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Im Koalitionsvertrag der Ampel-Koalition wird für die laufende Legislaturperiode ein Gesundheitsdatennutzungsgesetz (GDNG) angekündigt. Dieses Gesetz soll „zu einer besseren wissenschaftlichen Nutzung in Einklang mit der DSGVO“ führen. Bekanntermaßen steht unser Gesundheitssystem vor großen Herausforderungen (Demografie, Digitalisierung, Fachkräftemangel, Klimakrise, regionale Unterschiede, etc.) und ist jetzt schon das teuerste in Europa bei mittelmäßiger Leistung. Diese Herausforderungen können effizienter und evidenzgeleitet bewältigt werden, wenn wie im geplanten GDNG angedacht, die Datenressourcen für die Evaluierung und Weiterentwicklung des Gesundheitssystems und der Gesundheitsversorgung optimal genutzt werden. In den folgenden Ausführungen werden aus Sicht von Versorgungsforscher*innen Voraussetzungen und Desiderata für eine optimale Ausgestaltung des Gesetzes formuliert. Das Papier wurde durch das Deutsche Netzwerk Versorgungsforschung (DNVF) und die Arbeitsgruppe Erhebung und Nutzung von Sekundärdaten (AGENS) der Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP) und der Deutschen Gesellschaft für Epidemiologie (DGEpi) erstellt und wird von den unterzeichnenden Fachgesellschaften getragen. Das vorliegende Positionspapier und die hier aufgestellten Forderungen sind vor der Veröffentlichung und damit in Unkenntnis des Referentenentwurfs zum GDNG formuliert worden.

BACKGROUND: In some areas of Germany, there is a shortage of specialist physicians for patients with inflammatory rheumatic diseases. Delegating certain medical care services to qualified, specialized rheumatological assistants (SRAs) might be an effective way to supplement the available capacity for specialized medical care. METHODS: Patients under stable treatment for rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were included in this trial, which was designed to demonstrate, in a first step, the non-inferiority of a form of care involving delegation of physicians’ tasks to SRAs (team-based care), in comparison to standard care, with respect to changes in disease activity at one year. “Non-inferiority,” in this context, means either superiority or else an irrelevant extent of inferiority. In a second step, in case non-inferiority could be shown, the superiority of team-based care with respect to changes in patients’ health-related quality of life would be tested as well. Disease activity was measured with the Disease Activity Score 28, and health-related quality of life with the EQ-5D-5L. This was a randomized, multicenter, rater-blinded trial with two treatment arms (team-based care and standard care). The statistical analysis was performed with mixed linear models (DRKS00015526). RESULTS: From September 2018 to June 2019, 601 patients from 14 rheumatological practices and 3 outpatient rheumatological clinics in the German states of North Rhine–Westphalia and Lower Saxony were randomized to either team-based or standard care. Team-based care was found to be non-inferior to standard care with respect to changes in disease activity (adjusted difference = -0.19; 95% confidence interval [-0.36; -0.02]; p

Background: Many refugees have experienced multiple traumatic events in their country of origin and/or during flight. Trauma-related disorders such as posttraumatic stress disorder (PTSD) or complex PTSD (CPTSD) are prevalent in this population, which highlights the need for accessible and effective treatment. Imagery Rescripting (ImRs), an imagery-based treatment that does not use formal exposure and that has received growing interest as an innovative treatment for PTSD, appears to be a promising approach. Objective: This randomized-controlled trial aims to investigate the efficacy of ImRs for refugees compared to Usual Care and Treatment Advice (UC+TA) on (C)PTSD remission and reduction in other related symptoms. Method: Subjects are 90 refugees to Germany with a diagnosis of PTSD according to DSM-5. They will be randomly allocated to receive either UC+TA (n = 45) or 10 sessions of ImRs (n = 45). Assessments will be conducted at baseline, post-intervention, three-month follow-up, and 12-month follow-up. Primary outcome is the (C)PTSD remission rate. Secondary outcomes are severity of PTSD and CPTSD symptoms, psychiatric symptoms, dissociative symptoms, quality of sleep, and treatment satisfaction. Economic analyses will investigate health-related quality of life and costs. Additional measures will assess migration and stress-related factors, predictors of dropout, therapeutic alliance and session-by-session changes in trauma-related symptoms. Results and Conclusions: Emerging evidence suggests the suitability of ImRs in the treatment of refugees with PTSD. After positive evaluation, this short and culturally adaptable treatment can contribute to close the treatment gap for refugees in high-income countries such as Germany. Trial registration: German Clinical Trials Register under trial number DRKS00019876, registered prospectively on 28 April 2020., Highlights • Many refugees have experienced traumatic events. • This trial investigates the efficacy of imagery rescripting, a short and culturally adaptable treatment that can contribute to close the treatment gap for refugees with posttraumatic stress disorder in high-income countries.

