AN OUTCOMES MODEL OF MEDICAL DECISION MAKING

JOANNE LYNN a AND DAVID DeGRAZIAb a Department of Health Care Sciences, b Department of Philosophy, George Washington University, Washington, DC 20037, USA

ABSTRACT. In the traditional 'fix-it' model of medical decision making, the identified problem is typically characterized by a diagnosis that indicates a deviation from normalcy. When a medical problem is multifaceted and the available interventions are only partially effective, a broader vision of the health care endeavor is needed. What matters to the patient, and what should matter to the practitioner, is the patient's future possibilities. More specifically, what is important is the character of the alternative futures that the patient could have and choosing among them so as to achieve the best future possible, with the ranking of outcomes determined by the patient's preferences. This paper describes the fix-it model, presents and defends the outcomes-based model, and demonstrates that the latter is useful in developing normative conceptions of informed consent and decision making and in establishing a basis for societal involvement in the decision making process. Finally, several shortcomings of the model will be acknowledged. Key words: decision making, futures, outcomes, preferences

1. INTRODUCTION In telling a patient about a proposed appendectomy, the surgeon may well be heard to explain that the diseased appendix will be removed, that there are certain surgical risks, and that the present situation includes the minute-tominute danger of rupture. In writing a policy for ' d o not resuscitate' orders, a hospital committee might restrict applicability o f the orders to those who are 'terminally ill'. A nurse insisting on antibiotics to treat a dying patient's pneumonia may insist that patients should not die o f treatable infections. In these and myriad other c o m m o n examples, a seriously flawed conception o f the role o f health care is at work. In this conception, the identified problem is a particular current condition, usually characterized by a diagnosis that communicates what are taken to be important deviations from a normal state. This might seem to be a natural characterization. Indeed, how could it be wrong to diagnose abnormality and seek to correct it? In many situations, this conception - which we will term the 'fix-it m o d e l ' - works well, for example, when the illness is acute and normalcy can readily be restored.

Theoretical Medicine 12: 325-343, 1991. © 1991 KluwerAcademic Publishers. Printed in the Netherlands.

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But when a medical problem is chronic and multifaceted and when the available interventions are at best partially effective, the need for a broader vision of the health care endeavor becomes evident. What matters to the patient, and what should matter to the practitioner, is the future possibilities that might be effectuated for this patient. More specifically, what is important is understanding the length and character of the alternative futures that the patient could have and choosing among them so as to achieve the best futures that are possible, with the ranking of outcomes dependent upon the patient's preferences and interests. 1 This conception should also seem quite familiar, for it is merely an expansion of the diagnose-and-treat, fix-it model. However, important misconceptions and errors arise when professionals and policymakers persist in the use of the more limited model instead of one oriented to future outcomes. This paper will describe the fix-it model, before presenting the broader outcome-based model and the arguments for its soundness. Then, the pape r will demonstrate that the outcomes-oriented model is useful in developing normative conceptions of informed consent and decision making and in establishing a basis for societal involvement in the decision making process. Finally, the shortcomings of our model that are already apparent to us will be acknowledged. In characterizing a model of medical decision making, one must consider the boundaries of the medical endeavor, which are set differently at different times and places 2 and which inevitably are somewhat ambiguous. We recognize that the boundaries of health care and the authority of its practitioners are set by social practices; accordingly, the model that we propose will utilize the limits society has settled upon at any particular time and place. This is not meant to indicate an acceptance of the status quo but simply a recognition that society can, does, and should set the limits of the health care endeavor. If some believe that the current bounds of health care are suboptimal, they may call for reform and may succeed, thereby establishing a new societal understanding of the limits of health care. Whatever the scope, the goals of health care should be broad enough to include the optimizing of each person's future physiological and psychological functioning. Therefore the persons and institutions that provide health care must be concerned with all conditions that affect this functioning, including even economic and social factors. Health care providers are responsible for considering, but not for satisfying, every need that falls under this conception. Which situations can and should lead to considering health care interventions varies not only with the degree of medical proficiency at a given time and place, but also with the society's determination of health care's proper role and therefore the kinds of interventions that health care is allowed to bring to bear. The goal of seeking to improve futures is broad, the means to pursue the goal are limited by practical realities and social agreement, and the responsibility to achieve the

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goals is likewise limited to the optimal employment of those interventions that are available and permitted to health care providers.

