Point: The Ethics of Unilateral “Do Not Resuscitate” Orders
2007; Elsevier BV; Volume: 132; Issue: 3 Linguagem: Inglês
10.1378/chest.07-0745
ISSN1931-3543
AutoresJ. Randall Curtis, Robert A. Burt,
Tópico(s)Ethics and Legal Issues in Pediatric Healthcare
ResumoDeath is prevalent in the ICU. A study1Angus DC Barnato AE Linde-Zwirble WT et al.Use of intensive care at the end of life in the United States: an epidemiologic study.Crit Care Med. 2004; 32: 638-643Crossref PubMed Scopus (849) Google Scholar suggests that approximately 20% of deaths in America occur in an ICU. Many investigators2Cook D Rocker G Marshall J et al.Withdrawal of mechanical ventilation in anticipation of death in the intensive care unit.N Engl J Med. 2003; 349: 1123-1132Crossref PubMed Scopus (347) Google Scholar3Sprung CL Cohen SL Sjokvist P et al.End-of-life practices in European intensive care units: the Ethicus Study.JAMA. 2003; 290: 790-797Crossref PubMed Scopus (800) Google Scholar4Prendergast TJ Claessens MT Luce JM A national survey of end-of-life care for critically ill patients.Am J Respir Crit Care Med. 1998; 158: 1163-1167Crossref PubMed Scopus (521) Google Scholar have shown that the majority of deaths in the ICU involve withholding or withdrawing life-sustaining therapies. There is growing consensus regarding the importance of shared decision making in the ICU, where clinicians and family members work together to make decisions about life-sustaining treatments.5Carlet J Thijs LG Antonelli M et al.Challenges in end-of-life care in the ICU: statement of the 5th International Consensus Conference in Critical Care; Brussels, Belgium, April 2003.Intensive Care Med. 2004; 30: 770-784Crossref PubMed Scopus (393) Google Scholar However, there remains considerable controversy over the appropriate role of unilateral decisions by physicians to withhold or withdraw life-sustaining treatments. In 1991, the American Thoracic Society6American Thoracic Society Withholding and withdrawing life-sustaining therapy.Ann Intern Med. 1991; 115: 478-485Crossref PubMed Scopus (179) Google Scholar defined a life-sustaining intervention as futile "if reasoning and experience indicate that the intervention would be highly unlikely to result in a meaningful survival for that patient" and argued that physicians are not obligated to provide such treatments. The Society for Critical Care Medicine came to similar conclusions.7The Ethics Committee of the Society of Critical Care Medicine Consensus statement of the Society of Critical Care Medicine Ethics Committee regarding futile and other possibly inadvisable treatments.Crit Care Med. 1997; 25: 887-891Crossref PubMed Scopus (230) Google Scholar There have been cogent descriptions of the definition and value of this principle in medical decision making8Schneiderman LJ Jecker NS Jonsen AR Medical futility: its meaning and ethical implications.Ann Intern Med. 1990; 112: 949-954Crossref PubMed Scopus (912) Google Scholar9Schneiderman LJ Jecker NS Jonsen AR Medical futility: response to critiques.Ann Intern Med. 1996; 125: 669-674Crossref PubMed Scopus (135) Google Scholar and evidence that the principle of futility is currently being used in clinical practice in the United States10Curtis JR Park DR Krone MR et al.Use of the medical futility rationale in do-not-attempt-resuscitation orders.JAMA. 1995; 273: 124-128Crossref PubMed Scopus (131) Google Scholar and around the world.11Crippen D Kilcullen JK Kelly DF Three patients: international perspectives on intensive care at the end of life. Kluwer Academic Publishers, Boston, MA2002Crossref Google Scholar However, there have also been cogent arguments made against the use of the futility principle,12Lantos JD Singer PA Walker RM et al.The illusion of futility in clinical practice.Am J Med. 1989; 87: 81-84Abstract Full Text PDF PubMed Scopus (212) Google Scholar13Burt RA The medical futility debate: patient choice, physician obligation, and end-of-life care.J Palliat Med. 2002; 5: 249-254Crossref PubMed Scopus (46) Google Scholar14Helft PR Siegler M Lantos J The rise and fall of the futility movement.N Engl J Med. 2000; 343: 293-296Crossref PubMed Scopus (271) Google Scholar and a landmark article proclaimed the "fall of the futility movement" based on these arguments.14Helft PR Siegler M Lantos J The rise and fall of the futility movement.N Engl J Med. 2000; 343: 293-296Crossref PubMed Scopus (271) Google Scholar Currently, there is no general professional consensus about the value and pitfalls of unilateral clinician decision making based on the principle of medical futility. We hope to move this debate forward by reframing the role of unilateral decision making within the context of clinician/family communication and shared decision making about withholding and withdrawing life-sustaining treatments. We propose incorporation of the notion of "informed assent" for some types of these decisions.The Value and Risk of Informed AssentIn the critical care setting, there are specific circumstances when some standard therapies, such as cardiopulmonary resuscitation, may not provide any benefit to the patient. In these circumstances, are clinicians always obliged to obtain informed consent from patients or family members to withhold or withdraw such therapies? Because the process of obtaining informed consent may cause considerable distress for some patients and family members, we contend that obtaining informed assent—when the patient or family is explicitly invited to defer to clinicians' judgment in favor of withholding or withdrawing life-sustaining therapy—is an appropriate, ethical alternative.Recent research15Stapleton RD Engelberg RA Wenrich MD et al.Clinician statements and family satisfaction with family conferences in the intensive care unit.Crit Care Med. 2006; 43: 1679-1685Crossref Scopus (173) Google Scholar suggests that family satisfaction with communication during decisions about end-of-life care in the ICU is higher if clinicians make explicit recommendations and provide the families with support for the decisions made concerning withholding or withdrawing life support. There is, moreover, growing evidence of a significant burden of anxiety, depression, and posttraumatic stress disorder among family members of critically ill patients.16Pochard F Azoulay E Chevret S et al.Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity.Crit Care Med. 2001; 29: 1893-1897Crossref PubMed Scopus (521) Google Scholar17Azoulay E Pochard F Kentish-Barnes N et al.Risk of post-traumatic stress symptoms in family members of intensive care unit patients.Am J Respir Crit Care Med. 2005; 171: 987-994Crossref PubMed Scopus (893) Google Scholar18Lautrette A Darmon M Megarbane B et al.A communication strategy and brochure for relatives of patients dying in the ICU.N Engl J Med. 2007; 356: 469-478Crossref PubMed Scopus (878) Google Scholar Observed risk factors for these psychological symptoms include family involvement in decision making.17Azoulay E Pochard F Kentish-Barnes N et al.Risk of post-traumatic stress symptoms in family members of intensive care unit patients.Am J Respir Crit Care Med. 2005; 171: 987-994Crossref PubMed Scopus (893) Google ScholarConcerns about adverse effects of decision making have been invoked to justify physicians' withholding of information from patients and families on the grounds of a so-called "therapeutic privilege."19Canterbury v. Spence, 464 F. 2d 772 (D.C.Circuit 1972). Developments in the law: medical technology and the law.D.C. Circuit 1972, ed.103. Harvard Law Review. 1990; : 1643-1676Google Scholar There are considerable risks that unilateral physician decision making to withhold information can cross the line between appropriate beneficence and inappropriate medical authoritarianism. This should not mean, however, that clinicians are obliged to ignore the risks of harm to patients and their families from burdens of decision making that they are not prepared to bear, especially when clinicians have reached a clear judgment that the therapy will confer no benefit for the patient. There is a middle ground between wrongful withholding of information from patients and families and harmful impositions of decision-making burdens on them. That middle ground should include the concept of informed assent.By informed assent, we envision a process in which clinicians provide full information about the risks and benefits of treatments, convey specific recommendations about the medically proposed course, and clearly indicate that the patient and family are entitled to defer to the clinicians' judgment. As an abstract matter, this is no different from the conventional conception of informed consent: a fully informed patient or family surrogate can always make an affirmative choice to accept clinicians' recommendations. But as a psychological proposition, informing the patient or family surrogate that they are entitled to accept those recommendations can convey to them the information that the clinicians are prepared to relieve them of unwanted burdens of making life-or-death decisions.Patients and family members vary in their interest in being involved in medical decision making about end-of-life care. There are some who want to be centrally involved in all decisions, while others want to defer such decisions to the clinicians.20Heyland DK Cook DJ Rocker GM et al.Decision-making in the ICU: perspectives of the substitute decision-maker.Intensive Care Med. 2003; 29: 75-82Crossref PubMed Scopus (209) Google Scholar21Heyland DK Tranmer J O'Callaghan CJ et al.The seriously ill hospitalized patient: preferred role in end-of-life decision making?.J Crit Care. 2003; 18: 3-10Abstract Full Text Full Text PDF PubMed Scopus (102) Google Scholar High-quality communication about withholding and withdrawing life support in the ICU must not assume "one size fits all." An important aspect of this communication is to determine the role an individual patient or family wants to play in such decisions. There are family members who will be greatly relieved that clinicians are willing to take responsibility for decisions, for example, to withhold cardiopulmonary resuscitation when it is not indicated. There are others who will accept a clinician's determination that cardiopulmonary resuscitation is not indicated but who could not be personally involved in making this decision. However, there are also family members who will feel that being involved in such decisions allows them to provide an important gift to the critically ill patient by ensuring that the patient's wishes are followed. It is the responsibility of the clinicians to determine where on this spectrum individual patients and families fall and to conduct the communication and decision making accordingly. Moreover, when patients or families disagree with clinicians' recommendations, we believe that clinicians will need to develop a systematic approach for dealing with such disagreement. The American Medical Association recommends a process be initiated to reconcile differences between clinicians and patients or families, and that life support be continued until reconciliation is achieved.22Council on Ethical and Judicial Affairs Medical futility in end-of-life care: report of the Council on Ethical and Judical affairs.JAMA. 1999; 281: 937-941Crossref PubMed Scopus (285) Google ScholarSome clinicians may worry about the potential legal ramifications of informed assent. Obtaining informed assent would not require a signed form by patients or their surrogates; indeed, a signature is not necessary even for legally effective informed consent. The signed form is useful as proof in any subsequent legal proceeding that consent was in fact obtained, but there is no special legal significance in the signature as such.23Jones v. Malloy. 