A Longitudinal Assessment of the Reporting Quality of Randomized Controlled Trials for Surgical Interventions to Treat Nephrolithiasis Over 16 Years (2002 to 2017)

Abstract

Purpose: Transparently reported, high-quality randomized controlled trials (RCTs) play a critical role in guiding evidence based clinical practice and informing evidence-based guidelines in patients with nephrolithiasis. Prior studies have found reporting quality to be low. We performed this study to assess whether the reporting of RCTs has improved over time. Materials and Methods: This study was governed by an a priori protocol. We performed a systematic literature search for RCTs analyzing nephrolithiasis treatment. Selection of eligible studies and data abstraction were performed by two of three reviewers independently and in duplicate. We developed and pilot tested a data extraction checklist based on the Consolidated Standards of Reporting Trials (CONSORT) criteria on a scale of 0 to 25. Our primary outcome measure was the mean CONSORT score. We performed statistical hypothesis testing to compare scores between 2002-2006, 2007-2011, and 2012-2017. Results: A total of 203 studies (2002-06: 38; 2007-11: 64; 2012-17: 101) met inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (35.1%), shockwave lithotripsy (25.4%), and ureteroscopy (22.9%). Asia contributed an increasing proportion of studies (25.6%, 44.6%, and 74.3%, respectively) in these three time periods. The main journals of publication were the Journal of Endourology (23.9%), the Journal of Urology (19.5%), and Urology (8.3%). The mean ± standard error of the CONSORT summary scores was 11.4 ± 0.4, (2002 to 2006), 12.1 ± 0.3, (2007 to 2011), and 13.3 ± 0.4 (p = 0.003) reflecting an increase by 1.92 (95% confidence interval: 0.86 - 2.98). Conclusions: The number of RCTs investigating the use of urologic devices to treat stone disease has substantially increased overtime. There has been a small improvement in reporting quality; however, this remains suboptimal overall. Increased efforts to promote the transparent reporting of RCTs in endourology are warranted.

Keywords: CONSORT; guidelines; randomized controlled trials; reporting quality; stone surgery.