EarlyTect BCD, a Streamlined PENK Methylation Test in Urine DNA, Effectively Detects Bladder Cancer in Patients with Hematuria.

The current noninvasive diagnostic approaches for detecting bladder cancer (BC) often exhibit limited clinical performance, especially for the initial diagnosis. This study aims to evaluate the validity of a streamlined urine-based PENK methylation test called EarlyTect BCD in detecting BC in patients with hematuria scheduled for cystoscopy in Korean and American populations. The test seamlessly integrates two steps, linear target enrichment and quantitative methylation-specific PCR within a single closed tube. The detection limitation of the test was approximately two genome copies of methylated PENK per milliliter of urine. In the retrospective training set (n = 105), an optimal cutoff value was determined to distinguish BC from non-BC, resulting in a sensitivity of 87.3% and a specificity of 95.2%. In the prospective validation set (n = 210, 122 Korean and 88 American patients), the overall sensitivity for detecting all stages of BC was 81.0%, with a specificity of 91.5% and an area under the curve value of 0.889. There was no significant difference between the two groups. The test achieved a sensitivity of 100% in detecting high-grade Ta and higher stages of BC. The negative predictive value of the test was 97.7%, and the positive predictive value was 51.5%. The findings of this study demonstrate that EarlyTect BCD is a highly effective noninvasive diagnostic tool for identifying BC among patients with hematuria.

The Effect of Digital Three-Dimensional Reality Models on Patient Counseling for Renal Masses.

Background and Objectives: Patient counseling for treatment of renal masses is complex. It can be difficult for patients to understand their disease and make treatment decisions when being shown standard black-and-white, two-dimensional computed tomography scans or magnetic resonance images. In a telehealth setting, the patient-physician interaction can be even more challenging. We sought to determine the impact of using digital three-dimensional (3D) models during consultation visits for patients with renal masses. Methods: Forty-seven patients participating in a consultation visit for renal masses, both in-person and virtual, were shown a digital 3D model comprised of their kidney, renal mass, and key adjacent structures as part of their counseling. Patients then completed a five-question survey to assess the impact of the 3D model on their visit, with a sixth question administered to telehealth patients. Results: Thirty-five patients undergoing telehealth visits and 12 patients seen in-person were shown the digital 3D model and surveyed. Survey results were universally positive, with all Likert scores > 4.7 (1 - 5 scale). There were no differences between the telehealth and in-person groups. Patients noted the digital 3D model made telehealth visits as effective as in-person visits (average Likert score 4.94). Conclusion: Counseling for patients with renal masses can be augmented with patient-specific digital 3D models, leading to increased provider loyalty, lower levels of patient anxiety, and better understanding and shared decision making.

Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial.

PURPOSE: Planning complex operations such as robotic-assisted radical prostatectomy requires surgeons to review 2-dimensional magnetic resonance imaging (MRI) cross-sectional images to understand 3-dimensional (3D), patient-specific anatomy. We sought to determine surgical outcomes for robotic-assisted radical prostatectomy when surgeons reviewed 3D, virtual reality (VR) models for operative planning. MATERIALS AND METHODS: A multicenter, randomized, single-blind clinical trial was conducted from January 2019 to December 2020. Patients undergoing robotic-assisted laparoscopic radical prostatectomy were prospectively enrolled and randomized to either a control group undergoing usual preoperative planning with prostate biopsy results and MRI only or to an intervention group where MRI and biopsy results were supplemented with a 3D VR model. The primary outcome measure was margin status, and secondary outcomes were oncologic control, sexual function and urinary function. RESULTS: Ninety-two patients were analyzed, with trends toward lower positive margin rates (33% vs 25%) in the intervention group, no significant difference in functional outcomes and no difference in traditional operative metrics (p >0.05). Detectable postoperative prostate specific antigen was significantly lower in the intervention group (31% vs 9%, p=0.036). In 32% of intervention cases, the surgeons modified their operative plan based on the model. When this subset was compared to the control group, there was a strong trend toward increased bilateral nerve sparing (78% vs 92%), and a significantly lower rate of postoperative detectable prostate specific antigen in the intervention subset (31% vs 0%, p=0.038). CONCLUSIONS: This randomized clinical trial demonstrated patients whose surgical planning involved 3D VR models have better oncologic outcomes while maintaining functional outcomes.

Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial.

Importance: Planning complex operations such as robotic-assisted partial nephrectomy requires surgeons to review 2-dimensional computed tomography or magnetic resonance images to understand 3-dimensional (3-D), patient-specific anatomy. Objective: To determine surgical outcomes for robotic-assisted partial nephrectomy when surgeons reviewed 3-D virtual reality (VR) models during operative planning. Design, Setting, and Participants: A single-blind randomized clinical trial was performed. Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals were prospectively enrolled and randomized. Enrollment and data collection occurred from October 2017 through December 2018, and data analysis was performed from December 2018 through March 2019. Interventions: Patients were assigned to either a control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model. This model was viewed on the surgeon's smartphone in regular 3-D format and in VR using a VR headset. Main Outcomes and Measures: The primary outcome measure was operative time. It was hypothesized that the operations performed using the 3-D VR models would have shorter operative time than those performed without the models. Secondary outcomes included clamp time, estimated blood loss, and length of hospital stay. Results: Ninety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed. The analysis included 48 patients randomized to the control group and 44 randomized to the intervention group. When controlling for case complexity and other covariates, patients whose surgical planning involved 3-D VR models showed differences in operative time (odds ratio [OR], 1.00; 95% CI, 0.37-2.70; estimated OR, 2.47), estimated blood loss (OR, 1.98; 95% CI, 1.04-3.78; estimated OR, 4.56), clamp time (OR, 1.60; 95% CI, 0.79-3.23; estimated OR, 11.22), and length of hospital stay (OR, 2.86; 95% CI, 1.59-5.14; estimated OR, 5.43). Estimated ORs were calculated using the parameter estimates from the generalized estimating equation model. Referent group values for each covariate and the corresponding nephrometry score were summed across the covariates and nephrometry score, and the sum was exponentiated to obtain the OR. A mean of the estimated OR weighted by sample size for each nephrometry score strata was then calculated. Conclusions and Relevance: This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay. Trial Registration: ClinicalTrials.gov identifiers (1 registration per site): NCT03334344, NCT03421418, NCT03534206, NCT03542565, NCT03556943, and NCT03666104.

The Use of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Partial Nephrectomy.

OBJECTIVE: To determine whether 3-dimensional virtual reality models of patient-specific anatomy improve outcomes in patients undergoing robotic partial nephrectomy. MATERIALS AND METHODS: Computed tomography and magnetic resonance imaging scans for 30 patients undergoing robotic partial nephrectomy were converted to 3-dimensional virtual reality models prior to the patient's operation. These models were then viewed on the surgeon's mobile phone pre- and intraoperatively using a Google Cardboard headset to assist in surgical planning. This group was compared to 30 patients who previously underwent robotic partial nephrectomy. We compared operative time, clamp time, estimated blood loss, hospital stay, complications, and margin status between these groups. We used forward selecting multivariate regression models to create the final model controlling for significant demographic and clinical variables. RESULTS: When controlling for case complexity and surgeon, patients with 3-dimensional, virtual reality-assisted surgical planning had significantly lower operative time (141 minutes vs 201 minutes, P < .0001), clamp time (13.2 minutes vs 17.4 minutes, P = .0274), and estimated blood loss (134 cc vs 259 cc, P = .0233). Patients without 3-dimensional, virtual reality-assisted surgical planning were more likely to have a hospital stay of greater than 2 days (odds ratio 5.1, 95% confidence interval 1.0, 26.4). There were no complications or positive margins noted in the VR group. CONCLUSION: Use of a 3-dimensional, virtual reality model when performing robotic partial nephrectomy improves key surgical outcome parameters.

Decisional Quality in Patients With Small Renal Masses.

