在英国开发通用临床试验动画解释视频:调查和案例研究结果
Clare Calvert1, Vicki S Barber2, Duncan Appelbe2
1Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK. clare.calvert@ndorms.ox.ac.uk.
Trials
|January 22, 2025
概括
动画解释视频 (AEV) 可以提高对临床研究的理解. 这项研究确定并创建了关于同意,治疗分配和安全的AEV,优先考虑更好的参与者参与的主题.
科学领域:
- 临床研究参与者教育教育.
- 健康沟通策略 卫生沟通策略
- 在试验中参与患者参与.
背景情况:
- 动画解释视频 (AEV) 为临床研究中的传统参与者信息表提供了替代方案.
- 目前的AEV往往专注于试验的具体情况,忽视了临床研究的共同方面.
- 在EXPLAIN倡议中,确定了对英国利益相关者重要的关键通用临床试验主题.
研究的目的:
- 确定和优先考虑对潜在参与者至关重要的通用临床试验主题.
- 为常常误解的临床试验概念开发动画解释视频 (AEV).
- 加强参与者对临床研究的理解和参与.
主要方法:
- 进行了两轮的Delphi调查,涉及各种利益相关者群体 (患者,公众,现场工作人员).
- 调查数据被用来扩大和优先考虑通用临床试验主题列表.
- 优先考虑的议题与患者和公共合作伙伴共同开发为AEV.
主要成果:
- 发展AEV的前三大优先主题是:1. 什么是同意?什么是同意? 2.谁决定治疗/什么是随机化? 3. 3. 3. 3. 这是一件很棒的事情. 参与是安全的吗/你怎么知道一个试验是安全的?
- 在第一个Delphi轮中收到了228个回复,其中167个完成了第二轮.
- 脚本与患者合作伙伴共同制作,并由一家专门的公司开发成AEV.
结论:
- 动画解释视频 (AEV) 具有显著的潜力,可以提高参与者对临床研究的理解.
- 已经建立了一个以共识为导向的重要通用概念解释层次结构.
- 三个开发的AEV的目的是为试验者形成一个基础图书馆.
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