412 NW2d 837 (Nebraska Supreme Court 1987)Google Scholar24Kovacs v. Freeman. 957 SW2d 251 (Kentucky Supreme Court 1997)Google Scholar25Bornneke v. Rutherford. 89 P3d 40 (Nevada Supreme Court 2004)Google Scholar26Corpus juris secundum physicians and surgeons. 70. West Publishing Company, Saint Paul, MN2007Google Scholar The fact of consent or assent can be adequately documented by other means, such as a contemporaneous medical record entry by the attending physician and/or other clinicians. Optimally, several members of the ICU team would have participated in the family conferences where assent had been obtained; and separate record entries by several of the team members involved would both affirm this best practice and serve as evidence if there were ever a subsequent legal challenge. Even a note in the medical record by a single clinician should, as a legal matter, be sufficient.Three Categories of Withholding or Withdrawing Life SupportIn the ICU, we can identify three categories of decisions to withhold or withdraw life-sustaining therapies that clinicians believe are clearly not indicated; the concept of informed assent is not equally relevant for all three categories. The first category is withholding treatments that patients or family members are not likely to expect for the patients' specific condition (for example an exploratory laparotomy or activated protein C for a moribund patient with severe septic shock and multiple organ failure); and, accordingly, clinicians need not discuss each treatment withheld if they do not regard it as medically indicated (although clinicians would be obliged to discuss such treatment if a patient or family member takes the initiative to inquire). In this category, decisions about medical futility are commonly made unilaterally and such treatments are frequently withheld without necessarily informing or discussing each treatment with patients and families. This is an entirely appropriate use of medical judgment and consistent with good-quality care, provided the clinicians are careful in the determination that the treatment is not indicated and that the family does not expect the treatment.The second category is withholding treatments or procedures that are clearly not indicated but that most patients or families have come to expect. We believe clinicians are obliged to discuss such interventions on their own initiative. Cardiopulmonary resuscitation is currently in this category. It may be that specific patients or families do not in fact expect this intervention. But the expectation is so widespread in our contemporary culture that clinicians should assume that the intervention is expected unless the patient or family indicates otherwise.The third category is withdrawing a therapy that has already been started but which due to the patient's clinical course is no longer indicated. Although many medical ethicists conclude that withholding and withdrawing life-sustaining treatments are ethically and legally equivalent, decisions about withdrawing interventions that clinicians have previously viewed as potentially beneficial often have a different and more powerful impact on patients and families than decisions not to initiate therapies in the first place. Accordingly, communication with families about withdrawal decisions should take account of those differences. As in the second category, clinicians should assume that patients or families expect interventions to be continued, once they are begun, unless the patient or family indicates otherwise.For these second and third categories, we believe that obtaining informed assent to withhold or withdraw interventions is an ethically acceptable alternative to insisting that patients or families always bear the full burden of explicit consent. This alternative should not be offered when clinicians are uncertain about the possibility of success or when the clinicians' convictions about withholding or withdrawing treatment are based on their value judgments about the patient's resulting quality of life. In these circumstances, there are insufficient grounds for unilateral clinician decisions, and the alternative of deferring to a unilateral clinician decision, which is at the core of the informed assent process, should not be offered to the patient or family. In these circumstances, clinicians may express their opinions and recommendations about the likelihood and desirability of treatment alternatives, but patients and families should be clearly informed that medical expertise has limited relevance in coming to an ultimate decision.We believe informed assent, in the appropriate context, offers an opportunity to improve the quality of care for patients and families. The ethical propriety of the assenting process depends on clinicians' careful attention to the particular wishes and needs of specific patients and families. But it is equally true that the process of informed consent demands from clinicians the same communication skills and willingness to spend time with patients and families. Acknowledging informed assent as a suitable alternative in appropriate situations provides an option for protecting patients and families in the decision-making process in a way that the current conception of informed consent does not adequately convey. Death is prevalent in the ICU. A study1Angus DC Barnato AE Linde-Zwirble WT et al.Use of intensive care at the end of life in the United States: an epidemiologic study.Crit Care Med. 2004; 