Informed Consent, Medical Mistakes, End of Life

Question 1

Informed Decision Making

Components

Answer 1

• Voluntariness = Patient makes the choice freely and without coercion
• Decision-making capacity = Patient must have the cognitive capacity to make a decision
• Disclosure = All necessary informational elements must be provided
• Comprehension = Information must be provided in a way that achieves patient comprehension

Question 2

Autonomy

Answer 2

The right to make one’s own medical decisions and have sovereignty over one’s own body and mind.

Basis of informed decision-making and informed consent.

A person needs:

• Mental capacity to understand and make decisions (decisional capacity)
• Freedom from coercion (voluntariness)
• Adequate quantity and quality of info

Question 3

Beneficient Parentalism and Therapeutic Privilege

Answer 3

Opposes autonomy:

• Beneficent parentalism = principle of doctor knows best and acts for the good of the patient
• Therapeutic privilege = act of physician withholding info from a patient w/ the presumption that the deception is for the good of the patient

Question 4

Informed decision-making may lead to…

Answer 4

informed consent or informed refusal

Question 5

Types of Informed Consent

Answer 5

• Implied:
  
  • Risk is minimal and a procedure is common
  • Ex. rolling up sleeve to take BP
• Verbal:
  
  • Some weighing of risks and benefits is made
  • Ex. writing a new prescription for common med
• Written:
  
  • Risk is significant
  • Practical need to document the discussion
  • An actual consent form is used
  • Ex. surgery

Question 6

Decisional Capacity

Answer 6

• Loss can be temporary (acute delirium) or permanent (advanced dementia)
• Relative to the decision that needs to be made
• Loss of capacity is common
• Loss of decisional capacity is often unrecognized by physicians
  
  • When patients agree with physician recommendations, the physician is less likely to suspect diminished decisional capacity

Question 7

Decisional Capacity vs. Mental Competency

Answer 7

• Decisional Capacity = determined by the physician, related to medical issues only, temp/permanent
• Mental Competency = determined by a judge, refers to ability to reason, make decisions, stand trial and manage life affairs

Question 8

How to determine capacity

Answer 8

• The patient demonstrates understanding of the information.
• The patient uses reasoning to reach a decision.
• The patient makes a choice and communicates that choice.
• The decision is consistent with the patient’s known values and goals.

If the patient lacks decision-making capacity, then a substitute decision-maker is identified.

Question 9

Disclosure for Informed Constent

Answer 9

Informed decision-making requires that specific informational elements be provided.

Historically these included:

a) Diagnosis

b) Nature of the treatment

c) Purpose of the treatment

d) Risks and their consequences

e) Benefits of the treatment

f) Treatment alternatives

g) Probability of success

h) Prognosis if therapy is foregone

Even if your patient doesn’t ask about an informational element, you must still provide it.

You are not required to give pt info that they say they do not want.

Question 10

Disclosure Standards

Answer 10

How detailed should you be in the disclosure?

Reasonable patient standard – how much information a reasonable patient would want to know

Professional standard – how much information would another physician in your community disclose

Individual (subjective) – how much does this particular patient want or need to know

Question 11

Exceptions to Informed Consent

Answer 11

• Emergency
• Govt/court mandated tx
• Therapeutic privilege **highly controversial

Question 12

Informed Consent in Children

Answer 12

• Children cannot give informed consent → children assent and parents give permission
  
  • Assent = when a child who lacks either DC or decisional authority agrees to go along w/ the proposed medical intervention
  • Permission: an individual who has decisional authority for another person decides to accept a proposed medical intervention for another person
• Mature minor rule (ethical rule): a child > 14 y/o may be mature enough to consent and refuse medical tx just as an adult
• Limits of parental refusal of treatment: society is willing to step in and override parental authority, via child protective agencies, only when parental decisions involve abuse or neglect, including medical neglect

Question 13

Medical Mistake

Types

Answer 13

• Adverse Event: Harm resulting from the process of medical care rather than from disease
  
  • Serious Error: Results in death or compromised patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient
  • Minor Error: Error that causes some temporary harm that resolves w/o additional tx
• Near Miss: Medical error that did not lead to AE

Question 14

Disclosure of Error

Answer 14

A patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment.

In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred.

