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Biomedical subjects

J Lantos

Publications and source records attributed to J Lantos.

At least 55 records · Page 3Linked to original sources

Informed consent. The whole truth for patients?

Two misconceptions about informed consent concern the difference between the legal and moral justification for it, and the rationale for more rigorous consent for research than for "standard" therapy. Legally, informed consent for therapy is a risk-management tool that functions essentially as a release of liability. If the patient is informed of all expected or potential side-effects or toxicities of a treatment, he cannot sue because those side effects occur. The moral doctrine of informed consent is derived from a respect for the patient's autonomy as well as the patient's vulnerability. The physician's goal is not to minimize liability, but to help the patient make the best decision. These two goals are not necessarily incompatible, but they often lead to different attitudes toward informed consent and different decisions about what information needs to be shared with patients. If the goal is risk-management, then informed consent forms should be encyclopedic, providing the "whole truth" to patients. This would, however, not meet the moral goals of shared decision-making, because few patients could make sense of such data. Informed consent for research often leads to a different paradox. If a new therapy becomes available and a physician thinks it may benefit a patient, the physician may use it in an uncontrolled manner. This does not require the approval of an institutional review board and does not need the more rigorous approach to informed consent generally associated with research. In contrast, if the physician wants to evaluate the effectiveness of the same therapy carefully and intends to gather data to do so, he will need to describe his protocol, defend it before an institutional review board, and provide a more carefully written and closely scrutinized informed consent form. The paradox derives from the fact that the patient in the first, uncontrolled situation is inevitably at higher risk of harm than the patient in the second situation. The distinction between informed consent for treatment and informed consent for research is based on a distinction that is growing ever more cloudy and ever less relevant to the moral goals that informed consent seeks to achieve. Current standards for informed consent for research are, in many ways, counterintuitive and probably counter-productive.

Ethics, Medical↗

Ought 'standard care' be the 'standard of care'? A study of the time to administration of antibiotics in children with meningitis.

OBJECTIVE: To determine the time from triage in an emergency department until administration of parenteral antibiotics in children with bacterial meningitis. RESEARCH DESIGN: Retrospective review of medical records and survey of medical subspecialists in infectious diseases and emergency medicine. SETTING: Emergency departments of two university-affiliated pediatric hospitals. PARTICIPANTS: All children with bacterial meningitis identified in medical records from 1987 to 1989 (N = 93). MEASUREMENTS: For each child, the time from presentation to the emergency department until administration of antibiotics (AB time) was determined; when possible, time from triage to contact with a physician, from triage to lumbar puncture, and from lumbar puncture to administration of antibiotics was measured. We then surveyed specialists in both pediatric infectious diseases (n = 23) and pediatric emergency medicine (n = 54) as to their beliefs about AB time in children with meningitis. STATISTICAL ANALYSES: Mann-Whitney Rank Sum Test and Kruskal-Wallis Test. RESULTS: Median AB time was 2.0 hours (interquartile range, 1.25 to 3.33 hours). Only one (1%) of 93 children received antibiotics within 30 minutes of presentation. Median time from triage until contact with a physician was 0.45 hour. Median time from lumbar puncture until antibiotics administration was about 0.5 hour. The estimates of median AB time differed significantly between emergency medicine (0.93 hour) and infectious disease (1.45 hours) experts, and estimates from both differed significantly from the median AB time (2.0 hours) actually observed. CONCLUSIONS: These data reveal that the usual and customary practice (ie, standard medical care) by qualified physicians may differ from opinions of standard medical care promulgated by medical experts. Even among experts there is a wide range of (mistaken) opinions about standard medical care. Insofar as jurors in medical malpractice cases are instructed to consider what physicians "ordinarily do in similar circumstances," a data-based definition of "standard" medical care should supplant anecdotal testimony by individual expert witnesses.

Anti-Bacterial Agents↗

[Short-term prognosis in patients with congestive heart failure and normal left ventricular systolic function].

Congestive heart failure (CHF) has been traditionally associated with impairment of the left ventricular systolic function (LVSF). There are few clinical assays that describe the prognosis of patients with CHF and intact LVSF. The aims of this prospective assay are: to describe a group of 70 patients admitted to an internal medicine department with the clinical syndrome of CHF, to determine the contractile state of the left ventricle with echocardiography and to establish the short term prognosis. There were 39 males and 31 females with a mean age of 76.4. The LVSF was impaired in 38 (54.3%) [Group I] and preserved in 32 (45.7%) [Group II] (Table 1). Sex distribution was different between both groups with women predominating in group II (Figure 1). Fourteen patients belonging to Group II had diastolic function impairment according to cardiac Doppler. There was no other evidence of cardiac abnormality that could justify CHF. During an average of 8 months follow-up 20 (28%) patients died. There were no differences in overall mortality between Groups I and II (Figure 2). Multivariate analysis was used to determine the relative risk in prognosis of the covariates age, gender, systolic function and diameters of the LV. None of these were statistically significant (Table 2). In our series 45.7% of the patients with CHF had normal LVSF. The short term prognosis proved to be the same in patients with and without impaired LVSF.

