Competence-based catalog of learning objectives for the subject area of quality management in medical studies - position paper of the working group Quality Management in Education, Training and Continuing Education of the Society for Quality Management in Health Care (GQMG).

Background: Traditionally, direct medical competences are taught in medical studies, whereas leadership and quality management competences are hardly taught, although graduates are already confronted with management tasks at the beginning of their clinical work. With the upcoming amendment of the Medical Licensing Regulations, this topic area will probably be addressed and must be adequately taught by the faculties. The learning objectives in the area of quality management listed in the current working version of the German National Catalogue of Learning Objectives in Medicine (NKLM) 2.0 have so far been formulated in rather general terms and need to be concretized. Aim: To develop a competence-based learning objectives catalog for the topic area of quality management in medical studies as a structured framework recommendation for the design of faculty teaching-learning programs and as a suggestion for further development of the NKLM. Methods: The competence-based learning objectives catalog was developed by an eight-member working group "Quality Management in Education, Training and Continuing Education" of the Gesellschaft für Qualitätsmanagement in der Gesundheitsversorgung e.V. (GQMG) within the framework of a critical synthesis of central publications. The members of the project group have many years of project experience in quality management in health care as well as in university didactics. Results: Six basic competence goals as well as 10 specific competence goals could be formulated and consented upon. These are each flanked by a list of essential basic concepts and examples. These focus on quality improvements, including patient safety and treatment success against the background of a physician leadership role in an interprofessional context. Discussion: A competency-based set of learning objectives has been compiled that encompasses the necessary concepts and basic knowledge of quality management required for those entering the profession to understand and actively participate in quality management after completing medical school. To the authors' knowledge, no comparable learning objectives catalog is currently available for medical studies, even internationally.

Assessment of Two Different Glucagon Assays in Healthy Individuals and Type 1 and Type 2 Diabetes Patients.

Methods for glucagon analysis suffered in the past from lack of specificity and a narrow sensitivity range, which has led to inaccurate results and to the suggestion that type 1 diabetes (T1D) and type 2 diabetes (T2D) patients have elevated fasting glucagon levels. However, the availability of more specific and more sensitive methods to detect intact glucagon has shown that actual glucagon levels are lower than previously assumed. This study aimed to characterize fasting plasma glucagon levels in healthy individuals and T1D and T2D patients with two different glucagon assays. The study included 20 healthy individuals, 20 T1D and 20 T2D patients. Blood was collected under fasting conditions. A double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) and a conventional radioimmunoassay (RIA) were used. A significant difference in fasting glucagon levels between healthy individuals and T2D was observed by ELISA, but not by RIA. ELISA also yielded lower glucagon levels in healthy individuals than in T1D and T2D patients which RIA did not. RIA produced significantly (p = 0.0001) higher overall median glucagon values than ELISA in a pooled analysis. These results underline the notion that the choice of selective laboratory methods is highly relevant for mechanistic endocrine research.

Bone Phenotyping Approaches in Human, Mice and Zebrafish - Expert Overview of the EU Cost Action GEMSTONE ("GEnomics of MusculoSkeletal traits TranslatiOnal NEtwork").

A synoptic overview of scientific methods applied in bone and associated research fields across species has yet to be published. Experts from the EU Cost Action GEMSTONE ("GEnomics of MusculoSkeletal Traits translational Network") Working Group 2 present an overview of the routine techniques as well as clinical and research approaches employed to characterize bone phenotypes in humans and selected animal models (mice and zebrafish) of health and disease. The goal is consolidation of knowledge and a map for future research. This expert paper provides a comprehensive overview of state-of-the-art technologies to investigate bone properties in humans and animals - including their strengths and weaknesses. New research methodologies are outlined and future strategies are discussed to combine phenotypic with rapidly developing -omics data in order to advance musculoskeletal research and move towards "personalised medicine".

Assessment of trimethylamine N-oxide (TMAO) as a potential biomarker of severe stress in patients vulnerable to posttraumatic stress disorder (PTSD) after acute myocardial infarction.

