941 resultados para Multicriteria approval


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BACKGROUND: Treatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments. METHODS: Data from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures. RESULTS: Ethics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P=.043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons. CONCLUSIONS: Olanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.

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OBJECTIVES: Direct-acting antiviral agents (DAAs) have become the standard of care for the treatment of chronic hepatitis C virus (HCV) infection. We aimed to assess treatment uptake and efficacy in routine clinical settings among HIV/HCV coinfected patients after the introduction of the first generation DAAs. METHODS: Data on all Swiss HIV Cohort Study (SHCS) participants starting HCV protease inhibitor (PI) treatment between September 2011 and August 2013 were collected prospectively. The uptake and efficacy of HCV therapy were compared with those in the time period before the availability of PIs. RESULTS: Upon approval of PI treatment in Switzerland in September 2011, 516 SHCS participants had chronic HCV genotype 1 infection. Of these, 57 (11%) started HCV treatment during the following 2 years with either telaprevir, faldaprevir or boceprevir. Twenty-seven (47%) patients were treatment-naïve, nine (16%) were patients with relapse and 21 (37%) were partial or null responders. Twenty-nine (57%) had advanced fibrosis and 15 (29%) had cirrhosis. End-of-treatment virological response was 84% in treatment-naïve patients, 88% in patients with relapse and 62% in previous nonresponders. Sustained virological response was 78%, 86% and 40% in treatment-naïve patients, patients with relapse and nonresponders, respectively. Treatment uptake was similar before (3.8 per 100 patient-years) and after (6.1 per 100 patient-years) the introduction of PIs, while treatment efficacy increased considerably after the introduction of PIs. CONCLUSIONS: The introduction of PI-based HCV treatment in HIV/HCV-coinfected patients improved virological response rates, while treatment uptake remained low. Therefore, the introduction of PIs into the clinical routine was beneficial at the individual level, but had only a modest effect on the burden of HCV infection at the population level.

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Le traitement de l'hépatite C chronique a été révolutionné par l'introduction de nouveaux antiviraux (directly acting antivirals [DAA]). Ces inhibiteurs de protéase, de la protéine NS5A et de la polymérase peuvent être associés dans des traitements oraux hautement efficaces et bien tolérés sans interféron. Dans cet article, nous fournissons un aperçu du traitement actuel de l'hépatite C chronique avec considération particulière des DAA actuellement autorisés en Suisse. Treatment of chronic hepatitis C is currently being revolutionised, with the introduction of directly acting antivirals (DAA), including protease, NS5A and polymerase inhibitors. These can be combined in interferon-free oral therapies with unprecedented efficacy and good tolerance. Here, we review the current therapy of chronic hepatitis C, with a particular focus on DAA that are approved in Switzerland today.

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Background: Endometriosis is an estrogen-dependent, pro-inflammatory, pro-angiogenic condition that affects 5 to 10% of women of reproductive age. Its defining feature is the presence of endometrium-like tissue in sites outside the uterine cavity, primarily on the pelvic peritoneum and ovaries. The main clinical features are chronic pain, pain during intercourse and infertility. In patients with endometriosis, inflammatory and immune responses, angiogenesis and apoptosis are altered in favour of the survival and replenishment of endometriotic tissue. These basic pathological processes depend on the excessive formation of estrogen and prostaglandins. Recently, new cellular and molecular mechanisms for the resolution of inflammation have been discovered, revealing key roles for lipid mediators such as lipoxins, resolvins and protectins. It is possible that disequilibrium in the expression of these molecules exists in endometriosis. Objective: To compare the expression of two proteins involved in the synthe sis and in the function of lipid mediators; the Arachidonate 15-lipoxygenase (ALOXI5), implicated in the synthesis of lipoxins A4 and B4 and the Formyl peptide receptor 1 (FPRLI), the specific receptor for Lipoxin A4 and B4, between women who suffer from endometriosis and a control group. We wish to demonstrate the cellular localisation of these two molecules and to investigate if their expression is alteted in this pathology. Methods and Materials Using immunohistochemistry we will compare ALOXI5 and FPRLI staining, in endometrium, normal peritoneum and endometriotic lesions. The samples are being collected in the department of Gynaecology and Obstetrics at the Centre Hospitalier Universitaire Lausanne (CHUV). Women attending the department for laparoscopic investigation of pain/infertility, suspected endometriosis or for a hysterectomy, are invited to participate. Approval of the ethics committee (Commission d'Ethique de la recherché clinique) was obtained in March 2009. Clinical samples will only be obtained from subjects having consented. Expected results and interpretation: No published studies investigating the expression of these two molecules in endometriotic lesions exist. A better understanding of the mechanisms underlying this disease will result in the development of new medical therapies and new diagnostic tests, with the aim of ameliorating the quality of life of endometriosis patients.

