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INTRODUCTION: Use of placebo in oncology randomized controlled trials (RCT) is ethically controversial. Placebo may introduce bias, as toxicity profiles of treatment arms can inadvertently unblind subjects and investigators. We investigated the use of placebo in urologic oncology RCTs, hypothesizing that most placebo-controlled trials are effectively unblinded, either explicitly with open-label design or implicitly due to large differences in adverse events (AE) or oncologic outcomes. METHODS: Urologic oncology RCTs utilizing placebo were identified via ClinicalTrials.gov. Interventional prostate, bladder/urothelial, and renal cancer trials from 2014 to 2024 were included. Subject incompletion, all-cause mortality, AE rates, and serious AE (SAE) rates were identified and compared between placebo and active arms using χ2 and Fisher's exact tests. RESULTS: Sixty studies met inclusion criteria and included 66 placebo arms with 12,918 subjects and 81 active arms with 16,098 subjects. There was no significant difference in incompletion rates between placebo and active arms. Subjects enrolled in active arms reported statistically significant higher SAE and AE rates compared to those in placebo arms across the majority of physiological domains, including 18/24 domains for SAEs and 13/24 for AEs. This relationship persisted in sensitivity analyses where unblinded trials were excluded. CONCLUSIONS: In urologic oncology placebo-controlled RCTs, active arms are associated with significantly higher rates of AEs and SAEs compared with placebo arms. These findings indicate a strong possibility that true blinding is not possible in oncology RCTs, even with optimal study design, and serve to better inform future clinical trial design and implementation challenges in employing placebo control.
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INTRODUCTION: Recent AUA guidelines for the management of benign prostatic hyperplasia (BPH) recommend routine collection of the International Prostate Symptom Score (IPSS) data, but routine collection can be challenging to fully implement. We investigated the impact of distributing the IPSS by electronic patient portal (EPP) on IPSS completion and its impact on BPH management. METHODS: We performed a retrospective, longitudinal study of men undergoing a new patient visit (NPV) for BPH at our academic medical center. From September 2019 to November 2022, we identified patients undergoing an NPV for BPH. Prior to January 2021, the IPSS was collected in person at NPVs via paper forms; afterwards, the IPSS was distributed before the NPV using the EPP. Our primary outcome was IPSS completion; secondary outcomes were new BPH medications and BPH surgery ordered within 6 months. RESULTS: We identified 485 patients who underwent an NPV for BPH. EPP implementation significantly increased IPSS questionnaire completion (36.5% vs 56.9%, P < .0001). Following EPP implementation, we found that new BPH medications ordered at time of NPV decreased (10.4% vs 4.7%, P = .02). Although BPH surgery ordered within 6 months was similar, patients following EPP implementation had shorter time to BPH surgery compared to prior. CONCLUSIONS: Our study revealed that EPP distribution of the IPSS improves IPSS collection compliance, aligning our practice closer with AUA guidelines. Routine collection of the IPSS may impact clinical practice through the detection of more severe BPH, which reduces medical BPH management and time to definitive BPH therapy. Further work is needed to confirm findings.
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Registros Electrónicos de Salud , Portales del Paciente , Hiperplasia Prostática , Humanos , Hiperplasia Prostática/terapia , Hiperplasia Prostática/diagnóstico , Masculino , Estudios Retrospectivos , Anciano , Estudios Longitudinales , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Evaluación de Síntomas/métodosRESUMEN
INTRODUCTION: Urology has seen shifts in the management of many urologic conditions with the advent of noninvasive procedures that rely on multidisciplinary radiological modalities. This study seeks to analyze changes in urologists, radiologists, and advanced practice providers (APPs) performing uroradiology procedures over time. METHODS: The Centers for Medicare & Medicaid Services Physician/Procedure Summary data from 2010 to 2021 were utilized to examine uroradiology Current Procedural Terminology codes billed by urologists, radiologists, and APPs. Percent of total reimbursement and higher volume procedure count (after excluding providers with <11 procedures by per year) by each provider field was calculated and analyzed for changes in distribution from 2010 to 2021. RESULTS: There were significant changes in all procedures when examining procedure reimbursement distribution in 2010 to 2021 (P < .001). During the period, urology saw decreases in reimbursement proportion as large as 28.7% for kidney cryoablation and increases as large as 14.2% for nephrostomy tube removals. Radiology saw the largest decreases in reimbursement proportion with an 18.9% decrease for nephrostograms, while the largest increase was 23.6% for suprapubic tube placements. APPs saw the largest increase in suprapubic tube changes reimbursement proportion, which rose 14.2% from 2010 to 2021. There were significant changes in proportion in all procedures, except for antegrade stent, renal cryoablation, renal biopsy, and renal thermoablation. CONCLUSIONS: Uroradiology procedures have seen shifts in the distribution of which provider type performs each procedure. Most large changes in reimbursement and procedure proportion were shifted between urology and radiology, with APPs seeing smaller changes.
