Currently accepted at: JMIR Diabetes
Date Submitted: Oct 6, 2025
Open Peer Review Period: Oct 23, 2025 - Dec 18, 2025
Date Accepted: Mar 13, 2026
(closed for review but you can still tweet)
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/83287
The final accepted version (not copyedited yet) is in this tab.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
User-centred development of a digital health service for diabetic foot ulcer risk stratification
ABSTRACT
Background:
Globally 537 million persons lives with diabetes, with a lifetime risk of up to 34% of developing diabetic foot ulcers (DFUs), drives preventative initiatives.
Objective:
The aim was to develop and evaluate a clinical decision support system (CDSS) to be used by healthcare professionals (HCPs) in foot assessment and risk stratification, as a base for prevention.
Methods:
Based on human interaction design, the CDSS was developed for DFU. Users, HCPs from Region Västra Götaland in Sweden evaluated the functions regarding effectiveness, efficiency and satisfaction. Expectations and experiences of using the CDSS was evaluated with the System Usability Scale (SUS).
Results:
User expectations of the CDSS, measured by SUS, averaged 77.2±14.6. Post-test SUS scores were 68.9±14.3, with a mean difference of 8.3 (P=.071), a non-significant reduction of usability after test. The effectiveness of the CDSS in supporting users to complete nine clinical tasks, showed that for seven out of nine tasks (78%), at least five of the nine testers (56%) successfully achieved the intended goals. Tasks involving the identification of ingrown toenails and the confirmation of foot status, including the risk stratification for the patient, were completed by fewer testers. Efficiency, measured as mean task completion time, ranged from 7 seconds to 9 minutes and 20 seconds. The users found that a structured CDSS has the potential to contribute to a digital health service leading to an equal, good, and person-centred DFU prevention.
Conclusions:
A digital health service for DFU risk stratification, was developed based on national and international guidelines. Although the users’ expectations of the usability were higher compared to how they experienced the CDSS, the SUS test was near a threshold of 70, indicating that the system being tested was above average in usability. Further development, national and international, where the users’ needs and preferences are considered, is recommended. Clinical Trial: ClincalTrials.gov ID: NCT05692778
Citation
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Copyright
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