Evidence-Based Ethics: Introduction and Applications to Medicine and Public Health

1. John E. Snyder Evidence-Based Ethics:Introduction and Applications toMedicine and Public Health

2. Outline • Introduction • History of medical ethics • Key ethical principles • Advance Directives • Cases • Applications to public health

3. Introduction • A need for practical medical ethics education • Recognizes omnipresence of dilemmas • Systematic approach • Case-based • Offers guidance • Doesn’t define right/wrong • Incorporates cultural competence

4. H/O Medical Ethics in Super FF  • Oath of Hippocrates ~5 B.C. • Respect for confidentiality • Strict prohibition for euthanasia • Relationship boundaries with patients • Limitations in applicability to modern world/medicine • Oath of Maimonides ~1100 A.D.

5. H/O Medical Ethics in Super FF  • First AMA Code of Ethics in 1847 • Doctor’s Trial in Nuremburg in 1947 Nuremburg Code • “Voluntary Consent” • Good for society and not “random” • Based on animals first • Risk should be low, or include the scientists • Tuskegee Syphilis Study, 1932-1972 The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research • IRBs • Informed Consent • Beauchamp & Childress, 1979

6. Principles of Medical Bioethics • The Principle of Beneficence • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • The Principle of Respect for Dignity* • The Principle of Respect for Veracity* • The Principle of Distributive Justice * Snyder/Gauthier

7. The Principle of Beneficence • Medical practitioners should act in the best interests of the patient.

8. The Principle of Non-Maleficence • Medical practitioners must not harm the patient.

9. The Principle of Respect for Autonomy • Capable persons must be allowed to accept or refuse recommended medical interventions.

10. The Principle of Respect for Dignity • Patients, their families, and surrogate decision makers, as well as their health care providers, all have the right to dignity.

11. The Principle of Respect for Veracity • The capable patient must be provided with the complete truth about her/his medical condition.

12. The Principle of Distributive Justice • Health care resources should be distributed in a fair way among the members of society.

13. Evidence-Based Medical Ethics • Proposed approach of evidence-based medical ethics • Based on the tenets of evidence-based medicine (EBM), which: • Aims to apply the best available evidence (gained from rigorous application of the scientific method) to clinical decision making • Seeks to assess the strength of evidence of the risks and benefits of treatments (including lack of treatment) and diagnostic tests • Helps clinicians to learn whether or not any treatment will do more good than harm

14. Evidence-Based Medical Ethics • Evidence-Based Medical Ethics: • Aims to apply the best available “evidence” gained from EBM, widely accepted ethical principles, and legal precedent • Incorporates aspects of cultural competency and an evolving medical knowledge set/technology (we can/but should we?), and an evolving set of laws • Helps clinicians guide patients to make “good decisions” for themselves, particularly when options have potential to do both good and harm • Emphasizes that “right” and “wrong” decisions are personal choices of the patient and are acceptable if they are well-informed (it’s not about you)

15. Advance Directives • Some of the most difficult medical decisions are made when the patient themselves is unable to make them • Includes how a patient’s life will end • Natural Death Act, 1976 (California) • First time a state allowed citizens to make their choices for end-of-life care known in advance • Physicians honoring this “directive” cannot be charged with criminal liability or unprofessional conduct • Led to development of the “Living Will” • Later led to the “Power of Attorney for Health Care” • These two documents collectively make up Advance Directives

16. Living Will • Legally executed document by a capable patient • Authorizes physicians to withhold or withdraw life-sustaining medical treatment when the patient, in the future, lacks the capacity to make health care decisions • In some states requires a “terminal condition”, but in others includes states like PVS • Can include decisions on “artificial nutrition and hydration”

17. (Durable) Power of Attorney for Health Care • Legal document a capable patient uses to appoint a “health care agent” (HCA) • Aka “representative”, “proxy”, “surrogate” • Rules vary greatly from state to state • That person will make decisions for the patient when they are no longer capable • Includes employing/discharging providers • Includes consent to admit/discharge from facilities • Includes ability to give, withdraw, or withhold consent for diagnostic and therapeutic procedures

