Life-sustaining Technology Research Articles

Evaluation of an EOL Critical Care Nurse Liaison Program

Death in the critical care area of hospitals is often preceded by withdrawal of life-sustaining technology, creating immeasurable stress and grief for patients and the families of the person dying. This study was designed to evaluate a critical care nurse liaison program to determine its effectivene

Pacemaker and ICD Malfunction—An Incomplete Picture

IN THIS ISSUE OF JAMA, THE REPORTS BY MAISEL AND COLleagues and by Gould and Krahn represent substantial pieces of an information mosaic that is developing about life-sustaining and life-saving implantable arrhythmia device technologies. It is apparent, not only to the medical community, but also to patients, the press, regulators, investors, and the legal community, that this information mosaic is complex. The technologies are complex. The medical issues are complex. The ethical issues are complex. The financial issues are complex. No effort should trivialize this complexity or oversimplify and produce “the solution” without understanding that the information comes with gaps and never forms more than an incomplete mosaic. These 3 studies provide new data to inform the most important issue—how physicians and patients should make individual decisions regarding pacemaker or implantable cardioverter-defibrillator (ICD) surgery. In the first study, Maisel uses meta-analysis to evaluate the incidence of pacemaker and ICD malfunction requiring device explantation. There are strengths and weaknesses in this approach. A significant strength is the longitudinal perspective, providing outcomes for pacemakers from 1983 through 2004 and for ICDs from 1988 through 2004. Unfortunately, only 3 registries contributed data to the meta-analysis. The Bilitch North American Registry was voluntary and not a complete registration of all devices, representing 6 pacemaker sites and 13 ICD sites that ended malfunction reporting in 1993. The UK National Pacemaker and ICD Registry included all pacemaker and ICD implantations in the United Kingdom and Republic of Ireland but contributed data on pacemaker malfunction only from 1983 through 2004. The Danish Pacemaker and ICD Registry reported information about all devices implanted in every Danish center (14 pacemaker and 5 ICD) and contributed malfunction data between 1994 and 2004. The consistency of the reported pacemaker malfunction incidence between the Bilitch and UK registries from 1983 through 1993 and between the UK and Danish registries between 1994 and 2004 is reassuring. However, a noteworthy regional difference was noted in 2001, with a substantially higher pacemaker malfunction rate in the Danish Registry related to an unfortunate choice of a pacemaker model. Although there was a clear decline in the pacemaker malfunction rate with a leveling of the incidence from 1988 through 2004, the trends for the ICD patients (dependent on the Bilitch Registry from 1988-1993 and the Danish Registry from 1994-2004) are much less clear and appear to vary significantly. In a second study, Maisel et al estimate the rate of device malfunction using the number of manufacturerconfirmed malfunctions that caused device explantation as reported to the US Food and Drug Administration (FDA) through annual reports, as compared with the number of device implantations each year, between 1990 and 2002. This is a substantially different methodology with an end point similar to that of the meta-analysis approach that was indexed to device prevalence. Although no attempt was made to measure the number of devices at risk for malfunction, “all” device explantations due to device malfunction were counted. The strength of this approach is the enormous number of devices (2.25 million pacemakers and 415 780 ICDs) that were implanted in the United States and therefore at risk for premature explantation and analysis. Despite the magnitude of this data set, there are 3 substantial gaps in the data. Manufacturers and hospitals are required to report by FDA regulation all pacemaker and ICD malfunctions, especially those that result in a surgery. However, some device malfunctions may be missed due to poor communication, failed administrative issues in the operating room, or inconsistent physician reporting. A second, more important, gap is that patients who die either with or possibly in part related to a malfunctioning device may be missed. Third, and perhaps most important, pacemakers and ICDs are dependent on the entire implanted system to function properly. The device, the leads, the chosen programmed parameters, and the patient’s response are all interdependent. The system malfunction rate may be the most impor-

What Would Terri Want? On the Psychological Challenges of Surrogate Decision Making

