Visualising Data Models of Patient Registries and Clinical Studies - A Method for Quality Check of EDC Systems.
| Autor: | Coldewey B; Institute of Medical Informatics, RWTH Aachen University, Germany., Honrath P; Department of Neurology, Epilepsy Section, RWTH Aachen University, Germany., Wolking S; Department of Neurology, Epilepsy Section, RWTH Aachen University, Germany., Niemeyer A; TMF - Technology, Methods and Infrastructure for Networked Medical Research, Berlin, Germany., Röhrig R; Institute of Medical Informatics, RWTH Aachen University, Germany.; TMF - Technology, Methods and Infrastructure for Networked Medical Research, Berlin, Germany., Weber Y; Department of Neurology, Epilepsy Section, RWTH Aachen University, Germany., Lipprandt M; Institute of Medical Informatics, RWTH Aachen University, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | Studies in health technology and informatics [Stud Health Technol Inform] 2024 Aug 30; Vol. 317, pp. 95-104. |
| DOI: | 10.3233/SHTI240843 |
| Abstrakt: | Introduction: The configuration of electronic data capture (EDC) systems has a relevant impact on data quality in studies and patient registries. The objective was to develop a method to visualise the configuration of an EDC system to check the completeness and correctness of the data definition and rules. Methods: Step 1: transformation of the EDC data model into a graphical model, step 2: Checking the completeness and consistency of the data model, step 3: correction of identified findings. This process model was evaluated on the patient registry EpiReg. Results: Using the graphical visualisation as a basis, 21 problems in the EDC configuration were identified, discussed with an interdisciplinary team, and corrected. Conclusion: The tested methodological approach enables an improvement in data quality by optimising the underlying EDC configuration. |
| Databáze: | MEDLINE |
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