Long-Term Cost Analysis of Third-Line Treatment Options for Overactive Bladder.

INTRODUCTION: We aimed to analyze the long-term cost of overactive bladder third-line treatments. METHODS: This insurance claims review analyzed the 2015 to 2020 MarketScan (MKS) claims data set subjects age ≥ 18, diagnosis of overactive bladder (OAB) using ICD-9/ICD-10 codes and receipt of treatment for percutaneous tibial nerve stimulation, sacral neuromodulation (SNM), or botulinum A. Age, gender, treatment types, and cost were extracted. Treatment costs were aggregated at the level of patient and treatment type for total payment and patient contribution by combining copay, coinsurance, and deductible. We used the Wilcoxon rank-sum test for continuous and chi-square test for categorical variables. SAS v9.4 was used for analyses. Significance was set at P < .05. RESULTS: We identified 17,755 patients from the commercial claims MKS and 10,912 patients from the Medicare supplemental (MDC) database with mean age 50.7±11.1 and 75.5±7.6 years, respectively, who underwent ≥ 1 third-line OAB treatment. Patients receiving third-line treatment were predominantly female (84.9%, MKS, 74.8%, MDC). Long-term costs over a 15-year period were estimated. Percutaneous tibial nerve stimulation is the most expensive in terms of total net payment ($105,337.50 MKS, $94,102.50 MDC) and patient contribution ($9177.60 MKS, $3921.00 MDC). Total net payment for botulinum A was $67,968 (MSK), $54,261 (MDC), and patient contribution cost was $2850 (MSK), $1110 (MDC). The most cost-effective option was SNM in terms of both total net payment ($5179.10 MKS, $6099.00 MDC) and patient contribution ($59.10 MKS, $60.00 MDC). CONCLUSIONS: SNM was the most cost-effective third-line treatment for OAB looking over a 15-year period in terms of both total net payment and patient contribution.

Prolonged Opioid Use Following Bladder Tumor Resection for Opioid-naïve Patients.

INTRODUCTION: Bladder cancer patients represent a high-risk group for opioid dependence due to the frequency of surgical procedures. Using MarketScan insurance commercial claims and Medicare-eligible databases, we sought to identify whether filling an opioid prescription following initial transurethral resection of bladder tumor resulted in increased odds of prolonged opioid use. METHODS: We analyzed 43,741 commercial claims and 45,828 Medicare-eligible opioid-naïve patients with a new diagnosis of bladder cancer from 2009 to 2019. Multivariable analyses were completed to assess the odds of prolonged opioid use at 3-6 months based on initial exposure to opioids and initial opioid dose quartile. We performed subgroup analyses by sex and eventual treatment modality. RESULTS: Those who filled an opioid prescription following initial transurethral resection of bladder tumor had greater odds of persistent opioid use (commercial claims: 27% vs 12%, OR 2.14, 95% CI 1.84-2.45; Medicare-eligible: 24% vs 12%, OR 1.95, 95% CI 1.70-2.22). Increasing dosage quartile of opioids was associated with increased odds of prolonged opioid use. Those going on to radical therapy had the highest rates of an initial opioid prescription (31% commercial claims and 23% Medicare eligible). Men and women had similar rates of initial prescriptions, but female sex was associated with higher odds of persistent opioid use at 3-6 months in the Medicare-eligible group (OR 1.08, 95% CI 1.01-1.16). CONCLUSIONS: Opioids following initial transurethral resection of bladder tumor increase the odds of continued use at 3-6 months, with the greatest odds in those prescribed the highest initial doses. These data suggest that short-term prescriptions have long-term effects, and additional research on opioid use and bladder cancer outcomes is merited.

Covariate adjustment in continuous biomarker assessment.

Continuous biomarkers are common for disease screening and diagnosis. To reach a dichotomous clinical decision, a threshold would be imposed to distinguish subjects with disease from nondiseased individuals. Among various performance metrics, specificity at a controlled sensitivity level (or vice versa) is often desirable because it directly targets the clinical utility of the intended clinical test. Meanwhile, covariates, such as age, race, as well as sample collection conditions, could impact the biomarker distribution and may also confound the association between biomarker and disease status. Therefore, covariate adjustment is important in such biomarker evaluation. Most existing covariate adjustment methods do not specifically target the desired sensitivity/specificity level, but rather do so for the entire biomarker distribution. As such, they might be more prone to model misspecification. In this paper, we suggest a parsimonious quantile regression model for the diseased population, only locally at the controlled sensitivity level, and assess specificity with covariate-specific control of the sensitivity. Variance estimates are obtained from a sample-based approach and bootstrap. Furthermore, our proposed local model extends readily to a global one for covariate adjustment for the receiver operating characteristic (ROC) curve over the sensitivity continuum. We demonstrate computational efficiency of this proposed method and restore the inherent monotonicity in the estimated covariate-adjusted ROC curve. The asymptotic properties of the proposed estimators are established. Simulation studies show favorable performance of the proposal. Finally, we illustrate our method in biomarker evaluation for aggressive prostate cancer.