OBJECTIVE: To measure decisional quality in patients being counseled on treatment for small renal masses and identify potential areas of improvement. MATERIALS AND METHODS: A total of 73 patients diagnosed with small renal masses at the University of California, Los Angeles Health completed an instrument measuring decisional conflict, patient satisfaction with care, disease-specific knowledge, and patient impression that shared decision-making occurred in the visit after counseling by a specialist. Participant characteristics were compared between those with high and low decisional conflict using chi-square or Student t test (or Wilcoxon rank-sum test). RESULTS: Participants were mostly older (mean age 63.5), white (84%), in a relationship (61%), and unemployed or retired (63%). Mean knowledge score was 59% correct. The mean (standard deviation) decisional conflict score was 16.4 (18.4) indicating low levels of decisional conflict but with a wide range of scores. Comparing participants with high decisional conflict with those with low decisional conflict, there were significant differences in knowledge scores (Wilcoxon P = .0069), patient satisfaction with care (P = .0011), and perceived shared decision-making (P <.0001). CONCLUSION: Patients with small renal masses generally have low levels of decisional conflict and can identify a preferred treatment after a physician visit. However, both groups lack overall knowledge about their disease even after counseling, and thus may be heavily influenced by paternalistic care. Those patients with decisional conflicts are less likely to perceive their care as satisfactory and are less likely to be involved in decision-making.

Does Patient Preference Measurement in Decision Aids Improve Decisional Conflict? A Randomized Trial in Men with Prostate Cancer.

BACKGROUND: Shared decision making (SDM) has been advocated as an approach to medical decision making that can improve decisional quality. Decision aids are tools that facilitate SDM in the context of limited physician time; however, many decision aids do not incorporate preference measurement. OBJECTIVES: We aim to understand whether adding preference measurement to a standard patient educational intervention improves decisional quality and is feasible in a busy clinical setting. METHODS: Men with incident localized prostate cancer (n = 122) were recruited from the Greater Los Angeles Veterans Affairs (VA) Medical Center urology clinic, Olive View UCLA Medical Center, and Harbor UCLA Medical Center from January 2011 to May 2015 and randomized to education with a brochure about prostate cancer treatment or software-based preference assessment in addition to the brochure. Men undergoing preference assessment received a report detailing the relative strength of their preferences for treatment outcomes used in review with their doctor. Participants completed instruments measuring decisional conflict, knowledge, SDM, and patient satisfaction with care before and/or after their cancer consultation. RESULTS: Baseline knowledge scores were low (mean 62%). The baseline mean total score on the Decisional Conflict Scale was 2.3 (±0.9), signifying moderate decisional conflict. Men undergoing preference assessment had a significantly larger decrease in decisional conflict total score (p = 0.023) and the Perceived Effective Decision Making subscale (p = 0.003) post consult compared with those receiving education only. Improvements in satisfaction with care, SDM, and knowledge were similar between groups. CONCLUSIONS: Individual-level preference assessment is feasible in the clinic setting. Patients with prostate cancer who undergo preference assessment are more certain about their treatment decisions and report decreased levels of decisional conflict when making these decisions.

Is More Really Better? An Examination of Services and Payment Patterns among Urologists from the Centers for Medicare & Medicaid Services.

INTRODUCTION: We examined provider and regional variation in services provided and payments made to urologists by CMS (Centers for Medicare & Medicaid Services) by linking payments to individual beneficiaries and examining the proportion of submitted charges resulting in payments. METHODS: We analyzed Medicare Part B Provider Utilization and Payment Data released by CMS for 2012, the last year of the purely fee-for-service reimbursement model. For each provider we determined the ratio of number of services provided to individual beneficiaries as well as the ratio of total submitted charges-to-total Medicare payments. Each provider was stratified into deciles of total Medicare payments and the mean per decile of total Medicare payment was calculated. Finally, to elucidate the potential association between the ratio of services-to-beneficiaries, we conducted multivariate linear regressions. RESULTS: The 20th, 40th, 60th and 80th percentiles for the ratio of number of services per individual beneficiary ratios to total Medicare Part B payments are 2.8, 4.0, 5.2 and 7.4, respectively. Urologists with greater payments received provided more services to individual beneficiaries. Submitted charges exceeded payments by 3:1. Finally, female providers had lower ratios (p <0.01) and there was significant regional variation in the ratio of services per unique beneficiary (p <0.001 for each of the 10 Standard Federal Regions). CONCLUSIONS: We found significant variation in services and payment in CMS. Reimbursement models replacing fee-for-service should be tailored to ensure appropriate health care resource utilization.

