EXPERIENCE AND REASON—Briefly Recorded
‘‘In Medicine one must pay attention not to plausible theorizing but to experience and reason together. . . . I agree that theorizing is to be approved, provided that it is based on facts, and systematically makes its deductions from what is observed. . . . But conclusions drawn from unaided reason can hardly be serviceable; only those drawn from observed fact.’’ Hippocrates: Precepts. (Short communications of factual material are published here. Comments and criticisms appear as letters to the Editor.)
Medical Futility in the Neonatal Intensive Care Unit:
Hope for a Resolution
Robert L. Fine, MD*‡; Jonathan M. Whitfield, MBChB§; Barbara L. Carr, MD§; and Thomas W. Mayo, JD*¶
ABSTRACT. Contemporary medical practice in the NICU sometimes leads to conflicts between providers and parents in which the parent demands continuation of life-sustaining treatment that the medical team deems medically inappropriate or futile. Such conflicts can be difficult to resolve and trying for all parties. Here we describe a conflict involving a 25-week-gestation, 825-g newborn with multiple intractable medical problems and resolution of the conflict through ethics consultation under provisions of the Texas Advance Directives Act. The process established under Texas law sets conceptual and temporal boundaries around the problem of medical futility and provides a legal safe harbor for physicians who seek to withdraw life-sustaining treatments in the setting of medical futility, allowing resolution of such conflicts in a timely and effective manner. As such, it may provide a model for physicians in other states to follow.Pediatrics2005;116:1219–1222;conflict resolution, end of life, ethics, intensive care, futility.
ABBREVIATIONS. AAP, American Academy of Pediatrics; CPR, cardiopulmonary resuscitation; DOL, day of life.
I
t has been said that we practice medicine in an age of miracles and wonders. This is easy to see in the world of the NICU. Yet, despite the many successes, there are also failures, and contemporary neonatology may be either a blessing or a curse. It is not always clear to either the neonatologist or the patient’s family when life-sustaining treatment should be maintained or withdrawn.The American Academy of Pediatrics (AAP) Com-mittee on Bioethics supports the notion of shared decisions between the treatment team and the family when making choices for critically ill newborns and follows a “best-interests-of-the-child” ethical
stan-dard.1 However, what is in the best interest of the
child is often debatable. There are times when good families and good physicians disagree about the ap-propriateness of continuing or stopping life-sustain-ing treatments. The AAP notes that parents may wish to forgo life-sustaining treatment that the phy-sician feels should be maintained, with the parents often arguing that their child has a “right to die.” In those circumstances it is recommended that the par-ties try to resolve their disagreements with the help of ethics committees or consultants, and if that fails, the physician may “invoke established child protec-tive mechanisms.”
However, what if physicians believe that life-sus-taining treatment should be stopped, but the parents of the child demand that such treatment continue? In such cases, the neonatal team has concluded that treatment beyond that needed for comfort is “futile,” because it is either merely prolonging dying or yield-ing a dismally poor quality of life. The AAP is rela-tively silent on this “futility” scenario, perhaps be-cause it is an area so fraught with not only medical and ethical uncertainty but legal uncertainty as well. In this brief report, we describe the application of the first legislatively approved extrajudicial due-process mechanism for resolving disputes over end-of-life treatment, in particular, disputes over medically fu-tile treatment.
CASE REPORT
Baby Isaac was an 825-g male infant delivered at 25 weeks’ gestation to a 14-year-old gravida-1 female. The pregnancy was complicated by a chlamydial infection that was treated with eryth-romycin. The mother presented from school fully dilated, and the infant was delivered in the emergency department of a commu-nity hospital. Delivery was complicated by footling breech pre-sentation. The breech extraction was difficult and resulted in mandibular fracture as well as head and neck lacerations. Cardio-pulmonary resuscitation (CPR) was required after delivery, and Apgar scores were 0, 1, and 3 at 1, 5, and 10 minutes, respectively. After stabilization, the infant was transferred to Baylor University Medical Center’s level 3 NICU for additional care.
