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PubMed1998

A comprehensive clinical epidemiological theory based on the concept of the source person-time and four distinct study stages.

The medical community is forced to accelerate the move from opinion-based to evidence-based medicine, that is, to aim at basing all caring and clinical practice on empiri. A clear-cut epistemology would facilitate this process. In this article we present a comprehensive clinical epidemiological theory which can be used for validity issues in caring science, quality of life research, controlled clinical trials and compilations of uncontrolled evidence. The theory is based on four distinct stages that can be identified in a study, whereof the first is demarcation of the source person-time. A source person-time ('study base') can be identified for any study in all disciplines, giving an argument for using this concept as the common reference point for validity issues. Apart from identifying the source person-time, recovery of the actually observed person-time, collection of data and calculation of an ('adjusted') effect parameter (e.g., incidence ratio) are additional stages of a study. When the source person-time is demarcated confounding is introduced, when the actually observed person-time is recovered misrepresentation, in the third stage misclassification and in the fourth analytical alteration of the parameter of effect. The concept of the source person-time can, in addition, link examination of validity in caring and clinical sciences to observational studies, thereby allowing the field to benefit from all theoretical achievements for preventing, handling and understanding systematic errors developed in epidemiology. We conclude it is possible to implement a common terminology of validity for all caring and medical sciences. Drawing causal inferences in these disciplines is not mechanical, it can never, for example, be done with statistical inference. Establishing a causal relation always includes an assessment of the magnitude and direction of systematic errors influencing the adjusted effect parameter. From the presented epistemology it follows that differences in validity from a case history to a large randomized, placebo-controlled and double-blinded study are quantitative rather than qualitative. This realization in turn opens up for a more refined discussion of when a decision is evidence-based rather than opinion-based.

Clinical Trials as Topic↗

PubMed2005

Successful implementation of genetic Education for Native Americans workshops at national conferences.

Genetic Education for Native Americans (GENA) was a National Human Genome Research Institute (NHGRI)/Ethical, Legal, and Social Implications (ELSI)-funded educational intervention designed to provide a unique genetics education program for Native American college and university students. A curriculum was developed and implemented in workshops in geographically diverse settings throughout the United States, primarily in conjunction with regional and national scientific conferences that include substantial numbers of Native American attendees. The original curriculum includes 24 objectives and has been offered in two formats, as a 16-hr "comprehensive" program and in briefer workshops (referred to as "customized" hereafter) that are designed to include objectives for selected audiences. Both formats teach sufficient genetics to allow discussion and understanding of the ELSI and cultural issues related to genetics science. This article describes the evaluation findings from our implementation of both formats of the GENA curriculum.

Congresses as Topic↗

PubMed1992

Medical school libraries' handling of articles that report invalid science.

In 1989-90 the authors conducted a nationwide study to examine how academic medical libraries handled articles that report invalid science and to determine the effectiveness of any policies implemented to limit the use of such articles. Ninety-five of the 127 medical school libraries the authors surveyed completed questionnaires analyzing policy and attitude issues. Eighty-four of these libraries manually reviewed the available copies they held of ten retracted articles. Of the 811 copies of the retracted, invalid articles reviewed, 742 (91.5%) were not tagged as being invalid. Seventy-nine percent of the libraries had tagged none of the retracted studies and only 16% had policies for managing articles that report invalid science. Academic librarians reflected a common attitude against perceived library censorship and emphasized the user's role in assuring validity. The nation's medical libraries, at least in part by intent, do not commonly identify or have policies to handle the invalid articles they hold. The authors conclude that biomedical researchers, clinicians, and teachers should not assume published studies held in libraries are inherently valid. The lack of stated policy and the disparate assumptions about the role libraries play in this area may perpetuate the use of invalid articles.

Data Collection↗

PubMed1994

Behavioral science in translational research and cancer control.

