Comparing Patient-reported Functional Outcomes After Radical Prostatectomy in Historical and Contemporary Practice.

PURPOSE: Modifications to surgical technique, particularly the widespread adoption of robotic surgery, have been proposed to improve functional recovery after prostate cancer surgery. However, rigorous comparison of men in historical vs contemporary practice to evaluate the cumulative effect of these changes on urinary and sexual function after radical prostatectomy is lacking. MATERIALS AND METHODS: We compared prospectively collected patient-reported urinary and sexual function from historical (PROSTQA [Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment study], n=235) and contemporary (MUSIC-PRO [Michigan Urological Surgery Improvement Collaborative Patient Reported Outcome] registry, n=1,215) cohorts at the University of Michigan to understand whether modern techniques have resulted in functional improvements for men undergoing prostate cancer surgery. RESULTS: We found significant differences in baseline function, with better urinary (median [IQR]; 100 [93.8-100] vs 93.8 [85.5-100], P < .001) and sexual scores (median [IQR]; 83.3 [66.7-100] vs 74.4 [44.2-87.5], P < .001) prior to treatment in PROSTQA compared to MUSIC-PRO patients, respectively. There was no statistically significant difference in the pattern of urinary incontinence recovery after surgery from 6-24 months between groups (P = .14). However, men in the contemporary MUSIC-PRO group did have significantly better recovery of sexual function compared to men in the historical PROSTQA group (P < .0001). Further, we found that contemporary practice consists of men with more unfavorable demographic and clinical characteristics compared to historical practice. CONCLUSIONS: Our results demonstrate that the widespread alterations in prostate cancer surgery over the past 2 decades have yielded improvements in sexual, but not urinary, function recovery.

Accountable care organizations and use of surgery among patients with Alzheimer disease and related dementias.

OBJECTIVE: To understand the effects of accountable care organizations (ACOs) on use of surgery in patients with Alzheimer disease and related dementias (ADRD). STUDY DESIGN: Retrospective national cohort study of all Medicare beneficiaries identified in a 20% sample between 2010 and 2017. The primary exposure was participation in ACOs. The primary outcome was use of 1 of 6 common surgical procedures (aortic valve replacement [AVR], abdominal aortic aneurysm [AAA] repair, colectomy, carotid artery repair, major joint repair, and prostatectomy). METHODS: Multivariable logistic regression models were fit using beneficiary-year as the unit of analysis to estimate the likelihood of undergoing each procedure among patients with ADRD and without ADRD, stratified by ACO participation. Additional models were fit to determine how the relationship between ACO participation and surgery was altered based on procedure urgency and the availability of minimally invasive technology. RESULTS: Adjusted odds for use of surgery were lower among patients with ADRD compared with patients without ADRD for all procedures. ACO participation had varying impact on patients with ADRD, with higher odds of AVR and major joint surgery and lower odds of carotid artery repair. Availability of minimally invasive technology increased the likelihood of AVR and AAA repair among patients with ADRD; however, ACO participation reduced these effects. The effect of ACO participation on the likelihood of undergoing surgery did not vary by urgency of the procedure. CONCLUSIONS: The likelihood of undergoing surgery is overall lower among patients with ADRD and may vary by ACO participation for specific procedures.

Guidelines for Reporting Observational Research in Urology: The Importance of Clear Reference to Causality.

Observational studies often dance around the issue of causality. We propose guidelines to ensure that papers refer to whether or not the study aim is to investigate causality, and suggest language to use and language to avoid.

Satisfaction With Clinician-Led Germline Genetic Counseling in Patients With Prostate Cancer.

