Active surveillance, radiofrequency ablation, or cryoablation for the nonsurgical management of a small renal mass: a cost-utility analysis.

BACKGROUND: Patients with a cortical small (≤4 cm) renal mass often are not candidates for or choose not to undergo surgery. The optimal management strategy for such patients is unclear. METHODS: A decision-analytic Markov model was developed from the perspective of a third party payer to compare the quality-adjusted life expectancy and lifetime costs for 67-year-old patients with a small renal mass undergoing premanagement decision biopsy, immediate percutaneous radiofrequency ablation or percutaneous cryoablation (without premanagement biopsy), or active surveillance with serial imaging and subsequent ablation if needed. RESULTS: The dominant strategy (most effective and least costly) was active surveillance with subsequent cryoablation if needed. On a quality-adjusted and discounted basis, immediate cryoablation resulted in a similar life expectancy (3 days fewer) but cost $3,010 more. This result was sensitive to the relative rate of progression to metastatic disease. Strategies that employed radiofrequency ablation had decreased quality-adjusted life expectancies (82-87 days fewer than the dominant strategy) and higher costs ($3,231-$6,398 more). CONCLUSIONS: Active surveillance with delayed percutaneous cryoablation, if needed, may be a safe and cost-effective alternative to immediate cryoablation. The uncertainty in the relative long-term rate of progression to metastatic disease in patients managed with active surveillance versus immediate cryoablation needs to be weighed against the higher cost of immediate cryoablation. A randomized trial is needed directly to evaluate the nonsurgical management of patients with a small renal mass, and could be limited to the most promising strategies identified in this analysis.

Estimation of the impact of diabetes-related complications on health utilities for patients with type 2 diabetes in Ontario, Canada.

OBJECTIVES: The goal of this study was to analyze health-related quality of life (HRQL) data from a Canadian population with type 2 diabetes in order to estimate the disutility associated with experiencing a diabetes-related complication. METHODS: The EQ-5D, a standardized instrument for use as a measure of health outcome, was administered to 1,147 patients in Hamilton, Ontario, with type 2 diabetes. After controlling for age, gender, and duration of diabetes, changes in utility values were estimated by regressing the EQ-5D scores onto binary indicators for the presence of an event. The primary method of analysis was Ordinary Least Squares (OLS) and due to concerns over non-Normality, bootstrap standard errors (SE) were calculated. RESULTS: The analysis included 1,143 participants. Based on the OLS model, reductions in HRQL were associated with duration of diabetes (-0.0015, SE = 0.0006), experiencing a myocardial infarction (MI) (-0.059, SE = 0.017), amputation (-0.063, SE = 0.059), stroke (-0.046, SE = 0.023), and kidney failure (-0.102, SE = 0.047). CONCLUSION: This study estimated the reductions in HRQL associated with several important complications commonly experienced in patients with diabetes. The greatest impacts on HRQL were associated with kidney failure and MI. The utility values calculated here can be used to assess the outcome of interventions that reduce these diabetes-related complications and will have a useful impact on future economic evaluations of diabetes management strategies in Canada.

Community based intervention to optimize osteoporosis management: randomized controlled trial.

BACKGROUND: Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. METHODS: This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. RESULTS: 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene) for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40). More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12) and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65). CONCLUSIONS: A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. TRIAL REGISTRATION: This trial has been registered with clinicaltrials.gov (ID: NCT00465387).

The unintended (and costly) effects due to the introduction of an unrestricted reimbursement policy for atypical antipsychotic medications in a Canadian public prescription drug program: 1996/97 to 2005/06.

BACKGROUND: Due to the increasing costs of pharmaceuticals, drug benefit programs often implement various policies that limit availability of drugs. These policies can have unforeseen consequences. OBJECTIVES: To examine the utilization and expenditures for antipsychotic medications in a provincial government community-based drug program over a 10-year period when atypical antipsychotics were introduced and multiple reimbursement policy changes with respect to these agents were employed. METHODS: Retrospective analysis of the Newfoundland and Labrador Prescription Drug Program (NLPDP) claims database from 1996/97 to 2005/06. Antipsychotic medication utilization and expenditure were measured and effects of changes in reimbursement policies examined. Excess expenditure was measured by subtracting the actual from modelled expenditure under different policies. RESULTS: Between 1996/97 and 2005/06, the number of prescriptions for antipsychotic medications increased by 75% and expenditures by more than 720% to $7.2 million (peaking at $7.9 million in 2003/04), with atypical agents making up 96% of the total. Expenditure for antipsychotic medications grew by an annual average rate of 26.3%. At the same time, the number of people enrolled in the drug program declined by an annual average rate of 1.13%. The total excess amount of money spent was $266,195 per 1,000 beneficiaries during unlimited access to atypical agents. CONCLUSION: There has been a substantial, unintentional, increase in the prescribing of atypical antipsychotics each year in Newfoundland and Labrador over the 10 years, likely due to off-label use following the unrestricted and partial restrictive access policies for these medications. Perhaps restricted access for recognized usage should be enforced.