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Medical research: civil liability and compensation for personal injury--a discussion paper. Ciba Foundation Study Group.

The Ciba Foundation Study Group has considered the most appropriate means of compensating participants (or their relatives) for injuries received as a consequence of medical research. The group recognises that injury may occur despite the exercise of the highest degree of skill and care by the investigator and that compensation through an action for negligence is therefore not available. At present injured participants have to rely on ex gratia payments. The group considers this unsatisfactory and recommends the establishment of a centrally operated fund with authority to provide compensation on a no-fault basis. These recommendations do not diminish the rights of the participant to bring an action in the event of negligence on the part of the investigator or an action under the law relating to product liability against the manufacturers of defective equipment or drugs.

Drug Evaluation↗

Guidelines for the early management of patients with myocardial infarction. British Heart Foundation Working Group.

In light of recent publications relating to resuscitation and pre-hospital treatment of patients suffering acute myocardial infarction of British Heart Foundation convened a working group to prepare guidelines outlining the responsibilities of general practitioners, ambulance services, and admitting hospitals. The guidelines emphasise the importance of the rapid provision of basic and advanced life support; adequate analgesia; accurate diagnosis; and, when indicted, thrombolytic treatment. The working group developed a standard whereby patients with acute myocardial infarction should receive thrombolysis, when appropriate, within 90 minutes of alerting the medical or ambulance service--the call to needle time. Depending on local circumstances, achieving this standard may involve direct admissions to coronary care units, "fast track" assessments in emergency departments, or pre-hospital thrombolytic treatment started by properly equipped and trained general practitioners.

Clinical Protocols↗

A logical foundation for representation of clinical data.

OBJECTIVE: A general framework for representation of clinical data that provides a declarative semantics of terms and that allows developers to define explicitly the relationships among both terms and combinations of terms. DESIGN: Use of conceptual graphs as a standard representation of logic and of an existing standardized vocabulary, the Systematized Nomenclature of Medicine (SNOMED International), for lexical elements. Concepts such as time, anatomy, and uncertainty must be modeled explicitly in a way that allows relation of these foundational concepts to surface-level clinical descriptions in a uniform manner. RESULTS: The proposed framework was used to model a simple radiology report, which included temporal references. CONCLUSION: Formal logic provides a framework for formalizing the representation of medical concepts. Actual implementations will be required to evaluate the practicality of this approach.

Computer Simulation↗

The religious foundations of health care: a conceptual approach.

The relationship of religion and health is often misunderstood owing to a tendency to concentrate on the medical model and to ignore the wider context of heath care. A conceptual--as opposed to a historical--examination of this context reveals nine central religious ideas or categories which provide an ethical foundation and heritage for medical practice and health care delivery. These include doctrines of creation; dominion or stewardship; freedom and responsibility; human dignity or sanctity of life; love or compassion; covenant; justice; vocation; and finitude. A discussion of the complementarity of religion and medicine is necessary and should proceed from these shared values and common concerns.

Delivery of Health Care↗

On the microscopic foundations of elasticity.

The modeling of the elastic properties of disordered or nanoscale solids requires the foundations of the theory of elasticity to be revisited, as one explores scales at which this theory may no longer hold. The only cases for which microscopically based derivations of elasticity are documented are (nearly) uniformly strained lattices. A microscopic approach to elasticity is proposed. As a first step, microscopically exact expressions for the displacement, strain and stress fields are derived. Conditions under which linear elastic constitutive relations hold are studied theoretically and numerically. It turns out that standard continuum elasticity is not self-evident, and applies only above certain spatial scales, which depend on details of the considered system and boundary conditions. Possible relevance to granular materials is briefly discussed.

Journal Article↗

Foundations of a query and simulation system for the modeling of biochemical and biological processes.

