Search

During the last decade, medical education in the German-speaking world has been striving to become more practice-oriented. This is currently being achieved in many schools through the implementation of simulation-based instruction in Skills Labs. Simulators are thus an essential part of this type of medical training, and their acquisition and operation by a Skills Lab require a large outlay of resources. Therefore, the Practical Skills Committee of the Medical Education Society (GMA) introduced a new project, which aims to improve the flow of information between the Skills Labs and enable a transparent assessment of the simulators via an online database (the Simulator Network).

Due to the introduction of a variety of new features to the German health system, such as a new reimbursement system for inpatient work based on diagnosis-related groups, an obligation to detailed documentation for total quality management, as well as due to the continuing increase in the amount of imaging and other data within invasive cardiology, the use of electronic databases for documentation in the cardiac cath lab is of significant importance. The user friendliness and robustness of the software system for daily clinical practice is crucial for the acceptance of electronic documentation systems by physicians, nurses and technicians. This survey was aimed to explore the current practice and experiences of German cardiac catheterization labs with electronic databases particularly designed for documentation in invasive cardiology, including report generation of cath studies, risk and complication management and logistics for medical material ordering for the cath lab. Of the 176 hospitals and practices having agreed in taking part in this surveillance 165, are currently using an electronic database for administration of medical data and study reports. In 64% of the cath labs, a sub-specialized software system for detailed documentation of the course and the results of an invasive procedure, the human and material resources used, generation of the cath report, and documentation of procedural and post-procedural complications for total quality management is used. The acceptance and satisfaction with the software solutions currently available reveals to be rather inhomogeneous. While user-friendliness and flexibility of a number of software products were positively mentioned, main issues, such as missing hardware of software interfaces with the hospital information system for patient administration, missing stability of several systems, image management too complex and report configuration too inconvenient for daily clinical practice, were criticized. In general, in the light of continuing increase of the amount of clinical and imaging data as well as due to the legal obligation of detailed procedural documentation in all areas of invasive cardiology, a documentation system based on electronic databases bears the potential of an enormous economization of the daily workload of a cardiac cath lab. Prerequisites for the acceptance of such a system in clinical practice is not only the stability and reliability of the system but also the ability to link such a sub-system to existing databases via suitable interfaces and the flexibility of the system for modification of its features to meet the individual requirements of each user.

Background: Haemostatic puncture closure devices for rapid and effective hemostasis after arterial catheterisation are a comfortable alternative to manual compression. Implanting a collagen plug against the vessel wall may become responsible for other kind of vascular injuries i.e. thrombotic or stenotic lesions and peripheral embolisation. The aim of this paper is to report our clinically relevant vascular complications after Angio-Seal and to discuss the results in the light of the current literature., Patients and Methods: We report the symptomatic vascular complications in 17 of 7376 patients undergoing diagnostic or therapeutic catheterisation between May 2000 and March 2003 at the University Hospital Basel., Results: Most patients presented with ischaemic symptoms, arterial stenoses or occlusions and thrombotic lesions (n = 14), whereas pseudoaneurysms were extremely rare (n = 3). Most patients with ischaemic lesions underwent vascular surgery and all patients with a pseudoaneurysm were successfully treated by ultrasound-guided compression., Conclusions: Severe vascular complications after Angio-Seal are rare, consistent with the current literature. There may be a shift from pseudoaneurysms to ischaemic lesions.

The synthetic cannabinoid receptor agonist (SCRA) market is transnational, and the availability of individual SCRAs changes regularly in response to national and international legislative controls. This generates a cyclic pattern and near constant evolution of SCRA compounds. This study reports toxicology-based and/or seized sample-based prevalence data relating to SCRA use in prisons from Germany, the United Kingdom (UK; Scotland and Wales), and the United States (US), representing 4427 individual test results. The study examines SCRA detections in prisons from July 2018 to September 2020, and where possible, prison-based data are compared with SCRA prevalence data in the wider population. The relative influence of Chinese, other international, and national drug legislation on the prevalence of individual SCRAs in prisons is also considered. tert-Leucinate- and valinate-indole- and indazole-3-carboxamides were the most common SCRA detections, and MDMB-4en-PINACA was one of the most commonly detected SCRAs in all jurisdictions by September 2020. However, despite there being a global production and supply market, there were notable regional differences. Analog controls in German and US legislation may have led to increased compound diversity that is not reflected in the UK which has both analog controls and a blanket ban on psychoactive substances. While there were regional differences, SCRA prevalence in prisons closely aligned with the SCRAs detected on the local market, demonstrating that SCRA (and possibly other NPS) monitoring programs in prisons can act as early warning systems for the wider population in that given jurisdiction., (© 2021 The Authors. Drug Testing and Analysis published by John Wiley & Sons Ltd.)

Objective: Simulation-based teaching is gaining increasing importance in veterinary education worldwide and is by now an integral part of all German veterinary educational institutions in the form of Skills Labs. Students and teachers of the University of Veterinary Medicine Hannover, Foundation (TiHo) showed a good acceptance for the establishment and curricular use of a Clinical Skills Lab (CSL). This study will now examine the perspectives of non-university stakeholders in order to assess the acceptance of such a facility among clinicians. In addition, experiences in implementing a CSL in veterinary teaching are taken into account by interviewing experts., Material and Methods: Semi-structured guided interviews were conducted with alumni of the TiHo, senior veterinarians from various German clinics and practices and leading experts from some of the largest veterinary CSLs worldwide., Results: The interviews revealed a need for improvement in the clinical-practical training of veterinary students among senior veterinarians and alumni. Respondents could imagine that teaching in the CSL may play a major role in this. Overall, the participants pleaded for a mandatory implementation of simulation-based teaching in the curriculum., Conclusion: The study suggests that the training of clinical-practical skills of veterinary students should be continuously adapted to the requirements of the veterinary profession in a clinical environment. Non-university stakeholders seem to support the use of a CSL to improve these skills and encourage its further implementation in the curriculum., Competing Interests: Die Autoren versichern, dass keine geschützten, beruflichen oder anderweitigen persönlichen Interessen an einem Produkt oder einer Firma bestehen, welche die in dieser Veröffentlichung genannten Inhalte oder Meinungen beeinflussen können., (Thieme. All rights reserved.)

Objective: In German-speaking countries (Germany, Austria, Switzerland), simulated patients (SPs) have been a fixture for years and are used in teaching and examinations. As part of ongoing methodological standardization efforts and to support current and future faculty and curriculum developments, this exploratory study systematically investigates how and under what framework and conditions SPs are currently used in German-speaking countries. Methodology: The online questionnaire developed in cooperation with the Committee for Simulated Patients of the Society for Medical Education comprises 58 questions covering the organization and administration, size and design of the SP pool, general conditions and minimum standards for the assignments of the SPs. All medical faculties from Germany, Austria and German-speaking Switzerland were invited to participate in the survey and a descriptive data analysis was performed. Results: 38 responses from 45 faculties were included in the evaluation of the survey (response rate: 84.4%). Most SP programs are affiliated with the Office of the Dean of Studies and skills labs or training centers and funded by faculty resources. Both the working hours in the SP programs and the qualifications of the employees vary extensively. The same applies to the number and average age of the employed SPs. On average each faculty uses 1,290 SP hours per year (min=45, max=6,500). The majority of SPs are used in a teaching environment, together with lecturers. At all sites, SPs provide feedback to students. This is always based on a uniform standard. All SPs receive training, which predominantly focuses on playing their role and giving feedback. Discussion: There are a variety of SP programs in German-speaking countries. While there are a few clear similarities (for example, feedback from SPs), many organizational and methodological aspects are handled differently. Although this allows innovation and flexibility, it also weakens the didactic SP method in its standardization and thus in the comparability of quality. A certain degree of standardization and high methodical quality is of great importance, especially in scientific and faculty internal discussions and with a view to the use of SPs in high-stakes examinations which must be improved in the future., Competing Interests: The authors declare that they have no competing interests.

