The Impact of Polymerase Chain Reaction Urine Testing on Clinical Decision-Making in the Management of Complex Urinary Tract Infections.

While urinary polymerase chain reaction (PCR) testing is effective in organism identification in patients with complex urinary tract infections (cUTI), limited data exists on the clinical usefulness of this test. We serially surveyed physicians treating symptomatic patients with cUTI both at presentation and after PCR, and urine culture (UC) results were available to ascertain how the test results modified the therapy. A total of 96 unique surveys completed by 21 providers were included in the data analysis. The mean age for female and male patients was 69.4 ± 15.5 and 71.6 ± 12.7 years, respectively. The test positivity and line-item concordance for UC and PCR were consistent with prior reports. The PCR results modified or confirmed treatment in 59/96 (61.5%) and 25/96 (26.0%) of the cases, respectively, with 12/29 (41.4%) and 47/67 (70.1%) having negative and positive PCR results, respectively, resulting in treatment change (difference 28.7%, p < 0.01). Of these, 55/59 (57.3%) were alterations in the antibiotic regimen. PCR use to modify treatment was similar across providers and not statistically different when stratified by patient age, gender, or prior empiric therapy. In 31/59 (52.5%) of the cases, the PCR results modified the treatment where UC would not; conversely, UC would have modified the treatment in 3/37 (8.1%) of the cases where PCR did not (difference 44.4%, p < 0.01). We find that PCR test results are used by clinicians in managing cUTI, and use of this test provides an opportunity to improve antibiotic stewardship in this difficult-to-treat subset of patients.

Comparison of Polymerase Chain Reaction and Urine Culture in the Evaluation of Patients with Complex Urinary Tract Infections.

To compare organism identification using polymerase chain reaction (PCR) and urine culture (UC) in patients with complex urinary tract infections (cUTIs), we reviewed the results of 3395 patients seen during 2022 with cUTI who underwent concomitant PCR and UC testing. We compared the overall positivity rates as well as the ability of each test to identify fastidious organisms (FOs) and the presence of polymicrobial infections (PMOs) and conducted concordance analysis between the tests. PCR detected 36.4% more organisms than UC and was 20 and nearly 36 times more likely to detect PMOs and FOs, respectively. PCR identified 90.6% of organisms found in UC, whereas UC identified 40.7% of organisms found in PCR testing. We found that 62.4% of organisms found in PCR were not found in urine culture, while UC found 9.4% of organisms not identified in polymerase chain reaction. All these differences were statistically significant (p < 0.05). Although we found that PCR was superior to UC in overall pathogen detection, and detection of both PMOs and FOs, both identified potentially pathogenic organisms not found in the corresponding test. Our data strongly suggest that the evaluation of patients with cUTI is best accomplished using PCR in conjunction with UC.

The Essential Role of PCR and PCR Panel Size in Comparison with Urine Culture in Identification of Polymicrobial and Fastidious Organisms in Patients with Complicated Urinary Tract Infections.

Complicated urinary tract infections (cUTIs) are difficult to treat, consume substantial resources, and cause increased patient morbidity. Data suggest that cUTI may be caused by polymicrobial and fastidious organisms (PMOs and FOs, respectively); as such, urine culture (UC) may be an unreliable diagnostic tool for detecting cUTIs. We sought to determine the utility of PCR testing for patients presumed to have a cUTI and determine the impact of PCR panel size on organism detection. We reviewed 36,586 specimens from patients with presumptive cUTIs who received both UC and PCR testing. Overall positivity rate for PCR and UC was 52.3% and 33.9%, respectively (p < 0.01). PCR detected more PMO and FO than UC (PMO: 46.2% vs. 3.6%; FO: 31.3% vs. 0.7%, respectively, both p < 0.01). Line-item concordance showed that PCR detected 90.2% of organisms identified by UC whereas UC discovered 31.9% of organisms detected by PCR (p < 0.01). Organism detection increased with expansion in PCR panel size from 5-25 organisms (p < 0.01). Our data show that overall positivity rate and the detection of individual organisms, PMO and FO are significantly with PCR testing and that these advantages are ideally realized with a PCR panel size of 25 or greater.

