Medical Futility: clarity or confusion?

1. Medical Futility: clarity or confusion? Jay M. Baruch, MD Chairman, Ethics Committee Memorial Hospital of Rhode Island Faculty, Center for Biomedical Ethics Brown Medical School

2. Objectives • Examine the various definitions of medical futility • Consider what’s at the heart of disagreements involving futility judgments • Address moral positions of stakeholders, and common pitfalls in “futility” discussions • Explore strategies HECs can use to facilitate medically and ethically sound solutions

3. Case 1 • 86-year-old woman in PVS requiring ventilator support, repeated courses of antibiotics, frequent airway suctioning, tube feedings, air flotation bed and biochemical monitoring • Medical team suggested to family that treatment be withdrawn because not benefiting the patient. • Husband, son, and daughter insist txm’t continue. • Patient’s treatment preferences unknown.

4. Helga Wanglie case • Husband said physicians should not play G-d • Helga would not be better off dead • Removing life-support evidence of moral decay in our civilization • Miracle could occur • Hospital went to court to get permission to withdraw treatment • Husband’s role as surrogate and his judgment took precedent over team’s view of “nonbeneficial” txm’t. Angell M.The case of Helga Wanglie. NEJM 1991;325: 511-512. Miles SH. Informed demand for “nonbeneficial treatment. NEJM 1991;325:512-515.

5. Case 2 • 72-year-old with past medical history of DM, anemia, renal insufficiency, CVA, CAD, PVD, Parkinsons, heal ulcers, three hip replacements fell and broke her hip in May 1989. • Prior to surgery, experienced multiple grand mal seizures. • Afterwards, was posturing, rigid, unresponsive to noise or pain. Per neurology, chance functional recovery dismal. • Family refused DNR • Tracheostomy and gastrostomy tube placed • More seizures, arrhythmias, GI bleeding, DIC, muscle wasting. Chance neurological recovery nil.

6. Gilgunn v. MGH • ICU attending--after multiple meetings with family, ethics consults, and involvement with hospital attorney--weaned patient off ventilator. She died shortly after. • 1st case in which jury asked to consider legitimacy of values involved in physician’s refusal to attempt CPR in comatose patient with multiple medical problems out of belief in would be ineffective. • Daughter wanted everything done regardless of cost • “The family’s opinion is relevant only when there is a genuine therapeutic option. For this patient, CPR is not one of them…” Paris JJ, Cassem EH, Dec GW, et al. Use of DNR order over family objections: The Case of Gilgunn v. MGH. J Intensive Care Med 1999;14:41-45.

7. Medical Futility—moral perspective Are the benefits of certain treatments or interventions—usually at the end of life-- so remote or limited that physicians may unilaterally decide not to offer them as feasible options, or refuse to consider them despite the patient’s or surrogate’s request?

8. Clinicalscenarios • Life-sustaining interventions for patients in persistent vegetative state ( ie,Helga Wangle) • CPR in terminally ill • DNR without consent • “Slow code” • Tube feeding • Organ transplantation

9. The futility debate • Problems with definition • Who defines the terms; who decides that treatment is futile? • Ethical implications • Problems of meaning • Professional standards vs. patient’s rights • How is conflict resolved?

10. Futility • Definition: inadequacy to produce a result or bring about a required end; ineffectiveness, uselessness • Etymology: futtilis—that easily pours out, leaky, hence untrustworthy, vain, useless Oxford English Dictionary

11. Futility--Definitions • Intervention has no pathophysiologic benefit*** • Uncertain or controversial benefits • Burdens/harms/cost >> benefits • Intervention has already failed in the patient • Maximal treatment is failing

12. Definitions—Futility: Objective Standards • Less than 1% likelihood of success • Treatment preserves permanent unconsciousness or cannot end dependence on ICU • “No survivors after CPR have been reported under the circumstances in well-designed studies.” • “Highly unlikely to result in meaningful survival” • Certain medical conditions (ie, met CA, cirrhosis) with poor prognosis Schneiderman LJ et al. Medical Futility: Its Meanings and Ethical Implications. Ann Intern Med 1990;112:949-954. AHA, Emergency Cardiac Care Committee JAMA 1992; 268: 2282-2288. American Thoracic Society Ann Intern Med 1991;115: 478-485.