The amendments introduced to the current Veterinary Licensing Ordinance (TAppV) by the Veterinary Licensing Regulation (TAppO) have brought a high degree of skills orientation to fill the gap between academic study and preparing for a wide range of professional skills. In order to improve the veterinary skills of students while conveying fundamental methods in a structured and reproducible way, the University of Veterinary Medicine Hannover, Foundation, has set up the first central veterinary skills lab in Germany. Practical training is provided by means of a three-tier delivery approach. This involves around 40 simulators on an area of approx. 800 m(2) under the guidance of 6-8 staff members, along with supplementary resources such as posters, text instructions and YouTube videos. Since it opened in March 2013, there have been 769 visits to the skills lab and 30,734 hits on YouTube. Initial results show that the skills lab helps to maintain student motivation by teaching them practical skills at an early stage of the basic study-based acquisition of knowledge, whilst reinforcing skills acquisition per se in competence-based teaching. It enables veterinary students to prepare for their first examinations and treatments of live patients in a manner compliant with animal welfare.

Unlabelled: The standardized training of practical competences in skills labs is relatively new among German Medical Faculties. The broad acceptance and outstanding evaluation results do not provide objective data on the efficiency and cost-efficiency of these trainings. This study aims on the quantification of the teaching effect of the surgical scrubbing technique EN1500 and its comparison with clinical references of OR personnel., Methods: 161 4(th) year medical students were randomized into intervention and control group. The intervention group received a 45 minute standardized peer-teaching training of practical competences necessary in the OR including the scrubbing according to EN1500. Fluorescence dye was mixed in the disinfectant solution. After hand disinfection, standardized fotographs and semi-automated digital processing resulted in quantification of the insufficiently covered hand area. These results were compared with the control group that received the training after the test. In order to provide information on the achieved clinical competence level, the results were compared with the two clinical reference groups., Results: The intervention group remained with 4,99% (SD 2,34) insufficiently covered hand area after the training compared to the control group 7,33% (SD 3,91), p<0,01. There was no significant difference between control group and reference groups: surgeons 9,32% (SD 4,97), scrub nurses 8,46% (SD 4,66). The student intervention group showed results that were significantly better than the clinical references. The methodic mistake remained negligible. In the sub-group analysis, the students with low or medium experience in surgical scrubbing and hand disinfection derived highest benefit from the training, whereas students with no or high experience did benefit less. All participants showed better results on hand palms compared to back of hand areas., Discussion: A single standardized peer-teaching of surgical scrubbing and hand disinfection according to EN1500 is sufficient to improve the measurable coverage of hand area and reduce the disinfection gap by 1/3. In absolute measures, the competence level of experienced surgeons and scrub nurses is achieved or even exceeded.

Background: Living Labs, as a type of academic-practice partnerships, possess the potential to transform care and research into a participatory partnership and narrow the research-practice gap to improve evidence-based and Person-centred care. Given the lack of systematic investigations of Living Labs in healthcare, we will establish a dementia-specific academic-practice partnership (Living Lab Dementia) in Germany and conduct a process evaluation. The aim of this study is to gain insights into the intervention itself (mechanisms of impact) and its implementation process (degree of implementation, barriers, and facilitators)., Methods: This process evaluation of the multi-center research project PraWiDem (German acronym for linking professional nursing practice and research in dementia) will be conducted applying a convergent mixed methods design and will be based on the Medical Research Council (MRC) framework for the development and evaluation of complex interventions. The intervention is presented in a logic model which describes relevant basic theoretical assumptions, intervention components, implementation aspects, mechanisms of impact, relevant outcomes, and the context in which the intervention is delivered. Data will be collected before the intervention (T 0 ), during the intervention period, and at follow-up after 18 months (T 1 ). Qualitative data will be collected through semi-structured interviews and focus groups. Quantitative data sources will be process documents and questionnaires., Discussion: Our study will provide important insights into the Living Lab Dementia intervention and its implementation processes. The results of this evaluation will contribute to the refinement of the intervention and its implementation processes, and will enable to measure the impact of these processes in future studies., Competing Interests: Declarations. Ethics approval and consent to participate: The study is carried out according to the current data protection regulations (European General Data Protection Regulation and the German Federal Data Protection Regulation). The Ethics Committee of the German Society for Nursing Science has provided ethical approval for the project’s process evaluation (No. 22–035). In the event of protocol amendments, serious or unexpected adverse events or premature termination of the study, we will inform the Ethics Committee immediately. The participants, including the Linking Pins, staff, members of the management of the care facilities, people living with dementia and their legal representatives, will be informed about the study both verbally and in writing. Written informed consent will be obtained. Information about the procedures will be provided before the data collection begins. The participants are informed that the data obtained in the study will be published in scientific publications. In accordance with the consent, the researchers also reserve the right to reuse the collected data in further research work, such as secondary data analyses. Participants have the option to withdraw their consent at any point during the study. Given the variability in the ability of people living with dementia to remember, express themselves verbally, and relate to their diagnosis, the decision to conduct an interview will be made collaboratively in each case through joint discussions between the responsible nursing home staff and the project team during each data collection session. In cases where verbal or physical signs before or during data collection indicate discomfort or declining interest in the interview, ongoing and current consent [49] is obtained to verify the persistence of the initial consent [50]. If, by mutual agreement or if the initial consent is no longer affirmed, the interview will not commence or, if already started, will be promptly terminated. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: In recent years, health care has undergone a rapid and unprecedented digital transformation. In many fields of specialty care, such as rheumatology, this shift is driven by the growing number of patients and limited resources, leading to increased use of digital health technologies (DHTs) to maintain high-quality clinical care. Previous studies examined user acceptance of individual DHTs in rheumatology, such as telemedicine, video consultations, and mHealth. However, it is essential to conduct cross-technology and continuous analyses of user acceptance and DHT use to maximize the benefits for all relevant stakeholders., Objective: This study aimed to explore the current acceptance, use, and preferences regarding DHTs among patients in rheumatology care in Germany., Methods: Rheumatology patients from 3 clinics in Germany were surveyed to understand their perspectives on DHTs. The survey included main themes, including acceptance, preferences, COVID-19's impact, potential, and barriers related to DHTs. The data were analyzed using descriptive statistics and correlation analysis., Results: Out of 337 participants, 53% (179/337) reported using DHTs. Specific technologies included wearables (72/337, 21%), mHealth apps (71/337, 21%), digital therapeutics (32/337, 9%), electronic prescriptions (30/337, 9%), video consultations (15/337, 4%), and at-home blood self-sampling (3/337, 1%). Nearly two-thirds (220/337, 65%) found DHTs useful, and 69% (233/337) held a generally positive attitude toward DHTs. Attitudes shifted positively during the COVID-19 pandemic for 40% (135/337) of participants. Higher education was more prevalent among DHT users (114/179, 63.7%) compared with nonusers (42/151, 27.8%; P=.02). The main potential benefits identified were location-independent use (244/337, 72%) and time-independent use (216/337, 64%). Key barriers included insufficient user knowledge (165/337, 49%) and limited information on DHTs (134/337, 40%)., Conclusions: Patient acceptance and use of DHTs in rheumatology is increasing in Germany. A prospective, standardized monitoring of digital transformation in rheumatology care is highly needed., (©Susann May, Robert Darkow, Johannes Knitza, Katharina Boy, Philipp Klemm, Martin Heinze, Nicolas Vuillerme, Pascal Petit, Patricia Steffens-Korbanka, Heike Kladny, Johannes Hornig, Peer Aries, Martin Welcker, Felix Muehlensiepen. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 06.01.2025.)