ABSTRACT The Terri Schiavo case was unique in the media attention it garnered, but the decision making challenges faced by Terri's family are common ones encountered by all families who must make choices about the use of life-sustaining medical treatment for an incapacitated loved one. This article highlights three key issues that were particularly problematic in the Schiavo case, but that represent general psychological challenges inherent to the task of surrogate decision making. The 3 central points of uncertainty, and therefore conflict, in the Schiavo case concerned: (a) the appropriate standard by which medical decisions for Terri should be made, (b) the specific nature of Terri's wishes about the use of life-sustaining medical technology, and (c) the true extent of disability and prognosis for recovery represented by Terri's medical condition. No simple remedy is possible that will resolve all of the uncertainties inherent to surrogate decision making, but some general strategies for improving the quality of end-of-life medical decisions are discussed.

The Costs of Caring: Who Pays? Who Profits? Who Panders?

Avastin, a widely used colon cancer drug manufactured by San Francisco-based biotech company Genentech, has proven a somewhat effective treatment for lung and breast cancer when administered at twice normal dose. In February, New York Times carried a story about Avastin's extraordinarily high price when used in this alternative way: $100,000 for one year's treatment--a figure fully twice price of normal dose, even though producing higher dose costs company little additional money. And treatment yields only an average gain in life expectancy of five months--very modest relative to cost. What garnered media attention, however, was Genentech's novel justification for price: the inherent value of these life-sustaining technologies. (1) Rather than making usual appeal to high research costs, company cited pricelessness of human life, implying a moral reason for pricing decision. I will pass in silence over obviously self-serving disingenuousness of this appeal. The fact is that many in our society--and perhaps a substantial majority--think human life should be thought of as priceless. That assertion can be taken in three very different ways. We can take pricelessness of human life to mean that social worth of an individual (their social status or contribution to national economy) should be completely irrelevant when it comes to determining how much society should spend to save or prolong that individual's life in face of a life-threatening illness or accident--a worthy moral principle. Likewise, we should affirm nonutilitarian view that cost of saving either a life or a life-year should not determine by itself what will count as a just allocation of limited health resources when we cannot afford to save all life-years medical technology may salvage. But we need to reject view that we have a moral obligation to spend any amount of money to save all lives and life-years that medical technology permits. The result of adopting this view would be a gross distortion in our society's health care priorities that would not be just, compassionate, or prudent. To see why this is true, let us look at some facts and reasonable projections. Health spending in United States topped $1.8 trillion in 2004, roughly 16.3 percent of our gross domestic product (GDP), compared to 5.2 percent in 1960. Projections to 2015 show us spending more than $4 trillion on health care then--almost 20 percent of expected GDP. (2) Medicare spending in 2005 was about $330 billion. With deployment of prescription drug benefit in 2006, spending will be about $424 billion--a price tag expected to rise by 2014 to $747 billion. Over ten-year period ending in 2015, Medicare spending will exceed $4 trillion. (3) These figures are socially and politically problematic, especially in light of growing federal deficits. Health policy analysts generally agree that emerging medical technologies drive escalating health costs. (4) Yet they and public feel medical innovation should not be slowed or stopped--a conclusion I endorse as well. However, if we couple this belief with that third sense of pricelessness of human life, results are morally and economically disastrous. The problems posed by pricey medical innovation combined with a belief in pricelessness of human life began with passage of 1972 End Stage Renal Disease (ESRD) amendments to Medicare program. Those amendments created a program that would pay for renal dialysis or transplant for virtually any U.S. citizen in kidney failure. The program was motivated by fact that thousands of patients died every year in late 1960s because they could not afford cost of dialysis (roughly $90,000 a year per patient in 2005 dollars). The rhetoric at time was that no one should be denied access to effective, life-sustaining medical technology simply because they could not afford it, and society pressured Congress to pass program quickly. …

