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16 年来(2002 年至 2017 年)外科干预治疗肾结石随机对照试验报告质量的纵向评估。

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

机构信息

Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.

Urology Section, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA.

出版信息

J Endourol. 2020 Apr;34(4):502-508. doi: 10.1089/end.2019.0649. Epub 2020 Mar 24.

Abstract

Transparently reported, high-quality randomized controlled trials (RCTs) play a critical role in guiding evidence based clinical practice and informing evidence-based guidelines in patients with nephrolithiasis. Prior studies have found reporting quality to be low. We performed this study to assess whether the reporting of RCTs has improved over time. This study was governed by an protocol. We performed a systematic literature search for RCTs analyzing nephrolithiasis treatment. Selection of eligible studies and data abstraction were performed by two of three reviewers independently and in duplicate. We developed and pilot tested a data extraction checklist based on the Consolidated Standards of Reporting Trials (CONSORT) criteria on a scale of 0 to 25. Our primary outcome measure was the mean CONSORT score. We performed statistical hypothesis testing to compare scores between 2002-2006, 2007-2011, and 2012-2017. A total of 203 studies (2002-06: 38; 2007-11: 64; 2012-17: 101) met inclusion criteria. The most common procedure types studied were percutaneous nephrolithotomy (35.1%), shockwave lithotripsy (25.4%), and ureteroscopy (22.9%). Asia contributed an increasing proportion of studies (25.6%, 44.6%, and 74.3%, respectively) in these three time periods. The main journals of publication were the (23.9%), the (19.5%), and (8.3%). The mean ± standard error of the CONSORT summary scores was 11.4 ± 0.4, (2002 to 2006), 12.1 ± 0.3, (2007 to 2011), and 13.3 ± 0.4 ( = 0.003) reflecting an increase by 1.92 (95% confidence interval: 0.86 - 2.98). The number of RCTs investigating the use of urologic devices to treat stone disease has substantially increased overtime. There has been a small improvement in reporting quality; however, this remains suboptimal overall. Increased efforts to promote the transparent reporting of RCTs in endourology are warranted.

摘要

透明报告、高质量的随机对照试验(RCT)在指导循证临床实践和为肾结石患者制定循证指南方面发挥着关键作用。先前的研究发现报告质量较低。我们进行这项研究是为了评估 RCT 的报告是否随着时间的推移而有所改善。

这项研究受一项方案的指导。我们对分析肾结石治疗的 RCT 进行了系统的文献检索。两名审稿人独立、重复地进行了合格研究的选择和数据提取。我们根据 CONSORT 标准制定并试点了一个数据提取检查表,该检查表的评分范围为 0 到 25。我们的主要观察指标是 CONSORT 评分的平均值。我们进行了统计假设检验,以比较 2002-2006 年、2007-2011 年和 2012-2017 年的分数。共有 203 项研究(2002-06 年:38 项;2007-11 年:64 项;2012-17 年:101 项)符合纳入标准。研究中最常见的手术类型是经皮肾镜碎石术(35.1%)、体外冲击波碎石术(25.4%)和输尿管镜检查(22.9%)。亚洲在这三个时期的研究比例分别为 25.6%、44.6%和 74.3%。主要的出版期刊是《柳叶刀》(23.9%)、《美国医学会杂志》(19.5%)和《英国医学杂志》(8.3%)。CONSORT 总结评分的平均值为 11.4±0.4(2002 年至 2006 年)、12.1±0.3(2007 年至 2011 年)和 13.3±0.4( = 0.003),反映出增加了 1.92(95%置信区间:0.86-2.98)。

研究泌尿系结石疾病治疗的泌尿科设备使用情况的 RCT 数量已经大大增加。报告质量有了很小的提高;然而,总体而言,这仍然不理想。需要加大力度促进泌尿科 RCT 的透明报告。

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