Falls in senior home residents are common. Individual preventive training can lower the fall risk. To detect the need for training, a systematic assessment of the individual fall risk is needed. The aim of this study was thus to assess whether a fall risk score based on free field insole measurements can distinguish between an at-risk group of senior home residents and a healthy young control group. A published fall risk score was used in senior home residents over the age of 75 and a young (< 40 years) control group to determine the individual fall risk. In addition, the fall events over 12 months were assessed. Statistical analysis including ROC analysis was performed to determine the ability of the score to detect participants at heightened fall risk. In total, 18 nursing home residents and 9 young control participants were included. Of the nursing home residents, 15 had at least one fall, with a total of 37 falls recorded over 12 months. In the control group, no falls were recorded. The fall risk score was significantly different between nursing home residents and the control group (9.2 + 3.2 vs. 5.7 ± 2.2). Furthermore, the score significantly differentiated fallers from non-fallers (10.3 ± 1.8 vs. 5.2 ± 2.5), with a cut-off > 7.5 (AUC: 0.95) and a sensitivity of 86.7% (specificity 83.3%). The fall risk score is able to detect the difference between senior nursing home residents and young, healthy controls, as well as between fallers and non-fallers. Its main proof of concept is demonstrated, as based on movement data outside special gait labs, and it can simplify the risk of fall determination in geriatric nursing home residents and can now be used in further, prospective studies., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: Previous studies have demonstrated telemedicine to be an effective tool to complement rheumatology care and address workforce shortage. With the COVID-19 outbreak, telemedicine experienced a massive upswing. An earlier analysis revealed that the motivation of patients with rheumatic and musculoskeletal diseases to use telemedicine is closely connected to their disease. It remains unclear which factors are associated with patients' motivation to use telemedicine in certain rheumatic and musculoskeletal diseases groups, such as rheumatoid arthritis (RA)., Objective: This study aims to identify factors that determine the willingness to try telemedicine among patients diagnosed with RA., Methods: We conducted a secondary analysis of data from a German nationwide cross-sectional survey among patients with RA. Bayesian univariate logistic regression analysis was applied to the data to determine which factors were associated with willingness to try telemedicine. Predictor variables (covariates) studied individually included sociodemographic factors (eg, age, sex) and health characteristics (eg, health status). All the variables positively and negatively associated with willingness to try telemedicine in the univariate analyses were then considered for Bayesian model averaging analysis after a selection based on the variance inflation factor (≤ 2.5) to identify determinants of willingness to try telemedicine., Results: Among 438 surveyed patients in the initial study, 210 were diagnosed with RA (47.9%). Among them, 146 (69.5%) answered either yes or no regarding willingness to try telemedicine and were included in the analysis. A total of 22 variables (22/55, 40%) were associated with willingness to try telemedicine (region of practical equivalence %≤5). A total of 9 determinant factors were identified using Bayesian model averaging analysis. Positive determinants included desiring telemedicine services provided by a rheumatologist (odds ratio [OR] 13.7, 95% CI 5.55-38.3), having prior knowledge of telemedicine (OR 2.91, 95% CI 1.46-6.28), residing in a town (OR 2.91, 95% CI 1.21-7.79) or city (OR 0.56, 95% CI 0.23-1.27), and perceiving one's health status as moderate (OR 1.87, 95% CI 0.94-3.63). Negative determinants included the lack of an electronic device (OR 0.1, 95% CI 0.01-0.62), absence of home internet access (OR 0.1, 95% CI 0.02-0.39), self-assessment of health status as bad (OR 0.44, 95% CI 0.21-0.89) or very bad (OR 0.47, 95% CI 0.06-2.06), and being aged between 60 and 69 years (OR 0.48, 95% CI 0.22-1.04) or older than 70 years (OR 0.38, 95% CI 0.16-0.85)., Conclusions: The results suggest that some patients with RA will not have access to telemedicine without further support. Older patients, those not living in towns, those without adequate internet access, reporting a bad health status, and those not owning electronic devices might be excluded from the digital transformation in rheumatology and might not have access to adequate RA care. These patient groups certainly require support for the use of digital rheumatology care., (©Felix Muehlensiepen, Pascal Petit, Johannes Knitza, Martin Welcker, Nicolas Vuillerme. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 19.08.2024.)

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe, chronic multisystemic disease which, depending on its severity, can lead to considerable physical and cognitive impairment, loss of ability to work and the need for nursing care including artificial nutrition and, in very severe cases, even death.The aim of this D-A-CH (Germany, Austria, Switzerland) consensus statement is 1) to summarize the current state of knowledge on ME/CFS, 2) to highlight the Canadian Consensus Criteria (CCC) as clinical criteria for diagnostics with a focus on the leading symptom post-exertional malaise (PEM) and 3) to provide an overview of current options and possible future developments, particularly with regard to diagnostics and therapy. The D-A-CH consensus statement is intended to support physicians, therapists and valuer in diagnosing patients with suspected ME/CFS by means of adequate anamnesis and clinical-physical examinations as well as the recommended clinical CCC, using the questionnaires and other examination methods presented. The overview of the two pillars of therapy for ME/CFS, pacing and symptom-relieving therapy options, is intended not only to provide orientation for physicians and therapists, but also to support decision-makers from healthcare policy and insurance companies in determining which therapy options should already be reimbursable by them at this point in time for the indication ME/CFS., (© 2024. The Author(s).)

Telemedicine (TM) has augmented healthcare by enabling remote consultations, diagnosis, treatment, and monitoring of patients, thereby improving healthcare access and patient outcomes. However, successful adoption of TM depends on user acceptance, which is influenced by technical, socioeconomic, and health-related factors. Leveraging machine learning (ML) to accurately predict these adoption factors can greatly contribute to the effective utilization of TM in healthcare. The objective of the study was to compare 12 ML algorithms for predicting willingness to use TM (TM try) among patients with rheumatic and musculoskeletal diseases (RMDs) and identify key contributing features. We conducted a secondary analysis of RMD patient data from a German nationwide cross-sectional survey. Twelve ML algorithms, including logistic regression, random forest, extreme gradient boosting (XGBoost), and neural network (deep learning) were tested on a subset of the dataset, with the inclusion of only RMD patients who answered "yes" or "no" to TM try. Nested cross-validation was used for each model. The best-performing model was selected based on area under the receiver operator characteristic (AUROC). For the best-performing model, a multinomial/multiclass ML approach was undertaken with the consideration of the three following classes: "yes", "no", "do not know/not answered". Both one-vs-one and one-vs-rest strategies were considered. The feature importance was investigated using Shapley additive explanation (SHAP). A total of 438 RMD patients were included, with 26.5% of them willing to try TM, 40.6% not willing, and 32.9% undecided (missing answer or "do not know answer"). This dataset was used to train and test ML models. The mean accuracy of the 12 ML models ranged from 0.69 to 0.83, while the mean AUROC ranged from 0.79 to 0.90. The XGBoost model produced better results compared with the other models, with a sensitivity of 70%, specificity of 91% and positive predictive value of 84%. The most important predictors of TM try were the possibility that TM services were offered by a rheumatologist, prior TM knowledge, age, self-reported health status, Internet access at home and type of RMD diseases. For instance, for the yes vs. no classification, not wishing that TM services were offered by a rheumatologist, self-reporting a bad health status and being aged 60-69 years directed the model toward not wanting to try TM. By contrast, having Internet access at home and wishing that TM services were offered by a rheumatologist directed toward TM try. Our findings have significant implications for primary care, in particular for healthcare professionals aiming to implement TM effectively in their clinical routine. By understanding the key factors influencing patients' acceptance of TM, such as their expressed desire for TM services provided by a rheumatologist, self-reported health status, availability of home Internet access, and age, healthcare professionals can tailor their strategies to maximize the adoption and utilization of TM, ultimately improving healthcare outcomes for RMD patients. Our findings are of high interest for both clinical and medical teaching practice to fit changing health needs caused by the growing number of complex and chronically ill patients., (© 2024. The Author(s).)

