Journal article

Meta-analysis of noninferiority and equivalence trials: ignoring trial design leads to differing and possibly misleading conclusions

Sergio A Acuna, Fahima Dossa, Nancy Baxter

Journal of Clinical Epidemiology | ELSEVIER SCIENCE INC | Published : 2020

Abstract

OBJECTIVE: The objective of the study is to examine the analytic approach of meta-analyses that include noninferiority or equivalence (NI/EQ) trials. STUDY DESIGN AND SETTING: We used Scopus to identify meta-analyses including NI/EQ trials. We extracted data from the meta-analyses and their included randomized clinical trials (RCTs). We used the RCT's NI/EQ margins to reinterpret the results of the meta-analyses, assessed for risk of biases unique to NI/EQ trials, and evaluated the consistency of the meta-analysis interpretation when using NI/EQ margins. RESULTS: We identified 38 unique meta-analyses including 515 RCTs, of which 125 (24.3%) were NI/EQ trials. Fourteen meta-analyses (36.8%) r..

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Grants

Awarded by Canadian Institutes of Health Foundation Grant


Funding Acknowledgements

This study was funded by a Canadian Institutes of Health Research Knowledge Synthesis Grant and Foundation Grant (Funding Reference No. 362493 and No. 148470). The funding sources had no role in the design or conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.