Futility and the Common Cold

ethics in cardiopulmonary medicine Futility and the Common Cold* How Requests for Antibiotics Can Illuminate Care at the End of Life Thomas]. Prendergast, MD The dominant approach to futility in medicine assumes that the probability and utility of medical interventions may be separated to provide a quantitative (probabilistic) definition of futility. This assumption is not only misleading but also responsible for much of the confusion that futility has engendered in medical discussions. The divorce of utility from probability is the opposite of how clinicians reason: an improbable intervention looks different if it is cheap, easy, and without morbidity than if it is technology intensive, expensive, and likely to involve great pain and suffering. Futility is how physicians describe the sense of being compelled to proceed with resource intensive care for marginal benefits. Outside the intensive care unit, physicians weigh and sometimes

reject patient requests without the need to invoke futility. By examining the ways that physicians can legitimately evaluate patient requests, we can show that appeals to futility are both unnecessary and counterproductive. In cases where such appeals are unavoidable, the outpatient model suggests a process to adjudicate the competing claims of patient autonomy and physician responsibility. (Chest 1995; 107:836-44)

consider the healthy patient with an uncomplicated upper respiratory tract infection who requests antibiotics. Many discussions of medical futility present this request in order to dismiss it as an example of futile medical care.l·2 Typically, it is considered so self-evident that few words are wasted on analysis. Erythromycin is not an appropriate treatment for the common cold, but this conclusion is neither selfevident nor grounded in futility .3 The judgment rests on an assessment of the likelihood of an antibioticsensitive infection, an analysis of the risks and benefits of antibiotics, an estimation of the impact on the public health of different strategies of antibiotic use, and the social importance of vesting control of certain drugs in the hands of physicians. The beauty of this example is that no one argues in favor of antibiotics, despite the fact that the process that molds multiple considerations into a standard of care is so elusive. The common cold also demonstrates how easily futility can be wielded to obscure the complexities underlying medical decision making: a judgment of futility should rest on an existing standard of care, not the other way around.

Unlike the common cold, there is no clear consensus regarding the initiation or withdrawal of lifesustaining therapies in critically ill patients.3· 6 Despite this lack of common standards, it is in the critically ill that appeals to futility appear most often in medical discussions. 1•7- 15 Such appeals serve an important function: futility represents the language that physicians use to describe being compelled into patterns of care where there is a profound sense of disproportion. Freed from this sense of disproportion , physicians regularly weigh and sometimes reject requests from patients without the need to invoke futility . The same process used to reconcile competing interests in the example of the common cold can help us think clearly about difficult situations in critically ill patients.

*From the Division of Pulmonary and Critical Care Medicine, Cardiovascular Research Institute, Program in Medical Ethics, University of California, San Francisco. This work was supported by the National Institutes of Health Multidisciplinary Research Training Program in Lung Diseases grant NIH HL07185.

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CPR=cardiopulmonary resuscitation; URI=upper respiratory tract infection

Key words: critical care; decision making; ethics, medical; futility ; life support care

WHERE DOES THE S ENSE OF F UTILITY ARISE?

Greek Roots Futility is a rich and subtle concept. In Greek mythology, Danaus, King of Argos, commanded his 50 daughters to murder their husbands. All but Hypermnestra obeyed, and as punishment the gods condemned the others to Hades to draw water from a deep well using sieves. 16 Their efforts were doomed to eternity by their flawed tools. Three points of this story are worth noting. First , Danaus' daughters were not simply asked to do the Futility and the Common Cold (Thomas J. Prendergast)

impossible. To draw water from a well is a common, clearly defined, and eminently achievable activity. In this case, their actions were thwarted by their flawed tools. Futility arose from the process, not from the outcome. Second, the situation was concocted by the gods as punishment; the myth suggests that repetitive attempts without hope of success are uniquely frustrating to mortals. Finally, it was those holding the tools who felt the burden of punishment; in our medical application, that means the physicians. Patients suffer from debilitating diseases and ineffective treatments, but it is their physicians who may repetitively confront hopeless situations. Futility does not simply refer to an outcome whose probability is zero; it refers to a process that is rational and goal directed but unlikely to achieve its goal. The quandary of the daughters of Danaus was not that they were charged with a goal beyond their grasp; their goal was futile but for the presence of a sturdy bucket. The punishment lay in the very proximity of that goal while possessing tools that undermined their efforts.

