Trials In Urology Research Articles

The current status and global trends of clinical trials related to robotic surgery: a bibliometric and visualized study.

Conducting clinical trials can evaluate the effectiveness and safety of surgical robots. To promote the advancement of academic robotic programs in surgery, this study captures the development trend and research hotspots of clinical trials related to surgical robots by bibliometric analysis. Bibliometrix package in R software was used to analyze the publication year, authors, countries, institutes, and journals. The visualization maps of keywords were formed using VOSviewer. The keywords with the strongest citation bursts and the institutional collaboration map were created by CiteSpace. Urology dominates with 31.3% of publications and the controlled clinical trials in urology and orthopedic accounted for the highest proportion, reaching 73%. North America, the USA, and Seoul National University lead in productivity. The most productive country, region and institution are North America, USA and Seoul National University, respectively. The trend of collaboration is regional instead of international. Keyword and burst keyword analysis revealed a primary focus in clinical research on robotic surgery: evaluating process improvements, comparing robotic and traditional surgery, and assessing feasibility. Long-term clinical trials assess surgical robots not only intraoperative performance but also postoperative complications and overall surgical outcomes. The development in the field is unbalanced between regions and countries. To promote multi-center clinical trials, governments can streamline review procedures and establish international consensus review standards, while academic institutions can form academic alliances. Also, the study offers recommendations for the development of academic robotic programs and regional collaboration units in robotic surgery, which may provide researchers with a strong reference for future research.

Paradigm-shifting, Practice-changing Clinical Trials in Urology (P2)

Paradigm-shifting, Practice-changing Clinical Trials in Urology (P2)

MP21-10 SEX BIAS IN CONTEMPORARY CLINICAL DRUG TRIALS IN UROLOGY

You have accessJournal of UrologyCME1 Apr 2023MP21-10 SEX BIAS IN CONTEMPORARY CLINICAL DRUG TRIALS IN UROLOGY Andres Guillen Lozoya, Candace Granberg, Vidit Sharma, Patricio Gargollo, and Kevin Koo Andres Guillen LozoyaAndres Guillen Lozoya More articles by this author , Candace GranbergCandace Granberg More articles by this author , Vidit SharmaVidit Sharma More articles by this author , Patricio GargolloPatricio Gargollo More articles by this author , and Kevin KooKevin Koo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003246.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Despite federal policies to foster equal representation of female and male participants, sex bias remains common in clinical trial enrollment, leading to underrepresentation of women among trial participants. The extent of sex bias in clinical trials in urology is not well characterized. This study aimed to evaluate enrollment rates by sex for clinical trials leading to new drug approvals in urology. METHODS: We retrospectively reviewed the US Food and Drug Administration database for new drug approvals for urological indications from 2016 through 2021. Published trials that supported these approvals were analyzed to determine enrollment rates of female participants. The sample was grouped and analyzed by demographic and clinical variables. To assess sex bias, we defined a “sex-matching ratio” as the proportion of female to male trial enrollees, where a ratio of 1.0 would indicate equal numbers of women and men. A ratio ≥0.9 was considered “optimal” based on prior published studies. RESULTS: Of a total of 20 trials supporting novel drugs in urology, 6 were excluded due to sex-specific conditions, leaving a total of 14 trials that enrolled 10,875 female and male participants. The clinical indications in the trials included urinary tract infection (4 trials, 29%), urothelial carcinoma (4 trials, 29%), renal cell carcinoma (1 trial,7%), and overactive bladder (1 trial, 7%). Women accounted for 43% of the total sample and had significantly less enrollment in trials for cancer indications; women were only 26% of enrollees in urothelial and renal cancer trials vs 45% in non-cancer trials (p<0.001). Five trials (36%) enrolled more women than men overall; however, the participants in these majority-women trials (3,215) only comprised 30% of total enrolled sample. In terms of sex bias, 7 of the trials (50%) achieved an optimal sex-matching ratio ≥0.9. Among the other 7 trials with suboptimal sex-matching ratios, 1 trial had a ratio of 0.75, while the remaining 6 trials had ratios <0.5 (range 0.26-0.42), indicating that women accounted for less than half the number of men in these trials. The total enrollees in the 7 trials with suboptimal sex-matching ratios was 6,728; of these, women (1,962) accounted for just 29% of the sample. CONCLUSIONS: Sex bias is common in contemporary clinical trials for new drugs in urology. In half the trials with the strongest sex bias, women accounted for just 29% of the study population. Renewed efforts are urgently needed to ensure inclusive drug trials in urology. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e289 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andres Guillen Lozoya More articles by this author Candace Granberg More articles by this author Vidit Sharma More articles by this author Patricio Gargollo More articles by this author Kevin Koo More articles by this author Expand All Advertisement PDF downloadLoading ...

