在虚拟随机临床试验招生中调查种族和性别差异:来自BE ACTIVE研究的见解
Michael P Fortunato1, Anthony Girard2, Samantha Coratti2
1New York Medical College School of Medicine, Valhalla, NY.
American heart journal
|August 25, 2024
概括
虚拟随机临床试验 (vRCTs) 可能无法改善,而且可能会恶化边缘化群体的不足. 在BE ACTIVE研究中,根据性别和种族/族裔,发现了显著的入学差异,非白人患者面临参与障碍.
科学领域:
- 临床试验方法论 临床试验方法论
- 健康 公平 卫生 公平
- 数字健康数字健康
背景情况:
- 随机临床试验 (RCT) 历来一直在与参与者代表的多样性作斗争.
- 虚拟随机临床试验 (vRCT) 对人口代表性的影响尚不清楚.
- 在VRCT中潜在的招生过程元素可能会加剧现有的代表性不足问题.
研究的目的:
- 在特定的虚拟RCT (BE ACTIVE研究) 中调查人口入学差异.
- 确定可能导致vRCT中代表人数不足的障碍.
主要方法:
- 在单一卫生系统内进行的BE ACTIVE虚拟RCT的入学数据分析.
- 在不同的人口群体 (性别,种族/种族) 中,随机化比例的比较.
- 检查诸如电子邮件可用性和参与研究邀请等因素.
主要成果:
- 基于性别 (男性与女性) 和种族/种族 (白人,黑人,西班牙裔,亚洲人) 观察到随机化比例的显著差异.
- 非白人患者比白人患者更不可能拥有有效的电子邮件地址.
- 非白人患者对研究电子邮件邀请的参与度较低,影响了入学启动.
结论:
- 在BE ACTIVE虚拟RCT中,招生人数存在人口差异,这表明vRCT本身可能不会提高代表性.
- 包括缺乏有效电子邮件地址和非白人人口参与度较低在内的障碍妨碍了公平参与vRCT.
- 需要进一步的研究和战略来解决数字沟,并确保虚拟临床试验的包容性.
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