Quality assessment of the reports of randomized controlled trials published in 5 journals of psychiatry in China from 2004 to 2008 by Consolidated Standards of Reporting Trials Statement

Objective To explore the quality of methodology about the reports of randomized controlled trials (RCTs) in 5 journals of psychiatry in China from 2004 to 2008 by CONSORT statement. Methods The reporting of randomized controlled trials related to psychiatry in five Chinese psychiatric academic journals were searched through Chongqing VIP full-text database (VIP). According to the revised CONSORT statement and other addition methods of appraisal, the quality of randomized controlled trials was assessed. Results 518 studies, which account for 8.24% of all the articles were identified. Regarding to the criteria of inclusion and exclusion criteria about subjects (92.1%),intervention (99.4%), statistical description(90.2%), recruitment (94.2%), baseline data (98.1%),results (97.7%) and adverse events(87.8%), most of the studies reported in details. But the titles and abstracts (67.8%), and discussions (77.4%), were reported less focused contents in detail. However, as to the most important methodology of randomized controlled trails was poorly reported or was not reported, for instance, the estimation of sample size (0.4%), the sequence generation of randomization (9.8%), allocation concealment (1.4%), implementation of randomization (1.5%), primary and secondary outcomes (3.9%), blinding(14.7%), analysis of the intention to treatment (6.0%), and application of the flowchart (0.0%), much content needed to improve. Conclusion The quality of the reports of RCTs in academic journals of psychiatry in China was still poor, and the CONSORT statement should be widely used in reports of RCTs. Key words: Randomized controlled trials; Quality assurance, health care; Bibliometrics; CONSORT statement