How clinical research nursing is shaping the future of urology trials

Nursing research has been developing, particularly over the past 15 years. The role of the clinical research nurse (CRN) is vital because of nurses' high level of patient contact. They are therefore involved in the identification of suitable study participants, initial contacts, enrolment, monitoring and follow-up. The COVID-19 pandemic has emphasised the importance of research to government, the NHS and patients. In this article, the author describes three research studies in which she has taken part and emphasises the importance of research and the role of CRNs in bringing together nursing, medicine and science through the CRN's specialist knowledge and how this particular career choice in nursing is now gaining greater attention and momentum.

MP31-13 DISPARITIES IN RACE AND ETHNICITY REPORTING IN CONTEMPORARY CLINICAL TRIALS LEADING TO NEW DRUG APPROVALS IN UROLOGY

You have accessJournal of UrologyCME1 May 2022MP31-13 DISPARITIES IN RACE AND ETHNICITY REPORTING IN CONTEMPORARY CLINICAL TRIALS LEADING TO NEW DRUG APPROVALS IN UROLOGY Andres Guillen Lozoya, Vidit Sharma, Bradley Leibovich, Candace Granberg, Patricio Gargollo, and Kevin Koo Andres Guillen LozoyaAndres Guillen Lozoya More articles by this author , Vidit SharmaVidit Sharma More articles by this author , Bradley LeibovichBradley Leibovich More articles by this author , Candace GranbergCandace Granberg More articles by this author , Patricio GargolloPatricio Gargollo More articles by this author , and Kevin KooKevin Koo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002580.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Population-based clinical trials are the foundation of new drug development and approval. However, trial participants frequently do not represent the racial and ethnic composition of the population they are intended to emulate. To assess the impact of recent efforts to improve trial diversity in urology, this study aimed to assess race and ethnicity reporting in clinical trials (CT) leading to recent urological drug approvals. METHODS: We retrospectively reviewed US Food and Drug Administration new drug approvals for urological indications from 2015 through 2021. Published trials that supported these approvals were analyzed to determine reporting of participant race and ethnicity. We calculated proportional race/ethnicity reporting after censoring trials that did not report race/ethnicity in part or overall. The sample was clustered and analyzed by demographic and clinical variables. RESULTS: Of 314 new drug trials, a total of 20 were specific for novel therapies in urology with at least 1 race reported as a baseline characteristic. Of the 18,637 trial participants, 17,629 (95%) included race/ethnicity data (Table 1): 72% White, 15% Asian, 6% Black, 1% Native American, and 6% other unspecified race. Of the total participant sample, only 7,653 (41%) had reported ethnicity; of these, 19% were reported as Hispanic. We found significant differences in reporting rates for participant race and ethnicity rates among trials (p <0.01). The proportional representation of race/ethnicity among trial participants was compared to US population data from the 2020 Census; White participants were significantly overrepresented in drug trials relative to the overall population (72% vs 58%), while Black participants were significantly underrepresented (6% vs 12%; p <0.001). CONCLUSIONS: Despite efforts to improve the racial and ethnic diversity of clinical trial participants, gaps in race/ethnicity reporting and disparities in representation persist in urological drug trials. Non-White trial participants remain underrepresented relative to the US population for drugs targeting cancer and non-cancer conditions. Renewed efforts are urgently needed to ensure inclusive drug trials in urology. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e527 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andres Guillen Lozoya More articles by this author Vidit Sharma More articles by this author Bradley Leibovich More articles by this author Candace Granberg More articles by this author Patricio Gargollo More articles by this author Kevin Koo More articles by this author Expand All Advertisement PDF DownloadLoading ...

