Report quality assessment and study characteristic analysis of randomized controlled trials published in Chinese Journal of Health Management / 中华健康管理学杂志

ABSTRACT

Objective:To evaluate the report quality and study characteristics of randomized controlled trials (RCT) published in the Chinese Journal of Health Management.Methods:All studies published in the Chinese Journal of Health Management from January 2007 to July 2019 were retrieved via Wanfang data. Two researchers screened the articles strictly according to the inclusion and exclusion criteria independently. Based on the Consolidated Standards of Reporting Trials (CONSORT) statement 2010, the report quality and characteristics of the articles (including the type of participants, recruiting site, interventions, outcome measure, etc.) were extracted and summarized. Then the report quality, study characteristics were analysed among three periods based on the publishing date (2008—2011 , 2012—2015 , 2016—2019). Results:Titles, abstracts, and full text manuscripts were screened against inclusion criteria by two independent reviewers and 57 studies were included. There were 13/25 items of the CONSORT statement were fulfilled completely, the other 8/25 items were partly fulfilled, and the else 4/25 items were not met the standards in these studies. There was statistically significant difference in the description ratio of ‘randomization sequence generation’ (16.7% vs. 47.6% vs. 66.7%), foundation (25.0% vs. 33.3% vs. 75.0%) and informed consent (50.0% vs. 76.2% vs. 100.0%) during the three periods (all P<0.05). There was no statistically significant difference in the proportion of chronic diseases (58.3% vs. 85.7% vs. 66.7%), the description ratio of participant flow (41.7% vs. 33.3% vs. 75.0%) and baseline data (83.3% vs. 95.2% vs. 100.0%) in the studies from different periods, however, the description situation of participant flow and baseline data has been improved along the time. Conclusion:According to the CONSORT statement, it is found that the quality of research in health management still needs to be improved, especially in the concealment of randomization and trial registration.