Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies.

BACKGROUND: Many men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse. METHODS: Our survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation-Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer ("yes"/"probably yes," "probably no"/"no"), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses. RESULTS: Our survey was completed by 84 respondents (13% response rate), with 27% indicating "probably no"/"no" to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity-Social, Motivation-Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse. CONCLUSIONS: Our study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03579680.

Real-World Effectiveness of Preventive Pharmacological Therapy in Patients With Urolithiasis: A Retrospective Cohort Study.

RATIONALE & OBJECTIVE: Data supporting the efficacy of preventive pharmacological therapy (PPT) to reduce urolithiasis recurrence are based on clinical trials with composite outcomes that incorporate imaging findings and have uncertain clinical significance. This study evaluated whether the use of PPT leads to fewer symptomatic stone events. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare enrollees with urolithiasis who completed 24-hour urine collections that revealed hypercalciuria, hypocitraturia, low urine pH, or hyperuricosuria. EXPOSURE: PPT (thiazide diuretics for hypercalciuria, alkali for hypocitraturia or low urine pH, or uric acid lowering drugs for hyperuricosuria) categorized as (1) adherent to guideline-concordant PPT, (2) nonadherent to guideline-concordant PPT, or (3) untreated. OUTCOME: Symptomatic stone event occurrence (emergency department [ED] visit or hospitalization for urolithiasis or stone-directed surgery). ANALYTICAL APPROACH: Cox proportional hazards regression. RESULTS: Among 13,942 patients, 31.0% were prescribed PPT. Compared with no treatment, concordant/adherent PPT use was associated with a significantly lower hazard of symptomatic stone events for patients with hypercalciuria (HR, 0.736 [95% CI, 0.593-0.915]) and low urine pH (HR, 0.804 [95% CI, 0.650-0.996]) but not for patients with hypocitraturia or hyperuricosuria. These associations were largely driven by significantly lower rates of ED visits after initiating PPT among the concordant/adherent group versus untreated patients. Patients with hypercalciuria had adjusted 2-year predicted probabilities of a visit of 3.8% [95% CI, 2.5%-5.2%%] and 6.9% [95% CI, 6.0%-7.7%] for the concordant/adherent PPT and no-treatment groups, respectively. Among patients with low urine pH, these probabilities were 4.3% (95% CI, 2.9%-5.7%) and 7.3% (95% CI, 6.5%-8.0%) for the concordant/adherent PPT and no-treatment groups, respectively. LIMITATIONS: Potential bias from the possibility that patients prescribed PPT had more severe disease than untreated patients. CONCLUSIONS: Patients with urolithiasis and hypercalciuria who were adherent to treatment with thiazide diuretics as well as those with low urine pH adherent to prescribed alkali therapy had fewer symptomatic stone events than untreated patients. PLAIN-LANGUAGE SUMMARY: Despite multiple clinical trials demonstrating the efficacy of thiazide diuretics and alkali for secondary prevention of kidney stones, they are infrequently prescribed due in part to a lack of data about their effectiveness in real-world settings. We analyzed medical claims from older adults with kidney stones for whom urine chemistry data were available. We found that patients who took prescribed thiazide diuretics for elevated urine calcium levels or alkali for low urinary pH were less likely to experience symptomatic stone recurrences than untreated patients. This benefit was expressed as lower rates of emergency department visits after initiating therapy. Our findings should inform the prescription of and adherence to treatment with thiazide diuretics and alkali for the prevention of recurrent kidney stones.

Preventive Pharmacological Therapy and Risk of Recurrent Urinary Stone Disease.

