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PubMed2003

[Commentary note on the Italian translation of the Council for International Organizations of Medical Sciences 2002 Guidelines].

The new CIOMS International Ethical Guidelines on Biomedical Research Involving Human Subjects were published in August 2002. The aim of the present paper was to prepare a reasoned Italian translation of the guidelines. A preliminary version was submitted to a group of bioethicists and scientific research experts. Besides verifying the correctness and the adherence of the Italian version to the original text, a number of problematic terms were analysed. Some uncertainties emerged about the translation of expressions such as "ethical review committee" and "sponsor" and the difficulty to distinguish between "should" and "must". In the present globalisation era the need was apparent for a new approach to produce faithful translations based on a multidisciplinary approach that takes into account specific contexts and local peculiarities, but remains respectful to the original text.

Adult↗
PubMed2003

PRIME--PRocess modelling in ImpleMEntation research: selecting a theoretical basis for interventions to change clinical practice.

BACKGROUND: Biomedical research constantly produces new findings but these are not routinely translated into health care practice. One way to address this problem is to develop effective interventions to translate research findings into practice. Currently a range of empirical interventions are available and systematic reviews of these have demonstrated that there is no single best intervention. This evidence base is difficult to use in routine settings because it cannot identify which intervention is most likely to be effective (or cost effective) in a particular situation. We need to establish a scientific rationale for interventions. As clinical practice is a form of human behaviour, theories of human behaviour that have proved useful in other similar settings may provide a basis for developing a scientific rationale for the choice of interventions to translate research findings into clinical practice. The objectives of the study are: to amplify and populate scientifically validated theories of behaviour with evidence from the experience of health professionals; to use this as a basis for developing predictive questionnaires using replicable methods; to identify which elements of the questionnaire (i.e., which theoretical constructs) predict clinical practice and distinguish between evidence compliant and non-compliant practice; and on the basis of these results, to identify variables (based on theoretical constructs) that might be prime targets for behaviour change interventions. METHODS: We will develop postal questionnaires measuring two motivational, three action and one stage theory to explore five behaviours with 800 general medical and 600 general dental practitioners. We will collect data on performance for each of the behaviours. The relationships between predictor variables (theoretical constructs) and outcome measures (data on performance) in each survey will be assessed using multiple regression analysis and structural equation modelling. In the final phase of the project, the findings from all surveys will be analysed simultaneously adopting a random effects approach to investigate whether the relationships between predictor variables and outcome measures are modified by behaviour, professional group or geographical location.

Biomedical Research↗
PubMed2001

Obstacles facing translational research in academic medical centers.

Over the last quarter of the 20th century, there has been a boom in biomedical research discoveries that, for the most part, has not been successfully exploited for improving medical therapy or diagnosis. This lack of success is surprising because there is a broad consensus within academic medical centers (AMCs) that a primary mission is to move scientific discoveries into meaningful clinical outcomes, and there are numerous opportunities for doing so. We illustrate the latter point with 10 clinical opportunities for translating scientific discoveries from our field of vascular biology and transplantation. We attribute the limited success of translation to various factors, chief of which is that translation is rarely straightforward and requires continuing research in both the clinic and the laboratory. Translational research is hindered by insufficient targeted resources, a shortage of qualified investigators, an academic culture that hinders collaboration between clinical and laboratory-based investigators, a traditional structure of the AMC that favors departmental efforts over interdisciplinary programs, an increasing regulatory burden, and a lack of specific mechanisms within the AMC for facilitating solutions to these problems. We offer several suggestions to reduce these impediments.

Clinical Medicine↗
PubMed1993

Mendelian inheritance in man: diagnoses in the UMLS.

Because they deal with many distinct but rare inheritance diseases, geneticists have difficulty translating from their codes to other biomedical coding schemes. The objective of this research was to investigate the potential uses and difficulties of using the UMLS Metathesaurus for genetic diagnoses and to make recommendations to UMLS developers for improvements in UMLS for common genetic disorders. The 110 most common Mendelian Inheritance in Man disorders from the Missouri Genetic Disease Program over the period of one year were translated into MeSH, ICD and SNOMED. The more common diseases are more likely to be mapped than the rarer ones. Diseases with a proven genetic inheritance pattern are more likely to be mapped than those with speculated inheritance patterns. Approximately one third of all diagnoses were not mapped across all three coding schemes in Meta-1.2. The ICD coding scheme was found to be too broad to be meaningful for genetic diagnosis or epidemiological purposes. MeSH and SNOMED need to be made more specific and complete, and all of the new version of SNOMED needs to be included in the Metathesaurus.

Abstracting and Indexing↗
PubMed2005

New developments in pediatric plastic surgery research.

