Faculty Bibliography

OBJECTIVE:To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS:An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS:Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P < .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, P = .02). Decision satisfaction measures were similar in both arms. DISCUSSION/CONCLUSIONS:Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.

Transgender and non-binary (TGNB) individuals often experience gender dysphoria. TGNB individuals with gender dysphoria may undergo genital gender-affirming surgery including vaginoplasty, phalloplasty, or metoidioplasty so that their genitourinary anatomy is congruent with their experienced gender. Given decreasing social stigma and increasing coverage from private and public payers, there has been a rapid increase in genital gender-affirming surgery in the past few years. As the incidence of genital gender-affirming surgery increases, a concurrent increase in the development and utilization of patient reported outcome measurement tools is critical. To date, there is no systematic way to assess and measure patients' perspectives on their surgeries nor is there a validated measure to capture patient reported outcomes for TGNB individuals undergoing genital gender-affirming surgery. Without a systematic way to assess and measure patients' perspectives on their care, there may be fragmentation of care. This fragmentation may result in challenges to ensure patients' goals are at the forefront of shared- decision making. As we aim to increase access to surgical care for TGNB individuals, it is important to ensure this care is patient-centered and high-quality. The development of patient-reported outcomes for patients undergoing genital gender-affirming surgery is the first step in ensuring high quality patient-centered care. Herein, we discuss the critical need for development of validated patient reported outcome measures for transgender and non-binary patients undergoing genital reconstruction. We also propose a model of patient-engaged patient reported outcome measure development.

Importance/UNASSIGNED:SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. Objective/UNASSIGNED:To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. Design, Setting, and Participants/UNASSIGNED:The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021. Interventions/UNASSIGNED:Patients stratified by age, history of hypertension, and disease severity were centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo. Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone. Main Outcomes and Measures/UNASSIGNED:The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. Secondary end points were time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference range, maximum severity of COVID-19, and the composite end point at 30 days. Results/UNASSIGNED:The trial was stopped for futility after the planned interim analysis, at which time there were 96 evaluable patients, including 62 patients randomized to the degarelix group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%]; P = .67). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns. Conclusions and Relevance/UNASSIGNED:In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04397718.

OBJECTIVE:To determine if there is an association between patient race and physician time spent with the patient during outpatient urology consultations. METHODS:We identified all adult urology new outpatient visits in the National Ambulatory Medical Care Survey dataset for 2012-2016. Patient race was dichotomized as White or non-White. Our primary outcome was time spent during the visit between the patient and urologist. Using population-level weighting, we compared differences in mean time spent during visits with White and non-White patients. Mixed-effects linear regression was used to adjust for confounding factors and to account for clustering among individual physicians. Secondary outcomes included number of services provided and if ancillary providers were seen. RESULTS:Over the 5 year period, 1668 raw visits met criteria and were used to estimate 21million new outpatient urology visits nationwide. 80% of all visits were with White patients. Mean physician time spent among visits with white patients was 23.9 minutes and 24.4 minutes for non-White patients. There was no difference in number of services provided but visits with non-white patients were less likely to include an ancillary provider. After adjustment, there was no significant difference in mean time spent with the urologist among visits with White and non-White patients (difference 0.9 minutes, 95% CI: -0.6-2.4). There were also no differences in adjusted mean time spent among return visits or new visits for hematuria, urologic cancers, or BPH. CONCLUSION/CONCLUSIONS:We found no statistically significant difference in time spent with a urologist during outpatient office consultations between White and non-White patients.

