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Visions and strategies to improve evaluation of health information systems. Reflections and lessons based on the HIS-EVAL workshop in Innsbruck.

BACKGROUND: Health care is entering the Information Society. It is evident that the use of modern information and communication technology offers tremendous opportunities to improve health care. However, there are also hazards associated with information technology in health care. Evaluation is a means to assess the quality, value, effects and impacts of information technology and applications in the health care environment, to improve health information applications and to enable the emergence of an evidence-based health informatics profession and practice. OBJECTIVE: In order to identify and address the frequent problems of getting evaluation understood and recognised, to promote transdisciplinary exchange within evaluation research, and to promote European cooperation, the Exploratory Workshop on "New Approaches to the Systematic Evaluation of Health Information Systems" (HIS-EVAL) was organized by the University for Health Sciences, Medical Informatics and Technology (UMIT), Innsbruck, Austria, in April 2003 with sponsorship from the European Science Foundation (ESF). METHODS: The overall program was structured in three main parts: (a). discussion of problems and barriers to evaluation; (b). defining our visions and strategies with regard to evaluation of health information systems; and (c). organizing short-term and long-term activities to reach those visions and strategies. RESULTS: The workshop participants agreed on the Declaration of Innsbruck (see ), comprising four observations and 12 recommendations with regard to evaluation of health information systems. Future activities comprise European networking as well as the development of guidelines and standards for evaluation studies. CONCLUSION: The HIS-EVAL workshop was intended to be the starting point for setting up a network of European scientists working on evaluation of health information systems, to obtain synergy effects by combining the research traditions from different evaluation fields, leading to a new dimension and collaboration on further research on information systems' evaluation.

Education↗

Use of animals in research: a science - society controversy? The European perspective.

The use of animals for research and testing purposes has decreased substantially during the last two decades but is now increasing again, mainly because of the increased use of transgenic animal models. Presently, 10-12 millions of vertebrate animals are used per year within EU Member States. Scientists who are using animals in research are frequently criticised by animal protection groups and blamed that they do not respect the integrity of an animal's life. The European Science Foundation (ESF) is recognising that legislation cannot be the only answer to those worries in society and that it is essential to take a stand and to clearly explain what the Foundation's position with regard to the use of animals is. In a recently published position paper, ESF has discussed its views and has adopted guidelines for the use of animals in research. The document explicitly states that laboratory animals have an intrinsic value, which must be respected. The consequences of recognising the intrinsic value have been elaborated in the position paper and include, among others, strong endorsement of the replacement, reduction, refinement principles. It is stated that, prior to the performance of an animal experiment, the protocol should be subjected to independent expert review including the weighing of the likely benefit versus the likely animal suffering. Also, the development and organisation of accredited courses on laboratory animal science, including information on animal alternatives, welfare and ethics are encouraged. The guidelines, as formulated in the position paper, can be seen as reinforcement of developments that have already been started in several countries, but have not always received full support from the scientific community. With this document, the association of 70 leading national science organisations in Europe has taken a position that, in several aspects, exceeds current European legislative regulations. For bridging the science - society controversy, it is essential to continue this initiative by promoting the implementation of the guidelines at all levels of the scientific community. This requires commitment and scientific leadership.

Animal Testing Alternatives↗

International coordination of biomedical research.

Recent efforts at international coordination in biomedical research have taken place at two levels. At the level of the working clinician and scientist, European regionalism has become increasingly manifest in such organizations as the European Society for Clinical Investigation, the European Organization for Research into the Treatment of Cancer, the European Molecular Biology Organization and many others. These have developed largely, though not entirely, independently of government funding. At the level of science policy, i.e. of bodies supporting biomedical research mainly from public funds, the major developments have been the Comité de la Recherche Médicale of the European Community and the much wider association of European Medical Research Councils, based on the whole of Western Europe; in October 1975 the latter group became incorporated into the new European Science Foundation as the first Standing Committee of that body. Wider, interregional, cooperation presents greater problems, though there have been some modest successes, and the multinational drive on research into six of the major health problems of the Third World now being proposed by WHO holds further promise for the future.