BACKGROUND: Urinary stone disease is a prevalent condition associated with a high recurrence risk. Preventive pharmacological therapy has been proposed to reduce recurrent stone episodes. However, limited evidence exists regarding its effectiveness, contributing to its underutilization by physicians. This study aimed to evaluate the association between preventive pharmacological therapy (thiazide diuretics, alkali therapy, and uric acid-lowering medications) and clinically significant urinary stone disease recurrence. METHODS: Using data from the Veterans Health Administration, adults with an index episode of urinary stone disease from 2012 through 2019 and at least one urinary abnormality (hypercalciuria, hypocitraturia, or hyperuricosuria) on 24-hour urine collection were included. The primary outcome was a composite variable representing recurrent stone events that resulted in emergency department visits, hospitalizations, or surgery for urinary stone disease. Cox proportional hazards regression was performed to estimate the association between preventive pharmacological therapy use and recurrent urinary stone disease while adjusting for relevant baseline patient characteristics. RESULTS: Among the cohort of patients with urinary abnormalities ( n =5637), treatment with preventive pharmacological therapy was associated with a significant 19% lower risk of recurrent urinary stone disease during the 12-36-month period after the initial urine collection (hazard ratio, 0.81; 95% confidence interval, 0.65 to 1.00; P = 0.0496). However, the effectiveness of preventive pharmacological therapy diminished over longer follow-up periods (12-48 and 12-60 months after the urine collection) and did not reach statistical significance. When examining specific urinary abnormalities, only alkali therapy for hypocitraturia was associated with a significant 26% lower recurrence risk within the 12-36-month timeframe (hazard ratio, 0.74; 95% confidence interval, 0.56 to 0.97; P = 0.03). CONCLUSIONS: When considering all urinary abnormalities together, this study demonstrates that the use of preventive pharmacological therapy is associated with a lower risk of clinically significant recurrent episodes of urinary stone disease in the 12-36 month timeframe after urine collection, although only the association with the use of alkali therapy for hypocitraturia was significant when individual abnormalities were examined.

The 340B Program and oral specialty drugs for advanced prostate cancer.

INTRODUCTION: Expensive oral specialty drugs for advanced prostate cancer can be associated with treatment disparities. The 340B program allows hospitals to purchase medications at discounts, generating savings that can improve care of the socioeconomically disadvantaged. This study assessed the effect of hospital 340B participation on advanced prostate cancer. METHODS: The authors performed a retrospective cohort study of Medicare beneficiaries with advanced prostate cancer from 2012 to 2019. The primary outcome was use of an oral specialty drug. Secondary outcomes included monthly out-of-pocket costs and treatment adherence. We evaluated the effects of 1) hospital 340B participation, 2) a regional measure vulnerability, the social vulnerability index (SVI), and 3) the interaction between hospital 340B participation and SVI on outcomes. RESULTS: There were 2237 and 1100 men who received care at 340B and non-340B hospitals. There was no difference in specialty drug use between 340B and non-340B hospitals, whereas specialty drug use decreased with increased SVI (odds ratio, 0.95, p = .038). However, the interaction between hospital 340B participation and SVI on specialty drug use was not significant. Neither 340B participation, SVI, or their interaction were associated with out-of-pocket costs. Although hospital 340B participation and SVI were not associated with treatment adherence, their interaction was significant (p = .020). This demonstrated that 340B was associated with better adherence among socially vulnerable men. CONCLUSIONS: The 340B program was not associated with specialty drug use in men with advanced prostate cancer. However, among those who were started on therapy, 340B was associated with increased treatment adherence in more socially vulnerable men.

Association Between Urologist Merit-Based Incentive Payment System Performance and Quality of Prostate Cancer Care.

