A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan.

Background: The method of collecting electronic patient-reported outcome (ePRO) data using the bring your own device (BYOD) approach has become very common recently, especially in clinical trials. We conducted a preliminary study to evaluate the processes before introducing ePRO using BYOD in regulatory-required observational post-marketing surveillance (PMS) in Japan.

Methods: We conducted a multicenter observational study using a two-period, two-sequence, cross-over design. Participants were allocated to Group 1 (starting with ePRO) or Group 2 (starting with paper PRO). The observation period was 14 days in total: seven days each for ePRO and paper PRO. We assessed the usability, implementation process, support system, and materials for ePRO through questionnaires.

Results: All participants in Group 1 (n = 78) and Group 2 (n = 73) were included in the analysis set. The collection of information with ePRO was comparable to that with paper PRO. We found no remarkable difference in data entry status between ePRO and paper PRO based on sex and no trend toward a higher proportion of missing data in ePRO with age. More than half of the participants responded favorably to most of the questionnaire items about ePRO. Although the investigators considered the materials for the ePRO system useful, there is still room for improvement.

Conclusion: Our two-week pilot indicates that ePRO can achieve data completeness comparable to paper in motivated clinics. The points to consider when using ePRO in actual PMS were confirmed. Further assessment in actual studies conducted in compliance with local regulations is needed.