Performance of PI-RADS v2 assessment categories assigned prior to MR-US fusion biopsy in a new fusion biopsy program.

OBJECTIVE: To validate the performance of PI-RADS v2 for detection of clinically significant prostate cancer (csPca, Gleason ≥7) within the context of a new fusion biopsy program. MATERIAL AND METHODS: Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified. Diagnostic performance of PI-RADS v2 was calculated using fusion biopsy results as reference standard using receiver operating characteristic curve analysis. Patient and lesion characteristics were analyzed with one-way ANOVA and Wilcoxon rank sum test. RESULTS: Of 83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7. csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001). For prediction of csPCa, patient-level AUC was 0.68 and lesion-level AUC was 0.77. Biopsy threshold of PI-RADS ≥3 was 92.6% sensitive and 22.1% specific. A threshold of PI-RADS ≥4 was 87.2% sensitive and 58.1% specific. Rate of csPca detection on concurrent standard 12 core biopsy only was 6.7%. CONCLUSION: PI-RADS v2 assessment categories assigned prior to biopsy predict pathologic outcome reasonably well in a new prostate fusion biopsy program. Biopsy threshold of PI-RADS ≥3 is highly sensitive. A threshold of ≥4 increases specificity but misses some csPCa.

An ecological approach to monitor geographic disparities in cancer outcomes.

BACKGROUND: Area-level indices are widely used to assess the impact of socio-environmental characteristics on cancer outcomes. While area-level measures of socioeconomic status (SES) have been previously used in cancer settings, fewer studies have focused on evaluating the impact of area-level health services supply (HSS) characteristics on cancer outcomes. Moreover, there is significant variation in the methods and constructs used to create area-level indices. METHODS: In this study, we introduced a psychometrically-induced, reproducible approach to develop area-level HSS and SES indices. We assessed the utility of these indices in detecting the effects of area-level characteristics on prostate, breast, and lung cancer incidence and stage at diagnosis in the US. The information on county-level SES and HSS characteristics were extracted from US Census, County Business Patterns data and Area Health Resource Files. The Surveillance, Epidemiology, and End Results database was used to identify individuals diagnosed with cancer from 2010 to 2012. SES and HSS indices were developed and linked to 3-year age-adjusted cancer incidence rates. SES and HSS indices empirically summarized the level of employment, education, poverty and income, and the availability of health care facilities and health professionals within counties. RESULTS: SES and HSS models demonstrated good fit (TLI = 0.98 and 0.96, respectively) and internal consistency (alpha = 0.85 and 0.95, respectively). Increasing SES and HSS were associated with increasing prostate and breast cancer and decreasing lung cancer incidence rates. The results varied by stage at diagnosis and race. CONCLUSION: Composite county-level measures of SES and HSS were effective in ranking counties and detecting gradients in cancer incidence and stage at diagnosis. Thus, these measures provide valuable tools for monitoring geographic disparities in cancer outcomes.

Recruitment and Participation of African American Men in Church-Based Health Promotion Workshops.

Health promotion interventions in African American communities are frequently delivered in church settings. The Men's Prostate Awareness Church Training (M-PACT) intervention aimed to increase informed decision making for prostate cancer screening among African American men through their churches. Given the significant proportion and role of women in African American churches, the M-PACT study examined whether including women in the intervention approach would have an effect on study outcomes compared with a men-only approach. The current analysis discusses the men's participation rates in the M-PACT intervention, which consisted of a series of 4 bimonthly men's health workshops in 18 African American churches. Data suggest that once enrolled, retention rates for men ranged from 62 to 69 % over the workshop series. Among the men who were encouraged to invite women in their lives (e.g., wife/partner, sister, daughter, friend) to the workshops with them, less than half did so (46 %), suggesting under-implementation of this "health partner" approach. Finally, men's participation in the mixed-sex workshops were half the rate as compared to the men-only workshops. We describe recruitment techniques, lessons learned, and possible reasons for the observed study group differences in participation, in order to inform future interventions to reach men of color with health information.