INTRODUCTION: We performed a study to evaluate the association between urologist performance in the Merit-Based Incentive Payment System (MIPS), and quality and spending for prostate cancer care. METHODS: Medicare beneficiaries with prostate cancer diagnosed between 2017 and 2019 were assigned to their primary urologist. Associated MIPS scores were identified and categorized based on thresholds for payment adjustment as low (worst), moderate, and high (best). Multivariable mixed effects models were used to measure the association between MIPS performance and adherence to quality measures and price standardized spending for prostate cancer. RESULTS: Adherence to quality measures did not vary across MIPS performance groups for pretreatment counselling by both a urologist and radiation oncologist (low-76%, [95% CI 73%-80%], moderate-77% [95% CI 74%-79%], and high-75% [95% CI 74%-76%]) and avoiding treatment in men with a high risk of noncancer mortality within 10 years of diagnosis (low-40% [95% CI 35%-45%], moderate-39% [95% CI 36%-43%], high-38% [95% CI 36%-39%]). Men on active surveillance managed by high performers more likely received a confirmatory test (44% [95% CI 43%-46%]) compared to those managed by moderate (38% [95% CI 33%-42%]) performers, but not low performers (36% [95% CI 29%-44%]). There was no difference in adjusted spending across MIPS performance groups. CONCLUSIONS: Better performance in MIPS is associated with a higher rate of confirmatory testing in men initiating active surveillance for prostate cancer. However, performance was not associated with other dimensions of quality nor spending.

National Trends in Management of Newly Diagnosed Prostate Cancer.

BACKGROUND: Deciding whether to treat or conservatively manage patients with prostate cancer is challenging. Recent changes in guidelines, advances in treatment technologies, and policy can influence decision making surrounding management, particularly for those for whom the decision to treat is discretionary. Contemporary trends in management of newly diagnosed prostate cancer are unclear. METHODS: Using national Medicare data, men with newly diagnosed prostate cancer were identified between 2014 and 2019. Patients were classified by 5- and 10-year noncancer mortality risk. Multinomial logistic regression models were fit to assess adjusted trends in management over time. The primary outcome was management of prostate cancer: local treatment (inclusive of surgery, radiation, brachytherapy, or cryotherapy), hormone therapy, or observation. RESULTS: Local treatment was the most common form of management and stable across years (68%). Use of observation increased (21%-23%, P < .001) and use of hormone therapy decreased (11%-8%, P < 0.001). After stratifying by 10-year non-cancer mortality risk, observation increased among men with low (22.3%-26.1%, P < .001) and moderate (19.9%-23.5%, P < .001) mortality risk. Conversely, use of treatment increased among those with high (62.8%-68.0%, P = .004) and very high (45.5%-54.1%, P < .001) risk of noncancer mortality. These trends were similar across groups when stratified by 5-year noncancer mortality risk. CONCLUSION: Nationally, use of local treatment remains common and was stable throughout the study period. However, while local treatment declined among men with a lower risk of noncancer mortality, it increased among men with a higher risk of non-cancer mortality.

Comparison of Class-Specific Side Effects Across Preventative Pharmacologic Therapies for Kidney Stone Disease.

INTRODUCTION: Clinical guidelines recommend monitoring for metabolic derangements while on preventive pharmacologic therapy for kidney stone disease. The study objective was to compare the frequency of side effects among patients receiving alkali citrate, thiazides, and allopurinol. METHODS: Using claims data from working-age adults with kidney stone disease (2008-2019), we identified those with a new prescription for alkali citrate, thiazide, or allopurinol within 12 months after their index stone-related diagnosis or procedure. We fit multivariable logistic regression models, adjusting for cohort characteristics like comorbid illness and medication adherence, to estimate 2-year measured frequencies of claims-based outcomes of acute kidney injury, falls/hip fracture, gastritis, abnormal liver function tests/hepatitis, hypercalcemia, hyperglycemia/diabetes, hyperkalemia, hypokalemia, hyponatremia, and hypotension. RESULTS: Our cohort consisted of 1776 (34%), 2767 (53%), and 677 (13%) patients prescribed alkali citrate, thiazides, or allopurinol, respectively. Comparing unadjusted rates of incident diagnoses, thiazides compared to alkali citrate and allopurinol were associated with the highest rates of hypercalcemia (2.3% vs 1.5% and 1.0%, respectively, P = .04), hypokalemia (6% vs 3% and 2%, respectively, P < .01), and hyperglycemia/diabetes (17% vs 11% and 16%, respectively, P < .01). No other differences with the other outcomes were significant. In adjusted analyses, compared to alkali citrate, thiazides were associated with a higher odds of hypokalemia (OR=2.01, 95% CI 1.44-2.81) and hyperglycemia/diabetes (OR=1.52, 95% CI 1.26-1.83), while allopurinol was associated with a higher odds of hyperglycemia/diabetes (OR=1.34, 95% CI 1.02-1.75). CONCLUSIONS: These data provide evidence to support clinical guidelines that recommend periodic serum testing to assess for adverse effects from preventive pharmacologic therapy.

