500-gram infants--and 800-pound gorillas--in the delivery room.
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Decision Making↗
Biomedical subjects
William Meadow
Publications and source records attributed to William Meadow.
The fiction of futility: what to do with policy?
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Legislation, Medical↗
Evidence-based expert testimony.
Expert witnesses undoubtedly know a great deal about topics on which ordinary people lack information. But experts, no less than other people, are subject to predictable memory biases. No plaintiff lawyer can enter the courtroom alone, without a doctor by his or her side to serve as an expert witness. The behavior of the plaintiff's experts (and the behavior of the experts who walk alongside the defense lawyers as well) is the subject of this article. What should guide expert testimony? How should those guidelines be implemented? How has our profession dealt with these issues?
Databases as Topic↗
Importance of bilirubin effect questioned.
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Developmental Disabilities↗
Changes in mortality for extremely low birth weight infants in the 1990s: implications for treatment decisions and resource use.
OBJECTIVE: Much has changed in neonatal intensive care unit (NICU) care over the past decade. High-frequency oscillation, inhaled nitric oxide, and antenatal corticosteroids are now widely available. We wondered how these medical advances had affected both the epidemiology and ethics of life and death for extremely low birth weight (ELBW) infants in the NICU. METHODS: We identified 1142 ELBW infants (birth weight [BW] < 1000 g) consecutively admitted to our NICU between 1991 and 2001. We abstracted BW, gestational age, survival or death, and length of stay in the NICU. Statistical analyses were performed by using linear regression and 2-way analysis of variance. RESULTS: Both increasing BW and later year were significantly associated with improved survival. However, for larger ELBW infants, survival was approximately 90% for the entire decade, and large-scale improvement was hardly possible. For smaller infants, greater improvements were both possible and observed, at least early in the decade. From 1991 to 1997, overall ELBW survival increased steadily (approximately 4% per year). However, from 1997 to 2001, there was no significant improvement in survival for ELBW infants. There was no change in the distribution of deaths accounted for by BW subgroups within the ELBW population from 1991 to 2001. Median length of stay for infants who eventually expired before discharge rose from 2 days in 1991 to 10 days in 2001. As a consequence, during the past decade, the percentage of infants whose outcome was "undeclared" by day of life 4 rose from 10% to 20% for ELBW infants overall and to 33% for infants with BWs of 450 to 700 g. The percentage of ELBW NICU bed-days occupied by nonsurvivors remained very low (approximately 7%) from 1991 to 2001. CONCLUSIONS: 1) Fewer infants in all ELBW subgroups are dying, compared with a decade ago, and the improvement has been most prominent for BWs of 450 to 700 g, at which mortality was and remains to be greatest. 2) This progress seems to have slowed, or even stopped, by the end of the decade. 3) Although most NICU nonsurvivors still expire early, doomed infants are lingering longer. 4) Nonsurvivors continue to occupy a constant (and extremely small) fraction of NICU bed-days.
Humans↗
End-of-life after birth: death and dying in a neonatal intensive care unit.
OBJECTIVE: In canonical modern bioethics, withholding and withdrawing medical interventions for dying patients are considered morally equivalent. However, electing not to administer cardiopulmonary resuscitation (CPR) struck us as easily distinguishable from withdrawing mechanical ventilation. Moreover, withdrawing mechanical ventilation from a moribund infant "feels" different from withdrawing mechanical ventilation from a hemodynamically stable child with a severe neurologic insult. Most previous descriptions of withdrawing and withholding intervention in the neonatal intensive care unit (NICU) have blurred many of these distinctions. We hypothesized that clarifying them would more accurately portray the process of end-of-life decision-making in the NICU. METHODS: We reviewed the charts of all newborn infants who had birth weight >400 g and died in our hospital in 1988, 1993, and 1998 and extracted potential ethical issues (resuscitation, withdrawal, withholding, CPR, do-not-resuscitate orders, neurologic prognosis, ethics consult) surrounding each infant's death. RESULTS: Using traditional definitions, roughly half of all deaths in our NICU in 1993 and 1998 were associated with "withholding or withdrawing." In addition, by 1998, >40% of our NICU deaths could be labeled "active withdrawal," reflecting the extubation of infants regardless of their physiologic instability. This practice is growing over time. However, 2 important conclusions arise from our more richly elaborated descriptions of death in the NICU. First, when CPR was withheld, it most commonly occurred in the context of moribund infants who were already receiving ventilation and dopamine. Physiologically stable infants who were removed from mechanical ventilation for quality-of-life reasons accounted for only 3% of NICU deaths in 1988, 16% of NICU deaths in 1993, and 13% of NICU deaths in 1998. Moreover, virtually none of these active withdrawals took place in premature infants. Second, by 1998 infants, who died without CPR almost always had mechanical ventilation withdrawn. Finally, the median and average day of death for 100 nonsurvivors who received full intervention did not differ significantly from the 78 nonsurvivors for whom intervention was withheld. CONCLUSIONS: In our unit, a greater and greater percentage of doomed infants die without ever receiving chest compressions or epinephrine boluses. Rather, we have adopted a nuanced approach to withdrawing/withholding NICU intervention, providing what we hope is a humane approach to end-of-life decisions for doomed NICU infants. We suggest that ethical descriptions that reflect these nuances, distinguishing between withholding and withdrawing interventions from physiologically moribund infants or physiologically stable infants with morbid neurologic prognoses, provide a more accurate reflection of the circumstances of dying in the NICU.