Europe↗

Back to basics: thermodynamics in biochemical engineering.

Rational and efficient process development in chemical technology always makes heavy use of process analysis in terms of balances, kinetics, and thermodynamics. While the first two of these concepts have been extensively used in biotechnology, it appears that thermodynamics has received relatively little attention from biotechnologists. This state of affairs is one among several reasons why development and design of biotechnological processes is today mostly carried out in an essentially empirical fashion and why bioprocesses are often not as thoroughly optimized as many chemical processes. Since quite a large body of knowledge in the area of bio thermodynamics already existed in the early nineties, the Steering Committee of a European Science Foundation program on Process Integration in Biochemical Engineering identified a need to stimulate a more systematic use of thermodynamics in the area. To this effect, a bianual course for advanced graduate students and researchers was developed. The present contribution uses the course structure to provide an outline of the area and to characterize very briefly the achievements, the challenges, and the research needs in the various sub-topics.

Animals↗

The advisory subgroup in toxicology of the european medical research councils.

The European Medical Research Councils set up an Advisory Group in Toxicology which met from 1975 to 1988. Since encouragement of cross discipline research is still difficult, a resumé is presented of the procedures developed to encourage interdisciplinary research in toxicology in Europe. A programme of grants in toxicology for collaborative research between European countries was begun in 1981 under the auspices of the European Science Foundation. Resulting from the final meeting of AST in Milan, the need for the development of links between epidemiology and molecular aspects of toxicology and for new approaches in eco-toxicology are briefly discussed.

Environmental Monitoring↗

New trends in nucleic acid based biosensors: University of Florence (Italy), 25-28 October 2003.

The Workshop on "New Trends in Nucleic Acids Based Biosensors" was held at the University of Florence (Italy), from 25th to 28th October 2003. The workshop was funded by the European Science Foundation (ESF) within the programme "Functional Genomics" (Programme Area: DNA arrays and chips). This report describes the main arguments discussed during the workshop considering the state of art and the future trends in the field of nucleic acid-based biosensors, with particular attention on the aptamer field.

Biosensing Techniques↗

Health inequalities and the psychosocial environment-two scientific challenges.

As social inequalities in health continue to be a key public health problem, scientific advances in explaining these inequalities are needed. It is unlikely that there will be a single explanation of social inequalities in health. This introductory paper sets out one explanatory framework, exposure to adverse psychosocial environments during midlife, and particularly at work. We argue that exposure to an adverse psychosocial environment, in terms of job tasks, defined by high demands and low control and/or by effort-reward imbalance, elicits sustained stress reactions with negative long-term consequences for health. These exposures may be implicated in the association of socioeconomic status with health in two ways. First, these exposures are likely to be experienced more frequently among lower socioeconomic groups. Second, the size of the effects on health produced by adverse working conditions may be higher in lower status groups, due to their increased vulnerability. In this special issue, these arguments are illustrated by a collection of original contributions from collaborative research across Europe. The papers, in our view, advance the case for the robust associations between measures of adverse psychosocial environment and ill health, as they are based on comparative studies across several European countries and as they combine different types of study designs. This collaboration was enabled and supported by a European Science Foundation scientific programme on 'Social Variations in Health Expectancy in Europe'.

Health Status Indicators↗

Molecular phylogenetics and the evolution of antarctic notothenioid fishes.

