临床临床试验在重症监护医学的随机临床试验的资格标准
Alya Heirali1, Kiyan Heybati2, Jariya Sereeyotin3
1Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada.
JAMA network open
|January 17, 2025
概括
在重症监护试验中,大多数排除标准都是合理的. 然而,缺乏充分理由的标准,比如排除孕妇或有沟通障碍的人,限制了概括性和参与者纳入.
科学领域:
- 关键护理医学 关键护理医学
- 临床试验的设计
- 卫生公平性健康公平性
背景情况:
- 随机临床试验 (RCT) 的资格标准旨在针对临床相关人群.
- 然而,一些标准可能缺乏强有力的理由,可能会排除边缘化群体并限制可通用性.
研究的目的:
- 总结和评估在重症监护医学领域发表的RCT中排除标准的合理性.
主要方法:
- 在顶尖的一般内科医学期刊 (2018-2023) 中发表的并行组RCT的系统审查.
- 包括注册成人重症监护室 (ICU) 患者或需要ICU启动的维持生命干预的重症患者的RCT.
- 排除标准被独立审查员分类为缺乏,潜在或强烈的理由.
主要成果:
- 分析了75个具有1455个排除标准的RCT.
- 大多数标准被强烈 (74.2%) 或潜在 (20.4%) 证明是合理的.
- 缺乏充分理由的标准 (5.4%) 往往排除了怀孕/哺乳期,有沟通障碍或缺乏医疗保险的人.
结论:
- 虽然大多数排除标准是合理的,但缺乏合理的标准可能会不适当地排除参与者.
- 解决这些标准对于提高临床试验的概括性和重症监护研究参与者的多样性至关重要.
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