Behavioral science plays an integral, essential role in cancer control. This review examines that role in two broad areas: (1) in the development and implementation of cancer control technologies, and (2) in the emerging focus on the process of translating cancer research into clinical practice. In developing and implementing cancer control technologies, what we know of human processes as a result of behavioral science is identified as the common link in all stages of the cancer process (prevention, detection, treatment, rehabilitation, terminal care). The value of behavioral science is shown in conservative projections (incorporating likely rates of patient noncooperation) of the health benefits obtainable by the year 2000 if effective behavioral strategies in three key areas were broadly implemented. Smoking prevention and cessation programs could lead to 7.2 million fewer smokers; application of cancer screening programs might result in 45,000 additional 5-year cancer survivors each year; and behavioral programs could lead to improved quality of life in 150,000 patients per year who experience treatment side effects despite the use of antiemetics. Behavioral science also is shown to contribute to translational science by providing a pragmatic conceptual model for clinical practice and facilitating collaborative research between basic scientists and clinical researchers. As an example of behavioral science's contribution to translational research, behavioral issues in genetic screening for cancer risk are outlined based on the experience of several families with the BRCA1 genetic marker and patients with Huntington's disease.

Behavioral Sciences↗

PubMed1997

Making science clinically relevant.

Clinical practice requires a sound foundation in the basic and clinical sciences. However, the traditional dental curriculum often separates the two in a variety of ways that reduce their integration. The basic sciences are commonly taught in the first two years by a basic science faculty with inconsistent integration with clinical dental practice. The clinical sciences are often taught by faculty who may not be actively involved in research-related activities. The curriculum is dense and is difficult to modify to adapt to evolving scientific discovery and application. The 1995 IOM report focuses much of its attention on these issues. The Harvard School of Dental Medicine has dramatically modified its curriculum twice in the recent past to more closely integrate the basic and clinical sciences and to promote the clinical relevance of the basic sciences. The class entering in 1980 began a five-year D.M.D. program that was designed to decompress the curriculum and increase experiences that enhance scientific and clinical integration. The class entering in 1994 initiated a four-year program that uses a problem-based learning design throughout the entire curriculum. Strategies for integrating the clinical and the basic sciences along with research training and experience were developed and implemented in both programs.

Clinical Competence↗

PubMed1987

Effect of Federal programs on health sciences libraries.

The radical changes and improvements in health sciences libraries during the last quarter century have been primarily achieved through the leadership of the National Library of Medicine (NLM) in the application of technology and in the creation of a biomedical communications network. This article describes principal programs and activities of the National Library of Medicine and their effects on health sciences libraries: the Medical Literature Analysis and Retrieval System (MEDLARS), implementation of the Medical Library Assistance Act (MLAA), and defense of "fair use" of copyrighted material. The article briefly summarizes more recent Federal activities which directly affect access to and dissemination of health information and concludes with a summary of problems for which solutions must be found if health sciences libraries are to be prepared to meet the future. It is clear from comparing the programs described with current government attitudes that, although the Federal government has promoted advancement in the dissemination of biomedical information in the past, this trend is reversing, and Federal funding to libraries is decreasing while the cost of accessing information is increasing.

Forecasting↗

PubMed2006

The role of academic medicine in improving health care quality.

Academic medicine, often entrenched in biomedical and clinical research, has largely ignored the development and application of quality metrics to ensure the delivery of high-quality health care. Nevertheless, academic medicine has substantial opportunities to lead the charge in building a quality infrastructure with the goal of delivering high-quality and cost-efficient health care to all Americans. The American College of Cardiology (ACC) and American Heart Association (AHA) have worked jointly to measure and improve the quality of cardiovascular care. This effort has led to the development of clinical practice guidelines, performance measures, data standards, national registries, and appropriateness criteria for cardiovascular care. Academic medicine should actively embrace and promote the type of quality metrics and criteria developed by ACC and AHA and apply this model across the entire academic medicine community. Academic medicine, with its many resources, could lead the way in the expanding field of quality science by supporting fundamental research in quality improvement, supporting academicians to improve quality at their own institutions, developing educational models for quality assessment and improvement, creating and implementing data registries, and serving as a conduit for developing the emerging science of quality assessment. In this and many other ways, academic medicine must offer the health care community leadership for improving our nation's health care quality with the same fervor presently exhibited for the advancement of basic science, the development of specialized and experimental therapy, and as centers for tertiary and quaternary patient care.

Academic Medical Centers↗

PubMed2000

Reaching maturity - 25 years of the TDR.

