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Ethical Challenges Concerning Futile Critical Care : Ethical Challenges Concerning Futile Critical Care Laurence B. McCullough, Ph.D. Professor of Medicine and Medical Ethics Center for Medical Ethics and Health Policy Baylor College of Medicine Houston, Texas

Objectives: Objectives Define preventive ethics and ethical challenges of preventive ethics in critical care at the end of life Define critical care, starting with resuscitation of seriously ill, as a trial of intervention Identify the short-term and long-term goals of critical care Identify a preventive ethics framework for making clinical judgments of futility to justify limits on life-sustaining treatment/critical care at the end of life Rabeneck, McCullough, Wray 1997 McCullough, Jones 2001

Preventive Ethics: Preventive Ethics Preventive ethics = development of policies and practices intended to anticipate and prevent ethical conflicts and to respond to them rapidly when they occur A preventive ethics approach is better than a reactive approach to ethical conflict, because a preventive ethics approach should reduce the biopsychosocial toll on patients, parents, healthcare professional teams, and organizational culture of ethical conflicts

Ethical Challenges -1: Ethical Challenges -1 Default position of resuscitation of patients without DNR orders Resulted from application of CPR to sicker and sicker patients without attention to outcomes and whether they were being improved by resuscitation Blurred distinction between technically possible and medically reasonable Technically possible = personnel, medications, and machines available to perform an intervention Medically reasonable = best available evidence supports clinical judgment that intervention will result in acceptable outcome

Ethical Challenges -2: Ethical Challenges -2 Acceptable outcome can be defined from a clinical perspective Prevents imminent death Accomplishes usually expected physiological outcome Preserves at least some functional status and therefore interactive capacity Prevents unnecessary pain, distress, and suffering, both disease-related and iatrogenic Pain, distress, and suffering are unnecessary when they are not required as iatrogenic cost of achieving above goals and when they cannot be managed to an acceptable level

Ethical Challenges -3: Ethical Challenges -3 Acceptable outcome can be defined from the patient’s perspective Quality of life = ability to engage in life tasks and derive satisfaction from doing so Resulting functional status allows patient to engage in valued life tasks and derive sufficient satisfaction from doing so Risk of erroneous external evaluation of patient’s quality of life by health care professionals QoL judgments must be made by patient or on basis of reliable account of patient’s valued life tasks and whether predicted functional status supports those life tasks

Ethical Challenges -4: Ethical Challenges -4 QoL judgments have no applicability in neonatal critical care and to patients whose values history cannot be reliably identified Clinical application of the concept of quality of life requires psychosocial capacity of the patient to have life tasks and to have values on the basis of which having and engaging in those life tasks has value for oneself and infants lack such psychosocial capacity Patients with unknown values history have had such capacity but we do not have a reliable account of how they exercised it Focus for these patients should be on whether a clinically acceptable outcome is reliably expected An outcome that preserves interactive capacity and therefore the capacity for later having whatever quality of life the individual chooses

Ethical Challenges -5: Ethical Challenges -5 Recognize that resuscitation is often the initial step of critical care management of a seriously ill patient’s condition Recognize that high-risk surgery is often the initial step of critical care management of a seriously ill patient’s condition Recognize that critical care intervention is now understood to be trial of management Ethical obligation to initiate or continue a trial of intervention ends when there is no reasonable expectation of achieving the intervention’s goals

Two Goals of Critical Care: Two Goals of Critical Care Neonatal, pediatric, and adult critical care have both a short-term goal and a long-term goal Short-term goal: prevent imminent death Long-term goal: survival with an acceptable functional status Understood from a clinical perspective Understood from the patient’s perspective

Invoking Futility to Set Ethically Justified Limits on Critical Care -1: Invoking Futility to Set Ethically Justified Limits on Critical Care -1 Does best available evidence support reliable clinical judgment that there is no reasonable expectation of achieving intended physiologic outcome of intervention? Specify outcome precisely For example: Outcome of resuscitation = restoration of spontaneous circulation For example: Outcome of mechanical ventilation = maintenance of adequate levels of oxygenation Distinguish clearly specified physiologic outcome from physiologic effect (e.g., transient heart beat during resuscitation)

Invoking Futility to Set Ethically Justified Limits on Critical Care -2: Invoking Futility to Set Ethically Justified Limits on Critical Care -2 Does best available evidence support reliable clinical judgment that there is no reasonable expectation of achieving intended physiologic outcome of intervention? If yes, ethical obligation to continue intervention ends, because of physiologic futility Because physiologic futility of a critical care intervention means that imminent death cannot be prevented, there is no reasonable expectation that the short-term goal and, therefore, the long-term goal of continued critical care intervention can be achieved Recommend that intervention be withheld/discontinued If no, continue critical care intervention and ask the following:

Invoking Futility to Set Ethically Justified Limits on Critical Care -3: Invoking Futility to Set Ethically Justified Limits on Critical Care -3 Does best available evidence support reliable clinical judgment that intervention will be physiologically effective for a short period of time (days to weeks) but then result in death (in the critical care unit) with no recovery beforehand of any interactive capacity? If yes, ethical obligation to continue intervention ends, because of imminent-demise futility There is no reasonable expectation that short-term goal and, therefore, long-term goal of continued critical care intervention can be achieved Recommend that intervention be withheld/discontinued If no, continue critical care intervention and ask the following:

