Health service research: the square peg in human subjects protection regulations.

Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results.

The cost of pneumonia after acute stroke.

OBJECTIVE: To determine the incremental costs of pneumonia occurring during hospitalization for stroke. METHODS: We reviewed hospital records of all Medicare patients admitted for ischemic or hemorrhagic stroke to 29 hospitals in a large metropolitan area, 1991 through 1997, excluding those who died or had do not resuscitate orders written within 3 days of admission. Hospital costs of patients with stroke were determined using Medicare Provider Analysis and Review data after adjustment for baseline factors affecting cost and propensity for pneumonia. Secondary analyses examined the risk-adjusted relationship of pneumonia to discharge disposition. RESULTS: Pneumonia occurred in 5.6% (635/11,286) of patients with stroke, and was more common among patients admitted from nursing homes and those with greater severity of illness (p < 0.001). Mean adjusted costs of hospitalization for patients with stroke with pneumonia were $21,043 (95% CI $19,698 to 22,387) and were $6,206 (95% CI $6,150 to 6,262) for patients without pneumonia, resulting in an incremental cost of $14,836 (95% CI $14,436 to 15,236). Patients with pneumonia were over 70% more likely to be discharged with requirements for extended care (adjusted OR 1.73, 95% CI 1.32 to 2.26). CONCLUSION: Extrapolated to the over 500,000 similar patients hospitalized for stroke in the United States, the annual cost of pneumonia as a complication after acute stroke is approximately $459 million.

The effect of pneumonia on mortality among patients hospitalized for acute stroke.

OBJECTIVE: To determine the effect of pneumonia on 30-day mortality in patients hospitalized for acute stroke. METHODS: Subjects in the initial cohort were 14,293 Medicare patients admitted for stroke to 29 greater Cleveland hospitals between 1991 and 1997. The relative risk (RR) of pneumonia for 30-day mortality was determined in a final cohort (n = 11,286) that excluded patients dying or having a do not resuscitate order within 3 days of admission. Clinical data were obtained from chart abstraction and were merged with Medicare Provider Analysis and Review files to obtain deaths within 30 days. A predicted-mortality model (c-statistic = 0.78) and propensity score for pneumonia (c-statistic = 0.83) were used for risk adjustment in logistic regression analyses. RESULTS: Pneumonia was identified in 6.9% (n = 985) of all patients and in 5.6% (n = 635) of the final cohort. The rates of pneumonia were higher in patients with greater stroke severity and features indicating general frailty. Unadjusted 30-day mortality rates were six times higher for patients with pneumonia than for those without (26.9% vs 4.4%, p < 0.001). After adjusting for admission severity and propensity for pneumonia, RR of pneumonia for 30-day death was 2.99 (95% CI 2.44 to 3.66), and population attributable risk was 10.0%. CONCLUSION: In this large community-wide study of stroke outcomes, pneumonia conferred a threefold increased risk of 30-day death, adding impetus to efforts to identify and reduce the risk of pneumonia in patients with stroke.

Reporting BRCA test results to primary care physicians.

PURPOSE: The main purpose of this study was to determine if comprehension of the cancer risk information presented in a hypothetical report for BRCA1/2 gene analyses was influenced by the format in which the information was presented. A secondary objective was to determine physician characteristics that might influence comprehension of the report. METHODS: A survey was conducted in which a case vignette describing a young woman at high risk for carrying a BRCA mutation was presented. Survey participants, all primary care practitioners, were asked to interpret a laboratory report that provided the patient's BRCA1/2 test result and accompanying data about the cumulative risk and incidence rates of breast cancer for BRCA1/2 mutation carriers and the general population. These data were presented in the report in either a tabular or a graphic format. The main outcome was measured by the responses to four questions that addressed the probabilistic cancer risk information. Physician predictor variables included medical specialty, practice setting, years in practice, continuing medical education in genetics, and knowledge of cumulative risk. RESULTS: Knowledge of cumulative risk was the only physician variable that influenced comprehension of the cancer risk information (OR = 31.9; P < 0.001). After adjusting for this variable, the graphic format tended to perform better than the tabular format in conveying breast cancer risk information (OR = 3.1; P = 0.102). CONCLUSIONS: Many physicians may be unprepared to interpret genetic risk information, due to lack of understanding of basic epidemiologic terms used to express the risk of disease.

