Futility and Rationing NANCYS. JECKER,P~.D., Scn Diego, California
Seattle, Washington, LAWRENCE J. SCHNEIDERMAN, M.D.,
It seems more than coincidental that at a time of great concern over rising health care costs and fears of rampant technology, debates are suddenly taking place about medical futility and health care rationing. This article examines the economic, historical, and demographic factors that have motivated increased attention to both these concepts, explores differences and similarities in the meaning of these terms, and discusses their ethical implications. Specifically, we identify four common sources of current debates on futility and rationing: the rise in health care costs; the development of high-technology medicine; the aging of society; and the effort to limit the scope of patient autonomy. We propose that when rationing criteria refer to medical benefit, the meanings of futility and rationing share certain common features. Futility and rationing differ, however, in important ways. Futility refers to treatment and outcome relationships not in a general population but in a specific patient. Rationing criteria usually are supported by reference to theories of justice, whereas the definition of futility, if achieved, will probably be arrived at by empirical community agreement. Rationing always occurs against a backdrop of resource scarcity, but futility need not. Toward the end of the paper, we clarify how the various connotations and contexts we associate with each term enhance or frustrate ethical debate.
From the University of Washington (NSJ), School of Medicine, Department of Medical History and Ethics and Department of Philosophy, Seattle, Washington, and the University of California at San Diego (LJS), School of Medicine, Department of Community and Family Medicine and Department of Medicine, San Diego, California. This work was presented in 1991 at Stanford University School of Medicine and at the Annual Meeting of the Society for Health and Human Values. Requests for reprints should be addressed to Nancy S. Jecker, Ph.D., University of Washington School of Medicine, Department of Medical History and Ethics, SB-20. Seattle, Washington 98195. Manuscript submitted June 4, 1991, and accepted in revised form September 2, 1991.
t seems more than coincidental that at a time of great concern over rising health care costs and fears of rampant technology, debates are suddenly taking place about medical futility and health care rationing. Are futility and rationing merely two different words to describe the same impulse, the desire to cut costs? Is the idea of futility nothing more than a subterfuge for rationing? Is rationing inappropriately invoked when making judgments about medical futility? Are they both ominous signs that society is seeking covert ways to dispose of unwanted persons? To address these questions, we first examine the economic, historical, and demographic factors that have motivated the increased attention paid to futility and rationing. Second, we explore differences and similarities in the meaning of these terms and discuss their ethical implications.
I
COMMON ECONOMIC,HISTORICAL,AND DEMOGRAPHICFORCES In recent years, the ideas of medical futility and health care rationing have gained prominence in the medical literature and in legal and clinical settings. The increased prominence of these topics has emerged alongside more traditional bioethical debates concerning physician paternalism and patient autonomy. We suggest that four common factors contribute to the recent increased focus on futility and rationing. The Rise in Health Care Costs There is no doubt that increasing health care costs represent a growing source of public and professional concern. The price of health care goods and services has risen at a faster rate than other consumer prices. Rising costs, in turn, have helped to fuel increased health care expenditures. In 1989, consumers, private insurers, and state and federal programs spent a record total of more than $604 billion dollars, or 11.6% of the gross national product (GNP), on health care. This total translated into roughly $2,400 for each person in the country [l]. Comparing this figure with those of prior years conveys its significance. In 1960, national health care expenditures represented just 5.3% of the GNP; in 1970, 7.4%, but by 1985 that figure had jumped to 10.7%. Increased health care expenditures cannot be explained by economic growth and
February
1992
The American
Journal
of Medicine
Volume
92
189
FUTILITY
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
The Development of High-Technology Medicine A second reason why the topics of futility and rationing command greater attention of late has to do with medical success and the development and diffusion of high-technology medicines. By “high technology,” we mean apparatus and procedures based on modern sciences, as opposed to simpler healing arts; new, as opposed to long-accepted methods; scientifically complex, as distinct from common-sense approaches; costly, rather than in-
expensive treatments; and limited, rather than widespread, expertise in using a particular technique [5]. Until the first half of this century, physicians were “long on charity and short on science” [6]. Medicine offered little in the way of successful or proven therapies, and its central function consisted of dispensing comfort and care, rather than cure. The historically recent availability of new and effective medical technologies brings to the fore issues of futility and rationing. Early in the development of a new technology, there will be the question of whether it is not only effective but beneficial, This is where questions of futility enter. For example, it is well recognized that renal dialysis can replace kidney function and cardiopulmonary resuscitation (CPR) can restore cardiac function, yet it is less clear whether these interventions provide overall benefits to certain groups of patients. For example, renal dialysis may keep a patient in a persistent vegetative state alive even though life is not perceived by the unconscious patient as a benefit; similarly, CPR may revive a patient with advanced metastatic cancer for a brief period of time without ever allowing the patient to leave the intensive care unit (ICU) even briefly [7]. Even after a new procedure has established its effectiveness and beneficial value, if it is associated with conditions of scarcity, it will raise issues of justice in the distribution of limited resources. This is due, in part, to the high cost often associated with a technology’s research, development, and delivery. In addition, the number of health professionals initially trained to apply new techniques in the clinical setting may be limited. Thus, when a new technology appears on the scene, it usually is rationed, either explicitly and according to publicly stated criteria, or implicitly and without acknowledgment and deliberation. After a new technology becomes more widely available, the ethical problems it raises may turn from that of justly distributing a scarce medical resource back to that of limiting its inappropriate use. Enthrallment with new techniques, together with the prestige sometimes associated with them, may encourage excessive use, thereby exacerbating the ethical problem of using technologies under futile circumstances. One example of this is CPR, which originally was developed to apply to patients with acute medical conditions, such as sudden cardiac or respiratory arrest, whose conditions were largely reversible. Eventually, CPR was applied to all patients who experienced a cardiac arrest, regardless of their underlying disease or quality of life, unless they explicitly refused this intervention [8]. This has prompted some to counsel limiting resuscitation in
190
92
gains in productivity alone, but have required the transfer of resources from other areas of the economy [21. These economic facts have led many to call for measures to stem the rising cost of health care and limit health care spending. One direct response to this call for limits has been increased attention to health care rationing. The debate concerning medical futility may represent an indirect response to the same economic circumstances. Certainly, the increased allocation of public funds to health care can be checked by reducing the use of nonbeneficial medical treatments. Nonbeneficial or futile treatments might be thought to include those that, even when fully successful, provide a quality of life well below a threshold considered minimal, or those in which the likelihood of achieving medical goals is exceedingly low. Recently, we proposed using the term “futility” to apply to both of these contexts: medical treatment is futile if it has less than 1 chance in 100 of success or if it merely preserves permanent unconsciousness or dependence on intensive medical care [3]. It is important to note that in this definition, medical costs, scarcity of resources, and consideration of rationing play no role. On the other hand, under conditions of scarcity, even beneficial medical treatment will be denied, either in an explicit and ethically defensible fashion or in a covert and unsystematic manner. Such is clearly the case in organ transplantation where potential recipients greatly outnumber donors and rationing is clearly needed. Yet even where no shortage exists in medical resources, or in the elementary ingredients from which medical resources are produced, money to pay for medical care is itself limited. For example, whether at 12%, 15%, or 25%, an upper limit on the percentage of the GNP allocated to health care inevitably will be reached. This is because continued increases in health care spending divert public funds away from other social goods, such as education and the environment. Eventually, reducing investments in other social goods to pay for health care will meet resistance. Thus, medical therapies are evaluated, compared, and rationed on the basis of cost as well as benefit
[41.