The placebo and nocebo effects in functional urology.

A placebo is an inert substance normally used in clinical trials for comparison with an active substance. However, a placebo has been shown to have an effect on its own; commonly known as the placebo effect. A placebo is an essential component in the design of conclusive clinical trials but has itself become the focus of intense research. The placebo effect is partly the result of positive expectations of the recipient on the state of health. Conversely, a nocebo effect is when negative expectations from a substance lead to poor treatment outcomes and/or adverse events. Randomized controlled trials in functional urology have demonstrated the importance of the placebo and nocebo effects across different diseases such as overactive bladder, urinary incontinence, lower urinary tract symptoms and interstitial cystitis/painful bladder syndrome, as well as male and female sexual dysfunction. Understanding the true nature of the placebo-nocebo complex and the scope of its effect in functional urology could help urologists to maximize the positive effects of this phenomenon while minimizing its potentially negative effects.

Reviving Cav1.2 as an attractive drug target to treat bladder dysfunction.

Inhibition of bladder contraction with antimuscarinics is a common approach to treat bladder hyperactivity, and the L-type voltage-gated calcium channel α1C (Cav1.2) is crucial for bladder contractility. Therefore, strategies aimed at inhibiting Cav1.2 appear warranted. However, multiple clinical trials that attempted to treat bladder overactivity with calcium channel blockers (CCBs) have been unsuccessful, creating an unsolved mystery. In contrast, cardiologists and epidemiologists have reported strong associations between CCB use and bladder hyperactivity, opposing expectations of urologists. Recent findings from our lab offer a potential explanation. We have demonstrated that ketamine which can cause cystitis, functions, like nifedipine, as a Cav1.2 antagonist. We also show that a Cav1.2 agonist which potentiates muscle contraction, rather than antagonizing it, can increase the volume of voids and reduce voiding frequency. This perspective will discuss in detail the unsuccessful urological trials of CCBs and the promise of Cav1.2 agonists as potential novel therapies for bladder dysfunctions.

Are randomized controlled trials in urology being conducted with justification?

Considering the substantial increase in research funding in the field of urology, minimizing research wasteshould be a top priority. Systematic reviews (SRs) compile available evidence regarding a clinical question into a single critical resource. If properly utilized, SRs can help minimize redundant studies, focus attention to unsubstantiated treatments, and reduce research waste. To appraise the use of SRs as justification for conducting randomized controlled trials (RCTs) published in high impact urology journals, and to report the ways SRs were incorporated into RCT manuscripts published in the top four urology journals by h5 index. On December 13, 2019, a PubMed search was conducted for RCTs published in the top four urology journals according to the Google Scholar h5-index: European Urology, BJU International, The Journal of Urology, and Urology. For an article to be eligible for inclusion in this study, it must have been a full length RCT, published between November 30, 2014, and November 30, 2019 in one of the identified journals, reported only human subjects, and been accessible in English. The following data points were extracted independently by select investigators from each included RCT: manuscript title, year of publication, journal title, type of intervention (drug, medical device, procedure, other), funding source (government, hospital/university, industry, mixed) type of trial (parallel groups, crossover, cluster), and total number of participants reported in each RCT. The included RCTs were searched for reference to an SR, which was then recorded as "yes- verbatim," "yes- inferred," or "not used as justification" and the location in the manuscript where the SR was cited was recorded. Of the 566 articles retrieved, 276 were included. Overall, 150 (54.3%) RCTs cited an SR as either verbatim (108; 39.1%) or inferred (42; 15.2%) trial justification, while 126 (45.7%) did not use an SR for RCT justification. Of those 126, 107 (84.9%) RCTs did not cite an SR to any extent. A significant association was noted between verbatim justification and type of intervention (x 2=20.23, p=0.017), with 18 of 31 (58.1%) "other" interventions (i.e. psychosocial intervention, exercise programs, and online therapy) having an SR cited as verbatim justification. Only 39 of 118 (33.1%) pharmaceutical trials referenced an SR as verbatim justification. Of 403 systematic review citations, 205 (50.8%) appeared in the Discussion section, while 15 (3.7%) were in the Methods section. We found that RCTs published in four high impact urology journals inconsistently referenced an SR as justification and 39.1% of our entire sample did not reference an SR at all. These findings indicate that a divide exists between the instruction and implementation of evidence based medicine in the field of urology concerning RCTs published in the top four journals. Educating clinicians and researchers on the use of SR as justification for RCTs in urology may reduce research waste and increase the quality of RCTs in the field.