Urologist practice divestment from radiation vault ownership and treatment patterns for prostate cancer.

BACKGROUND: Urologists practicing in single-specialty groups with ownership in radiation vaults are more likely to treat men with prostate cancer. The effect of divestment of vault ownership on treatment patterns is unclear. METHODS: A 20% sample of national Medicare claims was used to perform a retrospective cohort study of men with prostate cancer diagnosed between 2010 and 2019. Urology practices were categorized by radiation vault ownership as nonowners, continuous owners, and divested owners. The primary outcome was use of local treatment, and the secondary outcome was use of intensity-modulated radiation therapy (IMRT). A difference-in-differences framework was used to measure the effect of divestment on outcomes compared to continuous owners. Subgroup analyses assessed outcomes by noncancer mortality risk (high [>50%] vs. low [≤50%]). RESULTS: Among 72 urology practices that owned radiation vaults, six divested during the study. Divestment led to a decrease in treatment compared with those managed at continuously owning practices (difference-in-differences estimate, -13%; p = .03). The use of IMRT decreased, but this was not statistically significant (difference-in-differences estimate, -10%; p = .13). In men with a high noncancer mortality risk, treatment (difference-in-differences estimate, -28%; p < .001) and use of IMRT (difference-in-differences estimate, -27%; p < .001) decreased after divestment. CONCLUSIONS: Urology group divestment from radiation vault ownership led to a decrease in prostate cancer treatment. This decrease was most pronounced in men who had a high noncancer mortality risk. This has important implications for health care reform by suggesting that payment programs that encourage constraints on utilization, when appropriate, may be effective in reducing overtreatment.

The immediate effects of private equity acquisition of urology practices on the management of newly diagnosed prostate cancer.

INTRODUCTION: Some worry that physician practices acquired by private equity may increase the use of services to maximize revenue. We assessed the effects of private equity acquisition on spending, use of treatment, and diagnostic testing in men with prostate cancer. METHODS: We used a 20% sample of national Medicare claims to perform a retrospective cohort study of men with prostate cancer diagnosed from 2014 through 2019. The primary outcome was prostate cancer spending in the first 12 months after diagnosis. Secondary outcomes included the use of treatment and a composite measure of diagnostic testing (e.g., imaging, genomics) in the first 12 months after diagnosis. Multilevel modeling was used to adjust for differences in patient and market characteristics. The effect of practice acquisition on each outcome was assessed using a difference-in-differences design. RESULTS: There were 409 and 4021 men with prostate cancer managed by urologists in acquired and nonacquired practices, respectively. After acquisition, prostate cancer spending was comparable between acquired and nonacquired practices (difference-in-differences estimate $1182, p = 0.36). Acquisition did not affect the use of treatment (difference-in-differences estimate 3.7%, p = 0.30) or the use of diagnostic testing in men who were treated (difference-in-differences -5.5%, p = 0.12) and those managed conservatively (difference-in-differences -2.0%, p = 0.82). CONCLUSIONS: In the year following acquisition of urology practices, private equity did not increase prostate cancer spending, the use of treatment or diagnostic testing in men with prostate cancer. Future work should evaluate the effects of private equity acquisition on practice patterns and quality over a longer time horizon.

Value-based payment models and management of newly diagnosed prostate cancer.

