Objective To evaluate the reporting quality of randomized controlled trials (RCTs) in seven military medical journals.
Methods Seven journals in 2007, including Medical Journal of Chinese People’s Liberation Army, Journal of South Medical University, Journal of Second Military Medical University, Journal of Third Military Medical University, Journal of Fourth Military Medical University, Bulletin of the Academy of Military of Medical Sciences and Academic Journal of PLA Postgraduate Medical School, were handsearched. We identified RCTs labeled “random” and assessed the quality of these reports using the Consolidated Standards for Reporting of Trials (CONSORT) statement.
Results We identified 99 RCTs, but found an incorrect randomized method was used in 6 RCTs. According to the items in the CONSORT statement in 93 RCTs, 62 (66.7%) RCTs described baseline demographic and clinical characteristics in each group. Sixteen (17.2%) RCTs mentioned the method of random sequence generation, with 5 (5.4%) using a computer allocation. Only 1 RCT had adequate allocation concealment. Only 9 (9.7%) RCTs used blinding, with 2 mentioning blinding, 1 using single blinding and 6 described as double-blind (2 were correct). Zero (0%) reported the sample size calculation and 1 RCT reported the intention-to-treat (ITT) analysis.
Conclusion The reporting quality of RCTs in seven journals is poor. The CONSORT statement should be used to standardize the reporting of RCTs.
Citation: ZHANG Xiaoli,JIA Wannian,HU Quanbing,LI Jing,XIONG Xiaoran,SHENning,ZHANG Qingshan,FAN Chenfang,LI Enjiang. Assessment of Reporting Quality of Randomized Controlled Trials in Seven Journals Using the CONSORT Statement. Chinese Journal of Evidence-Based Medicine, 2010, 10(4): 501-504. doi: 10.7507/1672-2531.20100437 Copy