Ethics guidelines for research with the recently dead.

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

Private groups enunciate "Baby Doe" principles.

KIE: A group of nine organizations concerned with the rights and treatment of handicapped newborns has issued a statement of "Principles of Treatment of Disabled Infants." The statement reaffirms the rights of ill and disabled newborns and appears to preclude quality of life considerations in decisions concerning medical care. Interpretation of the principles varies among the signatories, however, with the American Academy of Pediatrics differing from the Association for Retarded Citizens in its construction of phrases such as "limited potential" and "clearly futile" surgery.^ieng

"Baby Doe" regs thrown out by court.

KIE: On April 14, 1983, federal district court judge Gerhard Gesell overturned, as "arbitrary and capricious," a Department of Health and Human Services regulation that required hospitals to post notices concerning the illegality of denying life-saving care to handicapped infants and encouraged anyone with knowledge of such a case to report it to HHS via a telephone hotline. This article reviews the evolution and implementation of the HHS regulation, the legal challenge to it, and the judge's ruling.^ieng

"Baby Doe" squad adviser says HHS was insensitive.

KIE: The Department of Health and Human Services has been accused of "insensitive and arbitrary" behavior while investigating a possible violation of its "Baby Doe" regulations by a Rochester, N.Y., hospital. Dr. Frederick Wirth, a Virginia neonatologist who had agreed to advise DHHS teams on the care of handicapped newborns, was sent to Rochester without special authority to review patients' records in New York. DHHS personnel were already at the hospital, examining medical records without permission of the parents. Wirth left, and later told Science that DHHS had exposed him to legal action and violated patient privacy rights.^ieng

Federal court strikes down Baby Doe rules.

KIE: As the result of a suit brought by the American Medical Association and five other medical organizations, a federal district court judge has struck down the February 1984 version of the Department of Health and Human Services' "Baby Doe" regulations. It was the second time a court had denied the government's claim that federal statutes forbidding discrimination against the handicapped give it the authority to intervene in treatment decisions concerning handicapped newborns. At the time of the ruling, no complaints about the care of any infant had been handled by DHHS under the provisions of this latest set of regulations.^ieng

Government intercedes in "Baby Jane Doe".

KIE: Holden outlines events in the "Baby Jane Doe" case leading up to a Department of Justice suit in November 1983 against the State University Hospital in Stony Brook, New York, to obtain the infant's medical records. Parents and physicians had decided against treatment for the severely handicapped newborn, but legal action was begun by right-to-life advocates to appoint a guardian for the child and to order surgery. The Department of Justice became involved after two New York courts ruled against the action; the Department's intervention is based on Section 504 of the Rehabilitation Act, which forbids discrimination against the handicapped.^ieng

HHS preparing to issue new Baby Doe rules.

KIE: Since a U.S. district court struck down its initial "Baby Doe" regulations, the Department of Health and Human Services is preparing a second version of federal rules designed to ensure appropriate treatment of handicapped newborns with life-threatening but correctible conditions. While child advocacy groups support the regulations with some reservations about the intrusive style of enforcement, most medical organizations, led by the American Academy of Pediatrics, are strongly opposed. Both houses of Congress have become involved with the issue by proposing to include handicapped infants under the Child Abuse and Treatment Act.^ieng

Raising consciousness.

The national debate over Terri Schiavo exposed a critical gap between emotional fervor about brain-injured patients and the medical science that informs standards of care for them. Some of the questions raised in the public and legal forums point to a need for research and enhanced understanding of the mechanisms of recovery from disorders of consciousness.

