Everything that Should Be Done-Not Everything that Can Be Done
Ethical principles (1) in critical care, as elsewherein medicine and life, are meant to be lighthouses, helping us navigate through the stormy seas of patient care. Unfortunately, in a confusing era of high technology, litigious behavior, and diminishing health care resources, ethical principles and common sense don't always seem to point us in the same direction. What course should we choose, for instance, when "beneficence" and "nonmaleficence" indicate that treatments that do no good and may even do harm should be withheld, but patient "autonomy" directs us to do what the patient or his surrogate wishes? The answer, I predict, will set the tone on how we as a society choose to use our resources in critical care during the coming decade. Is the problem that we misunderstand how these principles apply, or is it that they are in conflict with one another? In the past decade, numerous groups, including many of our own professional societies (2-4), have grappled with the onerous problem of "who decides" when it comes to withholding or withdrawing life-sustaining treatment from the critically ill. Fortunately, a consensus seems to have emerged on many important issues (5, 6): a competent adult has the right to refuse medical treatment, and an appropriate surrogate (usually a family member) may make the same choice for an incompetent adult; withholding/ withdrawing life-sustaining therapy, including "do not resuscitate" orders, does not require prior court approval unless there is a dispute or an incompetent patient lacks an appropriate surrogate, and withholding or withdrawing treatmentincluding nutrition and hydration by artificial means - are legally and morally equivalent. With such work behind us, both the patient's physician and the ICU team have been able, thankfully, to turn their attention back to healing the spirit as well as the body, for the family as well as the patient, in these most difficult times at the end of life. Yet lurking in the background of all such discussions has been the unstated but ever-present notion that at some point patient autonomy must yield to physician authority. And, at a minimum, 508
this transition should at least occur when the treatment in question is futile, i.e., in the words ofthe recent ATS Statement on Withholding and Withdrawing Lifesustaining Therapy (2), "if reasoning and experience indicate that the intervention would be highly unlikely to result in a meaningful survival for that patient." Indeed, quoting the statement further: "A physician has no ethical obligation to provide a life-sustainingintervention that is judged futile ... even if the intervention is requested by the patient or surrogate decision maker. To force physicians to provide medical interventions that are clearly futile would undermine the ethical integrity of the medical profession." If an increasing number of articles on the subject is any yardstick by which to judge (2,6-13), then "futility" in critical care is a major obstacle we must still confront and surmount. And it will not be easy because the problem of futility is distinct from the issues of the past decade. It was relatively simple for physicians to relinquish paternalistic attitudes as long as the decisions were ultimately those the physicians would have made themselves. But inherent in the concept of futility is the notion that an individual's future must be subsumed to the rights or benefits of others - a notion not readily accepted in the second half of twentieth-century America. At first, perhaps, it may seem surprising that this issue is even controversial, for if an action is truly futile, who could argue for its continuation? The problem, however, is essentially this: who decides what is futile, and on what basis? As opposed to treatment to which the patient is entitled, the decision to administer treatment to which the patient has no a priori right (such as apparently futile treatment) can only be made by a wellinformed physician. But this paradigm requires that the physician be accorded powers no longer accepted by our society with equanimity. Physicians, unfortunately, liketoo many others in our communities, no longer automatically merit the trust of the public they serve. Despite support from statements such as those by the ATS, most physicians have
remained reluctant to withhold or withdraw treatment simply on the basis of "reasoning and experience." Yet, inevitably, new data have been collected, and increasingly we can predict with frightening precision what one's chances are after events such as non-traumatic coma, or in- or out-of-hospital cardiopulmonary resuscitation (7, 14, 15). Indeed, with the advent of the APACHE-III severity-of-illness scoring system, we may be able to provide reasonably exact estimates of chances for survival for most ICU patients (16). What then shall wedo with such information? Schneiderman and colleagues (13) have recently suggested that a futile effort is not necessarily an impossible, nor an implausible, nor a hopeless, action. Rather, it is an action for which the expectation of success "is either predictably or empirically so unlikely that its exact probability is often incalculable." Given this definition, they suggest that if the chances for survival as the result of treatment are less than 1in a 100,then the treatment may be legitimately considered