Physician views regarding the benefits and burdens of prenatal surgery for myelomeningocele.

OBJECTIVE: Examine how pediatric and obstetrical subspecialists view benefits and burdens of prenatal myelomeningocele (MMC) closure. STUDY DESIGN: Mail survey of 1200 neonatologists, pediatric surgeons and maternal-fetal medicine specialists (MFMs). RESULTS: Of 1176 eligible physicians, 670 (57%) responded. Most respondents disagreed (68%, 11% strongly) that open fetal surgery places an unacceptable burden on women and their families. Most agreed (65%, 10% strongly) that denying the benefits of open maternal-fetal surgery is unfair to the future child. Most (94%) would recommend prenatal fetoscopic over open or postnatal MMC closure for a hypothetical fetoscopic technique that had similar shunt rates (40%) but decreased maternal morbidity. When the hypothetical shunt rate for fetoscopy was increased to 60%, physicians were split (49% fetoscopy versus 45% open). Views about burdens and fairness correlated with the likelihood of recommending postnatal or fetoscopic over open closure. CONCLUSION: Individual and specialty-specific values may influence recommendations about prenatal surgery.

Neonatologists' opinions about the 'foreseeable risks' in comparative effectiveness research: Results from an online survey.

OBJECTIVE: To examine how neonatologists determine which risks require inclusion for informed consent per the 'Common Rule' and 'Draft Guidance' regulations in comparative effectiveness research (CER). STUDY DESIGN: Neonatologists active in research were invited to complete an online survey. Questions focused on clinical practices for treating hyperbilirubinemia in premature infants and about risk disclosure related to a hypothetical randomized trial. RESULTS: Response rate was 57%. 43% were primarily researchers; 31% primarily clinicians. 69% had conducted CER. 81% thought hypothetical study enrollment was not riskier than receiving routine care. 76% labeled the study 'minimal risk' by comparing study risks to clinical care risks. Respondents would not currently disclose many of the treatment risks but would disclose more if the Draft Guidance were enacted into law. CONCLUSION: Findings suggest the Draft Guidance requires disclosure of more risks than does the Common Rule; applying either rule results in disclosure of more risks than in standard clinical care.

Growth hormone therapy for Prader-Willi and Down syndromes: a post-modern medical dilemma.

Post-modernism means the end of traditional certainties. In this paper, growth hormone (GH) is conceptualized as a post-modern medical therapy. It is used in the treatment of conditions that are not traditional diseases, for indications that are not precisely defined. Down syndrome and Prader-Willi syndrome represent two clinical conditions in which GH can possibly be used. It is argued that the difference between the two syndromes instructs us as to the principles that might guide appropriate use of GH in the future. In particular, for children, the more GH treatment can be shown to produce benefits other than increased height, the more justifiable its use will be.

Have we treated AIDS too well? Rationing and the future of AIDS exceptionalism.

During the past decade, medical therapy for AIDS has become more effective but also prohibitively expensive. A medical tragedy has been transformed into a financial crisis, and society has responded by establishing special programs and sources of funding for AIDS. These maneuvers parallel earlier approaches to HIV testing and reporting that have collectively come to be known as 'exceptionalism.' This paper suggests that exceptionalism in resource allocation is a fragile, short-term solution. In the long run, AIDS exceptionalism will create growing injustice and should be avoided. However, we should not eliminate the advances that this exceptionalism has already achieved. Instead, we need a working dialogue between these advances and public policy.

Resource allocation in neonatal and medical ICUs. Epidemiology and rationing at the extremes of life.

This study compared resource allocation to patients who eventually die in neonatal ICUs (NICUs) and adult medical ICUs (MICUs). It was performed via retrospective, chart review study at ICUs at the University of Chicago-an inner city, tertiary care, academic medical center. All patients were admitted to the neonatal, general medical, or coronary ICU during 1 calendar yr. Overall mortality in the NICU (66/827; 7.9%) was significantly lower than in the adult ICUs (219/1320; 16.5%) (p < 0.001). However, mortality for the smallest newborns (< 751 g; 51% mortality) was higher than for the oldest adults (> 54 yr; 30% mortality) (p = 0.05). Fifty-six percent (37/66) of all neonates who died in the NICU did so within the first 48 hr of life. In contrast, nearly two-thirds (134/219) of adult ICU deaths occurred after 48 hours in the ICU (p < 0.02). The percentage of ICU bed-days devoted to nonsurviving adults (28.8%) was significantly larger than the percentage of NICU bed-days devoted to nonsurviving babies (7.8%). Even among babies at greatest risk to die (birth weight < 751 g), the percentage of NICU bed-days allocated to nonsurviving infants was less than 20%. In contrast, for the oldest ICU patients (> 84 yr) this value exceeded 50%, for ICU patients > 84 yr old who required mechanical ventilation, the percentage of ICU bed-days allocated to nonsurvivors approached 90%. Care for the elderly in MICUs involves a far greater proportional expenditure of money toward those who will not survive than does care for newborns in NICUs. To the extent that allocation decisions are driven by concerns about distributive justice and the efficient use of scarce resources, it would be more justifiable to ration intensive care for the very old than the very young.

