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PubMed2005

Challenges in the transition to model-based development.

Practitioners of the art and science of pharmacometrics are well aware of the considerable effort required to successfully complete modeling and simulation activities for drug development programs. This is particularly true because of the current, ad hoc implementation wherein modeling and simulation activities are piggybacked onto traditional development programs. This effort, coupled with the failure to explicitly design development programs around modeling and simulation, will continue to be an important obstacle to the successful transition to model-based drug development. Challenges with timely data availability, high data discard rates, delays in completing modeling and simulation activities, and resistance of development teams to the use of modeling and simulation in decision making are all symptoms of an immature process capability for performing modeling and simulation. A process that will fulfill the promise of model-based development will require the development and deployment of three critical elements. The first is the infrastructure--the data definitions and assembly processes that will allow efficient pooling of data across trials and development programs. The second is the process itself--developing guidelines for deciding when and where modeling and simulation should be applied and the criteria for assessing performance and impact. The third element concerns the organization and culture--the establishment of truly integrated, multidisciplinary, and multiorganizational development teams trained in the use of modeling and simulation in decision-making. Creating these capabilities, infrastructure, and incentivizations are critical to realizing the full value of modeling and simulation in drug development.

Animals↗

PubMedDate not supplied

Informing environmental health policy in urban areas: the HEADLAMP approach.

Urban areas represent complex environments in which to protect health. Accurate and highly resolved information is thus a prerequisite for effective environmental health policy. The HEADLAMP approach is designed to improve decision-making by providing indicators, based on sound science, to all relevant stakeholders, in an appropriate and usable form. The approach comprises three linked stages: categorization of the issues to be addressed, construction of relevant indicators, and policy formulation and implementation. Nevertheless, the application of this approach faces many challenges. The environment-health chain is both lengthy and complex, so that a wide range of indicators is needed from different points in this chain. The DPSEEA framework provides a useful, though limited, structure to help define and organize these indicators. This complexity also means that the indicators have to be linked, so that problems can be tracked from cause to effect and the effectiveness of actions at different points in the DPSEEA chain can be evaluated. Indicators also have to be designed in ways reflecting the spatial and temporal complexity of urban areas--namely, the rapid rates of change in urban environments and the marked spatial variations in environmental and sociodemographic conditions. Effective methods of participation are equally essential if the indicators are to represent the concerns of the stakeholders involved, and if decisions are to be made on a collective basis. Good indicators thus must be designed to fit many different and varying purposes. The challenge is to devise indicators that serve these purposes by representing the intricacies that are inherent in urban areas, rather than by hiding that complexity.

Data Collection↗

PubMed2002

Role of short tandem repeat DNA in forensic casework in the UK--past, present, and future perspectives.

The analysis of short tandem repeat (STR) DNA sequences is of fundamental importance to forensic science because they have become the recognized standard in constructing national public databases. Consequently, considerable effort has been expended in developing multiplexed (one tube) reactions that analyze several loci in combination. The implementation of STRs in casework cannot take place without a full understanding of the systems used. The purpose of validation is to characterize multiplexes when one is challenged with forensic samples. For example, mixtures are often encountered that may be particularly difficult to interpret against a background of allelic artifacts. By increasing the number of PCR amplification cycles, it is possible to dramatically boost the sensitivity of the system so that just a handful of cells may be successfully analyzed. However, interpretation is much more complex because the origin of DNA profiles may be less certain and complicated by issues such as contamination, the potential for innocent transfer and a predominance of mixtures. This review provides a brief historical background of the development of STRs in forensic casework that culminated in the creation of national DNA databases. The development of guidelines to interpret complex DNA profiles, such as mixtures, is outlined. Finally, the recent innovation of low copy number DNA profiling is explained along with the special considerations needed to report in court.

DNA↗

PubMed1991

Problem-based curriculum: outcome evaluation.

