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Biomedical subjects

Mark D Schleinitz

Publications and source records attributed to Mark D Schleinitz.

7 recordsLinked to original sources

Can differences in breast cancer utilities explain disparities in breast cancer care?

BACKGROUND: Black, older, and less affluent women are less likely to receive adjuvant breast cancer therapy than their counterparts. Whereas preference contributes to disparities in other health care scenarios, it is unclear if preference explains differential rates of breast cancer care. OBJECTIVE: To ascertain utilities from women of diverse backgrounds for the different stages of, and treatments for, breast cancer and to determine whether a treatment decision modeled from utilities is associated with socio-demographic characteristics. PARTICIPANTS: A stratified sample (by age and race) of 156 English-speaking women over 25 years old not currently undergoing breast cancer treatment. DESIGN AND MEASUREMENTS: We assessed utilities using standard gamble for 5 breast cancer stages, and time-tradeoff for 3 therapeutic modalities. We incorporated each subject's utilities into a Markov model to determine whether her quality-adjusted life expectancy would be maximized with chemotherapy for a hypothetical, current diagnosis of stage II breast cancer. We used logistic regression to determine whether socio-demographic variables were associated with this optimal strategy. RESULTS: Median utilities for the 8 health states were: stage I disease, 0.91 (interquartile range 0.50 to 1.00); stage II, 0.75 (0.26 to 0.99); stage III, 0.51 (0.25 to 0.94); stage IV (estrogen receptor positive), 0.36 (0 to 0.75); stage IV (estrogen receptor negative), 0.40 (0 to 0.79); chemotherapy 0.50 (0 to 0.92); hormonal therapy 0.58 (0 to 1); and radiation therapy 0.83 (0.10 to 1). Utilities for early stage disease and treatment modalities, but not metastatic disease, varied with socio-demographic characteristics. One hundred and twenty-two of 156 subjects had utilities that maximized quality-adjusted life expectancy given stage II breast cancer with chemotherapy. Age over 50, black race, and low household income were associated with at least 5-fold lower odds of maximizing quality-adjusted life expectancy with chemotherapy, whereas women who were married or had a significant other were 4-fold more likely to maximize quality-adjusted life expectancy with chemotherapy. CONCLUSIONS: Differences in utility for breast cancer health states may partially explain the lower rate of adjuvant therapy for black, older, and less affluent women. Further work must clarify whether these differences result from health preference alone or reflect women's perceptions of sources of disparity, such as access to care, poor communication with providers, limitations in health knowledge or in obtaining social and workplace support during therapy.

Adult↗

Pharmacist-led cardiac risk reduction model.

The Cardiovascular Risk Reduction Clinic (CRRC) is a pharmacist-coordinated care model that incorporates the 4 major modifiable risk factors into a single treatment program. The authors aimed to assess the effectiveness of the CRRC model by comparing the Framingham point score before and after CRRC intervention. Retrospective data between 2001 and 2002 were analyzed for 375 veterans (age 65+/-10 years) with diabetes (88.8%) or coronary artery disease (44%) referred to the CRRC for intensive cardiac risk management. Total Framingham point score decreased from 14.5 at baseline to 13.6 after CRRC intervention (mean change 0.9+/-0.3). When considering only the patients not at target goals at baseline (n=200), significant improvements in guideline adherence was observed in low-density lipoprotein cholesterol, systolic blood pressure, hemoglobin A1c, and smoking. The CRRC model reduces the risk of cardiovascular events as assessed by Framingham point score in patients with established coronary artery disease and/or diabetes.

Aged↗

A cost-effectiveness analysis of combination antiplatelet therapy for high-risk acute coronary syndromes: clopidogrel plus aspirin versus aspirin alone.

BACKGROUND: Although clopidogrel plus aspirin is more effective than aspirin alone in preventing subsequent vascular events in patients with unstable angina, the cost-effectiveness of this combination has yet to be examined in this high-risk population. OBJECTIVE: To determine the cost-effectiveness of clopidogrel plus aspirin compared with aspirin alone. DESIGN: Cost-utility analysis. DATA SOURCES: Published literature. TARGET POPULATION: Patients with unstable angina and electrocardiographic changes or non-Q-wave myocardial infarction. time horizon: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: Combination therapy with clopidogrel, 75 mg/d, plus aspirin, 325 mg/d, for 1 year, followed by aspirin monotherapy, was compared with lifelong aspirin therapy, 325 mg/d. OUTCOME MEASURES: Lifetime costs, life expectancy in quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio. RESULTS OF BASE-CASE ANALYSIS: Patients treated with aspirin alone lived 9.51 QALYs after their initial event and incurred expenses of 127,700 dollars; the addition of clopidogrel increased life expectancy to 9.61 QALYs and costs to 129,300 dollars. The incremental cost-effectiveness ratio for clopidogrel plus aspirin compared with aspirin alone was 15,400 dollars per QALY. RESULTS OF SENSITIVITY ANALYSES: The analysis of 1 year of therapy was robust to all sensitivity analyses. In the probabilistic sensitivity analysis, fewer than 3% of simulations resulted in cost-effectiveness ratios over 50,000 dollars per QALY. The cost-effectiveness of longer combination therapy depends critically on the balance of thrombotic event rates, durable efficacy, and the increased bleeding rate in patients taking clopidogrel. LIMITATIONS: This analysis may not apply to patients with severe heart failure, those undergoing long-term anticoagulant therapy, those recently managed with revascularization, or those undergoing short-term treatment with glycoprotein IIb/IIIa inhibitors. CONCLUSIONS: In patients with high-risk acute coronary syndromes, 1 year of therapy with clopidogrel plus aspirin results in greater life expectancy than aspirin alone, at a cost within the traditional limits of cost-effectiveness. The durable efficacy of clopidogrel relative to the risk for hemorrhage should be further explored before more protracted therapy can be recommended.

