Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

Abstract

Background Medicine use is the most common intervention in health care. The frequency with which medicines are used means medication-related problems are very common. One common type of medication-related problems is adverse drug events, which are unintended and harmful effects associated with use of medicines. Reporting of adverse drug events to regulatory authorities is important for evaluation of safety of medicines; however, these adverse effects are frequently unreported due to various factors, including lack of consumer-friendly reporting tools. Objective The aim of this study was to develop a user-friendly digital tool for consumers to report medication-related adverse effects. Methods The project consisted of 3 parts: (1) content development, including a systematic literature search; (2) iterative system development; and (3) usability testing. The project was guided by participatory design principles, which suggest involving key stakeholders throughout the design process. The first 2 versions were developed as a mobile app and were tested with end users in 2 workshops. The third version was developed as a web application and was tested with consumers who were taking regular medicines. Consumers were asked to complete a modified version of the mHealth app usability questionnaire (MAUQ), an 18-item questionnaire with each item scored using a 7-point Likert scale ranging from 0 (strongly disagree) to 7 (strongly agree). The MAUQ assessed 3 subscales including ease of use (5 items), interface and satisfaction (7 items), and usefulness (6 items). Continuous variables were reported as mean (SD) values, whereas categorical variables were presented as frequencies (percentages). Data analysis was conducted in Microsoft Excel. Results The content for the system was based on a systematic literature search and short-listing of questions, followed by feedback from project team members and consumers. Feedback from consumers in the 2 workshops were incorporated to improve the functionality, visual design, and stability of the third (current) version. The third version of the system was tested with 26 consumers. A total of 79% (N=307/390) of all responses on the MAUQ were scored 6 or 7, indicating that users generally strongly agree with the usability of the system. When looking at the individual domains, the system had an average score of 6.3 (SD 0.9) for “ease of use,” 6.3 (SD 0.8) for “interface and satisfaction,” and 5.2 (SD 1.4) for “usefulness.” Conclusions The web-based system for medicine adverse effects reporting is a user-friendly tool developed using an iterative participatory design approach. Future research includes further improving the system, particularly the usefulness of the system, as well as testing the scalability and performance of the system in practice.