The monophyly of the antarctic fish suborder Notothenioidei and the monophyly of its earliest family the Bovichtidae have been investigated with 12S and 16S mitochondrial DNA sequences. New data from Cottoperca, Pseudaphritis, Harpagifer and several outgroups, in addition to available sequences, show that the bovichtids are paraphyletic. Pseudaphritis is the sister group of all the non-bovichtid notothenioids. The same results are found from two independent genetic markers, the nuclear 28S rDNA and the 12S and 16S mitochondrial rDNA. This reliably refutes a previous hypothesis that placed Pseudaphritis as the sister group of all the remaining notothenioids (including Cottoperca and Bovichtus). Bootstrap analyses show that the Notothenioidei are monophyletic (although members of the suborder Trachinoidei have not been surveyed). Subsequent data from hemoglobin composition confirm the present relationships. After discussions between members of the European Science Foundation (ESF) network during its last two meetings, we point out here some fundamental aspects of comparative biology to improve understanding between the physiologist community and phylogeneticists. The most important points are differences in how the concept of homology is used and differences in the consideration of adaptation. When adaptation is evoked or questioned, endless speculations and untestable scenarios are often developed. We strongly advocate the use of phylogenetic trees for testing hypotheses of adaptation (through multiple character mapping). Such a "research program" in comparative biology has the power to improve knowledge because it can potentially lead to new experiments for testing adaptive hypotheses.

Animals↗

Epidemiological research needs access to data.

Data protection laws and their implementation have led to serious restrictions on access to personal data for research purposes. This seriously affects the development of social medicine and public health by making effective prevention of illness, and rational planning of health services, and their evaluation impossible in many instances. The conflict between people's need for knowledge about prevention and cure of illness and the control over personal data must be solved. Therefore, it is necessary to change the laws and ensure access to data for research use in accordance with the guidelines laid down by the European Science Foundation.

Confidentiality↗

Concurrent validity of the OPCRIT diagnostic system. Comparison of OPCRIT diagnoses with consensus best-estimate lifetime diagnoses.

BACKGROUND: OPCRIT (a suite of computer programs that allow data entry and generate diagnoses according to 12 operational diagnostic systems) is used in a wide range of psychiatric research including both European Science Foundation and NIMH research initiatives in the molecular genetics of mental disorders. We examined its concurrent validity in 100 subjects collected for linkage studies of Bipolar Disorder and Schizophrenia. METHOD: We compared diagnoses generated by OPCRIT from data rated by two trained clinicians with diagnoses made according to consensus, best-estimate, lifetime procedures by the same two raters according to DSM-III-R and RDC classifications. RESULTS: Good to excellent agreement was achieved between OPCRIT diagnoses and those made by consensus best-estimate procedures. CONCLUSIONS: OPCRIT provides a convenient, reliable, rapid and valid approach to polydiagnostic assessment that can be used as an adjunct to conventional (but time consulting) best-estimate consensus diagnostic procedures.

Bipolar Disorder↗

[Environment and genetics in the etiology of cleft lip and cleft palate with reference to the role of folic acid].

The combined birth prevalence of cleft palate [CP] and cleft lip with or without cleft palate [CL(P)] in Europe is approximately one in 700 with characteristic regional variations. Orofacial clefting (OC) is therefore now one of the most frequent congenital anomalies, with a higher birth prevalence that Down's Syndrome or Neural Tube defects, but still lower than cardiovascular malformation. Babies with OC require a multidisciplinary medical approach, surgery and rehabilitative treatments over time. This means an important effort in terms of social organization as well as economical costs for the health care system. In Italy, the health care costs for approximately 800 children born with orofacial clefting per year has been estimated at around 150 billion Lire (80 million Euros). The etiology of OC is complex and heterogeneous both for isolated and associated defects; causes linked to environment, genetics and gene-environment interaction are known, although there is still a lot to do, especially in clarifying the role of genetics in producing susceptibility to the environment. Four categories of genes for which there are results suggestive of a genetic susceptibility to OCs are: 1) genes expressed in a particular area of the embryo or in a particular period of the palatine arch development, such as the transforming growth factors alpha and beta (TGF alpha, TGF beta 2, TGF beta 3); 2) genes having biological activities linked to the OC's pathogenesis without direct involvement (e.g. the retinoic acid receptor (RARA), the methylenetetrahydrofolate reductase receptor (MTHFR) and the folic acid receptor (FOLR1); 3) genes or locus identified in experimental animals as the homeotic genes MSX-1 and MSX-2; 4) genes involved in the interaction with the xenobiotics metabolism as those in P-450 cytochrome system. Several environmental factors have been implicated in the OC etiology; among those, the folic acid supplementation during the periconceptional period that was found effective in the prevention of neural tube defects. In fact, folic acid deficiency may be responsible for different malformations through a common mechanism that interferes with the embryonic development, depending on the maternal or embryo genotype. Further investigation is required to study in depth how the genotype would modify the role of environmental factors like folic acid. Well-designed and conducted epidemiological studies seem to be able to give worthwhile information. Studies carried out in Europe on these issues are a few, particularly those on gene-environment interaction. Recent results obtained in molecular biology and the availability of wealth of data can allow to perform ad hoc investigations, being important not only for the basic research but also for their public health implications. For this objective a specific scientific network at the European level has been set by the European Science Foundation (ESF), whose first step will be to establish consistent case ascertainment and data collection across Europe and to develop standardized protocols and methods of analysis. It is hoped that in the longer term such multicentre collaborative research will enable combined analysis and lead to the identification of genetic susceptibility to certain environmental factors, including nutrition. Such studies would inform the current debate about the efficacy of folic acid and other nutritional factors in prevention of disease in the developing embryo. Subsequent public health measures targeted according to risk might reduce the prevalence of disorders such as orofacial clefting.