After an initial course of respiratory distress syndrome compli-cated by pulmonary interstitial emphysema managed with high-frequency ventilation, Isaac developed severe chronic lung dis-ease. He was never successfully weaned from mechanical ventilation. Bilateral grade 3 intraventricular hemorrhages were documented by cranial ultrasound in the first week of life. He subsequently developed severe progressive posthemorrhagic hy-drocephalus. His hospital course was also complicated by multi-From the *Office of Clinical Ethics, Baylor Health Care System, Dallas,
Texas; ‡Department of Internal Medicine and §Division of Neonatology, Department of Pediatrics, Baylor University Medical Center, Dallas, Texas; and ¶Southern Methodist University, Dedman School of Law, Dallas, Texas.
Accepted for publication Mar 2, 2005. doi:10.1542/peds.2004-2790 No conflict of interest declared.
Address correspondence to Robert L. Fine, MD, 3434 Swiss Ave, Suite 205, Dallas, TX 75204. E-mail: robertf@baylorhealth.edu
ple episodes of bacterial sepsis, a patent ductus arteriosus treated with Indocin, and hyperbilirubinemia.
On day of life (DOL) 21, he developed abdominal distention, and abdominal radiographs revealed pneumatosis intestinalis consistent with necrotizing enterocolitis. He was taken for an exploratory laparotomy on DOL 24, and 3 cm of bowel was removed. The medical team met with the family on DOL 35 and discussed the ongoing infection, worsening chronic lung disease, intestinal problems, and progressive hydrocephalus. The family wished to continue all treatments.
Because of persistent bacteremia, coagulopathy, and concern for development of an abdominal abscess, Isaac was taken to surgery again 14 days later. The bowel was felt to be nonviable, and the surgeon closed the abdomen without removing any ad-ditional bowel. The family was apprised of the infant’s condition and lack of any chance of long-term survival, but they refused to remove life support postoperatively as recommended by the care team.
The infant continued on intravenous nutrition, antibiotics, and narcotics. Cultures obtained intraoperatively grew Candida albi-cans,and antifungal therapy was added. Isaac had an ongoing coagulopathy requiring frequent platelet and fresh frozen plasma transfusions. He was treated for pain with narcotics. The medical team met with the infant’s family again 5 days postoperatively (DOL 43). His critical condition and lack of chance for survival were reiterated, and withdrawal of care was again recommended. The family continued to refuse consent for withdrawal of life-sustaining treatment other than consenting to a “do-not-resusci-tate” status.
Must the treatment team continue treatment that in their judg-ment is futile until there is a final circulatory collapse?
DISCUSSION
The problem of medical futility is as old as medi-cine itself, although not always specifically articu-lated by that name. Although the ancient Hippo-cratic physicians noted that “[d]readful diseases demand dreadful remedies,”2 they also observed
that physicians should “refuse to treat those over-mastered by their illness.”3The Hippocratic tradition
was clearly paternalistic and expected that physi-cians alone would decide when treatments should be given or withheld.
In the contemporary era, controversy exists about the idea that physicians should unilaterally decide when a patient is overmastered by illness and that life-sustaining treatment should be stopped. At a minimum, given the powers of contemporary medi-cal technology, it can be difficult to determine when additional treatment is “futile” because the patient is overmastered by illness. Indeed, there has been a good deal of controversy over the definition of futil-ity itself and how the profession should face it when it arises.