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Trastuzumab (Herceptin ®, Roche) is approved in UK for the treatment of the metastatic breast cancer since 2001. As of 2005, concomitantly with the publication of 3 studies that showed it produces a 50% reduction of the recurrence rates of breast cancer, trastuzumab started to be prescribed in the earlt adjuvant treatrnent of this disease. Und June 2006, trastuzumab did not have both: 1) regulatory approval and 2) NICE [National Institute for Health and Clinical Excellence] recommendation for the use in early stages of breast cancer. During the period until June 2006, the trastuzumab use in those patients was not reimbursed and because the cost of trastuzumab is equal with the yearly UK average income, most of patients could not self fund their treatrnent. Before the publication of the final NICE guidance, the new data of trastuzumab in early breast cancer raised enormous patient and professional interest and expectations. A great volume of public and professional pressure was generated to transcend a system by which Primary Care Trusts can reimburse a treatment only after a formal guidance was issued. This paper draw on a case study depicting and analyzing the process by which regulatory approval and NICE recommendations were achieved in a record time and how trastuzumab became a standard treatment on early adjuvant breast cancer. According to the data we gathered in this work we were witnessing one of the fastest processes of adoption of a health care technology since the creation of NICE, in 1999. This study addresses the following research question: How and why does the adoption pattern of trastuzumab differ from the rational decision-making model of the reimbursement process in UK? [Author, p. 4]

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Early warning systems (EWSs) rely on the capacity to forecast a dangerous event with a certain amount of advance by defining warning criteria on which the safety of the population will depend. Monitoring of landslides is facilitated by new technologies, decreasing prices and easier data processing. At the same time, predicting the onset of a rapid failure or the sudden transition from slow to rapid failure and subsequent collapse, and its consequences is challenging for scientists that must deal with uncertainties and have limited tools to do so. Furthermore, EWS and warning criteria are becoming more and more a subject of concern between technical experts, researchers, stakeholders and decision makers responsible for the activation, enforcement and approval of civil protection actions. EWSs imply also a sharing of responsibilities which is often averted by technical staff, managers of technical offices and governing institutions. We organized the First International Workshop on Warning Criteria for Active Slides (IWWCAS) to promote sharing and networking among members from specialized institutions and relevant experts of EWS. In this paper, we summarize the event to stimulate discussion and collaboration between organizations dealing with the complex task of managing hazard and risk related to active slides.

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The general objective of the international MEDiterranean EXperiment (MEDEX) was the better understanding and forecasting of cyclones that produce high impact weather in the Mediterranean. This paper reviews the motivation and foundation of MEDEX, the gestation, history and organisation of the project, as well as the main products and scientific achievements obtained from it. MEDEX obtained the approval of World Meteorological Organisation (WMO) and can be considered as framed within other WMO actions, such as the ALPine EXperiment (ALPEX), the Mediterranean Cyclones Study Project (MCP) and, to a certain extent, THe Observing System Research and Predictability EXperiment (THORPEX) and the HYdrological cycle in Mediterranean EXperiment (HyMeX). Through two phases (2000 2005 and 2006 2010), MEDEX has produced a specific database, with information about cyclones and severe or high impact weather events, several main reports and a specific data targeting system field campaign (DTS-MEDEX-2009). The scientific achievements are significant in fields like climatology, dynamical understanding of the physical processes and social impact of cyclones, as well as in aspects related to the location of sensitive zones for individual cases, the climatology of sensitivity zones and the improvement of the forecasts through innovative methods like mesoscale ensemble prediction systems.

