克服实施患者参与临床试验的障碍:嵌入式研究的可行性测试
Geneviève Castonguay1, Sylvain Bédard2, Anick Dubois3
1Canada Research Chair in Partnership with Patients and Communities, Montreal University Hospital Research Center, 850 St-Denis St, Montreal, QC, H2X 0A9, Canada.
Research involvement and engagement
|February 26, 2025
概括
将患者参与研究纳入临床试验是可行的,但需要仔细规划. 早期的合作和了解临床试验背景对于成功的患者伙伴关系和改善参与者体验至关重要.
科学领域:
- 临床试验 临床试验
- 患者参与 患者参与
- 医疗保健服务研究 医疗服务研究
背景情况:
- 患者参与越来越被认为具有提高临床试验进行的潜力,特别是在参与者招募方面.
- 需要进一步的研究,以了解其对参与者的留住和坚持的影响.
- 嵌入式研究,其中二级研究被整合到一个更大的主体研究中,提供了一种新的方法.
研究的目的:
- 调查在正在进行的多中心临床药物试验中嵌入患者合作研究的可行性.
- 确定影响临床试验中成功实施患者参与干预措施的因素.
主要方法:
- 开发了一种患者参与干预措施,并嵌入到第三阶段随机临床药物试验中.
- 使用了定性方法,包括与患者合作伙伴和研究小组成员的半结构面试,以及文档分析.
- 对收集的数据进行了专题分析.
主要成果:
- 实施障碍包括迟到的整合,对患者伙伴关系的不同看法,沟通挑战和感知到的负担.
- 潜在的好处包括通过共享经验改善参与者体验,支持同意,并加强知识转移.
结论:
- 背景因素和设计决策对嵌入式患者参与研究的实施产生重大影响.
- 嵌入式和主机研究团队之间的早期合作,以及对临床试验背景的全面了解,对于成功至关重要.
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