2. THE FIX-IT MODEL The fix-it model is our reconstruction of prevalent attitudes and beliefs among health care providers into a fairly coherent system of medical decision making. We do not claim that a majority of practitioners follow or subscribe to it in toto, only that it is a reasonable approximation, one that we may have made more coherent than it is in practice. Many practitioners and ethicists may already have little sympathy for the fix-it model and work with a form of the outcomes model presented below. Our method for characterizing the fix-it model will be to articulate a series of assertions, with clarifications and elaboration only when necessary. (1) 'The patient has a health abnormality (some dysfunction, either physiological or psychological) that needs fixing, in order to restore normalcy insofar as possible'. An abnormality is any degree or quality of functioning that departs significantly from what is descriptively normal or 'full' functioning. The abnormality may either be manifest or 'latent'. Because health, the goal of medicine, is a matter of normal functioning, the idea of fixing is appropriate to describe what someone with a health problem needs, for to fix something is to return it to its properly functioning state. The goal of returning something (the person) to its properly functioning state (that of health) has generated considerable focus upon dysfunctions that are readily measured and enthusiasm for interventions with measurable results. Practitioners working within this model tend to rate success on whether, for example, the patient's vision has returned to its pre-accident accuracy (which is easily and reliably measured), rather than on the degree of satisfaction the patient feels as a result (which is difficult to measure, being subject to unreliability of various sorts). This has led to a standardization of approach to clinical situations. (2) 'To obtain informed consent (a societally imposed procedural requirement), the practitioner should present the essential facts of the medical situation, make a recommendation, and allow the patient either to consent or not; thus, the possibilities are bifurcated into either agreeing to the recommended treatment or refusing that treatment'. Informed consent within this model is understood as: (a) an event, (b) occurring on one occasion, (c) with practitioner informing patient, (d) (usually) recommending one procedure and offering no alternatives, and (e) (usually) not seeking patient's values. The observational research of Lidz and Meisel strongly supports our claims

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about (c)-(e): Typically, the doctor's ordinary role, in practice, was to decide what was to be done and to inform the patient of that decision. Ordinarily this information came in the form of a recommendation ... The patient's ordinary role, in practice, was to acquiesce in the doctor's recommendation ([5], pp. 391-392). Their conclusions include the following: Quite early in the process the physician reaches a diagnosis and a decision about a preferable treatment. Seldom does the doctor see a series of alternative possible treatments. Rather, for each problem there typically exists a medically preferable treatment, not a series of alternatives from which the patient may choose. It does not seem to the doctor to be a decisionmaking process but simply a question of persuading the patient to accept proper treatment ... IT]he doctor's self-perceived role is to get the patient to go along with this recommendation ... This is done by some explanation about the need for the recommended treatment and the consequences of not heeding the recommendation ([5], pp. 399-400). In his b o o k on informed consent, Jay Katz confirms the claims that, generally, alternatives are not presented and the patient's pre-disclosure preferences and values are not sought (cf. (d) and (e), above): Since the promulgation of the informed consent doctrine in 1957, physicians have of necessity become more aware of their new obligation to talk with patients about recommended treatments. Yet, by and large any disclosures have been limited to informing patients about the risks and benefits of proposed treatments, not about alternatives, and surely not about the certainties and uncertainties inherent in most treatment options. Most importantly, conversations with patients are not conducted in the spirit of inviting patients to share with their physicians the burdens of decision. Without such a commitment, dialogue is reduced to a monologue ([6], p. 26). The idea o f patients' accepting the physician's recommended course o f treatment leads naturally to the idea o f their complying with or failing to comply with the physician's medical instructions for the future (for how to get and stay 'fixed'). The problem o f compliance also arises for patients whose decision making capacity is seriously compromised yet who are still able to act (unlike, e.g., comatose patients). This brings us to another key assertion: (3) ' I f (a) the patient consents to the course proposed by the practitioner, or (b) the patient has enough capacity to act but not enough to be considered autonomous, competent, etc. (as with e.g., children, certain psychiatric patients), a problem o f compliance arises - due to possible conflicts between medically responsible actions and a patient's preferences at a given time'. Conflicts may take the form o f either (1) a disagreement between practitioner and patient about what should be done at a particular time (due either to disagreement over goals or disagreement over means to c o m m o n goals), or (2) agreement between patient and practitioner about goals and means b y inability o f the patient to implement the necessary behavior changes. W h a t responsibilities, if any, does a patient have to follow a

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physician's orders? What limits, if any, are there on the responsibilities of the health practitioner toward the noncompliant patient? 3 As will become clearer in our presentation of the newer model, the problem of compliance is largely the result of practitioners' imposing their will on patients and giving too little weight to patients' values and preferences in determining what courses are possible and in deciding among them. (4) 'Decisions for incompetent patients are strongly presumed to be those established as standard, with little concern to individualize the choices in accord with what is known of the patient's preferences and interests'. In the fix-it model, the problem of decision making for a patient who cannot make his or her own choices is met by a procedural requirement of a surrogate's consent, a thin and fairly weak requirement imposed by society in order to protect what is recognizable as the rights of patients who cannot claim their own rights. (5) 'A very high priority is to prevent death whenever doing so is possible (except, for some practitioners, when the patient is suffering greatly and death can be delayed only for a very short time)'. This simplifying presumption is based on the idea that the goal of medicine is health or normal functioning and the fact that one is obviously not functioning when dead. The fix-it model is relatively closed to the possibility that an earlier death may be a better outcome than continued living. Various courses of action are considered so obviously standard that the fix-it model would allow no consideration of a plan of care that did not implement them. For example, physicians consider it obvious that a patient's fractured arm should he set; leaving a broken arm unstable and malformed is so clearly detrimental to the patient's functioning as to be out of the question. Another more general example is electing not to receive medical care at all, even though one is ill. Having portrayed the fix-it model with a series of assertions that portray some of its central beliefs and attitudes, let us turn to a new model that we think more defensible in the light of certain medical and ethical insights.