Can and should level II nurseries care for newborns who require mechanical ventilation?

Perinatal regionalization was conceived roughly 25 years ago to provide centralized care for critically ill newborn infants. As for many 25-year-old concepts, the obligatory centripetal design of many regionalization policies may need to be modified. This article presents the outcomes of 408 surviving patients who required mechanical ventilation (136 born in one community hospital and 272 birthweight-matched infants born in our tertiary center), and were cared for in our perinatal network. Mechanical ventilation of a resident population of newborns at a community NICU appeared to be as effective as ventilatory care at a regionalized tertiary neonatal intensive care unit, when assessed by comparing birthweight-matched populations for length of hospital stay, days on ventilator, and the need for home O2. Some may still claim that every baby who requires mechanical ventilation must be transferred to a tertiary care center. In an era of heightened interest in health services, health outcomes, and cost-effectiveness analysis, however, the authors believe that such claims will be subjected to increasing scrutiny. Our study represents a first attempt at determining the shape such scrutiny might take, and the sort of data analyses that may be required to reformat a perinatal network.

Expert testimony, legal reasoning, and justice. The case for adopting a data-based standard of care in allegations of medical negligence in the NICU.

Sunstein has written, "First, and most obviously, judgments about specific cases must be made consistent with one another. A requirement of coherence, or principled consistency, is a hallmark of analogic reasoning (as it is of reasoning of almost all sorts)." In cases of alleged medical negligence, our current system of malpractice litigation supports the possibility that inaccurate anecdotal testimony by expert witnesses may be credited equally or even preferred to more accurate testimony based on empiric data. This condition lends itself to inconsistent outcomes that violate basic principles of justice. In our view, the standard of medical care ought not be described by the idiosyncratic postulation of single behavior (analogous to promulgating the equation of a single line on a Cartesian plane). Rather, the standard of medical care is best viewed as a distribution of behaviors (family of lines) that can be empirically determined to account for most practice decisions in comparable cases. The recent Daubert formulation of admissibility of expert testimony can be interpreted as providing judicial support for a hierarchy of expert testimony in cases of alleged medical negligence. On this view, testable comparisons of the behavior in question against reliably documented distributions of standard medical behavior in similar circumstances rank higher than untestable comparisons using unreliable anecdotal recollections of individual expert's undocumented experience. We believe that widespread adoption by the medical community of the principle that the value of expert testimony describing the standard of medical care increases in direct proportion to its congruence with a data-based determination of the distribution of skill and care ordinarily provided in similar circumstances would significantly reduce the potential for injustice visited on plaintiff and defendant alike.

Distributive justice across generations. Epidemiology of ICU care for the very young and the very old.

Babies of extremely low birthweight and elderly adults both require expensive and scarce resources, and both have a relatively poor prognosis for survival if they require intensive care. Thus, proposals for rationing often target one or both of these groups. We suspected that although mortality rates might be higher in the neonatal intensive care unit (NICU) than in the adult intensive care unit (ICU), NICU care might nevertheless be more cost effective, where cost efficiency is measured along the dimension of resources targeted to survivors. We examined mortality patterns in our NICU and for adults admitted to our medical intensive care units. We found that adult ICU patients who died consumed many times more ICU resources before their death than did their NICU confreres, independent of the severity of illness or likelihood of dying. Although there may be many legitimate concerns about justice and ethics in the NICU, undue expenditure of society's resources prolonging the dying of extremely low birthweight infants is not among them. To the extent that concerns about distributive justice drive allocation decisions in ICU care, it would seem more justifiable to ration intensive care for the very old, not the very young.

Cardiopulmonary resuscitation on television. Miracles and misinformation.

BACKGROUND: Responsible, shared decision making on the part of physicians and patients about the potential use of cardiopulmonary resuscitation (CPR) requires patients who are educated about the procedure's risks and benefits. Television is an important source of information about CPR for patients. We analyzed how three popular television programs depict CPR. METHODS: We watched all the episodes of the television programs ER and Chicago Hope during the 1994-1995 viewing season and 50 consecutive episodes of Rescue 911 broadcast over a three-month period in 1995. We identified all occurrences of CPR in each episode and recorded the causes of cardiac arrest, the identifiable demographic characteristics of the patients, the underlying illnesses, and the outcomes. RESULTS: There were 60 occurrences of CPR in the 97 television episodes--31 on ER, 11 on Chicago Hope, and 18 on Rescue 911. In the majority of cases, cardiac arrest was caused by trauma; only 28 percent were due to primary cardiac causes. Sixty-five percent of the cardiac arrests occurred in children, teenagers, or young adults. Seventy-five percent of the patients survived the immediate arrest, and 67 percent appeared to have survived to hospital discharge. CONCLUSIONS: The survival rates in our study are significantly higher than the most optimistic survival rates in the medical literature, and the portrayal of CPR on television may lead the viewing public to have an unrealistic impression of CPR and its chances for success. Physicians discussing the use of CPR with patients and families should be aware of the images of CPR depicted on television and the misperceptions these images may foster.