ASSESSMENT OF THE METHODOLOGICAL QUALITY OF RANDOMIZED CONTROLLED TRIALS PUBLISHED IN «RUSSIAN ALLERGOLOGY JOURNAL» IN 2009-2013 (PART 1)

Background. To assess the methodological quality of randomized controlled trials (RCTs) published in «Russian Allergology Journal» (RAJ) in 2009-2013. Materials and methods. Retrospective analysis of 96 original publications was carried out. For 8 RCT the risks of biases were assessed using the methodology of the Cochrane Collaboration. Accuracy of statistical analysis was assessed in accordance with established in 2009 journal’s requirements (will be presented in next publication). Results. 96 articles were analyzed, 8 (8%) of them were identified as RCTs. All the RCTs have a high risk of the biases and major mistakes in the statistical analysis. Conclusion. The methodological quality of RCTs is insufficient and needs to be improved. We consider that improvement of trials’ planning should play the most important role. Collaboration with the experts in clinical trials’ methodology is strongly recommended. The analysis empowers researchers to consider existing experience and to improve methodological quality of RCTs, their relevance to international standards.

randomized controlled trials, bias, statistical analysis, methodological quality, randomization, blinding, significance level