0000000000427035
AUTHOR
Thomas Ganslandt
Leitfaden zum Datenschutz in medizinischen Forschungsprojekten: Generische Lösungen der TMF 2.0
Scroll down to open individual chapters Das Vertrauen von Patienten und Probanden ist eine unverzichtbare Voraussetzung fur den Erfolg medizinischer Forschungsprojekte, die ohne die Erhebung, langfristige Speicherung und Analyse von klinischen Daten und Proben nicht durchgefuhrt werden konnen. Medizinische Forschung arbeitet heute uberwiegend vernetzt in zunehmend groseren Forschungsverbunden. Entsprechend nimmt auch die Bedeutung von Datenschutz und Datensicherheit immer weiter zu. Die TMF hat bereits 2003 erstmals generische Datenschutzkonzepte fur medizinische Forschungsverbunde veroffentlicht. Auf dieser Basis konnten zahlreiche Forschungsprojekte ihre Datenschutzkonzepte schneller erar…
Small airway disease (SAD) is associated with respiratory symptoms and relevant for therapy in early COPD
Background: SAD is common in patients with COPD. Occurring early in the course of the disease, it is frequently missed by currently used diagnostic tests. Multiple breath washout (MBW) testing detects ventilation heterogeneity (VH) while oscillometry (OS) assesses peripheral obstruction, both associated with SAD. We therefore set out to evaluate the presence and symptoms of SAD in patients with early COPD. Methods: We prospectively evaluated 26 patients (FEV1 77±19% pred., 88% GOLD I/II). In an 8-week cross-over design, the effect of dual bronchodilatation (tiotropium/olodaterol, T/O) on lung function and symptoms (CAT) was compared to monotherapy (formoterol). Lung function was assessed by…
Towards Implementation of OMOP in a German University Hospital Consortium
Background In 2015, the German Federal Ministry of Education and Research initiated a large data integration and data sharing research initiative to improve the reuse of data from patient care and translational research. The Observational Medical Outcomes Partnership (OMOP) common data model and the Observational Health Data Sciences and Informatics (OHDSI) tools could be used as a core element in this initiative for harmonizing the terminologies used as well as facilitating the federation of research analyses across institutions. Objective To realize an OMOP/OHDSI-based pilot implementation within a consortium of eight German university hospitals, evaluate the applicability to support dat…