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Biomedical subjects

John Lantos

Publications and source records attributed to John Lantos.

At least 19 recordsLinked to original sources
PubMed2006

Summary proceedings from the neonatal pain-control group.

Recent advances in neurobiology and clinical medicine have established that the fetus and newborn may experience acute, established, and chronic pain. They respond to such noxious stimuli by a series of complex biochemical, physiologic, and behavioral alterations. Studies have concluded that controlling pain experience is beneficial with respect to short-term and perhaps long-term outcomes. Yet, pain-control measures are adopted infrequently because of unresolved scientific issues and lack of appreciation for the need for control of pain and its long-term sequelae during the critical phases of neurologic maturation in the preterm and term newborn. The neonatal pain-control group, as part of the Newborn Drug Development Initiative (NDDI) Workshop I, addressed these concerns. The specific issues addressed were (1) management of pain associated with invasive procedures, (2) provision of sedation and analgesia during mechanical ventilation, and (3) mitigation of pain and stress responses during and after surgery in the newborn infant. The cross-cutting themes addressed within each category included (1) clinical-trial designs, (2) drug prioritization, (3) ethical constraints, (4) gaps in our knowledge, and (5) future research needs. This article provides a summary of the discussions and deliberations. Full-length articles on procedural pain, sedation and analgesia for ventilated infants, perioperative pain, and study designs for neonatal pain research were published in Clinical Therapeutics (June 2005).

Analgesia↗
PubMed2006

When parents request seemingly futile treatment for their children.

This paper reviews the development of the concept of medical futility, particularly as it applies to pediatrics. It discusses the difference between technical considerations and value considerations in futility determinations, and then breaks down the concept of futility into four components - power, money, trust and hope.

Child↗
PubMed2005

Analgesia and anesthesia for neonates: study design and ethical issues.

OBJECTIVE: The purpose of this article is to summarize the clinical, methodologic, and ethical considerations for researchers interested in designing future trials in neonatal analgesia and anesthesia, hopefully stimulating additional research in this field. METHODS: The MEDLINE, PubMed, EMBASE, and Cochrane register databases were searched using subject headings related to infant, newborn, neonate, analgesia, anesthesia, ethics, and study design. Cross-references and personal files were searched manually. Studies reporting original data or review articles related to these topics were assessed and critically evaluated by experts for each topical area. Data on population demographics, study characteristics, and cognitive and behavioral outcomes were abstracted and synthesized in a systematic manner and refined by group members. Data synthesis and results were reviewed by a panel of independent experts and presented to a wider audience including clinicians, scientists, regulatory personnel, and industry representatives at the Newborn Drug Development Initiative workshop. Recommendations were revised after extensive discussions at the workshop and between committee members. RESULTS: Designing clinical trials to investigate novel or currently available approaches for analgesia and anesthesia in neonates requires consideration of salient study designs and ethical issues. Conditions requiring treatment include pain/stress resulting from invasive procedures, surgical operations, inflammatory conditions, and routine neonatal intensive care. Study design considerations must define the inclusion and exclusion criteria, a rationale for stratification, the confounding effects of comorbid conditions, and other clinical factors. Significant ethical issues include the constraints of studying neonates, obtaining informed consent, making risk-benefit assessments, defining compensation or rewards for participation, safety considerations, the use of placebo controls, and the variability among institutional review boards in interpreting federal guidelines on human research. For optimal study design, investigators must formulate well-defined study questions, choose appropriate trial designs, estimate drug efficacy, calculate sample size, determine the duration of the studies, identify pharmacokinetic and pharmacodynamic parameters, and avoid drug-drug interactions. Specific outcome measures may include scoring on pain assessment scales, various biomarkers and their patterns of response, process outcomes (eg, length of stay, time to extubation), intermediate or long-term outcomes, and safety parameters. CONCLUSIONS: Much more research is needed in this field to formulate a scientifically sound, evidence-based, and clinically useful framework for management of anesthesia and analgesia in neonates. Newer study designs and additional ethical dilemmas may be defined with accumulating data in this field.

Analgesia↗
PubMed2005

Improving asthma research in an inner-city Latino neighborhood with community health workers.

This study tests the feasibility of a partnership between an academic medical center and community health workers to perform mutually beneficial research investigating asthma in an urban Latino neighborhood. Community heath workers participated in the study design, instrument development, implementation, and analysis. The 103 participants recruited by the community health workers were primarily Mexican with very low education and acculturation levels. After the 1-year enrollment period, the community health workers described the challenges of data collection and gave explanations for the access to care outcomes. This academic-community partnership showed that community health workers can be effective research partners.

Academic Medical Centers↗
PubMed2005

Extracorporeal membrane oxygenation after stem cell transplant: clinical decision-making in the absence of evidence.

