Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Spitalstrasse 12, 4056 Basel, Switzerland.
Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.
J Clin Epidemiol. 2019 Sep;113:159-167. doi: 10.1016/j.jclinepi.2019.05.014. Epub 2019 May 24.
The objective of the study was to systematically survey the methodological literature and collect suggested criteria for assessing the credibility of effect modification and associated rationales.
We searched MEDLINE, Embase, and WorldCat up to March 2018 for publications providing guidance for assessing the credibility of effect modification identified in randomized trials or meta-analyses. Teams of two investigators independently identified eligible publications and extracted credibility criteria and authors' rationale, reaching consensus through discussion. We created a taxonomy of criteria that we iteratively refined during data abstraction.
We identified 150 eligible publications that provided 36 criteria and associated rationales. Frequent criteria included significant test for interaction (n = 54), a priori hypothesis (n = 49), providing a causal explanation (n = 47), accounting for multiplicity (n = 45), testing a small number of effect modifiers (n = 38), and prespecification of analytic details (n = 39). For some criteria, we found more than one rationale; some criteria were connected through a common rationale. For some criteria, experts disagreed regarding their suitability (e.g., added value of stratified randomization; trustworthiness of biologic rationales).
Methodologists have expended substantial intellectual energy providing criteria for critical appraisal of apparent effect modification. Our survey highlights popular criteria, expert agreement and disagreement, and where more work is needed, including testing criteria in practice.
本研究旨在系统地调查文献，并收集评估效应修饰可信度的建议标准及其相关原理。
我们检索了 MEDLINE、Embase 和 WorldCat 截至 2018 年 3 月的文献，以获取评估随机试验或荟萃分析中效应修饰可信度的指南。两名研究人员团队独立识别合格的出版物，并提取可信度标准和作者的原理，通过讨论达成共识。我们创建了一个分类法标准，在数据抽象过程中不断完善。
我们确定了 150 篇合格的出版物，提供了 36 条标准及其相关原理。常见的标准包括交互作用的显著检验（n=54）、预先假设（n=49）、提供因果解释（n=47）、考虑多重性（n=45）、检验少量效应修饰（n=38）和预先规定分析细节（n=39）。对于一些标准，我们发现了不止一个原理；有些标准通过共同的原理联系在一起。对于一些标准，专家们对其适用性存在分歧（例如，分层随机化的附加价值；生物学原理的可信度）。
方法学家在提供评估明显效应修饰的批判性评估标准方面付出了大量的智力努力。我们的调查突出了流行的标准、专家的一致和分歧，以及需要进一步研究的地方，包括在实践中测试标准。