PURPOSE: Indications for germline testing in prostate cancer patients have expanded substantially over the past decade. With a near-universal shortage of genetic counselors and increasing demand, increased access to genetic counseling is crucial. We sought to prospectively implement and assess a clinician-led approach to genetic counseling and testing. MATERIALS AND METHODS: Patients with metastatic or localized prostate cancer meeting National Comprehensive Cancer Network® criteria for consideration of genetic testing were offered pre-test genetic counseling by their urologist or medical oncologist as part of their routine clinical care and concurrently approached for enrollment in the Germline Genetics in Prostate Cancer Study. Consented patients filled out a post-counseling survey using validated instruments to assess the quality of counseling. For patients who elected to undergo genetic testing, an additional validated questionnaire was completed following disclosure of results. The primary outcome was the proportion of patients undergoing testing, with a target >60% of patients. The secondary outcome was overall satisfaction with counseling, with a target >85% of patients. RESULTS: A total of 275 patients enrolled, and 203 patients elected to undergo genetic testing. Post-counseling surveys were obtained from 265 patients, and post-genetic testing surveys were obtained from 132 patients. Patient satisfaction was high, with 98% of patients reporting being satisfied with the overall quality of pre-test counseling, and 74% of patients elected to undergo genetic testing. CONCLUSIONS: These results support the effectiveness of clinician-led genetic counseling in prostate cancer. With clinician training, this approach can be utilized to expand access to appropriate germline genetic testing.

Factors Associated with Decision Aid Use in Localized Prostate Cancer.

Purpose: Decision aids have been found to improve patients' knowledge of treatments and decrease decisional regrets. Despite these benefits, there is not widespread use of decision aids for newly diagnosed prostate cancer (PCa). This analysis investigates factors that impact men's choice to use a decision aid for newly diagnosed prostate cancer. Materials and Methods: This is a retrospective analysis of a PCa registry from the Michigan Urological Surgery Improvement Collaborative (MUSIC). We included data from men with newly diagnosed, clinically localized PCa seen from 2018-21 at practices offering a PCa decision aid (Personal Patient Profile-Prostate; P3P). The primary outcome was men's registration to use P3P. We fit a multilevel logistic regression model with patient-level factors and included urologist specific random intercepts. We estimated the intra-class correlation (ICC) and predicted the probability of P3P registration among urologists. Results: A total of 2629 men were seen at practices that participated in P3P and 1174 (45%) registered to use P3P. Forty-one percent of the total variance of P3P registration was attributed to clustering of men under a specific urologist's care. In contrast, only 1.5% of the variance of P3P registration was explained by patient factors. Our model did not include data on socioeconomic, literacy or psychosocial factors, which limits the interpretation of the results. Conclusions: These results suggest that urologists' effect far outweighs patient factors in a man's decision to enroll in P3P. Strategies that encourage providers to increase decision aid adoption in their practices are warranted.

Interstate Telehealth Use By Medicare Beneficiaries Before And After COVID-19 Licensure Waivers, 2017-20.

During the COVID-19 pandemic, all fifty states and Washington, D.C., passed licensure waivers that allowed patients to participate in telehealth visits with out-of-state clinicians (that is, interstate telehealth). Because many of these temporary flexibilities have expired or are set to expire, we analyzed trends in interstate telehealth use by Medicare beneficiaries during 2017-20, which covers the period both directly before and during the first year of the pandemic. Although the volume of interstate telehealth use increased in 2020, out-of-state telehealth made up a small share of all outpatient visits (0.8 percent) and of all telehealth visits (5 percent) overall. For individual states, out-of-state telehealth made up between 0.2 percent and 9.3 percent of all outpatient visits. We found that most out-of-state telehealth use was for established patient care and that a higher percentage of out-of-state telehealth users lived in rural areas compared with beneficiaries who did not receive care outside of their state (28 percent versus 23 percent). Our collective findings suggest that the elimination of pandemic licensure flexibilities will affect different states to varying degrees and will also affect the delivery of care for both established patients and rural patients.

Development and Validation of Dynamic Multivariate Prediction Models of Sexual Function Recovery in Patients with Prostate Cancer Undergoing Radical Prostatectomy: Results from the MUSIC Statewide Collaborative.