OBJECTIVE: To discuss the ethical dilemmas that arise in considering innovative therapies for critically ill children when there is little data to support their use. DESIGN: Case report of a 13-yr-old patient after autologous peripheral blood stem cell transplant for stage III neuroblastoma with sepsis and hemodynamic instability who survived to discharge after a 6-day course of extracorporeal membrane oxygenation (ECMO) support. The case serves as a source of discussion of the following: the use of available data in deciding to proceed with an unproved therapy, the approach to conversations to obtain informed consent, and the need for institutional oversight and hypothesis-driven data collection to advance pediatric critical care. SETTING: Pediatric intensive care unit at a university hospital. PATIENT: One adolescent with stage III neuroblastoma. RESULTS: Despite a lack of data to support the use of ECMO in a neutropenic oncology patient after autologous peripheral blood stem cell transplant, our patient had clinical features that suggested he was a reasonable ECMO candidate. His family gave informed consent to use ECMO and he survived. It is ethical to consider and use innovative therapies when patient characteristics are suggestive that the therapy may be successful even in the absence of evidence. This requires physicians' attention to the best interest of the patient and should occur in the setting of informed consent and rigorous data collection. CONCLUSIONS: The boundaries among standard therapy, innovative therapy, and research can be quite fluid. This case illustrates the ethical imperative to consider therapies that may be appropriate for a critically ill child even without evidence predictive of success, to have entry criteria and treatment protocols for such therapies, and to collect data from such experiences to advance the standard of care.

Adolescent↗
PubMed2004

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↗
PubMed2004

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↗
PubMed2003

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↗
PubMed2002

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↗
PubMed2002

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↗
PubMedDate not supplied

Reducing home triggers for asthma: the Latino community health worker approach.

This study assessed the ability of a community health worker asthma intervention to change home asthma triggers. A total of 56 children and 47 adults with asthma were enrolled. Home trigger scores for the children averaged 2.8 at the initial home visit and then 2.3, 2.1, and 2.0 at 3, 6, and 12 months. Home trigger scores for the adults showed a similar trend. Every home visit was associated with a 0.32 reduction in home trigger score (p < 0.01) for children and a 0.41 reduction (p < 0.01) for adults. This intervention shows promise as a way to reduce asthma triggers in urban low-income Latino communities.

Adolescent↗
PubMedDate not supplied

Who cares for the children? Pediatricians and parental leave.

CONTEXT: Evidence suggests that parental leave (PL) benefits child health and infant-parent attachment, yet little is known about how pediatricians view and discuss PL with parents. OBJECTIVE: To determine pediatricians' attitudes, practices, and their own use of PL, and how these may vary by gender. DESIGN: Random mail surveys to 750 male and 750 female pediatricians focusing on attitudes about PL and the discussion of PL. Respondents with children were asked about their own PL use. After stratifying by gender, questions were compared using the chi-square, linear trend, and t test. Logistic regression was used to predict the likelihood of discussing PL. RESULTS: Forty-four percent of men and 92% of women took time off after the arrival of a new child--a median of 14 days and 67 days, respectively. The majority (55%) believe it is important to discuss PL; however, 8% of men and 24% of women do so (P<.01). Men who took PL were 3.6 times more likely to discuss PL (P=.04) than men who did not. For women, each month increase in length of leave was associated with 2.2 times greater likelihood of discussing PL (P<.01). Women in smaller practices were 2.1 times more likely to discuss PL (P=.01) than women in larger practices. CONCLUSION: Many pediatricians take PL and believe it is an important topic for discussion. Few pediatricians, however, incorporate discussion into their practices. In an era when most children grow up in households where both parents work outside the home, pediatricians should consider discussing with parents this important element of child health.

Adolescent↗
PubMedDate not supplied

Youth targeting by tobacco manufacturers since the Master Settlement Agreement.

The 1998 Master Settlement Agreement (MSA) between tobacco manufacturers and forty-six states bans manufacturers from targeting minors through advertising. To determine how youth targeting in magazine cigarette advertisements changed after the MSA, we analyzed magazine readership and cigarette ads in U.S. magazines from 1997 to 2000. In 2000 all three major manufacturers (Philip Morris, R.J. Reynolds, and Brown and Williamson) failed to comply with the MSA's youth-targeting ban, selectively increasing their youth targeting. Banning all magazine advertising of cigarettes may be necessary to eliminate youth targeting in magazines.

Adolescent↗
PubMedDate not supplied

RVUs blues. How should docs get paid?

It has become increasingly difficult to place a value on the work that doctors do. Yet fiscal pressures have lead to economic incentives for performing certain kinds work instead of others. So the question arises: what are the ethics and consequences of trying to objectively compare the many services physicians offer?

Clinical Competence↗