Does the reporting of randomized clinical trials published in Chinese pediatrics journals improve after the CONSORT Statement is adopted?

Background: There is no systematic assessment whether the quality of reporting has been improved since the CONSORT Statement was introduced into China in 1997. The aim of this study is to determine whether the use of the CONSORT Statement is associated with improved quality of reporting of RCTs published in Chinese pediatrics journals.

Methods: Six core Chinese pediatrics journals that included Journal of Clinical Pediatrics, Chinese Journal of Contemporary Pediatrics, Chinese Journal of Practical Pediatrics, Chinese Journal of Evidence-based Pediatrics, Chinese Journal of Pediatrics, and Chinese Journal of Pediatric Surgery were searched from inception through Dec. 2010. The CONSORT checklists were used to assess the quality of reporting. Data was collected using a standardized form. Analyses were performed using SPSS 15.0 software.

Results: A total of 619 RCTs were included. The quality of reporting has improved significantly in aspects such as introduction, recruitment, baseline data, and ancillary analyses (p<0.05), but not in several important methodological components, including sample size calculation (0.63% vs.1.08%), randomization sequence generation (3.18% vs. 7.58%), allocation concealment (0% vs. 1.08%), and blinding (0% vs. 0.87%).

Conclusions: The quality of reporting of RCTs has not significantly improved since the CONSORT Statement was introduced into China. The reporting remains poor, and often inadequate for assessment of the rigor of studies. Chinese pediatrics journals should reinforce the use of the CONSORT Statement in the reporting of trials.