Utility of ultrasonography in preoperative assessment of tumor thrombi in kidney cancer.

INTRODUCTION: This study examined the clinical accuracy of ultrasonography compared to magnetic resonance imaging (MRI) and intraoperative findings for evaluation of tumor thrombi level in patients with renal cell carcinoma. MATERIALS AND METHODS: We retrospectively identified 38 patients at our institution who underwent both ultrasonography and MRI before undergoing open radical nephrectomy with tumor thrombectomy between 2010 and 2019. We compared tumor thrombus level findings of both ultrasonography and MRI, as well as the diagnostic accuracy of each to intraoperative findings. Agreement between ultrasonography, MRI, and surgery was tested with kappa. Logistic regression models identified factors that predict a mismatched thrombus level between an imaging modality and surgical findings. RESULTS AND CONCLUSIONS: Tumor thrombus levels determined by ultrasonography matched with MRI in 26 (68.4%) cases. Compared to operative findings, ultrasonography accurately identified the cephalad extent of thrombi in 30 (79.0%) cases, under-staged five (13.2%) cases, and over-staged three (7.9%). Magnetic resonance imaging agreed with operative findings in 30 (79.0%) cases, under-staged five (13.2%) and over-staged three (7.9%) cases. On univariable regression assessment, M1 stage was predictive of a mismatched result between MRI and surgery (OR: 6.0, 95% CI: 1.02-35.3, p = 0.047), but this association did not hold-up in a multivariable model. Ultrasonography and magnetic resonance imaging identified the preoperative tumor thrombus level at a rate of 79%. Ultrasonography is an effective preoperative imaging modality for evaluating tumor thrombi associated with kidney cancer, notably as an adjunct to magnetic resonance imaging.

Trends in Urethral Suspension With Robotic Prostatectomy Procedures Following Medicare Payment Policy Changes.

Importance: In 2016, the Centers for Medicare and Medicaid Services cut payments for robotic prostatectomy performed for Medicare beneficiaries. Although regulations mandate that billing for urethral suspension is only acceptable for preexisting urinary incontinence, reductions in reimbursement may incentivize billing for the use of this procedure in other scenarios. Objective: To assess trends and geographic variations in payments for urethral suspension with robotic prostatectomy in the context of Medicare payment policy. Design, Setting, and Participants: This US population-based retrospective cohort study analyzed data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Database for men with employer-based insurance (primary commercial or Medicare supplemental coverage) who underwent robotic prostatectomy (Current Procedural Terminology [CPT] code 55866) between 2009 and 2019. Exposures: Time period and metropolitan statistical area of patient residence. Main Outcomes and Measures: Payment for urethral suspension (CPT code 51990) with robotic prostatectomy. Results: We identified 87 774 men with prostate cancer treated with robotic prostatectomy; 3352 (3.8%) had undergone urethral suspension. The mean (SD) patient age was 59.7 (6.5) years; 16 870 patients (19.2%) had Medicare supplemental coverage. From 2015 to 2016, median payments for robotic prostatectomy changed by -$358 (-17.0%) for Medicare beneficiaries vs -$9 (0%) for commercially insured patients. With urethral suspension vs without, median (IQR) episode payments for robotic prostatectomy were higher for commercially insured men ($3678 [$3090-$4503] vs $3322 [$2601-$4306]) and Medicare beneficiaries ($2927 [$2450-$3909] vs $2379 [$2014-$3512]). Compared with men treated between 2013 and 2015, those treated between 2016 and 2017 were twice as likely to undergo urethral suspension (8.5% vs 4.1%; odds ratio, 2.17 [95% CI, 1.96-2.38]). The proportion of patients who underwent urethral suspension was stable for 2018 to 2019 and 2016 to 2017 (8.5% vs 9.0%; odds ratio, 1.06 [95% CI, 0.96-1.18]). From 2015 to 2019, the proportion of patients who underwent urethral suspension was highest in Charleston, South Carolina (92.0%), Knoxville, Tennessee (66.0%), and Columbia, South Carolina (58.0%). These regions neighbored high-volume areas without patients who underwent prostatectomy with urethral suspension (eg, 146 patients in Greenville, South Carolina, and 173 in Nashville, Tennessee). Conclusions and Relevance: In this study, urethral suspension was associated with increased costs for patients with both commercial insurance and Medicare. Patients treated between 2016 and 2017 were more likely than those treated between 2013 and 2015 to undergo this procedure. Geographic variation in use exceeded what was expected for the preexisting condition for which billing is permitted for Medicare beneficiaries. Policy statements from professional societies highlighting appropriate billing for urethral suspension may have tempered, but not reversed, the broad adoption of this procedure.

Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie's Disease: A Claims-Based Analysis (2009-2019).

BACKGROUND: Collagenase Clostridium histolyticum (CCH), which was approved by the FDA for the treatment of Peyronie's disease (PD) in 2013, may obviate the need for surgery but its historically high cost must be considered when offering CCH vs surgical intervention to affected patients. AIM: To compare trends of intralesional injections vs surgical treatment for PD and assess the contemporary cost of treatment with CCH vs surgical intervention. METHODS: We reviewed 2009-2019 MarketScan Commercial Claims data to identify all men 18 years and older with PD. CPT and HCPCS codes were used to identify PD treatments for each patient. Associated insurance claims in USD were summed for each treatment type. OUTCOMES: Total and out-of-pocket costs, as well as frequencies, for treatments were calculated on a yearly basis and the Cochran-Armitage test was used to compare frequencies before and after FDA approval of CCH. RESULTS: Of 89,205 men diagnosed with PD, 21,605 (24.2%) underwent treatment; most required only intralesional injections, however 1,519 (7.0%) received only surgical therapy and 1,951 (9.0%) required medical and surgical therapy. Intralesional CCH use sharply increased after its FDA-approval in 2013 with a concomitant fall of intralesional verapamil use. The use of both surgical plication and plaque grafting decreased steadily from 2009 to 2019. The median cost per patient for all 3 treatments increased over the study time-period: $1,856 to $3,196 for plication, $2,233 to $3,631 for plaque grafting, and $6,940 to $8,895 per cycle for CCH. Out-of-pocket median patient contribution for plication, plaque grafting, and per cycle intralesional CCH injection were similar over the study period and never exceeded $300. CLINICAL IMPLICATIONS: CCH is significantly more expensive than any surgical treatment option, however, the out-of-pocket patient contribution for surgery and CCH are similar. STRENGTHS & LIMITATIONS: This study incorporated all procedure costs and is the most contemporary, comprehensive, and accurate reflection of overall and out-of-pocket costs to patients for surgical and intralesional PD therapies. We anticipate these data to allow for a more complete discussion between patients and providers regarding their care. The use of a commercial claims database prohibited assessment of post-procedural costs and treatment outcomes. CONCLUSION: CCH use has increased significantly since its FDA approval in 2013 with out-of-pocket patient contribution comparable to surgical therapy despite significantly higher total treatment costs. Walton EL, Quinn TP, Mulloy E, et al. Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie's Disease: A Claims-Based Analysis (2009-2019). Sex Med 2022;10:100517.

Epidemiology, clinical presentation and management of COVID-19 associated mucormycosis: A single centre experience from Pune, Western India.

BACKGROUND: The second COVID-19 wave in India has been associated with an unprecedented increase in cases of COVID-19 associated mucormycosis (CAM), mainly Rhino-orbito-cerebral mucormycosis (ROCM). METHODS: This retrospective cohort study was conducted at Noble hospital and Research Centre (NHRC), Pune, India, between 1 April, 2020, and 1 August, 2021, to identify CAM patients and assess their management outcomes. The primary endpoint was incidence of all-cause mortality due to CAM. RESULTS: 59 patients were diagnosed with CAM. Median duration from the first positive COVID-19 RT PCR test to diagnosis of CAM was 17 (IQR: 12,22) days. 90% patients were diabetic with 89% having uncontrolled sugar level (HbA1c >7%). All patients were prescribed steroids during treatment for COVID-19. 56% patients were prescribed steroids for non-hypoxemic, mild COVID-19 (irrational steroid therapy), while in 9%, steroids were prescribed in inappropriately high dose. Patients were treated with a combination of surgical debridement (94%), intravenous liposomal Amphotericin B (91%) and concomitant oral Posaconazole (95.4%). 74.6% patients were discharged after clinical and radiologic recovery while 25.4% died. On relative risk analysis, COVID-19 CT severity index ≥18 (p = .017), presence of orbital symptoms (p = .002), presence of diabetic ketoacidosis (p = .011) and cerebral involvement (p = .0004) were associated with increased risk of death. CONCLUSIONS: CAM is a rapidly progressive, angio-invasive, opportunistic fungal infection, which is fatal if left untreated. Combination of surgical debridement and antifungal therapy leads to clinical and radiologic improvement in majority of cases.

Access to Care for Infertile Men: Referral Patterns of Fertility Clinics in the United States.

