OBJECTIVES: Electronic migration of paper patient-reported outcomes (PRO) is a lengthy process with current guidance recommending stages. This study aimed to evaluate whether an online-only method of performing usability and cognitive debriefing could provide a more feasible approach to the standard interview method, and whether similar data can be generated.

METHODS: A mobile responsive web-based version of the Treatment Satisfactions Questionnaire for Medication (TSQM) was developed following ePRO design good practice. The survey first administered the eTSQM; then two TSQM items (selected at random in real-time) and administer item-specific usability questions (concurrent probing) and finally to administer general usability questions (retrospective probing). The survey was administered to an online patient community (n=350,000) in the US, UK, France, Germany, Spain and Australia.

RESULTS: Integration of real-time randomized usability questions was feasibly implemented into the web-based survey platform. An interim cut contained completed eTSQM data for 2000 subjects, the majority having some college education, female and mean 50 years of age. Recruitment for the online survey is ongoing, with data cut off set for June 30^th.In the final dataset, response rate, TSQM item completion and usability results will be described. Responses to open-ended usability questions will be coded qualitatively and described. Results will be presented by subgroups including country, indication, demography, device type and viewport size. In addition, analyses will be given describing the rate of concept saturation based on random sampling of the acquired data.

CONCLUSIONS: The methodology allows with only minor modification to the ePRO the ability to rapidly capture concurrent and retrospective probing online, from available subject populations in multiple countries. We believe the results of this feasibility study will be important to researchers considering this alternative to interviewing for the generation of usability and cognitive debriefing data during PRO migration.