18. (Durable) Power of Attorney for Health Care • A patient’s wishes for end-of-life care, in particular, should be discussed in advance with the HCA… but often are not • When not, often result in conflicts between family members • Sometimes wishes are discussed but not legally documented • When a patient’s wishes are not documented, the HCA should act using one of two principles: • “Substituted judgment” • “Best interests standard”

19. Surrogate Decision Makers • Come into play when there are no ADs • Laws vary to some degree by state with respect to “priority” status of an individual to be a HCA on behalf of the patient • Laws also vary state to state by what determines a “marriage” or “family”

20. Breather!

21. Case 1: When a Patient is Unidentifiable • John Doe, 50 year old AAM, found unresponsive in an alleyway by passersby • Covered with blood and dirt • ? Homeless • No identifying information • Weak pulse, shallow respirations

22. Case 1: When a Patient is Unidentifiable • In the field: • Placed on a backboard, intubated, and a hard cervical collar placed • In the ED: • Fractures to the pelvis and bilateral femurs • Splenic and liver lacerations • Collapsed left lung • Large intracranial hemorrhage (subdural hematoma) • Police involved, fingerprinting unrevealing

23. What do you do next? • Place/keep on a ventilator ? • Insert a PEG tube for nutrition? • Place an IV? A “central line”? • Transfuse blood? • Take to the OR?

24. What do you do next? • How much do you do to help this patient? • How long do you wait before moving forward? • When do you stop efforts/where do you draw the line?

25. The Medicine • In patients with CNS injuries, mechanical ventilation may be necessary to support life • Prolonged need for ventilation and placement of a tracheostomy may be observed • The goal of any patient on a ventilator is weaning • Study of 100 patients by Namen, et al.: • GCS < 8: 33% success rate of extubation • GCS > 8: 75% success rate

26. The Law • Canterbury V. Spence [1972] 464 F 2d 772, U.S. Court of Appeals, District of Columbia Circuit • Legally-recognized exceptions to Informed Consent: “… when a patient is unconscious or otherwise incapable of consenting, and harm from a failure to treat is imminent and outweighs any harm threatened by the proposed treatment” X

27. The Ethics • The Principle of Beneficence • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • The Principle of Respect for Dignity • The Principle of Respect for Veracity • The Principle of Distributive Justice

28. The Ethics • The Principle of Beneficence • Injuries have been initially treated • Immediate death has been prevented • Life sustained until chances for recovery could be determined • Pain was treated • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • The Principle of Respect for Dignity • The Principle of Respect for Veracity • The Principle of Distributive Justice

29. The Ethics • The Principle of Beneficence • The Principle of Non-Maleficence • Risks of interventions to date were weighed against benefits • Further plan is being considered carefully with respect to this principle • Must consider a “line” to draw re: possible futility of efforts • The Principle of Respect for Autonomy • The Principle of Respect for Dignity • The Principle of Respect for Veracity • The Principle of Distributive Justice

30. The Ethics • The Principle of Beneficence • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • Does not apply here • Patient cannot be identified • Family cannot be contacted • No “substituted judgment” can be made • A legal guardian must be sought • Must use “best interests standard” based on above two principles • Take likelihood for recovery/improvement and contrast with pain/suffering and QOL may attain • Will reasonable goals be met or will the end of life be artificially postponed? • Are there aspects of culture that should be considered here? • The Principle of Respect for Dignity • The Principle of Respect for Veracity • The Principle of Distributive Justice

31. The Ethics • The Principle of Beneficence • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • The Principle of Respect for Dignity • Important as the patient is vulnerable and has no “voice” • Must protect privacy and bodily integrity to greatest extent possible • Invasive life-sustaining measures should not be initiated simply because the patient’s own wishes cannot be known • The Principle of Respect for Veracity • The Principle of Distributive Justice

32. The Ethics • The Principle of Beneficence • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • The Principle of Respect for Dignity • The Principle of Respect for Veracity • The legal guardian must receive all possible and relevant information • Information must be presented clearly and without bias/leading • The Principle of Distributive Justice

