title: Randomized controlled trials in the journal of sexual medicine: a quality assessment and relevant clinical impact.
abstract: BACKGROUND
  Quality assessment of randomized clinical trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice.
  
  
  OBJECTIVE
  The aim if this study was to analyze the quality of studies reporting RCTs in the Journal of Sexual Medicine (JSM) and to find relevant clinical impact.
  
  
  METHODS
  A quality assessment was conducted in all studies identified as RCTs published in the JSM from 2004 to 2012. The review period was divided into three periods: early (2004-2006), mid (2007-2009), and late (2010-2012).
  
  
  METHODS
  The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) quality scoring instruments were used. The RCTs were also categorized by country of origin, topic, the inclusion of institutional review board (IRB) approval, funding, citation rate, and impact factor.
  
  
  RESULTS
  A total of 2,418 original articles were published in the JSM during the review period, and 188 were reports of RCTs. There were 39 (14.89%), 70 (7.77%), and 76 (6.29%) RCTs published during the early, mid, and late terms, respectively (P < 0.001). No significant increases in Jadad or van Tulder scale scores were found over time nor were there any significant changes in the number of low-risk articles as assessed by the CCRBT. However, significant differences in quality analysis were found in funding and IRB approval. Citation rates and impact factor were not correlated with RCT quality using any of the tools.
  
  
  CONCLUSIONS
  The number of original articles and RCTs published in the JSM increased over time. However, the ratio of RCTs to original articles did not increase significantly. Adequate randomization and blinding methods, IRB review, and financial support are required for the conduct of high-quality RCTs.
authors.affiliation: Department of UrologyHanyang University College of MedicineSeoulKorea.
authors.forename: Jung Ki
authors.initials: JK
authors.lastname: Jo
authors.affiliation: Department of UrologyHanyang University College of MedicineSeoulKorea.
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Chung
authors.affiliation: Department of UrologyHanyang University College of MedicineSeoulKorea.
authors.forename: Kyu Shik
authors.initials: KS
authors.lastname: Kim
authors.affiliation: Department of UrologyHanyang University Guri HospitalGuriKorea.
authors.forename: Jeong Woo
authors.initials: JW
authors.lastname: Lee
authors.affiliation: Department of UrologyHanyang University Guri HospitalGuriKorea. Electronic address: swleepark@hanyang.ac.kr.
authors.forename: Seung Wook
authors.initials: SW
authors.lastname: Lee
mesh_terms: D055811:Journal Impact Factor; D010506:Periodicals as Topic / Q000592:standards* / Q000706:statistics & numerical data; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D044347:Sexology / Q000592:standards* / Q000706:statistics & numerical data
keywords: CONSORT Statement; Randomized Control Trial; Reporting Quality