1. Medical Ethics Medical Decision Making Jeffrey J Kaufhold, MD FACP Chair, Bioethics Advisory Committee, Grandview Hospital

2. Factors to Consider Medical Indicators Medical Indicators Diagnosis Diagnosis Prognosis Prognosis Treatment Treatment Quality of Life Quality of Life Patient Preference Advance Directive Prior Statements Prior Choices pt has made. Context Social Cultural Legal Financial

3. Medical Decision Making Heirarchy for decision making Heirarchy for decision making 1. Competent Patient is always first 1. Competent Patient is always first 2. Substituted judgment 2. Substituted judgment Family in rank order: Family in rank order: Spouse Spouse Parents Parents Children Children Others Others 3. Best Interest of the Patient 3. Best Interest of the Patient Paternalistic approach by caregivers Paternalistic approach by caregivers 4. Ethics Committee. 4. Ethics Committee. July 17, 2004 Robert Orr

4. Summary History of Conflict in medicine History of Conflict in medicine Justice in Medicine Justice in Medicine Social responsibilities of Physicians Social responsibilities of Physicians Medical Futility Medical Futility

5. Justice in Clinical Medicine Edmund Pellegrino, MD Edmund Pellegrino, MD Professor Emeritus of Medicine and Medical Ethics, Georgetown University Medical Center Professor Emeritus of Medicine and Medical Ethics, Georgetown University Medical Center Lecture from conference: Lecture from conference: Conflict and Conscience in Healthcare Conflict and Conscience in Healthcare July 16, 2004 July 16, 2004

6. History of Conflict in Medicine Pre-Hippocrates: Self Interest of Physician Pre-Hippocrates: Self Interest of Physician Hippocrates dared to see pt as primary focus Hippocrates dared to see pt as primary focus This was taken up by all of the monotheistic religions, and preserved by the Muslims during the middle ages This was taken up by all of the monotheistic religions, and preserved by the Muslims during the middle ages Adam Smith: Enlightened self interest Adam Smith: Enlightened self interest Bad outcome is bad advertising Bad outcome is bad advertising Karl Marx: All serve society Karl Marx: All serve society

7. History of Conflict in Medicine Managed Care Managed Care Limited Resources (Marx influence) Limited Resources (Marx influence) Are they really limited? Are they really limited? Physician is steward of those resources Physician is steward of those resources Inevitable ranking of the Worth of Patients Inevitable ranking of the Worth of Patients Healthy pt is good for society Healthy pt is good for society Chronic illness is bad for society Chronic illness is bad for society Patient may not be the primary focus Patient may not be the primary focus

8. Justice in Medicine Assumptions: Assumptions: Physician has competence, acts professionally, and in the interest of the patient. Physician has competence, acts professionally, and in the interest of the patient. Implicit covenent with society Implicit covenent with society We are allowed to do Illegal acts, in order to learn the art. We are allowed to do Illegal acts, in order to learn the art.

9. Justice in Medicine Commutative Justice Commutative Justice Contract with patient Contract with patient Distributive Justice Distributive Justice Allocation of resources Allocation of resources Charitable Justice Charitable Justice What we ought to do even if pt is abusing themselves What we ought to do even if pt is abusing themselves General Justice General Justice What do we owe the common good? What do we owe the common good? What does the patient owe the common good? What does the patient owe the common good?

10. Justice in Medicine General Justice General Justice Patient has obligation to follow the recommendations of the physician Patient has obligation to follow the recommendations of the physician Physician must take responsibility to define what the patient needs Physician must take responsibility to define what the patient needs Not required to do what pt wants Not required to do what pt wants What good can we do for the patient. What good can we do for the patient. Epicaya Epicaya Preservation of equity Preservation of equity Look at the big picture/everyone makes mistakes Look at the big picture/everyone makes mistakes

11. Social Responsibility of Physicians Best Medicine possible Best Medicine possible Stay up to date Stay up to date Participate in public debate Participate in public debate We have the knowledge needed to inform the debate We have the knowledge needed to inform the debate Advocacy for those who need help Advocacy for those who need help Legislators have the responsibility to make decisions about distribution of resources. Legislators have the responsibility to make decisions about distribution of resources.

13. Medical Futility Daniel P Sulmasy, OFM, MD, PhD Director, The Bioethics Institute New York Medical Center July 17, 2004

14. Case 76 y.o. female with Multiple Myeloma admitted with Sepsis. 76 y.o. female with Multiple Myeloma admitted with Sepsis. Heavily pretreated, no further chemo available Heavily pretreated, no further chemo available On vent, Pressors On vent, Pressors Daughter wants everything done. Daughter wants everything done.

