Cost of upper tract imaging obtained during hematuria evaluation: Analysis of a national claims database.

INTRODUCTION: To investigate the actual cost of hematuria evaluation using nationally representative claims data, given that the workup for hematuria burdens the healthcare system with significant associated costs. We hypothesized that evaluation with contrast-enhanced computed tomography (CT) confers more cost to hematuria evaluation than renal ultrasound (US). METHODS: Using a national, privately insured database (MarketScan), we identified all individuals with an incident diagnosis of hematuria. We included patients who underwent cystoscopy and upper tract imaging within 3 months of diagnosis. We tabulated the costs of the imaging study as well as the total healthcare cost per patient. A multivariable model was developed to evaluate patient factors associated with total healthcare costs. RESULTS: We identified 318,680 patients with hematuria who underwent evaluation. Median costs associated with upper tract imaging were $362 overall, $504 for CT with contrast, $163 for US, $680 for magnetic resonance imaging (MRI), $283 for CT without contrast, and $294 for retrograde pyelogram. Median cystoscopy cost was $283. Total healthcare costs per patient were highest when utilizing MRI and CT imaging. When adjusted for comorbidities, the use of any imaging other than ultrasound was associated with higher costs. CONCLUSIONS: In this nationally representative analysis, hematuria evaluation confers a significant cost burden, while the primary factor associated with higher costs of screening was imaging type. Based upon reduced cost of US-based strategies, further investigation should delineate its cost-effectiveness in the diagnosis of urological disease.

Neoadjuvant Cisplatin-based Chemotherapy in Nonmetastatic Muscle-invasive Bladder Cancer: A Systematic Review and Pooled Meta-analysis to Determine the Preferred Regimen.

OBJECTIVE: To determine whether neoadjuvant gemcitabine and cisplatin (GC) vs dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) before radical cystectomy improves overall survival (OS), progression-free survival (PFS), and pathologic complete response (pCR) for patients with muscle-invasive bladder cancer with secondary analyses of pathological downstaging and toxicity. MATERIALS AND METHODS: This systematic review and meta-analysis identified studies of patients with muscle-invasive bladder cancer treated with neoadjuvant GC compared to ddMVAC from PubMed, Web of Science, and EMBASE. Random-effect models for pooled log-transformed hazard ratios (HR) for OS and PFS and pooled odds ratios for pCR and downstaging were developed using the generic inverse variance method and Mantel-Haenszel method, respectively. RESULTS: Ten studies were identified (4 OS, 2 PFS, and 6 pCR clinical endpoints). Neoadjuvant ddMVAC improved OS (HR 0.71 [95% confidence intervals 0.56; 0.90]), PFS (HR 0.76 [95% confidence intervals 0.60; 0.97]), and pathological downstaging (odds ratio 1.34 [95% confidence interval 1.01; 1.78]) as compared to GC. There was no significant difference between regimens for pCR rates (odds ratio 1.38 [95% confidence interval 0.90; 2.12]). Treatment toxicity was greater with ddMVAC. Limitations result from differences in number of ddMVAC cycles and patient selection between studies. CONCLUSION: Neoadjuvant ddMVAC is associated with improved OS and PFS vs gemcitabine/cisplatin for patients with muscle-invasive bladder cancer before radical cystectomy. Although rates of pathological complete response were not significantly different, pathological downstaging correlated with OS. ddMVAC should be preferred over gemcitabine/cisplatin for patients with muscle-invasive bladder cancer who can tolerate its greater toxicity.

The association of patient and disease characteristics with the overtreatment of low-risk prostate cancer from 2010 to 2016.