Advance Care Planning (ACP) in the US is complex due in part to a lack of a unified health care system, though more recent policy changes permitting reimbursement for ACP conversations offer some hope. One key barrier to ACP is public perceptions of ACP, made worse by a historical focus on messaging that is unappealing and does not meet people's need to focus on the present before contemplating the future. As we learn more about how to engage the public, there is also increasing recognition that the previous focus on making very specific decisions about the future needs to shift to a focus on preparing people for communication and decision making. Numerous programs exist for health care professionals to support meaningful explorations of goals, values, and preferences, and there is growing availability of resources to support this work, both in the community and health care setting. Further research is needed to understand the full complexity of ACP implementation and to identify person-centred outcomes to support high quality ACP., (Copyright © 2023. Published by Elsevier GmbH.)

Background: The COVID-19 pandemic poses new challenges to health care providers and the delivery of continuous care. Although many diabetes technologies, such as insulin pumps and continuous glucose monitors, have been established, the data from these devices are rarely assessed. Furthermore, telemedicine has not been sufficiently integrated into clinical workflows., Objective: We sought to remotely support children with type 1 diabetes and their caregivers, enhance the clinical outcomes and quality of life of children with diabetes, increase multiple stakeholders' engagement with digital care via a participatory approach, evaluate the feasibility of using an interoperable open-source platform in a university hospital setting, and analyze the success factors and barriers of transitioning from conventional care to digital care., Methods: Service design methods were used to adapt clinical workflows. Remote consultations were performed on a monthly and on-demand basis. Diabetes device data were uploaded from patients' homes to an open-source platform. Clinical and patient-reported outcomes were assessed before, during, and after the COVID-19 lockdown period in Germany., Results: A total of 28 children with type 1 diabetes and their caregivers enrolled in this study and completed 6 months of remote visits. Of these 28 participants, 16 (57%) also opted to attend at least one of their regular visits remotely. After 3 months of remote visits, participants' time in range (P=.001) and time in hyperglycemia (P=.004) significantly improved, and their time in hypoglycemia did not increase. These improvements were maintained during the COVID-19 lockdown period (ie, between months 3 and 6 of this study). Participants' psychosocial health improved after 6 months., Conclusions: Remote consultations and commonly shared data access can improve the clinical outcomes and quality of life of children with type 1 diabetes, even during challenging circumstances. A service design approach helped with the delivery of comprehensive and holistic solutions that accounted for the needs of multiple stakeholders. Our findings can inform the future integration of digital tools into clinical care during and beyond the pandemic., Trial Registration: German Clinical Trials Register DRKS00016170; https://tinyurl.com/skz4wdk5., (©Katarina Braune, Karina Boss, Jessica Schmidt-Herzel, Katarzyna Anna Gajewska, Axel Thieffry, Lilian Schulze, Barbara Posern, Klemens Raile. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 05.04.2021.)

African swine fever (ASF) is a contagious viral hemorrhagic disease of domestic pigs and wild boars. The disease is notifiable to the World Organisation for Animal Health (OIE) and is responsible for high mortality and serious economic losses. PCR and real-time PCR (qPCR) are the OIE-recommended standard methods for the direct detection of African swine fever virus (ASFV) DNA. The aim of our work was the simplification and standardization of the molecular diagnostic workflow in the lab. For validation of this "easy lab" workflow, different sample materials from animal trials were collected and analyzed (EDTA blood, serum, oral swabs, chewing ropes, and tissue samples) to identify the optimal sample material for diagnostics in live animals. Based on our data, the EDTA blood samples or bloody tissue samples represent the best specimens for ASFV detection in the early and late phases of infection. The application of prefilled ready-to-use reagents for nucleic acid extraction or the use of a Tissue Lysis Reagent (TLR) delivers simple and reliable alternatives for the release of the ASFV nucleic acids. For the qPCR detection of ASFV, different published and commercial kits were compared. Here, a lyophilized commercial kit shows the best results mainly based on the increased template input. The good results of the "easy lab" strategy could be confirmed by the ASFV detection in field samples from wild boars collected from the 2020 ASFV outbreak in Germany. Appropriate internal control systems for extraction and PCR are key features of the "easy lab" concept and reduce the risk of false-negative and false-positive results. In addition, the use of easy-to-handle machines and software reduces training efforts and the misinterpretation of results. The PCR diagnostics based on the "easy lab" strategy can realize a high sensitivity and specificity comparable to the standard PCR methods and should be especially usable for labs with limited experiences and resources.

Background: Practical contents are gaining in importance in medical curricula in Germany. In times of a lack of applicants, practical courses provide an increased level of interest for students in the respective disciplines. A practical appeal of ophthalmology is microsurgical procedures. A microsurgical suture wet lab can be an introduction for medical students., Objective: Assessment of the increased interest in ophthalmology through evaluation of a suture wet lab course, including suturing under a microscope., Material and Methods: The data were obtained from the practical course in ophthalmology during the sixth semester for medical students at the university medical center in Mainz in April 2019. In a questionnaire developed in collaboration with the Center for Quality Assurance and Development various statements had to be answered and evaluated using ordinal scales., Results: A total of 64 evaluation questionnaires from 8 groups each with 8 medical students supervised by different tutors were analyzed. The wet lab was rated with 1.24 ± 0.5 (mean ± SD) on a German school grade scale (1 = best, 6 = worst). There was agreement (1 = total agreement, 7 = total disagreement) concerning the desire for further microscopic wet labs (1.86 ± 1.28) as well as learning more ophthalmological surgical techniques (2.02 ± 1.13). The interest in ophthalmology (1 = very high interest, 7 = very low interest) increased from 3.66 ± 1.55 before the course to 2.52 ± 1.00., Conclusion: Interest in ophthalmology can be increased through a microsurgical wet lab. The interest of students can therefore be awakened, which can have advantageous effects in job application situations and in research work. In this way experience and practical skills in ophthalmology can already be acquired during medical studies.

Augmented Reality has been utilized for surgical training. During the implementation, displaying instructional information at the right moment is critical for skill acquisition. We built a new surgical training platform combining augmented reality system (HoloLens, Microsoft) with an eye-tracker (Pupil labs, Germany). Our goal is to detect the moments of performance difficulty using the integrated eye-tracker so that the system could display instructions at the precise moment when the user is seeking instructional information during a surgical skill practice in simulation. In the paper, we describe the system design, system calibration and data transferring between these devices.

