Evaluation of clinical trials published in Chinese Journal of Cardiovascular Medicine from 2009 to 2013 depending on consolidated standards of reporting trials statement

Abstract

Objective To explore the quality of clinical trial articles published in Chinese Journal of Cardiovascular Medicine from 2009 to 2013. Methods A total of 279 clinical trial articles published in the past 5 years in this magazine were evaluated by checklist depending on consolidated standards of reporting trials(CONSORT) statement. Results The contents of the Introduction part were much more standardized as compared with other parts (Methods, Results, Discussion). The proportion of random control trials(RCT)in Methods part was very low (9%), and only 12 articles used double- or triple-blind method. Application of sample size calculation was poor, and only 2 articles which were published in 2010 applied pre-test calculation method of sample size. Intervention measures were clear in 50%-70% articles, and the proportions of articles setting reasonable controls (>70%) and applying correct statistics methods (>90%) were high. In Results part, descriptions of follow-up and baseline information were more standardized than other items of this part. Main outcome was explicit in 89.6% articles; however, only 22 articles (7.9%) mentioned the lost of follow-up and no article described compliance. 71.0% of the articles did not describe important adverse event and side effect. In Discussion part, 39.4% and 56.3% of the articles discussed limitation and application of the trial results, respectively. Conclusions Most contents in Chinese Journal of Cardiovascular Medicine are standardized and clear, however, application of random, double- or triple-blind method, sample calculation, and description of follow-up, lost of follow-up, important adverse event and side effect should be enhanced in clinical research as well as academic writing. Key words: Clinical trial; Bibliometrics; Randomized controlled trial