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Diplomityön tarkoituksena oli kehittää mikroprosessoriohjattu digitaalinen pölymittarituoteperhe vanhan analogisen hiukkasmittarin tilalle. Työssä käydään läpi mittarin teoreettista perustaa ja kehitysprojektin eri vaiheita sekä tutustutaan hiukkasmittauksen perusteisiin, lainsäädäntöön sekä hiukkasten terveysvaikutuksiin, joista saadaan motivaatiota sille, miksi hiukkasia yleensä kannattaa ja pitää mitata. Työssä tutustutaan myös lainsäädännön mittarilta vaatimiin hyväksyntöihin eri sovelluskohteissa, käytännön mittauksissa esiintyviin haasteisiin sekä käydään läpi hyväk-syntöjen läpäisemiseksi vaaditut testit. Diplomityön lopuksi tutustutaan mittarin kaupalliseen menestykseen, ehdotetaan kehi-tyskohteita ja tutustutaan tribosähköisen mittauksen tulevaisuuden mahdollisuuksiin.

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This paper presents a procedure that allows us to determine the preference structures(PS) associated to each of the different groups of actors that can be identified in a groupdecision making problem with a large number of individuals. To that end, it makesuse of the Analytic Hierarchy Process (AHP) (Saaty, 1980) as the technique to solvediscrete multicriteria decision making problems. This technique permits the resolutionof multicriteria, multienvironment and multiactor problems in which subjective aspectsand uncertainty have been incorporated into the model, constructing ratio scales correspondingto the priorities relative to the elements being compared, normalised in adistributive manner (wi = 1). On the basis of the individuals’ priorities we identifydifferent clusters for the decision makers and, for each of these, the associated preferencestructure using, to that end, tools analogous to those of Multidimensional Scaling.The resulting PS will be employed to extract knowledge for the subsequent negotiationprocesses and, should it be necessary, to determine the relative importance of thealternatives being compared using anyone of the existing procedures

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Current technology trends in medical device industry calls for fabrication of massive arrays of microfeatures such as microchannels on to nonsilicon material substrates with high accuracy, superior precision, and high throughput. Microchannels are typical features used in medical devices for medication dosing into the human body, analyzing DNA arrays or cell cultures. In this study, the capabilities of machining systems for micro-end milling have been evaluated by conducting experiments, regression modeling, and response surface methodology. In machining experiments by using micromilling, arrays of microchannels are fabricated on aluminium and titanium plates, and the feature size and accuracy (width and depth) and surface roughness are measured. Multicriteria decision making for material and process parameters selection for desired accuracy is investigated by using particle swarm optimization (PSO) method, which is an evolutionary computation method inspired by genetic algorithms (GA). Appropriate regression models are utilized within the PSO and optimum selection of micromilling parameters; microchannel feature accuracy and surface roughness are performed. An analysis for optimal micromachining parameters in decision variable space is also conducted. This study demonstrates the advantages of evolutionary computing algorithms in micromilling decision making and process optimization investigations and can be expanded to other applications

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One of the main industries which form the basis of Russian Economical structure is oil and gas. This industry is also playing a significant role for CIS countries. Oil and gas industry is developing intensively attracting foreign investments. This situation is providing sustainable development of machinery production for hazardous areas. Operating in oil and gas areas is always related with occurrence of explosion gas atmospheres. Machines for hazardous areas must be furnished with additional protection of different types. Explosion protection is regulated with standards according to which equipment must be manufactured. In Russia and CIS countries explosion-proof equipment must be constructed in compliance with GOST standards. To confirm that equipment is manufactured according to standards’ requirements and is safe and reliable it must undergo the approval procedure. Certification in Russia is governed by Federal Laws and legislation. Each CIS country has its own approval certificates and permissions for operating in hazardous areas.