OBJECTIVE: To examine the effect of urologist participation in value-based payment models on the initial management of men with newly diagnosed prostate cancer. METHODS: Medicare beneficiaries with prostate cancer diagnosed between 2017 and 2019, with 1 year of follow-up, were assigned to their primary urologist, each of whom was then aligned to a value-based payment model (the merit-based incentive payment system [MIPS], accountable care organization [ACO] without financial risk, and ACO with risk). Multivariable mixed-effects logistic regression was used to measure the association between payment model participation and treatment of prostate cancer. Additional models estimated the effects of payment model participation on use of treatment in men with very high risk (i.e., >75%) of non-cancer mortality within 10 years of diagnosis (i.e., a group of men for whom treatment is generally not recommended) and price-standardized prostate cancer spending in the 12 months after diagnosis. RESULTS: Treatment did not vary by payment model, both overall (MIPS-67% [95% CI 66%-68%], ACOs without risk-66% [95% CI 66%-68%], ACOs with risk-66% [95% CI 64%-68%]). Similarly, treatment did not vary among men with very high risk of non-cancer mortality by payment model (MIPS-52% [95% CI 50%-55%], ACOs without risk-52% [95% CI 50%-55%], ACOs with risk-51% [95% CI 45%-56%]). Adjusted spending was similar across payment models (MIPS-$16,501 [95% CI $16,222-$16,780], ACOs without risk-$16,140 [95% CI $15,852-$16,429], ACOs with risk-$16,117 [95% CI $15,585-$16,649]). CONCLUSIONS: How urologists participate in value-based payment models is not associated with treatment, potential overtreatment, and prostate cancer spending in men with newly diagnosed disease.

Association between urology practice use of multiparametric MRI and genomic testing and treatment of men with newly diagnosed prostate cancer.

INTRODUCTION: Biomarkers for prostate cancer, such as multiparametric MRI (mpMRI) and tissue-based genomics, are increasingly used for treatment decision-making. Using biomarkers indiscriminately and thus ignoring competing risks of mortality may lead to treatment in some men who derive little clinical benefit. We assessed the relationship between urology practice use of biomarkers and subsequent treatment in men with newly diagnosed prostate cancer. METHODS: We used a 20% random sample of national Medicare data to perform a retrospective cohort study of men with newly diagnosed prostate cancer diagnosed from 2015 through 2019. Urology practice-level use of biomarkers was characterized based on urology practice propensity to use either biomarker after diagnosis (never, below median, above the median). Noncancer mortality risk within 10 years of diagnosis was calculated for all men. Multilevel models were used to assess the relationship between practice-level biomarker use and treatment by noncancer mortality risk. RESULTS: Between 2015 and 2019, 1,764 (65%) urology practices used mpMRI and 897 (33%) used genomic testing for prostate cancer. Compared with urology practices never using each biomarker, those using mpMRI above the median (56% vs. 47%, P = 0.003) and tissue-based genomics below the median (56% vs. 50%, P = 0.03) were more likely to treat men with >75% risk of noncancer mortality. Additionally, compared with urology practices never using either biomarker, use of mpMRI (72% vs. 69%, P = 0.07) or tissue-based genomics (71% vs. 70%, P = 0.65) did not impact treatment in the healthiest group (i.e., those with <25% risk of noncancer mortality). CONCLUSIONS: Compared to practices that do not use each biomarker in men with newly diagnosed prostate cancer, urology practices using mpMRI, and tissue-based genomics to a lesser extent, are more likely to treat men at very high risk of dying from competing risks of mortality within 10 years of prostate cancer diagnosis.

In-office dispensing of oral targeted agents by urology practices in men with advanced prostate cancer.

