The reporting quality of randomized controlled trials and experimental animal studies for urethroplasty.

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.
(© 2020. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)