Cost-effectiveness of transesophageal echocardiographic-guided cardioversion: a decision analytic model for patients admitted to the hospital with atrial fibrillation.

OBJECTIVES: Using a decision-analytic model, we sought to examine the cost-effectiveness of three strategies for cardioversion of patients admitted to the hospital with atrial fibrillation. BACKGROUND: Transesophageal echocardiographic (TEE)-guided cardioversion has been proposed as a method for early cardioversion of patients with atrial fibrillation. The cost-effectiveness of this approach, relative to conventional therapy, has not been studied. METHODS: We ascertained the cost per quality-adjusted life-year (QALY) of three strategies: 1) conventional therapy--transthoracic echocardiography (TTE) and warfarin therapy for 1 month before cardioversion; 2) initial TTE, followed by TEE and early cardioversion if no thrombus is detected; 3) initial TEE, with early cardioversion if no thrombus is detected. With strategies 2 and 3, if a thrombus is seen, follow-up TEE is performed. If no thrombus is seen, cardioversion is then performed. All strategies utilized anticoagulation before and extending for 1 month after cardioversion. Life expectancy, utilities (quality-of-life weights) and event probabilities were ascertained from published reports. Cost estimates were based on published data and hospital accounting information. RESULTS: Transesophageal echocardiographic-guided early cardioversion (strategy 3: cost $2,774, QALY 8.49) dominates TTE/TEE-guided cardioversion (strategy 2: cost $3,106, QALY 8.48) and conventional therapy (strategy 1: cost $3,070, QALY 8.48) because it is the least costly with similar effectiveness. Sensitivity analyses demonstrated that TEE-guided cardioversion (strategy 3) dominates conventional therapy if the risk of stroke after TEE negative for atrial thrombus is slightly less than that after conventional therapy (baseline estimate 0.8%). The results also depend on the risk of major hemorrhage but are less sensitive to baseline estimates of morbidity from TEE, cost of TTE, cost of hospital admission for cardioversion and utilities for health states. CONCLUSIONS: On the basis of a decision-analytic model, TEE-guided early cardioversion, without TTE, is a reasonable cost-saving alternative to conventional therapy for patients admitted to the hospital with atrial fibrillation. Such a strategy appears particularly beneficial for patients with an increased risk of hemorrhagic complications. Future clinical studies examining the TEE strategy should consider eliminating initial TTE and carefully assess both the thromboembolic and hemorrhagic risk.

Cost-effectiveness of a smoking cessation program after myocardial infarction.

OBJECTIVES: The purpose of this study was to evaluate the cost-effectiveness of a smoking cessation program initiated after acute myocardial infarction. BACKGROUND: The value of allocating health care resources to smoking cessation programs after myocardial infarction has not been compared with the value of other currently accepted interventions. METHODS: A model was developed to examine the cost-effectiveness of a recently reported smoking cessation program after an acute myocardial infarction. The cost was estimated by considering the resources necessary to implement the program, and the effectiveness was expressed as discounted years of life saved. Years of life saved were estimated by modeling life expectancy using a single declining exponential approximation of life expectancy based on data from published reports. RESULTS: The cost-effectiveness of the nurse-managed smoking cessation program was estimated to be $220/year of life saved. In a one-way sensitivity analysis, the cost-effectiveness of the program remained < $20,000/year of life saved if the program decreased the smoking rate by only 3/1,000 smokers (baseline assumption 26/100 smokers), or if the program cost as much as $8,840/smoker (baseline assumption $100). In a two-way sensitivity analysis, even if the cost of the program were as high as $2,000/participant, the cost-effectiveness of the program would be < $10,000/year of life saved so long as the program helped an additional 12 smokers quit for every 100 enrolled. CONCLUSIONS: Over a wide range of estimates of costs and effectiveness, a nurse-managed smoking cessation program after acute myocardial infarction is an extremely cost-effective intervention. This program is more cost-effective than beta-adrenergic antagonist therapy after myocardial infarction.

Cost-effectiveness of captopril therapy after myocardial infarction.