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Enfermedades Urológicas , Urología , Anciano , Estados Unidos , Humanos , Urólogos , Medicare , RadiólogosRESUMEN
INTRODUCTION: The impact of Medicare reimbursement changes on urology office visit reimbursements has not been fully examined. This study aims to analyze the impact of urology office visit Medicare reimbursements from 2010 to 2021, with a focus on 2021 Medicare payment reforms. METHODS: The Centers for Medicare and Medicaid Services Physician/Procedure Summary data from 2010-2021 were utilized to examine office visit CPT (Current Procedural Terminology) new patient visit codes 99201-99205 and established patient visit codes 99211-99215 by urologists. Mean office visit reimbursements (2021 USD), CPT specific reimbursements, and proportion of level of service were compared. RESULTS: The 2021 mean visit reimbursement was $110.95, up from $99.42 in 2020 and $94.44 in 2010 (both P < .001). From 2010 to 2020, all CPT codes, except for 99211, had a decrease in mean reimbursement. From 2020 to 2021, there was an increase in mean reimbursement for CPT codes 99205, 99212-99215 and decreases in 99202, 99204 and 99211 (P < .001). New and established patient urology office visits had significant migration of billing codes from 2010 to 2021 (P < .001). New patient visits were most commonly as 99204, which increased from 47% in 2010 to 65% in 2021 (P < .001). The most commonly billed established patient urology visit was 99213 until 2021 when 99214 became the most common at 46% (P < .001). CONCLUSIONS: Urologists have seen increases in mean reimbursements for office visits both before and after the 2021 Medicare payment reform. Contributing factors consist of increased established patient visit reimbursements despite decreased new patient visit reimbursements, and changes in level of CPT code billings.
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Medicare , Urología , Anciano , Humanos , Estados Unidos , Visita a Consultorio Médico , Urólogos , Centers for Medicare and Medicaid Services, U.S.RESUMEN
BACKGROUND: Improving clinical trial design is important for optimizing approval of safe and effective drugs. Phase 1 clinical trials seek to determine phase 2 doses by investigating predefined dose-limiting toxicities. Traditional definitions of dose-limiting toxicity may not be applicable to intravesical therapies for bladder cancer. This study compared the frequency of dose-limiting toxicities and serious adverse events in bladder cancer trials for intravesical therapies to other routes of administration. METHODS: Studies were abstracted from ClinicalTrials.gov and reconciled with a PubMed search. Primary and secondary end points were predefined before data abstraction, and the primary end point was subject-level dose-limiting toxicity rate. Fisher exact tests were performed with p < .05 designated as significant. RESULTS: Eighteen intravesical studies and 24 studies with other routes of administration (the per os/intravenous/intramuscular [PO/IV/IM] group) were identified. Dose-limiting toxicities were reported in 38.9% of intravesical studies, affecting 3.29% of subjects, compared with 30.0% of PO/IV/IM studies representing 4.19% of subjects (p = .52 for study-level and p = .60 for subject-level comparisons). Serious adverse events occurred in 53.9% of intravesical studies in 10.3% of subjects versus 91.0% of studies reporting serious adverse events affecting 41.4% of subjects in the PO/IV/IM group (p = .03 for subject-level and p < .0001 for study-level comparisons). CONCLUSIONS: There was no difference in subject-level dose-limiting toxicity rate between intravesical and PO/IV/IM bladder cancer trials. The serious adverse event rate was lower in the intravesical group. Heterogeneity of dose-limiting toxicity definition may affect interpretation of toxicity in phase 1 bladder cancer clinical trials studying different routes of administration. LAY SUMMARY: Bladder cancer is a common cancer type that may be treated with therapies that are instilled into the bladder and act locally, called intravesical therapies. This study used publicly available regulatory data from early phase clinical trials to determine whether measures of tolerability used in clinical trials are applicable to intravesical therapies for bladder cancer.
