Analysis of randomized controlled trials in Rheumatology International from 1981 to 2012: methodological assessment

Abstract

The aim of the study is to assess the methodological quality of randomized controlled trials (RCTs) published in Rheumatology International (RI) by using three types of analytical tools. MEDLINE was used to extract RCTs from original articles published in the RI from 1981 (vol. 1) to 2012 (vol. 32). The relationship between the number of articles and RCTs with time and that between various factors and the quality of RCTs were analyzed. To analyze the methodological quality of the RCTs, the time period was divided into several sections and three tools were applied (e.g., the Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool). The number of RCTs published gradually increased with time significantly (p < 0.001). The differences in RCT quality scores by each method in the publication years evaluated were not statistically significant, but RCTs that included descriptions of allocation concealment methods had received institutional review board (IRB) approval, and that conducted in the multicenter had significantly higher-quality scores than other studies. In conclusion, although the number of RCTs published in RI since its publishing in 1981 has increased with time, but no qualitative improvement of RCT was observed over time. It is necessary to improve the reporting of concealment of allocation, generation of randomization sequences, design of blinded studies, and obtaining IRB approval, all of which are criteria of high-quality RCTs.