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Admissibility of scientific evidence post-Daubert.

Proof of medical causation is the key element in cases involving alleged radiation injury. Until 1993, the use of scientific testimony in the courtroom was governed by the Frye doctrine requiring that a theory be "generally accepted" before it can be the basis of an expert's opinion. Applying that rule trial courts adopted a "let it all in" approach resulting in a near overdose of pseudoscience presented to juries. With its decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786 (1993), the U.S. Supreme Court announced a new five-factor, non-exclusive test for federal district courts to consider when assessing the opinion of scientific experts. The Court further directed that the trial courts, acting as a gatekeeper for expert evidence, must evaluate whether there is an adequate "fit" between the expert's data and the opinion offered. This article examines how the Daubert standard has been implemented in federal court to combat junk science. Examples from recent case law dealing with operational health physics issues are presented as an illustration of the use of the five-factor test to challenge questionable testimony on causation. Guidance is offered to prospective expert witnesses in radiation-related litigation to insure that proposed testimony will be admissible in district court.

Causality↗

Reorganization of a burn unit in response to underutilization: a critical assessment.

The incidence of burn injury in the United States has declined over the past few years, resulting in a dramatic decrease in the number of admissions to burn centers. This decrease has generated considerable concern, leading to a variety of proposals to modify burn units to control the cost of inpatient care. In 1986 Albany Medical Center Hospital, a 654-bed regional academic health sciences center, closed its burn unit and implemented a program to manage thermally injured patients in the intensive and progressive care areas of the medical center. A retrospective study was performed to compare patient outcomes and length of stay for the dedicated burn unit and the integrated burn program. Between the year before and the year after this change there was no significant difference in mortality rate, length of stay, or number of positive blood cultures. The relationship between burn severity and length of stay was unaltered by the burn program change. A comparison of data collected just after the change to those collected 2 years later again showed no difference, except that the annual census had dropped more than 50%. The results suggest that burn units can be converted to integrated burn programs without compromising patient care outcomes, although the lack of a cohesive burn team and the unavailability of beds designated for patients with burns ultimately resulted in a deemphasis of the burn program and consequent marked reduction in the number of patients with burns seen in the institution.

Burn Units↗

Sleep loss and fatigue in medical training.

The effects of sleep loss and fatigue in the context of medical training is a topic that has generated considerable interest, as well as controversy, over the past two decades. The sleep deprived state in medical trainees potentially impacts on a variety of domains relevant to medical care, including performance on neurobehavioral and work-related tasks, mood and affect, learning, risk for and commission of medical errors, and the health and well-being of medical students and residents. The following review provides a summary of research conducted on this topic in the past decade, including the relation of sleep loss and fatigue to medical errors and the quality of patient care. Those few studies that have analyzed the use of operational alertness management strategies, countermeasures, and educational interventions to address and mitigate the effects of sleep loss and fatigue are also reviewed. There is clearly a need for additional research to further explore the complex interaction between sleep and fatigue and medical care, and to support the development and implementation of regulatory policies based on sound science.

Clinical Competence↗

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

Attitude of Health Personnel↗

Effect of a mandatory geriatric medicine clerkship on third-year students.

A nationwide push has increased geriatric medicine instruction within medical school curricula. Some institutions have proceeded with an integrated 4-year curriculum while others have constructed discrete courses in the third or fourth year of medical school. This paper describes the impact of a new mandatory 4-week geriatric medicine clerkship on third-year students developed by the Donald W. Reynolds Department of Geriatric Medicine at the University of Oklahoma Health Sciences Center. In the first year of implementation, 135 students took the course on both the Oklahoma City and Tulsa campuses. Clinical sites included inpatient, VA extended care unit, outpatient clinics, dementia clinics, home care, long-term care settings, and hospice. Didactic instruction used formal lectures and problem-based learning. The impact of the clerkship on students was assessed in three areas: knowledge, skills, and attitude using a pre- and postknowledge test, student satisfaction survey, and written comments. This article discusses how the clerkship resulted in increased knowledge of geriatric medicine. Student self-report indicates that the clerkship enhanced clinical evaluation and patient assessment skills. Students indicated that the experience was positive and recognized the importance of geriatric medicine in their development as doctors.

Aged↗

Student evaluation of an OSCE in paediatrics at the University of the West Indies, Jamaica.

BACKGROUND: The Faculty of Medical Sciences, University of the West Indies first implemented the Objective Structured Clinical Examination (OSCE) in the final MB Examination in Medicine and Therapeutics during the 2000-2001 academic year. Simultaneously, the Child Health Department initiated faculty and student training, and instituted the OSCE as an assessment instrument during the Child Health (Paediatric) clerkship in year 5. The study set out to explore student acceptance of the OSCE as part of an evaluation of the Child Health clerkship. METHODS: A self-administered questionnaire was completed by successive groups of students immediately after the OSCE at the end of each clerkship rotation. Main outcome measures were student perception of examination attributes, which included the quality of instructions and organisation, the quality of performance, authenticity and transparency of the process, and usefulness of the OSCE as an assessment instrument compared to other formats. RESULTS: There was overwhelming acceptance of the OSCE in Child Health with respect to the comprehensiveness (90%), transparency (87%), fairness (70%) and authenticity of the required tasks (58-78%). However, students felt that it was a strong anxiety-producing experience. And concerns were expressed regarding the ambiguity of some questions and inadequacy of time for expected tasks. CONCLUSION: Student feedback was invaluable in influencing faculty teaching, curriculum direction and appreciation of student opinion. Further psychometric evaluation will strengthen the development of the OSCE.

Attitude of Health Personnel↗

Clinical data retrieval: 25 years of temporal query management at the University of Vienna Medical School.

OBJECTIVES: Today, many clinical information systems include analysis components which allow clinicians to apply a selection of predefined statistical functions that satisfy typical cases. They are mostly to inflexible to handle complex, non-standard problems, however. The focus of this paper, therefore, is to present an approach that enables clinicians to autonomously create ad hoc queries including temporal relations in an interactive environment. METHODS: We developed the query language AMAS, which was specifically customized for users from the medical domain to flexibly retrieve and interpret temporal, clinical data. AMAS provides for a significant temporal expressiveness in data retrieval using time-stamped clinical databases and relies on an operator-operand concept for the specification of a query. RESULTS: Within the last 25 years, four different clinical retrieval systems have been implemented at the Department of Medical Computer Sciences, based on the AMAS query language. Currently, these systems allow access to the medical records of more than 2 million patients. Physicians of 46 different departments at the University of Vienna and Graz Medical Schools have made extensive use of these systems in the course of clinical research and patient care, executing more than 10,000 queries per year. CONCLUSIONS: We discuss a list of 20 issues that represent the most essential lessons we have learned in the development of the four systems mentioned above. Amongst others, our experiences indicate that the operator-operand concept allows on intuitive specification of complex, temporal queries. Further, customization to different user classes, based on their statistical background, is essential.

Austria↗

[How to improve the initial management of adult patients with tumors of bone and soft tissues: the experience of a multidisciplinary committee from the Oncolor network before the distribution of regional guidelines].

Tumors of bone and soft tissues in adults are rare accounting in France for 2000 to 2500 new cases per year. These tumors are heterogenous and their diagnosis is made after first surgery. Therefore, an early pluridisciplinary approach, by physicians who have acquired an expertise in this field, is advised before any biopsy or surgical resection and at all the further step in the subfrequent management. This paper describes the experience of a pluridisciplinary committee, specialized in malignant tumors of bone and soft tissues in adults, with a highly specialized team which is part of a network in the treatment of cancer in Lorraine, the Oncolor network, before the distribution of regional guidelines. After a description of the organisation of this committee, we made a retrospective analysis of all the cases submitted to these experts advice for the first time, between January and December 2000. This study reveals an insufficient pluridisciplinary coordination at the initial management, which has been done by making regional referentials available, and therefore some errors which lead in some cases to inadapted treatment. It underlines therefore the necessity to implement more actively the present data of science, and to develop the management in multidisciplinary committees. Oncolor aims to harmonize this pluridisciplinary approach as well as to diffuse standard recommendations.

Adult↗

Preparing the next generation of advanced practice nurses.

The Institute of Medicine's vision for health professions education highlights the importance of informatics competencies for all graduates. This paper describes an innovative course, required for all graduate students at the University of Colorado Health Sciences Center School of Nursing. The design, implementation, and evaluation of NURS6013, Human Technology Interface provides evidence to support it as one model for consideration in meeting the Institute of Medicine's vision for health professions education: The course provides learning opportunities which examine the impact of technology on society and health care, informatics and human factors, as well as the legal, ethical, and policy issues related to the use of technology.

Colorado↗

[The development, transfer and use of medical technology as a special subject of research].

Regardless of the real exposion of scientific findings and information concerning medical sciences, research in the field, especially fundamental one, has rather insignificant influence on the development of new technologies, applicable in everyday medical practice (pull technologies). Far greater significance has been put on research in other fields, usually initiated with other purposes. "Side product" of that research is the development of these technologies which are best applicable in medicine (push-technologies). This is not the only reason why, as a rule, there is no direct connection between researchers and those supposed to apply and use new technologies. Initiation of evaluational research in the field of medical technologies will be the only way to establish the relationship between the two groups of actors: researchers and implementators.