OBJECTIVE: To evaluate fertility clinic management of male factor infertility, including website educational content as well as factors associated with referral for urologic evaluation and care. MATERIALS AND METHODS: Using 2015-2018 Centers for Disease Control and Prevention Fertility Clinic Success Rates Reports, 480 operative fertility clinics in the United States were identified. Clinic websites were systematically reviewed for content regarding male infertility. Structured telephone interviews of clinic representatives were performed to determine clinic-specific practices for management of male factor infertility. Multivariable logistic regression models were used to predict how clinic characteristics (geographic region, practice size, practice setting, proximity to urologist, in-state andrology fellowship, state-mandated fertility coverage, annual in vitro fertilization cycles, and percentage of in vitro fertilization cycles for male factor infertility) were associated with patient referral to a urologist for male infertility care. RESULTS: We interviewed 477 fertility clinics and analyzed available websites (n = 474). The majority of websites (77%) discussed male infertility evaluation while 46% discussed treatment. Fifty clinics (11%) had an on-site urologist. Clinics with on-site urologists were more likely to be larger practices, academically affiliated, and discuss male infertility treatment on their website (all P ≤ .05). For clinics without an on-site urologist, practice size and presence of an in-state andrology fellowship program were the strongest predictors of urologic referral (P <.02). CONCLUSION: Variability in patient-facing education and infertility practice setting and size influence access to urologic care for couples with male factor infertility.

Longitudinal impact of bladder cancer diagnosis on common psychiatric disorders.

BACKGROUND: The presence of psychiatric disorders in patients with cancer is associated with increased morbidity and poorer outcomes. We sought to determine the impact of a new bladder cancer diagnosis on the incidence of depression and anxiety. METHODS: We used a database of billing claims (MarketScan®) to identify patients newly diagnosed with bladder cancer between 2009 and 2018. Patients with preexisting psychiatric disorders or use of anxiolytics/antidepressants were excluded. We matched cases to patients without a bladder cancer or psychiatric diagnosis. Our primary outcome was a new diagnosis of depression, anxiety, or use of anxiolytics/antidepressants. Other exposures of interest included gender and treatment received. We used multivariable regression to estimate odds ratios for these exposures. RESULTS: We identified 65,846 cases with a new diagnosis of bladder cancer (31,367 privately insured; 34,479 Medicare-eligible). Compared to controls, bladder cancer patients were more likely to develop new-onset depression/anxiety at 6 months (privately insured: 6.9% vs. 3.4%, p < 0.001; Medicare-eligible: 5.7% vs. 3.4%, p < 0.001) and 36 months (privately insured: 19.2% vs. 13.5%, p < 0.001; Medicare-eligible: 19.3% vs. 16.0%, p < 0.001). Women (vs. men, privately insured: OR 1.65, 95%CI 1.53-1.78; Medicare-eligible: OR 1.63, 95%CI 1.50-1.76) and those receiving cystectomy and chemotherapy (vs. no treatment, privately insured: OR 4.94, 95%CI 4.13-5.90; Medicare-eligible: OR 2.35, 95%CI 1.88-2.94) were more likely to develop significant depression/anxiety. CONCLUSION: A new diagnosis of bladder cancer was associated with increased burden of significant depression/anxiety compared with matched controls. Women and patients receiving more radical treatments had higher rates of depression and anxiety.

Disparities in magnetic resonance imaging of the prostate for traditionally underserved patients with prostate cancer.

BACKGROUND: Prebiopsy magnetic resonance imaging (MRI) of the prostate improves detection of significant tumors, while decreasing detection of less-aggressive tumors. Therefore, its use has been increasing over time. In this study, the use of prebiopsy MRI among Medicare beneficiaries with prostate cancer was examined. It was hypothesized that patients of color and those in isolated areas would be less likely to undergo this approach for cancer detection. METHODS: Using cancer registry data from the Surveillance, Epidemiology, and End Results (SEER) program linked to billing claims for fee-for-service Medicare beneficiaries, men with nonmetastatic prostate cancer were identified from 2010 through 2015 with prostate-specific antigen (PSA) <30 ng/mL. Outcome was prebiopsy MRI of the prostate performed within 6 months before diagnosis (ie, Current Procedural Terminology 72197). Exposures were patient race/ethnicity and rural/urban status. Multivariable regression estimated the odds of prebiopsy prostate MRI. Post hoc analyses examined associations with the registry-level proportion of non-Hispanic Black patients and MRI use, as well as disparities in MRI use in registries with data on more frequent use of prostate MRI. RESULTS: There were 50,719 men identified with prostate cancer (mean age, 72.1 years). Overall, 964 men (1.9% of cohort) had a prebiopsy MRI. Eighty percent of patients with prebiopsy MRI lived in California, New Jersey, or Connecticut. Non-Hispanic Black men (0.6% vs 2.1% non-Hispanic White; odds ratio [OR], 0.28; 95% CI, 0.19-0.40) and men in less urban areas (1.1% vs 2.2% large metro; OR, 0.65; 95% CI, 0.44-0.97) were less likely to have prebiopsy MRI of the prostate. CONCLUSIONS: Non-Hispanic Black patients with prostate cancer and those in less urban areas were less likely to have prebiopsy MRI of the prostate during its initial adoption as a tool for improving prostate cancer detection.

