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CC BY-NC-ND 4.0 · Appl Clin Inform 2024; 15(02): 234-249
DOI: 10.1055/a-2259-0008
State of the Art/Best Practice Paper

Simplifying Multimodal Clinical Research Data Management: Introducing an Integrated and User-friendly Database Concept

Anna Schweinar
1   Biomagnetic Center, University Hospital Jena, Friedrich Schiller University, Jena, Germany
2   Else Kröner Graduate School for Medical Students “JSAM,” Jena University Hospital, Jena, Germany
,
Franziska Wagner
1   Biomagnetic Center, University Hospital Jena, Friedrich Schiller University, Jena, Germany
3   Department of Neurology, Jena University Hospital, Jena, Germany
,
Carsten Klingner
1   Biomagnetic Center, University Hospital Jena, Friedrich Schiller University, Jena, Germany
3   Department of Neurology, Jena University Hospital, Jena, Germany
,
Sven Festag
4   Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany
,
Cord Spreckelsen
4   Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany
,
Stefan Brodoehl
1   Biomagnetic Center, University Hospital Jena, Friedrich Schiller University, Jena, Germany
3   Department of Neurology, Jena University Hospital, Jena, Germany
› Author Affiliations Funding This work was supported by funding from the Foundation “Else Kröner-Fresenius-Stiftung” within the Else Kröner Graduate School for Medical Students “Jena School for Ageing Medicine (JSAM)” and Else Kröner Anti Age.
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Abstract

Background Clinical research, particularly in scientific data, grapples with the efficient management of multimodal and longitudinal clinical data. Especially in neuroscience, the volume of heterogeneous longitudinal data challenges researchers. While current research data management systems offer rich functionality, they suffer from architectural complexity that makes them difficult to install and maintain and require extensive user training.

Objectives The focus is the development and presentation of a data management approach specifically tailored for clinical researchers involved in active patient care, especially in the neuroscientific environment of German university hospitals. Our design considers the implementation of FAIR (Findable, Accessible, Interoperable, and Reusable) principles and the secure handling of sensitive data in compliance with the General Data Protection Regulation.

Methods We introduce a streamlined database concept, featuring an intuitive graphical interface built on Hypertext Markup Language revision 5 (HTML5)/Cascading Style Sheets (CSS) technology. The system can be effortlessly deployed within local networks, that is, in Microsoft Windows 10 environments. Our design incorporates FAIR principles for effective data management. Moreover, we have streamlined data interchange through established standards like HL7 Clinical Document Architecture (CDA). To ensure data integrity, we have integrated real-time validation mechanisms that cover data type, plausibility, and Clinical Quality Language logic during data import and entry.

Results We have developed and evaluated our concept with clinicians using a sample dataset of subjects who visited our memory clinic over a 3-year period and collected several multimodal clinical parameters. A notable advantage is the unified data matrix, which simplifies data aggregation, anonymization, and export. This streamlines data exchange and enhances database integration with platforms like Konstanz Information Miner (KNIME).

Conclusion Our approach offers a significant advancement for capturing and managing clinical research data, specifically tailored for small-scale initiatives operating within limited information technology (IT) infrastructures. It is designed for immediate, hassle-free deployment by clinicians and researchers.

The database template and precompiled versions of the user interface are available at: https://github.com/stebro01/research_database_sqlite_i2b2.git.

Keywords

clinical data management - research data management - neurology - database - SQLite

Protection of Human and Animal Subjects

The study adhered to the World Medical Association Declaration of Helsinki's ethical guidelines for research involving human subjects and received approval from our local Ethics board (Reference: 2022-2658-Daten).


Supplementary Material



Publication History

Received: 14 July 2023

Accepted: 22 November 2023

Accepted Manuscript online:
01 February 2024

Article published online:
27 March 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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