Section/Topic | Item No | Checklist item | Reported on page No |
---|---|---|---|
Title and abstract | |||
 | 1a | Identification as a randomised trial in the title | N/Y |
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 1 | |
Introduction | |||
  Background and objectives | 2a | Scientific background and explanation of rationale | 1–3 |
2b | Specific objectives or hypotheses | 3 | |
Methods | |||
  Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 4 |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 4 | |
  Participants | 4a | Eligibility criteria for participants | 4 |
4b | Settings and locations where the data were collected | 3–4 | |
  Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 5–6 |
  Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 6 |
6b | Any changes to trial outcomes after the trial commenced, with reasons | N/Y | |
  Sample size | 7a | How sample size was determined | 5 |
7b | When applicable, explanation of any interim analyses and stopping guidelines | N/Y | |
Randomisation: | |||
  Sequence generation | 8a | Method used to generate the random allocation sequence | 5 |
8b | Type of randomisation; details of any restriction (such as blocking and block size) | N/Y | |
  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 | 5 |
  Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 5 |
  Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | N/Y |
11b | If relevant, description of the similarity of interventions | N/Y | |
  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 recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 7 |
13b | For each group, losses and exclusions after randomisation, together with reasons | 7 | |
  Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 7–8 |
14b | Why the trial ended or was stopped | N/Y | |
  Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | 7–8 |
  Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 7–8 |
  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) | 7–8 |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | N/Y | |
  Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | N/Y |
  Harms | 19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | N/Y |
Discussion | |||
  Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 10 |
  Generalisability | 21 | Generalisability (external validity, applicability) of the trial findings | 8 |
  Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 8–10 |
Other information | 9–10 | ||
  Registration | 23 | Registration number and name of trial registry | 12 |
  Protocol | 24 | Where the full trial protocol can be accessed, if available | 6 |
  Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 12 |