February
1992
The American
Journal
of Medicine
Volume
FUTILITY
the name of medical futility. In a recent paper, Tomlinson and Brody [9] argue that when resuscitation offers no medical benefit, the physician can make a reasoned determination that a do-not-resuscitate order should be written without any knowledge of the patient’s values in the matter. The decision that CPR is unjustified because it is futile is, in their view, a judgment that falls entirely within the physician’s technical experience. In contrast to rationing, the main thrust of this appeal is not that resources or staff are limited but that treatment is not medically beneficial. Naturally, sceptics may wonder, “Is futility invoked to disguise rationing? Would the issue of futility be raised in the absence of competition for limited medical resources?” The Aging of Society A third element encouraging greater focus on futility and rationing is the aging of society. Although our population has been aging since 1800, the pace of this aging has accelerated greatly in recent years. Since 1900, our country has witnessed an eightfold increase in the number of Americans over the age of 65. Those over the age of 85, the fastest growing age group in the country, are 21 times as numerous as in 1900 [lo]. The elderly are also the heaviest users of health services. Persons 65 and over represent approximately 12% of the population but account for about one third of the nation’s total personal health care expenditures, exclusive of research costs [ll]. The phenomenon of an aging society has led some to question public funding of life-extending health care in old age. According to one bioethicist, Daniel Callahan [12], even if life-extending medical care were unlimited, the elderly themselves would be wise to settle for the achievement of a limited natural lifespan. The suggestion is not that public investments in life-extending therapies for older individuals produce no medical benefit. Rather, life-extending care in old age is futile in a broader sense: death in old age is inevitable and an acceptance of limits is therefore fitting. This broad sense of futility should not be confused with our own. Callahan’s definition is not based on medical criteria, such as the poor likelihood of achieving medical benefits for older patients or the low quality of medical benefits in older age groups. Indeed, such an approach would be difficult to sustain, as evidence is mounting that no significant age difference exists in mortality or morbidity outcomes associated with various interventions, including survival after CPR for in-hospital cardiac arrest [13-171, coronary arteriography and coronary bypass surgery [18], liver [19] and kidney [20-241 transplantation, other surgeries [25], chemotherapy [26], and dialysis [27]. Rather than basing his understanding of futility on
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
medical criteria, Callahan’s approach to futility is strictly age-based, drawing a line at an upper age limit. By contrast, we define futility in terms of medical outcome and perceive no necessary correlation between the futility of an intervention and the age of a patient. Despite the absence of evidence to show that older individuals have poorer medical outcomes, the elderly recently have become a target for denial of care based on rationing as well as futility. The appeal of age-based rationing is due in part to the fact that the ranks of older Americans are swelling, and the cost of care for the elderly is disproportionately high. While not all agree that rationing health care based on age is ethically [28,29] or philosophically [30] sound, several arguments have been advanced in support of such a proposal. Productivity arguments hold that the goal of maximizing life years saved, or cost savings, or contributions to the public good, can best be achieved by limiting health care to the elderly [31]. Other arguments claim that if individuals were to view their lives as a whole, rather than from a particular moment in time, their considered preferences would sometimes be to distribute more medical resources to earlier than to later years [32,33]. Limits on Patient Autonomy A final basis for greater attention to futility and rationing has been a growing tendency to place restrictions on patient autonomy. Since the early 196Os, the principle of patient autonomy has dominated the fields of bioethics [34] and physician paternalism has been replaced by an ethic of respect for the choices of competent patients. Autonomy often has been interpreted as an overriding ethical principle, trumping other moral values, such as beneficence. Veatch [35], for example, maintains that: reasonable people might not favor a mandate to physicians to do even what is objectively most beneficial to the patient in caseswhere the autonomous patient chooses otherwise. The freedom of the individual might. . . actually overcome the production of maximum benefit. But more recently, the principle of autonomy has been challenged from a variety of sources. Most important for our purposes are challenges that invoke medical futility and rationing of scarce health care resources. While some continue to insist that patients are entitled to care that is medically useless or only marginally medically beneficial [36-381, many others assign to physicians primary ethical responsibility in refraining from offering or continuing futile treatment. Brett and McCullough [39], for example, argue that when a patient seeks to exercise a right to medical care, a necessary condition is that there is
February
1992
The American
Journal
of Medicine
Volume
92
191
FUTILITY
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
either an established or theoretical medical basis for the patient’s request. In the absence of at least a modicum of medical benefit, they argue, the raison d’etre of the physician-patient interaction disappears. Others defend a similar stance, arguing that moral authority to make decisions regarding futile resuscitation does not rest with the patient [8,40] or family [41]. Rather, the community of physicians is entitled to establish a professional consensus about the purposes to which their skills are put [42,43]. For example, it is argued that physicians may withhold or refrain from offering specific futile therapies to burn patients in an acute care setting [44], low birth weight infants in a neonatal ICU [45], patients without a reasonable chance of discharge from an ICU [46], patients with no chance of recovery from CPR [47], patients whose lives will not be preserved or suffering alleviated [48], severely ill infants incapable of experiencing pain and whose prognosis is poor and survival questionable [49], and terminally ill incompetent patients whose families request aggressive therapies [50]. Another source of challenge to patient autonomy is the fact that health care resources are scarce and may be exhausted long before patients’ requests for those resources can be met. Although health care has always been rationed, the recent shift from retrospective reimbursement to a policy of prospective payment according to diagnosis-related groups (DRG) increasingly places health care rationing choices on the shoulders of physicians “at the bedside.” Whereas society’s costs for providing hospital care for each episode of illness are directly fixed in advance, by the category of patients’ diseases, physicians indirectly fix costs by decisions they make about individual patients [51]. Will a patient be admitted to the hospital? How long will he or she stay? What number and types of tests will be ordered? What referrals will be recommended? Many have begun to argue that the moral role of physicians requires balancing justice in the distribution of resources with the responsibility to advocate their patients’ interests. While some continue to press for physicians to devote their professional energies exclusively to meeting patients’ requests and promoting patients’ welfare [52-541, many now hold that physicians do not owe patients a level of resources beyond what patients are entitled to receive, nor must physicians sacrifice their honor, professional integrity, or personal welfare in order to satisfy patients’ demands [55]. Others argue that patients’ requests should be checked, either by placing physician-patient relationships in the context of institutions that guarantee a fair distribution of resources [56] or by instituting socially sound public policies [57,58]. Reflecting these senti192
February
1992
The American
Journal
of Medicine
Volume
ments, the President’s Commission, in its 1983 report Securing Access to Health Care, acknowledges that the health care system, like every system for organizing an activity, places some limitations on individual choice. . . . Thus, the issue is what kinds of limitations on choice are most consistent with fulfilling society’s moral obligation to provide equitable accessto health care for all . . . since an adequate level is something less than all care that might be beneficial, patients’ choices will be limited to that range unless they are able to pay for care that exceeds adequacy [59].
THE MEANING OF FUTILITY AND RATIONING Appeals to both futility and rationing have been made for the purpose of supporting denials of health care resources. But to what, more precisely, do such appeals refer? To answer this question, we first note the myriad ways in which each term is used in the current literature. In debates about medically futile care, applications of the term “futility” have tended to cluster around situations in which physicians, patients, or surrogates decide that there is an unacceptable likelihood of achieving (1) life prolongation [44,60,61]; (2) the patient’s goals [35,36]; (3) a physiologic effect on the body [62,63]; or (4) a therapeutic benefit or a minimum quality of life for the patient [3,36,46,64].
Debates about the distribution of health care resources also associate a variety of different meanings with the term “rationing.” Rationing has been understood to mean (1) limiting expectations of health care, even where health care is beneficial [65]; (2) sharing of health care resources, even by those in need [61]; (3) denying health care treatments, even where treatments are life-extending, restorative; or ameliorative 1661; (4) apportioning medical resources equitably based on need [67]; (5) distributing resources unequally [68]; or (6) allocating health care resources by means of pricing and queuing when supply and demand are out of balance [69]. These different ways in which futility and rationing are used add confusion to already difficult ethical debates. While it is not our aim to stipulate final or universal definitions of futility and rationing, we do propose to clarify further the meanings of futility and rationing by identifying common and distinguishing features. Common
Features of Futility and Rationing
Futility and rationing share a common ground in situations in which rationing is based on either the quality or likelihood of medical benefit. First, in situations 92
in which rationing
assigns a low priority
FUTILITY
to persons who have the poorest quality of medical outcome, treatment may also be withheld based on a judgment that the quality of a particular medical outcome is futile [3]. To state that the quality of outcome is futile is to judge that the result achieved by an intervention falls below a threshold considered minimal. Second, rationing that rests on the low likelihood that a medical benefit will occur bears a resemblance to futility assessments based on the poor chance of achieving a certain outcome [3]. Futility in this sense expresses the idea that the likelihood of a medical benefit occurring is below a threshold considered minimal. A final resemblance between futility and rationing concerns the manner in which such decisions are reached and implemented. This can range from clearly stated to never articulated, publicly defended to covertly accomplished, and ethically supported to ethically indefensible. Illustration of the Common Features of Futility and Rationing To illustrate these common features, consider Oregon’s recent proposal for distributing limited Medicaid funds. In its initial (May 1990) plan [70], a computer generated a list of diseases rated by a formula that takes into account the cost of treatment, length of benefit, and quality of well-being after treatment. For example, office visits and hospitalization for cystic fibrosis cost $494.92, the estimated number of years that a patient would survive is 2, and the quality of well-being rated by a representative sample of Oregonian citizens is 0.400. The overall rating for cystic fibrosis is 619.28 along a range from 1.46 to 999,999.0. On average, this approach rates more highly procedures that offer greater improvements in health and quality of life per dollar spent on health care. Topping the list are treatments for bacterial meningitis, phenylketonuria, non-Hodgkin’s lymphoma, septicemia, meningoccal infection, candidiasis, salmonellosis, Wilms’ tumor, bacterial infection, and listeriosis. This approach tends to assign a relatively low rating to procedures that confer small improvements per dollar spent, such as organ transplants and treatment for viral herpes. After coming under intense criticism, the Oregon Health Commission retained its original formula but made changes based on a line-by-line vote of members and polls and interviews with Oregon citizens. The latest (February 1991) plan [71] emphasizes preventive care and treatable life-threatening diseases that affect many, rather than conditions that are minor or are fatal and incurable. For example, organ transplants have been moved from the bottom to near the middle of the priority list and
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
familiar ailments, such as pneumonia, have been placed near the top. How far down the list treatments are covered depends upon the availability of funds in each biennium. At some point along the list, a line will be drawn, and diseases and injuries that fall below it will not be covered. How do ideas of rationing and futility inform Oregon’s plan in light of the distinctions we have drawn? First, medical resources are scarce relative both to patients’ needs and demands and to Oregon’s Medicaid dollars. Second, although rationing is proposed in an unusually explicit manner [72], medical futility is not mentioned or discussed as a basis for denial of care. Finally, since treatments inevitably vary with respect to the kinds of patients likely to receive them, e.g., elderly or children, smoker or nonsmoker, male or female, qualities of persons inevitably become factors in rationing. For example, favoring immunization over heart transplantation entails favoring children over adults, In addition, since Medicaid patients are the only people affected by Oregon’s rationing plan, ability to pay is a rationing criterion. Whereas rationing is clearly endorsed under Oregon’s plan, whether or not futile treatment is provided is determined indirectly and depends upon the total amount of funding available. Since items are ranked by medical benefit per dollar spent, treatments that offer little quality or likelihood of benefit will rate extremely low and will be unlikely to receive coverage. It is important to notice, however, that where futile therapies are denied, the state’s explicit rationale would not be that treatment is futile but that medical resources are Scarce relative to Medicaid dollars. Therefore, although Oregon’s plan does not explicitly address futility, an implication of the state’s proposal seems to be that Oregon’s responsibility to pay for medical treatment decreases as the medical benefit that treatment offers decreases. If this is so, then Oregon has minimal or no responsibility to pay for futile care. Notice also how the ideas of benefit and likelihood of benefit are relevant to both rationing and futility in the plan. First, medical benefit represents a criterion for rationing, and at the low end of the quality of benefit scale, a point of futility will be reached. Second, the likelihood of medical benefit is also a rationing criterion. When this likelihood reaches the low end along a probability continuum, treatment can be called futile. Finally, the manner in which medical treatments are rationed under Oregon’s proposal are at one end of a continuum, since Oregon’s plan has been unusually explicit and vigorously debated. By contrast, the withholding of futile treatments that is implied is at the other end
February
1992
The American
Journal
of Medicine
Volume
92
193
of a continuum, since no explicit statement bate about futile care has occurred.
