Accessible data collection methods in clinical trials: Do current best practices for the implementation of electronic patient-reported outcome measures (ePROMs) meet accessibility standards?

Background Apps and web browsers, whether on smartphones, tablets or laptops, have become the mainstream methods of capturing clinical outcome assessment (COA) data, and patient-reported outcome measures (PROMs) in particular, in clinical trials. There has long been concern around whether implementing traditionally paper-based questionnaires on electronic systems may impact the measurement properties of these carefully validated questionnaires, with migration best practices focusing predominately on this issue. In parallel, app and web-design best practices outside of clinical research have focused on the accessibility and usability of these electronic systems for the widest range of users. Methods This article evaluates how existing Web Content Accessibility Guidelines (WCAG 2.2) compare to electronic PROM (ePROM) design best practices, identifying where there is alignment or tension, where further evidence is needed to ensure both accessibility and the maintenance of the questionnaire measurement properties, and what accessibility practices can be incorporated into ePROM design best practices today. Results Many of the accessibility criteria can be applied to electronic clinical outcome assessment (eCOA) systems now without concern for the integrity of the measure, given their focus is on the software being programmed and built to support content being implemented in a way that enhances overall accessibility and its usability with assistive technologies. The main tensions identified between the accessibility success criteria and ePROM best practices concerned increasing content size and device orientation. Conclusions Many accessibility best practices can be adopted in ePROM implementations today , and we must strive to achieve a point where accessibility best practices are (e)PROM best practices to ensure electronic data capture is accessible and usable, leading to more representative trials that are lower burden for patients.