CONSORT 2010 Statement ACADEMIA AND CLINIC Zable.CONSORT 2010 Checklist of Information to Include When Reporting a Randomized Trial be Page Numbe Tite and abstract 21.31 and wmioen Participants ticipants Interventions mary and s udin Whn applicablextion ofany inrim analyses and stopping guidines Allocation concealment mechanism bing any steps t eal the ssigne Implementation 10 atio nce.who ervolled participants.and Binding 11a Statistical methods 13a for each Recruitment yedoeoehewit or was stopp 6 g ba er t Outcomes and estimation 17a 95%c 18 Harms 19 20 t evidenc RegOC nd y Funding CONTable. CONSORT 2010 Checklist of Information to Include When Reporting a Randomized Trial* Section/Topic Item Number Checklist Item Reported on Page Number Title and abstract 1a Identification as a randomized trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance, see CONSORT for abstracts [21, 31]) Introduction Background and objectives 2a Scientific background and explanation of rationale 2b Specific objectives or hypotheses Methods Trial design 3a Description of trial design (such as parallel, factorial), including allocation ratio 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomization Sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomization; details of any restriction (such as blocking and block size) Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the similarity of interventions Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome 13b For each group, losses and exclusions after randomization, together with reasons Recruitment 14a Dates defining the periods of recruitment and follow-up 14b Why the trial ended or was stopped Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Numbers analyzed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms [28]) Discussion Limitations 20 Trial limitations; addressing sources of potential bias; imprecision; and, if relevant, multiplicity of analyses Generalizability 21 Generalizability (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol can be accessed, if available Funding 25 Sources of funding and other support (such as supply of drugs), role of funders CONSORT
Consolidated Standards of Reporting Trials. * We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration (13) for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomized trials (11), noninferiority and equivalence trials (12), nonpharmacologic treatments (32), herbal interventions (33), and pragmatic trials (34). Additional extensions are forthcoming: For those and for up-to-date references relevant to this checklist, see www.consort-statement.org. CONSORT 2010 Statement Academia and Clinic www.annals.org 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 727