1,920 research outputs found

    Clearing up the hazy road from bench to bedside: A framework for integrating the fourth hurdle into translational medicine

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    <p>Abstract</p> <p>Background</p> <p>New products evolving from research and development can only be translated to medical practice on a large scale if they are reimbursed by third-party payers. Yet the decision processes regarding reimbursement are highly complex and internationally heterogeneous. This study develops a process-oriented framework for monitoring these so-called fourth hurdle procedures in the context of product development from bench to bedside. The framework is suitable both for new drugs and other medical technologies.</p> <p>Methods</p> <p>The study is based on expert interviews and literature searches, as well as an analysis of 47 websites of coverage decision-makers in England, Germany and the USA.</p> <p>Results</p> <p>Eight key steps for monitoring fourth hurdle procedures from a company perspective were determined: entering the scope of a healthcare payer; trigger of decision process; assessment; appraisal; setting level of reimbursement; establishing rules for service provision; formal and informal participation; and publication of the decision and supplementary information. Details are given for the English National Institute for Health and Clinical Excellence, the German Federal Joint Committee, Medicare's National and Local Coverage Determinations, and for Blue Cross Blue Shield companies.</p> <p>Conclusion</p> <p>Coverage determination decisions for new procedures tend to be less formalized than for novel drugs. The analysis of coverage procedures and requirements shows that the proof of patient benefit is essential. Cost-effectiveness is likely to gain importance in future.</p

    Boundary representations of operator spaces, and compact rectangular matrix convex sets

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    We initiate the study of matrix convexity for operator spaces. We dene the notion of compact rectangular matrix convex set, and prove the natural analogs of the Krein-Milman and the bipolar theorems in this context. We deduce a canonical correspondence between compact rectangular matrix convex sets and operator spaces. We also introduce the notion of boundary representation for an operator space, and prove the natural analog of Arveson's conjecture: every operator space is completely normed by its boundary representations. This yields a canonical construction of the triple envelope of an operator space

    Boundary representations of operator spaces, and compact rectangular matrix convex sets

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    We initiate the study of matrix convexity for operator spaces. We define the notion of compact rectangular matrix convex set, and prove the natural analogs of the Krein--Milman and the bipolar theorems in this context. We deduce a canonical correspondence between compact rectangular matrix convex sets and operator spaces. We also introduce the notion of boundary representation for an operator space, and prove the natural analog of Arveson's conjecture: every operator space is completely normed by its boundary representations. This yields a canonical construction of the triple envelope of an operator space

    Identificação de Candida dubliniensis isoladas no Brasil, através do método comercial ID 32C

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    The purpose of the present study was to evaluate the identification of 19 Brazilian C. dubliniensis based on the biochemical profile exhibited when tested by the commercial identification kit ID 32C (bioMerieux). Thirteen of the isolates were rigorously identified as C. dubliniensis and the remaining isolates (six) were considered as having a doubtful profile but the software also suggested that there was 83.6% of chances for them to be C. dubliniensis. As well as pointed by the literature the identification obtained by phenotypic tests should be considered presumptive for C. dubliniensis due to variability of this new species.Dezenove culturas de C. dubliniensis isoladas no Brasil, previamente identificadas através de métodos genotípicos, foram avaliadas pelo kit comercial ID 32C (bioMerieux). Treze culturas foram identificadas como C. dubliniensis, mas as demais (seis) evidenciaram perfil duvidoso, embora o software do sistema sugerisse 83,6% de chances das mesmas pertencerem à espécie C. dubliniensis. A literatura tem registrado grande variabilidade fenotípica com esta espécie e, por isto, as identificações obtidas com este sistema deverão ser consideradas como presuntivas.Universidade Federal de Santa Maria Centro de Ciências da Saúde Departamento de Microbiologia e ParasitologiaUniversidade Federal do Rio Grande do SulUniversidade Federal do Rio Grande do NorteUniversidade Federal de São Paulo (UNIFESP)UNIFESPSciEL

    Carbohydrate assimilation profiles of Brazilian Candida dubliniensis isolates based on ID 32C system

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    The purpose of the present study was to evaluate the identification of 19 Brazilian C. dubliniensis based on the biochemical profile exhibited when tested by the commercial identification kit ID 32C (bioMerieux). Thirteen of the isolates were rigorously identified as C. dubliniensis and the remaining isolates (six) were considered as having a doubtful profile but the software also suggested that there was 83.6% of chances for them to be C. dubliniensis. As well as pointed by the literature the identification obtained by phenotypic tests should be considered presumptive for C. dubliniensis due to variability of this new species.Dezenove culturas de C. dubliniensis isoladas no Brasil, previamente identificadas através de métodos genotípicos, foram avaliadas pelo kit comercial ID 32C (bioMerieux). Treze culturas foram identificadas como C. dubliniensis, mas as demais (seis) evidenciaram perfil duvidoso, embora o software do sistema sugerisse 83,6% de chances das mesmas pertencerem à espécie C. dubliniensis. A literatura tem registrado grande variabilidade fenotípica com esta espécie e, por isto, as identificações obtidas com este sistema deverão ser consideradas como presuntivas

    The impact of bark beetle infestations on monoterpene emissions and secondary organic aerosol formation in western North America

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    Over the last decade, extensive beetle outbreaks in western North America have destroyed over 100 000 km2 of forest throughout British Columbia and the western United States. Beetle infestations impact monoterpene emissions through both decreased emissions as trees are killed (mortality effect) and increased emissions in trees under attack (attack effect). We use 14 yr of beetle-induced tree mortality data together with beetle-induced monoterpene emission data in the National Center for Atmospheric Research (NCAR) Community Earth System Model (CESM) to investigate the impact of beetle-induced tree mortality and attack on monoterpene emissions and secondary organic aerosol (SOA) formation in western North America. Regionally, beetle infestations may have a significant impact on monoterpene emissions and SOA concentrations, with up to a 4-fold increase in monoterpene emissions and up to a 40% increase in SOA concentrations in some years (in a scenario where the attack effect is based on observed lodgepole pine response). Responses to beetle attack depend on the extent of previous mortality and the number of trees under attack in a given year, which can vary greatly over space and time. Simulated enhancements peak in 2004 (British Columbia) and 2008 (US). Responses to beetle attack are shown to be substantially larger (up to a 3-fold localized increase in summertime SOA concentrations) in a scenario based on bark-beetle attack in spruce trees. Placed in the context of observations from the IMPROVE network, the changes in SOA concentrations due to beetle attack are in most cases small compared to the large annual and interannual variability in total organic aerosol which is driven by wildfire activity in western North America. This indicates that most beetle-induced SOA changes are not likely detectable in current observation networks; however, these changes may impede efforts to achieve natural visibility conditions in the national parks and wilderness areas of the western United States.National Science Foundation (U.S.) (ATM- 0929282)National Science Foundation (U.S.) (ATM-0939021)National Science Foundation (U.S.) (ATM-0938940)United States. Dept. of Energy. Office of Scienc
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