3. THE OUTCOMES MODEL The central contention in the outcomes model is this: the health care provider is obliged to implement the plan of care for each patient that is expected to yield the best possible future for the patient, as judged from the patient's own perspective. The ensuing discussion will explain this. The basic definition of health care and of the domain of the health care provider is given above. This social definition is important in creating some limits on the scope of the health care provider's obligations, as that provider

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(individual, institutional, or systemic) is obliged to incorporate only those interventions that are considered to be within the purview of 'health care', not all potential interventions. However, the health care provider must consider all medical and nursing interventions, all forgoings of these, all placement and community service options, and all personal efforts that the patient might be able to bring to bear. The health care provider is not generally permitted and certainly is not obligated to consider implementing interventions that are not included by the society within the scope of health care, such as improving the prospects for employment or avoiding incarceration for a crime. In the usual case, the patient presents because he or she has a current bodily dysfunction or has an identifiable risk of developing such a problem. What is at stake is how well and how long this person will live, and not merely what the diagnosis is or whether any measurable abnormality can be rectified (cf. assertion (1) in sec. 2). Thus, the first obligation of the health care provider who is presented with a patient is to ascertain the array of outcomes that are to be expected, if no particular intervention in the 'natural history' of the condition is taken. The provider is obligated to consider outcomes over the duration of the patient's life, although ambiguity and uncertainty are likely to require some discounting of effects in the far future. Usually, the possibilities are many and characterizing them will require estimating the likelihood, length, and nature of various life courses. The metaphor of the life story seems particularly fitting. At a particular time, the patient's life is a partly told story. Growing from an understanding of the current and past physiologic, anatomic, social, and psychological events and trends, the health care provider has to project the possible stories yet to be written by this person's living. After discerning the likely life stories if the situation is left untouched, then the provider must project the alternative life stories that could occur, or for which the likelihood changes, with the application of a health care intervention, or, stated more broadly, with the application of each alternative plan of care. In effect, the stories can be imagined as a series of books on a series of shelves. One shelf would be the stories that result with no particular health care intervention. The varying lengths of the stories on that shelf would parallel the likely mortality curve for a group of patients just like this one. The expected kinds of sufferings and dysfunctions and the conjunctions of these and lifespans would also be conveyed in the collection of stories on this shelf. To extend the imagery, by reading all of these stories, one would have a thorough understanding (by the recurrence of certain elements) of the likely outcome with the plan of care of leaving the situation alone. Other shelves would contain the series of life stories that would result with

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each of the major possible plans of care that might be implemented now. Each shelf would also contain books that vary by length and nature of the life to be lived, depending upon the initial situation, the effects of interventions, and chance. Again, reading all of each shelf would characterize the outcome to be expected with each plan of care. Only if there is a strong central tendency among the possible stories would one expect that the outcomes could be characterized well by a single story. Sometimes this is the case. It is probably sufficient to tell the schoolchild with a skin infection that all he needs to do is to take this antibiotic for the prescribed period and he will be as well as before. In other situations, the impacts of differing plans of care upon lifespan and the life to be lived are quite trivial. However, for the patient with a serious chronic disease, it is probably never sufficient to give such a limited story, with so little acknowledgement of its permutations and ambiguities. Two major shortcomings of current practices are that providers often fail to consider fully both the likely outcomes of the situation without intervention and the full array of options for intervention. In essence, the tendency is to focus very quickly upon the measured physiologic abnormality and upon how to fix it. The story-telling our model demands may seem to be an entirely unattainable ideal. For many plans of care, the outcomes are not well characterized. In many situations, the array of possible outcomes is broad and the ambiguities profound. Nevertheless, the nature of those stories on the shelf - even the fact that we do not now know how to write some of them - needs to be understood by the decision makers whenever the choice among plans of care would be likely to have a substantial impact upon the length or nature of the life to be lived. Again, that is exactly what is at stake - the length and nature of the life to be lived. When a substantial impact upon how the patient can live hangs in the balance, the health care provider must do what can be done to understand the implications and to share them with other decision makers. Death in this model is merely one among many outcomes (cf. assertion (5) in sec. 2). An earlier death may well be a feature of a plan of care that has other substantial merits (such as less pain, more self-control, or improved function in the near future). Under these Circumstances, the best choice of plan of care may be one that accepts an earlier death in order to attain other desirable outcomes. There is nothing aberrant about this decision making. Time until death is but one attribute of the rest of our lives. Extending life does not always outweigh other considerations. In fact, time until death is part of every projection of outcomes. There is no need for a different process for decision making for a group of patients labelled 'terminally ill', for we will all die someday. Of course, when life is expected to be short no matter what is done, there might (or might not) be reason to reflect this in the assessment of the relative desirability of various

