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.

Assessment of Agreement between Two Difference Prostate-Specific Antigen Assay Modalities.

There is controversy over the usefulness of prostate-specific antigen (PSA) as a prostate cancer (PCa) biomarker. This controversy arises when there are differences in the results of PSA assay modalities. In this study, which aimed to evaluate a proper validation between the two PSA assay modalities, the agreement between the results of the two modalities was analyzed. PSA examinations were conducted using two PSA assay modalities in 4810 patients. The intra-class correlation coefficient (ICC) and weighted kappa analysis were used to evaluate the agreement between the two assay modalities. A linear regression was performed to evaluate the association between the two assay modalities. According to ICC values (ICC: 0.999, p < 0.001) and weighted kappa analysis values (kappa: 0.951, alpha's standard error (ASE): 0.001, p < 0.0001), the agreement between the assay modalities was rated as excellent. However, the strength of agreement was poor in the following PSA sub-groups: 0.05-0.1 ng/mL (ICC: 0.281, p = 0.0860); 0.15-0.2 ng/mL (ICC: 0.288, p = 0.0036); 1.5-2.0 ng/mL (ICC: 0.360, p = 0.0860); and 2.0-2.5 ng/mL (ICC: 0.303, p = 0.0868). In linear regression analysis, when modality B PSA yielded a value of 0.2 ng/mL, the expected value for modality A was 0.258 ng/mL (95% CI: 0.255-0.260), and when modality B PSA yielded a value of 4 ng/mL, the expected value for modality A was 3.192 ng/mL (95% CI: 3.150-3.235). The difference in the PSA values between the two PSA assay modalities is confirmed, and this difference may be clinically meaningful.

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.

Economic Evaluation of Recombinant Human Thyroid Stimulating Hormone Stimulation vs. Thyroid Hormone Withdrawal Prior to Radioiodine Ablation for Thyroid Cancer: The Korean Perspective.

BACKGROUND: Previous studies have suggested that recombinant human thyroid stimulating hormone (rhTSH) stimulation is an acceptable alternative to thyroid hormone withdrawal (THW) when radioiodine remnant ablation is planned for thyroid cancer treatment, based on superior short-term quality of life with non-inferior remnant ablation efficacy. This study evaluated the cost-effectiveness of radioiodine remnant ablation using rhTSH, compared with the traditional preparation method which renders patients hypothyroid by THW, in Korean perspective. METHODS: This economic evaluation considered the costs and benefits to the Korean public healthcare system. Clinical experts were surveyed regarding the current practice of radioiodine ablation in Korea and their responses helped inform assumptions used in a cost effectiveness model. Markov modelling with 17 weekly cycles was used to assess the incremental costs per quality-adjusted life year (QALY) associated with rhTSH. Clinical inputs were based on a multi-center, randomized controlled trial comparing remnant ablation success after rhTSH preparation with THW. The additional costs associated with rhTSH were considered relative to the clinical benefits and cost offsets. RESULTS: The additional benefits of rhTSH (0.036 QALY) are achieved with an additional cost of Korean won W961,105, equating to cost per QALY of W26,697,361. Sensitivity analyses had only a modest impact upon cost-effectiveness, with one-way sensitivity results of approximately W33,000,000/QALY. CONCLUSION: The use of rhTSH is a cost-effective alternative to endogenous hypothyroid stimulation prior to radioiodine ablation for patients who have undergone thyroidectomy in Korea.

Incidence and Prevalence of Overt Hypothyroidism and Causative Diseases in Korea as Determined Using Claims Data Provided by the Health Insurance Review and Assessment Service.

BACKGROUND: The incidence and prevalence of overt hypothyroidism have been reported to be 2 to 4/1,000 population/year and 8 to 13/1,000 population, respectively, in foreign countries. As there has been no nationwide survey to obtain data in Korea, the present study investigated the incidence and prevalence of overt hypothyroidism in Korea using claims data provided by the Health Insurance Review and Assessment Service. The proportions of causative diseases for hypothyroidism were also analyzed. METHODS: This study was retrospectively performed with 541,969 Korean patients (92,832 men and 449,137 women), with overt hypothyroidism, treated with thyroid hormone between 2008 and 2012. RESULTS: The incidence of overt hypothyroidism in Korea was 2.26/1,000 population/year (0.78 in men and 3.72 in women), and the prevalence was 14.28/1,000 population (4.40 in men and 24.03 in women). When patients with thyroid cancer were excluded, the incidence was 1.56/1,000 population/year (0.54 in men and 2.57 in women). The incidence increased with age, with peaks in and after the late 60s in men and in the early 50s in women. The prevalence peaked in the early 70s in men and in the late 50s in women. CONCLUSION: This is a report of the first nationwide investigation of the incidence and prevalence of overt hypothyroidism in Korea, although it is limited to patients treated with thyroid hormone.

