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Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study.
Open accessAbstract
BACKGROUND: Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews. METHOD: We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers' Handbook, and the process was repeated. RESULTS: The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based a-priori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented. CONCLUSIONS: There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies.
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“Both moderators and predictors of change should be measured prior to treatment randomization (Turner et al., 2007; Pincus et al., 2011).”
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“However, our study is in accordance with the methodological requirements of exploratory moderator analyses [68].”
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Metadata
- Authors
- Pincus, T., Miles, C., Froud, R., Underwood, M., Carnes, D., & Taylor, S. J.
- Affiliations
- University of London (GB)
- Queen Mary University of London (GB)
- University of Warwick (GB)
- Corresponding author
- Pincus, Tamar
- Venue
- BMC Medical Research Methodology
- Published
- 2011-01-31
- Volume
- 11
- Issue
- 1
- Pages
- 14-14
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC3044921
- OpenAlex
- W2111680408
- Cited by
- 161
- References
- 28
- Citations by year
- 2026: 14 · 2025: 15 · 2024: 9 · 2023: 22 · 2022: 8 · 2021: 14 · 2020: 14 · 2019: 10 · 2018: 2 · 2017: 15 · 2016: 10 · 2015: 9 · 2014: 7 · 2013: 8 · 2012: 2
- FWCI
- 1.48
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- ePrints Soton (University of Southampton) (submittedVersion)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by)
- Royal Holloway Digital Repository (Royal Holloway University of London) (submittedVersion)
- Royal Holloway Digital Repository (Royal Holloway University of London) (submittedVersion, cc-by)
- Funders
- Arizona State University
- University of Washington
- Université Laval
- Queen Mary University of London
- Advantage West Midlands
- National Institute for Health and Care Research (RP-PG-0707-10189)
- Keele University
- Programme Grants for Applied Research
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- moderators, subgroup analysis, randomized controlled trials, methodological quality criteria, level of evidence, interaction testing, consensus recommendations
- MeSH terms
- Humans, Review Literature as Topic, Sampling Studies, Meta-Analysis as Topic, Effect Modifier, Epidemiologic, Randomized Controlled Trials as Topic, Databases, Bibliographic, Treatment Outcome, Consensus
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