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kinds of suffering and various possibilities for prolonging life. A few plans of care can be imagined but may not be offered in the care of a patient. First, the health care provider may not offer a plan of care that requires illegal homicide including suicide, assisted suicide, or murder. For the purposes of this essay, we accept that the range of actions that are thereby forbidden is set by society, although there will always be a few cases that are difficult to classify. So whatever is considered to be illegal homicide is not among the plans of care that may be offered to a patient, even if doing so might be, in the decision maker's eyes, a good option for the patient. 4 Second, the health care provider may not offer a plan of care that so endangers others that it is forbidden under a law or regulation designed to protect the public health or the well-being of vulnerable third parties. Even if a person might prefer to proceed in his or her ordinary life rather than be treated for tuberculosis and be confined to a hospital for a period of time, the society will not allow the person to forgo this treatment, since doing so puts others at unreasonable risk. Third, the health care provider may not offer a plan of care that cannot actually be implemented for a given patient in his or her particular situation. Sometimes the constraints are simply those of unusual circumstances. The physician stopping at an auto accident in a remote area and with no telephone cannot offer the plan of care (and the better outcomes) that would be routine in a sophisticated shock-trauma unit. More often, the constraints are those that arise because of the way that the health care system is arranged and financed. A poor person may really have no access to a liver transplant. Many persons in need of long-term care at home cannot have that service because it is so expensive and difficult to arrange. A pregnant teenager may have no real access to prenatal care in a state that does not make her eligible for Medicaid family services until she has had a first child. The examples are legion, and this is the origin of the most numerous constraints upon the ability to provide a full range of plans of care. 5 Once the provider has considered the broadest possible array of possible plans of care, has characterized the likely outcomes for each, and has eliminated those that cannot be implemented, he or she will routinely have a few major alternative plans of care, only one of which can be followed. In addition, the major options will likely differ in many dimensions of experience - pain, disability, survival time, cost, family impact, indignities of care, etc. Yet, the array of likely outcomes associated with each must be combined into a single ranking that reflects how the overall likely outcomes are ranked by the patient. How should this choice be made? People differ substantially in how they assess these disparate elements of their likely futures. Some will take almost any risk to maintain function or life, others

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will do almost anything to avoid pain, and others find the balancing to be a series of close questions. Some find it important to adhere to a particular religious view, or to have the opportunity to pursue religious obligations; others find these concems to be quite alien. No coherent and authoritative ordering and weighting of these disparate concerns that would apply to all persons has been developed. Indeed, currently in the U.S., the body politic is suspicious of virtually any effort to adopt societal preference orderings. We celebrate our pluralism and are much more concerned that we defend each person's right to be different in such personal matters than that any one person's views are justified, coherent, or consonant with some moral authority. Thus, the answer within our tradition must be that the choices are the patient's, whenever the patient can make his or her own choice (within the limits described above). Furthermore, the patient's preferences among possible arrays of outcomes must be elicited and honored, to the extent possible. This is the heart of 'informed consent', which (as characterized by assertion (2) in sec. 2) has often been trivialized as an obligation to notify the patient of the possibility of various adverse outcomes with the recommended treatment (and possibly with no treatment). This is but a faint shadow of the real obligation, which is to inform the patient of the characteristics of the stories that result from each of the major possible choices, and to situate the patient so as to make a choice based on his or her own values and preferences. We ground this obligation in a deeper appreciation of what it means to respect patient autonomy. 6 The decision making process should end up avoiding transfusions for certain Jehovah's Witnesses, providing vigorous life-sustaining treatment for most Orthodox rabbis, and trying painful and hazardous treatments for the young father who is willing to try anything in order to live longer. In other words, the decisions must be tailored to the patient. If the patient is able to understand the situation, discern the best available choice in the light of his or her preferences and values, and communicate that choice, then the patient should be the key decision maker. However, nothing requires that the patient act in such a solitary fashion. The collaboration of a physician or another responsible health care professional is ordinarily part of the decision making. In addition, most patients need the support and assistance of family and friends. Sometimes, the mentally capable patient will hand over decisions to the physician or someone else. This may occur, for example, when the patient finds the desirability of the choices to be unavoidably ambiguous, when the responsibility to choose is too threatening, or when the patient feels that the other person is more likely to choose in accord with the patient's own true interests. As long as the patient truly understands that the choice is his or hers to make and the final choice is made so as to reflect the