Background: Posttraumatic stress disorder (PTSD) is a frequently observed stress-related disorder after acute myocardial infarction (AMI) and it is characterized by numerous symptoms, such as flashbacks, intrusions and anxiety, as well as uncontrollable thoughts and feelings related to the trauma. Biological correlates of severe stress might contribute to identifying PTSD-vulnerable patients at an early stage. Objective: Aims of the study were (1) to determine whether blood levels of trimethylamine N-oxide (TMAO) vary immediately after AMI in patients with/without AMI-induced PTSD symptomatology, (2) to investigate whether TMAO is a potential biomarker that might be useful in the prediction of PTSD and the PTSD symptom subclusters re-experiencing, avoidance and hyperarousal, and (3) to investigate whether TMAO varies immediately after AMI in patients with/without depression 6 months after AMI. Method: A total of 114 AMI patients were assessed with the Hamilton-Depression Scale after admission to the hospital and 6 months later. The Clinician Administered PTSD Scale for DSM-5 was used to explore PTSD-symptoms at the time of AMI and 6 months after AMI. To assess patients' TMAO status, serum samples were collected at hospitalization and 6 months after AMI. Results: Participants with PTSD-symptomatology had significantly higher TMAO levels immediately after AMI than patients without PTSD-symptoms (ANCOVA: TMAO(PTSD x time), F = 4.544, df = 1, p = 0.035). With the inclusion of additional clinical predictors in a hierarchical logistic regression model, TMAO became a significant predictor of PTSD-symptomatology. No significant differences in TMAO levels immediately after AMI were detected between individuals with/without depression 6 months after AMI. Conclusions: An elevated TMAO level immediately after AMI might reflect severe stress in PTSD-vulnerable patients, which might also lead to a short-term increase in gut permeability to trimethylamine, the precursor of TMAO. Thus, an elevated TMAO level might be a biological correlate for severe stress that is associated with vulnerability to PTSD.

Antecedentes: El trastorno de estrés postraumático (TEPT) es un trastorno relacionado con el estrés que se observa con frecuencia después de un infarto agudo de miocardio (IAM) y se caracteriza por numerosos síntomas, como flashbacks, intrusiones y ansiedad, así como pensamientos y sentimientos incontrolables relacionados con el trauma. Los correlatos biológicos del estrés severo podrían contribuir a identificar a los pacientes vulnerables al TEPT en una etapa temprana.Objetivo: Los objetivos del estudio fueron (1) determinar si los niveles sanguíneos de N-óxido de trimetilamina (TMAO, por sus siglas en ingles) varían inmediatamente después del IAM en pacientes con o sin sintomatología de TEPT inducida por IAM, (2) investigar si el TMAO es un biomarcador potencial que podría ser útil en la predicción de TEPT y los subgrupos de síntomas de TEPT que experimentan, evitación e hiperactivación, y (3) para investigar si el TMAO varía inmediatamente después del IAM en pacientes con o sin depresión 6 meses después del IAM.Método: Un total de 114 pacientes con IAM fueron evaluados con la Escala de Depresión de Hamilton tras su ingreso al hospital y 6 meses después. La Escala de TEPT para el DSM-5 administrada por el médico se utilizó para explorar los síntomas de TEPT en el momento del IAM y 6 meses después del IAM. Para evaluar el estado de TMAO de los pacientes, se recolectaron muestras de suero en la hospitalización y 6 meses después del IAM.Resultados: Los participantes con sintomatología de TEPT tenían niveles de TMAO significativamente más altos inmediatamente después del IAM que los pacientes sin síntomas de TEPT (ANCOVA: TMAO (TEPT x tiempo), F = 4.544, df = 1, p = 0.035). Con la inclusión de predictores clínicos adicionales en un modelo de regresión logística jerárquica, TMAO se convirtió en un predictor significativo de la sintomatología del TEPT. No se detectaron diferencias significativas en los niveles de TMAO inmediatamente después del IAM entre individuos con o sin depresión 6 meses después del IAM.Conclusiones: Un nivel elevado de TMAO inmediatamente después del IAM podría reflejar un estrés severo en pacientes vulnerables al TEPT, lo que también podría conducir a un aumento a corto plazo de la permeabilidad intestinal a la trimetilamina, el precursor de TMAO. Por lo tanto, un nivel elevado de TMAO podría ser un correlato biológico del estrés severo asociado con la vulnerabilidad al TEPT.

Risk assessment for preterm preeclampsia in first trimester: Comparison of three calculation algorithms.