The Clinical Cell-Cycle Risk (CCR) Score Is Associated With Metastasis After Radiation Therapy and Provides Guidance on When to Forgo Combined Androgen Deprivation Therapy With Dose-Escalated Radiation.

PURPOSE: The clinical cell-cycle risk (CCR) score, which combines the University of California, San Francisco's Cancer of the Prostate Risk Assessment (CAPRA) and the cell cycle progression (CCP) molecular score, has been validated to be prognostic of disease progression for men with prostate cancer. This study evaluated the ability of the CCR score to prognosticate the risk of metastasis in men receiving dose-escalated radiation therapy (RT) with or without androgen deprivation therapy (ADT). METHODS AND MATERIALS: This retrospective, multi-institutional cohort study included men with localized National Comprehensive Cancer Network (NCCN) intermediate-, high-, and very high-risk prostate cancer (N = 741). Patients were treated with dose-escalated RT with or without ADT. The primary outcome was time to metastasis. RESULTS: The CCR score prognosticated metastasis with a hazard ratio (HR) per unit score of 2.22 (95% confidence interval [CI], 1.71-2.89; P < .001). The CCR score better prognosticated metastasis than NCCN risk group (CCR, P < .001; NCCN, P = .46), CAPRA score (CCR, P = .002; CAPRA, P = .59), or CCP score (CCR, P < .001; CCP, P = .59) alone. In bivariable analyses, CCR score remained highly prognostic when accounting for ADT versus no ADT (HR, 2.18; 95% CI, 1.61-2.96; P < .001), ADT duration as a continuous variable (HR, 2.11; 95% CI, 1.59-2.79; P < .001), or ADT given at or below the recommended duration for each NCCN risk group (HR, 2.19; 95% CI, 1.69-2.86; P < .001). Men with CCR scores below or above the multimodality threshold (CCR score, 2.112) had a 10-year risk of metastasis of 3.7% and 21.24%, respectively. Men with below-threshold scores receiving RT alone had a 10-year risk of metastasis of 3.7%, and for men receiving RT plus ADT, the 10-year risk of metastasis was also 3.7%. CONCLUSIONS: The CCR score accurately and precisely prognosticates metastasis and adds clinically actionable information relative to guideline-recommended therapies based on NCCN risk in men undergoing dose-escalated RT with or without ADT. For men with scores below the multimodality threshold, adding ADT may not significantly reduce their 10-year risk of metastasis.

Development of Physician Leaders.

The complexity of health care today along with the drive towards value-based care are strong forces in support of growing and expanding the physician leadership workforce. Physician led organizations are associated with improved physician engagement, quality of care and cost efficiency. Physicians would benefit from more formal leadership training which incorporates a structed leadership curriculum, mentorship and on the job progressive leadership experience. Special attention must be placed on increasing the diversity of our physician leaders. There are many important characteristics to look for in our physician leaders including emotional intelligence, integrity, visioning, humility, persuasion and the ability to listen.

The Role of Advanced Practice Providers in Urology.

The nation's undersupply of urology services disproportionately affects Medicare beneficiaries compared to the general population. Advanced Practice Providers (APPs), most commonly nurse practitioners and physician assistants may be a vehicle to meet this need. The increased use of APPs in urology is hampered by physician discomfort with delegating responsibility to APPs. This discomfort may be compounded by complexities with billing issues and interstate variation in scope of practice regulations. To expand access to urological services while simultaneously ensuring service quality, it is imperative that urologists engage with APPs individually and as a specialty.

Private Equity and Urology: An Emerging Model for Independent Practice.

Independent urology practices are under increasing competitive pressure in a changing marketplace. By providing access to capital and business management expertise, private equity can help practices consolidate and scale to unlock new growth opportunities, navigate an increasingly complex regulatory environment, and institute best practice across a network, while retaining physician ownership and an opportunity for equity appreciation. This article examines the role of private equity in urology and the potential benefits of private equity investment. It also looks at what firms look for in investment partners, how to prepare for private equity investment, and how private equity investments are structured.

Health Policy and Advocacy.

