Beyond Screen Formats: Towards Context-Aware, Patient-Centric ePRO Design in Clinical Trials.

Lord-Bessen et al. demonstrated that both single-item-per-screen and multiple-items-per-screen ePRO formats are acceptable, with minimal differences in usability and completion time. While format preference may be individual-specific, broader considerations-including patient cognitive load, device type, language complexity, and trial phase-are crucial for context-aware ePRO design. Future research should explore adaptive systems that dynamically adjust format in real time, subgroup analyses for older adults and low digital literacy participants, and language-specific validation. Moving beyond fixed formats toward adaptive, patient-tailored delivery can better align with regulatory priorities for patient-focused drug development, enhancing both participant experience and data integrity.