Background/UNASSIGNED:The incidence and severity of coronavirus disease 19 (COVID-19) is substantially higher in men. Sex hormones may be a potential mechanism for differences in COVID-19 outcome in men and women. We hypothesized that men treated with androgen deprivation therapy (ADT) have lower incidence and severity of COVID-19. Methods/UNASSIGNED:We conducted an observational study of male Veterans treated in the Veterans Health Administration from February 15th to July 15th, 2020. We developed a propensity score model to predict the likelihood to undergo Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. We performed multivariable logistic regression modeling adjusted with inverse probability weighting to examine the relationship between ADT and COVID-19 incidence. We conducted logistic regression analysis among COVID-19 patients to test the association between ADT and COVID-19 severity. Results/UNASSIGNED:= 0.03). Conclusion/UNASSIGNED:ADT is associated with reduced incidence and severity of COVID-19 amongst male Veterans. Testosterone and androgen receptor signaling may confer increased risk for SARS-CoV-2 infection and contribute to severe COVID-19 pathophysiology in men.

Cancer survivors benefit from evidence-based smoking cessation treatment. A crucial first step in this process is a clinician recommending that the patient quit smoking. However, contemporary delivery of advice to quit among patients with cancer is not well known. In a cross-sectional analysis of all adult smokers included in a prospective population-representative study of US adults, we analyzed the frequency that patients reported receiving advice to quit smoking from a healthcare professional according to reported cancer history (no cancer, tobacco-related cancer, non-tobacco related cancer history). Among an estimated 28.3 million smokers, 9.3% reported a history of cancer, 48.8% of which were tobacco-related cancers. In general, advice to quit was reported by more (67.8%) cancer survivors than those adults without any cancer (56.0%). After adjustment for sociodemographic factors, smokers with a non tobacco-related cancer (0.51, 95% CI 0.32-0.83) and those without any cancer history (0.43, 95% CI 0.30-0.63) were both less likely to report being advised to quit smoking than patients with a tobacco-related cancer history.

OBJECTIVES/OBJECTIVE:Treatment with epidermal growth factor receptor monoclonal antibodies extends life for patients with advanced colorectal cancers (CRCs) whose tumors exhibit wild-type KRAS, but KRAS testing may be underused. We studied the role of socioeconomic factors in the application of KRAS testing. MATERIALS AND METHODS/METHODS:We identified subjects with stage IV colorectal adenocarcinoma diagnosed 2010-2015 in the Surveillance, Epidemiology, and End Results (SEER) database. We used multivariable logistic regression models to evaluate associations between clinical/demographic factors and the rate of KRAS testing. We used multivariable-adjusted Cox proportional hazards models to assess survival. RESULTS:We identified 37,676 patients with stage IV CRC, 31.1% of whom were tested for KRAS mutations, of those who had documented KRAS testing, 44% were KRAS mutant. Patients were more likely to be tested if they were younger (odds ratio [OR]=5.10 for age 20 to 29 vs. 80+, 95% confidence interval [CI]: 3.99-6.54, P<0.01), diagnosed more recently (OR=1.92 for 2015 vs. 2010, 95% CI: 1.77-2.08, P<0.01), or lived in an area of high median household income (OR=1.24 for median household income of >$69,311 vs. <$49,265, 95% CI: 1.14-1.35, P<0.01). Patients were less likely to be tested if they had Medicaid (OR=0.83, 95% CI: 0.77-0.88, P<0.01) or were unmarried (OR=0.78, 95% CI: 0.75-0.82, P<0.0001). The risk of death was decreased in patients who received KRAS testing (hazard ratio=0.77, 95% CI: 0.75-0.80, P<0.01). CONCLUSIONS:We found a low rate of KRAS testing in CRC patients with those living in low-income areas less likely to be tested, even after controlling for Medicaid insurance. Our study suggests that socioeconomic disparities persist despite Medicaid insurance.