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Neoplasias de la Vejiga Urinaria , Humanos , Administración Intravesical , Preparaciones Farmacéuticas , Neoplasias de la Vejiga Urinaria/tratamiento farmacológicoRESUMEN
OBJECTIVE: To examine overall trends in opioid prescribing after ureteroscopy and compared opioid use between private and academic practice settings. We also analyzed the potential for spillover effect from an unrelated opioid-reduction initiative for major oncologic surgery. METHODS: We conducted a retrospective chart review of all ureteroscopies performed within our system at four distinct time points from 2016-2019. We recorded the type and number of opioid pills prescribed and calculated oral morphine equivalents. Analysis included comparison between community and academic hospitals as well as pre- and post-initiative. RESULTS: 555 patients undergoing ureteroscopy and 29 attending surgeons were included in the analysis. The median prescription size per ureteroscopy decreased throughout the study period in both the private and academic settings. From 2016-2017, median oral morphine equivalents (OMEs) decreased from 60 to 0 in the private setting and remained at 0 for the duration of the study period. Opioid reduction in the academic setting lagged behind private practitioners but median OMEs did steadily decrease to 0 in 2019. No significant spillover effect was observed. CONCLUSION: Since 2016, opioid prescribing following ureteroscopy has decreased in both the private and academic practice settings. Notably, private practice urologists achieved a median of 0 opioids 2 years prior to academic urologists. These data suggest that, in some circumstances, academic institutions may have been slower to respond to the opioid epidemic.
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Analgésicos Opioides , Ureteroscopía , Analgésicos Opioides/uso terapéutico , Prescripciones de Medicamentos , Humanos , Derivados de la Morfina/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/epidemiología , Pautas de la Práctica en Medicina , Práctica Privada , Estudios Retrospectivos , UrólogosRESUMEN
OBJECTIVE: To evaluate the use of 3D computed aided designs and 3D-printed models as pre-operative planning tools for urologists, in addition to radiologist interpreted mp-MRIS, prior to radical prostatectomy procedures. METHODS: Ten patients with biopsy-positive lesions detected on mp-MRI were retrospectively selected. Radiologists identified lesion locations using a Prostate Imaging-Reporting and Data System (PI-RADS) map and segmented the prostate, lesion(s), and surrounding anatomy to create 3D-CADs and 3D-printed models for each patient. 6 uro-oncologists randomly reviewed three modalities (mp-MRI, 3D-CAD, and 3D-printed models) for each patient and identified lesion locations which were graded for accuracy against the radiologists' answers. Questionnaires assessed decision confidence, ease-of-interpretation, and usefulness for preoperative planning for each modality. RESULTS: Using 3D-CADs and 3D-printed models compared to mp-MRI, urologists were 2.4x and 2.8x more accurate at identifying the lesion(s), 2.7x and 3.2x faster, 1.6x and 1.63x more confident, and reported it was 1.6x and 1.7x easier to interpret. 3D-CADs and 3D-printed models were reported significantly more useful for overall pre-operative planning, identifying lesion location(s), determining degree of nerve sparing, obtaining negative margins, and patient counseling. Sub-analysis showed 3D-printed models demonstrated significant improvements in ease-of-interpretation, speed, usefulness for obtaining negative margins, and patient counseling compared to 3D-CADs. CONCLUSION: 3D-CADs and 3D-printed models are useful adjuncts to mp-MRI in providing urologists with more practical, accurate, and efficient pre-operative planning.
