互联网与非互联网参与去中心化临床试验:从适应性研究中吸取教训
Rebecca Shen1, Hillary Mulder2, Lisa Wruck2
1Duke University School of Medicine Durham NC USA.
Journal of the American Heart Association
|June 22, 2023
概括
基于互联网的试验可能会排除各种人群. 在ADAPTABLE研究中,非互联网参与者年龄较大,健康状况较差,结果较差,这凸显了包容性试验设计的必要性.
科学领域:
- 临床试验 临床试验
- 数字健康数字健康
- 健康 公平 卫生 公平
背景情况:
- 基于互联网的参与可以通过增加代表性和通用性来改善务实和分散的试验.
- ADAPTABLE (阿司匹林剂量:以患者为中心的试验,评估益处和长期有效性) 研究探讨了互联网和非互联网参与者之间的差异.
- 了解这些差异对于优化试验包容性和数据完整性至关重要.
研究的目的:
- 在 ADAPTABLE 试验中,将互联网和非互联网参与者之间的人口特征,药物坚持和临床结果进行比较.
- 评估参与模式对研究保留和遵守指定的阿司匹林剂量的影响.
- 为提高多样性和参与远程临床试验的战略提供信息.
主要方法:
- 在ADAPTABLE研究的一项子分析中,将互联网参与者与那些选择非互联网/电话参与的人进行了比较.
- 关键指标包括参与者在同意时的人口统计数据,药物坚持,研究保留和复合临床结果 (死亡率,心脏病发作,中风).
- 统计分析比较了两组之间的结果和坚持率.
主要成果:
- 非互联网参与者年龄较大,更有可能是女性,黑人或西班牙裔,并有更多的并发症.
- 在非互联网参与者中,复合临床结果是两倍以上.
- 与互联网参与者相比,与互联网参与者相比,非互联网参与者不遵守阿司匹林剂量的风险高出46%.
结论:
- 非互联网参与者代表了一个更多样化,但也更病态的人群,健康结果更差.
- 仅在互联网上的试验可能无意中将代表性不足的群体和更健康的个体排除在外.
- 需要策略来确保非互联网参与者保留和遵守,以最大限度地提高试验的多样性和通用性.
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