32: 638-643Crossref PubMed Scopus (849) Google Scholar suggests that approximately 20% of deaths in America occur in an ICU. Many investigators2Cook D Rocker G Marshall J et al.Withdrawal of mechanical ventilation in anticipation of death in the intensive care unit.N Engl J Med. 2003; 349: 1123-1132Crossref PubMed Scopus (347) Google Scholar3Sprung CL Cohen SL Sjokvist P et al.End-of-life practices in European intensive care units: the Ethicus Study.JAMA. 2003; 290: 790-797Crossref PubMed Scopus (800) Google Scholar4Prendergast TJ Claessens MT Luce JM A national survey of end-of-life care for critically ill patients.Am J Respir Crit Care Med. 1998; 158: 1163-1167Crossref PubMed Scopus (521) Google Scholar have shown that the majority of deaths in the ICU involve withholding or withdrawing life-sustaining therapies. There is growing consensus regarding the importance of shared decision making in the ICU, where clinicians and family members work together to make decisions about life-sustaining treatments.5Carlet J Thijs LG Antonelli M et al.Challenges in end-of-life care in the ICU: statement of the 5th International Consensus Conference in Critical Care; Brussels, Belgium, April 2003.Intensive Care Med. 2004; 30: 770-784Crossref PubMed Scopus (393) Google Scholar However, there remains considerable controversy over the appropriate role of unilateral decisions by physicians to withhold or withdraw life-sustaining treatments. In 1991, the American Thoracic Society6American Thoracic Society Withholding and withdrawing life-sustaining therapy.Ann Intern Med. 1991; 115: 478-485Crossref PubMed Scopus (179) Google Scholar defined a life-sustaining intervention as futile "if reasoning and experience indicate that the intervention would be highly unlikely to result in a meaningful survival for that patient" and argued that physicians are not obligated to provide such treatments. The Society for Critical Care Medicine came to similar conclusions.7The Ethics Committee of the Society of Critical Care Medicine Consensus statement of the Society of Critical Care Medicine Ethics Committee regarding futile and other possibly inadvisable treatments.Crit Care Med. 1997; 25: 887-891Crossref PubMed Scopus (230) Google Scholar There have been cogent descriptions of the definition and value of this principle in medical decision making8Schneiderman LJ Jecker NS Jonsen AR Medical futility: its meaning and ethical implications.Ann Intern Med. 1990; 112: 949-954Crossref PubMed Scopus (912) Google Scholar9Schneiderman LJ Jecker NS Jonsen AR Medical futility: response to critiques.Ann Intern Med. 1996; 125: 669-674Crossref PubMed Scopus (135) Google Scholar and evidence that the principle of futility is currently being used in clinical practice in the United States10Curtis JR Park DR Krone MR et al.Use of the medical futility rationale in do-not-attempt-resuscitation orders.JAMA. 1995; 273: 124-128Crossref PubMed Scopus (131) Google Scholar and around the world.11Crippen D Kilcullen JK Kelly DF Three patients: international perspectives on intensive care at the end of life. Kluwer Academic Publishers, Boston, MA2002Crossref Google Scholar However, there have also been cogent arguments made against the use of the futility principle,12Lantos JD Singer PA Walker RM et al.The illusion of futility in clinical practice.Am J Med. 1989; 87: 81-84Abstract Full Text PDF PubMed Scopus (212) Google Scholar13Burt RA The medical futility debate: patient choice, physician obligation, and end-of-life care.J Palliat Med. 2002; 5: 249-254Crossref PubMed Scopus (46) Google Scholar14Helft PR Siegler M Lantos J The rise and fall of the futility movement.N Engl J Med. 2000; 343: 293-296Crossref PubMed Scopus (271) Google Scholar and a landmark article proclaimed the "fall of the futility movement" based on these arguments.14Helft PR Siegler M Lantos J The rise and fall of the futility movement.N Engl J Med. 2000; 343: 293-296Crossref PubMed Scopus (271) Google Scholar Currently, there is no general professional consensus about the value and pitfalls of unilateral clinician decision making based on the principle of medical futility. We hope to move this debate forward by reframing the role of unilateral decision making within the context of clinician/family communication and shared decision making about withholding and withdrawing life-sustaining treatments. We propose incorporation of the notion of "informed assent" for some types of these decisions. The Value and Risk of Informed AssentIn the critical care setting, there are specific circumstances when some standard therapies, such as cardiopulmonary resuscitation, may not provide any benefit to the patient. In these circumstances, are clinicians always obliged to obtain informed consent from patients or family members to withhold or withdraw such therapies? Because the process of obtaining informed consent may cause considerable distress for some patients and family members, we contend that obtaining informed assent—when the patient or family is explicitly invited to defer to clinicians' judgment in favor of withholding or withdrawing life-sustaining therapy—is an appropriate, ethical alternative.Recent research15Stapleton RD Engelberg RA Wenrich MD et al.Clinician statements and family satisfaction with family conferences in the intensive care unit.Crit Care Med. 2006; 43: 1679-1685Crossref Scopus (173) Google Scholar suggests that family satisfaction with communication during decisions about end-of-life care in the ICU is higher if clinicians make explicit recommendations and provide the families with support for the decisions made concerning withholding or withdrawing life support. There is, moreover, growing evidence of a significant burden of anxiety, depression, and posttraumatic stress disorder among family members of critically ill patients.16Pochard F Azoulay E Chevret S et al.Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity.Crit Care Med. 2001; 29: 1893-1897Crossref PubMed Scopus (521) Google Scholar17Azoulay E Pochard F Kentish-Barnes N et al.Risk of post-traumatic stress symptoms in family members of intensive care unit patients.Am J Respir Crit Care Med. 2005; 171: 987-994Crossref PubMed Scopus (893) Google Scholar18Lautrette A Darmon M Megarbane B et al.A communication strategy and brochure for relatives of patients dying in the ICU.N Engl J Med. 2007; 356: 469-478Crossref PubMed Scopus (878) Google Scholar Observed risk factors for these psychological symptoms include family involvement in decision making.17Azoulay E Pochard F Kentish-Barnes N et al.Risk of post-traumatic stress symptoms in family members of intensive care unit patients.Am J Respir Crit Care Med. 2005; 171: 987-994Crossref PubMed Scopus (893) Google ScholarConcerns about adverse effects of decision making have been invoked to justify physicians' withholding of information from patients and families on the grounds of a so-called "therapeutic privilege."19Canterbury v. Spence, 464 F. 2d 772 (D.C.Circuit 1972). Developments in the law: medical technology and the law.D.C. Circuit 1972, ed.103. Harvard Law Review. 1990; : 1643-1676Google Scholar There are considerable risks that unilateral physician decision making to withhold information can cross the line between appropriate beneficence and inappropriate medical authoritarianism. This should not mean, however, that clinicians are obliged to ignore the risks of harm to patients and their families from burdens of decision making that they are not prepared to bear, especially when clinicians have reached a clear judgment that the therapy will confer no benefit for the patient. There is a middle ground between wrongful withholding of information from patients and families and harmful impositions of decision-making burdens on them. That middle ground should include the concept of informed assent.By informed assent, we envision a process in which clinicians provide full information about the risks and benefits of treatments, convey specific recommendations about the medically proposed course, and clearly indicate that the patient and family are entitled to defer to the clinicians' judgment. As an abstract matter, this is no different from the conventional conception of informed consent: a fully informed patient or family surrogate can always make an affirmative choice to accept clinicians' recommendations. But as a psychological proposition, informing the patient or family surrogate that they are entitled to accept those recommendations can convey to them the information that the clinicians are prepared to relieve them of unwanted burdens of making life-or-death decisions.Patients and family members vary in their interest in being involved in medical decision making about end-of-life care. There are some who want to be centrally involved in all decisions, while others want to defer such decisions to the clinicians.20Heyland DK Cook DJ Rocker GM et al.Decision-making in the ICU: perspectives of the substitute decision-maker.Intensive Care Med. 2003; 29: 75-82Crossref PubMed Scopus (209) Google Scholar21Heyland DK Tranmer J O'Callaghan CJ et al.The seriously ill hospitalized patient: preferred role in end-of-life decision making?.J Crit Care. 2003; 18: 3-10Abstract Full Text Full Text PDF PubMed Scopus (102) Google Scholar High-quality communication about withholding and withdrawing life support in the ICU must not assume "one size fits all." An important aspect of this communication is to determine the role an individual patient or family wants to play in such decisions. There are family members who will be greatly relieved that clinicians are willing to take responsibility for decisions, for example, to withhold cardiopulmonary resuscitation when it is not indicated. There are others who will accept a clinician's determination that cardiopulmonary resuscitation is not indicated but who could not be personally involved in making this decision. However, there are also family members who will feel that being involved in such decisions allows them to provide an important gift to the critically ill patient by ensuring that the patient's wishes are followed. It is the responsibility of the clinicians to determine where on this spectrum individual patients and families fall and to conduct the communication and decision making accordingly. Moreover, when patients or families disagree with clinicians' recommendations, we believe that clinicians will need to develop a systematic approach for dealing with such disagreement. The American Medical Association recommends a process be initiated to reconcile differences between clinicians and patients or families, and that life support be continued until reconciliation is achieved.22Council on Ethical and Judicial Affairs Medical futility in end-of-life care: report of the Council on Ethical and Judical affairs.JAMA. 1999; 281: 937-941Crossref PubMed Scopus (285) Google ScholarSome clinicians may worry about the potential legal ramifications of informed assent. Obtaining informed assent would not require a signed form by patients or their surrogates; indeed, a signature is not necessary even for legally effective informed consent. The signed form is useful as proof in any subsequent legal proceeding that consent was in fact obtained, but there is no special legal significance in the signature as such.23Jones v. Malloy. 412 NW2d 837 (Nebraska Supreme Court 1987)Google Scholar24Kovacs v. Freeman. 957 SW2d 251 (Kentucky Supreme Court 1997)Google Scholar25Bornneke v. Rutherford. 