Adult↗

Evaluation--the Cinderella science of ICT in health.

OBJECTIVES: Information systems are expensive to create, and consume resources in their operation. They are justified in order to achieve clearly defined objectives in health service quality and efficiency. To ensure that these objectives are being met, and in order to build up an evidence-base to support well focused policies, systems, and practice, evaluation would seem to be fully justified and indeed essential. However, there are major factors jeopardising good evaluation practice, ranging from reluctance to commit resources or expose decisions to scrutiny, through to lack of appreciation of the full range of dimensions which should be studied. This paper seeks to create fuller appreciation of the issues and their importance. METHODS: Experiential and literature reviews form the basis of an exposition of principles, methods, and key current activities. RESULTS: A summary has been produced of the key challenges to health ICT evaluation, and its adverse comparison with other sectors. An explanation of the viewpoints and levels of health information evaluation is followed by a short history of principal milestones, current scientific methodology activity, and key collaborative activities. CONCLUSION: The need for a stronger commitment to health ICT evaluation is demonstrated if the application of health informatics systems is to receive due recognition as scientifically and empirically justified. Commitment of resources and scientific endeavour are needed, and thus the recent Declaration of Innsbruck, arising out of an event sponsored by the European Science Foundation, is timely and fully justified.

Evaluation Studies as Topic↗

[Mortality of unskilled workers in different countries of Europe].

The fact that lower socioeconomic groups experience the highest mortality rates is widely recognized. However, few attempts have been made to compare the situation between countries, taking into consideration the causes of death. The existence of comparable nation-wide data, and collaborative work in the workshops of the European Science Foundation, made possible the comparison presented in this paper. The mortality experience of male unskilled workers is described for Finland, Norway, Denmark, England and Wales, and France. The excess of mortality in the group is more pronounced in some countries; it is especially high in France. The causes of death responsible for extra deaths are not the same in every country: in Finland accidents and cardiovascular diseases have an important place; respiratory diseases are more important in England and Wales than in other countries; in France, a large part of differential mortality is linked to diseases related to alcohol consumption.

Adult↗

Simple sequence repeats (microsatellites): mutational mechanisms and contributions to bacterial pathogenesis. A meeting review.

This review summarises the presentations and discussions that took place during a European Science Foundation-funded workshop whose purpose was to gain current perspectives on the mutational mechanisms of simple sequence repeats and the contribution of localised hypermutation in such repeats to bacterial pathogenesis. In vitro biophysical and biochemical assays of mutational mechanisms were covered as well as genetic studies in various eukaryotic and prokaryotic organisms. Presentations on bacterial pathogenesis elaborated investigations of the use of repeats for typing of strains, epidemiological investigations of mutation rates and functions of loci whose expression is controlled by simple sequence repeats. This review tabulates current perspectives on the cis- and trans-acting factors for mutation of simple sequence repeats and the orientations of mononucleotide repeats in some bacterial species that utilise repeats for adaptation.

Bacteria↗