Table 1 Overall quality of reporting rating using items from the Consolidated Standards for Reporting Trials (CONSORT) statement (n = 246)
From: Quality of randomized controlled trials reporting in the treatment of melasma conducted in China
Item | Criteria | Description | Number of positive trials | % | Cohen’sкcoefficient | 95% CI |
|---|---|---|---|---|---|---|
1 | ‘Randomized’ in the title or abstract | Study identified as a randomized controlled in the title or abstract | 226 | 92 | 1 | 1 |
2 | Background | Adequate description of the scientific background and explanation of rationale | 70 | 29 | 0.72 | 0.63 to 0.79 |
3 | Trial design | Description of trial design (such as parallel, factorial) including allocation ratio | 5 | 2 | 0.69 | 0.56 to 0.75 |
4 | Participants | Description of the eligibility criteria for participants | 194 | 79 | 0.93 | 0.85 to 0.99 |
5 | Interventions | Details of the interventions intended for each group | 244 | 99 | 0.75 | 0.66 to 0.88 |
6 | Outcomes | Definition of primary (and secondary when appropriate) outcome measures | 201 | 82 | 0.83 | 0.74 to 0.98 |
7 | Sample size | Description of sample size calculation | 0 | 0 | 0.76 | 0.68 to 0.97 |
12 | Statistical methods | Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses, or adjusted analyses | 241 | 98 | 0.81 | 0.72 to 0.93 |
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) | 242 | 98 | 0.95 | 0.92 to 0.98 |
14 | Recruitment | Dates defining the periods of recruitment and follow-up | 31 | 13 | 0.69 | 0.60 to 0.78 |
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) | 244 | 99 | 0.82 | 0.70 to 0.96 |
18 | Ancillary analyses | Clear statement of whether subgroup/adjusted analyses were prespecified or exploratory | 19 | 8 | 0.73 | 0.65 to 0.83 |
19 | Harms | Description of all important adverse events in each group | 113 | 46 | 0.78 | 0.73 to 0.86 |