Prostate cancer outcomes among older men: insurance status comparisons results from CaPSURE database.

With growing number of older adults in the United States and complexity of issues related to Medicare and other insurances more research is needed to evaluate an effectiveness of the different insurance types in prevention, screening and treatment of cancer. With prostate cancer being highly prevalent disease in older men, the importance of appropriate treatment and favorable outcomes is imperative. In this study we examine whether prostate cancer outcomes, such as risk category at diagnosis, treatment and survival differ in relationship to insurance status in older patients in CaPSURE. Data were abstracted from CaPSURE, a longitudinal observational database of 13 124 men with prostate cancer. Men were selected for the study if they were older than 65 years old at diagnosis, newly diagnosed between 1995 and 2005 at entry to CaPSURE with localized disease and received radical prostatectomy (RP), external beam radiation (EBRT), brachytherapy (BT), hormonal therapy or expectant management (EM). Insurance status was summarized by eight categories: Medicare only, Medicare+supplement, Medicare+HMO, Medicare+PPO, Medicare+FFS, health maintenance organization (HMO), preferred provider organization (PPO) and Veteran's Administration (VA). A total of 2983 men met the inclusion criteria. Odds ratios (OR) for the likelihood of receiving each type of therapy compared to RP by insurance status and likelihood of presenting with high-risk classification at diagnosis were derived using multinomial logistic regression, adjusting for clinical and demographic characteristics. Difference in survival between insurance groups was evaluated by Cox's multivariate regression. Multivariate analysis demonstrated a strong association between initial treatment and insurance status. Compared to Medicare patients, men in the CaPSURE database treated at HMO, PPO and VA systems were more likely to receive BT than RP (OR, 1.71-1.92) and less likely to receive this treatment if they were in Medicare+FFS and Medicare+PPO (OR, 0.18-0.38). Hormonal treatment demonstrated similar pattern, however OR did not reached statistical significance for HMO and PPO. Use of EM was much more predominant for patients in VA system (OR, 4.74; 95% CI, 1.94-11.55). Use of EBRT was significantly associated with type of insurance. Men with VA, Medicare+FFS and Medicare+PPO insurance were less likely to receive this treatment compared to RP. Survival and clinical risk at diagnosis was associated with insurance status in univariate analysis but this association diminished after adjusting for possible covariates. This study provides important information on relationship between insurance status and several outcomes in patients with prostate cancer. Even after controlling for important clinical and sociodemographic factors we found marked differences in prostate cancer treatment according to type of insurance. Future explorations of associations between health care delivery system, cancer care and outcomes are needed.

History of diabetes, clinical features of prostate cancer, and prostate cancer recurrence-data from CaPSURE (United States).

OBJECTIVES: There is a growing epidemiologic literature suggesting an inverse association between history of diabetes and risk of incident prostate cancer. To our knowledge, the relationship between diabetes and tumor features and risk of recurrence among men with prostate cancer has not been examined previously. We hypothesized that men with diabetes would present with more favorable prostate cancer and experience lower risk of recurrence. METHODS: We identified 691 men with diabetes at the time of prostate cancer diagnosis, among 6722 men diagnosed with prostate cancer in 1989 to 2002 within CaPSURE(TM), a community-based prostate cancer registry study. We compared clinical and socio-demographic variables by diabetes status, using chi2 tests, t-tests, and multinomial logistic regression. We examined recurrence rates for prostate cancer among patients with and without diabetes using Kaplan-Meier log-rank tests and Cox proportional hazard models. RESULTS: In multivariate analyses, history of diabetes was not associated with any diagnostic clinical parameter, and treatment-specific recurrence rates for prostate cancer generally did not differ by diabetes history. Among men with low-prognostic risk or who were younger at prostate cancer diagnosis, being diabetic (versus not) was associated with an elevated risk of recurrence after radiation therapy, in multivariate analyses. CONCLUSIONS: Contrary to data suggesting that diabetes may be modestly protective against risk of incident prostate cancer, we did not observe any evidence of an inverse association between history of diabetes and aggressiveness at diagnosis or risk of recurrence, in this population of men with prostate cancer.

Validation of the Restless Legs Syndrome Quality of Life Instrument (RLS-QLI): findings of a consortium of national experts and the RLS Foundation.

