影响试验后维持或取消研究干预措施实施的因素:叙述性审查
Terren Green1, Hayden B Bosworth1,2,3,4, Gloria D Coronado5
1Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Journal of general internal medicine
|January 12, 2024
概括
嵌入式实用临床试验 (ePCT) 表明,即使干预措施无效,也可能持续,但如果资源密集,有效的干预措施可能会失败. 政策调整是维持和扩大规模的关键.
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
- 实施科学 实施科学
背景情况:
- 嵌入式实用临床试验 (ePCT) 将研究整合到医疗保健环境中,使用现实世界的人口和基础设施.
- 电子PCT的目的是与卫生系统的优先事项保持一致,促进干预措施的实施和采用到常规实践中.
- 美国国立卫生研究院实用试验协作室 (NIH Pragmatic Trials Collaboratory) 已经开展了针对公共卫生问题的大型ePCT示范项目.
研究的目的:
- 总结了从六个完成的NIH实用试验实验室演示项目中所吸取的经验教训,这些项目涉及对试验后结果的解释.
- 探索对在ePCT中测试的干预措施的维持或不实施的影响.
- 为计划审判后干预维持提供建议.
主要方法:
- 分析六个已完成的ePCT示范项目的案例研究.
- 审查经验与试验后的结果解释和干预维持的经验.
- 确定有关干预有效性,资源需求和政策调整的关键经验教训.
主要成果:
- 由于二次利益或感知价值,不有效的干预措施可能会持续存在.
- 有效的干预措施可能无法持续,如果他们需要大量的资源.
- 有效干预措施的持续和扩大取决于与政策激励措施的协调.
结论:
- 考虑二次结果,子组分析和临床医生/工作人员的经验对于解释ePCT结果至关重要.
- 在试验过程的早期参与决策者是确保干预持续和扩大必不可少的.
- 在试验开始之前,应开始对干预维持或取消实施的战略规划.
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