Influence of age on Medicare expenditures and medical care in the last year of life.

CONTEXT: Expenditures for Medicare beneficiaries in the last year of life decrease with increasing age. The cause of this phenomenon is uncertain. OBJECTIVES: To examine this pattern in detail and evaluate whether decreases in aggressiveness of medical care explain the phenomenon. DESIGN, SETTING, AND PATIENTS: Analysis of sample Medicare data for beneficiaries aged 65 years or older from Massachusetts (n = 34 131) and California (n = 19 064) who died in 1996. MAIN OUTCOME MEASURE: Medical expenditures during the last year of life, analyzed by age group, sex, race, place and cause of death, comorbidity, and use of hospital services. RESULTS: For Massachusetts and California, respectively, Medicare expenditures per beneficiary were $35 300 and $27 800 among those aged 65 through 74 years vs $22 000 and $21 600 for those aged 85 years or older. The pattern of decreasing Medicare expenditures with age is pervasive, persisting throughout the last year of life in both states for both sexes, for black and white beneficiaries, for persons with varying levels of comorbidity, and for those receiving hospice vs conventional care, regardless of cause and site of death. The aggressiveness of medical care in both Massachusetts and California also decreased with age, as judged by less frequent hospital and intensive care unit admissions and by markedly decreasing use of cardiac catheterization, dialysis, ventilators, and pulmonary artery monitors, regardless of cause of death. Decrease in the cost of hospital services accounts for approximately 80% of the decrease in Medicare expenditures with age in both states. CONCLUSIONS: Medicare expenditures in the last year of life decrease with age, especially for those aged 85 years or older. This is in large part because the aggressiveness of medical care in the last year of life decreases with increasing age.

The ethics of Pharmaceutical benefit management.

Efforts to limit pharmacy costs raise both ethical and economic considerations. Six values should inform pharmacy benefit management: (1) accepting resource constraints; (2) helping the sick; (3) protecting the worst off; (4) respecting autonomy; (5) sustaining trust; and (6) promoting inclusive decision making. Direct controls, such as formularies, step therapy, and prior authorization, can focus limited resources on the sick and worst off. However, direct controls limit autonomy and are administratively burdensome. Indirect controls, such as physician capitation, tiered copayments, and drug benefit caps, align physicians' and patients' interests with resource constraints, respect autonomy, and are administratively efficient. Unfortunately, they deter use based on cost, not medical need; they do not focus cuts on unnecessary or marginal drug use or focus resources on the sick. Budget caps are the least defensible, while tiered copays and physician capitation can be justified if implemented with safeguards. Formularies and step therapy are ethically justifiable if they can be efficiently instituted.

How managed care can be ethical.

The growth of managed care in the United States has been paralleled by a rising tide of anti-managed care sentiment. The "managed care problem" is understood generally as the need to protect individuals against large companies that care more about their bottom line than about people. The premise of the BEST (Best Ethical Strategies for Managed Care) project is that the "managed care problem" is best understood as an ethical problem--a conflict of values that arises as the country changes from a patient-centered to a population-centered approach to health care. The BEST project team worked with nine managed care organizations to identify their most intractable problems. The team redefined these problems in terms of ethical dilemmas, then studied each organization in search of innovative, exemplary approaches. These exemplary approaches are being shared publicly with the aim that they be adapted and adopted by other organizations facing similar difficulties and by regulators and legislators hoping to improve the health care system.

Understanding the experience of pain in terminally ill patients.

BACKGROUND: Terminally ill patients commonly experience substantial pain. Unresolved pain has been cited as evidence that end-of-life care is of poor quality. However, the data on which that conclusion is based are limited. We aimed to provide additional data on the experience of pain in such patients. METHODS: We interviewed 988 terminally ill patients from six randomly selected US sites. We asked them who had treated their pain in the previous 4 weeks (primary-care physician, pain specialist, or both), and whether they wanted more pain medication than they were receiving, or why they did not want more. FINDINGS: 496 (50%) terminally ill patients reported moderate or severe pain. 514 (52%) individuals had seen a primary-care physician for treatment of pain in the previous 4 weeks and 198 (20%) saw a pain specialist. Of those who had been treated by their primary-care physician, 287 (29%) wanted more therapy, 613 (62%) wanted their pain therapy to remain the same, and 89 (9%) wanted to reduce or stop their pain therapy. Several reasons for not wanting additional therapy were offered-fear of addiction, dislike of mental or physical side-effects, and not wanting to take more pills or injections. We saw no association between disease and amount of pain between disease and the desire for more treatment. Black patients were more likely to seek additional pain therapy, see a pain specialist, and refuse additional medication because of fear of addiction than other populations. INTERPRETATION: Although half of terminally ill patients experienced moderate to severe pain, only 30% of them wanted additional pain treatment from their primary-care physician. The number of patients experiencing pain remains too high. However, the number is not as large as perceived. Additionally, most are willing to tolerate pain. Furthermore, the experience of pain is constant across major terminal diseases.