This paper presents a report on outcomes of the 10th Computational Modeling in Biology Network (COMBINE) meeting that was held in Heidelberg, Germany, in July of 2019. The annual event brings together researchers, biocurators and software engineers to present recent results and discuss future work in the area of standards for systems and synthetic biology. The COMBINE initiative coordinates the development of various community standards and formats for computational models in the life sciences. Over the past 10 years, COMBINE has brought together standard communities that have further developed and harmonized their standards for better interoperability of models and data. COMBINE 2019 was co-located with a stakeholder workshop of the European EU-STANDS4PM initiative that aims at harmonized data and model standardization for in silico models in the field of personalized medicine, as well as with the FAIRDOM PALs meeting to discuss findable, accessible, interoperable and reusable (FAIR) data sharing. This report briefly describes the work discussed in invited and contributed talks as well as during breakout sessions. It also highlights recent advancements in data, model, and annotation standardization efforts. Finally, this report concludes with some challenges and opportunities that this community will face during the next 10 years.

Depressive symptomatology is manifested in greater first-person singular pronoun use (i.e., I-talk), but when and for whom this effect is most apparent, and the extent to which it is specific to depression or part of a broader association between negative emotionality and I-talk, remains unclear. Using pooled data from N = 4,754 participants from 6 labs across 2 countries, we examined, in a preregistered analysis, how the depression-I-talk effect varied by (a) first-person singular pronoun type (i.e., subjective, objective, and possessive), (b) the communication context in which language was generated (i.e., personal, momentary thought, identity-related, and impersonal), and (c) gender. Overall, there was a small but reliable positive correlation between depression and I-talk (r = .10, 95% CI [.07, .13]). The effect was present for all first-person singular pronouns except the possessive type, in all communication contexts except the impersonal one, and for both females and males with little evidence of gender differences. Importantly, a similar pattern of results emerged for negative emotionality. Further, the depression-I-talk effect was substantially reduced when controlled for negative emotionality but this was not the case when the negative emotionality-I-talk effect was controlled for depression. These results suggest that the robust empirical link between depression and I-talk largely reflects a broader association between negative emotionality and I-talk. Self-referential language using first-person singular pronouns may therefore be better construed as a linguistic marker of general distress proneness or negative emotionality rather than as a specific marker of depression. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Introduction: Surgical education of medical students within "skills labs" have not been standardised throughout Germany as yet; there is a substantial impact of available aspects such as personal and space at the various medical schools. Aim: The aim of this contribution is to illustrate the concept of a surgical skills lab in detail, including curricular teaching and integrated facultative courses at the Medical School, University of Magdeburg ("The Magdeburg Model") in the context of a new and reconstructed area for the skills lab at the Magdeburg's apprenticeship center for medical basic abilities (MAMBA). Method: We present an overview on the spectrum of curricular and facultative teaching activities within the surgical part of the skills lab. Student evaluation of this teaching concept is implemented using the programme "EvaSys" and evaluation forms adapted to the single courses. Results: By establishing MAMBA, the options for a practice-related surgical education have been substantially improved. Student evaluations of former courses presented within the skills lab and the chance of moving the skills lab into a more generous and reconstructed area led to a reorganisation of seminars and courses. New additional facultative courses held by student tutors have been introduced and have shown to be of great effect, in particular, because of their interdisciplinary character. Conclusion: Practice-related surgical education within a skills lab may have the potential to effectively prepare medical students for their professional life. In addition, it allows one to present and teach the most important basic skills in surgery, which need to be pursued by every student. An enthusiastic engagement of the Office for Student Affairs can be considered the crucial and indispensable link between clinical work and curricular as well as facultative teaching with regard to organisation and student evaluation. The practice-related teaching parts and contents at the surgical section of a skills lab should be integrated into the National Competence-based Catalogue of Teaching Aims in Medicine ("NKLM")., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Neurofeedback has been applied effectively in various areas, especially in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). This study protocol is designed to investigate the effect of slow cortical potential (SCP) feedback and a new form of neurofeedback using near-infrared spectroscopy (NIRS) on symptomatology and neurophysiological parameters in an adult ADHD population. A comparison of SCP and NIRS feedback therapy methods has not been previously conducted and may yield valuable findings about alternative treatments for adult ADHD., Methods/design: The outcome of both neurofeedback techniques will be assessed over 30 treatment sessions and after a 6-month follow-up period, and then will be compared to a nonspecific biofeedback treatment. Furthermore, to investigate if treatment effects in this proof-of-principle study can be predicted by specific neurophysiological baseline parameters, regression models will be applied. Finally, a comparison with healthy controls will be conducted to evaluate deviant pretraining neurophysiological parameters, stability of assessment measures, and treatment outcome., Discussion: To date, an investigation and comparison of SCP and NIRS feedback training to an active control has not been conducted; therefore, we hope to gain valuable insights in effects and differences of these types of treatment for ADHD in adults., Trial Registration: This study is registered with the German Registry of Clinical Trials: DRKS00006767 , date of registration: 8 October 2014.

Trichinosis (Trichinellosis) is a zoonotic disease acquired by eating raw or not adequately processed pork or wild game infected with the larvae of the roundworm genus Trichinella. According to European regulations, animals susceptible to Trichinella have to be examined for infestation. To evaluate the performance of laboratories in Germany, inter-laboratory comparisons known as "ring trials" were introduced by the Federal Institute for Risk Assessment in 2004. The current method of analysis makes use of tolerance zones based on the number of larvae in the sample, but does not permit one to determine if a given lab can detect an infested sample reliably, as required by the quality assurance recommendations of the International Commission on Trichinellosis (ICT). A new way of analysing the ring trial data is presented here, which is based on Bayesian hierarchical models. The model implements the ICT requirement by providing an estimate for the probability that a given lab would fail to detect a sample containing, say, five larvae. When applied to the 87 labs that participated in Germany's 2009 ring trials, it turns out this probability is greater than 10% for 21 of them, although only 10 of these in fact returned a false negative result. Such a new method is required to abide by the ICT requirements and make ring trials effective.

Background and Objective: The goal of treatment of patients with ST-segment elevation acute myocardial infarction (STEMI) is to restore perfusion as soon as possible, preferably by primary percutaneous coronary intervention (PCI). The aim of this study of the German Myocardial Infarction Registry (DHR) was to document acute care and in-hospital course of STEMI patients in Germany., Methods: Over three months patients with STEMI were consecutively included and their basic data, treatments and in-hospital complications were centrally recorded using an internet-based standardized questionnaire., Results: Included were 6,330 patients from 243 hospitals, in group 1 (primary admission in 136 hospitals with cath lab) 4,656 patients (74%) and in group 2 (primary admission in 107 hospitals without cath lab) 1,674 (26%). Reperfusion therapy was performed more frequently in patients of group 1 (91.1% PCI, 2.7% fibrinolysis) than in group 2 (80.7% PCI after transfer, 6.4% fibrinolysis). In-hospital mortality was 7.3% in all patients, 7.0% in group 1 and 8.3% in group 2., Conclusion: The DHR data show that about three quarters of patients with STEMI are primarily admitted to hospitals with cath labs. Primary PCI is the preferred treatment option both in hospitals with and without cath labs (in the latter after transfer); it is performed in about 85% of STEMI patients. In-hospital mortality is with over 7% higher in real-life than in randomized studies., (© Georg Thieme Verlag KG Stuttgart · New York.)

