Large reduction in opioid prescribing by a multipronged behavioral intervention after major urologic surgery.

BACKGROUND: Surgeons play a pivotal role in combating the opioid crisis that currently grips the United States. Changing surgeon behavior is difficult, and the degree to which behavioral science can steer surgeons toward decreased opioid prescribing is unclear. METHODS: This was a single-institution, single-arm, pre- and postintervention study examining the prescribing of opioids by urologists for adult patients undergoing prostatectomy or nephrectomy. The primary outcome was the quantity of opioids prescribed in oral morphine equivalents (OMEs) after hospital discharge. The primary exposure was a multipronged behavioral intervention designed to decrease opioid prescribing. The intervention had 3 components: 1) formal education, 2) individual audit feedback, and 3) peer comparison performance feedback. There were 3 phases to the study: a pre-intervention phase, an intervention phase, and a washout phase. RESULTS: Three hundred eighty-two patients underwent prostatectomy, and 306 patients underwent nephrectomy. The median OMEs decreased from 195 to 19 in the prostatectomy patients and from 200 to 0 in the nephrectomy patients (P < .05 for both). The median OMEs prescribed did not increase during the washout phase. Prostatectomy patients discharged with opioids had higher levels of anxiety than patients discharged without opioids (P < .05). Otherwise, prostatectomy and nephrectomy patients discharged with and without opioids did not differ in their perception of postoperative pain management, activity levels, psychiatric symptoms, or somatic symptoms (P > .05 for all). CONCLUSIONS: Implementing a multipronged behavioral intervention significantly reduced opioid prescribing for patients undergoing prostatectomy or nephrectomy without compromising patient-reported outcomes.

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.

The Safety and Short-term Outcomes of Leukocyte Depleted Autologous Transfusions During Radical Cystectomy.

OBJECTIVE: To examine long- and short-term outcomes using cell salvage with a commercially available leukocyte depletion filter following radical cystectomy in an oncologic population. MATERIALS AND METHODS: One hundred and fifty-seven patients, 87 of whom received a cell salvage transfusion, were retrospectively identified from chart review. Ninety-day outcomes as well as long-term mortality and cancer recurrence data were collected. Chi-square, Student's t, or Mann-Whitney U tests were used as appropriate. Multivariable regressions of survival were performed with a Cox proportional-hazards model. RESULTS: Those who received a cell salvage transfusion did not show any differences in rate of cancer recurrence (23%) vs those who did not receive a cell salvage transfusion (24%; P = .85). There were also no differences noted in mortality rates between the 2 populations (12% vs 17%; P = .36). Furthermore, no differences were noted in postoperative complication rates, length of hospital stay, 90-day culture positive infections or readmissions (P >.05). CONCLUSION: There are no significant differences in short-term or long-term patient outcomes between those who did and did not receive an intraoperative cell salvage transfusion. Cell salvage transfusions with a leukocyte depletion filter are safe and effective methods to reduce the need for allogeneic blood transfusions while controlling for the theoretical risk of metastatic spread.

Marketing and Testosterone Treatment in the USA: A Systematic Review.

CONTEXT: Testosterone replacement therapy (TRT) is currently approved by the Food and Drug Administration only for classic hypogonadism, although off-label indications have resulted in a dramatic expansion in prescriptions in the USA. Marketing may significantly affect prescriber behavior. OBJECTIVE: To systematically review all available evidence on marketing and TRT in the USA. EVIDENCE ACQUISITION: PubMed, Embase, and Scopus were searched up to July 2017 for all relevant publications reporting on assessments of the TRT market size, economic costs associated with hypogonadism, trends in TRT prescriptions, drug discontinuation rates, and advertising and sales efforts in the USA. EVIDENCE SYNTHESIS: Twenty retrospective studies were included in the final analysis. The market size for hypogonadism constitutes 5.6-76.8% of men in the USA, with the lower end of the range representing the strictest criteria for diagnosis. Men with a diagnosis of hypogonadism consume $14 118 in direct and indirect costs to the payer. Over the last 2 decades, TRT prescriptions have increased between 1.8- and 4-fold. After 1 yr, 80-85% of men discontinue TRT. There is an association between direct-to-consumer advertising and testosterone testing, TRT prescriptions, and TRT without testosterone testing. There is a high prevalence of misinformation on Internet advertising. CONCLUSIONS: Off-label indications have driven the dramatic expansion of TRT prescriptions over the last 2 decades. Direct-to-consumer advertising poses a unique challenge in the USA. Overtreatment can be avoided by applying strict diagnostic criteria for hypogonadism, which limits the addressable market for TRT. PATIENT SUMMARY: In this report, we reviewed the relationship between marketing and testosterone therapy in the USA. We found that many patients are prescribed testosterone without an appropriate diagnosis of hypogonadism, which may be related to the marketing efforts for off-label prescribing.

The lack of a relationship between physician payments from drug manufacturers and Medicare claims for abiraterone and enzalutamide.

