Social Determinants of Health and the Availability of Cancer Clinical Trials in the United States.

This cohort study investigates whether county-level social determinants of health are associated with cancer clinical trial availability in the United States.

Social Vulnerability and Receipt of Neoadjuvant Chemotherapy in Patients Undergoing Radical Cystectomy for Bladder Cancer.

OBJECTIVE: To evaluate the association between a population-level measure of social determinants of health, the Centers for Disease Control and Prevention Social Vulnerability Index (SVI), and receipt of neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy. METHODS: We queried our institutional database for patients with nonmetastatic MIBC treated with radical cystectomy between 2000 and 2022. Patients were assigned an SVI via ZIP code of residence and grouped into quintiles of SVI (i.e. least vulnerable to most vulnerable). Multivariable logistic regression was performed to evaluate the association between SVI and receipt of neoadjuvant chemotherapy, adjusting for age, race, gender, and cancer stage. A sub-analysis was performed to evaluate the association between subthemes of SVI (socioeconomic status, household composition/disability, race/ethnicity/language, and housing/transportation) and receipt of neoadjuvant chemotherapy. RESULTS: Of the 978 patients identified, 490 (50.1%) received neoadjuvant chemotherapy. Patients that received neoadjuvant chemotherapy had a lower SVI, were younger, and had >cT2 stage (all, p<0.05). The most vulnerable patients had lower odds of receiving neoadjuvant chemotherapy (OR 0.61, 0.39 - 0.95) compared to the least vulnerable patients. Analysis of subthemes of SVI demonstrated similar associations by socioeconomic status (OR 0.56, 0.36 - 0.86) and household composition/disability (OR 0.57, 0.33 - 0.99). DISCUSSION: Adverse social determinants of health, or social vulnerability, is associated with suboptimal and disparate utilization of neoadjuvant chemotherapy in patients with MIBC undergoing radical cystectomy. Strategies for identifying vulnerable populations may allow for more targeted interventions that would improve equity in bladder cancer care.

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.

Differentiating gender-based reproductive concerns among adolescent and young adult cancer patients: A mixed methods study.

INTRODUCTION: Few studies have examined the distinct reproductive concerns (RC) of men and women in the adolescent and young adult (AYA) cancer patient population. The purpose of this mixed-methods study was to explore and differentiate the RC of AYAs. METHODS: Participants completed the Reproductive Concerns After Cancer (RCAC) scale and participated in a semistructured interview. Interviews were deductively coded based on an analytic schema derived from the RCAC. RESULTS: After identifying participants through the electronic health record, 27 younger AYAs, ages 12-25, enrolled in the study. Four inductive themes emerged and differed by gender. These include differential temporality, acceptance, and openness to alternatives, partner influence, and parental/guardian influence. AYA men reported fewer RC (M = 49.4, SD = 9.6) compared to AYA women (M = 56.8, SD = 8.4). CONCLUSIONS: Oncofertility care providers are advised to account for short- and long-ranging concerns based on AYAs' gender. Future evaluations of patient-reported outcome measures specific to AYA RC are recommended.

Body image disturbances in adolescent and young adult cancer patients confronting infertility risk and fertility preservation decisions.

PURPOSE: Body image is a major psychosocial concern for all cancer patients but can affect the adolescent and young adult (AYA) population in distinct ways. Similarly, the prospect of infertility and the fertility preservation process can create additional stress during cancer treatment. Discussions regarding infertility inherently implicate the body and its reproductive function, but downstream effects on self-perception have not been previously described. The aim of this study was to explore the experiences of AYAs as they considered their risk of infertility and options for fertility preservation (FP), specifically the ways in which this impacted body image and FP decision-making. METHODS: AYA cancer patients (n = 27) aged 12-25 years whose cancer and treatment conferred risk of infertility were recruited through electronic health record query at an NCI-Designated Comprehensive Cancer Center. Participants completed semi-structured interviews, which were recorded, transcribed, and deductively coded for themes related to information needs, knowledge of treatment effects on fertility, and reproductive concerns after cancer. Emergent, inductive themes related to body image were identified. RESULTS: Body image concerns, related to both physical appearance and body functioning emerged. Common concerns included anticipating change as it pertains to the body and its functions, physical discomfort, fear of judgment, and meeting expectations of the body. While these themes are broad in nature, they have been previously explored in relation to body image in general and their emergence in the oncofertility space provides guidance for further optimization of infertility and fertility preservation discussions. CONCLUSIONS: AYA cancer patients experience a multitude of body image related disturbances when faced with the possibility of infertility and fertility preservation. In identifying and exploring these themes, future opportunities for improving oncofertility practice and discussions among AYAs with a focus on body image positivity are called upon.