Introduction Success rates of psychotherapy in post-traumatic stress disorder related to childhood maltreatment (PTSD-CM) are limited. Methods and analysis Observer-blind multicentre randomised clinical trial (A-1) of 4-year duration comparing enhanced methods of STAIR Narrative Therapy (SNT) and of trauma-focused psychodynamic therapy (TF-PDT) each of up to 24 sessions with each other and a minimal attention waiting list in PTSD-CM. Primary outcome is severity of PTSD (Clinician-Administered PTSD Scale for DSM-5 total) assessed by masked raters. For SNT and TF-PDT, both superiority and non-inferiority will be tested. Intention-to-treat analysis (primary) and per-protocol analysis (secondary). Assessments at baseline, after 10 sessions, post-therapy/waiting period and at 6 and 12 months of follow-up. Adult patients of all sexes between 18 and 65 years with PTSD-CM will be included. Continuing stable medication is permitted. To be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions and concurrent psychotherapy. To be assessed for eligibility: n=600 patients, to be e randomly allocated to the study conditions: n=328. Data management, randomisation and monitoring will be performed by an independent European Clinical Research Infrastructure Network (ECRIN)-certified data coordinating centre for clinical trials (KKS Marburg). Report of AEs to a data monitoring and safety board. Complementing study A-1, four inter-related add-on projects, including subsamples of the treatment study A-1, will examine (1) treatment integrity (adherence and competence) and moderators and mediators of outcome (B-1); (2) biological parameters (B-2, eg, DNA damage, reactive oxygen species and telomere shortening); (3) structural and functional neural changes by neuroimaging (B-3) and (4) cost-effectiveness of the treatments (B-4, costs and utilities). Ethics and dissemination Approval by the institutional review board of the University of Giessen (AZ 168/19). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media. Trial registration number DRKS 00021142.

BACKGROUND Recent research efforts have focused on the effects of deep brain stimulation of the subthalamic nucleus (STN DBS) for selected patients with mild-to-moderate PD experiencing motor complications. OBJECTIVES We assessed the cost utility of subthalamic DBS compared with the best medical treatment for German patients below the age of 61 with early motor complications of PD. METHODS We applied a previously published Markov model that integrated health utilities based on EuroQoL and direct costs over patients' lifetime adjusted to the German health care payer perspective (year of costing: 2013). Effectiveness was evaluated using the Parkinson's Disease Questionnaire 39 summary index. We performed sensitivity analyses to assess uncertainty. RESULTS In the base-case analysis, the incremental cost-utility ratio for STN DBS compared to best medical treatment was 22,700 Euros per quality-adjusted life year gained. The time to, and costs for, battery exchange had a major effect on the incremental cost-utility ratios, but never exceeded a threshold of 50,000 Euros per quality-adjusted life year. CONCLUSIONS Our decision analysis supports the fact that STN DBS at earlier stages of the disease is cost-effective in patients below the age of 61 when compared with the best medical treatment in the German health care system. This finding was supported by detailed sensitivity analyses reporting robust results. Whereas the EARLYSTIM study has shown STN DBS to be superior to medical therapy with respect to quality of life for patients with early motor complications, this further analysis has shown its cost-effectiveness. © 2016 International Parkinson and Movement Disorder Society.

