CONSORT 2010 Checklist and percentage of articles that adequately report each CONSORT 2010 checklist item
| Title and abstract | ||
| 1a | Identification as a randomised trial in the title | 30.3% (23/33) |
| 1b | Structured summary of trial design, methods, results and conclusions (for specific guidance, see CONSORT for abstracts) | 9.1% (3/33) |
| Introduction | ||
| Background and objectives | ||
| 2a | Scientific background and explanation of rationale | 93.9% (31/33) |
| 2b | Specific objectives or hypotheses | 87.9% (29/33) |
| Methods | ||
| Trial design | ||
| 3a | Description of trial design (such as parallel, factorial) including allocation ratio | 42.4% (14/33) |
| 3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 100% (6/6) |
| Participants | ||
| 4a | Eligibility criteria for participants | 97% (32/33) |
| 4b | Settings and locations where the data were collected | 21.2% (7/33) |
| Interventions | ||
| 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 78.8% (26/33) |
| Outcomes | ||
| 6a | Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed | 66.7% (22/33) |
| 6b | Any changes to trial outcomes after the trial commenced, with reasons | NA (0/0)* |
| Sample size | ||
| 7a | How sample size was determined | 69.7% (23/33) |
| 7b | When applicable, explanation of any interim analyses and stopping guidelines | 100% (4/4) |
| Randomisation | ||
| Sequence generation | ||
| 8a | Method used to generate the random allocation sequence | 33.3% (11/33) |
| 8b | Type of randomisation; details of any restriction (such as blocking and block size) | 33.3% (11/33) |
| 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 | 12.1% (4/33) |
| Implementation | ||
| 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 21.2% (7/33) |
| Blinding | ||
| 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 32.3% (10/31) |
| 11b | If relevant, description of the similarity of interventions | 34.5% (10/29) |
| Statistical methods | ||
| 12a | Statistical methods used to compare groups for primary and secondary outcomes | 97.0% (32/33) |
| 12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 77.8% (14/18) |
| Results | ||
| Participant flow | ||
| 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 66.7% (22/33) |
| 13b | For each group, losses and exclusions after randomisation, together with reasons | 65.6% (21/32) |
| Recruitment | ||
| 14a | Dates defining the periods of recruitment and follow-up | 45.5% (15/33) |
| 14b | Why the trial ended or was stopped | 12.1% (4/33) |
| Baseline data | ||
| 15 | A table showing baseline demographic and clinical characteristics for each group | 90.9% (30/33) |
| Numbers analysed | ||
| 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 54.5% (18/33) |
| 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) | 39.4% (13/33) |
| 17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 0.0% (0/7) |
| Ancillary analyses | ||
| 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory | 68.8% (11/16) |
| Harms | ||
| 19 | All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms) | 53.1% (17/32) |
| Discussion | ||
| Limitations | ||
| 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 78.8% (26/33) |
| Generalisability | ||
| 21 | Generalisability (external validity, applicability) of the trial findings | 87.9% (29/33) |
| Interpretation | ||
| 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 97.0% (32/33) |
| Other information | ||
| Registration | ||
| 23 | Registration number and name of trial registry | 48.5% (16/33) |
| Protocol | ||
| 24 | Where the full trial protocol can be accessed, if available | 100.0% (13/13) |
| Funding | ||
| 25 | Sources of funding and other support (such as supply of drugs), role of funders | 36.4% (12/33) |