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patient's values and preferences, there is no strong objection in most situations to allowing the patient to choose the decision maker rather than make the decision directly. But how should choices be made when the patient cannot make them and cannot devolve them to another? This question may arise because the patient is unable to communicate, or to understand, or has no settled values and preferences (as, for example, an infant or a severely retarded person). The goal of the decision making for incompetent persons is still to make choices that serve the patient well, as the patient did or would determine his or her interests (cf. assertion (4) in sec. 2). In many situations, the patient's values and preferences are easy to identify, either because this person has left clear indications of his or her preferences or because it would be a very unusual person who would deviate from a common ranking of the desirability of outcomes in the situation at hand. For example, very few persons would not want to have a painful fracture splinted or a deep cut sutured. In the absence of an indication that the person had quite unusual values and preferences, it would be reasonable to proceed with treating conditions that are easily treated, mitigate suffering, and have little implication for lifespan. When the patient had no preferences or the patient's preferences cannot be known, the standards of 'substituted judgment' and 'best interests' become one and the same. Many persons will have left clear instructions about their preferences. Formal advance directives (living wills and durable powers of attorney) are probably a small but important part of this leaving of clear instructions. In addition, persons often have clear patterns of behavior, clear religious commitments, clear discussions with family and physicians, clear responses to the problems encountered by others during illness, and other indications as to their own preferences. These can often allow choices to be made quite confidently as to which among the possible plans of care would yield the most desirable array of outcomes, from the patient's perspective. Even when such a high degree of clarity cannot be achieved, the decision makers must still try to approximate the patient's choice. If, instead, society were to adopt some authoritative ranking of the desirability of the full range of possible outcomes and therefore the associated plans of care, then many people would be denied personalized care simply because they could not contemporaneously make their own choices and had not set out to differentiate themselves from the social norm clearly enough in advance. 7 There is a broad range of incomplete information that is still important to utilize in decision making. However, at some degree of ambiguity, information as to the patient's preferences and values becomes meaningless in shaping a plan of care. In such a case, we do have to act for this person in the way that we think most such people

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would want. While most people want their lives safeguarded in most situations, for example, most also are willing to yield at least small life extensions in order to gain, for example, comfort. The decision making process must take account of the fact that most people value their networks of friends and relatives and want to serve the interests of these others as well as those interests that are more narrowly self-serving. This provides the basis for allowing those who love and cherish an incompetent patient to have a fair range of discretion as to the merits of various possible plans of care for him or her. On the other hand, the patient who is known and loved by no one must be treated with respect and compassion within a system of impersonal professionals. Various safeguards may be justified in order to ensure that such relatively isolated persons are so treated, in order that their likely interests are not abrogated and obtainable evidence as to their values and preferences is brought to bear on decision naking. One problem of the more limited fix-it model, that of 'compliance' (see assertion (3) of sec. 2), is radically redefined with our model. No patient who has made a decision within the alternative futures model has had a treatment plan imposed without his or her full endorsement. Also, patients with predictable lapses of will power or other known potential impediments to following through on their own decisions 8 can and should have such limitations factored into the projection of likely outcomes. Moreover, outcomes are not to be projected based on physiology alone but also on psychosocial realities. Of course, with stable preferences but expected lapses of will power or of decision making capacity, the decision could include an 'Odysseus contract' that allows no undoing of the decision for a critical period of time. 9

4. EXAMPLES AND APPLICATIONS A few examples demonstrate the superiority of the outcomes model over the traditional fix-it model in framing critical ethical and medical issues.

4.1. Quackenbush: Possibly CompetentPerson Facing Amputation Consider first the case of Robert Quackenbush, 10 a 72-year-old man with extensive gangrene in both legs who had lived for ten years in a trailer with little interpersonal contact. At the request of neighbors, a rescue squad brought Mr. Quackenbush to a hospital emergency room, where he belligerently refused treatment. Two months earlier, he had been hospitalized and refused an advised operation for arteriosclerosis in the legs. The treating physician now indicated

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that without amputation one foot was likely to fall off and he would probably die within three weeks. The probability of recovery from amputation was said to be good and the risks limited, but nursing care that the hospital could not provide would be needed. A hospital social worker indicated that it could take up to six months to secure a nursing home placement. On the basis of a psychiatrist's testimony, the hospital argued that the patient was mentally incompetent to make the medical decision at hand - specifically, that he suffered from organic brain syndrome with psychotic elements. In favor of compelling the operation, the hospital was reported as: [describing] the decision of Quackenbush in refusing the operation as an aberration from the normal behavior. It equates the refusal to suicide and asserts a compelling state interest in preventing Quackenbush from refusing vital medical care and treatment. 11 A court-appointed independent psychiatrist, however, testified that Quackenbush was not incompetent. The hospital representatives clearly worked within the fix-it model. They emphasized that Quackenbush's decision deviated from normal behavior, suggesting that amputation was the standard procedure and therefore the proper course of care. It is also reasonable to suppose that their attribution of incompetence was provoked by this assessment that the decision was aberant. Finally, the hospital asserted a state interest in preserving life, which they took to be decisive at least when the patient is incompetent. The outcomes model would approach the analysis quite differently. Assuming, as the court decided, that Quackenbush really was competent, his preferences would rule, even though they may be unusual and might eventuate in a quick death. In discussing Mr. Quackenbush's options with him, an outcomes-model physician would have paid a great deal of attention to details like the necessity of nursing care and the possibility of its unavailability for six months - facts highly relevant to Mr. Quackenbush's possible futures had he elected amputation. Even if Mr. Quackenbush was not competent, the outcomes model would not simply assume that continued life trumps all other considerations but would study available evidence for the possibility of a substituted judgment. 12

4.2. Dietary Change and Medications for Reduction of Cholesterol The differing approaches of the two models are also evident in clinical decisions about preventive care, for example, in how to reduce serum cholesterol levels and, thereby, risk of coronary disease. The fix-it model favors dietary programs and lipid-lowering drugs for persons with hypercholesterolemia [14]. Various studies have demonstrated that, in conjunction with improved diet, the drugs may reduce incidence of some adverse cardiovascular events when asymp-