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.

Patient characteristics associated with care by a cardiologist among adults hospitalized with severe congestive heart failure. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

OBJECTIVES: The goal of this study was to determine factors associated with receiving cardiologist care among patients with an acute exacerbation of congestive heart failure. BACKGROUND: Because cardiologist care for acute cardiovascular illness may improve care, barriers to specialty care could impact patient outcomes. METHODS: We studied 1,298 patients hospitalized with acute exacerbation of congestive heart failure who were cared for by cardiologists or generalist physicians. Using multivariable logistic models we determined factors independently associated with attending cardiologist care. RESULTS: Patients were less likely to receive care from a cardiologist if they were black (adjusted odds ratio [AOR] 0.53, 95% confidence interval [CI] 0.35, 0.80), had an income of less than $11,000 (AOR 0.65, 95% CI 0.45, 0.93) or were older than 80 years of age (AOR 0.23, 95% CI 0.12, 0.46). Patients were more likely to receive cardiologist care if they had college level education (AOR 1.89, 95% CI 1.02, 3.51), a history of myocardial infarction (AOR 1.59, 95% CI 1.17, 2.16), a serum sodium less than 133 on admission (AOR 1.96, 95% CI 1.30, 2.95) or a systolic blood pressure less than 90 on admission (AOR 1.97, 95% CI 1.20, 3.24). Patients who stated a desire for life extending care were also more likely to receive care from a cardiologist (AOR 1.40, 95% CI 1.04, 1.90). CONCLUSIONS: After adjusting for severity of illness and patient preferences for care, patient sociodemographic factors were strongly associated with receiving care from a cardiologist. Future investigations are required to determine whether these associations represent unmeasured preferences for care or inequities in our health care system.

Generalists and oncologists show similar care practices and outcomes for hospitalized late-stage cancer patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks for Treatment.

OBJECTIVE: The objective of this work was to identify similarities and differences in primary attending physicians' (generalists' versus oncologists') care practices and outcomes for seriously ill hospitalized patients with malignancy. DESIGN: This was a prospective cohort study (SUPPORT project). SETTING: Subjects were recruited from 5 US teaching hospitals; data were gathered from 1989 to 1994. SUBJECTS: Included in the study was a matched sample of 642 hospitalized patients receiving care for non-small-cell lung cancer, colon cancer metastasized to the liver, or multiorgan system failure associated with malignancy with either a generalist or an oncologist as the primary attending physician. MEASUREMENTS: Care practices and patient outcomes were determined from hospital records. Length of survival was identified with the National Death Index. Physicians' perceptions of patient's prognosis, preference for cardiopulmonary resuscitation (CPR), and length of relationship were assessed by interview. A propensity score for receiving care from an oncologist was constructed. After propensity-based matching of patients, practices and outcomes of oncologists' and generalists' patients were assessed through group comparison techniques. RESULTS: Generalist and oncologist attendings showed comparable care practices, including the number of therapeutic interventions, eg, "rescue care" and chemotherapy, and the number of care topics discussed with patients/ families. Length of stay, discharge to supportive care, readmission, total hospital costs, and survival rates were similar. For both physician groups, perception of patients' wish for CPR was associated with rescue care (P < 0.03), and such care was related to higher hospital costs (P < 0.000). Poorer prognostic estimates predicted aggressiveness-of-care discussions by both types of physicians. Length of the patient-doctor relationship was associated with oncologists' care practices. More documented discussion about aggressiveness of care was related to higher hospital costs and shorter survival for patients in both physician groups (P < 0.001). CONCLUSIONS: Generalists and oncologists showed similar care practices and outcomes for comparable hospitalized late-stage cancer patients. Physicians' perceptions about patients' preferences for CPR and prognosis influenced decision making and outcomes for patients in both physician groups. Length of relationship with patients was associated only with oncologists' care practices. Rescue care increased hospital costs but had no effect on patient survival. Future studies should compare physicians' palliative care as well as acute-care practices in both inpatient and ambulatory care settings. Patients' end-of-life quality and interchange between physician groups should also be documented and compared.