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Logistics management is increasingly being recognised by many companies to be of critical concern. The logistics function includes directly or indirectly many of the new areas for achieving or maintaining competitive advantage that companies have been forced to develop due to increasing competitive pressures. The key to achieving a competitive advantage is to manage the logistics function strategically which involves determining the most cost effective method of providing the necessary customer service levels from the many combinations of operating procedures in the areas of transportation, warehousing, order processing and information systems, production, and inventory management. In this thesis, a comprehensive distribution logistics strategic management process is formed by integrating the periodic strategic planning process with a continuous strategic issues management process. Strategic planning is used for defining the basic objectives for a company and assuring co operation and synergy between the different functions of a company while strategic issues management is used on a continuous basis in order to deal with environmental and internal turbulence. The strategic planning subprocess consists of the following main phases: (1) situational analyses, (2) defining the vision and strategic goals for the logistics function, (3) determining objectives and strategies, (4) drawing up tactical action plans, and (5) evaluating the implementation of the plans and making the needed adjustments. The aim of the strategic issues management subprocess is to continuously scan the environment and the organisation for early identification of the issues having a significant impact on the logistics function using the following steps: (1) the identification of trends, (2) assessing the impact and urgency of the identified trends, (3) assigning priorities to the issues, and (4) planning responses to the, issues. The Analytic Hierarchy Process (AHP) is a systematic procedure for structuring any problem. AHP is based on the following three principles: decomposition, comparative judgements, and synthesis of priorities. AHP starts by decomposing a complex, multicriteria problem into a hierarchy where each level consists of a few manageable elements which are then decomposed into another set of elements. The second step is to use a measurement methodology to establish priorities among the elements within each level of the hierarchy. The third step in using AHP is to synthesise the priorities of the elements to establish the overall priorities for the decision alternatives. In this thesis, decision support systems are developed for different areas of distribution logistics strategic management by applying the Analytic Hierarchy Process. The areas covered are: (1) logistics strategic issues management, (2) planning of logistic structure, (3) warehouse site selection, (4) inventory forecasting, (5) defining logistic action and development plans, (6) choosing a distribution logistics strategy, (7) analysing and selecting transport service providers, (8) defining the logistic vision and strategic goals, (9) benchmarking logistic performance, and (10) logistic service management. The thesis demonstrates the potential of AHP as a systematic and analytic approach to distribution logistics strategic management.

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No hace más de 3 años se podía leer en las revistas especializadas que España había pasado a ocupar el tercer puesto en el ranking mundial por potencia eólica instalada. La industria eólica española a su vez ha pasado a ocupar el tercer puesto en la fabricación e instalación de aerogeneradores, con una cuota de mercado del 13%, siendo así un sector con gran capacidad de exportación. Por otra parte, tras diez años de promulgación de la Ley 31/95, de 8 de noviembre, de Prevención de Riesgos Laborales, y después su desarrollo reglamentario, es un hecho incontestable que, pese a todo, y a los ingentes esfuerzos realizados por los distintos actores implicados en la prevención de riesgos laborales (Estado, Comunidades Autónomas, Agentes Sociales, Entidades especializadas, etcetera), existe un sector como el de la construcción que, constituyendo uno de los ejes del crecimiento económico de nuestro país, está sometido a unos riesgos especiales y continúa registrando una siniestralidad laboral muy notoria por sus cifras y gravedad. La legislación de prevención, los manuales sobre las distintas disciplinas preventivas, los libros especializados, los expertos... han abordado ya, con mayor o menor acierto, muchas de las cuestiones generales y específicas que afectan a la seguridad y salud: la evaluación de riesgos, las medidas higiénicas, los equipos de trabajo y equipos de protección individual, la planificación, la formación, los servicios de prevención , los sistemas de gestión de la prevención, las auditorías ... forman parte de los contenidos que se han ido creando en torno a este tema. No obstante, resulta de gran interés la elaboración de un estudio de Seguridad y Salud, en el que partiendo de un desarrollo técnico concreto, pero sobre todo integral, es decir, que comprenda todas las fases para el suministrp e instalación de aerogeneradores para un parque eólico, vayamos desgranando cada uno de los puntos desarrollados en su construcción. Entre las conclusiones más destacadas de este trabajo, se encuentra la definición de las condiciones relativas a la prevención de accidentes y enfermedades laborales durante la ejecución de los trabajos de suministro e instalación de un parque eólico y la gestión de su prevención, las características de las instalaciones preceptivas para higiene y bienestar de los trabajadores, así como directrices básicas mínimas, que deben reflejarse y desarrollarse en el Plan de Seguridad y Salud que las empresas contratistas deberán presentar para su aprobación por el director de obra, antes del comienzo de los trabajos, de forma que sea posible la disminución de accidentes laborales así como evitar las posibles sanciones administrativas y/o penales.

