1,721,449 research outputs found
FEAM Statement on Mental Health Policy Issues
Get PDFDas Thema psychische Erkrankungen wurde in der EU-Politik bisher vernachlässigt. Die derzeitige Praxis in der Psychiatrie wird erschwert durch ein unzureichendes biologisches Verständnis psychischer Störungen, mangelnde Anerkennung, Stigmatisierung, ein Mangel an wirksamen Therapien und einen schlechten Zugang zur Gesundheitsversorgung. Der vorliegende Bericht stützt sich auf die Diskussion kritischer Fragen der Psychiatrie auf dem FEAM-Treffen in Prag 2009.The present report draws on discussion from a Prague meeting organised in 2009 by FEAM (Federation of European Academies of Medicine) to review some of the critical issues in contemporary psychiatry and is intended to provide advice to decision-makers at the EU and national levels in developing a more coherent policy for mental health. We cover policy priorities relating to research and public health for major contributors to the disease burden, including depression, bipolar disorder, schizophrenia, and their co-morbidities. We also address cross-cutting issues for mental health policy, including stigma, suicide, addiction, workplace stress and the challenges of adolescence and ageing
The perspective from EASAC and FEAM on direct-to-consumer genetic testing for health-related purposes
No full textDirect-to-consumer (DTC) genetic testing services raise scientific, regulatory and ethical questions. A report was prepared by consultation with an expert Working Group and published by the academies of science (European Academies of Science Advisory Council, EASAC) and medicine (Federation of European Academies of Medicine, FEAM). This report reviews current scientific evidence, ascertains the principles that should underpin the options for action by policy-makers, and discusses the potential for devising proportionate and flexible regulation that enables future innovation, taking account of the work of other expert groups, most notably the European Society of Human Genetics. EASAC-FEAM concluded that DTC genetic testing has little clinical value at present, and expresses especial caution in several specific respects, for example relating to testing for high penetrance, serious disorders, prenatal screening, nutrigenomic and pharmacogenetic testing. It was emphasised that regulation must be on the basis that claims about the link between genetic marker and disease are scientifically valid. Other key issues to address include quality assurance (that includes the professional interpretation of results), transparent supply of accurate information, consideration of the implications for established health services, and clarification of consent procedures for any use of data for research purposes. There are important implications: for the European Commission, in revising the Directive on In Vitro Diagnostic Medical Devices; for professional bodies, in supporting training and guideline development; for the broader research community, in generating the evidence base; and for the public health community, in improving the routine translation of research advances into clinical practice
A Comparison of the Conditioning Regimens BEAM and FEAM for Autologous Hematopoietic Stem Cell Transplantation in Lymphoma: An Observational Study on 1038 Patients From Fondazione Italiana Linfomi
Get PDFBEAM (carmustine [bis-chloroethylnitrosourea (BCNU)]-etoposide-cytarabine-melphalan) chemotherapy is the standard conditioning regimen for autologous stem cell transplantation (ASCT) in lymphomas. Owing to BCNU shortages, many centers switched to fotemustine-substituted BEAM (FEAM), lacking proof of equivalence. We conducted a retrospective cohort study in 18 Italian centers to compare the safety and efficacy of BEAM and FEAM regimens for ASCT in lymphomas performed from 2008 to 2015. We enrolled 1038 patients (BEAM = 607, FEAM = 431), of which 27% had Hodgkin lymphoma (HL), 14% indolent non-Hodgkin lymphoma (NHL), and 59% aggressive NHL. Baseline characteristics including age, sex, stage, B-symptoms, extranodal involvement, previous treatments, response before ASCT, and overall conditioning intensity were well balanced between BEAM and FEAM; notable exceptions were median ASCT year (BEAM = 2011 versus FEAM = 2013, P < .001), Sorror score ≥3 (BEAM = 15% versus FEAM = 10%, P = .017), and radiotherapy use (BEAM = 18% versus FEAM = 10%, P < .001). FEAM conditioning resulted in higher rates of gastrointestinal and infectious toxicities, including severe oral mucositis grade ≥3 (BEAM = 31% versus FEAM = 44%, P < .001), and sepsis from Gram-negative bacteria (mean isolates/patient: BEAM = .1 versus FEAM = .19, P < .001). Response status at day 100 post-ASCT (overall response: BEAM = 91% versus FEAM = 88%, P = .42), 2-year overall survival (83.9%; 95% confidence interval [CI], 81.5% to 86.1%) and progression-free survival (70.3%; 95% CI, 67.4% to 73.1%) were not different in the two groups. Mortality from infection was higher in the FEAM group (subhazard ratio, 1.99; 95% CI, 1.02 to 3.88; P = .04). BEAM and FEAM do not appear different in terms of survival and disease control. However, due to concerns of higher toxicity, fotemustine substitution in BEAM does not seem justified, if not for easier supply
Challenges and potential in regenerative medicine: a joint report from EASAC and FEAM
Get PDFRegenerative medicine comprises novel interdisciplinary approaches, including several based on cell and gene therapies, aimed at tissue regeneration and repair. All regenerative medicine strategies depend upon harnessing, stimulating, guiding or replacing endogenous developmental or repair processes. Regenerative medicine offers significant promise for treating intractable diseases but, so far, has proved itself in only a few specific clinical indications, for example for haematopoietic and skin disorders. Stem-cell-based medicine is now established and will undoubtedly advance towards treating a progressively larger spectrum of diseases, so it is essential to address some critical scientific issues for evidence-based implementation and regulation. The consequences of not doing this would be to waste investment, researcher activity and aspirations to cure, as well as to undermine patient protection. This report, from a project conducted by EASAC (European Academies’ Science Advisory Council) and FEAM (Federation of European Academies of Medicine), explores opportunities and challenges in this rapidly advancing field, discusses what principles should be offered for guidance in policy development and what the strategic priorities are in the European Union (EU) for products in the category of advanced therapy medicinal products, which includes those used for regenerative medicine