The Importance of Disproportion The medical literature has lost sight of this emphasis on process to focus exclusively on the outcomes of care. For example, Schneiderman et al 10 suggest that futility is defined by the outcomes of ineffective interventions and that the only thing important about those outcomes is their probability of benefit. In their words, "All other factors are extraneous." 17 This position propagates an eviscerated notion of futility. In fact, there are multiple aspects of care that evoke the emotions embedded in the myth. I suggest it is primarily a sense of disproportion that gives rise to the sense of futility. As the effectiveness of a treatment plan falls, more and more patients who do not benefit are subjected to therapy for each one who does. If the therapy lacks significant morbidity, then the utility calculation is largely unaffected by this disproportion and the decision is guided by the potential benefit to the rare survivor. When therapy is extremely burdensome, the utility calculation is heavily weighted by the majority whose real suffering is to no purpose. The intuition of proportional care rests on an implicit calculation: the clinician is reluctant to subject many patients to a destructive course in order to benefit very few.l Embedded in the idea of proportion are many different assessments. Patient suffering affects the sense of futility as part of a calculation of expected benefit. Suffering is tolerable only as it is tempered by the likelihood of benefit at the end of a protracted course. When b enefits pale, the physician may be the active agent in a hopeless and destructive process, not once but dozens or hundreds of times. Much has been

made of the need to separate futility from rationing;l.l7·18 even if that distinction is valid, it does not follow that cost issues are not part of the experience of futility. (If appeals to futility restrict access to the least effective care, and the point of rationing to ensure access to the most effective care, then the deep divide placed between them is artificial. Monetary costs are one part of the sense of disproportion that generates the sense of futility. Where they predominate, the use of futility is properly one extreme case of rationing.) Not only may patients request inappropriate therapies, they may request scarce, expensive, and capital- and labor-intensive inappropriate therapies. When physicians are confronted with demands for care they consider inappropriate, it is inevitable that the incremental cost of these services be part of their assessments.19·20 Embedded in the importance of cost is also a sense of justice or fair allocation. To spend large sums on therapies that rarely work when other interventions proven effective, eg, prenatal care, go unfunded strikes many physicians as irrational. 21 The motive to limit patient choice arises partly from this sense of justice, that in an era of competing resources it is better to restrict high-cost ineffective therapies before rationing those that are more clearly beneficial. Further, the profession may find itself held accountable for patterns of spending despite the absence of any social warrant to redirect resources. 22 To act out a pattern one did not create, does not like, but cannot change, and to do so repetitively, evokes the frustration that emerges as the need to label care futile.

The Misuse of Probabilities Probabilities vex the entire literature on futility . In some ways, this is puzzling since the visceral appeal of the myth arises not from the impossibility of drawing water in sieves but in being required to repeat this process ad infinitum. The literature provides a quantitative definition of futility but does so at the cost of being both unhelpful and misleading. It is unhelpful because thresholds are arbitrary; it is misleading because statistics obscure underlying assumptions. Consider a patient with small cell carcinoma of the lung who has developed extensive metastases despite chemotherapy. The patient is admitted to the hospital with impending respiratory failure. Two courses are considered. The first is transfer to a hospice where the medical director insists on administration of his special herbal tea. He claims it has therapeutic efficacy: of the last 100 patients so treated, one improved enough to leave the hospice to live at home for a year before d ying. The second course is aggressive chemotherapy with marrow rescue. Of the last 100 patients so treated, one improved enough to live at CHEST I 107 I 3 I MARCH, 1995

