在多中心研究中,用于早期检测异常中心的四种集中统计监测方法的表现
Serge Niangoran1,2,3, Valérie Journot1,2, Olivier Marcy1,2
1University of Bordeaux, National Institute for Health and Medical Research (INSERM) UMR 1219, Bordeaux Population Health Research Center, Bordeaux, France.
Contemporary clinical trials communications
|July 10, 2023
概括
集中统计监测 (CSM) 方法在检测临床试验中的数据异常方面有所不同. 德塞特和远程方法为常规使用提供了高的特异性,而学生和Hatayama方法显示了更高的灵敏度,但由于错误报警,它们的实用性较低.
科学领域:
- 临床试验 临床试验
- 数据监控数据监控
- 统计分析 统计分析
背景情况:
- 数据质量对于多中心临床试验的可信度至关重要.
- 集中统计监测 (CSM) 识别特定中心的非典型数据分布.
- 有效的CSM方法应该能够在参与者参与最小的情况下早期发现问题.
研究的目的:
- 为了比较四种CSM方法 (学生,Hatayama,Desmet,距离) 的性能.
- 评估他们检测异常定量变量分布在各中心的能力.
- 根据参与者数量和平均偏差幅度来评估绩效.
主要方法:
- 模拟的临床试验被用于比较.
- 评估了四种CSM方法:学生,Hatayama,Desmet和距离.
- 检测非典型的定量变量分布是主要结果.
主要成果:
- 学生和Hatayama方法表现出良好的灵敏度,但特异性较差.
- 对于所有测试的平均偏差,Desmet和Distance方法的特异性非常高.
- 德斯梅特和远程方法对50%以下的平均偏差的灵敏度较低.
结论:
- 学生和Hatayama方法是不切实际的CSM由于低的特异性和过度的警报.
- 尽管对小偏差的灵敏度较低,但Desmet和Distance方法由于高的特异性和效率,适合常规的CSM.
- CSM,特别是Desmet和距离方法,应该补充,而不是取代传统的监测程序.
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