BACKGROUND: Although active surveillance is the preferred management for low-risk prostate cancer (PCa), some men remain at risk of overtreatment with definitive local therapy. We hypothesized that baseline characteristics may be associated with overtreatment and represent a potential source of health disparities. We therefore examined the associations of patient and disease characteristics with the surgical overtreatment of low-risk PCa. METHODS: We identified men aged 45-75 years with cT1 cN0 cM0 prostate adenocarcinoma with biopsy Gleason score 6 and PSA < 10 ng/ml from 2010-2016 in the National Cancer Database (NCDB) and who underwent radical prostatectomy (RP). We evaluated the associations of baseline characteristics with clinically insignificant PCa (iPCa) at RP (i.e., "overtreatment"), defined as organ-confined (i.e., pT2) Gleason 3 + 3 disease, using multivariable logistic regression. RESULTS: We identified 36,088 men with low-risk PCa who underwent RP. The unadjusted rate of iPCa decreased during the study period, from 54.7% in 2010 to 40.0% in 2016. In multivariable analyses adjusting for baseline characteristics, older age (OR 0.98, 95% CI 0.97-0.98), later year of diagnosis (OR 0.62, 95% CI 0.57-0.67 for 2016 vs. 2010), Black race (OR 0.85, 95% CI 0.79-0.91), treatment at an academic/research program (OR 0.82, 95% CI 0.73-0.91), higher PSA (OR 0.91, 95% CI 0.90-0.92), and higher number of positive biopsy cores (OR 0.87, 95% CI 0.86-0.88) were independently associated with a lower risk of overtreatment (iPCa) at RP. Conversely, a greater number of biopsy cores sampled (OR 1.01, 95% CI 1.01-1.02) was independently associated with an increased risk of overtreatment (iPCa) at RP. CONCLUSIONS: We observed an ~27% reduction in rates of overtreatment of men with low-risk PCa over the study period. Several patient, disease, and structural characteristics are associated with detection of iPCa at RP and can inform the management of men with low-risk PCa to reduce potential overtreatment.

Association of Frailty and Complications Following Prostate Biopsy: Results From a Population-Based, Privately Insured Cohort.

INTRODUCTION: Prostate needle biopsy (PNBx) is essential for prostate cancer diagnosis, yet it is not without risks. We sought to assess patients who underwent PNBx using a claims-based frailty index to study the association between frailty and postbiopsy complications from a large population-based cohort. We hypothesized that increased frailty would be associated with adverse outcomes. METHODS: Using Market Scan, we identified all men who underwent PNBx from 2010 to 2015. Individuals were stratified by claims-based frailty index into 2 prespecified categories: not frail, frail. Complications occurring within 30 days from prostate biopsy requiring emergency department, clinic, or hospital evaluations constituted the primary outcome. Unadjusted and adjusted analyses identified patient covariates associated with complications. RESULTS: We identified 193,490 patients who underwent PNBx. The mean age was 57.6 years (SD: 5.0). In all, 5% were prefrail, mildly frail, or moderately to severely frail. The rate of overall complications increased from 11.1% for not frail to 15.5% for frail men. After adjusting for covariates, individuals with any degree of frailty experienced a higher risk of overall complication (odds ratio [OR]: 1.29; P < .001), clinic (OR: 1.26; P < .001) and emergency department visits (OR: 1.32; P = .02), and hospital readmissions (OR: 1.41; P < .001). CONCLUSIONS: Frailty was associated with a higher risk of complications for patients undergoing PNBx. Frailty assessment should be integrated into shared decision-making to limit the provision of potentially harmful care associated with prostate cancer screening.

Are Diagnostic Delays Associated with Distress in Breast Cancer Patients?

