A Critical Assessment of the Quality of Reporting of Randomized, Controlled Trials in the Urology Literature.

Purpose: Randomized, controlled trials are the gold standard for evidence based assessment of therapeutic interventions. In 1996 the Consolidated Standards of Reporting Trials statement was published in an effort to standardize the reporting of clinical trials. To our knowledge we report the first systematic assessment of randomized, controlled trial quality in the urology literature by Consolidated Standards of Reporting Trials standards. Materials and Methods: All human subject randomized, controlled trials published in 4 leading urology journals in 1996 and 2004 were identified for formal review. A standardized evaluation form was developed based on the Consolidated Standards of Reporting Trials statement. Each article was evaluated by 2 independent reviewers and discrepancies were settled by consensus. A Consolidated Standards of Reporting Trials criteria summary score was calculated on a scale of 0 to 22. Results: A total of 152 randomized, controlled trials met inclusion criteria. The mean ± SEM Consolidated Standards of Reporting Trials summary score was 10.2 ± 0.3 (median 10.3) and 12.0 ± 0.3 (median 12.2) in 1996 and 2004, respectively, with a mean difference of 1.8 (95% CI 1.0, 2.6; p = 0.001). Reporting of important methodological criteria, eg sample size justification and randomization implementation, improved from 1996 to 2004. Improvement notwithstanding, reporting of key methodological criteria remained consistently below 50% in 2004. Conclusions: This formal review suggests that randomized, controlled trial reporting in the urology literature has improved since the publication of the Consolidated Standards of Reporting Trials statement in 1996. Certain areas, such as reporting of trial methods, continue to meet Consolidated Standards of Reporting Trials criteria in fewer than half of publications. Ongoing graduate and postgraduate education in trial design and evidence based practice may result in further improvement in randomized, controlled trial reporting. [Copyright &y& Elsevier]