OBJECTIVES: This study sought to assess the cost-effectiveness of captopril therapy for survivors of myocardial infarction. BACKGROUND: The recent randomized, controlled Survival and Ventricular Enlargement (SAVE) trial showed that captopril therapy improves survival in survivors of myocardial infarction with an ejection fraction < or = 40%. The present ancillary study was designed to determine how the costs required to achieve this increase in survival compared with those of other medical interventions. METHODS: We developed a decision-analytic model to assess the cost-effectiveness of captopril therapy in 50- to 80-year old survivors of myocardial infarction with an ejection fraction < or = 40%. Data on costs, utilities (health-related quality of life weights) and 4-year survival were obtained directly from the SAVE trial, and long-term survival was estimated using a Markov model. In one set of analyses, we assumed that the survival benefit associated with captopril therapy would persist beyond 4 years (persistent-benefit analyses), whereas in another set we assumed that captopril therapy incurred costs but no survival benefit beyond 4 years (limited-benefit analyses). RESULTS: In the limited-benefit analyses, the incremental cost-effectiveness of captopril therapy ranged from $3,600/quality-adjusted life-year for 80-year old patients to $60,800/quality-adjusted life-year for 50-year old patients. In the persistent-benefit analyses, incremental cost-effectiveness ratios ranged from $3,700 to $10,400/quality-adjusted life-year, depending on age. The outcome was generally not sensitive to changes in estimates of variables when they were varied individually over wide ranges. In a "worst-case" analysis, incremental cost-effectiveness ratios for captopril therapy remained favorable ($8,700 to $29,200/quality-adjusted life-year) for 60- to 80-year old patients but were higher ($217,600/quality-adjusted life-year) for 50-year old patients. CONCLUSIONS: We conclude that the cost-effectiveness of captopril therapy for 50- to 80-year old survivors of myocardial infarction with a low ejection fraction compares favorably with other interventions for survivors of myocardial infarction.

Depressed mood and survival in seriously ill hospitalized adults. The SUPPORT Investigators.

OBJECTIVES: To assess the relationship among depressed mood, physical functioning, and severity of illness and to determine the relationship between depressed mood and survival time, controlling for severity of illness, baseline functioning, and characteristics of patients. METHODS: Prospective cohort study of data for 3529 seriously ill hospitalized adults who received care at 5 tertiary care teaching hospitals and who completed a depressed mood assessment 7 to 11 days after admission to the study. The Profile of Mood States depression subscale was used to assess depressed mood. A stratified Cox proportional hazards model was used to assess the independent effect of depressed mood on survival time, adjusting for demographic characteristics of patients and health status. RESULTS: Greater magnitudes of depressed mood were associated with worse levels of physical functioning (r = 0.151; P < .001) and more severity of illness. Depressed mood was associated with reduced survival time after adjusting for patient demographics and health status (hazards ratio, 1.134; 95% confidence interval, 1.071-1.200; P < or = .001). CONCLUSION: Seriously ill patients should be assessed for the presence of depressed mood even if they have not been given a diagnosis of depression. Further study is needed to determine whether interventions aimed at relieving depressed mood may improve prognosis.

Outcomes of acute exacerbation of severe congestive heart failure: quality of life, resource use, and survival. SUPPORT Investigators. The Study to Understand Prognosis and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Congestive heart failure (CHF) is a common disease with high health care costs and high mortality rates. Knowledge of the health-related quality of life outcomes of CHF may guide decision making and be useful in assessing new therapies for this population. METHODS: A prospective cohort study was conducted involving 1390 adult patients hospitalized with an acute exacerbation of severe CHF (New York Heart Association class III-IV). Demographic data and health-related quality of life were determined by interview; physiologic status and cost and intensity of care were determined from hospital charts. RESULTS: The median (25th, 75th percentiles) age of patients was 68.0 (58.2, 76.9) years; 61.7% were male. Survival was 93.4% at discharge from the index hospitalization, 72.9% at 180 days, and 61.5% at 1 year. Of patients interviewed at 180 days, the median health rating on a scale of 0 to 100 (0 indicates death; 100, excellent health) was 60 (interquartile range, 50-80), and 59.7% were independent in their activities of daily living. Overall quality of life was reported to be good, very good, or excellent in 58.2% at 180 days. Patients with worse functional capacity were more likely to die. Health perceptions among the patients with available interview data improved at 60 and 180 days after acute exacerbation of severe CHF. CONCLUSIONS: Patients hospitalized for acute exacerbation of severe CHF have a generally poor 6-month survival, but survivors retain relatively good functional status and have good health perceptions. Furthermore, health perceptions improve after the acute exacerbation.

