Developing A Patient-Centric Measure Of Nocturnal Scratch: A Q&A With DiMe

By Sylvain Zorman, Ph.D.

The utilization of wearable Digital Health Technologies (DHTs) for gauging outcomes of interest in clinical trials is on the rise. Digital outcome measures offer an enhancement or complement to traditional patient-reported outcomes by providing an objective and continuous assessment of patient behaviors in real-world environments. A notable advantage over conventional measures, which often offer only snapshots in time or gather data in controlled laboratory settings, is the creation of a more patient-centric outcome measure that mirrors real-life functioning.

To successfully integrate digital measures as outcomes in drug development, establishing a foundation for a shared vocabulary, clinical relevance, and regulatory acceptance is an indispensable step that cannot be underestimated.

In contexts where an objective, patient-centric measure holds significant importance and is technically achievable through wearable DHTs, one compelling example is the measurement of nocturnal scratch behaviors in dermatological conditions. I had the privilege of conversing with Lucy Cesnakova, MS, Program Lead at the Digital Medicine Society (DiMe), discussing their development efforts showcasing the relevance of measuring nocturnal scratch behaviors for individuals with Atopic Dermatitis.

Our conversation also delved into Lucy's insights on the DECODE Nocturnal Scratch working group, initiated by ActiGraph in collaboration with multiple pharmaceutical companies in 2023. This collaborative effort is taking strides to provide a valid, scalable digital measure of nocturnal scratch, aiming to contribute to both drug development and clinical care.