Pediatric Palliative Care: Relationships Matter and So Does Pain Control

More than 50,000 children die each year in the United States, and hundreds of thousands more struggle with the challenges of a life-threatening condition. Much about their tragic circumstances is beyond medicine’s control. Nevertheless, three articles in this issue provide new insights into the needs of these children and their parents. Careful reading of these studies suggests concrete steps committed clinicians can take to help meet those needs. A theme across all three studies is clear: relationships matter. In addition, two of the studies bring attention to the continuing problem of unrelieved pain near the end of life. Because modern medicine does have the technical means to reduce nearly all pain, it can be argued that the failure to do so is not a technical failing but rather a symptom of insufficient commitment. Viewed this way, all three articles underscore the centrality of nonabandonment. They underscore the importance of staying connected with patients and families and providing the best that medicine can offer, including both human contact and palliative interventions like optimal pain medication, even and especially when death is imminent. Hinds et al surveyed pediatric patients with advanced cancer, who were aged 10 to 20 years old, within 7 days of participating in one of following three end-of-life decisions: whether to enroll in a phase I trial, whether to institute a do not resuscitate order, and whether to forego life-sustaining technologies in favor of palliative care measures only. They found that these children and adolescents realized they were involved in an end-of-life decision, understood the consequences of their decision (that death is the outcome no matter what and that a phase I trial brings personal hazards but may help others), and could share the reasons for their preferences. In short, Hinds et al demonstrate that older children and particularly adolescents have sufficient cognitive ability to warrant an active role in decision making about their care. Moreover, both children and adolescents were influenced by their concern about others. Sometimes, this manifested as concern to act in ways that would make their parents happy (for example, by enrolling in the phase I trial even when they did not wish to). However, both children and their parents were also often motivated out of concern for others not personally known to them. The authors report this altruistic stance toward strangers as surprising because at least one study has documented that altruism is not a major motivator of phase I trial enrollment for adults, and they speculate that such altruism among the young people they surveyed may be part of the maturational effect of a life-ending illness on a child or adolescent. It also strikes us that altruism may be more important among gravely ill children and their parents than among adults near the end of life because of the desire to see some good arise in the context of such great despair. The poignancy of a young life cutoff so prematurely may provide a context in which both the children and their parents seek a way to make something good happen in an otherwise deeply tragic situation. There are studies documenting that, after death, parents have found meaning and solace in the opportunity to donate their children’s organs. There may be a similar underlying urge, even among the children themselves, to choose actions before death that will enable them to make a positive contribution to others as part of their legacy. These explanations are only speculative but are worthy of further exploration in future research. Mack et al surveyed parents of children who had died of cancer and their oncologists to ascertain parents’ and physicians’ assessments of the quality of care the children had received. A full 82% of the parents felt that the quality of physician care at the end of life was excellent or very good. However, the better the communication between physicians and parents, the greater was the parental assessment of JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 23 NUMBER 36 DECEMBER 2

Pathogenesis of ventilator-induced lung injury: trials and tribulations

research into ventilator-induced lung injury (VILI) spans the decades since this life-sustaining technology was introduced into widespread clinical use in the mid-twentieth century ([24][1]). Early on, it was recognized that lungs ventilated with high ventilatory pressures have a propensity to

Views of patients with gynecologic cancer about the end of life

This study was designed as a descriptive work assessing the reactions of gynecologic cancer patients to poor prognosis, determining their desires for the location of terminal care, and their preferences about life-sustaining technology. The study was carried out between 2002 and 2003 in a gynecologic oncology clinic of a university hospital located in Istanbul. Data were collected through interviews with 68 patients with gynecologic cancers. Collected data were analyzed through content analysis. It was found that survival is utterly important for the patients and that they wish to stay at hospitals as inpatients and receive life-sustaining treatments during the end-stage disease.

