Presentation Authors: Ellen C Thompson*, Minneapolis, MN, Andrew Lai, Chicago, IL, Luke B Morrey, Philipp Dahm, Minneapolis, MN
Introduction: 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. We performed this study to assess whether the reporting of RCTs involving medical devices has improved over time.
Methods: This study was governed by an a priori protocol as an extension of a prior published study (Zavitsanos PJ et al, J Urol, 2014). We performed a systematic literature search for RCTs analyzing urolithiasis treatment. Selection of eligible studies and data abstraction was 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. We performed statistical hypothesis testing to compare scores between 2002-2006, 2007-2011 and 2012-2017 and by journal of publication.
Results: Two-hundred-and-five (2002-06: 39, 2007-11: 65; 2012-17: 101) studies met inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (35.1%), shockwave lithotripsy (25.4%) and ureteroscopy (22.9%). Asia contributed a rising 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 Â± SD CONSORT summary scores were 11.4 Â± 2.3, 12.1 Â± 2.3 and 13.3 Â± 3.7, respectively (p=0.003). A subset of individual criteria is reported in the attached Table. Analyzed by journal for the most recent time period (2012-17) only, mean scores by journals ranged from 12.6 Â± 2.6 (Journal of Urology) to 18.4 Â± 3.1 (p=0.001).
Conclusions: While the number of RCTs investigating the use of urological devices to treat stone disease has substantially increased over time, reporting quality has improved little and remains sub-optimal in most journals. Increased efforts to promote the transparent reporting of RCTs in endourology are warranted.
Source of Funding: Departmental