实施框架,以提高患者在使用可穿戴设备的临床试验中的坚持.
Meghan McCarthy1, Aubrey Pope1, Gabriel Smock1
1Department of Surgery, Massachusetts General Hospital, Boston MA, USA.
Research square
|December 3, 2025
概括
提高使用可穿戴设备的临床试验的遵守率需要解决技术障碍和参与者的参与. 战略包括明确的标准,数字素养支持和定期监测,以确保高质量的数据和公平的参与.
科学领域:
- 数字卫生技术数字卫生技术
- 临床试验设计 临床试验设计
- 可穿戴生物传感器
背景情况:
- 可穿戴设备对于在临床试验中持续收集生理数据至关重要.
- 诸如数字素养,设备同步和社会经济差异等挑战阻碍了患者的一致遵守.
- 提高遵守性对于研究环境中高质量,可分析的数据至关重要.
研究的目的:
- 使用可穿戴设备合成临床试验的见解.
- 开发一个实用的框架,以优化基于可穿戴设备的临床试验的坚持.
- 为了应对不断收集生理学数据的挑战.
主要方法:
- 来自NIH-NHLBI资助的可穿戴设备临床试验的综合见解.
- 进行了关于可穿戴设备粘附的专注文献审查.
- 根据实际实施和研究结果制定了战略框架.
主要成果:
- 关键策略包括明确的纳入/排除标准和灵活的招聘选择 (虚拟/面对面).
- 加强数字素养,定期数据监测和与参与者保持一致的联系至关重要.
- 这些方法提高了参与度,减少了数据缺失,并促进了公平的参与.
结论:
- 解决技术障碍,参与者参与和数据监测的战略可以提高可穿戴临床试验的遵守率.
- 拟议的框架指导优化研究设计,数据质量和不同人群的可访问性.
- 学习的经验可以为未来的研究提供信息,并促进在临床研究中采用数字健康技术.
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