Urology Section, Minneapolis VA Health Care System, 112D, One Veterans Drive, Minneapolis, MN, 55417, USA.
Department of Urology, University of Minnesota, Minneapolis, MN, USA.
World J Urol. 2021 Jul;39(7):2677-2683. doi: 10.1007/s00345-020-03501-8. Epub 2020 Nov 11.
To assess the reporting quality of randomized controlled trials and experimental animal studies examining urethroplasty in reconstructive urological surgery literature.
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.
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%).
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.
评估重建泌尿外科中尿道成形术相关文献中随机对照试验和实验动物研究的报告质量。
我们进行了全面的文献检索，以确定所有涉及人类和动物模型的尿道成形术相关 RCT 研究。我们使用 CONSORT（报告临床试验的统一标准）和 ARRIVE（动物实验报告规范）指南来评估报告质量。两位评审员独立且重复地进行数据提取。然后，我们使用中位数和四分位距生成描述性统计数据，包括 CONSORT（0-25）和 ARRIVE（0-20）总结评分。
最终纳入了 20 项研究；14 项随机对照试验和 6 项实验动物研究。所有研究均为双盲、平行组研究。人体和动物研究的中位样本量（四分位距）分别为 48.5（31.8-53.8）和 18（15.3-27.5）。CONSORT 和 ARRIVE 的中位数评分为 10.0（8.75-12.63）和 7.97（6.79-8.64）。人体随机对照试验并未一致报告分配隐藏方法（6/14；42.9%）、盲法（2/14；14.3%）或讨论结果的可推广性（6/14；42.9%）。动物研究很少报告为什么选择特定的动物模型（1/6；16.7%）、如何将它们分配到组中（0/6；0%）或实验的主要和次要结果是什么（0/6；0%）。
尿道成形术文献缺乏随机对照试验和实验设计动物研究。现有的研究报告不一致，因此方法学质量不确定。