15. The Basis for Medical Futility History of Futility History of Futility Religious Principles Religious Principles Moral Principles Moral Principles Probability Probability Dealing with the case. Dealing with the case.

16. Futility, a History Smith Papyrus, 1700 B.C. Smith Papyrus, 1700 B.C. Entreaty to not intervene if spinal cord is transected Entreaty to not intervene if spinal cord is transected This Egyptian papyrus, found in 1900’s, references a much older text. This Egyptian papyrus, found in 1900’s, references a much older text.

17. Futility, a History Smith Papyrus, 1700 B.C. Smith Papyrus, 1700 B.C. Entreaty to not intervene if spinal cord is transected Entreaty to not intervene if spinal cord is transected Hippocrates, 460 – 377 B.C. Hippocrates, 460 – 377 B.C. “On The Art” – the physician should refuse to treat in cases where medicine is powerless “On The Art” – the physician should refuse to treat in cases where medicine is powerless

18. Social norms regarding cancer 1950’s – call it something else. 1950’s – call it something else. 1960’s – Inform pt of diagnosis 1960’s – Inform pt of diagnosis 1970’s – Informed consent 1970’s – Informed consent 1990’s - Informed Demand 1990’s - Informed Demand

19. Religious Principles Intrinsic Dignity Intrinsic Dignity Made in the image of God Made in the image of God Alien Dignity Alien Dignity Relationships define our being. Relationships define our being. Also a fact that we are Finite Also a fact that we are Finite

20. Religious Principles Life is a gift, and we are its stewards Life is a gift, and we are its stewards Limits to stewardship Limits to stewardship Illness is a burden Illness is a burden Costs and burden to family/caregivers Costs and burden to family/caregivers Futile care need not be given. Futile care need not be given.

21. Moral Principles No moral obligation to provide futile Tx. No moral obligation to provide futile Tx. What is Futile Treatment? What is Futile Treatment? Non-beneficial Non-beneficial Inappropriate treatment at the end of life Inappropriate treatment at the end of life What is the real goal? What is the real goal? Free of pain and suffering Free of pain and suffering

22. Moral Principles What is Futile Treatment? What is Futile Treatment? Subjective Futility Subjective Futility Patient won’t be able to appreciate benefit Patient won’t be able to appreciate benefit This is not sufficient moral argument to withhold therapy This is not sufficient moral argument to withhold therapy Objective Futility (biomedical use) Objective Futility (biomedical use) No objective benefit to any observer No objective benefit to any observer

23. Moral Principles Medical Realism Medical Realism There are facts There are facts Trained people can make judgements Trained people can make judgements But we are fallible But we are fallible We have to relate the data to the patient We have to relate the data to the patient This is the tricky part of the art. This is the tricky part of the art. Requires use of probability. Requires use of probability.

24. Probability Is this patient going to die? Is this patient going to die? Probably. Probably. Even with treatment? Even with treatment? Probably. Probably. Can you be more specific? Can you be more specific? Probably. Probably.

25. Probability Prognosis is the probability that a patient will respond to tx, plus the probability that the disease will kill them. Prognosis is the probability that a patient will respond to tx, plus the probability that the disease will kill them. Probability that we use in individual cases comes from objective data about the particulars of the case, plus experience, plus common sense. Probability that we use in individual cases comes from objective data about the particulars of the case, plus experience, plus common sense. This process is fallible, but we do the best we can. This process is fallible, but we do the best we can.

26. Probability Three factors: Three factors: Frequency: Frequency: Prediction: Prediction: Strength of belief Strength of belief Lets apply to the case: Lets apply to the case:

27. Probability Myeloma with sepsis Frequency: (80% of myeloma pts do not wean from vent) Frequency: (80% of myeloma pts do not wean from vent) Based on studies Based on studies Prediction: (1% likelihood of survival for this pt) Prediction: (1% likelihood of survival for this pt) Based on Karnovsky score in Onc literature Based on Karnovsky score in Onc literature Based on APACHE score in ICU literature Based on APACHE score in ICU literature Strength of belief Strength of belief P value P value “Reasonable degree of medical certitude” “Reasonable degree of medical certitude”

28. “Ultimately, Ethics is about What to Do” Aristotle, 384 – 322 B.C.

29. Morality of Futility Judgment enters Morality when decision is made about taking action. Judgment enters Morality when decision is made about taking action. Actions: Actions: Wean from vent? Wean from vent? Wean from pressors? Wean from pressors? Stop Antibiotics? Stop Antibiotics? Stop tube feedings/ IV fluids? Stop tube feedings/ IV fluids?

