ePROs

Electronic patient-reported outcomes (ePROs) are health-status data collected directly from patients through electronic devices. They capture symptoms, functioning, quality of life, and treatment impact. ePRO data are gathered via tablets, smartphones, computers, web portals, or dedicated apps and are used in clinical trials as well as routine clinical care to monitor patient experiences.

ePROs are typically collected within an electronic clinical outcome assessment (eCOA) framework and can take the form of electronic diaries, scheduled questionnaires, or event-driven assessments. Compared with paper-based PROs, electronic administration can reduce missing data, enable real-time or near real-time data capture, provide time stamps, and simplify data management. Automated reminders may improve completion rates and adherence.

Regulatory and methodological considerations apply to ePROs. Instruments must be validated for electronic use, and data handling must comply with applicable privacy and security requirements (for example, data integrity, audit trails, and access controls). Regulators such as the FDA provide guidance on PRO measures and their use in product development, with emphasis on equivalence to paper versions and robust documentation of validation.

Challenges include digital literacy gaps, language and cultural adaptation, and unequal access to devices or connectivity. Ensuring accessibility and inclusivity, maintaining data quality, and achieving standardization across platforms are ongoing concerns. Despite these challenges, ePROs support patient-centered care, enable remote monitoring, and are increasingly incorporated into clinical trials, regulatory submissions, and value-based healthcare initiatives.