对处方数字疗法的研究往往缺乏严谨性和包容性
Anika Kumar1, Joseph S Ross2, Nisarg A Patel3
1Anika Kumar, University of California San Francisco, San Francisco, California.
Health affairs (Project Hope)
|November 6, 2023
概括
很少有处方数字疗法 (PDT) 有严格的临床证据. 大多数研究都是市场后的,缺乏多样性数据,并且有参与者限制,这表明需要更好的研究标准.
科学领域:
- 数字健康数字健康
- 医疗信息学医学信息学
- 临床研究方法论临床研究方法论
背景情况:
- 处方数字疗法 (PDT) 是FDA监管的基于软件的工具,需要临床医生的处方.
- 对于支持PDT临床使用的证据的了解有限.
研究的目的:
- 分析支持FDA授权的处方数字治疗的证据基础.
- 评估已销售的PDT临床研究的严谨性和包容性.
主要方法:
- 对20个FDA授权的PDT的临床研究进行回顾性横截面分析,截至2022年11月可用.
- 评估研究设计 (例如随机化,盲目化),数据报告 (种族,种族) 和参与者标准 (语言,年龄).
主要成果:
- 只有两个PDT得到了至少一个随机盲目的研究的支持.
- 三分之二的研究是市场后的,通常与市场前研究相比,标准不那么严格.
- 超过一半的研究遗漏了种族数据;超过80%的研究遗漏了种族数据. 英语水平和年龄限制是常见的.
结论:
- 对于许多处方数字疗法,高质量的临床证据存在重大差距.
- 目前的PDT研究实践缺乏包容性和严格性,可能会影响临床决策和覆盖范围.
- 加强,包容性研究对于建立对PDT有效性的信心和指导其采用至关重要.
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