13. Statistical uncertainty • Estimates of probability prone to error • Clinical assessment often imprecise tools to determine diagnosis and prognosis • Applying empirical data to the particular patient • Heuristic strategies • Exceptions to the rule

14. Futility--Definitions • Treatment(s) will not accomplish intended goal • Conflicts arise when disagreement about intended goals of treatment: • Appropriateness of goals (ie, pulse and respiration if PVS) • Qualitative goals: poor likelihood of benefit • Quantitative goals: low grade outcome virtually certain • Conflicts of values, rather than facts Ethics Committee of the Society of Critical Care Medicine. Consensus statement of the Society of Critical Care Medicine’s Ethics Committee regarding futile and other possibly inadvisable treatments Crit Care Med 25;1997:887-891

15. Futility and Ambiguity • “Hides many deep and serious ambiguities that threaten its legitimacy as a rationale for limiting treatment.” • Plurality of values—agreement difficult • That goals are not worth pursuing is a conflict of values, not a question of futility. Truog RD, Brett AS, Frader J. The Problem with Futility NEJM 326;1992:1560-1564

16. Are any “futile” treatments futile? • Treatments that offer no pathophysiologic benefit are considered futile • CPR for patient with ruptured aorta • Treatments where the benefit is uncertain, unlikely, or controversial, should not be considered futile. • Address sources of conflict, including goals of treatment, POV about “success”, problems in doctor/patient relationship

17. Ethical considerations

18. Language and Meaning • “part of their [physicians’] angst comes not simply from the pressure to provide burdensome treatment, but also from in inability to find the right language and conceptual framework for talking about the problem with patients and families.” • The word “futility” used in multiple and contradictory ways • Double meaning • Evaluative judgment (Quality of life assessment) • Medical judgment on efficacy of treatment Solomon MZ. How physicians talk about futility: making words mean too many things. Journal of Law, Medicine, and Ethics 1993;21:231-237.

19. Sources of conflict • Patient’s right to be autonomous and self-determining, to make a plan that reflects his/her own values, interests, goals for future • Respect for diverse values • Different interpretations of goods and harms • Treatments that prolong death • Increase suffering • Worthy option • Time with family • Chance of survival • Religious/cultural beliefs • PVS • Different perceptions of personhood

20. Dilemma not simply a result of miscommunication or misunderstanding between involved parties. But a real, substantive difference of values regarding the meaning of life, death, disability, family obligation, etc.

21. Ethical arguments in favor of futility • Professional integrity • Physicians as moral agents • Patients can’t make unrestricted demands for certain treatments • Professional expertise • Based on scientific evidence, not opinion or bias • The physician isn’t morally required to offer non-beneficial treatment. • Must the physician even discuss “futile” treatment with patients or surrogates? • Stewardship of scarce resources • Guardian of ICU

22. Ethical considerations against futility • Patient autonomy • Informed consent • Prognostic uncertainty • Competing values • Patient or surrogate in best position to decide on questionably beneficial treatment options • Last vestiges of paternalism • Undermines pluralistic society • Social consensus

23. Pitfalls in discussion • Definition slippery • Misuse of empirical data • Opinions disguised as data • Decision-making reduced to struggle between patient autonomy and autonomy of clinician • Goals not clarified: what parties believe will be achieved by treatment or intervention. • Subjective perceptions of quality of this life • No established transparent process to resolve disputes Helft PR, Siegler M, Lantos J. The Rise and Fall of the Futility Movement. NEJM 343;2000;293-296.

24. President’s Commission on Biomedical Ethics • Rejected position that a physician could withhold futile CPR without patient’s consent • Found “it necessary for the patient or surrogate to have given valid consent to any plan of treatment, whether involving omissions or actions.” Deciding to Forego Life-Sustaining Treatment. Washington, DC:President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.1983:240-241.

25. “…The health care professional’s value judgment that although a treatment will produce physiologic benefit, the benefit is not sufficient to warrant the treatment, should not be used as a basis for determining a treatment to be futile.” Guidelines on the Termination of Life-Sustaining Treatment and the Care of the Dying: A Report of the Hastings Center. Briarcliff Manor, NY:Hastings Center; 1987:32.

26. “The physician’s obligation to respect a patients decision does not require a physician to provide a treatment that is not medically sound…Sound medical treatment is defined as the use of medical knowledge or means to cure or prevent a medical disorder, preserve life, or relieve distressing symptoms.” Council on Ethical and Judicial Affairs, American Medical Association. Decision near the end of life. JAMA 1992;267: 2229-2233.

27. Which value judgments are reasonable? • Societal consensus • Professional integrity • Physicians as moral agents • Do no harm • Role of profession in assessing the “good” • Protection of patient autonomy • Illusion of choice

28. Working through family/physician conflict

29. Physician-family conflicts with life-sustaining treatments: family issues • Don’t understand medical situation • Denial—can’t recognize facts because of unacceptable psychological consequences (ie, grief or guilt) • May lead to focus on trivial but controllable matters • Denial may be “misdiagnosed” as misunderstanding • Bad news poorly processed and not remembered well • Physician’s communication styles  misunderstanding • Jargon: “usually” “most of the time” “cannot rule out” “futile” • Semantics: “death with dignity” “everything done” “vegetable” • Multiple sources—TV, internet, friends, relatives • Multiple voices of heath care team Goold SD, Williams B, Arnold RM. Conflicts regarding decisions to limit treatment. JAMA 2000; 283:909-914.