30. Morality of Futility Judgment enters Morality when decision is made about taking action. Judgment enters Morality when decision is made about taking action. Approaches: Approaches: Pragmatic – does this help the patient? Pragmatic – does this help the patient? Remember, removing pt from life support may kill them, but might it also stop their suffering? Remember, removing pt from life support may kill them, but might it also stop their suffering? Moral (prudential) – is this the right thing to do? Moral (prudential) – is this the right thing to do?

31. Back to the Case Myeloma with sepsis Frequency: Frequency: (80% of myeloma pts do not wean from vent) (80% of myeloma pts do not wean from vent) Prediction: Prediction: (1% likelihood of survival for this pt) (1% likelihood of survival for this pt) Strength of belief Strength of belief “Reasonable degree of medical certitude” “Reasonable degree of medical certitude” Pragmatic approach Pragmatic approach CPR will not help pt get better CPR will not help pt get better Prudential approach Prudential approach Morally wrong to provide inappropriate treatment. Morally wrong to provide inappropriate treatment.

32. Back to the Case Myeloma with sepsis Pragmatic approach Pragmatic approach CPR will not help pt get better CPR will not help pt get better Prudential approach Prudential approach Morally wrong to provide inappropriate treatment. Morally wrong to provide inappropriate treatment. Recommendation: Recommendation: Make the pt DNR – CC arrest Make the pt DNR – CC arrest Consider withdrawal of life support Consider withdrawal of life support How do we proceed with the family? How do we proceed with the family?

33. Back to the Case Myeloma with sepsis The family in town wants to keep Mom comfortable, and see she is suffering on life support. The family in town wants to keep Mom comfortable, and see she is suffering on life support. However, the out of town daughter is “in charge” and insists everything be done. However, the out of town daughter is “in charge” and insists everything be done. Cultural barriers arise. Cultural barriers arise. Tilden. Nurs Res: 2001, 50;105-115. Tilden. Nurs Res: 2001, 50;105-115. Its Stressful to be the surrogate Its Stressful to be the surrogate Guilt, Ambivalence, Depression, Anger. Guilt, Ambivalence, Depression, Anger.

34. How to proceed Clinically Establish relationship with family Establish relationship with family Review case (how did she get here) Review case (how did she get here) Describe level of illness Describe level of illness Lay out options Lay out options Establish goals Establish goals keep her alive until son gets here keep her alive until son gets here Maintain comfort no matter what. Maintain comfort no matter what. Establish Limits Establish Limits will not resuscitate her if heart stops. will not resuscitate her if heart stops.

35. Praying for a Miracle Affirm that this is OK Affirm that this is OK Bear witness in faith, resurrection Bear witness in faith, resurrection God is present and answering all our prayers, even if a miracle doesn’t come God is present and answering all our prayers, even if a miracle doesn’t come

37. Hippocratic Oath Now being admitted to the profession of medicine, I solemnly pledge to consecrate my life to the service of humanity. Now being admitted to the profession of medicine, I solemnly pledge to consecrate my life to the service of humanity. I will give respect and gratitude to my deserving teachers. I will give respect and gratitude to my deserving teachers. I will practice medicine with conscience and dignity. I will practice medicine with conscience and dignity. The health and life of my patients will be my first consideration. The health and life of my patients will be my first consideration. Part 1

38. Hippocratic Oath I will hold in confidence all that my patient confides in me. I will hold in confidence all that my patient confides in me. I will maintain the honor and noble traditions of the medical profession. I will maintain the honor and noble traditions of the medical profession. My colleagues will be as my brothers and sisters. My colleagues will be as my brothers and sisters. I will not permit consideration of race, religion, nationality politics or social standing to intervene between my duty and my patient. I will not permit consideration of race, religion, nationality politics or social standing to intervene between my duty and my patient. Part 2

39. Hippocratic Oath I will maintain the utmost respect for human life. I will maintain the utmost respect for human life. Even under threat I will not use my knowledge contrary to the laws of humanity. Even under threat I will not use my knowledge contrary to the laws of humanity. These promises I make freely and upon my honor. These promises I make freely and upon my honor. Part 3

40. Aesculpius Staff with single serpent Staff with single serpent “Life is short, Art is long, experience difficult.” “Life is short, Art is long, experience difficult.” Greek: Obi OE BpAXYE, HTEXNH MA KPH, O KAI POE OE YE. Greek: Obi OE BpAXYE, HTEXNH MA KPH, O KAI POE OE YE.