The College of Medicine and Medical Sciences of the Arabian Gulf University (CMMS-AGU) in Bahrain is, in its innovativeness, unique in the region in that a problem-based strategy is used in the planning and implementation of the curriculum. The first batch of graduates have completed their internship programme in the different countries of the region. This paper presents an evaluative study of the outcome of the programme in relation to the institutional goals. Assessment of the intern's performance in clinical competence, interpersonal relations, self-directed learning, and their relative standing vis-à-vis graduates from other schools was done by supervisors. The findings of the study confirm the relative merits of the problem-based curricular strategy in medical education.

Bahrain↗

PubMed1976

[Legal aspects of mineral waters].

The Author takes up the subject of the report in order to carry out a comprehensive legal recognition of the mineral water regulations in Italy and emphasizes that in this field the results of scientific conclusions, or rather of the various scientific branches (medical hydrology, microbiology, chemics, hydrogeology, medical clinics, pharmacology, etc.) supply a cognitive support to the legislator and the substantial contents to the legal standards. He therefore illustrates the two main outlines of the rules, i.e. the hygienic sanitary one and the mineral one: such lay-out is subsequently related to the implementation of the Regions on one hand and to the enforcement of CEE-rules on the other. This has led to the fact that the hygienic-sanitary legislation was confirmed to the State while the mineral one was transferred to the Regions. After having shown up contrasts and expressed the necessity of clearness and uniformity of rules and criteria, the Author connects these requirements mainly with the implementation of hygienic-sanitary surveillance and consequently with the evaluation of the banal bacterical contents under the point of view of merit--i.e. the rules should include the probative results of science--as well as from a point of view of coordinated allotments of competence by the various organisms.

Food Inspection↗

PubMed1976

Socio-cultural modalities in population control.

Overpopulation with its identifiable and noxious results, is probably the most ominous and potentially destructive condition existing in current world society. The etiology of this problem includes the failure of mankind to develop compatible interrelationships between members of his own family, clan, society, and world population. The author predicts that all efforts to achieve world population control will be essentially ineffective unless the insights of the holistically oriented science of social psychiatry are refined into principles and rules which direct population control endeavors. This paper reviews the extent and severity of the problem and stresses the need for the operational implementation of the value systems and methodologies of social psychiatry. The author believes that effective population control is possible if the actions of world leaders are directed toward efforts to achieve satisfaction of the basic (Ur) needs of all individuals and groups for physical survival, socialization, and transcendence.

Community Psychiatry↗

PubMed2001

Designing a library: everyone on the same page?

Excerpts are presented from an interview by the Bulletin of the Medical Library Association buildings projects editor with four academic health sciences library directors: one who had recently completed a major library building project and three who were involved in various stages of new building projects. They share their experiences planning for and implementing library-building programs. The interview explores driving forces leading to new library buildings, identifies who should be involved, recalls the most difficult and exciting moments of the building projects, relates what they wished they had known before starting the project, assesses the impact of new library facilities on clients and services, reviews what they would change, and describes forces impacting libraries today and attributes of the twenty-first century library.

Architecture↗

PubMed1994

[The teaching of chemistry at the Spanish University in the nineteenth century].

Except for some loose attempts without any continuity, the actual beginning of the teaching of chemistry at the Spanish university must be associated to the establishment of the University of Madrid, in 1836. The first chairs of this branch were incorporated into the framework of the philosophical studies and were designed to contribute useful data to other careers considered at that time of a higher rank. The introduction of chemistry as a special subject in the Faculty of Philosophy, dates back to the implementation of the education plan known as "Pidal Plan". The present article analyzes the circumstances of that introduction until the incorporation of the subject into a specific branch of the Faculty of Sciences, as ruled by the Moyanno Act of 1857.

Chemistry↗

PubMed2001

Psychoneuroimmunological Outcomes in Dementia Caregiver Intervention Studies: An Idea Whose Time Has Come?

