Decision Making and Informed Consent 8-25-14

Question 1

What entails medical decision making for physicians?

Answer 1

Similar to other decision-making, but more complex:

Knowledge and Understanding
- Acquired in medical school, but constantly evolving

Experience
- What happens when we apply knowledge in clinical situations?

Values and culture

Paradigms

Algorithms and reasoning

Clinical practice guidelines (CPG)
- Usually derived from evidence-based studies and consensus of experts

Question 2

What is decisional conflict?

Answer 2

The concurrent opposing tendencies within a person to accept and decline an option

Question 3

Do physicians and patients feel decisional conflict?

Answer 3

Physicians often feel decisional conflict
- 40-50% of healthcare interventions have “insufficient evidence of usefulness”

Large surveys of patients show that 50-60% of patients express uncertainty (hallmark of decisional conflict) about their chosen treatment option

Some factors are non-modifiable while others are modifiable

Question 4

What are some modifiable factors in decisional conflict?

Answer 4

1 Knowledge, Understanding and Expectations
Condition, options, benefits, risks, probabilities

2 Clarity of values or priorities
Personal desirability or importance of benefits vs. harms

3 Support and resources
Advice, support, discussion with others involved in decision, personal skills, self-confidence, community resources

Question 5

What are some tools for measuring decisional conflict?

Answer 5

Tools for measuring decisional conflict usually used in studies
Decisional Conflict Scale
Can be used for both patients and providers

Ottawa Decision Support Framework
Evaluates decisional needs, decision quality, and decision support
Available at www.decisionaid.ohri.ca/decguide

A to Z inventory of decision aids
www.decisionaid.ohri.ca/AZinvent.php

Question 6

Why is informed consent important in the eyes of the law? What are the consequences?

Answer 6

BATTERY (Based on doctrine of personal freedom-1906)
Touching without consent
Harm need not be demonstrated
If consent obtained, intent to withhold or misrepresent disclosure must be demonstrated (fraud and deceit)

NEGLIGENCE (Based on Doctrine of “thoroughgoing self-determination”)
Malpractice Law (U S Case Law—1957)
Breach of Duty (Standard of Care)
Harm to the Patient
Causality

Question 7

What are the standards of informed consent?

Answer 7

Professional Standard–1957
Patient-oriented Standard–1972
Individual Patient Standard

Question 8

What are some subsets of disclosure?

Answer 8

Subsets of Disclosure
Physician Self-Disclosure
Institutional Disclosure
Role of Trainees

Question 9

What is the history of informed consent in the medical profession? When did things start to change?

Answer 9

History
Throughout most of medical history, physicians practiced paternalism and withholding of information
Hippocrates
Percival—Medical Ethics (1803)
Code of Ethics of AMA (1847)
AMA Principles of Medical Ethics (1957)

Societal trends toward greater individual decision-making (Autonomy) since 1960
Based philosophically on the importance of autonomy in moral discourse

Question 10

What are some objections to informed consent?

Answer 10

Patients are unable to understand complex medical information adequately

Patients do not want to make decisions for themselves

Patients make decisions that contradict their best interests

There are harmful effects in informing patients fully; the patient may become afraid of the best option

Informed consent takes too much time for the benefits obtained

Full disclosure interferes with a physician’s defense mechanisms

Question 11

What are the 5 elements of informed consent?

Answer 11

VOLUNTARISM
Free will with lack of coercion, unfair persuasions and inducements

CAPACITY
The patient’s ability to make and express healthcare decisions

DISCLOSURE
Nature of recommended therapy with its risks, benefits, and alternatives (with their risks and benefits), including risks and benefits of doing nothing

UNDERSTANDING

DECISION

Question 12

What tools are helpful with informed consent within the patient-physician relationship?

Answer 12

Timing

Language
- Cultural sensitivity

Mirroring

Adjunct communication methods

• Printed material
• Recorded material

Question 13

What should be established for informed consent when a patient visits a physician? (Hint: similar to ‘setting an agenda’ and f/u)

Answer 13

Agreeing on the problem to be addressed
The reason for the visit

Agreeing on the treatment goals
Setting realistic expectations
Patient values (time, finances, esthetics, culture)

Updating of information, evaluation of patient’s progress, and monitoring of expectations

Question 14

Explain the difference between persuasion and coercion.

Answer 14

Coercion
“If you don’t do this, I’ll make something terrible happen” (threat intended to control patient’s behavior)

Persuasion
“These are the reasons that I think you should do this.” (cooperation)

Question 15

What should be avoided in the physician-patient partnership? What should be there instead?

Answer 15

Paternalism (bad)
“I know what’s best for you”

Self-determination (good)
“Let me help you decide what’s best for you”

Question 16

What can informed consent do for you?

Answer 16

Good informed consent process forges a spirit of partnership and reduces the risk of litigation if complications occur

Question 17

Why is documentation important?

Answer 17

Record details

Serves as a template for discussion in subsequent office visits

Best defense in a malpractice case

Question 18

What are some limitations of informed consent?

Answer 18

Patient may not have any good choices

• Choices limited by patient’s condition, finances, or other circumstances
• Emergencies and the concept of Implied Consent

Informed consent may not be amenable to all cultures

• Patriarchal or family-centered decision-making
• Disclosure of risks may be viewed as self-fulfilling prophesy

Question 19

Reading assignment summary:

Answer 19

All options must be described
All major adverse effects must be described
Consent is required for each specific procedure
Beneficence isn’t sufficient to eliminate the need for consent
Decisions made while competent are valid when capacity is lost
Consent is implied in an emergency
The person performing the procedure should obtain consent
Telephone consent is valid
Pregnant women can refuse therapy

Question 20

Explain informed consent for a never-competent person.

Answer 20

Obtain consent through:

1. Parent or guardian
2. Health-care proxy or durable P.O.A.
   - AKA Advance Directives, made while competent. Cannot be given by a never-competent person. Also applies to living will
3. Substituted judgement
4. family member
5. courts/administrators

Question 21

What is malpractice?

Answer 21

Preventable error in care of the patient that results in harm

Question 22

What are some things that determine malpractice?

Answer 22

1. Deviations from standard of care
2. Not obtaining informed consent
   - informed refusal is as important as informed consent!

Question 23

What are the responsibilities of the patient and of the hospital in care?

Answer 23

Patients must fully inform the physician of their medical problems

Administration should apply risk management

Question 24

Should patients be informed of mistakes?

Answer 24

Yes, if it had any impact on their care.

On the flipside, if an error had no impact on care/outcomes, it isn’t strictly necessary to inform the patient.