Euthanasia and physician-assisted suicide among patients with amyotrophic lateral sclerosis in the Netherlands.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a disease that causes progressive paralysis leading to respiratory failure. Patients with ALS may consider physician-assisted suicide. However, it is not known how many patients, if given the option, would actually decide to end their lives by physician-assisted suicide or euthanasia nor at what stage of the disease they would choose to do so. METHODS: We identified physicians of 279 patients in the Netherlands with a diagnosis of ALS who died between 1994 and 1999. Physicians were asked to fill out a validated questionnaire about the end-of-life decisions that were made. Of 241 eligible physicians, 203 returned the questionnaire (84 percent). RESULTS: Of the 203 patients, 35 (17 percent) chose euthanasia and died that way. An additional six patients (3 percent) died as a result of physician-assisted suicide. Patients to whom religion was important were less likely to have died as a result of euthanasia or physician-assisted suicide. The choice of euthanasia or physician-assisted suicide was not associated with any particular characteristics of the disease or of the patient's care, nor was it associated with income or educational level. Disability before death was significantly more severe in patients who died as a result of euthanasia than among those who died in other ways. Physician-assisted suicide appeared to occur somewhat earlier in the course of the disease than did euthanasia. An additional 48 patients (24 percent) received palliative treatment, which probably shortened their lives. CONCLUSIONS: In the Netherlands, we found that one in five patients with ALS died as a result of euthanasia or physician-assisted suicide.

Understanding the treatment preferences of seriously ill patients.

BACKGROUND: The questions patients are asked about their preferences with regard to life-sustaining treatment usually focus on specific interventions, but the outcomes of treatment and their likelihood affect patients' preferences. METHODS: We administered a questionnaire about treatment preferences to 226 persons who were 60 years of age or older and who had a limited life expectancy due to cancer, congestive heart failure, or chronic obstructive pulmonary disease. The study participants were asked whether they would want to receive a given treatment, first when the outcome was known with certainty and then with different likelihoods of an adverse outcome. The outcome without treatment was specified as death from the underlying disease. RESULTS: The burden of treatment (i.e., the length of the hospital stay, extent of testing, and invasiveness of interventions), the outcome, and the likelihood of the outcome all influenced treatment preferences. For a low-burden treatment with the restoration of current health, 98.7 percent of participants said they would choose to receive the treatment (rather than not receive it and die), but 11.2 percent of these participants would not choose the treatment if it had a high burden. If the outcome was survival but with severe functional impairment or cognitive impairment, 74.4 percent and 88.8 percent of these participants, respectively, would not choose treatment. The number of participants who said they would choose treatment declined as the likelihood of an adverse outcome increased, with fewer participants choosing treatment when the possible outcome was functional or cognitive impairment than when it was death. Preferences did not differ according to the primary diagnosis. CONCLUSIONS: Advance care planning should take into account patients' attitudes toward the burden of treatment, the possible outcomes, and their likelihood. The likelihood of adverse functional and cognitive outcomes of treatment requires explicit consideration.

Withdrawal of mechanical ventilation in anticipation of death in the intensive care unit.

BACKGROUND: In critically ill patients who are receiving mechanical ventilation, the factors associated with physicians' decisions to withdraw ventilation in anticipation of death are unclear. The objective of this study was to examine the clinical determinants that were associated with the withdrawal of mechanical ventilation. METHODS: We studied adults who were receiving mechanical ventilation in 15 intensive care units, recording base-line physiological characteristics, daily Multiple Organ Dysfunction Scores, the patient's decision-making ability, the type of life support administered, the use of do-not-resuscitate orders, the physician's prediction of the patient's status, and the physician's perceptions of the patient's preferences about the use of life support. We examined the relation between these factors and withdrawal of mechanical ventilation, using Cox proportional-hazards regression analysis. RESULTS: Of 851 patients who were receiving mechanical ventilation, 539 (63.3 percent) were successfully weaned, 146 (17.2 percent) died while receiving mechanical ventilation, and 166 (19.5 percent) had mechanical ventilation withdrawn. The need for inotropes or vasopressors was associated with withdrawal of the ventilator (hazard ratio, 1.78; 95 percent confidence interval, 1.20 to 2.66; P=0.004), as were the physician's prediction that the patient's likelihood of survival in the intensive care unit was less than 10 percent (hazard ratio, 3.49; 95 percent confidence interval, 1.39 to 8.79; P=0.002), the physician's prediction that future cognitive function would be severely impaired (hazard ratio, 2.51; 95 percent confidence interval, 1.28 to 4.94; P=0.04), and the physician's perception that the patient did not want life support used (hazard ratio, 4.19; 95 percent confidence interval, 2.57 to 6.81; P<0.001). CONCLUSIONS: Rather than age or the severity of the illness and organ dysfunction, the strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physician's predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors.

