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

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 < 40%) and 12 (44%) as moderate quality (40-70%). No studies were classified as high quality (> 70%). Hypospadias RCTs published between 2007 and 2014 versus those reported before 2007 (44 +/- 9% vs 33 +/- 11%, P=0.01), RCTs with a sample size > 100 patients versus those < 100 (47 +/- 8% vs 36 +/- 11%, P = 0.01), RCTs that disclosed having received funding versus those that did not (56 +/- 4% vs 38 +/- 10%, P < 0.01) and RCTs that had proof of biostatistician/epidemiologist support versus those that did not (58 +/- 5% vs 36 +/- 11%, P=0.01) had a higher mean OQS. The number of articles that met specific 2010 CONSORTcriteria is illustrated in Summary Fig. Discussion It was found that the contemporary hypospadias literature continues to suffer from suboptimal reporting standards. There seems to be an improvement in the OQS for studies published after 2007 and those with larger sample sizes, usually > 100 patients. Nevertheless, none of the studies obtained high quality of reporting (OQS > 70%) as per the CONSORT statement checklist. The inadequacies in reporting were related to sample size justifications, randomization method, allocation concealment strategy, blinding, description of subjects lost to follow-up and Intention To Treat (ITT) analysis. These findings were consistent with the poor quality of reporting observed in other surgical fields. Conclusions The current overall quality score in hypospadias literature is suboptimal and efforts must be made to improve quality.