Cause of Death↗
Operationalizing the standard of medical care: uses and limitations of epidemiology to guide expert testimony in medical negligence allegations.
In most U.S. jurisdictions, jurors are instructed that physicians must use "the skill and care ordinarily provided in similar circumstances." A failure to do so is called malpractice. However, how is a lay juror to know what ordinary medical care is? From physician experts testifying about their experience? Given that individual recollections of experience are likely to be skewed in the direction which, in retrospect, is preferred (the "Monday Morning Quarterback" phenomenon), and that the database upon which they are drawn is likely to be small (at least when compared with what might be available elsewhere), idiosyncratic generalizations of medical expert witnesses are almost certainly fraught with potential inaccuracies. Statistical descriptions of standard medical practices, published in peer-reviewed journals whenever possible, would provide a necessary buffer for jurors specifically, and the public more generally, against the inevitable possibility that an individual expert's experience is skewed, or recollection faulty.
Epidemiology↗
Some are old, some are new: life and death in the ICU.
We compared 560 adults hospitalized in our Medical Intensive Care Unit (MICU) to 245 ventilated babies hospitalized in our Neonatal ICU (NICU). Both ICUs had comparable mortality rates--roughly 1 patient in 5 died. The average length of hospitalization for nonsurvivors versus survivors was disproportionately short for NICU babies (13d v 33d) and long for MICU adults (15d v 12d). This phenomenon resulted in a redistribution of ICU bed-days and resources in favor of survivors for NICU babies (approximately 9 of every 10 NICU beds were devoted to babies who survived), and nonsurvivors for MICU adults (roughly 1 MICU bed in 2). Both ICUs had comparable percentages of patients predicted to die--roughly 1 patient in 3. The predictive power of an intuition of die was comparable--and not all that great. Almost one third of patients in both ICUs with a single prediction of "die in hospital" survived to be discharged. However, the likelihood of finding a neurologically normal NICU survivor after a prediction of "die" was only 5 in 100. To the extent that informed decisions can be made with 95% certainty, we may have found a foothold on the slippery ethical slope of benefit/burden calculations in the NICU. Unfortunately, we have no comparable data for MICU survivors.
Adult↗
Cardiopulmonary effects of nebulized sodium nitroprusside in term infants with hypoxic respiratory failure.
OBJECTIVE: To study whether nebulized nitroprusside (neb-NP) improves oxygenation in term infants with hypoxic respiratory failure (HRF). STUDY DESIGN: We studied 22 newborn term infants (gestational age, 39.7+/-0.4 weeks [mean+/-SEM]; birth weight, 3.6+/-0.1 kg) with hypoxia (Pao2<100 mm Hg) during mechanical ventilation (Fio2=1.0). Sodium nitroprusside (5 mg followed by 25 mg) was nebulized into the inspiratory arm of the ventilator circuit. Vital signs and arterial blood gas values were recorded after 20 minutes at each dose and before and after initiation of inhaled nitric oxide (iNO). RESULTS: Pao2 increased significantly with 5 mg neb-NP (from 64.6+/-5.6 to 90.1+/-15.3 mm Hg, P=.04) and with 25 mg neb-NP (113.2+/-20.4 mm Hg, P=.009). Differences between mean Pao2 at 5 mg versus 25 mg neb-NP were also statistically significant (P=.03). When comparing the effect of neb-NP to iNO, the treatment-induced increases in Pao2 were similar (52.1+/-18.7 vs 62.2+/-18.2 mm Hg, respectively, P=not significant). CONCLUSIONS: Neb-NP causes a dose-dependent increase in oxygenation in term infants with HRF, similar in magnitude to iNO* Neb-NP may be beneficial in infants with HRF when iNO is not readily available.