Background: Radical prostatectomy (RP) is the most common definitive treatment for men with intermediate-risk prostate cancer and is frequently complicated by erectile dysfunction. Objective: To develop and validate models to predict 12- and 24-month post-RP sexual function. Design setting and participants: Using Michigan Urological Surgery Improvement Collaborative (MUSIC) registry data from 2016 to 2021, we developed dynamic, multivariate, random-forest models to predict sexual function recovery following RP. Model factors (established a priori) included baseline patient characteristics and repeated assessments of sexual satisfaction, and Expanded Prostate Cancer Index Composite 26 (EPIC-26) overall scores and sexual domain questions. Outcome measurements and statistical analysis: We evaluated three outcomes related to sexual function: (1) the EPIC-26 sexual domain score (range 0-100); (2) the EPIC-26 sexual domain score dichotomized at ≥73 for "good" function; and (3) a dichotomized variable for erection quality at 12 and 24 months after RP. A gradient-boosting decision tree was used for the prediction models, which combines many decision trees into a single model. We evaluated the performance of our model using the root mean squared error (RMSE) and mean absolute error (MAE) for the EPIC-26 score as a continuous variable, and the area under the receiver operating characteristic curve (AUC) for the dichotomized EPIC-26 sexual domain score (SDS) and erection quality. All analyses were conducted using R v3.6.3. Results and limitations: We identified 3983 patients at 12 months and 2494 patients at 24 months who were randomized to the derivation cohort at 12 and 24 months, respectively. Using baseline information only, our model predicted the 12-month EPIC-26 SDS with RMSE of 24 and MAE of 20. The AUC for predicting EPIC-26 SDS ≥73 (a previously published threshold) was 0.82. Our model predicted 24-month EPIC-26 SDS with RMSE of 26 and MAE of 21, and AUC for SDS ≥73 of 0.81. Inclusion of post-RP data improved the AUC to 0.91 and 0.94 at 12 and 24 months, respectively. A web tool has also been developed and is available at https://ml4lhs.shinyapps.io/askmusic_prostate_pro/. Conclusions: Our model provides a valid way to predict sexual function recovery at 12 and 24 months after RP. With this dynamic, multivariate (multiple outcomes) model, accurate predictions can be made for decision-making and during survivorship, which may reduce decision regret. Patient summary: Our prediction model allows patients considering prostate cancer surgery to understand their probability before and after surgery of recovering their erectile function and may reduce decision regret.

Survival Outcomes Associated With Cytoreductive Nephrectomy in Patients With Metastatic Clear Cell Renal Cell Carcinoma.

Importance: Level I evidence has failed to demonstrate an overall survival (OS) advantage for cytoreductive nephrectomy in patients with metastatic clear cell renal cell carcinoma (ccRCC) in the modern era, which is at odds with observational studies reporting a marked OS benefit associated with these operations. These observational studies were not designed to adjust for unmeasured confounding. Objective: To assess whether cytoreductive nephrectomy is associated with improved OS in patients with metastatic ccRCC. Design, Setting, and Participants: This cohort study identified patients with metastatic ccRCC in the National Cancer Database from January 1, 2006, to December 31, 2016, who received systemic targeted therapy. The analysis was finalized on July 23, 2021. Exposures: Receipt of cytoreductive nephrectomy. Main Outcomes and Measures: The primary outcome was OS from the date of diagnosis to death or censoring at last follow-up. Distance from the patients' zip code of residence to the treating facility was identified as a valid instrument and was used in a 2-stage residual inclusion instrumental variable analysis. Conventional adjustments for selection bias, multivariable Cox proportional hazards regression, and propensity score matching were performed for comparison. Measured covariates adjusted for in all analyses included age, sex, race, Charlson-Deyo score, facility type, year of diagnosis, clinical T stage, and clinical N stage. Results: The final study population included 12 766 patients (median age, 63 years; IQR, 56-70 years; 8744 [68%] male; 11 206 [88%] White). Cytoreductive nephrectomy was performed in 5005 patients (39%). Conventional adjustments for selection bias demonstrated a significant OS benefit associated with cytoreductive nephrectomy (multivariable Cox proportional hazards regression: hazard ratio [HR], 0.49; 95% CI, 0.47-0.51; propensity score matching: HR, 0.48; 95% CI, 0.46-0.50). Instrumental variable estimates did not demonstrate an association between cytoreductive nephrectomy and OS (HR, 0.92; 95% CI, 0.78-1.09). Conclusions and Relevance: Instrumental variable analysis did not demonstrate a survival advantage associated with cytoreductive nephrectomy for patients with metastatic ccRCC. This discrepancy likely reflects the fact that surgical indication for cytoreductive nephrectomy is primarily driven by factors that are not commonly measured or available in observational data sets.