Introduction: Receiving a new breast cancer diagnosis can cause anxiety and distress, which can lead to psychologic morbidity, decreased treatment adherence, and worse clinical outcomes. Understanding sources of distress is crucial in providing comprehensive care. This study aims to evaluate the relationship between delays in breast cancer diagnosis and patient-reported distress. Secondary outcomes include assessing patient characteristics associated with delay. Methods: Newly diagnosed breast cancer patients who completed a distress screening tool at their initial evaluation at an academic institution between 2014 and 2019 were retrospectively evaluated. The tool captured distress levels in the emotional, social, health, and practical domains with scores of "high distress" defined by current clinical practice guidelines. Delay from mammogram to biopsy, whether diagnostic or screening mammogram, was defined as >30 days. Result: 745 newly diagnosed breast cancer patients met inclusion criteria. Median time from abnormal mammogram to core biopsy was 12 days, and 11% of patients experienced a delay in diagnosis. The non-delayed group had higher emotional (p = 0.04) and health (p = 0.03) distress than the delayed group. No statistically significant differences in social distress were found between groups. Additionally, patients with higher practical distress had longer time interval between mammogram and surgical intervention compared to those with lower practical distress. Older age, diagnoses of invasive lobular carcinoma or ductal carcinoma in situ, and clinical anatomic stages 0-I were associated with diagnostic delay. Conclusion: Patients with higher emotional or health-related distress were more likely to have timely diagnoses of breast cancer, suggesting that patients with higher distress may seek healthcare interventions more promptly. Improved understanding of sources of distress will permit early intervention regarding the devastating impact of breast cancer diagnosis.

Racial differences in survival for early stage (T1) penile cancer: Analysis from the SEER database.

BACKGROUND: Penile cancer accounts for less than 1% of male cancers in the United States. Localized disease, particularly T1 tumors are potentially curable with local therapy. We present the racial differences in survival outcomes for T1, penile cancer from the SEER database. METHODS: From 2004 to 2016 all men with T1, N0, M0 penile cancer in the SEER-18 database were included. Kaplan-Meier analysis and multivariable Cox-Regression analysis were conducted to investigate prognostic variables for cancer specific survival (CSS). RESULTS: A total of 4,406 men were identified with penile cancer; 1,941 men had T1 disease. The Kaplan-Meier (KM) analysis showed those with primary site surgery had better 5-year CSS compared to those without primary site surgery (P <.0001) and a significant difference in CSS based on race (P= 0.0078). On multivariable analysis, Hispanic individuals had worse CSS (HR 1.92; P = 0.0057) compared to the White men. Black men were also found to have a poor CSS however this was not statistically significant (HR 1.53, P = 0.118). Men with penile cancer who had either penectomy (HR 0.45; P = 0.006) or penile preservation surgery (HR 0.25; P< 0.001) had improved CSS. CONCLUSION: Racial disparities in CSS exist among men with in early-stage penile cancer. KM analysis showed significant differences in CSS by race and in those receiving primary site surgery. On multivariable analysis, the CSS is worse in Hispanic compared to White men. There is a trend towards worse CSS in Black men however this was not statistically significant.

The Impact of Within-Consultation and Preconsultation Decision Aids for Localized Prostate Cancer on Patient Knowledge: Results of a Patient-Level Randomized Trial.

OBJECTIVE: To evaluate the role of timing (either before or during initial consultation) on the effectiveness of decision aids (DAs) to support shared-decision-making in a minority-enriched sample of patients with localized prostate cancer using a patient-level randomized controlled trial design. METHODS: We conducted a 3-arm, patient-level-randomized trial in urology and radiation oncology practices in Ohio, South Dakota, and Alaska, testing the effect of preconsultation and within-consultation DAs on patient knowledge elements deemed essential to make treatment decisions about localized prostate cancer, all measured immediately following the initial urology consultation using a 12-item Prostate Cancer Treatment Questionnaire (score range 0 [no questions correct] to 1 [all questions correct]), compared to usual care (no DAs). RESULTS: Between 2017 and 2018, 103 patients-including 16 Black/African American and 17 American Indian or Alaska Native men-were enrolled and randomly assigned to receive usual care (n = 33) or usual care and a DA before (n = 37) or during (n = 33) the consultation. After adjusting for baseline characteristics, there were no statistically significant proportional score differences in patient knowledge between the preconsultation DA arm (0.06 knowledge change, 95% CI -0.02 to 0.12, P = .1) or the within-consultation DA arm (0.04 knowledge change, 95% CI -0.03 to 0.11, P = .3) and usual care. CONCLUSION: In this trial oversampling minority men with localized prostate cancer, DAs presented at different times relative to the specialist consultation showed no improvement in patient knowledge above usual care.

