Consolidation of standards for reporting trials–CONSORT
| Heading | Subheading | Descriptor | Was it reported? |
|---|---|---|---|
| Title | Identify the study as a randomised trial | ||
| Abstract | Use a structured formal | ||
| 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 difference(s) and indicate how the target sample size was projected | |||
| Rationale and methods for statistical analyses, detailing comparative analyses and whether they were completed on an intention to treat basis | |||
| Prospectively defined stopping rules (it 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, outcome assessors, and data analysts | ||
| Results | |||
| Participant flow and follow up | Provide a trial profile (fig) summarising participant flow, numbers and timing of randomisation assignment, interventions, and measurements for each randomised group | ||
| Analysis | State estimated effect 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 statistics 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 (eternal 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 | |||