试验招募干预研究中的患者参与和共享决策:系统性审查
Tamara L Morgan1,2, Natasha Hudek3, Kelly Carroll3
1Methodological and Implementation Research, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, CPCR L1, Ottawa, ON, K1H 8L6, Canada. tamorgan@ohri.ca.
Research involvement and engagement
|December 6, 2025
概括
患者参与 (PE) 和共享决策 (SDM) 在临床试验招聘干预中未得到充分利用. 有限的PE是最常见的,偶尔也会报告SDM,即使是在研究集中在配资应得的人群中.
科学领域:
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
- 患者参与 患者参与
- 共享决策 - - 分享决策
背景情况:
- 临床试验参与和决策面临着持续的挑战.
- 患者参与 (PE) 和共享决策 (SDM) 通过让患者参与研究和支持知情选择,提供了潜在的解决方案.
- 在临床试验招聘干预措施中,PE和SDM的整合在很大程度上仍未得到审查.
研究的目的:
- 探讨PE如何为临床试验招聘干预提供信息,特别是对应得公平的人群.
- 调查使用PE进行招聘的研究中的人口差异.
- 检查SDM对临床试验招聘干预措施的影响程度,包括对配当群体的影响.
主要方法:
- 随机和准随机临床试验调试干预研究的系统审查.
- 评估PE报告,包括水平 (实质性,有限) 和参与领域 (研究问题,设计,结果,传播).
- 在六个领域中编码SDM:信息提供,概率沟通,结果澄清,审议支持,证据使用和透明度.
主要成果:
- 在122项研究中,只有30.3%报告了PE,最常见的是有限的参与 (59.5%).
- PE主要用于招聘干预设计 (86.5%),较少用于研究问题,结果或传播.
- 在20.5%的研究中报告了SDM,最常用于提供有关选择的信息 (9.0%).
- 19.7%的研究聚焦于配资应有的群体,其中9.0%的研究也报告了PE.
结论:
- 临床试验招募干预很少包含PE和SDM,通常患者参与有限.
- 这些发现甚至在针对应受公平待遇的人群的研究中也存在.
- 加强PE和SDM的整合可以显著改善试验招聘,研究影响,参与者体验和临床研究中的公平性.
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