Writing in theJournal of the American Medical Asso-ciationin 1993, Lundberg4suggested that physicians
should define medical futility and that hospitals should develop guidelines for dealing with it. Nu-merous definitions were offered, including the con-cepts of physiologic, quantitative, and qualitative futility.5,6 Some argued that the concept was too
value-laden to be used by the medical profession alone.7Others, however, suggested that just because
the term was value-laden did not mean that it could not or should not be used by the profession. Schus-ter, for example, argued that the profession must distinguish between everything that can be done and everything that should be done.8 Lo argued that
although the concept could sometimes be justified, it
was “fraught with confusion, inconsistency and con-troversy.”9
The legal system has also provided conflicting opinions about notions of medical futility. In the 1994 Baby Kcase, familiar to many pediatricians and neo-natologists, physicians and ethics committees in Vir-ginia argued that it was “futile” to provide certain treatments such as mechanical ventilation to an anencephalic newborn. These professionals noted that such treatment “would serve no therapeutic or palliative purpose” and was “medically and ethically inappropriate.”10It was a legally complex case, most
appropriately discussed in the legal literature. How-ever, the judicial process in essence determined that the family was the final judge on the appropriateness of continuing or stopping treatment that physicians or ethics committees considered medically futile. On the other hand, in the 1995 case ofGilgunn v Massa-chusetts General Hospital, a court found in favor of the physicians who argued that CPR need not be pro-vided to a patient dying with multiple organ system failure (because such CPR was futile) even if re-quested by the patient’s family.11
As recently as July 2000, Helft et al12 seemed to
suggest that it was perhaps futile to use the concept of medical futility. They argued that “[f]utile care in hospitals is still very much an issue” but then went on to claim that it was a moot point because “doctors today are no more empowered to declare a treatment futile unilaterally than they were 15 years ago.”12
Although this statement is true in most states, the Texas Advance Directives Act13provides a
due-pro-cess mechanism that empowers physicians, at least in Texas, to limit life-sustaining treatments that are deemed futile by the medical team. The process cre-ates a legal safe harbor for practitioners and health care facilities. It has been described previously in the medical literature for physicians who work in adult medicine but may not be familiar to pediatricians and neonatologists.14The basic process described in
the law is as follows.
When there is a request for treatment (through either an advance directive or the patient’s surro-gate) that the treatment team feels is medically inap-propriate (futile), an ethics consultation may be re-quested. Under the law, the following process must occur if the treatment team and institution wish to take full advantage of the law’s safe-harbor provi-sions:
1. The family must be given written information concerning hospital policy on the ethics consulta-tion process as well as informaconsulta-tion about a state-wide referral registry maintained by the Texas Health Care Information Council.
2. The family must be given 48 hours’ notice and be invited to participate in the ethics consultation process.
3. Those involved with the ethics consultation pro-cess must provide a written report to the family detailing the findings of the ethics review process. 4. If the ethics consultation process fails to resolve the dispute, the hospital, working with the family, must try to arrange transfer to another physician
or institution that is willing to give the treatment requested by the family and refused by the cur-rent treatment team.
5. If after 10 days (measured from the time the fam-ily receives the written summary of the ethics consultation process) no such provider can be found, the hospital and physician may unilater-ally withhold or withdraw the therapy that has been determined to be futile.
6. The patient or surrogate may ask a state court judge to grant an extension of time before treat-ment is withdrawn. This extension is to be granted only if the judge determines that there is a reason-able likelihood of finding a willing provider of the disputed treatment if more time is granted. 7. If the family does not seek an extension or if the
judge fails to grant one, the disputed treatment may be unilaterally withdrawn by the treatment team with immunity from civil or criminal pros-ecution. (This is the “legal safe harbor” for physi-cians, institutions, and ethics committees, the first of its kind in the country.)
In the case of Isaac, the treatment team requested ethics consultation on DOL 46. A multidisciplinary ethics consultation team from the hospital’s larger institutional ethics committee was convened to re-view the case with all parties involved. The dismal medical facts including progressive hydrocephalus, ongoing infection, the nonfunctioning intestinal tract, and the profound lung injury substantiating the irreversible and ultimately terminal nature of Isaac’s condition were confirmed.
Next, several meetings occurred between the eth-ics team and Isaac’s mother and maternal grandpar-ents. The biological father resided in another state, was not married to the mother, and by mutual agree-ment with the mother was not involved. Additional family history was obtained that revealed that a rel-ative who had been thought not to be able to survive as an infant was now “normal.” This made the family believe that Isaac could also survive to a normal childhood. In addition, the mother and her parents were Pentecostals and persons of great religious faith. They had been praying constantly for God to “make a miracle.” Isaac’s grandmother reported that she had a vision in her dreams of Isaac sitting in the lap of Jesus in heaven. Both the grandmother and mother interpreted this dream as meaning that the doctors should continue all treatments because “Jesus wants to make Isaac well.”