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.

Shock wave lithotripsy versus ureteroscopy for ureteral calculi: a prospective assessment of patient-reported outcomes.

OBJECTIVE: To compare patient-reported outcomes (PROs) with objective outcomes after shock wave lithotripsy (SWL) and ureteroscopic surgery (URS) for ureteral calculi (UC). METHODS: We prospectively evaluated 160 consecutive patients who underwent SWL (n = 65) or URS (n = 95) for a single radiopaque UC ranging from 4 to 15 mm. For patients who underwent URS, a 6-Fr double-J stent was routinely placed for 2 weeks after surgery. To examine PRO, we used a self-administered nonvalidated questionnaire evaluating overall satisfaction and PRO in four domains (pain, hematuria, voiding symptom, and time to return to routine activity) and willingness to undergo the treatment procedure again. Propensity-score matching analysis was performed to adjust for potential confounding by discrepancy of pretreatment parameters between groups. Stone-free rates (SFRs) and complications were also compared. RESULTS: SFRs after the first, second, and third sessions of SWL were 61.5, 81.0, and 93.5%, respectively. SFR after URS was 100%, which was significantly better than SFRs for third-session SWL (p = 0.023). Complications were comparable. By propensity-score matching analysis, overall satisfaction was similar between groups, whereas PRO for voiding symptom and time to return to routine activity were significantly better in the SWL group (all p < 0.05). The two groups were not different in willingness to undergo the same procedure again. CONCLUSIONS: Despite significantly higher SFR after URS for UC, overall patient satisfaction was comparable after SWL and URS, meanwhile PRO of the SWL group was better than URS for voiding symptom and time to return to routine activity. In addition of objective treatment outcomes, PROs should be considered in counseling treatment methods for UC.

Quality assessment of randomized controlled trials published in the korean journal of urology over the past 20 years.

PURPOSE: Because low-quality trials may lead to erroneous conclusions, quality assessments are necessary. Thus, in this study, we scrutinized randomized controlled trials (RCTs) published in the Korean Journal of Urology (KJU) to assess their quantity and quality. MATERIALS AND METHODS: Upon extracting RCTs from all articles published in the KJU from 1991 to 2010, assessments were made on the basis of the Jadad scale and the adequacy of allocation concealment. The selections and assessments were performed independently by two researchers, and adjustment of the differences was done by a third-party researcher. In addition, the factors that may affect quality were analyzed. RESULTS: A total of 3,516 original articles were searched and 28 RCTs were extracted. In the 1990s, RCTs constituted only 0.27% of the total original articles, but in the 2000s, RCTs constituted 1.34%. The mean total Jadad score increased from 1.6 points in the 1990s to 1.65 points in the 2000s. However, the percentage of "good quality" trials also increased from 20% to 30.43%. As for adequate allocation concealment, one study was observed in the 2000s. The aspect most lacking was appropriate dropout and double-blinding. Studies with medical interventions or funded or examined by institutional review boards tended to receive higher quality assessments. CONCLUSIONS: Although RCTs consistently increased in both quantity and quality, in future studies, researchers should continue to strive toward achieving adequate allocation concealment and appropriate double-blinding. In addition, researchers must become more interested in receiving external funding and undergoing examination by institutional review boards.

Three-day continuous glucose monitoring for rapid assessment of hypoglycemic events and glycemic variability in type 1 diabetic patients.

This study was to determine whether glycemic variability is related to hypoglycemic events in type 1 diabetic patients, and whether the hypoglycemic events during a short-term continuous glucose monitoring system (CGMS) period parallel those measured during a 4-week self-monitoring of blood glucose (SMBG) period. We also evaluated whether glycemic variability indexes from a short-term CGMS correlate with those from a 4-week SMBG. A total of 49 type 1 diabetic patients wore CGMS devices for 3 days. These patients also performed SMBG for 4 weeks. Several indexes from the CGMS data were compared with indexes from the SMBG data. Hypoglycemic events (glucose levels <70 mg/dL) that occurred during the 3-day CGMS and 4-week SMBG periods were evaluated and compared. Hypoglycemic events were detected in 33 patients (67%) during the 3-day CGMS period. The patients with hypoglycemic events had a significantly higher glycemic variability index divided by mean glucose of CGMS, and a higher number of hypoglycemic events during the 4-week SMBG, compared to those with non-hypoglycemic events during the 3-day CGMS period. The percentage of hypoglycemic events using the 3-day CGMS was correlated with that from the 4-week SMBG (r=0.49, P<0.05) and low blood glucose index (r=0.51, P<0.05). The glycemic variability indexes from the 4-week SMBG correlated with the glycemic variability indexes from the 3-day CGMS. The short-term CGMS appears to be clinically useful for rapidly assessing the risk of hypoglycemic events and glycemic variability.