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Context: Chronic hepatitis C (CHC) infection affects nearly 4 million people in the United States. Treatment with interferon alfa-2b has been limited by its cost and low likelihood of long-term response., Objective: To examine the cost-effectiveness of alternative pretreatment management strategies for patients with CHC., Design: Decision and cost-effectiveness analysis using a Markov model to examine prevalence of genotypes, viral load, and histological characteristics in relation to the sustained response rate with treatment. Data were based on a previously published decision model and a MEDLINE literature search for hepatitis C, biopsy, and liver from 1966 to 1996., Patients: A hypothetical population of patients with CHC infection and elevated serum alanine aminotransferase level., Interventions: Combinations of liver biopsy, genotyping, and quantitative viral load determination prior to a single 6-month course of interferon alfa-2b; empirical interferon treatment; and conservative management., Main Outcome Measures: Proportion of sustained responders, lifetime costs, life expectancy, and quality-adjusted life expectancy., Results: Strategies involving hepatitis C virus (HCV) RNA testing had marginal cost-effectiveness ratios up to $4400 per discounted quality-adjusted life-year gained but would miss up to 36% of sustained responders. Empirical interferon treatment had a marginal cost-effectiveness ratio of $12400 per discounted quality-adjusted life-year gained and reached all potential sustained responders. Strategies involving liver biopsy were more expensive and would miss 6% of sustained responders and yield slightly lower life expectancies., Conclusions: Routine liver biopsy before treatment with interferon increases the cost of managing patients with CHC without improving health outcomes. Using quantitative HCV RNA testing to guide therapy misses some potential sustained responders. Empirical interferon treatment has a marginal cost-effectiveness ratio within the bounds of other commonly accepted therapies and misses none of the sustained responders.

Objective: To examine the effect of hormone replacement therapy on life expectancy in postmenopausal women with different risk profiles for heart disease, breast cancer, and hip fracture., Design: Decision analysis using a Markov model. Published regression models were used to link risk factors to disease incidence and to estimate the lifetime risks of developing coronary heart disease (CHD), breast cancer, hip fracture, and endometrial cancer. The impact of hormone therapy on disease incidence was estimated from published epidemiologic studies., Setting: Mathematical model applicable to primary care., Interventions: Treatment with hormone replacement therapy or no hormone replacement therapy., Main Outcome Measure: Life expectancy., Results: Hormone replacement therapy should increase life expectancy for nearly all postmenopausal women, with some gains exceeding 3 years, depending mainly on an individual's risk factors for CHD and breast cancer. For women with at least 1 risk factor for CHD, hormone therapy should extend life expectancy, even for women having first-degree relatives with breast cancer. Women without any risk factors for CHD or hip fracture, but who have 2 first-degree relatives with breast cancer, however, should not receive hormone therapy., Conclusions: The benefit of hormone replacement therapy in reducing the likelihood of developing CHD appears to outweigh the risk of breast cancer for nearly all women in whom this treatment might be considered. Our analysis supports the broader use of hormone replacement therapy.

Objective: To examine the cost-effectiveness of approaches to the diagnosis and treatment of patients with type II (non-insulin-dependent) diabetes mellitus (NIDDM) who have foot infections and suspected osteomyelitis., Design: Decision and cost-effectiveness analyses were performed using a Markov model. We examined the prevalence of osteomyelitis, the major complications and efficacies of long-term antibiotic therapy and surgery, and the performance characteristics of four diagnostic tests (roentgenography, technetium Tc 99m bone scanning, indium in 111-labeled white blood cell scanning, and magnetic resonance imaging). Data were drawn from the English-language literature using MEDLINE searches and bibliographies from selected articles., Setting: Primary care., Patients: Patients with NIDDM who had foot infections and suspected osteomyelitis but no signs of systemic toxicity., Interventions: Following hospitalization for surgical débridement and intravenous antibiotic therapy: (1) treatment for presumed soft-tissue infection, (2) culture-guided empiric treatment for presumed osteomyelitis, (3) 71 combinations of diagnostic tests preceding antibiotic therapy for osteomyelitis, (4) 71 combinations of tests preceding amputation, and (5) immediate amputation., Main Outcome Measures: Quality-adjusted life expectancy, average costs., Results: Culture-guided empiric treatment for osteomyelitis with 10 weeks of oral antibiotic therapy has similar effectiveness to testing followed by a long course of antibiotic therapy if any test result is positive. However, empiric treatment is the least expensive strategy., Conclusions: Noninvasive testing adds significant expense to the treatment of patients with NIDDM in whom pedal osteomyelitis is suspected, and such testing may result in little improvement in health outcomes. In patients without systemic toxicity, a 10-week course of culture-guided oral antibiotic therapy following surgical débridement may be as effective as and less costly than other approaches.