Patient Function and the Value of Surgical Care for Kidney Cancer.

PURPOSE: Frailty and functional status have emerged as significant predictors of morbidity and mortality for patients undergoing cancer surgery. To articulate the impact on value (ie quality per cost), we compared perioperative outcomes and expenditures according to patient function for older adults undergoing kidney cancer surgery. MATERIALS AND METHODS: Using linked SEER (Surveillance, Epidemiology and End Results)-Medicare data, we identified 19,129 elderly patients with kidney cancer treated with nonablative surgery from 2000 to 2009. We quantified patient function using function related indicators (claims indicative of dysfunction and disability) and measured 30-day morbidity, mortality, resource use and cost. Using multivariable, mixed effects models to adjust for patient and hospital characteristics, we estimated the relationship of patient functionality with both treatment outcomes and expenditures. RESULTS: Of 19,129 patients we identified 5,509 (28.8%) and 3,127 (16.4%) with a function related indicator count of 1 and 2 or greater, respectively. While surgical complications did not vary (OR 0.95, 95% CI 0.86-1.05), patients with 2 or more indicators more often experienced a medical event (OR 1.22, 95% CI 1.10-1.36) or a geriatric event (OR 1.55, 95% CI 1.33-1.81), or died within 30 days of surgery (OR 1.43, 95% CI 1.10-1.86) compared with patients with no baseline dysfunction. These patients utilized significantly more medical resources and amassed higher acute care expenditures (p <0.001). CONCLUSIONS: During kidney cancer surgery, patients in poor functional health can face a more eventful medical recovery at elevated cost, indicating lower value care. Greater consideration of frailty and functional status during treatment planning and transitions may represent areas for value enhancement in kidney cancer and urology care.

Health status and use of partial nephrectomy in older adults with early-stage kidney cancer.

INTRODUCTION: The long-term benefits of nephron-sparing surgery for kidney cancer depend on patient health. Accordingly, we examined whether receipt of partial nephrectomy varied with baseline comorbidity or functionality among older adults with stage I kidney cancer. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data from 2000 to 2009, we identified patients treated with partial or radical nephrectomy for stage I kidney cancer. We examined treatment trends according to baseline comorbidity, function, and relevant health conditions. We then estimated the probability of partial nephrectomy using multivariable, mixed-effects models adjusting for patient, surgeon, and hospital characteristics. RESULTS: Overall, 2,956 of 11,678 patients (25.3%) underwent treatment with partial nephrectomy. Receipt of partial nephrectomy was associated with younger age, male sex, higher socioeconomic position, smaller tumor size, and treatment by a high-volume provider, cancer center, or academic institution (P<0.001). During the study period, utilization increased significantly (P<0.001) but did not differ according to comorbidity or patient function. Adjusting for patient, surgeon, and hospital characteristics, the probability of partial nephrectomy by comorbidity and function categories remained within a narrow range from 19.6% to 22.8%. Only preexisting kidney disease appeared to be linked to partial nephrectomy usage (odds ratio = 1.49, 95% CI: 1.33-1.66). CONCLUSION: With the exception of kidney disease, the increasing use of partial nephrectomy did not vary with respect to health status. As the potential benefits of partial nephrectomy differ according to a patient׳s underlying health, selection tools and algorithms that match treatment to patient comorbidity or function may be needed to optimize kidney cancer care in the United States.

From QOL to QALYs: Comparing nononcologic outcomes in prostate cancer survivors across treatments.

