The reporting quality of randomized controlled trials and experimental animal studies for urethroplasty
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ORIGINAL ARTICLE
The reporting quality of randomized controlled trials and experimental animal studies for urethroplasty Jacob Albersheim1,2 · Daniel W. Smith1,2 · Joseph J. Pariser2 · Philipp Dahm1,2 Received: 27 June 2020 / Accepted: 14 October 2020 © This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2020
Abstract Objectives To assess the reporting quality of randomized controlled trials and experimental animal studies examining urethroplasty in reconstructive urological surgery literature. Methods We performed a comprehensive literature search to identify all urethroplasty-related RCTs examining humans as well as animal models. We used the Consolidated Standards of Reporting Trials (CONSORT) and the Animals in Research: Reporting in vivo Experiments (ARRIVE) guidelines to assess reporting quality. Two reviewers performed data abstraction independently and in duplicate. We then generated descriptive statistics including CONSORT (0–25) and ARRIVE (0–20) summary scores using the median and interquartile range. Results Twenty studies were ultimately included; 14 randomized controlled trials and 6 experimental animal studies. All studies were two-armed, parallel group studies. Median sample sizes (and interquartile range) of the human and animal studies were 48.5 (31.8–53.8) and 18 (15.3–27.5), respectively. The median CONSORT and ARRIVE scores were 10.0 (8.75–12.63) and 7.97 (6.79–8.64), respectively. Human randomized controlled trials did not consistently report the method of allocation concealment (6/14; 42.9%), blinding (2/14; 14.3%), or discuss the generalizability of the results (6/14; 42.9%). Animal studies infrequently reported why a given animal model was used (1/6; 16.7%), how they were allocated to groups (0/6; 0%) or what the experimental primary and secondary outcomes were (0/6; 0%). Conclusions Urethroplasty literature is marked by a paucity of both randomized controlled trials and experimental design animal studies. The existing studies are inconsistently reported and are therefore of uncertain methodological quality. Keywords Reporting quality · Urethroplasty · Randomized controlled trial · CONSORT · ARRIVE
Introduction Evidence-based healthcare adopts and implements principles derived from methodologically sound and transparently reported research evidence. In considering the impact of study design on evidentiary strength, randomized controlled trials (RCTs) continue to be one of the most reliable methods available to determine the effects of treatments across Presentation: accepted as a virtual (online) podium presentation at the NCS AUA Annual Meeting October 14–17, 2020. * Philipp Dahm [email protected] 1
Urology Section, Minneapolis VA Health Care System, 112D, One Veterans Drive, Minneapolis, MN 55417, USA
Department of Urology, University of Minnesota, Minneapolis, MN, USA
2
all disciplines of medical practice [1]. However, this only holds true if the studies are transparently reported. Various guidelines have bee
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