The analysis of large amounts of data, produced as (numerical) traces of in vivo, in vitro and in silico experiments, has become a central activity for many biologists and biochemists. Recent advances in the mathematical modeling and computation of biochemical systems have moreover increased the prominence of in silico experiments; such experiments typically involve the simulation of sets of Differential Algebraic Equations (DAE), e.g., Generalized Mass Action systems (GMA) and S-systems. In this paper we reason about the necessary theoretical and pragmatic foundations for a query and simulation system capable of analyzing large amounts of such trace data. To this end, we propose to combine in a novel way several well-known tools from numerical analysis (approximation theory), temporal logic and verification, and visualization. The result is a preliminary prototype system: simpathica/xssys. When dealing with simulation data simpathica/xssys exploits the special structure of the underlying DAE, and reduces the search space in an efficient way so as to facilitate any queries about the traces. The proposed system is designed to give the user possibility to systematically analyze and simultaneously query different possible timed evolutions of the modeled system.

Biochemical Phenomena↗

Theoretical foundation of Chinese medicine: a modern interpretation.

The theoretical foundation of Chinese medicine as laid down in Hwang Ti Nei Ching is presented and interpreted here in modern language and conception. Our attempt is to bring Chinese medicine in harmony with Western science. Three Yin-Yang laws are formulated based on I Ching and Nei Ching and are justified from physics, mathematics and biology. The Wu-Hsing dynamic model is explained on the basis of dynamic interactions rather than static elements. The Ching-Lo doctrine is stressed upon its apparent correlations with the autonomic nervous system. Finally, the Chi is taken to play a role in life as the fields (gravitational, magnetic, nuclear, etc.) do in the physical world.

China↗

Forensics and mitochondrial DNA: applications, debates, and foundations.

Debate on the validity and reliability of scientific methods often arises in the courtroom. When the government (i.e., the prosecution) is the proponent of evidence, the defense is obliged to challenge its admissibility. Regardless, those who seek to use DNA typing methodologies to analyze forensic biological evidence have a responsibility to understand the technology and its applications so a proper foundation(s) for its use can be laid. Mitochondrial DNA (mtDNA), an extranuclear genome, has certain features that make it desirable for forensics, namely, high copy number, lack of recombination, and matrilineal inheritance. mtDNA typing has become routine in forensic biology and is used to analyze old bones, teeth, hair shafts, and other biological samples where nuclear DNA content is low. To evaluate results obtained by sequencing the two hypervariable regions of the control region of the human mtDNA genome, one must consider the genetically related issues of nomenclature, reference population databases, heteroplasmy, paternal leakage, recombination, and, of course, interpretation of results. We describe the approaches, the impact some issues may have on interpretation of mtDNA analyses, and some issues raised in the courtroom.

DNA, Mitochondrial↗

Teleradiology as a foundation for an enterprise-wide health care delivery system.

An effective, integrated telemedicine system has been developed that allows (a) teleconsultation between local primary health care providers (primary care physicians and general radiologists) and remote imaging subspecialists and (b) active patient participation related to his or her medical condition and patient education. The initial stage of system development was a traditional teleradiology consultation service between general radiologists and specialists; this established system was expanded to include primary care physicians and patients. The system was developed by using a well-defined process model, resulting in three integrated modules: a patient module, a primary health care provider module, and a specialist module. A middle agent layer enables tailoring and customization of the modules for each specific user type. Implementation by using Java and the Common Object Request Broker Architecture standard facilitates platform independence and interoperability. The system supports (a) teleconsultation between a local primary health care provider and an imaging subspecialist regardless of geographic location and (b) patient education and online scheduling. The developed system can potentially form a foundation for an enterprise-wide health care delivery system. In such a system, the role of radiologist specialists is enhanced from that of a diagnostician to the management of a patient's process of care.

Appointments and Schedules↗

First principles: physical science concepts as a foundation for advanced studies in physiology.