PURPOSE: Mounting evidence indicates that the chronic stress of family caregiving has physiological effects and that caregiver stress may be associated with changes in the caregiver's physical health. Existing caregiver behavioral intervention studies have focused on caregiver stress and psychological distress outcomes. To date, no known caregiver intervention studies have included psychoneuroimmunological (PNI) outcome measures. Two bodies of literature were reviewed to determine if the current state-of-the-science supports the development of caregiver intervention studies that examine PNI outcomes--first, dementia caregiver PNI studies; and second, cognitive behavioral PNI intervention studies conducted with other clinical populations. CONCLUSIONS: If this line of research is pursued, the following issues need to be addressed: a) sampling strategies and study designs; b) measurement issues; and c) the need for multidisciplinary collaborative research teams. IMPLICATIONS: Nurses' preparation in the biomedical and behavioral sciences establishes a knowledge base that enables nurses to apply a PNI model in clinical situations. Their preparation and access to family caregivers put them in a unique position to design and implement improved caregiver interventions that focus on caregiver psychological, physiological, and physical health outcomes.

Journal Article↗

PubMedDate not supplied

[Public health in times of bureaucratization: the case of the physician Noel Nutels].

This case study of the trajectory of sanitarian Noel Nutels argues that starting in the 1930s and particularly during the long Vargas period, the history of Brazilian public health became characterized by a process of bureaucratization. Although the chief consequence was an increase in problem in implementing public policies, these difficulties do not appear to have prompted any immediate ideological demobilization within the sanitation movement, as occurred under the Old Republic, having instead engendered conflicts between those directly responsible for designing and implementing public policies, on the one hand, and the growing State bureaucracy, on the other. The historical period initiated in 1930 thus marked a broad divergence between the conduct of 'men of science' and 'men of State'. If the period preceding the revolution was characterized by a certain harmony between these two social sectors, won in the late nineteenth century, the process of bureaucratization altered this balance, dislodging public health agents and authorities from the special roles they had enjoyed within the Brazilian State machinery.

Brazil↗

PubMed2004

Attitudes to immunisation: a survey of health professionals in the Rotorua District.

AIM: To examine the personal attitudes and practice of health professionals regarding childhood vaccinations in order to provide guidance to local professional education strategies. METHODS: A questionnaire was circulated to those involved in the implementation of the childhood immunisation schedule in the Rotorua District. Responses were stratified: a) community vs hospital; b) nurses, midwives, doctors, others. RESULTS: 85% responded, of whom 94% supported vaccinations. 91% considered science the most important basis for recommendations; 91% considered current scientific support adequate. 11% thought immunisations held unacceptable dangers; 17% were unsure. 41% of nurses, 45% of midwives, and 21% of doctors were unsure whether the MMR vaccine was associated with autism or Crohn's disease. Professional training, reading and personal experience were identified most often as having an influence on opinions, while the media and Internet ranked least often. Amongst respondents who had children, 96% reported vaccination (no significant difference between professional groups, but lower rates for children of hospital providers). CONCLUSIONS: Strong national support of vaccinations was demonstrated in this survey of professionals involved with vaccination in one district. Significant underlying uncertainties or concerns were identified regarding risks, the MMR vaccine, and ethical tensions between community protection and perceived individual risk. Continuing education and dialogue through professional training and medical literature are indicated to address these concerns.

Adolescent↗

PubMed2006

Student laboratories as a component of a web-based curriculum.

OBJECTIVE: To enable place-bound working clinical laboratory technicians (CLTs) to benefit from hands-on student laboratory sessions taught in University of Texas Medical Branch (UTMB) facilities by UTMB professors. DESIGN: Weekend student laboratory sessions similar to "wet workshops" were implemented and integrated into regular coursework. Student laboratory sessions of 12 hours to 16 hours in length were provided. SETTING: The UTMB student laboratories. PARTICIPANTS: Web-based education in Clinical Laboratory Science (WEBCLS) students who are working CLTs in rural place-bound situations. MAIN OUTCOME MEASURES: Course grades and certification examination scores on laboratory and comprehensive examinations given to both on-campus students and WEBCLS students. RESULTS: Of 68 WEBCLS students enrolled in laboratory courses during the calendar years 2003, 2004, and 2005, 66.2% earned grades of A or B in the course compared with 64.2% of students enrolled in the same laboratory courses on-campus. Over a three year period, the WEBCLS students averaged 564.8 on certification exam scores, while on-campus students averaged 470.9.