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home for a year before dying. Given that the probabilities are the same, are these different courses equally futile? I suggest that the calculation of futility differs because everything but the probabilities is different. The herbal tea costs a few dollars a month, is pleasant to administer, and can be done within a context of care and concern for the dying. Chemotherapy will cost tens of thousands of dollars, strain the medical and nursing staffs in a course many will believe is a charade, pose extreme discomfort to the patient, and separate him from his family at a time of near certain death. Of two interventions with exactly the same probability of success, the second may appear futile while the first may seem highly appropriate. Several points follow from this example. First, futility in medicine is not exclusively about prognosis. The likelihood of success is critically important, but so is the process of care. Probability without attention to process conveys nothing about futility; it is just a number. Second, it is these considerations, sketched above as part of a sense of disproportion, that need to be made explicit. They are only obscured by being labeled "futile." Third, this example illustrates an important but neglected opportunity cost of aggressive low-yield strategies: most patients not only do not benefit but they may also not receive optimal terminal care. The Impossibility of a Threshold The attempt to set a threshold of probability contains an important insight, namely, that in a medical application, futility need not imply the certainty of failure. 23 However, this insight is lost when process is ignored and futility is seen as exclusively probabilistic. The probabilistic interpretation leads to an inevitable but specious question: how infrequent does an outcome have to be to be futile? This question has no answer. To assign any number, to say that l in 20 is different from l in 50 or 1 in 200, commits the declarer to one of two value judgments: the threshold is either arbitrary or it is determined by other considerations. To say the threshold is arbitrary means that there is no reason why 1 in 50 should be considered unacceptable rather than 1 in 200. Schneiderman et al 10 declare that the threshold should be 1 in 100 with the sole rationale that there needs to be some threshold. The absence of explanation removes the common ground of debate and predisposes to stalemate. 2 It also makes this distinction a poor candidate for determining care at the end of life. To say that the threshold of futility is guided by other considerations is to acknowledge that explicit value judgments such as the availability of resources, monetary cost, patient suffering, and wider allocation decisions are integral to the notion. In response to the question, "When does the unlikely become futile?," the approach from proba838

bilities is a statement without defense. The approach from process provides an answer: we choose not to attempt to save a life because the process itself is intolerable. The aspects of the process that make it intolerable can be defined by judgments that are value laden, but that serves only to illustrate that the issue is not futility per se but debatable social policies. 1

Futility as a Subjective Response The relevant fact of the ancient myth is that the sieves leaked and, despite this, the daughters were compelled to continue. Futility arose in the experience of the daughters repetitively laboring with faulty tools. In a medical analogy, the sense of futility arises in the experience of physicians who find themselves repetitively compelled to pursue interventions they believe not in their patients' interests. Medical futility is more appropriately viewed as a subjective response than as an objective characteristic of a situation. This position has several implications. First , we need to consider not only the interventions to which physicians object but also the reasons they feel compelled to provide them. The model of futility as discoverable fact ignores the fact that the sense of futility arises where physicians find themselves unable to refuse patient requests. Outpatient requests that fail the 1% criterion are generally negotiated without prompting an appeal to futility. One unifying characteristic of these requests is that these outpatients are not at imminent risk of death. It is in patients who will die without treatment that physician discretion has been most sharply circumscribed by dominant patient autonomy. Since discretion persists despite autonomy in patients who are neither critically nor terminally ill, we must pursue how the absence of therapeutic alternatives to death alters the physician-patient relationship and may affect physician responsibility. Second, if patients may demand burdensome, low-yield therapies, they effectively force physicians to treat 100 failures for every 1 (or fewer) who benefits. Patient advocates may argue that a patient is entitled to undertake therapy, however burdensome, for its potential benefit if he or she accepts the risk. This perspective ignores the essential bilateral nature of the physician-patient relationship. 3 Patients do not just act out their private risk-taking preferences; they engage a physician to participate in the process with them . The physician thereby acquires a stake in the decision making. This stake is both general and specific to the physician's role. Like other people, the physician is an autonomous moral agent, responsible for his or her actions and the consequences that flow from those actions. To assert that physicians have no discretion to judge patient requests vitiates their auFutility and the Common Cold (Thomas J. Prendergast)