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Els processos per a l’aprovació i la implementació de la Llei per a l’Autonomia personal i l’Atenció a les Persones en situació de Dependència (LAPAD) han donat lloc a un intens debat polític i social que, coincidint també amb les millores en la provisió de serveis i els avenços mèdics, ha contribuït a un procés de classificació i d’etiquetatge basats en els dèficits de les persones que es troben en aquestes circumstàncies. Aquesta visió anul·la el subjecte i la seva experiència singular i condiciona l’abordatge dels models d’atenció i de cura. L’estudi pretén fer una aproximació a les persones grans amb pèrdua d’autonomia funcional, fent emergir les seves veus, que expressen com perceben, interpreten, afronten i es reajusten a la nova situació. Partint d’un enfocament constructivista, basat en la subjectivitat, es fa un recorregut sobre els models de la discapacitat que han reeixit en l’activitat científica dels darrers anys, els mecanismes de regulació de les pèrdues que defensen les teories del cicle vital i les aportacions que s’han fet sobre el model de la resiliència aplicat a les persones que envelleixen. El resultats de l’estudi mostren com les representacions i els significats que les persones grans atribueixen a la seva experiència s’inscriuen en les seves trajectòries vitals, donant un sentit únic i singular a la forma de viure i de respondre a la pèrdua d’autonomia funcional i les seves conseqüències. Aquelles que expressen una vivència d’integritat respecte de la vida viscuda, amb predomini d’afectes positius envers un mateix i els altres, que conserven l’esperança i el desig de continuar vivint, s’ajusten a les pèrdues de manera més satisfactòria que aquelles que expressen desconfiança i una certa amargor respecte de la pròpia vida. D’això se’n deriva que els espais d’escolta i d’acompanyament poden ser un recurs vàlid i necessari en el qual, a través de la paraula i el testimoni narrat, el subjecte pugui repensar i resignificar les seves experiències.

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Aim: To investigate and understand patient's satisfaction with nursing care in the intensive care unit to identify the dimensions of the concept of"satisfaction" from the patient's point of view. To design and validate a questionnaire that measures satisfaction levels in critical patients. Background: There are many instruments capable of measuring satisfaction with nursing care; however, they do not address the reality for critical patients nor are they applicable in our context. Design: A dual approach study comprising: a qualitative phase employing Grounded Theory and a quantitative and descriptive phase to prepare and validate the questionnaire. Methods: Data collection in the qualitative phase will consist of: in-depth interview after theoretical sampling, on-site diary and expert discussion group. The sample size will depend on the expected theoretical saturation n = 27-36. Analysis will be based on Grounded Theory. For the quantitative phase, the sampling will be based on convenience (n = 200). A questionnaire will be designed on the basis of qualitative data. Descriptive and inferential statistics will be used. The validation will be developed on the basis of the validity of the content, the criteria of the construct and reliability of the instrument by the Cronbach's alpha and test-retest approach. Approval date for this protocol was November 2010. Discussion: Self-perceptions, beliefs, experiences, demographic, socio-cultural epistemological and political factors are determinants for satisfaction, and these should be taken into account when compiling a questionnaire on satisfaction with nursing care among critical patients.