Attitudes and practices among pediatric oncologists regarding end-of-life care: results of the 1998 American Society of Clinical Oncology survey.

PURPOSE: In 1998, the American Society of Clinical Oncology (ASCO) surveyed its membership to assess the attitudes, practices, and challenges associated with end-of-life care of patients with cancer. In this report, we summarize the responses of pediatric oncologists and the implications for care of children dying from cancer. METHODS: The survey consisted of 118 questions, covering eight categories. All ASCO members in the United States, Canada, and the United Kingdom were mailed a survey, which was completed by 228 pediatric oncologists. Predictors of particular attitudes and practices were identified using stepwise logistic regression analysis. Potential predictors were age, sex, religious affiliation, importance of religious beliefs, recent death of a relative, specialty, type of practice (rural or urban, academic or nonacademic), amount of time spent in patient care, number of new patients in the past 6 months, and number of patients who died in the past year. RESULTS: Pediatric oncologists reported a lack of formal courses in pediatric palliative care, a strikingly high reliance on trial and error in learning to care for dying children, and a need for strong role models in this area. The lack of an accessible palliative care team or pain service was often identified as a barrier to good care. Communication difficulties exist between parents and oncologists, especially regarding the shift to end-of-life care and adequate pain control. CONCLUSION: Pediatric oncologists are working to integrate symptom control, psychosocial support, and palliative care into the routine care of the seriously ill child, although barriers exist that make such comprehensive care a challenge.

Attitudes and desires related to euthanasia and physician-assisted suicide among terminally ill patients and their caregivers.

CONTEXT: Euthanasia and physician-assisted suicide (PAS) are highly controversial issues. While there are studies of seriously ill patients' interest in euthanasia and PAS, there are no data on the attitudes and desires of terminally ill patients regarding these issues. OBJECTIVE: To determine the attitudes of terminally ill patients toward euthanasia and PAS, whether they seriously were considering euthanasia and PAS for themselves, the stability of their desires, factors associated with their desires, and the proportion of patients who die from these interventions. DESIGN: Prospective cohort of terminally ill patients and their primary caregivers surveyed twice between March 1996 and July 1997. SETTING: Outpatient settings in 5 randomly selected metropolitan statistical areas and 1 rural county. PARTICIPANTS: A total of 988 patients identified by their physicians to be terminally ill with any disease except for human immunodeficiency virus infection (response rate, 87. 4%) and 893 patient-designated primary caregivers (response rate, 97. 6%). MAIN OUTCOME MEASURES: Support for euthanasia or PAS in standard scenarios; patient-expressed considerations and discussions of their desire for euthanasia or PAS; hoarding of drugs for suicide; patient death by euthanasia or PAS; and patient-reported sociodemographic factors and symptoms related to these outcomes. RESULTS: Of the 988 terminally ill patients, a total of 60.2% supported euthanasia or PAS in a hypothetical situation, but only 10. 6% reported seriously considering euthanasia or PAS for themselves. Factors associated with being less likely to consider euthanasia or PAS were feeling appreciated (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.52-0.82), being aged 65 years or older (OR, 0.52; 95% CI, 0.34-0.82), and being African American (OR, 0.39; 95% CI, 0. 18-0.84). Factors associated with being more likely to consider euthanasia or PAS were depressive symptoms (OR, 1.25; 95% CI, 1.05-1. 49), substantial caregiving needs (OR, 1.09; 95% CI, 1.01-1.17), and pain (OR, 1.26; 95% CI, 1.02-1.56). At the follow-up interview, half of the terminally ill patients who had considered euthanasia or PAS for themselves changed their minds, while an almost equal number began considering these interventions. Patients with depressive symptoms (OR, 5.29; 95% CI, 1.21-23.2) and dyspnea (OR, 1.68; 95% CI, 1.26-2.22) were more likely to change their minds to consider euthanasia or PAS. According to the caregivers of the 256 decedents, 14 patients (5.6%) had discussed asking the physician for euthanasia or PAS and 6 (2.5%) had hoarded drugs. Ultimately, of the 256 decedents, 1 (0.4%) died by euthanasia or PAS, 1 unsuccessfully attempted suicide, and 1 repeatedly requested for her life to be ended but the family and physicians refused. CONCLUSIONS: In this survey, a small proportion of terminally ill patients seriously considered euthanasia or PAS for themselves. Over a few months, half the patients changed their minds. Patients with depressive symptoms were more likely to change their minds about desiring euthanasia or PAS. JAMA. 2000;284:2460-2468.