BACKGROUND: Management of men with advanced prostate cancer has evolved to include urologists, made possible by oral targeted agents (eg, abiraterone or enzalutamide) that can be dispensed directly to patients in the office. We sought to investigate whether this increasingly common model improves access to these agents, especially for Black men who are historically undertreated. METHODS: We used 20% national Medicare data to perform a retrospective cohort study of men with advanced prostate cancer from 2011 through 2019, managed by urology practices with and without in-office dispensing. Using a difference-in-difference framework, generalized estimating equations were used to measure the effect of in-office dispensing on prescriptions for abiraterone and/or enzalutamide, adjusting for differences between patients, including race. RESULTS: New prescription fills for oral targeted agents increased after the adoption of in-office dispensing (+4.4%, 95% confidence interval [CI] = 3.4% to 5.4%) relative to that for men managed by practices without dispensing (+2.4%, 95% CI = 1.4% to 3.4%). The increase in the postintervention period (difference-in-difference estimate) was 2% higher (95% CI = 0.6% to 3.4%) for men managed by practices adopting dispensing relative to men managed by practices without dispensing. The effect was strongest for practices adopting dispensing in 2015 (difference-in-difference estimate: +4.2%, 95% CI = 2.3% to 6.2%). The effect of dispensing adoption did not differ by race. CONCLUSION: Adoption of in-office dispensing by urology practices increased prescription fills for oral targeted agents in men with advanced prostate cancer. This model of delivery may improve access to this important class of medications.

Health care delivery system contributions to management of newly diagnosed prostate cancer.

BACKGROUND: Despite clinical guidelines advocating for use of conservative management in specific clinical scenarios for men with prostate cancer, there continues to be tremendous variation in its uptake. This variation may be amplified among men with competing health risks, for whom treatment decisions are not straightforward. The degree to which characteristics of the health care delivery system explain this variation remains unclear. METHODS: Using national Medicare data, men with newly diagnosed prostate cancer between 2014 and 2019 were identified. Hierarchical logistic regression models were used to assess the association between use of treatment and health care delivery system determinants operating at the practice level, which included measures of financial incentives (i.e., radiation vault ownership), practice organization (i.e., single specialty vs. multispecialty groups), and the health care market (i.e., competition). Variance was partitioned to estimate the relative influence of patient and practice characteristics on the variation in use of treatment within strata of noncancer mortality risk groups. RESULTS: Among 62,507 men with newly diagnosed prostate cancer, the largest variation in the use of treatment between practices was observed for men with high and very high-risk of noncancer mortality (range of practice-level rates of treatment for high: 57%-71% and very high: 41%-61%). Addition of health care delivery system determinants measured at the practice level explained 13% and 15% of the variation in use of treatment among men with low and intermediate risk of noncancer mortality in 10 years, respectively. Conversely, these characteristics explained a larger share of the variation in use of treatment among men with high and very high-risk of noncancer mortality (26% and 40%, respectively). CONCLUSIONS: Variation among urology practices in use of treatment was highest for men with high and very high-risk noncancer mortality. Practice characteristics explained a large share of this variation.

Practice Competition and Treatment of Newly Diagnosed Prostate Cancer.

OBJECTIVE: To examine the effect of urology practice market competition on use of treatment in men with newly diagnosed prostate cancer. METHODS: We performed a retrospective national cohort study of 48,067 Medicare beneficiaries with newly diagnosed prostate cancer between 2014 and 2018. The primary exposure was urology practice-level market competition. Markets were established by the flow of patients to a practice using a variable radius approach. Practice level competition was measured annually using the Herfindahl-Hirschman Index. The primary outcome was use of treatment for prostate cancer (ie, surgery, radiation, or cryotherapy) stratified by 10-year risk of noncancer mortality. RESULTS: Between 2014 and 2018, there was a decrease in the total percent of urologists practicing in small single-specialty groups (49%-41%) with an increase in multispecialty practices (38%-47%). After adjusting for demographic and clinical characteristics, a lower percentage of men underwent treatment in practices with low competition relative to those managed in practices with high competition (70% vs 67.0%, P < .001). Among men with the highest risk of noncancer mortality, those managed in practices in the least competitive markets were less likely to receive treatment relative to men managed by practices in the most competitive markets (48% vs 60%, P-value<.001). CONCLUSION: Reduction in competition between urology practices is not associated with greater use of treatment in men with newly diagnosed prostate cancer, particularly in those with a high risk of noncancer mortality.

