MP46-11 A QUANTITATIVE ASSESSMENT OF THE QUALITY OF RANDOMIZED CONTROLLED TRIAL REPORTING IN UROLOGICAL LITERATURE

Abstract

INTRODUCTION AND OBJECTIVES: Randomized controlled trials (RCTs) are the gold standard format for clinical research questions of therapy and prevention, and transparent reporting of their design, conduct and analysis is vital to informing evidence-based clinical practice, guidelines and health policy decisions. In 1996 the Consolidated Standards of Reporting Trials (CONSORT) statement was published to provide guidelines and standardization when reporting clinical trials. We systematically assessed the quality of RCT reporting in 2013 as compared to RCTs in 2004 and 1996. Our objective was to quantify any improvement in the intervening time period. METHODS: All RCTs published in 4 leading urology journals in 2013 were identified for formal review, and compared to a prior analysis of studies from 1996 and 2004 using the same inclusion criteria. Two reviewersabstracteddatausingastandardizedevaluation formbasedon the CONSORT checklist. We calculated a summary reporting score (range 022) for each study and compared mean summary scores for 1996, 2004, and2013.Wesettleddisagreements by consensus and third party referee. Chi-square, student’s T test, and ANOVA were used for analysis. RESULTS: A total of 82 RCTs published in 2013 met inclusion criteria and were compared to 65 and 87 studies from 1996 and 2004, respectively. The mean ( SD) CONSORT summary scores were significantly different between years, 15.6 ( 2.0) in 2013, 12.0 ( 2.5) in 2004, and 10.2 ( 2.3) in 1996 (p <0.01). Provision of a flow diagram improved from 3.1% (1996) to 19.5% (2004) to 87.8% (2013; p<0.001). Overall, reporting of important methodological criteria varied within journals, but improved substantially overall from 1996 to 2004 and from 2004 to 2013, with reporting of many key methodological criteria appearing in more than 50% of RCTs for the first time in 2013. However, many items continue to be underreported, including blinding of study participants and personnel as well as outcome assessors. CONCLUSIONS: The quality of RCT reporting in the urological literature has substantially improved since the publication of the initial CONSORT statement. Meanwhile, the reporting of many key methodological criteria remain underreported. Further efforts are needed to continue improving the reporting quality of the urological literature.