153 research outputs found

    Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology

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    Background Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) imposes several conditions on pathology departments that develop and use in-house in vitro diagnostic medical devices (IH-IVDs). However, not all of these conditions need to be implemented immediately after the IVDR entered into force on 26 May 2022. Based on an amending regulation of the European Parliament and the Council of the European Union, the requirements for IH-IVDs will be phased in. Conformity with the essential safety and performance requirements of annex I must be ensured from May 2022. Objectives With this article, we would like to present the practical implementation of the currently valid conditions for IH-IVDs at the Institute of Pathology at the University Hospital of Heidelberg, in order to provide possible assistance to other institutions. Conclusions In addition to the intensive work on the requirements for IH-IVDs, several guidance documents and handouts provide orientation for the implementation and harmonisation of the requirements for healthcare institutions mentioned in Article 5 (5). Exchange in academic network structures is also of great importance for the interpretation and practical implementation of the IVDR. For university and nonuniversity institutions, ensuring conformity with the IVDR represents a further challenge in terms of personnel and time, in addition to the essential tasks of patient care, teaching and research and the further development of methods for optimal and targeted diagnostics, as well as the maintenance of the constantly evolving quality management system

    Evaluation of Interventions in Blended Learning Using a Communication Skills Serious Game

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    Serious games often employ a scripted dialogue for player interaction with a virtual character. In our serious game Communicate, a domain expert develops a structured, scripted scenario as a sequence of potential interactions in an authoring tool. A player is often a student learning communication skills and a virtual character represents a person that a student talks to. In the original version of Communicate, a player `converses' with a virtual character by clicking on one of the multiple statement options. Since 2018, we perform blended learning sessions for final year computer science students using Communicate. Our goal is to improve these sessions and in this paper, we apply the action research method over three semesters to iteratively improve these blended learning sessions. In the first semester, our baseline, we conduct sessions where students play a scenario in multiple choice format. In the second semester, we enhance Communicate by enabling a student to enter open text input in an improved scenario. In the third semester, we enhance a session by incorporating peer teaching. Students fill in an evaluation survey after a session and we compare the evaluation of students from the three semesters. Results show that student ratings are significantly higher in sessions incorporating peer teaching compared to the baseline

    Deficient Pms2, ERCC1, Ku86, CcOI in Field Defects During Progression to Colon Cancer

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    In carcinogenesis, the "field defect" is recognized clinically because of the high propensity of survivors of certain cancers to develop other malignancies of the same tissue type, often in a nearby location. Such field defects have been indicated in colon cancer. The molecular abnormalities that are responsible for a field defect in the colon should be detectable at high frequency in the histologically normal tissue surrounding a colonic adenocarcinoma or surrounding an adenoma with advanced neoplasia (well on the way to a colon cancer), but at low frequency in the colonic mucosa from patients without colonic neoplasia

    Structure and content of the EU-IVDR: current status and implications for pathology

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    Background Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-certified IVDs (CE-IVDs), in-house IVDs (IH-IVDs), and research use only (RUO) devices are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities. Objectives Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge. Conclusions The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments

    Die Verordnung (EU) 2017/746 (IVDR) in der Praxis: Umsetzung von Anhang I in der Pathologie

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    Hintergrund Die Verordnung (EU) 2017/746 über In-vitro-Diagnostika (IVDR) stellt mehrere Bedingungen an Pathologische Institute, die hausinterne In-vitro-Diagnostika (IH-IVD) entwickeln und anwenden. Diese Bedingungen müssen jedoch nicht alle unmittelbar mit dem Geltungsbeginn der IVDR zum 26.05.2022 umgesetzt worden sein. Auf der Grundlage einer Änderungsverordnung des Europäischen Parlaments und des Rates der Europäischen Union werden die Anforderungen an IH-IVD stufenweise eingeführt. Die Konformität mit den grundlegenden Sicherheits- und Leistungsanforderungen gemäß Anhang I muss seit Mai 2022 gewährleistet sein Ziel der Arbeit Mit diesem Artikel möchten wir die praktische Umsetzung der aktuell gültigen Bedingungen für IH-IVD im Pathologischen Institut des Universitätsklinikums Heidelberg vorstellen und damit mögliche Hilfestellung für andere Einrichtungen geben Schlussfolgerungen Neben der intensiven Auseinandersetzung mit den Anforderungen an IH-IVD geben mehrere Handreichungen und Hilfestellungen eine Orientierungshilfe zur Umsetzung und Harmonisierung der in Artikel 5 (5) genannten Anforderungen an Gesundheitseinrichtungen. Auch der Austausch in akademischen Netzwerkstrukturen ist für die Interpretation und die praktische Umsetzung der IVDR von großer Bedeutung. Für universitäre und nicht-universitäre Einrichtungen stellt die Sicherstellung der IVDR-Konformität – neben den wesentlichen Aufgaben in der Krankenversorgung, in der Lehre und der Forschung und Weiterentwicklung von Methoden zur optimalen und zielgerichteten Diagnostik sowie der Aufrechterhaltung des sich stetig weiterentwickelnden Qualitätsmanagementsystems – eine weitere personelle und zeitliche Herausforderung dar