or de-
a patient virtually no possibility of medical benefit, we could not correctly claim to be rationing such resources based on a standard of medical benefit, because they are not scarce in any relevant sense to begin with. The fact that only rationing presupposes scarcity also means that an exorbitantly expensive yet helpful treatment may be rationed, but it cannot properly be regarded as futile. Suppose, for example, that a certain medication costs $100,000 per dosage and has proven beneficial 60% of the time. In light of its high cost, it may be rationed because a less expensive treatment provides more benefit per dollar spent. However, regardless of how much the more expensive treatment costs, it cannot properly be withheld on grounds of medical futility. Cost does not figure into a determination of medical futility: all that matters is the likelihood that the treatment will confer a benefit and the quality of benefit to be achieved. The point that rationing presupposes scarcity also suggests that a scarce and nonbeneficial treatment can be withheld on the basis either of futility or rationing. For example, in the recent case at Hennepin County Medical Center [74,75], the family of a patient in a persistent vegetative state insisted on all life-sustaining treatment including a respirator, antibiotics for recurrent pneumonia, tube feedings, and normalization of frequently monitored biochemical parameters. At the same time, physicians and ethics committee members favored removing life support on grounds of futility. While it can be argued that continuing life support is futile, it can also be pointed out that the patient, Helga Wanglie, cost her private insurance company $300,000 for her first hospital visit and $400,000 for her second hospitalization. A case could be made that Wanglie’s treatments should be rationed, e.g., based on standards of medical benefit. According to this line of reasoning, the quality of medical benefit Wanglie gains by continued life-sustaining treatment is less than the quality of benefit that would be produced by similar investments in other patients or other categories of health care.
Distinguishing Features of Futility and Rationing Despite the commonality of meaning between futility and rationing, several distinctions can be noted. Foremost is the point that futility has no explicit distributive meaning but refers instead to a specific cause-and-effect relationship. Rationing, by contrast, always indicates a distributive choice, rather than a cause-and-effect logic. Thus, although rationing based on quality or probability of medical outcome partially overlaps with futility, a difference remains. Whereas rationing indicates a priority between scarce resources, futility implies that a particular medical intervention produces a low likelihood or quality of effect. A second point of contrast between futility and rationing is that criteria for rationing are far broader in scope than are criteria for defining futility. For example, it might be argued that we should ration based on standards such as ability to pay, social utility, or equality. However, no one could intelligibly argue that medical care is futile on grounds of ability to pay, social utility, or equality. Medically futile care is denied because of the low likelihood of achieving a certain effect or the low quality of perceived outcome. A third, and related, point is that ethical rationing must meet standards articulated in theories of distributive justice. However, the manner of determining and justifying criteria of medical futility does not make reference to any corresponding theory. Instead, reference is made to general professional opinion about such things as medical indications and community values and goals. In other words, if a standard of care regarding futility is to be established it must be decided by a broad consensus of opinion among health professionals and others. A good model to follow here is the definition of death in terms of brain death criteria. Originally, the definition of death was ambiguous and disputed; however, critical ethical debate resulted in a convergence of opinion and consistent policy [73]. If, by contrast, we fail to achieve agreement about the definition of medical futility, this will only invite a CONCLUSION multitude of case law definitions and inconsistent We return finally to the questions we raised at the policies. outset of this paper: Are futility and rationing A final difference between futility and rationing merely two different words to describe the same is that the circumstances of rationing always pre- impulse, the desire to cut cost? Is futility nothing suppose scarcity. By contrast, it is possible to argue more than a subterfuge for rationing? Is rationing for denying futile treatment even where a resource inappropriately confused with judgments about is abundant or cheap. This observation has several medical futility? Are they both ominous signs that implications. One is that abundant resources can be society is looking for covert ways to dispose of unfutile when applied to a particular patient, but it is wanted persons? not possible for such resources to be rationed. For We have acknowledged and examined the reaexample, where cheap and plentiful resources offer sons for these concerns. These questions arise in an 194
February
1992
The American
Journal
of Medicine
Volume
92
FUTILITY
era of seemingly uncontrollable increases in health care costs; effective, but also expensive, high-technology medicine; a rapidly aging society; and greater challenges to patient autonomy. There is concern that the effort to contain health care costs will prompt society to take actions that will be harmful to its most vulnerable members, such as children, the elderly or the poor. To avoid this possibility, many have grown suspicious and scornful of any attempt to implement restrictive health care practices. We believe that a better alternative is for concerned parties to address futility and rationing directly by thinking clearly about their meaning and about the goals and limits of medicine. In our view, discussions about futility and rationing are not necessarily sinister simply because they arise from societal concerns about costs. And although both concepts have gained attention in the current climate of medical care, one distinction should be made clear: futility refers to the treatment of a single patient; rationing involves a communal decision about many patients. Therefore, in making judgments about futility, the patient’s benefit is of paramount concern and all that matters is medicine’s ability to offer some minimal promise to achieve that benefit. All other factors are extraneous. With respect to rationing, by contrast, society must decide how to deal with conditions of scarcity in which certain treatments cannot be made available to all who would benefit. At this time, little consensus has been reached in the medical community about futility, or in our broader society about rationing. In neither case will it be easy to achieve a consensus. Acknowledging futility plays havoc with contemporary medical optimism, which is highly colored by medical progress. Acknowledging the need to ration violates the cherished ideal that no member of society should be considered less worthy and less desirable than another. Nor can we expect debates on these subjects to be unemotional. In the area of rationing, in particular, the tendency is to make choices by not making them, and so to revert to some form of implicit and unsystematic rationing. One reason it may be exceedingly difficult to approach rationing choices directly is that the historical contexts and connotations we associate with rationing speak against this. For example, rationing brings to mind the triaging of patients during war or makes us think of an overcrowded emergency room after a major disaster. Or rationing conjures up the image of a young child on television dying for lack of a bone marrow or liver transplant. Our response to these images is intense and emotional, rather than cool and deliberate. Futility has quite different connotations. It suggests, for example, that medical care is wasteful,
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
that even our best efforts will be pointless, useless, or hopeless. This may explain, in part, why futility sometimes functions as a convenient subterfuge for allocation decisions. It is easier for a physician to tell a patient that medical care is being withheld because there is nothing that can be done, than it is to say that medical care is unavailable because it is costly. Yet careful observers are aware that our society already has made choices about both rationing and futility by not making them. We already have engaged in a form of irrational rationing and applied biased and inconsistent definitions of medical futility. These less visible approaches may be comforting to those who do not wish to be aware of what is happening, but critics should realize that covert tactics are ironically a more convenient way to dispose of unwanted persons than an open policy debate. For in a democratic society openly acknowledged health policies would, despite their many shortcomings, hold out the promise of gradually evolving toward a more consistent and ethical system of health care.