Age differences in care practices and outcomes for hospitalized patients with cancer.

OBJECTIVE: To identify age group differences in care practices and outcomes for seriously ill hospitalized patients with malignancy. DESIGN: Prospective cohort study (SUPPORT project). SETTING: Five United States teaching hospitals; data was gathered between 1989 and 1994. SUBJECTS: Nine hundred twenty five older (age > or = 65 years), 983 middle aged (age = 45-64 years), and 274 younger (age = 18-44 years) hospitalized patients receiving care for non-small cell lung cancer, colon cancer metastasized to the liver, or multi-organ system failure associated with malignancy. MEASUREMENTS: Care practices and patient outcomes were determined from hospital records. Length of survival was identified using the National Death Index. After adjusting for important variables, including severity of illness (i.e., SUPPORT model estimate for 2-month survival, cancer condition), hospital site, selection to intervention and sociodemographic variables, age group differences in care practices and outcomes were identified using general linear models. RESULTS: Older patients with cancer had lower resource utilization during hospitalization (P < .04) and were less likely to receive cancer-related treatments (i.e., chemotherapy, platelet infusions, scheduled intravenous medications) than middle-aged and young-adult patients in the first week of hospitalization (P < or = .01). More care topics were discussed with older patients and their families then with younger patients and their families (P < .001). Length of stay and total hospital costs were lower for older and middle-aged patients than for younger patients. Although more older patients had discussions about transfer to hospice (P < .001), older patients were no more likely to be discharged with supportive care (inpatient hospice or home with home/ hospice care). Older patients died sooner than middle-aged patients (P < .01). CONCLUSIONS: Patient age influenced care decisions and outcomes. Older patients (age > or = 65 years) received less aggressive care, had more discussions about care decisions, and died sooner than younger patients with cancer. Younger patients had longer stays, higher hospital costs, and greater probability of rehospitalization. Although well over half of patients died within 6 months of hospitalization, few patients in any age group were discharged with supportive care. Future studies should examine age differences in palliation, as well as acute care of cancer patients across inpatient and ambulatory care settings and should assess quality of care at the end of life.

The effect of nutritional supplementation on survival in seriously ill hospitalized adults: an evaluation of the SUPPORT data. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Enteral tube and parenteral hyperalimentation are widely used nutritional support systems. Few studies examine the relation between nutritional support and patient outcomes in seriously ill hospitalized adults. OBJECTIVE: To explore the association between nutritional support and survival in seriously ill patients enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). DESIGN: A prospective study of preferences, decision-making, and outcomes. SETTING: Five teaching hospitals PARTICIPANTS: 6298 patients aged 18 or older meeting diagnostic and illness severity criteria. MEASUREMENT: Demographic characteristics, diagnoses, comorbid conditions, acute physiology score, nutritional support, and functional status before hospitalization. RESULTS: A total of 2149 patients received nutritional support. In patients who received artificial nutrition on hospital days 1 or 3 (Cohort 1), enteral feeding was associated with improved survival in coma (hazard: 0.53; 95%CI, 0.42-0.66), and reduced survival in COPD (hazard: 1.57; 95%CI, 1.18-2.08). In patients who were hospitalized on Day 7 and received artificial nutrition on days 1, 3, or 7 (Cohort 2), enteral tube feeding (hazard: 0.35; 95%CI, 0.27-0.46) or hyperalimentation (hazard: 0.58; 95%CI, 0.38-0.90) was associated with improved survival in coma. Tube feeding was associated with decreased survival in acute respiratory failure (ARF) or multiorgan system failure (MOSF) with sepsis (hazard: 1.21; 95%CI, 10.4-1.41), cirrhosis (hazard: 2.15; 95%CI, 1.35-3.42), and COPD (hazard: 1.37; 95%CI, 1.04-1.80). Hyperalimentation was associated with decreased survival in ARF or MOSF with sepsis (hazard: 1.34; 95%CI, 1.12-1.59). CONCLUSIONS: Nutritional support was associated with improved survival in coma. Enteral feeding and hyperalimentation was associated with decreased survival in ARF or MOSF with sepsis. Tube feeding was associated with decreased survival in cirrhosis and COPD. Except for patients in coma, artificial nutrition was not associated with a survival advantage.