89 P3d 40 (Nevada Supreme Court 2004)Google Scholar26Corpus juris secundum physicians and surgeons. 70. West Publishing Company, Saint Paul, MN2007Google Scholar The fact of consent or assent can be adequately documented by other means, such as a contemporaneous medical record entry by the attending physician and/or other clinicians. Optimally, several members of the ICU team would have participated in the family conferences where assent had been obtained; and separate record entries by several of the team members involved would both affirm this best practice and serve as evidence if there were ever a subsequent legal challenge. Even a note in the medical record by a single clinician should, as a legal matter, be sufficient. In the critical care setting, there are specific circumstances when some standard therapies, such as cardiopulmonary resuscitation, may not provide any benefit to the patient. In these circumstances, are clinicians always obliged to obtain informed consent from patients or family members to withhold or withdraw such therapies? Because the process of obtaining informed consent may cause considerable distress for some patients and family members, we contend that obtaining informed assent—when the patient or family is explicitly invited to defer to clinicians' judgment in favor of withholding or withdrawing life-sustaining therapy—is an appropriate, ethical alternative. Recent research15Stapleton RD Engelberg RA Wenrich MD et al.Clinician statements and family satisfaction with family conferences in the intensive care unit.Crit Care Med. 2006; 43: 1679-1685Crossref Scopus (173) Google Scholar suggests that family satisfaction with communication during decisions about end-of-life care in the ICU is higher if clinicians make explicit recommendations and provide the families with support for the decisions made concerning withholding or withdrawing life support. There is, moreover, growing evidence of a significant burden of anxiety, depression, and posttraumatic stress disorder among family members of critically ill patients.16Pochard F Azoulay E Chevret S et al.Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity.Crit Care Med. 2001; 29: 1893-1897Crossref PubMed Scopus (521) Google Scholar17Azoulay E Pochard F Kentish-Barnes N et al.Risk of post-traumatic stress symptoms in family members of intensive care unit patients.Am J Respir Crit Care Med. 2005; 171: 987-994Crossref PubMed Scopus (893) Google Scholar18Lautrette A Darmon M Megarbane B et al.A communication strategy and brochure for relatives of patients dying in the ICU.N Engl J Med. 2007; 356: 469-478Crossref PubMed Scopus (878) Google Scholar Observed risk factors for these psychological symptoms include family involvement in decision making.17Azoulay E Pochard F Kentish-Barnes N et al.Risk of post-traumatic stress symptoms in family members of intensive care unit patients.Am J Respir Crit Care Med. 2005; 171: 987-994Crossref PubMed Scopus (893) Google Scholar Concerns about adverse effects of decision making have been invoked to justify physicians' withholding of information from patients and families on the grounds of a so-called "therapeutic privilege."19Canterbury v. Spence, 464 F. 2d 772 (D.C.Circuit 1972). Developments in the law: medical technology and the law.D.C. Circuit 1972, ed.103. Harvard Law Review. 1990; : 1643-1676Google Scholar There are considerable risks that unilateral physician decision making to withhold information can cross the line between appropriate beneficence and inappropriate medical authoritarianism. This should not mean, however, that clinicians are obliged to ignore the risks of harm to patients and their families from burdens of decision making that they are not prepared to bear, especially when clinicians have reached a clear judgment that the therapy will confer no benefit for the patient. There is a middle ground between wrongful withholding of information from patients and families and harmful impositions of decision-making burdens on them. That middle ground should include the concept of informed assent. By informed assent, we envision a process in which clinicians provide full information about the risks and benefits of treatments, convey specific recommendations about the medically proposed course, and clearly indicate that the patient and family are entitled to defer to the clinicians' judgment. As an abstract matter, this is no different from the conventional conception of informed consent: a fully informed patient or family surrogate can always make an affirmative choice to accept clinicians' recommendations. But as a psychological proposition, informing the patient or family surrogate that they are entitled to accept those recommendations can convey to them the information that the clinicians are prepared to relieve them of unwanted burdens of making life-or-death decisions. Patients and family members vary in their interest in being involved in medical decision making about end-of-life care. There are some who want to be centrally involved in all decisions, while others want to defer such decisions to the clinicians.20Heyland DK Cook DJ Rocker GM et al.Decision-making in the ICU: perspectives of the substitute decision-maker.Intensive Care Med. 2003; 29: 75-82Crossref PubMed Scopus (209) Google Scholar21Heyland DK Tranmer J O'Callaghan CJ et al.The seriously ill hospitalized patient: preferred role in end-of-life decision making?.J Crit Care. 2003; 18: 3-10Abstract Full Text Full Text PDF PubMed Scopus (102) Google Scholar High-quality communication about withholding and withdrawing life support in the ICU must not assume "one size fits all." An important aspect of this communication is to determine the role an individual patient or family wants to play in such