REFERENCES 1. US. reports rise to $604 billion in health care spending in 1989. New York Times, 1990 Dee 22; Sect. A: 12 (col. 1, 2). 2.Ginzberg E. A hard look at cost containment. N Engl J Med 1987; 316: 1151-4. 3. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning and ethical implications. Ann Intern Med 1990; 112: 949-54. 4. Emery D, Schneiderman LJ. Cost-effectiveness analysis in health care. Hastings Cent Rep 1989; 19: 813. 5. McGregor M. Technology and the allocation of resources. N Engl J Med 1989; 320: 118-20. 6. Jennett B. High technology medicine: benefits and burdens. New York: Oxford University Press, 1986. 7. Faber-Langendoen K. Resuscitation of patients with metastatic cancer: is transient benefit still futile? Arch Intern Med 1991; 151: 235-9. 8. Blackhall L. Must we always use CPR? N Engl J Med 1987; 317: 1281-4. 9. Tomlinson T, Brody H. Ethics and communication in do-not-resuscitate orders. N Engl J Med 1988; 318: 43-6. 10. Mills C. The graying of America. Report from the Institute for Philosophy and Public Policy 1988; 1. 11. US Senate Special Committee on Aging. Aging America: trends and projections Washington, DC: Public Health Service, Department of Health and Human Services, 1985-1986. 12. Callahan D. Setting limits: medical goals in an aging society. New York: Simon and Schuster, 1987. 13. Urberg M, Ways C. Survival after cardiopulmonary resuscitation for an inhospital cardiac arrest. J Fam Pratt 1987; 25: 41-4. 14. DeBard ML. Cardiopulmonary resuscitation: analysis of six years’ experience and review of the literature. Ann Emerg Med 1981; 10: 408-16. 15. Scott RPF. Cardiopulmonary resuscitation in a teaching hospital. Anaesthesia 1981; 36: 526-30. 16. Gulati RS, Bhan GL, Horan MA. Cardiopulmonary resuscitation of old people. Lancet 1983; 2: 267-9. 17. Murphy DJ, Murray AM, Robinson BE, Campion EW. Outcomes of cardiopulmonary resuscitation in the elderly. Ann Intern Med 1989; 111: 199-205. 18. Gersh BJ, Kronmal RA, Frye RL, et al. Participants in the Coronary Artery Surgery Study. Coronary arteriography and coronary artery bypass surgery: morbidity and mortality in patients ages 65 years and older. Circulation 1983: 67:483-91. 19. Randall T. Successful liver transplantation in older patients raises new
February
1992
The American
Journal
of Medicine
Volume
92
195
FUTILITY
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
hopes, challenges, ethics questions. JAMA 1990; 264: 428-9. 20. Pirsch JD, Stratta RJ, Armbrust MJ. et al. Cadaveric renal transplantation with cyclosporine in patients more than 60 years of age. Transplantation 1989; 47: 259-61. 21. Shah B, Roy M, Munda R, Penn I, Fidler JP, Alexander JW. Current experience with renal transplantation in older patients. Am J Kidney Dis 1988; 12: 516-23. 22. Fehrman I, Brattstrom C, Duraj F, Groth CG. Kidney transplantation in patients 65 and 75 years of age. Transplant Proc 1989; 21: 2018-19. 23. Howard RJ, F’faff WW. Salomon D, et al. Kidney transplantation in older patients. Transplant Proc 1989; 21: 2020-l. 24. Murie JA. Lauffer G, Gray D, Ting A, Momrris PJ. Renal transplantation in the older patient. Transplant Proc 1989; 21: 2024-5. 25. Hosking MP. Warner MA, Lobdell CM, Offord KP, Melton LJ. Outcomes of surgery in patients 90 years of age and older. JAMA 1989; 261: 1909-15. 26. Begg CB, Cohen JL, Ellerton J. Are the elderly predisposed to toxicity from cancer chemotherapy? Cancer Clinical Trials 1980; 3: 369-74. 27. Westlie L, Umen A, Nestrud S. eta/. Mortality, morbidity and life satisfaction in the very old dialysis patient, Trans Am Sot Artificial Intern Organs 1984; 30: 21-30. 28. Jecker NS, Pearlman RA. Ethical constraints on rationing medical care by age. J Am Geriatr Sot 1989; 37: 1067-75. 29. Jecker NS. Disenfranchising the elderly from life-extending medical care. In: Homer P, Holstein M. editors. A Good old age?: the paradox of setting limits. New York: Simon and Schuster, 1990: 157-69. 30. Jecker NS. Appeals to nature in theories of age group justice. In: Jecker NS, editor. Aging and ethics. Clifton, New Jersey: Humana Press, 1991: 269-83. 31. Spitter M. Growing old in America: can we restore the dignity of age? In: Bandman E, Bandman B, editors. Bioethics and human rights. Boston: Little Brown and Co, 1978. 32. Daniels N. Am I my parents’ keeper?: an essay on health care between the young and the old. New York: Oxford University Press, 1988. 33. Menzel P. Strong medicine: the ethical rationing of health care. New York: Oxford University Press, 1990. 34. Morison RS. The biological limits on autonomy. Hastings Cent Rep 1984; 14: 43-9. 35. Veatch RM. A theory of medical ethics. New York: Basic Books, 1981. 36. Perkins HS. Ethics at the end of life: practical principles for making resuscitation decisions. J Gen Intern Med 1986; 1: 170-6. 37. Ruark JE, Raffin TA. Stanford University Medical Center Committee on Ethics. Initiating and withdrawing life support: principles and practice in adult medicine. N Engl J Med 1988; 318: 25-30. 38. Veatch RM. Justice and the economics of terminal illness. Hastings Cent Rep 1988; 18: 34-40. 39. Brett AS, McCullough LB. When patients request specific interventions. N Engl J Med 1986; 315: 1347-51. 40. Tomlinson T, Brody H. Futility and the ethics of resuscitation. JAMA 1990; 264: 1276-80. 41. Hackler C. Hiller FC. Family consent to orders not to resuscitate. JAMA 1990; 264: 1281-3. 42. Jecker NS. Knowing when to stop: the limits of medicine. Hastings Cent Rep 1991; 21: 5-8. 43. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility. Ann Intern Med 1991; 114: 169-70. 44. Hammond J, Ward CG. Decisions not to treat: ‘do not resuscitate’ order for the burn patient in the acute setting. Crit Care Med 1989; 17: 136-8. 45. Lantos J, Miles SH, Silverstein MD, Stocking SB. Survival after cardiopulmonary resuscitation in babies of very low birth weight: is CPRfutile? N Engl J Med
1988; 318: 91-5. 46. Taffet GE, Tearsdale TA, Luchi RJ. In-hospital cardiopulmonary resuscitation. JAMA 1988; 260: 2069-72. 47. Murphy DJ. Do-not-resuscitate orders: time for reappraisal in long term care institutions. JAMA 1988; 260: 2098-101. 48. Schneiderman W, Spragg RG. Ethical decisions in discontinuing mechanical intervention. N Engl J Med 1988; 318: 984-8. 49. Paris JJ, Crone RK, Reardon F. Physicians’ refusal of requested treatment: the case of Baby L. N Engl J Med 1990; 322: 1012-5. 50. Brennan TA. Ethics committees and decisions to limit care: the experience at the Massachusetts General Hospital. JAMA 1988; 260: 803-7. 51. Morreim EH. The MD and the DRG. Hastings Cent Rep 1985; 15: 30-4. 52. Loewy EH. Cost should not be a factor in medical care [letter]. N Engl J Med 1980; 302: 697. 53. Levinsky N. The doctor’s master. N Engl J Med 1984; 311: 1573-5. 54.Angel M. Cost containment and the physician. JAMA 1985; 254: 1203-7. 55. Morreim H. Cost containment: challengingfidelity and justice. Hastings Cent Rep 1988; 18: 20-5. 56. Daniels N. The ideal advocate and limited resources. Theor Med 1987; 8: 69-80. 57. Cassel CK. Doctors and allocation decisions: a new role in the new Medicare. J Health Polit Policy Law 1985; 109: 549-65. 58. Jecker NS. Integrating medical ethics with normative theory: patient advocacy and social responsibility. Theor Med 1990; 11: 125-39. 59. Presidents Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Securingaccess to health care: theethical implications of differences in the availability of health services, vol 3. Washington, DC: US Government Printing Office, 1983. 60. Reagan MD. Health care rationing: what does it mean? N Engl J Med 1988; 319: 1149-51. 61. lserson KV, Sanders AB, Mathieu DR, Buchanan AE. Ethics in emergency medicine. Baltimore: Williams and Wilkens, 1986. 62. Lantos JD, Singer PA, Walker RM, et al. The illusion of futility in clinical practice. Am J Med 1989; 87: 81-4. 63. Younger SJ. Who defines futility? JAMA 1988; 260: 2094-5. 64. Asch A, Cohen CB. Edgar H, et a/. Who should decide? Hastings Cent Rep 1987; 17: 17-21. 65. Aaron HJ, Schwartz WB. The painful prescription: rationing hospital care. Washington, DC: Brookings Institution, 1984. 66. Priester R, Caplan AL. Ethics, cost containment, and the allocation of scarce resources. Invest Radio1 1988; 24: 918-26. 67. Strauss MJ, LoGerfo JP, Yeltatzie JA, et al. JAMA 1986: 255: 1143-6. 68.Fuchs VR. The “rationing” of medical care. N Engl J Med 1984; 311: 1572-3. 69. Childress JF. Rationing of medical treatment. In: Reich WT, editor. Encyclopedia of bioethics. New York: Macmillan, 1978: 1414-9. 76. Egan T. Oregon lists illnesses by priority to see who gets Medicaid. New York Times, 1990 Jul 9; Sect. A: 1. 18 (col. l-4). 71. Egan T. Oregon shakes up pioneering health plan for the poor. New York Times, 1991 Feb 22; Sect. A: 12 (col. 3-6). 72. Schwartz WB. Aaron HJ. The Achilles heel of health care rationing. New York Times, 1990 Jul 9; Sect. A: 17 (col. l-5). 73. Veatch R. Death, dying and the biological revolution. New Haven: Yale University Press, 1989. 74. Belkin L. As family protests, hospital seeks an end to woman’s life support. New York Times 1991 Jan 10; Sect. A: 1, 16 (col. l-6). 75. Miles S. Unpublished memo to interested medical ethicists regarding the case of Helga Wanglie.
