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  • 1
    Online Resource
    Online Resource
    Toolbox for Research, or how to facilitate a central data management in small-scale research projects
    Springer Science and Business Media LLC ; 2018
    In:  Journal of Translational Medicine Vol. 16, No. 1 ( 2018-12)
    Details
    In: Journal of Translational Medicine, Springer Science and Business Media LLC, Vol. 16, No. 1 ( 2018-12)
    Type of Medium: Online Resource
    ISSN: 1479-5876
    URL: Article
    DOI: 10.1186/s12967-018-1390-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2018
    detail.hit.zdb_id: 2118570-0
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  • 2
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    Sekundäre Nutzung von hausärztlichen Routinedaten ist machbar – Bericht vom RADAR Projekt
    Georg Thieme Verlag KG ; 2021
    In:  Das Gesundheitswesen Vol. 83, No. S 02 ( 2021-11), p. S130-S138
    Details
    In: Das Gesundheitswesen, Georg Thieme Verlag KG, Vol. 83, No. S 02 ( 2021-11), p. S130-S138
    Abstract: Ziel der Studie „Real world“-Daten aus der ambulanten Gesundheitsversorgung sind in Deutschland nur schwer systematisch und longitudinal zu erlangen. Unsere Vision ist eine permanente Datenablage mit repräsentativen, de-identifizierten Patienten- und Versorgungsdaten, längsschnittlich, fortwährend aktualisiert und von verschiedenen Versorgern, mit der Möglichkeit zur Verknüpfung mit weiteren Daten, etwa aus Patientenbefragungen oder biologischer Forschung, zugänglich für andere Forscher. Wir berichten methodische Vorgehensweisen und Ergebnisse aus dem RADAR Projekt.Methodik Untersuchung des Rechtsrahmens, Entwicklung prototypischer technischer Abläufe und Lösungen, mit Machbarkeitsstudie zur Evaluation von technischer und inhaltlicher Funktionalität sowie Eignung für Fragestellungen der Versorgungsforschung.Ergebnisse Ab 2016 entwickelte ein interdisziplinäres Wissenschaftlerteam ein Datenschutzkonzept für Exporte von Versorgungsdaten aus elektronischen Praxisverwaltungssystemen. Eine technische und organisatorische Forschungsinfrastruktur im ambulanten Sektor wurden entwickelt und im Anwendungsfall „Orale Antikoagulation“ (OAK) umgesetzt. In 7 niedersächsischen Hausarztpraxen wurden 100 Patienten gewonnen und nach informierter Einwilligung ihre ausgewählten Behandlungsdaten, reduziert auf 40 relevante Datenfelder, über die Behandlungs datentransfer-Schnittstelle extrahiert, unmittelbar vor Ort in identifizierende bzw. medizinische Daten getrennt und verschlüsselt zur Treuhandstelle (THS) bzw. an den Datenhalter übertragen. 75 Patienten, die die Einschlusskriterien erfüllten (mind. 1 Jahr Behandlung mit OAK), erhielten einen Lebensqualitäts-Fragebogen über die THS per Post. Von 66 Rücksendungen wurden 63 Fragebogenergebnisse mit den Behandlungsdaten in der Datenablage verknüpft.Schlussfolgerung Die rechtskonforme Machbarkeit der Gewinnung von pseudonymisierten hausärztlichen Routinedaten mit expliziter informierter Patienteneinwilligung und deren wissenschaftliche Nutzung einschließlich Re-Kontaktierung und Einbindung von Fragebogendaten konnte nachgewiesen werden. Die Schutzkonzepte Privacy by design und Datenminimierung (Artikel 25 mit Erwägungsgrund 78 DSGVO) wurden systematisch in das RADAR Projekt integriert und begründen wesentlich, dass der Machbarkeitsnachweis rechtskonformer Primärdatengewinnung und sekundärer Nutzung für Forschungszwecke gelang. Eine Nutzung hinreichend anonymisierter, aber noch sinnvoller hausärztlicher Gesundheitsdaten ohne individuelle Einwilligung ist im bestehenden Rechtsrahmen in Deutschland schwerlich umsetzbar.
    Type of Medium: Online Resource
    ISSN: 0941-3790 , 1439-4421
    URL: Article
    DOI: 10.1055/a-1676-4020
    RVK:
    XF 1000
    RVK:
    QX 700
    RVK:
    XF 1100
    RVK:
    XA 10000
    Language: German
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2021
    detail.hit.zdb_id: 1101426-X
    SSG: 20,1
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  • 3
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    Designing and piloting a generic research architecture and workflows to unlock German primary care data for secondary use
    Springer Science and Business Media LLC ; 2020
    In:  Journal of Translational Medicine Vol. 18, No. 1 ( 2020-12)
    Details
    In: Journal of Translational Medicine, Springer Science and Business Media LLC, Vol. 18, No. 1 ( 2020-12)
    Abstract: Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor’s practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany. Methods The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires). Results The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated—for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders. Conclusion The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor’s settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project’s extension phase.
    Type of Medium: Online Resource
    ISSN: 1479-5876
    URL: Article
    DOI: 10.1186/s12967-020-02547-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2118570-0
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  • 4
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    A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine
    Springer Science and Business Media LLC ; 2022
    In:  BMC Medical Informatics and Decision Making Vol. 22, No. 1 ( 2022-12-19)
    Details
    In: BMC Medical Informatics and Decision Making, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2022-12-19)
    Abstract: The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The “COVID-19 Data Exchange Platform” (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing. All 34 participating university hospitals (NUM sites) work upon a harmonised infrastructural as well as legal basis for their data protection-compliant collection and transfer of their research dataset to the central CODEX platform. Each NUM site ensures that the exchanged consent information conforms to the already-balloted HL7 FHIR consent profiles and the interoperability concept of the MII Task Force “Consent Implementation” (TFCI). The Independent Trusted Third-Party (TTP) of the University Medicine Greifswald supports data protection-compliant data processing and provides the consent management solutions gICS. Methods Based on a stakeholder dialogue a required set of FHIR-functionalities was identified and technically specified supported by official FHIR experts. Next, a “TTP-FHIR Gateway” for the HL7 FHIR-compliant exchange of consent information using gICS was implemented. A last step included external integration tests and the development of a pre-configured consent template for the BC for the NUM sites. Results A FHIR-compliant gICS-release and a corresponding consent template for the BC were provided to all NUM sites in June 2021. All FHIR functionalities comply with the already-balloted FHIR consent profiles of the HL7 Working Group Consent Management. The consent template simplifies the technical BC rollout and the corresponding implementation of the TFCI interoperability concept at the NUM sites. Conclusions This article shows that a HL7 FHIR-compliant and interoperable nationwide exchange of consent information could be built using of the consent management software gICS and the provided TTP-FHIR Gateway. The initial functional scope of the solution covers the requirements identified in the NUM-CODEX setting. The semantic correctness of these functionalities was validated by project-partners from the Ludwig-Maximilian University in Munich. The production rollout of the solution package to all NUM sites has started successfully.
    Type of Medium: Online Resource
    ISSN: 1472-6947
    URL: Article
    DOI: 10.1186/s12911-022-02081-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2046490-3
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  • 5
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    A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
    Springer Science and Business Media LLC ; 2021
    In:  Translational Medicine Communications Vol. 6, No. 1 ( 2021-12)
    Details
    In: Translational Medicine Communications, Springer Science and Business Media LLC, Vol. 6, No. 1 ( 2021-12)
    Abstract: The consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved. Methods We used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary. Results The results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes. Conclusions A release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.
    Type of Medium: Online Resource
    ISSN: 2396-832X
    URL: Article
    DOI: 10.1186/s41231-021-00086-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2866853-4
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  • 6
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    The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies
    Springer Science and Business Media LLC ; 2023
    In:  Clinical Research in Cardiology Vol. 112, No. 7 ( 2023-07), p. 923-941
    Details
    In: Clinical Research in Cardiology, Springer Science and Business Media LLC, Vol. 112, No. 7 ( 2023-07), p. 923-941
    Abstract: The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.