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Diseño Asistido por Computadora , Imágenes de Resonancia Magnética Multiparamétrica , Cuidados Preoperatorios , Impresión Tridimensional , Próstata/diagnóstico por imagen , Prostatectomía , Simulación por Computador , Humanos , Imagenología Tridimensional , Masculino , Modelos Anatómicos , Proyectos Piloto , Próstata/cirugía , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Estudios RetrospectivosRESUMEN
OBJECTIVES: To evaluate the impact of centralized surgical and nonsurgical care (i.e., radiation and chemotherapy) on travel distances and survival outcomes for patients with advanced bladder cancer. Bladder cancer is a disease with high mortality for which treatment access is paramount and survival is superior in patients receiving surgery at high-volume centers. METHODS: Using SEER-Medicare, we identified patients 66 years or older diagnosed with bladder cancer between 2004-2013. We categorized patients as treated with either surgical (i.e., radical cystectomy) or nonsurgical (i.e., radiation or chemotherapy) care. We fit a linear probability model to generate the predicted proportion of patients treated at the top quintile of volume over time and assessed travel distance, 1-year all-cause mortality, and 1-year bladder cancer-specific mortality over time. RESULTS: A total of 6,756 and 10,383 patients underwent surgical and nonsurgical care, respectively. The percentage of patients treated at high-volume centers increased over the study period for both surgical care (53% to 62%) and nonsurgical care (47% to 55%), (both P< 0.001). Median travel distance increased (11.8 to 20.3 miles) for surgical care and (6.5 to 8.3 miles) for nonsurgical care, (both P < 0.001). The 1-year adjusted all-cause mortality and 1-year adjusted bladder-cancer specific mortality decreased significantly for both surgical and nonsurgical care (both P < 0.05). CONCLUSIONS: Over time, centralization of surgical and nonsurgical care for bladder cancer patients increased, which was associated with increasing patient travel distance and decreased all-cause and bladder-cancer specific mortality.
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Accesibilidad a los Servicios de Salud/normas , Programa de VERF/normas , Viaje/estadística & datos numéricos , Neoplasias de la Vejiga Urinaria/epidemiología , Anciano , Femenino , Humanos , Masculino , Medicare , Análisis de Supervivencia , Estados Unidos , Neoplasias de la Vejiga Urinaria/mortalidadRESUMEN
Over the last two decades, robotic surgery has become a mainstay in hospital systems around the world. Leading this charge has been Intuitive Surgical Inc.'s da Vinci robotic system (Sunnyvale, CA, USA). Through its innovative technology and unique revenue model, Intuitive has installed 4,986 robotic surgical systems worldwide in the last two decades. The rapid rate of adoption and diffusion of the surgical robot has been propelled by many important industry-specific factors. In this review, we propose a model that explains the successful adoption of robotic surgery due to its three core groups: the surgeon, the hospital administrator, and the patient.
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INTRODUCTION: Our urology residency program transitioned to a night float system, where dedicated residents cover nights and are off duty during the day. Junior residents previously covered 5 hospitals every 5 to 7 nights and worked the following day (home call). This prospective observational study compared the 2 systems before and after the transition. METHODS: A validated survey was administered to residents and faculty to evaluate patient care, communication, quality of life, resident education, and duty hour violations. A separate survey was administered to nurses evaluating the on-call resident. Sleep was measured using actigraphy. RESULTS: Survey response rates were 80% to 100%. Junior residents rated night float as equivalent to home call for surgical case volume and superior in all other respects (p <0.05). Senior residents rated night float as superior for continuity of care, compassion, safety, efficiency for the day team, communication with nurses, quality of life, and time for reading and research (p <0.05). Faculty rated night float as superior for efficiency for the day team, handoffs, quality of life, and time for research (p <0.05). Nurses rated night float higher for availability, knowledge of plan for patient, respectfulness, communication, and ability to identify the resident on call (p <0.05). Mean duration of sleep was 2.5 and 7.1 hours for home call and night float, respectively (p <0.001). Junior residents reported fewer violations of the 80-hour and 8-hour-off rules with night float (p <0.001). CONCLUSIONS: Physicians and nurses perceived night float to improve multiple domains. Residents slept more and had fewer duty hour violations on night float.