Contemporary Patterns of Third-line Treatments for Privately Insured Individuals With Overactive Bladder in the United States.

OBJECTIVE: To evaluate utilization of third-line overactive bladder (OAB) treatments including percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS), and intradetrusor botulinum toxin A (BTX) among privately insured patients and examine factors associated with their use. MATERIALS AND METHODS: Using MarketScan claims (2015-2017), we identified patients who underwent third-line OAB treatments based on procedure codes. Factors of interest included location, age, health plan, among others. We fit multivariable logistic regression models to estimate associations between pertinent factors with receipt of PTNS and SNS relative to BTX and associations between provider type and practice location with each treatment modality. RESULTS: We identified 7383 patients (mean age 50.9) in our cohort. SNS was used most frequently (n = 3602, 48.8%), while PTNS was used least frequently (n = 955, 12.9%). PTNS patients were more likely to reside in metropolitan areas (vs BTX: OR 1.6, 95%CI 1.3-2.1; vs SNS: OR 2.2, 95%CI 1.7-2.8), be aged 55 years or older (vs BTX: 54% vs 47%, OR 1.6, 95%CI 1.2-2.1; vs SNS: 54% vs 45%, OR 1.6, 95%CI 1.2-2.0), and be covered under a health maintenance organization (vs BTX: 17% vs 10%; vs SNS: 17% vs 10%, P <.01). Urologists were most likely to perform SNS, and gynecologists were most likely to perform BTX. 91% of PTNS procedures were performed in office settings. CONCLUSION: Among patients receiving third-line OAB treatment, PTNS was used infrequently. PTNS utilization was concentrated within urban areas, and among older patients and those covered by cost-conscious health maintenance organizations.

Payments and Patient Cost Sharing for Prostate Biopsies According to Image Guidance, Practice Site and Use of Anesthesia.

INTRODUCTION: Use of magnetic resonance imaging for prostate biopsies has increased and more biopsies are performed in nonoffice based settings. These changes will likely impact payments related to prostate biopsies. METHODS: Using private insurance claims from 2009 to 2015 we identified men who underwent transrectal ultrasound guided (CPT 55700) or transperineal (CPT 55706) prostate biopsies. We assumed any magnetic resonance imaging of the pelvis within 3 months prior to biopsy was for image based guidance. We assigned biopsy site as being performed in the office, ambulatory surgical center or hospital. Use of anesthesia was based on CPT codes 00100-01999. Our primary outcome was aggregate payments for anesthesia, pathology, imaging and procedural services. We also studied patient out-of-pocket costs. Multivariable regression was used to generate predicted payments based on magnetic resonance imaging performance, anesthesia and site of biopsy. RESULTS: We identified 304,388 biopsy episodes, of which 2.2% were magnetic resonance imaging guided and 0.7% were transperineal. Median cost of magnetic resonance imaging guided biopsies was greatest at $4,396 (IQR $2,784-$7,127) compared to the costs of transperineal and transrectal ultrasound guided biopsies. Imaging accounted for the greatest share of magnetic resonance imaging guided biopsy costs (median $1,704, IQR $975-$3,043). Magnetic resonance imaging guided biopsies in a hospital with anesthesia had the highest cost at $5,832 per episode (95% CI $5,732-$5,934). There was a fivefold difference in patient cost sharing between the least expensive (transperineal, office and no anesthesia $168) and most expensive (magnetic resonance imaging guided, ambulatory surgical center with anesthesia $891) modality. CONCLUSIONS: Total and out-of-pocket costs for prostate biopsies vary substantially based on modality, location and anesthesia use.

Use of Office Versus Ambulatory Surgery Center Setting and Associated Ancillary Services on Healthcare Cost Burden for Vasectomy Procedures.

OBJECTIVE: To analyze variation in total healthcare costs for vasectomies performed in the United States, based on procedure setting and use of ancillary pathology services. METHODS: We queried the MarketScan Commercial Claims database using CPT, ICD, and HCPCS codes to identify men who underwent vasectomy between 2009 and 2015, either in the office or ambulatory surgical center (ASC) setting, with or without use of pathology services. All payments for each treatment episode were calculated based on relevant claims. Patient out-of-pocket expenses were defined as the sum of copayments, coinsurance, and deductibles for each claim. Trends in vasectomy use, and differences in procedure costs by practice setting were compared over the study period. RESULTS: 453,492 men underwent a vasectomy between 2009 and 2015. The number of procedures decreased from 76,197 in 2009 to 37,575 in 2015 (P = .002). Average procedural costs increased from $870 in 2009 to $938 in 2015 (P = .001). Overall, 82.6% and 17.4% of procedures were performed in the office vs ASCs, respectively. In-office procedures were associated with lower total healthcare costs ($707 vs $1851) and lower patient out-of-pocket expenses ($173 vs $356) than those performed in ASCs. Vasal segments were submitted for pathologic evaluation in 40% of cases, which increased average payments by 55%. The use of ASCs and ancillary pathology services for vasectomies performed during the study period increased vasectomy-associated costs by $64 million. CONCLUSION: The unnecessary use of ASCs and ancillary pathology services for vasectomy may lead to tens of millions of dollars in potentially avoidable healthcare costs annually.

