Abstract
BACKGROUND: Adverse effects are a common burden for cancer patients, impacting their well-being and diminishing their quality of life. Therefore, it is essential to have a clinical decision support system that can proactively monitor patient progress to prevent and manage complications. AIMS: This research aims to thoroughly test the usability and user-friendliness of a medical device designed for managing adverse events for cancer patients and healthcare professionals (HCPs). The study seeks to assess how well the device meets both patients' and HCPs' needs in real-world scenarios. METHODS AND RESULTS: The study used a multi-method approach to obtain a comprehensive understanding of participants experience and objective measure of usability. The testing was conducted with a diverse group of participants of six patients and six HCPs. Analysis included a descriptive summary of the demographic data, scenario completion rates, System Usability Scale (SUS) questionnaire score, and qualitative feedback from users. All participants successfully completed 100% of the activities, indicating a high level of understanding and usability across both user groups. Only two out of six patients encountered errors during the login activities, but these errors were unrelated to product safety. The obtained SUS score is in the 90th percentile for both user groups, classifying the device as grade A and highlighting its superior usability. Patients and HCPs found the interface intuitive and expressed an interest in incorporating the application into their daily routines and would recommend the application to others. CONCLUSION: The assessed digital health medical device demonstrates excellent usability, safety, and ease of use for oncology patients and HCPs. Based on the received constructive feedback, minor improvements were identified for further refinement of the application that do not affect either its intended functionality or the overall functioning of the tool. Future work will focus on implementing these improvements and conducting further usability studies in clinical environments.