在分散的临床试验中对数字疗法进行评估:范围审查
Cinja Koller1, Marc Blanchard1, Thomas Hügle1
1Department of Rheumatology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
PLOS digital health
|June 23, 2025
概括
数字疗法 (DTx) 的分散临床试验 (DCT) 显示参与者的坚持和参与度较低. 需要进一步的研究和更明确的指导方针来标准化这些试验并改善结果.
科学领域:
- 数字健康数字健康
- 临床试验设计 临床试验设计
- 监管科学 监管科学
背景情况:
- 数字疗法 (DTx) 和软件作为医疗器械 (SaMD) 的分散临床试验 (DCT) 正在出现.
- 在DTx/SaMD测试中DCT的标准化和实际考虑仍然不清楚.
研究的目的:
- 确定DCT评估DTx或SaMD的基本设计,行为和安全考虑因素.
- 为未来在这一领域的DCT提供一个框架.
主要方法:
- 根据阿克西和奥马利框架进行范围审查.
- 在Cochrane CENTRAL,EMBASE,MEDLINE和Web of Science中搜索了涉及DTx/SaMD的DCT.
- 包括41篇专注于DCT设计和经验的同行评审文章.
主要成果:
- DTx主要针对抑郁症;试验设计在武器,参与者和失明方面有显著差异.
- 共同特征包括电子招聘 (78%),电子知情同意 (68%) 和电子患者报告结果 (e-PROs) (88%).
- 参与者访问和纳入是有效的,但坚持 (例如,应用程序安装~40%) 和参与度低,学率为~50%.
结论:
- 对于DTx的DCT目前是非标准化和异质的,具有较低的粘附性.
- 需要进一步的研究来应对参与挑战.
- 标准化需要更明确的指导和监管框架.
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