Living Will, Resuscitation Preferences, and Attitudes towards Life in an Aged Population

Background: The growth of life-sustaining medical technology and greater attention to medical care at the end of life have provoked interest in issues related to advance care planning. Objective: To investigate how having a living will (LW), resuscitation preferences, health condition, and life attitudes are related in home-dwelling elderly people. Methods: In a cross-sectional descriptive study, detailed assessments were made of 378 home-dwelling elderly individuals participating in a cardiovascular prevention study (DEBATE Study). The participants were inquired about a preexistence of a written document (LW) concerning life-sustaining care, preferences of cardiopulmonary resuscitation (CPR) in their current situation, and attitudes towards life. General health, physical and cognitive functioning, the presence of depression, and quality of life were also assessed. Results: Forty-four of the 378 participants (12%) had a LW. As compared with those without one (n = 334), there were more women [82% (36/44) vs. 63% (210/334)] and widows [57% (25/44) vs. 41% (135/334)] among those with a LW. They were also more educated and considered their health to be better. Despite having a LW, 46% (20/44) of them preferred CPR in their current condition, a proportion not statistically different from the 58% (194/334) of the individuals without a LW. In the whole sample, 39% (149/378) of the individuals preferred to forgo CPR. As compared with those preferring CPR, they were older, more often women, and widowed. Participants preferring to forgo CPR had a poorer quality of life, were more lonely, and showed signs of depression more often than those preferring CPR. The preference to forgo CPR was related to attitudes towards life regardless of physical or cognitive functioning. Conclusions: Having a LW does not reduce the reported preference of CPR which is related more to current mental status and life attitudes. In-depth assessment of the patient’s preferences should be performed in any comprehensive care plan.

Legal implications for failure to comply with advance directives: an examination of the incompetent individual's right to refuse life-sustaining medical treatment.

Life-sustaining medical technology in the past century has created a growing body of case law and legislation recognizing the incompetent individual's right to make his or her own end-of-life decisions. This article focuses on California's leadership in the area of these specific end-of-life issues: specifically, exploring the right of an incompetent individual to refuse life-sustaining medical treatment. The article examines advance directives along with various judicial decision-making standards for incompetent individuals and explores the sociobehavioral and legal rationale for compliance with incompetent individual's rights to make end-of-life decisions. Finally this article concludes (i) that advance directives allow competent individuals to state the medical treatment they would prefer in the event they should later become incompetent and (ii) that when advance directives are properly executed in a detailed manner, under laws currently in effect in some jurisdictions, the preferences stated in the directive bind health care providers.

Metabolic replacement of kidney function in uremic animals with a bioartificial kidney containing human cells

Current renal substitution therapy with hemodialysis or hemofiltration has been an important life-sustaining technology, but it still has suboptimal clinical outcomes in patients with end-stage renal disease or acute renal failure. This therapy replaces the small solute clearance function of the glomerulus but does not replace the metabolic and endocrinologic functions of the tubular cells. This article shows that the combination of a synthetic hemofiltration cartridge and a renal tubule cell assist device (RAD) containing human cells in an extracorporeal circuit replaces filtration, metabolic, and endocrinologic functions in acutely uremic dogs. The RAD maintained excellent performance and durability characteristics for 24 hours of continuous use in the uremic animals. The RAD increased ammonia excretion, glutathione metabolism, and 1,25-dihydroxyvitamin D3 production. Cardiovascular stability in the animals was documented in these studies during this extracorporeal treatment. With these results, clinical evaluation of this device in the treatment of severely ill patients with acute renal failure in an intensive care unit has been initiated.

Critical Illness in the Elderly: Review of Pathophysiology of Aging and Outcome of Intensive Care