Physician understanding of patient resuscitation preferences: insights and clinical implications.

OBJECTIVE: To describe physician understanding of patient preferences concerning cardiopulmonary resuscitation (CPR) and to assess the relationship of physician understanding of patient preferences with do not resuscitate (DNR) orders and in-hospital CPR. DESIGN: We evaluated physician understanding of patient CPR preference and the association of patient characteristics and physician-patient communication with physician understanding of patient CPR preferences. Among patients preferring to forego CPR, we compared attempted resuscitations and time to receive a DNR order between patients whose preference was understood or misunderstood by their physician. PATIENTS/SETTING: Seriously ill hospitalized adult patients were enrolled in the Study to Understand Prognoses and Preferences for the Outcomes of Treatments. GENERAL RESULTS: Physicians understood 86% of patient preferences for CPR, but only 46% of patient preferences to forego CPR. Younger patient age, higher physician-estimated quality of life, and higher physician prediction of 6-month survival were independently associated with both physician understanding when a patient preferred to receive CPR and physician misunderstanding when a patient preferred to forego CPR. Physicians who spoke with patients about resuscitation and had longer physician-patient relationships understood patients' preferences to forego CPR more often. Patients whose physicians understood their preference to forego CPR more often received DNR orders, received them earlier, and were significantly less likely to undergo resuscitation. CONCLUSIONS: Physicians often misunderstand seriously ill, hospitalized patients' resuscitation preferences, especially preferences to forego CPR. Factors associated with misunderstanding suggest that physicians infer patients' preferences without asking the patient. Patients who prefer to forego CPR but whose wishes are not understood by their physician may receive unwanted treatment.

A prospective study of patient-physician communication about resuscitation.

OBJECTIVE: To evaluate prospectively seriously ill patients' characteristics, perceptions, and preferences associated with discussing resuscitation (CPR) with their physicians. DESIGN: Prospective cohort. SETTING: Five academic medical centers. PARTICIPANTS: Patients enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments who had not communicated with their physicians about CPR at admission to a hospital for life-threatening illness (n = 1288). MEASUREMENTS: Baseline surveys of patients' characteristics, health status, desires for participation in medical decision making, and cardiopulmonary resuscitation. Two month follow-up surveys of patients' communication of resuscitation preference. Chart reviews for clinical indicators. RESULTS: Thirty percent of patients communicated their resuscitation preference to their physician during a 2 month-period following hospital admission. Patients whose preference was to forego CPR (odds ratio (OR) 2.9;(95% CI, 1.9-4.2)) and whose preference had changed from desiring to foregoing CPR (OR 1.6; (95% CI, 1.1-2.4)) were more likely to communicate their preference than patients who continued to prefer to receive CPR. However, only 50% of patients who maintained a preference to forego CPR communicated this over a 2-month period. Having an advance directive and remaining in the hospital at 2-month follow-up were also independently associated with communication, whereas patients' preference for participation in decision-making, health status, and prognostic estimate were not. CONCLUSIONS: Communication about resuscitation preferences occurred infrequently after hospital admission for a serious illness, even among patients wishing to forego resuscitation. Factors such as declining quality of life, which were expected to be associated with communication, were not. An invitation to communicate about CPR preference is important after hospital admission for a serious illness. Novel approaches are needed to promote physician-patient discussions about resuscitation.

Living and dying with chronic obstructive pulmonary disease.