Effects of In-office Dispensing by Single-specialty Urology Practices on Management of Advanced Prostate Cancer.

INTRODUCTION: We examine changes in the volume of patients with advanced prostate cancer and prescriptions for abiraterone and enzalutamide among urology practices with and without in-office dispensing. METHODS: Using data from the National Council for Prescription Drug Programs, we identified in-office dispensing by single-specialty urology practices from 2011 to 2018. As the greatest growth in implementing dispensing occurred among large groups in 2015, outcomes were measured at the practice level in 2014 (before) and 2016 (after) for dispensing and non-dispensing practices. Outcomes included the volume of men with advanced prostate cancer managed by a practice and prescriptions for abiraterone and/or enzalutamide. Using national Medicare data, generalized linear mixed models were fit to compare the practice-level ratio of each outcome (2016 relative to 2014) adjusting for regional contextual factors. RESULTS: In-office dispensing increased from 1% to 30% of single-specialty urology practices from 2011 to 2018, with 28 practices implementing dispensing in 2015. In 2016 compared to 2014, adjusted changes in the volume of patients with advanced prostate cancer managed by a practice were similar between non-dispensing (0.88, 95% CI 0.81-0.94) and dispensing (0.93, 95% CI 0.76-1.09) practices (P = .60). Prescriptions for abiraterone and/or enzalutamide increased in both non-dispensing (2.00, 95% CI 1.58-2.41) and dispensing (8.99, 95% CI 4.51-13.47) practices (P < .01). CONCLUSIONS: In-office dispensing is increasingly common in urology practices. This emerging model is not associated with changes in patient volume but is associated with increased prescriptions for abiraterone and enzalutamide.

Differential adoption of castration-resistant prostate cancer treatment across facilities in a national healthcare system.

BACKGROUND: Over the past decade, abiraterone and enzalutamide have largely replaced ketoconazole as oral treatments for castration-resistant prostate cancer (CRPC). We investigated the differential adoption of abiraterone and enzalutamide across facilities in a national healthcare system to understand the impact a facility has on the receipt of these novel therapies. METHODS: Using data from the VA Corporate Data Warehouse, we identified a cohort of men with CRPC who received the most common first-line therapies: abiraterone, enzalutamide, docetaxel, or ketoconazole between 2010 and 2017. We described variability in the adoption of abiraterone and enzalutamide across facilities by time period (2010-2013 or 2014-2017). We categorized facilities depending on the timing of adoption of abiraterone and enzalutamide relative to other facilities and described facility characteristics associated with early and late adoption. RESULTS: We identified 4998 men treated with ketoconazole, docetaxel, abiraterone, or enzalutamide as first-line CRPC therapy between 2010 and 2017 at 125 national facilities. When limiting the cohort to oral therapies, most patients treated earlier in the study period (2010-2013) received ketoconazole. A dramatic shift was seen by the second half of the study period (2014-2017) with most men treated with first-line abiraterone (61%). Despite this shift and a new standard of care, some facilities persisted in the widespread use of ketoconazole in the later period, so-called late adopting facilities. After multivariable adjustment, patients who received treatment at a late adopting facility were more likely receiving care at a lower complexity, rural facility, with less urology and hematology/oncology workforce (all p < 0.01). CONCLUSION: Many facilities persisted in their use of ketoconazole as first-line CRPC therapy, even when other facilities had adopted the new standard of care abiraterone and enzalutamide. Further work is needed to identify the effect of this late adoption on outcomes important to patients.

Treatment patterns and survival of low and intermediate-risk prostate cancer in end-stage kidney disease: A retrospective population cohort study.