Assessing the Impact of Decision Aid Use on Post Prostatectomy Patient Reported Outcomes.

OBJECTIVE: To evaluate whether completing a decision aid, Personal Patient Profile - Prostate (P3P), prior to prostatectomy, affects self-reported bother from post-prostatectomy urinary incontinence and erectile dysfunction. MATERIALS AND METHODS: This retrospective analysis included data from men with newly diagnosed clinically localized, very low to intermediate risk prostate cancer who elected for prostatectomy within the Michigan Urological Surgery Improvement Collaborative between 2018-2021. Multivariable logistic regression models were used to estimate the association between P3P use and bother from post prostatectomy erectile dysfunction and urinary incontinence as measured by the Expanded Prostate Cancer Index Composite (EPIC-26). RESULTS: Among the 3987 patients included, 7% used P3P (n = 266). Men who used P3P reported significantly less bother from erectile dysfunction at 6 months vs non-users (aOR 0.42 [95% CI 0.27-0.66]). At 12 months, the effect of P3P on bother from erectile dysfunction was not statistically significant (aOR 0.62 [95% CI 0.37-1.03]). Men who used P3P did not have a statistically significant difference in bother from urinary incontinence (3-month: aOR 0.56 [95% CI 0.30-1.06]; 6-month; aOR 0.79 [95% CI 0.31-1.97]). CONCLUSION: Within the stated limitations of this study, we find that use of a decision aid for localized prostate cancer was associated with decreased odds of men being bothered from sexual dysfunction but not urinary incontinence at 6 months post prostatectomy.

TrueNTH Sexual Recovery Intervention for couples coping with prostate cancer: Randomized controlled trial results.

BACKGROUND: Despite significant sexual dysfunction and distress after localized prostate cancer treatment, patients typically receive only physiologic erectile dysfunction management. The authors performed a randomized controlled trial of an online intervention supporting couples' posttreatment recovery of sexual intimacy. METHODS: Patients treated with surgery, radiation, or combined radiation and androgen deprivation therapy who had partners were recruited and randomized to an online intervention or a control group. The intervention, tailored to treatment type and sexual orientation, comprised 6 modules addressing expectations for sexual and emotional sequelae of treatment, rehabilitation, and guidance toward sexual intimacy recovery. Couples, recruited from 6 sites nationally, completed validated measures at the baseline and 3 and 6 months after treatment. Primary outcome group differences were assessed with t tests for individual outcomes. RESULTS: Among 142 randomized couples, 105 patients (mostly surgery) and 87 partners completed the 6-month survey; this reflected challenges with recruitment and attrition. There were no differences between the intervention and control arms in Patient-Reported Outcomes Measurement Information System Global Satisfaction With Sex Life scores 6 months after treatment (the primary outcome). Three months after treatment, intervention patients and partners reported more engagement in penetrative and nonpenetrative sexual activities than controls. More than 73% of the intervention participants reported high or moderate satisfaction with module content; more than 85% would recommend the intervention to other couples. CONCLUSIONS: Online psychosexual support for couples can help couples to connect and experience sexual pleasure early after treatment despite patients' sexual dysfunction. Participants' high endorsement of the intervention reflects the importance of sexual health support to couples after prostate cancer treatment. LAY SUMMARY: This study tested a web-based program supporting couples' sexual recovery of sexual intimacy after prostate cancer treatment. One hundred forty-two couples were recruited and randomly assigned to the program (n = 60) or to a control group (n = 82). The program did not result in improvements in participants' satisfaction with their sex life 6 months after treatment, but couples in the intervention group engaged in sexual activity sooner after treatment than couples in the control group. Couples evaluated the program positively and would recommend it to others facing prostate cancer treatment.

Delayed radical prostatectomy after a period of active surveillance is not associated with the use of secondary treatments compared with immediate prostatectomy.