Understanding of prognosis among parents of children who died of cancer: impact on treatment goals and integration of palliative care.

CONTEXT: Parents' understanding of prognosis or decision making about palliative care for children who die of cancer is largely unknown. However, a more accurate understanding of prognosis could alter treatment goals and expectations and lead to more effective care. OBJECTIVES: To evaluate parental understanding of prognosis in children who die of cancer and to assess the association of this factor with treatment goals and the palliative care received by children. DESIGN, SETTING, AND PARTICIPANTS: Survey, conducted between September 1997 and August 1998, of 103 parents of children who received treatment at the Dana-Farber Cancer Institute and Children's Hospital, Boston, Mass, and who died of cancer between 1990 and 1997 (72% of those eligible and those located) and 42 pediatric oncologists. MAIN OUTCOME MEASURE: Timing of parental understanding that the child had no realistic chance for cure compared with the timing of physician understanding of this prognosis, as documented in the medical record. RESULTS: Parents first recognized that the child had no realistic chance for cure a mean (SD) of 106 (150) days before the child's death, while physician recognition occurred earlier at 206 (330) days before death. Among children who died of progressive disease, the group characterized by earlier recognition of this prognosis by both parents and physicians had earlier discussions of hospice care (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.06; P =.01), better parental ratings of the quality of home care (OR, 3.31; 95% CI, 1.15-9.54; P =.03), earlier institution of a do-not-resuscitate order (OR, 1.03; 95% CI, 1.00-1.06; P =.02), less use of cancer-directed therapy during the last month of life (OR, 2.80; 95% CI, 1.05-7.50; P =.04), and higher likelihood that the goal of cancer-directed therapy identified by both physician and parent was to lessen suffering (OR, 5.17; 95% CI, 1.86-14.4; P =.002 for physician and OR, 6.56; 95% CI, 1.54-27.86; P =.01 for parents). CONCLUSION: Considerable delay exists in parental recognition that children have no realistic chance for cure, but earlier recognition of this prognosis by both physicians and parents is associated with a stronger emphasis on treatment directed at lessening suffering and greater integration of palliative care. JAMA. 2000;284:2469-2475.

Attitudes and practices of U.S. oncologists regarding euthanasia and physician-assisted suicide.

BACKGROUND: The practices of euthanasia and physician-assisted suicide remain controversial. OBJECTIVE: To achieve better understanding of attitudes and practices regarding euthanasia and physician-assisted suicide in the context of end-of-life care. DESIGN: Cohort study. SETTING: United States. PARTICIPANTS: 3299 oncologists who are members of the American Society of Clinical Oncology. MEASUREMENTS: Responses to survey questions on attitudes toward euthanasia and physician-assisted suicide for a terminally ill patient with prostate cancer who has unremitting pain, requests for and performance of euthanasia and physician-assisted suicide, and sociodemographic characteristics. RESULTS: Of U.S. oncologists surveyed, 22.5% supported the use of physician-assisted suicide for a terminally ill patient with unremitting pain and 6.5% supported euthanasia. Oncologists who were reluctant to increase the dose of intravenous morphine for terminally ill patients in excruciating pain (odds ratio [OR], 0.61 [95% CI, 0.48 to 0.77]) and had sufficient time to talk to dying patients about end-of-life care issues (OR, 0.79 [CI, 0.71 to 0.87]) were less likely to support euthanasia or physician-assisted suicide. During their career, 3.7% of surveyed oncologists had performed euthanasia and 10.8% had performed physician-assisted suicide. Oncologists who were reluctant to increase the morphine dose for patients in excruciating pain (OR, 0.58 [CI, 0.43 to 0.79]) and those who believed that they had received adequate training in end-of-life care (OR, 0.86 [CI, 0.79 to 0.95]) were less likely to have performed euthanasia or physician-assisted suicide. Oncologists who reported not being able to obtain all the care that a dying patient needed were more likely to have performed euthanasia (P = 0.001). CONCLUSIONS: Requests for euthanasia and physician-assisted suicide are likely to decrease as training in end-of-life care improves and the ability of physicians to provide this care to their patients is enhanced.

Ethics. Protecting communities in biomedical research.

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research.

Justice and managed care. Four principles for the just allocation of health care resources.

The debate about justice and health care has occurred largely at a remove from the institutions it concerns; it has been about our most general moral principles, and about what things we value. This debate has foundered. But if the debate is turned in another direction, toward some moral principles that are widely accepted within those institutions, and toward principles that have to do with control over allocation decisions rather than with actually how to make those decisions, agreement may be nearer at hand.

What makes clinical research ethical?

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.

Understanding economic and other burdens of terminal illness: the experience of patients and their caregivers.

BACKGROUND: Terminal illness imposes substantial burdens--economic and otherwise--on patients and caregivers. The cause of these burdens is not understood. OBJECTIVE: To determine the mechanism for economic and noneconomic burdens of terminal illness and to identify potential ameliorating interventions. DESIGN: In-person interviews of terminally ill patients and their caregivers. SETTING: Six randomly selected U.S. sites: Worcester, Massachusetts; St. Louis, Missouri; Tucson, Arizona; Birmingham, Alabama; Brooklyn, New York; and Mesa County, Colorado. PARTICIPANTS: 988 terminally ill patients and 893 caregivers. MEASUREMENTS: Needs for transportation, nursing care, homemaking, and personal care; subjective perception of economic burden; expenditure of more than 10% of household income on health care costs; caregiver depression and sense of interference with his or her life; and patient consideration of euthanasia or physician-assisted suicide. RESULTS: Of all patients, 34.7% had substantial care needs. Patients who had substantial care needs were more likely to report that they had a subjective sense of economic burden (44.9% compared with 35.3%; difference, 9.6 percentage points [95% CI, 3.1 to 16.1]; P = 0.005); that 10% of their household income was spent on health care (28.0% compared with 17.0%; difference, 11.0 percentage points [CI, 4.8 to 17.1]; P < or = 0.001); and that they or their families had to take out a loan or mortgage, spend their savings, or obtain an additional job (16.3% compared with 10.2%; difference, 6.1 percentage points [CI, 1.4 to 10.6]; P = 0.004). Patients with substantial care needs were more likely to consider euthanasia or physician-assisted suicide (P = 0.001). Caregivers of these patients were more likely to have depressive symptoms (31.4% compared with 24.8%; difference, 6.6 percentage points [CI, 0.4 to 12.8]; P = 0.01) and to report that caring for the patients interfered with their lives (35.6% compared with 24.3%; difference, 11.3 percentage points [CI, 5.0 to 17.7]; P = 0.001). Caregivers of patients whose physicians listened to patients' and caregivers' needs had fewer burdens. CONCLUSIONS: Substantial care needs are an important cause of the economic and other burdens imposed by terminal illness. Through empathy, physicians may be able to ameliorate some of these burdens.

Drug coverage decisions: the role of dollars and values.

Given the increasing costs of pharmaceuticals today, it is important to understand how pharmacy benefits decisions are made and the role of cost and values in these decisions. This study examines what coverage decisions insurers make and the information and processes used in making these decisions. Fifty-three organizations, differing in size, tax status, and region, were asked about their policies for four new and controversial drugs: Viagra, Enbrel, Zyban, and Celebrex. Enbrel and Celebrex were much more likely to be covered than Viagra and Zyban. In addition, coverage of Enbrel and Celebrex was limited through strategies such as prior authorization, to encourage medically appropriate use of these agents, whereas coverage of Viagra and Zyban was limited predominantly through generalized exclusion or through restrictions on quantity or duration of use. Value judgments, rather than cost, seem to play a central, though largely unspoken, role in these coverage decisions.

Symptoms and suffering at the end of life in children with cancer.

BACKGROUND: Cancer is the second leading cause of death in children, after accidents. Little is known, however, about the symptoms and suffering at the end of life in children with cancer. METHODS: In 1997 and 1998, we interviewed the parents of children who had died of cancer between 1990 and 1997 and who were cared for at Children's Hospital, the Dana-Farber Cancer Institute, or both. Additional data were obtained by reviewing medical records. RESULTS: Of 165 eligible parents, we interviewed 103 (62 percent), 98 by telephone and 5 in person. The interviews were conducted a mean (+/-SD) of 3.1+/-1.6 years after the death of the child. Almost 80 percent died of progressive disease, and the rest died of treatment-related complications. Forty-nine percent of the children died in the hospital; nearly half of these deaths occurred in the intensive care unit. According to the parents, 89 percent of the children suffered "a lot" or "a great deal" from at least one symptom in their last month of life, most commonly pain, fatigue, or dyspnea. Of the children who were treated for specific symptoms, treatment was successful in 27 percent of those with pain and 16 percent of those with dyspnea. On the basis of a review of the medical records, parents were significantly more likely than physicians to report that their child had fatigue, poor appetite, constipation, and diarrhea. Suffering from pain was more likely in children whose parents reported that the physician was not actively involved in providing end-of-life care (odds ratio, 2.6; 95 percent confidence interval, 1.0 to 6.7). CONCLUSIONS: Children who die of cancer receive aggressive treatment at the end of life. Many have substantial suffering in the last month of life, and attempts to control their symptoms are often unsuccessful. Greater attention must be paid to palliative care for children who are dying of cancer.

