Table 1 Overall quality of reporting rating using items from the CONSORT statement (n = 39)
Item | Criteria | Description | Number. of positive trials | % | 95% CI | Cohen’s к coefficient | 95% CI |
|---|---|---|---|---|---|---|---|
1 | ‘Randomized’ in the title or abstract | Study identified as a randomized controlled in the title or abstract | 36 | 92 | 84 to 100 | 1 | 1 |
2 | Background | Adequate description of the scientific background and explanation of rationale | 38 | 97 | 92 to 100 | 0.62 | 0.35 to 0.95 |
3 | Trial design | Description of trial design (such as parallel, factorial) including allocation ratio | 34 | 87 | 76 to 98 | 0.74 | 0.52 to 0.98 |
4 | Participants | Description of the eligibility criteria for participants | 36 | 92 | 84 to 100 | 0.92 | 0.83 to 1.00 |
5 | Interventions | Details of the interventions intended for each group | 35 | 90 | 80 to 100 | 0.63 | 0.42 to 0.98 |
6 | Outcomes | Definition of primary (and secondary when appropriate) outcome measures | 23 | 59 | 43 to 75 | 0.81 | 0.65 to 0.99 |
7 | Sample size | Description of sample size calculation | 19 | 49 | 32 to 65 | 0.78 | 0.54 to 0.97 |
12 | Statistical methods | Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses, or adjusted analyses | 29 | 74 | 60 to 89 | 0.68 | 0.43 to 0.96 |
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) | 21 | 54 | 37 to 70 | 0.93 | 0.85 to 1.00 |
14 | Recruitment | Dates defining the periods of recruitment and follow-up | 20 | 51 | 35 to 68 | 0.54 | 0.36 to 0.92 |
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 | 51 | 35 to 68 | 0.86 | 0.73 to 0.99 |
18 | Ancillary analyses | Clear statement of whether subgroup/adjusted analyses were prespecified or exploratory | 20 | 51 | 35 to 68 | 0.66 | 0.31 to 0.97 |
19 | Harms | Description of all important adverse events in each group | 16 | 41 | 25 to 57 | 0.73 | 0.62 to 0.96 |