New all oral therapy for chronic hepatitis C virus (HCV): a novel long-term cost comparison.

BACKGROUND: In the US, the prevalence of hepatitis C virus (HCV) has surpassed the prevalence of human immunodeficiency virus (HIV), with about 3.3 million people chronically infected with the disease. Given the aging of the Baby Boomer generation and the subsequent implementation of age-based screening recommendations, HCV diagnoses are expected to increase. Utilization of anti-viral pharmacotherapy is also expected to increase as more effective and tolerable all-oral therapies for HCV become available in the United States. This research allows payors to assess the disease burden and treatment impact of HCV in their member group. METHODS: A set of three integrated economic models was developed to estimate the disease and cost burden of HCV based on existing literature, wholesale acquisition costs, industry standards, and actuarial judgment. Model 1 estimates the HCV antibody prevalence of HCV in a payer's member group based on population size and the age, sex, and region distribution of the members. Model 2 predicts the number of uncured chronic HCV members who represent the future treatment and medical cost burden for the payer over the next 14 years. Model 3 contrasts the pharmacy, medical, and overall costs for treatment and medical care over 14 years for three therapeutic scenarios: interferon-based standard of care (SOC), all oral therapy, and natural course of disease progression, while accounting for the frequency of HCV genotype within the member population. RESULTS: In a payer population of 100,000 members with an age, sex, and region distribution matching the United States, the seroprevalence of HCV was estimated to be 1.26 %. Combined pharmacy and medical costs for uncured chronic HCV positive members was least expensive for all oral therapy. The per patient with HCV cost savings for all oral therapy compared to SOC were about $3000 per year over 14 years. In a sensitivity analysis, the 12-week all oral therapy for genotype 1 provided overall cost savings vs. a 24-week interferon-based SOC regimen until all oral therapy costs exceeded $99,000. CONCLUSIONS: In most modeled scenarios, the all-oral therapeutic scenario was less costly than SOC, even in sensitivity analyses.

Walgreens connected care: impact of managed therapy on adherence to medications used to treat multiple sclerosis and related comorbid conditions.

BACKGROUND: The Walgreens Connected Care Multiple Sclerosis (CCMS) treatment management program provides enhanced levels of monitoring, oversight, and care for patients taking MS disease-modifying agents. This study compared rates of adherence to MS medications for patients participating in the CCMS program for at least 6 months with those for patients participating for less than 6 months. For a subsample of patients, we also examined the relationship between adherence and the presence of fatigue or depression. METHODS: This was a retrospective study of patients new to the CCMS program and followed up for 1 year of participation. Adherence to MS medications was measured as the proportion of days covered, with propensity scores used to match the CCMS intervention group to the less-managed comparison group. The impact of program participation on the relationship between depression or fatigue and adherence over time was a separate analysis. RESULTS: Mean proportion of days covered rates improved significantly in the group managed for at least 6 months compared with those who were less managed. Positive screenings for fatigue and depression reduced adherence in the less-managed group but not in patients with longer participation in the program. CONCLUSIONS: Overall, the CCMS program significantly increased adherence to MS medications. This improved adherence was not negatively impacted by positive screenings for fatigue and depression.

Impact of HIV-specialized pharmacies on adherence to medications for comorbid conditions.

OBJECTIVE: To determine if patients using human immunodeficiency virus (HIV)-specialized pharmacies have greater adherence to drugs used to treat comorbid conditions and HIV compared with patients who use traditional pharmacies. DESIGN: Retrospective cohort study, with patients' propensity matched based on pharmacy use: HIV-specialized versus traditional. SETTING: Nationwide pharmacy chain. PARTICIPANTS: Adult patients who filled at least two prescriptions for an antiretroviral therapy (ART). Patients also needed to have at least two prescriptions for an angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) or a statin for analyses examining comorbid conditions. MAIN OUTCOME MEASURE: Proportion of days covered (PDC). RESULTS: The adherence analyses for ART, ACE inhibitors/ARBs, and statins included 14,278, 1,484, and 1,372 pairs, respectively. The mean PDC for ART patients using HIV-specialized pharmacies was higher than that for patients using traditional pharmacies (86.20% vs. 81.87%; P <0.0001). Patients taking ACE inhibitors/ARBs in the specialized group also had a higher mean PDC compared with patients in the traditional group (82.61 vs. 79.66; P = 0.0002), as did specialized pharmacy users in the statin group (83.77 vs. 81.29; P = 0.0009). CONCLUSION: HIV patients managed by an HIV-specialized pharmacy have significantly higher adherence to medication for comorbid conditions compared with patients using traditional pharmacies. Patients of HIV-specialized pharmacies also have significantly higher adherence to ART compared with peers using traditional pharmacies.

Evaluation of increased adherence and cost savings of an employer value-based benefits program targeting generic antihyperlipidemic and antidiabetic medications.

BACKGROUND: A major employer implemented a change to its employee health benefits program to allow beneficiaries with diabetes or high cholesterol to obtain preselected generic antidiabetic or generic antihyperlipidemic medications with a zero dollar copayment. To receive this benefit, plan beneficiaries were required to participate in a contracted vendor's case management and/or wellness program.  OBJECTIVE: To assess changes in medication adherence and the costs for generic antidiabetic and generic antihyperlipidemic medications resulting from participation in a zero copay (ZCP) program.   METHODS: This was a retrospective pre-post comparison group study, evaluating adherence and cost. Participants using an antihyperlipidemic and/or antidiabetic medication during the study identification period and post-implementation period for the program were considered eligible for the study. Eligible beneficiaries who enrolled in the ZCP program during the post-implementation period were considered participants, while those who did not enroll during this period were considered nonparticipants. ZCP program participants and nonparticipants were matched via a 1-to-1 propensity scoring method using age, gender, comorbidity count, medication type (antihyperlipidemic, antidiabetic, or both), and baseline adherence as matching criteria. The proportion of days covered (PDC) metric expressed as a mean percentage was used to assess adherence to medication therapy, while payer cost was examined using prescription drug utilization expressed as per member per year (PMPY) and cost change per 30 days of medication expressed in dollars.   RESULTS: Among participants who were users of antidiabetic medications, the mean adherence rate was sustained from pre- to post-implementation (81.8% vs. 81.9%); however, it decreased in the matched nonparticipant group (81.9% vs. 73.1%). This difference in mean adherence over time between the participants and nonparticipants was statistically significant (0.1% vs. -8.8%, P less than 0.001). Similar results were found among users of antihyperlipidemics. The mean adherence rate was sustained over time for participants (77.7% vs. 78.3%) but declined over time for nonparticipants (77.6% vs. 70.8%). The difference in mean change over time was statistically significant between participants and nonparticipants (0.6% vs. -6,8%, P less than 0.001). Average prescription costs PMPY increased for participants of the ZCP program during the post-implementation period; however, the increase was not larger than the cost increase among nonparticipants ($581 vs. $584, P = 0.95). Furthermore, among antihyperlipidemics the cost increase post-implementation was actually significantly less for participants than nonparticipants ($51 vs. $143, P less than 0.001).  CONCLUSIONS: Plan sponsors are increasingly evaluating the use of value-based benefit design (VBBD) to change member behavior. This ZCP program used a reduction in cost sharing to incentivize members to use more generic drugs and to enroll in a care management coaching program. The study also demonstrated that a VBBD program can have a positive impact on adherence and cost outcomes among those who participate compared with nonparticipants. 

Fear of recurrence, symptom burden, and health-related quality of life in men with prostate cancer.

OBJECTIVES: To examine the contributions of fear of recurrence and the more commonly examined treatment-related symptoms to the health-related quality of life (HRQOL) of men treated for localized prostate cancer. METHODS: A total of 730 men with localized disease were identified from the Cancer of the Prostate Strategic Urologic Research Endeavor, a national, prospective study of men with prostate cancer. Pre- to post-treatment changes in fear of recurrence, treatment-specific symptoms and burden, comorbidities at diagnosis, number of new symptoms, and post-treatment HRQOL data were analyzed. RESULTS: Linear regression, adjusted for clinical and demographic characteristics, showed that improved fear of recurrence (P <0.01), higher number of post-treatment symptoms (P <0.01), and improved bowel function (P <0.01) significantly predicted better mental health scores. For physical health, improved urinary bother (P <0.01) and lower number of post-treatment symptoms (P <0.01) were associated with better physical health. CONCLUSION: Understanding men's fears about cancer recurrence and how these fears influence physical and mental health are important components of providing care to this growing population.

Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research Endeavor.

OBJECTIVE: To evaluate the effect of medical insurance coverage on health-related quality of life (HRQoL) outcomes in men newly diagnosed with prostate cancer, as insurance status has been shown to be related to clinical presentation, and types of treatments received for localized prostate cancer, but the relationship of insurance and QoL has not been explored sufficiently. PATIENTS AND METHODS: Data from the Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE), a national longitudinal database registry of men with prostate cancer, were used for this study. Men who were newly diagnosed at entry to CaPSURE and completed one questionnaire before treatment, and one or more afterwards, were included. Insurance groups specific to age distribution of the study population were assessed, i.e. Medicare, preferred provider organizations (PPOs), health maintenance organizations (HMOs), fee for service (FFS), and the Veterans Administration (VA) for the younger group, and Medicare only, Medicare plus supplement (+S), and HMO/PPO for the older group. Associations between patients' clinical and sociodemographic characteristics and insurance status were evaluated by chi-square and analysis of variance. Relationships between insurance status and HRQoL outcomes over time were evaluated by multivariate mixed model. RESULTS: Of 2258 men who met the study criteria, 1259 were younger and 999 were older than 65 years. More than half of the younger patients belonged to an HMO or PPO (42.2% and 32.5%, respectively), with the remainder distributed between Medicare, FFS and VA. In the older group most men belonged to Medicare only and the Medicare +S groups (22.4% and 58.8%, respectively). There was greater variation in clinical risk categories at presentation by insurance groups in the younger group. In the multivariate analysis, insurance status was significantly associated with changes in most HRQoL outcomes over time in the younger group, while in the older patients the effect of insurance diminished. Men in the VA and Medicare systems had lower scores at baseline and a steeper decline in Physical Function, Role Physical, Role Emotional, Social Function, Bodily Pain, Vitality, and General Health domains over time, controlling for type of initial treatment received, timing of HRQoL assessment, number of comorbidities, clinical risk at presentation, and income. CONCLUSION: Insurance was independently related to changes in a wide range of HRQoL outcomes in men aged <65 years treated for prostate cancer. With the latest advances in early diagnosis and treatment of prostate cancer, clinicians and researchers should be aware of the specific groups of patients who are more vulnerable to the adverse effects of treatment and subsequent decline in functioning. The present findings could provide important tools for understanding the process of recovery after treatment for prostate cancer, and identifying needs for specific services.

The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance.

PURPOSE: Little is known about psychosocial factors affecting the decision to move from surveillance to active treatment in men with localized prostate cancer. We examined the impact of cancer anxiety on the decision to move from surveillance to treatment. MATERIALS AND METHODS: We analyzed data from CaPSURE, a national observational prostate cancer registry. A total of 105 participants had localized disease, selected surveillance vs treatment and had at least 3 prostate specific antigen values available after baseline. Cancer anxiety was measured with a 3-item scale (alpha = 0.78). We calculated the rate of change in prostate specific antigen with time (prostate specific antigen velocity) and used the same formula to calculate the rate of change in cancer anxiety. We fit a Cox regression model to determine predictors of receiving treatment in the 3-year observation period, controlling for prostate specific antigen velocity, demographics and baseline clinical characteristics. RESULTS: Prostate specific antigen velocity and the cancer anxiety change rate were significant independent predictors of treatment receipt (HR 1.02, 95% CI 1.004, 1.035, each p <0.01). Men with higher prostate specific antigen velocity (1.51 ng/ml per year or greater) were significantly more likely to receive treatment than men with lower prostate specific antigen velocity (HR 3.18, 95% CI 1.122, 9.016). The 2 velocity measures correlated only modestly (r = 0.29, p <0.001). CONCLUSIONS: Rather than being based only on clinical presentation and disease progression, decisions about treatment receipt for some men are influenced by cancer related anxiety. Men should be provided with more psychosocial support to perhaps delay treatment and the ensuing decrements in health related quality of life.

Incidence of urethral stricture after primary treatment for prostate cancer: data From CaPSURE.

