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

Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study
Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study
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
1471-2288
14
Pincus, Tamar
55388347-5d71-4fc0-9fd2-66fbba080e0c
Miles, Clare
e9baac68-90b1-4d6d-98de-bba1cd8377c3
Froud, Robert
303169a8-8486-4e37-98f8-494c4be01dfd
Underwood, Martin
239a8609-e7b5-4acb-aaf9-9e7f717f0d62
Carnes, Dawn
bd9800b7-b0aa-46f0-b7f0-bcff5f8f0326
Taylor, Stephanie J.C.
62fdb6bf-40a7-4e4b-b705-a96e71dbebbe
Pincus, Tamar
55388347-5d71-4fc0-9fd2-66fbba080e0c
Miles, Clare
e9baac68-90b1-4d6d-98de-bba1cd8377c3
Froud, Robert
303169a8-8486-4e37-98f8-494c4be01dfd
Underwood, Martin
239a8609-e7b5-4acb-aaf9-9e7f717f0d62
Carnes, Dawn
bd9800b7-b0aa-46f0-b7f0-bcff5f8f0326
Taylor, Stephanie J.C.
62fdb6bf-40a7-4e4b-b705-a96e71dbebbe

Pincus, Tamar, Miles, Clare, Froud, Robert, Underwood, Martin, Carnes, Dawn and Taylor, Stephanie J.C. (2011) Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study. BMC Medical Research Methodology, 11 (1), 14. (doi:10.1186/1471-2288-11-14). (PMID:21281501)

Record type: Article

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

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More information

Published date: 2011
Organisations: Psychology

Identifiers

Local EPrints ID: 355340
URI: http://eprints.soton.ac.uk/id/eprint/355340
ISSN: 1471-2288
PURE UUID: 675549a7-5836-49f1-aa91-bbd0aa1af9b1
ORCID for Tamar Pincus: ORCID iD orcid.org/0000-0002-3172-5624

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Date deposited: 15 Aug 2013 14:23
Last modified: 15 Mar 2024 04:11

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Contributors

Author: Tamar Pincus ORCID iD
Author: Clare Miles
Author: Robert Froud
Author: Martin Underwood
Author: Dawn Carnes
Author: Stephanie J.C. Taylor

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