Clinical Pharmacology Department, La Paz University Hospital (IdiPAZ), School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
Internal Medicine Department, La Paz University Hospital (IdiPAZ), School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
J Med Internet Res. 2021 Feb 25;23(2):e23441. doi: 10.2196/23441.
In April 2020, two independent clinical trials to assess SARS-CoV-2 prophylaxis strategies among health care workers were initiated at our hospital: MeCOVID (melatonin vs placebo) and EPICOS (tenofovir disoproxil/emtricitabine vs hydroxychloroquine vs combination therapy vs placebo).
This study aimed to evaluate the reasons why health care workers chose to participate in the MeCOVID and EPICOS trials, as well as why they chose one over the other.
Both trials were offered to health care workers through an internal news bulletin. After an initial screening visit, all subjects were asked to respond to a web-based survey.
In the first month, 206 health care workers were screened and 160 were randomized. The survey participation was high at 73.3%. Health care workers cited "to contribute to scientific knowledge" (n=80, 53.0%), followed by "to avoid SARS-CoV-2 infection" (n=33, 21.9%) and "the interest to be tested for SARS-CoV-2" (n=28, 18.5%), as their primary reasons to participate in the trials. We observed significant differences in the expected personal benefits across physicians and nurses (P=.01). The vast majority of volunteers (n=202, 98.0%) selected the MeCOVID trial, their primary reason being their concern regarding adverse reactions to treatments in the EPICOS trial (n=102, 69.4%).
Health care workers' reasons to participate in prophylaxis trials in an acute pandemic context appear to be driven largely by their desire to contribute to science and to gain health benefits. Safety outweighed efficacy when choosing between the two clinical trials.
2020 年 4 月，我院启动了两项独立的临床试验，旨在评估医护人员中 SARS-CoV-2 预防策略：MeCOVID（褪黑素与安慰剂对照）和 EPICOS（替诺福韦二吡呋酯/恩曲他滨与羟氯喹与联合治疗与安慰剂对照）。
本研究旨在评估医护人员选择参与 MeCOVID 和 EPICOS 试验的原因，以及他们为何选择其中一项而非另一项。
通过内部新闻公告向医护人员提供两项试验。初次筛选就诊后，所有受试者均被要求回答在线调查。
在第一个月，对 206 名医护人员进行了筛查，160 名被随机分组。调查参与率高达 73.3%。医护人员选择参与试验的主要原因是“为科学知识做贡献”（n=80，53.0%），其次是“避免 SARS-CoV-2 感染”（n=33，21.9%）和“对 SARS-CoV-2 检测感兴趣”（n=28，18.5%）。我们观察到医生和护士对个人预期获益的看法存在显著差异（P=.01）。绝大多数志愿者（n=202，98.0%）选择 MeCOVID 试验，他们选择的主要原因是担心 EPICOS 试验的治疗会产生不良反应（n=102，69.4%）。
在急性大流行背景下，医护人员参与预防试验的原因似乎主要是出于对科学贡献和健康获益的渴望。在两项临床试验之间做出选择时，安全性优先于疗效。
