Artikel
EVAluation research based on data from routine clinical care 4 the MII (EVA4MII) – a consultancy platform for evaluation based research in the MII
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Autoren
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Kai Günther
- University Hospital Würzburg, Institute for Medical Data Sciences, Würzburg, Germany
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Kathrin Ungethüm
- University Hospital Würzburg, Institute for Medical Data Sciences, Würzburg, Germany; Julius-Maximilian University Würzburg, Institute for Clinical Epidemiology and Biometry, Würzburg, Germany
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Viktoria Rücker
- Julius-Maximilian University Würzburg, Institute for Clinical Epidemiology and Biometry, Würzburg, Germany
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Michelle Pfaffenlehner
- Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, Freiburg, Germany; Freiburg Centre for Data Analysis and Modelling, University of Freiburg, Freiburg, Germany
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Max Behrens
- Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, Freiburg, Germany; Freiburg Centre for Data Analysis and Modelling, University of Freiburg, Freiburg, Germany
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Nadine Binder
- Universitätsklinikum Freiburg, Institut für Allgemeinmedizin, Freiburg im Breisgau, Germany
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Miriam Kesselmeier
- Institut für Medizinische Statistik, Informatik und Datenwissenschaften (IMSID), Universitätsklinikum Jena, Jena, Germany
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Flavia Remo
- Institut für Medizinische Statistik, Informatik und Datenwissenschaften (IMSID), Universitätsklinikum Jena, Jena, Germany
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Philip Kleinert
- TMF e.V. - Technology, Methods, and Infrastructure for Networked Medical Research, Berlin, Germany
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Jens-Peter Reese
- Julius-Maximilian University Würzburg, Institute for Clinical Epidemiology and Biometry, Würzburg, Germany
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Harald Binder
- Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, Freiburg, Germany; Freiburg Centre for Data Analysis and Modelling, University of Freiburg, Freiburg, Germany
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André Scherag
- Institut für Medizinische Statistik, Informatik und Datenwissenschaften (IMSID), Universitätsklinikum Jena, Jena, Germany; Center for Clinical Studies, Jena University Hospital – Friedrich Schiller University Jena, Jena, Germany
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Peter Heuschmann
- Julius-Maximilian University Würzburg, Institute for Clinical Epidemiology and Biometry, Würzburg, Germany; University Hospital Würzburg, Institute for Medical Data Sciences, Würzburg, Germany; University Hospital Würzburg, Clinical Trial Centre Würzburg, Würzburg, Germany
| Veröffentlicht: | 6. September 2024 |
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Gliederung
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Background: In Germany, the importance of real-world evidence in medical research is increasing together with the availability of routine clinical care data, for example through electronic health records, registry data and data standardisation initiatives. Evaluation of real-world data offers a range of possibilities and advantages compared to classical observational studies with primary data collection. However, there are also considerable challenges when analysing such data. Within the German Medical Informatics Initiative (MII), Data Integration Centres (DIC) were established at each participating university hospital. These DIC extract selected routine clinical care data from the individual hospital information system according to a standardised core data set provided by the MII in the Fast Healthcare Interoperability Resources (FHIR) format. Data from this MII core data set is made available for researchers through an application process via the “Forschungsdatenportal für Gesundheit” (FDPG). The EVA4MII project aims to establish a methodology consultancy platform for researchers planning or conducting evaluation projects using the routine data from the MII.
Methods: The EVA4MII project offers consultancy services for researchers using the MII data at all steps of the evaluation process: study design, development of the study protocol and evaluation concept, data application using the FDPG platform, statistical analyses and interpretation of results. In addition, EVA4MII offers tutorials and webinars within the MII structure. A stakeholder survey and workshops are conducted for further elucidation of the barriers and needs of national institutional stakeholders in utilising routine clinical care data. The results of these workshops will be published.
Results: A helpdesk and central contact point is established via the e-Mail address eva4mii@ukw.de. Researchers interested in a consultancy can contact the multidisciplinary EVA4MII team using the standardised form available at www.ukw.de/eva4mii. The first tutorial, introducing the concepts of evaluation research, has been published (https://youtu.be/sPWJ_QWniYg) and a first workshop on common biases in routine clinical care data evaluation was held on the basis of a literature review. The first researchers have already started to use the EVA4MII consultancy services for their research projects. Additionally, in cooperation with the FPDG, the EVA4MII consultancy platform evaluated 22 applications regarding their methodology as part of the first round of a joint call from the MII and the “Netzwerk Universitätsmedizin” (NUM). Moreover, EVA4MII consults Module 3 projects of the MII in methodological aspects, such as an exploratory feasibility analysis of cardiovascular risk score calculations based on the MII core data set within the ACRIBiS („Advancing Cardiovascular Risk Identification with Structured Clinical Documentation and Biosignal Derived Phenotypes Synthesis”) project.
Conclusion: EVA4MII provides a helpdesk offering consultancy services and resources for researchers planning to conduct evaluation research using data from the MII. The consultancy services and resources of EVA4MII can improve evaluation projects using the MII data to ensure a sound methodology and informative results.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