The economic impact of delaying 5-alpha reductase inhibitor therapy in men receiving treatment for symptomatic benign prostatic hyperplasia.

BACKGROUND: Pharmacologic treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia often includes alpha-blockers and 5-alpha reductase inhibitors. Many clinicians use alpha-blockers for rapid symptom control, later adding 5-alpha reductase inhibitors to modify long-term disease progression. Delaying the addition of these medications has been shown to result in reduced clinical outcomes. The economic impact of this practice has not been widely studied or reported to date. OBJECTIVE: The objective of this study was to assess the economic impact of delaying initiation of concomitant 5-alpha reductase inhibitor therapy (≥30 days) in patients receiving alpha-blockers for lower urinary tract symptoms. METHODS: Using 2 nationally representative databases (Integrated Health Care Information Solutions and PharMetrics), 2 retrospective analyses were conducted involving 2636 and 4260 men, respectively, aged ≥50 years treated for benign prostatic hyperplasia between 2000 and 2007. Economic outcomes (ie, the cost of therapy and the use of healthcare resources) were compared for adding 5-alpha reductase inhibitor therapy early (within <30 days of initiating an alpha-blocker) versus delaying these medications (≥30 days after initiating an alpha-blocker). RESULTS: In the Integrated Health Care Information Solutions analysis, patients in the early add-on therapy group (n = 1572) had lower benign prostatic hyperplasia-related medical costs in the posttreatment period than those in the delayed-therapy group (n = 1064), $349 versus $618 (P <.0001). Similar trends were seen in the PharMetrics analysis-the medical costs in the early add-on therapy group (n = 2604) and delayed group (n = 1656) were $344 versus $449, respectively (P <.001). Pharmacy costs were $1068 for the early-treatment cohort and $989 for the delayed-treatment cohort for the Integrated Health Care Information Solutions database, yielding total costs of $1417 and $1606, respectively, for a $189 savings per patient over the initial year of treatment (P <.0001). In the PharMetrics analysis, pharmacy costs were $1391 for the early-treatment cohort and $1237 for the delayed-treatment cohort, resulting in total cost of $1735 and $1686, respectively, yielding $59 in additional costs per patient annually for those treated early (P = .8645). CONCLUSION: These results suggest that patients receiving 5-alpha reductase inhibitor therapy within 30 days after initiating alpha-blocker treatment have lower benign prostatic hyperplasia-related medical costs than those who start combination treatment later. The increase in pharmacy costs associated with early initiation of 5-alpha reductase inhibitor therapy resulted in total costs that were similar or significantly lower than those of delayed combination users.

Impact of delaying 5-alpha reductase inhibitor therapy in men on alpha-blocker therapy to treat BPH: assessment of acute urinary retention and prostate-related surgery.

OBJECTIVE: Pharmacologic treatment of lower urinary tract symptoms from benign prostatic hyperplasia (BPH) commonly includes alpha-blockers (ABs) and 5alpha-reductase inhibitors (5ARIs). Many clinicians use ABs for rapid symptom control and 5ARIs to modify long-term disease progression. The purpose of this study was to assess the clinical impact of delayed 5ARI therapy in patients treated with AB for lower urinary tract symptoms. RESEARCH DESIGN AND METHODS: Using two nationally representative databases, two retrospective analyses were conducted including patients aged > or =50 years treated for BPH between 2000 and 2007. Clinical outcomes for those using add-on 5ARI therapy early (within 30 days of initiating AB) and late (>30 days after initiating AB) were compared. Likelihood of clinical progression, defined as the presence of acute urinary retention (AUR) and prostate surgery, was assessed over 1 year after AB initiation, and modeled as a function of the treatment cohorts and the following baseline covariates: AUR, BPH stage, Charlson Comorbidity Index, age, and number of unique diagnosis codes, unique non-BPH-related classes of prescriptions filled, and specialty care. RESULTS: Of 6896 men included in the analyses, approximately 60% initiated 5ARI therapy within 30 days of AB therapy (the early cohort). Patients in the early cohort were less likely to have clinical progression. Each 30-day delay in starting 5ARIs resulted in an increased likelihood of overall clinical progression (average 21.1%), AUR (average 18.6%), and prostate-related surgery (average 26.7%). CONCLUSIONS: These results suggest that delaying 5ARI therapy in men with BPH increases the risk of AUR and prostate surgery. LIMITATIONS: Confounding factors, such as symptom severity and prostate volume, may have influenced the findings of the study.

