1. Patient Understanding in Informed Consent Robert F. Dunton, MD Chief, Division of Cardiothoracic Surgery Upstate Medical University

2. Informed Consent Do patients need to understand as well as be informed in consent? Informed Consent Guiding Principles Essentials of Understanding

3. Informed Consent Conflicts of interest:

4. Informed Consent The process by which a fully invested patient participates in choices concerning their health care Originates from ethical considerations and legal rights a patient has to determine what will happen to his or her body Includes the ethical duty of the caregiver to involve the patient in such decisions

5. Informed Consent Elements of Informed Consent: The nature of the present illness and it’s potential natural history The nature of the decision or procedure at hand Reasonable alternative treatment strategies

6. Informed Consent Elements of Informed Consent: Relevant risks, benefits and uncertainties of each possible choice of treatment Assessment of patient’s understanding Acceptance of the intervention by the patient

7. Informed Consent Elements of Informed Consent: Patient must be competent and have capacity Voluntary and non-coercive Invitation for the patient to participate in shared decision-making

9. Informed Consent Principles of Bioethics: Autonomy Beneficence Non-maleficence Justice

11. Informed Consent Standards of Adequacy: Reasonable Physician Standard Reasonable Patient Standard Patient-Specific Subjective Standard

12. Informed Consent Standards of Adequacy: Reasonable Physician Reasonable Patient Subjective Standard Less Patient Understanding More Patient Understanding

13. Informed Consent Cognitive Understanding The ability to appreciate current conditions Appropriate sense of future probabilities Clear grasp of the pro’s and con’s of an intervention Evaluative Understanding Judging the merits of treatment based upon individual values

14. Informed Consent Informed consent as a process of shared medical decision-making Physician is the Authority Patient is in Authority Patient will require increasing understanding for effective input

15. Informed Consent End result will be the patient’s acceptance or rejection of the physician’s advice Understanding is critical to helping he patient arrive at a decision and accepting the therapy

16. Informed Consent Clinicians have a duty to assess patients ability to make decisions Capacity vs. competency Imperative for clinicians Scope of practice for all clinicians Critical component of overall assessment

17. Assessment of Patient Understanding Clinicians need to check patient understanding –Additional staff to help explain material –Information sheets or pamphlets –Use consent form as an outline –“Read back” method –Open-ended questions –Interactive discussion –Other (A-V media, web based, phone)

19. Informed consent: how much and what do patients understand? Matthew E. Falagas, M.D., M.S., D.Sc. Ioanna P. Korbila, M.D. Konstantina P. Giannopoulou, M.D. Barbara K. Kondilis, M.P.H. George Peppas, M.D., Ph.D.

21. Informed Consent Patient Understanding is Critical Higher level of involvement Making decision consonant with their personal values and beliefs Effective shared decision-making Acceptance or rejection of the treatment plan

24. Informed Consent Definition of Informed Consent History of Informed Consent Identify the Elements of Informed Consent Consider what is required for Adequate Consent When is Informed Consent Required

25. Schloendorff v. New York Hospital 105 N.E. 92, 82-94 (1914) New York Court of Appeals Justice Cordozo, Majority Opinion Elderly lady admitted for abdominal pain Underwent surgery without consent

26. Schloendorff v. New York Hospital “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages.”

27. Canterbury v. Spence United States Court of Appeals for the District of Columbia Young man underwent spinal surgery Experienced complications which he was not told might happen 464 F.2d 772 (D.C. 1969)

28. Canterbury v. Spence “The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn, the requirement, of a reasonable divulgence by physician to patient to make such a decision possible.”

29. Informed Consent When is Informed Consent Necessary: Invasive Procedures Surgery Anesthesia Blood Utilization

30. Informed Consent Other Situations: Common Daily Interactions Disclosing Medical Errors Caring for Public Figures Multimedia Utilization Photographs, Video, Audio, etc.

31. Informed Consent Other Situations Reporting Surgeon Outcomes Data Reporting Surgeon Experience Levels Reporting Conflicts of Interest Consent as being Task or Situation Specific

32. Informed Consent Omitting Informed Consent: Life Threatening Emergencies Situations in which Medical Information may be too Overwhelming for a Patient, Potentially Interfering with Effective Treatment

33. Informed Consent Conflicting Situations: “ Wandering” Consent External Influences Refusing of Life-Saving Therapies Teaching Cases Pediatric Cases