UNLABELLED: This study was designed to assess the initial psychometric properties of a new disease-specific health-related quality of life (HRQL) measure, the Restless Legs Syndrome (RLS) Quality of Life Instrument (RLS-QLI). METHODS: Draft items were generated from a literature review, consultation with MD and PhD specialists in the fields of neurology and sleep medicine, and input from two patient focus groups. The initial item reduction was accomplished using a survey of 392 persons with self-reported RLS symptoms from the membership of the RLS Foundation. The final (independent) validation sample consisted of 574 of persons on the RLS Foundation's Interest Group List Serve who also reported having RLS. The mean age of participants was 54.5 (SD 12.3), with a sex ratio of 1M:2F, and the majority was on some form of medication for RLS (66%). RESULTS: Four factors were identified (Daily Function, Social Function, Sleep Quality, and Emotional Well-Being) consisting of 17 items that explained 73.3% of the total variance. Each scale had good internal consistency (Cronbach's alpha's between 0.85 and 0.91) and 2-week test retest stability (Pearson Correlations between 0.81 and 0.93). Convergent validity was demonstrated using related scales on the SF-36 (r = 0.47-0.60) and criterion-related validity was shown using the clinical IRLS Scale of Symptom Severity (r = -0.45 to -0.77). CONCLUSION: The RLS-QLI is a valid disease-specific HRQL instrument that will contribute to our understanding of how RLS impacts the lives of those affected with this CNS disorder.

The cost-effectiveness of early cabergoline treatment compared to levodopa in Sweden.

The cost of Parkinson's disease (PD) is associated with the progression of the disease. Levodopa is a potent treatment for this disease, but long-term treatment results in motor complications that are associated with both costs and considerable patient discomfort. The introduction of dopamine agonists early in the treatment of PD leads to a delay in these complications, but the treatment as such is associated with higher costs. We compared the cost-effectiveness of the dopamine agonist cabergoline (with the possibility of adding levodopa later) with that of levodopa alone. A Markov model with states of the disease without motor complications defined by Hoehn and Yahr stages, and a specific state for patients with motor complications was constructed. Transition probabilities between Hoehn and Yahr states were calculated from a previously published clinical trial using an ordered probit regression model. The risk of suffering from motor complications was estimated using a Weibull model. Mortality was assumed to be the same as in the general population. Costs were estimated based on a cross-sectional study performed in southern Sweden, and only direct costs were included. In the base case the model was run for 5 years (10 cycles) and extended to 10 years in a sensitivity analysis, and costs and effects were discounted at a rate of 3%. In the base case it was predicted that the cost in the levodopa arm was 7,453 euros (67,754 Swedish crowns) compared to 11,777 euros (107,065 crowns) in the cabergoline arm. However, patients treated with cabergoline gained 0.31 years without motor complications, giving an incremental cost-effectiveness ratio for cabergoline of 13,863 euros (126,023 crowns) per year of motor complications avoided (YMA). Running the model for 10 years resulted in a more favorable cost-effectiveness ratio: 6,122 euros/YMA (55,659 crowns). The model was robust to variations in discounting rates and to variations in the estimation of costs. Although no benchmark figure pertaining specifically to Parkinson's disease has been reported to suggest the economic value of a year without motor complications (gained as a result of treatment for Parkinson's disease), US$ 60,000 per QALY gained is a figure that is often used to assess cost-effectiveness in the literature. Using this criterion, cabergoline is cost-effective if the treatment saves 0.065 QALYs. Cabergoline is even more likely to be cost-effective when also considering indirect and informal costs. More research on the relationship between motor complications and quality of life is needed.

Drug utilization review in the managed care environment.

Traditional drug use evaluation (DUE) and Medicaid drug utilization review (DUR) prototypes do not meet the needs of managed care organizations. yet, creating entirely new systems for measuring quality drug use in managed care, such as HEDIS, needlessly discards the good clinical foundations already built in the other health care settings. A better solution would be for managed care to apply its hallmark traits, namely state-of-the-art electronic data management systems, integrated health care system interchange, and strong customer communication, to make the DUR process better. A strong union between clinical criteria and sophisticated health care management can revolutionize the DUR/DUE process.