Cost-effectiveness of an urinary biomarker panel in combination with MRI for prostate cancer diagnosis.

PURPOSE: The health impact and cost-effectiveness of the biomarker test SelectMDx were evaluated when used in combination with MRI, in two US populations: biopsy naïve men and men with a previous negative biopsy. METHODS: Using a decision model, the current MRI strategy was compared with two SelectMDx strategies: SelectMDx used before MRI to select men for MRI and SelectMDx used after a negative MRI to select men for biopsy. Parameters were informed by the literature most relevant for both populations. Differences in quality-adjusted life years (QALYs) and costs between the current strategy and the SelectMDx strategies were calculated using two different assumptions regarding PCa-specific mortality (SPCG-4 and PIVOT). RESULTS: In biopsy naïve men, the use of SelectMDx before MRI results in a gain of 0.004 QALY per patient under the SPCG-4 scenario, and a gain of 0.030 QALY under the PIVOT scenario. The cost savings are $1650 per patient. When used after MRI, SelectMDx results in a QALY gain per patient of 0.004 (SPCG-4), and 0.006 (PIVOT) with $262 in cost savings. In the previous negative population, SelectMDx before MRI results in a QALY gain of 0.006 (SPCG-4) and 0.022 (PIVOT), with $1281 in cost savings per patient. SelectMDx after MRI results in a QALY gain of 0.003 (SPCG-4) and 0.004 (PIVOT) with $193 in cost savings. CONCLUSION: Application of SelectMDx results in better health outcomes and cost savings. The value of SelectMDx was highest when used before MRI to select patients for MRI and subsequent biopsy.

National Variation in Elective Colon Resection for Diverticular Disease.

OBJECTIVE: This study aims to characterize the extent of geographic variation in elective sigmoid resection for diverticulitis and to identify factors associated with observed variation. INTRODUCTION: National guidelines for treatment of recurrent diverticulitis fail to offer strong recommendations for or against surgical intervention. We hypothesize that healthcare market factors will be significantly associated with geographic variation in colon resection for diverticulitis, a discretionary surgical intervention. METHODS: We used Center for Medicare Services 100% inpatient Limited Data Set (LDS) files from January 2013 through September 2015 to calculate an observed to expected standardized colon resection ratio for each hospital referral region (HRR). We then analyzed patient, hospital-, and market-level factors associated with variation of colectomy. For each HRR, a Herfindahl-Hirschman index, a measure of market competition, was calculated. RESULTS: A total of 19,557 Medicare patients underwent an elective colon resection for diverticulitis at 2462 hospitals over the study period. Standardized colon resection ratios ranged from 0 in the Tuscaloosa HRR to 3.7 in the Royal Oak, MI HRR. Few patient factors were associated with variation, but a number of hospital factors (size, area, profit status, and critical access designation) all were associated with variation. In an analysis of market factors, increased surgeon density, and decreased market competition were associated with higher predicted rates of colon resection. CONCLUSION: We observed pronounced variation (excess of 3-fold) in standardized colon resection ratios for recurrent diverticulitis. Surgeon density and hospital level factors were strongly associated with this variation and may be the main drivers of colonic resection for diverticular disease. Further investigation and stronger national guidelines are needed to optimize patient selection for colectomy.

Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II.

PURPOSE: The summary presented herein represents Part II of the two-part series dedicated to Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline discussing prognostic and treatment recommendations for patients with castration-resistant disease. Please refer to Part I for discussion of the management of patients with biochemical recurrence without metastatic disease after exhaustion of local treatment options as well as those with metastatic hormone-sensitive prostate cancer. RESULTS: The Advanced Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with advanced prostate cancer. Such statements are summarized in figure 1[Figure: see text] and detailed herein. MATERIALS AND METHODS: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE (1998 to January Week 5 2019), Cochrane Central Register of Controlled Trials (through December 2018), and Cochrane Database of Systematic Reviews (2005 through February 6, 2019). An updated search was conducted prior to publication through January 20, 2020. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles. CONCLUSIONS: This guideline attempts to improve a clinician's ability to treat patients diagnosed with advanced prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to improve the level of care for these patients.

Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART I.

PURPOSE: The summary presented herein represents Part I of the two-part series dedicated to Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline discussing prognostic and treatment recommendations for patients with biochemical recurrence without metastatic disease after exhaustion of local treatment options as well as those with metastatic hormone-sensitive prostate cancer. Please refer to Part II for discussion of the management of castration-resistant disease. MATERIALS AND METHODS: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE (1998 to January Week 5 2019), Cochrane Central Register of Controlled Trials (through December 2018), and Cochrane Database of Systematic Reviews (2005 through February 6, 2019). An updated search was conducted prior to publication through January 20, 2020. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles. RESULTS: The Advanced Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with advanced prostate cancer. Such statements are summarized in figure 1[Figure: see text] and detailed herein. CONCLUSIONS: This guideline attempts to improve a clinician's ability to treat patients diagnosed with advanced prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to improve the level of care for these patients.