Despite PCR per se being a powerful and sensitive technique, regarding the detection of fungi in patients' blood, no consensus for a standardised PCR protocol yet exists. To complement other ongoing or accomplished studies which tackle this problem, the German Reference Center for Systemic Mycoses conducted an interlaboratory comparison starting with blood samples spiked with fungal cell elements. Altogether, six laboratories using in-house PCR-protocols from Germany and Austria participated in the trial. Blood samples were spiked with vital cells of Candida albicans or Aspergillus fumigatus. Candida was used in the yeast form, whereas Aspergillus cells were either spiked as conidia or as very young germlings, also known as smoo cells. Spiked blood samples contained between 10 and 10 000 cells ml(-1). Depending on the techniques used for fungal cell disruption and DNA-amplification, detection quality was variable between laboratories, but also differed within single laboratories in different trials particularly for samples spiked with less than 100 cells ml(-1). Altogether, at least regarding the detection of A. fumigatus, two of six laboratories showed constant reliable test results also with low fungal cell number spiked samples. Protocols used by these labs do not differ substantially from others. However, as particularities, one protocol included a conventional phenol chloroform extraction during the DNA preparation process and the other included a real time PCR-protocol based on FRET probes. Other laboratory comparisons on the basis of clinical samples should follow to further evaluate the procedures. The difficulties and problems of such trials in general are discussed., (© 2012 Blackwell Verlag GmbH.)

Background: Laparoscopic surgery demands from the surgeon specific operative skills. Learning -curves have been described for many procedures in this technique. In order to evaluate the avail-able laparoscopic teaching resources and meth-ods in Germany an opinion survey was per-formed., Materials and Methods: Directors of 284 surgical departments were polled using a questionnaire regarding department and operation statistics, -laparoscopic education and availability of simulation facilities ("Skills Labs" SL)., Results: The response rate was 54 %. 88 % of the department directors considered laparoscopic -simulation an efficient teaching method and 91 % felt that simulation improves operating room performance. A SL was available in 27 % of these -departments. The training modules most commonly offered were basic laparoscopic skills such as coordination exercises (100 %) and suturing techniques (89 %). The actual median acquisition costs amounted to 20 000 € in our evaluation, with annual running costs of a median of 1000 €., Conclusion: Although most of the questioned surgeons acknowledged the value of SL, this method of education is not widely available in Germany. Therefore we feel that simulation training in Germany still requires stronger support., (© Georg Thieme Verlag KG Stuttgart ˙ New York.)

The in vivo monitoring laboratory (IVM) at Karlsruhe Institute of Technology (KIT), with one whole body counter and three partial-body counters, is an approved lab for individual monitoring according to German regulation. These approved labs are required to prove their competencies by accreditation to ISO/IEC 17025:2005. In 2007 a quality management system (QMS), which was successfully audited and granted accreditation, was set up at the IVM. The system is based on the ISO 9001 certified QMS of the central safety department of the Research Centre Karlsruhe the IVM belonged to at that time. The system itself was set up to be flexible and could be adapted to the recent organisational changes (e.g. founding of KIT and an institute for radiation research) with only minor effort.

Introduction: Encouraged by the change in licensing regulations the practical professional skills in Germany received a higher priority and are taught in medical schools therefore increasingly. This created the need to standardize the process more and more. On the initiative of the German skills labs the German Medical Association Committee for practical skills was established and developed a competency-based catalogue of learning objectives, whose origin and structure is described here. Goal of the catalogue is to define the practical skills in undergraduate medical education and to give the medical schools a rational planning basis for the necessary resources to teach them., Methods: Building on already existing German catalogues of learning objectives a multi-iterative process of condensation was performed, which corresponds to the development of S1 guidelines, in order to get a broad professional and political support., Results: 289 different practical learning goals were identified and assigned to twelve different organ systems with three overlapping areas to other fields of expertise and one area of across organ system skills. They were three depths and three different chronological dimensions assigned and the objectives were matched with the Swiss and the Austrian equivalent., Discussion: This consensus statement may provide the German faculties with a basis for planning the teaching of practical skills and is an important step towards a national standard of medical learning objectives., Looking Ahead: The consensus statement may have a formative effect on the medical schools to teach practical skills and plan the resources accordingly.

In the context of house searches in Germany, numerous drugs were confiscated and subjected to chemical analysis, including anabolic agents such as various anabolic-androgenic steroids (stanozolol, testosterone derivatives, trenbolone esters, etc.) and clenbuterol, as well as agents with anti-estrogenic activity (tamoxifen, clomiphene), drugs stimulating virility (sildenafil, tadalafil), and unlabeled plastic bags. Liquid chromatography-tandem mass spectrometry, gas chromatography-mass spectrometry with nitrogen-phosphorus specific detection, gel electrophoresis, and immunological tests were employed to test for the effective content of 70 products. In 18 cases (25.7%), the declared ingredients differed from the actual content, in particular concerning anabolic-androgenic steroids. Nandrolone and trenbolone esters, for instance, were frequently substituted or complemented by various testosterone derivatives, and several testosterone depot formulations originally composed of four different esters were found to contain fewer or wrong components. Except for those drugs supposedly originating from so-called underground labs, fake packings were hardly or not distinguishable from original boxes by visual inspection.

The improvement of surgical skills of trainees in Germany often occurs solely in the operating room. In recent years, several countries have established surgical skills labs as an essential part of surgical education, with the goal of improving and refining surgical skills before clinical application. Several years ago, training units were established by the industry wherein the curricula focused on products of the respective company. Selected training courses are still offered in a few clinics. Presently, laboratories which train the surgical skills of novices in an individually adapted form are lacking. A surgical skills lab with a comprehensive curriculum of training courses was introduced at the University Hospital of Marburg in 2005. The present article describes the development and introduction of such facilities. The authors are convinced that surgical skills labs will become increasingly important in German surgical education for improving patient safety in the operating room.

Background and Purpose: Computer-based teaching and learning are getting more and more important in medical education. To integrate this type of training into the curricula, medical faculties must provide supervised computer labs. The present study was conducted to evaluate the acceptance and efficiency of the student-organised concept of computer labs established at the Charité Hospital in Berlin., Methods: An electronic online questionnaire comprising 25 items was distributed to all users of the two computer labs at the Charité to ask their opinions about the quality of the student-organised concept and their satisfaction with the working conditions in the labs and to compare them longitudinally with the results obtained 4 years ago., Results: A total of 1275 users worked in the labs during the survey period and 702 answered the questionnaire (return rate: 55.1%). The users assigned good to very good ratings to different components of the concept with student self-administration and helpfulness of the student tutors achieving the highest rating (both 1.5 +/- 0.7). In the longitudinal study no component of the concept was rated worse in the current questionnaire, whereas the opening hours were assigned significantly higher ratings than 4 years ago (1.6 +/- 0.8 vs. 2 +/- 0.9; p < 0.001). Over 20% of all users stated they would be interested in actively participating as tutors in the project. Students used the computer labs for a mean of 3.1 hours per week. The support of students working on a voluntary basis allowed for weekly opening hours of the labs of 146 hours with the personnel expenditure costs that would be necessary for the position of one faculty member., Conclusions: The good to excellent ratings, the high acceptance by users, and the low costs of the project presented here suggest that this student initiative can be recommended to other medical faculties to serve as a basis for integration of computer-based education into the curriculum.