decisions. There are family members who will be greatly relieved that clinicians are willing to take responsibility for decisions, for example, to withhold cardiopulmonary resuscitation when it is not indicated. There are others who will accept a clinician's determination that cardiopulmonary resuscitation is not indicated but who could not be personally involved in making this decision. However, there are also family members who will feel that being involved in such decisions allows them to provide an important gift to the critically ill patient by ensuring that the patient's wishes are followed. It is the responsibility of the clinicians to determine where on this spectrum individual patients and families fall and to conduct the communication and decision making accordingly. Moreover, when patients or families disagree with clinicians' recommendations, we believe that clinicians will need to develop a systematic approach for dealing with such disagreement. The American Medical Association recommends a process be initiated to reconcile differences between clinicians and patients or families, and that life support be continued until reconciliation is achieved.22Council on Ethical and Judicial Affairs Medical futility in end-of-life care: report of the Council on Ethical and Judical affairs.JAMA. 1999; 281: 937-941Crossref PubMed Scopus (285) Google Scholar Some clinicians may worry about the potential legal ramifications of informed assent. Obtaining informed assent would not require a signed form by patients or their surrogates; indeed, a signature is not necessary even for legally effective informed consent. The signed form is useful as proof in any subsequent legal proceeding that consent was in fact obtained, but there is no special legal significance in the signature as such.23Jones v. Malloy. 412 NW2d 837 (Nebraska Supreme Court 1987)Google Scholar24Kovacs v. Freeman. 957 SW2d 251 (Kentucky Supreme Court 1997)Google Scholar25Bornneke v. Rutherford. 89 P3d 40 (Nevada Supreme Court 2004)Google Scholar26Corpus juris secundum physicians and surgeons. 70. West Publishing Company, Saint Paul, MN2007Google Scholar The fact of consent or assent can be adequately documented by other means, such as a contemporaneous medical record entry by the attending physician and/or other clinicians. Optimally, several members of the ICU team would have participated in the family conferences where assent had been obtained; and separate record entries by several of the team members involved would both affirm this best practice and serve as evidence if there were ever a subsequent legal challenge. Even a note in the medical record by a single clinician should, as a legal matter, be sufficient. Three Categories of Withholding or Withdrawing Life SupportIn the ICU, we can identify three categories of decisions to withhold or withdraw life-sustaining therapies that clinicians believe are clearly not indicated; the concept of informed assent is not equally relevant for all three categories. The first category is withholding treatments that patients or family members are not likely to expect for the patients' specific condition (for example an exploratory laparotomy or activated protein C for a moribund patient with severe septic shock and multiple organ failure); and, accordingly, clinicians need not discuss each treatment withheld if they do not regard it as medically indicated (although clinicians would be obliged to discuss such treatment if a patient or family member takes the initiative to inquire). In this category, decisions about medical futility are commonly made unilaterally and such treatments are frequently withheld without necessarily informing or discussing each treatment with patients and families. This is an entirely appropriate use of medical judgment and consistent with good-quality care, provided the clinicians are careful in the determination that the treatment is not indicated and that the family does not expect the treatment.The second category is withholding treatments or procedures that are clearly not indicated but that most patients or families have come to expect. We believe clinicians are obliged to discuss such interventions on their own initiative. Cardiopulmonary resuscitation is currently in this category. It may be that specific patients or families do not in fact expect this intervention. But the expectation is so widespread in our contemporary culture that clinicians should assume that the intervention is expected unless the patient or family indicates otherwise.The third category is withdrawing a therapy that has already been started but which due to the patient's clinical course is no longer indicated. Although many medical ethicists conclude that withholding and withdrawing life-sustaining treatments are ethically and legally equivalent, decisions about withdrawing interventions that clinicians have previously viewed as potentially beneficial often have a different and more powerful impact on patients and families than decisions not to initiate therapies in the first place. Accordingly, communication with families about withdrawal decisions should take account of those differences. As in the second category, clinicians should assume that patients or families expect interventions to be continued, once they are begun, unless the patient or family indicates otherwise.For these second and third categories, we believe that obtaining informed assent to withhold or withdraw interventions is an ethically acceptable alternative to insisting that patients or families always bear the full burden of explicit consent. This alternative should not be offered when clinicians are uncertain about the possibility of success or when the clinicians' convictions about withholding or