Additional file 3.
CONSORT 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 | 1-2 | |
| 1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 1-2 | |
| Introduction | |||
| Background and | 2a | Scientific background and explanation of rationale | 2 |
| objectives | 2b | Specific objectives or hypotheses | 3 |
| Methods | |||
| Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 3 |
| 3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 3 | |
| Participants | 4a | Eligibility criteria for participants | 3 |
| 4b | Settings and locations where the data were collected | 3 | |
| Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 6 |
| Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they | 6 |
| were assessed | |||
| 6b | Any changes to trial outcomes after the trial commenced, with reasons | 3 | |
| Sample size | 7a | How sample size was determined | 3 |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines | 3 | |
| Randomisation: | |||
| Sequence | 8a | Method used to generate the random allocation sequence | 3 |
| generation | 8b | Type of randomisation; details of any restriction (such as blocking and block size) | 4 |
| Allocation | 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 | 4 |
| concealment | |||
| mechanism | |||
| Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 4 |
| Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 4 |
| 11b | If relevant, description of the similarity of interventions | 7 | |
| Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | 7 |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 7 | |
| Results | |||
| Participant flow (a diagram is strongly | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 5 |
| recommended) | 13b | For each group, losses and exclusions after randomisation, together with reasons | 7 |
| Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 7 |
| 14b | Why the trial ended or was stopped | 7 | |
| Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 8 |
| Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 9 |
| 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) | 10 |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 11 | |
| Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing | 12 |
| pre-specified from exploratory | |||
| Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 13 |
| Discussion | |||
| Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 16 |
| Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | 14 |
| Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 15 |
| Other information | |||
| Registration | 23 | Registration number and name of trial registry | 16 |
| Protocol | 24 | Where the full trial protocol can be accessed, if available | 16 |
| Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 16 |