futile. In this month's issue of ThE REVIEW we see the problem with this suggestion. Crawford and Petersen (17) have provided us with very clear data about the chances of survival once mechanical ventilation becomes necessary after bone marrow transplantation. Of 348 patients, . only 15 (4010) were discharged from the hospital, and only 10 (3%) were alive 6 months after hospitalization. This study is important, not so much because of the new information it provides as the basic conclusion is largely confirmatory of many similar but smaller prior studies (18-25), but because its size, prospective nature, and attention to statistical methods narrows the confidence interval around the main result. The investigators calculate that the chance of surviving for 6 months after requiring mechanical ventilation after bone marrow transplantation is between 2 and 6%. Indeed, no survivor required mechanical ventilation for more than 9 days, also supporting several previous studies that the small chance of survival diminishes even further as the duration of ventilatory support increases, AM REV RESPIR DIS 1992; 145:508-509
509
EDITORIAL
especially if there is no progress toward improvement (9, 19). Regardless, is a treatment that offers one a chance of survival of at least 2070 meaningfully different from a "futile" action, defined as one with < 1% chance of producing survival? Crawford and Petersen argue that it is, and thus "medical futility may not be a valid argument for withholding mechanical ventilation from the marrow transplant recipient ..." Therefore, they recommend that "autonomous decisions by the patient should be followed." Something is left out here, something that makes this splitting of hairs about 1% or 2% or 3% less important - and that something is cost. And I don't mean cost simply in terms of dollars and cents, although these treatments are almost incredibly expensive. I mean the cost in human suffering - the patient who is paralyzed with drugs and sedated to the point of unconsciousness so that effective mechanical ventilation is even possible; the family who must watch for days, weeks, and occasionally months as they cling to the small statistical chance that we offer them; the nursing staff who work unbelievably hard on an effort that to them seems useless and pointless. I am truly delighted for the three out of 100patients who beat the odds and live for at least 6 more months - but what about the other 97? Clearly, there is an important difference between a futile action with little "cost" (how about vitamin therapy for respiratory failure?) and one for which the cost is very great. Why did we get to this point, as physicians, as a society, where wecan let - no, actually be the cause of-such suffering? And even do it in the name of patient "autonomy"? Most patients and their families who take on the rigors of bone marrow transplantation are by their nature not "quitters." If counseled that the chance of long-term survival is 3% or so, when the alternative is certain death, I suspect many will still opt for "doing everything." Indeed, I suspect that as long as we present data that there is any "reasonable" chance, many of these patients or their families will ask us to continue on. Must we allow those with this small chance of survival to dictate the "ICU agenda"? The data of Crawford and Petersen present us with a rare opportunity, for in most cases we either lack the data to provide an accurate prognosis or we deal with the problem after the fact, when withdrawal- despite its moral equivalence with withholding - is viewed suspiciously by some families as represent-
ing some other, hidden agenda. In this case, however,we know beforehand what the problem is and what the consequences are. If a patient and a family are willing to take on bone marrow transplantation, then they must be told in the clearest possible terms that the chance of requiring mechanical ventilatory support for respiratory failure sometime in the post-transplant period is about one in four. However, if they are unlucky enough to require mechanical ventilation for survival, their chance of living for even 6 months is only 2 to 6%. Given these facts, they must be told that their physicians (the oncologist, the pulmonologist, or the intensivist) will evaluate whether there is any reason to believethat the cause might be readily reversible. If so, a reasonably short trial of ventilatory support might be justified, until the problem in question is evaluated. If new treatments for respiratory failure are developed, than mechanical ventilatory support should be offered if the patient/ family are willing to participate in carefully designed research protocols. Lacking such reasons, however, neither the patient nor the family should expect that mechanical ventilatory support will be initiated. Ethical principles, for all their illumination, don't always shine with the same intensity - nor should they. We must learn to distinguish "everything that can be done" from "everything that should be done." Making the distinction is not easy - and that's OK. It doesn't bother me at all that these decisions are tough, gut-wrenching, anxiety-provoking. But that is part of our responsibility - and it's about time that we began to accept it. Acknowledgment The writer gratefully acknowledges the many thoughtful suggestions of Dr. Daniel Goodenberger. DANIEL P. SCHUSTER, M.D.
