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Good clinical practices: past, present, and future.

Clinical quality assurance has its roots in the evolution of the GCPs. Historically, the fundamental elements of GCPs provided a springboard to develop and refine a paradigm of standard measurements to assure the integrity and quality of research. The research community spontaneously responded by voluntarily establishing quality assurance units and implementing auditing functions to ensure the highest standards in an industry that encompasses science, medicine, and ethics. Although clinical quality assurance is still unregulated in the United States, the performance of good clinical practices has become an integral part of the clinical research process and has impacted the research community on worldwide basis. The establishment of the EC guidelines, the WHO guidelines, and the International Conference on Harmonization are testaments to the increasing emphasis on the future of GCP-related activities.

Drug Approval↗

Interdisciplinarity: the story of a journey.

Everywhere we turn, interdisciplinarity has become a key concept guiding health care education and practice. Granting agencies call for it. Educational and health policy makers extol its virtues. Accreditation agencies across health disciplines recommend it as a competency for the present and future. But what is it? How do we get it from our educational and practice systems that are compartmentalized by claims to discipline-specific knowledge, tradition, and the flow of dollars from funding sources? What is it like after we do get it? And most of all, why would we ever want it in the first place? We have had some significant experience within our Division of Health Sciences in interdisciplinary teaching, practice, and scholarship. Our experience was initially framed by implementation of one of the seven W.K. Kellogg Foundation Community Partnerships for Health Professions Education grants. The grant brought the education of medical, nursing, and other health professions students out of the hospital to interdisciplinary primary care experiences in and with the community. We will never tell you we have a straightforward prescription for success. Living interdisciplinarity, like living life itself, is something that frequently poses more questions than it answers. We will, with enthusiasm, share with you what we have learned in our unique journey together in hopes that you and your colleagues will find something useful for your own voyage into interdisciplinarity.

Clinical Competence↗

[The organization of the database and data flow in mass screening for cervical cancer].

Mass screening, because of very many potential patients, requires storing and processing a great deal of medical and population information. That is why it should be supported not only by human resources but by computer techniques as well. The example of a computer science application in medicine is Populations Database System (PDB) which was designed and implemented in the Department of Institute of Mother and Child in Białystok. The aim of this work is to evaluate PDB System's effectiveness in mass screening for cervical cancer. Population database contains several standard database files (DBF) and indexes. All the data is organized as a relational database. Every data relationship is at least in 1NF (first normal form). Functional dependency holds for the structures of database. Because of great variety of stored data it was essential to design how to enter information and how to combine database files to avoid redundancy. It has particular importance for the special functions of system, for example printing and sending individual invitation for an examination. In addition the system can realize all standard database functions and some statistical analysis. Special attention was paid to the problem of data security which is particularly important for medical information. Thanks to PDB system we could realize mass and active screening for cervical cancer in Białystok. Without computer techniques it would be impossible to store, process and interpret so much data.

Databases as Topic↗

Establishing an endovascular abdominal aortic program--decisions, decisions, decisions: The London Health Sciences Centre experience.

The endovascular repair of abdominal or thoracic aortic aneurysms is an alternative approach to conventional repair in the compromised patient. Although the long-term efficacy of these procedures has yet to be proved, there is growing interest among vascular surgeons and interventional radiologists throughout North America and Europe in the more frequent use of this technique. Starting an endovascular program necessitates extensive cooperation of the interdisciplinary vascular team. Decisions regarding patient selection, equipment, supplies, staff education, and the location of the procedure must be based on sound principles. This article demonstrates how a program can be planned, implemented, and evaluated by the use of a "decision tree." The experience of the London Health Sciences Centre will be used as a benchmark in the discussion of relative merits of branch points in program development. The article gives persons contemplating a program a structured process in decision making to avoid potential pitfalls.

Angioplasty↗

Assessing outcomes of curricular change: a view from program graduates.

Graduates of dental programs constitute a stakeholder group that is able to provide unique information concerning the effectiveness of the dental curriculum in preparing them for dental careers. Following the implementation of planned curricular changes, graduates of the former and the new curricula were surveyed. Results indicate that, while both groups perceive themselves to have been adequately prepared by their D.D.S. program for practice, graduates of the new curriculum indicated a higher level of preparedness in several areas, especially regarding selecting, prescribing and administering pharmacotherapeutic agents. In addition, the results suggest that the change in the first two years from an emphasis on basic sciences and preclinical laboratory work to an early introduction to live dental patients and the integration of foundation sciences and clinical courses were endorsed. The evidence gathered from this alumni survey indicates that the reforms implemented in the dental curriculum were appropriate. Areas requiring further investigation are also discussed.

Attitude of Health Personnel↗

Crossing boundaries: implementing an interprofessional module into uniprofessional Bachelor programmes.