BACKGROUND: In accordance with guidelines, observation with or without active surveillance for low-risk prostate cancer increased in recent years in the general population. We compared treatment patterns and mortality for low- and intermediate-risk prostate cancer and mortality rates among end-stage kidney disease (ESKD) and non-ESKD patients. METHODS: This is a retrospective population-based observational cohort study of Surveillance, Epidemiology, and End Results-Medicare data of men aged 66 years and older with localized prostate cancer (2004-2015). ESKD status was determined using Medicare billing codes. Multivariable logistic regression models and Cox-proportional hazards models were used to study definitive treatment patterns and mortality, respectively. RESULTS: For low-risk prostate cancer, dialysis patients (N = 83) had lower but not statistically significant odds (OR, 0.74; 95% CI: 0.48-1.16) of receiving definitive treatment than non-ESKD patients (N = 24,935). For those with intermediate-risk prostate cancer, dialysis patients (N = 254) had lower odds to receive definitive treatment (OR, 0.54; 95% CI: 0.42-0.72) than non-ESKD patients (N = 60,883). From 2004-2010 to 2011-2015, for patients with low-risk prostate cancer, while the receipt of definitive treatment for non-ESKD patients trended down from 72% to 48%, it trended up for dialysis patients from 55% to 65%. Kidney transplant patients (N = 33 for low-risk and N = 91 for intermediate-risk) had lower rates of definitive treatment for low-risk and similar rates of treatment for intermediate-risk prostate cancer compared to non-ESKD patients. CONCLUSIONS: The disparity in definitive treatment rates for low-risk prostate cancer among dialysis patients exists despite their high mortality, compared to the general population.

Effects of Advanced Practice Providers on Single-specialty Surgical Practice.

OBJECTIVE: To assess the effects of adding advanced practice providers to surgical practices on surgical complications, readmissions, mortality, episode spending, length of stay, and access to care. SUMMARY BACKGROUND DATA: There has been substantial growth in the number of nurse practitioners and physician assistants (ie, advanced practice providers) in the United States. The extent to which advanced practice providers have been integrated into surgical practice, and their impact on surgical outcomes and access is unclear. METHODS: Using a 20% sample of national Medicare claims, we performed a retrospective cohort study of fee-for-service beneficiaries undergoing one of 4 major procedures (coronary artery bypass graft, colectomy, major joint replacement, and cystectomy) between 2010 and 2016. We limited our study population for each procedure to patients treated by single-specialty surgical groups to ensure that the advanced practice providers have direct interactions with its surgeons and patients. All outcomes were measured at the practice level for the year before and the year after the addition of the first advanced practice provider. Outcomes included: complications, readmission, mortality, episode payments, length of stay. Models were adjusted for age, race, sex, comorbidity, socioeconomic class and procedure type. Secondary outcome: practice-level office visits by surgical group type. RESULTS: The number of advanced practice providers increased by 13%, from 6713 to 7596 between 2010 and 2016. The largest relative increases occurred in general (46.9%) and urologic (27.6%) surgical practices. The year after an advanced practice provider was added to a surgical practice, the odds of complications were 17% and 16% lower at 30- and 90-days postprocedure, respectively. Additionally, 90-day readmissions were 18% less likely and length of stay was 0.33 days shorter (a 7.1% reduction). Average 30-day and90-day episode spending was $1294.73 and $1427.76 lower, respectively ( P < 0.001). General surgical, orthopedic, and urology practices realized increases of 49.0 (95% CI 13.5-84.5), 112.0 (95% CI 83.0-140.5), and 205.0 (95% CI 117.5-292.0) in-office visits per surgeon, respectively. CONCLUSIONS: The addition of advanced practice providers to single-specialty surgical groups is associated with improvements in surgical outcomes and access. Future work should clarify the mechanisms by which advanced practice providers within surgical practices contribute to health outcomes to identify best practices for deployment.