Expanded Prostate Cancer Index Composite-26 (EPIC-26) Online: Validation of an Internet-Based Instrument for Assessment of Health-Related Quality of Life After Treatment for Localized Prostate Cancer.

OBJECTIVES: To test the validity of an Internet-based version of Expanded Prostate Cancer Index Composite (EPIC-26) versus the phone-based version. Most men will survive for years after treatment for localized prostate cancer (PCa) and may experience lasting treatment-related toxicities affecting health-related quality of life. The EPIC-26 is a validated instrument that measures health-related quality of life across 5 PCa-specific domains. Previously, EPIC-26 was administered via phone in a large multicenter clinical trial. METHODS: We developed an Internet-based version of EPIC-26. We recruited subjects from two prospective longitudinal study cohorts of PCa patients undergoing local therapy: PROST-QA, and PROSTQA-RP2. Subjects were randomized to either an "Internet-first" or "phone-first" group. Subjects were offered the alternate questionnaire modality 2 weeks after completing the initial modality. RESULTS: 181 subjects were offered enrollment; 133 agreed to participate. 65 subjects were randomized to the "Internet- first" group and 68 subjects to the "phone-first" group. Of these, 37 and 26 subjects respectively completed both questionnaire versions (response rate: 44.4%). Test-retest analysis showed significant intraclass correlations in all 5 domains of EPIC-26: urinary incontinence (r = 0.96), urinary irritation (r = 0.85), bowel function (r = 0.61), sexual function (r = 0.94), and hormonal function (r = 0.89). There was no effect of order of questionnaire administration. CONCLUSION: This study demonstrates excellent correlation of responses between Internet-based and phone-based EPIC-26 administration. All domains demonstrated test-retest reliability between modalities, without ordering effect. This validates the use of internet-based EPIC-26 in international registries as part of the International Consortium for Health Outcomes Measurement effort, and may facilitate its use in clinical practice and quality improvement.

Surgical sterilization among US men and women with employer-based insurance: A claims data analysis.

OBJECTIVE: To assess variability in the use of surgical sterilization among privately insured U.S. men and women. STUDY DESIGN: We queried the MarketScan Commercial Claims database using CPT, ICD9, and HCPCS codes to identify 658,509 individuals between 18-65 years old (0.37% of total) who underwent male or female sterilization between 2009-2014. We examined annual trends using Cochran-Mantel-Haenszel test. We analyzed differences in age, geographic distribution, and family size using Wilcoxon sum-rank and generalized chi-squared tests. RESULTS: Between 2009-2014, 422,290 men (0.55% of total men) and 236,219 women (0.24% of total women) with employer-sponsored insurance underwent male and female sterilization, respectively. Annual male sterilizations decreased from 77,565 (0.60%) in 2009 to 61,436 (0.51%) in 2014 (p<.001), while annual female sterilizations decreased from 43,766 (0.26%) to 30,465 (0.19%) (p<.001) over the same time period. Median age at time of male or female sterilization was 38 and 37 years, respectively. The decision to undergo sterilization at age 35 or older was associated with family size of 4 or more individuals (p<.001). Sterilization was more common in urban areas, with 84% of male sterilizations and 79% of female sterilizations performed in urban areas. 79% of men compared to 60% of women who underwent sterilization were the primary policyholders of their employer-sponsored healthcare plans (p<.001). CONCLUSION: Male sterilization was twice as common as female sterilization in this privately insured cohort. Use of surgical sterilization was associated with increased age and larger family size. There was a decline in the annual number of male and female sterilizations during the study period. IMPLICATIONS: Male sterilization is more common among US men with employer-based insurance than among the general population. The decline in sterilization may reflect cultural factors and the rise of long-acting reversible contraception. Analyzing the sociodemographic factors impacting sterilization may provide insight into contraceptive choice and improve reproductive health services.

The Clinical Course of Patients With Prostate-Specific Antigen ≥100 ng/ml: Insight Into a Potential Population for Targeted Prostate-Specific Antigen Screening.