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tomatic middle-aged men with high cholesterol levels are treated for five years or longer [15]. (Though asymptomatic patients may seem to need no fixing, their high cholesterol levels constitute a 'latent' problem that can be fixed.) Researchers have encouraged generalizing to other age groups, women, and persons with lower cholesterol levels [15]. In contrast, the outcomes model would allow questioning the merits of dietary measures and drug therapies. It would require marshalling the available evidence concerning outcomes for each plan of care, discussing them with patients, and enabling them to make their own assessments of the merits of each option. The available evidence concerning hypercholesterolemia is, in fact, quite mixed. The American Heart Association and a majority of participants at a Consensus Conference at the National Institutes of Health recommend a 'prudent diet' for all persons - not just those at greatest risk. A lifetime lowcholesterol diet has been calculated to offer gains in life expectancy of 18 days to 12 months for those at high risk, ages 20 to 60; low-risk persons of this age group average a calculated gain of 3 days to 3 months ([14], p. 605). Patients (especially those of low risk) may believe a lifetime of careful eating is too high a price for such possibilities of benefit. Similarly, although the results of the two major drug trials were described as offering a 19% reduction in cardiovascular morbidity and mortality and a 34% reduction in the incidence of coronary disease, the absolute reductions were only 1.7% and 1.4%, respectively. Thus, only a very few participants showed discernable benefit ([15], p. 677). Meanwhile, the yearly costs of cholestyramine and gemfibrozil, the two drugs studied, are $1500 and $700, respectively - plus the expense and burden of follow-up visits. Of course, these costs are incurred by all treated patients and not just the small percentage who benefit ([ 15], p. 678). Recognizing that patient preferences will differ in the light of these facts, the outcomes model leaves the decision of treatment up to any patient capable of making a decision.

4.3. Prostatectomy Even in routine medical and surgical care, the two models differ. For example, patients with symptomatic prostatism now routinely have prostatectomy to reduce symptoms and to prevent future morbidity and mortality. Standard practice is to operate on asymptomatic patients with chronic urinary retention of large volumes or evidence of hydronephrosis or hydroureter ([16], p. 3010). Prostatectomy for benign hypertrophy is one of the most common surgical procedures performed in this country ([17], p. 3018). Transurethral prostatectomy has also overtaken open prostatectomy as the surgical procedure of choice ([18], p. 1120). Practitioners working from the outcomes model would not regard prostatec-

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tomy as a standard procedure and would not automatically favor transurethral over open prostatectomy. They would begin by turning to the available evidence conceming the outcomes of these procedures and of electing not to undergo surgery. What does the evidence suggest? First, prostatectomy is effective in reducing symptoms of urinary retention and frequency: improvement was found in 93% of severely and 79% of moderately symptomatic patients. However, improvements in quality of life were statistically significant only among patients who had had acute retention or severe symptoms prior to surgery. Twenty-four percent of patients experienced short-term complications; additionally, 5% reported impotence and 4% reported persistent incontinence ([ 17], p. 3018) - complications that might be extremely significant to some patients. In a study of 70-year-old men, immediate surgery lowered life expectancy slightly, by 1.01 months ([16], p. 3010). After adjustments were made for quality of life, surgery scored slightly higher with 122.91 QALMs (quality-adjusted life months) over 119.97 QALMs for 'watchful waiting', with no surgery at all unless an acute problem occurred ([16], p. 3012). Patients who appreciate these data will not automatically elect surgery of either kind. How much weight each gives to a small decrease in life expectancy, to the risks of various complications, and to the desirability of relieving urinary symptoms will determine the selection. Those who elect surgery will also have to choose between the two approaches. Transurethral prostatectomy appears to be less effective than open prostatectomy: The cumulative percentage of patients undergoing a second prostatectomy was substantially higher after transurethral than after open prostatectomy (12.0 vs 4.5 percent in Denmark, 12.0 vs. 1.8 percent in Oxfordshire, and 15.5 vs. 4.2 percent in Manitoba). The longterm age-specific mortality rates associated with transurethral prostatectomy as compared with open prostatectomy were also elevated in each country ([18], p. 1120). In any event, the outcomes model would encourage the patient to be the key decision maker and to be informed and thereby enabled to weigh these considerations.

