QUOROM Guidelines for Meta-Analyses and Systematic Reviews of RCTs*
Title Identify the study as a meta-analysis (or systematic review) of RCTs
Abstract Use the journal’s structured format
Introduction Present
- The clinical problem
- The biological rationale for the intervention
- The rationale for the review
- An explicit statement of objectives which includes the study population, the condition of interest, the exposure or intervention, and the outcome(s) considered
Sources Describe
- The information sources in detail (eg databases, registers, personal files, experts, agencies, hand-searching)
- Any restriction (years considered, publication status, language of publication)
Study Selection Describe
- Inclusion and exclusion criteria (defining population, intervention, main outcomes, and study design)
- How clinical heterogeneity was assessed
- Methods used for validity assessment
- The criteria and process used for validity assessment (eg, masked conditions, quality assessment)
- The data abstraction process (eg, completed independently, in duplicate)
- Study characteristics and how clinical heterogeneity was assessed
- The principal measures of effect (eg, relative risk)
- Method of combining results (statistical testing and confidence intervals)
- Handling of missing data
- How statistical heterogeneity was assessed
- Rationale for any a-priori sensitivity and subgroup analyses
Results Present
- A meta-analysis profile summarizing trial flow
- Descriptive data for each trial (study design, participant characteristics, sample size, details of intervention, outcome definitions, length of follow-up)
- Agreement on the selection and validity assessment
- Simple summary results (for each treatment group in each trial, for each primary outcome)
- Data needed to calculate effect sizes and confidence intervals in intention-to-treat analyses
Discussion Discuss
- Key findings
- Clinical inferences based on internal and external validity
- The results in light of the totality of available evidence
- Strengths and weaknesses
- Potential biases in the review process (eg, publication bias)
- Future research agenda
*Modified from Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999;354:1896–900.