An alternative interpretation of the dream was gently offered, suggesting that perhaps Jesus was calling Isaac home to heaven, that it was time to “let go and let God,” and that the doctors were actually interfering with God’s plans for Isaac. Despite these conversations and others emphasizing the suffering of Isaac, necessitating continuous palliative sedation, the mother and grandparents indicated that they could never make the decision to withdraw life-sus-taining treatment from Isaac.
The ethics team explained to the mother and grandparents the fact that under Texas law, the phy-sicians and hospital were not required to provide
treatment that the physicians and ethics committee deemed to be futile. The team further explained the process for resolving disagreements under Texas law, including the right to receive a written report from the ethics committee and the right to search for an alternative willing provider of the disputed treat-ment for up to 10 days. The family declined the written report but did wish to seek transfer to an-other facility as outlined in the law. The treatment team assisted the family in obtaining a second opin-ion from several other neonatology groups and hos-pitals. Those other neonatologists confirmed the fu-tile nature of ongoing treatment and refused to accept Isaac in transfer.
At this point, Isaac’s mother and grandparents indicated that they would not seek a court order to further extend treatment while searching for other potential willing providers of life-sustaining treat-ment. In fact, they ultimately revealed not only ac-ceptance that it was time to stop life-sustaining treat-ment but also a sense of relief. Members of the ethics consultation team sensed that the family was re-lieved because they had “put up the good fight” to keep Isaac alive, but now the decision was out of their hands. They did not have to consent so much as simply refuse to seek court intervention. One day later, DOL 54, 8 days after the initial consult and 4 days after the first meeting between the family and the ethics consultation team, life-sustaining treat-ment was withdrawn and Isaac died peacefully as his mother held him in her arms.
The resolution of the futility dispute between Isaac’s mother, grandparents, and the treatment team was not surprising. Before this legislatively sanctioned due-process mechanism existed, the eth-ics committee was frequently consulted in cases of explicit medical futility. By this we mean cases in which the treatment team had come to the conclu-sion that ongoing life-sustaining treatment of criti-cally ill patients was futile and had been unable to persuade the relevant surrogates or family to consent to withdrawal of such treatment. In ⬃80% of such cases, the ethics consultants were able to persuade families to agree to withdrawal of life-sustaining therapies, typically within days to weeks of consul-tation. However, in the other 20% of cases, families insisted on continued life-sustaining treatment, and physicians complied, being unwilling to subject themselves to legal jeopardy by overruling the fam-ily/surrogate.
This process has been used extensively in our in-stitution, primarily in the adult care setting, and less commonly in the NICU or pediatric setting. It is worth considering possible distinctions between adult and neonatal/pediatric medicine in the appli-cation of this process. Medical futility may have both physiologic and qualitative components, often inter-twined with each other. A treatment that cannot achieve its physiologic purpose or goal is considered “physiologically futile,” whereas a treatment that cannot meet a qualitative goal is said to be “qualita-tively futile.” We consider qualitative futility to be much more value-laden.
patients are often knowable through their prior state-ments, advance directives, or evidence of how they lived their life. Clinical ethicists working with adult incompetent patients often refer to making the deci-sion that the patients would make for themselves.
This is not possible in the neonatal world or in most pediatric cases. In these circumstances, ethical decisions are normally based on the “best interest” of the child. This concept then raises the question of who is most appropriate to make such a judgment about best interests. Is it the parents, the bedside physician, or perhaps a multidisciplinary ethics con-sultation service? Is the best interest of the child determined by the parent’s value system or the in-stitutional value system? In adult medicine, the tient is the essential unit of treatment, and the pa-tient’s values hold great authority. In neonatal and pediatric medicine, however, the unit of treatment is often said to be the child and parent(s) together. Despite this broader unit of treatment, neonatolo-gists will generally intervene, even to the point of seeking regulatory or court intervention, to protect the best interest of the child when doing so requires saving a life. When provided a legislatively sanc-tioned mechanism for pursuing the best interest of the child by withdrawing life-sustaining treatment and allowing death to come, will neonatologists and pediatricians speak with as much moral force as when seeking to save a life? We suspect that there may be considerable variability across the profession in this area.