196
92
February
1992
The American
Journal
of Medicine
Volume
Seattle, Washington, LAWRENCE J. SCHNEIDERMAN, M.D.,
It seems more than coincidental that at a time of great concern over rising health care costs and fears of rampant technology, debates are suddenly taking place about medical futility and health care rationing. This article examines the economic, historical, and demographic factors that have motivated increased attention to both these concepts, explores differences and similarities in the meaning of these terms, and discusses their ethical implications. Specifically, we identify four common sources of current debates on futility and rationing: the rise in health care costs; the development of high-technology medicine; the aging of society; and the effort to limit the scope of patient autonomy. We propose that when rationing criteria refer to medical benefit, the meanings of futility and rationing share certain common features. Futility and rationing differ, however, in important ways. Futility refers to treatment and outcome relationships not in a general population but in a specific patient. Rationing criteria usually are supported by reference to theories of justice, whereas the definition of futility, if achieved, will probably be arrived at by empirical community agreement. Rationing always occurs against a backdrop of resource scarcity, but futility need not. Toward the end of the paper, we clarify how the various connotations and contexts we associate with each term enhance or frustrate ethical debate.
From the University of Washington (NSJ), School of Medicine, Department of Medical History and Ethics and Department of Philosophy, Seattle, Washington, and the University of California at San Diego (LJS), School of Medicine, Department of Community and Family Medicine and Department of Medicine, San Diego, California. This work was presented in 1991 at Stanford University School of Medicine and at the Annual Meeting of the Society for Health and Human Values. Requests for reprints should be addressed to Nancy S. Jecker, Ph.D., University of Washington School of Medicine, Department of Medical History and Ethics, SB-20. Seattle, Washington 98195. Manuscript submitted June 4, 1991, and accepted in revised form September 2, 1991.
t seems more than coincidental that at a time of great concern over rising health care costs and fears of rampant technology, debates are suddenly taking place about medical futility and health care rationing. Are futility and rationing merely two different words to describe the same impulse, the desire to cut costs? Is the idea of futility nothing more than a subterfuge for rationing? Is rationing inappropriately invoked when making judgments about medical futility? Are they both ominous signs that society is seeking covert ways to dispose of unwanted persons? To address these questions, we first examine the economic, historical, and demographic factors that have motivated the increased attention paid to futility and rationing. Second, we explore differences and similarities in the meaning of these terms and discuss their ethical implications.
I
COMMON ECONOMIC,HISTORICAL,AND DEMOGRAPHICFORCES In recent years, the ideas of medical futility and health care rationing have gained prominence in the medical literature and in legal and clinical settings. The increased prominence of these topics has emerged alongside more traditional bioethical debates concerning physician paternalism and patient autonomy. We suggest that four common factors contribute to the recent increased focus on futility and rationing. The Rise in Health Care Costs There is no doubt that increasing health care costs represent a growing source of public and professional concern. The price of health care goods and services has risen at a faster rate than other consumer prices. Rising costs, in turn, have helped to fuel increased health care expenditures. In 1989, consumers, private insurers, and state and federal programs spent a record total of more than $604 billion dollars, or 11.6% of the gross national product (GNP), on health care. This total translated into roughly $2,400 for each person in the country [l]. Comparing this figure with those of prior years conveys its significance. In 1960, national health care expenditures represented just 5.3% of the GNP; in 1970, 7.4%, but by 1985 that figure had jumped to 10.7%. Increased health care expenditures cannot be explained by economic growth and
February
1992
The American
Journal
of Medicine
Volume
92
189
FUTILITY
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
The Development of High-Technology Medicine A second reason why the topics of futility and rationing command greater attention of late has to do with medical success and the development and diffusion of high-technology medicines. By “high technology,” we mean apparatus and procedures based on modern sciences, as opposed to simpler healing arts; new, as opposed to long-accepted methods; scientifically complex, as distinct from common-sense approaches; costly, rather than in-
expensive treatments; and limited, rather than widespread, expertise in using a particular technique [5]. Until the first half of this century, physicians were “long on charity and short on science” [6]. Medicine offered little in the way of successful or proven therapies, and its central function consisted of dispensing comfort and care, rather than cure. The historically recent availability of new and effective medical technologies brings to the fore issues of futility and rationing. Early in the development of a new technology, there will be the question of whether it is not only effective but beneficial, This is where questions of futility enter. For example, it is well recognized that renal dialysis can replace kidney function and cardiopulmonary resuscitation (CPR) can restore cardiac function, yet it is less clear whether these interventions provide overall benefits to certain groups of patients. For example, renal dialysis may keep a patient in a persistent vegetative state alive even though life is not perceived by the unconscious patient as a benefit; similarly, CPR may revive a patient with advanced metastatic cancer for a brief period of time without ever allowing the patient to leave the intensive care unit (ICU) even briefly [7]. Even after a new procedure has established its effectiveness and beneficial value, if it is associated with conditions of scarcity, it will raise issues of justice in the distribution of limited resources. This is due, in part, to the high cost often associated with a technology’s research, development, and delivery. In addition, the number of health professionals initially trained to apply new techniques in the clinical setting may be limited. Thus, when a new technology appears on the scene, it usually is rationed, either explicitly and according to publicly stated criteria, or implicitly and without acknowledgment and deliberation. After a new technology becomes more widely available, the ethical problems it raises may turn from that of justly distributing a scarce medical resource back to that of limiting its inappropriate use. Enthrallment with new techniques, together with the prestige sometimes associated with them, may encourage excessive use, thereby exacerbating the ethical problem of using technologies under futile circumstances. One example of this is CPR, which originally was developed to apply to patients with acute medical conditions, such as sudden cardiac or respiratory arrest, whose conditions were largely reversible. Eventually, CPR was applied to all patients who experienced a cardiac arrest, regardless of their underlying disease or quality of life, unless they explicitly refused this intervention [8]. This has prompted some to counsel limiting resuscitation in
190
92
gains in productivity alone, but have required the transfer of resources from other areas of the economy [21. These economic facts have led many to call for measures to stem the rising cost of health care and limit health care spending. One direct response to this call for limits has been increased attention to health care rationing. The debate concerning medical futility may represent an indirect response to the same economic circumstances. Certainly, the increased allocation of public funds to health care can be checked by reducing the use of nonbeneficial medical treatments. Nonbeneficial or futile treatments might be thought to include those that, even when fully successful, provide a quality of life well below a threshold considered minimal, or those in which the likelihood of achieving medical goals is exceedingly low. Recently, we proposed using the term “futility” to apply to both of these contexts: medical treatment is futile if it has less than 1 chance in 100 of success or if it merely preserves permanent unconsciousness or dependence on intensive medical care [3]. It is important to note that in this definition, medical costs, scarcity of resources, and consideration of rationing play no role. On the other hand, under conditions of scarcity, even beneficial medical treatment will be denied, either in an explicit and ethically defensible fashion or in a covert and unsystematic manner. Such is clearly the case in organ transplantation where potential recipients greatly outnumber donors and rationing is clearly needed. Yet even where no shortage exists in medical resources, or in the elementary ingredients from which medical resources are produced, money to pay for medical care is itself limited. For example, whether at 12%, 15%, or 25%, an upper limit on the percentage of the GNP allocated to health care inevitably will be reached. This is because continued increases in health care spending divert public funds away from other social goods, such as education and the environment. Eventually, reducing investments in other social goods to pay for health care will meet resistance. Thus, medical therapies are evaluated, compared, and rationed on the basis of cost as well as benefit
[41.