BACKGROUND: We evaluated the use of secondary treatments in men with grade group (GG) 1 PC following a period of active surveillance (AS) compared with men undergoing immediate radical prostatectomy (RP) to evaluate what is potentially lost in terms of cancer control, if a patient trials AS and transitions to treatment. METHODS: We reviewed the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry for men with GG1 PC undergoing RP from April 2012 to July 2018. Men were classified into groups based on time from diagnosis to RP: immediate (surgery within 1 year of diagnosis) and delayed RP (surgery >1 year after initiation of AS). Time to secondary treatment was estimated using Kaplan-Meier curves and compared using the log-rank test. A multivariable Cox proportional hazards model was fit to assess the association between timing of RP and use of secondary treatments. A chi-squared test was used to assess the association between delayed RP and adverse pathology. RESULTS: We identified 1878 men that underwent an RP during the study period, of which 1489 (79%) underwent immediate RP and 389 (21%) underwent delayed RP. The incidence of adverse pathology was higher in men with delayed versus immediate RP (49% vs. 36%, p < 0.0001, respectively). However, we noted only a small absolute difference in the estimated 24-month secondary treatment-free probability between men with delayed versus immediate RP (93% and 96%, respectively). On multivariable analysis, delayed RP was associated with increased use of secondary treatments (hazard ratio = 1.94, 95% confidence interval = 1.23-3.06, p = 0.004). CONCLUSIONS: The use of secondary treatment after RP in men with GG1 PC undergoing immediate or delayed prostatectomy was rare. These data suggest that the burden of treatment is near equivalent in patients who progress to treatment on AS compared with those who underwent immediate RP.

Patient- and Surgeon-Level Variation in Patient-Reported Sexual Function Outcomes Following Radical Prostatectomy Over 2 Years: Results From a Statewide Surgical Improvement Collaborative.

Importance: Of patient-reported outcomes for individuals undergoing radical prostatectomy, sexual function outcomes are among the most reported and the most detrimental to quality of life. Understanding variations at the patient and surgeon level may inform collaborative quality improvement. Objective: To describe patient- and surgeon-level sexual function outcomes for patients undergoing radical prostatectomy in the Michigan Urological Surgery Improvement Collaborative (MUSIC) and to examine the correlation between surgeon case volume and sexual function outcomes. Design, Setting, and Participants: This is a prospective cohort study using the MUSIC registry and patient-reported sexual function outcome data. Patient- and surgeon-level variation in sexual function outcomes were examined among patients undergoing radical prostatectomy from May 2014 to August 2019. Sexual function outcome data were collected using validated questionnaires, which were completed before surgery and at 3, 6, 12, and 24 months' follow-up following surgery. All participants were male. Race and ethnicity data were self-reported and were included to examine potential variation in outcomes by race and/or ethnicity. Data were analyzed from January 2021 to March 2021. Main Outcomes and Measures: There were 4 outcomes in this study, including the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) sexual function scores at 3, 6, 12, and 24 months' follow-up; patient-level sexual function recovery at 12- and 24-month follow-up; surgeon-level variation in sexual function outcomes at 12- and 24-month follow-up; and correlation between surgeon case volume and sexual function outcomes. Results: A total of 1426 male patients met inclusion criteria for this study. The median (IQR) age was 64 (58-68) years. A total of 115 participants (8%) were Black, 1197 (84%) were White, 25 (2%) were of another race or ethnicity (consolidated owing to low numbers), and 89 (6%) were of unknown race or ethnicity. Among patients undergoing bilateral nerve-sparing radical prostatectomy, mean (SD) EPIC-26 sexual function scores at 12- and 24-month follow-up (12 months, 39 [28]; 24 months, 63 [29]) did not return to baseline levels. There was wide variation in EPIC-26 sexual function scores at both 12-month follow-up (range, 23-69; P < .001) and 24-month follow-up (range, 27-64; P < .001). Similar variations were found in EPIC-26 sexual function scores and recovery of sexual function by surgeon. Recovery rates ranged from 0% to 40% of patients at 12-month follow-up (18 surgeons; P < .001) and 3% to 44% of patients at 24-month follow-up (12 surgeons; P < .001). Surgeon case volume and sexual function outcomes were not significantly correlated. On multivariable analysis, the following variables were associated with better recovery at 24-month follow-up: younger age (P < .001), lower baseline EPIC-26 sexual function score (P < .001), lower Gleason score (P = .05), and nonobesity (P = .03). Conclusions and Relevance: In this study, there was significant patient- and surgeon-level variation in sexual function recovery over 2 years following radical prostatectomy. Variation in surgeon-level sexual function outcomes presents an opportunity and model for surgical collaborative quality improvement.