OBJECTIVE: To characterize chronic obstructive pulmonary disease (COPD) over patients' last 6 months of life. STUDY DESIGN: A retrospective analysis of a prospective cohort from the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). SETTING: Hospitalization for exacerbation of COPD at five US teaching hospitals. PARTICIPANTS: COPD patients who died within 1 year (n = 416) among 1016 enrolled. METHODS: Interview and medical record data were organized into time windows beginning with death and ending 6 months earlier. OUTCOME MEASURES: Days in hospital, prognosis, illness severity, function, symptoms, patients' preferences, and impacts on families. RESULTS: One-year survival was 59%, 39% had > or = 3 comorbidities, and 15 to 25% of the patients' last 6 months were in hospitals. Exacerbation etiologies included respiratory infection (47%) and cardiac problems (30%). Better quality of life predicted longer survival (ARR: 0.36; 95% CI, 0.19-0.87) as did heart failure etiology of exacerbation (ARR: 0.57; CI, 0.40, 0.82). Estimates of survival by physicians and by prognostic model were well calibrated, although patients with the worst prognoses survived longer than predicted. Patients' estimates of prognosis were poorly calibrated. One-quarter of patients had serious pain throughout, and two-thirds had serious dyspnea. Patients' illnesses had a major impact on more than 25% of families. Patients' preferences for Do-Not-Resuscitate orders increased from 40% at 3 to 6 months before death to 77% within 1 month of death; their decisions not to use mechanical ventilation increased from 12 to 31%, and their preferences for resuscitation decreased from 52 to 23%. CONCLUSIONS: Patients with advanced COPD often die within 1 year and have substantial comorbidities and symptoms. Adequate description anchors improved care.

Dying with end stage liver disease with cirrhosis: insights from SUPPORT. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment.

OBJECTIVES: To understand patterns of care and end-of-life preferences for patients dying with end stage liver disease with cirrhosis (ESLDC). METHODS: Data were collected during the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT), a prospective cohort study of seriously ill hospitalized adults at five teaching hospitals in the United States, and included all patients enrolled in SUPPORT with ESLDC. RESULTS: Of 575 patients with ESLDC, 166 died during index hospitalization, and 168 died in the following year. The majority were male (65%) and white (80%); the median age was 52 years. Most rated their quality of life as poor or fair, and multiple comorbidities were common. Most spent their last few days completely disabled. Families often reported loss of most income and the need to leave work or other activities in order to care for patients. Pain was at least moderately severe most of the time in one-third of patients. End-of-life preferences were not associated with survival. Most patients (66.8%) preferred CPR, but DNR orders and orders against ventilator use increased near death. CONCLUSIONS: Patients with liver disease were young, likely to be male, and often had low incomes. The high burden of pain was comparable to that reported for patients with lung and colon cancer. Persons dying with liver disease may benefit from increased attention to relief of symptoms, improved home care, and advanced care planning.

Dying with acute respiratory failure or multiple organ system failure with sepsis.

BACKGROUND: The dying experience of patients with acute respiratory failure (ARF) or multiple organ system failure with sepsis (MOSF) has not been described. OBJECTIVES: To describe patients dying from ARF or MOSF, including demographic characteristics, baseline function and quality of life, symptoms, preferences, use of life-sustaining treatments, satisfaction with care, and family burden. DESIGN: A multicenter prospective study. SETTING: Five US teaching hospitals, in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). PARTICIPANTS: A total of 1295 adults who died during hospitalization for ARF or MOSF. MEASUREMENTS: Chart reviews and interviews with patients and surrogates. RESULTS: SUPPORT enrolled 2956 patients with ARF or MOSF, and 44% died during enrollment hospitalization. Quality of life before hospitalization was reported as fair by 87% of patients. The mean number of impairments in their baseline activities of daily living was 1.6. At the time of death, 79% had a DNR order and 31% had an order to withhold ventilator support. The average time from the DNR order to death was 2 days. Dying patients spent an average of 9 days on a ventilator. Surrogates indicated that one out of four patients died with severe pain and one out of three with severe confusion. Families of 42% of the patients who died reported one or more substantial burden. CONCLUSIONS: Patients in this study reported substantial functional impairments and reduced quality of life. Limitations to aggressive treatments were usually implemented only when death was imminent. Family impact and physical and emotional suffering were substantial.

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.

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.

