Table 1 Overall quality score of reporting using items from the CONSORT statement (n = 63)
Item | Criteria | Description | Number of positive trials | % | Cohen’s к coefficient | 95% CI |
|---|---|---|---|---|---|---|
1 | ‘Randomized’ in The title or abstract | Study identified as a randomized controlled in the title or abstract | 63 | 100 | 1.00 | 1.00 |
2 | Background | Adequate description of the scientific background and explanation of rationale | 17 | 27 | 0.82 | 0.66 to 0.97 |
3 | Trial design | Description of trial design (such as parallel, factorial) including allocation ratio | 4 | 6 | 1.00 | 1.00 |
4 | Participants | Description of the eligibility criteria for participants | 50 | 79 | 0.58 | 0.28 to 0.87 |
5 | Interventions | Details of the interventions intended for each group | 54 | 86 | 0.77 | 0.52 to 1.02 |
6 | Outcomes | Definition of primary (and secondary when appropriate) outcome measures | 49 | 78 | 0.79 | 0.60 to 0.99 |
7 | Sample size | Description of sample size calculation | 1 | 2 | 1.00 | 1.00 |
12 | Statistical methods | Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses, or adjusted analyses | 49 | 78 | 0.85 | 0.69 to 1.02 |
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) | 59 | 84 | 0.85 | 0.56 to 1.14 |
14 | Recruitment | Dates defining the periods of recruitment and follow-up | 38 | 60 | 0.59 | 0.37 to 0.81 |
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) | 53 | 84 | 0.71 | 0.44 to 0.99 |
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 | 3 | 1.00 | 1.00 |