Aged↗

Scientific and ethical consequences of disease prediction.

HLA-typing, gene analysis, anti-islet cell antibody testing and metabolic studies can identify people at high risk for developing Type 1 (insulin-dependent) diabetes mellitus prior to the onset of clinical disease. The positive predictive value of these tests is high in first degree relatives of patients with Type 1 diabetes, but six times less so in the general population, where disease incidence is much lower but where 90% of new cases occur. Multiple testing improves sensitivity but decreases specificity. Intervention strategies are being designed with the aim of delaying or preventing progression to clinical disease. The more invasive the intervention, the greater is the specificity required. The practical and ethical implications of identifying high risk of diabetes in healthy individuals are complex and require further research, but some lessons can be learned from the experience of other disease prediction programmes.

Adult↗

What is the legal 'standard of medical care' when there is no standard medical care? A survey of the use of home apnea monitoring by neonatology fellowship training programs in the United States.

In treating a patient, a doctor is obliged to use the skill and care that is ordinarily used by reasonably well-qualified doctors in similar cases. In addition, the only way in which a juror may decide whether the defendant used the skill and care which the law required of him or her is from evidence presented by doctors called as expert witnesses (cf Illinois Pattern Jury Instructions). However, what should be done if expert opinions differ concerning the care that is "ordinarily used"? Home apnea monitoring (HAM) is prescribed at times for graduates of neonatal intensive care units despite the fact that indications for its use are not well established and efficacy is completely unknown. The authors attempted to determine standards for HAM as it is currently practiced in neonatology training programs. The primary teaching hospital for each of the 99 neonatology training programs in the United States was identified. Both the medical director (MD) and a neonatal intensive care unit nurse manager (RN) were asked about the use of HAM in their own nursery for four clinical vignettes. Each vignette depicted a 1000-g birth weight infant, currently 7 weeks old and ready for discharge. In three vignettes, the infant had demonstrated no apnea, mild apnea (resolved by 2 weeks of age), or moderate apnea (requiring theophylline therapy at discharge) during the hospital course. In the fourth vignette, the infant had no apnea but was to be discharged home with supplemental oxygen. For 67 of 99 training programs, paired responses of RN managers and MD directors were obtained.(ABSTRACT TRUNCATED AT 250 WORDS)

Aftercare↗

Bone marrow transplantation for sickle cell disease. A study of parents' decisions.

BACKGROUND: Bone marrow transplantation has been shown to cure sickle cell disease, but it carries a 15 percent mortality risk. To determine whether parents would accept this risk to cure their children of sickle cell disease, we interviewed parents of children with sickle cell disease who were being followed in a university hospital clinic. METHODS: We assessed parents' attitudes by using questions based on the standard reference-gamble paradigm. After we gave them descriptions of bone marrow transplantation and graft-versus-host disease (GVHD), the parents were presented with a series of hypothetical situations. In the first situation, bone marrow transplantation was described as offering certain (100 percent) survival with cure of sickle cell disease. In subsequent descriptions, the mortality rate associated with bone marrow transplantation was increased by 5 percent increments. The parents indicated the highest mortality risk at which they would consent to the procedure in order to cure their children. RESULTS: In order to obtain a cure for their children, 36 of 67 parents (54 percent) were willing to accept some risk of short-term mortality, 25 of 67 (37 percent) were willing to accept at least the 15 percent short-term mortality risk we estimate to be the current figure for bone marrow transplantation, and 8 of 67 (12 percent) were willing to accept a short-term mortality risk of 50 percent or more. Nine parents (13 percent) said they would accept both a mortality risk of 15 percent or more and an additional 15 percent risk of GVHD. The parents' decisions were not related to the clinical severity of their children's illness. CONCLUSIONS: At current rates of mortality and morbidity with bone marrow transplantation, a substantial minority of the parents of children with sickle cell disease may consent to bone marrow transplantation for their children. Parental attitudes should be factored into decisions about whether to offer bone marrow transplantation to children with sickle cell disease.

Adolescent↗

Clonal distribution of K1 and K5 antigen possessing Escherichia coli isolates.

A significant difference was observed in the occurrence of the examined markers (Col+, ColV+, Hly+, Aer+, AbR) and in the plasmid carrier state between strains with and without K1 and K5 antigens. Plasmids of the same size were harboured by serotypes possessing K1 and K5 antigens, e.g. among O1: K1: H- strains plasmids of 60-79 Md, among O1: K1: H7, O18ac: K1: H7, O45: K1: H7 and O83: K1: H- strains plasmids of 80-95 Md were frequent. The average plasmid number was higher in K1 strains than in K5 strains. In serogroup O1 the frequency of the plasmid carrier state was associated with the O serogroup and not with the K antigen. The plasmid number in K5 of serogroups O6 and O18 was lower than in K5- strains. Plasmids of 80-95 Md were predominant among the strains derived from blood and cerebrospinal fluid, whereas these plasmids were rare among the K1 and K5 strains isolated from other sources. Plasmids of 60-79 Md were frequent among strains derived from different sources. The 30-40 Md plasmids were relatively frequent among strains isolated from urine. In contrast with literary data, O1: K1: H-, O1: K1: H7 and other frequent serotypes consisted of different clones. Different clones were found within a single serotype, too.

