Checklist for reporting a randomised trial

Identification as a randomized trial in the title. Read more

Structured summary of trial design, methods, results, and conclusions. Read more

Scientific background and explanation of rationale. Read more

Specific objectives or hypothesis. Read more

Description of trial design (such as parallel, factorial) including allocation ratio. Read more

Important changes to methods after trial commencement (such as eligibility criteria), with reasons. Read more

Eligibility criteria for participants. Read more

Settings and locations where the data were collected. Read more

The experimental and control interventions for each group with sufficient details to allow replication, including how and when they were actually administered. Read more

Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed. Read more

Any changes to trial outcomes after the trial commenced, with reasons. Read more

How sample size was determined. Read more

When applicable, explanation of any interim analyses and stopping guidelines. Read more

Method used to generate the random allocation sequence. Read more

Type of randomization; details of any restriction (such as blocking and block size). Read more

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. Read more

Who generated the allocation sequence, who enrolled participants, and who assigned participants to interventions. Read more

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how. Read more

If relevant, description of the similarity of interventions. Read more

Statistical methods used to compare groups for primary and secondary outcomes. Read more

Methods for additional analyses, such as subgroup analyses and adjusted analyses. Read more

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome. Read more

For each group, losses and exclusions after randomization, together with reason. Read more

Dates defining the periods of recruitment and follow-up. Read more

Why the trial ended or was stopped. Read more

A table showing baseline demographic and clinical characteristics for each group. Read more

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups. Read more

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval). Read more

For binary outcomes, presentation of both absolute and relative effect sizes is recommended. Read more

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory. Read more

All important harms or unintended effects in each group (For specific guidance see CONSORT for harms). Read more

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses. Read more

Generalisability (external validity, applicability) of the trial findings. Read more

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence. Read more

Registration number and name of trial registry. Read more

Where the full trial protocol can be accessed, if available. Read more

Sources of funding and other support (such as supply of drugs), role of funders. Read more