Ethical justification includes:

a. Autonomy – Information about your body, your health and your medical care should be under your control as the person who is ultimately in charge of your life.
b. Beneficence – Disclosure may relieve suffering caused by confusion and doubt about what happened. It may also provide a means for the individual who has been harmed to receive an apology or compensation.
c. Non-maleficence – Disclosure, along with peer and administrative review, is the starting point for reviewing flaws in the system and fixing them. The argument that disclosure only upsets the patient and itself causes harm is weak – generally the motivation behind hiding the truth is protecting the physician, not the patient.
d. Justice – Disclosure empowers the vulnerable. All patients are vulnerable, and members of socially vulnerable groups are poorly resourced to advocate for themselves and bear the burden of injury.
e. Duty to maintain trust – physicians’ fiduciary responsibility. Trust is impossible without honesty and transparency.

Question 15

Apology

Answer 15

Risk of being sued is cut in half when an apology is offered as soon as the mistake is realized.

Every real apology must have 4 components:

1. Acknowledgement of what happened – clear admission of error
2. Explanation of how it happened – not as an excuse but provides context
3. Expression of true remorse – one is truly distressed about what happened
4. Reparation – Making amends within the realm of what is appropriate.

An apology heals in critical ways:

• It restores respect and dignity to the injured person
• It is an expression of caring for the person
• It restores some power to the person (who likely feels a loss of control)
• The suffering in the offender is made visible (shame, remorse, regret) – the injured party needs to know that the offending person is distressed
• It validates that the offense occurred
• It designates fault to the right person and to the right extent
• It assures that both parties continue to share values (the basis of a relationship)
• It allows the victim to enter into dialogue with the offender (and actually be in relationship).
• It offers reparations – some kind of making amends
• It offers a promise for the future, of changing things so that it doesn’t happen again.

Question 16

Second Victim

Answer 16

Health care providers involved in an unanticipated adverse patient event, medical error or patient related injury and become victimized in the sense that the provider is traumatized by the event.

Frequently, second victims:

• Feel personally responsible for the unexpected patient outcomes
• Feel as though they have failed the patient
• Second-guess their clinical skills
• Second-guess their knowledge base

Question 17

Maladaptive Responses to Having Made a Mistake

Answer 17

Psychological stress & cultural attitudes leads to maladaptive responses, including:

• Denial and forgetting
• Reframing mistakes as non-mistakes
• Suppression of information
• Emotional withdrawal from colleagues or patients
• Blaming the system, the disease, or the patient

Question 18

Medical Malpractice

Answer 18

Civil law, not criminal law

The tort of negligence has 4 elements:

1. Duty: (that arises from the physician-patient relationship)

• Did the physician exercise independent judgment on the patient’s behalf, and
• Did the patient reasonably rely on the physician’s advice, or
• Did the physician’s actions create in the patient a reasonable expectation of care?

2. Breach of the Duty: Did the physician exercise the skill, diligence and judgment as would be exercised by a reasonable physician under the same or similar circumstances?
3. Causation: Was the breach of the duty the proximate cause of the patient’s damages?
4. Damages: Is the bad outcome compensable in monetary damages?

The plaintiff must prove all four elements (A-D) before the defendant (the physician) incurs legal liability for a negligent act or failure to act.

Occasionally a plaintiff is also awarded punitive damages, which are damages awarded as punishment for willful harm and/or gross negligence on the part of the defendant.

Question 19

Disability Paradox

Answer 19

Patients with chronic illness or disability report a significantly greater QOL than predicted or assumed by healthy people.

Question 20

Projection Bias

Answer 20

• Our present circumstances bias our perception of the future
• Current pain or misery effects view of the future – this can even fluctuate hour by hour.
• Patients experiencing greater suffering are more likely to perceive themselves as having a poorer, future, quality of life

Question 21

Focusing Illusion

Answer 21

Tendency to focus on all the things that would change in a negative way, rather than all the things that are satisfactory that would not change in one’s life.

Question 22

Imminence of Death

Answer 22

Patients not currently facing death consider themselves less willing to undergo future, grueling treatments to extend life compared to patients who are currently facing death.

Question 23

Framing

Answer 23

Patients are much less likely to choose an option when it is framed for them in a negative way as opposed to a positive way.

Question 24

Medical Futility

Answer 24

• Strict definition of medical futility.
  