withdrawing treatment are based on their value judgments about the patient's resulting quality of life. In these circumstances, there are insufficient grounds for unilateral clinician decisions, and the alternative of deferring to a unilateral clinician decision, which is at the core of the informed assent process, should not be offered to the patient or family. In these circumstances, clinicians may express their opinions and recommendations about the likelihood and desirability of treatment alternatives, but patients and families should be clearly informed that medical expertise has limited relevance in coming to an ultimate decision.We believe informed assent, in the appropriate context, offers an opportunity to improve the quality of care for patients and families. The ethical propriety of the assenting process depends on clinicians' careful attention to the particular wishes and needs of specific patients and families. But it is equally true that the process of informed consent demands from clinicians the same communication skills and willingness to spend time with patients and families. Acknowledging informed assent as a suitable alternative in appropriate situations provides an option for protecting patients and families in the decision-making process in a way that the current conception of informed consent does not adequately convey. In the ICU, we can identify three categories of decisions to withhold or withdraw life-sustaining therapies that clinicians believe are clearly not indicated; the concept of informed assent is not equally relevant for all three categories. The first category is withholding treatments that patients or family members are not likely to expect for the patients' specific condition (for example an exploratory laparotomy or activated protein C for a moribund patient with severe septic shock and multiple organ failure); and, accordingly, clinicians need not discuss each treatment withheld if they do not regard it as medically indicated (although clinicians would be obliged to discuss such treatment if a patient or family member takes the initiative to inquire). In this category, decisions about medical futility are commonly made unilaterally and such treatments are frequently withheld without necessarily informing or discussing each treatment with patients and families. This is an entirely appropriate use of medical judgment and consistent with good-quality care, provided the clinicians are careful in the determination that the treatment is not indicated and that the family does not expect the treatment. The second category is withholding treatments or procedures that are clearly not indicated but that most patients or families have come to expect. We believe clinicians are obliged to discuss such interventions on their own initiative. Cardiopulmonary resuscitation is currently in this category. It may be that specific patients or families do not in fact expect this intervention. But the expectation is so widespread in our contemporary culture that clinicians should assume that the intervention is expected unless the patient or family indicates otherwise. The third category is withdrawing a therapy that has already been started but which due to the patient's clinical course is no longer indicated. Although many medical ethicists conclude that withholding and withdrawing life-sustaining treatments are ethically and legally equivalent, decisions about withdrawing interventions that clinicians have previously viewed as potentially beneficial often have a different and more powerful impact on patients and families than decisions not to initiate therapies in the first place. Accordingly, communication with families about withdrawal decisions should take account of those differences. As in the second category, clinicians should assume that patients or families expect interventions to be continued, once they are begun, unless the patient or family indicates otherwise. For these second and third categories, we believe that obtaining informed assent to withhold or withdraw interventions is an ethically acceptable alternative to insisting that patients or families always bear the full burden of explicit consent. This alternative should not be offered when clinicians are uncertain about the possibility of success or when the clinicians' convictions about withholding or withdrawing treatment are based on their value judgments about the patient's resulting quality of life. In these circumstances, there are insufficient grounds for unilateral clinician decisions, and the alternative of deferring to a unilateral clinician decision, which is at the core of the informed assent process, should not be offered to the patient or family. In these circumstances, clinicians may express their opinions and recommendations about the likelihood and desirability of treatment alternatives, but patients and families should be clearly informed that medical expertise has limited relevance in coming to an ultimate decision. We believe informed assent, in the appropriate context, offers an opportunity to improve the quality of care for patients and families. The ethical propriety of the assenting process depends on clinicians' careful attention to the particular wishes and needs of specific patients and families. But it is equally true that the process of informed consent demands from clinicians the same communication skills and willingness to spend time with patients and families. Acknowledging informed assent as a suitable alternative in appropriate situations provides an option for protecting patients and families in the decision-making process in a way that the current conception of informed consent does not adequately convey.
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