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

Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study

“…Although recommendations have been developed for the design, conduct and reporting of trials with nonregulated interventions (5,6), study reports of these trials often lack important study information, such as final sample size (7), age (8), or health status of participants (8), and adherence to the CONSORT (Consolidated Standards of Reporting Trials) Statement is generally poor. (8)(9)(10)(11)(12) Careful writing of a clinical trial protocol is important for all involved stakeholders, i.e. researchers, ethics review boards, funders, journal editors and patients (13), because this document describes the planned research steps and methods in a comprehensive manner.…”

Editorial Comment

“…The authors of this study deserve major credit for publishing a randomized controlled trial addressing the important question of whether pregabalin compared to placebo reduces pain and opioid use after ureteroscopy. 1 In contrast to too many studies in the field of endourology, 2 its reporting transparently addresses all important methodological safeguards against bias including that of an a priori registered protocol, assurance of concealed allocation, blinding of all relevant parties, and an intention-to-treat analysis. An intriguing finding of this study was the marked imbalance in the age distribution of the 2 randomized study groups (with a lower average age in the intervention group), which the authors sought to adjust for statistically.…”