The goal of this article is to review the literature on age and its influence on the pathophysiology of critical illness, outcome after critical illness, and end of life decision making in critically ill elderly patients. Sources for this review included the MEDLINE database and bibliographies of original articles, reviews, and book chapters. The population is aging and the need for medical care and its costs increase with increasing age. A majority of the elderly lead independent lives, although some need help with various functional activities related to daily living. It is difficult to separate the effects of aging from the effects of the comorbidities that develop with increasing age. The physiologic reserve decreases in the elderly and they may not be able to tolerate a critical injury or illness as well as a younger individual. As the elderlyare usually on multiple medications, they are prone to have more drug interactions and side effects, and need close monitoring of the drugs and adjustment of the dosage. Mortality after a critical illness in the elderly is higher compared to younger patients, and it is more related to the acuity of physiologic disturbance than age alone. The effect of age alone on long-term outcome is not well studied, but individuals with poor functional status and/or increased comorbidities have a poor short-term outcome. Functional status usually deteriorates after critical illness, but the long-term survivors usually recover functional abilities, and they are satisfied with their quality of life. Decision making at the end of life is difficult because of the paucity of data on long-term mortality and quality of life, lack of information about patient wishes, and the uncertainty of the prognosis. Because many elderly patients survive critical illness and may return to their previous lifestyle, age alone should not weigh heavily in end of life decisions. As with other age groups, end of life decisions in the elderly should be made after considering long-term outcomes, patient goals, and the benefits and burdens of life-sustaining technology.

The medical ethics of physician-assisted suicide.

Absolute prohibitions of physician assistance in suicide have long been canonical in medical ethics, but a powerful reformation of views on euthanasia and physician-assisted suicide is now underway in several...

Ethical issues in the intensive care unit

T ODAY'S PRACTICING intensivist is likely to face ethically challenging situations with regularity. This is because in addition to the background frequency of ethical issues encountered in general practice, intensivists work in an environment in which end-of-life decisions are made commonly and life-sustaining technology is readily available, greatly increasing the frequency of these scenarios. To deal effectively with ethically charged situations in the intensive care unit (ICU), perhaps the most important tool is a solid grounding in the basics of medical decision making. Accordingly, this report provides the reader with a discussion of informed consent and surrogate decision making, as well as sections that address factors that may modify these general approaches, such as the role of family interests in medical decision making and the possible futility of medical intervention. Beyond these issues, decisions to forego lifesustaining therapy merit special consideration for the intensivist. Therefore, we end with a section on the ethical considerations surrounding this important and frequently difficult situation.

Giving "moral distress" a voice: ethical concerns among neonatal intensive care unit personnel.

Advances in life-sustaining medical technology as applied to neonatal cases frequently present ethical concerns with a strong emotional component. Neonates delivered in the “gray area” gestation period of approximately 23–25 weeks may result in situations where various people involved in such cases may feel “held hostage” to technological imperatives. Legal decisions and standards have evolved that are discordant with the views of many clinicians most familiar with the treatment of such patients. Increasing concerns regarding such scenarios have fueled much academic and professional debate about the need for consensus about ethical limits to clinical interventions with high probability of nonbeneficial impact. While at least some clinicians and ethicists may be inching toward consensus regarding limits to such treatment, the voices of some bedside personnel, particularly neonatal intensive care unit (NICU) nurses, have been relatively muted in this debate. At least one previous survey of clinicians, which included nurses, indicated that many nurses experienced a high level of “moral distress” regarding aggressive courses of treatment for some patients. Some of this distress results from a feeling of powerlessness regarding treatment decisions, coupled with a high intensity of hands-on contact with the patients and family. Lack of authority coupled with high responsibility may itself be a recipe for a different kind of futility.

Public information and private search: evaluating the Patient Self-Determination Act.

Despite substantial regulatory efforts to improve consumer information regarding health and health care, little is known about the impact of such efforts on consumer behavior. This article examines the effect of federal legislation to enhance consumer information regarding the use of life-sustaining technology in end-of-life medical treatment decision making. Using a unique set of data abstracted from the medical records of six hundred elderly patients in nursing homes, the study finds a substantial impact of the law in promoting improved documentation of patient wishes for end-of-life medical care. Further, the data reveal that the effect of the law varies among identifiable subgroups. Consistent with the theory of search, the article demonstrates that the effects of regulatory efforts that promote the public provision of consumer information are greatest among individuals for whom information is most beneficial but for whom private search is costly. Implications for health policy are discussed.

Patients' perceptions of their experiences with ESRD and hemodialysis treatment.