tonomy and belittles their moral status. 1 Unlike other people, physicians have traditionally been held to an additional responsibility to act in their patients' best interests. This fiduciary responsibility is rooted in specialized knowledge and requires physicians to consider themselves accountable not only for what the patient chooses but also for whether that choice is in the patient's best interests. The fiduciary is required independently to evaluate the patient's interests. The difficulty is in understanding how to implement this responsibility while respecting patient autonomy and avoiding the excesses of paternalism. Third, if futility is not a discoverable fact about a situation but the experience of a particular process of care, it follows that the sense of futility cannot be used to make individual treatment decisions. If physicians with different expectations and experiences act on their subjective impressions, similar patients are treated differently. This violates the principle of fairness that similar patients be treated similarly . However, if the sense of futility derives from a sense of disproportion that can be analyzed into more fundamental issues, those issues are the natural starting point for a discussion of common expectations. Open debate over the importance of patient suffering, cost, quality of life, allocation of resources, and the appropriate use of technology offers hope of discovering shared values, if not genuine consensus. These shared values may then become appropriate bases for individual decisions if they become part of physicians' and patients' common expectations for care. Statements from the American College of Chest Physicians, 24 the Society of Critical Care Medicine, 25 and the American Thoracic Society 26 may be viewed as first steps toward resetting expectations of practitioners and patients for care at the end of life. Fourth, basing decisions on futility helps and hinders this process of social debate. It helps as a sentinel concept, one that exposes fundamental issues in situations where those issues might otherwise go unrecognized. Medicine has traditionally found it difficult to address quality of life and the allocation of resources. Insofar as appeals to futility force confrontation with these issues, futility is invaluable at this stage of the debate. However, the objectification of futility has the opposite effect. Futility then obscures ignorance and uncertainty through an illusion of objectivity; it curtails or terminates discussion and leaves physicians with the last word; it provides a trump card that appropriates decision making. These qualities may be advantageous to physicians whose interest is to limit discussion and retake decision making. The same attributes make objective futility a poor choice to uncover reasoning or develop social consensus. 27

Finally, there is the overriding concern among practicing physicians that removing futility from the bedside will concede too much and leave physicians vulnerable to any and all patient requests. I suggest that the truth is the reverse: continued reliance on futility without probing the underlying issues retards resolution of the clash between physician responsibility and patient autonomy. Physicians, especially those who regularly treat critically ill patients, can no longer be content with judging an intervention futile. They need to pursue the frustration of being compelled to render care they find objectionable to its roots in cost, quality of life, allocation of resources , and the appropriate use of technology. At the same time, they must acknowledge the need for a new model of the physician-patient relationship that preserves physician discretion at the end of life. How Do WE JusTIFY REFUSING AuToNoMous PATIENTS' REQUESTS?

Physicians are not compelled by the fact of a patient request to provide the desired intervention. This discretion is widely accepted 3,28 •29 but its limits are not clearly defined . The question is whether physicians may simply refuse requests they deem medically inappropriate or whether, in an era of enhanced patient autonomy, they are required to provide more specific and detailed justifications of their decisions. I shall accept that they must provide specific justifications because this obligation returns us to the debate over futility: what sort of reasoning justifies physician discretion when the alternative to treatment is death? I propose that the same reasoning employed in negotiating requests with patients who are not critically ill applies in those who are. There is nothing esoteric about the requests below or the reasoning that underlies them. In all cases, physician discretion rests on simple logic, social consensus, or the ethical principles of beneficence, nonmalfeasance, and justice.

The Nonmedical A physician-patient relationship exists between a person with specialized knowledge and training who accepts responsibility to employ these skills to protect or maintain the health of another. There is no obligation to provide services that go outside this medical relationship such as financial support, letters of recommendation, or invitations to social events. Nonmedical goals are by definition nonmedical and therefore discretionary within the medical relationship. Their refusal does not infringe autonomous choice. 1·30 The Nonsequitur An elderly patient is obsessed with the threat of a heart attack despite a normal exercise thallium study CHEST I 107 I 3 I MARCH, 1995

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and coronary arteriogram. Such a patient would be denied his request for coronary artery bypass surgery. The justification for refusal is that there is no reason to accede to the request. To be appropriate, an intervention must bear some relation to the offered goal. Here there is none. Indeed, it is arguably the physician's function to protect patients from interventions they may seek out of neurosis, ignorance, or lack of medical sophistication. Confronted with a request for such therapy, respect for autonomy does not require the physician to provide inappropriate care. (This should not preclude the physician from pursuing nonstandard therapy for less clearly medical goals, such as maintaining communication with a difficult patient or attempting to take advantage of the placebo effect. The point is that while the physician may offer to go beyond the bounds of the medical relationship he or she is not obliged to do so. In the language of ethics, it is a supererogatory act. 31 )