Objective: To register all newly diagnosed patients with primary systemic vasculitides (PSV) in a large region in northern Germany., Methods: Between January 1, 1998 and December 31, 2002 all newly diagnosed cases of PSV were identified in a large mixed rural/urban northern German region consisting of 2,777,275 habitants in a population-based prospective study. The following sources were used: departments of all hospitals, including their outpatient clinics; all departments of pathology; and the reference immunologic labs serving the catchment area., Results: During 5 years, 642 PSV patients were identified. The incidence rates for all PSV were between 40 and 54 cases per 1 million and per year. People at age 50 years and older had a 3-5-fold higher risk of developing PSV compared with those younger than 50 years. The incidence rates of antineutrophil cytoplasmic antibody (ANCA)-associated PSV (Wegener's granulomatosis [WG], microscopic polyangiitis [MPA], Churg-Strauss syndrome [CSS]) were between 9.5 and 16/million/year. WG occured 2-3 times more frequently than MPA or CSS., Conclusion: Results of a population-based vasculitis register over 5 years for the incidence of PSV among 2.78 million habitants in northern Germany revealed a stable incidence for all PSV. Compared with other European studies coming from small regions or referral centers, the incidence rates for ANCA-associated PSV were the same as in Norway, lower than those in United Kingdom, but higher than those in Spain.

Inflammatory bowel diseases (IBD) are intermittently appearing, often chronic diseases mostly affecting young people between 20-30 years of age influencing their quality of life and socioeconomic efficiency. The triggering factors for the development of IBD are not completely understood: besides environmental factors there is clear evidence for additional genetic factors influencing the risk of disease and the pattern of gut inflammation in Crohn's disease. Pathopysiological discoveries are leading to new therapeutic opportunities which are conducted in large clinical studies with main participation of the competence network IBD. The disseminated structure of the network comprising universitary and nonuniversitary hospitals and labs, the self-help-organization DCCV and its vertical cooperation with general practitioners nationwide gives opportunity to describe the diseases from the point of view of the scientist and the physician simultaneously. Therefore the competence network IBD yields the basis for the standardized integration of patient information, for the development of guidelines and the establishment of a quality management system thus leading to an improvement of scientific and clinical research.

Medical research confirmed the relevance of diagnosis and therapy of sleep-related breathing disorders, revealing prevalence and patho-physiological mechanisms [1-10]. Reliable sleep assessment currently demands examinations in the sleep-lab, which is very technical and time-consuming. Thus, expanding the conventional procedure to meet capacity demands does not seem realistic regarding cost aspects. As a solution, the authors present telemetric system concepts for the unattended assessment of a patient's sleep profile and cardio-respiratory parameters. Taking initial experience with home polysomnography into consideration, the presented research work focuses on easily applicable sensors, the corresponding sleep profile assessment rules, wireless data recording, intelligent signal processing algorithms and telemedical information logistics to include sleep-labs in the diagnosis and treatment process as competence centers.

The aim of this investigation was to evaluate and compare the reproducibility of cytotoxicity data generated in two different laboratories using the same testing protocols. A series of dental alloys that are widely used in both countries were chosen. These alloys (five precious, two nonprecious) were wet ground up to 1200 grit SiC, sterilized in 70% ethanol, and extracted in sterile culture medium for 7 days. Pure copper was used as a positive control and Teflonreg and media only were used as negative controls. Test and control samples were randomized and blinded to each laboratory. Cells, primary human gingival fibroblasts, and immortalized 3T3 fibroblasts, were exposed to the extracts for 24 h. Extract cytotoxicity was evaluated spectrophotometrically with the use of a mitochondrial enzyme activity assay. Data were collected from both laboratories, combined, and subjected to a mixed-model analysis of variance. No statistical difference was obtained for the immortalized 3T3 cells, except for two extracts in which differences between the two labs were significant but were still not cytotoxic. Furthermore, no statistical differences were found for the primary cells. These data strongly suggest that cytotoxicity tests performed in different laboratories with the use of the same test materials may lead to comparable results if sample preparation, cells, test procedures, and data analyses are carefully considered., (Copyright 2002 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 63: 214--219, 2002; DOI 10.1002/jbm.10124)

To evaluate intra- and inter-laboratory agreement concerning hair mineral analysis and interpretation of results, hair samples from 2 volunteers were sent to seven laboratories, which commercially offer hair mineral analysis in Germany. 6 weeks later, another identical part from the hair sample of volunteer 1 was sent to all seven labs. Altogether, 50 elements were analyzed, 23 by all seven labs. For comparability, only the results for these 23 elements were assessed. The intra-laboratory reproducibility was evaluated by the 2 identical hair samples from volunteer 1. On the average, the reproducibility seems to be sufficient (median +/- 9.48% to +/- 20.59%), but for individual elements there were unacceptable out-rulers up to 100%. Only one lab classified all elements of the first and the second analysis of the identical hair sample in the same category (below, within, or above normal range). The others grouped 4 to 7 elements different. This is not tolerable. The inter-laboratory comparability was assessed by the results of the hair samples of both volunteers. For the sample of volunteer 1 at least the results of 6 (out of 23) elements were within an acceptable range of +/- 30% from the consensus value (= mean of all seven labs). For volunteer 2 this was only the case for 2 (!) elements. Differences of more than 100% were found for most other elements. Moreover, in the vast majority of the tested elements there was no comparability of the cLassification to the respective reference ranges of the different laboratories. For example, for volunteer 1 only 3 elements (our of 23!) were identically classified by all seven labs. As neither the analytical results nor the classification to the individual reference ranges by the laboratories correspond in tolerable borders, conclusions, drawn from these results, cannot be valid. Hair mineral analysis from these laboratories is unreliable. Therefore we must recommend to refrain from using such analysis to assess individual nutritional status or suspected environmental exposure.

Authors refer the current level of diagnosis and therapy of sleep apnea syndrome in Germany. The sleep labs are perfectly equipped with recently developed diagnostic systems. Also the treatment of patients with CPAP system (continuous positive airways pressure) is very good organized.

In view of the limited capacity of hospital sleep labs, and the high prevalence of the sleep apnea syndrome, there is a requirement for a preliminary ambulatory diagnostic work-up. Nocturnal polygraphy has proved to be a useful screening method. The continuous measurement of respiratory flow, oxygen saturation, heart rate and body position enables the severity and frequency of respiratory events to be monitored. With consideration being given to the patient's symptoms, examination findings, cardiovascular disease and the risks resulting from disturbed vigilance, a decision can be made on the need for an inpatient diagnostic work-up, and its urgency. Ambulatory apnea screening is not suitable for the differential diagnosis of nocturnal respiratory disorders, since it does not permit the correlation of symptoms to sleep stages and respiratory movements.

