核心成果集开发中的患者研究合作伙伴:系统性审查
Nan-Su Huang1, Ian J Saldanha2, Ann-Margret Ervin3
1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
患者研究合作伙伴 (PRP) 在开发核心结果集 (COS) 中发挥着至关重要的作用. 这次审查发现PRP参与度各不相同,强调需要使用一致的术语和参与策略,以COMET手册等资源为指导.
科学领域:
- 临床试验方法论 临床试验方法论
- 以患者为中心的研究.
- 健康研究成果研究结果
背景情况:
- 核心结果集 (COS) 标准化临床试验报告.
- 患者研究合作伙伴 (PRP) 为COS开发提供了宝贵的实践经验.
- PRP角色的变化可能会阻碍对COS开发的有意义参与.
研究的目的:
- 系统地审查PRP在COS发展研究中的作用.
- 将PRP参与策略与现有指南进行比较.
主要方法:
- 对涉及PRP的正在进行和已完成的COS开发研究进行系统审查.
- 在Medline,Embase和Web of Science进行的搜索.
- 使用COS发展标准进行质量评估.
主要成果:
- 包含了94篇文章,描述了64个COS开发研究.
- 大多数研究 (64%) 引用了COMET患者参与手册.
- PRP任务包括指导流程 (70%) 和设计问卷 (64%).
结论:
- 在PRP术语,角色和参与COS研究方面存在显著差异.
- 建议遵守指南,如COMET手册,以保持一致的PRP参与.
- 未来的努力应该平衡有意义的患者伙伴关系与COS开发的实际可行性.
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