PURPOSE:We examined changes in urological care delivery due to COVID-19 in the U.S. based on patient, practice, and local/regional demographic and pandemic response features. MATERIALS AND METHODS:We analyzed real-world data from the American Urological Association Quality (AQUA) Registry collected from electronic health record systems. Data represented 157 outpatient urological practices and 3,165 providers across 48 U.S. states and territories, including 3,297,721 unique patients, 12,488,831 total outpatient visits and 2,194,456 procedures. The primary outcome measure was the number of outpatient visits and procedures performed (inpatient or outpatient) per practice per week, measured from January 2019 to February 2021. RESULTS:We found large (>50%) declines in outpatient visits from March 2020 to April 2020 across patient demographic groups and states, regardless of timing of state stay-at-home orders. Nonurgent outpatient visits decreased more across various nonurgent procedures (49%-59%) than for procedures performed for potentially urgent diagnoses (38%-52%); surgical procedures for nonurgent conditions also decreased more (43%-79%) than those for potentially urgent conditions (43%-53%). African American patients had similar decreases in outpatient visits compared with Asians and Caucasians, but also slower recoveries back to baseline. Medicare-insured patients had the steepest declines (55%), while those on Medicaid and government insurance had the lowest percentage of recovery to baseline (73% and 69%, respectively). CONCLUSIONS:This study provides real-world evidence on the decline in urological care across demographic groups and practice settings, and demonstrates a differential impact on the utilization of urological health services by demographics and procedure type.

BACKGROUND:Studies have demonstrated that Black men may undergo definitive prostate cancer (CaP) treatment less often than men of other races, but it is unclear whether they are avoiding overtreatment of low-risk disease or experiencing a reduction in appropriate care. The authors' aim was to assess the role of race as it relates to treatment benefit in access to CaP treatment in a single-payer population. METHODS:The authors used the Veterans Health Administration (VHA) Corporate Data Warehouse to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017. RESULTS:The authors identified 35,427 men with incident low- or intermediate-risk CaP. When they controlled for covariates, Black men had 1.05 times the odds of receiving treatment in comparison with non-Black men (P < .001), and high-treatment-benefit men had 1.4 times the odds of receiving treatment in comparison with those in the low-treatment-benefit group (P < .001). The interaction of race and treatment benefit was significant, with Black men in the high-treatment-benefit category less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001). CONCLUSIONS:Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations. The influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.

BACKGROUND:Men with prostate cancer are often treated with the suppression of testosterone through long-acting injectable drugs termed chemical castration or androgen deprivation therapy (ADT). In most cases, ADT is not an appropriate treatment for localized prostate cancer, indicating low-value care. Guided by the Theoretical Domains Framework (TDF) and the Behavior Change Wheel's Capability, Opportunity, Motivation Model (COM-B), we conducted a qualitative study to identify behavioral determinants of low-value ADT use to manage localized prostate cancer, and theory-based opportunities for de-implementation strategy development. METHODS:We used national cancer registry and administrative data from 2016 to 2017 to examine the variation in low-value ADT use across Veterans Health Administration facilities. Using purposive sampling, we selected high- and low-performing sites to conduct 20 urology provider interviews regarding low-value ADT. We coded transcripts into TDF domains and mapped content to the COM-B model to generate a conceptual framework for addressing low-value ADT practices. RESULTS:Our interview findings reflected provider perspectives on prescribing ADT as low-value localized prostate cancer treatment, including barriers and facilitators to de-implementing low-value ADT. We characterized providers as belonging in 1 of 3 categories with respect to low-value ADT use: 1) never prescribe 2); willing, under some circumstances, to prescribe: and 3) prescribe as an acceptable treatment option. Provider capability to prescribe low-value ADT depended on their knowledge of localized prostate cancer treatment options (knowledge) coupled with interpersonal skills to engage patients in educational discussion (skills). Provider opportunity to prescribe low-value ADT centered on the environmental resources to inform ADT decisions (e.g., multi-disciplinary review), perceived guideline availability, and social roles and influences regarding ADT practices, such as prior training. Provider motivation involved goals of ADT use, including patient preferences, beliefs in capabilities/professional confidence, and beliefs about the consequences of prescribing or not prescribing ADT. CONCLUSIONS:Use of the TDF domains and the COM-B model enabled us to conceptualize provider behavior with respect to low-value ADT use and clarify possible areas for intervention to effect de-implementation of low-value ADT prescribing in localized prostate cancer. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov , NCT03579680.