In 1998, the German DNA Exchange offered the possibility to report typing data as virtual DNA. Participating labs have been equipped with software based on the principle of Virtual DNA Analysis (VDA). This approach allows the combination of sequence-specific oligonucleotide (SSO), sequence-specific primer (SSP) and sequence-based typing (SBT) results. The use of all types of test kits has been allowed without any limitations, as long as basic sequence information on SSOs or SSPs was available, at least the sequence and the position of the detected motif on the sample DNA. Typing raw data of the actual SSO-SSP and, if performed, SBT information was collected. Participating labs received 20 DNA samples to type. Fourteen labs returned data on 1,250 single-locus testings. Reported data consisted of 317 SBT data, 452 SSO kits and 1,795 SSP kits with 43,312 single SSO/ SSP reactivities. One hundred and twenty-six different typing kits (unique laboratory-specific kits, commercial kits from 7 companies) have been used. In 30 (2.4%) single-locus testings, at least one single SSO/SSP reactivity has been false-positive or -negative, thus not leading to a valid result on primary evaluation. Eight of these 30 cases were due to the presence of a new DRB1*14 allele in sample no. 2. Thirty-five tests (2.8%) showed wrong allele assignments. This first attempt to collect raw typing data instead of typing interpretation on a larger scale shows the advantages of Virtual DNA Analysis like interlaboratory data exchange without loss of information, transparency of typing interpretation and reinterpretation of typing data with an updated allele database. The VDA format is a useful tool for workshops and bone marrow donor registries.

A review is given on the current state of German and European legislation concerning the control of zoonotic diseases. In the past considerable success was achieved when eliminating or reducing zoonosis such as brucellosis or tuberculosis in Germany and in Europe. Today foodborne infections such as salmonellosis or EHEC are dominating. A series of seven different federal laws and their legal regulations are involved in zoonosis control in Germany. In Europe the Council Directive 92/117/EEC, amended by directive 97/22/EU represents a framework for all Member States which have to deliver yearly trend reports on the sources of infections from areas such as human medicine, veterinary medicine and feed production. The data reports are concentrating on salmonellosis, tuberculosis, brucellosis and trichinellosis. Some data are given on the incidence of human salmonellosis in the Member States. There are existing two European reference laboratories for zoonotic diseases and six national labs in Germany. The aim of the new strategy is to fight the infectious agents of zoonotic diseases on farm level already. The most urgent task is to amend and adapt the directive for zoonosis. The necessary actions are under way on European level.

The German Society for Cardiac Angiography and Interventions in Private Practice has started a registry of cardiac procedures since 1996 in order to establish a standard for performance. Although quality management for the cath lab makes sense and is also legally required, there is no generally recommended infrastructure for quality assurance existing in Germany at this time. Therefore, the German Society of Cardiologists in Private Practice (BNK) initiated a project in 1994 to develop a computer program for paperless documentation of diagnostic cardiac catheterizations and coronary interventions (PTCA) using a minimal data set. In 1996, 8 private associated groups participated in this project. The (anonymous) analysis of 10,316 diagnostic cardiac catheterizations and 2597 PTCA yielded the following results: In 95% of the patients, diagnostic cardiac catheterization was performed using the femoral and in 5% the brachial/radial approach. The mean volume of administered contrast medium was 164 +/- 138 ml/patient. The mean LV-EF was greater than 50% in 58.4% of the patients and between 30% and 50% in 10.1%. Coronary artery disease was diagnosed in 69.6% of the patients and valvular/congenital heart disease in 8.5%. In 18.4% of the patients undergoing diagnostic cardiac catheterizations no significant heart disease was identified. Mortality in the cath lab as well as the rate of cerebral insults was 0.05%. In 22.9% and 19% of the patients PTCA and cardiac surgery respectively was recommended. In patients undergoing PTCA, stable angina was present in 74.4% and unstable angina in 13.1%. Of the total number of PTCA procedures, 5.8% were performed in the setting of acute myocardial infarction. The PTCA lesion success rate was 96%, the mean diameter stenosis was 81% pre and 6% post-intervention. The mortality rate at 1 month post-PTCA was 0.4%, and myocardial infarction 1.0%. An acute occlusion occurred in 1.3% of the PTCA patients; 0.6% had to be transferred for emergency bypass surgery. None of the cath labs had on-site surgery. In comparison to other registries, our data show some similarities but also some different trends. Thus, our newly developed software proved to be reliable, fast and easy to use. Participating centers receive immediate feedback regarding their position within the whole group.

Quality assurance is a touchy subject: difficult to implement, time-demanding and expensive. The goal of quality assurance is to assist both the patients and the physicians. In addition to legal requirements, quality assurance is necessary for medical as well as economical reasons. It makes sense that the license to practice medicine does not automatically entail the right to perform all medical procedures; the development of new methods and the insights won from important scientific studies necessitates constant training. Furthermore, the decreasing allocation of funds for medical care combined with increased demand effected by new treatment methods and longer life expectancy force the development of instruments for specific and reasonable budgeting of medical expenditures. The primary goal of quality management in respect to economical regards must be the avoidance of unnecessary hospital admissions. But the patient must retain the right to choose the physician he prefers. The organization of the supervising structures in Germany is inconsistent: in 1995, a new Zentralstelle der Deutschen Arzteschaft zur Qualitätssicherung in der Medizin (German Physicians Headquarters for Quality Assurance in Medicine) was founded; it is proportionally staffed by representatives of the Bundesärztekammer (BAK, Federal Board of Physicians) and the Kassenärztliche Bundesvereinigung (KBV, Federal Commission of Panel Physicians). Furthermore, there is the Arbeitsgemeinschaft zur Förderung der Qualitätssicherung in der Medizin (Working Group for the Advancement of Quality Assurance in Medicine), in which the Bundesministerium für Gesundheit (Federal Ministry of Health) and the Kassenärztliche Vereinigung (KV, Public Health Insurance Providers) are represented. The KV is already seeing to it that stricter regulations govern physicians with private practice than those governing hospital physicians. There are three data banks existing on a voluntary basis for invasive diagnostic and therapy: a general, annual survey with baseline data from all German cardiac catheter laboratories; a data bank for storing records of PTCA's performed primarily in non-university-affiliated cardiac catheter labs (ALKK); and a data bank for recording diagnostic cardiac catheterization and PTCA's performed by physicians with private practice (BNK). In 1994, 15% of the diagnostic catheterizations and 16% of the coronary interventions were performed by physicians with private practice. Our survey shows that only 58% of German institutions record the data with a computer, 60% use their own developments; thus, the majority of groups in Germany are not linked to a central data bank. The least requirement for quality assurance should be the recording of major and minor complications as well as a comparison of one's own data with those of a central data bank.

In the collaborative exercise GEDNAP IV one EDTA blood sample (2 ml) and 5 bloodstains (0.5 ml on cotton) were investigated and in GEDNAP V, a total of 8 bloodstains (0.5 ml on cotton), including 2 mixed bloodstains. DNA typing was carried out using the RFLP systems YNH24/Hinf I and MS43a/Hinf I and the PCR systems HLA DQ alpha, D1S80, ApoB and YNZ22. In both exercises approximately 20 laboratories obtained results using the RFLP systems. Of the PCR systems, D1S80 was the most commonly used (14 labs in GEDNAP IV; 18 labs in GEDNAP V). The interlaboratory standard deviation for YNH24 in both exercises was approx. 0.6%, for MS43a 0.7-2.2% (GEDNAP IV) and 0.4-1.4% (GEDNAP V), depending on the fragment size. The fragment size calculation performed in each laboratory yielded a standard deviation twice that obtained when the fragment size calculation was performed centrally (IfR, Münster). In GEDNAP III, a system-specific corridor was developed to define the limits of deviation; this was modified for the present study by combining the fragment size ranges of YNH24 and MS43a. In both studies a subgroup of laboratories was involved in preliminary exercises using three PCR VNTRs and the system HLA DQ alpha. Owing to the substantial variation in experience of the participating laboratories with PCR typing the results obtained in these two studies do not fulfil the basic quality criteria of the GEDNAP studies.