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OBJECTIVE: To investigate the association of female sex with the selected treatment for patients with nonmetastatic muscle-invasive bladder cancer. Sex is a known independent predictor of death from bladder cancer. A potential explanation for this survival disparity is difference in treatment pattern and stage presentation among males and females. MATERIALS AND METHODS: Using the surveillance, epidemiology, and end results-medicare data set, we identified 6809 patients initially diagnosed with nonmetastatic muscle-invasive bladder cancer between 2004 and 2014. We fit multivariable logistic regression and Cox models to assess the relationship of sex with treatment modality and survival adjusting for differences in patient characteristics. RESULTS: Of the 6809 patients with nonmetastatic muscle invasive bladder cancer, 2528 (37%) received a radical cystectomy while 4281 (63%) received an alternative bladder sparing intervention. Women were significantly more likely to receive a cystectomy (odds ratios [OR] 1.39; 95% confidence intervals [CI] 1.20-1.61), present at an older age with less comorbidities compared to men (P <.001). Women were also found to have worse bladder cancer-specific survival (CSS) than men (hazard ratio [HR] 1.18; 95% CI 1.05-1.32), no difference in overall survival (OS) (female HR 0.93; 0.86-1.01) and lower mortality from other causes (HR 0.78; 95% CI 0.70-0.86). There were no differences in OS and CSS by sex in patients with stage pT4a. CONCLUSION: Female sex predicted more aggressive treatment with radical cystectomy yet worse cancer-specific survival than males. This sex disparity in CSS reduced the known OS advantage observed in women.
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Cistectomía/estadística & datos numéricos , Neoplasias de la Vejiga Urinaria/mortalidad , Neoplasias de la Vejiga Urinaria/terapia , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Humanos , Masculino , Invasividad Neoplásica , Programa de VERF , Factores Sexuales , Análisis de Supervivencia , Estados Unidos/epidemiología , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
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.
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Analgésicos Opioides/administración & dosificación , Prescripciones de Medicamentos/estadística & datos numéricos , Morfina/administración & dosificación , Nefrectomía , Manejo del Dolor/métodos , Dolor Postoperatorio/tratamiento farmacológico , Prostatectomía , Administración Oral , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Manejo del Dolor/psicología , Medición de Resultados Informados por el Paciente , Cirujanos/psicología , Resultado del Tratamiento , Estados Unidos , Urólogos/psicologíaRESUMEN
OBJECTIVE: To examine the geographic and pharmacy-type variation in costs for generic benign prostatic hyperplasia (BPH) medications in order to improve drug price transparency and reduce health disparities. Medical therapy for BPH can be expensive, having significant implications for uninsured and underinsured patients. METHODS: We generated a 20% random sample of all pharmacies in Pennsylvania and queried each for the uninsured cash price of a 30-day prescription of tamsulosin 0.4mg daily, finasteride 5mg daily, oxybutynin immediate release 5mg TID and oxybutynin XL 10mg daily. Our primary objectives were to identify price variation based on pharmacy type (i.e., big chain and independent) and between geographic regions (predetermined by the Pennsylvania Health Care Cost Containment Council Database). We fit multivariable quantile regression models to test for an association between drug price and region after controlling for pharmacy type. RESULTS: Among 575 retail pharmacies contacted, 473 responded (82% response rate). The median cash price was significantly higher for big chain pharmacies than for independent pharmacies for tamsulosin ($66 vs. $15), finasteride ($68 vs. $15), oxybutynin immediate release ($49 vs. $35), and oxybutynin XL ($79 vs. $31) (all p < 0.05). When controlling for region, the median and 75th percentile price of all drugs was significantly higher for big chain pharmacies. When controlling for pharmacy type, regional variation was noted in all four drugs at the 75th percentile price and was greater for independent pharmacies. CONCLUSION: Compared to independent pharmacies, big chain pharmacies charged significantly more for generic BPH medications to uninsured patients. However, independent pharmacies demonstrated more regional variation in their pricing.
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Costos y Análisis de Costo , Medicamentos Genéricos/economía , Finasterida/economía , Ácidos Mandélicos/economía , Hiperplasia Prostática/economía , Tamsulosina/economía , Finasterida/uso terapéutico , Humanos , Masculino , Ácidos Mandélicos/uso terapéutico , Pennsylvania , Hiperplasia Prostática/tratamiento farmacológico , Tamsulosina/uso terapéuticoRESUMEN
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Predicción , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/normasRESUMEN
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.
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Conflicto de Intereses/economía , Conflicto de Intereses/legislación & jurisprudencia , Industria Manufacturera/economía , Urología/economía , Centers for Medicare and Medicaid Services, U.S. , Bases de Datos Factuales/economía , Bases de Datos Factuales/estadística & datos numéricos , Humanos , Relaciones Interinstitucionales , Industria Manufacturera/ética , Encuestas y Cuestionarios/estadística & datos numéricos , Estados Unidos , Urología/educación , Urología/ética , Urología/estadística & datos numéricosRESUMEN
OBJECTIVE: To examine the effectiveness of the introduction of the Pennsylvania Prescription Drug Monitoring Program (PDMP) on discharge postoperative opioid prescriptions in patients undergoing major urologic procedures within a large single tertiary care hospital. Opioids have historically been prescribed to control postoperative pain, but with growing concern regarding opioid overdose, misuse, and diversion, measures have been introduced to curb opioid prescribing. Numerous states have introduced PDMP programs as a method to search patients' prior opioid prescriptions. These programs have reduced opioid prescriptions in emergency department and outpatient settings, but their effectiveness, and the use of a prescriber query mandate, in reducing postoperative opioid prescribing has not been established. METHODS: We identified 582 patients who underwent major prostate or renal surgery between July 1st 2016 and June 30th 2017 at a single large academic hospital. We examined prescribing trends in both opioid naive and opioid tolerant patients measuring 5mg oxycodone equivalents before and after a PDMP query was mandated on January 1st 2017. RESULTS: There was no significant difference is the number of opioid prescriptions given after introduction of the required PDMP query, but there was an 18% decrease in the median number of 5mg oxycodone equivalents prescribed before and after the PDMP query (P < .001). This was consistent in both an opioid naive and opioid exposed population. CONCLUSION: This is the first study to establish that required PDMP queries may reduce the number of discharge opioid pills prescribed in a surgical setting. Required PDMP queries may help reduce the harm associated with opioid overprescribing.
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Analgésicos Opioides/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Alta del Paciente/estadística & datos numéricos , Pautas de la Práctica en Medicina/tendencias , Procedimientos Quirúrgicos Urológicos , Eficiencia Organizacional , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor Postoperatorio/epidemiología , Programas de Monitoreo de Medicamentos Recetados , Estados Unidos/epidemiología , Procedimientos Quirúrgicos Urológicos/efectos adversos , Procedimientos Quirúrgicos Urológicos/estadística & datos numéricos , Urología/métodos , Urología/normasRESUMEN
OBJECTIVES: To examine the distribution of industry payments to male and female academic urologists and the relationship between industry funding, academic rank, and scholarly impact. MATERIAL AND METHODS: Academic urologists from 131 programs with publicly available websites were compiled. Gender, rank, fellowship training, and scholarly impact metrics were recorded. Data from the 2016 Centers for Medicare and Medicaid Services Open Payments database were paired with faculty names. Comparisons were made using Fisher's Exact, Wilcoxon Rank Sum, and Spearman's Rank-Order tests. Multivariable logistic regression modeling identified predictors of receiving payments in the top quintile. RESULTS: Among 1,657 academic urologists, males comprised 84%. While there were no gender differences in the number of urologists listed in the Open Payments Database, males received more total funding (P < .001) and higher median general payments per capita (P < .03). Males also received higher proportions of research funding (P = .002), speaker fees (P = .03), education fees (P = .03) and higher median consulting fees (P = .003). Overall, males had higher scholarly impact (P < .001), which correlated with total industry payments (rho = 0.27, P < .001). Predictors of accepting the top quintile payments include male gender, associate professorship and H-index score ≥10. CONCLUSION: Most academic urologists accepted at least one industry payment in 2016, but males received more funding than females. There is a positive correlation between total industry payments, H-index, and total publications. More research is needed to understand why gender and scholarly productivity are associated with higher payouts. This is another important area that may influence career advancement and compensation for female urologists.