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Ethical Dilemmas in the

Emergency Department: The


Challenge of “Informed Consent”

Joshua M. Kosowsky, MD
Clinical Director, Department of Emergency Medicine, BWH
Assistant Professor, Harvard Medical School
Case I
• 75 yo woman with diabetes and PVD is
admitted with a gangrenous ulcer on her
left foot
• Below the knee amputation is
recommended
• Patient declines the procedure; she
wants to die with her body intact
• Her internist of 15 years is concerned
about her competence to make this
decision
Case II
• 60 year-old, primarily Spanish-speaking
man with 2 days of intermittent chest
tightness and “dizziness” occurring at rest
• High cholesterol; smoker
• Mother just died – funeral is in Chile
tomorrow.
• ECG is normal – patient would like to sign
out AMA
Informed consent

• “Physicians are required by law


and medical ethics to obtain
informed consent of patients
before initiating treatment.”

– N Eng J Med 2000;357:1834-40


The Importance of
Informed Consent
• Informed consent fosters
fundamental moral values of
patient well-being and autonomy
• Informed consent allows patients
to choose among treatment
options based on their personal
values and desires
Definitions

• Competence” refers to legal


judgments and “capacity” to clinical
ones
• In practice resorting to judicial
review in every case of suspected
impairment of capacity is not
practical
Epidemiology

• In one study, as many as 48% of


inpatients lacked capacity to
consent to medical treatment
• Only one-quarter of these patients
were identified by the clinical team
as being impaired
• No good data on ED population
Populations in which capacity is
often impaired
• Dementia
• Stroke
• Psychiatric illness
• Substance abuse
• Any critical condition
Essential Features of
Informed Consent

• Patient must posses decision-


making capacity
• Patient must be given sufficient
information to make an informed
decision
• Patient must be free to make a
decision, without coercion/duress
Exceptions to the
Consent Requirement
• Emergency privilege
– Patient lacks decision-making capacity
(and no surrogate available)
– Serious risk / time is of the essence
• Treatment mandated to protect the
public health
• Therapeutic privilege
The Clinical Problem
• Informed consent is premised on
disclosure of information to a patient
with capacity
• When patients lack capacity, substitute
decision makers must be sought
• The goal is to strike a critical balance
between respect for autonomy and
protecting patients with cognitive
impairment
Determining if Impairment
Constitutes Incompetence
• The level of impairment that renders a
patient incompetent should reflect a
social judgment regarding the balance
between autonomy and protecting a pt
from the consequences of a bad
decision
• The stringency of the assessment
should vary with the seriousness of the
likely consequences
Approaches to Assessment
• Capacity assessment is an implicit part
of every physician-patient interaction
• When an explicit evaluation is required,
ideally a structured approach to
assessment should be followed
• A determination of capacity should
ideally be deferred until at least two
evaluations have been performed at
different times
• Explicit consent for the assessment is
not required
Consequences of
Finding Lack of Capacity
• Efforts should be made to identify the causes
of the impairment and remedy them
• If this is not possible, a substituted decision
maker must be sought
– State statutes determine priority order of family
members, in general the order is: spouse, adult
children, parents, siblings, other relatives
• In emergencies physicians can provide
appropriate care under the presumption that a
reasonable person would have consented to
such treatment
Criteria for Assessment of
Decision-Making Capacity
• Legal standards for decision-
making capacity generally embody
four criterion
– Ability to communicate a choice
– Ability to understand relevant
information
– Ability to appreciate the medical
consequences of the situation
– Ability to reason about tx choices
The Foundations of
Decision-Making Capacity
• The ability to comprehend information
and appreciate consequences
• The ability to evaluate, compare risks
and benefits, and make a rational,
consistent choice
• The ability to communicate that
choice coherently
Factors for Assessing Decision-
Making Capacity in the ED
• Presence of basic mental functioning (awareness,
orientation, memory, attention)
• Presence of conditions that might be expected to
impair mental function
• Understanding of treatment-related information
• Appreciation of the significance of the information
to the situation
• Reasoning about treatment alternatives in light of
goals and values
• Complexity of the decision-making task
• Risks relating to the decision
Informed Consent the ED: Unique
Challenges
• Patients may not have chosen to be there
– transported by others or came as a last resort
• No prior relationship with patients & families
• Stressful environment, lack of privacy
• Often imperfect information with regard to
diagnosis, prognosis, treatment options
– Is there decision-making capacity?
– Is there serious risk?
Difficulties in Determining
Capacity in the ED
• Physicians are often making decisions about
capacity based on limited information
• Without patient cooperation it can be
difficult to gather more information about
cognitive functioning
• The physician needs to weigh the risks and
benefits of the patient’s refusal
• A higher threshold for capacity is justified
when a patient’s decision poses substantial
risk of harm without significant benefits
Difficulties in Determining
Capacity in the ED
• Physicians should not equate the presence
of an impairing condition (e.g., intoxication)
with a lack of decision making capacity
– The physician must assess the patient’s actual cognitive
functioning
• Possession of basic abilities assessed by a
mini-mental status exam does not imply
capacity to make a particular treatment
decision
– Patients may have the capacity to make simple treatment
decisions, but not more complex decisions
Common Refusal of Care
Scenarios in the ED
• “Irrational patient”
– Mental illness, substance abuse,
advanced dementia, other neurologic
disability
• “Irrational choice”
– Unrealistic attitudes toward risk
– Unfounded fears about procedures
Refusal of Care does not
Terminate Responsibility
• Offer reasonable best alternatives
• Inform about the anticipated
consequences of refusal and what to
do in the event they occur
• Allow for opportunity to reconsider
decision and seek treatment without
prejudice
Other Consent
Challenges in the ED
• Allowing residents to perform invasive procedures
on newly dead patients
– Interest in helping residents master essential skills for the
sake of future patients
– Importance of receiving the family’s consent
• Caring for federal and state prisoners
– US Supreme Court: prisoners “retain those rights that are
not inconsistent with [their] status as a prisoner or with the
legitimate penological objectives of the corrections system.”
• Treating criminal suspects in police custody
– Weighing professional obligation to do no harm against
assisting law enforcement with the collection of evidence
Case Resolution
• Patient advised that observation and
monitoring with serial EKG’s and laboratory
testing was indicated to ascertain that he
wasn’t at imminent risk of a heart attack
• Patient very much wanted to see his wife
off at the airport before she left to Chile for
two weeks
• Not eager to have his wife know that he
was in the ED
Case Resolution (cont.)
• Decision-making capacity felt to be
adequate
– Rational patient
– Rational decision
• Discussed potential consequences of
unrecognized and untreated heart attack
• Advised to call 911 if chest discomfort
recurred, and to return to ED or follow up
with PCP as soon as possible to complete
evaluation
Derse AR, What part of “no” don’t you
understand? Patient refusal of
recommended treatment in the
emergency department. Mt Sinai J
Med 2005;72:221-227.

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