Experiences of Oregon nurses and social workers with hospice patients who requested assistance with suicide.

BACKGROUND: Oregon's 1997 Death with Dignity Act legalizes physician-assisted suicide. To date, information about patients who have requested this option has come from surveys of physicians. Although 78 percent of the 91 Oregonians who have died by assisted suicide were enrolled in hospice programs, there is little information about the experiences of hospice practitioners with these patients. METHODS: In 2001, we mailed a questionnaire to all hospice nurses and social workers in Oregon. RESULTS: Of 545 eligible hospice nurses and social workers, 397 (73 percent) returned the survey, including 71 percent of nurses and 78 percent of social workers. Since November 1997, 179 of the respondents (45 percent) had cared for a patient who requested assistance with suicide. Hospice nurses reported on 82 patients who had received prescriptions for lethal medication. Ninety-eight percent of the nurses had discussed the request with a coworker, and 77 percent of the requests had been presented at a hospice interdisciplinary conference on patient care. A very important reason for the request was to control the circumstances of death. The least important reasons included depression, lack of social support, and fear of being a financial drain on family members. Although the patients were concerned about burdening others, only 11 percent of hospice nurses rated their family caregivers as more burdened than family caregivers for other hospice patients. CONCLUSIONS: Since assisted suicide was legalized in Oregon, many hospice nurses and social workers have provided care for a patient who requested assistance with suicide. They rated desire for control as a very important reason for these requests.

Nurses' experiences with hospice patients who refuse food and fluids to hasten death.

BACKGROUND: Voluntary refusal of food and fluids has been proposed as an alternative to physician-assisted suicide for terminally ill patients who wish to hasten death. There are few reports of patients who have made this choice. METHODS: We mailed a questionnaire to all nurses employed by hospice programs in Oregon and analyzed the results. RESULTS: Of 429 eligible nurses, 307 (72 percent) returned the questionnaire, and 102 of the respondents (33 percent) reported that in the previous four years they had cared for a patient who deliberately hastened death by voluntary refusal of food and fluids. Nurses reported that patients chose to stop eating and drinking because they were ready to die, saw continued existence as pointless, and considered their quality of life poor. The survey showed that 85 percent of patients died within 15 days after stopping food and fluids. On a scale from 0 (a very bad death) to 9 (a very good death), the median score for the quality of these deaths, as rated by the nurses, was 8. On the basis of the hospice nurses' reports, the patients who stopped eating and drinking were older than 55 patients who died by physician-assisted suicide (74 vs. 64 years of age, P<0.001), less likely to want to control the circumstances of their death (P<0.001), and less likely to be evaluated by a mental health professional (9 percent vs. 45 percent, P<0.001). CONCLUSIONS: On the basis of reports by nurses, patients in hospice care who voluntarily choose to refuse food and fluids are elderly, no longer find meaning in living, and usually die a "good" death within two weeks after stopping food and fluids.

Terminal sedation and euthanasia: a comparison of clinical practices.

BACKGROUND: An important issue in the debate about terminal sedation is the extent to which it differs from euthanasia. We studied clinical differences and similarities between both practices in the Netherlands. METHODS: Personal interviews were held with a nationwide stratified sample of 410 physicians (response rate, 85%) about the most recent cases in which they used terminal sedation, defined as administering drugs to keep the patient continuously in deep sedation or coma until death without giving artificial nutrition or hydration (n = 211), or performed euthanasia, defined as administering a lethal drug at the request of a patient with the explicit intention to hasten death (n = 123). We compared characteristics of the patients, the decision-making process, and medical care of both practices. RESULTS: Terminal sedation and euthanasia both mostly concerned patients with cancer. Patients receiving terminal sedation were more often anxious (37%) and confused (24%) than patients receiving euthanasia (15% and 2%, respectively). Euthanasia requests were typically related to loss of dignity and a sense of suffering without improving, whereas requesting terminal sedation was more often related to severe pain. Physicians applying terminal sedation estimated that the patient's life had been shortened by more than 1 week in 27% of cases, compared with 73% in euthanasia cases. CONCLUSIONS: Terminal sedation and euthanasia both are often applied to address severe suffering in terminally ill patients. However, terminal sedation is typically used to address severe physical and psychological suffering in dying patients, whereas perceived loss of dignity during the last phase of life is a major problem for patients requesting euthanasia.