    Type of Medium: Online Resource
    ISSN: 1861-0684 , 1861-0692
    URL: Article
    DOI: 10.1007/s00392-023-02177-5
    RVK:
    XA 37040
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2218331-0
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  • 7
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    MAGIC: once upon a time in consent management—a FHIR® tale
    Springer Science and Business Media LLC ; 2018
    In:  Journal of Translational Medicine Vol. 16, No. 1 ( 2018-12)
    Details
    In: Journal of Translational Medicine, Springer Science and Business Media LLC, Vol. 16, No. 1 ( 2018-12)
    Type of Medium: Online Resource
    ISSN: 1479-5876
    URL: Article
    DOI: 10.1186/s12967-018-1631-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2018
    detail.hit.zdb_id: 2118570-0
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  • 8
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    Assessment of scalability and performance of the record linkage tool E-PIX® in managing multi-million patients in research projects at a large university hospital in Germany
    Springer Science and Business Media LLC ; 2020
    In:  Journal of Translational Medicine Vol. 18, No. 1 ( 2020-12)
    Details
    In: Journal of Translational Medicine, Springer Science and Business Media LLC, Vol. 18, No. 1 ( 2020-12)
    Abstract: The identity management is a central component in medical research. Patients are recruited from various sites, which requires an error tolerant record linkage method, to ensure that patients are registered only once. In large research projects or institutions, the identity management has to deal with several thousands or millions of patients. In environments with large numbers of patients the register process could lead to high runtimes caused by record linkage. The Central Biomaterial Bank of the Charité (ZeBanC) searched for an identity management solution, which can handle millions of patients in large research projects with an acceptable performance. The goal of this paper was to simulate the registration of several million patients using the E-PIX service at Charité – Universitätsmedizin Berlin. The E-PIX service was evaluated in terms of needed runtimes, memory requirements, and processor utilization. A total of at least 20 million patients had to be registered. The runtimes to register patients into databases with various sizes should be examined, and the maximum number of patients, which the E-PIX service could handle, should be determined. Methods Tools were set up or developed to measure the needed runtimes, the memory used and the processor usage to register patients into various sizes of databases. To generate runtimes close to reality, modified patient data based on transposed real patient data were used for the simulation. The transposed patient data were sent to E-PIX to measure the runtimes of the registration process. This measurement was repeated for various database sizes. Results E-PIX is suitable to manage multi-million patients within a dataset. With the given hardware, it was possible to register a total of more than 30 million patients. It was possible to register more than 16 thousand patients per day into this database. Conclusions The E-PIX tool fulfills the requirements of the Charité to be used for large research projects. The use of E-PIX is intended for the research context in the Charité.
    Type of Medium: Online Resource
    ISSN: 1479-5876
    URL: Article
    DOI: 10.1186/s12967-020-02257-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2118570-0
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  • 9
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    The generic Informed Consent Service gICS®: implementation and benefits of a modular consent software tool to master the challenge of electronic consent management in research
    Springer Science and Business Media LLC ; 2020
    In:  Journal of Translational Medicine Vol. 18, No. 1 ( 2020-12)
    Details
    In: Journal of Translational Medicine, Springer Science and Business Media LLC, Vol. 18, No. 1 ( 2020-12)
    Abstract: Defining and protecting participants’ rights is the aim of several ethical codices and legal regulations. According to these regulations, the Informed Consent (IC) is an inevitable element of research with human subjects. In the era of “big data medicine”, aspects of IC become even more relevant since research becomes more complex rendering compliance with legal and ethical regulations increasingly difficult. Methods Based on literature research and practical experiences gathered by the Institute for Community Medicine (ICM), University Medicine Greifswald, requirements for digital consent management systems were identified. Results To address the requirements, the free-of-charge, open-source software “generic Informed Consent Service” (gICS ® ) was developed by ICM to provide a tool to facilitate and enhance usage of digital ICs for the international research community covering various scenarios. gICS facilitates IC management based on IC modularisation and supports various workflows within research, including (1) electronic depiction of paper-based consents and (2) fully electronic consents. Numerous projects applied gICS and documented over 336,000 ICs and 2400 withdrawals since 2014. Discussion Since the consent’s content is a prerequisite for securing participants’ rights, application of gICS is no guarantee for legal compliance. However, gICS supports fine-granular consents and accommodation of differentiated consent states, which can be directly exchanged between systems, allowing automated data processing. Conclusion gICS simplifies and supports sustained IC management as a major key to successfully conduct studies and build trust in research with human subjects. Therefore, interested researchers are invited to use gICS and provide feedback for further improvements.
    Type of Medium: Online Resource
    ISSN: 1479-5876
    URL: Article
    DOI: 10.1186/s12967-020-02457-y
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
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