Evaluating Usability And Incorporating The Patient Experience In DECODE-Nocturnal Scratch

By Sylvain Zorman, Ph.D.

The DECODE-Nocturnal Scratch group, launched in November 2023, aims to introduce a purpose-built digital measure of nocturnal scratching to enhance patient-focused drug development in dermatology and provide deeper clinical insights. Achieving this requires a stringent validation process, which reached a milestone in March 2024 with IRB approval for the validation study. This study integrates various measures, including night vision cameras, polysomnography, Clinician-Reported Outcomes, Patient-Reported Outcomes, and the ActiGraph LEAP™ device.

Recognizing the importance of usability in digital health technologies, the FDA emphasizes its evaluation to ensure patient ease and minimal burden. This aligns with the DiMe’s DATAcc V3+ framework, underscoring the significance of usability validation alongside verification, analytical, and clinical validation. Welcoming IQVIA’s Patient Centered Solution group as a collaborator in DECODE-Nocturnal Scratch underscores our commitment to ensuring effective patient use and satisfaction with digital health solutions.