Transcript Ethical Challenges: Lecture 8

Ethical Challenges in the NICU
Laurence B. McCullough, Ph.D.
Dalton Tomlin Chair in Medical Ethics and Health Policy
Center for Medical Ethics and Health Policy
Baylor College of Medicine
Houston, Texas
Objectives
• Identify the best interests of the child standard in
pediatric ethics
• Identify the concept of parental permission in
pediatric ethics
• Identify an algorithm for implementing clinical
judgments of futility
– Rabeneck, McCullough, Wray 1997
– McCullough, Jones 2001
• Apply this algorithm to clinical cases
Preventive Ethics
• Preventive ethics = development of policies and
practices intended to anticipate and prevent ethical
conflicts and to respond to them rapidly when they
occur
• A preventive ethics approach is better than a
reactive approach to ethical conflict, because a
preventive ethics approach should reduce the
biopsychosocial toll on patients, parents, healthcare
professional teams, and organizational culture of
ethical conflicts
Best Interests of the Child
• Pediatric healthcare professionals have an ethical
obligation to protect the health-related interests of
children who are patients
– This is a beneficence-based ethical standard and is the
foundational standard for pediatric ethics
– Beneficence is an ethical principle that obligates clinicians
to seek a greater balance of clinical goods over clinical
harms in the outcomes of patient care
Parental Permission
• Parents are ethically obligated to protect and
promote the interests of their children, including a
child’s health-related interests
• The primary ethical relationship between a parent
and a child who is a patient is that of ethical
obligation to protect and promote the health-related
interests of their child who is a patient
• Parents are therefore asked for permission rather
than consent
– American Academy of Pediatrics 1995
Ethical Challenges -1
• Default position of resuscitation of patients without
DNR orders
– Resulted from application of CPR to sicker and sicker
patients without attention to outcomes and whether they
were being improved by resuscitation
– Blurred distinction between technically possible and
medically reasonable
• Technically possible = personnel, medications, and machines
available to perform an intervention
• Medically reasonable = best available evidence supports
clinical judgment that intervention will result in acceptable
outcome
Ethical Challenges -2
• Acceptable outcome can be defined from a clinical
perspective
– Prevents imminent death
– Accomplishes usually expected physiological outcome
– Preserves at least some functional status and therefore
interactive capacity
– Prevents unnecessary pain, distress, and suffering, both
disease-related and iatrogenic
• Pain, distress, and suffering are unnecessary when they are
not required as iatrogenic cost of achieving above goals and
when they cannot be managed to an acceptable level
Ethical Challenges -3
• Acceptable outcome can be defined from the
patient’s perspective
– Quality of life = ability to engage in life tasks and derive
satisfaction from doing so
– Resulting functional status allows patient to engage in
valued life tasks and derive sufficient satisfaction from
doing so
– Risk of erroneous external evaluation of patient’s quality of
life by health care professionals
• QoL judgments must be made by patient or on basis of reliable
account of patient’s valued life tasks and whether predicted
functional status supports those life tasks
Ethical Challenges -4
• QoL judgments have no applicability in neonatal
critical care
– Clinical application of the concept of quality of life requires
psychosocial capacity of the patient to have life tasks and to
have values on the basis of which having and engaging in
those life tasks has value for oneself and infants lack such
psychosocial capacity
– Patients with unknown values history have had such
capacity but we do not have a reliable account of how they
exercised it
• Focus for neonatal patients should be on whether a
clinically acceptable outcome is reliably expected
– Based on the best interests of the child standard: An
outcome that preserves interactive capacity and therefore
the capacity for later having whatever quality of life the
individual chooses
Ethical Challenges -5
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•
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Recognize that resuscitation is often the initial step of critical care
management of a seriously ill patient’s condition
Recognize that high-risk surgery and other invasive clinical
management is often the initial step of critical care management of a
seriously ill patient’s condition
Recognize that critical care intervention is now understood to be trial
of management
– Ethical obligation to initiate or continue a trial of intervention ends when
there is no reasonable expectation of achieving the intervention’s goals
– Consistent with best interests of the child standard
Two Goals of Critical Care
• Neonatal critical care has both a short-term goal and
a long-term goal
– Short-term goal: prevent imminent death
– Long-term goal: survival with an acceptable functional
status
• Understood from a clinical perspective
• Understood from the patient’s perspective
Invoking Futility to Set Ethically
Justified Limits on Critical Care -1
• Does the patient have a terminal condition or an irreversible
condition as defined in applicable law or policy (VHA), in the
clinical judgment of the patient’s attending physician?
– Terminal condition: “An incurable condition caused by injury,
disease, or illness that, according to reasonable medical judgment,
will produce death within six months, even with available lifesustaining treatment provided in accordance with the prevailing
standard of medical care” (TADA 1999)
– Irreversible condition: “a condition, injury or illness
• that may be treated but is never cured or eliminated
• that leaves a person unable to care for or make decisions for the
person’s own self; and
• that, without life-sustaining treatment provided in accordance with the
prevailing standard of medical care, is fatal” (TADA 1999)
– Alternative of discontinuing life-sustaining treatment is consistent
with best interests standard should be offered
Invoking Futility to Set Ethically
Justified Limits on Critical Care -2
• Does best available evidence support reliable clinical
judgment that there is no reasonable expectation of
achieving intended physiologic outcome of
intervention?
