Criterion | CONSORT item | Frequency | % |
---|---|---|---|
1a | Identification as a randomized trial in the title | 80 | 44.0% |
1b | Structured summary of trial design, methods, results, and conclusions | 5 | 2.7% |
2a | Scientific background and explanation of rationale | 182 | 100% |
2b | Specific objectives or hypotheses | 182 | 100% |
3a | Description of trial design (such as parallel, factorial) including allocation ratio | 182 | 100% |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 3 | 100% |
4a | Eligibility criteria for participants | 168 | 92.3% |
4b | Settings and locations where the data were collected | 140 | 76.9 |
5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 181 | 99.5% |
6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 77 | 42.3% |
6b | Any changes to trial outcomes after the trial commenced, with reasons | 1 | 100% |
7a | How sample size was determined | 74 | 40.6% |
7b | When applicable, explanation of any interim analyses and stopping guidelines | 2 | 100% |
8a | Method used to generate the random allocation sequence | 106 | 58.6% |
8b | Type of randomization; details of any restriction (such as blocking and block size) | 45 | 24.7% |
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 | 113 | 62.1% |
10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 12 | 6.6% |
11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 108 | 59.7% |
11b | If relevant, description of the similarity of interventions | 54 | 32.3% |
12a | Statistical methods used to compare groups for primary and secondary outcomes | 176 | 96.7% |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 23 | 88.5% |
13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | 171 | 94.0% |
13b | For each group, losses and exclusions after randomization, together with reasons | 146 | 80.2% |
14a | Dates defining the periods of recruitment and follow-up | 96 | 52.7% |
14b | Why the trial ended or was stopped | 1 | 100% |
15 | A table showing baseline demographic and clinical characteristics for each group | 132 | 72.5% |
16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 164 | 90.1% |
17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 59 | 32.4% |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 13 | 41.9% |
18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 7 | 6.5% |
19 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 138 | 78.0% |
20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 109 | 59.9% |
21 | Generalizability (external validity, applicability) of the trial findings | 59 | 32.4% |
22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 175 | 96.2% |
23 | Registration number and name of trial registry | 19 | 10.4% |
24 | Where the full trial protocol can be accessed, if available | 7 | 3.8% |
25 | Sources of funding and other support (such as supply of drugs), role of funders | 156 | 85.7% |