43 resultados para LABORATORY QUALITY ASSURANCE

em BORIS: Bern Open Repository and Information System - Berna - Suiça


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Enterprise Applications are complex software systems that manipulate much persistent data and interact with the user through a vast and complex user interface. In particular applications written for the Java 2 Platform, Enterprise Edition (J2EE) are composed using various technologies such as Enterprise Java Beans (EJB) or Java Server Pages (JSP) that in turn rely on languages other than Java, such as XML or SQL. In this heterogeneous context applying existing reverse engineering and quality assurance techniques developed for object-oriented systems is not enough. Because those techniques have been created to measure quality or provide information about one aspect of J2EE applications, they cannot properly measure the quality of the entire system. We intend to devise techniques and metrics to measure quality in J2EE applications considering all their aspects and to aid their evolution. Using software visualization we also intend to inspect to structure of J2EE applications and all other aspects that can be investigate through this technique. In order to do that we also need to create a unified meta-model including all elements composing a J2EE application.

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PURPOSE Different international target volume delineation guidelines exist and different treatment techniques are available for salvage radiation therapy (RT) for recurrent prostate cancer, but less is known regarding their respective applicability in clinical practice. METHODS AND MATERIALS A randomized phase III trial testing 64 Gy vs 70 Gy salvage RT was accompanied by an intense quality assurance program including a site-specific and study-specific questionnaire and a dummy run (DR). Target volume delineation was performed according to the European Organisation for the Research and Treatment of Cancer guidelines, and a DR-based treatment plan was established for 70 Gy. Major and minor protocol deviations were noted, interobserver agreement of delineated target contours was assessed, and dose-volume histogram (DVH) parameters of different treatment techniques were compared. RESULTS Thirty European centers participated, 43% of which were using 3-dimensional conformal RT (3D-CRT), with the remaining centers using intensity modulated RT (IMRT) or volumetric modulated arc technique (VMAT). The first submitted version of the DR contained major deviations in 21 of 30 (70%) centers, mostly caused by inappropriately defined or lack of prostate bed (PB). All but 5 centers completed the DR successfully with their second submitted version. The interobserver agreement of the PB was moderate and was improved by the DR review, as indicated by an increased κ value (0.59 vs 0.55), mean sensitivity (0.64 vs 0.58), volume of total agreement (3.9 vs 3.3 cm(3)), and decrease in the union volume (79.3 vs 84.2 cm(3)). Rectal and bladder wall DVH parameters of IMRT and VMAT vs 3D-CRT plans were not significantly different. CONCLUSIONS The interobserver agreement of PB delineation was moderate but was improved by the DR. Major deviations could be identified for the majority of centers. The DR has improved the acquaintance of the participating centers with the trial protocol.

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Objective: Two patient-focused long-term research projects performed in the German outpatient psychotherapy system are focused on in this article. The TK (Techniker Krankenkasse) project is the first study to evaluate a quality assurance and feedback system with regard to its practical feasibility in German routine care. The other study (“Quality Assurance in Outpatient Psychotherapy in Bavaria”; QS-PSY-BAY) was designed to test a new approach for quality assurance in outpatient psychotherapy using electronic documentation of patient characteristics and outcome parameters. In addition this project provides the opportunity to analyze data on health-related costs for the patients undergoing outpatient psychotherapy. Method: Both projects and their results indicating high effect sizes are briefly described. Results: From the perspectives of the research teams, advisory boards and other stakeholders, the experiences with these projects are discussed focusing on obstacles, challenges, difficulties, and benefits in developing and implementing the studies. The triangle collaboration of therapists, researchers, and health insurance companies/health service institutions turned out to be fruitful in both studies. Conclusions: Despite some controversies between the partners the experiences indicate the importance of practiced-research collaborations to provide relevant information about the delivery of outpatient psychotherapy in the health system

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Introduction The purpose of this paper is to present the technical specifications of the Forensic Reference Phantom (FRP), to test its behavior relative to organic test materials, and discuss potential applications of the phantom in forensic radiology. Materials and method The FRP prototype is made of synthetic materials designed to simulate the computed tomography (CT) attenuation of water. It has six bore holes that accommodate multiuse containers. These containers were filled with test materials and scanned at 80 kVp, 120 kVp, and 140 kVp. X-ray attenuation was measured by two readers. Intra- and inter-reader reliability was assessed using the intra-class correlation coefficient (ICC). Significance levels between mean CT numbers at 80 kVp, 120 kVp, and 140 kVp were assessed with the Friedman-test. The T-test was used to assess significance levels between the FRP and water. Results Overall mean CT numbers ranged from −3.0–3.7HU for the FRP; −1000.3–−993.5HU for air; −157.7– −108.1HU for oil; 35.5–42.0HU for musle tissue; and 1301.5–2354.8HU for cortical bone. Inter-reader and intra-reader reliability were excellent (ICC>0.994; and ICC=0.999 respectively). CT numbers were significantly different at different energy levels. There was no significant difference between the attenuation of the FRP and water. Conclusions The FRP is a new tool for quality assurance and research in forensic radiology. The mean CT attenuation of the FRP is equivalent to water. The phantom can be scanned during routine post-mortem CT to assess the composition of unidentified objects. In addition, the FRP may be used to investigate new imaging algorithms and scan protocols in forensic radiology.

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The performance of high-resolution CZE for determination of carbohydrate-deficient transferrin (CDT) in human serum based on internal and external quality data gathered over a 10-year period is reported. The assay comprises mixing of serum with a Fe(III) ion-containing solution prior to analysis of the iron saturated mixture in a dynamically double-coated capillary using a commercial buffer at alkaline pH. CDT values obtained with a human serum of a healthy individual and commercial quality control sera are shown to vary less than 10%. Values of a control from a specific lot were found to slowly decrease as function of time (less than 10% per year). Furthermore, due to unknown reasons, gradual changes in the monitored pattern around pentasialo-transferrin were detected, which limit the use of commercial control sera of the same lot to less than 2 years. Analysis of external quality control sera revealed correct classification of the samples over the entire 10-year period. Data obtained compare well with those of HPLC and CZE assays of other laboratories. The data gathered over a 10-year period demonstrate the robustness of the high-resolution CZE assay. This is the first account of a CZE-based CDT assay with complete internal and external quality assessment over an extended time period.

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Introduction In our program, simulated patients (SPs) give feedback to medical students in the course of communication skills training. To ensure effective training, quality control of the SPs’ feedback should be implemented. At other institutions, medical students evaluate the SPs’ feedback for quality control (Bouter et al., 2012). Thinking about implementing quality control for SPs’ feedback in our program, we wondered whether the evaluation by students would result in the same scores as evaluation by experts. Methods Consultations simulated by 4th-year medical students with SPs were video taped including the SP’s feedback to the students (n=85). At the end of the training sessions students rated the SPs’ performance using a rating instrument called Bernese Assessment for Role-play and Feedback (BARF) containing 11 items concerning feedback quality. Additionally the videos were evaluated by 3 trained experts using the BARF. Results The experts showed a high interrater agreement when rating identical feedbacks (ICCunjust=0.953). Comparing the rating of students and experts, high agreement was found with regard to the following items: 1. The SP invited the student to reflect on the consultation first, Amin (= minimal agreement) 97% 2. The SP asked the student what he/she liked about the consultation, Amin = 88%. 3. The SP started with positive feedback, Amin = 91%. 4. The SP was comparing the student with other students, Amin = 92%. In contrast the following items showed differences between the rating of experts and students: 1. The SP used precise situations for feedback, Amax (=maximal agreement) 55%, Students rated 67 of SPs’ feedbacks to be perfect with regard to this item (highest rating on a 5 point Likert scale), while only 29 feedbacks were rated this way by the experts. 2. The SP gave precise suggestions for improvement, Amax 75%, 62 of SPs’ feedbacks obtained the highest rating from students, while only 44 of SPs’ feedbacks achieved the highest rating in the view of the experts. 3. The SP speaks about his/her role in the third person, Amax 60%. Students rated 77 feedbacks with the highest score, while experts judged only 43 feedbacks this way. Conclusion Although evaluation by the students was in agreement with that of experts concerning some items, students rated the SPs’ feedback more often with the optimal score than experts did. Moreover it seems difficult for students to notice when SPs talk about the role in the first instead of the third person. Since precision and talking about the role in the third person are important quality criteria of feedback, this result should be taken into account when thinking about students’ evaluation of SPs’ feedback for quality control. Bouter, S., E. van Weel-Baumgarten, and S. Bolhuis. 2012. Construction and Validation of the Nijmegen Evaluation of the Simulated Patient (NESP): Assessing Simulated Patients’ Ability to Role-Play and Provide Feedback to Students. Academic Medicine: Journal of the Association of American Medical Colleges

