参与者理解和接受增强的电子知情同意与仅文本的知情同意:一项创新的定性试点研究
Amy Corneli1,2, Summer Starling3, Yujung Choi3
1Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC, 27701, USA. amy.corneli@duke.edu.
Pilot and feasibility studies
|January 17, 2024
概括
增强电子知情同意 (eIC) 改善了参与者在分散试验中的体验. 电子信息中心的数字元素促进了参与和准备,超出了基本的理解和满意度.
科学领域:
- 临床试验 临床试验
- 医疗信息学 医疗信息学
- 患者参与 患者参与
背景情况:
- 分散的临床试验利用电子知情同意 (eIC) 来扩大参与者的覆盖范围.
- eIC促进了不同地理位置的招生,提高了试验的可访问性.
研究的目的:
- 评估参与者对纯文本和增强电子知情同意 (eIC) 的理解和接受度.
- 在模拟的III期高血压试验中,在两个eIC格式之间比较参与者的满意度,可用性和偏好.
主要方法:
- 采用了一种随机交叉研究设计.
- 在模拟高血压试验中对纯文本eIC和增强的eIC进行定性描述性评估.
- 评估了参与者的理解,满意度,可用性和偏好.
主要成果:
- 招募了24名患有高血压的不同参与者.
- 只有文本和增强的eIC之间没有观察到理解或满意度的显著差异.
- 优选的是增强的eIC,参与者报告了更多的知情感,参与感,舒适感和准备感.
结论:
- 通过数字元素增强eIC提供了超出理解和满意度的好处.
- 在eIC的数字增强可以积极影响参与者在临床研究中的经验.
- 提高参与者参与度和准备度是增强eIC的关键成果.
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