电子患者报告结果评估:评估患者对每个屏幕项数的偏好
Jennifer Lord-Bessen1, Danielle Rodriguez2, Karin S Coyne2
1Bristol Myers Squibb, Lawrenceville, NJ, USA. jennifer.lordbessen@abbvie.com.
Therapeutic innovation & regulatory science
|June 10, 2025
概括
参与者对电子患者报告结果 (ePRO) 的偏好有所不同,单项和多项-每屏幕格式之间的完成时间或分数没有显著差异. 这两种格式均可用于临床试验.
科学领域:
- 临床信息学 临床信息学
- 人与计算机的交互
- 患者报告的结果
背景情况:
- 电子患者报告结果 (ePRO) 在临床试验中通常使用单项-每屏幕格式.
- 参与者对单项与多项每屏 ePRO 格式的偏好以前没有被调查过.
- 这项研究旨在评估用户偏好,完成时间,并评分这两种ePRO格式之间的可比性.
研究的目的:
- 为了比较参与者对单项与多项每屏幕ePRO格式的偏好.
- 评估ePRO格式对数据完成时间的影响.
- 为了确定从不同的屏幕格式中获得的ePRO分数的可比性.
主要方法:
- 采用了一种随机,交叉,观察性研究设计.
- 参与者在两次研究访问中,在电子平板电脑上以单项-每屏幕和多项-每屏幕的格式完成了ePRO.
- 纸质问卷被用来捕捉每次访问的参与者偏好.
主要成果:
- 参与者的偏好分为33.3%喜欢单项,33.3%喜欢多项,27.8%没有偏好.
- 值得注意的是,47.2%的人更喜欢单项格式,专门用于临床试验参与.
- 单项格式 (6:42) 的ePRO完成时间略长于多项格式 (6:21),但在统计学上并不显著 (p=0.1540).
- ePRO的分数在两种格式中都显示出相似之处.
结论:
- 用户可以接受电子平板电脑上呈现的单项和多项每屏 ePRO 格式.
- 对于ePRO格式的个人用户偏好可能会有很大的不同.
- 在选择ePRO格式时,临床试验设计应考虑具体的研究人群,预期用途和整体试验目标.
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