Table 2.

CONSORT 2010 Checklist of Information to Include When Reporting a Randomized Trial

Section/Topic	Item No	Checklist Item	Reported on Page No
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)	— — —
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 analysed	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 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 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	— — —

Reproduced with permission from BMJ.³⁷