Clinical Trial Outcomes in Urology: Assessing Early Discontinuation, Results Reporting and Publication in ClinicalTrials.Gov Registrations 2007-2019.

Clinical trials require significant resources, but benefits are only realized after trial completion and dissemination of results. We comprehensively assessed early discontinuation, registry results reporting, and publication by trial sponsor and subspecialty in urology trials. We assessed trial registrations from 2007 to 2019 on ClinicalTrials.gov and publication data from PubMed®/MEDLINE®. Associations between sponsor or subspecialty with early discontinuation were assessed using Cox proportional hazards and results reporting or publication with logistic regression at 3 years after completion. Of 8,636 trials 3,541 (41.0%) were completed and 999 (11.6%) were discontinued. Of completed trials 26.9% reported results and 21.6% were published. Sponsors included academic institutions (53.1%), industry (37.1%) and the U.S. government (9.8%). Academic-sponsored (adjusted HR 0.81, 95% CI 0.69-0.96, p=0.012) and government-sponsored trials (adjusted HR 0.62, 95% CI 0.49-0.78, p <0.001) were less likely than industry to discontinue early. Government-sponsored trials were more likely to report (adjusted OR 1.72, 95% CI 1.17-2.54, p=0.006) and publish (adjusted OR 1.89, 95% CI 1.23-2.89, p=0.004). Academic-sponsored trials were less likely to report (adjusted OR 0.65, CI:0.48-0.88, p=0.006) but more likely to publish (adjusted OR 1.72, 95% CI 1.25-2.37, p <0.001). These outcomes were similar across subspecialties. However, endourology was more likely to discontinue early (adjusted HR 2.00, 95% CI 1.53-2.95, p <0.001), general urology was more likely to report results (adjusted OR 1.54, 95% CI 1.13-2.11, p=0.006) and andrology was less likely to publish (adjusted OR 0.53, 95% CI 0.35-0.81, p=0.003). Sponsor type is significantly associated with trial completion and dissemination. Government-sponsored trials had the best performance, while industry and academic-sponsored trials lagged in completion and results reporting, respectively. Subspecialty played a lesser role. Lack of dissemination remains a problem for urology trials.

Clinical Trials in Urology: Predictors of Successes and Failures.

Clinical trials serve as a critical source of information to guide evidence-based practices in urology. Conversely, trials that are abandoned consume significant resources and results are underreported in the literature. ClinicalTrials.gov was queried for urology trials from 2006 to 2016. Trials were screened by 2 screeners for applicability to urology and disputes were resolved by a third independent reviewer. Overall 1,340 trials met final inclusion criteria (722 successful trials, 618 failed trials). Univariable analysis used Fisher's exact, chi-squared and Wilcoxon rank sum tests. Trial characteristics, including AUA (American Urological Association) section, phase, subspecialty, intervention type, source of funding and randomization were examined for association with failure using multivariable logistic regression. Trial failure is associated with oncology subspecialty (adjusted odds ratio 2.25, 95% CI 1.60-3.18), infertility/andrology subspecialty (AOR 4.99, CI 1.60-17.61), device trials (AOR 1.64, CI 1.00-2.70) and combination funding by industry/government/grants (AOR 3.13, CI 2.21-4.48). Clinical trials in AUA sections were less likely to fail than international and multisectional trials. Among trials that failed, poor accrual was the primary reason for trial failure, comprising 41% of all failures. Other reasons for failure include inadequate budget (9%), sponsor cancellation (7%), poor interim results (7%) and toxicity (3%). Despite their significance, many urological trials fail prematurely due to poor accrual. Complex features inherent to oncology, andrology/infertility, devices and multisectional trials pose significant barriers to success.