Prostate cancer clinical trial completion: The role of geography.

BACKGROUND/AIMS: One in five cancer clinical trials fails with another third failing to meet enrollment goals. Prior efforts to improve enrollment focus on patient facing interventions, but geographic factors such as regional cancer incidence may doom trials before they even begin. For these reasons, we examined associations of regional prostate cancer incidence with trial termination, and identified scientifically-underserved areas where future trials might thrive. METHODS: We merged US phase 2-3 prostate cancer clinical trial data from ClinicalTrials.gov with prostate cancer incidence data from statecancerprofiles.cancer.gov. We matched trial information from 293 closed and 560 active trials with incidence data for 2947 counties. Using multivariable logistic regression, we identified associations with trial termination. We identified 'scientifically-underserved' counties with the highest cancer incidence quintile (>61 annual cases) but lowest active trials quintile (0 or 1 trial). RESULTS: Of 293 closed trials, one in three was terminated (n = 96, 32.8%). On multivariable analysis, only lower regional prostate cancer incidence was associated with higher likelihood of premature trial termination (OR 0.98, 95% CI [0.96-0.99] for every 100 cases, p = 0.03). We identified 188 counties with >61 annual prostate cancer cases but 0 or 1 active trials, indicating potential scientifically-underserved areas. CONCLUSIONS: In this novel study, we found prostate cancer trials in areas with low prostate cancer incidence were more likely to fail. We also identified scientifically-underserved areas where trials might thrive. Our findings provide a more nuanced understanding of clinical trial feasibility and upstream opportunities for improvement.

A Statewide Quality Improvement Collaborative's Adherence to the 2017 American Urological Association Guidelines Regarding Initial Evaluation of Patients With Clinical T1 Renal Masses.

OBJECTIVE: To evaluate MUSIC-KIDNEY's adherence to the American Urological Association (AUA) guidelines regarding the initial evaluation of patient's with clinical T1 (cT1) renal masses. METHODS: We reviewed MUSIC-KIDNEY registry data for patients with newly diagnosed cT1 renal masses to assess for adherence with the 2017 AUA guideline statements regarding recommendations to obtain (1) CMP, (2) CBC, (3) UA, (4) abdominal cross-sectional imaging, and (5) chest imaging. An evaluation consisting of all 5 guideline measures was considered "complete compliance." Variation with guideline adherence was assessed by contributing practice, management strategy, and renal mass size. RESULTS: We identified 1808 patients with cT1 renal masses in the MUSIC-KIDNEY registry, of which 30% met the definition of complete compliance. Most patients received care that was compliant with recommendations to obtain laboratory testing with 1448 (80%), 1545 (85%), and 1472 (81%) patients obtaining a CMP, CBC, and UA respectively. Only 862 (48%) patients underwent chest imaging. Significant variation exists in complete guideline compliance for contributing practices, ranging from 0% to 45% as well as for patients which underwent immediate intervention compared with initial observation (37% vs 23%) and patients with cT1b masses compared with cT1a masses (36% vs 28%). CONCLUSION: Complete guideline compliance in the initial evaluation of patients with cT1 renal masses is poor, which is mainly driven by omission of chest imaging. Significant variation in guideline adherence is seen across practices, as well as patients undergoing an intervention vs observation, and cT1a vs cT1b masses. There are ample quality improvement opportunities to increase adherence and decrease variability with guideline recommendations.

