Item | Criteria | Description | Number of positive trialsa | Percentage | Cohen’s к coefficient | 95% CI |
---|---|---|---|---|---|---|
1 | “Randomized” in the title or abstract | Study identified as a randomized controlled in the title or abstract | 25 | 96 | 1.00 | 1.00 |
2 | Background | Adequate description of the scientific background and explanation of rationale | 14 | 54 | 0.68 | 0.39 to 0.97 |
3 | Trial design | Description of trial design (such as parallel, factorial) including allocation ratio | 2 | 8 | 1.00 | 1.00 |
4 | Participants | Description of the eligibility criteria for participants | 26 | 100 | 1.00 | 1.00 |
5 | Interventions | Details of the interventions intended for each group | 26 | 100 | 1.00 | 1.00 |
6 | Outcomes | Definition of primary (and secondary when appropriate) outcome measures | 19 | 73 | 0.78 | 0.49 to 1.07 |
7 | Sample size | Description of sample size calculation | 1 | 4 | 0.65 | -0.03 to 1.32 |
12 | Statistical methods | Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses, or adjusted analyses | 23 | 88 | 0.78 | 0.36 to 1.20 |
13 | Flow chart | Details on the flow of participants through each stage of the trials (number of patients randomly assigned, receiving intended treatment, completing the protocol and analyzed) | 22 | 85 | 0.62 | 0.12 to 1.12 |
14 | Recruitment | Dates defining the periods of recruitment and follow up | 21 | 81 | 0.71 | 0.32 to 1.10 |
17 | Outcomes and estimation | For each primary and secondary outcome, a summary of results for each group is given, and the estimated effect size and its precision (for example, 95% CI) | 20 | 77 | 0.75 | 0.42 to 1.08 |
18 | Ancillary analyses | Clear statement of whether subgroup/adjusted analyses were prespecified or exploratory | 0 | 0 | 1.00 | 1.00 |
19 | Harms | Description of all important adverse events in each group | 2 | 8 | 0.63 | 0.13 to 1.12 |