Objective: To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China.
Methods: The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials (RCT) and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A (1999 - 2001) and group B (2009 - 2011) of the quality documents were compared and analyzed.
Results: Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen (82.4%) in the 17 RCTs mentioned 'eligibility criteria for participants', 11 (64.7%) RCTs mentioned 'details of the interventions', 15 (88.2%) RCTs mentioned 'adverse effects'. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% (2 out of 17) were high-quality trials (≥ 3 points). Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items.
Conclusions: The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledge in clinical epidemiology, clinical trial methodology, and improve the quality of research reports.