PURPOSE: We determined the incidence of treatment for urethral stricture, including bladder neck contracture, after primary treatment for clinically localized prostate cancer. MATERIALS AND METHODS: A total of 6,597 men with newly diagnosed, localized prostate cancer and no history of urethral stricture disease were identified in the CaPSURE database. Treatment modalities included radical prostatectomy, external beam radiotherapy, brachytherapy, cryotherapy, androgen deprivation therapy, radical prostatectomy plus external beam radiotherapy, brachytherapy plus external beam radiotherapy and watchful waiting. The database was queried for patient reported history or International Classification of Diseases, 9th revision/Common Procedural Terminology codes consistent with stricture treatment after prostate cancer therapy. Time to obstruction was examined by the Kaplan-Meier method. Risk factors for stricture were examined in a multivariate Cox proportional hazards model. RESULTS: The incidence of stricture treatment was 344 of 6,597 cases (5.2%, range 1.1% to 8.4% by prostate cancer treatment type). Median followup was 2.7 years. In the multivariate model primary treatment type (p <0.0001), body mass index (p <0.0001) and age (p = 0.0002) were significant predictors of stricture treatment. After controlling for age and body mass index the HR for treatments compared to watchful waiting was significantly higher for radical prostatectomy (HR = 10.4, p <0.0001) and brachytherapy plus external beam radiotherapy (HR = 4.6, p = 0.0231). After radical prostatectomy most failures occurred within the first 6 months and failures were rare after 24 months, whereas after radiation failures occurred later. CONCLUSIONS: The risk of urethral stricture treatment after prostate cancer therapy is 1.1% to 8.4% depending on cancer treatment type. Risk was highest after radical prostatectomy or brachytherapy plus external beam radiotherapy and in those with advanced age or obesity. Stricture after radical prostatectomy occurred within the first 24 months, whereas onset was delayed after radiation.

Prostate brachytherapy: a descriptive analysis from CaPSURE.

PURPOSE: The purpose of this study was to describe demographic and clinical characteristics in a large disease registry of prostate cancer patients treated with prostate brachytherapy (PB) and to identify factors influencing the use of supplemental external beam (SEB) radiation therapy and choice of isotope. METHODS AND MATERIALS: Data were abstracted from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a disease registry of 11,804 men with various stages of prostate cancer. The study population consisted of those men who were diagnosed with prostate cancer between 1990 and 2003, had no prior history of cancer and were treated with PB (alone or with SEB). The influence of patient demographics, disease characteristics, and year of diagnosis on the use of SEB and isotope choice was examined. RESULTS: The study population included 791 men. Six hundred nine men (77%) were treated with PB alone and 182 men (23%) were treated with PB and SEB. Patient demographics were not associated with the use of SEB. Disease characteristics were associated with the use of SEB. Patients treated with PB and SEB had higher pretreatment prostate-specific antigen (PSA), higher T-stage, higher Gleason score, and were more likely to be placed in the high-risk category (all p<0.01). The use of SEB increased over the period studied. In a multivariate analysis, patients diagnosed after 1999 were much more likely to receive SEB after controlling for disease characteristics (PSA, T-stage, Gleason). Likewise, higher clinical PSA (odds ratio [OR]=1.08; 95% confidence interval [CI]: 1.04-1.13), higher biopsy Gleason (OR=3.64; 95% CI: 2.60-5.09), and cT2 vs. cT1 (OR=2.06; 95% CI: 1.22-3.48) were more likely to have PB with SEB than PB alone. Patient demographics differed according to isotope. Compared to men treated with 125)I, men treated with (103)Pd were older, less educated, less wealthy, and less likely to have private insurance. Disease characteristics also differed according to isotope. Compared to men treated with 125I, men treated with 103Pd had higher T-stages, higher Gleason scores, and were more likely to be placed in the intermediate- or high-risk category. The choice of isotope did not change over time. CONCLUSIONS: The use of SEB is associated with disease characteristics. SEB has increased over the period studied. Isotope choice is associated with patient demographics and disease characteristics.

Education predicts quality of life among men with prostate cancer cared for in the Department of Veterans Affairs: a longitudinal quality of life analysis from CaPSURE.

