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CC BY-NC-ND 4.0 · Appl Clin Inform 2021; 12(03): 551-563
DOI: 10.1055/s-0041-1731286
State of the Art/Best Practice Paper

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

Michael Reichold
1   Department of Medical Informatics, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany
,
Nikolas Dietzel
2   Interdisciplinary Center for Health Technology Assessment (HTA) and Public Health (IZPH), Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany
,
Christina Chmelirsch
2   Interdisciplinary Center for Health Technology Assessment (HTA) and Public Health (IZPH), Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany
,
Peter L. Kolominsky-Rabas
2   Interdisciplinary Center for Health Technology Assessment (HTA) and Public Health (IZPH), Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany
,
Elmar Graessel
3   Center for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany
,
Hans-Ulrich Prokosch
1   Department of Medical Informatics, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany
› Author Affiliations Funding The project is funded by the Bavarian State Ministry of Health and Care as part of the funding initiative BAYERN DIGITAL II ' (funding code: G42d-G8300–2017/1606–83).
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Abstract

Background Registries are an essential research tool to investigate the long-term course of diseases and their impact on the affected. The project digiDEM Bayern will set up a prospective dementia registry to collect long-term data of people with dementia and their caregivers in Bavaria (Germany) supported by more than 300 research partners.

Objective The objective of this article is to outline an information technology (IT) architecture for the integration of a registry and comprehensive participant management in a dementia study. Measures to ensure high data quality, study governance, along with data privacy, and security are to be included in the architecture.

Methods The architecture was developed based on an iterative, stakeholder-oriented process. The development was inspired by the Twin Peaks Model that focuses on the codevelopment of requirements and architecture. We gradually moved from a general to a detailed understanding of both the requirements and design through a series of iterations. The experience learned from the pilot phase was integrated into a further iterative process of continuous improvement of the architecture.

Results The infrastructure provides a standardized workflow to support the electronic data collection and trace each participant's study process. Therefore, the implementation consists of three systems: (1) electronic data capture system for Web-based or offline app-based data collection; (2) participant management system for the administration of the identity data of participants and research partners as well as of the overall study governance process; and (3) videoconferencing software for conducting interviews online. First experiences in the pilot phase have proven the feasibility of the framework.

Conclusion This article outlines an IT architecture to integrate a registry and participant management in a dementia research project. The framework was discussed and developed with the involvement of numerous stakeholders. Due to its adaptability of used software systems, a transfer to other projects should be easily possible.

Keywords

registries - data collection - workflow - research planning and conduct - dementia - participant management

Protection of Human and Animal Subjects

The study obtained ethical approval by the Ethics Committee of Medical Faculty of Friedrich-Alexander-University Erlangen-Nürnberg (FAU) (application number: 253_20 B).




Publication History

Received: 04 March 2021

Accepted: 05 May 2021

Article published online:
16 June 2021

© 2021. 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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