February
1992
The American
Journal
of Medicine
Volume
FUTILITY
the name of medical futility. In a recent paper, Tomlinson and Brody [9] argue that when resuscitation offers no medical benefit, the physician can make a reasoned determination that a do-not-resuscitate order should be written without any knowledge of the patient’s values in the matter. The decision that CPR is unjustified because it is futile is, in their view, a judgment that falls entirely within the physician’s technical experience. In contrast to rationing, the main thrust of this appeal is not that resources or staff are limited but that treatment is not medically beneficial. Naturally, sceptics may wonder, “Is futility invoked to disguise rationing? Would the issue of futility be raised in the absence of competition for limited medical resources?” The Aging of Society A third element encouraging greater focus on futility and rationing is the aging of society. Although our population has been aging since 1800, the pace of this aging has accelerated greatly in recent years. Since 1900, our country has witnessed an eightfold increase in the number of Americans over the age of 65. Those over the age of 85, the fastest growing age group in the country, are 21 times as numerous as in 1900 [lo]. The elderly are also the heaviest users of health services. Persons 65 and over represent approximately 12% of the population but account for about one third of the nation’s total personal health care expenditures, exclusive of research costs [ll]. The phenomenon of an aging society has led some to question public funding of life-extending health care in old age. According to one bioethicist, Daniel Callahan [12], even if life-extending medical care were unlimited, the elderly themselves would be wise to settle for the achievement of a limited natural lifespan. The suggestion is not that public investments in life-extending therapies for older individuals produce no medical benefit. Rather, life-extending care in old age is futile in a broader sense: death in old age is inevitable and an acceptance of limits is therefore fitting. This broad sense of futility should not be confused with our own. Callahan’s definition is not based on medical criteria, such as the poor likelihood of achieving medical benefits for older patients or the low quality of medical benefits in older age groups. Indeed, such an approach would be difficult to sustain, as evidence is mounting that no significant age difference exists in mortality or morbidity outcomes associated with various interventions, including survival after CPR for in-hospital cardiac arrest [13-171, coronary arteriography and coronary bypass surgery [18], liver [19] and kidney [20-241 transplantation, other surgeries [25], chemotherapy [26], and dialysis [27]. Rather than basing his understanding of futility on
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
medical criteria, Callahan’s approach to futility is strictly age-based, drawing a line at an upper age limit. By contrast, we define futility in terms of medical outcome and perceive no necessary correlation between the futility of an intervention and the age of a patient. Despite the absence of evidence to show that older individuals have poorer medical outcomes, the elderly recently have become a target for denial of care based on rationing as well as futility. The appeal of age-based rationing is due in part to the fact that the ranks of older Americans are swelling, and the cost of care for the elderly is disproportionately high. While not all agree that rationing health care based on age is ethically [28,29] or philosophically [30] sound, several arguments have been advanced in support of such a proposal. Productivity arguments hold that the goal of maximizing life years saved, or cost savings, or contributions to the public good, can best be achieved by limiting health care to the elderly [31]. Other arguments claim that if individuals were to view their lives as a whole, rather than from a particular moment in time, their considered preferences would sometimes be to distribute more medical resources to earlier than to later years [32,33]. Limits on Patient Autonomy A final basis for greater attention to futility and rationing has been a growing tendency to place restrictions on patient autonomy. Since the early 196Os, the principle of patient autonomy has dominated the fields of bioethics [34] and physician paternalism has been replaced by an ethic of respect for the choices of competent patients. Autonomy often has been interpreted as an overriding ethical principle, trumping other moral values, such as beneficence. Veatch [35], for example, maintains that: reasonable people might not favor a mandate to physicians to do even what is objectively most beneficial to the patient in caseswhere the autonomous patient chooses otherwise. The freedom of the individual might. . . actually overcome the production of maximum benefit. But more recently, the principle of autonomy has been challenged from a variety of sources. Most important for our purposes are challenges that invoke medical futility and rationing of scarce health care resources. While some continue to insist that patients are entitled to care that is medically useless or only marginally medically beneficial [36-381, many others assign to physicians primary ethical responsibility in refraining from offering or continuing futile treatment. Brett and McCullough [39], for example, argue that when a patient seeks to exercise a right to medical care, a necessary condition is that there is
February
1992
The American
Journal
of Medicine
Volume
92
191
FUTILITY
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
either an established or theoretical medical basis for the patient’s request. In the absence of at least a modicum of medical benefit, they argue, the raison d’etre of the physician-patient interaction disappears. Others defend a similar stance, arguing that moral authority to make decisions regarding futile resuscitation does not rest with the patient [8,40] or family [41]. Rather, the community of physicians is entitled to establish a professional consensus about the purposes to which their skills are put [42,43]. For example, it is argued that physicians may withhold or refrain from offering specific futile therapies to burn patients in an acute care setting [44], low birth weight infants in a neonatal ICU [45], patients without a reasonable chance of discharge from an ICU [46], patients with no chance of recovery from CPR [47], patients whose lives will not be preserved or suffering alleviated [48], severely ill infants incapable of experiencing pain and whose prognosis is poor and survival questionable [49], and terminally ill incompetent patients whose families request aggressive therapies [50]. Another source of challenge to patient autonomy is the fact that health care resources are scarce and may be exhausted long before patients’ requests for those resources can be met. Although health care has always been rationed, the recent shift from retrospective reimbursement to a policy of prospective payment according to diagnosis-related groups (DRG) increasingly places health care rationing choices on the shoulders of physicians “at the bedside.” Whereas society’s costs for providing hospital care for each episode of illness are directly fixed in advance, by the category of patients’ diseases, physicians indirectly fix costs by decisions they make about individual patients [51]. Will a patient be admitted to the hospital? How long will he or she stay? What number and types of tests will be ordered? What referrals will be recommended? Many have begun to argue that the moral role of physicians requires balancing justice in the distribution of resources with the responsibility to advocate their patients’ interests. While some continue to press for physicians to devote their professional energies exclusively to meeting patients’ requests and promoting patients’ welfare [52-541, many now hold that physicians do not owe patients a level of resources beyond what patients are entitled to receive, nor must physicians sacrifice their honor, professional integrity, or personal welfare in order to satisfy patients’ demands [55]. Others argue that patients’ requests should be checked, either by placing physician-patient relationships in the context of institutions that guarantee a fair distribution of resources [56] or by instituting socially sound public policies [57,58]. Reflecting these senti192
February
1992
The American
Journal
of Medicine
Volume
ments, the President’s Commission, in its 1983 report Securing Access to Health Care, acknowledges that the health care system, like every system for organizing an activity, places some limitations on individual choice. . . . Thus, the issue is what kinds of limitations on choice are most consistent with fulfilling society’s moral obligation to provide equitable accessto health care for all . . . since an adequate level is something less than all care that might be beneficial, patients’ choices will be limited to that range unless they are able to pay for care that exceeds adequacy [59].
THE MEANING OF FUTILITY AND RATIONING Appeals to both futility and rationing have been made for the purpose of supporting denials of health care resources. But to what, more precisely, do such appeals refer? To answer this question, we first note the myriad ways in which each term is used in the current literature. In debates about medically futile care, applications of the term “futility” have tended to cluster around situations in which physicians, patients, or surrogates decide that there is an unacceptable likelihood of achieving (1) life prolongation [44,60,61]; (2) the patient’s goals [35,36]; (3) a physiologic effect on the body [62,63]; or (4) a therapeutic benefit or a minimum quality of life for the patient [3,36,46,64].
Debates about the distribution of health care resources also associate a variety of different meanings with the term “rationing.” Rationing has been understood to mean (1) limiting expectations of health care, even where health care is beneficial [65]; (2) sharing of health care resources, even by those in need [61]; (3) denying health care treatments, even where treatments are life-extending, restorative; or ameliorative 1661; (4) apportioning medical resources equitably based on need [67]; (5) distributing resources unequally [68]; or (6) allocating health care resources by means of pricing and queuing when supply and demand are out of balance [69]. These different ways in which futility and rationing are used add confusion to already difficult ethical debates. While it is not our aim to stipulate final or universal definitions of futility and rationing, we do propose to clarify further the meanings of futility and rationing by identifying common and distinguishing features. Common
Features of Futility and Rationing
Futility and rationing share a common ground in situations in which rationing is based on either the quality or likelihood of medical benefit. First, in situations 92
in which rationing
assigns a low priority
FUTILITY
to persons who have the poorest quality of medical outcome, treatment may also be withheld based on a judgment that the quality of a particular medical outcome is futile [3]. To state that the quality of outcome is futile is to judge that the result achieved by an intervention falls below a threshold considered minimal. Second, rationing that rests on the low likelihood that a medical benefit will occur bears a resemblance to futility assessments based on the poor chance of achieving a certain outcome [3]. Futility in this sense expresses the idea that the likelihood of a medical benefit occurring is below a threshold considered minimal. A final resemblance between futility and rationing concerns the manner in which such decisions are reached and implemented. This can range from clearly stated to never articulated, publicly defended to covertly accomplished, and ethically supported to ethically indefensible. Illustration of the Common Features of Futility and Rationing To illustrate these common features, consider Oregon’s recent proposal for distributing limited Medicaid funds. In its initial (May 1990) plan [70], a computer generated a list of diseases rated by a formula that takes into account the cost of treatment, length of benefit, and quality of well-being after treatment. For example, office visits and hospitalization for cystic fibrosis cost $494.92, the estimated number of years that a patient would survive is 2, and the quality of well-being rated by a representative sample of Oregonian citizens is 0.400. The overall rating for cystic fibrosis is 619.28 along a range from 1.46 to 999,999.0. On average, this approach rates more highly procedures that offer greater improvements in health and quality of life per dollar spent on health care. Topping the list are treatments for bacterial meningitis, phenylketonuria, non-Hodgkin’s lymphoma, septicemia, meningoccal infection, candidiasis, salmonellosis, Wilms’ tumor, bacterial infection, and listeriosis. This approach tends to assign a relatively low rating to procedures that confer small improvements per dollar spent, such as organ transplants and treatment for viral herpes. After coming under intense criticism, the Oregon Health Commission retained its original formula but made changes based on a line-by-line vote of members and polls and interviews with Oregon citizens. The latest (February 1991) plan [71] emphasizes preventive care and treatable life-threatening diseases that affect many, rather than conditions that are minor or are fatal and incurable. For example, organ transplants have been moved from the bottom to near the middle of the priority list and
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
familiar ailments, such as pneumonia, have been placed near the top. How far down the list treatments are covered depends upon the availability of funds in each biennium. At some point along the list, a line will be drawn, and diseases and injuries that fall below it will not be covered. How do ideas of rationing and futility inform Oregon’s plan in light of the distinctions we have drawn? First, medical resources are scarce relative both to patients’ needs and demands and to Oregon’s Medicaid dollars. Second, although rationing is proposed in an unusually explicit manner [72], medical futility is not mentioned or discussed as a basis for denial of care. Finally, since treatments inevitably vary with respect to the kinds of patients likely to receive them, e.g., elderly or children, smoker or nonsmoker, male or female, qualities of persons inevitably become factors in rationing. For example, favoring immunization over heart transplantation entails favoring children over adults, In addition, since Medicaid patients are the only people affected by Oregon’s rationing plan, ability to pay is a rationing criterion. Whereas rationing is clearly endorsed under Oregon’s plan, whether or not futile treatment is provided is determined indirectly and depends upon the total amount of funding available. Since items are ranked by medical benefit per dollar spent, treatments that offer little quality or likelihood of benefit will rate extremely low and will be unlikely to receive coverage. It is important to notice, however, that where futile therapies are denied, the state’s explicit rationale would not be that treatment is futile but that medical resources are Scarce relative to Medicaid dollars. Therefore, although Oregon’s plan does not explicitly address futility, an implication of the state’s proposal seems to be that Oregon’s responsibility to pay for medical treatment decreases as the medical benefit that treatment offers decreases. If this is so, then Oregon has minimal or no responsibility to pay for futile care. Notice also how the ideas of benefit and likelihood of benefit are relevant to both rationing and futility in the plan. First, medical benefit represents a criterion for rationing, and at the low end of the quality of benefit scale, a point of futility will be reached. Second, the likelihood of medical benefit is also a rationing criterion. When this likelihood reaches the low end along a probability continuum, treatment can be called futile. Finally, the manner in which medical treatments are rationed under Oregon’s proposal are at one end of a continuum, since Oregon’s plan has been unusually explicit and vigorously debated. By contrast, the withholding of futile treatments that is implied is at the other end
February
1992
The American
Journal
of Medicine
Volume
92
193
of a continuum, since no explicit statement bate about futile care has occurred.