BACKGROUND: Previous findings have suggested that patient educational attainment is related to cancer stage at presentation and treatment for localized prostate cancer, but there is little information on education and quality of life outcomes. Patient education level and quality of life were examined among men diagnosed with prostate cancer and cared for within an equal-access health care system, the Department of Veterans Affairs Veterans Health Administration (VA). METHODS: Participants were 248 men with prostate cancer cared for in the VA and enrolled in CaPSURE. Repeated-measures analysis of variance was used to examine quality of life over time according to education level, controlling for age, ethnicity, income, site of clinical care, and year of diagnosis. RESULTS: Patients with lower levels of education tended to be younger, nonwhite, and have lower incomes. Controlling for age, ethnicity, income, year of diagnosis, and site, men with less formal education, compared with those with more, had worse functioning in the physical (P=.0248), role physical (P=.0048), role emotional (P=.0089), vitality (P=.0034), mental health (P=.0054), social function (P=.0056), and general health (P=.0002) domains and worse urinary (P=.003) and sexual (P=.0467) side effects. CONCLUSIONS: Men with less education experienced worse health-related quality of life across a wide range of domains and greater urinary and sexual symptoms than their peers who had more education. Clinicians should be aware that, even within an equal access to health care system, men with less education are vulnerable, having greater difficulty functioning in their daily lives after their prostate cancer treatment.

Bladder cancer incidence and risk factors in men with prostate cancer: results from Cancer of the Prostate Strategic Urologic Research Endeavor.

PURPOSE: We evaluated a large disease registry to determine the incidence of bladder cancer in patients with prostate cancer and investigate whether the type of treatment for prostate cancer increased the risk of bladder cancer. MATERIALS AND METHODS: We analyzed the CaPSURE disease registry for men diagnosed with prostate cancer plus bladder cancer between 1989 and 2003. Demographics, comorbidities and prostate cancer treatment modalities were compared in patients with and without bladder cancer. A backward stepwise Cox proportional hazards regression model was used to predict bladder cancer onset after treatment for prostate cancer in patients who had bladder cancer 30 days or greater after prostate cancer treatment. RESULTS: Of 9,780 patients from CaPSURE 143 (1.46%) also had bladder cancer. Patients with bladder cancer and prostate cancer were older (p<0.01) and more likely to be white (p=0.03), and they had lower levels of income (p<0.01) and education (p=0.04) than patients with prostate cancer only. Comorbidities did not differ between patients with and without bladder cancer. Patients treated with radical prostatectomy were approximately half as likely to have posttreatment bladder cancer as patients who underwent radiation therapy (HR 0.51, 95% CI 0.29-0.89). Patients who smoked had an independent increase in the risk of bladder cancer (HR 2.08, 95% CI 1.09-3.97), while smokers treated with radiation therapy were at almost 4-fold risk for bladder cancer (HR 3.65, 95% CI 1.45-9.16). CONCLUSIONS: The incidence of bladder cancer in patients with prostate cancer was 1.5%. Radiation therapy and smoking increased the risk of bladder cancer.

Limited pelvic lymph node dissection at the time of radical prostatectomy does not affect 5-year failure rates for low, intermediate and high risk prostate cancer: results from CaPSURE.

PURPOSE: Limited bilateral pelvic lymph node dissection performed at radical prostatectomy provides staging information that is used to guide further disease management. Given the effects of widespread prostate specific antigen testing and stage migration, most procedures in the United States are performed for low risk disease, which has a low probability (less than 1%) of lymph node metastasis. We compared 5-year treatment failure rates in patients with low, intermediate and high risk disease who underwent radical prostatectomy with or without pelvic lymph node dissection. MATERIALS AND METHODS: We compared treatment failure rates for radical prostatectomy in 4,693 patients enrolled in the CaPSURE database who underwent radical prostatectomy with or without limited pelvic lymph node dissection. Secondary analysis was performed as a function of pelvic lymph node dissection and risk group based on pretreatment stage, grade and prostate specific antigen. Treatment failure rates were estimated by Kaplan-Meier analysis. RESULTS: The 5-year failure-free survival rate was 70% in the no pelvic lymph node dissection group and 74% in the limited pelvic lymph node dissection group (p = 0.11), while the rates in the low, intermediate and high risk groups were 81% and 82% (p = 0.83), 71% and 63% (p = 0.21), and 42% and 48% (p = 0.45) in the no vs limited pelvic lymph node dissection groups, respectively. Multivariate analysis demonstrated that pelvic lymph node dissection status was not a predictor of treatment failure (p = 0.93). CONCLUSIONS: This study demonstrates in a large cohort of patients that limited pelvic lymph node dissection at radical prostatectomy has no effect on treatment failure rates at 5 years in those at low, intermediate and high risk.