Anti-Bacterial Agents↗

Influence of protective drugs on the elevation of extracellular potassium ion concentration in the brain during ischaemia.

Influence of drugs on the changes of extracellular potassium ion concentration in the brain during total cerebral ischaemia was investigated. The aorta of the dogs was clamped twice with an intermittent reperfusion period of 60 min. In control experiments no significant difference was found in the elevation of extracellular potassium ion concentration of the brain during the first and second clampings. In the present study drugs were administered 10 min prior the second aorta occlusion. Verapamil in a dose of 0.125 mg/kg proved to be ineffective. Piridoxilate in a dose of 10 mg/kg and piracetam in a dose of 100 mg/kg delayed to a small extent the potassium outflow. The following drugs enhanced significantly the duration before the steep increase of potassium ion outflow: phenytoin in a dose of 10 mg/kg by 31.8 sec (p less than 0.01), ethyl-butyl-thiobarbital in a dose of 15 mg/kg by 30.2 sec (p less than 0.05), and lidocaine in a dose of 100 mg/kg by 115.8 sec (p less than 0.01). Comparing present results to our earlier data (obtained after 50 sec ischaemia) it can be concluded, that these protective influences become more effective during longer ischaemic period (2-5 min), when lidocaine, phenytoin and ethyl-butyl-thiobarbital were used. Moreover, in spite of the observation seen during shorter ischaemia, even piridoxilate and piracetam exerted some degree of protective effect. No such effect of verapamil could be detected in the present experimental model.

Animals↗

Influence of protective drugs on the EEG during short-term transient ischaemia.

Influence of drugs on the cessation time of the brain electrical activity (resistance time) during total cerebral ischaemia evoked by clamping of the aorta for 50 sec; on the duration of its reappearance during reperfusion (restitution time) and on the background activity of EEG were studied. The experiments were carried out in 7 groups. Each group contained 5 animals. Nine clampings with intermittent reperfusion periods of 10 min were performed in each animal. One group served as control. In the remaining ones after the first three clampings the animals were given Glyo-6, Nootropil, Verpamil, Epanutin, Inactin or Lidocain. The resistance and restitution times measured in the control group as well as the reproductibility of the power spectrum values of the EEG provided evidence for the stability of the model. Glyo-6 in a dose of 10 mg/kg, Nootropil in a dose of 100 mg/kg or Verpamil in a dose of 0.125 mg/kg did not alter the above-mentioned parameters. As an effect of the administration of Epanutin in a dose of 10 mg/kg, the resistance time increased slightly, whereas restitution time decreased significantly. Administration of Inactin in a dose of 15 mg/kg, or Lidocain in a dose of 100 mg/kg increased considerably resistance time for a period of about one hour. The results indicate that in the initial phase of ischaemic brain damage both the cessation of EEG activity and the restitution during reperfusion after short-term occlusion of the circulation can be influenced favourable with drugs which decrease cerebral metabolism, inhibit synaptic transmission and have membrane stabilizing effect.

Animals↗

Ethical issues in growth hormone therapy.

Pediatricians face clinical and ethical dilemmas about therapy to augment growth in short children who do not meet classic criteria for growth hormone (GH) deficiency. Biologic norms of health are unhelpful because of the uncertain relationship between stature, GH secretion, health, and disease. Instead, we suggest that GH therapy be evaluated from the perspective of cultural norms. We compare GH therapy for short normal children with currently accepted therapies for non--life-threatening pediatric conditions such as well-child care, cosmetic therapy, treatment of psychological problems, and invasive outpatient therapy for chronic conditions. Based on this analysis, we argue that the burdens of therapy, the uncertainty about long-term risks and benefits, the unclear therapeutic end point, and the implications for child health policy place routine GH therapy for children without documented deficiency of GH secretion outside current pediatric ethical norms. Such therapy is properly administered within a comprehensive clinical research protocol.

Beauty Culture↗

Possibility of brain recovery after electrically induced cardiac arrest and reanimation in dogs.

The changes of aortic blood pressure (BP), carotid artery flow (CAF), power spectrum of analysed EEG, neurologic deficit and survival rate were determinated in dogs after experimental cardiac arrest of different duration. Following artificially induced ventricular fibrillation of 1, 4, 10, 12 and 15 min duration successful cardiopulmonary resuscitation was performed in 30 experimental animals. Alterations of power spectrum during and after reanimation procedures, severity of the neurologic state and the survival rate deteriorated in parallel with the increasing duration of circulatory stop. Advantageous effect of direct heart massage could be demonstrated by the measuring circulatory parameters. Following a 15 min fibrillation, all animals were lost in a few hours despite the successful restoration of circulation and ventilation. Considering the various experimental and clinical conditions experimental cardiac arrest lasting for 12 min seems to be useful in extrapolating the results to human cases. The suggested model allows to study the brain function recovery after circulatory stop and resuscitation.

Animals↗