In accordance with the curriculum reforms within health education in Norway, the Faculty of Health Sciences at Oslo University College introduced in 1998 an interprofessional module, entitled "VEKS", for eight different professional programmes. A shared module of 30 credits (15 for technically oriented programmes) was introduced into the three-year programmes. A problem-based and project-oriented format was chosen as the teaching and learning model to enhance the interactive, experiential and collaborative learning. This paper describes experience gained during the five-year implementation period. Empirical data were collected through participatory observations, students' and tutors' evaluations and group interviews with tutors and faculty leaders. The innovative project described challenged traditional educational boundaries and structures, frames of thought and habits. It broadened perspectives within the particular professional programmes as well as preparing students for their future professional careers. Lessons learned can be summed up as: Time, resources and a certain staff consensus are needed to deal with and overcome traditions and attitudes, the students' learning is a socialization process which needs to be developed over time; intermittent interprofessional interventions during the three-year period was found to be inadequate, and the tutor role is essential in order to support the students' learning process.

Cooperative Behavior↗

Putting things in perspective: building on our experience.

The science and policy underlying food labeling and food fortification have evolved over the past 30 years to a point where dietary guidance and nutrition labeling now provide consumers with highly sophisticated, very specific information about links between diet and health. The focus was once on prevention of nutrient deficiency diseases, but today it is on reducing the risk of chronic diseases and health-related conditions. The Nutrition Labeling and Education Act of 1990, with its provisions for authorization of health claims on food labels, has provided a gateway through which a broader realm of nutrition and health information can be made available to consumers. However, the interpretation and implementation of the health claim provisions must evolve, based on a strong foundation of supporting science, so that industry may more readily make health information available to consumers in a form that is easily understood and effectively used in making their dietary choices. We must develop a database to support claims of beneficial effects of food components. We must be assured that the beneficial effects are not outweighed by safety concerns. And we must develop an environment that is conducive to conducting the research to develop these data. This can only be accomplished through the collaborative efforts of industry, academia, consumers and public health agencies.

Food Labeling↗

Perceptual symbol systems.

Prior to the twentieth century, theories of knowledge were inherently perceptual. Since then, developments in logic, statistics, and programming languages have inspired amodal theories that rest on principles fundamentally different from those underlying perception. In addition, perceptual approaches have become widely viewed as untenable because they are assumed to implement recording systems, not conceptual systems. A perceptual theory of knowledge is developed here in the context of current cognitive science and neuroscience. During perceptual experience, association areas in the brain capture bottom-up patterns of activation in sensory-motor areas. Later, in a top-down manner, association areas partially reactivate sensory-motor areas to implement perceptual symbols. The storage and reactivation of perceptual symbols operates at the level of perceptual components--not at the level of holistic perceptual experiences. Through the use of selective attention, schematic representations of perceptual components are extracted from experience and stored in memory (e.g., individual memories of green, purr, hot). As memories of the same component become organized around a common frame, they implement a simulator that produces limitless simulations of the component (e.g., simulations of purr). Not only do such simulators develop for aspects of sensory experience, they also develop for aspects of proprioception (e.g., lift, run) and introspection (e.g., compare, memory, happy, hungry). Once established, these simulators implement a basic conceptual system that represents types, supports categorization, and produces categorical inferences. These simulators further support productivity, propositions, and abstract concepts, thereby implementing a fully functional conceptual system. Productivity results from integrating simulators combinatorially and recursively to produce complex simulations. Propositions result from binding simulators to perceived individuals to represent type-token relations. Abstract concepts are grounded in complex simulations of combined physical and introspective events. Thus, a perceptual theory of knowledge can implement a fully functional conceptual system while avoiding problems associated with amodal symbol systems. Implications for cognition, neuroscience, evolution, development, and artificial intelligence are explored.

Cognition↗

Longitudinal and horizontal integration of nutrition science into medical school curricula.

The overall goal of our Nutrition Academic Award (NAA) medical nutrition program at Mercer University School of Medicine is to develop, implement and evaluate a medical education curriculum in nutrition and other aspects of cardiovascular disease (CVD) prevention and patient management with emphasis on the training of primary care physicians for medically underserved populations. The curriculum is 1) vertically integrated throughout all 4 y of undergraduate medical education, including basic science, clinical skills, community science and clinical clerkships as well as residency training; 2) horizontally integrated to include allied healthcare training in dietetics, nursing, exercise physiology and public health; and 3) designed as transportable modules adaptable to the curricula of other medical schools. The specific aims of our program are 1) to enhance our existing basic science problem-based Biomedical Problems Program with respect to CVD prevention through development of additional curriculum in nutrition/diet/exercise and at-risk subpopulations; 2) to integrate into our Clinical Skills Program objectives for medical history taking, conducting patient exams, diet/lifestyle counseling and referrals to appropriate allied healthcare professionals that are specific to CVD prevention; 3) to enhance CVD components in the Community Science population-based medicine curriculum, stressing the health-field concept model, community needs assessment, evidence-based medicine and primary care issues in rural and medically underserved populations; 4) to enhance the CVD prevention and patient management component in existing 3rd- and 4th-y clinical clerkships with respect to nutrition/diet/exercise and socioeconomic issues, behavior modification and networking with allied health professionals; and 5) to integrate a nutrition/behavior change component into Graduate Residency Training in CVD prevention.