Pediatric plastic surgery research is a rapidly expanding field. Unique in many ways, researchers in this field stand at the union of multiple scientific specialties, including biomedical engineering, tissue engineering, polymer science, molecular biology, developmental biology, and genetics. The goal of this scientific effort is to translate research advances into improved treatments for children with congenital and acquired defects. Although the last decade has seen a dramatic acceleration in research related to pediatric plastic surgery, the next 10 years will no doubt lead to novel treatment strategies with improved clinical outcomes.

Animals↗
PubMed2002

Isolation and characterization of multipotential mesenchymal stem cells from feline bone marrow.

OBJECTIVE: Although several types of stem cells have been isolated from rodent and human tissues, very few data exist on stem cell isolation from nonrodent animals, which seriously limits the advancement of stem cell biology and its ultimate translation to human clinical applications. Domestic cats are used frequently in biomedical research and are the preferred species for studies of normal physiology and disease, particularly in neuroscience. Therefore, the objective of this study was to characterize mesenchymal stem cells (MSC) from feline bone marrow for use in research on the application of stem cells to human health problems for which cats are the preferred model. METHODS: Mesenchymal stem cells from feline bone marrow were isolated by standard methodology developed for other species and characterized according to morphology, growth traits, cell-surface antigen profile, and differentiation repertoire in vitro. RESULTS: Feline mesenchymal stem cells exhibit a fibroblast-like morphology with bipolar or polygonal cell bodies and possess a cell-surface antigen profile similar to their rodent and human counterparts. Feline MSC exist at a frequency of 1 in 3.8 x 10(5) bone marrow mononuclear cells and are capable of differentiation to adipocytic, osteocytic, and neuronal phenotypes when exposed to appropriate induction media. CONCLUSIONS: Mesenchymal stem cells isolated from feline bone marrow possess several traits typical of MSC from other species. Characterization of feline mesenchymal stem cells will facilitate future studies of stem cell biology and therapeutics for which the domestic cat is an indispensable model.

Adipocytes↗
PubMed2002

Chemogenomics: bridging a drug discovery gap.

With the successful completion of the human genome sequencing and the resulting plethora of genetic information now available novel technologies and applications have to be established to translate the huge amount of data generated into successful biological and biomedical research programs. The integration of various drug discovery disciplines within the parallel quest for novel targets and new molecular entities has meanwhile given rise to a quite popular term in pharmaceutical research named "chemogenomics". This review article gives an overview of the disciplines involved in this field and discusses the possible implications of this novel paradigm in drug discovery for the near future.

Algorithms↗
PubMed2006

Genomic platforms for cancer research: potential diagnostic and prognostic applications in clinical oncology.

The completion of the Human Genome Project and the achievement of similar goals in other organisms have generated a huge amount of free available information with high potential in biomedical sciences. However, the identification of the DNA sequence was only a starting point for genomic research. This research has been facilitated by the development of new powerful genomic tools that allow the use of the wide amount of genomic information generated to address new biological and biomedical questions. One of these widely accepted and accessible technologies is DNA microarrays. Although the most popular use of DNA microarrays is gene expression profiling, due to the continuous advances in microarray technologies, scientists have also successfully used them for multiple applications, including genotyping, re-sequencing, DNA copy number analysis and DNA methylation. In short, DNA microarrays are changing the way cancer research scientists are addressing different biological questions and will allow the translation of genome research to clinical practice.

Biomedical Research↗
PubMed2003

Clinical and outcome research in oncology. The need for integration.

Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR), defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care) that matter to decision makers (from patients to society at large), with special emphasis on the use of patient-reported outcomes (PRO). Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon the availability of specific knowledge, methods, instruments and resources and upon their appropriate integration in the mainstream of clinical research. In the USA specific interdisciplinary projects have been launched by the NCI. In Europe there is a lack of such initiatives. The correct placement of OR in the anti-cancer drug development process will guarantee the highest possible standard of validity and reliability of OR at European level and better integration of both translational and outcome research in the mainstream of clinical research into anti-cancer drugs, thus speeding up the introduction of the results of patient-oriented translational clinical research into clinical practice.

Antineoplastic Agents↗
PubMedDate not supplied

The challenge of implementing the prevention goals: some questions for researchers and communicators.

Two important issues in achieving change are how biomedical and behavioral research advances are viewed and used and the problem of "translation"--that is, how the results are put into practice. Momentum in federally funded research has been continued because we are betting that today's knowledge is limited relative to what remains to be learned about the prevention of disease. Those who administer programs, give primary care, and educate health professionals would benefit if they became fully sensitized to the world of research, and the planning of research would be invigorated by the perceptions of administrators and practitioners. The process of translation depends on the information function, and this function is as important as research and delivery. The schools and the media have created a public interested in science and medicine, but persuading people to change lifestyles is relatively unexplored territory. More knowledge in this area would help to decrease, for example, the number of smokers in the population and the number of accidents on the highways and in the workplace.

Communication↗