Among the most necessary and deeply rewarding experiences of critical care practitioners is that of shepherding, alongside ICU nurses, respiratory therapists, and other healthcare team members, the families of the seriously ill and dying, assisting these distraught individuals in coming to terms with the impending death of their loved ones. ICU physicians have vast experience interpreting clinical data and observing their patients. As a result, blending the science and art of medicine, critical care physicians and nurses see coming, many times before all others, the certain downward trajectory and death of the patient.
The compassionate and wise physician will, in word and presence, guide the stricken family through this dark valley to a place of acceptance of the inevitable. In the overwhelming majority of instances, both medical team and family recognize that death is near, that all that can be done has been done, and that further invasive high-tech interventions will be fruitless. Critical care literature has reported that as many as 90% of deaths in the ICU follow a decision to withhold or withdraw advanced life-sustaining measures, when such an understanding among healthcare team and family is reached[1] following the failure of a therapeutic trial of aggressive interventions.[2]
However, other studies estimate that up to 20% of patients in the ICU may receive care that is “probably futile.”[3] Many families, surrogate decision makers, and patients, however, will continue to request, then insist, that further measures be undertaken, measures that, in the view of the critical care team, serve not as a bridge to recovery of health, but rather only to prolong and complicate the certain dying process. Conflict inevitably ensues, as the goals and paradigms of these families seem not to align with those of the physicians. Conversations may become difficult at best and openly confrontational at worst, as a family’s distrust for a physician or hospital, or the physician’s frustration with a family, becomes manifest.[4]
Recent attempts have been made by the medical community to manage these very situations—that is, to facilitate the medical team’s ability to cope with a family’s insistence on aggressive care in situations that are, in the team’s view, unequivocally futile. In 2015, the critical care community in the U.S. published a multi-organizational policy statement (henceforth, “the Policy”) that endorsed a step-wise process for the vetting of “requests for potentially inappropriate treatments” in ICUs.[5] This process opens a pathway whereby the medical team ultimately may withhold or withdraw therapeutic modalities which surrogates have insisted upon, against the surrogates’ explicit directives. In this brief essay, we shall review the concept of futility and how it has evolved in the ethics of the ICU bedside; we shall then consider whether the recent Policy proposal by the critical care community will, finally, assuage the age-old futility dilemma.
The term “futile” comes to us from the Latin futilis, meaning “leaky,” as in “untrustworthy, vain, failing of the desired end through intrinsic defect.”[6] The concept of medical futility has its roots in Greek antiquity: “Hippocrates warned, ‘Whenever the illness is too strong for the available remedies, the physician must surely not expect that it can be overcome by medicine’ . . . . Accordingly, Hippocrates admonished, the physician must ‘refuse to treat those who are overmastered by their disease, realizing that in such cases medicine is powerless.’”[7]
The terms of the present futility debate were established by two seismic events in the science and culture of medicine in the past forty years. The first of these was the introduction of life-saving and life-prolonging interventions and technologies such as CPR, mechanical ventilation, and continuous renal-replacement therapy.[8] Critical care medicine, the specialty in which these interventions have been practiced and stewarded, came into its own over the course of the 1970s into the 1980s. The second event, which arose simultaneously, was the ascendance of the principle of patient autonomy, which has moved from a negative-rights (the right to refuse certain treatment) to a positive-rights (the right to demand certain treatment) ethical paradigm.[9] It has been suggested that in contemporary medical ethics, autonomy has assumed the mantle of a moral absolute.[10]
For a generation, then, the location of the futility debate has been at the technology-laden bedside of the critically ill, and at the intersection of the physician’s beneficence and non-maleficence, on the one hand, and a patient’s or surrogate’s autonomy, on the other. In the ideal situation, physician beneficence and patient/surrogate autonomy are held in delicate and carefully negotiated equilibrium, or therapeutic alliance; if beneficence assumes the phenotype of paternalism or if autonomy claims incontestable moral high ground (I shall call this “uber-autonomy”), the shalom (that is, the harmony and balance) of the alliance is lost.