OBJECTIVE: To better adjust the risk for preeclampsia, multifactorial models in first trimester of pregnancy have found the way in clinical practice. This study compares the available test algorithms. STUDY DESIGN: In a cross-sectional study between November 2013 and April 2016 we compared the tests results of three first trimester testing algorithms for preeclampsia in 413 women. Risk for preterm preeclampsia was calculated with three different algorithms: Preeclampsia Predictor™ Software by PerkinElmer (PERK), ViewPoint® Software by GE Healthcare (VP) and the online calculator of the Fetal Medicine Foundation (FMF).We analyzed the data descriptively and determined Cohen's Kappa to assess the agreement among the algorithms. RESULTS: VP classified 89(21.5%) women, PERK 43(10.4%) women and FMF 90 (21.8%) women as having high risk for preterm preeclampsia (<34 weeks of gestation for VP and PERK and <37 weeks of gestation for FMF). Agreement between tests ranged from moderate to substantial (PERK/VP: κ = 0.56, PERK/ FMF: κ = 0.50, and VP/ FMF: κ = 0.72). CONCLUSION: The three algorithms are similar but not equal. This may depend on chosen cut off, but also on test properties. This study cannot decide which algorithm is the best, but differences in results and cut offs should be taken into account.

International comparison of minimum volume standards for hospitals.

INTRODUCTION: Minimum volume standards have been implemented in various countries for quality or safety policies. We present minimum volume standards in an international comparison, focusing on regulatory approaches, selected sets of procedures and thresholds as well as predetermined consequences of non-compliance. MATERIALS AND METHODS: We combined a comprehensive literature search in electronic databases in March 2016 with a hand-search of governmental and related organisations' webpages. We also contacted international experts to verify the information we found in the literature and to obtain additional data. RESULTS: Minimum volume standards have been introduced in different countries predominantly for highly specialized surgical procedures. The same evidence has led to different definitions and ways of implementation of minimum volume standards in Germany, Canada (Ontario), the Netherlands, Switzerland, and Austria. The regulatory approaches to minimum volume standards and the predetermined consequences of non-compliance differ across the countries. CONCLUSION: The sets of procedures for which minimum volume standards and corresponding thresholds have been introduced vary across countries, possibly due to different regulatory approaches. In addition, key attributes of the health care system might affect the development and implementation of minimum volume standards. Therefore, it is not feasible to formulate uniform recommendations that are applicable to all countries. Our results provide a comprehensive overview of international minimum volume standards and can be used to inform policy decisions.

Comparison of two-risk assessment algorithms for preeclampsia in first trimester with consecutive intake of low-dose aspirin in the high-risk group - an observational study.

We analyzed outcome of women screened for preeclampsia with two different multifactorial risk algorithms (Predictor®Software by PerkinElmer, PerkinElmer, Waltham, MA; PERK-group: n = 214 and Viewpoint® by GE Healthcare, Dornstadt, Germany; VIEW-group: n = 209) in first trimester. Women at high risk for developing preeclampsia were advised to take low-dose acetylsalicylic acid (LDA). Screening positive rates for early onset preeclampsia differed significantly between the two groups (7.9% versus 26.3%; p = 0.000). According the clinical use of screening test criteria, LDA was prescribed in 63 (29.4%) women in the PE-group and 55 (26.3%) in the VP-group (p = 0.516). There were no differences in onset of preeclampsia [4 (1.9%) versus 6 (2.9%); p = 0.540]. No early or severe preeclampsia occurred in the whole population.

New considerations on the management of osteoporosis in Central and Eastern Europe (CEE): summary of the "3rd Summit on Osteoporosis-CEE", November 2009, Budapest, Hungary.

INTRODUCTION: In November 2009, the "3rd Summit on Osteoporosis-Central and Eastern Europe (CEE)" was held in Budapest, Hungary. The conference aimed to tackle issues regarding osteoporosis management in CEE identified during the second CEE summit in 2008 and to agree on approaches that allow most efficient and cost-effective diagnosis and therapy of osteoporosis in CEE countries in the future. DISCUSSION: The following topics were covered: past year experience from FRAX® implementation into local diagnostic algorithms; causes of secondary osteoporosis as a FRAX® risk factor; bone turnover markers to estimate bone loss, fracture risk, or monitor therapies; role of quantitative ultrasound in osteoporosis management; compliance and economical aspects of osteoporosis; and osteoporosis and genetics. Consensus and recommendations developed on these topics are summarised in the present progress report. CONCLUSION: Lectures on up-to-date data of topical interest, the distinct regional provenances of the participants, a special focus on practical aspects, intense mutual exchange of individual experiences, strong interest in cross-border cooperations, as well as the readiness to learn from each other considerably contributed to the establishment of these recommendations. The "4th Summit on Osteoporosis-CEE" held in Prague, Czech Republic, in December 2010 will reveal whether these recommendations prove of value when implemented in the clinical routine or whether further improvements are still required.