Analysis of expanded criteria to select candidates for active surveillance of low-risk prostate cancer.

We aimed to analyze the value of each criterion for clinically insignificant prostate cancer (PCa) in the selection of men for active surveillance (AS) of low-risk PCa. We identified 532 men who were treated with radical prostatectomy from 2006 to 2013 who met 4 or all 5 of the criteria for clinically insignificant PCa (clinical stage ≤ T1, prostate specific antigen [PSA] density ≤ 0.15, biopsy Gleason score ≤ 6, number of positive biopsy cores ≤ 2, and no core with > 50% involvement) and analyzed their pathologic and biochemical outcomes. Patients who met all 5 criteria for clinically insignificant PCa were designated as group A (n = 172), and those who met 4 of 5 criteria were designated as group B (n = 360). The association of each criterion with adverse pathologic features was assessed via logistic regression analyses. Comparison of group A and B and also logistic regression analyses showed that PSA density > 0.15 ng ml-1 and high (≥7) biopsy Gleason score were associated with adverse pathologic features. Higher (> T1c) clinical stage was not associated with any adverse pathologic features. Although ≤ 3 positive cores were not associated with any adverse pathology, ≥4 positive cores were associated with higher risk of extracapsular extension. Among potential candidates for AS, PSA density > 0.15 ng ml-1 and biopsy Gleason score > 6 pose significantly higher risks of harboring more aggressive disease. The eligibility criteria for AS may be expanded to include men with clinical stage T2 tumor and 3 positive cores.

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.

Analysis of randomized controlled trials in Rheumatology International from 1981 to 2012: methodological assessment.

The aim of the study is to assess the methodological quality of randomized controlled trials (RCTs) published in Rheumatology International (RI) by using three types of analytical tools. MEDLINE was used to extract RCTs from original articles published in the RI from 1981 (vol. 1) to 2012 (vol. 32). The relationship between the number of articles and RCTs with time and that between various factors and the quality of RCTs were analyzed. To analyze the methodological quality of the RCTs, the time period was divided into several sections and three tools were applied (e.g., the Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool). The number of RCTs published gradually increased with time significantly (p < 0.001). The differences in RCT quality scores by each method in the publication years evaluated were not statistically significant, but RCTs that included descriptions of allocation concealment methods had received institutional review board (IRB) approval, and that conducted in the multicenter had significantly higher-quality scores than other studies. In conclusion, although the number of RCTs published in RI since its publishing in 1981 has increased with time, but no qualitative improvement of RCT was observed over time. It is necessary to improve the reporting of concealment of allocation, generation of randomization sequences, design of blinded studies, and obtaining IRB approval, all of which are criteria of high-quality RCTs.

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.