分析使用GLMM,GEE1,GEE2和QIF的集群随机对照试验:来自四个案例研究的结果
Bright C Offorha1, Stephen J Walters2, Richard M Jacques2
1Division of Population Health, School of Medicine & Population Health, University of Sheffield, Sheffield, UK. bcofforha1@sheffield.ac.uk.
BMC medical research methodology
|December 13, 2023
概括
本研究比较了分析集群随机对照试验 (cRCT) 的四种统计方法. 虽然方法通常一致,但二次推理函数在cRCT分析中需要谨慎使用少数集群.
科学领域:
- 生物统计学 生物统计学
- 临床试验方法论 临床试验方法论
- 流行病学 流行病学
背景情况:
- 集群随机对照试验 (cRCT) 需要专门的统计分析,因为集群中的相关结果.
- 现有的文献提出了各种建模方法,但对于它们在cRCTs中的应用需要实际指导.
研究的目的:
- 为分析集群随机对照试验 (cRCTs) 提供实际指导和建议.
- 为了比较四种不同的cRCT数据统计建模方法的性能.
主要方法:
- 文献审查确定了四种建模方法:通用线性混合模型 (GLMM),通用估计方程 (GEE) (第一和第二顺序) 和二次推理函数 (QIF).
- 这些方法应用于cRCT的四个案例研究,其中有不同数量的集群和参与者,分析了连续和二进制结果.
- 分析使用R和SAS统计数据包进行.
主要成果:
- 集群内相关系数 (ICC) 估计值一般较低 (<0.05),与初级保健和社区基的cRCTs一致.
- 大多数方法在案例研究中产生了类似的结果.
- 在一些分析中,二次推理函数 (QIF) 与GLMM和GEE相比产生了不同的结果,特别是在小到中等数量的集群中.
结论:
- 在大多数场景中,四种建模方法在cRCT分析中显示了可比的结果.
- 在少数集群的试验中使用二次推理函数 (QIF) 时建议谨慎使用;建议进行小样本校正.
- 需要进行进一步的模拟研究,以全面评估cRCT这些统计方法的性能.
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