or de-
a patient virtually no possibility of medical benefit, we could not correctly claim to be rationing such resources based on a standard of medical benefit, because they are not scarce in any relevant sense to begin with. The fact that only rationing presupposes scarcity also means that an exorbitantly expensive yet helpful treatment may be rationed, but it cannot properly be regarded as futile. Suppose, for example, that a certain medication costs $100,000 per dosage and has proven beneficial 60% of the time. In light of its high cost, it may be rationed because a less expensive treatment provides more benefit per dollar spent. However, regardless of how much the more expensive treatment costs, it cannot properly be withheld on grounds of medical futility. Cost does not figure into a determination of medical futility: all that matters is the likelihood that the treatment will confer a benefit and the quality of benefit to be achieved. The point that rationing presupposes scarcity also suggests that a scarce and nonbeneficial treatment can be withheld on the basis either of futility or rationing. For example, in the recent case at Hennepin County Medical Center [74,75], the family of a patient in a persistent vegetative state insisted on all life-sustaining treatment including a respirator, antibiotics for recurrent pneumonia, tube feedings, and normalization of frequently monitored biochemical parameters. At the same time, physicians and ethics committee members favored removing life support on grounds of futility. While it can be argued that continuing life support is futile, it can also be pointed out that the patient, Helga Wanglie, cost her private insurance company $300,000 for her first hospital visit and $400,000 for her second hospitalization. A case could be made that Wanglie’s treatments should be rationed, e.g., based on standards of medical benefit. According to this line of reasoning, the quality of medical benefit Wanglie gains by continued life-sustaining treatment is less than the quality of benefit that would be produced by similar investments in other patients or other categories of health care.
Distinguishing Features of Futility and Rationing Despite the commonality of meaning between futility and rationing, several distinctions can be noted. Foremost is the point that futility has no explicit distributive meaning but refers instead to a specific cause-and-effect relationship. Rationing, by contrast, always indicates a distributive choice, rather than a cause-and-effect logic. Thus, although rationing based on quality or probability of medical outcome partially overlaps with futility, a difference remains. Whereas rationing indicates a priority between scarce resources, futility implies that a particular medical intervention produces a low likelihood or quality of effect. A second point of contrast between futility and rationing is that criteria for rationing are far broader in scope than are criteria for defining futility. For example, it might be argued that we should ration based on standards such as ability to pay, social utility, or equality. However, no one could intelligibly argue that medical care is futile on grounds of ability to pay, social utility, or equality. Medically futile care is denied because of the low likelihood of achieving a certain effect or the low quality of perceived outcome. A third, and related, point is that ethical rationing must meet standards articulated in theories of distributive justice. However, the manner of determining and justifying criteria of medical futility does not make reference to any corresponding theory. Instead, reference is made to general professional opinion about such things as medical indications and community values and goals. In other words, if a standard of care regarding futility is to be established it must be decided by a broad consensus of opinion among health professionals and others. A good model to follow here is the definition of death in terms of brain death criteria. Originally, the definition of death was ambiguous and disputed; however, critical ethical debate resulted in a convergence of opinion and consistent policy [73]. If, by contrast, we fail to achieve agreement about the definition of medical futility, this will only invite a CONCLUSION multitude of case law definitions and inconsistent We return finally to the questions we raised at the policies. outset of this paper: Are futility and rationing A final difference between futility and rationing merely two different words to describe the same is that the circumstances of rationing always pre- impulse, the desire to cut cost? Is futility nothing suppose scarcity. By contrast, it is possible to argue more than a subterfuge for rationing? Is rationing for denying futile treatment even where a resource inappropriately confused with judgments about is abundant or cheap. This observation has several medical futility? Are they both ominous signs that implications. One is that abundant resources can be society is looking for covert ways to dispose of unfutile when applied to a particular patient, but it is wanted persons? not possible for such resources to be rationed. For We have acknowledged and examined the reaexample, where cheap and plentiful resources offer sons for these concerns. These questions arise in an 194
February
1992
The American
Journal
of Medicine
Volume
92
FUTILITY
era of seemingly uncontrollable increases in health care costs; effective, but also expensive, high-technology medicine; a rapidly aging society; and greater challenges to patient autonomy. There is concern that the effort to contain health care costs will prompt society to take actions that will be harmful to its most vulnerable members, such as children, the elderly or the poor. To avoid this possibility, many have grown suspicious and scornful of any attempt to implement restrictive health care practices. We believe that a better alternative is for concerned parties to address futility and rationing directly by thinking clearly about their meaning and about the goals and limits of medicine. In our view, discussions about futility and rationing are not necessarily sinister simply because they arise from societal concerns about costs. And although both concepts have gained attention in the current climate of medical care, one distinction should be made clear: futility refers to the treatment of a single patient; rationing involves a communal decision about many patients. Therefore, in making judgments about futility, the patient’s benefit is of paramount concern and all that matters is medicine’s ability to offer some minimal promise to achieve that benefit. All other factors are extraneous. With respect to rationing, by contrast, society must decide how to deal with conditions of scarcity in which certain treatments cannot be made available to all who would benefit. At this time, little consensus has been reached in the medical community about futility, or in our broader society about rationing. In neither case will it be easy to achieve a consensus. Acknowledging futility plays havoc with contemporary medical optimism, which is highly colored by medical progress. Acknowledging the need to ration violates the cherished ideal that no member of society should be considered less worthy and less desirable than another. Nor can we expect debates on these subjects to be unemotional. In the area of rationing, in particular, the tendency is to make choices by not making them, and so to revert to some form of implicit and unsystematic rationing. One reason it may be exceedingly difficult to approach rationing choices directly is that the historical contexts and connotations we associate with rationing speak against this. For example, rationing brings to mind the triaging of patients during war or makes us think of an overcrowded emergency room after a major disaster. Or rationing conjures up the image of a young child on television dying for lack of a bone marrow or liver transplant. Our response to these images is intense and emotional, rather than cool and deliberate. Futility has quite different connotations. It suggests, for example, that medical care is wasteful,
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
that even our best efforts will be pointless, useless, or hopeless. This may explain, in part, why futility sometimes functions as a convenient subterfuge for allocation decisions. It is easier for a physician to tell a patient that medical care is being withheld because there is nothing that can be done, than it is to say that medical care is unavailable because it is costly. Yet careful observers are aware that our society already has made choices about both rationing and futility by not making them. We already have engaged in a form of irrational rationing and applied biased and inconsistent definitions of medical futility. These less visible approaches may be comforting to those who do not wish to be aware of what is happening, but critics should realize that covert tactics are ironically a more convenient way to dispose of unwanted persons than an open policy debate. For in a democratic society openly acknowledged health policies would, despite their many shortcomings, hold out the promise of gradually evolving toward a more consistent and ethical system of health care.
