Table 1.
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 | ||
| 1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts [21,31]) | ||
| 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 pre-specified 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 | ||
| Randomisation: | |||
| Sequence generation | 8a | Method used to generate the random allocation sequence | |
| 8b | Type of randomisation; 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 analysed for the primary outcome | |
| 13b | For each group, losses and exclusions after 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 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 [28]) | |
| Discussion | |||
| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | |
| Generalisability | 21 | Generalisability (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 | |
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration [13] for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials [11], non-inferiority and equivalence trials [12], non-pharmacological treatments [32], herbal interventions [33], and pragmatic trials [34]. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see http://www.consort-statement.org.