Showing all 42 criteria.
Title and abstract Title and structured abstract 1a Title and structured abstract 1a Identification as a randomised trial1b 1b Structured summary of the trial design, methods, results, and conclusions
Open science Trial registration 2 Trial registration 2 Name of trial registry, identifying number (with URL) and date of registrationProtocol and statistical analysis plan 3 Protocol and statistical analysis plan 3 Where the trial protocol and statistical analysis plan can be accessedData sharing 4 Data sharing 4 Where and how the individual de-identified participant data (including data dictionary), statistical code and any other materials can be accessedFunding and conflicts of interest 5a Funding and conflicts of interest 5a Sources of funding and other support (e.g., supply of drugs), and role of funders in the design, conduct, analysis and reporting of the trial5b 5b Financial and other conflicts of interest of the manuscript authors
Introduction Background and rationale 6 Background and rationale 6 Scientific background and rationaleObjectives 7 Objectives 7 Specific objectives related to benefits and harms
Methods Patient and public involvement 8 Patient and public involvement 8 Details of patient or public involvement in the design, conduct and reporting of the trialTrial design 9 Trial design 9 Description of trial design including type of trial (e.g., parallel group, crossover), allocation ratio, and framework (e.g., superiority, equivalence, non-inferiority, exploratory)Changes to trial protocol 10 Changes to trial protocol 10 Important changes to the trial after it commenced including any outcomes or analyses that were not prespecified, with reasonTrial setting 11 Trial setting 11 Settings (e.g., community, hospital) and locations (e.g., countries, sites) where the trial was conductedEligibility criteria 12a Eligibility criteria 12a Eligibility criteria for participants12b 12b If applicable, eligibility criteria for sites and for individuals delivering the interventions (e.g., surgeons, physiotherapists)Intervention and comparator 13 Intervention and comparator 13 Intervention and comparator with sufficient details to allow replication. If relevant, where additional materials describing the intervention and comparator (e.g., intervention manual) can be accessedOutcomes 14 Outcomes 14 Pre-specified primary and secondary outcomes, including the specific measurement variable (e.g., systolic blood pressure), analysis metric (e.g., change from baseline, final value, time to event), method of aggregation (e.g., median, proportion), and time point for each outcomeHarms 15 Harms 15 How harms were defined and assessed (e.g., systematically, non-systematically)Sample size 16a Sample size 16a How sample size was determined, including all assumptions supporting the sample size calculation16b 16b Explanation of any interim analyses and stopping guidelinesRandomisation: sequence generation 17a Randomisation: sequence generation 17a Who generated the random allocation sequence and the method used17b 17b Type of randomisation and details of any restriction (e.g., stratification, blocking and block size)Allocation concealment mechanism 18 Allocation concealment mechanism 18 Mechanism used to implement the random allocation sequence (e.g., central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions were assignedImplementation 19 Implementation 19 Whether the personnel who enrolled and those who assigned participants to the interventions had access to the random allocation sequenceBlinding 20a Blinding 20a Who was blinded after assignment to interventions (e.g., participants, care providers, outcome assessors, data analysts)20b 20b If blinded, how blinding was achieved and description of the similarity of interventionsStatistical methods 21a Statistical methods 21a Statistical methods used to compare groups for primary and secondary outcomes, including harms21b 21b Definition of who is included in each analysis (e.g., all randomised participants), and in which group21c 21c How missing data were handled in the analysis21d 21d Methods for any additional analyses (e.g., subgroup and sensitivity analyses), distinguishing prespecified from post-hoc
Results Participant flow, including flow diagram 22a Participant flow, including flow diagram 22a For each group, the numbers of participants who were randomly assigned, received intended intervention, and were analysed for the primary outcome22b 22b For each group, losses and exclusions after randomisation, together with reasonsRecruitment 23a Recruitment 23a Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms23b 23b If relevant, why the trial ended or was stoppedIntervention and comparator delivery 24a Intervention and comparator delivery 24a Intervention and comparator as they were actually administered (e.g., where appropriate, who delivered the intervention/comparator, whether participants adhered, whether they were delivered as intended [fidelity])24b 24b Concomitant care received during the trial for each groupBaseline data 25 Baseline data 25 A table showing baseline demographic and clinical characteristics for each groupNumbers analysed, outcomes and estimation 26 Numbers analysed, outcomes and estimation 26 For each primary and secondary outcome, by group: the number of participants included in the analysis; the number with available data at the outcome time point; a result for each group, and the estimated effect size and its precision (such as 95% confidence interval); for binary outcomes, presentation of both absolute and relative effect sizeHarms 27 Harms 27 All harms or unintended events in each groupAncillary analyses 28 Ancillary analyses 28 Any other analyses performed, including subgroup and sensitivity analyses, distinguishing pre-specified from post-hoc
Discussion Interpretation 29 Interpretation 29 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidenceLimitations 30 Limitations 30 Trial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analysesCONSORT 2025 checklist items reproduced from the published guideline . Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 Statement: updated guideline for reporting randomised trials. BMJ. 2025;388:e081123. CC BY 4.0.