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.

Acquisition of Urology Practices by Private Equity Firms and Performance in the Merit-based Incentive Payment System.

INTRODUCTION: Private equity is increasingly engaged in the acquisition of urology practices. The implications of strategies to enhance practice value deployed by these firms for patients are unclear. METHODS: We conducted a retrospective study of urologist performance in the MIPS (Merit-based Incentive Payment System) program for 2017 to 2020 using national Medicare data from the Quality Payment Program file. The primary outcome was the overall MIPS score. Secondary outcomes included MIPS component scores (ie, quality, interoperability, improvement activities, cost) and the percentage of urologists receiving a bonus payment. Generalized estimating equations were used to estimate the relationship between private equity acquisition and outcomes using a difference-in-differences framework. RESULTS: Between 2017 and 2020, 181 urologists were in a urology practice acquired by private equity with MIPS data available the year before and after acquisition. Compared to urologists in practices not acquired by private equity, those in acquired practices had worse overall MIPS performance after acquisition (difference-in-differences estimate, -14 points, P = .04). The decrease in the overall score was driven by worse performance in the quality score (difference-in-differences estimate, -28 points, P < .001). Finally, acquisition resulted in a decrease in the percentage of urologists receiving bonus payments (difference-in-differences estimate, -43%, P < .001). CONCLUSIONS: Private equity acquisition of urology practices was associated with significantly lower MIPS performance. As private equity acquisition of urology practices becomes more prevalent, key stakeholders should ensure that the quality of patient care is maintained and that the involvement of for-profit entities in health care is being made transparent to patients.

The Future is Female: Urology Workforce Projection from 2020 to 2057.

Multiple estimates have approximated a urologist shortage per capita of around 30% by 2030. In the context of the impending urologic workforce shortage, it is critical to have a nuanced understanding of the degree of workforce shortage in comparison with the US population to mitigate the negative downstream effects in the future. In continued growth and stagnant growth projection models, we found that female urologists make up a significant proportion of the workforce growth over the next four decades. This projection highlights the need for purposeful recruitment, structural changes, and advocacy among urology leadership to support and retain female urologists.

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.

Building a Roadmap for Surveillance of Renal Masses Using a Modified Delphi Method to Help Achieve Consensus.

OBJECTIVE: To establish a consensus for initial evaluation and follow-up of patients on active surveillance (AS) for T1 renal masses (T1RM). METHODS: A modified Delphi method was used to gather information about AS of T1RM, with a focus on patient selection, timing/type of imaging modality, and triggers for intervention. A consensus panel of Michigan Urological Surgery Improvement Collaborative-affiliated urologists who routinely manage renal masses was formed. Areas of consensus (defined >80% agreement) about T1RM AS were established iteratively via 3 rounds of online questionnaires. RESULTS: Twenty-six Michigan Urological Surgery Improvement Collaborative urologists formed the panel. Consensus was achieved for 321/587 scenarios (54.7%) administered through 124 questions. Life expectancy, age, comorbidity, and renal function were most important for patient selection, with life expectancy ranking first. All tumors <3 cm and all patients with life expectancy <1 year were considered appropriate for AS. Appropriateness also increased with elevated perioperative risk, increasing tumor complexity, and/or declining renal function. Consensus was for multiphasic axial imaging initially (contrast CT for GFR >60 or MRI for GFR >30) with first repeat imaging at 3-6 months and subsequent imaging timing determined by tumor size. Consensus was for chest imaging for tumors >3 cm initially and >5 cm at follow up. Renal biopsy was not felt to be a requirement for entering AS, but useful in several scenarios. Consensus indicated rapid tumor growth as an appropriate trigger for intervention. CONCLUSION: Our consensus panel was able to achieve areas of consensus to help define a clinically useful and specific roadmap for AS of T1RM and areas for further discussion where consensus was not achieved.

Out-of-Pocket Costs for Prostate Cancer Medications Substantially Vary by Medicare Part D Plan: An Online Tool Presents an Opportunity to Mitigate Financial Toxicity.