Clinical Laboratory Techniques↗

PubMed2006

Food safety begins on the farm: the viewpoint of the producer.

Consumers expect the food they purchase to be safe. Governments seek to provide them with assurances of food safety through regulation, but additional steps are needed to more fully address the issue. Producers are increasingly aware of their responsibility in this area and are working in concert with other segments of the agri-food industry. Hazard analysis critical control point-based (HACCP) quality assurance programmes are being developed and implemented at the farm level for most species, in many countries. These approaches will enhance food safety for consumers everywhere. Producers continue to demonstrate that they respond positively to programmes based on science and good management practices. The authors conclude that the use of HACCP programmes will continue to increase.

Animal Husbandry↗

PubMed1997

[Computerization of a clinical chemical laboratory. A contribution for quality assurance].

The application of computer science to the practice of laboratory medicine, one of the medical informatics fields, brings a complete revolution in laboratory work and the clinical pathologists profile. The authors explain the methodology for the implementation of such a system, in a perspective of quality assurance, defining the goals, objectives, customer requirements and analysis of the benefits they achieve. Finally the authors explain the future perspectives.

Clinical Laboratory Information Systems↗

PubMedDate not supplied

Emerging infections: getting ahead of the curve.

The early history of infectious diseases was characterized by sudden, unpredictable outbreaks, frequently of epidemic proportion. Scientific advances in the late 19th and early 20th centuries resulted in the prevention and control of many infectious diseases, particularly in industrialized nations. Despite these improvements in health, outbreaks of infectious disease continue to occur, and new infections emerge. Since 1987, the National Academy of Science's Institute of Medicine (IOM) has published three reports that have identified erosion of the public health infrastructure among the factors contributing to new and reemerging infectious diseases. In partnership with many public and private organizations in the United States and abroad, the Centers for Disease Control and Prevention (CDC) has developed a strategic plan that addresses the priorities set forth in the IOM reports and serves as a guide for CDC and its partners to combat emerging microbial threats to health. Laboratory-based surveillance, better communication networks, and improvements in the public health infrastructure are the cornerstones of the strategy. Emerging Infectious Diseases, a new periodical produced by CDC, will serve as a forum for exchange of information about incipient trends in infectious diseases, analysis of factors contributing to disease emergence, and development and implementation of prevention measures.

Centers for Disease Control and Prevention, U.S.↗

PubMed2005

From innovation to implementation.

Requirements for the safety and nutritional adequacy of infant formula are set by legislation and aim for the best possible substitute for human milk with regard to growth, development and biological effects. This is, however, a continuous process and has to be supported by science-driven innovative activities of manufacturers and be confirmed by adequate clinical studies performed according to agreed standards.

Consumer Product Safety↗

PubMed1993

Office management of benign headache. The science and the art.

Headache management requires a comprehensive strategy that includes accurate diagnosis, reassurance and education of the patient, nonpharmacologic methods of preventing attacks, and appropriate use of prophylactic and abortive medications. Personal input from the physician and judicious selection of headache medications are crucial. Implementation of such a strategy gives patients greater ability to control and cope with their headaches.

Analgesics↗

PubMed2006

Translation in the health professions: converting science into action.

The systematic translation of evidence-based research findings, tools, and information into practice is critical to improving the quality of our nation's health. However, despite several decades of advances in developing medical knowledge based on high-quality empirical evidence, widespread implementation of these findings into practice in diverse applied settings has not been achieved. This article reviews definitions and conceptual models that describe the translation of research from basic discovery to real-world applications, summarizes the various issues involved in the process of translation, discusses multiple barriers, and provides recommendations to surmount these hurdles. Areas of further research in this arena are suggested. Finally, the article concludes that translational research is an important area to continue to pursue requiring long-term collaborative commitment among researchers and practitioners.

Biomedical Research↗