Publications

33 Publications visible to you, out of a total of 33

Abstract (Expand)

Clinical Trial Recruitment Support Systems can booster patient inclusion of clinical trials by automatically analyzing eligibility criteria based on electronic health records. However, missing interoperability has hindered introduction of those systems on a broader scale. Therefore, our aim was to develop a recruitment support system based on FHIR R4 and evaluate its usage and features in a cardiology department. Clinical conditions, anamnesis, examinations, allergies, medication, laboratory data and echocardiography results were imported as FHIR resources. Clinical trial information, eligibility criteria and recruitment status were recorded using the appropriate FHIR resources without extensions. Eligibility criteria linked by the logical operation “OR” were represented by using multiple FHIR Group resources for enrollment. The system was able to identify 52 of 55 patients included in four clinical trials. In conclusion, use of FHIR for defining eligibility criteria of clinical trials may facilitate interoperability and allow automatic screening for eligible patients at multiple sites of different healthcare providers in the future. Upcoming changes in FHIR should allow easier description of “OR”-linked eligibility criteria.

Authors: Clemens Scherer, Stephan Endres, Martin Orban, Stefan Kääb, Steffen Massberg, Alfred Winter, Matthias Löbe

Date Published: 1st May 2022

Publication Type: Journal article

Abstract (Expand)

The constant upward movement of data-driven medicine as a valuable option to enhance daily clinical practice has brought new challenges for data analysts to get access to valuable but sensitive data due to privacy considerations. One solution for most of these challenges are Distributed Analytics (DA) infrastructures, which are technologies fostering collaborations between healthcare institutions by establishing a privacy-preserving network for data sharing. However, in order to participate in such a network, a lot of technical and administrative prerequisites have to be made, which could pose bottlenecks and new obstacles for non-technical personnel during their deployment. We have identified three major problems in the current state-of-the-art. Namely, the missing compliance with FAIR data principles, the automation of processes, and the installation. In this work, we present a seamless on-boarding workflow based on a DA reference architecture for data sharing institutions to address these problems. The on-boarding service manages all technical configurations and necessities to reduce the deployment time. Our aim is to use well-established and conventional technologies to gain acceptance through enhanced ease of use. We evaluate our development with six institutions across Germany by conducting a DA study with open-source breast cancer data, which represents the second contribution of this work. We find that our on-boarding solution lowers technical barriers and efficiently deploys all necessary components and is, therefore, indeed an enabler for collaborative data sharing.

Authors: Sascha Welten, Lars Hempel, Masoud Abedi, Yongli Mou, Mehrshad Jaberansary, Laurenz Neumann, Sven Weber, Kais Tahar, Yeliz Ucer Yediel, Matthias Löbe, Stefan Decker, Oya Beyan, Toralf Kirsten

Date Published: 1st Apr 2022

Publication Type: Journal article

Abstract (Expand)

The current availability of electronic health records represents an excellent research opportunity on multimorbidity, one of the most relevant public health problems nowadays. However, it also poses at also poses a methodological challenge due to the current lack of tools to access, harmonize and reuse research datasets. In FAIR4Health, a European Horizon 2020 project, a workflow to implement the FAIR (findability, accessibility, interoperability and reusability) principles on health datasets was developed, as well as two tools aimed at facilitating the transformation of raw datasets into FAIR ones and the preservation of data privacy. As part of this project, we conducted a multicentric retrospective observational study to apply the aforementioned FAIR implementation workflow and tools to five European health datasets for research on multimorbidity. We applied a federated frequent pattern growth association algorithm to identify the most frequent combinations of chronic diseases and their association with mortality risk. We identified several multimorbidity patterns clinically plausible and consistent with the bibliography, some of which were strongly associated with mortality. Our results show the usefulness of the solution developed in FAIR4Health to overcome the difficulties in data management and highlight the importance of implementing a FAIR data policy to accelerate responsible health research.

Authors: Jonás Carmona-Pírez, Beatriz Poblador-Plou, Antonio Poncel-Falcó, Jessica Rochat, Celia Alvarez-Romero, Alicia Martínez-García, Carmen Angioletti, Marta Almada, Mert Gencturk, A. Anil Sinaci, Jara Eloisa Ternero-Vega, Christophe Gaudet-Blavignac, Christian Lovis, Rosa Liperoti, Elisio Costa, Carlos Luis Parra-Calderón, Aida Moreno-Juste, Antonio Gimeno-Miguel, Alexandra Prados-Torres

Date Published: 1st Feb 2022

Publication Type: Journal article

Abstract (Expand)

Health data from hospital information systems are valuable sources for medical research but have known issues in terms of data quality. In a nationwide data integration project in Germany, health care data from all participating university hospitals are being pooled and refined in local centers. As there is currently no overarching agreement on how to deal with errors and implausibilities, meetings were held to discuss the current status and the need to develop consensual measures at the organizational and technical levels. This paper analyzes the discovered similarities and differences. The result shows that although data quality checks are carried out at all sites, there is a lack of both centrally coordinated data quality indicators and a formalization of plausibility rules as well as a repository for automatic querying of the rules, for example in ETL processes.

Authors: Matthias Löbe, Gaetan Kamdje-Wabo, Adriana Carina Sinza, Helmut Spengler, Marcus Strobel, Erik Tute

Date Published: 2022

Publication Type: Journal article

Abstract (Expand)

Sharing data is of great importance for research in medical sciences. It is the basis for reproducibility and reuse of already generated outcomes in new projects and in new contexts. FAIR data principles are the basics for sharing data. The Leipzig Health Atlas (LHA) platform follows these principles and provides data, describing metadata, and models that have been implemented in novel software tools and are available as demonstrators. LHA reuses and extends three different major components that have been previously developed by other projects. The SEEK management platform is the foundation providing a repository for archiving, presenting and secure sharing a wide range of publication results, such as published reports, (bio)medical data as well as interactive models and tools. The LHA Data Portal manages study metadata and data allowing to search for data of interest. Finally, PhenoMan is an ontological framework for phenotype modelling. This paper describes the interrelation of these three components. In particular, we use the PhenoMan to, firstly, model and represent phenotypes within the LHA platform. Then, secondly, the ontological phenotype representation can be used to generate search queries that are executed by the LHA Data Portal. The PhenoMan generates the queries in a novel domain specific query language (SDQL), which is specific for data management systems based on CDISC ODM standard, such as the LHA Data Portal. Our approach was successfully applied to represent phenotypes in the Leipzig Health Atlas with the possibility to execute corresponding queries within the LHA Data Portal.

Authors: A. Uciteli, C. Beger, J. Wagner, A. Kiel, F. A. Meineke, S. Staubert, M. Lobe, R. Hansel, J. Schuster, T. Kirsten, H. Herre

Date Published: 24th May 2021

Publication Type: Journal article

Abstract (Expand)

Sharing data is of great importance for research in medical sciences. It is the basis for reproducibility and reuse of already generated outcomes in new projects and in new contexts. FAIR data principles are the basics for sharing data. The Leipzig Health Atlas (LHA) platform follows these principles and provides data, describing metadata, and models that have been implemented in novel software tools and are available as demonstrators. LHA reuses and extends three different major components that have been previously developed by other projects. The SEEK management platform is the foundation providing a repository for archiving, presenting and secure sharing a wide range of publication results, such as published reports, (bio)medical data as well as interactive models and tools. The LHA Data Portal manages study metadata and data allowing to search for data of interest. Finally, PhenoMan is an ontological framework for phenotype modelling. This paper describes the interrelation of these three components. In particular, we use the PhenoMan to, firstly, model and represent phenotypes within the LHA platform. Then, secondly, the ontological phenotype representation can be used to generate search queries that are executed by the LHA Data Portal. The PhenoMan generates the queries in a novel domain specific query language (SDQL), which is specific for data management systems based on CDISC ODM standard, such as the LHA Data Portal. Our approach was successfully applied to represent phenotypes in the Leipzig Health Atlas with the possibility to execute corresponding queries within the LHA Data Portal.

Authors: Alexandr Uciteli, Christoph Beger, Jonas Wagner, Alexander Kiel, Frank A Meineke, Sebastian Stäubert, Matthias Löbe, René Hänsel, Judith Schuster, Toralf Kirsten, Heinrich Herre

Date Published: 1st May 2021

Publication Type: InCollection

Abstract (Expand)

Planning clinical studies to check medical hypotheses requires the specification of eligibility criteria in order to identify potential study participants. Electronically available patient data allows to support the recruitment of patients for studies. The Smart Medical Information Technology for Healthcare (SMITH) consortium aims to establish data integration centres to enable the innovative use of available healthcare data for research and treatment optimization. The data from the electronic health record of patients in the participating hospitals is integrated into a Health Data Storage based on the Fast Healthcare Interoperability Resources standard (FHIR), developed by HL7. In SMITH, FHIR Search is used to query the integrated data. An investigation has shown the advantages and disadvantages of using FHIR Search for specifying eligibility criteria. This paper presents an approach for modelling eligibility criteria as well as for generating and executing FHIR Search queries. Our solution is based on the Phenotype Manager, a general ontological phenotyping framework to model and calculate phenotypes using the Core Ontology of Phenotypes.

Authors: A. Uciteli, C. Beger, J. Wagner, T. Kirsten, F. A. Meineke, S. Staubert, M. Lobe, H. Herre

Date Published: 26th Apr 2021

Publication Type: Journal article

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