42. Competency Assessing Decision Making Capacity Jeffrey J Kaufhold, MD FACP Jeffrey J Kaufhold, MD FACP Chair, Bioethics Advisory Committee, Chair, Bioethics Advisory Committee, Grandview Hospital Grandview Hospital

43. A Guide to assessing Decision Making Capacity. A Guide to assessing Decision Making Capacity. Roger C. Jones, MD, Timothy Holden, MD Roger C. Jones, MD, Timothy Holden, MD Cleveland Clinic Journal of Medicine Cleveland Clinic Journal of Medicine Vol 71, December 2004, p 971-5. Vol 71, December 2004, p 971-5.

44. Summary Physicians need an efficient way to determine a pts decision making capacity Physicians need an efficient way to determine a pts decision making capacity This capacity must be assessed for each decision and not inferred on the basis of pts diagnosis. This capacity must be assessed for each decision and not inferred on the basis of pts diagnosis. Documentation of the process used and decisions reached is necessary. Documentation of the process used and decisions reached is necessary.

45. Case 1 Pt admitted for sepsis Pt admitted for sepsis Poor access for pressors and labs Poor access for pressors and labs Pt is confused Pt is confused No family is available No family is available Can pt consent to line placement? Can pt consent to line placement?

46. Case 2 Elderly pt with Alzheimers and a MMSE score of 23 of 30 refuses elective Chole. Elderly pt with Alzheimers and a MMSE score of 23 of 30 refuses elective Chole. Daughter/DPAHC requests surgery. Daughter/DPAHC requests surgery. Can the pt refuse? Can the pt refuse? How can his competency be evaluated? How can his competency be evaluated?

47. Case 3 Pt admitted with acute pneumonia Pt admitted with acute pneumonia Also diagnosed with severe depression Also diagnosed with severe depression Many answers are “I don’t know/I don’t care” Many answers are “I don’t know/I don’t care” Pt refuses treatment, stating “ I don’t care if I live or die” Pt refuses treatment, stating “ I don’t care if I live or die” Does pt have decision making capacity? Does pt have decision making capacity? If not how do you procede? If not how do you procede?

48. Consent Requirements: Requirements: Autonomy Autonomy Capacity to understand and communicate Capacity to understand and communicate Ability to reason Ability to reason Recognized set of values or goals Recognized set of values or goals Agreement with the physician does not imply that pts capacity to give consent is intact! Agreement with the physician does not imply that pts capacity to give consent is intact!

49. Competency Legal designations determined by the courts. Legal designations determined by the courts. Decision making capacity is clinically determined by physician at the bedside. Decision making capacity is clinically determined by physician at the bedside. Adults are presumed competent unless legally judged to be incompetent. Adults are presumed competent unless legally judged to be incompetent. President’s commission for the study of Ethical Problems in Medicine 1982. President’s commission for the study of Ethical Problems in Medicine 1982. Avoid Routine recourse to legal system. Avoid Routine recourse to legal system.

50. Clinical Approach Urgency of the clinical situation determines how to procede. Urgency of the clinical situation determines how to procede. Urgent situation Urgent situation Pt not able to communicate / no spokesperson Pt not able to communicate / no spokesperson Assume that a reasonable person would not want to be denied life saving treatment. Assume that a reasonable person would not want to be denied life saving treatment. “Implied Consent” “Implied Consent”

51. Clinical approach Nonemergent situation Nonemergent situation What are the risks and benefits? What are the risks and benefits? Low risk may not require much decision making capacity. Low risk may not require much decision making capacity. I’m here to draw your blood for a hct. I’m here to draw your blood for a hct. High risk may require significant deliberation. High risk may require significant deliberation. Should a pt with lung cancer and severe CAD undergo pneumonectomy for possible cure? Should a pt with lung cancer and severe CAD undergo pneumonectomy for possible cure?

52. Algorithm for assessment Miller and Marin, Emergency Med Clinic North Am, 2000; 18: 233-241. Miller and Marin, Emergency Med Clinic North Am, 2000; 18: 233-241. Series of simple questions Series of simple questions Doesn’t take into account the level of risk or benefit of a treatment. Doesn’t take into account the level of risk or benefit of a treatment.

53. Algorithm 1. Do the history and physical confirm that the pt can communicate a choice? 1. Do the history and physical confirm that the pt can communicate a choice? Is their memory good? Is their memory good? Is judgement appropriate? Is judgement appropriate? Can they maintain a conversation/follow your line of questioning? Can they maintain a conversation/follow your line of questioning? Are their answers consistent? Are their answers consistent? If yes: procede to question 2 If yes: procede to question 2 If No: pt needs help with decision making. If No: pt needs help with decision making.