Whether in the adult ICU or in the NICU, our experience suggests that the process is changing the nature of conversations about medical futility. It does this by placing both a conceptual and temporal boundary around the problem. The law uses the term “medically inappropriate treatment” in place of medical futility but does not attempt to define either concept. Rather, it provides for a community-based definition in that if another institution is willing to provide a disputed treatment that the first institution believes is medically inappropriate or futile, the dis-puted treatment may not be stopped. Such a com-munity-based definition is not without flaws, yet it is a definition that may evolve as medical technology evolves. The temporal boundary is maximally 48
hours plus 10 days, for a total of 12 days between the onset of the ethics process and resolution, with many cases resolving much more quickly. Most families, when confronted by an ethics report that does not support their view and a failed search for an alter-native willing provider, do not wish to draw out the process for the full time allotted under the law.
Although the Texas Advance Directives Act is less than perfect, the process it provides for has been quite effective. It has been most widely used in adult medicine but also has its place in the NICU. When the law was first passed, many had some concern that it might create a “slippery slope” in which phy-sicians and hospitals would be too quick to with-draw various life-sustaining treatments. This does not seem to have materialized to date, and we be-lieve that the mandated search for alternative willing providers provides adequate safeguards. We believe it is a process that the medical and bioethics commu-nities should pursue and hopefully improve on in other states.
REFERENCES
1. American Academy of Pediatrics, Committee on Bioethics. Ethics and the care of critically ill infants and children.Pediatrics.1996;98:149 –152 2. Hippocrates. Aphorisms. In: Chadwick J, Mann WN, trans.The Medical Works of Hippocrates. Oxford, United Kingdom: Blackwell Scientific Publications; 1950:149
3. Jecker NS. Knowing when to stop: the limits of medicine.Hastings Cent Rep.1991;21(3):5– 8
4. Lundberg GD. American health care system management objectives: the aura of inevitability becomes incarnate.JAMA.1993;269:2554 –2555 5. Youngner SJ. Who defines futility?JAMA.1988;260:2094 –2095 6. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its meaning
and ethical implications.Ann Intern Med.1990;112:949 –954
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8. Schuster DP. Everything that should be done—not everything that can be done.Am Rev Respir Dis.1992;145:508 –509
9. Lo B. Futile interventions. In:Resolving Ethical Dilemmas: A Guide for Clinicians. Baltimore, MD: Williams and Wilkins; 1995;73– 81 10. In re Baby “K,” 16 F3d 590 (4th Cir),cert denied, 513 US 825 (1994) 11. Gilgunn v Massachusetts General Hospital, No. SUCV92-4820 (Mass Super
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N Engl J Med.2000;343:293–296 13. Texas Health & Safety Act, ch 166 (2003)
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FROM PETAFLOP TO TERAFLOP!
“A global race is under way to reach the next milestone in supercomputer performance, many times the speed of today’s most powerful machines. . . . A petaflop is a measure of computing performance that describes the ability to perform 1,000 trillion mathematical operations a second, roughly eight times the speed of today’s fastest computer. . . . One teraflop is one trillion mathematical operations a second. . . . ‘These machines can be used to answer questions that literally will mean the life or death of humanity,’ said Peter A. Freeman, assistant director for computer and information sciences and engineering for the National Science Foundation.”
Markoff J.New York Times.August 19, 2005
Noted by JFL, MD
DOI: 10.1542/peds.2004-2790
2005;116;1219
Pediatrics
Robert L. Fine, Jonathan M. Whitfield, Barbara L. Carr and Thomas W. Mayo
Medical Futility in the Neonatal Intensive Care Unit: Hope for a Resolution
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Robert L. Fine, Jonathan M. Whitfield, Barbara L. Carr and Thomas W. Mayo
Medical Futility in the Neonatal Intensive Care Unit: Hope for a Resolution
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