A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses

被引：21

作者：

Schandelmaier, Stefan ^{[1
,2
,3
]}

Chang, Yaping ^{[1
]}

Devasenapathy, Niveditha ^{[4
]}

Devji, Tahira ^{[1
]}

Kwong, Joey S. W. ^{[5
]}

Lozano, Luis E. Colunga ^{[1
]}

Lee, Yung ^{[1
,6
]}

Agarwal, Arnav ^{[7
]}

Bhatnagar, Neera ^{[1
]}

Ewald, Hannah ^{[2
,3
]}

Zhang, Ying ^{[1
,8
]}

Sun, Xin ^{[9
]}

Thabane, Lehana ^{[1
,10
]}

Walsh, Michael ^{[1
,11
]}

Briel, Matthias ^{[1
,2
,3
]}

Guyatt, Gordon H. ^{[1
,11
]}

机构：

[1] McMaster Univ, Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4K1, Canada

[2] Univ Basel, Basel Inst Clin Epidemiol & Biostat, Dept Clin Res, Spitalstr 12, CH-4056 Basel, Switzerland

[3] Univ Hosp Basel, Spitalstr 12, CH-4056 Basel, Switzerland

[4] Publ Hlth Fdn India, Indian Inst Publ Hlth Delhi, Plot 47,Sect 44, Gurgaon 122002, Haryana, India

[5] Chinese Univ Hong Kong, Fac Med, JC Sch Publ Hlth & Primary Care, Hong Kong, Peoples R China

[6] Michael G DeGroote Sch Med, 1280 Main St West, Hamilton, ON L8S 4K1, Canada

[7] Univ Toronto, Dept Med, 190 Elizabeth St,R Fraser Elliott Bldg 3-805, Toronto, ON M5G 2C4, Canada

[8] Beijing Univ Chinese Med, Ctr Evidence Based Chinese Med, 11 Bei San Huan Dong Lu, Beijing 100029, Peoples R China

[9] Sichuan Univ, West China Hosp, Chinese Evidence Based Med Ctr, Chengdu 610041, Sichuan, Peoples R China

[10] St Josephs Healthcare Hamilton, Biostat Unit, 50 Charlton St East, Hamilton, ON L8N 4A6, Canada

[11] McMaster Univ, Dept Med, 1200 Main St West, Hamilton, ON L8S 4L8, Canada

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2019年 / 113卷

基金：

瑞士国家科学基金会;

关键词：

Epidemiologic methods (MeSH); Meta-analysis as topic (MeSH); Clinical trials as topic (MeSH); Health care evaluation mechanisms (MeSH); Precision medicine (MeSH); Subgroup analysis; CONTINUOUS VARIABLE SIMULATION; SUBGROUP ANALYSES; CLINICAL-TRIALS; HETEROGENEITY; SEX;

D O I：

10.1016/j.jclinepi.2019.05.014

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Objective: 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. Study Design and Setting: 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. Results: 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). Conclusion: 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. (C) 2019 Published by Elsevier Inc.

引用

页码：159 / 167

页数：9

共 55 条

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