In its first 25 years of existence, TDR has become a key player in the development of new tools for the control of tropical diseases and the training of researchers from disease-endemic countries. In order to maintain its leading position, cope with new health challenges and profit from new avenues opened by science and technology breakthroughs, a new strategic vision is now being implemented. It aims at a closer interaction with health systems and disease control programmes, capacity strengthening based on selected research initiatives and full exploitation of scientific and technological advances in the biomedical, social and information sciences, as discussed here by Carlos Morel.

Africa↗

PubMed2001

Risk assessment under FQPA: case study with chlorpyrifos.

Key science policies have had significant impact on the evolving implementation of the Food Quality and Protection Act (FQPA) (PL 104-170, 1996) by the US Environmental Protection Agency (EPA). The impact offour of these policies will be examined using the risk assessment for chlorpyrifos as a case study. These policies are selection of a regulatory endpoint, use of animal data without consideration of human data for setting the reference dose, a 10 FQPA safety factor and use of the 99.9 percentile of modeled consumer exposure in the acute dietary assessment. Each of these policy decisions had individual impact that was then compounded as cumulative impact on the revised risk assessment for chlorpyrifos conducted by the US EPA in 2000 [Federal Register Notice 65(159) (2000) 49982]. But embedded within each science policy, there are assumptions which may be too conservative and which together have resulted in a very large multiplicative reduction in the allowable exposure limits for chlorpyrifos in the US. These new exposure limits are quite different from other regulatory standards around the world. There is third party opposition to many of these policies and many believe the understanding of the relationship between exposure and what is known about human and animal responses to chlorpyrifos has been clouded. These changes in policy insert a new level of conservatism into the scientific statement of risk and create confusion that threatens to weaken the credibility of the regulatory process.

Animals↗

PubMed2006

Doxycycline-rifampicin: physicians' inferior choice in brucellosis or how convenience reigns over science.

OBJECTIVES: Brucellosis treatment is based on sub-optimal, not universally implemented regimens (doxycycline-rifampicin and doxycycline-streptomycin). The authors sought to evaluate specialists' and physicians' attitude towards regimens used, non-medical aspects, and future trends in human brucellosis treatment. METHODS: A questionnaire-based survey of multi-national specialists, physicians, and trainees, was conducted, questionnaire answered following lectures outlining major scientific facts about existing regimens. Responders indicated preference between the two regimens, their opinion on protracted monotherapy or triple regimens of shorter duration, awareness of disease notification and hospitalization practices. Results were evaluated in relation with professional status and experience with the disease. RESULTS: Although scientifically inferior to doxycycline-streptomycin, doxycycline-rifampicin is the choice regimen for 64.6% of the participants. A shorter triple regimen, but not protracted monotherapy, would be desirable (60.2% and 10.4%, respectively). Low awareness of disease-notifying status and related procedures were recorded in 53.9%. CONCLUSION: When choosing between currently acceptable brucellosis regimens, medical personnel prefer convenience, even at the cost of a slightly higher relapse percentage. Future trials should evaluate shorter triple regimens. Enhancement of awareness on the disease and its principles may increase therapeutic cost effectiveness.

Anti-Bacterial Agents↗

PubMed2004

Retention of basic science knowledge: a comparison between body system-based and clinical presentation curricula.

BACKGROUND: When the University of Calgary implemented the clinical presentation (CP) curriculum in 1994, it was prospectively decided to administer the National Board of Medical Examiner's Comprehensive Basic Science Exam (CBSE) as a measure of students' basic science knowledge retention. PURPOSE: The exam performance from 2 classes (1995, 1996) of the previous system-based (SB) curriculum was compared to exam performance of 2 classes (2000, 2002) of the CP curriculum. METHODS: Data analyses employed 2 statistical models (covariate multiple linear regression and hierarchical mixed effects), and effect sizes were computed. RESULTS: Differences between CBSE mean scores produced by students from the SB and CP curricula showed a curricular effect on students' retention of basic science knowledge. However, preexisting differences between groups were found to be in the small-to-medium range. CONCLUSION: Evidence supporting the potential of schemes within a CP curriculum and their relation to basic science knowledge retention was observed. Effect size for the CP curriculum on students' retention of basic science knowledge was substantial; however, a notable part of that difference can be accounted for by extraneous and confounding factors. Further research utilizing more rigorous designs to investigate the relation between schemes and basic science retention is warranted.