Respiratory and Critical Care Medicine Division Washington University School of Medicine St. Louis, Missouri 63110 References 1. Luce JM. Ethical principles in critical care. JAMA 1990; 696-700. 2. Lanken PN. Withholding and withdrawing lifesustaining therapy. Am Rev Respir Dis 1991; 144:726. 3. Hyers TM, Briggs DD, Hudson LD, et al. NIH workshop summary. Withholding and withdrawing mechanical ventilation. Am Rev Respir Dis 1986;
134:1327-30. 4. Butler P, Carton RW, Elpern E, et al. Ethical and moral guidelines for the initiation, continuation, and withdrawing of intensive care. Chest 1990; 97:949-58. 5. Armstrong CJ. Judicial involvement in treatment decisions: the emerging consensus. In: Civetta JM, Taylor RW, Kirby RR, eds. Critical care. Philadelphia: J.B. Lippincott, 1989; 1649-55. 6. Ayers SM. Who decides when care is futile? Hosp Pract [Off] 1991; 26:41-53. 7. Hansen-Flaschen J. When life support is futile. Chest 1991; 100:1191-2. 8. Gray WA, Capone RJ, Most AS. Unsuccessful emergency medical resuscitation: are continued efforts in the emergency department justified? N Eng! J Med 1991; 325:1393-8. 9. Schuster DP, Marion JM. Precedents for meaningful recovery during treatment in a medical intensive care unit. Outcome in patients with hematologic malignancy. Am J Med 1983;75:402-8. 10. Carlon GC. Just say no. Crit Care Med 1989; 17:106-8. 11. Lantos JD, Singer PA, Walker RM, et al. The illusion of futility in clinical practice. Am J Med 1987; 81-4. 12. Imbus SH, Zawacki BE. Autonomy for burned patients when survival is unprecedented. N Engl J Med 1977; 297:308-11. 13. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning and ethical implications. Ann Intern Med 1990; 112:949-54. 14. Rinaldo JE, Snyder JV. Survival data base: central nervous system injury. Am Rev Respir Dis 1989; 14O(Suppl:25-7). 15. Bedell SE, Delbanco TL, Cook EF, Epstein FH. Survival after cardiopulmonary resuscitation in the hospital. N Engl J Med 1983; 309:569-76. 16. Knaus WA, Wagner DP, Lynn J. Short-term mortality predications for critically ill hospitalized adults: science and ethics. Science 1991; 253:1-6. 17. Crawford SW, Petersen FB. Long-term survival from respiratory failure after marrow transplantation for malignancy. Am Rev Respir Dis 1992; 145:510-4. 18. Thrnbull AD, Carlon G, Baron R, Sichel W, Young C, Howland W. The inverse relationship between cost and survival in the critically ill cancer patient. Crit Care Med 1979; 7:20-23. 19. Denardo SJ, Oye RK, Bellamy PE. Efficacy of intensive care for bone marrow transplant patients with respiratory failure. Crit Care Med 1989; 17:4-6. 20. Butt W, Baker G, Walker C, Gillis J, Kilham H, Stevens M. Outcome of children with hematologic malignancy who are admitted to an intensive care unit. Crit Care Med 1988; 16:761. 21. Peters SG, Meadows JA, Gracey DR. Outcome of respiratory failure in hematologic malignancy. Chest 1988; 94:99-102. 22. Torrecilla C, Cortes JL, Chamorro C, Rubio JJ, Galdos P, Domingues de Villota E. Prognostic assessment of the acute complications of bone marrow transplantation requiring intensive therapy. Intensive Care Med 1988; 14:393-8. 23. Snow RM, Miller WC, Rice DL, Ali MK. Respiratory failure in cancer patients. JAMA 1979; 214:2039-42. 24. Lloyd-Thomas AR, Dhaliwal HS, Lister TA, Hinds CJ. Intensive therapy for life-threatening medical complications of hematologic malignancy. Intensive Care Med 1986; 12:317-24. 25. Crawford SW, Schwartz DA, Petersen FB, Clark JG. Mechanical ventilation after marrow transplantation. Risk factors and clinical outcome. Am Rev Respir Dis 1988; 137:682-7.