INTRODUCTION: Patients with advanced prostate cancer are frequently prescribed enzalutamide or abiraterone, often requiring high out-of-pocket costs. Many of these patients are insured through Medicare and have an option to select among 54 different Part D drug plans. However, less than 30% of patients report comparing costs before selecting a plan. An online Part D plan navigator is publicly available and allows patients to compare estimated out-of-pocket prescriptions costs. In this study, we examine the variability of out-of-pocket costs based on available Part D drug plans for patients with prostate cancer and demonstrate how an online tool could save patients thousands of dollars. METHODS: We identified drug plans available for selection in 2023 using the online Medicare Part D Plan Finder. We sampled plan options for 12 different zip codes within the United States. A university-sponsored specialty cancer pharmacy and online mail-order pharmacy were included for comparison. We identified out-of-pocket costs for enzalutamide and abiraterone based on all Part D plans available for selection. RESULTS: On average, 24 Part D drug plans were available for each zip code. Median annual out-of-pocket costs were $11,626 for enzalutamide and $9,275 for abiraterone. The range of annual out-of-pocket costs were $9,854 to $13,061 for enzalutamide and $1,379 to $13,274 for abiraterone. Within certain zip codes, potential out-of-pocket cost savings were $2,512 for enzalutamide and $9,321 for abiraterone. Median difference of out-of-pocket cost between enzalutamide and abiraterone was $8,758. CONCLUSIONS: Out-of-pocket costs vary considerably across Part D drug plans. The Medicare Part D Plan Finder is a simple and effective tool to identify affordable drug plans. Guidance on plan selection could save patients thousands of dollars and help mitigate the financial toxicity of treatment. Comprehensive cancer centers could include plan navigators as an essential component of treatment.

Use of a physical activity monitor to track perioperative activity of radical cystectomy patients. Our first glimpse at what our patients are doing before and after surgery.

PURPOSE: To optimize recovery after radical cystectomy (RC), providers stress the importance of ambulation and adequate rest. However, little is known about the activity and sleep habits of patients undergoing RC. Therefore, we utilized a wearable physical activity monitor (PAM) in the perioperative period to provide the first objective data on physical activity and sleep habits for RC patients. MATERIALS AND METHODS: We prospectively identified patients ≥60 years old with planned RC. Participants completed a 4-week prehabilitation exercise program prior to surgery. They wore a PAM for 7-day intervals: at baseline, after prehabilitation, at postoperative day (POD) 30 and POD90. We tracked physical activity via metabolic equivalents (METs). METs were categorized by intensity: light (MET 1.5-<3), moderate (MET 3-<6), and vigorous (MET ≥6). We calculated daily step totals. We tracked hours slept and number of sleep awakenings. We correlated activity and sleep with self-reported quality of life (QOL). RESULTS: Forty-two patients completed prehabilitation and RC. Moderate intensity exercise decreased at POD30 (61 minutes/d at baseline, 30 minutes/d at POD30, P = 0.005). Physical activity did not significantly differ for light or vigorous activity at any timepoint. RC did not significantly affect sleep. Sleep and physical activity were associated with mental and physical QOL, respectively. CONCLUSIONS: This is the first study utilizing patient-worn monitors in RC to track physical activity and sleep. This study gives patients and providers a better understanding of postcystectomy recovery expectations. With these results in mind, interventions may be implemented to optimize activity and sleep in the perioperative period.

Can you have it all? Parenting in Urology and Work-Life Balance Satisfaction.

OBJECTIVE: To evaluate the association between work-life balance satisfaction for practicing urologists who have children <18 years compared to those who do not have children or have children ≥18 years. METHODS: We evaluated the association between work-life balance satisfaction based on partner status, partner employment status, child status, primary responsible party for family, total work hours per week, and total vacation weeks per year using 2018 and 2019 American Urological Association (AUA) census data with post-stratification adjustment methods. RESULTS: Of 663 respondents, 77 (9.0%) were female and 586 (91%) were male. Female urologists are more likely to have an employed partner (79.vs 48.9%, P <.001), more likely to have children <18 years (75.0 vs 41.7%, P <.0001), and less likely to have a partner as primary caretaker of family (26.5 vs 50.3%, P <.0001) compared to male urologists. Urologists with children <18 years reported lower work-life balance satisfaction than those without (OR 0.65, P = .035). For every 5 additional hours works per week, urologists reported lower work-life balance (OR 0.84, P <.001). However, there are no statistically significant associations between work-life balance satisfaction and gender, employment status of their partner, primary responsible party for family responsibilities, and total weeks of vacation per year. CONCLUSION: According to recent AUA census data, having children <18 years is associated with lower work-life balance satisfaction. This highlights opportunities to support young parents, both male and female, in the workplace to prevent burnout and maximize well-being among urologists.

