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探究“研究双胞胎”的异质性。

Investigating the Heterogeneity of "Study Twins".

机构信息

Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.

DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany.

出版信息

Biom J. 2024 Sep;66(6):e202300387. doi: 10.1002/bimj.202300387.

Abstract

Meta-analyses are commonly performed based on random-effects models, while in certain cases one might also argue in favor of a common-effect model. One such case may be given by the example of two "study twins" that are performed according to a common (or at least very similar) protocol. Here we investigate the particular case of meta-analysis of a pair of studies, for example, summarizing the results of two confirmatory clinical trials in phase III of a clinical development program. Thereby, we focus on the question of to what extent homogeneity or heterogeneity may be discernible and include an empirical investigation of published ("twin") pairs of studies. A pair of estimates from two studies only provide very little evidence of homogeneity or heterogeneity of effects, and ad hoc decision criteria may often be misleading.

摘要

元分析通常基于随机效应模型进行,而在某些情况下,也可以主张采用共同效应模型。例如,对于两个“研究双胞胎”,如果它们遵循共同(或至少非常相似)的方案进行,则可能属于这种情况。在这里,我们研究了一对研究的元分析的特殊情况,例如,总结临床开发计划第三阶段的两项确证性临床试验的结果。因此,我们专注于可以识别出多大程度的同质性或异质性的问题,并包括对已发表的(“双胞胎”)研究对的实证研究。来自两项研究的一对估计值仅提供了有关效果同质性或异质性的非常有限的证据,并且特定的决策标准可能常常具有误导性。

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