A grounded theory methodology was used to explore patients' experiences with end-stage renal disease (ESRD) and hemodialysis. The emerging theory suggests that a "new sense of self" is an emotional/psychological state that fluctuates with the evolving meanings of illness and treatment and perceived quality of supports. The findings indicate that when confronted with this new way of being in the world, the individual becomes cognizant of an uncertain future, continued dependence on life-sustaining technology and the expertise of health care providers, and the demands on and sacrifices incurred by significant others. All aspects of patients' experiences with ESRD and hemodialysis treatment must be considered if health care providers are to facilitate positive health outcomes.

End of life decisions in amyotrophic lateral sclerosis: a cross-cultural perspective

In an era where life-sustaining technology offers physicians unprecedented powers to prolong survival in terminal illness, the question of how end of life decisions are made has become a major subject of study and debate. Amyotrophic lateral sclerosis (ALS) is a disease in which physical ability declines while mental capacity most often remains intact. Since most patients with ALS die of respiratory failure, a distinguishing feature of this disease is whether a patient is offered and accepts a chance to go on long-term mechanical ventilation. This unusual feature makes ALS a compelling model for studying end of life decisions in different countries. This paper reviews the literature and presents preliminary data on how end of life decisions in ALS are made in the US, Great Britain, and Japan. We address this issue by examining how cultural differences in truth-telling and informed consent, societal differences in attitudes toward the use of artificial life support, and legal differences in the role and status of advance directives in each country influenced decisions in the following three groups of patients: (1) the mentally competent; (2) mentally incompetent patients who previously completed advance directives when competent; and (3) mentally incompetent patients who have not provided advance guidance about their wishes.

The right to refuse treatment is not a right to be killed.

It is widely accepted now that a patient's right to refuse treatment extends to circumstances in which the exercise of that right may lead to the patient's death. However, it...

Attitudes of college students about physician-assisted suicide: the influence of life experiences, religiosity, and belief in autonomy.

This study describes attitudes of college students about physician-assisted suicide, analyzes key factors that predict attitudes on this issue, and compares these attitudes with those regarding other forms of end-of-life actions. Data were collected via personal interviews with 200 randomly selected students at a 4-year college. A majority of respondents believe that a physician should be able to assist in the suicide of a terminally ill person who requests help, though larger percentages support the withholding or withdrawing of life-sustaining technology and the right of a terminally ill person to end his or her own life. Results of multiple regression analysis determine that the key predictors of this attitude are student's level of religiosity (students higher in religiosity are more likely to disapprove) and belief in autonomy as a philosophical principle (students placing more value on autonomy are more likely to approve). Respondent's sex, cumulative grade point average, and amount of exposure to these issues are not significant predictors.

Medical specialists prefer to withdraw familiar technologies when discontinuing life support.

To assess how members of different specialties vary in their decisions about which form of life support to withdraw. The hypothesis was that each specialty would be more comfortable withdrawing its "own" form of life support relative to other forms and other specialties. Mail survey. 24 medical centers. 225 specialists in six specialties and 225 comparison physicians randomly matched according to percentage of time devoted to clinical practice. The six specialties were linked with six life-sustaining technologies related to their special expertise: 1) pulmonologists with mechanical ventilation, 2) nephrologists with hemodialysis, 3) gastroenterologists with tube feedings, 4) hematologists with blood products, 5) cardiologists with intravenous vasopressors, and 6) infectious disease specialists with antibiotics. The subjects ranked different forms of life support in the order in which they would prefer to withdraw them. They also expressed their preferences in response to hypothetical clinical vignettes. In five of the six specialties, the specialists had a relative preference for withdrawing their "own" form of life support, compared with the preferences of the comparison physicians. Overall, the physicians tended to prefer withdrawing a form of life support closely linked with their own specialty. Just as some specialist physicians tend to reach for different technologies first in treating patients, they also tend to reach for different technologies first when ceasing treatment. Specialists' preferences for different ways to withdraw life support not only may reflect a special understanding of the limits of certain technologies, but also may reveal how ingrained are physicians' patterns of practice.