Objective: To determine the clinical and economic effects of screening for prostate cancer with prostate-specific antigen (PSA), transrectal ultrasound (TRUS), and digital rectal examination (DRE)., Design: Decision analytic cost-utility analysis comparing four screening strategies with a strategy of not screening. We assumed that the cancer detection rate and stage distribution were predicted by each combination of tests and that localized cancer was treated with radical prostatectomy. For each strategy, we calculated life expectancy, quality-adjusted life expectancy (QALE), and cost-utility ratios for unselected and high-prevalence populations., Data: Probabilities and rates for clinical events were gathered from published data. We assessed utilities by the time-trade-off method using urologists, radiation oncologists, and internists as subjects. The Clinical Cost Manager at the New England Medical Center provided cost data., Results: In unselected men between the ages of 50 and 70 years, screening with PSA or TRUS prolonged unadjusted life expectancy but diminished QALE. Screening with DRE alone yielded no reduction in mortality at any age. All programs increased costs. Results were sensitive only to assumptions about the efficacy of treatment. In high-prevalence populations, screening produced a similar pattern: gains in unadjusted life expectancy, losses in QALE, and increased costs., Conclusions: Our analysis does not support using PSA, TRUS, or DRE to screen asymptomatic men for prostatic cancer. Screening may result in poorer health outcomes and will increase costs dramatically. Assessment of comorbidity, risk attitude, and valuation of sexual function may identify individuals who will benefit from screening, but selecting high-prevalence populations will not improve the benefit of screening.

Objectives: --To determine the extent to which interinstitutional variations in length of stay are explained by differences in patient characteristics and to determine whether patients in hospitals with shorter lengths of stay had worse outcomes., Design: --We reviewed patients' medical records and surveyed patients between 3 and 12 months after hospital discharge using a questionnaire., Setting: --Six teaching hospitals in California and Massachusetts., Patients: --A cohort of 2484 selected patients who had been hospitalized for acute myocardial infarction or to rule out acute myocardial infarction, coronary artery bypass graft surgery, total hip replacement, cholecystectomy, or transurethral prostatectomy. Between 73% and 84% of the patients with each condition completed a follow-up questionnaire., Outcome Measures: --In-hospital complications, deaths, length of stay, functional status after hospital discharge, readmission, and patient satisfaction with hospital care were analyzed., Results: --Significant interinstitutional differences in length of stay were noted for all conditions except rule-out acute myocardial infarction. Statistical adjustment for case-mix differences accounted for most of the interinstitutional differences in length of stay for total hip replacement but explained little of the differences in the other conditions. When we controlled statistically for other predictors, length of stay did not have a significant impact on deaths, functional status after hospital discharge, the probability of readmission, or patient satisfaction with hospital care., Conclusion: --More research is needed to determine the medical practices that are related to variations in lengths of stay. Routinely available outcome data may help preserve quality in the face of efforts to decrease costs by effecting more standardized practices of care.

Hospitalizations for patients with prosthetic heart valves undergoing noncardiac surgery are frequently prolonged for intravenous heparin therapy to decrease the incidence of thromboembolism while patients are not taking oral anticoagulant agents. Because the rate of thromboembolic events is quite low and the period of increased risk is very short, the cost of preventing these rare events can be great. We performed cost-effectiveness analyses addressing these issues. We calculated the marginal cost per additional quality-adjusted year of life gained per thromboembolic event averted and per death averted. We conclude that the marginal cost of prolonging hospitalization to administer heparin is prohibitively high compared with most contemporary therapies, except when the patient has the most thrombogenic of valves. We also discuss the ethical and legal ramifications of integrating the results of cost-effectiveness analyses into clinical practice.

Carotid endarterectomy is being performed with increasing frequency, now over 100,000 times annually in the United States. We used the methods of decision analysis to examine the question of when to perform carotid endarterectomy. We developed a model that simulates the possible outcomes for a cohort of patients at risk for stroke. Estimates of surgical risk, surgical efficacy, annual stroke rate, and nonstroke mortality were derived from the literature. Using sensitivity analysis, we found that surgical risk, surgical efficacy, and stroke risk are the most important factors in determining when surgery is appropriate. By examining a series of clinical scenarios, we constructed guidelines for carotid endarterectomy based on the estimated risk of future stroke. The analysis suggests that for patients with a risk of less than 3% per year, surgery is not indicated. For patients with risk between 3% and 5% per year, low-risk surgery can be expected to provide a benefit of at most three months of quality life, depending on the efficacy of surgery. For stroke risk between 5% and 10% per year, even high-risk surgery is favored if surgical efficacy is above 30%. Above a stroke risk of 10% per year, even high-risk, low-efficacy surgery should be considered. The challenge to advocates of carotid endarterectomy is to develop a cost-effective strategy for identifying patients at high risk for stroke.