33. The Ethics • The Principle of Beneficence • The Principle of Non-Maleficence • The Principle of Respect for Autonomy • The Principle of Respect for Dignity • The Principle of Respect for Veracity • The Principle of Distributive Justice • Does not apply here • Resources are not limited in this case*** • Decisions to withdraw or withhold medical treatment cannot be made because: • Patient cannot be identified • Patient’s “societal value”

34. The Formulation • Review • Medical evidence • Legal precedence • Ethical principles • Decide • Act • Attempt to foresee/preempt challenges } Delve further to assist in sound decision-making

35. Breather!

36. Public Health Ethics • Represented on the PHLS Public Health Code of Ethics Committee are public health professionals from: • Local and state public health • Academia • The Centers for Disease Control and Prevention (CDC) • The American Public Health Association (APHA) • Guide is published on the APHA website • Has 12 guiding principles • Has a different perspective than medical bioethics

37. Public Health Ethics • Public health should address principally the fundamental causes of disease and requirements for health, aiming to prevent adverse health outcomes. • Public health should achieve community health in a way that respects the rights of individuals in the community. • Public health policies, programs, and priorities should be developed and evaluated through processes that ensure an opportunity for input from community members. • Public health should advocate and work for the empowerment of disenfranchised community members, aiming to ensure that the basic resources and conditions necessary for health are accessible to all. • Public health should seek the information needed to implement effective policies and programs that protect and promote health. • Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community’s consent for their implementation.

38. Public Health Ethics • Public health institutions should act in a timely manner on the information they have within the resources and the mandate given to them by the public. • Public health programs and policies should incorporate a variety of approaches that anticipate and respect diverse values, beliefs, and cultures in the community. • Public health programs and policies should be implemented in a manner that most enhances the physical and social environment. • Public health institutions should protect the confidentiality of information that can bring harm to an individual or community if made public. Exceptions must be justified on the basis of the high likelihood of significant harm to the individual or others. • Public health institutions should ensure the professional competence of their employees. • Public health institutions and their employees should engage in collaborations and affiliations in ways that build the public’s trust and the institution’s effectiveness.

39. Public Health Ethics • Principles offer guidance but not answers • Principles should be considered when working on public health initiatives • Principles often need to be thought of in light of medical bioethics • Who “polices” this?

40. Please stop talking Dad!

41. Case 2: When a Partner is Excluded • José M., 34 year old Latino male in NC • Known HIV infection x5 years, not on ART • Had not seen an MD x2 years as is uninsured • Last known CD4+ count was 201/μL • 2 months of cough, malaise, fevers, 15# weight loss • Progressive shortness of breath, weakness • Encouraged to come in by partner of 4 years, Justin (HIV neg.)

42. Case 2: When a Partner is Excluded • In the ED: • Fever • High heart and respiratory rates • Low oxygen saturation • Chest x-ray suggestive of diffuse pneumonia in both lungs • Sputum examination indicates presence of Pneumocystisjirovecii • CD4+ count reported now as 12/μL

43. Case 2: When a Partner is Excluded • Hospital course: • Symptoms worsened • Transferred to the ICU • Developed acute respiratory distress syndrome (ARDS) and progressive multi-system organ failure (MSOF) • Sedated and placed on mechanical ventilation • Had not completed a Living Will or HCPOA paperwork previously

44. Case 2: When a Partner is Excluded • Hospital course: • José’s parents notified • Although he had been in close contact with his parents, José had never disclosed his S.O. or HIV status to them • Had never introduced them to Justin out of concern they would not be accepting

45. Case 2: When a Partner is Excluded • Hospital course: • José’s father asks “does my son have AIDS?” • José’s mother says “that man” (Justin) should not be allowed into the ICU room any more

46. What do you do next? • How much information do you disclose to José’s family? • What decisions do they need to make now? • What decisions might they need to make soon? • What rights does Justin have? • Should José’s parents be told that Justin is HIV negative? • Can José’s parents make “good” medical decisions for him? • What cultural aspects are important in this case? • How does one best balance the principles of beneficence, autonomy, non-maleficence, veracity, and dignity in this case?

47. FIN