Meta-analysis of rare and adverse event data

Sutton, Alexander J; Cooper, Nicola J; Lambert, Paul C; Jones, David R; Abrams, Keith R; Sweeting, Michael J

doi:10.1586/14737167.2.4.367

Cited by 141Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsPharmacovigilance and Adverse Drug Reactions

Meta-analysis of rare and adverse event data

Sutton, Alexander J, Cooper, Nicola J, Lambert, Paul C, Jones, David R, Abrams, Keith R, Sweeting, Michael J·2002·Expert Review of Pharmacoeconomics & Outcomes Research

DOI 10.1586/14737167.2.4.367

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Abstract

Potentially beneficial drugs may have side effects. Such adverse events may be serious but rare, making their effect difficult to quantify, or even their identification problematic within randomized controlled trials. Meta-analysis provides a means of combining such outcome data across a series of studies and provides a more powerful analysis than is possible from a single study. However, meta-analysis of adverse event data presents some unique methodological challenges. Procedural issues pertaining to study selection and the inclusion of both randomized and observational data are discussed. The statistical problem of combining rare outcomes is also considered at length. Model choice, continuity corrections, exact statistics, Bayesian methods and sensitivity analysis are all covered. The application of results from adverse event meta-analyses to clinical and economic decision models is also considered. A number of examples are presented to illustrate the key points.

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Another article stressed that methods to appropriately combine data from multiple study designs need further development.
“Another article stressed that methods to appropriately combine data from multiple study designs need further development [78].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [78]

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Authors: Sutton, A. J., Cooper, N. J., Lambert, P. C., Jones, D. R., Abrams, K. R., & Sweeting, M. J.
Affiliations: University of Leicester (GB)
St George's, University of London (GB)
ORCID: Cooper, Nicola J
Lambert, Paul C
Jones, David R
Abrams, Keith R
Sweeting, Michael J
Venue: Expert Review of Pharmacoeconomics & Outcomes Research
Publisher: Informa UK Limited
Published: 2002-08
Volume: 2
Issue: 4
Pages: 367-379
ISSN: 1473-7167 (ISSN-L)
1744-8379
DOI: 10.1586/14737167.2.4.367
OpenAlex: W2122849467
Cited by: 141
References: 63
Citations by year: 2026: 1 · 2025: 3 · 2024: 2 · 2023: 3 · 2022: 2 · 2021: 22 · 2020: 8 · 2019: 6 · 2018: 11 · 2017: 5 · 2016: 10 · 2015: 9 · 2014: 8 · 2013: 11 · 2012: 8
FWCI: 0.67
Type: journal article
Language: en
Open access: closed
Locations: Expert Review of Pharmacoeconomics & Outcomes Research (publishedVersion)
PubMed (publishedVersion)
Leicester Research Archive (University of Leicester) (submittedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: adverse drug reactions, rare outcomes, meta-analysis methodology, study selection, continuity correction, Bayesian analysis, sensitivity analysis, model selection, economic decision models, clinical decision model

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Meta-analysis of rare and adverse event data

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