Predicting Execution Readiness of MPI Binaries with FEAM, a Framework for Efficient Application Migration
Get PDFAbstract-Today's scientific computing infrastructures provide scientists with easy access to a wide variety of computing resources. However, migrating applications to new computing sites can be tedious and time consuming. When optimal performance is not a concern, scientists can benefit by moving binaries instead of source code. Our work aims to make migration of MPI application binaries more efficient by automation. We present general methods that assess if binaries are a good match for execution at computing sites. We also present methods for increasing execution readiness by resolving missing shared libraries. Our work aims to free scientists from extensive manual preparation at new sites. To evaluate the effectiveness of our methods, we present an automated Linux-based implementation called FEAM, a Framework for Efficient Application Migration. We show that FEAM is more than 90% accurate at predicting execution readiness of MPI application binaries from the NAS Parallel and SPEC MPI2007 benchmark suites. In our evaluation, only half of the migrated binaries execute successfully at sites configured with a matching MPI implementation. We show that by automatically resolving shared libraries requirements, FEAM is able to increase the number of successful executions by a third
Predicting Execution Readiness of MPI Binaries with FEAM, a Framework for Efficient Application Migration
Get PDFAbstract-As computational science becomes increasingly relevant for performing research, shared computing resources made accessible by cyberinfrastructures emerge as especially valuable for the majority of scientists who have not traditionally been the dominant users of such resources. However, in order to provide these newer computational scientists the opportunities to do great research, the ease-of-use of shared computing resources needs to be increased. In this paper, we present techniques that aim to make the migration to (and between) shared computing resources more efficient. Specifically, we focus on determining whether a computing site is a good fit for running an MPI binary. We present our methods and a Linux-based implementation called FEAM (a Framework for Efficient Application Migration). FEAM predicts execution readiness, resolves missing shared libraries, and composes site-specific configurations. We show that FEAM is more than 90% accurate at predicting execution readiness of MPI application binaries from the NAS Parallel and SPEC MPI2007 benchmark suites. In our evaluation, only half of the migrated binaries execute successfully at sites only configured with a matching MPI implementation. We show that by automatically resolving shared libraries requirements, FEAM is able to increase the number of successful executions by a third
Direct-to-consumer genetic testing for health-related purposes in the European Union: the view from EASAC and FEAM
Get PDFUntil recently, human genetic testing was mainly confined to specialist medical genetic services, traditionally focusing on the relatively rare inherited disorders. However, the rapid pace of advance in DNA analysis has led to increasing interest in the development of genetic tests for determining susceptibility to the more common, complex disorders. Such tests are increasingly being offered by companies through the internet. These consumer genetic services raise scientific, regulatory and ethical questions. Various concerns have been expressed about the quality and validity of the direct-to-consumer genetic testing offered, the clinical usefulness of the information supplied and the implications for the consumer, their family and the public health services. These issues affect all of us and are of sufficient importance and relevance to warrant attention by all the national academies in the European Union (EU). Our Report represents the first joint project between the academies of science in EASAC (the European Academies Science Advisory Council) and of medicine in FEAM (the Federation of European Academies of Medicine); we decided to collaborate on this occasion and in this way to draw upon the widest possible expertise in the scientific disciplines and experience in the Member States
Kaplan Meier plot of CMV reactivation according to the type of conditioning chemotherapy regimen (BEAM vs. FEAM vs. MEL).
No full textKaplan Meier plot of CMV reactivation according to the type of conditioning chemotherapy regimen (BEAM vs. FEAM vs. MEL).</p
Prospective study on the impact of BEAM versus FEAM conditioning on occurrence of neutropenic enterocolitis and on transplant outcome in lymphoma patients
Get PDFIntroduction: Carmustine (BCNU), etoposide, cytarabine, and melphalan (BEAM) are a widely used high-dose chemotherapy regimen for autologous stem cell transplantation transplant (ASCT) in lymphoid malignancies. During BCNU shortages, some centers switched to fotemustine-substituted BEAM (FEAM). Neutropenic enterocolitis (NEC) is a life-threatening complication occurring after intestinal mucosa damage related to intensive chemotherapy. NEC mortality may be up to 30%-50%. In our study, we compared NEC incidence, symptoms, mortality, and transplant outcome in terms of overall survival (OS) and progression-free survival (PFS) in the BEAM vs. FEAM groups. Furthermore, we compared the cost of hospitalization of patients who did vs. patients who did not experience a NEC episode (NECe). Methods: A total of 191 patients were enrolled in this study (N = 129 and N = 62 were conditioned with BEAM and FEAM, respectively). All patients received bed-side high-resolution ultrasound (US) for NEC diagnosis. Results and discussion: NEC incidence and NEC-related mortality were similar in the BEAM and FEAM groups (31% and 40.3%, p = 0.653, and 5% and 8%, p = 0.627, respectively). At a median follow-up of 116 months, no difference was noted between BEAM vs. FEAM groups in terms of OS and PFS (p = 0.181 and p = 0.978, respectively). BEAM appeared equivalent to FEAM in terms of NEC incidence and efficacy. The high incidence of NEC and the low mortality is related to a timely US diagnosis and prompt treatment. US knowledge in NEC diagnosis allows to have comparable days of hospitalization of patients NECpos vs. patients NECneg. The cost analysis of NECpos vs. NECneg has been also performed
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