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Programme: MII - Medical Informatics Initiative8
POLAR – „POLypharmazie, Arzneimittelwechselwirkungen und Risiken“ – wie können Daten aus der stationären Krankenversorgung zur Beurteilung beitragen?
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

Zusammenfassung Hintergrund Mit der zunehmenden Anzahl eingenommener Arzneimittel steigt die Prävalenz von Medikationsrisiken. Hierzu zählen beispielsweise Arzneimittelwechselwirkungen, welche erwünschte … und unerwünschte Wirkungen einzelner Arzneistoffe reduzieren aber auch verstärken können. Fragestellung Das Verbundvorhaben POLAR (POLypharmazie, Arzneimittelwechselwirkungen und Risiken) hat das Ziel, mit Methoden und Prozessen der Medizininformatikinitiative (MII) auf Basis von „Real World Data“ (stationärer Behandlungsdaten von Universitätskliniken) einen Beitrag zur Detektion von Medikationsrisiken bei Patient:innen mit Polymedikation zu leisten. Im Artikel werden die konkreten klinischen Probleme dargestellt und am konkreten Auswertebeispiel illustriert. Material und Methoden Konkrete pharmakologische Fragestellungen werden algorithmisch abgebildet und an 13 Datenintegrationszentren in verteilten Analysen ausgewertet. Eine wesentliche Voraussetzung für die Anwendung dieser Algorithmen ist die Kerndatensatzstruktur der MII, die auf internationale IT-, Interoperabilitäts- und Terminologiestandards setzt. Ergebnisse In POLAR konnte erstmals gezeigt werden, dass stationäre Behandlungsdaten standortübergreifend auf der Basis abgestimmter, interoperabler Datenaustauschformate datenschutzkonform für Forschungsfragen zu arzneimittelbezogenen Problemen nutzbar gemacht werden können. Schlussfolgerungen Als Zwischenstand in POLAR wird ein erstes vorläufiges Ergebnis einer Analyse gezeigt. Darüber hinaus werden allgemeinere technische, rechtliche, kommunikative Chancen und Herausforderungen dargestellt, wobei der Fokus auf dem Fall der Verwendung stationärer Behandlungsdaten als „Real World Data“ für die Forschung liegt.

Authors: André Scherag, Wahram Andrikyan, Tobias Dreischulte, Pauline Dürr, Martin F Fromm, Jan Gewehr, Ulrich Jaehde, Miriam Kesselmeier, Renke Maas, Petra A Thürmann, Frank Meineke, Daniel Neumann, Julia Palm, Thomas Peschel, Editha Räuscher, Susann Schulze, Torsten Thalheim, Thomas Wendt, Markus Loeffler, D Ammon, W Andrikyan, U Bartz, B Bergh, T Bertsche, O Beyan, S Biergans, H Binder, M Boeker, H Bogatsch, R Böhm, A Böhmer, J Brandes, C Bulin, D Caliskan, I Cascorbi, M Coenen, F Dietz, F Dörje, T Dreischulte, J Drepper, P Dürr, A Dürschmid, F Eckelt, R Eils, A Eisert, C Engel, F Erdfelder, K Farker, M Federbusch, S Franke, N Freier, T Frese, M Fromm, K Fünfgeld, T Ganslandt, J Gewehr, D Grigutsch, W Haefeli, U Hahn, A Härdtlein, R Harnisch, S Härterich, M Hartmann, R Häuslschmid, C Haverkamp, O Heinze, P Horki, M Hug, T Iskra, U Jaehde, S Jäger, P Jürs, C Jüttner, J Kaftan, T Kaiser, K Karsten Dafonte, M Kesselmeier, S Kiefer, S Klasing, O Kohlbacher, D Kraska, S Krause, S Kreutzke, R Krock, K Kuhn, S Lederer, M Lehne, M Löbe, M Loeffler, C Lohr, V Lowitsch, N Lüneburg, M Lüönd, I Lutz, R Maas, U Mansmann, K Marquardt, A Medek, F Meineke, A Merzweiler, A Michel-Backofen, Y Mou, B Mussawy, D Neumann, J Neumann, C Niklas, M Nüchter, K Oswald, J Palm, T Peschel, H Prokosch, J Przybilla, E Räuscher, L Redeker, Y Remane, A Riedel, M Rottenkolber, F Rottmann, F Salman, J Schepers, A Scherag, F Schmidt, S Schmiedl, K Schmitz, G Schneider, A Scholtz, S Schorn, B Schreiweis, S Schulze, A K Schuster, M Schwab, H Seidling, S Semler, K Senft, M Slupina, R Speer, S Stäubert, D Steinbach, C Stelzer, H Stenzhorn, M Strobel, T Thalheim, M Then, P Thürmann, D Tiller, P Tippmann, Y Ucer, S Unger, J Vogel, J Wagner, J Wehrle, D Weichart, L Weisbach, S Welten, T Wendt, R Wettstein, I Wittenberg, R Woltersdorf, M Yahiaoui-Doktor, S Zabka, S Zenker, S Zeynalova, L Zimmermann, D Zöller, für das POLAR-Projekt

Date Published: 1st Sep 2022

Publication Type: Journal article

Algorithmic surveillance of ICU patients with acute respiratory distress syndrome (ASIC): protocol for a multicentre stepped-wedge cluster randomised quality improvement strategy
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

INTRODUCTION: The acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic … measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure. METHODS AND ANALYSIS: In this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested. ETHICS AND DISSEMINATION: Ethical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00014330.

Authors: Gernot Marx, Johannes Bickenbach, Sebastian Johannes Fritsch, Julian Benedict Kunze, Oliver Maassen, Saskia Deffge, Jennifer Kistermann, Silke Haferkamp, Irina Lutz, Nora Kristiana Voellm, Volker Lowitsch, Richard Polzin, Konstantin Sharafutdinov, Hannah Mayer, Lars Kuepfer, Rolf Burghaus, Walter Schmitt, Joerg Lippert, Morris Riedel, Chadi Barakat, André Stollenwerk, Simon Fonck, Christian Putensen, Sven Zenker, Felix Erdfelder, Daniel Grigutsch, Rainer Kram, Susanne Beyer, Knut Kampe, Jan Erik Gewehr, Friederike Salman, Patrick Juers, Stefan Kluge, Daniel Tiller, Emilia Wisotzki, Sebastian Gross, Lorenz Homeister, Frank Bloos, André Scherag, Danny Ammon, Susanne Mueller, Julia Palm, Philipp Simon, Nora Jahn, Markus Loeffler, Thomas Wendt, Tobias Schuerholz, Petra Groeber, Andreas Schuppert

Date Published: 1st Apr 2021

Publication Type: Journal article

Design and Concept of the SMITH Phenotyping Pipeline.
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

Phenotyping means the determination of clinical relevant phenotypes, e.g. by classification or calculation based on EHR data. Within the German Medical Informatics Initiative, the SMITH consortium is … working on the implementation of a phenotyping pipeline. to extract, structure and normalize information from the EHR data of the hospital information systems of the participating sites; to automatically apply complex algorithms and models and to enrich the data within the research data warehouses of the distributed data integration centers with the computed results. Here we present the overall picture and essential building blocks and workflows of this concept.

Authors: F. A. Meineke, S. Staubert, M. Lobe, A. Uciteli, M. Loffler

Date Published: 3rd Sep 2019

Publication Type: Journal article

Design and concept of the SMITH phenotyping pipeline
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

Phenotyping means the determination of clinical relevant phenotypes, e.g. by classification or calculation based on EHR data. Within the German Medical Informatics Initiative, the SMITH consortium is … working on the implementation of a phenotyping pipeline. to extract, structure and normalize information from the EHR data of the hospital information systems of the participating sites; to automatically apply complex algorithms and models and to enrich the data within the research data warehouses of the distributed data integration centers with the computed results. Here we present the overall picture and essential building blocks and workflows of this concept.

Authors: Frank A Meineke, Sebastian Stäubert, Matthias Löbe, Alexandr Uciteli, Markus Löffler

Date Published: 1st Sep 2019

Publication Type: Journal article

Design of Metadata Services for Clinical Data Interoperability in Germany.
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

Secondary use of electronic health record (EHR) data requires a detailed description of metadata, especially when data collection and data re-use are organizationally and technically far apart. This … paper describes the concept of the SMITH consortium that includes conventions, processes, and tools for describing and managing metadata using common standards for semantic interoperability. It deals in particular with the chain of processing steps of data from existing information systems and provides an overview of the planned use of metadata, medical terminologies, and semantic services in the consortium.

