Design and Usability Assessment of a User-Centered, Modular Platform for Real-World Data Acquisition in Clinical Trials involving Post-bariatric Surgery Patients.

Cossu, Luca; Cappon, Giacomo; Streicher, Olivia; Herzig, David; Bally, Lia; Facchinetti, Andrea (2023). Design and Usability Assessment of a User-Centered, Modular Platform for Real-World Data Acquisition in Clinical Trials involving Post-bariatric Surgery Patients. (In Press). Journal of diabetes science and technology(19322968231220061), p. 19322968231220061. Diabetes Technology Society 10.1177/19322968231220061

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BACKGROUND

Clinical trials often face challenges in efficient data collection and participant monitoring. To address these issues, we developed the IMPACT platform, comprising a real-time mobile application for data collection and a web-based dashboard for remote monitoring and management.

METHODS

This article presents the design, development, and usability assessment of the IMPACT platform customized for patients with post-bariatric surgery hypoglycemia (PBH). We focus on adapting key IMPACT components, including continuous glucose monitoring (CGM), symptom tracking, and meal logging, as crucial elements for user-friendly and efficient PBH monitoring.

RESULTS

The adapted IMPACT platform demonstrated effectiveness in data collection and remote participant monitoring. The mobile application allowed patients to easily track their data, while the clinician dashboard provided a comprehensive overview of enrolled patients, featuring filtering options and alert mechanisms for identifying data collection issues. The platform incorporated various visual representations, including time plots and category-based visualizations, which greatly facilitated data interpretation and analysis. The System Usability Scale questionnaire results indicated a high level of usability for the web dashboard, with an average score of 86.3 out of 100. The active involvement of clinicians throughout the development process ensured that the platform allowed for the collection and visualization of clinically meaningful data.

CONCLUSIONS

By leveraging IMPACT's existing features and infrastructure, the adapted version streamlined data collection, analysis, and trial customization for PBH research. The platform's high usability underscores its alignment with the requirements for conducting research using continuous real-world data in PBH patients and other populations of interest.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition
UniBE Contributor:	Streicher, Olivia Lea, Herzig, David, Bally, Lia Claudia
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1932-2968
Publisher:	Diabetes Technology Society
Language:	English
Submitter:	Pubmed Import
Date Deposited:	27 Dec 2023 10:22
Last Modified:	28 Dec 2023 00:17
Publisher DOI:	10.1177/19322968231220061
PubMed ID:	38142364
Uncontrolled Keywords:	digital health health care technology health data visualization multidisciplinary collaboration user feedback user-centered design
URI:	https://boris.unibe.ch/id/eprint/190769