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随机对照试验在泌尿外科中的应用:质量评估。

Randomized controlled trials in endourology: a quality assessment.

机构信息

Department of Urology, Hanyang University College of Medicine, Seoul, Korea.

出版信息

J Endourol. 2013 Aug;27(8):1055-60. doi: 10.1089/end.2013.0036. Epub 2013 Jul 26.

Abstract

PURPOSE

To analyze the quality of studies reporting randomized clinical trials (RCTs) in the field of endourology.

MATERIALS AND METHODS

RCTs published in the Journal of Endourology from 1993 until 2011 were identified. The Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool (CCRBT) were used to assess the quality of the studies. The review period was divided into early (1993-1999), mid (2000-2005), and late (2006-2011) terms. Studies were categorized by country of origin, subject matter, single- vs multicenter setting, Institutional Review Board (IRB) approval and funding support, and blinding vs nonblinding.

RESULTS

In total, 3339 articles had been published during the defined review period, of which 165 articles were reporting a RCT. There was a significant increase in the number of RCTs published over time, with 18 (2.81%), 43 (4.88%), and 104 (5.72%) studies identified in the early, mid, and late term, respectively (P=0.009). Nevertheless, there was no difference in terms of quality of reporting, as assessed with the Jadad scale, van Tulder scale, or CCRBT, between the three study terms. On the other hand, significant differences were found in both the number of high qualitative RCTs that used blinding methodology and those that had IRB review, when comparing the early, mid, and late terms.

CONCLUSION

There has been a growing number of Journal of Endourology publications reporting on RTC over the last two decades. The quality of reporting for these studies remains suboptimal, however. Researchers should focus on a more appropriate description of key features of any given RCT, such as randomization and allocation methods, as well as disclosure of IRB review and financial support.

摘要

目的

分析腔内泌尿外科学领域随机临床试验(RCT)研究报告的质量。

材料与方法

确定了 1993 年至 2011 年期间在《泌尿外科杂志》上发表的 RCT。使用 Jadad 量表、van Tulder 量表和 Cochrane 协作风险偏倚工具(CCRBT)评估研究质量。审查期间分为早期(1993-1999 年)、中期(2000-2005 年)和晚期(2006-2011 年)。根据原籍国、主题、单中心与多中心设置、机构审查委员会(IRB)批准和资金支持以及盲法与非盲法对研究进行分类。

结果

在定义的审查期间共发表了 3339 篇文章,其中 165 篇报告了 RCT。随着时间的推移,发表的 RCT 数量显著增加,分别在早期、中期和晚期发现 18(2.81%)、43(4.88%)和 104(5.72%)项研究(P=0.009)。然而,使用 Jadad 量表、van Tulder 量表或 CCRBT 评估报告质量时,三个研究时段之间没有差异。另一方面,在比较早期、中期和晚期时,使用盲法方法和具有 IRB 审查的高质量 RCT 的数量存在显著差异。

结论

在过去的二十年中,《泌尿外科杂志》上发表的报告 RCT 的文章数量不断增加。然而,这些研究的报告质量仍然不尽如人意。研究人员应更加注重描述任何给定 RCT 的关键特征,例如随机化和分配方法,以及披露 IRB 审查和财务支持。

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