5. SOME LIMITATIONS We will conclude by mentioning some limitations of the model we propose, in its current development. One limitation is that by understanding the value of outcomes as determined entirely by the patient's preferences, we have probably not done justice to the importance of the family's wishes. Even a loving family can sometimes have interests that are not perfectly coincident with the patient's preferences. Imagine that the Ortegas have always had a good relationship with their son Luis, but he now lies in a persistent vegetative state, dependent on a

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respirator. It tums out that Luis had clearly expressed a desire to be kept alive under all circumstances, in keeping with the tenets of a religious sect he had been a member of for several years. After two years of his being in PVS, his family - psychologically damaged by seeing their son not get better - come to the conclusion that enough is enough. It seems to us that the interests of such a family have some independent moral weight and might rightly prevail, a point not reflected in the relatively simple model we have presented. 13 The outcomes model also fails to settle various critical issues conceming valuation. First, nothing in the outcomes model (nor, for that matter, the fix-it model) indicates the criteria for justified substituted judgments. Should a PVS patient be removed from her respirator? Certainly, in our model, she should be if it is made sufficiently clear that she would have preferred that course of action. What is not clear is what constitutes substantial enough evidence. 14 Matters become even worse when an incompetent patient has no known preferences and the options for care yield very different outcomes - but none of them is clearly what a plurality of similarly placed persons would want. Imagine that an incompetent homeless person with no known family or friends is brought into the emergency room with a badly mangled leg. One option is amputation. Another is very aggressive surgery that entails greater risk of dying and considerable rehabilitative work, but is the only possible means of preserving function in the damaged leg. In the absence of known preferences, our model turns to the question of what persons similarly placed would most commonly prefer. But who are 'persons similarly placed'? Are they Americans, homeless persons, indigent persons of a particular race, or some other category? While our model does not answer these questions, it at least recognizes important issues to which the fix-it model is blind. A third problem concerning valuation is well beyond the answers provided by our model. It arises with predictable changes in a patient's preferences. Imagine a man with a spinal cord transection who elects not to receive life-preserving treatment. Wanting to ensure that the patient understands his options and the consequences of his decisions, his physician mentions the possibility that, after a very disagreeable first few months following surgery, the patient will appreciate being alive and will take satisfaction in more modest accomplishments, e.g., controlling various machines in his environment by blinking his eyes. If the patient agrees that he might come to appreciate life but insists that he does not want to be the kind of person who gets satisfaction this way, we have not examined adequately how our model would resolve this conflict between present and (possible) future preferences. Again, we can take small comfort in noting that at least the model points to this problem. Another difficulty is the heavy obligations that our model entails for health providers. The burden comes essentially in the form of time and, therefore,

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money. In our model the provider often has to get to know the patient's values fairly well. Moreover, he or she has to discuss an array of plans of action and the likely outcomes of each. Many providers will find these responsibilities quite burdensome. The obligations entailed by this model might require some negotiation between physicians and patients (and the public) as to how much resource use should be devoted to decision making (rather than to implementing plans of care). A related problem concerns enforcement. Should it become a matter of law that the outcomes model be implemented, requiring, for example, that physicians discuss an array of possible futures with the patient? If so, what will be the legal minimum? Perhaps one must disclose possible outcomes with that degree of comprehensiveness that is considered standard or usual in the medical profession. However, a standard that is set and enforced internal to the profession risks not being ethically acceptable. 15 Providing appropriate data for implementing the model will be quite onerous. When a physician informs a patient that she has options A, B, C, and D, the physician needs to be able to say what the likely futures are for these four options. But describing the likely futures cannot be done responsibly without some empirical data backing up the story-telling for each option. After all, these stories are not fictional; they have been and will be lived out by actual people, including the present patient. The possibility of incomplete story-telling brings us to a final limitation. The outcomes model is somewhat less attractive when a person's future is filled with pervasive uncertainty. Imagine that a patient contracts an extremely rare form of cancer and that there is no available data on how patients as young as the present one fare with various therapies. When a person's future hangs in the balance, a bookcase that is mostly empty and containing only incomplete stories is of limited value. Of course, in such a Circumstance, the fix-it model provides only the hollow reassurance of a clear mandate for a plan of action - hollow because that plan cannot be known to lead to the outcomes that matter. The outcomes model improves upon the current fix-it model in a number of ways. It makes sense of relevant patient-centered considerations (stemming from respect for autonomy), sets the decision making in an understandable social context, and does not impose new and irrelevant problems. It may well be useful in pointing to the key considerations in allocation and health care system design. Many of the problems we outline above may be ameliorated as we and others work with the model. - The authors would like to thank Donald Murphy and Gail Povar, whose criticisms and suggestions led to a much improved paper.

