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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

2 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

3 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

4 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

5 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

6 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

7 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

8 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

9 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

10 Ethical Challenges -5 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

11 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

12 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 life- sustaining 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

13 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)

14 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:

15 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:

16 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

17 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

18 Texas Advance Directives Act: Section Attending physician is free to refuse to implement a medically inappropriate directive or treatment decision –Anyone can request an ethics consult (a separate matter) 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 Life-sustaining treatment to continue for 10 days, after which it may be discontinued, with grant of immunity from civil and criminal liability

19 References American Academy of Pediatrics, Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 1995; 95: Rabeneck L, McCullough LB, Wray NP. Ethically justified, clinically comprehensive guidelines for percutaneous endoscopic gastrostomy tube placement. The Lancet 1997; 349: McCullough LB, Jones JW. Postoperative futility: a clinical algorithm for setting limits. Brit J Surg 2001; 88: Texas Advance Directives Act. Texas Health and Safety Code Chapter 166. Available at accessed August 15,

20 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


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