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Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support.
Dugas, Martin; Blumenstock, Max; Dittrich, Tobias; Eisenmann, Urs; Feder, Stephan Christoph; Fritz-Kebede, Fleur; Kessler, Lucy J; Klass, Maximilian; Knaup, Petra; Lehmann, Christoph U; Merzweiler, Angela; Niklas, Christian; Pausch, Thomas M; Zental, Nelly; Ganzinger, Matthias.
Afiliação
  • Dugas M; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Blumenstock M; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Dittrich T; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Eisenmann U; Department of Hematology, Oncology and Rheumatology, Heidelberg University Hospital, Heidelberg, Germany.
  • Feder SC; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Fritz-Kebede F; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Kessler LJ; Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Klass M; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Knaup P; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Lehmann CU; Department of Ophthalmology, Heidelberg University Hospital, Heidelberg, Germany.
  • Merzweiler A; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Niklas C; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Pausch TM; Clinical Informatics Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
  • Zental N; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
  • Ganzinger M; Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
NPJ Digit Med ; 7(1): 10, 2024 Jan 12.
Article em En | MEDLINE | ID: mdl-38216645
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.

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Idioma: En Revista: NPJ Digit Med Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Idioma: En Revista: NPJ Digit Med Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Alemanha