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

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-07-30 DOI:10.1016/j.ahj.2024.06.003

Michael P. Fortunato MD , Anthony Girard ScM , Samantha Coratti BA , David Farraday BA , Laurie Norton MA, MBE , Charles Rareshide MA , Jingsan Zhu MS, MBA , Neel Chokshi MD, MBA , Julia E. Szymczak PhD , Tamar Klaiman PhD , Louise B. Russell PhD , Dylan S. Small PhD , Mitesh S. Patel MD, MBA , Kevin G.M. Volpp MD, PhD , Alexander C. Fanaroff MD, MHS

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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.

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调查虚拟随机临床试验注册中的种族和性别差异：BE ACTIVE 研究的启示

随机临床试验（RCT）往往缺乏历史上被边缘化人群的代表性，目前还不确定虚拟 RCT（vRCT）是否能提高代表性，或者其同意和注册过程中的一些因素是否会导致这些群体的代表性不足。在本研究中，我们的目的是确定在一项虚拟 RCT（BE ACTIVE 研究）中注册人口统计学方面的差异，该研究在单一医疗系统内招募患者。我们发现，符合随机化条件的患者比例在性别和种族/民族方面存在显著差异（男性 1.2%，女性 2.0%，P <.001；白人 1.8%，黑人 1.3%，西班牙裔 0.7%，亚裔 0.9%；P <.001），与白人患者相比，非白人患者拥有有效电子邮件地址的可能性较低，点击电子邮件链接进入研究网页并开始注册的可能性也较低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.