Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida.
Department of Urology, University of Florida and Malcom Randall Veterans Affairs Medical Center, Gainesville (PD), Florida.
J Urol. 2014 Apr;191(4):988-93. doi: 10.1016/j.juro.2013.10.067. Epub 2013 Oct 19.
We assessed the methodological and reporting quality of randomized, controlled trials of stone disease management and determined whether the reporting quality of randomized, controlled trials improved with time.
We systematically searched the literature for randomized, controlled trials of urolithiasis treatment. We developed and pilot tested a data extraction checklist based on CONSORT (Consolidated Standards of Reporting Trials) criteria as well as a clinical checklist relevant to urolithiasis, each scored as 0 to 25. Our primary outcome measures were the mean differences in CONSORT and clinical summary scores with time. We performed statistical hypothesis testing using the Student t-test with 2-sided α = 0.05 to compare scores between 2002 to 2006 and 2007 to 2011.
A total of 104 randomized, controlled trials met study inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (41.3%), ureteral stenting (28.8%) and shock wave lithotripsy (25.0%). Mean ± SE CONSORT summary scores were 11.4 ± 0.4 and 12.1 ± 0.3 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 0.7 (95% CI -0.3-1.6, p = 0.167). Mean clinical summary scores were 7.4 ± 0.5 and 9.3 ± 0.4 in 2002 to 2006 and 2007 to 2011, respectively, with a mean difference of 1.8 (95% CI 0.6-3.1, p = 0.004).
While the number of randomized, controlled trials of urological devices used to treat stone disease substantially increased with time, methodological and clinical reporting quality remains suboptimal. This compromises their credibility and warrants efforts to promote appropriate performance of future endourological studies.
我们评估了结石病管理的随机对照试验的方法学和报告质量，并确定了随机对照试验的报告质量是否随时间的推移而提高。
我们系统地检索了关于尿路结石治疗的随机对照试验文献。我们根据 CONSORT（临床试验报告统一标准）标准以及与尿路结石相关的临床检查表制定并试点测试了数据提取检查表，每项检查表的得分为 0 到 25 分。我们的主要结局指标是 CONSORT 和临床总结评分随时间的平均差异。我们使用双侧 α = 0.05 的学生 t 检验进行统计假设检验，以比较 2002 年至 2006 年和 2007 年至 2011 年之间的评分。
共有 104 项随机对照试验符合研究纳入标准。研究中最常见的手术类型是经皮肾镜碎石术（41.3%）、输尿管支架置入术（28.8%）和体外冲击波碎石术（25.0%）。2002 年至 2006 年和 2007 年至 2011 年的 CONSORT 总结评分均值分别为 11.4 ± 0.4 和 12.1 ± 0.3，平均差异为 0.7（95%置信区间-0.3-1.6，p = 0.167）。2002 年至 2006 年和 2007 年至 2011 年的临床总结评分均值分别为 7.4 ± 0.5 和 9.3 ± 0.4，平均差异为 1.8（95%置信区间 0.6-3.1，p = 0.004）。
尽管用于治疗结石病的泌尿科设备的随机对照试验数量随时间显著增加，但方法学和临床报告质量仍然不理想。这影响了它们的可信度，并需要努力促进未来内窥镜研究的适当开展。
