This document outlines the 25 item CONSORT 2010 checklist for reporting randomized controlled trials. The checklist includes key items such as trial design, methods, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods, results, limitations, interpretation, and other information. Adhering to this checklist ensures randomized trials are fully reported to allow for critical appraisal and replication.
This document outlines the 25 item CONSORT 2010 checklist for reporting randomized controlled trials. The checklist includes key items such as trial design, methods, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods, results, limitations, interpretation, and other information. Adhering to this checklist ensures randomized trials are fully reported to allow for critical appraisal and replication.
This document outlines the 25 item CONSORT 2010 checklist for reporting randomized controlled trials. The checklist includes key items such as trial design, methods, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods, results, limitations, interpretation, and other information. Adhering to this checklist ensures randomized trials are fully reported to allow for critical appraisal and replication.
This document outlines the 25 item CONSORT 2010 checklist for reporting randomized controlled trials. The checklist includes key items such as trial design, methods, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods, results, limitations, interpretation, and other information. Adhering to this checklist ensures randomized trials are fully reported to allow for critical appraisal and replication.
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Consort 2010 checklist of information toinclude when reporting a randomised trial
Section/Topi Item Checklist item Reporte
c d on page No No 688 Title and abstract 1a Identification as a randomised trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see 688 CONSORT for abstracts)
Introduction 688 Background 2a Scientific background and explanation of and rationale objectives 2b Specific objectives or hypotheses 689
Methods Trial design Description of trial design (such as parallel, 3a factorial) including allocation ratio 689 3b Important changes to methods after trial - commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 689 4b Settings and locations where the data were 689 collected Interventions 5 The interventions for each group with 689 sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined pre-specified primary 691 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 689 7b When applicable, explanation of any interim 691 analyses and stopping guidelines Randomisation : Sequence 8a Method used to generate the random 689 allocation sequence Generation 8b Type of randomisation; details of any restriction (such as blocking and block size) - Allocation 9 Mechanism used to implement the random - allocation sequence (such as sequentially numbered containers), Concealment describing any steps taken to conceal the 689 sequence until interventions were assigned Mechanism Implementatio 10 Who generated the random allocation 689 n sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment 689 to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the similarity of 692 interventions Statistical 12a Statistical methods used to compare groups 691 methods for primary and secondary outcomes 12b Methods for additional analyses, such as - subgroup analyses and adjusted analyses Results 689 Participant 13a For each group, the numbers of participants flow (a who were randomly assigned, received intended treatment, and diagram is were analysed for the primary outcome 692 strongly recommende 13b For each group, losses and exclusions after 692 d) randomisation, 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 691 clinical characteristics for each group Numbers 16 For each group, number of participants 691 analysed (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes 17a For each primary and secondary outcome, 692 and results for each group, and the estimated effect size and its estimation precision (such as 95% confidence interval) 690 17b For binary outcomes, presentation of both 692 absolute and relative effect sizes is recommended Ancillary 18 Results of any other analyses performed, 692 analyses including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Harms 19 All important harms or unintended effects in - each group (for specific guidance see CONSORT for harms) Discussion Limitations 20 Trial limitations, addressing sources of 690 potential bias, imprecision, and, if relevant, multiplicity of analyses Generalability 21 General ability (external validity, 693 applicability) of the trial findings Interpretation 22 Interpretation consistent with results, 693 balancing benefits and harms, and considering other relevant evidence Other - information 23 Registration number and name of trial Registration registry Protocol 24 Where the full trial protocol can be 693 accessed, if available Funding 25 Sources of funding and other support 693 (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.
