Quality of reporting for randomized controlled trials in the hypospadias literature: where do we stand?

Summary Introduction To assess the quality of reporting of randomized controlled trials (RCTs) in the hypospadias literature using the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. It was hypothesized that hypospadias RCTs that contained clear descriptions of key methodological items, allocation concealment, blinding, and sample size justification would have higher overall quality of reporting scores (OQS). Materials and Methods A comprehensive search was conducted through MEDLINE to identify RCTs in hypospadias surgical techniques and postoperative management during the period 1990-2014. Two reviewers independently selected articles, which were evaluated using the CONSORT checklist. An overall quality score (%) was calculated to assess the quality of reporting. In addition, a methodological index score out of 4 was calculated based on the following items: use of intention to treat/sample size justification, allocation concealment, specification of randomization type, and blinding of outcome assessors. Results Of the 76 initial results, 39 (51%) were excluded due to their predominant focus on anesthesia. After full-text screening, 10 (13%) citations were further excluded because they were case control studies or did not focus on hypospadias techniques, resulting in 27 (36%) studies included for analysis. The mean overall quality score was 37±12% and a median of 36% (range: 14-61%). Fifteen (56%) studies were identified as low quality (score 70%). Hypospadias RCTs published between 2007-2014 versus those reported before 2007 (44±9% vs 33±11%, P =0.01), RCTs with a sample size >100 patients versus those 70%) as per the CONSORT statement checklist. The inadequacies in reporting were related to sample size justifications, randomization method, allo