Intakte Sinnesorgane sind eine der wichtigsten Voraussetzungen für den Spracherwerb. Zusätzlich können erbliche, soziokulturelle und emotionale Faktoren die Hör- und Sprachentwicklung beeinflussen. Eine Untersuchung von 1999 an hörgeschädigten Kindern ergab, dass selbst[for full text, please go to the a.m. URL], 26. Wissenschaftliche Jahrestagung der Deutschen Gesellschaft für Phoniatrie und Pädaudiologie (DGPP)

The proto-oncogene c-Myc is a transcription factor and is essential for the maintenance of the cellular homeostasis. Since c-Myc acts as both activator and inhibitor of transcription of many genes, it’s deregulation leads to a dysfunction in cell cycle control, cell growth or apoptosis and promotes tumor development. Like the majority of proteins Myc functions through interaction with other proteins in multi protein complexes. An important interactor of c-Myc is Miz-1, which is able to activate genes by DNA binding. c-Myc inhibits this activation through interaction with Miz-1 via an unknown mechanism. In the present study , two approaches were used to identify interaction partners of c-Myc and Miz-1: A tandem affinity purification (TAP) and a fractioning approach by chromatography. Both approaches resulted in bona fide interaction partners, which were identified by mass spectrometry. The TAP yielded Hsp 70, a heat shock protein, as potential interaction partner of Miz-1. Additionally, three different Miz-1 variants could be identified. The fractioning provided a list of 171 different bona fide binding partners of c-Myc and/or Miz-1. The identified proteins belong to factors from transcription, RNA processing, DNA repair, protein modification and degradation as well as to cell structure, metabolism and protein synthesis. The results of this study may serve as a basis for further investigation of the c-Myc/Miz-1 function not only in the well known context of transcriptional regulation, but also in other processes, which are possibly regulated by c-Myc or Miz-1 and could contribute to tumorigenesis., Das Proto-Onkogen c-myc ist durch seine Funktion als Transkriptionsfaktor entscheidend an vielen Prozessen beteiligt, welche die zelluläre Homöostase aufrechterhalten. Wegen seiner Rolle als Aktivator und Repressor vieler Gene, führt die Deregulation der Expression von c-Myc auch zur Deregulation physiologischer Prozesse wie Zellzykluskontrolle, Zellwachstum oder Apoptose und begünstigt die Tumorentstehung. Wie die meisten Proteine kann auch c-Myc seine Funktion nur durch Interaktion mir anderen Polypeptiden in Multiproteinkomplexen ausüben. Ein wichtiger Interaktionspartner von c-Myc ist Miz-1. Durch Bindung an DNA kann Miz-1 Gene aktivieren. c-Myc reprimiert die Aktivierung durch Miz-1, indem es an Miz-1 bindet. Der genaue Mechanismus dieser Repression ist jedoch unbekannt. In der vorliegenden Arbeit wurden zwei experimentelle Ansätze zur Identifizierung von möglichen Interaktionspartnern von c-Myc und Miz-1 etabliert. Eine Tandem-Affinitäts-Aufreinigung (TAP), um Protein-Protein Wechselwirkungen des Miz-1 Proteins zu identifizieren und eine chromatographische Fraktionierung, um Komplexe mit c-Myc bzw. Miz-1 als Untereinheiten zu identifizieren. In beiden Ansätzen erfolgte die Identifzierung durch Massenspektroskopie. Mit der Tandem-Affinitäts-Aufreinigung gelang zum einen die Identifizierung des Hitzschockproteins Hsp70 als potentieller Interaktionspartner. Zum anderen konnten drei verschiedene Varianten von Miz-1 mit der TAP Methode gefunden werden. Die Fraktionierung lieferte eine Liste mit 171 verschiedenen potentiellen Bindungspartnern von c-Myc bzw. Miz-1. Es konnten Proteine aus der Transkription, RNA Prozessierung, DNA-Reparatur, der Proteinmodifikation und-degradation, der Zellstruktur, des Metabolismus und der Proteinsynthese identifiziert werden. Die Ergebnisse der Arbeit liefern eine Grundlage für die weitere Untersuchung der Funktion von c-Myc und Miz-1. Dies gilt aber nicht nur für den schon bekannten Kontext der Transkription. c-Myc und Miz-1 sind vermutlich an einer Reihe weiterer Prozesse beteiligt, die für die Tumorigenese eine entscheidende Rolle spielen könnten.