The importance of mathematics and physical science to physiology is amply evident in both the classic and current literature of this field. Students who have completed typical medical school preparatory programs, however, have been poorly equipped to embark on serious graduate study in physiology. Because undergraduate education in the sciences is typically structured as narrowly defined, disjointed degree programs in separate disciplines, students of biology have had only limited access to the resources of physical science departments. Attempts by physiology faculty to remedy specific deficiencies on a piecemeal basis have been found to be both time consuming and ineffective. We describe an intensive one-semester course as an alternative. Maintaining high levels of generality and concentrating on the development of physical insight were possible only when the mathematical foundation attained by the students was adequate. Although physiological applications were stressed throughout, extended examination of complex problems was limited to a few examples of particular interest. Emphasis was placed on rigor and sophistication rather than proficiency and detail.

Mathematics↗

Current status of renal replacement therapy for acute renal failure. A survey of US nephrologists. The National Kidney Foundation Council on Dialysis.

Although the management of acute renal failure (ARF) constitutes a major component of the activities of practicing nephrologists, minimal information is available on the dialysis techniques utilized to treat ARF in the USA. It is evident from several recent publications that there are wide variations in the dialytic and nondialytic management of ARF. In order to obtain a better understanding of the current practice for dialytic management of ARF, the National Kidney Foundation (NKF) Council on Dialysis commissioned a survey of NKF members. This article describes the results of this survey and provides a snapshot of the current management practices for ARF. It is our hope that this information will provide a baseline for further research in this area.

Acute Kidney Injury↗

Image guidance: the Foundation for the Future Design of Neurosurgical Procedural Facilities.

Today's image guidance systems are the foundation of minimally invasive diagnosis and therapy and are the basis for the rational design of the neurosurgical operating room of the future. The building blocks of this procedural arena will be (1) high-resolution MR/CT anatomic imaging supplemented with (2) functional imaging using MR and magnetoencephalography, (3) real-time image monitoring using ultrasound probes, open MR and portable CT adapted to image guidance systems and (4) conformal radiosurgery systems. Although the initial investment in such facilities may be high, eventual cost saving through added precision and safety will result in shorter inpatient stays, lower morbidity and more complete realization of treatment goals.

Diagnostic Imaging↗

The Stanley Foundation Bipolar Network: results of the naturalistic follow-up study after 2.5 years of follow-up in the German centres.

The Stanley Foundation Bipolar Network (SFBN) is an international, multisite network investigating the characteristics and course of bipolar disorder. Methods (history, ratings and longitudinal follow-up) are standardized and equally applied in all 7 centres. This article describes demographics and illness characteristics of the first 152 German patients enrolled in the SFBN as well as the results of 2.5 years of follow-up. Patients in Germany were usually enrolled after hospitalisation. More than 72% of the study population suffered from bipolar I disorder and 25% from bipolar II disorder. The mean +/- SD age of the study participants was 42.08 +/- 13.5 years, and the mean +/- SD age of onset 24.44 +/- 10.9 years. More than 40% of the sample reported a rapid-cycling course in history, and even more a cycle acceleration over time. 37% attempted suicide at least once. 36% had an additional Axis I disorder, with alcohol abuse being the most common one, followed by anxiety disorders. During the follow-up period, only 27% remained stable, 56% had a recurrence, 12.8% perceived subsyndromal symptoms despite treatment and regular visits. 27% suffered from a rapid-cycling course during the follow-up period. Recurrences were significantly associated with bipolar I disorder, an additional comorbid Axis I disorder, rapid cycling in history, a higher number of mood stabilizers and the long-term use of typical antipsychotics. Rapid cycling during follow-up was only associated with a rapid-cycling course in history, a higher number of mood stabilizers and at least one suicide attempt in history.

Adult↗

Effects of dementia on mortality in the radiation effects research foundation adult health study.