Four categories of reasons have been suggested for why surrogates request treatments that are not recommended by treating physicians.[11] First, a family’s distrust in a physician’s estimate of prognosis, or in the medical system generally, often translates into an insistence on an open-ended prolongation or escalation of interventions. Evidence indicates that distrust of the medical community is particularly prevalent among African American and Hispanic families and surrogates. Second, cognitive issues, such as a surrogate’s lack of understanding of the medical situation (owing, in some instances, to inadequate physician explanation, language barriers, or perceived or real pressure to make a decision) may result in prolongation of potentially inappropriate treatments.[12]
Third, psychological and emotional issues such as depression, anxiety, acute grief, long-incubated guilt, or secondary gain may impair a surrogate’s capacity, ability, or willingness to make appropriate end-of-life decisions. Finally, a family’s religion and their anticipation of an impending miracle are at the root of the most difficult goals-of-care discussions in the ICU.[13]
C. Christopher Hook has reviewed the origin of the futility debate and suggests several reasons that physicians tend to resist such demands, among them professional and personal integrity and a backlash against autonomy.[14] The first of these, professional integrity, is traceable to Hippocratic thought:
First I will define what I conceive medicine to be. . . . it is to do away with the suffering of the sick, to lessen the violence of their diseases, and to refuse to treat those who are overmastered by their diseases, realizing that in such cases medicine is powerless.[15]
Implicit in such a mandate is the existence of an intrinsic moral code of professional and clinical conduct. Pellegrino more recently has argued that the profession of medicine is endowed with precisely such an intrinsic morality. Arguing from natural law, Pellegrino states,
An internal morality of medicine is not a morality defined or authenticated by physicians or the profession of medicine. The moral authority of an internal morality of medicine is independent of whether or not physicians accept or reject it. . . . That authority arises from an objective order of morality that transcends the self-defined goals of a profession.[16]
On this construct, it is incumbent upon the medical professional to treat disease, but to understand when treatment must be abandoned. “The caregiver,” says Hook, “has always had the responsibility to determine which interventions have the possibility of benefitting the patient and not offering those that do not.”[17]
Similarly, the beneficent physician possesses personal integrity that should prevent his being required to provide interventions he believes to be morally wrong.[18] Whereas the futility debate may be fueled in part by a “backlash” against an incontestable assertion of patient and surrogate autonomy,[19] many physicians, instead, see a surrogate’s insistence on certain interventions as running counter to what the patient actually would desire; hence the physician’s objections may be grounded in advocacy on behalf of the patient.[20]
Efforts to resolve the dilemma have taken the form of definitional and procedural approaches.[21] Definitional approaches include those articulating the physiological futility of certain interventions or their medical ineffectiveness. Physiologic futility, in clinical practice, is necessarily very narrowly defined and may be tied to goals agreed upon by medical team and surrogate. An example is the setting in which CPR is being considered. Consider a patient who is on maximum ventilator support and maximum doses of vasopressors who sustains a cardiac arrest. CPR will reliably not restore circulation, is physiologically futile, and therefore may not be offered as an option by the physician. However, in a patient who is dying from extensive and end stage metastatic disease who suffers cardiac arrest, circulation may be restored by CPR, if transiently, and therefore this intervention may not be seen by all involved as futile. Thus, a physiologic definition is useful only in limited circumstances; a medical ineffectiveness definition is hamstrung by a lack of consensus of what constitutes “ineffectiveness,” and potentially becomes, therefore, a value-laden enterprise centering on what constitutes quality of life. The literature abounds with documentation of the disconnect between physicians’ and patients’ assessment of the patient’s quality of life.
Attempts have been made to apply quantitative parameters to futility such as physiologic scoring systems that might be used to assign a probability of non-survival. But the arbitrariness of thresholds for decision-making renders these scoring systems essentially useless at the bedside or in the consultation room, apart from being a resource to help educate surrogates as to the severity of the patient’s disease. Similarly, qualitative refinements of futility have been proposed based upon the physician’s “benefit/burden” analysis or on his or her sense of the proportionality (or disproportionality) of a given intervention. Such qualitative adjustments have been criticized for their tendency toward a paternalistic valuation of the patient’s quality of life by the physician.[22] Additionally, qualitative assessment is at the mercy of the state of the art of medicine, the accuracy of prognostication, and the sensitivity of diagnostic tests.[23]
It would seem, then, that a definitional approach, however refined, to resolve the question of futility has not gained traction at the bedside of the critically ill, nor in the consultation room of surrogates and physicians, and has therefore given way to procedural process-based approaches. In the late 1990s both the Society of Critical Care Medicine (SCCM) and the American Medical Association (AMA) endorsed process-based approaches to resolving end-of-life-care related conflict.[24] The AMA Council on Ethical and Judicial Affairs recommended a seven-step process of second opinions, ethics consultation, and provision of the opportunity for treatment venue changes, with a final endorsement of the physician’s empowerment unilaterally to limit or discontinue life-sustaining treatments. However, the Council stated that “the legal ramifications of this course of action are uncertain,”[25] leading Robert Fine of the Baylor University Medical Center Office of Clinical Ethics to point out that “it is unclear how effective such guidelines can be in the face of legal uncertainty.”[26]
The Texas Advance Directive Act (TADA), specifically in provisions of Section 166.046, would seem to be the first codification of a just such a set of guidelines. Signed into law by then Governor George W. Bush in 1999, the legislation provides physicians with legal immunity from prosecution following their unilateral decision to withdraw life-sustaining treatments provided a seven-step process is followed:
As of 2005, 22 of 974 (2.2%) of ethics consults in Texas related to futility had resulted in a unilateral decision to withdraw life-sustaining treatments. Fine argues that the law, if imperfect, serves as a “much needed conceptual and temporal framework for facing medical futility disputes that is not available elsewhere.”[28]
But the TADA has been criticized for giving decision-making on the termination of life support to ethics committees or medical review committees, who are likely to be physicians of the same hospital and of similar philosophical leanings as the involved clinicians themselves, and may not represent the diversity of a community at large. Additionally, the TADA lacks a provision for the family to find meaningful representation in the courts—according to TADA, the court may only grant an extension to time prior to life support being removed, but not overturn the decision itself. “The most fundamental flaw with TADA is that it specifically excludes the involvement of the courts, ceding all of the authority to the hospital ethics committee or medical review committees.”[29] Truog concludes that “the Texas law’s effectiveness as a mechanism for reaching closure in difficult cases . . . relies on a due-process approach that is more illusory than real and that risks becoming a rubber-stamp mechanism for systematically overriding families’ requests that seem unreasonable to the clinicians involved.”[30] The issue, according to Truog, is that meaningful safeguards do not exist in TADA.
Misak and coworkers, therefore, suggest reframing the futility discussion by arguing that “Medical decisions are never made unilaterally, even though at times this may appear to be the case. Medical decisions are made in the context of an implicit and evolving social contract among patients, physicians, and societies at large.”[31] Within such a broad conceptual framework, which invokes provisions of society, the current multi-society policy statement has emerged.
Gabriel Bosslet, heading a taskforce with representation of the American Thoracic Society (ATS), the American Association of Critical Care Nurses (AACN), the American College of Chest Physicians (ACCP), the European Society for Intensive Care Medicine (ESICM), and the Society of Critical Care Medicine (SCCM), established guidelines which seek to prevent intractable treatment conflicts, to avoid the term “futile” in preference for “potentially inappropriate,” and to provide a mechanism, with safeguards, for the conflict resolution when it occurs.[32]
Like the TADA, the Policy establishes a seven-step process for conflict resolution:
Unlike the TADA, the Policy commends an extensive effort for the prevention of conflict, the engagement of independent experts in the art of conflict resolution, and offers recourse to the courts, not simply to grant a temporary injunction of the physician’s decision to withdraw life support, but also, possibly, to overturn such a decision.
Endorsing the Policy to the SCCM, Kon et al. stress that the embrace of the Policy is neither exhaustive nor obligatory, and leaves freedom to invoke it, or not, up to the individual practitioners caring for a given patient. Importantly, he also endorses, in appropriate circumstances, the initiation of a mutually agreed-upon, time-limited therapeutic trial of an intervention.[34] To be sure, this latter practice is a two-edged sword; whereas it may provide reassurance to the surrogate that all measures have indeed been undertaken, or validate for both parties the physician’s prognosis, the discontinuing of a fruitless intervention often is more complicated emotionally for surrogates than the withholding of it in the first place.
Like the TADA, the Policy proffers to families and surrogates the option of transferring the patient to a facility that will acquiesce to the surrogate’s wishes. This, along with the ability to appeal to the courts, is seen as a safeguard. However, the likelihood, realistically speaking, of finding an accepting alternate facility is vanishingly small. From my own experience, most intensivists will agree with the referring physician’s assessment, and administrators will be loath to acquire such a patient in an era when bed shortages, length-of-stay considerations, and reimbursement issues are determining factors. Additionally, recourse to the courts is a cumbersome, time-consuming, and potentially cost-prohibitive endeavor for surrogates. Consequently, one might have cause to doubt how meaningful these safeguards really are.
As of this writing, the impact of the Policy statement upon the practice of critical care medicine in the U.S. is not known, and efforts are underway at Georgetown University Medical Center to assess, at least preliminarily, what the awareness and uptake of this Policy may be. It is my own sense that insufficient time has elapsed for there to be a broad acceptance of the Policy; concerns undoubtedly exist on the part of hospitals’ or corporations’ risk management and legal departments regarding the institutional codification and implementation of such a program.
Regardless, it does not seem premature to pose the question of whether the Policy has made headway in the resolution of the futility debate. Has process, finally, with safeguards, paved the way to a balance of beneficence and autonomy? Are unchecked individual and institutional paternalism, as well as unbridled uber-autonomy, held at bay? Is the sacredness of the life in the ICU bed, in the end, honored by the appeal to a process that is accountable to society at large? Again, Pellegrino:
Futility has been defined . . . as a prudential guide to moral assessment of the good of the patient and to the moral permissiveness of withholding or withdrawing particular treatments in seriously ill or dying patients. On this view, if a treatment is judged to be futile after weighing its benefits, burdens, and effectiveness, it need not, and ought not, be offered and used. However, like any prudential guide, there is a danger of misuse if the metaphysical, theological, and ethical presuppositions upon which judgments are based are faulty.[35]
Let us remind ourselves that, despite its recasting in the mantle of “potentially inappropriate treatments,” the TADA and the Policy have simply renamed the concept of “futility.” Practitioners of critical care will certainly welcome a strategy for negotiating the difficult discussions with surrogates; whereas we can and must acknowledge the presence of our own value systems in our recommendations and decisions, we also, as a professional group, embrace the ethos of Pellegrino and Hook, that we are endowed with both perspective and duty regarding when to treat and when to withhold, as matters of professional and personal integrity.
Haavi Morreim has stated that the “futility debate is itself largely futile,” fraught as it is with “fundamentally irresolvable moral conflicts” involving disparate value systems of surrogates and providers.[36] As such, one could opine that the Policy does nothing to resolve the debate. Notwithstanding, it does provide the most comprehensive attempt published to date, to provide for prudent negotiation of diverse value systems brought to the table by physicians, families, and surrogates. It approaches, albeit asymptotically, the restoration of shalom to the therapeutic alliance. But Pellegrino is right; the compassionate and wise physician ever will be vigilant for fault lines in himself, the institution, and the society to which the policy appeals.
[1] Thomas J. Prendergast and J. M. Luce, “Increasing Incidence of Withholding and Withdrawal of Life Support from the Critically Ill,” American Journal of Respiratory and Critical Care Medicine 155, no. 1 (1997): 15–20, https://doi.org/10.1164/ajrccm.155.1.9001282.
[2] Robert D. Truog et al., “Recommendations for End-of-Life Care in the Intensive Care Unit: A Consensus Statement by the American College of Critical Care Medicine,” Critical Care Medicine 36, no. 3 (2008): 953–963, https://doi.org/10.1097/CCM.0B013E3181659096.
[3] Douglas B. White and Thaddeus M. Pope, “Medical Futility and Potentially Inappropriate Treatment,” in The Oxford Handbook of Ethics at the End of Life, ed. Stuart Youngner and Robert Arnold (New York: Oxford University Press, 2016), 68.
[4] See Robert D. Truog, “Counterpoint: The Texas Advance Directive Act is Ethically Flawed: Medical Futility Disputes Must Be Resolved by a Fair Process,” Chest 136, no. 44 (2009): 968–971, https://doi.org/10.1378/chest.09-1269. Truog opines that the vast majority of cases of insistence on futile interventions arise not from the patient but from the surrogate.
[5] Gabriel Bosslet et al., “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Potentially Inappropriate Treatments in Intensive Care Units,” American Journal of Respiratory and Critical Care Medicine 191, no. 11 (2015): 1318–1330, https://doi.org/10.1164/rccm.201505-0924ST.