The cost-effectiveness of elective Cesarean delivery for HIV-infected women with detectable HIV RNA during pregnancy.

OBJECTIVES: To determine the net health consequences, costs, and cost-effectiveness of alternative delivery strategies for HIV-infected pregnant women with detectable HIV RNA in the USA. DESIGN: Cost-effectiveness analysis using a probabilistic decision model. METHODS: The model compared two strategies: elective Cesarean section and vaginal delivery. Data for HIV transmission rate, maternal death rate, health-related quality of life and costs were obtained from the literature, national databases, and a tertiary hospital's cost accounting system. Model outcomes included total lifetime costs, quality-adjusted life expectancy, maternal death rate, HIV transmission rate, and incremental cost-effectiveness ratios. RESULTS: Elective Cesarean section resulted in a vertical HIV transmission rate of 34.9 per 1000 births compared with 62.3 per 1000 births for vaginal delivery. Elective Cesarean section was more effective (38.7 quality adjusted life years per mother and child pair) and less costly ($10600 per delivery) than trial of labor (38.2 combined quality adjusted life years at a cost of $14500 per delivery). However, elective Cesarean section increased maternal mortality by 2.4 deaths per 100000 deliveries. The results were consistent over a wide range of the variables, but were sensitive to the risk of HIV transmission with vaginal delivery and the relative risk of HIV transmission with elective Cesarean section. CONCLUSIONS: In pregnant HIV-infected women with detectable HIV RNA, elective Cesarean section would reduce total costs and increase overall quality-adjusted life expectancy for the mother-child pair, albeit at a slight loss of quality adjusted life expectancy to the mother.

Impact and cost-effectiveness of smoking interventions.

Cigarette smoking is the foremost preventable cause of death in the United States. Along with being a major contributor to lung cancer, chronic obstructive pulmonary disease, and cerebrovascular disease, smoking is one of several modifiable risk factors for coronary artery disease (CAD). The Coronary Heart Disease Policy Model is a computer simulation model of CAD in the United States. Using the model, one can project CAD incidence, prevalence, events, mortality, cost, cost-effectiveness, and gains in life expectancy from various risk factor modifications, including smoking interventions. The model projects that reducing the number of cigarettes smoked by 50% would increase the population-wide life expectancy of 35-year-old U.S. citizens by 0.4 year. Eliminating smoking would yield population-wide gains of 0.8 year for 35-year-old males and 0.7 year for 35-year-old females. These gains are comparable to those achieved with strict control of cholesterol levels, diastolic blood pressure, or weight. Gains for the smokers themselves would be much greater. On average, 35-year-old male smokers would live 1.2 years longer if they reduced the number of cigarettes smoked by 50%, and 2.3 years longer if they quit smoking. Females 35 years of age would live 1.5 years longer by cutting back by 50% and 2.8 years longer by quitting. These gains are equal to or greater than gains that individuals would realize by reducing serum cholesterol levels of 240-299 mg/dL to 200 mg/dL; controlling mild hypertension; or reducing weight from greater than or equal to 130% ideal body weight to ideal body weight. Gains projected by the Coronary Heart Disease Policy Model are comparable to those forecast by others, who have projected that young adults would gain approximately 0.2-8.7 years by quitting smoking, depending on their smoking history. Two studies have examined the cost-effectiveness of smoking interventions. One found that counseling smokers to quit would cost only $705-988 per year of life saved for males and $1,204-2,058 per year of life saved for females. The second study found that prescribing nicotine gum as an adjunct to counseling would cost only $4,113-6,465 per year of life saved for males and $6,880-9,473 per year of life saved for females. These cost-effectiveness ratios are more favorable than those of most other current healthcare interventions. Smoking cessation would increase population-wide life expectancy by about a year and the life expectancy of a smoker by several years.(ABSTRACT TRUNCATED AT 400 WORDS)

Outcomes and cost-effectiveness of ventilator support and aggressive care for patients with acute respiratory failure due to pneumonia or acute respiratory distress syndrome.