5-Alpha reductase inhibitors in men with an enlarged prostate: an evaluation of outcomes and therapeutic alternatives.

This article presents background information and highlights key findings from a managed care perspective related to enlarged prostate (EP) in Medicare-eligible patients. This article does not provide a comprehensive review of EP but instead attempts to increase the current understanding of EP through discussion of its prevalence in men aged > or =65 years, its associated economic burden, and some available treatment options. This supplement includes 3 additional articles, all of which present data from a naturalistic, managed care setting. The article by Fenter et al assesses differences in outcomes between elderly EP patients treated with finasteride and those treated with dutasteride in relation to the risks of acute urinary retention and prostate-related surgery. Issa et al conduct a comparative analysis of the combined use of alpha-blockers and 5-alpha reductase inhibitors to treat EP. The final article compares medical costs incurred within the first year of initiating treatment for EP patients receiving finasteride versus dutasteride. This supplement is intended to assist managed care formulary decision makers in evaluating key clinical and economic data that differentiate dutasteride and finasteride within the Medicare-aged population. Although the information presented is not designed to illustrate the superiority of one product over the other, it answers important questions in relation to treating EP in elderly men and raises substantial issues beyond medication costs.

Cost comparison of finasteride and dutasteride for enlarged prostate in a managed care setting among Medicare-aged men.

OBJECTIVE: To assess cost differences between dutasteride and finasteride use within the first year of initiating treatment for enlarged prostate (EP) among men aged > or =65 years in a managed care setting. METHODS: For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for EP patients aged > or =65 years who were treated with dutasteride or finasteride. Analysis of average monthly costs over each patient's 1-year follow-up period incorporated total charges for EP-related medical care, including physician, inpatient and outpatient hospital care, emergency department, and other ancillary services. RESULTS: A total of 4498 patients met selection criteria, with comparable demographics between treatment cohorts. Patients taking dutasteride incurred $51 less per month in medical expenses than finasteride-treated patients ($122 vs $173; P <.001), attributable to lower monthly inpatient hospitalization costs ($55.84 vs $70.34), outpatient costs ($22.07 vs $44.25), and physician office visit costs ($40.69 vs $51.10). CONCLUSION: Medicare-aged patients treated with dutasteride incurred $51 less per month in medical costs than those treated with generic finasteride, suggesting that the higher price of dutasteride may be offset by decreased medical resource consumption.

Differences in alpha blocker usage among enlarged prostate patients receiving combination therapy with 5 ARIs.