Bioethics↗

From science to application: the development of an intervention package.

Many community-based organizations and health departments want to implement HIV prevention interventions with scientifically demonstrated effectiveness. The Replicating Effective Programs (REP) project supported researchers in developing intervention packages designed to help prevention partners replicate effective programs in their settings. Intervention packages convey the intervention's foundation, components, and methods and are one part of a larger system needed to transfer research-based HIV prevention technology to service providers. Implementation packages were developed using a multistage process. The original researchers drafted the materials, advisory groups reviewed the packages, and adopting agencies used the materials in trial runs. The advisory groups and adopting agencies recommended extensive use of examples, thorough explanations about the rationale for each intervention component, explicit representation of people of color in the materials, clear statements about the intended audience(s), and an easy-to-use and visually appealing format. Packages were revised based on these recommendations and the outcomes of the trial runs.

Community Health Services↗

Science and norms in policies for sustainable development: assessing and managing risks of chemical substances and genetically modified organisms in the European Union.

Use of chemical substances and genetically modified organisms cause complex problems characterised by scientific uncertainty and controversies. Aiming at sustainable development, policies for assessment, and management of risks in the two areas are under development in the European Union. The article points out that both science and norms play a central role in risk assessment as well as risk management and suggests that the precautionary principle, the principle of public participation, and the polluter pays principle, all adopted in the European Union, offer a way to operationalise the concept of sustainable development. It is shown, however, that a number of steps ought to be taken to better implement the principles through different policy measures. In doing so, and by recognising the role of both science and norms, the decision-making on risks related to the use of chemicals or genetically modified organisms can be improved to better promote sustainable development.

Chemical Industry↗

Memories for life: a review of the science and technology.

This paper discusses scientific, social and technological aspects of memory. Recent developments in our understanding of memory processes and mechanisms, and their digital implementation, have placed the encoding, storage, management and retrieval of information at the forefront of several fields of research. At the same time, the divisions between the biological, physical and the digital worlds seem to be dissolving. Hence, opportunities for interdisciplinary research into memory are being created, between the life sciences, social sciences and physical sciences. Such research may benefit from immediate application into information management technology as a testbed. The paper describes one initiative, memories for life, as a potential common problem space for the various interested disciplines.

Computer Simulation↗

The ArrayExpress gene expression database: a software engineering and implementation perspective.

MOTIVATION: The lack of microarray data management systems and databases is still one of the major problems faced by many life sciences laboratories. While developing the public repository for microarray data ArrayExpress we had to find novel solutions to many non-trivial software engineering problems. Our experience will be both relevant and useful for most bioinformaticians involved in developing information systems for a wide range of high-throughput technologies. RESULTS: ArrayExpress has been online since February 2002, growing exponentially to well over 10,000 hybridizations (as of September 2004). It has been demonstrated that our chosen design and implementation works for databases aimed at storage, access and sharing of high-throughput data. AVAILABILITY: The ArrayExpress database is available at http://www.ebi.ac.uk/arrayexpress/. The software is open source. CONTACT: ugis@ebi.ac.uk.

Algorithms↗

An integrated undergraduate pain curriculum, based on IASP curricula, for six health science faculties.

Pain education, especially for undergraduates, has been identified as important to changing problematic pain practices, yet, no published data were found describing an integrated, interprofessional pain curriculum for undergraduate students. Therefore, this project aimed to develop, implement, and evaluate an integrated pain curriculum, based on the International Association for the Study of Pain curricula [http://www.iasp-pain.org/curropen.html], for 540 students from six Health Science Faculties/Departments. Over an 18-month period, the University of Toronto Centre for the Study of Pain's Interfaculty Pain Education Committee developed a 20-h undergraduate pain curriculum to be delivered during a 1-week period. Students from Dentistry, Medicine, Nursing, Pharmacy, Physical Therapy, and Occupational Therapy participated as part of their 2nd or 3rd year program. Teaching strategies included large and small groups, Standardized Patients, and 63 facilitators. Evaluation methods included: (a) pre- and post-tests of the Pain Knowledge and Beliefs Questionnaire (PKBQ) and (b) Daily Content and Process Questionnaire (DCPQ) to obtain feedback about process, content, and format across the curriculum's 5 days. A significant improvement in pain knowledge and beliefs was demonstrated (t = 181.28, P < 0.001), although non-responders were problematic at the post-test. DCPQ overall ratings of 'exceeding or meeting expectations' ranged from 74 to 92%. Ratings were highest for the patient-related content and panel, and the small-group discussions with Standardized Patients. Overall evaluations were positive, and statistically significant changes were demonstrated in students' pain knowledge and beliefs. This unique and valuable learning opportunity will be repeated with some modifications next year.

Curriculum↗

[Quality assurance in nursing care--approach and implementation of a comprehensive professional and institutional quality assurance project].

In cooperation between a seminar of course of study in nursing science, ambulatory and stationary patient care facilities and a municipal administration, quality assurance is developed in the form of moderated inter-institutional quality circles assembled from overlapping professions. A unit-based approach for quality assurance in the Netherlands has been modified to form the basis of this project's innovative approach. A link between internal and external quality assurance is included in this approach. Resulting experience in quality assurance work indicates that this theory and practice method appears productive and successful in practice as well as for academic studies and knowledge transfer. This article deals with the transfer from theory into practice.

Ambulatory Care↗

Medical informatics and the science of cognition.

Recent developments in medical informatics research have afforded possibilities for great advances in health care delivery. These exciting opportunities also present formidable challenges to the implementation and integration of technologies in the workplace. As in most domains, there is a gulf between technologic artifacts and end users. Since medical practice is a human endeavor, there is a need for bridging disciplines to enable clinicians to benefit from rapid technologic advances. This is turn necessitates a broadening of disciplinary boundaries to consider cognitive and social factors pertaining to the design and use of technology. The authors argue for a place of prominence for cognitive science. Cognitive science provides a framework for the analysis and modeling of complex human performance and has considerable applicability to a range of issues in informatics. Its methods have been employed to illuminate different facets of design and implementation. This approach has also yielded insights into the mechanisms and processes involved in collaborative design. Cognitive scientific methods and theories are illustrated in the context of two examples that examine human-computer interaction in medical contexts and computer-mediated collaborative processes. The framework outlined in this paper can be used to refine the process of iterative design, end-user training, and productive practice.

Cognitive Science↗

Traditional healing systems and the ethos of science.

This paper addresses the challenge posed to traditional Chinese medicine by the ethos of science and explores three related assumptions. First, the ethos of traditional Chinese medicine is incompatible with the ethos of science. Second, the challenge of science to traditional Chinese medicine is represented by the requirement to comply with internationally recognized standards of medical research and practice applied to biomedicine, adopted and implemented by the State. The State requires that the safety and effectiveness of traditional Chinese medicine procedures and medications be ascertained following the methodology chartered by the ethos of science. Third, traditional Chinese medicine practitioners present a third ethos, the "ethos of pragmatic healing" based on the pragmatic acculturation of clinical practice, as an alternative to the ethos of science. This third ethos is an inadequate response to the challenge because it increases the divergence between health care policy requirements of scientific scrutiny and the fostering of traditional Chinese medicine as an icon of Chinese culture. The study is based on data from personal interviews with representative samples of three ethnic populations in Singapore; secondary data from other studies; relevant official data; and documents from biomedical and traditional Chinese medicine organizations. The methods include inductive analysis, multiple correlation and regression, and factor analysis among others. The analysis indicates that the pressure to comply with official health regulations and the inability to succeed under the ethos of science lead traditional Chinese medicine practitioners to respond with an ethos of pragmatic healing that eschews conceptual analysis, ignores the paradigmatic divide with biomedicine, and focuses on "using what works". This third ethos can only be a temporary response to the pressure to upgrade the practice of traditional Chinese medicine and it does not correspond to pragmatic acculturation commonly found in the population. The ethos of pragmatic healing leaves the challenge of science unresolved and it is likely to increase the level of conflict between the realm of biomedicine (including health care policy requirements of scientific scrutiny) and the ethos of traditional Chinese medicine.

Acculturation↗

Teaching nurses to focus on the health needs of populations: a Master's Degree Program in Population Health Nursing.

Responding to the mandate to prepare nurses for practice in population-based healthcare, the faculty at Cleveland State University (CSU) developed a unique Master of Science in Nursing program to prepare Population Health Nurse Experts. The program prepares nurses to examine the health status of populations and to design, implement, and evaluate nursing interventions accounting for the varied factors impacting on the health of a defined group. The speciality of population health nursing is practiced by nurses who can use population sciences (epidemiology, demography, population projections, and population behavioral theories) along with post-baccalaureate nursing competencies to work with defined populations across care environments. The authors discuss a curriculum that prepares nurses for this emerging speciality.

Community Health Planning↗