REFERENCES 1. US. reports rise to $604 billion in health care spending in 1989. New York Times, 1990 Dee 22; Sect. A: 12 (col. 1, 2). 2.Ginzberg E. A hard look at cost containment. N Engl J Med 1987; 316: 1151-4. 3. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning and ethical implications. Ann Intern Med 1990; 112: 949-54. 4. Emery D, Schneiderman LJ. Cost-effectiveness analysis in health care. Hastings Cent Rep 1989; 19: 813. 5. McGregor M. Technology and the allocation of resources. N Engl J Med 1989; 320: 118-20. 6. Jennett B. High technology medicine: benefits and burdens. New York: Oxford University Press, 1986. 7. Faber-Langendoen K. Resuscitation of patients with metastatic cancer: is transient benefit still futile? Arch Intern Med 1991; 151: 235-9. 8. Blackhall L. Must we always use CPR? N Engl J Med 1987; 317: 1281-4. 9. Tomlinson T, Brody H. Ethics and communication in do-not-resuscitate orders. N Engl J Med 1988; 318: 43-6. 10. Mills C. The graying of America. Report from the Institute for Philosophy and Public Policy 1988; 1. 11. US Senate Special Committee on Aging. Aging America: trends and projections Washington, DC: Public Health Service, Department of Health and Human Services, 1985-1986. 12. Callahan D. Setting limits: medical goals in an aging society. New York: Simon and Schuster, 1987. 13. Urberg M, Ways C. Survival after cardiopulmonary resuscitation for an inhospital cardiac arrest. J Fam Pratt 1987; 25: 41-4. 14. DeBard ML. Cardiopulmonary resuscitation: analysis of six years’ experience and review of the literature. Ann Emerg Med 1981; 10: 408-16. 15. Scott RPF. Cardiopulmonary resuscitation in a teaching hospital. Anaesthesia 1981; 36: 526-30. 16. Gulati RS, Bhan GL, Horan MA. Cardiopulmonary resuscitation of old people. Lancet 1983; 2: 267-9. 17. Murphy DJ, Murray AM, Robinson BE, Campion EW. Outcomes of cardiopulmonary resuscitation in the elderly. Ann Intern Med 1989; 111: 199-205. 18. Gersh BJ, Kronmal RA, Frye RL, et al. Participants in the Coronary Artery Surgery Study. Coronary arteriography and coronary artery bypass surgery: morbidity and mortality in patients ages 65 years and older. Circulation 1983: 67:483-91. 19. Randall T. Successful liver transplantation in older patients raises new
February
1992
The American
Journal
of Medicine
Volume
92
195
FUTILITY
AND RATIONING
/ JECKER
AND SCHNEIDERMAN
hopes, challenges, ethics questions. JAMA 1990; 264: 428-9. 20. Pirsch JD, Stratta RJ, Armbrust MJ. et al. Cadaveric renal transplantation with cyclosporine in patients more than 60 years of age. Transplantation 1989; 47: 259-61. 21. Shah B, Roy M, Munda R, Penn I, Fidler JP, Alexander JW. Current experience with renal transplantation in older patients. Am J Kidney Dis 1988; 12: 516-23. 22. Fehrman I, Brattstrom C, Duraj F, Groth CG. Kidney transplantation in patients 65 and 75 years of age. Transplant Proc 1989; 21: 2018-19. 23. Howard RJ, F’faff WW. Salomon D, et al. Kidney transplantation in older patients. Transplant Proc 1989; 21: 2020-l. 24. Murie JA. Lauffer G, Gray D, Ting A, Momrris PJ. Renal transplantation in the older patient. Transplant Proc 1989; 21: 2024-5. 25. Hosking MP. Warner MA, Lobdell CM, Offord KP, Melton LJ. Outcomes of surgery in patients 90 years of age and older. JAMA 1989; 261: 1909-15. 26. Begg CB, Cohen JL, Ellerton J. Are the elderly predisposed to toxicity from cancer chemotherapy? Cancer Clinical Trials 1980; 3: 369-74. 27. Westlie L, Umen A, Nestrud S. eta/. Mortality, morbidity and life satisfaction in the very old dialysis patient, Trans Am Sot Artificial Intern Organs 1984; 30: 21-30. 28. Jecker NS, Pearlman RA. Ethical constraints on rationing medical care by age. J Am Geriatr Sot 1989; 37: 1067-75. 29. Jecker NS. Disenfranchising the elderly from life-extending medical care. In: Homer P, Holstein M. editors. A Good old age?: the paradox of setting limits. New York: Simon and Schuster, 1990: 157-69. 30. Jecker NS. Appeals to nature in theories of age group justice. In: Jecker NS, editor. Aging and ethics. Clifton, New Jersey: Humana Press, 1991: 269-83. 31. Spitter M. Growing old in America: can we restore the dignity of age? In: Bandman E, Bandman B, editors. Bioethics and human rights. Boston: Little Brown and Co, 1978. 32. Daniels N. Am I my parents’ keeper?: an essay on health care between the young and the old. New York: Oxford University Press, 1988. 33. Menzel P. Strong medicine: the ethical rationing of health care. New York: Oxford University Press, 1990. 34. Morison RS. The biological limits on autonomy. Hastings Cent Rep 1984; 14: 43-9. 35. Veatch RM. A theory of medical ethics. New York: Basic Books, 1981. 36. Perkins HS. Ethics at the end of life: practical principles for making resuscitation decisions. J Gen Intern Med 1986; 1: 170-6. 37. Ruark JE, Raffin TA. Stanford University Medical Center Committee on Ethics. Initiating and withdrawing life support: principles and practice in adult medicine. N Engl J Med 1988; 318: 25-30. 38. Veatch RM. Justice and the economics of terminal illness. Hastings Cent Rep 1988; 18: 34-40. 39. Brett AS, McCullough LB. When patients request specific interventions. N Engl J Med 1986; 315: 1347-51. 40. Tomlinson T, Brody H. Futility and the ethics of resuscitation. JAMA 1990; 264: 1276-80. 41. Hackler C. Hiller FC. Family consent to orders not to resuscitate. JAMA 1990; 264: 1281-3. 42. Jecker NS. Knowing when to stop: the limits of medicine. Hastings Cent Rep 1991; 21: 5-8. 43. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility. Ann Intern Med 1991; 114: 169-70. 44. Hammond J, Ward CG. Decisions not to treat: ‘do not resuscitate’ order for the burn patient in the acute setting. Crit Care Med 1989; 17: 136-8. 45. Lantos J, Miles SH, Silverstein MD, Stocking SB. Survival after cardiopulmonary resuscitation in babies of very low birth weight: is CPRfutile? N Engl J Med
1988; 318: 91-5. 46. Taffet GE, Tearsdale TA, Luchi RJ. In-hospital cardiopulmonary resuscitation. JAMA 1988; 260: 2069-72. 47. Murphy DJ. Do-not-resuscitate orders: time for reappraisal in long term care institutions. JAMA 1988; 260: 2098-101. 48. Schneiderman W, Spragg RG. Ethical decisions in discontinuing mechanical intervention. N Engl J Med 1988; 318: 984-8. 49. Paris JJ, Crone RK, Reardon F. Physicians’ refusal of requested treatment: the case of Baby L. N Engl J Med 1990; 322: 1012-5. 50. Brennan TA. Ethics committees and decisions to limit care: the experience at the Massachusetts General Hospital. JAMA 1988; 260: 803-7. 51. Morreim EH. The MD and the DRG. Hastings Cent Rep 1985; 15: 30-4. 52. Loewy EH. Cost should not be a factor in medical care [letter]. N Engl J Med 1980; 302: 697. 53. Levinsky N. The doctor’s master. N Engl J Med 1984; 311: 1573-5. 54.Angel M. Cost containment and the physician. JAMA 1985; 254: 1203-7. 55. Morreim H. Cost containment: challengingfidelity and justice. Hastings Cent Rep 1988; 18: 20-5. 56. Daniels N. The ideal advocate and limited resources. Theor Med 1987; 8: 69-80. 57. Cassel CK. Doctors and allocation decisions: a new role in the new Medicare. J Health Polit Policy Law 1985; 109: 549-65. 58. Jecker NS. Integrating medical ethics with normative theory: patient advocacy and social responsibility. Theor Med 1990; 11: 125-39. 59. Presidents Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Securingaccess to health care: theethical implications of differences in the availability of health services, vol 3. Washington, DC: US Government Printing Office, 1983. 60. Reagan MD. Health care rationing: what does it mean? N Engl J Med 1988; 319: 1149-51. 61. lserson KV, Sanders AB, Mathieu DR, Buchanan AE. Ethics in emergency medicine. Baltimore: Williams and Wilkens, 1986. 62. Lantos JD, Singer PA, Walker RM, et al. The illusion of futility in clinical practice. Am J Med 1989; 87: 81-4. 63. Younger SJ. Who defines futility? JAMA 1988; 260: 2094-5. 64. Asch A, Cohen CB. Edgar H, et a/. Who should decide? Hastings Cent Rep 1987; 17: 17-21. 65. Aaron HJ, Schwartz WB. The painful prescription: rationing hospital care. Washington, DC: Brookings Institution, 1984. 66. Priester R, Caplan AL. Ethics, cost containment, and the allocation of scarce resources. Invest Radio1 1988; 24: 918-26. 67. Strauss MJ, LoGerfo JP, Yeltatzie JA, et al. JAMA 1986: 255: 1143-6. 68.Fuchs VR. The “rationing” of medical care. N Engl J Med 1984; 311: 1572-3. 69. Childress JF. Rationing of medical treatment. In: Reich WT, editor. Encyclopedia of bioethics. New York: Macmillan, 1978: 1414-9. 76. Egan T. Oregon lists illnesses by priority to see who gets Medicaid. New York Times, 1990 Jul 9; Sect. A: 1. 18 (col. l-4). 71. Egan T. Oregon shakes up pioneering health plan for the poor. New York Times, 1991 Feb 22; Sect. A: 12 (col. 3-6). 72. Schwartz WB. Aaron HJ. The Achilles heel of health care rationing. New York Times, 1990 Jul 9; Sect. A: 17 (col. l-5). 73. Veatch R. Death, dying and the biological revolution. New Haven: Yale University Press, 1989. 74. Belkin L. As family protests, hospital seeks an end to woman’s life support. New York Times 1991 Jan 10; Sect. A: 1, 16 (col. l-6). 75. Miles S. Unpublished memo to interested medical ethicists regarding the case of Helga Wanglie.
196
92
February
1992
The American
Journal
of Medicine
Volume