OBJECTIVE: The objective of this study was to directly assess the likelihood and timing of alpha blocker discontinuation in patients receiving combination therapy with dutasteride or finasteride plus an alpha blocker. METHODS: A retrospective analysis of the PharMetrics Integrated Medical and Pharmaceutical Database (Watertown, Mass) was conducted to assess differences in alpha blocker discontinuation rates for patients initiated on 5-alpha reductase inhibitor (5ARI) therapy. The database is nationally representative, encompassing more than 45 million patients from 85 managed healthcare plans. Male patients aged >50 years with a diagnosis of enlarged prostate (EP) who were receiving alpha blocker therapy and who began 5ARI treatment (dutasteride or finasteride) between January 1, 1999, and March 1, 2005, were included. Patients were studied for up to 12 months to evaluate the likelihood and timing of alpha blocker discontinuation. RESULTS: Overall, 56.7% of the patients remained on alpha blocker therapy for 6 months. At 1 year, more dutasteride patients had discontinued alpha blocker therapy (48.9% remained on alpha blocker) than finasteride patients (58.7% remained on alpha blocker). After controlling for background covariates, dutasteride patients were 19.9% more likely to discontinue alpha blocker therapy over 365 days. CONCLUSION: Patients with EP who are taking an alpha blocker and 5ARI in combination for urinary symptom relief discontinue their alpha blocker 19.9% earlier when taking dutasteride than when taking finasteride. The ability to discontinue alpha blocker therapy earlier could reduce the costs of pharmacotherapy while continuing to provide an adequate level of symptom control and disease modification, which may result in cost savings to healthcare plans.

Clinical and economic outcomes in patients treated for enlarged prostate.

BACKGROUND: Benign prostatic hyperplasia (BPH), also referred to as enlarged prostate, is a highly prevalent condition in men aged 50 years or older. It is a progressive disease with significant morbidity from complications. OBJECTIVE: The purpose of this study was to assess the likelihood of having acute urinary retention (AUR) and prostate surgery after initiating therapy with an alpha blocker or 5-alpha reductase inhibitor in a real-world setting. STUDY DESIGN: This was a retrospective study of patients who were treated for BPH between January 1, 2003, and November 30, 2003, in a large, national managed care claims database. Outcomes measures of interest included rate of AUR, prostate surgery, and surgical complications. RESULTS: There were 2959 patient records with a diagnosis of BPH who were taking prostate medications in the database. Eighty-nine percent of patients were receiving alpha blocker therapy, whereas 11% of patients were receiving 5-alpha reductase inhibitors. Overall, the 1-year AUR rate was 12.1%, and the prostate surgery rate was 5.8%. Patients who initiated 5-alpha reductase inhibitor therapy only were less likely to have AUR or surgery compared with patients taking alpha blockers, although surgical differences did not reach statistical significance (P = .0576). Overall, the surgical complication rate was 49.4%, and the rate of AUR within 180 days of prostate surgery was 30.6%. Rates of prostate surgery, AUR, and surgical complications all increased with age. CONCLUSION: Patients receiving 5-alpha reductase inhibitor therapy alone were less likely to have AUR compared with patients receiving alpha blockers and tended to be less likely to have surgery (P = .054).

The cost of treating the 10 most prevalent diseases in men 50 years of age or older.

OBJECTIVE: Costs of treating the 10 most prevalent diagnosed diseases in men > or = 50 years of age were examined in hopes of identifying areas for better medical management and opportunities to decrease healthcare costs. METHODS: A retrospective analysis of a large national managed care database was utilized to assess the costs of treating the 10 most diagnosed diseases in aging men. All men initiating pharmacy treatment between July 1, 1997, and January 31, 2003, for (1) hypertension; (2) coronary artery disease (CAD); (3) type 2 diabetes; (4) enlarged prostate; (5) osteoarthritis; (6) gastroesophageal reflux disease; (7) bursitis; (8) arrhythmias; (9) cataracts; and (10) depression were included. Patients were continuously followed 6 months before and 12 months after initiating treatment. Costs of treatment and likelihood of experiencing a significant event were examined. RESULTS: One-year total disease-specific medical costs were highest for arrhythmias, osteoarthritis, cataracts, and CAD. Total medical costs for bursitis, type 2 diabetes, and enlarged prostate were between $400 and $500. Inpatient costs as a percentage of total medical costs were highest for CAD (75%), osteoarthritis (61%), arrhythmias (57%), and enlarged prostate (40%). For most diseases, pharmacy charges were <50% of the total cost. The likelihood of experiencing a significant clinical event within 1 year of initiating treatment was highest in men with bursitis (23%, surgery) and enlarged prostate (19.2%, acute urinary retention and/or surgery), hypertension (13.5%), and diabetes (9.5%). CONCLUSION: The most costly conditions in the 10 most prevalent diseases in men > or = 50 years of age were typically those that required substantial inpatient care. Conditions such as enlarged prostate, diabetes, and hypertension demonstrated a high likelihood of a clinical event within 1 year of initiating treatment. These conditions are therapeutic areas with the greatest likelihood of improvement, given what is known about the use of appropriate pharmacotherapy and the likelihood of treating to goal. Proactive patient management (eg, initiating/maximizing pharmacotherapy) may have the potential to positively impact clinical and economic outcomes for aging men.

