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Randomized controlled trials on erectile dysfunction: quality assessment and relevant clinical impact (2007–2018)
International Journal of Impotence Research ( IF 2.8 ) Pub Date : 2019-04-25 , DOI: 10.1038/s41443-019-0143-x
Kyu Shik Kim , Jae Hoon Chung , Seung Wook Lee

The aim of this study was to assess the quality of randomized controlled trials (RCTs) on erectile dysfunction (ED) conducted from 2007 to 2018. We searched for RCT original articles on ED published between 2007 and 2018 using PubMed, Embase, and Cochrane Library databases. RCT quality assessment was performed using Jadad scale, van Tulder scale, and Cochrane Collaboration’s Risk of Bias Tool. The effects on RCT quality of including treatment methods, funding sources, institutional review board (IRB) approval statements, and intervention description to the studies were assessed. Blinding and allocation concealment were described in 67.9 and 8.7% of the RCTs, respectively. Blinding tended to decrease, but a sharp rise in blinding was observed in 2011–2012 and allocation in 2017–2018. Funding statement inclusion (60.3% overall) and intervention description (96.4% overall) tended to increase steadily. IRB statement inclusion (78.3% overall) increased (p = 0.05). Jadad scores rose significantly until 2011–2012 but decreased thereafter except 2017–2018 (p = 0.09). RCTs with funding statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and 0.02, respectively). Quality improvement has observed from 2007 to 2012 and 2017 to 2018 with Jadad scale because of increased funding, multicenter studies, and intervention description.



中文翻译:

勃起功能障碍的随机对照试验:质量评估和相关的临床影响(2007-2018年)

这项研究的目的是评估2007年至2018年进行的关于勃起功能障碍(ED)的随机对照试验(RCT)的质量。我们使用PubMed,Embase和Cochrane库搜索了2007年至2018年间发表的关于ED的RCT原始文章。数据库。使用Jadad量表,van Tulder量表和Cochrane Collaboration的“偏见风险”工具进行了RCT质量评估。评估了对RCT质量的影响,包括治疗方法,资金来源,机构审查委员会(IRB)批准声明以及对研究的干预说明。盲区和分配隐藏区分别在67.9和8.7%的RCT中进行了描述。致盲的趋势有所减少,但在2011-2012年观察到的盲目性急剧上升,而在2017-2018年观察到的分配率急剧上升。列入财务报表(60。总体上占3%)和干预说明(总体上占96.4%)趋于稳定增长。IRB声明包含率(总体为78.3%)增加了(p  = 0.05)。Jadad分数在2011-2012年之前显着上升,但此后下降(2017-2018年除外)(p  = 0.09)。带有资助声明的RCT的Jadad和van Tulder得分高于未资助的RCT( 分别为p <0.01和0.02)。由于资金,多中心研究和干预描述的增加,从2007年到2012年以及从2017年到2018年,Jadad规模的质量得到了改善。

更新日期:2019-05-16
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