Alberta↗

PubMed2000

FORUM: The Relationship of Ecosystem Management to NEPA and Its Goals.

/ The National Environmental Policy Act of 1969 (NEPA) was intended to promote a systematic, comprehensive, interdisciplinary approach to planning and decisionmaking, including the integration of the natural and social sciences and the design arts. NEPA critics have cited three key shortcomings in its implementation: (1) a lack of engagement with the NEPA process early in the planning process through interdisciplinary collaboration; (2) a lack of rigorous science and the incorporation of ecological principles and techniques; and (3) a lack of emphasis on the Act's substantive goals and objectives. In recent years and independent of NEPA, a policy of ecosystem management has been developed, which represents a fundamental change from a fragmented, incremental planning and management approach to a holistic, comprehensive, interdisciplinary land and resource management effort. We postulate that by incorporating ecosystem management principles in their planning and decisionmaking, federal agencies can address the shortcomings in NEPA implementation and move closer to NEPA's intent. A case analysis of EISs prepared by the USDA Forest Service before and after adopting an ecosystem management approach supports our hypothesis.

Journal Article↗

PubMed2000

[The problem-based medical curriculum in Trondheim--did it turn out as planned?].

BACKGROUND: A problem-based (PBL) medical curriculum was implemented in 1993 at the Medical School of the Norwegian University of Science and Technology. The objective of this study was to examine how the planned reduction in scheduled activities, the emphasis on student-centred learning, and the integration of disciplines have been implemented. MATERIAL AND METHODS: The schedules in the old and new programmes were the main sources of data. Each scheduled activity was coded according to discipline taught and chosen learning method. RESULTS: The number of hours spent on scheduled activities was much higher in the new programme (n = 4,009) than in the intended (n = 2,974), and it was even slightly higher than in the old programme (n = 3,785). In contrast to plans there was less student-centered learning, and basic science was mainly taught during the two first years. INTERPRETATION: Contrary to plans, the new curriculum in Trondheim has not become a pure PBL curriculum. It is a hybrid model involving a number of learning methods. A high degree of autonomy of the individual faculty members in the planning, and resistance to change among faculty members may have caused less radical changes. This is not necessarily negative; the new model may be a pragmatic synthesis between new and traditional medical education.

Curriculum↗

PubMed2003

Astrobiology, the transcendent science: the promise of astrobiology as an integrative approach for science and engineering education and research.

Astrobiology is rapidly gaining the worldwide attention of scientists, engineers and the public. Astrobiology's captivation is due to its inherently interesting focus on life, its origins and distribution in the Universe. Because of its remarkable breadth as a scientific field, astrobiology touches on virtually all disciplines in the physical, biological and social sciences as well as engineering. The multidisciplinary nature and the appeal of its subject matter make astrobiology ideal for integrating the teaching of science at all levels in educational curricula. The rationale for implementing novel educational programs in astrobiology is presented along with specific research and educational policy recommendations.

Biological Evolution↗

PubMed1987

A computerized information management system for educational programs in the health sciences.

The Physician Assistant Program at the University of Florida has developed and implemented a computerized information management system that eliminates time-consuming duplication of effort in record-keeping and covers all functional components of the educational program. Data-base files for admissions, curriculum and/or evaluation design, student records, graduate follow-up, and research activities and a master file for administrative activities permit rapid accessing and transfer of information across files, continual updating of information, and efficient generating of records and reports pertaining to all program functions. Research about the program is enhanced through the correlation of data available in the five data-base files. This comprehensive system facilitates the audit of the program's educational process and the evaluation of its accomplishment of its stated objectives. The system can be easily adapted for use by other educational programs in medicine and the allied health sciences.

Allied Health Personnel↗

PubMed2006

Interprofessional educational partnerships in school health for children with special oral health needs.