BACKGROUND: Interactions between industry and prescribers have raised concerns regarding conflicts of interest. To the best of the authors' knowledge, quantitative data measuring these interactions have been limited until recently. In the current study, the authors sought to determine whether an association exists between industry payments and prescriber behavior with regard to abiraterone and enzalutamide. METHODS: Two Centers for Medicare and Medicaid Services databases were combined to analyze oncologists and urologists who received industry payments and/or prescribed abiraterone and enzalutamide. Correlation analysis was constructed on prescription count and industry payments. Multivariable median regression examined predictors of change in prescription count per dollar of industry payment. Stratifying prescribers by quantile evaluated threshold effects on prescribers. RESULTS: The number of prescriptions was similar between prescribers who did and those who did not receive industry payment for both drugs. The median industry payment amount to prescribers differed between prescribers and nonprescribers for abiraterone ($72 vs $56) and enzalutamide ($59 vs $31). Although no statistical association was found to exist between industry payment amount and prescription count for abiraterone prescribers, an association was found to exist for enzalutamide prescribers (rho = 0.31). A small change was found with regard to prescription count per dollar of industry payment for abiraterone (0.0007 prescriptions) and enzalutamide (0.0006 prescriptions). The amount of industry payment needed to predict one additional prescription was found to be lower in the fourth and fifth quantiles compared with the first through third quantiles. CONCLUSIONS: No difference in prescription count was found to exist between prescribers who received industry payments and those who did not. A positive correlation was noted between industry payments and prescription count for enzalutamide. Ease of adoption may affect differences between the 2 drugs. Cancer 2017;123:4356-62. © 2017 American Cancer Society.

Defining the Rate of Primary Ureteroscopic Failure in Unstented Patients: A Multi-Institutional Study.

PURPOSE: Primary ureteroscopic intervention for kidney or ureteral stones occasionally encounters difficulty with passage of the ureteroscope in the initial procedure. These patients require a second procedure after stenting. We aim to define the contemporary failure rate of primary ureteroscopy (URS) and identify predictive factors that necessitate prestenting. This will assist in preoperative patient counseling, informed consent, and clinical decision-making. MATERIALS AND METHODS: We conducted a multi-institutional retrospective review of 535 unstented patients undergoing primary URS from August 2011 to August 2013. The primary outcome was gaining access to the unstented ureter. RESULTS: The failure rate for accessing the unstented ureter was 7.7% (41/535). The median age of females with primary ureteroscopic failure was significantly lower than in females who had successful ureteroscopic access (34 vs 52 years; p = 0.0041). There was no difference in the median age of males with access vs failure (58 vs 57 years; p = 0.3683). Proximal ureteral stones had the highest failure rate for ureteral access at 18.28% (p = 0.006). On multivariable logistic regression, proximal ureteral stone location remained a significant predictor of failure when compared to renal stones (odds ratio [OR] 3.14, p = 0.006). When including only ureteral stones in the multivariable analysis, stone location in the proximal ureter compared to the distal ureter remained the only significant predictor of access failure (OR 0.24, p = 0.015). CONCLUSIONS: A low overall rate of ureteral access failure in unstented patients is shown. Young female patients and proximal ureteral stones were less likely to be accessed primarily. This study provides information that will help urologists counsel their patients preoperatively regarding their likelihood of failing primary URS necessitating a second procedure. This will also help the patient to make an informed decision during the consent process and may guide urologists on selective prestenting in higher risk patients.

Bipolar Transurethral Incision of Bladder Neck Stenoses with Mitomycin C Injection.

Introduction. To determine the efficacy of bipolar transurethral incision with mitomycin C (MMC) injection for the treatment of refractory bladder neck stenosis (BNS). Materials and Methods. Patients who underwent bipolar transurethral incision of BNS (TUIBNS) with MMC injection at our institution from 2013 to 2014 were retrospectively reviewed. A total of 2 mg of 40% mitomycin C solution was injected in four quadrants of the treated BNS. Treatment failure was defined as the need for subsequent intervention. Results. Thirteen patients underwent 17 bipolar TUIBNS with MMC injection. Twelve (92%) patients had failed a mean of 2.2 ± 1.1 prior endoscopic procedures. Median follow-up was 16.5 months (IQR: 14-18.4 months). Initial success was 62%; five (38%) patients had a recurrence with a median time to recurrence of 7.3 months. Four patients underwent a repeat procedure, 2 (50%) of which failed. Overall success was achieved in 77% (10/13) of patients after a mean of 1.3 ± 0.5 procedures. BNS recurrence was not significantly associated with history of pelvic radiation (33% versus 43%, p = 0.9). There were no serious adverse events. Conclusions. Bipolar TUIBNS with MMC injection was comparable in efficacy to previously reported techniques and did not result in any serious adverse events.

Control of the vertebral artery from a posterior approach: a technical report.

BACKGROUND CONTEXT: Vertebral artery (VA) injury is a rare but potentially devastating complication of cervical spinal fusion. The Magerl and Harms techniques are associated with a rate between 0% to 8% and 0% to 5%, respectively. Most of reported VA injuries are related to surgical exposure or screw placement, which in turn is likely due to variability in VA anatomy. PURPOSE: The purpose of this report was to present the case of a 77-year-old woman, with a history of right VA occlusion, who sustained an intraoperative left VA injury during posterior cervical spine fusion and the subsequent intraoperative and postoperative management strategies. STUDY DESIGN: This is a single-patient case report. METHODS: The patient was placed prone and into Mayfield tongs. A midline incision was made, and dissection was carried down to the lamina and facet joints from occiput to T2. During dissection, she sustained a left-sided VA injury, which was subsequently controlled. RESULTS: The patient was doing well at her 1-year postoperative visit without any residual neurologic deficits. Her severe neck pain had resolved. CONCLUSION: A detailed understanding of VA anatomy of each individual patient is paramount. There are four types of anomalies: intraforaminal; extraforaminal; arterial; and anomalies of the surrounding bony and soft-tissue architecture. In the event of a posterior intraoperative VA injury, we outlined an algorithm to deal with this complication: control bleeding temporarily to gain visualization of the arterial injury; remove lateral masses and tissue to adequately visualize the arterial injury; once visualized, control the bleeding and see if there are any neuromonitoring changes as a result of the VA occlusion; and proceed with definitive control of the artery by either repair or ligation.