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CONSORT Checklist
Title and Abstract
- Identification as a randomised trial in the title
- Structured summary of trial design, methods, results, and conclusions
Introduction
- Scientific background and explanation of rationale
- Specific objectives or hypotheses
Methods - Trial Design
- Description of trial design (parallel, factorial) including allocation ratio
- Important changes to methods after trial commencement with reasons
Methods - Participants
- Eligibility criteria for participants
- Settings and locations where data were collected
Methods - Interventions
- Interventions for each group with sufficient details to allow replication
- How and when they were actually administered
Methods - Outcomes
- Completely defined pre-specified primary and secondary outcome measures
- Any changes to trial outcomes after the trial commenced with reasons
Methods - Sample Size
- How sample size was determined
- When applicable, explanation of any interim analyses and stopping guidelines
Methods - Randomisation
- Method used to generate random allocation sequence
- Type of randomisation; details of any restriction
- Mechanism used to implement random allocation sequence
- Who generated sequence, who enrolled, who assigned participants
Methods - Blinding
- If done, who was blinded after assignment to interventions
- Description of the similarity of interventions
Methods - Statistical Methods
- Statistical methods used to compare groups for primary and secondary outcomes
- Methods for additional analyses, such as subgroup and adjusted analyses
Results - Participant Flow
- For each group, numbers of participants randomly assigned, received intended treatment, and analysed
- For each group, losses and exclusions after randomisation with reasons
Results - Baseline Data
- A table showing baseline demographic and clinical characteristics for each group
Results - Outcomes and Estimation
- For each primary and secondary outcome, results for each group and estimated effect size with confidence interval
- For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Discussion
- Trial limitations, addressing sources of potential bias, imprecision
- Generalisability of the trial findings
- Interpretation consistent with results, balancing benefits and harms
Other Information
- Registration number and name of trial registry
- Where the full trial protocol can be accessed
- Sources of funding and other support