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Open Access Research article

Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study

Tamar Pincus1*, Clare Miles1, Robert Froud2, Martin Underwood3, Dawn Carnes2 and Stephanie JC Taylor2

Author Affiliations

1 Department of Psychology, Royal Holloway, University of London, London, UK

2 Centre for Health Sciences, Institute of Health Science Education, Queen Mary University of London, UK

3 Warwick Clinical Trials Unit, University of Warwick, Coventry, UK

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BMC Medical Research Methodology 2011, 11:14  doi:10.1186/1471-2288-11-14

Published: 31 January 2011

Abstract

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.