PURPOSE: Many patients with acute respiratory failure die despite prolonged and costly treatment. Our objective was to estimate the cost-effectiveness of providing rather than withholding mechanical ventilation and intensive care for patients with acute respiratory failure due to pneumonia or acute respiratory distress syndrome. SUBJECTS AND METHODS: We studied 1,005 patients enrolled in a five-center study of seriously ill patients (the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments [SUPPORT]) with acute respiratory failure (pneumonia or acute respiratory distress syndrome and an Acute Physiology Score > or =10) who required ventilator support. We estimated life expectancy based on long-term follow-up of SUPPORT patients. Utilities were estimated using time-tradeoff questions. Costs (in 1998 dollars) were based on hospital fiscal data and Medicare data. RESULTS: Of the 963 patients who received ventilator support, 48% survived for at least 6 months. At 6 months, survivors reported a median of 1 dependence in activities of daily living, and 72% rated their quality of life as good, very good, or excellent. Among the 42 patients in whom ventilator support was withheld, the median survival was 3 days. Among patients whose estimated probability of surviving at least 2 months from the time of ventilator support ("prognostic estimate") was 70% or more, the incremental cost per quality-adjusted life-year (QALY) saved by providing rather than withholding ventilator support and aggressive care was $29,000. For medium-risk patients (prognostic estimate 51% to 70%), the incremental cost-effectiveness was $44,000 per QALY, and for high-risk patients (prognostic estimate < or =50%), it was $110,000 per QALY. When assumptions were varied from 50% to 200% of baseline estimates, the results ranged from $19,000 to $48,000 for low-risk patients, from $29,000 to $76, 000 for medium-risk patients, and from $67,000 to $200,000 for high-risk patients. CONCLUSIONS: Ventilator support and intensive care for acute respiratory failure due to pneumonia or acute respiratory distress syndrome are relatively cost-effective for patients with >50% probability of surviving 2 months. However, for patients with an expected 2-month survival < or =50%, the cost per QALY is more than threefold greater at >$100,000.

Health status versus quality of life in older patients: does the distinction matter?

PURPOSE: Although health-related quality of life in older people is generally assessed by measuring specific domains of health status, such as activities of daily living or pain, the association between health-status measures and patients' perceptions of their quality of life is not clear. Indeed, it is controversial whether these health-status measures should be considered measures of quality of life at all. Our objective was to determine the association between health-status measures and older patients' perceptions of their global quality of life. SUBJECTS AND METHODS: We performed a cross-sectional study of 493 cognitively intact patients 80 years of age and older, interviewed 2 months after a hospitalization. We measured patients' self-assessed global quality of life and four domains of health status: physical capacity, limitations in performing activities of daily living, psychological distress, and pain. RESULTS: Each of the four scales was significantly correlated with patients' global perceptions of their quality of life (P <0.001). The ability of the health-status scales to discriminate between patients with differing global quality of life was generally good, especially for the physical capacity (c statistic = 0.72) and psychological distress scales (c statistic = 0.70). However, for a substantial minority of patients, scores on the health-status scales did not accurately reflect their global quality of life. For example, global quality of life was described as fair or poor by 15% of patients with the highest (best tertile) physical capacity scores, 25% of patients who were independent in all activities of daily living, 21% of patients with the least psychological distress (best tertile), and by 30% with no pain symptoms. Similarly, global quality of life was described as good or better by 43% of patients with the worst physical capacity (worst tertile), 49% of patients who were dependent in at least two activities of daily living, 47% of patients with the most psychological distress (worst tertile), and 51% of patients with severe pain. CONCLUSION: On average, health status is a reasonable indicator of global quality of life for groups of older patients with recent illness. However, disagreement between patients' reported health status and their perceptions of their global quality of life was common. Therefore, assumptions about the overall quality of life of individual patients should not be based on measures of their health status alone.

Which renal transplant patients should receive cytomegalovirus immune globulin? A cost-effectiveness analysis.

Our study objective was to determine the cost-effectiveness of prophylaxis with cytomegalovirus immune globulin for preventing CMV-associated disease in renal transplant patients. We used a decision analytic model applied to 5 groups of renal transplant recipients at varying risks of developing CMV-associated disease. We obtained the rates of developing CMV-associated disease, graft rejection, and mortality, and the effectiveness of CMV-IG from the published literature. We used actual variable costs of CMV-IG, hospitalization, dialysis, and outpatient follow-up. The incremental cost of administering CMV-IG compared with withholding it ranged from $29,800 per life saved for the highest risk group, CMV-seronegative recipients of kidneys from CMV-seropositive cadaveric donors, to $1.68 million per additional life saved for the lowest risk group, CMV-seronegative recipients of grafts from CMV-seronegative donors. The outcome was somewhat sensitive to the effectiveness of CMV-IG in preventing CMV-associated disease but not sensitive to wide variations in CMV-IG costs, dialysis costs, outpatient costs, and the probability of graft rejection. Our conclusion is that prophylaxis with CMV-IG is very worthwhile for renal transplant recipients at high risk of CMV-associated disease and is possibly worthwhile for some patients at lower risk. The cost-effectiveness of other strategies for preventing CMV-associated disease, such as prophylaxis with acyclovir, CMV vaccine, or unselected immune globulin, should be compared with CMV-IG.