Angina, Unstable↗

Clopidogrel versus aspirin for secondary prophylaxis of vascular events: a cost-effectiveness analysis.

PURPOSE: Clopidogrel is more effective than aspirin in preventing recurrent vascular events, but concerns about its cost-effectiveness have limited its use. We evaluated the cost-effectiveness of clopidogrel and aspirin as secondary prevention in patients with a prior myocardial infarction, a prior stroke, or peripheral arterial disease. METHODS: We constructed Markov models assuming a societal perspective, and based analyses on the lifetime treatment of a 63-year-old patient facing event probabilities derived from the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial as the base case. Outcome measures included costs, life expectancy in quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios, and events averted. RESULTS: In patients with peripheral arterial disease, clopidogrel increased life expectancy by 0.55 QALYs at an incremental cost-effectiveness ratio of $25,100 per QALY, as compared with aspirin. In poststroke patients, clopidogrel increased life expectancy by 0.17 QALYs at a cost of $31,200 per QALY. Aspirin was both less expensive and more effective than clopidogrel in post-myocardial infarction patients. In probabilistic sensitivity analyses, our evaluation for patients with peripheral vascular disease was robust. Evaluations of stroke and myocardial infarction patients were sensitive predominantly to the cost and efficacy of clopidogrel, with aspirin therapy more effective and less expensive in 153 of 1000 simulations (15.3%) in poststroke patients and clopidogrel more effective in 119 of 1000 simulations (11.9%) in the myocardial infarction sample. CONCLUSION: Clopidogrel provides a substantial increase in quality-adjusted life expectancy at a cost that is within traditional societal limits for patients with either peripheral arterial disease or a recent stroke. Current evidence does not support increased efficacy with clopidogrel relative to aspirin in patients following myocardial infarction.

Aspirin↗

Cilostazol, clopidogrel or ticlopidine to prevent sub-acute stent thrombosis: a meta-analysis of randomized trials.

BACKGROUND: Sub-acute thrombosis is a serious complication of coronary artery stenting. Clopidogrel plus aspirin is the accepted prophylactic regimen, but has yet to be proven superior to ticlopidine plus aspirin, and a new regimen combining cilostazol and aspirin has been introduced. METHODS: We conducted a meta-analysis of all trials that compared >or=2 oral anti-thrombotic strategies in patients undergoing coronary stent placement to determine which treatment optimally prevents adverse cardiac events in the 30 days following stent insertion. We used meta-regression to compare all strategies to a shared control strategy: ticlopidine plus aspirin. We also compared randomized trials to historically controlled and other non-randomized trials. We conducted sensitivity analysis and subgroup analysis to assess for possible heterogeneity. RESULTS: In comparison to ticlopidine plus aspirin the odds-ratios for cardiac events, with 95% confidence intervals were: aspirin alone, 4.29 (3.09-5.97), coumadin plus aspirin, 2.65 (2.18-3.21), clopidogrel plus aspirin, 1.06 (0.86-1.31), cilostazol plus aspirin, 0.73 (0.47-1.14). Among trials that compared clopidogrel plus aspirin to ticlopidine plus aspirin, historically controlled trials were statistically distinct from randomized trials. The analysis of cilostazol was sensitive to the small size of the included studies. CONCLUSIONS: Neither clopidogrel plus aspirin nor cilostazol plus aspirin can be statistically distinguished from ticlopidine plus aspirin for the prevention of adverse cardiac events in the 30 days after stenting. A randomized trial including cilostazol is warranted.

Anticoagulants↗

Evaluating detection and diagnostic decision support systems for bioterrorism response.

We evaluated the usefulness of detection systems and diagnostic decision support systems for bioterrorism response. We performed a systematic review by searching relevant databases (e.g., MEDLINE) and Web sites for reports of detection systems and diagnostic decision support systems that could be used during bioterrorism responses. We reviewed over 24,000 citations and identified 55 detection systems and 23 diagnostic decision support systems. Only 35 systems have been evaluated: 4 reported both sensitivity and specificity, 13 were compared to a reference standard, and 31 were evaluated for their timeliness. Most evaluations of detection systems and some evaluations of diagnostic systems for bioterrorism responses are critically deficient. Because false-positive and false-negative rates are unknown for most systems, decision making on the basis of these systems is seriously compromised. We describe a framework for the design of future evaluations of such systems.

Bioterrorism↗