Aortic valve replacement among patients with Alzheimer's disease and related dementias.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has made palliation from aortic stenosis more broadly available to populations previously thought to be too high risk for surgery, such as those with Alzheimer's disease and related dementias (ADRD); however, its safety and effectiveness in this context are uncertain. METHODS: We performed a retrospective cohort study of national Medicare beneficiaries, aged 66 and older with Parts A and B, between 2010 and 2016. Patients undergoing AVR were identified, and follow-up was available through 2017. Multivariable regression was used to measure the independent association between having a diagnosis of ADRD at the time of AVR, stratified by TAVR and surgery, and outcomes (mortality and Medicare institutional days at 1 year after AVR). RESULTS: The average rate of increase in AVR per year was 17.5 cases per 100,000 ADRD and 8.4 per 100,000 non-ADRD beneficiaries, largely driven by more rapid adoption of TAVR. Adjusted mortality following AVR declined significantly between those treated in 2010 and 2016, from 13.5% (95% CI 10.2%-17.7%) to 6.3% (95% CI 5.2%-7.6%) and from 13.7% (95% CI 12.7%-14.7%) to 6.3% (95% CI 5.8%-6.9%) in those with and without ADRD, respectively. The sharpest decline was noted for patients undergoing TAVR between 2011 and 2016, with adjusted mortality declining from 19.9% (95% CI 11.2%-32.8%) to 5.2% (95% CI 4.1%-6.5%) and from 12.2% (95% CI 9.3%-15.8%) to 5.0% (95% CI 4.4%-5.6%) in patients with and without ADRD, respectively. Similar declines were evident for Medicare institutional days in the year after AVR in both patient groups. CONCLUSIONS: Rates of AVR in those with ADRD increased during the past decade largely driven by the diffusion of TAVR. The use of TAVR in this vulnerable population did not come at the expense of increasing Medicare institutional days or mortality at 1-year.

Association of Urinary MyProstateScore, Age, and Prostate Volume in a Longitudinal Cohort of Healthy Men: Long-term Findings from the Olmsted County Study.

BACKGROUND: Serum prostate-specific antigen (PSA), used in prostate cancer screening, is nonspecific for cancer and is affected by age and prostate volume. More specific biomarkers could be more accurate for early detection of prostate cancer and reduce unnecessary prostate biopsies. OBJECTIVE: To evaluate the association of age and prostate volume with urinary MyProstateScore (MPS) in a screened, longitudinal cohort without evidence of prostate cancer. DESIGN SETTING AND PARTICIPANTS: The Olmsted County Study included men aged 40-79 yr who underwent biennial prostate cancer screening. PSA ≥4.0 ng/ml or abnormal rectal examination triggered prostate biopsy, and patients with cancer were excluded. The remaining men submitted urinary specimens for PCA3 and TMPRSS2:ERG testing. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: MPS was calculated using the validated, locked model for grade group ≥2 cancer that includes serum PSA, urinary PCA3, and urinary TMPRSS2:ERG. The associations of age and volume with biomarkers were assessed in multivariable regression models. The t statistic was used to quantify the strength of associations independent of the unit of measurement, and R 2 values were used to estimate the proportion of biomarker variance explained by each factor. RESULTS AND LIMITATIONS: The study included 314 screened men without evidence of cancer. In multivariable models including age and volume, PCA3 score was significantly associated with age (t = 7.51; p < 0.001), while T2:ERG score was not associated with age or volume. MPS was significantly associated with both age (t = 7.45; p < 0.001) and volume (t = 3.56; p < 0.001), but accounting for age alone explained the variability observed (R 2 = 0.29) in a similar way to the model including age and volume (R 2 = 0.31). The variability of PCA3, T2:ERG, and MPS was less dependent on age and volume than the variability for PSA (R 2 = 0.45). CONCLUSIONS: In a cohort of longitudinally screened men without evidence of cancer, we found that MPS demonstrated less variability with noncancer factors (age, prostate volume) than PSA did. These findings support the biology of these markers as more cancer-specific than PSA and highlight their promise in reducing the morbidity associated with PSA-based screening. PATIENT SUMMARY: In a group of men with no evidence of prostate cancer, we found that each of three urine-based markers of cancer-PCA3, T2:ERG, and the commercially available MyProstateScore test-showed less variability with noncancer factors (age and prostate volume) than serum PSA (prostate-specific antigen) did. These findings support their proposed use as noninvasive markers of prostate cancer that could improve the accuracy of early detection.