Quality of life for men receiving a second treatment for prostate cancer.

PURPOSE: We assessed the impact of second treatment on health related quality of life for men with prostate cancer. This issue is important because second treatment resulting from prostate specific antigen recurrence has the potential to further negatively impact health related quality of life and affect the overall value of treatment. We compared differences in health related quality of life before and after second treatment for men who had asymptomatic prostate specific antigen recurrence with those who did not have biochemical failure. MATERIALS AND METHODS: Men in this analysis (897) had localized disease, initially underwent radical prostatectomy monotherapy, and completed at least 1 health related quality of life questionnaire before and after radical prostatectomy. In this cohort 175 men underwent second treatment (nonadjuvant). The Medical Outcomes Survey Short Form-36 and UCLA Prostate Cancer Index were used to measure health related quality of life. Associations between patient groups and time on health related quality of life were analyzed using repeated measures. RESULTS: Men who received a second treatment presented with more severe disease before radical prostatectomy and had worse general health related quality of life. Although health related quality of life differed significantly with time for the 2 groups, most domains for the second treatment group improved or remained stable until 15 months before second treatment, at which point they declined. Scores in the sexual functioning and role-physical domains showed clinically and statistically significant patterns of decreasing with time. CONCLUSIONS: Health related quality of life is affected following second treatment but starts to decline approximately 1 year before second treatment. Not all aspects of health related quality of life decreased at the same rate, so patients should be counseled that certain domains may be affected more by additional treatment.

Cumulative cost pattern comparison of prostate cancer treatments.

BACKGROUND: Studies that compare prostate cancer treatment costs show wide variation. None compare all contemporary treatment costs, and most focus on initial treatment costs. The authors compared healthcare utilization and cost patterns of prostate cancer treatments over a span of 5.5 years in 4553 newly diagnosed patients stratified by age and risk group. METHODS: Contemporary treatment and evaluation patterns for prostate cancer were identified by using CaPSURE, a national disease registry of men with prostate cancer that included ongoing clinical data collection from 31 academic and community urology practices and biennial patient-reported outcome questionnaires that included demography, medical condition, comorbidity, risk measures, and healthcare utilization. Costs of outpatient visits, medications, and hospitalizations were applied from various national sources. Recurrent events analysis (MCF) accounted for left and right censorship. A mixed effects regression model with bootstrapping for skewed cost data quantified the relation between MCF cost, age, and risk. RESULTS: Prostate-related costs in the first 6 months after treatment were 11,495 dollars, (from 2586 dollars for watchful waiting (WW) to 24,204 dollars for external beam radiation. After 6 months, average cost was only 3044 dollars. Annual cost is 7740 dollars, highest for androgen deprivation therapy (12,590 dollars) and lowest for watch waiting (5843 dollars). Risk and age were significantly related to initial treatment choice. Cumulative cost (42,570 dollars) allowed a better estimate of treatment pattern costs. CONCLUSIONS: The cost burden of prostate cancer is high, but it varies by treatment type even when controlling for disease, age, and stage. Cumulative cost analysis allowed inclusion of adverse events and disease recurrence costs, making new cost comparisons evident among treatments.

Health-related quality of life for men with prostate cancer and diabetes: a longitudinal analysis from CaPSURE.

