程序干预的随机试验中的安慰剂控制和失明:系统性审查和元回归
Christopher A Rajkumar1, Katharine E Thomas2, Michael Foley1
1National Heart and Lung Institute, Imperial College London, London, United Kingdom.
JAMA surgery
|April 17, 2024
概括
在没有安慰剂对照的情况下,程序性干预显示出更大的效果大小,特别是与运动相关的结果,生活质量和专业评估的终点. 这凸显了安慰剂效应在临床试验中的重大影响.
科学领域:
- 医疗干预 医疗干预
- 临床试验设计 临床试验设计
- 基于证据的医学基于证据的医学.
背景情况:
- 在临床采用之前,程序干预很少与安慰剂进行评估.
- 这种缺乏安慰剂对照可能会高估公认程序的有效性.
- 在程序干预试验中调查安慰剂手臂的影响至关重要.
研究的目的:
- 评估安慰剂对照在手术和干预手术试验中的重要性.
- 为了比较同样的干预措施与安慰剂手臂和没有安慰剂手臂的试验之间的效果大小.
主要方法:
- 在MEDLINE和Embase系统搜索过程性干预的安慰剂对照试验.
- 与缺乏安慰剂对照的随机临床试验进行对比.
- 随机效应元回归来分析安慰剂对照对各种终点的影响.
主要成果:
- 没有盲目的试验 (没有安慰剂控制) 显示了与运动相关的结果,生活质量和医疗保健专业人员评估的终点的显著更大的效果大小.
- 对于这些终点,安慰剂效应占了未盲目的试验中观察到的效应的很大一部分 (分别为88.1%,55.2%和61.3%).
- 对于患者报告的结果,血压,死亡率,疼痛或出血事件,在盲目的和未盲目的试验之间没有发现显著差异.
结论:
- 在程序干预试验中,安慰剂效应的幅度因终点而异.
- 避孕药控制对评估运动相关结果,生活质量和专业评估结果的试验产生重大影响.
- 在程序干预的随机临床试验中,建议根据终点相关性考虑安慰剂对照.
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