BACKGROUND: Although dementia is rarely listed on death certificates, it does contribute to mortality. The predominant immediate causes of death coincident with dementia are pneumonia and cardiovascular diseases. OBJECTIVE: To estimate the impact of dementia on specific mortality risks. METHODS: We applied DSM-III/R criteria for Alzheimer's disease (AD) and vascular dementia (VaD) to 2,172 subjects of the Adult Health Study of the Radiation Effects Research Foundation who were 60 or more years old when examined from 1992 to 1996. The underlying causes of death were compiled from death certificates. We performed a Poisson regression analysis to evaluate specific causes of mortality for which AD or VaD was a significant risk factor. RESULTS: The relative risk of mortality was 2.2 for AD and 2.4 for VaD. Mortality from pneumonia and stroke was elevated for both types of dementia, independent of other medical conditions. AD was also associated with death from trauma. CONCLUSION: Dementia was a predictor of death due to pneumonia, stroke, and trauma among the Japanese elderly. The prevention and early detection of those conditions are important in the medical care and treatment of dementia cases.

Aged↗

Physical and technical foundations of diagnostic ultrasound.

The physical and technical foundations of investigations with diagnostic ultrasound are discussed. Two questions need to be answered: what is ultrasound, and how does an ultrasonic device operate? The mechanical properties of the human body are described by physical laws, such as the propagation of ultrasound waves, the interaction of ultrasound with tissue, attenuation, reflection, refraction, etc. Today high-technology ultrasonic devices are driven by computers. Imaging of the same kidney with different devices shows the progress made in image quality over a period of about 15 years. Details of tissue and biometry are largely enhanced. Powerful tools allow different forms of precise analysis of online measurements. Advanced handling of information gives further opportunities to image processing. The final question is the extent to which the physician and surgeon want to work with such as sophisticated high-technology imaging system and learn to manage its hard- and software.

Humans↗

Activation of emergency medical services for acute stroke in a nonurban population: the T.L.L. Temple Foundation Stroke Project.

BACKGROUND AND PURPOSE: Activating emergency medical services (EMS) is the most important factor in reducing delay times to hospital arrival for stroke patients. Determining who calls 911 for stroke would allow more efficient targeting of public health initiatives. METHODS: The T.L.L. Temple Foundation Stroke Project is an acute stroke surveillance and intervention project in nonurban East Texas. Prospective case ascertainment allowed chart abstraction and structured interviews for all hospitalized stroke patients to determine if EMS was activated, and if so, by whom. RESULTS: Of 429 validated strokes, 38.0% activated EMS by calling 911. Logistic regression analysis comparing those who called 911 with those who did not activate EMS found that individuals who were employed were 81% less likely to have EMS activated (OR 0.19, 95% CI 0.04 to 0.63). Of the 163 cases in which 911 was called, the person activating EMS was: self (patient), 4.3%; family member of significant other, 60. 1%; paid caregiver, 18.4%; and coworker or other, 12.9%. Significant associations between the variables age group (P=0.02), insurance status (P=0.007), and living alone (P=0.05) with who called 911 was found on chi(2) analysis. CONCLUSIONS: Educational efforts directed at patients themselves at risk for stroke may be of low yield. To increase the use of time dependent acute stroke therapy, interventions may wish to concentrate on family, caregivers, and coworkers of high-risk patients. Large employers may be good targets to increase utilization of EMS services for acute stroke.

Acute Disease↗

Overview: foundations of cultural psychiatry.

The authors demonstrate the significance of adding the cultural dimension to basic psychiatric concepts. They point out the areas in which the work of anthropology and social psychology are relevant to psychiatry, including understanding mental health and illness, child-rearing practices and their effects on personality, cognition, family and social networks, sex roles and behavior, alcohol use, communication, and therapy. They also present some of the major conceptual foundations of cultural psychiatry, which include ethnography, emic and etic approaches, the cross-cultural approach, and the study of subjective culture.

Alcohol Drinking↗

Philosophical foundations of French and U.S. nosology.

The author examines the philosophical foundations of French and American nosology with a view toward understanding the relatively minor influence of French psychiatry in America. Despite the excellence of its descriptive psychiatry, much of French nosological writing is based on philosophical viewpoints that are antithetical to the empirical and pragmatic traditions of American psychiatry. French nosology, which is closely involved with the metaphysical issues of existentialism, phenomenalism, and structuralism, reveals these interests in language and concepts that do not easily permit its hypotheses to be scientifically tested, a prerequisite for any American classification.

France↗