Administration, Inhalation↗
Which nurseries currently care for ventilated neonates in Illinois and Wisconsin? Implications for the next generation of perinatal regionalization.
We were interested in the extent to which advances in the availability of neonatalogy expertise have provided a centrifugal impetus to perinatal care. Specifically, we wondered where infants who were sick enough to require mechanical ventilation were currently being managed. We surveyed 116 of 140 hospitals in Illinois and Wisconsin that offered obstetric/newborn services in 1998-1999. The 23 Level I nurseries were consistently small, and offered virtually no "advanced" neonatal intensive care unit (NICU) technology. The 16 Level III NICUs were consistently large, offered advanced technology and personnel, and received sick infants from many hospitals in their regional network. The 77 Level II nurseries (two thirds of all hospitals with newborn services) were less consistently characterized. In general, Level II nurseries were a "spoke" (not a hub), and did not offer extracorporeal-membrane oxygenation (ECMO), nitric oxide (NO), or cardiovascular (CV) surgery. However, 19 (25%) of 77 Level II centers self-designated as "Level II+". These were significantly more likely to offer ventilators, percutaneous central venous catheters (PCVCs), total parenteral nutrition (TPN), and surgery. Fifty-three percent (18/34) of all nurseries offering mechanical ventilation self-designated as a Level II or II+, as opposed to Level III. Facile inferences about the appropriate role of Level II centers derived from decades-old data are probably unsupportable. It is time to acknowledge the distinction between the Level II nursery of the past and the newly evolving Level II+ NICUs.
Health Care Surveys↗
Direct comparison of the effects of nebulized nitroprusside versus inhaled nitric oxide on pulmonary and systemic hemodynamics during hypoxia-induced pulmonary hypertension in piglets.
OBJECTIVE: To test the hypothesis that nebulized nitroprusside and inhaled nitric oxide would not differ in producing selective pulmonary vasodilation during hypoxia-induced pulmonary hypertension in piglets. SETTING: University laboratory. SUBJECTS: Five piglets. INTERVENTIONS: Piglets (n = 5) were anesthetized and instrumented to monitor systemic arterial pressure, pulmonary artery pressure, and cardiac output continuously. Hypoxia was induced (DeltaFio2 from 0.5 to 0.08), and either nebulized nitroprusside (5 mg/mL at 4 L/min flow; total dose 25 mg) or inhaled nitric oxide (20 ppm) was introduced into the ventilator circuit for 15 mins. Normoxia was then restored, and a repeat cycle of hypoxia followed by the alternate vasodilator treatment was initiated. MEASUREMENTS AND MAIN RESULTS: Hypoxia significantly reduced Pao2 (from 206 to 30 torr) and elevated pulmonary artery pressure (from 18 to 33 torr) while not significantly affecting systemic arterial pressure or cardiac output. During hypoxia, inhaled nitric oxide reduced pulmonary artery pressure from 33 to 21 torr (p <.01), whereas systemic arterial pressure and cardiac output were unchanged. During hypoxia, nebulized nitroprusside also reduced pulmonary artery pressure from 33 to 23 mm Hg (p <.01; p = nonsignificant vs. inhaled nitric oxide), whereas systemic arterial pressure and cardiac output again remained constant. The time course of the reduction in pulmonary artery pressure during inhaled nitric oxide was roughly ten-fold more rapid (<5 secs) than during nebulized nitroprusside ( approximately 1 min). Neither inhaled nitric oxide nor nebulized nitroprusside altered pH, Pao2, or Paco2. CONCLUSION: Both inhaled nitric oxide and nebulized nitroprusside produced prompt, significant, selective reduction of pulmonary artery pressure and pulmonary vascular resistance in piglets with hypoxia-induced pulmonary hypertension, without apparent effects on systemic hemodynamics or pulmonary gas exchange. The equivalence of the two effects in this animal model suggests that cautious extrapolation of the use of nebulized nitroprusside as a convenient bridge to inhaled nitric oxide in selected clinical contexts for human infants may be warranted.