An examination of treatment patterns and costs of care among patients with benign prostatic hyperplasia.

OBJECTIVE: To examine utilization and costs of care for benign prostatic hyperplasia (BPH)-related services in a large cohort of commercially insured persons. METHODS: Pharmacy and medical claims data were obtained from 61 US healthcare plans. Men aged > or = 45 years who were newly diagnosed with BPH between January 2000 and March 2001 were identified. Each patient was followed for 12 months after diagnosis; utilization and costs were calculated for common procedures and disease-related events. Costs were estimated based on health plan payments. Univariate statistics were provided for relevant measures. RESULTS: A total of 77 040 patients were selected (mean age, 58.1 years). Thirty-six percent of patients had 1 or more urologist visits in the year after diagnosis. Two thirds of patients had a prostate-specific antigen test, whereas 7% had a prostate biopsy. A total of 14 392 patients (18.7%) received an alpha blocker during follow-up; 1860 patients (2.4%) received a 5-alpha reductase inhibitor. Approximately 2% of patients had a surgical procedure (either invasive or minimally invasive); transurethral prostatectomy costs averaged approximately dollar 5600, consisting of mean (standard deviation) costs of dollar 794 (dollar 470) for the procedure and dollar 4810 (dollar 8487) in associated inpatient costs. Re-treatment was common (18.7%) among patients with a surgical procedure, at a mean cost of dollar 1888 (dollar 1636). CONCLUSION: Most patients newly diagnosed with BPH appear to undergo watchful waiting in the year after diagnosis. Although rates of surgical intervention and adverse events at 1 year are low, these events are costly. Strategies to prevent or delay the need for surgery, such as regular examinations, testing, and use of pharmacotherapy where indicated, may further reduce the need for surgical intervention.

The effect of dysfunctional voiding on the costs of treating vesicoureteral reflux: a computer model.

PURPOSE: We created a computer model for evaluating the effect of dysfunctional voiding on the costs of managing vesicoureteral reflux in children. MATERIALS AND METHODS: The literature on vesicoureteral reflux was reviewed to create a set of assumptions regarding the epidemiology, likelihood of resolution, need for operative intervention, risk of infection and appropriate regimen for nonoperative surveillance. Recent literature describing the effect of dysfunctional voiding on the clinical course of vesicoureteral reflux was included in the model to compare the costs of treating vesicoureteral reflux in children with and without dysfunctional voiding. A 5-year management period was considered. RESULTS: Dysfunctional voiding in children with vesicoureteral reflux increased the cost of treatment per patient by 51.2%. The cost per patient increased with increasing grade in those with and without dysfunctional voiding. The difference in costs in the 2 groups increased from 18.7% for grade 1 reflux to 62.1% for grade 5. Sensitivity analysis was performed, in which the risk of urinary tract infection, rate of surgical resolution, incidence of dysfunctional voiding and discount rate varied. The cost in children with dysfunctional voiding remained higher in all scenarios studied, showing the robustness of the model. CONCLUSIONS: Dysfunctional voiding substantially increases the costs of treating children with vesicoureteral reflux due to the higher rate of urinary tract infection in children with dysfunctional voiding. Methods that would decrease the rate of urinary tract infection in children with dysfunctional voiding and vesicoureteral reflux would lead to a significant saving of health care dollars.