Checklist of items to include when reporting a randomised trial (from the CONSORT statement)
| Paper section and topic | Description | |
|---|---|---|
| Title and abstract | How participants were allocated to interventions (for example, “random allocation,” “randomised,” or “randomly assigned”). | |
| Introduction | Background | Scientific background and explanation of rationale. |
| Methods | Participants | Eligibility criteria for participants and the settings and locations where the data were collected. |
| Interventions | Precise details of the interventions intended for each group and how and when they were actually administered. | |
| Objectives | Specific objectives and hypotheses. | |
| Outcomes | Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (for example, multiple observations, training of assessors). | |
| Sample size | How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules. | |
| Randomisation – sequence generation | Method used to generate the random allocation sequence, including details of any restriction (for example, blocking, stratification). | |
| Randomisation – allocation concealment | Method used to implement the random allocation sequence. (for example, numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned. | |
| Randomisation – implementation | Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups. | |
| Blinding (masking) | Whether or not participants, those giving the interventions, and those assessing the outcomes were blinded to group assignment. When relevant, how the success of blinding was evaluated. | |
| Statistical methods | Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses. | |
| Results | Participant flow | Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analysed for the primary outcome. Describe protocol deviations from study as planned, together with reasons. |
| Recruitment | Dates defining the periods of recruitment and follow up | |
| Baseline data | Baseline demographic and clinical characteristics of each group. | |
| Numbers analysed | Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention to treat”. State the results in absolute numbers when feasible (for example, 10/20, not 50%). | |
| Outcomes and estimation | For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (for example, 95% confidence interval). | |
| Ancillary analyses | Address multiplicity by reporting any other analyses undertaken, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory. | |
| Adverse events | All important adverse events or side effects in each intervention group. | |
| Discussion | Interpretation | Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes. |
| Generalisability | Generalisability (external validity) of the trial findings. | |
| Overall evidence | General interpretation of the results in the context of current evidence. | |