OBJECTIVE: We aim to highlight the progression from the early definition of nononcologic outcomes in prostate cancer (PC) to measurement and use of preferences to ensure appropriate treatment decisions in men with localized disease. METHODS: We review the assessment of nononcologic outcomes after PC treatment and ways to use the outcomes to augment patient care. RESULTS: PC treatments may have similar oncologic efficacy in men with certain clinical features, but they differ in their nononcologic outcomes. Tools to assess these outcomes have been developed and are useful in areas from treatment reimbursement to shared decision-making. CONCLUSIONS: The ability to measure and make useful data on nononcologic outcomes evolved substantially over the past 20 years. Current work suggests that individual preference assessment for nononcologic outcomes is a promising means of matching patients with appropriate treatment.

Patient experience and quality of urologic cancer surgery in US hospitals.

BACKGROUND: Care interactions as perceived by patients and families are increasingly viewed as both an indicator and lever for high-value care. To promote patient-centeredness and motivate quality improvement, payers have begun tying reimbursement with related measures of patient experience. Accordingly, the authors sought to determine whether such data correlate with outcomes among patients undergoing surgery for genitourinary cancer. METHODS: The authors used the Nationwide Inpatient Sample and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) data from 2009 through 2011. They identified hospital admissions for cancer-directed prostatectomy, nephrectomy, and cystectomy, and measured mortality, hospitalization length, discharge disposition, and complications. Mixed effects models were used to compare the likelihood of selected outcomes between the top and bottom tercile hospitals adjusting for patient and hospital characteristics. RESULTS: Among a sample of 46,988 encounters, the authors found small differences in patient age, race, income, comorbidity, cancer type, receipt of minimally invasive surgery, and procedure acuity according to HCAHPS tercile (P<.001). Hospital characteristics also varied with respect to ownership, teaching status, size, and location (P<.001). Compared with patients treated in low-performing hospitals, patients treated in high-performing hospitals less often faced prolonged hospitalization (odds ratio, 0.77; 95% confidence interval, 0.64-0.92) or nursing-sensitive complications (odds ratio, 0.85; 95% confidence interval, 0.72-0.99). No difference was found with regard to inpatient mortality, other complications, and discharge disposition (P>.05). CONCLUSIONS: Using Nationwide Inpatient Sample and HCAHPS data, the authors found a limited association between patient experience and surgical outcomes. For urologic cancer surgery, patient experience may be optimally viewed as an independent quality domain rather than a mechanism with which to improve surgical outcomes. Cancer 2016;122:2571-8. © 2016 American Cancer Society.

Health Insurance Status and Disparities in Kidney Cancer Care.

INTRODUCTION: Through PPACA (Patient Protection and Affordable Care Act) many adults have or will gain health insurance via Medicaid expansion. To understand how this policy change may potentially impact patients with kidney cancer we examined the relationship between insurance status and cancer related outcomes. METHODS: Using SEER (Surveillance, Epidemiology and End Results) data we identified 18,632 patients 26 to 64 years old with kidney cancer from 2007 to 2009. For each patient we classified insurance status as no insurance, Medicaid or private insurance. After adjusting for patient and county characteristics we measured the association of insurance status with cancer stage, treatment and 1-year mortality using multinomial logistic regression with clustering or generalized estimating equations as appropriate. RESULTS: In our study cohort 937 (5.0%) and 2,027 patients (10.9%) had no insurance and Medicaid, respectively. These patients were more likely to be younger, nonwhite, unmarried and residing in areas with lower income, education or employment (p <0.001). On adjusted analyses uninsured and Medicaid patients more often presented with advanced disease (21.3% vs 19.6% vs 11.0%) but less frequently received treatment (86.2% vs 87.9% vs 93.4%, each p <0.001) compared with privately insured patients. These adults also died of kidney cancer more often (13.6% vs 12.5% vs 6.4%, p <0.001) likely due to differences in stage and receipt of cancer directed therapy. CONCLUSIONS: Uninsured and Medicaid patients suffer disproportionately from kidney cancer with equal magnitude. Given the reliance on Medicaid, even as insurance coverage expands differences in outcomes will likely persist, underscoring the need for additional efforts that address disparities in kidney cancer care.