Resource use and survival of patients hospitalized with congestive heart failure: differences in care by specialty of the attending physician. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Previous studies suggest that specialty care is more costly but may produce improved outcomes for patients with acute cardiac illnesses. OBJECTIVE: To determine whether patients with congestive heart failure who are cared for by cardiologists experienced differences in costs, care patterns, and survival compared with patients of generalists. DESIGN: Prospective cohort study. SETTING: 5 U.S. teaching hospitals between 1989 and 1994. PATIENTS: 1298 patients hospitalized with an exacerbation of congestive heart failure. MEASUREMENTS: Hospital costs; average daily Therapeutic Intervention Scoring System (TISS) score; and survival censored at 30, 180, and 365 days and 31 December 1994. RESULTS: Compared with patients of generalists, patients of cardiologists were younger (mean age, 63.3 and 71.4 years; P < 0.001) and had lower Acute Physiology Scores at the time of admission (35.1 and 36.7; P < 0.001) but were more likely to have a history of ventricular arrhythmias (21.0% and 10.2%; P < 0.001). At 6 months, 201 (27%) patients of cardiologists and 149 (27%) patients of generalists had died. After adjustment for sociodemographic characteristics and severity of illness, patients of cardiologists incurred costs that were 42.9% (95% CI, 27.8% to 59.8%) higher and average daily TISS scores that were 2.83 points (CI, 1.96 to 3.68 points) higher than those of patients of generalists. Patients of cardiologists were more likely to undergo right-heart catheterization (adjusted odds ratio, 2.9 [CI, 1.7 to 4.9]) or cardiac catheterization (adjusted odds ratio, 3.9 [CI, 2.4 to 6.2]) and had higher odds for transfer to an intensive care unit and electrocardiographic monitoring. Adjusted survival did not differ significantly between groups at 30 days; however, there was a trend toward improved survival among patients of cardiologists at 1 year (adjusted relative hazard, 0.82 [CI, 0.65 to 1.04]) and at maximum follow-up (adjusted relative hazard, 0.80 [CI, 0.66 to 0.96]). CONCLUSIONS: In this observational study of patients hospitalized with congestive heart failure, cardiologist care was associated with greater costs and resource use and no difference in survival at 30 days of follow-up. Whether the trend toward better survival at longer follow-up represents differences in care or unadjusted illness severity is uncertain.

Evaluation of prognostic criteria for determining hospice eligibility in patients with advanced lung, heart, or liver disease. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

CONTEXT: Many individuals involved with care of the dying advocate expanding access to hospice care for persons with advanced lung, heart, or liver disease. However, to be eligible, these patients generally must have a prognosis for survival of less than 6 months. OBJECTIVE: To test the ability of currently available criteria to identify a population with a survival prognosis of 6 months or less among seriously ill hospitalized patients with 1 of 3 commonly fatal chronic diseases. DESIGN: Validation study using data from the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) phase 1 (June 1989-June 1991) and phase 2 (January 1992-January 1994), with a 6-month follow-up. SETTING AND PATIENTS: Consecutive sample of 2607 seriously ill patients from 5 US medical centers who were hospitalized with chronic obstructive pulmonary disease, congestive heart failure, or end-stage liver disease, and who survived to hospital discharge. MAIN OUTCOME MEASURES: Descriptive and operating characteristics of 5 general and 2 disease-specific clinical criteria for identifying patients with a survival prognosis of 6 months or less, and 3 sets of combination criteria (broad, intermediate, and narrow inclusion) aimed at providing low, medium, and high thresholds for hospice eligibility based on National Hospice Organization guidelines. RESULTS: Seventy-five percent of the sample survived more than 6 months after hospital discharge; 44% expressed a preference for palliative care. Broad inclusion criteria identified 923 patients eligible for hospice care, of whom 70% survived longer than 6 months. Intermediate inclusion criteria identified 300 patients, of whom 65% survived longer than 6 months. Narrow inclusion criteria identified 19 patients, of whom 53% survived longer than 6 months. Sensitivities and specificities of the combination criteria were 41.7% and 66.7% (broad inclusion), 16.2% and 90.1 % (intermediate inclusion), and 1.4% and 99.5% (narrow inclusion), respectively. CONCLUSIONS: These data indicate that for seriously ill hospitalized patients with advanced chronic obstructive pulmonary disease, congestive heart failure, or end-stage liver disease, recommended clinical prediction criteria are not effective in identifying a population with a survival prognosis of 6 months or less.