The accuracy of surrogate decision makers: a systematic review.

BACKGROUND: Clinicians currently rely on patient-designated and next-of-kin surrogates to make end-of-life treatment decisions for incapacitated patients. Surrogates are instructed to use the substituted judgment standard, which directs them to make the treatment decision that the patient would have made if he or she were capacitated. However, commentators have questioned the accuracy with which surrogates predict patients' treatment preferences. METHODS: A systematic literature search was conducted using PubMed, the Cochrane Library, and manuscript references, to identify published studies that provide empirical data on how accurately surrogates predict patients' treatment preferences and on the efficacy of commonly proposed methods to improve surrogate accuracy. Two of us (D.I.S. and D.W.) reviewed all articles and extracted data on the hypothetical scenarios used to assess surrogate accuracy and the percentage of agreement between patients and surrogates. RESULTS: The search identified 16 eligible studies, involving 151 hypothetical scenarios and 2595 surrogate-patient pairs, which collectively analyzed 19 526 patient-surrogate paired responses. Overall, surrogates predicted patients' treatment preferences with 68% accuracy. Neither patient designation of surrogates nor prior discussion of patients' treatment preferences improved surrogates' predictive accuracy. CONCLUSIONS: Patient-designated and next-of-kin surrogates incorrectly predict patients' end-of-life treatment preferences in one third of cases. These data undermine the claim that reliance on surrogates is justified by their ability to predict incapacitated patients' treatment preferences. Future studies should assess whether other mechanisms might predict patients' end-of-life treatment preferences more accurately. Also, they should assess whether reliance on patient-designated and next-of-kin surrogates offers patients and/or their families benefits that are independent of the accuracy of surrogates' decisions.

Physicians' decisions to withhold and withdraw life-sustaining treatment.

BACKGROUND: Few data are available about physicians' decisions in regard to withholding or withdrawing life-sustaining measures. We therefore studied internists' views on this subject. METHODS: We surveyed 1000 generalist and subspecialist internists about their views on withholding or withdrawing life-sustaining treatment. Thirty-two hypothetical cases were included. The effect of the demographic data on withholding or withdrawing treatment was analyzed via analysis of covariance and multiple logistic regression. RESULTS: Of 1000 internists, 407 (41%) completed and returned surveys. A majority of respondents (51%) were willing to withhold or withdraw treatment in all 32 scenarios; 49% were unwilling to withhold or withdraw in at least 1 scenario. Respondents were likely to withhold treatment in 14 of 16 scenarios compared with 13.7 of 16 scenarios for withdrawing treatments (P<.001). Respondents withheld or withdrew feeding tubes in 6.6 of 8 scenarios (P<.001) and antibiotics in 6.7 of 8 scenarios (P = .001) compared with ventilators (7.1 of 8 scenarios) and dialysis (7.3 of 8 scenarios). Respondents were less likely to withhold or withdraw treatments in nonterminally ill (12.9 of 16 scenarios) (P = .02) and alert patients (13.2 of 16 scenarios) (P<.001) compared with terminally ill patients (14.9 of 16 scenarios) and patients with dementia (14.5 of 16 scenarios). CONCLUSIONS: A large percentage of internists would be unwilling to adhere to some of patients' wishes to withhold or withdraw life-sustaining treatment. The clinical scenario and type of treatment affect internists' decisions about whether they would withhold or withdraw such treatment.

Attitudes of patients with incurable cancer toward medical treatment in the last phase of life.