Awareness of the activities of federal and state legislative and regulatory activities is vital for physicians to avoid having their services misvalued and to protect patients' access to care. Professional organizations are encouraging physicians to develop political leadership and advocacy skills to protect patient care, research, and access to technology. The political polarization of the country and the public health emergency have had an impact on the ability and willingness of some to engage in policy discussions. This article reviews mechanisms by which urologists can engage in health policy and political activity and avenues to expand the number of urologists involved.

Current and Future Status of Merit-Based Incentive Payment Systems.

The Quality Payment Program was established by the Medicare Access and CHIP Reauthorization Act (MACRA) legislation in response to repeated efforts to create a permanent so-called doc fix in response to the failures of the sustainable growth formula. This article examines the history leading up to MACRA, the current pathways associated with the Quality Payment Program, and future expectation both from the Centers for Medicare and Medicaid Services, stakeholders, and patients.

The Impact of Systematic Safety Precautions on COVID-19 Risk Exposure and Transmission Rates in Outpatient Healthcare Workers.

We evaluated the impact of safety protocols, including rapid testing and contact tracing, on coronavirus disease 2019 (COVID-19) risk exposure and transmission rates amongst healthcare workers in the outpatient care setting. Over an 11-week period, a total of 254 employees representing 38% of our total workforce had potential COVID-19 exposure and underwent voluntary COVID-19 testing. Data was stratified based on severity of risk exposure and job description. During this period, the probability of a COVID exposure being high risk decreased in Administrative (-93.0%; P < 0.01) and Clinical (-77.0%; P < 0.01) staff; simultaneously, viral transmission rates declined in Administrative (-73.4%; P = 0.03) and Clinical (-69.9%; P = 0.04) staff as well. Systematic safety protocols effectively reduce exposure risk and transmission rates in outpatient healthcare workers and should be ubiquitously adopted.

The Cost of Prostate Biopsies and their Complications: A Summary of Data on All Medicare Fee-for-Service Patients over 2 Years.

INTRODUCTION: We define the cost of a contemporary prostate biopsy and the rate and incremental impact of complications on costs. METHODS: A retrospective analysis of all Medicare fee-for-service claims for prostate biopsies in the United States from January 31, 2014 to December 1, 2015 was performed. Costs of each biopsy episode (including 30 days after each biopsy) were calculated. The effects of complications, biopsy setting and subsequent inpatient hospitalization were explored. RESULTS: The average cost of the 234,819 biopsies reviewed was $2,020 and 46% of biopsy costs occurred in the 30 days following each biopsy. Biopsies performed in the office setting comprised 66% of the total and were least costly ($1,750) compared to biopsies performed in ambulatory surgical centers ($2,260) and outpatient hospital settings ($2,730, both p <0.001). Biopsies performed in the office setting were associated with fewer complications (10%) compared to the outpatient hospital (19%) or ambulatory surgical center settings (12%, both p <0.001). An uncomplicated biopsy episode cost an average of $1,740, which increased to $4,060 when at least 1 complication occurred (difference +$2,320, p <0.001). The largest charges incurred were related to inpatient admissions, which added $13,840 to the cost of a prostate biopsy (p <0.001) but were rare, constituting only 2.8% of biopsies. CONCLUSIONS: Nearly half of costs during prostate biopsy episodes occur due to complications that occur in the days following a biopsy. These data should be used as benchmarks to incentivize interventions to reduce complications and subsequent admissions following biopsies.

Weighted Gleason Grade Group (WGGG): A new prostate cancer biopsy reporting system with prognostic potential.

