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CONSORT 2010 checklist of information to include when reporting a randomised trial*Section/TopicItem NoChecklist itemReported on page NoTitle and abstract1aIdentification as a randomised trial in the title1bStructured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)IntroductionBackground and objectives2aScientific background and explanation of rationale2bSpecific objectives or hypothesesMethodsTrial design3aDescription of trial design (such as parallel, factorial) including allocation ratio3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasonsParticipants4aEligibility criteria for participants4bSettings and locations where the data were collectedInterventions5The interventions for each group with sufficient details to allow replication, including how and when they were actually administeredOutcomes6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessed6bAny changes to trial outcomes after the trial commenced, with reasonsSample size7aHow sample size was determined7bWhen applicable, explanation of any interim analyses and stopping guidelinesRandomisation:Sequence generation8aMethod used to generate the random allocation sequence8bType of randomisation; details of any restriction (such as blocking and block size)Allocation concealment mechanism9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assignedImplementation10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventionsBlinding11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how11bIf relevant, description of the similarity of interventionsStatistical methods12aStatistical methods used to compare groups for primary and secondary outcomes12bMethods for additional analyses, such as subgroup analyses and adjusted analysesResultsParticipant flow (a diagram is strongly recommended)13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome13bFor each group, losses and exclusions after randomisation, together with reasonsRecruitment14aDates defining the periods of recruitment and follow-up14bWhy the trial ended or was stoppedBaseline data15A table showing baseline demographic and clinical characteristics for each groupNumbers analysed16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groupsOutcomes and estimation17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommendedAncillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratoryHarms19All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)DiscussionLimitations20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analysesGeneralisability21Generalisability (external validity, applicability) of the trial findingsInterpretation22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidenceOther informationRegistration23Registration number and name of trial registryProtocol24Where the full trial protocol can be accessed, if availableFunding25Sources of funding and other support (such as supply of drugs), role of funders*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
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