Analysis of Variance↗
Current opinion in pediatrics: ethics and law 2001.
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Attitude of Health Personnel↗
Use of vasopressin in refractory hypotension in children with vasodilatory shock: five cases and a review of the literature.
This article describes case studies of five children treated with vasopressin for refractory hypotension. In addition, physiology and pharmacology of vasopressin are reviewed in a comprehensive survey of the literature from 1966 until the present. In all five children, blood pressure increased immediately after vasopressin administration. The preliminary success of vasopressin for hypotension the setting of vasodilatory shock is promising. This limited use of vasopressin in the setting of refractory hypotension in these patients appears to be safe; the appropriate patient population and dose regimen are not yet determined.
Journal Article↗
Serial assessment of mortality in the neonatal intensive care unit by algorithm and intuition: certainty, uncertainty, and informed consent.
OBJECTIVES: Does predictive power for outcomes of neonatal intensive care unit (NICU) patients get better with time? Or does it get worse? We determined the predictive power of Score for Neonatal Acute Physiology (SNAP) scores and clinical intuitions as a function of day of life (DOL) for newborn infants admitted to our NICU. METHODS: We identified 369 infants admitted to our NICU during 1996-1997 who required mechanical ventilation. We calculated SNAP scores on DOL 1, 3, 4, 5, 7, 10, 14, 21, 28, and weekly thereafter until either death or extubation. We also asked nurses, residents, fellows, and attendings on each day of mechanical ventilation: "Do you think this child is going to live to go home to their family, or die before hospital discharge?" RESULTS: Two thousand twenty-eight SNAP scores were calculated for 285 infants. On DOL 1, SNAP for nonsurvivors (24 +/- 8.7 [standard deviation]) was significantly higher than SNAP for survivors (13 +/- 6.1). However, this difference diminished steadily and by DOL 10 was no longer statistically significant (12.7 +/- 4.9 vs 10.0 +/- 4.8). On each NICU day, at all ranges of SNAP scores, there were at least as many infants who would ultimately survive as would die. Consequently, the positive predictive value of any SNAP value for subsequent mortality was <0.5 on all NICU days. Prediction profiles were obtained for 230 ventilated infants reflecting over 11 000 intuitions obtained on 2867 patient days. One hundred fifty-seven (81%) of 192 survivor profiles displayed consistent accurate prediction profiles-at least 90% of their NICU ventilation days were characterized by 100% prediction of survival. Twenty-five (13%) of 192 surviving infants survived somewhat unexpectedly; that is, after at least 1 day characterized by at least 1 estimate of "death." Thirty-three (60%) of the 55 nonsurvivors died before DOL 10. Eighty-two percent of the prediction profiles for these early dying infants were homogeneous, dismal, and accurate. Twenty-two (40%) of the 55 nonsurvivors died after DOL 10. Seventeen (78%) of these 22 late-dying infants were predicted to live by many observers on many hospital days. Sixty-one (30%) of 230 profiled patients had at least 1 NICU day characterized by at least 1 prediction of death; 26/61 (43%) of these patients were incorrectly predicted; that is, they survived. Seventeen infants who were predicted to die during but survived nonetheless were assessed neurologically at 1 year. Fourteen (82%) of these 17 were not neurologically normal-8 were clearly abnormal, 1 suspicious, and 5 had died. CONCLUSIONS: If absolute certainty about mortality is the only criterion that can justify a decision to withhold or withdraw life-sustaining treatment in the NICU, these data would make such decisions difficult on the first day of life, and increasingly problematic thereafter. However, if we acknowledge that medicine is inevitably an inexact science and that clinical predictions can never be perfect, we can ask the more interesting question of whether good but less-than-perfect predictions of imprecise but ethically relevant clinical outcomes can still be useful. We think that they can-and that they must.
Age Factors↗