Usability and User's Satisfaction of an Electronic Case Report Form Implemented in the REDCap System in the HIV Clinical Research Context: The Use Case of DOLAM Clinical Trial.

Background: The clinical data management within biomedical research has gained importance over the last decade producing an increasing need of a web‐based software application providing electronic data capture and clinical data management functionalities to ensure high quality data. We chose REDCap system over OpenClinica (free‐distribution) to implement the electronic case report form (eCRF) at our HIV Unit. We then evaluated eCRF usability and stakeholder satisfaction in an upcoming Phase 4 clinical trial. Methods: We assessed the perceived usability of the eCRF by different professional users, including nurses, researchers, study monitors and coordinators of the phase‐4 clinical trial, and their satisfaction using the System Usability Scale (SUS) questionnaire and the Net Promoter Score (NPS). Results: Nineteen out of 21 persons involved agreed to participate. All were female, with mean age of 35 years (SD: 7), 11 were study coordinators or monitors, 5 nurses and 3 clinicians/researchers. The median SUS was 72.5 (IQR: 62.5; 80.0): monitors/study coordinators had median score of 77.5, researchers/clinicians, 72.5 and nurses, 57.5. Less Information Technology (IT) or computer‐experienced scored higher 92.5 (57.5; 95.0) versus more experienced 71.3 (62.5; 78.8). The overall NPS (% promoters–% detractors) was 21.1, 7 (37%) users were promoters, 9 (47%) passives and 3 (16%) detractors. Conclusions: When adopting a new system, measuring user's perceived usability and satisfaction in a quantitative manner and with validated measures may be useful to identify users' uncovered needs and to improve future interaction user‐system that will positively affect the quality of data managed in clinical research. [ABSTRACT FROM AUTHOR]