Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support

被引：4

作者：

Dugas, Martin ^{[1
]}

Blumenstock, Max ^{[1
]}

Dittrich, Tobias ^{[1
,2
]}

Eisenmann, Urs ^{[1
]}

Feder, Stephan Christoph ^{[1
,3
]}

Fritz-Kebede, Fleur ^{[1
]}

Kessler, Lucy J. ^{[1
,4
]}

Klass, Maximilian ^{[1
]}

Knaup, Petra ^{[1
]}

Lehmann, Christoph U. ^{[5
]}

Merzweiler, Angela ^{[1
]}

Niklas, Christian ^{[1
]}

Pausch, Thomas M. ^{[1
,6
]}

Zental, Nelly ^{[1
,7
]}

Ganzinger, Matthias ^{[1
]}

机构：

[1] Heidelberg Univ Hosp, Inst Med Informat, Heidelberg, Germany

[2] Heidelberg Univ Hosp, Dept Hematol Oncol & Rheumatol, Heidelberg, Germany

[3] Heidelberg Univ Hosp, Dept Gen Internal Med & Psychosomat, Heidelberg, Germany

[4] Heidelberg Univ Hosp, Dept Ophthalmol, Heidelberg, Germany

[5] Univ Texas Southwestern Med Ctr, Clin Informat Ctr, Dallas, TX USA

[6] Heidelberg Univ Hosp, Dept Gen Visceral & Transplantat Surg, Heidelberg, Germany

[7] Heidelberg Univ Hosp, Dept Anesthesiol, Heidelberg, Germany

来源：

NPJ DIGITAL MEDICINE | 2024年 / 7卷 / 01期

关键词：

DATA MODEL; QUALITY;

D O I：

10.1038/s41746-023-00994-6

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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.

引用

页数：8

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