OBJECTIVE: To characterize men presenting to a tertiary care safety-net hospital with prostate-specific antigen (PSA) values ≥100 ng/mL and to identify a potential population for targeted PSA screening. MATERIALS AND METHODS: Retrospective review of 100 randomly selected patients of a total of 204 who presented to Grady Memorial Hospital from 2004 to 2011 with initial PSA ≥100 ng/mL was performed. Demographics, disease characteristics, and survival status were obtained via the Tumor Registry and a combination of electronic medical records and older paper charts, with missing data from paper charts excluded on analyses. RESULTS: Sixty-five patients were newly diagnosed with prostate cancer on presentation and 35 were previously diagnosed. Median PSA at presentation was 405.5 ng/mL (minimum, 100 and maximum, 7805), 81% had metastatic disease, and 94% had Gleason ≥7. Median Cancer of the Prostate Risk Assessment score was 8. Median age at presentation was 67.4 years (minimum, 40.8 and maximum, 90.6). Eighty-nine percent of patients were African American, 24% lived alone, 12% were homeless or incarcerated, 51% were insured by Medicare or Medicaid, and 47% were uninsured. Only 1% had human immunodeficiency virus, 19% had diabetes, and 13% had chronic kidney disease. Of the 65 newly diagnosed patients, only 23% had ever been screened and 9% were previously biopsied. Median time from presentation to death was 17.8 months (minimum, 0.16 and maximum, 107.1). CONCLUSION: Among men presenting with PSA ≥100 ng/ml at a safety-net hospital, the majority were African American, of lower socioeconomic status, and had metastatic disease. Uniform absence of prostate cancer screening may expose greater numbers of at-risk men to similar outcomes. Discussion is needed regarding targeted PSA screening in higher risk, vulnerable patients.

Association Between Combined TMPRSS2:ERG and PCA3 RNA Urinary Testing and Detection of Aggressive Prostate Cancer.

IMPORTANCE: Potential survival benefits from treating aggressive (Gleason score, ≥7) early-stage prostate cancer are undermined by harms from unnecessary prostate biopsy and overdiagnosis of indolent disease. OBJECTIVE: To evaluate the a priori primary hypothesis that combined measurement of PCA3 and TMPRSS2:ERG (T2:ERG) RNA in the urine after digital rectal examination would improve specificity over measurement of prostate-specific antigen alone for detecting cancer with Gleason score of 7 or higher. As a secondary objective, to evaluate the potential effect of such urine RNA testing on health care costs. DESIGN, SETTING, AND PARTICIPANTS: Prospective, multicenter diagnostic evaluation and validation in academic and community-based ambulatory urology clinics. Participants were a referred sample of men presenting for first-time prostate biopsy without preexisting prostate cancer: 516 eligible participants from among 748 prospective cohort participants in the developmental cohort and 561 eligible participants from 928 in the validation cohort. INTERVENTIONS/EXPOSURES: Urinary PCA3 and T2:ERG RNA measurement before prostate biopsy. MAIN OUTCOMES AND MEASURES: Presence of prostate cancer having Gleason score of 7 or higher on prostate biopsy. Pathology testing was blinded to urine assay results. In the developmental cohort, a multiplex decision algorithm was constructed using urine RNA assays to optimize specificity while maintaining 95% sensitivity for predicting aggressive prostate cancer at initial biopsy. Findings were validated in a separate multicenter cohort via prespecified analysis, blinded per prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) criteria. Cost effects of the urinary testing strategy were evaluated by modeling observed biopsy results and previously reported treatment outcomes. RESULTS: Among the 516 men in the developmental cohort (mean age, 62 years; range, 33-85 years) combining testing of urinary T2:ERG and PCA3 at thresholds that preserved 95% sensitivity for detecting aggressive prostate cancer improved specificity from 18% to 39%. Among the 561 men in the validation cohort (mean age, 62 years; range, 27-86 years), analysis confirmed improvement in specificity (from 17% to 33%; lower bound of 1-sided 95% CI, 0.73%; prespecified 1-sided P = .04), while high sensitivity (93%) was preserved for aggressive prostate cancer detection. Forty-two percent of unnecessary prostate biopsies would have been averted by using the urine assay results to select men for biopsy. Cost analysis suggested that this urinary testing algorithm to restrict prostate biopsy has greater potential cost-benefit in younger men. CONCLUSIONS AND RELEVANCE: Combined urinary testing for T2:ERG and PCA3 can avert unnecessary biopsy while retaining robust sensitivity for detecting aggressive prostate cancer with consequent potential health care cost savings.

Treatment of men with high-risk prostate cancer based on race, insurance coverage, and access to advanced technology.

