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与基于文本的关键信息相比,实施和评估视觉关键信息页面:一个阶梯集群随机试验的协议
Krista E Cooksey1, Eliana C Goldstein1, Clara N Lee2
1School of Public Health, Washington University in St. Louis, 4300 Duncan Avenue, St. Louis, MO, USA.
BMC medical ethics
|November 29, 2025
概括
本研究评估了视觉关键信息 (KI) 页面,以提高参与者对研究研究的理解. 视觉AI页面旨在通过使用健康素养最佳实践来增强知情同意和试验招生.
科学领域:
- 卫生识字 卫生识字
- 在知情同意的情况下同意.
- 临床试验设计 临床试验设计
背景情况:
- 知情同意文件往往是漫长而复杂的,阻碍了参与者理解.
- 2018年共同规则规定了一个关键信息部分,以简化研究细节.
- 包括颜色和图标在内的视觉辅助工具可以改善健康信息的可访问性.
研究的目的:
- 评估视觉关键信息 (KI) 页面对知情同意过程的影响.
- 在研究协调员和参与者层面评估视觉AI页面的有效性.
- 为了确定视觉AI页面是否可以提高参与者的理解和试验入学率.
主要方法:
- 一个阶梯集群随机试验在三个美国的学术中心.
- 12名研究协调员被随机分配到通常的护理或视觉KI页面干预.
- 主要结果:协调员准备好采用;次要结果:参与者知识,满意度,决策冲突和招生.
主要成果:
- 数据收集正在进行中;结果正在等待.
- 统计分析将比较干预实施前后的结果.
- 多变量回归将评估干预对二次结果的影响.
结论:
- 这项研究将评估视觉AI页面的实施和有效性,以获得知情同意.
- 成功实施可能会导致在研究环境中更广泛地采用.
- 视觉AI页面有可能提高研究参与者的理解和参与度.
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