Rethinking fundamental assumptions: SUPPORT's implications for future reform. Study to Understand Prognoses and Preferences and Risks of Treatment.

BACKGROUND: The intervention in SUPPORT, the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments, was ineffective in changing communication, decision-making, and treatment patterns despite evidence that counseling and information were delivered as planned. The previous paper in this volume shows that modest alterations in the intervention design probably did not explain the lack of substantial effects. OBJECTIVE: To explore the possibility that improved individual, patient-level decision-making is not the most effective strategy for improving end-of-life care and that improving routine practices may be more effective. DESIGN: This paper reflects our efforts to synthesize findings from SUPPORT and other sources in order to explore our conceptual models, their consistency with the data, and their leverage for change. RESULTS: Many of the assumptions underlying the model of improved decision-making are problematic. Furthermore, the results of SUPPORT suggest that implementing an effective intervention based on a normative model of shared decision-making can be quite difficult. Practice patterns and social expectations may be strong influences in shaping patients' courses of care. Innovations in system function, such as quality improvement or changing the financing incentives, may offer more powerful avenues for reform. CONCLUSIONS: SUPPORT's intervention may have failed to have an impact because strong psychological and social forces underlie present practices. System-level innovation and quality improvement in routine care may offer more powerful opportunities for improvement.

Are aggressive treatment strategies less cost-effective for older patients? The case of ventilator support and aggressive care for patients with acute respiratory failure.

OBJECTIVES: A common assumption is that life-sustaining treatments are much less cost-effective for older patients than for younger patients. We estimated the incremental cost-effectiveness of providing mechanical ventilation and intensive care for patients of various ages who had acute respiratory failure. DESIGN: Retrospective analysis of data on acute respiratory failure from Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). SETTING: Acute hospital. PARTICIPANTS: 1,005 with acute respiratory failure; 963 received ventilator support and 42 had ventilator support withheld. MEASUREMENTS: We studied 1,005 patients enrolled in a five-center study of seriously ill patients (SUPPORT) with acute respiratory failure (pneumonia or acute respiratory distress syndrome and an Acute Physiology Score > or = 10) requiring ventilator support. For cost-effectiveness analyses, we estimated life expectancy based on long-term follow-up of SUPPORT patients and estimated utilities (quality-of-life weights) using time-tradeoff questions. We used hospital fiscal data and Medicare data to estimate healthcare costs. We divided patients into three age groups (< 65, 65-74, and > or = 75 years); for each age group, we performed separate analyses for patients with a < or = 50% probability of surviving at least 2 months (high-risk group) and those with a > 50% probability of surviving at least 2 months (low-risk group). RESULTS: Of the 963 patients who received ventilator support, 44% were female; 48% survived 6 months; and the median (25th, 75th percentile) age was 63 (46, 75) years. For the 42 patients for whom ventilator support was withheld, the median survival was 3 days. For low-risk patients (> 50% estimated 2-month survival), the incremental cost (1998 dollars) per quality-adjusted life-year (QALY) saved by providing ventilator support and aggressive care increased across the three age groups ($32,000 for patients age < 65, $44,000 for those age 65-74, and $46,000 for those age > or = 75). For high-risk patients, the incremental cost-effectiveness was much less favorable and was least favorable for younger patients ($130,000 for patients age < 65, $100,000 for those age 65-74, and $96,000 for those age > or = 75). When we varied our assumptions from 50% to 200% of our baseline estimates in sensitivity analyses, results were most sensitive to the costs of the index hospitalization. CONCLUSIONS: For patients with relatively good short-term prognoses, we found that ventilator support and aggressive care were economically worthwhile, even for patients 75 years and older. For patients with poor short-term prognoses, ventilator support and aggressive care were much less cost-effective for adults of all ages.