The Ineffective Several years ago, there was brief enthusiasm for laetrile as a treatment for cancer. Following that initial hope for its potential, sound clinical research has shown no efficacy and possible harm. 32 A request for laetrile is now appropriately handled with reference to this literature. Another example is the otherwise healthy patient with a viral upper respiratory tract infection (URI) who requests erythromycin.l·3 There is no pathophysiologic or pharmacologic reason to prescribe an antibacterial agent for a self-limited viral process. Autonomy does not require physician compliance with a patient request where the evidence shows no benefit. Where the evidence is clear and convincing, autonomy is irrelevant. 8 •12

The Impossible A high school athlete suffers a complete transection of the spinal cord at C4 in a diving accident. Her parents request that you reconnect the cord to restore function. The request is impossible given our current technology. The physician's responsibility when confronted with a demand for the impossible is to educate the patient to the medical facts and respond to understandable emotional needs. There is no obligation to attempt the impossible. Futility is often confused with the impossible. This usage reflects the extension of futility to encompass the goals of care. Attempting the impossible in medicine might be unreasonable or irrational, or it might be thought noble if interpreted as a desire not to bow to the inevitable. It becomes futile if physicians are unwilling participants or if they feel compelled repetitively to attempt an impossible task. There is no reason why physicians should feel so compelled since a goal that cannot be met is a goal that may be refused . No additional reason is needed to refuse 840

patient requests for the impossible. Some authors separate the impossible from the merely unlikely in an attempt to justify unilateral withdrawal of care on grounds of futility .5- 7.13 •25,26,33 They refer to this as "physiologic" or "strict" futility . They argue that, at some point in a patient's demise, not only will the probability of saving the patient become infinitesimal but the proposed intervention will have no physiologic effect. For example, a patient with progressive hypotension despite vasopressive agents cannot have perfusion restored through cardiopulmonary resuscitation (CPR). Resuscitation would be "physiologically" futile and therefore may be withheld from the patient. Note that the introduction of futility into this scenario is entirely superfluous. If the probability of success is truly zero, then it is impossible and care may be withheld on those grounds; if a small but finite chance does exist, the intervention no longer qualifies as "physiologically" futile. If there is no obligation to attempt the impossible, then there is no need to invoke futility.

The Standard of Care Social Consensus: Consider a euthyroid obese patient who requests thyroxine or an aspiring athlete seeking anabolic steroids. Weight loss might be induced by administration of supraphysiologic doses of thyroid hormone, but it does so unpredictably and the potential complications are severe. 34•35 Steroids may enhance some athletes' performances but there are no good clinical studies and there is an unquantified risk of potentially severe side effects. The established medical community does not accept either as responsible practice. In both examples, one could imagine patients making such requests who might achieve their goals from these therapies. They could be extremely well informed about potential complications and openly willing to accept the risks. Are physicians then required to provide care they believe is substandard? Consider first the request for anabolic steroids. The reason the medical community withholds a potentially effective therapy from the aspiring athlete is not simply that the efficacy is unproved; this would normally lead to further clinical studies, for which there presumably would be no difficulty recruiting subjects. The medical community rejects this athlete's motive as illicit. This rejection of patient goals is permissible because of broad social agreement that the secret enhancement of performance through drugs is contrary to the ideal of fairness in sport. The social consensus, reflected in statutory law, supports the medical community in restricting the athlete's choice by refusing access to anabolic steroids. Professional Integrity: In contrast, the obese paFutility and the Common Cold (Thomas J. Prendergast)