  • Refers to physiological futility
  • A physician should not provide a treatment that meets this criterion.
  • This includes any of the following:

1. There is no physiologic rationale to the treatment
2. The treatment has already failed in the patient
3. A patient is in multi-organ system failure and actively dying

• Loose definitions of medical futility. “Normative Futility”
  
  • Involve subjective quality of life judgments
  • Treatment has physiologic effect but is believed to have insufficient clinical benefit
  • Quantitative Futility – likelihood of the benefit of the intervention is “exceedingly low.”
  • Qualitative Futility – quality of the benefit of the intervention is “exceedingly poor.”

Question 25

Karen Quinlan

Case

Answer 25

• Parents wanted her off ventilator, hospital didn’t want to commit murder
• KEY: court says take off ventilator ⇒ Right to Privacy
  
  • Extends to a person’s right to accept or refuse medical treatment
  • Balance State’s duty to preserve life with individual’s right to privacy

Question 26

Nancy Cruzan

Case

Answer 26

• Family wanted feeding tube removed
• KEY: Withdrawal of artificial feeding / hydration
• Balance the State’s duty to preserve life with the liberty interest of the individual
  
  • Competent persons have a liberty interest to refuse medical treatment.
  • States may require such a refusal to be proven by clear and convincing standard of evidence.
• Right to refuse treatment survives loss of decisional capacity.
• Endorsed advanced directives but states can regulate.

Question 27

Terri Schindler-Schiavo

Case

Answer 27

• Coma, no advanced directive
• Husband wanted discontinuation; her parents contested this
• KEY: courts favored husband
  
  • Affirmed Surrogate Decision-Making
  • Interference of the State in medical decision-making

Question 28

Physician Aid In Dying

Answer 28

• Assisted Suicide
  
  • Physician provides a lethal prescription, and patient self-administers medication
  • Constitution neither guarantees nor prohibits it, so it is up to each state to decide
• Euthanasia
  
  • Physician administers a lethal medication
  • Euthanasia is prohibited
  • ? If withdrawal of life sustaining treatment = passive euthanasia,
• Also extends to providing intensive comfort measures when a patient voluntarily ceases eating and drinking (VSED)
• Also terminal sedation, sedating a patient when extreme conscious suffering cannot be relieved in any other way

Question 29

Brain Death

Answer 29

Brain death = the irreversible end of all brain and brainstem activity (including involuntary activity necessary to sustain life)

In US medicine, brain death means clinical death.

Question 30

Dead Donor Rule

Answer 30

Ethical principle prohibiting homicide in order to harvest an organ from a dead donor.

Withdrawal of life support only for the sake of harvesting an organ for transplantation is considered homicide.

Question 31

Donation after Brain Death

Answer 31

• Diagnosis of brain death is made
• Brain death = clinical death
• The body may be maintained on “life support” until organs are harvested
• Patient became a non-living organ donor
• No conflict with the Dead Donor Rule

Question 32

Donation after Cardiac Death

Answer 32

• Decision is made to withdraw life support and allow a patient to die
• Patient becomes a non-living organ donor
• When spontaneous circulation of the blood stops, the patient is declared dead
• The organ is then harvested immediately

Question 33

Advance Directives

Answer 33

• Substitute decision-maker
  
  • Healthcare Agent or Healthcare Proxy w/ legal power called durable healthcare power of attorney
  • Patient incapacitated and unable to direct her or his own care
  • Can be temporary or permanent
  • Agent can make medical decisions under any circumstance that the patient does not have the capacity to do so
• Living Will
  
  • Person expresses wishes about how medical decisions are to be made in the event that the person loses decisional capacity
  • In PA, the living will becomes activated ONLY in the circumstance that the patient is either terminally ill or permanently unconscious

Question 34

Substitute Decision-Maker

Answer 34

• Patient loses decisional capacity but has not appointed a healthcare agent
• A substitute decision-maker is designated by law
• Called a health care representative (or healthcare surrogate)
• In PA law, there is a _statutory list that gives priority in the following orde_r:

1. Spouse and adult child who is not the child of the spouse
2. Adult child(ren)
3. Parent(s)
4. Adult sibling(s)
5. Adult grandchild(ren)
6. Close friend
7. Court-appointed guardian

Question 35

Standards of Substitute Decision-Making

Answer 35

Substituted Judgment Standard – patient’s wishes are known to the substitute decision maker

Best Interests Standard – patient’s wishes are unknown, and the decision-maker determines the option most similarly situated patients would choose

Question 36

AD vs DNR vs POLST

Answer 36

The three different documents that direct end-of-life decision-making: