Quality Assessment and Relevant Clinical Impact of Randomized Controlled Trials of Varicocele: Next Step to Good-Quality Randomized Controlled Trial of Varicocele Treatment.

PURPOSE: To assess the quality of randomized controlled trials (RCTs) on varicocele published from 1979 to 2017. MATERIALS AND METHODS: We searched for original RCT on varicocele published between 1979 and 2017. Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool were used to analyze RCT quality over time. Effects on RCT quality including funding source, Institutional Review Board (IRB) approval, and intervention were assessed. Treatment parameters of varicocele were also analyzed. RESULTS: Blinding and allocation concealment were described in 25.9% and 9.4% of RCT, respectively. Both tended to increase and a sharp dip in allocation concealment was observed in 2010-2017. Jadad scores increased steadily from 1979 to 2017 (1.28±0.59 to 2.19±1.10, p<0.01). Van Tulder scores tended to increase from 1979 to 2017 (4.21±0.94 to 5.58±1.58, p<0.01). RCTs with funding statements had higher Jadad (Yes vs. No, 3.25±0.50 vs. 1.70±0.97; p<0.01) and van Tulder (Yes vs. No, 7.25±1.26 vs. 4.81±1.26; p<0.01) scores than unfunded RCTs. IRB approval and intervention were associated with better quality. CONCLUSIONS: The number of RCTs on varicocele increased from 1979 to 2017. Also, quality improved over time with increasing IRB approval, funding, and multicenter trial. Most RCTs on varicocele reported the use of surgical treatment. RCTs of surgical treatments have limitations to satisfy the condition of RCT to conduct, but their quality has improved over time.

Randomized controlled trials on erectile dysfunction: quality assessment and relevant clinical impact (2007-2018).

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.

Reporting of randomized controlled trials in andrology journals: a quality assessment.

INTRODUCTION: Quality assessment of randomized controlled trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. AIM: 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]). METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION: 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.

Randomized controlled trials in the journal of sexual medicine: a quality assessment and relevant clinical impact.

INTRODUCTION: Quality assessment of randomized clinical trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. AIM: 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). MAIN OUTCOME MEASURES: 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.

Randomized controlled trials in endourology: a quality assessment.

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.