54. Algorithm 2. Can the pt understand the essential elements of informed consent? 2. Can the pt understand the essential elements of informed consent? What is your present condition? What is your present condition? What treatment is being recommended? What treatment is being recommended? What might happen to you if you agree to the treatment? What might happen to you if you agree to the treatment? What might happen to you if you refuse the treatment? What might happen to you if you refuse the treatment? What are the alternatives available? What are the alternatives available? Test of pts understanding of the discussion. Test of pts understanding of the discussion.

55. Algorithm 3. Can the pt assign personal values to the risks and benefits of intervention? 3. Can the pt assign personal values to the risks and benefits of intervention? Jehovahs witness refusal to accept transfusion reflects different set of values. Jehovahs witness refusal to accept transfusion reflects different set of values.

56. Algorithm 4. Can the pt manipulate the information rationally and logically? 4. Can the pt manipulate the information rationally and logically? Can you follow how the patient got to their decision? Can you follow how the patient got to their decision?

57. Algorithm 5. Is the patients decision making capacity stable over time? 5. Is the patients decision making capacity stable over time? Repeat the question several minutes later/ after more discussion. Repeat the question several minutes later/ after more discussion.

58. Algorithm Benefits of this approach: Benefits of this approach: Avoids the tendency to devalue capacity of chronically ill pts Avoids the tendency to devalue capacity of chronically ill pts Reduces reliance on surrogate decision makers when not necessary Reduces reliance on surrogate decision makers when not necessary Avoids judgement based on whether pt agrees with Doctor. Avoids judgement based on whether pt agrees with Doctor.

59. Algorithm Limitations: Limitations: Language barriers Language barriers Cultural barriers Cultural barriers African Americans tendency to not look at speaker, distrust of system leading to misinterpretation of options provided African Americans tendency to not look at speaker, distrust of system leading to misinterpretation of options provided Some of the assessment questions are subjective. Some of the assessment questions are subjective.

60. When surrogate must be consulted If the pt is incompetent as determined by the court If the pt is incompetent as determined by the court If the pts decision making capacity is in doubt If the pts decision making capacity is in doubt If the pt is unable to understand options or is unable to decide. If the pt is unable to understand options or is unable to decide.

61. Case 1 Pt admitted for sepsis Pt admitted for sepsis Poor access for pressors and labs Poor access for pressors and labs Pt is confused Pt is confused No family is available No family is available Does pt have to consent to line placement? Does pt have to consent to line placement? No, use implied consent. No, use implied consent.

62. Case 2 Elderly pt with Alzheimers and a MMSE score of 23 of 30 refuses elective Chole. Elderly pt with Alzheimers and a MMSE score of 23 of 30 refuses elective Chole. Daughter/DPAHC requests surgery. Daughter/DPAHC requests surgery. Can the pt refuse? Can the pt refuse? MMSE can miss cognitive deficits MMSE can miss cognitive deficits How can his competency be evaluated? How can his competency be evaluated? Psychiatry consult, ethics consult if needed. Psychiatry consult, ethics consult if needed. In this case, daughter served as decision maker. In this case, daughter served as decision maker.

63. Case 3 Pt admitted with acute pneumonia Pt admitted with acute pneumonia Also diagnosed with severe depression Also diagnosed with severe depression Many answers are “I don’t know/I don’t care” Many answers are “I don’t know/I don’t care” Pt refuses treatment, stating “ I don’t care if I live or die” Pt refuses treatment, stating “ I don’t care if I live or die” Does pt have decision making capacity? Does pt have decision making capacity? Physician determined that pt does not, due to depression. Physician determined that pt does not, due to depression. Treat depression and pneumonia. Treat depression and pneumonia. Capacity may return once depression treated. Capacity may return once depression treated.

64. Summary Physicians must determine decision making capacity every day. Physicians must determine decision making capacity every day. Diagnosis does not imply impaired capacity, nor does good MMSE imply that pt has capacity. Diagnosis does not imply impaired capacity, nor does good MMSE imply that pt has capacity. Agreement or disagreement with physicians recommendation does not imply capacity is intact or impaired. Agreement or disagreement with physicians recommendation does not imply capacity is intact or impaired.

65. Summary Differing pt values may result in conflict and raise questions about pts capacity. Differing pt values may result in conflict and raise questions about pts capacity. Algorithm provides a simple method to determine D.M. capacity Algorithm provides a simple method to determine D.M. capacity Competency is legal determination Competency is legal determination DMC is clinical determination. DMC is clinical determination.