Banking on Fertility Preservation: Financial Concern for Adolescent and Young Adult Cancer Patients Considering Oncofertility Services.

Purpose: Financial concern is a major issue for adolescent and young adult (AYA) cancer patients. Furthermore, unaddressed oncofertility challenges (e.g., infertility) are linked to psychological distress and decreased overall quality of life. Little is known about how financial concern in terms of oncofertility (i.e., concern regarding affording fertility preservation [FP] services) impacts AYAs' decision making and experiences. Methods: AYA cancer patients (n = 27) aged 12-25 years whose cancer treatment conferred risk of infertility were recruited through electronic health record query. Participants completed semi-structured interviews, which were recorded, transcribed, and deductively coded for themes related to information needs, knowledge of treatment effects on fertility, and reproductive concerns after cancer. Emergent, inductive themes related to financial concern were identified. The Institutional Review Board at the University of Michigan approved this study (HUM#00157267). Results: Financial concern was a dominant theme across the qualitative data. Emergent themes included (1) varied access to health insurance, (2) presence of parental/guardian support, (3) reliance upon financial aid, (4) negotiating infertility risk, and (5) lack of preparation for long-term costs. AYAs relied heavily upon parents for out-of-pocket and insurance coverage support. Some participants sought financial aid when guided by providers. Several participants indicated that no financial support existed for their circumstance. Conclusions: Financial consequences in terms of oncofertility are a major issue affecting AYA cancer patients. The incidence and gravity of financial concern surrounding affording oncofertility services merits attention in future research (measuring financial resources of AYAs' parental/support networks), clinical practice (strategically addressing short- and long-term costs; tailored psychosocial support), and health care policy (promoting legislation to mandate pre- and post-treatment FP coverage).

Association of Medicare Beneficiary and Hospital Accountable Care Organization Alignment With Surgical Cost Savings.

Importance: Although Medicare accountable care organizations (ACOs) account for half of program expenditures, whether ACOs are associated with surgical spending warrants further study. Objective: To assess whether greater beneficiary-hospital ACO alignment was associated with lower surgical episode costs. Design, Setting, and Participants: This retrospective cohort study was conducted between 2020 and 2022 using US Medicare data from a 20% random sample of beneficiaries. Individuals 18 years of age and older and without kidney failure who had a surgical admission between 2008 and 2015 were included. For each study year, distinction was made between beneficiaries assigned to an ACO and those who were not, as well as between admissions to ACO-participating and nonparticipating hospitals. Exposures: Time-varying binary indicators for beneficiary ACO assignment and hospital ACO participation and an interaction between them. Main Outcomes and Measures: Ninety-day, price-standardized total episode payments. Multivariable 2-way fixed-effects models were estimated. Results: During the study period, 2 797 337 surgical admissions (6% of which involved ACO-assigned beneficiaries) occurred at 3427 hospitals (17% ACO participating). Total Medicare payments for 90-day surgical episodes were lowest when ACO-assigned beneficiaries underwent surgery at a hospital participating in the same ACO as the beneficiary ($26 635 [95% CI, $26 426-$26 844]). The highest payments were for unassigned beneficiaries treated at participating hospitals ($27 373 [95% CI, $27 232-$27 514]) or nonparticipating hospitals ($27 303 [95% CI, $27 291-$27 314]). Assigned beneficiaries treated at hospitals participating in a different ACO and assigned beneficiaries treated at nonparticipating hospitals had similar payments (for participating hospitals, $27 003 [95% CI, $26 739-$27 267] and for nonparticipating hospitals, $26 928 [95% CI, $26 796-$27 059]). A notable factor in the observed differences in surgical episode costs was lower spending on postacute care services. Conclusions and Relevance: In this cohort study evaluating hospital and beneficiary ACO alignment and surgical spending, savings were noted for beneficiaries treated at hospitals in the same ACO. Allowing ACOs to encourage or require surgical procedures in their own hospitals could lower Medicare spending on surgery.