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The long-lived radionuclide 129I (T 1/2 = 15.7 My) occurs in the nature in very low concentrations. Since the middle of our century the environmental levels of 129I have been dramatically changed as a consequence of civil and military use of nuclear fission. Its investigation in environmental materials is of interest for environmental surveillance, retrospective dosimetry and for the use as a natural and man-made fracers of environmental processes. We are comparing two analytical methods which presently are capable of determining 129I in environmental materials, namely radiochemical neutron activation analysis (RNAA) and accelerator mass spectrometry (AMS). Emphasis is laid upon the quality control and detection capabilities for the analysis of 129I in environmental materials. Some applications are discussed.

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The improvement and performance of a micellar electrokinetic capillary chromatography assay for cefepime in human serum and plasma with a 50 μm id fused-silica capillary elongated from 40 to 60 cm is reported. Sample preparation with dodecylsulfate protein precipitation at pH 4.5, the pH 9.1 separation medium and the applied voltage were as reported previously[16]. The change resulted in a significant lower current, higher resolution and increased detection time intervals. The performance of the assay with multi-level internal calibration was assessed with calibration and control samples. Quality assurance data of a two year period assessed under the new conditions demonstrated the robustness of the assay. In serum samples of patients who received both cefepime and sulfamethoxazole, cefepime could not be detected due to the inseparability of the two compounds. The presence of an interference can be recognized by an increased peak width (width > 0.2 min), the appearance of a shoulder or an unresolved double peak. The patient data gathered during a three year period reveal that introduction of therapeutic drug monitoring led to a 50% reduction of the median drug level. The data suggest that therapeutic drug monitoring can help to minimize the risk of major adverse reactions and to increase drug safety on an individual basis. This article is protected by copyright. All rights reserved.

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Vector control is the mainstay of malaria control programmes. Successful vector control profoundly relies on accurate information on the target mosquito populations in order to choose the most appropriate intervention for a given mosquito species and to monitor its impact. An impediment to identify mosquito species is the existence of morphologically identical sibling species that play different roles in the transmission of pathogens and parasites. Currently PCR diagnostics are used to distinguish between sibling species. PCR based methods are, however, expensive, time-consuming and their development requires a priori DNA sequence information. Here, we evaluated an inexpensive molecular proteomics approach for Anopheles species: matrix assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). MALDI-TOF MS is a well developed protein profiling tool for the identification of microorganisms but so far has received little attention as a diagnostic tool in entomology. We measured MS spectra from specimens of 32 laboratory colonies and 2 field populations representing 12 Anopheles species including the A. gambiae species complex. An important step in the study was the advancement and implementation of a bioinformatics approach improving the resolution over previously applied cluster analysis. Borrowing tools for linear discriminant analysis from genomics, MALDI-TOF MS accurately identified taxonomically closely related mosquito species, including the separation between the M and S molecular forms of A. gambiae sensu stricto. The approach also classifies specimens from different laboratory colonies; hence proving also very promising for its use in colony authentication as part of quality assurance in laboratory studies. While being exceptionally accurate and robust, MALDI-TOF MS has several advantages over other typing methods, including simple sample preparation and short processing time. As the method does not require DNA sequence information, data can also be reviewed at any later stage for diagnostic or functional patterns without the need for re-designing and re-processing biological material.

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Introduction To meet the quality standards for high-stakes OSCEs, it is necessary to ensure high quality standardized performance of the SPs involved.[1] One of the ways this can be assured is through the assessment of the quality of SPs` performance in training and during the assessment. There is some literature concerning validated instruments that have been used to assess SP performance in formative contexts but very little related to high stakes contexts.[2], [3], [4]. Content and structure During this workshop different approaches to quality control for SPs` performance, developed in medicine, pharmacy and nursing OSCEs, will be introduced. Participants will have the opportunity to use these approaches in simulated interactions. Advantages and disadvantages of these approaches will be discussed. Anticipated outcomes By the end of this session, participants will be able to discuss the rationale for quality control of SPs` performance in high stakes OSCEs, outline key factors in creating strategies for quality control, identify various strategies for assuring quality control, and reflect on applications to their own practice. Who should attend The workshop is designed for those interested in quality assurance of SP performance in high stakes OSCEs. Level All levels are welcome. References Adamo G. 2003. Simulated and standardized patients in OSCEs: achievements and challenges:1992-2003. Med Teach. 25(3), 262- 270. Wind LA, Van Dalen J, Muijtjens AM, Rethans JJ. Assessing simulated patients in an educational setting: the MaSP (Maastricht Assessment of Simulated Patients). Med Educ 2004, 38(1):39-44. Bouter S, van Weel-Baumgarten E, Bolhuis S. Construction and validation of the Nijmegen Evaluation of the Simulated Patient (NESP): Assessing Simulated Patients' ability to role-play and provide feedback to students. Acad Med: Journal of the Association of American Medical Colleges 2012. May W, Fisher D, Souder D: Development of an instrument to measure the quality of standardized/simulated patient verbal feedback. Med Educ 2012, 2(1).

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Sample preparation procedures for AMS measurements of 129I and 127I in environmental materials and some methodological aspects of quality assurance are discussed. Measurements from analyses of some pre-nuclear soil and thyroid gland samples and of a systematic investigation of natural waters in Lower Saxony, Germany, are described. Although the up-to-now lowest 129I/127I ratios in soils and thyroid glands were observed, they are still suspect to contamination since they are significantly higher than the pre-nuclear equilibrium ratio in the marine hydrosphere. A survey on all available 129I/127I isotopic ratios in precipitation shows a dramatic increase until the middle of the 1980s and a stabilization since 1987 at high isotopic ratios of about (3.6–8.3)×10−7. In surface waters, ratios of (57–380)×10−10 are measured while shallow ground waters show with ratios of (1.3–200)×10−10 significantly lower values with a much larger spread. The data for 129I in soils and in precipitation are used to estimate pre-nuclear and modern 129I deposition densities.

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Since the seventies, the practice of drug smuggling in the form of body packing has increased in the Western world. The goal of our study was to present an algorithm for the safe management of intracorporal drug transport based on clinical experience and current evidence. The retrospective study, conducted over the past four years in our hospital prison, analyzes and discusses the diagnostic and therapeutic concepts. Thirty-four patients hospitalized 37 times in a 48-month period were included. In 28 patients drug packages were identified. Only two patients suffered from serious complications. The study demonstrates that following a specifically designed management algorithm based on clinical experience and principles of evidence-based medicine can optimize risk management, improve quality assurance and patient safety.