是错误的。大流行期间的建议错误相当严重。即使在危急情况下，尽早并协同开展随机试验的努力可能会减少无效措施的持续存在。