Attitudes and practices concerning the end of life: a comparison between physicians from the United States and from The Netherlands.

BACKGROUND: This study compares attitudes and practices concerning the end-of-life decisions between physicians in the United States and in the Netherlands, using the same set of questions. METHODS: A total of 152 physicians from Oregon and 67 from the Netherlands were interviewed using the same questions about (1) their attitudes toward increasing morphine with premature death as a likely consequence, physician-assisted suicide (PAS), and euthanasia; and (2) their involvement in cases of euthanasia, PAS, or the ending of life without an explicit request from the patient. Odds ratios, with 95% confidence intervals, were calculated to investigate relation between attitudes and various characteristics of the respondents. RESULTS: American physicians found euthanasia less often acceptable than the Dutch, but there was similarity in attitudes concerning increasing morphine and PAS. American physicians found increasing morphine and PAS more often acceptable in cases where patients were concerned about becoming a burden to their family. There was a discrepancy between the attitudes and practices of Dutch physicians concerning PAS. The proportions of physicians having practiced euthanasia, PAS, or ending of life without an explicit request from the patient differ more between the countries than do their attitudes, with American physicians having been involved in these practices less often than the Dutch. CONCLUSIONS: In this study of American and Dutch physicians, 2 important differences emerge: different attitudes toward the patient who is concerned over being a burden, and different frequency of euthanasia and PAS in the two countries.

What terminally ill patients care about: toward a validated construct of patients' perspectives.

BACKGROUND: Citizens have conveyed to professionals that care at the end of life is less than optimal. Efforts to improve matters have tended to work in piecemeal fashion, on tangible more than personal aspects of care, and without the benefit of documented perspectives of those who face dying. Policy initiatives and clinical interventions need guidance from a broad framework that is validated by patients' perspectives. PURPOSE: Our goals were to: (1) assess the construct validity and stability over time of the portions of a conceptual framework that concern patients' subjective experiences; (2) develop a foundation for measurement of these personally meaningful factors; and (3) examine these factors' associations for potential clinical or policy significance. POPULATION: Patients were from six diverse geographical areas whose physicians judged their survival prognosis to be 6 months or less. Physicians who referred the patients were randomly selected from state and specialty association lists. METHODS: We used in-person survey methodology and multivariate analysis of patient responses. The analysis fell into two parts. Using exploratory factor analysis, we looked for evidence of discrete dimensions of experiences. Using regression analysis, we examined associations among them. RESULTS: Of 1,131 eligible patients, 988 were interviewed (87.4% response rate). Of 682 patients who survived to follow-up interview 4-6 months later, 650 were interviewed (95.3% response rate). Exploratory factor analysis identified 12 discrete factors (accounting for 55% of variance; maximum Spearman's p = 0.24), 8 of which met criteria for representing measurable dimensions (accounting for 46% of variance). These 8 were: patient-clinician relationship; social connectedness; caregiving needs; psychological distress; spirituality/religiousness; personal acceptance; sense of purpose; and clinician communication. Eigenvalues ranged from 1.45 to 6.30 and Cronbach's alpha from 0.63 to 0.85. The concordance between these dimensions and those in the proposed framework indicated that two dimensions required minor modifications and six were confirmed, providing evidence of good construct validity for this portion of the framework. The same dimensions were also evident at follow-up except that the first two above-listed loaded on one combined factor, clinician interaction (eigenvalues 1.83-7.92; Cronbach's alpha from 0.64 to 0.86). This provides evidence of the construct's stability over time. Clinical communication and patient-clinician relationship were associated (odds ratio [OR] 2.79, 2.31-3.36). Better clinician communication correlated with somewhat better personal acceptance (OR 1.10,1.02-1.19), and a better patient-clinician relationship correlated with less psychological distress (OR 0.84, 0.75-0.95). CONCLUSIONS: We conclude that: (1) Personally meaningful aspects of patients' experience of terminal illness can be represented in valid, multidimensional constructs that are stable over time; (2) They are measurable; and (3) Aspects of the therapeutic relationship appear to correlate with patients' experience of the dying process.

Protecting communities in research: current guidelines and limits of extrapolation.

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed.