777 resultados para 150313 Quality Management


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This dissertation is the result of my participation in the Language Toolkit project, a recent collaboration between the Chamber of Commerce of Forlì and the School of Foreign Languages and Literatures, Interpreting and Translation at the University of Bologna, which aims to make students meet with the companies of our territory, in this case Ipack, based in Mercato Saraceno (FC). My dissertation is a specialized translation work from Italian into English of two documents that were entrusted to me: the declaration of compliance of Ipack’s products and a summary of the quality manual. They are two high technical texts and, therefore, the translation task required a preliminary phase of research on the topics and on the terminology of this specific domain. The dissertation consists of five chapters. The first chapter briefly introduces the company with which I collaborated for my dissertation project and provides an overview of business communication and a brief classification of Ipack’s communication tools. The second chapter covers the background topics, namely food packaging and quality management systems within companies. The third chapter concerns the analysis of the two texts, describing the intra-textual and extra-textual aspects, as well as the morphosyntaxical and lexical features. The fourth chapter is dedicated to the revision work on one of the two texts, the one about quality procedures. In the commentary following my review, I explain the methodology and the strategies that I used and I also provide some extended examples of the main changes applied to the original text, with respect to both content and linguistic features. Finally, the fifth chapter focuses on the translation of the texts followed by a commentary that explains the work methodology, resources and my translation choices, accompanied by practical examples.

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Sir, anti TNF-α agents (aTNFs) are the most commonly prescribed biological agents in RA. More recently abatacept (ABA), a T-cell costimulation modulator, and rituximab (RTX), a monoclonal antibody directed against CD20, have become available. Observational studies suggest that switching to a new drug class may be more effective in uncontrolled RA than switching to a class of biologics to which the patient had unsuccessfully been exposed [1]. Information about the efficacy and safety of cycling strategies through third-line biologics is lacking. This study aimed to analyse the effectiveness and safety of switching patients to ABA as the third biological class after failure of aTNF plus RTX. The Swiss Clinical Quality Management (SCQM) programme for RA is a longitudinal population-based cohort, which has been approved by the local ethics committees of all participating centres [2]. For this analysis, we collected all the …

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Diagnostic and therapeutic approaches to trauma patients are, depending on experience, equipment and different therapeutic doctrines, subject to wide variations. The ability to compare trauma centres using a standardised trauma register helps to reveal unresolved systemic issues and simplifies the quality management in an Emergency Department (ED).

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Observational studies have suggested that patients with rheumatoid arthritis (RA) who experience inadequate response to anti-tumour necrosis factor (anti-TNF) agents respond more favourably to rituximab (RTX) than to an alternative anti-TNF agent. However, the relative effectiveness of these agents on long-term outcomes, particularly in radiographic damage, remains unclear.

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PURPOSE OF REVIEW: Intensive care medicine consumes a high share of healthcare costs, and there is growing pressure to use the scarce resources efficiently. Accordingly, organizational issues and quality management have become an important focus of interest in recent years. Here, we will review current concepts of how outcome data can be used to identify areas requiring action. RECENT FINDINGS: Using recently established models of outcome assessment, wide variability between individual ICUs is found, both with respect to outcome and resource use. Such variability implies that there are large differences in patient care processes not only within the ICU but also in pre-ICU and post-ICU care. Indeed, measures to improve the patient process in the ICU (including care of the critically ill, patient safety, and management of the ICU) have been presented in a number of recently published papers. SUMMARY: Outcome assessment models provide an important framework for benchmarking. They may help the individual ICU to spot appropriate fields of action, plan and initiate quality improvement projects, and monitor the consequences of such activity.

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OBJECTIVE: Tumor necrosis factor (TNF) inhibitors have revolutionized the treatment of severe rheumatoid arthritis (RA), yet drug discontinuation is common. The aim of this study was to compare treatment retention rates and specific causes of anti-TNF discontinuation in a population-based RA cohort. METHODS: All patients treated with etanercept, infliximab, or adalimumab within the Swiss Clinical Quality Management RA cohort between 1997 and 2006 were included in the study. Causes of treatment discontinuation were broadly categorized as adverse events (AEs) or nontoxic causes, and further subdivided into specific categories. Specific causes of treatment interruption were analyzed using a Cox proportional hazards model and adjusted for potential confounders. RESULTS: A total of 2,364 anti-TNF treatment courses met the inclusion criteria. Treatment discontinuation was reported 803 times: 309 with etanercept, 249 with infliximab, and 245 with adalimumab. Drug inefficacy represented the largest single cause of treatment discontinuation (55.8% of cases). The median time of receiving anti-TNF therapy was 37 months, but discontinuation rates differed between the 3 anti-TNF agents (P < 0.001), with shorter retention rates for infliximab (hazard ratio [HR] 1.24, 99% confidence interval [99% CI] 1.01-1.51). The specific causes of treatment discontinuation revealed an increased risk of AEs with infliximab (HR 1.4, 99% CI 1.003-1.96), mostly due to an increased risk of infusion or allergic reactions (HR 2.11, 99% CI 1.23-3.62). Other discontinuation causes were equally distributed between the anti-TNF agents. CONCLUSION: In this population, infliximab was associated with higher overall discontinuation rates compared with etanercept and adalimumab, which is mainly due to an increased risk of infusion or allergic reactions.

