Skip to main content

Table 1 Overall quality of reporting rating using items from the CONSORT statement (n = 39)

From: A retrospective survey of quality of reporting on randomized controlled trials of metformin for polycystic ovary syndrome

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