研究参与炎症性肠病研究:患者想要什么?
Charles N Bernstein1,2, Gia Ly1,2, Zoann Nugent1,2
1University of Manitoba IBD Clinical and Research Centre, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
患者对炎症性肠病 (IBD) 研究参与的兴趣在安慰剂试验中较低,但在活性药物试验和观察性研究中较高. 由于COVID大流行,一些IBD患者对IBD的兴趣进一步下降.
科学领域:
- 胃肠病学 胃肠病学
- 临床研究 临床研究
- 患者报告的结果
背景情况:
- 调查患者对炎症性肠病 (IBD) 研究参与的看法.
- 评估COVID大流行对IBD研究参与的影响.
研究的目的:
- 为了确定患者对IBD研究参与的看法,跨越不同时代 (前,周,后COVID).
- 确定影响参与IBD研究的关键因素,包括研究设计和补偿.
主要方法:
- 调查分发给曼尼托巴大学IBD研究注册参与者 (2022年3月至2023年3月).
- 询问了个人与远程参与的偏好,报销,结果报告,以及加入各种研究类型的意愿.
- 对临床试验,生物标本收集,结肠镜检查和记录/样本获取研究的评估兴趣.
主要成果:
- 36.6%的响应率 (1105/3018) 进行了检查.
- 在疫情前,2/3不太可能参加安慰剂对照试验;如果保证有效药物,约50%会加入.
- 了解副作用是最重要的 (81%). 在COVID后,20-30%的兴趣下降,15-20%的兴趣增加,55-60%没有变化.
- 80%的人愿意参与观察性研究;付款不是主要的动机.
结论:
- 对安慰剂控制的IBD临床试验的兴趣较低,但对活性药物试验和观察性研究的意愿显著.
- 由于COVID大流行,IBD患者对参与研究的整体兴趣受到负面影响.
- 患者的偏好突出了关于参与研究的风险和益处的明确沟通的重要性.
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