tient and physician agree on the goals of care, to achieve lasting weight reduction, but they differ on the appropriate means to that end. Their disagreement is not over efficacy but over risks and benefits. The medical community restricts access to thyroxine by refusing to participate in what it considers unacceptably risk behavior. By setting limits on the activities it will tolerate, the profession circumscribes choice for some patients. Consider two justifications for these limits. The first is that the physician-patient relationship requires two parties. Personal liberty may permit a person to assume the risks he or she sees fit but it does not require the medical profession to participate in any and all such activities. Physicians are also moral agents and may refuse patient requests for harmful treatments. (The current debate over euthanasia and assisted suicide centers around whether this type of request may be honored; it is a reflection of this point that advocates of patientcontrolled death do not argue it must be honored.) Modern medical interventions range from the innocuous to the devastating. Along this continuum, autonomous choice in a risk-accepting patient may clash with the physician's desire not to harm. Patient preference cannot be assumed to override physician responsibility .30 The dispute must be resolved through analysis of the autonomy interests involved and the issues they protect. The second justification of the medical profession's prerogative to set and adhere to a standard of care is part of this analysis of autonomy. Society accepts and perpetuates the social institution of a medical profession . In so doing, society yields certain decisions to the medical community. Authority over medical training, the requirements of licensure, and the ability to prescribe medications are all ceded to the medical profession. The cost of this independence is to undertake a fiduciary responsibility to maintain individual and public health. If the institution fails to promote these ends, it may lose its legitimacy and its independence. 22 To protect individual and public health, it is their prerogative and duty to establish group standards based on special expertise. The importance of physicians' autonomy is that the profession cannot function if it is required to act contrary to its defining goals. 3 •30 Society cannot have an independent institution with a fiduciary responsibility yet require it to participate in substandard care. Standard of care guidelines, like the assessment of appropriate risks, are fluid and depend on accumulated evidence. For instance, the proscription of thyroid for weight loss is well studied and quite fixed . In other cases, the profession may not limit too strictly the risks that individual patients choose if society believes that those risks are reasonable. The acceleration of approval of experimental therapies for

patients with AIDS is an example where there has been rapid evolution in the perception of appropriate risks. Where a standard of care does exist, it is not casually disregarded and physicians should not step outside it without a compelling reason. A patient request itself is not sufficient reason. In the case of thyroid hormone for weight reduction, it is perfectly acceptable to refuse the request because it does not meet a professional standard of care, based on the scientific data of its effectiveness and the profession's judgment of appropriate risks. To argue that thyroxine is futile misses the point, which is to understand how society delegates authority to groups with special training. CAN WE APPLY THIS PROCESS TO THE CRITICALLY

ILL?

Applying Ethical Principles The requests sketched above are heterogeneous. They reflect the fact that requests within a physicianpatient relationship are circumscribed in various ways. 3 •29 Nonsequiturs, requests for the nonmedical or for the impossible are generally self-evident. Requests that violate professional standards of practice raise complex societal issues of professional prerogative. Requests for ineffective interventions are often contentious. The evidence may be neither clear nor convincing; evaluating such requests then requires balancing competing interests. For example, in the patient with a viral URI, there remains asmall chance of an atypical presentation of an antibiotic-sensitive infection. Why is the patient not within his rights to insist on antibiotics given some probability of a susceptible agent? Since ethical questions are affected by the details of the case,36 the background to any application of ethical principles to medicine is an understanding of the medical facts. This understanding generally takes the form of an assessment of various probabilities. In the appropriate clinical setting, the probability of a nonviral cause of a patient's URI is very small. The implication of this small-but-positive probability depends on multiple other factors; taken out of context, it is meaningless. Those factors include the following.31 The principle of beneficence holds that treatment must have the potential to change the natural history of the illness for the better. An empiric therapy must offer some benefit. The principle of nonmalfeasance holds that we must consider potential complications of treatment. In particular, is the probability of an antibiotic complication greater than the probability of benefit? The principle of justice holds that we must not ignore broader social concerns. The overuse of antibiotics presents a genuine threat to the public health. Further, the potential cost in antibiotics and physician visits for medicalizing a CHEST / 107 I 3 1 MARCH, 1995

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common, minor, self-limited problem could divert scarce resources from more valuable interventions. Finally, the context of this process is the integrity of the profession as a valued social institution. Guided by expert practice guidelines and good epidemiologic data, assessing all the above factors is the realm of clinical judgment. Taking the discretion to make this assessment out of physicians' hands removes their

raison d'etre.

Patients always require respectful, nonprejudicial treatment with care taken to elicit and weigh their preferences. However, patient autonomy alone does not determine decisions because the autonomy interest of the patient is one among many considerations. Other considerations are logical (the ineffective), social (professional standards of care) , and sometimes primarily ethical (the physician as a moral agent). In this particular instance, a balancing of reasons for and against a request for erythromycin involves applying basic ethical principles. In my view , the net result to this balancing is to show the patient's autonomy interest to be trivial compared with the variety of social factors and ethical principles that apply . The request for erythromycin remains at the physician's discretion .