Robot-assisted retroperitoneal lymph node dissection: a systematic review of perioperative outcomes.

OBJECTIVE: To assess the safety and feasibility of robot-assisted retroperitoneal lymph node dissection (R-RPLND) and to compare the perioperative outcomes of R-RPLND with open RPLND (O-RPLND), as RPLND forms an integral part of the management of testis cancer and R-RPLND is a minimally invasive treatment option for this disease. MATERIALS AND METHODS: The PubMed® , Scopus® , Cochrane Central Register of Controlled Trials, and Web of Science™ databases were searched for studies reporting perioperative outcomes of primary and post-chemotherapy R-RPLND and studies comparing R-RPLND with O-RPLND. RESULTS: The search yielded 42 articles describing R-RPLND, including five comparative studies. The systematic review included 4222 patients (single-arm studies, n = 459; comparative studies, n = 3763). Of 459 patients in the single-arm studies, 271 underwent primary R-RPLND and 188 underwent post-chemotherapy R-RPLND. For primary R-RPLND, the operative time ranged from 175 to 540 min and the major complication rate was 4.1%. For post-chemotherapy R-RPLND, the operative time ranged from 134 to 550 min and the major complication rate was 8.5%. The conversion rate to open surgery was 2.2% in primary R-RPLND and 9.0% in post-chemotherapy R-RPLND. In comparison with O-RPLND, R-RPLND was associated with a lower transfusion rate (14.5% vs 0.9%, P < 0.001) and a lower complication rate (18.5% vs 7.8%, P = 0.002). CONCLUSION: Robot-assisted RPLND has acceptable perioperative outcomes in both the primary and post-chemotherapy settings but a notable rate of conversion to open surgery in the post-chemotherapy setting. Compared with O-RPLND, R-RPLND is associated with a lower transfusion rate and fewer overall complications. Given the potential impact of selection bias, the optimal patient selection criteria for R-RPLND remain to be elucidated.

Urothelial carcinoma of the bladder with isolated lymph node metastasis: Natural history and outcomes following surgical resection.

INTRODUCTION: Although pathologic lymph node involvement carries a poor prognosis in patients with urothelial carcinoma of the bladder (UCB), a subset of patients may demonstrate durable survival following surgical resection. To this end, there are limited contemporary data describing the natural history of UCB in patients with isolated lymph node involvement (cN0pN+) following radical cystectomy (RC) with pelvic lymph node dissection (PLND). We therefore utilized a large, nationwide oncology dataset to examine the natural history and outcomes of cN0 pN+ UCB after surgical resection. MATERIALS AND METHODS: We identified patients in the National Cancer Database (NCDB) with cN0 pN+ cM0 UCB from 2006 to 2015 treated with RC and PLND. The associations of baseline characteristics with all-cause mortality (ACM) were evaluated using Cox regression. RESULTS: A total of 2,884 patients formed the study cohort, including 42% with pN1 and 58% with pN2-3 disease. Of these, 606 (21%) received multiagent neoadjuvant chemotherapy, while 1,172 (41%) received postoperative adjuvant chemotherapy. A median of 15 (IQR 9-23) LNs were removed during PLND. The 5- and 7-year OS for the entire cohort were 20% and 17%, respectively. Compared to the overall cohort, patients surviving ≤5 years had lower pN stage (59% vs. 42% pN1) and lower pT stage (41% vs. 22% ≤pT2). On multivariable analysis, higher pT stage (HR 2.85, 95% CI 1.52-5.36 for pT3, HR 3.27, 95% CI 1.73-6.18 for pT4 vs. pT0), higher pN stage (HR 1.17, 95% CI 1.05-1.31 for pN2-3 vs. pN1), and increasing LN density (HR 2.37, 95% CI 1.88-2.99) were most strongly associated with increased ACM, while receipt of adjuvant chemotherapy (HR 0.61, 95% CI 0.55-0.68) was associated with reduced ACM. CONCLUSIONS: Although OS for patients with cN0 pN+ M0 UCB is poor, a subset of patients demonstrates durable long-term survival with 5- and 7-year OS of 20% and 17%, respectively. pT and pN stage represent important prognostic characteristics, while administration of adjuvant chemotherapy represents a potential therapeutic intervention associated with improved ACM.

