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Meta-analysis of noninferiority and equivalence trials: ignoring trial design leads to differing and possibly
Sergio A Acuna1, Fahima Dossa1, Nancy Baxter2
1Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
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%) reported the study design of their included trials, but only one (2.6%) interpreted their pooled estimates using NI/EQ margins and none assessed for risks of bias unique to NI/EQ trials. Nearly all NI/EQ trials (n = 116, 92.8%) included in the meta-analyses reported NI/EQ margins. The meta-analyses of 30 outcomes were reinterpreted using the NI/EQ margins; reinterpretations conflicted with the conclusion of the meta-analyses in most cases (n = 20, 66.7%).
Conclusion:
Most meta-analyses including NI/EQ trials ignore trial design and do not assess risks of bias unique to NI/EQ studies. Meta-analyses addressing questions previously explored as NI/EQ should conduct an NI/EQ meta-analysis or use clear language when performing standard (i.e., superiority) meta-analyses.
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