Table 1 Overall quality of reporting rating using items from the CONSORT Statement (n = 98)
From: Quality of reporting on randomized controlled trials on recurrent spontaneous abortion in China
Item | Criteria | Description | No. 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 | 10 | 10 | 1.00 | - |
2 | Background | Adequate description of the scientific background and explanation of rationale | 85 | 87 | 0.67 | 0.43 to 0.91 |
3 | Trial design | Description of trial design (such as parallel, factorial) including allocation ratio | 84 | 86 | 0.78 | 0.54 to 0.96 |
4 | Participants | Description of the eligibility criteria for participants | 72 | 74 | 0.72 | 0.49 to 0.93 |
5 | Interventions | Details of the interventions intended for each group | 80 | 82 | 0.62 | 0.41 to 0.95 |
6 | Outcomes | Definition of primary (and secondary when appropriate) outcome measures | 82 | 84 | 0.75 | 0.48 to 0.97 |
7 | Sample size | Description of sample size calculation | 0 | 0 | 0.81 | 0.52 to 0.99 |
8 | Randomization | Description of the method used to generate the random sequence | 14 | 14 | 0.83 | 0.63 to 0.97 |
12 | Statistical methods | Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses or adjusted analyses | 71 | 72 | 1.00 | - |
13 | Flow chart | Details on the flow of participants through each stage of the trials (no. of patients randomly assigned, receiving intended treatment, completing the protocol and analyzed) | 87 | 88 | 0.77 | 0.61 to 0.97 |
14 | Recruitment | Dates defining the periods of recruitment and follow-up | 79 | 81 | 0.73 | 0.42 to 0.98 |
15 | Baseline data | An outline of baseline demographic and clinical characteristics of each group | 3 | 3 | 0.68 | 0.35 to 0.92 |
17 | Outcomes and estimation | For each primary and secondary outcome, a summary of results for each group is given, along with the estimated effect size and its precision (e.g., 95% CI) | 9 | 9 | 0.72 | 0.43 to 0.96 |
18 | Ancillary analyses | Clear statement of whether subgroup/adjusted analyses were pre-specified or exploratory | 8 | 8 | 0.74 | 0.37 to 0.95 |
19 | Harms | Description of all important adverse events in each group | 12 | 12 | 0.82 | 0.69 to 0.99 |