Jo Jung Ki, Chung Jae Hoon, Kim Kyu Shik, Song Soo Hyun, Lee Seung Wook
Department of Urology, Seoul National University Bundang Hospital, Seongnam, Korea.
J Sex Med. 2015 Feb;12(2):350-7. doi: 10.1111/jsm.12784. Epub 2014 Dec 23.
Quality assessment of randomized controlled trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice.
The aim of this study was to analyze the quality of studies reporting RCTs in andrology journals (The Journal of Sexual Medicine [JSM], the Asian Journal of Andrology [AJA], the Journal of Andrology [JOA], the International Journal of Andrology [IJA]).
A quality assessment was conducted on all studies identified as RCTs published in andrology journals (JSM, AJA, JOA, IJA) until 2011. The review period was divided into three terms: early, mid, and late each journal.
The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) were employed. The RCTs were also categorized by country of origin, the inclusion of institutional review board (IRB) approval, funding, and blindness.
There were1,954 original articles published in the JSM, 893 articles in the AJA, 2,527 articles in the JOA, and 2,086 articles in the IJA for the review period. There were 172 studies reporting on RCTs in the JSM, 33 RCTs in the AJA, 63 RCTs in the JOA, and 29 RCTs in the IJA. No significant increase in Jadad or van Tulder scale scores were found over time, nor were there any significant changes in the number of high-quality articles as assessed by CCRBT. However, significant differences in quality analysis were found according to blinding, funding, and IRB approval.
The number of original articles and RCTs in andrology increased over time. However, the ratio of RCTs to original articles as well as RCT quality was statistically insignificant. It would be required for the researchers to focus efforts in performing high-quality studies to ensure appropriate randomization, reviews by IRB, financial support, and inclusion of allocation concealment during study performance.
随机对照试验（RCT）的质量评估对于防止将低质量试验的结果应用于临床实践非常重要。
本研究的目的是分析男科学期刊（《性医学杂志》[JSM]、《亚洲男科学杂志》[AJA]、《男科学杂志》[JOA]、《国际男科学杂志》[IJA]）中报告RCT的研究质量。
对截至2011年在男科学期刊（JSM、AJA、JOA、IJA）上发表的所有被确定为RCT的研究进行质量评估。审查期分为每个期刊的早期、中期和后期三个阶段。
采用Jadad量表、van Tulder量表和Cochrane协作偏倚风险工具（CCRBT）。RCT还按原产国、是否纳入机构审查委员会（IRB）批准、资金和盲法进行分类。
在审查期内，JSM发表了1954篇原创文章，AJA发表了893篇文章，JOA发表了2527篇文章，IJA发表了2086篇文章。JSM中有172项研究报告了RCT，AJA中有33项RCT，JOA中有63项RCT，IJA中有29项RCT。随着时间的推移，未发现Jadad或van Tulder量表评分有显著增加，CCRBT评估的高质量文章数量也没有任何显著变化。然而，根据盲法、资金和IRB批准情况，在质量分析中发现了显著差异。
随着时间的推移，男科学领域的原创文章和RCT数量有所增加。然而，RCT与原创文章的比例以及RCT质量在统计学上并无显著差异。研究人员需要集中精力进行高质量的研究，以确保适当的随机化、IRB审查、资金支持以及在研究过程中纳入分配隐藏。