Death as the Only Alternative Consider the patient with metastatic small cell carcinoma, now neutropenic following chemotherapy with fungal sepsis and respiratory failure . He requests intubation. The evidence suggests beyond a reasonable doubt that he will die during this hospitalization regardless of therapy. Is he within his rights to insist on aggressive, life-sustaining intensive care? The application of ethical principles starts with an assessment of the medical facts. For this example, suppose that the probability of the patient surviving to leave the ICU is less than 1 in 100. Arguments from patient autonomy end the discussion here; since autonomy is first in the hierarchy of principles, if the competent patient requests further therapy, then his autonomous choice is dispositive. A physician may not refuse or withdraw life-sustaining therapies when the patient or his appropriate surrogate insists. (Even advocates of dominant patient autonomy give different interventions different amounts of leeway. In the case of Helga Wanglie, 15 the ventilator-dependent octogenarian in a persistent vegetative state, her physicians successfully negotiated an order not to resuscitate, tried unsuccessfully to withdraw mechanical ventilation, but did not address her feeding tube. One suspects that dialysis would not have been initiated, much less would she have had her aortic insufficiency fixed. These differences in practice arise from exactly the kind of negotiation that I propose.) Arguments that rely on a numerical threshold 10 also 842

end the discussion here. Since the therapy fails to meet their 1% efficacy standard, the patient's autonomy interest no longer applies. Therefore, the physician may refuse therapy at his or her discretion. Both dominant patient autonomy and quantitative futility propose a single standard to make this decision. Not only do these strategies come to opposite conclusions, but they also fail to reflect the complex texture of the competing interests. Consider a third option, to concede that no single fact determines decision making at the end of life. Instead we must seek to identify, understand, and weigh competing interests. This is the approach outlined above in those who are ill but not at risk of death; it is also the approach best suited to the critically ill. We accept the factual summary above, though we remain appropriately skeptical about the accuracy of estimates of improbable events. 23 Beneficence asks whether we can change the natural history of the illness for the better. Here we cannot. A realistic therapeutic objective is management of the acute complications of therapy before further complications and death ultimately ensue. The fact that the patient requests intubation neither precludes nor absolves the physician from considering whether such therapy would be of benefit. Nonmalfeasance insists on an honest assessment of the destructive potential of intensive medical care. Such an assessment includes not only physical pain and suffering endured by the patient, but also the pain of hopes repeatedly crushed, delays in preparing for the inevitable, and the odyssey of loved ones who never imagined what would follow from their decision. The assessment must also include the effect on the medical and nursing staff who may become cynical and demoralized by participating in a patient's loss of dignity.37 Justice insists that we not ignore allocation and cost issues. If current practice is to provide intensive care to patients in this clinical situation, that policy expends quantifiable resources for definable benefits. An honest assessment will not avoid making these calculations. Finally, we return to the role of the physician . Discretion to weigh patient therapies is necessary if he or she is to retain the moral status of an autonomous agent. It should not be that discretion is permitted only in egregious cases of conscience. 38 The same principles used in the evaluation of a request for erythromycin apply to the request for intubation. The difference lies in the autonomy interest of the critically ill patient. When death is the alternative, we may adopt one of several approaches. We may assert that imminent death renders patient choice inviolable. This is the argument from dominant patient autonomy. We may assert that death is irrelevant to our existing criteria. Appeals to futility apply the 1% criterion in this way. We may grant Futility and the Common Cold (Thomas J. Prendergast)

great importance to patient choice in the face of death, but maintain that choice as part of a balancing of ethical and social considerations. This is the extension of the outpatient approach to critically ill patients. The importance we grant to individual choice depends on how we assess the autonomy interest involved in specific cases. Since individual choices command social resources and may compete with other socially valued institutions, the autonomy interest involved needs to be explicitly stated. In this instance, the patient's autonomy interest appears to be to delay the inevitable at any cost. It is mitigated by the nearness of death, the invasiveness of the therapy, the resources involved, and the potential effects on the medical and nursing staffs of forced acquiescence. The request for intubation may be refused, not because it is futile , but because we take the request seriously enough to consider and weigh multiple competing relevant factors. Patient autonomy requires no less; it also requires no more.l·8•30 To attempt more may undermine autonomy in two ways. It may fail to treat autonomy seriously by offering false hopes. It also may fail to protect autonomy from flawed choices that result from sickness and fear in the face of death. A fiduciary does not easily acquiesce to low-yield destructive interventions because to do so would violate his responsibility to the patient's best interests.

Practical Implementation There are several reasons why decision-making practice in critically ill patients lags behind that in the outpatient arena . The expansion of life-sustaining therapies at atime of enhanced autonomy and the repudiation of paternalism gave rise to the debate over futility. During this time of rapid change, there has been no clear medical consensus on issues of care at the end of life.4•33•39 Without social or medical consensus to guide decision making, it is no surprise that the strategies that have captured attention, such as dominant patient autonomy and the appeal to qualitative futility, offer the benefit of a single standard that determines decisions. The weighing of competing interests has no similar single standard. Instead it proposes a fuller discussion of the relevant issues to facilitate consensus. One way to advance this process is through the organized efforts of professional groups. 20 Many physicians believe that it is a misuse of medical technology to continue to give mechanical ventilatory assistance to patients in a persistent vegetative state.26·33 In the a bsence of broad social consensus, it would be inappropriate for the medical community unilaterally towithdraw v entilatory support in these patients. This would be a n unacceptable infringement of patient autonomy, not because the profession

cannot evaluate goals but because that evaluation is subject to social warrant and the social warrant for this action does not yet exist. 40 The profession can further the discussion in two ways. On the social level, it can employ its special expertise to bring these questions to public attention. Through public education, physicians may increase understanding of prognosis and focus attention on issues of cost and allocation, thereby laying the groundwork for future social policy to emerge. On the practical level, expert committees from national and international groups can work to develop practice guidelines. Such guidelines both provide guidance to individual clinicians and help to crystallize the profession's sense of purpose. An example of this process is the American Heart Association guidelines regarding the appropriate use of CPR in the terminally ill. 41 Despite reliance on an insupportable interpretation of futility ,42•43 they rightly conclude that not every patient is an appropriate candidate for CPR. Similarly , the American Thoracic Society 26 and the Society of Critical Care Medicine 25 have formulated thoughtful position papers on the withdrawal of life-sustaining therapies in the seriously ill. The American Thoracic Society statement is of particular interest because it takes a forceful stand that physicians are not obliged to provide life-sustaining interventions that are " highly unlikely to result in meaningful survival for that patient" or that " undermine the ethical integrity of the medical profession." 26 This is an important start; the next step is to explore these positions directly rather than introducing them as a means to justify the use o f futility. FUTURE DIRECTIONS

The attempt throughout this analysis has been to strip the concept of futility to its roots, to show that much of the discussion in the literature has been around rather than directed toward the central issues. By redirecting the discussion, we can hope to promote an explicit public discussion of the a ppropriate objectives of medicine in our society. Part of that discussion must address the reality of shrinking resources for health care and the inevitability of explicit allocation. On the more abstract side, the notion of a standard of care sketched h erein is only a beginning, as is the concept of afiduciary a gent in an era of enhanced autonomy. If it is possible to protect autonomy by overriding flawed choices, we ne ed to consider and define the types of situation where this might reasonably occur. In the same way, we need to recognize that providing high-technology care at the end of life potentially turns the principle of autonomy on its head because it avoids treating the patient as a person. 8 To protect autonomy, w e ne ed a more developed notion of the physician-patient relationCHEST / 107 / 3 / MARCH, 1995

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ship that views the relationship as fundamentally cooperative, not competitive. 44 The sense of futility remains valuable in an era of transient and shifting standards because it forces to the surface questions not ordinarily discussed. It may uncover ignorance, uncertainty, miscommunication, and the clash between competing moral principles. It functions most effectively as a spur to further analysis. It fails when used to adjudicate individual cases. The technology of modern medicine is a two-edged sword in an increasingly older society, promising great advances but demanding unusual wisdom in its application. The ideal to be grasped is to address more directly issues of cost, allocation of resources, and quality of life to begin to wean futility from the daily experience of practicing physicians. ACKNOWLEDGMENTS: I am indebted to all my colleagues who read earlier drafts of this manuscript and made many insightful and helpful comments. REFERENCES

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