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Criteria | Item | Description | Number of positive trials | % | Cohen’s к coefficient | 95% CI |
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Title and abstract | 1a | Identification as a randomized trial in the title | 15 | 14.71 | 1.00 | 1.00 |
1b | Structured abstract including trial design, methods, results, and conclusions | 102 | 100 | 1.00 | 1.00 |
Background and objectives |
Introduction | 2a | Scientific background and explanation of rationality | 98 | 96.08 | 0.85 | 0.57 to 1.13 |
2b | Specific objectives or hypotheses | 102 | 100 | 1.00 | 1.00 |
Trial design |
Methods | 3a | Description of trial design | 102 | 100 | 0.66 | 0.04 to 1.28 |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 0 | 0 | 1.00 | 1.00 |
Participants |
| 4a | Eligibility criteria for participants | 102 | 100 | 1.00 | 1.00 |
4b | Settings and locations where the data were collected | 100 | 98.04 | 0.66 | 0.04 to 1.28 |
Interventions |
| 5 | Interventions for each group with sufficient details to allow replication | 101 | 99.02 | 1.00 | 1.00 |
5a | Procedure for tailoring the interventions to participants | 102 | 100 | 1.00 | 1.00 |
5b | Details of whether and how the interventions were standardized | 12 | 11.76 | 0.77 | 0.59 to 0.95 |
5c | Adherence of researchers to the protocol: whether they adhere to it and how to assess that | 5 | 4.90 | 0.7 | 0.42 to 0.98 |
5d | Adherence of participants to the intervention: whether they adhere to it and how to assess that | 0 | 0 | 1.00 | 1.00 |
Outcomes |
| 6a | Precisely defined prespecified primary and secondary outcome measures | 87 | 85.29 | 0.84 | 0.69 to 0.99 |
6b | Any changes to trial outcomes after trial commencement with reasons | 1 | 0.98 | 1.00 | 1.00 |
Sample size |
| 7a | How sample size was determined | 14 | 13.73 | 0.87 | 0.73 to 1.01 |
7b | Explanation of interim analyses and suspension principles | 17 | 16.67 | 0.73 | 0.57 to 0.89 |
Sequence generation |
Randomization | 8a | Method used to generate the random allocation sequence | 69 | 67.65 | 0.87 | 0.77 to 0.97 |
8b | Type of randomization with details of any restriction | 4 | 3.92 | 0.66 | 0.22 to 1.10 |
Allocation concealment mechanism |
| 9 | Description of the method used to implement the random allocation sequence (such as sequentially numbered containers), assuring concealment until interventions were assigned | 34 | 33.33 | 0.91 | 0.82 to 1.00 |
Implementation |
| 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned intervention to participants | 10 | 9.80 | 0.95 | 0.86 to 1.04 |
Blinding |
| 11a | If done, who was blinded and how | 23 | 22.55 | 0.89 | 0.79 to 0.99 |
11b | If relevant, description of the similarity of interventions | 9 | 8.82 | 0.8 | 0.61 to 0.99 |
11c | If blinding was not possible, description of attempts to limit bias | 7 | 6.86 | 0.82 | 0.58 to 1.06 |
Statistical methods |
| 12a | Statistical methods used to compare groups for primary and secondary outcomes | 100 | 98.04 | 0.69 | 0.43 to 0.95 |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 2 | 1.96 | 1.00 | 1.00 |
Participant flow |
Results | 13a | For each group, the numbers of participants randomly assigned, received intended treatment, and analyzed for the outcome indicator | 102 | 100 | 1.00 | 1.00 |
13b | For each group, the number of losses and exclusions after randomization with reasons | 33 | 32.35 | 0.91 | 0.84 to 0.98 |
13c | For each group, report of the delay from randomization to the initiation of the intervention | 4 | 3.92 | 0.85 | 0.57 to 1.13 |
Recruitment |
| 14a | Periods of recruitment and follow-up | 55 | 53.92 | 0.85 | 0.75 to 0.95 |
14b | Why the trial suspended | 0 | 00 | 1.00 | 1.00 |
Baseline data |
| 15 | A table showing baseline demographic and clinical characteristics for each group | 62 | 60.78 | 1.00 | 1.00 |
Numbers analyzed |
| 16 | The number of participants in each group included in each analysis and whether they were analyzed according to the original grouping | 102 | 100 | 1.00 | 1.00 |
Outcomes and estimation |
| 17a | The results of primary and secondary outcome indicators, the estimated value of effect size and its accuracy | 5 | 4.90 | 0.88 | 0.65 to 1.11 |
17b | For dichotomous outcomes, recommendation to provide both absolute and relative effect values | 0 | 0 | 1.00 | 1.00 |
Ancillary analyses |
| 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified analysis from exploratory one | 2 | 1.96 | 1.00 | 1.00 |
Harms |
| 19 | All important harms or unintended effects in each group | 45 | 44.12 | 0.96 | 0.91 to 1.01 |
Limitations |
Discussion | 20 | Report of potential source of bias, imprecision, and multiple analyses | 47 | 46.08 | 0.9 | 0.82 to 0.98 |
Generalizability |
| 21 | Generalizability (external validity, applicability) of the trial findings | 65 | 63.73 | 0.88 | 0.79 to 0.97 |
Interpretation |
| 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 50 | 49.02 | 0.89 | 0.80 to 0.98 |
Registration |
Other information | 23 | Registration number and name of trial registry | 12 | 11.76 | 1.00 | 1.00 |
Protocol |
| 24 | Where the full-trial protocol can be accessed, if available | 36 | 35.29 | 1.00 | 1.00 |
Funding |
| 25 | Sources of funding and other support (such as supply of drugs) and role of funders | 47 | 46.08 | 1.00 | 1.00 |
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