随机对两种不同同意程序的随机研究:数字酒精干预试验中的一项研究
Katarina Ulfsdotter Gunnarsson1, Elizabeth S Collier2,3, Jim McCambridge4
1Department of Health, Medicine and Caring Sciences, Division of Society and Health, Linköping University, 581 83, Linköping, Sweden. katarina.ulfsdotter.gunnarsson@liu.se.
Trials
|January 3, 2024
概括
参与者对试验程序的回忆因同意表格的布局而有所不同. 与"主动请求"格式相比",一页"格式显示了更好的个人数据处理回忆.
科学领域:
- 临床试验 临床试验
- 在知情同意的情况下同意.
- 数字健康干预措施 数字健康干预措施
背景情况:
- 参与者对同意表格的理解对于参与和保留研究至关重要.
- 有证据表明,参与者通常不会完全阅读,理解或回忆同意表格信息.
- 这项研究研究了数字酒精干预试验的参与者对试验程序的回忆.
研究的目的:
- 评估参与者对试验程序信息的回忆,这些信息出现在同意材料中.
- 为了比较两种不同的同意表格布局方法之间的回忆:"一页"和"主动请求".
主要方法:
- 在线有效性试验中的嵌套研究,比较"一页"与"主动请求"同意布局.
- 试验程序的回忆被测量使用四个问题,随机化后2个月.
- 量化数据补充了定性自由文本评论.
主要成果:
- 在两组之间,在四个审判程序问题中,在三个问题中没有观察到显著的回忆差异.
- 与"一页"组相比",主动请求"组的参与者对个人数据处理的回忆能力较低.
- 定性评论为定量发现提供了额外的背景.
结论:
- 同意表格的呈现格式会影响参与者对试验信息的回忆.
- 临床试验的设计者应仔细考虑同意表格的布局,以优化参与者的理解和回忆.
- 个人数据处理信息的回忆在单页同意格式下更好.
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