PURPOSE: We characterized factors related to nondefinitive management (NDM) of patients with high-risk prostate cancer and assessed impact from race, insurance status, and facility-level volume of technologically advanced prostate cancer treatments (i.e., intensity-modulated radiation therapy, robotic-assisted laparoscopic radical prostatectomy) on this outcome. METHODS: We identified men with high-risk localized prostate cancer (based on D׳Amico criteria) in the National Cancer Database (2010-2012). Primary outcome was NDM (i.e., delayed/no treatment with prostatectomy/radiation therapy or androgen-deprivation monotherapy). Treating facilities were classified by quartiles of proportions of patients treated with advanced technology. Multivariable regression estimated odds of primary outcome based on race, insurance status, and facility-level technology use, and evaluated for interactions between these covariates. RESULTS: Among 60,300 patients, 9,265 (15.4%) received NDM. This was more common among non-White men (P<0.001), Medicaid/uninsured patients (P<0.001), and those managed at facilities in the lowest quartile of technology use (25.1% vs. 11.0% highest, P<0.001). Though NDM was common among non-White men with Medicaid/no insurance treated at low-technology centers (43% vs. 10% White, private/Medicare, high-tech facility; adjusted odds ratios = 7.18, P<0.001), this was less likely if this group was managed at a high-tech hospital (22% vs. 43% low-tech, P<0.001). CONCLUSIONS: Technology use at a facility correlates with high-quality prostate cancer care and is associated with diminished disparities based on insurance status and patient race. More research is required to characterize other facility-level factors explaining these findings.

Relief of Urinary Symptom Burden after Primary Prostate Cancer Treatment.

PURPOSE: Harms of prostate cancer treatment on urinary health related quality of life have been thoroughly studied. In this study we evaluated not only the harms but also the potential benefits of prostate cancer treatment in relieving the pretreatment urinary symptom burden. MATERIALS AND METHODS: In American (1,021) and Spanish (539) multicenter prospective cohorts of men with localized prostate cancer we evaluated the effects of radical prostatectomy, external radiotherapy or brachytherapy in relieving pretreatment urinary symptoms and in inducing urinary symptoms de novo, measured by changes in urinary medication use and patient reported urinary bother. RESULTS: Urinary symptom burden improved in 23% and worsened in 28% of subjects after prostate cancer treatment in the American cohort. Urinary medication use rates before treatment and 2 years after treatment were 15% and 6% with radical prostatectomy, 22% and 26% with external radiotherapy, and 19% and 46% with brachytherapy, respectively. Pretreatment urinary medication use (OR 1.4, 95% CI 1.0-2.0, p = 0.04) and pretreatment moderate lower urinary tract symptoms (OR 2.8, 95% CI 2.2-3.6) predicted prostate cancer treatment associated relief of baseline urinary symptom burden. Subjects with pretreatment lower urinary tract symptoms who underwent radical prostatectomy experienced the greatest relief of pretreatment symptoms (OR 4.3, 95% CI 3.0-6.1), despite the development of deleterious de novo urinary incontinence in some men. The magnitude of pretreatment urinary symptom burden and beneficial effect of cancer treatment on those symptoms were verified in the Spanish cohort. CONCLUSIONS: Men with pretreatment lower urinary tract symptoms may experience benefit rather than harm in overall urinary outcome from primary prostate cancer treatment. Practitioners should consider the full spectrum of urinary symptom burden evident before prostate cancer treatment in treatment decisions.

Multicenter Evaluation of the Prostate Health Index to Detect Aggressive Prostate Cancer in Biopsy Naïve Men.

PURPOSE: We evaluated the ability of PHI to discriminate aggressive prostate cancer from indolent or no cancer in a biopsy naïve population. MATERIALS AND METHODS: Two independent prospective cohorts of 561 and 395 subjects, respectively, with no prior prostate biopsy who were enrolled at different clinical sites were used to validate the results. We compared the diagnostic specificity of PHI to prebiopsy total and percent free prostate specific antigen using prostate biopsy results. We also determined the optimal PHI threshold to discriminate aggressive prostate cancer (Gleason score 7 or greater) from indolent or no prostate cancer (Gleason score 6 or less). RESULTS: In the primary cohort higher PHI values were significantly associated with Gleason score 7 or greater. The AUC to detect aggressive prostate cancer was 0.815. At 95% sensitivity PHI specificity was 36.0% vs 17.2% and 19.4% for total and percent free prostate specific antigen, respectively. At 95% sensitivity for detecting aggressive prostate cancer the optimal PHI cutoff was 24, which would help avoid 41% of unnecessary biopsies. A cutoff of 24 led to 36% biopsies avoided with few aggressive cancers missed. These results were confirmed in the validation cohort. CONCLUSIONS: The PHI detected aggressive prostate cancer with better specificity than total and percent free prostate specific antigen in a biopsy naïve population. It could be a useful tool to decrease unnecessary prostate biopsies.