Variation in Accrual and Race/Ethnicity Reporting in Urological and Nonurological Related Cancer Trials.

We performed a multiregistry analysis to assess relative differences in accrual sufficiency and race/ethnicity reporting in trials of common urological cancers and other nonurological solid organ tumors. We queried ClinicalTrials.gov and the ISRCTN (International Standard Randomised Controlled Trial Number) Registry for closed phase III and IV trials focused on prostate, colorectal, kidney, bladder, testicular, breast and lung cancer. Identified trials were cross-verified with appropriate published data sources. Comparative accrual sufficiency and rates of race/ethnicity reporting were calculated. Multivariable logistic regression analysis was performed to determine factors associated with accrual status and race/ethnicity reporting. A total of 326 trials were identified based on our prespecified criteria, of which 63% reported sufficient accrual by time of closure and 58% reported data by race/ethnicity. Nonurological trials were significantly more likely to mention race data than urological trials (OR 3.25, 95% CI 1.24-8.55, p = 0.02). Industry sponsored trials were more likely to meet accrual targets than government funded projects (OR 5.44, 95% CI 1.64-18.20, p = 0.001). Although funding source did not influence race reporting, the reported recruitment of participants of African ethnicity was lower in industry sponsored trials (11.49% vs 3.18%, p <0.01). Two-thirds of the studies did not report baseline characteristics by African American race/ethnicity. Insufficient accrual and inadequate race/ethnicity reporting are prevalent issues, limiting interpretation of the results of clinical trials of major solid organ malignancies. Addressing these shortcomings would enhance result validity by raising statistical power and improving the transparency of reporting to better evaluate the generalizability of results.

Abiraterone +/- cabazitaxel in defining complete response in prostatectomy (ACDC-RP) trial.

TPS5095 Background: Given recent advances in the management of de novo metastatic hormone-sensitive prostate cancer with both docetaxel and abiraterone, as well as evidence of significant activity of cabazitaxel in the post-abiraterone castrate-resistant setting, we hypothesized that the addition of cabazitaxel to neoadjuvant abiraterone will improve pathological complete response rates by overcoming mechanisms of resistance in localized high-risk prostate cancer. Aim: To determine the relative efficacy of the addition of cabazitaxel to abiraterone in the neoadjuvant treatment of prostate cancer to achieve a complete response. Methods: Open label, randomized, 2-arm multi-centre, phase 2 clinical trial. Primary endpoint: Pathological complete response rate (pCR). Secondary endpoints: surgical outcomes (positive margins, extracapsular extension, seminal vesicle or nodal involvement), pharmacodynamic markers in residual tumour (apoptosis, androgen receptor expression, localization, and signaling), biomarkers (intra-prostatic androgen levels), and safety. Design: Study participants will be randomized in a 1:1 ratio to receive either: Arm A: Abiraterone (1000 mg/day), prednisone (5 mg b.i.d.), leuprolide (22.5 mg s.c. every 3 months), and cabazitaxel (25 mg/m2 starting at week 2, with 6 mg pegfilgrastim 24 h following cabazitaxel) or Arm B: Abiraterone (1000 mg/day), prednisone (5 mg b.i.d.) and leuprolide (22.5 mg s.c. every 3 months). Assessments will take place biweekly for the first 12 weeks, then monthly until the prostatectomy (scheduled for 24 weeks following start of treatment). Target accrual is 88 participants within 36 months. Study is powered to detect a 15% difference with 85% power, assuming a one-sided type 1 error rate of 20%. A 6 patient safety run-in is included. As of Jan 2017, 1 site is open in Canada, with 4 additional Canadian sites and 1 site in Australia pending. To date, 4 participants are randomized and undergoing treatment. ACDC-RP is an investigator-initiated trial led by the Princess Margaret Urology Trials Group with funding from Ontario Institute for Cancer Research (OICR) and in-kind contributions from Janssen and Sanofi. Clinical trial information: NCT02543255.