Financial Toxicity of Breast Cancer Care: The Patient Perspective Through Surveys and Interviews.

INTRODUCTION: Although the economic burden of cancer care is an emerging concern in the United States, the potential financial toxicity of breast cancer care at the patient level remains poorly understood. This study aims to characterize the scope of the contributors to financial distress on breast cancer patients and the resources utilized to address them. METHODS: Adult female patients diagnosed with invasive breast cancer or ductal carcinoma in situ between 2014 and 2019 at a single institution were retrospectively evaluated. Those who enrolled in copay assistance or indicated financial concerns on an intake distress screen were provided a web-based survey assessing financial changes, resources used, and financial engagement with providers. Semi-structured interviews further explored sources of financial distress and were analyzed by two researchers using grounded theory methodology. RESULTS: Sixty-eight patients completed the online survey, 15 of the 68 also participated in semi-structured phone interviews. On the online survey 74% of participants endorsed a financial distress score ≥5 on a scale of 0-10. Seventy-four percent changed their budget, 72% used their savings, and 60% cut down on spending. However, only 40% used resources such as financial counseling or financial assistance. Interviews revealed three major contributors to financial distress: (1) unexpected medical and nonmedical expenses, (2) lost revenue from missed work, and (3) altered budgeting. CONCLUSIONS: Many breast cancer patients experience significant financial distress without access to the resources they need. This study highlights the need for financial transparency, supportive financial services counseling at the time of diagnosis, throughout treatment and beyond.

Surgeon Perceptions of the Integration of Patient-Reported Outcome Measures into Clinical Practice.

INTRODUCTION: Patient-reported outcome measures (PROMs/PROM) are standardized, validated instruments used to measure the patient's perception of their own health status including their symptoms, functional wellbeing, and mental health. Although PROMs were initially developed as research tools, their use in clinical practice for shared decision-making and to assess the impact of disease and treatment on quality of life of individual patients has been increasing. There is a paucity of research exploring providers' perspectives on the clinical integration of PROMs. We sought to use a qualitative methodology to understand surgeons' perceptions of integrating PROMs into their clinical practices. METHODS: Semistructured interviews were performed from November 2019 until August 2020. All interviews were recorded and transcribed verbatim. Thematic saturation was achieved after interviewing nine surgeons representing eight surgical specialties. Qualitative interview data were thematically analyzed using an inductive approach facilitated by Atlas.ti qualitative software. RESULTS: Forty seven unique codes were identified that fit into 21 themes that revealed five novel insights. Key insights included: (1) PROM data can modify surgical practice on an individual and institutional level, (2) Surgeon's view PROM clinical integration as a potential method of advancing patient-centered care, (3) There are various institutional processes that must be in place, including strong leadership and an integrative platform, to enable successful clinical PROM integration, (4) Surgeons appreciate challenges of integrating PROMs into surgical practice including risks of incorrect use or interpretation, and (5) A PROM platform must be adaptable to the diversity within surgery and to unique physician workflows. CONCLUSIONS: Surgeons perceived value from integrating PROMs into routine care to better inform patients during preoperative discussions and to help identify at-risk patients in the postoperative period. However, they also identified numerous barriers to the implementation of an integrated system for the routine use of PROMs in clinical practice and expressed concern about using PROMs to compare operative outcomes between surgeons. Based on this work, institutions that want to incorporate PROMs into surgical practice need a leadership team capable of supporting the change management necessary for effective integration and use a PROM platform that gives individual surgeons and surgical teams the ability to customize platforms for their unique practices.

