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

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. This article evaluates how existing web accessibility success criteria 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.