Improved Reporting of Randomized Controlled Trials in the Urologic Literature

BackgroundWell-designed randomized controlled trials (RCTs) have the potential to provide high-quality evidence to inform questions of therapy and prevention, but this potential is contingent on the use of appropriate methods and transparent reporting. ObjectiveTo systematically assess the quality of urology RCT reporting and identify trends over time. Design, setting, and participantsAll RCTs published in four leading urology journals in 2013 were identified and compared to a prior analysis of studies from 1996 and 2004. Two reviewers abstracted data based on the Consolidated Standards of Reporting Trials (CONSORT) checklist. Outcome measurements and statistical analysisA summary reporting score (range: 0–22) for each study was determined. Mean overall scores for 1996, 2004, and 2013 were compared using analysis of variance. We used χ2 to compare the reporting frequency of individual criteria. Results and limitationsMean CONSORT scores for RCTs were 15.6±2.0 in 2013 (n=82), 12.0±0.3 in 2004 (n=87), and 10.2±0.3 in 1996 (n=65); p<0.01. Key deficiencies remain in reporting methods of allocation concealment and group assignment (selection bias), and blinding of participants, personnel, and outcome assessors (performance and detection bias). Study limitations are potential reviewer bias resulting from lack of journal deidentification and the relatively low number of studies reviewed. ConclusionsThere has been a substantial improvement in reporting quality of RCTs in urology since CONSORT. Some methodological criteria remain underreported, and increased efforts are necessary to further this improvement. Patient summaryTreatment decisions are often based on data from randomized controlled trials. We looked at whether these trials in urology are transparent in reporting their design and conduct using a framework known as the CONSORT criteria and found significant improvements over time. Some areas of deficiency remain, and our paper aimed to highlight these drawbacks to promote continued high-quality research.

Commentary to “Barriers to participation in surgical randomized controlled trials in pediatric urology: A qualitative study of key stakeholder perspectives”

As pediatric urologists and active clinical investigators, it is with great interest that we read the recently published paper “Barriers to participation in surgical randomized controlled trials in pediatric urology: a qualitative study of key stakeholder perspectives” by Vemoulakonda and Jones [1] in the Journal. This is a unique, single-center study providing qualitative perspectives in the typically quantitatively dominated field of pediatric urology research. The authors provide an important basis to understand potential parental and healthcare provider barriers to enroll children in randomized controlled trials (RCTs). With these perceived obstacles in mind, investigators may be able to modify recruitment strategies in such a way that it may facilitate enrollment and increase participation. While this is undoubtedly a significant contribution to the literature, the authors base their study [1] on the assumption that pediatric urology surgical trials suffer from similarly low recruitment rates as those seen in adult surgical oncology trials [2]. Although reasonable, this simply may not always be the case. A clear example of high recruitment within pediatric urology surgical trials can be seen in the currently ongoing “Expertise-Based Randomized Controlled Trial of Scrotal Versus Inguinal Orchidopexy on Post-operative Pain” (NCT02158780), where, to date, 41 of 50 (82%) eligible patients have been recruited to participate [3]. Another example of reasonably high recruitment rate is seen in the challenging setting of a placebo control versus antibiotic prophylaxis for infants with highgrade prenatal hydronephrosis [4]. A 57% recruitment rate has been achieved thus far, providing further proof that RCTs are a feasible (and needed) study design in pediatric

Barriers to participation in surgical randomized controlled trials in pediatric urology: A qualitative study of key stakeholder perspectives

Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. However, pediatric surgical RCTs have been limited in their ability to recruit patients. The purpose of this study was to identify barriers and motivators to pediatric participation in surgical RCTs. We conducted a series of two focus groups with parents and one focus group with urology providers for children aged <2 years of age with a diagnosis of Society for Fetal Urology grade 3 or 4 hydronephrosis. We then administered a survey to referring pediatricians based on the initial analysis of focus group findings. Theme analysis was used for all qualitative transcribed text data obtained from focus groups and open-ended survey questions using team-based inductive approaches. Descriptive statistics were obtained for the remainder of the provider survey. Using qualitative text from stakeholders (n=38) we identified four key themes across the data: responsibility to my child; responsibility to my patient; responsibility to the field; and irreversibility of surgery. Participants felt there was an obligation to be informed of relevant scientific research within a clinic research culture. However, there remains a disconnect for parents between randomized research studies that may ultimately benefit their child, depending on their age and concern their child is being treated as a 'guinea pig'. Some parents were willing to participate in RCTs but all were more open to participate in an observational study where the treatment decisions were felt to be under their control even when there was no "right answer" or multiple equivalent options for treatment. There was mixed opinion across the parents and providers whether research trial education and enrollment should be provided by the pediatrician or urologist. Active physician decisions were seen as critical within the context of a long term clinical relationship and provision of information of risks and benefits without pressure were considered essential for ethical research by both parents and providers. While some parents are open to participation in surgical RCTs, providers and parents of children with hydronephrosis feel discomfort with the element of chance in surgical randomized trials. Parents and providers are more likely to participate in observational studies where treatment decisions may be made jointly by the physician and the parent. These findings suggest that pragmatic trial strategies with the option for participation in an observational cohort may improve recruitment of pediatric patients into surgical clinical trials.

Clinical trials in urology

Clinical trials in urology

Assessing the Quality of Randomized Controlled Urological Trials Conducted by Korean Medical Institutions

PurposeTo assess the quality of randomized controlled urological trials conducted by Korean medical institutions.Materials and MethodsQuality assessment was conducted by using the Jadad scale; in addition, the van Tulder scale and the Cochrane Collaboration risk of bias tool were used as individual indices. All assessments were performed by two reviewers. If the outcomes differed, the two reviewers and a third reviewer adjusted the discrepancy in the results through discussion. Starting from 1986, a quality analysis of randomized controlled trials (RCTs) was conducted in 1-year and 5-year units. The quality assessment was conducted by subject, type of intervention, presence of double blinding, presence of funding, and review by an Institutional Review Board (IRB).ResultsWhereas the number of RCTs published has gradually increased, there was no significant difference in the quality of the RCTs according to publication year. Drug studies, double-blind studies, studies with funding, and studies reviewed by IRBs had higher quality scores and a higher percentage of high-quality RCTs than did other studies. Thirty-six RCTs were published in journals included in the Science Citation Index and 20 RCTs were published in journals included in the Science Citation Index Expanded. The largest number of RCTs (32.32%) were published by the Korean Journal of Urology.ConclusionsA quantitative increase was observed in RCTs over time, but no qualitative improvement in the RCTs was observed. It seems necessary to put effort into the quality improvement of RCTs at the design stage.

GRIST: Growing Recruitment in Interventional and Surgical Trials

GRIST: Growing Recruitment in Interventional and Surgical Trials

Das urologische Studienregister der DGU

Germany is an important hub for urological research and clinical trials are therefore very important for evidence-based medicine. In September 2010, the German Society of Urology commissioned a subject-specific clinical trial registry. The broad overview of ongoing and completed clinical trials in urology should help to increase transparency in research and to deploy resources in health care more efficiently. The urological trial registry aims to negotiate cooperation with a national primary registry to allow an automatic inclusion in the WHO Registry Network and to enable an ICMJE-compliant registry.

The role of randomized controlled trials in evidence-based urology

To review the current and future role of randomized controlled trials (RCTs) in urology. A review of the urological literature was performed to assess the current role of RCTs in urology. These findings were put in context of current practice, and methodologic limitations of observational study design were discussed. Several RCTs have improved treatment of urology patients. However, overall, few studies in the urologic literature convey high-level evidence. RCTs represent the only study design that can assess causality, thus are the only means to significantly advance knowledge about therapy and improve patient care. Increased incidence and improved quality of RCTs may be achieved through education, community outreach, and better access to research infrastructure. RCTs have significantly improved urologic practice. RCTs are superior to observational studies because of decreased risk of bias and confounding. To further advance clinical practice, clinical trials must play a predominant role and should be embraced by the urology community.