CoChat
Sign Up
Cited by 161Meta-analysis and systematic reviewsDelphi Technique in ResearchStatistical Methods in Clinical Trials

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

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

Open access
Pincus, Tamar, Miles, Clare, Froud, Robert, Underwood, Martin, Carnes, Dawn, Taylor, Stephanie JC·2011·BMC Medical Research Methodology
DOI 10.1186/1471-2288-11-14PMC PMC3044921
Open this paper in CoChat — free accountOpen PDF

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.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/1471-2288-11-14

Cites

28 of 28 references verified0 citation errors · 0 not checkable

Statistics

Figures

Figure 1 The study process.
Figure 1 The study process.CC BY · PubMed Central
Figure 2 The distribution of participants' ratings for each of the items (stage 1).
Figure 2 The distribution of participants' ratings for each of the items (stage 1).CC BY · PubMed Central
Figure 3 The distribution of participants' ratings for the additional items (stage 2).
Figure 3 The distribution of participants' ratings for the additional items (stage 2).CC BY · PubMed Central

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 28 references

Research works printed but not linked: 2

  1. Higgins JPT, Green S: Cochrane Handbook for Systematic Reviews of Interventions. Version 502 [updated September 2009]. 2009, The Cochrane Collaboration, 2009
  2. Fitch K: The Rand/UCLA appropriateness method user's manual. Santa Monica: Rand, c2001. 1991

Cited by

Sorted by citations

Items 101–161 of 161

Related

See all

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
ORCID
Venue
BMC Medical Research Methodology
Publisher
Springer Science and Business Media LLC
Published
2011-01-31
Volume
11
Issue
1
Pages
14-14
ISSN
1471-2288 (ISSN-L)
DOI
10.1186/1471-2288-11-14
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
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review