| |  Online-Ressource |
|---|
| Verfasst von: | Dugas, Martin [VerfasserIn]  |
|---|
| | Blumenstock, Max [VerfasserIn] |
|---|
| | Dittrich, Tobias [VerfasserIn] |
|---|
| | Eisenmann, Urs [VerfasserIn] |
|---|
| | Feder, Stephan Christoph [VerfasserIn] |
|---|
| | Fritz-Kebede, Fleur [VerfasserIn] |
|---|
| | Kessler, Lucy Joanne [VerfasserIn] |
|---|
| | Klass, Maximilian [VerfasserIn] |
|---|
| | Knaup-Gregori, Petra [VerfasserIn] |
|---|
| | Lehmann, Christoph U. [VerfasserIn] |
|---|
| | Merzweiler, Angela [VerfasserIn] |
|---|
| | Niklas, Christian [VerfasserIn] |
|---|
| | Pausch, Thomas [VerfasserIn] |
|---|
| | Zental, Nelly [VerfasserIn] |
|---|
| | Ganzinger, Matthias [VerfasserIn] |
|---|
| Titel: | Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support |
|---|
| Verf.angabe: | Martin Dugas, Max Blumenstock, Tobias Dittrich, Urs Eisenmann, Stephan Christoph Feder, Fleur Fritz-Kebede, Lucy J. Kessler, Maximilian Klass, Petra Knaup, Christoph U. Lehmann, Angela Merzweiler, Christian Niklas, Thomas M. Pausch, Nelly Zental and Matthias Ganzinger |
|---|
| E-Jahr: | 2024 |
|---|
| Jahr: | 12 January 2024 |
|---|
| Umfang: | 8 S. |
|---|
| Illustrationen: | Illustrationen |
|---|
| Fussnoten: | Gesehen am 07.03.2024 |
|---|
| Titel Quelle: | Enthalten in: npj digital medicine |
|---|
| Ort Quelle: | [Basingstoke] : Macmillan Publishers Limited, 2016 |
|---|
| Jahr Quelle: | 2024 |
|---|
| Band/Heft Quelle: | 7(2024), 1, Seite 1-8 |
|---|
| ISSN Quelle: | 2398-6352 |
|---|
| Abstract: | Structured patient data play a key role in all types of clinical research. They are often collected in study databases for research purposes. In order to describe characteristics of a next-generation study database and assess the feasibility of its implementation a proof-of-concept study in a German university hospital was performed. Key characteristics identified include FAIR access to electronic case report forms (eCRF), regulatory compliant Electronic Data Capture (EDC), an EDC with electronic health record (EHR) integration, scalable EDC for medical documentation, patient generated data, and clinical decision support. In a local case study, we then successfully implemented a next-generation study database for 19 EDC systems (n = 2217 patients) that linked to i.s.h.med (Oracle Cerner) with the local EDC system called OpenEDC. Desiderata of next-generation study databases for patient data were identified from ongoing local clinical study projects in 11 clinical departments at Heidelberg University Hospital, Germany, a major tertiary referral hospital. We compiled and analyzed feature and functionality requests submitted to the OpenEDC team between May 2021 and July 2023. Next-generation study databases are technically and clinically feasible. Further research is needed to evaluate if our approach is feasible in a multi-center setting as well. |
|---|
| DOI: | doi:10.1038/s41746-023-00994-6 |
|---|
| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
kostenfrei: Volltext: https://doi.org/10.1038/s41746-023-00994-6 |
|---|
| | kostenfrei: Volltext: https://www.nature.com/articles/s41746-023-00994-6 |
|---|
| | DOI: https://doi.org/10.1038/s41746-023-00994-6 |
|---|
| Datenträger: | Online-Ressource |
|---|
| Sprache: | eng |
|---|
| Sach-SW: | Clinical trial design |
|---|
| | Drug development |
|---|
| | Information technology |
|---|
| | Research data |
|---|
| K10plus-PPN: | 1882887263 |
|---|
| Verknüpfungen: | → Zeitschrift |
|---|
Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support / Dugas, Martin [VerfasserIn]; 12 January 2024 (Online-Ressource)