PURPOSE: When cancer has advanced to a stage in which cure becomes unlikely, patients may have to consider the aim of further treatment. We studied the relationship of patients' attitudes toward treatment with advance care planning and the development of these attitudes after diagnosis of incurable cancer. PATIENTS AND METHODS: Patients with incurable cancer were interviewed and asked to fill out a written questionnaire about their attitudes concerning life-prolonging treatment and end-of-life decision making. These questions were repeated after 6 and 12 months. RESULTS: One hundred twenty-two patients (mean age, 64 years; standard deviation, 10.5 years; 53% women) participated in the study. Patients' attitudes toward treatment could be categorized into the following three different profiles: striving for quality of life, striving for length of life, and no clear preference. Patients who were older, more tired, or had less positive feelings and patients who had more often taken initiatives to engage in advance care planning were more inclined to strive for quality of life than others. Patients with a history of cancer of less than 6 months were more inclined to prefer life prolongation than patients with a longer history of cancer. During follow-up, no changes in attitudes toward treatment were found, except for patients with a short history of cancer in whom the inclination to strive for length decreased. CONCLUSION: Patients who appreciate advance care planning were more inclined to strive for quality of life than other patients. Shortly after the diagnosis of cancer, patients typically seem to prefer life-prolonging treatment, whereas quality of life becomes more important when death is nearing.

Inadequate anaesthesia in lethal injection for execution.

Anaesthesia during lethal injection is essential to minimise suffering and to maintain public acceptance of the practice. Lethal injection is usually done by sequential administration of thiopental, pancuronium, and potassium chloride. Protocol information from Texas and Virginia showed that executioners had no anaesthesia training, drugs were administered remotely with no monitoring for anaesthesia, data were not recorded and no peer-review was done. Toxicology reports from Arizona, Georgia, North Carolina, and South Carolina showed that post-mortem concentrations of thiopental in the blood were lower than that required for surgery in 43 of 49 executed inmates (88%); 21 (43%) inmates had concentrations consistent with awareness. Methods of lethal injection anaesthesia are flawed and some inmates might experience awareness and suffering during execution.

Medical end-of-life decisions in neonates and infants in Flanders.

BACKGROUND: Paediatricians are increasingly confronted with end-of-life decisions in critically ill neonates and infants. Little is known about the frequency and characteristics of end-of-life decisions in this population, nor about the relation with clinical and patients' characteristics. METHODS: A death-certificate study was done for all deaths of neonates and infants in the whole of Flanders over a 12 month period (August, 1999, to July, 2000). We sent an anonymous questionnaire by mail to the attending physician for each of the 292 children who died under the age of 1 year. Information on patients was obtained from national registers. An attitude study was done for all physicians who attended at least one death during the study period. FINDINGS: 253 (87%) of the 292 questionnaires were returned, and 121 (69%) of the 175 physicians involved completed the attitude questions. An end-of-life decision was possible in 194 (77%; 95% CI 70.4-82.4) of the 253 deaths studied, and such a decision was made in 143 cases (57%; 48.9-64.0). Lethal drugs were administered in 15 cases among 117 early neonatal deaths and in two cases among 77 later deaths (13%vs 3%; p=0.018). The attitude study showed that 95 (79%; 70.1-85.5) of the 121 physicians thought that their professional duty sometimes includes the prevention of unnecessary suffering by hastening death and 69 (58%; 48.1-66.5) of 120 supported legalisation of life termination in some cases. INTERPRETATION: Death of neonates and infants is commonly preceded by an end-of-life decision. The type of decision varied substantially according to the age of the child. Most physicians favour legalisation of the use of lethal drugs in some cases.

Medical end-of-life decisions made for neonates and infants in the Netherlands, 1995-2001.

End-of-life decision-making for severely affected infants might be influenced by technical advances and societal debates. In 2001, we assessed the proportion of deaths of infants younger than 1 year that were preceded by end-of-life decisions, by replicating a questionnaire study from 1995. This proportion increased from 62% to 68% (weighted percentages), but the difference was not significant. Most of these decisions were to forgo life-sustaining treatment. Decisions to actively end the lives of infants not dependent on life-sustaining treatment remained stable at 1%. The practice of end-of-life decision-making in neonatology of 2001 has changed little since 1995.