解释新型数字测量的变化:统计审查和教程
Andrew Trigg1, Bohdana Ratitch2, Frank Kruesmann3
1Medical Affairs Statistics, Bayer plc, Reading, Berkshire, UK.
Digital biomarkers
|March 19, 2025
概括
确定数字临床测量的解释性值对于临床验证至关重要. 本研究审查了推导这些值的方法,确保对数字健康工具治疗效应的准确解释.
科学领域:
- 数字健康技术是数字健康技术.
- 临床结果评估临床结果评估
- 统计方法学的统计方法.
背景情况:
- 数字健康工具的新型临床测量需要值来解释随时间变化的变化.
- 确定值,就像临床重要差异最小值一样,对于临床验证至关重要.
- 这些值有助于理解治疗效应的临床相关性.
研究的目的:
- 介绍数字临床测量中的解释值的理论背景.
- 审查估计这些值的方法,包括以为基础的方法.
- 用现实世界的临床试验数据来说明值估计.
主要方法:
- 将患者报告结果的已知方法应用于数字临床测量.
- 根据感知重要性与测量误差区分值.
- 考虑群体和个人层面解释的门.
- 使用基于的方法进行值估计.
主要成果:
- 现有值推导方法对数字临床测量措施的应用性.
- 为理解不同类型的解释值提供了一个框架.
- 图示值估计与咳频率数据从可穿戴设备.
结论:
- 统计方法可以有效地估计用于解释数字临床测量变化的值.
- 门对于临床验证和数字健康数据的有意义解释至关重要.
- 所介绍的方法有助于更好地了解临床试验中的治疗效果.
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