Ethical principles (1) in critical care, as elsewherein medicine and life, are meant to be lighthouses, helping us navigate through the stormy seas of patient care. Unfortunately, in a confusing era of high technology, litigious behavior, and diminishing health care resources, ethical principles and common sense don't always seem to point us in the same direction. What course should we choose, for instance, when "beneficence" and "nonmaleficence" indicate that treatments that do no good and may even do harm should be withheld, but patient "autonomy" directs us to do what the patient or his surrogate wishes? The answer, I predict, will set the tone on how we as a society choose to use our resources in critical care during the coming decade. Is the problem that we misunderstand how these principles apply, or is it that they are in conflict with one another? In the past decade, numerous groups, including many of our own professional societies (2-4), have grappled with the onerous problem of "who decides" when it comes to withholding or withdrawing life-sustaining treatment from the critically ill. Fortunately, a consensus seems to have emerged on many important issues (5, 6): a competent adult has the right to refuse medical treatment, and an appropriate surrogate (usually a family member) may make the same choice for an incompetent adult; withholding/ withdrawing life-sustaining therapy, including "do not resuscitate" orders, does not require prior court approval unless there is a dispute or an incompetent patient lacks an appropriate surrogate, and withholding or withdrawing treatmentincluding nutrition and hydration by artificial means - are legally and morally equivalent. With such work behind us, both the patient's physician and the ICU team have been able, thankfully, to turn their attention back to healing the spirit as well as the body, for the family as well as the patient, in these most difficult times at the end of life. Yet lurking in the background of all such discussions has been the unstated but ever-present notion that at some point patient autonomy must yield to physician authority. And, at a minimum, 508
this transition should at least occur when the treatment in question is futile, i.e., in the words ofthe recent ATS Statement on Withholding and Withdrawing Lifesustaining Therapy (2), "if reasoning and experience indicate that the intervention would be highly unlikely to result in a meaningful survival for that patient." Indeed, quoting the statement further: "A physician has no ethical obligation to provide a life-sustainingintervention that is judged futile ... even if the intervention is requested by the patient or surrogate decision maker. To force physicians to provide medical interventions that are clearly futile would undermine the ethical integrity of the medical profession." If an increasing number of articles on the subject is any yardstick by which to judge (2,6-13), then "futility" in critical care is a major obstacle we must still confront and surmount. And it will not be easy because the problem of futility is distinct from the issues of the past decade. It was relatively simple for physicians to relinquish paternalistic attitudes as long as the decisions were ultimately those the physicians would have made themselves. But inherent in the concept of futility is the notion that an individual's future must be subsumed to the rights or benefits of others - a notion not readily accepted in the second half of twentieth-century America. At first, perhaps, it may seem surprising that this issue is even controversial, for if an action is truly futile, who could argue for its continuation? The problem, however, is essentially this: who decides what is futile, and on what basis? As opposed to treatment to which the patient is entitled, the decision to administer treatment to which the patient has no a priori right (such as apparently futile treatment) can only be made by a wellinformed physician. But this paradigm requires that the physician be accorded powers no longer accepted by our society with equanimity. Physicians, unfortunately, liketoo many others in our communities, no longer automatically merit the trust of the public they serve. Despite support from statements such as those by the ATS, most physicians have
remained reluctant to withhold or withdraw treatment simply on the basis of "reasoning and experience." Yet, inevitably, new data have been collected, and increasingly we can predict with frightening precision what one's chances are after events such as non-traumatic coma, or in- or out-of-hospital cardiopulmonary resuscitation (7, 14, 15). Indeed, with the advent of the APACHE-III severity-of-illness scoring system, we may be able to provide reasonably exact estimates of chances for survival for most ICU patients (16). What then shall wedo with such information? Schneiderman and colleagues (13) have recently suggested that a futile effort is not necessarily an impossible, nor an implausible, nor a hopeless, action. Rather, it is an action for which the expectation of success "is either predictably or empirically so unlikely that its exact probability is often incalculable." Given this definition, they suggest that if the chances for survival as the result of treatment are less than 1in a 100,then the treatment may be legitimately considered futile. In this month's issue of ThE REVIEW we see the problem with this suggestion. Crawford and Petersen (17) have provided us with very clear data about the chances of survival once mechanical ventilation becomes necessary after bone marrow transplantation. Of 348 patients, . only 15 (4010) were discharged from the hospital, and only 10 (3%) were alive 6 months after hospitalization. This study is important, not so much because of the new information it provides as the basic conclusion is largely confirmatory of many similar but smaller prior studies (18-25), but because its size, prospective nature, and attention to statistical methods narrows the confidence interval around the main result. The investigators calculate that the chance of surviving for 6 months after requiring mechanical ventilation after bone marrow transplantation is between 2 and 6%. Indeed, no survivor required mechanical ventilation for more than 9 days, also supporting several previous studies that the small chance of survival diminishes even further as the duration of ventilatory support increases, AM REV RESPIR DIS 1992; 145:508-509
509
EDITORIAL
especially if there is no progress toward improvement (9, 19). Regardless, is a treatment that offers one a chance of survival of at least 2070 meaningfully different from a "futile" action, defined as one with < 1% chance of producing survival? Crawford and Petersen argue that it is, and thus "medical futility may not be a valid argument for withholding mechanical ventilation from the marrow transplant recipient ..." Therefore, they recommend that "autonomous decisions by the patient should be followed." Something is left out here, something that makes this splitting of hairs about 1% or 2% or 3% less important - and that something is cost. And I don't mean cost simply in terms of dollars and cents, although these treatments are almost incredibly expensive. I mean the cost in human suffering - the patient who is paralyzed with drugs and sedated to the point of unconsciousness so that effective mechanical ventilation is even possible; the family who must watch for days, weeks, and occasionally months as they cling to the small statistical chance that we offer them; the nursing staff who work unbelievably hard on an effort that to them seems useless and pointless. I am truly delighted for the three out of 100patients who beat the odds and live for at least 6 more months - but what about the other 97? Clearly, there is an important difference between a futile action with little "cost" (how about vitamin therapy for respiratory failure?) and one for which the cost is very great. Why did we get to this point, as physicians, as a society, where wecan let - no, actually be the cause of-such suffering? And even do it in the name of patient "autonomy"? Most patients and their families who take on the rigors of bone marrow transplantation are by their nature not "quitters." If counseled that the chance of long-term survival is 3% or so, when the alternative is certain death, I suspect many will still opt for "doing everything." Indeed, I suspect that as long as we present data that there is any "reasonable" chance, many of these patients or their families will ask us to continue on. Must we allow those with this small chance of survival to dictate the "ICU agenda"? The data of Crawford and Petersen present us with a rare opportunity, for in most cases we either lack the data to provide an accurate prognosis or we deal with the problem after the fact, when withdrawal- despite its moral equivalence with withholding - is viewed suspiciously by some families as represent-
ing some other, hidden agenda. In this case, however,we know beforehand what the problem is and what the consequences are. If a patient and a family are willing to take on bone marrow transplantation, then they must be told in the clearest possible terms that the chance of requiring mechanical ventilatory support for respiratory failure sometime in the post-transplant period is about one in four. However, if they are unlucky enough to require mechanical ventilation for survival, their chance of living for even 6 months is only 2 to 6%. Given these facts, they must be told that their physicians (the oncologist, the pulmonologist, or the intensivist) will evaluate whether there is any reason to believethat the cause might be readily reversible. If so, a reasonably short trial of ventilatory support might be justified, until the problem in question is evaluated. If new treatments for respiratory failure are developed, than mechanical ventilatory support should be offered if the patient/ family are willing to participate in carefully designed research protocols. Lacking such reasons, however, neither the patient nor the family should expect that mechanical ventilatory support will be initiated. Ethical principles, for all their illumination, don't always shine with the same intensity - nor should they. We must learn to distinguish "everything that can be done" from "everything that should be done." Making the distinction is not easy - and that's OK. It doesn't bother me at all that these decisions are tough, gut-wrenching, anxiety-provoking. But that is part of our responsibility - and it's about time that we began to accept it. Acknowledgment The writer gratefully acknowledges the many thoughtful suggestions of Dr. Daniel Goodenberger. DANIEL P. SCHUSTER, M.D.