OBJECTIVES: To compare diabetic versus nondiabetic men with prostate cancer to understand whether diabetes mellitus (DM) imposes an additional burden on health-related quality of life (HRQOL) before and after radical prostatectomy, adjusting for obesity. METHODS: Data were abstracted from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a disease registry of 12,005 men with localized prostate cancer. Men were included who had undergone surgical treatment from 1989 to 2003, had body mass index (BMI) information available, and had completed both a pretreatment and at least one posttreatment HRQOL questionnaire within 24 months. A repeated-measures model adjusted for baseline clinical and demographic variables was used to evaluate group differences. RESULTS: The 1248 men were divided into two groups (117 with DM and 1131 without DM) on the basis of a history of DM or the reporting of diabetes medication use. The diabetic men were significantly more likely to be older and nonwhite, have lower education and income, and be less likely to have private insurance. They also had significantly more comorbid conditions (other than DM) and a greater BMI at baseline. Urinary function differed by diabetes status, BMI, and the DM x BMI interaction, with diabetic men who had a greater BMI reporting greater declines in urinary function over time. No other statistically significant differences in HRQOL were observed, although trends by BMI were noted in sexual function and bowel bother. CONCLUSIONS: Although previous studies of men with prostate cancer have found differences in HRQOL by obesity level, our results have indicated that the presence or absence of DM and a high BMI may have a greater impact on HRQOL than obesity alone.

Uterine fibroids: a review of health-related quality of life assessment.

OBJECTIVE: To summarize the literature describing the impact of uterine fibroids on health-related quality of life (HRQOL), the measures used to assess HRQOL, and related areas for future research. METHODS: A search of three electronic databases (MEDLINE, Embase, and Current Contents) was performed, and 40 papers were identified referencing leiomyoma or uterine fibroids and (health-related) quality of life (HRQOL). Studies including women with benign gynecological conditions other than uterine fibroids were also reviewed. RESULTS: The EQ-5D, SF-36, and related generic measures are used to assess HRQOL in women with diverse gynecological conditions, including uterine fibroids. The UFS-QOL, a condition- specific measure, provides scores on symptom severity and six HRQOL dimensions. All instruments consistently demonstrate that HRQOL is considerably impaired in women with symptomatic uterine fibroids and that appropriate treatment can lead to improved QOL. CONCLUSIONS: The published data on HRQOL associated with uterine fibroids report significantly lower HRQOL scores for women with fibroids than for women without this disorder. Additional research is needed to confirm these findings and provide greater detail describing the specific domains most affected by uterine fibroids. These advances are necessary to effectively compare new treatment modalities vs. standard invasive therapies, such as hysterectomy.

Changing patterns of pelvic lymphadenectomy for prostate cancer: results from CaPSURE.

PURPOSE: Widespread screening for prostate cancer in the United States has resulted in earlier tumor identification at lower stages. The fewer number of men with lymph node metastases at initial presentation has altered patterns of pelvic lymphadenectomy before definitive treatment. We characterized patterns of pelvic lymphadenectomy in conjunction with radical prostatectomy in a community based cohort. MATERIALS AND METHODS: In the CaPSURE database we identified men undergoing radical prostatectomy. Patients were stratified into 3 clinical risk groups based on serum prostate specific antigen, T stage and pathological grade. We examined temporal trends of pelvic lymphadenectomy and predictors of pelvic lymphadenectomy. RESULTS: From 1992 to 2004 the proportion of men undergoing pelvic lymphadenectomy in conjunction with radical prostatectomy decreased from 94% to 80%. Overall positive lymph nodes were identified in 0.87%, 2.0% and 7.1% of men in the low, intermediate and high risk groups, respectively. While men with high risk disease continued to undergo pelvic lymphadenectomy at a high rate (greater than 90%), the fraction of men at low and intermediate risk undergoing pelvic lymphadenectomy steadily decreased. Prostate specific antigen, Gleason sum, clinical stage and income were factors associated with pelvic lymphadenectomy. A mean of 5.7 lymph nodes (median 5.0) were removed. CONCLUSIONS: The performance of pelvic lymphadenectomy has decreased in patients at low and intermediate risk, and remained stable in patients at high risk. Further investigation of the role of extended pelvic lymphadenectomy and the potential therapeutic benefits of pelvic lymphadenectomy would better define the contemporary role of pelvic lymphadenectomy and identify appropriate candidates.

Reduced incidence of bony metastasis at initial prostate cancer diagnosis: data from CaPSURE.

