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调查虚拟随机临床试验入组中的种族和性别差异:来自 BE ACTIVE 研究的见解。

Investigating racial and gender disparities in virtual randomized clinical trial enrollment: Insights from the BE ACTIVE study.

机构信息

New York Medical College School of Medicine, Valhalla, NY.

University of Pennsylvania Center for Health Incentives and Behavioral Economics, Philadelphia, PA.

出版信息

Am Heart J. 2024 Oct;276:120-124. doi: 10.1016/j.ahj.2024.06.003. Epub 2024 Jul 30.

Abstract

Randomized clinical trials (RCTs) often suffer from a lack of representation from historically marginalized populations, and it is uncertain whether virtual RCTs (vRCTs) enhance representativeness or if elements of their consent and enrollment processes may instead contribute to underrepresentation of these groups. In this study, we aimed to identify disparities in enrollment demographics in a vRCT, the BE ACTIVE study, which recruited patients within a single health system. We discovered that the proportions of eligible patients who were randomized differed significantly by gender and race/ethnicity (men 1.2%, women 2.0%, P < .001; White 1.8%, Black 1.3%, Hispanic 0.7%, Asian 0.9%; P < .001), and compared with White patients, non-White patients were less likely to have a valid email address on file and were less likely to click on the email link to the study webpage and begin enrollment.

摘要

随机临床试验(RCTs)常常缺乏历史上处于边缘地位的人群的代表性,而且不确定虚拟 RCTs(vRCTs)是否会增强代表性,或者其同意和招募过程的某些元素是否反而导致这些群体的代表性不足。在这项研究中,我们旨在确定在 BE ACTIVE 研究(该研究在单一医疗系统内招募患者)这样一项 vRCT 中,入组人群在人口统计学方面的差异。我们发现,按性别和种族/族裔划分的合格患者被随机分配的比例存在显著差异(男性 1.2%,女性 2.0%,P<.001;白人 1.8%,黑人 1.3%,西班牙裔 0.7%,亚洲人 0.9%;P<.001),与白人患者相比,非白人患者在系统中保存的有效电子邮件地址较少,并且不太可能点击电子邮件链接到研究网页并开始入组。

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本文引用的文献

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