Medical Laboratory Science↗

Public, experts, and acceptance of advanced medical technologies: the case of organ transplant and gene therapy in Japan.

In 1997, after long social debates, the Japanese government enacted a law on organ transplantation from brain-dead bodies. Since 1993, on gene therapy, administrative agencies have issued a series of guidelines. This study seeks to elucidate when people became aware of the issues and when they formed their opinions on organ transplant and gene therapy. At the same time, it aims to examine at which point in time experts, those in university ethical committees and in academic societies, consider these technologies became accepted among the public. A self-administered questionnaire was sent by mail to a stratified random sampling of 3,000 people nationwide in Japan. Another questionnaire was sent both to the member societies of the Japanese Association of Medical Sciences and to the ethical committees of all the medical schools in Japan. Results of the surveys indicated that many of the public remained undecided on the desirability of organ transplant or gene therapy at the time of enactment of official guidelines. A substantial part of them formed their opinions in subsequent periods, especially around the time of first implementation and thereafter. Experts of the academic societies and of the university ethical committees regarded the time of implementation as an important factor in the acceptance of the technologies in society. Since many people formed their opinion during the period of technological implementation, communications efforts to facilitate public understanding of science and technology, as well as to advance practical discussion on policy alternatives in this period can play a key role in determining the fate of technological innovation and ethical debates in medicine.

Expert Testimony↗

Patient safety--how much is enough?

Awareness of errors in health care has skyrocketed in recent years, and huge resources have been mobilised to measure and reduce the harm. This is a good thing, and long overdue. But current improvement recommendations have ignored the costs of prevention and have prioritized improvements by the rigour with which they have been studied. The current proliferation of safety goals and required or recommended safe practices threatens to overwhelm the capacity of hospitals to safely implement change, yet the cost-effectiveness of most proposed improvements remains unknown. Unless we collect information on cost-effectiveness, and use it to prioritize both improvement initiatives and new safety research, society will not gain the maximum return (in terms of safety) for whatever resources are put into error reduction. This would be a bad thing. Hospitals are complex systems, largely dependent on human performance, so improving hospital safety is not simple. Every change must be implemented with an understanding of human factors engineering and safety science, and even good changes can create unexpected new hazards. Increased safety precautions reduce preventable adverse events but generally impose both direct costs (to implement the safety precautions) and hidden costs (in the form of delays, new errors, or lost opportunities elsewhere). Perfect safety is not always possible and near-perfect-safety may impose unacceptably high costs. The goal of minimizing the total cost of both accidents and accident-prevention requires information on both costs and effects of specific safety improvements. Such information is also needed to prioritize suggested safety improvements, when all cannot be implemented immediately. This evidence can best be produced using the economic evaluation loop, an iterative process involving routine, periodic, assessment of costs and effects, and targeted original research where initial estimates reveal uncertainty in key values.

Cost-Benefit Analysis↗

Science, technology and ethics: from critical perspective to dialectical perspective.

It has been agreed upon, according to critical perspective, to distinguish the problems raised by scientific issues on the one hand and the problems raised by moral issues on the other. This distinction, at the genesis of theoretical ideology, postulates that experimental science is mere knowledge which, since it has nothing to do with action, cannot raise a moral problem. Yet the use of experimental techniques turns out to be a necessary means, although an insufficient one, to put to the test and to confirm the theoretical hypothesis of science. Thus, those techniques produce perceptible effects which can be assimilated to genuine transformation and are consequently capable of raising moral problems. It follows that the technical imperative of science can be conditioned by a moral imperative of technique, which leads to modification of the object of the research and dubs it, a dialectical object. It is, however, advisable to effect a demarcation between that which, within the frame work of research in experimental science, can pose a moral problem and which cannot. The criterion of refusability of practical projects, by analogy with Popper's criterion of refutability of theoretical conjectures, allows for this demarcation to be implemented. It postulates that only the technical projects of science, apart from scientific theories, can pose a moral problem or can be recognized as moral, providing that the conditions of a possible ethical refusal can be expressed. From the analysis and the synthesis of heterogeneous possibilities, dialectical perspective thus outlined represents an endeavour to go beyond critical perspective, while trying to seek an intermediary channel between the "progressist dogmatism" of science and the obscurantist scepticism" of morals.

Ethics↗

The impact of a newly implemented PBL curriculum on the National Board of Chiropractic Examiners Part I Examinations at the National University of Health Sciences.

