Fixed vs random effects meta‐analysis in rare event studies: The Rosiglitazone link with myocardial infarction and cardiac death
Open accessAbstract
Meta‐analyses can be powerful tools to combine the results of randomized clinical trials and observational studies to make consensus inferences about a medical issue. It will be demonstrated that a common practice of testing for homogeneity of effect size, and acting upon the inference to decide between fixed vs random effects, can lead to potentially misleading results. A by‐product of this paper is a new ratio estimator approach to random effects meta‐analysis of a large set of studies with low event rates. As a case study, we shall use the recent Rosiglitazone example, where diagnostic testing failed to reject homogeneity, leading the investigators to use fixed effects. The results for the fixed and random effects analyses are discordant. In the fixed (random) effects analysis, the p‐values for myocardial infarction were 0.03 (0.11) while those for cardiac death were 0.06 (0.0017). Had the fixed effects analysis controlled the study error for multiple testing via a Bonferonni correction, the joint 95+ per cent confidence rectangle for the two outcomes would have included odds ratios of (1.0, 1.0). For the Rosiglitazone example, random effects analysis, where all studies receive the same weight, is the superior choice over fixed effects, where two large studies dominate. Copyright © 2007 John Wiley & Sons, Ltd.
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This test-based approach was often criticised because of low power to detect heterogeneity in case of few (< 10) included studies.
“This approach was, however, often criticised because of low power to detect heterogeneity in case of few (< 10) included studies [52, 77, 101, 104, 116, 118].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [118]
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- Authors
- Shuster, J. J., Jones, L. S., & Salmon, D. A.
- Affiliations
- University of Florida Health (US)
- Johns Hopkins University (US)
- Corresponding author
- Shuster, Jonathan J.
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 2007-09-03
- Volume
- 26
- Issue
- 24
- Pages
- 4375-4385
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W2050445438
- Cited by
- 105
- References
- 22
- Citations by year
- 2025: 3 · 2023: 4 · 2021: 4 · 2020: 2 · 2019: 3 · 2018: 9 · 2017: 8 · 2016: 6 · 2015: 5 · 2014: 10 · 2013: 5 · 2012: 3
- FWCI
- 13.83
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Statistics in Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- National Center for Research Resources (M01RR000082)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- fixed-effects meta-analysis, random-effects meta-analysis, rare events, ratio estimator, rosiglitazone, myocardial infarction, cardiovascular mortality, Bonferroni correction, multiple comparisons
- MeSH terms
- Rosiglitazone, Cardiovascular Diseases, Humans, Hypoglycemic Agents, Myocardial Infarction, Risk Factors, Meta-Analysis as Topic, Models, Statistical, Logistic Models, Proportional Hazards Models, Odds Ratio, Thiazolidinediones
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