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The Danish Minister of Social Affairs is a very eager protagonist of quality in treatment, almost searching for the “perfect“ treatment for children, youngsters, disabled, etc. Many expensive research projects dealing with quality management as well as developmental projects have been launched during the latest years in order to improve professional practice. Within that context this article will deal with the relations between paternalism and ignorance and between pro-social behaviour and anti-social treatment in order to grasp “why professions are doing vicious things“. The main focus is concerned with the knowledge field of social pedagogy.

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Nicht nur die vielfältigen funktionsbezogenen Anforderungen von Produkten und Bauteilen, sondern vor allem die heutigen Marktbedürfnisse stellen große Herausforderungen für aktuelle Fertigungstechnologien dar. Hierbei bildet die kontinuierlich steigende Variantenvielfalt bei gleichzeitiger Senkung der Stückzahlen je Variante die differenzierten Kundenwünsche ab. Diese Entwicklungen begünstigen die Perspektiven des Laserstrahlschmelzens im Allgemeinen sowie seiner speziellen Anwendungsgebiete Rapid Prototyping, Rapid Tooling und Rapid Manufac-turing. In den Branchen der Medizintechnik und der Gummi- und Kunststoffverarbeitung ist bereits seit einiger Zeit eine dynamische Entwicklung erkennbar. Besonders in der Medizintechnik wird der immer breitere Einsatz des Laserstrahlschmelzens durch die hohe Innovationsfähigkeit des Verfahrens und ein verbesserstes Qualitäts-management vorangetrieben. Aufgrund der zunehmenden Forderungen nach individualisierten und individuellen Produkten werden bereits heute patientenangepasste Implantate mit dem Laserstrahlschmelzverfahren gefertigt. Erwarten die Marktteilnehmer eine weiterhin steigende Nachfrage nach solchen Produkten? Wie muss das Verfah-ren verbessert werden, um seine Prozessstabilität zu erhöhen? Wo liegen die zukünftigen Herausforderungen in der Strahlschmelztechnologie? Um diese und weitere Fragen zu klären hat das Fraunhofer Institut für Produkti-onsanlagen und Konstruktionstechnik (IPK) eine Markt- und Trendanalyse für das Laserstrahlschmelzen durchge-führt.

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Ultrasound (US) has become a useful tool in the detection of early disease, differential diagnosis, guidance of treatment decisions and treatment monitoring of rheumatoid arthritis (RA). In 2008, the Swiss Sonography in Arthritis and Rheumatism (SONAR) group was established to promote the use of US in inflammatory arthritis in clinical practice. A scoring system was developed and taught to a large number of Swiss rheumatologists who already contributed to the Swiss Clinical Quality Management (SCQM) database, a national patient register. This paper intends to give a Swiss consensus about best clinical practice recommendations for the use of US in RA on the basis of the current literature knowledge and experience with the Swiss SONAR score. Literature research was performed to collect data on current evidence. The results were discussed among specialists of the Swiss university centres and private practice, following a structured procedure. Musculoskelatal US was found to be very helpful in establishing the diagnosis and monitoring the evolution of RA, and to be a reliable tool if used by experienced examiners. It influences treatment decisions such as continuing, intensifying or stepping down therapy. The definite modalities of integrating US into the diagnosis and monitoring of RA treatments will be defined within a few years. There are, however, strong arguments to use US findings as of today in daily clinical care. Some practical recommendations about the use of US in RA, focusing on the diagnosis and the use of the SONAR score, are proposed.

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Recently it has been proposed that the evaluation of effects of pollutants on aquatic organisms can provide an early warning system of potential environmental and human health risks (NRC 1991). Unfortunately there are few methods available to aquatic biologists to conduct assessments of the effects of pollutants on aquatic animal community health. The primary goal of this research was to develop and evaluate the feasibility of such a method. Specifically, the primary objective of this study was to develop a prototype rapid bioassessment technique similar to the Index of Biotic Integrity (IBI) for the upper Texas and Northwestern Gulf of Mexico coastal tributaries. The IBI consists of a series of "metrics" which describes specific attributes of the aquatic community. Each of these metrics are given a score which is then subtotaled to derive a total assessment of the "health" of the aquatic community. This IBI procedure may provide an additional assessment tool for professionals in water quality management.^ The experimental design consisted primarily of compiling previously collected data from monitoring conducted by the Texas Natural Resource Conservation Commission (TNRCC) at five bayous classified according to potential for anthropogenic impact and salinity regime. Standardized hydrological, chemical, and biological monitoring had been conducted in each of these watersheds. The identification and evaluation of candidate metrics for inclusion in the estuarine IBI was conducted through the use of correlation analysis, cluster analysis, stepwise and normal discriminant analysis, and evaluation of cumulative distribution frequencies. Scores of each included metric were determined based on exceedances of specific percentiles. Individual scores were summed and a total IBI score and rank for the community computed.^ Results of these analyses yielded the proposed metrics and rankings listed in this report. Based on the results of this study, incorporation of an estuarine IBI method as a water quality assessment tool is warranted. Adopted metrics were correlated to seasonal trends and less so to salinity gradients observed during the study (0-25 ppt). Further refinement of this method is needed using a larger more inclusive data set which includes additional habitat types, salinity ranges, and temporal variation. ^

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OBJECTIVE To evaluate the initiation of and response to tumor necrosis factor (TNF) inhibitors for axial spondyloarthritis (axSpA) in private rheumatology practices versus academic centers. METHODS We compared newly initiated TNF inhibition for axSpA in 363 patients enrolled in private practices with 100 patients recruited in 6 university hospitals within the Swiss Clinical Quality Management (SCQM) cohort. RESULTS All patients had been treated with ≥ 1 nonsteroidal antiinflammatory drug and > 70% of patients had a baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 before anti-TNF agent initiation. The proportion of patients with nonradiographic axSpA (nr-axSpA) treated with TNF inhibitors was higher in hospitals versus private practices (30.4% vs 18.7%, p = 0.02). The burden of disease as assessed by patient-reported outcomes at baseline was slightly higher in the hospital setting. Mean levels (± SD) of the Ankylosing Spondylitis Disease Activity Score were, however, virtually identical in private practices and academic centers (3.4 ± 1.0 vs 3.4 ± 0.9, p = 0.68). An Assessment of SpondyloArthritis international Society (ASAS40) response at 1 year was reached for ankylosing spondylitis in 51.7% in private practices and 52.9% in university hospitals (p = 1.0) and for nr-axSpA in 27.5% versus 25.0%, respectively (p = 1.0). CONCLUSION With the exception of a lower proportion of patients with nr-axSpA newly treated with anti-TNF agents in private practices in comparison to academic centers, adherence to ASAS treatment recommendations for TNF inhibition was equally high, and similar response rates to TNF blockers were achieved in both clinical settings.

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OBJECTIVE The primary aim of the study was to evaluate whether rheumatoid arthritis (RA) patients considered to be in remission according to clinical criteria sets still had persisting ultrasound (US) synovitis. We further intended to evaluate the capacity of our US score to discriminate between the patients with a clinically active disease versus those in remission. METHODS This is an observational study nested within the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) rheumatoid arthritis cohort. A validated US score (SONAR score) based on a semi-quantitative B-mode and Doppler (PwD) score as part of the regular clinical workup by rheumatologists in different clinical settings was used. To define clinically relevant synovitis, the same score was applied to 38 healthy controls and the 90st percentile was used as cut-off for 'relevant' synovitis. RESULTS Three hundred and seven patients had at least one US examination and concomitant clinical information on disease activity. More than a third of patients in both DAS28 and ACR/EULAR remission showed significant gray scale synovitis (P=0.01 and 0.0002, respectively) and PwD activity (P=0.005 and 0.0005, respectively) when compared to controls. The capacity of US to discriminate between the two clinical remission groups and patients with active disease was only moderate. CONCLUSION This observational study confirms that many patients considered to be in clinical remission according the DAS and the ACR/EULAR definitions still have residual synovitis on US. The prognostic significance of US synovitis and the exact place of US in patients reaching clinical remission need to be further evaluated.

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This document describes the guideline for peptide receptor radionuclide therapy (PRRT) published by the German Society of Nuclear Medicine (DGN) and accepted by the Association of the Scientific Medical Societies in Germany (AWMF) to be included in the official AWMF Guideline Registry. These recommendations are a prerequisite for the quality management in the treatment of patients with somatostatin receptor expressing tumours using PRRT. They are aimed at guiding nuclear medicine specialists in selecting likely candidates to receive PRRT and to deliver the treatment in a safe and effective manner. The recommendations are based on an interdisciplinary consensus. The document contains background information and definitions and covers the rationale, indications and contraindications for PRRT. Essential topics are the requirements for institutions performing the therapy, e. g. presence of an expert for medical physics, intense cooperation with all colleagues involved in the treatment of a patient, and a certificate of instruction in radiochemical labelling and quality control are required. Furthermore, it is specified which patient data have to be available prior to performance of therapy and how treatment has to be carried out technically. Here, quality control and documentation of labelling are of great importance. After treatment, clinical quality control is mandatory (work-up of therapy data and follow-up of patients). Essential elements of follow-up are specified in detail. The complete treatment inclusive after-care has to be realised in close cooperation with the involved medical disciplines. Generally, the decision for PRRT should be undertaken within the framework of a multi-disciplinary tumour board.