Predicting functional status outcomes in hospitalized patients aged 80 years and older.

OBJECTIVE: To develop a model estimating the probability of a patient aged 80 years or older having functional limitations 2 months and 12 months after being hospitalized. DESIGN: A prospective cohort study. SETTING: Four teaching hospitals in the US. PARTICIPANTS: Enrolled patients were nonelective hospital admissions aged 80 years or older who stayed in hospital at least 48 hours. The 804 patients who survived and completed an interview at 2 months and the 450 who completed an interview at 12 months were from the 1266 patients in the Hospitalized Elderly Longitudinal Project (HELP) (76% and 47% of survivors, respectively). Median age of the 2-month survivors was 84.7 years. MEASUREMENTS AND MAIN OUTCOMES: Patient function 2 and 12 months after enrollment was defined by the number of dependencies in Activities of Daily Living (ADLs). Ordinal logistic regression models were constructed to predict functional status. Predictors included demographic characteristics, disease category, geriatric conditions, severity of physiologic imbalance, current quality of life, and exercise capacity and ADLs 2 weeks before study admission. RESULTS: Before admission, 39% of patients were functionally independent in ADLs. Of patients who survived and were interviewed at 2 months, 32% were functionally independent, and at 12 months, 36% were independent. Among patients with no baseline dependencies, 42% had developed one or more limitations 2 months later, and 41 % had limitations 12 months later. The patient's ability to perform activities of daily living at baseline was the most important predictor of functional status at both 2 and 12 months. In a multivariable predictive model, independent predictors of poorer functional status at 2 months included: worse baseline functional status and quality of life; depth of coma, if any; lower serum albumin level; presence of dementia, depression, or incontinence; being bedridden; medical record documentation of need for nursing home; and older age. Model performance, assessed using Somers' D, was 0.61 for 2 months and 0.57 for 12 months (Receiver Operating Characteristic (ROC) area = 0.81 and .79, respectively.) Bootstrap validation of the month 2 model also yielded a Somers' D = 0.60. The models were well calibrated over the entire risk range. The ROC area for prediction of the loss of independence was 0.76 for 2 months and 0.68 for 12 months. CONCLUSIONS: Many older patients are functionally impaired at the time of hospitalization, and many develop new functional limitations. A limited amount of readily available clinical information can yield satisfactory predictions of functional status 2 months after hospitalization. Models like this may prove to be useful in clinical care. This work illuminates a potential method for risk adjustment in research studies and for monitoring quality of care.

Ineffectiveness of the SUPPORT intervention: review of explanations.

BACKGROUND: The aim of the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments -- SUPPORT -- was to improve the care of seriously ill patients by improving decision-making for patients with life-threatening illnesses. Several theories have been proposed to explain why the SUPPORT intervention was unsuccessful at improving outcomes. OBJECTIVE: To review and discuss explanations offered by others regarding why the SUPPORT intervention failed to have a discernible impact on its prespecified outcome measures. DESIGN: A descriptive review of published articles and book chapters, with synthesis of data-based and conceptual insights. METHODS: The Medline, Bioethicsline, and Ethx databases were searched for citations to SUPPORT articles between 1994 and the end of 1998. This search was supplemented by other published materials that had come to the authors' attention. RESULTS: The critiques and explanations regarding the reasons the SUPPORT intervention did not improve outcomes were catalogued and organized into 11 major categories, the first 10 of which are explored in the present study: (1) the inception cohort was biased against an effect of the intervention, (2) the intervention was not implemented as designed, (3) the intervention failed because nurses were too readily ignored, (4) the intervention was too polite, (5) the intervention presented information ineffectively, (6) the intervention did not focus on primary care physicians, (7) the intervention falsely dichotomized do not resuscitate (DNR) decisions, (8) the intervention needed more years on site or an earlier start with each patient, (9) the intervention required more appropriate outcome measures, (10) the intervention was irrelevant because usual care is not seriously flawed, (11) the conceptual model behind SUPPORT was fundamentally flawed in aiming to improve individual, patient-level decision-making as the way to improve seriously ill, hospitalized patients' experiences. CONCLUSIONS: Although some of the critiques were found to raise important concerns, we conclude in each case that the explanation offered is inadequate to explain the failure of the intervention. We urge further reflection on the fundamental assumptions that informed the design of that intervention and refer the reader to a more comprehensive treatment of that issue in the companion paper in this volume.