30. Physician-family conflicts with life-sustaining treatments: family issues (con’t) • Guilt of family members • “I cannot do this” “I won’t be able to live with myself” • Physicians require they take responsibility for medical decisions • Fear of abandonment • “withdrawing care” “CMO” “Stopping care.” • Intrinsic family issues • Conflict of interest • Values

31. Improving family understanding • Ask family to verbalize the patient’s history, what other providers have told them, and their understanding of clinical situation. • Help identify gaps or incorrect information • Slice in a larger story • Ask family to explain choices • assess reasoning skills and competence • Educational appropriate language • Open-ended listening and validating family’s emotions • Primary communicator

32. Improving family understanding (con’t) • Explore cause of denial • Repeat key concepts • Verbal and written information • Encourage questions • “Can you tell me your understanding of the situation?” • Family guilt—take responsibility off surrogate • Substituted judgment • Address abandonment-- set positive goals and recommend means to achieve them. (ie, maximum comfort)

33. Physician limitations • Uncomfortable with prognostic uncertainty • Uncomfortable with death and medical failure • Respond defensively • Underestimate quality of life of chronically ill • Don’t pay attention to • Religious beliefs of family especially regarding sanctity of life • How cultural differences impact medical decisions • Insecurity about skills in end of life care • Misunderstanding ethics/law • Fatigue, frustration, stress

34. Development of a futility policy

35. Futility policy--purpose • To promote appropriate treatment in those clinical situations where patients/surrogates request treatment that physician believes isn’t medically indicated. • Establish standard transparent process to resolve disagreements. • Establish mechanisms that recognize and clarify values and goals of the involved parties with aim of establishing richer understanding of treatment options.

36. Define terms • Futility • Treatment goals • Decision-making capacity • Life-sustaining treatment • Comfort care/palliative care

37. “Futility” policy development • Definitional policies • Probability of success or quality of outcome • Identify specific conditions with extremely poor prognosis • However, insensitive to values of individual patients • Procedural policies • Conflict resolution: spells clear process for judgment • Accounts for beliefs, values and preferences of patient • Prognosis relevant, not necessarily determinative

38. Review cases--inquiry • Why wouldn’t treatment achieve intended goals • If txm’t has clinical effects, why would it fail to benefit patient • Why did patient/surrogate disagree with team? • Effect of conflict on patient/family? • Effect on treatment team (nursing***) • What efforts attempted to resolve issue • Second opinion • Clergy, social work • Ethics committee

39. Procedural response • Document carefully why treatment considered “futile” • Second opinion from physician not part of txm’t team • Inform patient/family of decision and explain why • Should patient/proxy object • Good faith communication • Social work/clergy/psychiatrist • Role of hospital ethics committee • Involve family • Documentation in medical record • Follow up • Third party--hospital staff involvement--legal • Notification of decisions to patient/family • Appellate mechanisms • Criteria for transfer to another institution

40. Elements of futility policy • All health care institutions should adopt a futility policy • Deliberation of values • Joint decision-making • Consultants • Ethics committee • Chief of staff • Patient of surrogate notified, counseled as to implications • Attempt transfer within institution • Attempt transfer to another institution • Cease futile intervention Council on Ethical and Judicial Affairs, AMA. Medical futility in end-of-life care. JAMA 1999;281:937-941. Wear S, Phillips B, Shimmel S, et al. Developing and implementing a medical futility policy: One institution’s experience. Community Ethics. http://www.pitt.edu/~cep/31wear.html

41. Remember!! • Futility judgments not objective and value free, but subjective and value laden • Not only a dispute about goals, but a dispute about values • What principles are involved in this particular case, and how does it relate to others? • Physicians and nurses are moral agents, too.

42. Last thoughts on futility • Futility judgment should be be based on upon professional standards • A goal not worth striving for is a personal preference, not a decision based on futility • Communicate openly • Framing • Not “nothing I can do” but “we’ll do everything possible to ensure comfort and dignity” • Futility shouldn’t be used to justify allocation issues. Decisions should be explicit and justifiable.

43. “thorough discussions with individual patients, semipublic discussions…and broad public education are all needed to evolve a socially shared understanding of what counts as ‘reasonable’ chance for ‘worthwhile’ benefit relative to an ‘acceptable’ risk of harm.” Tomlinson T, Brody H. Futility and the ethics of resuscitation. JAMA 1990;264:1276-1280.