User experience testing of my ePRO app in a diabetes mellitus type 2 focus group (Preprint)

BACKGROUND Type 2 Diabetes Mellitus affects patients’ quality of life which easily can be assessed directly with patients using standardized and validated instruments. The my ePRO app was constructed as an innovative mobile application to collect patient-reported outcomes in an investigator free study (Digital collected Patient Reported Outcomes in a Diabetes population - DePRO study). OBJECTIVE We aimed to describe the qualitative and quantitative feedback received during user experience testing in a diabetes mellitus type 2 focus group. METHODS The DePRO user experience study was conducted in a qualitative and quantitative research design with focus group methodology to test the my ePRO app. Metformin containing drug taking patients aged 18 years or older completed a 37-item qualitative questionnaire as the quantitative 6 scales and 26 items containing User Experience Questionnaire (UEQ) in a single focus group interview. The qualitative interview required next to the completion of the entire study workflow feedback on user experience to 1) the download of the app, 2) scanning the 2D matrix code, 3) accepting the informed consent form, 4) completing the demographic questionnaire and the 3 PRO instruments EQ-5D-5L, SDSCA and DTSQ, 5). Furthermore, feedback on finding the informed consent form, the withdrawl button and data protection information within the app was requested. RESULTS Nine T2DM patients, 3 female and 6 male, aged 55-88 years were interviewed for 45 to 65 minutes. Patients missed lay language within the app, criticized the length of the patient information informed consent form, the completeness of health information which was requested, missed pictures of the drugs they scanned and judged the questions to income and education as too indiscreet. As positive feedback patient reported that everything was fine, the answering of the questions was self-explaining and could be read without glasses. The UEC scales (mean; variances) Perspicuity (0.722; 1.73), Efficiency (0.5; 0.89) and Novelty (0.25; 1.13) were rated neutral, Attractiveness (0.854: 0.63), Dependability (1.031; 0.1) and Stimulation (1.094; 0.39) represent a positive evaluation. CONCLUSIONS The qualitative feedback of T2DM patients increased the awareness to test study applications like the my ePRO app in an indication and age specific user group. User experiences were captured, analyzed and implemented in the final app version which was used to run the DePRO study. The quantitative feedback was compared to a benchmark data set, to which the my ePRO app means were below average in all scales. The user experience testing provided insight into usage, challenges and areas of improvement of my ePRO app in a type 2 Diabetes Mellitus focus group. Understanding the different views, experiences and expectations can lead to a better design of health apps and a successful study conduct. CLINICALTRIAL ClinicalTrials.gov: NCT04383041