Respiratory and Critical Care Medicine Division Washington University School of Medicine St. Louis, Missouri 63110 References 1. Luce JM. Ethical principles in critical care. JAMA 1990; 696-700. 2. Lanken PN. Withholding and withdrawing lifesustaining therapy. Am Rev Respir Dis 1991; 144:726. 3. Hyers TM, Briggs DD, Hudson LD, et al. NIH workshop summary. Withholding and withdrawing mechanical ventilation. Am Rev Respir Dis 1986;
134:1327-30. 4. Butler P, Carton RW, Elpern E, et al. Ethical and moral guidelines for the initiation, continuation, and withdrawing of intensive care. Chest 1990; 97:949-58. 5. Armstrong CJ. Judicial involvement in treatment decisions: the emerging consensus. In: Civetta JM, Taylor RW, Kirby RR, eds. Critical care. Philadelphia: J.B. Lippincott, 1989; 1649-55. 6. Ayers SM. Who decides when care is futile? Hosp Pract [Off] 1991; 26:41-53. 7. Hansen-Flaschen J. When life support is futile. Chest 1991; 100:1191-2. 8. Gray WA, Capone RJ, Most AS. Unsuccessful emergency medical resuscitation: are continued efforts in the emergency department justified? N Eng! J Med 1991; 325:1393-8. 9. Schuster DP, Marion JM. Precedents for meaningful recovery during treatment in a medical intensive care unit. Outcome in patients with hematologic malignancy. Am J Med 1983;75:402-8. 10. Carlon GC. Just say no. Crit Care Med 1989; 17:106-8. 11. Lantos JD, Singer PA, Walker RM, et al. The illusion of futility in clinical practice. Am J Med 1987; 81-4. 12. Imbus SH, Zawacki BE. Autonomy for burned patients when survival is unprecedented. N Engl J Med 1977; 297:308-11. 13. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning and ethical implications. Ann Intern Med 1990; 112:949-54. 14. Rinaldo JE, Snyder JV. Survival data base: central nervous system injury. Am Rev Respir Dis 1989; 14O(Suppl:25-7). 15. Bedell SE, Delbanco TL, Cook EF, Epstein FH. Survival after cardiopulmonary resuscitation in the hospital. N Engl J Med 1983; 309:569-76. 16. Knaus WA, Wagner DP, Lynn J. Short-term mortality predications for critically ill hospitalized adults: science and ethics. Science 1991; 253:1-6. 17. Crawford SW, Petersen FB. Long-term survival from respiratory failure after marrow transplantation for malignancy. Am Rev Respir Dis 1992; 145:510-4. 18. Thrnbull AD, Carlon G, Baron R, Sichel W, Young C, Howland W. The inverse relationship between cost and survival in the critically ill cancer patient. Crit Care Med 1979; 7:20-23. 19. Denardo SJ, Oye RK, Bellamy PE. Efficacy of intensive care for bone marrow transplant patients with respiratory failure. Crit Care Med 1989; 17:4-6. 20. Butt W, Baker G, Walker C, Gillis J, Kilham H, Stevens M. Outcome of children with hematologic malignancy who are admitted to an intensive care unit. Crit Care Med 1988; 16:761. 21. Peters SG, Meadows JA, Gracey DR. Outcome of respiratory failure in hematologic malignancy. Chest 1988; 94:99-102. 22. Torrecilla C, Cortes JL, Chamorro C, Rubio JJ, Galdos P, Domingues de Villota E. Prognostic assessment of the acute complications of bone marrow transplantation requiring intensive therapy. Intensive Care Med 1988; 14:393-8. 23. Snow RM, Miller WC, Rice DL, Ali MK. Respiratory failure in cancer patients. JAMA 1979; 214:2039-42. 24. Lloyd-Thomas AR, Dhaliwal HS, Lister TA, Hinds CJ. Intensive therapy for life-threatening medical complications of hematologic malignancy. Intensive Care Med 1986; 12:317-24. 25. Crawford SW, Schwartz DA, Petersen FB, Clark JG. Mechanical ventilation after marrow transplantation. Risk factors and clinical outcome. Am Rev Respir Dis 1988; 137:682-7.