INTRODUCTION: Presently, prostate biopsy (PBx) results report the highest Gleason Grade Group (GGG) as a single metric that gauges the overall clinical aggressiveness of cancer and dictates treatment. We hypothesized a PBx showing multiple cores of cancer with more volume cancer per core would represent more aggressive disease. We propose the Weighted Gleason Grade Group (WGGG), a novel scoring system that synthesizes all histopathologic data and cancer volume into a single numeric value representing the entire PBx, allowing for improved prediction of adverse pathology and risk of biochemical recurrence (BCR) following radical prostatectomy (RP). METHODS: We studied 171 men who underwent RP after standard PBx. The WGGG was calculated by summing each positive core using the formula: GGG + (GGG x %Ca/core). RP pathology was evaluated for extraprostatic extension (EPE), positive surgical margins (PSM), seminal vesicle invasion (SVI), and lymph node involvement (LNI), and patients were followed for BCR. We compared GGG vs. WGGG receiver operating characteristic curves for each outcome, and determined the predictive capability of GGG and WGGG to identify patients with BCR. Categorized WGGG groups were created based on risk of BCR using classification and regression tree analysis. We then sought to externally validate WGGG in a cohort of 389 patients in a separate institutional dataset. RESULTS: In the development cohort, area under the curves (AUCs) for the WGGG vs. GGG were significantly higher for predicting EPE (0.784 vs. 0.690, P = 0.002), SVI (AUC 0.823 vs. 0.721, P = .014), LNI (AUC 0.862 vs. 0.823, P = 0.039), and PSM (AUC 0.638 vs. 0.575, P = 0.031. Analysis of the validation cohort showed similar findings for EPE (AUC 0.764 vs. 0.729, P = 0.13), SVI (AUC 0.819 vs. 0.749, P = 0.01), LNI (AUC 0.939 vs. 0.867, P = 0.02), and PSM (AUC 0.624 vs. 0.547, P = 0.04). Patients with WGGG >30 (high-risk group) demonstrated ∼50% failure at 2 years in both cohorts. CONCLUSIONS: The WGGG, by providing a metric reflecting the entirety of the PBx, is more informative than conventional single GGG alone in identifying adverse pathologic outcomes and risk of BCR following RP. This superior discriminatory capability has been achieved without any consideration of other commonly available clinical disease characteristics.

The Effect of Local Antibiogram-based Augmented Antibiotic Prophylaxis on Infection-related Complications Following Prostate Biopsy.

Given the number of prostate biopsies performed annually in the United States and associated infectious events as a result, we sought to determine if implementation of a standardized biopsy protocol utilizing antibiotic prophylaxis based on locally derived antibiograms would result in a decrease, relative to a contemporary control population, in the incidence of infection-related complications among community-based practices. A total of nine member groups of LUGPA participated in both a retrospective review and a prospective study of infection-related complications following prostate biopsy. Historic infectious complications, defined as chills/rigor, temperature higher than 101 °F, or documented positive blood or urine cultures, were self-reported by a retrospective review of patients undergoing prostate biopsy under the practice's current protocol in the year prior to the study. The prospective phase of the study required each group to develop a locally derived augmented prophylaxis regimen (>2 antibiotics) based on local antibiograms. After implementation, the practices enrolled patients undergoing prostate biopsy over an 8-week period. Monitoring for infection-related complication took place over the ensuing 3 weeks post-biopsy. Seven hundred fifty-nine patients over nine practices were enrolled into the study utilizing the augmented locally determined prophylaxis protocol. There was a 53% reduction in the incidence of infection-related complication, relative to the historical rate. By developing a standardized biopsy protocol with specific emphasis on incorporating an augmented antibiotic prophylactic regimen based upon local antibiograms, we were able to demonstrate in a prospective trial across nine geographically distinct community practices a significant reduction in the incidence of infection-related complications.

The LUGPA Alternative Payment Model for Initial Therapy of Newly Diagnosed Patients With Organ-confined Prostate Cancer: Rationale and Development.

Over the past several decades, rapid expansion in healthcare expenditures has exposed the utilization incentives inherent in fee-for-service payment models. The passage of Medicare Access and CHIP Reauthorization Act of 2015 heralded a transition toward value-based care, creating incentives for practitioners to accept bidirectional risk linked to outcome and utilization metrics. At present, the limited availability of these vehicles excludes all but a handful of providers from participation in alternative payment models (APMs). The LUGPA APM supports the goals of the triple aim in improving the patient experience, enhancing population health and reducing expenditures. By requiring utilization of certified electronic health record technologies, tying payment to quality metrics, and requiring practices to bear more than nominal risk, the LUGPA APM qualifies as an advanced APM, thereby easing the reporting burden and creating opportunities for participating practices.