Management of sore throats in children: a cost-effectiveness analysis.

OBJECTIVE: To perform a cost-effectiveness analysis of treatment management strategies for children older than 3 years who present with signs or symptoms of pharyngitis. DESIGN: Decision model with 7 strategies, including neither testing for streptococcus nor treating with antibiotics; treating empirically with penicillin V; basing treatment on results of a throat culture (Culture); and basing treatment on results of enzyme immunoassay or optical immunoassay rapid tests, performed alone or in combination with throat cultures. In these 7 strategies, all tests are performed in a local reference laboratory. In a sensitivity analysis, we examined the cost-effectiveness of 4 strategies involving office-based testing. We obtained data on event probabilities and test characteristics from our hospital's clinical laboratory and the literature; costs for the analysis were based on resource use. RESULTS: At a baseline prevalence of 20.8% for streptococcal pharyngitis, the Culture strategy was the least expensive and most effective, with an average cost of $6.85 per patient. The outcome was sensitive to the prevalence of streptococcal pharyngitis, the rheumatic fever attack rate, the cost of the enzyme immunoassay test, and the cost of culturing and reporting culture results. The Culture strategy was also preferred if amoxicillin was substituted for oral penicillin. For office-based testing, Culture was the least costly strategy, but treatment based on results of the optical immunoassay test alone had an incremental cost-effectiveness ratio of $1.6 million per additional life saved. CONCLUSION: In a setting with adherent patients, children with sore throats should generally get throat cultures in lieu of rapid streptococcus antigen tests.

Finding the optimal multiple-test strategy using a method analogous to logistic regression: the diagnosis of hepatolenticular degeneration (Wilson's disease).

Finding the optimal strategy among a battery of tests may be cumbersome for decision analytic models. The authors present a method of examining multiple test combinations that is based on a modified Bayes' formula analogous to logistic regression. They examined all 16 combinations of four tests used to diagnose hepatolenticular degeneration. The four tests examined were: serum ceruloplasmin level, 24-hour urinary copper excretion, free serum copper level, and liver biopsy copper concentration. They also simulated the diagnostic workup of the disease for a hypothetical cohort of 15,000 patients at risk. Assuming the disutilities of false positives and false negatives to be equal, and considering sensitivity analysis of test characteristics, the following test combinations were found to be optimal for making the diagnosis at a prior probability of disease equal to 0.05: positive serum ceruloplasmin and 24-hour urinary copper excretion, combined with either positive liver biopsy or free serum copper (or both). The strategies obtained by the modified Bayes' formula were the same as those found using the simulated data set with a standard logistic-regression software package. The logistic model's diagnostic accuracy is 0.98 as measured by the area under the receiver operating characteristic curve. The optimal strategy for diagnosing hepatolenticular degeneration varies with the prior probability of disease. For prior probabilities of 0.05, 0.25, and 0.9, and the optimal strategy, model sensitivities are 0.801, 0.880, and 0.997, and model specificities are 0.991, 0.985, and 0.814, respectively. The new method provides a convenient alternative to decision trees when examining multiple diagnostic tests.

Warfarin for dilated cardiomyopathy: a bloody tough pill to swallow?

Although current recommendations for the treatment of dilated cardiomyopathy include long-term anticoagulation to diminish the likelihood of systemic embolization, there have been no clinical trials examining the effectiveness of anticoagulation in preventing systemic embolization in these patients. Furthermore, those recommendations do not address the issue of the quality of life associated with long-term warfarin therapy. Using decision analysis, the authors examined the benefits and risks of long-term anticoagulation for patients 35 to 75 years of age who have dilated cardiomyopathy. The results show that anticoagulant therapy increases quality-adjusted life expectancy by 76 to 128 days, depending on the patient's age. Sensitivity analysis, however, demonstrates that the outcome is dependent on the disutility associated with long-term warfarin therapy. Interestingly, anticoagulation exerts most of its benefit by preventing pulmonary embolization, not systemic embolization. The authors conclude that the current recommendation to anticoagulate these patients, although probably correct for many patients, should take into consideration the change in lifestyle imposed by long-term anticoagulant therapy. For some patients, the benefit may not outweigh the sacrifice.

