CONSORT checklist for randomised controlled trials
| Heading | Subheading | Descriptor | Was it reported? | On what page No? |
| Title | Identify the study as a randomised trial | |||
| Abstract | Use a structured format | |||
| Introduction | State prospectively defined hypothesis, clinical objectives, and planned subgroup or covariate analyses | |||
| Methods | Protocol | Describe | ||
| Planned study population, together with inclusion/exclusion criteria | ||||
| Planned interventions and their timing | ||||
| Primary and secondary outcome measure(s) and the minimum important differences(s), and indicate how the target sample size was projected | ||||
| Rationale and methods for statistical analyses, detailing main comparative analyses and whether they were completed on an intention-to-treat basis | ||||
| Prospectively defined stopping rules (if warranted) | ||||
| Assignment | Describe | |||
| Unit of randomisation (eg, individual, cluster, geographic) | ||||
| Method used to generate the allocation schedule | ||||
| Method of allocation concealment and timing of assignment | ||||
| Method to separate the generator from the executor of assignment | ||||
| Masking (blinding) | Describe mechanism (eg, capsules, tablets); similarity of treatment characteristics (eg, appearance, taste); allocation schedule control (location of code during trial and when broken); and evidence for successful blinding among participants, person doing intervention, outsome assessors, and data analysts. | |||
| Results | Participant flow and follow up | Provide a trial profile (figure) summarising participant flow, numbers, and timing of randomisationassignment, interventions, and measurements for each randomised group | ||
| Analysis | State estimated effect of intervention on primary and secondary outcome measures, including a point estimate and measure of precision (confidence interval) | |||
| State results in absolute numbers when feasible (eg, 10/20, not 50%) | ||||
| Present summary data and appropriate descriptive and inferential statisitics in sufficient detail to permit alternative analyses and replication | ||||
| Describe prognostic variables by treatment group and any attempt to adjust for them | ||||
| Describe protocol deviations from the study as planned, together with the reasons | ||||
| Comment | State specific interpretation of study findings, including sources of bias and imprecision (internal validity) and discussion of external validity, including appropriate quantitative measures when possible | |||
| State general interpretation of the data in light of the totality of the available evidence |