Strong Conflict of Interest Policies are not Associated With Decreased Industry Payments to Academic Urology Departments.

OBJECTIVE: To identify whether institutions with strong conflicts of interest (COI) policies receive less industry payments than those with weaker policies. While industry-physician interactions can have collaborative benefits, financial COI can undermine preservation of the integrity of professional judgment and public trust. To address this concern, academic institutions have adopted COI policies. It is unclear whether the strength of COI policy correlates with industry payments in urology. MATERIALS AND METHODS: 131 US academic urology programs were surveyed on their COI policies, and graded according to the American Medical Student Association (AMSA) criteria. Strength of COI policy was compared against industry payments in the Center for Medicare and Medicaid Services Open Payments database. RESULTS: Fifty-seven programs responded to the survey, for a total response rate of 44%. There was no difference between COI policy groups on total hospital payments (P = .05), total department payments (P = .28), or dollars per payment (P = .57). On correlation analysis, there was a weak but statistically nonsignificant correlation between AMSA Industry Policy Survey Score and Open Payments payments (ρ = -0.14, P = .32). CONCLUSION: Strength of conflicts of interest policy in academic urology did not correlate to industry payments within the Open Payments database. Establishment of strong COI policy may create offsetting factors that mitigate the intended effects of the policy. Further studies will be required to develop the evidence base for policy design and implementation across various specialties.

Contemporary Assessment of Match Violations within Urology: an Opportunity for Ethical Leadership.

PURPOSE OF REVIEW: The primary aim of this review is to: (1) adequately define Match violations, (2) thoroughly examine the nature and scope of Match violations in the American Urologic Association (AUA) Urology Match, and (3) propose and recommend policy guidelines, including consequences for applicants and programs, as it pertains to Match violations. These recommendations are intended to affect change at the level of the AUA and Society of Academic Urology (SAU) that more effectively mitigates future violations, intentional or not. RECENT FINDINGS: There is a paucity of specific guidelines published by the AUA on what constitutes a Match violation. Furthermore, in contrast to the National Resident Matching Program (NRMP), the AUA is surprisingly lenient in their existing guidelines. The Match violations most frequently reported were programs asking applicants illegal and restricted questions as well as inappropriate post-interview communication between applicants and programs. Review of current Match policies and violations suggest several areas for improvement, particularly regarding the specificity of AUA guidelines to define Match violations, the asking of illegal interview questions, and post-interview communication. The obligation to uphold a fair and equitable Match is an ethical imperative for the urologic community.

Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines.

BACKGROUND: Recent studies have highlighted the presence of disclosed and undisclosed financial conflicts of interest among authors of clinical practice guidelines. OBJECTIVE: We sought to determine to what extent urology guideline authors receive and report industry payments in accordance with the Physician Payment Sunshine Act. DESIGN, SETTING, AND PARTICIPANTS: We selected the 13 urology guidelines that were published by the American Urological Association (AUA) after disclosure was mandated by the Physician Payment Sunshine Act. Payments received by guideline authors were searched independently by two investigators using the Open Payments database. OUTCOME MEASURES AND STATISTICAL ANALYSIS: Our primary outcome measure was the number of authors receiving payments from industry, stratified by amount thresholds. Our secondary outcome measure was the number of authors with accurate conflict of interest disclosure statements. RESULTS AND LIMITATIONS: We identified a total of 54 author disclosures. Thirty-two authors (59.3%) received at least one payment from industry. Twenty (37.0%) received >$10 000 and six (11.1%) received >$50 000. Median total payments were $578 (interquartile range $0-19 228). Twenty (37.0%) disclosure statements were inaccurate. Via Dollars for Docs, we identified $74 195.13 paid for drugs and devices directly related to guideline recommendations. We were limited in our ability to determine when authors began working on guideline panels, as this information was not provided, and by the lack of specificity in Dollars for Docs. CONCLUSIONS: Many of the AUA guideline authors received payments from industry, some in excess of $50 000. A significant portion of disclosure statements were inaccurate, indicating a need for more stringent enforcement of the AUA disclosure policy. PATIENT SUMMARY: Pharmaceutical company payments to doctors have been shown to influence how doctors treat patients. If these doctors are charged with making clinical recommendations to other doctors, in the form of clinical practice guidelines, the issue of industry payments becomes more severe. We found that many urologists on guideline panels receive money from industry and that a significant portion did not disclose all payments received.

Performing in the surgical amphitheater of today: perception of urologists conducting live case demonstrations.

PURPOSE: To evaluate the perception of urologists who have participated in live case demonstrations (LCDs) regarding safety, educational value/benefits, and ethics. METHODS: A 19-question anonymous survey was sent to urologists who performed and/or moderated LCDs at the World Congress of Endourology meetings from 2008 to 2012. E-survey was distributed via e-mail, and automatic reminders were sent 2 weeks after original distribution if no response was obtained. RESULTS: Eighty-one percent (92/113) of the urologists responded to the survey of whom 75% practice full time in an academic setting. Only 48.0% were fellowship trained, however. More than 60% had performed more than five LCDs at their home and/or away institutions. Performing LCD at an away institution was associated with a higher level of anxiety when compared with performing LCDs at a home institution (79.8% vs 34.6%; P<0.01). Respondents considered film equipment and crew; audience and moderator discussions; unfamiliar team, instruments and tools; language barrier; and having to narrate the procedure, as distractors. Seventy-nine percent considered LCD as an ethical practice, and 90.5% regarded LCDs as a "beneficial" and a "great way" to educate. Similarly, considering the various factors and conditions associated with LCDs, 95% would agree to participate in another LCD. CONCLUSION: LCDs are perceived to be an effective mode of education by performers and moderators of LCDs. Standard guidelines and policies are needed, however, for the selection of patient, surgeon and team, equipment, and facility. Studies are needed to evaluate the impact of this education process.

Regenerative urology clinical trials: an ethical assessment of road blocks and solutions.

Tissue engineering--part of regenerative medicine--is a promising technology that could potentially offer elegant solutions to urogenital defects, but so far, it has fallen short of its potential. Within experimental studies for bladder and urethra reconstructions, two clinical applications have been described, but extension of these techniques to the broader urological patient population has not happened so far. In this article, we aim to identify the ethical road blocks in the clinical evaluation of tissue-engineered products under the European Medicines Agency and Food and Drug Administration regulations for pediatric urological conditions and, ultimately, to recommend strategies to overcome them. The use of human tissue-engineered products (HTEPs) to treat children with congenital urogenital defects poses challenges in the clinical testing phase, connected to three features of the application of this treatment in this patient group: (1) those associated with the product, namely, the multifaceted complexity of the HTEP; (2) those connected to the procedure, namely, the lack of a randomized controlled trial (RCT)-tested gold standard to compare the new treatment to and difficulties surrounding standardization of the treatment protocol; and (3) the patient's young age and associated problems concerning possible long-term effects and the informed consent process. Due to these problems, a conventional RCT is not the methodology of choice to evaluate this treatment in this patient group. The unpredictability of HTEPs necessitates stringent and long-term surveillance and registry to ensure the safety of patients treated with these products.