– Specify outcome precisely
• For example: Outcome of resuscitation = restoration of
spontaneous circulation
• For example: Outcome of mechanical ventilation =
maintenance of adequate levels of oxygenation
– Distinguish clearly specified physiologic outcome from
physiologic effect (e.g., transient heart beat during
resuscitation)
Invoking Futility to Set Ethically
Justified Limits on Critical Care -3
• Does best available evidence support reliable clinical
judgment that there is no reasonable expectation of
achieving intended physiologic outcome of
intervention?
– If yes, ethical obligation to continue intervention ends,
because of physiologic futility
• Because physiologic futility of a critical care intervention
means that imminent death cannot be prevented, there is no
reasonable expectation that the short-term goal and, therefore,
the long-term goal of continued critical care intervention can
be achieved
• Best interests of the child standard does not support
continued treatment
• Request permission to withhold/discontinue intervention
– If no, continue critical care intervention and ask the
following:
Invoking Futility to Set Ethically
Justified Limits on Critical Care -4
• Does best available evidence support reliable clinical
judgment that intervention will be physiologically
effective for a short period of time (days to weeks)
but then result in death (in the critical care unit) with
no recovery beforehand of any interactive capacity?
– If yes, ethical obligation to continue intervention ends,
because of imminent-demise futility
• There is no reasonable expectation that short-term goal and,
therefore, long-term goal of continued critical care intervention
can be achieved
• Best interests of the child standard does not support
continued treatment
• Request permission to withhold/discontinue intervention
– If no, continue critical care intervention and ask the
following:
Invoking Futility to Set Ethically
Justified Limits on Critical Care -5
• Does best available evidence support reliable clinical judgment
that intervention will be physiologically effective, prevent
imminent demise, but result in irreversible loss of interactive
capacity?
– If yes, ethical obligation to continue intervention ends, because of
clinical or overall futility
• There is a reasonable expectation that the short-term goal can be
achieved
• There is no reasonable expectation that the long-term goal of critical
care intervention can be achieved because of unacceptable outcome
from clinical perspective
• Best interests of the child standard does not support continued
treatment
• Request permission to withhold/discontinue intervention
– If no, continue critical care as a trial of intervention, attentive to
trends toward one or more of these three specifications of futility
applying
Professional Integrity
• Professional virtue of integrity is at stake in these cases
– Practice, conduct research, and teach medicine, nursing, and other
healthcare professions to standards of intellectual and moral
excellence
• Intellectual excellence: commit to the to discipline of evidence-based
reasoning about expected clinical benefit of treatment in clinical
judgment, decision making, and behavior and in communication with
patients/surrogates
• Moral excellence: commit to the protection and promotion of the
patient’s health-related and other interests as one’s primary concern
and motivation
• Both combine to create an ethical obligation to prevent over-treatment
at the end of life and to recommend against over-treatment
– Professional integrity has been recognized as bedrock
consideration in all end-of-life court cases, starting with In re
Quinlan, 1976 NJ Supreme Court
Texas Advance Directives Act:
Section 166.046
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Attending physician is free to refuse to implement a medically
inappropriate directive or treatment decision
– Anyone can request an ethics consult (a separate matter)
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Mandatory review of such refusal by medical or ethics committee, with
required notice to patient or surrogate
If committee disagrees, life-sustaining treatment continues
If committee agrees, life-sustaining treatment may be discontinued
after 10 days
Reasonable effort to transfer to other physician or other healthcare
facility
– Transfer costs are responsibility of patient
– If re-admitted within six months, previous decision applies if attending and
another physician on medical or ethics committee agree that patient’s
condition has not improved or deteriorated
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Life-sustaining treatment to continue for 10 days, after which it may be
discontinued, with grant of immunity from civil and criminal liability
References
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American Academy of Pediatrics, Committee on Bioethics. Informed
consent, parental permission, and assent in pediatric practice. Pediatrics
1995; 95: 314-317.
Rabeneck L, McCullough LB, Wray NP. Ethically justified, clinically
comprehensive guidelines for percutaneous endoscopic gastrostomy tube
placement. The Lancet 1997; 349: 496-498.
McCullough LB, Jones JW. Postoperative futility: a clinical algorithm for
setting limits. Brit J Surg 2001; 88: 1153-1154.
Texas Advance Directives Act. Texas Health and Safety Code Chapter
166. Available at
http://www.statutes.legis.state.tx.us/SOTWDocs/HS/pdf/HS.166.pdf,
accessed August 15, 2011.
Ethical Challenges in the NICU
Laurence B. McCullough, Ph.D.
Dalton Tomlin Chair in Medical Ethics and Health Policy
Center for Medical Ethics and Health Policy
Baylor College of Medicine
Houston, Texas