[6] E. S. C. Weiner et al., The Oxford English Dictionary 2nd ed., vol. 1 (Oxford: Clarendon Press, 1989), 248, cited in C. Christopher Hook, “Medical Futility,” in Dignity and Dying: A Christian Appraisal, ed. John Kilner, Arlene B. Miller, and Edmund D. Pellegrino (Grand Rapids: Eerdmans, 1996), 88.
[7] Hippocrates, quoted in White and Pope, “Medical Futility,” 66.
[8] Ibid., 67.
[9] Ibid
[10] Edmund Pellegrino, “Euthanasia and Assisted Suicide,” in Dignity and Dying: A Christian Appraisal, ed. John Kilner, Arlene B. Miller, and Edmund D. Pellegrino (Grand Rapids: Eerdmans, 1996), 109.
[11] White and Pope, “Medical Futility,” 68–70.
[12] Ibid., 69
[13] Ibid., 70.
[14] Hook, “Medical Futility,” 84–95.
[15] Hippocrates, “The Art,” in Hippocrates II, The Loeb Classic Library (Cambridge, MA: Harvard University Press, 1992), quoted in Hook, “Medical Futility,” 86.
[16] Edmund Pellegrino, “The Internal Morality of Clinical Medicine,” in The Philosophy of Medicine Reborn: A Pellegrino Reader, ed. H. Tristram Engelhardt and Fabrice Jotterand, (Notre Dame, IN: University of Notre Dame Press, 2008), 68.
[17] Hook, “Medical Futility,” 86.
[18] Ibid., 87.
[19] Ibid.
[20] White and Pope, “Medical Futility,” 70.
[21] These are concisely reviewed by White and Pope, “Medical Futility,” 71ff.
[22] Ibid., 74.
[23] See my discussion of patients with persistent vegetative state in Allen Roberts, “The Higher-Brain Concept of Death: A Christian Theological Appraisal,” Ethics & Medicine 33, no. 3 (2017): 177–191
[24] White and Pope, “Medical Futility,” 77.
[25] Ibid.
[26] Robert L. Fine, “Medical Futility and the Texas Advance Directive Act of 1999,” Baylor University Medical Center Proceedings 13, no. 2 (2000): 145, http://www.baylorhealth.edu/Documents/BUMC%20Proceedings/2000%20Vol%2013/No.%202/13_2_%20Fine.pdf.
[27] Adapted from Fine, “Medical Futility and the Texas Advance Directive Act of 1999,” 146.
[28] Robert L. Fine, “Point: The Texas Advance Directives Act Effectively and Ethically Resolves Disputes about Medical Futility,” Chest 136, no. 4 (2009): 963–967, https://doi.org/10.1378/chest.09-1267.
[29] Robert D.Truog, “Counterpoint: The Texas Advance Directives Act is Ethically Flawed,” Chest 136, no. 4 (2009): 968–971
[30] Robert D. Truog, “Tackling Medical Futility in Texas,” The New England Journal of Medicine 357, no. 1 (2007): 3, https://doi.org/10.1056/NEJMp078109.
[31] Cheryl J. Misak, Douglas B. White, and Robert D. Truog, “Medical Futility: A New Look at an Old Problem,” Chest 146, no. 6 (2014): 1667–1672, https://doi.org/10.1378/chest.14-0513.
[32] Bosslet et al, “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement.”
[33] Bosslet et al, “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement.”
[34] Alexander A. Kon et al., “Defining Futility and Potentially Inappropriate Interventions: A Policy Statement from the Society of Critical Care Medicine Ethics Committee,” Critical Care Medicine 44, no. 9 (2016): 1769–1774, https://doi.org/10.1097/CCM.0000000000001965.
[35] Edmund Pellegrino, “Decision at the End of Life: The Use and Misuse of the Concept of Futility,” in The Dignity of the Dying Person: Proceedings of the Fifth Assembly of the Pontifical Academy for Life, ed. Juan de Dios Vial Correa and Elio Sgreccia (Citta del Vaticano: Libreria editrace Vaticana, 2000), 230.
[36] E Haavi Morreim, “Profoundly Diminished Life: The Casualties of Coercion,” Hastings Center Report 24, no. 1 (1994): 33–42, quoted in Hook, “Medical Futility,” 88.
Allen H. Roberts, “Futility Recast: Do New Consensus Statements Resolve the Old Debate?” Dignitas 24, no. 4 (2017): 1, 4–8.