PURPOSE: Despite stage migration as a result of screening, many individuals are diagnosed each year with metastatic (M+), as opposed to localized (M0), prostate cancer. This study describes features that characterize patients with M+ compared to those diagnosed with M0 disease. MATERIALS AND METHODS: Patients enrolled in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a national, longitudinal registry of men with prostate cancer, formed the basis of this study. The prevalence, and changes with time, of patients with M+ and M0 cancer by clinical and sociodemographic characteristics were examined. RESULTS: Of 10,113 patients diagnosed between 1990 and 2003, 266 (2.6%) had M+ disease at diagnosis. From 1990 to 1997, 4.2% of 4020 total patients had M+ versus 1.6% of 6093 total patients diagnosed between 1998 and 2003 (odds ratio 0.34; 95% confidence interval 0.24-0.48; P < 0.0001). In univariate analysis, advanced age, higher prostate-specific antigen, Gleason grade, black race, lower income, and lower educational level were associated with M+ versus M0 disease (P < 0.01). However, in multivariate analysis, only higher serum prostate-specific antigen and higher Gleason grade, and not the sociodemographic variables, remained associated with M+ disease (P < 0.01). Patients with M+ diagnosed between 1998 and 2003 are more likely to harbor high-grade (Gleason > or =8) primary tumors (62% vs. 45%, P = 0.02) than those diagnosed between 1990 and 1997. No changes in age, race, education, insurance status, or income were observed in the early versus late era. CONCLUSIONS: These findings show a reduction in the incidence of metastatic disease at initial prostate cancer diagnosis. Furthermore, biologic, rather than socioeconomic, factors are associated with this type of disease presentation.

Impact of increased number of biopsies on the nature of prostate cancer identified.

PURPOSE: Increasing the number of cores obtained at the time of transrectal ultrasound guided prostate biopsy has increased the number of cancers identified. However, there is increasing recognition that many men with prostate cancer may not benefit from early, aggressive intervention and that over detection of prostate cancer has resulted in over treatment. We determined the impact of the greater number of prostate biopsies on the nature of cancer identified. MATERIALS AND METHODS: In the Cancer of the Prostate Strategic Urologic Research Endeavor database, a longitudinal disease registry of men with prostate cancer, we identified those men diagnosed between 1999 and 2002 with complete data on serum prostate specific antigen, Gleason score, clinical T stage, number of biopsies obtained and number involved with cancer. RESULTS: We identified 4,072 men with 6 or more prostate biopsies obtained at initial diagnosis. Of the men 30%, 47% and 24% underwent 6, 7 to 11, and more than 12 biopsies, respectively. The number of biopsies correlated significantly with numerous sociodemographic and clinical variables including prostate specific antigen, comorbidities and income. There did not appear to be differences in disease characteristics as assessed by Kattan and Cancer of the Prostate Risk Assessment scores among men with a biopsy number between 6 and 17. In the subset of 1,548 men undergoing radical prostatectomy, no differences in biochemical-free survival were observed among the various biopsy groups at a median followup of 2.2 years. CONCLUSIONS: The increasing number of prostate biopsies obtained at diagnosis increases cancer detection but the impact on disease characteristics remains unclear. Our data suggest that the risk stratification of prostate cancers is independent of biopsy number (6 or greater) in a contemporary cohort of men.

Comorbidity and primary treatment for localized prostate cancer: data from CaPSURE.

PURPOSE: The optimal approach for treating localized prostate cancer remains controversial, leading to a multifactorial decision making process. We characterized the extent to which the presence and number of comorbidities affects treatment for localized prostate cancer. MATERIALS AND METHODS: Data were abstracted from a longitudinal observational database of men with prostate cancer. A total of 5,149 men diagnosed with localized prostate cancer between 1995 and 2001 were included in this analysis if they had been treated with RP, external beam radiation, brachytherapy, hormonal therapy or surveillance. Comorbidity was assessed through a patient reported checklist of conditions. Multinomial logistic regression was used to determine the OR of the likelihood of receiving each type of therapy. The number of comorbidities and specific comorbidities in patients receiving RP were compared with comorbidities in patients receiving other treatment. RESULTS: The adjusted OR showed a dose response between the number of comorbidities and an increasing probability of any nonRP treatment. In addition, heart disease, stroke or another urinary condition were found to be associated with treatment. CONCLUSIONS: Patient comorbidities affect decision making regarding treatment for localized prostate cancer. Urologists and other physicians treating this disease appear to evaluate patient comorbidities when selecting treatment options.