    Microalbuminuria among Type 1 and Type 2 diabetic patients of African origin in Dar Es Salaam, Tanzania

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    BACKGROUND: The prevalences and risk factors of microalbuminuria are not full described among black African diabetic patients. This study aimed at determining the prevalence of microalbuminuria among African diabetes patients in Dar es Salaam, Tanzania, and relate to socio-demographic features as well as clinical parameters. METHODS: Cross sectional study on 91 Type 1 and 153 Type 2 diabetic patients. Two overnight urine samples per patient were analysed. Albumin concentration was measured by an automated immunoturbidity assay. Average albumin excretion rate (AER) was used and were categorised as normalbuminuria (AER < 20 ug/min), microalbuminuria (AER 20–200 ug/min), and macroalbuminuria (AER > 200 ug/min). Information obtained also included age, diabetes duration, sex, body mass index, blood pressure, serum total cholesterol, high-density and low-density lipoprotein cholesterol, triglycerides, serum creatinine, and glycated hemoglobin A(1c). RESULTS: Overall prevalence of microalbuminuria was 10.7% and macroalbuminuria 4.9%. In Type 1 patients microalbuminuria was 12% and macroalbuminuria 1%. Among Type 2 patients, 9.8% had microalbuminuria, and 7.2% had macroalbuminuria. Type 2 patients with abnormal albumin excretion rate had significantly longer diabetes duration 7.5 (0.2–24 yrs) than those with normal albumin excretion rate 3 (0–25 yrs), p < 0.001. Systolic and diastolic blood pressure among Type 2 patients with abnormal albumin excretion rate were significantly higher than in those with normal albumin excretion rate, (p < 0.001). No significant differences in body mass index, glycaemic control, and cholesterol levels was found among patients with normal compared with those with elevated albumin excretion rate either in Type 1 or Type 2 patients. A stepwise multiple linear regression analysis among Type 2 patients, revealed AER (natural log AER) as the dependent variable to be predicted by [odds ratio (95% confidence interval)] diabetes duration 0.090 (0.049, 0.131), p < 0.0001, systolic blood pressure 0.012 (0.003–0.021), p < 0.010 and serum creatinine 0.021 (0.012, 0.030). CONCLUSION: The prevalence of micro and macroalbuminuria is higher among African Type 1 patients with relatively short diabetes duration compared with prevalences among Caucasians. In Type 2 patients, the prevalence is in accordance with findings in Caucasians. The present study detects, however, a much lower prevalence than previously demonstrated in studies from sub-Saharan Africa. Abnormal AER was significantly related to diabetes duration and systolic blood pressure

    Incorporating Genomics and Bioinformatics across the Life Sciences Curriculum

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    Undergraduate life sciences education needs an overhaul, as clearly described in the National Research Council of the National Academies’ publication BIO 2010: Transforming Undergraduate Education for Future Research Biologists. Among BIO 2010’s top recommendations is the need to involve students in working with real data and tools that reflect the nature of life sciences research in the 21st century [1]. Education research studies support the importance of utilizing primary literature, designing and implementing experiments, and analyzing results in the context of a bona fide scientific question [1–12] in cultivating the analytical skills necessary to become a scientist. Incorporating these basic scientific methodologies in undergraduate education leads to increased undergraduate and post-graduate retention in the sciences [13–16]. Toward this end, many undergraduate teaching organizations offer training and suggestions for faculty to update and improve their teaching approaches to help students learn as scientists, through design and discovery (e.g., Council of Undergraduate Research [www.cur.org] and Project Kaleidoscope [ www.pkal.org])
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