Invoking Futility to Set Ethically Justified Limits on Critical Care -4: Invoking Futility to Set Ethically Justified Limits on Critical Care -4 Does best available evidence support reliable clinical judgment that intervention will be physiologically effective, prevent imminent demise, but result in irreversible loss of interactive capacity? If yes, ethical obligation to continue intervention ends, because of clinical or overall futility There is a reasonable expectation that the short-term goal can be achieved There is no reasonable expectation that the long-term goal of critical care intervention can be achieved because of unacceptable outcome from clinical perspective If no, continue critical care intervention and ask the following:

Invoking Futility to Set Ethically Justified Limits on Critical Care -5: Invoking Futility to Set Ethically Justified Limits on Critical Care -5 Does best available evidence support reliable clinical judgment that intervention will be physiologically effective, prevent imminent demise, not result in irreversible loss of interactive capacity but result in functional status not compatible with acceptable quality of life from the patient’s perspective? If yes, ethical obligation to continue intervention ends, because of qualitative futility There is a reasonable expectation that the short-term goal can be achieved There is no reasonable expectation that the long-term goal of critical care intervention can be achieved because of unacceptable outcome from patient’s perspective (even though outcome is acceptable from clinical perspective) If no, prospectively manage uncertainty of prognosis/trends toward of one or more of these three concepts of futility

Invoking Futility to Set Ethically Justified Limits on Critical Care -6: Invoking Futility to Set Ethically Justified Limits on Critical Care -6 The preceding algorithm implements the default position of intervention to prevent imminent death, by putting the burden of proof on clinical ethical justifications to limit life-sustaining treatment

Invoking Futility to Set Ethically Justified Limits on Critical Care -7: Invoking Futility to Set Ethically Justified Limits on Critical Care -7 Inherent risk of management of uncertainty about outcomes of continuing critical care needs to be responsibly managed Continuing life-sustaining treatment/critical care intervention to increase reliability of clinical ethical judgment that justified limits on intervention have been reached Not every burden of morbidity, reduced functional status, pain, distress, and suffering is justified in order to increase this reliability Especially when the real issues are individual “comfort levels” and risk management, both of which can become detached from evidence-based clinical judgment

Invoking Futility to Set Ethically Justified Limits on Critical Care -8: Invoking Futility to Set Ethically Justified Limits on Critical Care -8 For patients for whom continuing critical care intervention has a high probability of becoming futile in one of four senses, should we shift the burden of proof to continuing rather than discontinuing continuing intervention? Should we place a higher priority in such cases on preventing disease-related and iatrogenic morbidity, lost functional status, and unnecessary pain, distress, and suffering? Should we turn the traditional logic of critical care on its head and accept higher mortality as means to reduce unacceptable outcomes (understood from a clinical patient’s perspective)?

Invoking Futility to Set Ethically Justified Limits on Critical Care -9: Invoking Futility to Set Ethically Justified Limits on Critical Care -9 Continuous quality enhancement of discharge/transfer planning from the hospital for patients with chronic or serious disease or injury Discussion during discharge/transfer planning with parents or other surrogates of prognosis of physiologic, imminent-demise, clinical futility, or qualitative futility and its implication for clinical management of life-threatening events Document and write re-admission note, taking full advantage of EMR Out-of-Hospital DNR Orders

Conclusions -1: Conclusions -1 Resuscitation of seriously ill patients and high-risk surgery are often the initial steps of critical care intervention as a trial of intervention As a trial of intervention, critical care has both a short-term goal and a long-term goal Short-term goal: prevent imminent death Long-term goal: survival with acceptable functional status, understood from a clinical perspective or patient’s perspective

Conclusions -2: Conclusions -2 When there is no reasonable expectation of achieving either the short-term goal or the long-term goal, the ethical obligation to provide life-sustaining treatment/critical care intervention ends Four concepts of futility and their evidence-based clinical application In such cases, it is ethically justified to limit life-sustaining treatment/critical care Not initiate it Discontinue it

Conclusions -3: Conclusions -3 A preventive ethics approach should be taken in cases of trends toward one or more of these concepts of futility Responsibly manage uncertainty about prognosis, in light of the risk of subsequent over-treatment To patients To their families To health care professionals To organizational culture

Conclusions -4: Conclusions -4 For patients for whom continuing life-sustaining treatment/critical care intervention has a high probability of becoming futile, should we shift the burden of proof to continuing rather than discontinuing continuing intervention?

Conclusions -5: Conclusions -5 Discharge/transfer planning should take account of prognosis of one or more of the four concepts of futility

References: References Rabeneck L, McCullough LB, Wray NP. Ethically justified, clinically comprehensive guidelines for percutaneous endoscopic gastrostomy tube placement. The Lancet 1997; 349: 496-498. McCullough LB, Jones JW. Postoperative futility: a clinical algorithm for setting limits. Brit J Surg 2001; 88: 1153-1154.

Ethical Challenges Concerning Futile Critical Care: Ethical Challenges Concerning Futile Critical Care Laurence B. McCullough, Ph.D. Professor of Medicine and Medical Ethics Center for Medical Ethics and Health Policy Baylor College of Medicine Houston, Texas