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User-Centered Development of a Digital Health Service for Diabetic Foot Ulcer Risk Stratification: Usability Study
Ulla Hellstrand Tang1,2, Shivani Ravichandran3, Stefan Candefjord3
1Department of Prosthetics and Orthotics at the Department for Biomedical Engineering and Medical Physics, Sahlgrenska University Hospital, Falkenbergsgatan 3, Gothenburg, 41285, Sweden, 46 706397913, 46 31408162.
Background:
Globally, 537 million persons live with diabetes, and a lifetime risk of up to 34% of developing diabetic foot ulcers (DFUs) necessitates strengthened preventive initiatives.
Objective:
The study aimed to develop and evaluate a clinical decision support system (CDSS) to be used by health care professionals in foot assessment and risk stratification as a base for prevention.
Methods:
Based on principles of human-computer interaction, the CDSS was developed for DFU risk assessment. Users, health care professionals from Region Västra Götaland in Sweden, evaluated the functions regarding effectiveness, efficiency, and satisfaction using a mixed methods usability testing approach. Expectations and experiences of using the CDSS were evaluated with the System Usability Scale (SUS).
Results:
A total of 9 participants participated. User expectations of the CDSS, measured by SUS, averaged 77.2 (SD 14.6). Posttest SUS scores were 68.9 (SD 14.3), with a mean difference of 8.3 (P=.07), a nonsignificant reduction of usability after testing. The effectiveness of the CDSS in supporting users to complete 9 clinical tasks showed that for 7 (78%) tasks, at least 5 (56%) testers successfully achieved the intended goals. Tasks involving the identification of ingrown toenails and the confirmation of foot status, including risk stratification for the patient, were completed by fewer testers. Efficiency, measured as mean task completion time, ranged from 7 seconds to 9 minutes 20 seconds, and qualitative feedback informed recommendations for further system refinement. Users reported that a structured CDSS has the potential to support more equitable, consistent, and person-centered DFU prevention within a digital health service.
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 and validation, both nationally and internationally, with continued attention to users' needs and contextual factors, are recommended.
