CONSORT 2010 checklist of information to include when reporting a randomised trial* Item Reported Section/Topic No Checklist item on page No Title and abstract 1a Identification as a randomised trial in the title 1 1b Structured summary of trial design, methods, results, and conclusions 3-4 (for specific guidance see CONSORT for abstracts) Introduction Background and 2a Scientific background and explanation of rationale 5-6 objectives 2b Specific objectives or hypotheses 5-6 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 7-8 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 7 4b Settings and locations where the data were collected 7-8 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were 7-8 actually administered Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they 7-11 were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7-8 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation: Sequence 8a Method used to generate the random allocation sequence 7-8 generation 8b Type of randomisation; details of any restriction (such as blocking and block size) 8 Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), 8 concealment describing any steps taken to conceal the sequence until interventions were assigned mechanism Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 8 interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those
CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Item No Checklist item Reported on page No Title and abstract 1a Identification as a randomised trial in the title 1 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 3-4 Introduction Background and objectives 2a Scientific background and explanation of rationale 5-6 2b Specific objectives or hypotheses 5-6 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 7-8 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 7 4b Settings and locations where the data were collected 7-8 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 7-8 Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 7-11 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7-8 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation: Sequence generation 8a Method used to generate the random allocation sequence 7-8 8b Type of randomisation; details of any restriction (such as blocking and block size) 8 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 8 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 8 Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those