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Knowing what Works in Health Care: A Roadmap for the Nation
Appendix D
Standards for Reporting Meta-Analyses of Clinical Trials and Observational Studies: QUOROM and MOOSE
QUOROM CHECKLIST
Improving the quality of reports of meta-analyses of randomised controlledtrials (RCTs): The QUOROM statement checklist
Heading
Subheading
Descriptor
Title
Identify the report as a meta-analysis [or systematic review] of RCTs
Abstract
Use a structured format
Describe
Objectives
The clinical question explicitly
Data sources
The databases (i.e., list) and other information sources
Review methods
The selection criteria (i.e., population, intervention, outcome, and study design); methods for validity assessment, data abstraction, and study characteristics, and quantitative data synthesis in sufficient detail to permit replication
Results
Characteristics of the RCTs included and excluded; qualitative and quantitative findings (i.e., point estimates and confidence intervals); and subgroup analyses
Conclusion
The main results
Describe
Introduction
The explicit clinical problem, biological rationale for the intervention and rationale for review
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Appendix D
Standards for Reporting Meta-Analyses of Clinical Trials and Observational Studies: QUOROM and MOOSE
QUOROM CHECKLIST
Improving the quality of reports of meta-analyses of randomised controlled trials (RCTs): The QUOROM statement checklist
Heading
Subheading
Descriptor
Title
Identify the report as a meta-analysis [or systematic review] of RCTs
Abstract
Use a structured format
Describe
Objectives
The clinical question explicitly
Data sources
The databases (i.e., list) and other information sources
Review methods
The selection criteria (i.e., population, intervention, outcome, and study design); methods for validity assessment, data abstraction, and study characteristics, and quantitative data synthesis in sufficient detail to permit replication
Results
Characteristics of the RCTs included and excluded; qualitative and quantitative findings (i.e., point estimates and confidence intervals); and subgroup analyses
Conclusion
The main results
Describe
Introduction
The explicit clinical problem, biological rationale for the intervention and rationale for review
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Methods
Searching
The information sources, in detail (e.g., databases, registers, personal files, expert informants, agencies, hand-searching), and any restrictions (years considered, publication status, language of publication)
Selection
The inclusion and exclusion criteria (defining population, intervention, principal outcomes, and study design)
Validity assessment
The criteria and process used (e.g., masked conditions, quality assessment, and their findings)
Data abstraction
The process or processes used (e.g., completed independently, in duplicate)
Study characteristics
The type of study design, participants’ characteristics, details of intervention, outcome definitions, &c, and how clinical heterogeneity was assessed
Quantitative data Synthesis
The principal measures of effect (e.g., relative risk), method of combining results (statistical testing and confidence intervals), handling of missing data; how statistical heterogeneity was assessed; a rationale for any a-priori sensitivity and subgroup analyses; and any assessment of publication bias
Results
Trial flow
Provide a meta-analysis profile summarizing trial flow (see figure)
Study characteristics
Present descriptive data for each trial (e.g., age, sample size, intervention, dose, duration, follow-up period)
Quantitative data synthesis
Report agreement on the selection and validity assessment; present simple summary results (for each treatment group in each trial, for each primary outcome); present data needed to calculate effect sizes and confidence intervals in intention-to-treat analyses (e.g. 2×2 tables of counts, means and SDs (standard deviations), proportions)
Discussion
Summarize key findings; discuss clinical inferences based on internal and external validity; interpret the results in light of the totality of available evidence; describe potential biases in the review process (e.g., publication bias); and suggest a future research agenda
Quality of reporting of meta-analyses
Reprinted from Lancet, Vol 354, Moher, D., D. J. Cook, S. Eastwood, I. Olkin, D. Rennie, D. F. Stroup, and the QUOROM Group. Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement, 1896-1900, Copyright 1999, with permission from Elsevier.
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Improving the quality of reports of meta-analyses of randomized controlled trials: The QUOROM statement flow diagram
Reprinted from Lancet, Vol 354, Moher, D., D. J. Cook, S. Eastwood, I. Olkin, D. Rennie, D. F. Stroup, and the QUOROM Group. Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement, 1896-1900, Copyright 1999, with permission from Elsevier.
NOTE: The QUOROM Statement is currently being updated under the name PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). PRISMA will include a 27-item checklist and four-phase flow diagram. The intent of the update is to reflect a more comprehensive understanding of conceptual issues, methodological advances, and practical innovations in the conduct and reporting of systematic reviews.
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MOOSE CHECKLIST
A Proposed Reporting Checklist for Authors, Editors, and Reviews of Meta-analyses Of Observational Studies
Reporting of background should include
Problem definition
Hypothesis statement
Description of study outcome(s)
Type of exposure of intervention used
Type of study designs used
Study population
Reporting of search strategy should include
Qualifications of searchers (e.g., librarians and investigators)
Search strategy, including time period included in the synthesis and keywords
Effort to include all available studies, including contact with authors
Databases and registries searched
Search software used, name and version, including special features used (eg, explosion)
Use of hand searching (e.g., reference lists of obtained articles)
List of citations located and those excluded, including justification
Method of addressing articles published in languages other than English
Method of handling abstracts and unpublished studies
Description of any contact with authors
Reporting of methods should include
Description of relevance or appropriateness of studies assembled for assessing the hypothesis to be tested
Rationale for the selection and coding of data (e.g., sound clinical principles or convenience)
Documentation of how data were classified and coded (e.g., multiple raters, blinding, and interrater reliability)
Assessment of confounding (e.g., comparability of cases and controls in studies where appropriate)
Assessment of study quality, including blinding of quality assessors; stratification or regression on possible predictors of study results
Assessment of heterogeneity
Description of statistical methods (e.g., complete description of fixed or random effects models, justification of whether the chosen models account for predictors of study results, dose-response models, or cumulative meta-analyses) in sufficient detail to be replicated
Provision of appropriate tables and graphics
Reporting of results should include
Graphic summarizing individual study estimates and overall estimate
Table giving descriptive information for each study included
Results of sensitivity testing (e.g., subgroup analysis)
Indication of statistical uncertainty findings
Reporting of discussion should include
Quantitative assessment of bias (e.g., publication bias)
Justification for exclusion (e.g., exclusion of non-English-language citations)
Assessment of quality of included studies
Reporting of conclusions include
Consideration of alternative explanations for observed results
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Generalization of the conclusions (i.e., appropriate for the data presented and within the domain of the literature review)
Guidelines for future research
Disclosure of funding source
Reprinted, with permission, from JAMA 2000, 283:2008-2012. Copyright 2000 by American Medical Association. All rights reserved.
REFERENCES
Cochrane Collaboration. 2006. Revising the QUOROM Statement. Cochrane News 37 http://www.cochrane.org/newslett/CochraneNews37lores.pdf (accessed September 12, 2007).
Moher, D., D. J. Cook, S. Eastwood, I. Olkin, D. Rennie, D. F. Stroup, and the QUOROM Group. 1999. Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement. Lancet 354:1896-1900.
PLoS editors. 2007. Many reviews are systematic but some are more transparent and completely reported than others. PLoS Medicine 4(3):e147.
Stroup, D. F., J. A. Berlin, S. C. Morton, I. Olkin, G. D. Williamson, D. Rennie, D. Moher, B. J. Becker, T. A. Sipe, S. B. Thacker, and the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) Group. 2000. Meta-analysis of observational studies in epidemiology: A proposal for reporting. JAMA 283(15):2008-2012.
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