The association between Medicare accountable care organization enrollment and breast, colorectal, and prostate cancer screening.

BACKGROUND: Despite the rapid diffusion of accountable care organizations (ACOs), the effect of ACO enrollment on cancer diagnosis, treatment, and survivorship remains unknown. The objective of this study was to determine whether Medicare Shared Savings Program (MSSP) ACO enrollment was associated with changes in screening for breast, colorectal, and prostate cancers. METHODS: The authors built a cohort of Medicare beneficiaries from 2006 through 2014 comprising 39,218,652 person-years of observation before and 17,252,345 person-years of observation after MSSP enrollment. The Centers for Medicare & Medicaid Services attribution methodology was recapitulated; and screening services were identified for breast, colorectal, and prostate cancer, implementing both sensitive and specific definitions of cancer screening. Adjusted difference-in-differences analyses were performed using linear regression to characterize changes in annual screening rates after ACO enrollment relative to contemporaneous changes in a non-ACO control group of Medicare beneficiaries. RESULTS: Medicare beneficiaries attributed to ACO-enrolled providers had higher rates of breast, colorectal, and prostate cancer screening before enrollment. A 1.8% relative reduction in breast cancer screening was observed among women attributed to ACO providers (P < .0001), a 2.4% relative increase was observed in colorectal cancer screening (P = .0259), and a 3.4% relative reduction was observed in prostate cancer screening among men attributed to ACO providers (P = .0025) compared with contemporaneous changes in non-ACO controls. CONCLUSIONS: Small-magnitude reductions were observed in breast and prostate cancer screening rates, and a small increase was observed in colorectal cancer screening associated with ACO enrollment. Although ACO enrollment does not appear to drive wholesale changes in cancer screening, small differences may map to meaningful changes in the epidemiology of screen-detected cancers among Medicare beneficiaries.

Surgeon Participation in Early Accountable Care Organizations.

OBJECTIVE: We aimed to characterize the landscape of surgeon participation in early accountable care organizations (ACOs) and to identify specialty-, organization-, and market-specific factors associated with ACO participation. BACKGROUND: Despite rapid deployment of alternative payment models (APMs), little is known about the prevalence of surgeon participation, and key drivers behind surgeon participation in APMs. METHODS: Using data from SK&A, a research firm, we evaluated the near universe of US practices to characterize ACO participation among 125,425 US surgeons in 2015. We fit multivariable logistic regression models to characterize key drivers of ACO participation, and more specifically, the interaction between ACO affiliation and organizational structure. RESULTS: Of 125,425 US surgeons, 27,956 (22.3%) participated in at least 1 ACO program in 2015. We observed heterogeneity in participation by subspecialty, with trauma and transplant reporting the highest rate of ACO enrollment (36% for both) and plastic surgeons reporting the lowest (12.9%) followed by ophthalmology (16.0%) and hand (18.6%). Surgeons in group practices and integrated systems were more likely to participate relative to those practicing independently (aOR 1.57, 95% CI 1.50, 1.64; aOR 4.87, 95% CI 4.68, 5.07, respectively). We observed a statistically significant interaction (P <0.001) between surgical specialty and practice organization. Model-derived predicted probabilities revealed that, within each specialty, surgeons in integrated health systems had the highest predicted probabilities of ACO and those practicing independently generally had the lowest. CONCLUSIONS: We observed considerable variation in ACO enrollment among US surgeons, mediated at least in part by differences in practice organization. These data underscore the need for development of frameworks to characterize the strategic advantages and disadvantages associated with APM participation.

Racial variation in receipt of quality radiation therapy for prostate cancer.

PURPOSE: Racial disparities are apparent in the management and outcomes for prostate cancer; however, disparities in compliance to quality measures for radiation therapy for prostate cancer have not been previously studied. Therefore, the goal of the study was to characterize disparities in the compliance rates with quality measures. METHODS: The comparative effectiveness analysis of radiation therapy and surgery study is a population-based, prospective cohort study that enrolled 3708 men with clinically localized prostate cancer from 2011 to 2012. Compliance with 5 radiation-specific quality measures endorsed by national consortia as of 2011 was assessed, and compliance was compared by race using logistic regression. RESULTS: Overall, 604 men received definitive external beam radiation therapy (EBRT) of which 20% were self-reported black, 74% non-Hispanic white, and 6% Hispanic. Less than two-thirds of black and Hispanic men received EBRT that was compliant with all available quality measures (p = 0.012). Compared to white men, black men were less likely to receive dose-escalated EBRT (95% vs. 87%, p = 0.011) and less likely to avoid unnecessary pelvic radiation for low-risk disease (99% vs. 20%, p < 0.001). Compared to white men, Hispanic men were less likely to undergo image guidance (87% vs. 71%, p = 0.04). Black and Hispanic men were more likely to receive EBRT from low-quality providers than white men. CONCLUSIONS: Addressing disparities in access to providers that meet quality guidelines, and improving adherence to evidence-based processes of care may decrease racial/ethnic disparities in prostate cancer outcomes.

Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment.

PURPOSE: SelectMDx (MDxHealth®) is a panel of urinary biomarkers used in conjunction with traditional risk factors to individualize risk prediction for clinically significant prostate cancer. In this study we sought to characterize the effectiveness of SelectMDx in a population of American men with elevated prostate specific antigen. MATERIALS AND METHODS: We developed a Markov decision analytical model to simulate the chain of events and downstream outcomes associated with ultrasound guided prostate biopsy and a strategy in which the biomarker panel is implemented prior to biopsy. The primary outcome was health outcomes, measured in QALYs (quality-adjusted life years). The secondary outcome was health care costs from the Medicare payer perspective. Multiple 1-way sensitivity analyses were performed to characterize model robustness. RESULTS: The expected mean QALYs per patient under the current standard was 10.796 at a cost of $11,060 during an 18-year horizon. Incorporating the urinary biomarker panel resulted in an expected mean of 10.841 QALYs per patient and a mean cost of $9,366, representing an average of 0.045 QALYs gained at a cost savings of $1,694 per patient. When extrapolating these data to a conservative estimate of 311,879 men per year undergoing biopsy, one would expect that the biomarker panel would result in an incremental 14,035 QALYs gained at a cost savings of $528,323,026 in each yearly cohort. The biomarker panel strategy dominated the current standard across a wide range of sensitivity analyses. CONCLUSIONS: Routine use of the SelectMDx urinary biomarker panel to guide biopsy decision making improved health outcomes and lowered costs in American men at risk for prostate cancer. This strategy may optimize the value of prostate cancer risk assessment in an era of increasing financial accountability.

Castration-Resistant Prostate Cancer: AUA Guideline Amendment 2018.

PURPOSE: The purpose of this amendment is to incorporate newly-published literature to provide a rational basis for the management of patients with non-metastatic castration-resistant prostate cancer (CRPC). MATERIALS AND METHODS: The original systematic review and meta-analysis of the published literature yielded 303 studies published from 1996 through 2013. This review informed the majority of the guideline statements from the 2013 guideline. Clinical Principles and Expert Opinions were used for guideline statements lacking sufficient evidence. The guideline was subsequently amended in April 2014 and March 2015. The current 2018 amendment search yielded 770 references with 47 studies eventually providing relevant data. The resulting amendment focuses on the incorporation of information relating to the treatment of patients with non-metastatic CRPC. RESULTS: Guideline statements based on six Index Patients developed to represent the most common scenarios encountered in clinical practice were amended appropriately. The additional literature provided the basis for an update of current supporting text as well as the incorporation of new guideline statements for asymptomatic non-metastatic CRPC. CONCLUSIONS: Given the rapidly evolving nature of this field, this guideline should be used in conjunction with recent systematic literature reviews and an understanding of individual patients' treatment goals. Shared decision-making incorporating patients' preferences and personal goals should be implemented when choosing management strategies. This guideline will be continually updated as new literature emerges.

The Effect of Nerve Sparing Status on Sexual and Urinary Function: 3-Year Results from the CEASAR Study.

PURPOSE: Nerve sparing contributes to the recovery of sexual and urinary function after radical prostatectomy but it may be ineffective in some patients or carry the risk of a positive surgical margin. We evaluated sexual and urinary function outcomes according to the degree of nerve sparing in patients with prostate cancer treated with radical prostatectomy. MATERIALS AND METHODS: The CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study is a prospective, population based, observational study of men diagnosed with localized prostate cancer in 2011 to 2012. Patient reported sexual and urinary functions were measured using the 26-item Expanded Prostate Index Composite at baseline within 6 months after diagnosis, and 6, 12 and 36 months after enrollment. Study inclusion criteria included radical prostatectomy as primary treatment, documentation of nerve sparing status and absent androgen deprivation therapy. Nerve sparing status was defined as none, unilateral or bilateral according to the operative report. RESULTS: The final analytical cohort included 991 men. The 11 men treated with unilateral nerve sparing and the 75 treated with a nonnerve sparing procedure were grouped together. In the multivariable model there was a significant difference in the sexual function score 3 years after radical prostatectomy in the bilateral nerve sparing group compared with the unilateral and nonnerve sparing group (6.1 points, 95% CI 2.0-10.3, p = 0.004). This was more pronounced in men with high baseline sexual function (8.23 points, 95% CI 1.6-14.8, p = 0.014) but not in those with low baseline function (4.0 points, 95% CI -0.6-8.7, p = 0.090). Similar effects were demonstrated on urinary incontinence scores. CONCLUSIONS: Bilateral nerve sparing resulted in better sexual and urinary function outcomes than unilateral or nonnerve sparing but the difference was not significant in men with low baseline sexual function.