Patterns of Treatment and Outcomes in Older Men With Penile Cancer: A SEER Dataset Analysis.

Purpose: To evaluate clinicopathologic and treatment characteristics from a population-based cohort of penile cancer, with an emphasis in older adults, due to incomplete evidence to guide therapy in this age subgroup. Materials and Methods: Patients with malignant penile tumors diagnosed 2004-2016 were identified in the Surveillance, Epidemiology and End Results Program (SEER)-18 dataset. Demographic and treatment characteristics were obtained. Population was analyzed by age at diagnosis (<65 vs ≥65 years). We examined univariate associations between age groups with Chi-square analysis. To study survival, we calculated Kaplan-Meier survival curves, but due to the high number of competing events, we also performed a univariate competing risk analysis using the cumulative incidence function, and a multivariate analysis using the Fine-Gray method. We also described competing mortality due to penile cancer and other causes of death. Results: We included 3,784 patients. Median age was 68 years, 58.7% were aged ≥65. Older patients were less likely to have received chemotherapy (p<0.001), primary site surgery (p = 0.002), or therapeutic regional surgery (p <0.001). Median overall survival (OS) in patients <65 years was not reached (95% CI incalculable) vs 49 months in those ≥65 years (95% CI 45-53, p <0.0001). On univariate analysis, age was associated with a lower incidence of penile cancer death. On multivariate analysis, stage at diagnosis, and receipt of primary site surgery were associated with a higher incidence of penile cancer death. Estimated penile cancer-specific mortality was higher in patients <65 years in stages II-IV. Estimated mortality due to other causes was higher in older patients across all stages. Conclusions: Older patients are less likely to receive surgery, chemotherapy and radiotherapy for penile cancer. Primary surgical resection was associated with better penile cancer-specific mortality on multivariate analysis. Competing mortality risks are highly relevant when considering OS in older adults with penile cancer. Factors associated with undertreatment of older patients with penile cancer need to be studied, in order to develop treatment strategies tailored for this population.

Geographic Variation of Infectious Complications Following Prostate Biopsy in The United States: Results From a Population-Based Cohort of Privately Insured Patients.

OBJECTIVE: To elucidate regional trends of infectious complications following transrectal ultrasound prostate biopsy (TRUS-PB) from a national, privately-insured database. MATEREIAL AND METHODS: Using Market Scan, we identified all men who underwent TRUS-PB from 2010 to 2015. Infectious complications (UTI, prostatitis, sepsis) occurring 30 days after the prostate biopsy from emergency room (ER) visits or hospital admissions constituted the primary outcomes. We analyzed unadjusted and adjusted rates of infectious complications from ER visits and hospital admissions per 100 prostate biopsies by state. Multivariable logistic regression analyses were used to identify patient covariates associated with infectious complications. RESULTS: During the study interval, we identified 193,490 patients who underwent TRUS-PB. The mean age was 57.6 years (SD: 5.0). Over time the unadjusted national rates of infectious complications remained similar from 0.4 ER visits per 100 prostate biopsies in 2010 -0.2 in 2015 (P = 0.83), and 1.2 hospital admissions per 100 prostate biopsies in 2010 to 1.1 in 2015 (P= 0.58). Connecticut had the lowest unadjusted infectious complication rate per 100 biopsies at 0.64, whereas West Virginia had the highest at 2.34. Multivariable analysis revealed higher Elixhauser status and patient age were associated with higher odds of infectious complications (P<0.05). CONCLUSIONS: While rates of infectious complications attributable to prostate biopsies remain relatively stable, significant variation exists at the state level regarding this adverse outcome.