Dental caries is an infectious yet preventable disease that is rampant in some subpopulations in the United States, in particular among individuals with neurodevelopmental/intellectual disabilities (ND/ID). This article reports on the implementation and evaluation of the Louisiana State University Health Sciences Center (LSUHSC) School of Dentistry interprofessional school health educational model to improve oral health assessment and referral for children with ND/ID in an inner-city school system. During this project, dental hygiene students and elementary school nurses were paired to assess the oral health status of 255 inner-city children with developmental disabilities, improve referral/access to dental care for those identified as having need, and propose dental hygiene curriculum changes that would incorporate participation in a "real-life public health setting" for those with ND/ID. Following the program, 66 percent of dental hygiene students said their likelihood of participating in future oral health programs had increased and 75 percent of school nurses rated the educational process as very good or excellent. Modifications in dental hygiene curricula that provide students with training and experience in oral health risk assessment and referral for people with ND/ID is recommended to address the new Commission on Dental Accreditation educational standards 2-18 and 2-26 (implemented January 1, 2005) and dental standard 2-26 (implemented January 1, 2006), which state that dental hygiene and dental graduates must be competent in assessing the treatment needs of patients with special needs.

Child↗

PubMedDate not supplied

The ethical basis of psychiatric research: conceptual issues and empirical findings.

The study objective was to clarify the ethical basis of psychiatric research by outlining conceptual issues and empirical findings related to the ethics of human experimentation. A systematic review of scholarly and empirical literature covering three decades was performed. The ethics of human research has come to be understood in relation to the principles of respect for persons, beneficence, justice, and the ideal of informed consent. Subjects who cannot fully participate in informed-consent processes are especially vulnerable to exploitation. Current dilemmas stem from insufficient attention to the vulnerabilities of mentally ill research participants, problems in applying ethical concepts and guidelines to psychiatric research, and claims of research misconduct. Empirical studies indicate that (1) psychiatric symptoms significantly affect informed consent, (2) psychiatric patients may possess certain strengths with respect to research involvement, (3) proxy decision-making is problematic, (4) informed consent is also difficult to attain with the medically ill and others, (5) patients are motivated to participate in research by the hope of personal benefit, (6) ethical aspects of research are poorly documented, and (7) institutional review processes may not be adequate to protect vulnerable subjects. Psychiatric research can be performed ethically, according to standards set throughout the biomedical and behavioral sciences, so long as researchers and institutions are respectful of special ethical issues in human experimentation and strive to include vulnerable study participants fully in research decisions. However, many gaps in the empirical literature exist regarding the specific nature and implementation of ethics principles in psychiatric research. Efforts to advance both science and ethics, including the study of ethical dimensions of human research itself, are essential for the future of psychiatry.

Attitude to Health↗

PubMed2026

Current knowledge in pharmacogenomics and precision medicine: perspectives of the PGRN global PGx committee on improving drug therapies in underrepresented ethnic populations.

A precision medicine strategy is likely to be more impactful, when pharmacogenomics (PGx) guided selection of drugs and dosage wherever applicable is implemented across the globe. In regions where resources are disproportionately distributed, PGx implementation in routine clinical care can play a critical role in ensuring the optimal use of limited healthcare infrastructure. At present, PGx data from the majority of the distinct ethnic populations across Asia, Africa, and South America is limited. While international consortia, working groups, and scientific bodies have made significant contributions toward evaluating the evidence for PGx implementation, the majority of existing guidelines and recommendations are derived primarily from studies conducted in a limited number of ethnic groups. Precision Medicine Initiatives in countries like Korea, Taiwan, and Malaysia and PGx organizations like the African Institute of Biomedical Science and Technology (AiBST), Consortium for Genomics & Therapeutics in Africa (CGTA), implementation of pharmacogenetic testing for the effective care and treatment in Africa, Greater Middle East (GME) whole exome sequencing program, Ibero-American Network of Pharmacogenetics and Pharmacogenomics (RIBEF), Latin American Society of Pharmacogenomics and Personalized Medicine (SOLFAGEM), Latin American Network for Validation and Implementation of Pharmacogenomic Clinical Guidelines (RELIVAF), IndiGen initiative, Southeast Asian Pharmacogenomics Research Network (SEAPharm), are working toward consolidating the PGx presence in these regions.

Precision Medicine↗