Is experience a good teacher? How interns and attending physicians understand patients' choices for end-of-life care. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Recent studies have shown that physicians do not accurately assess patients' health status or treatment preferences. Little is known, however, about how physicians' levels of training or experience relate to their abilities to assess these preferences. To better understand this phenomenon, the authors compared the abilities of medical interns and attending physicians to predict the choices of their adult patients for end-of-life care. METHODS: 230 seriously-ill adult inpatients were surveyed about their desires for cardiopulmonary resuscitation, their current quality of life, and their attitudes toward six other common adverse outcomes. The medical intern and attending physician who cared for these patients were asked to estimate the patient's responses for all of the same items. Agreement was assessed using the kappa statistic. RESULTS: Compared with interns, attending physicians had known patients longer, had talked with patients more frequently about prognosis, and felt they knew more about their patients' preferences (all p < .0001). Despite this, the attending physicians were no more accurate than the interns in assessing patients' preferences. Both interns and attending physicians had only a fair understanding of patients' preferences for cardiopulmonary resuscitation or their quality of life (kappa statistics 0.32 to 0.47), and even less understanding of their willingness to tolerate adverse outcomes (kappa statistics -0.03 to 0.37). CONCLUSIONS: For this cohort of seriously ill patients, neither medical interns nor their attending physicians were consistently accurate in assessing patients' preferences, and attending physicians were not more accurate than medical interns. Attending physicians should not assume that they can infer patients' preferences any better than the interns caring for these hospitalized patients.

Stability of time-tradeoff utilities in survivors of myocardial infarction.

To investigate whether time-tradeoff utilities of survivors of myocardial infarction change over time and whether changes in utilities correlate with changes in functional status, the authors conducted serial interviews using a time tradeoff and three measures of functional status in a cohort of 67 patients who had recently had myocardial infarction. The patients were also asked to rate their overall health on a rating scale and were asked about chest pain, exercise status, and employment status. Each patient was interviewed two to five times over one and a half years. The mean (95% CI) time-tradeoff score for all patients was 0.88 (0.84, 0.93). Over a mean interval of 8.4 months, 28 (42%) patients changed Karnofsky scores, 28 (42%) changed Specific Activity Scale classes, and 11 (16%) changed New York Heart Association classes, with most changes representing improvements in functional status. Scores on the rating scale improved by a mean (95% CI) of 0.06 [(0.03, 0.10); p < 0.002], but scores on the time tradeoff remained stable, with a mean (95% CI) change of 0.03 [(-0.02, 0.08); p = NS]. Changes in time-tradeoff scores did not correlate with changes in Specific Activity Scale classes (Kendall's tau = 0.21), New York Heart Association classes (tau = -0.02), or Karnofsky scores (tau = 0.14); with changes on the verbal rating scale (R = 0.20); with changes in chest pain status (tau = -0.05), exercise status (tau = 0.11), or employment status (tau = 0.11); or with interim hospitalizations (tau = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

What should be reported in a methods section on utility assessment?

BACKGROUND: The measurement of utilities, or preferences, for health states may be affected by the technique used. Unfortunately, in papers reporting utilities, it is often difficult to infer how the utility measurement was carried out. PURPOSE: To present a list of components that, when described, provide sufficient detail of the utility assessment. METHODS: An initial list was prepared by one of the authors. A panel of 8 experts was formed to add additional components. The components were drawn from 6 clusters that focus on the design of the study, the administration procedure, the health state descriptions, the description of the utility assessment method, the description of the indifference procedure, and the use of visual aids or software programs. The list was updated and redistributed among a total of 14 experts, and the components were judged for their importance of being mentioned in a Methods section. RESULTS: More than 40 components were generated. Ten components were identified as necessary to include even in an article not focusing on utility measurement: how utility questions were administered, how health states were described, which utility assessment method(s) was used, the response and completion rates, specification of the duration of the health states, which software program (if any) was used, the description of the worst health state (lower anchor of the scale), whether a matching or choice indifference search procedure was used, when the assessment was conducted relative to treatment, and which (if any) visual aids were used. The interjudge reliability was satisfactory (Cronbach's alpha = 0.85). DISCUSSION: The list of components important for utility papers may be used in various ways, for instance, as a checklist while writing, reviewing, or reading a Methods section or while designing experiments. Guidelines are provided for a few components.