Authors: M. Lobe, O. Beyan, S. Staubert, F. Meineke, D. Ammon, A. Winter, S. Decker, M. Loffler, T. Kirsten

Date Published: 21st Aug 2019

Publication Type: Journal article

Continouus Annotation Quality Control, Support for Hierarchically Structured Label Sets and Long-Segment Annotation with WAT-SL 2.0
SMITH - Smart Medical Information Technology for Healthcare

Abstract

Not specified

Authors: Matthias Löbe, O. Beyan, Sebastian Stäubert, Frank A. Meineke, D. Ammon, Alfred Winter, S. Deckert, Markus Löffler, Toralf Kirsten

Date Published: 2019

Publication Type: InProceedings

Smart Medical Information Technology for Healthcare (SMITH).
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

INTRODUCTION: This article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. "Smart Medical Information Technology for Healthcare … (SMITH)" is one of four consortia funded by the German Medical Informatics Initiative (MI-I) to create an alliance of universities, university hospitals, research institutions and IT companies. SMITH's goals are to establish Data Integration Centers (DICs) at each SMITH partner hospital and to implement use cases which demonstrate the usefulness of the approach. OBJECTIVES: To give insight into architectural design issues underlying SMITH data integration and to introduce the use cases to be implemented. GOVERNANCE AND POLICIES: SMITH implements a federated approach as well for its governance structure as for its information system architecture. SMITH has designed a generic concept for its data integration centers. They share identical services and functionalities to take best advantage of the interoperability architectures and of the data use and access process planned. The DICs provide access to the local hospitals' Electronic Medical Records (EMR). This is based on data trustee and privacy management services. DIC staff will curate and amend EMR data in the Health Data Storage. METHODOLOGY AND ARCHITECTURAL FRAMEWORK: To share medical and research data, SMITH's information system is based on communication and storage standards. We use the Reference Model of the Open Archival Information System and will consistently implement profiles of Integrating the Health Care Enterprise (IHE) and Health Level Seven (HL7) standards. Standard terminologies will be applied. The SMITH Market Place will be used for devising agreements on data access and distribution. 3LGM(2) for enterprise architecture modeling supports a consistent development process.The DIC reference architecture determines the services, applications and the standardsbased communication links needed for efficiently supporting the ingesting, data nourishing, trustee, privacy management and data transfer tasks of the SMITH DICs. The reference architecture is adopted at the local sites. Data sharing services and the market place enable interoperability. USE CASES: The methodological use case "Phenotype Pipeline" (PheP) constructs algorithms for annotations and analyses of patient-related phenotypes according to classification rules or statistical models based on structured data. Unstructured textual data will be subject to natural language processing to permit integration into the phenotyping algorithms. The clinical use case "Algorithmic Surveillance of ICU Patients" (ASIC) focusses on patients in Intensive Care Units (ICU) with the acute respiratory distress syndrome (ARDS). A model-based decision-support system will give advice for mechanical ventilation. The clinical use case HELP develops a "hospital-wide electronic medical record-based computerized decision support system to improve outcomes of patients with blood-stream infections" (HELP). ASIC and HELP use the PheP. The clinical benefit of the use cases ASIC and HELP will be demonstrated in a change of care clinical trial based on a step wedge design. DISCUSSION: SMITH's strength is the modular, reusable IT architecture based on interoperability standards, the integration of the hospitals' information management departments and the public-private partnership. The project aims at sustainability beyond the first 4-year funding period.

Authors: A. Winter, S. Staubert, D. Ammon, S. Aiche, O. Beyan, V. Bischoff, P. Daumke, S. Decker, G. Funkat, J. E. Gewehr, A. de Greiff, S. Haferkamp, U. Hahn, A. Henkel, T. Kirsten, T. Kloss, J. Lippert, M. Lobe, V. Lowitsch, O. Maassen, J. Maschmann, S. Meister, R. Mikolajczyk, M. Nuchter, M. W. Pletz, E. Rahm, M. Riedel, K. Saleh, A. Schuppert, S. Smers, A. Stollenwerk, S. Uhlig, T. Wendt, S. Zenker, W. Fleig, G. Marx, A. Scherag, M. Loffler

Date Published: 18th Jul 2018

Publication Type: Journal article

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