Acknowledgement

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NOTES I For the purposes of this paper, an individual may be understood to have an interest in X if either (1) he or she prefers X or (2) it would be rational, given everything else he or she prefers, to prefer X. See also [1], pp. 30--60; [2], pp. 86-88; [3], pp. 16--47. 2 In the early days of the Hippocratic tradition, for example, dying was not a medical concern. The physician was admonished "to refuse to treat those who are overmastered by their diseases, realizing that in such cases medicine is powerless" [4]. This is no longer true; hospice care has become a regular part of health care covered in the U.S. by Medicare and other health insurance, and most Americans die in hospitals. See U.S. Supreme Court. Amicus Curiae brief on behalf of the American Hospital Association in In re Cruzan (June 25, 1990). The domain of health care can differ among persons even within a particular society. Housing is ordinarily taken to be a health care concern for the disabled and elderly, while for most others it is not. 3 See [7, 8]; [9], ch. 3; [10]. Studies such as these suggest that the reasons for noncompliance are often far more complicated than those provided by the fix-it model. Stimson's critique of numerous earlier studies and of prevalent physician attitudes towards noncompliance is revealing: "The 'problem' in these studies has been conceived from the point of view of the doctor and has used a model of the doctor-patient relationship where the doctor gives instructions to the patient who is expected to comply ... It is an ideal of the patient as a passive and obediant recipient of medical instructions ... The research problem has been conceived as one of conformity and its opposite, deviancy" ([10), p. 99). The picture emerging from more insightful studies is that noncompliance often results from misunderstanding the physician's instructions, psychological attributes of patients (e.g., anxiety), situational factors (e.g., lack of money, lack of transportation, pressing problems at home, lack of support from significant others), and religious or cultural impediments to compliance; also important are characteristics of the treatment, so that, for example, complicated treatments that interfere extensively with the patient's usual habits but yield no highly visible signs of improvement are less likely to be followed (see especially [9]). 4 This approach to the issue of killing has the advantage that it does not invite or force conceptual hair-splitting over what counts as unjustified cases of causing death. Because the fix-it model is committed to preventing death, it is afortiori committed to preventing killing. Since there is broad agreement that removing a respirator when death is the foreseeable consequence is sometimes permissible, the fix-it model is pressured to lean on distinctions like those of killing versus letting die, actions versus omissions, death's being intended versus being merely foreseen, and death's being caused by the practitioner versus its being caused by the underlying medical condition. 5 Whether the provider should include in the discussion of alternatives some that cannot be implemented is a subject for another essay. Here we will only note that there may be cause to inform patients of at least some of the potentially desirable alternatives that are barred by the current pattern of health care system financing and organization. The political force for reform probably cannot arise if those directly affected are unaware of how they are affected by our present system. Our model is one of decision making within an already given system of distribution. Because we do not here defend a particular system of distribution, our model is not per s e a model of distributional justice. 6 Similar conceptions of informed consent are Jay Katz's informed consent as conversation [6], Faden's and Beauchamp's informed consent as autonomous authorization [11], and Howard Brody's informed consent as involving transparent disclosure [ 12]. 7 This error has now been endorsed in the Cruzan opinion of the U.S. Supreme Court. See U.S. Supreme Court. In re Cruzan 760 S.W. 2d. 408 (affirmed, June 25, 1990). In allowing Missouri to make the preservation of life into an uncompromisable goal of health care, at least for incompetent persons who did not leave explicit instructions, the

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U.S. Supreme Court has allowed Missouri to overrule the individualization of care that our account requires. In effect, there is now an additional set of care plans that cannot be made available to certain patients. For those incompetent patients in Missouri who did not clearly state their preferences for the specific situation now facing them, the provider cannot offer a plan of care that accepts an earlier death. 8 See note 3. 9 In such a case, interestingly, a patient's short-term freedom (in the sense of a lack of external constraints) could be restricted in the name of his or her longer-term autonomy. (See [13], pp. 106-108). 10 See Superior Court of New Jersey. In re Quackenbusch 156 N.J. 282, 383 A.2d 785 (decided, January 13, 1978). 11 See 383 Atlantic Reporter, 2d series: 288-89. 12 The disparity between the two models can be even greater in the case of a patient who clearly lacks decision making capacity. Consider Claire Conroy, an eighty-four year-old bed-bound nursing home patient with major and irreversible mental and physical impairments. (See Supreme Court of New Jersey. In re Conroy 98 N.J. 321,486 A. 2d 1209 [decided, January 17, 1985]). Her nephew requested that Conroy's nasogastric tube be removed, an action expected to lead to death by dehydration in about a week. According to the fix-it model, since it is in the patient's best interests to avoid death, the nephew's request would probably be denied. The outcomes-oriented model would grant the nephew's request to discontinue nutrition and hydration (confirming the judgment of the Supreme Court of New Jersey). The evidence concerning Conroy's values and preferences indicated that she would not have wanted the naso-gastric tube in place. All of her possible futures looked quite bleak and the decision maker would have had to adopt what could be known of her own preferences and values concerning the extension of life. The outcomes model has no prior commitment to extending life whenever possible. 13 This point is crucially relevant to our analysis of the Cruzan decision (see note 7). Leaving aside our disagreement with the Supreme Court's decision to allow the states to determine evidentiary standards for substituted judgments, we think that the interests of the Cruzan family should have been taken into account. In cases like this, if a substituted judgment is not granted, given the formidable difficulties of determining what is in the PVS patient's best interests, we believe the family's interests should under ordinary circumstances prevail - or at least be given significant weight. 14 In Cruzan, the U.S. Supreme Court allowed states to require 'clear and convincing' evidence, a standard that might require written advance directives and that has been held to require more than informal discussions with family and friends. (See the Supreme Court report in note 7 and New York Court of Appeals. In re O'Connor 72 N.Y. 2d 517, 531 N.E. 2d 607 [decided October 14, 1988]). 15 This point was made in the landmark case Canterbury v. Spence, in which the appelate court of the District of Columbia enunciated the 'reasonable person standard'. See U.S. Court of Appeals, District of Columbia Circuit. Canterbury v. Spence 464 F.2d 772-796 (decided May 19, 1972).

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