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Background: Real world evidence (RWE) pose additional methodological challenges for evaluating causality, including confounding, missing/misclassified data, no clear treatment assignment, dynamic treatment regimens, and switching. We aimed to assess the type and impact of biases potentially occurring[for full text, please go to the a.m. URL], 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS)

Hintergrund/Fragestellung: Bei Vorhofflimmern (VHF) besteht die Schlaganfallprävention in der oralen Antikoagulation (OAK) mit Vitamin-K-Antagonisten (VKA) oder neuen oralen Antikoagulantien (NOAK). Bei Behandlung mit VKA wird für eine effektive Schlaganfallprävention eine Time in[zum vollständigen Text gelangen Sie über die oben angegebene URL], Brücken bauen – von der Evidenz zum Patientenwohl; 19. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Ergebnisse: Die derzeit gültige Definition des Krankheitsbildes beschreibt die Osteoporose als systemische Skeletterkrankung, die durch eine unzureichende Knochenfestigkeit charakterisiert ist. Die Knochenfestigkeit spiegelt dabei primär das Zusammenwirken von Knochendichte und Knochenqual[for full text, please go to the a.m. URL], 10. Deutscher Kongress für Versorgungsforschung; 18. GAA-Jahrestagung

Background The German statutory health insurance (GKV) reimburses all health care services that are deemed sufficient, appropriate, and efficient. According to the German Medical Association (BÄK), individual health services (IGeL) are services that are not under liability of the GKV, medically necessary or recommendable or at least justifiable. They have to be explicitly requested by the patient and have to be paid out of pocket. Research questions The following questions regarding IGeL in the outpatient health care of GKV insurants are addressed in the present report: What is the empirical evidence regarding offers, utilization, practice, acceptance, and the relation between physician and patient, as well as the economic relevance of IGeL? What ethical, social, and legal aspects are related to IGeL? For two of the most common IGeL, the screening for glaucoma and the screening for ovarian and endometrial cancer by vaginal ultrasound (VUS), the following questions are addressed: What is the evidence for the clinical effectiveness? Are there sub-populations for whom screening might be beneficial? Methods The evaluation is divided into two parts. For the first part a systematic literature review of primary studies and publications concerning ethical, social and legal aspects is performed. In the second part, rapid assessments of the clinical effectiveness for the two examples, glaucoma and VUS screening, are prepared. Therefore, in a first step, HTA-reports and systematic reviews are searched, followed by a search for original studies published after the end of the research period of the most recent HTA-report included. Results 29 studies were included for the first question. Between 19 and 53% of GKV members receive IGeL offers, of which three-quarters are realised. 16 to 19% of the insurants ask actively for IGeL. Intraocular tension measurement is the most common single IGeL service, accounting for up to 40% of the offers. It is followed by ultrasound assessments with up to 25% of the offers. Cancer screening and blood or laboratory services are also frequent and represent a major proportion of the demand. The ethical, social, and legal aspects discussed in the context of IGeL concern eight subject areas: autonomous patient decisions versus obtrusion, commercialization of medicine, duty of patient information, benefit, evidence, and (quality) control, role and relation of physicians and patients, relation to the GKV, social inequality, formally correct performance. For glaucoma screening, no randomized controlled trial (RCT) is identified that shows a patient relevant benefit. For VUS three RCT are included. However, they do not yet present mortality data concerning screened and non-screened persons. VUS screening shows a high degree of over-diagnosis in turn leading to invasive interventions. To diagnose one invasive carcinoma, 30 to 35 surgical procedures are necessary. Conclusion IGeL are a relevant factor in the German statutory health care system. To provide more transparency, the requests for evidence-based and independent patient information should be considered. Whether official positive and negative-lists could be an appropriate instrument to give guidance to patients and physicians, should be examined. Generally, IGeL must be seen in the broader context of the discussions about the future design and development of the German health care system., GMS Health Technology Assessment; 7:Doc05; ISSN 1861-8863

Einleitung/Hintergrund: Gemäß evidenzbasierten Leitlinien sollten postmenopausale Frauen mit Osteoporose zur Vermeidung von Frakturen mit Bisphosphonaten behandelt werden. Ziel der vorliegenden Studie ist es, zu analysieren, ab welchem Zeitpunkt die Wirksamkeit dieser Therapie bekannt[for full text, please go to the a.m. URL], 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds)