Patient Understanding in
Informed Consent
Robert F. Dunton, MD
Chief, Division of Cardiothoracic Surgery
Upstate Medical University
Informed Consent
• Do patients need to understand as well as
be informed in consent?
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Informed Consent
Guiding Principles
Essentials of Understanding
Informed Consent
• Conflicts of interest:
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
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
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
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
Informed Consent
• Principles of Bioethics:
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Autonomy
Beneficence
Non-maleficence
Justice
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Informed Consent
Standards of Adequacy:
• Reasonable Physician Standard
• Reasonable Patient Standard
• Patient-Specific Subjective Standard
Informed Consent
Standards of Adequacy:
• Reasonable Physician
Less Patient
Understanding
• Reasonable Patient
• Subjective Standard
More Patient
Understanding
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
Informed Consent
• Informed consent as a process of shared
medical decision-making
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Physician is the Authority
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Patient is in Authority
• Patient will require increasing
understanding for effective input
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
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
Assessment of Patient
Understanding
• Clinicians need to check patient understanding
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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)
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.
Informed Consent
• Patient Understanding is Critical
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Higher level of involvement
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Making decision consonant with their
personal values and beliefs
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Effective shared decision-making
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Acceptance or rejection of the treatment
plan
Informed Consent
• Definition of Informed Consent
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History of Informed Consent
Identify the Elements of Informed Consent
Consider what is required for Adequate Consent
When is Informed Consent Required
Schloendorff v. New York Hospital
105 N.E. 92, 82-94 (1914)
• New York Court of Appeals
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Justice Cordozo, Majority Opinion
• Elderly lady admitted for abdominal pain
• Underwent surgery without consent
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.”
Canterbury v. Spence
464 F.2d 772 (D.C. 1969)
• United States Court of Appeals for the
District of Columbia
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Young man underwent spinal surgery
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Experienced complications which he was
not told might happen
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.”
Informed Consent
When is Informed Consent Necessary:
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Invasive Procedures
Surgery
Anesthesia
Blood Utilization
Informed Consent
• Other Situations:
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Common Daily Interactions
Disclosing Medical Errors
Caring for Public Figures
Multimedia Utilization
Photographs, Video, Audio, etc.
Informed Consent
• Other Situations
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Reporting Surgeon Outcomes Data
Reporting Surgeon Experience Levels
Reporting Conflicts of Interest
Consent as being Task or Situation Specific
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
Informed Consent
• Conflicting Situations:
• “Wandering” Consent
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External Influences
Refusing of Life-Saving Therapies
Teaching Cases
Pediatric Cases