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<p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年8月26日

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  • Schawanya Kaewpitoon Rattanapitoon,
  • Nav La,
  • Patpicha Arunsan,
  • Nathakapch Kaewpitoon Rattanapitoon

摘要

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.