BACKGROUND: Performance differences between students of traditional lecture-based curricula and students of problem-based learning (PBL) curricula on standardized National Board Examinations have been studied. PURPOSE: To assess the impact and effectiveness of a change from a traditional lecture-based curriculum to a PBL curriculum. METHODS: Student performance in a traditional lecture-based curriculum (entering class of 1997) was compared to student performance in a PBL curriculum (entering class of 1998) on the standardized National Board of Chiropractic Examiners Part I Examination. RESULTS: There was a difference between the two curricula, with the PBL curriculum students outperforming the traditional lecture-based curriculum students on each individual part (d =.36-.95) of the National Board Examination and overall (d =.96). CONCLUSION: A comparison of student performance on a standardized National Board Examination has proved a useful tool at quantifying the impact of a newly implemented PBL curriculum.

Adult↗

Providing access to blacks and Hispanics in dietetics education.

To increase the number of blacks and Hispanics in dietetics and three other health professions, the Health Sciences Recruitment and Retention Program was developed and implemented in 1985 by the College of Health at Florida International University in Miami. The coordinated undergraduate program assisted in a federal grant to accomplish the objectives of recruiting and retaining minority students. High school and community college students were recruited using a slide/tape presentation featuring black and Hispanic professionals. In addition, the college offered a summer course entitled "Perspectives of the Health Sciences Professions" to students entering their senior year in high school. In this course, students learned how dietitians, medical laboratory scientists, and physical and occupational therapists treat various disease states. Field trips and site visits provided additional exposure to the professions. A summer orientation and tutorial program was established to retain minority students enrolled in the coordinated undergraduate program. We recommend that this program be considered as a model for dietetics educators to use in developing other programs to increase the number of minorities in the profession.

Black or African American↗

Understanding implementation: the case of a computerized physician order entry system in a large Dutch university medical center.

Most studies of the impact of information systems in organizations tend to see the implementation process as a "rollout" of technology, as a technical matter removed from organizational dynamics. There is substantial agreement that the success of implementing information systems is determined by organizational factors. However, it is less clear what these factors are. The authors propose to characterize the introduction of an information system as a process of mutual shaping. As a result, both the technology and the practice supported by the technology are transformed, and specific technical and social outcomes gradually emerge. The authors suggest that insights from social studies of science and technology can help to understand an implementation process. Focusing on three theoretical aspects, the authors argue first that the implementation process should be understood as a thoroughly social process in which both technology and practice are transformed. Second, following Orlikowski's concept of "emergent change," they suggest that implementing a system is, by its very nature, unpredictable. Third, they argue that success and failure are not dichotomous and static categories, but socially negotiated judgments. Using these insights, the authors have analyzed the implementation of a computerized physician order entry (CPOE) system in a large Dutch university medical center. During the course of this study, the full implementation of CPOE was halted, but the aborted implementation exposed issues on which the authors did not initially focus.

Academic Medical Centers↗

Social science and the public agenda: reflections on the relation of knowledge to policy in the United States and abroad.

It is tempting to oversell the practical value of applied research. A hard look at the effects of U.S. social science on public policy in areas such as active labor market policies (training, job creation, placement, etc.), crime prevention, fiscal policy, poverty reduction, and health care reform suggests an inverse relationship between social science consensus and policy and budgetary decisions. Fragmented and decentralized political economies (e.g., the United States) foster policy segmentation and isolated, short-run single-issue research--often politicized and misleading. More corporatist democracies (such as Sweden, Norway, Austria, and Germany) evidence a tighter relation between knowledge and power in which a wider range of issues is connected, longer-range effects are sometimes considered, and research is more often actually used for planning and implementation. Even in less hospitable societies, however, social science does make its way in the long run. Favorable conditions and examples are discussed.

Cross-Cultural Comparison↗

The LeMoyne-Owen College--UTCHS cooperative educational program: a model for minority recruitment.

A program of cooperative education between LeMoyne-Owen College and the University of Tennessee Center for the Health Sciences (UTCHS) was designed to attract students from the undergraduate institution to the various health professional schools at UTCHS. The program was initiated by a black faculty member at UTCHS. It involved a faculty exchange between the two institutions and the implementation of several changes in the pre-health science curriculum at the undergraduate institution. Other components of the program included: the gift of equipment and supplies to LeMoyne-Owen College by UTCHS; counseling of LeMoyne-Owen students by UTCHS faculty members; the generation of private funds by the faculty and staff at UTCHS for the support of LeMoyne-Owen students participating in the cooperative education program; and broad exposure of LeMoyne-Owen students to the laboratories and clinical facilities at UTCHS.

Black or African American↗