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Informed Consent – Considerations for Inclusivity

We aimed to address this gap and bring forth unified measurement definitions for nocturnal scratch.

We performed a narrative literature review of definitions of scratching in patients with skin inflammation and a targeted literature review of sleep in the context of the period during which such scratching occurred. Both searches were limited to English language studies in humans. The extracted data were synthesized into themes based on study characteristics: scratch as a behavior, other characterization of the scratching movement, and measurement parameters for both scratch and sleep. We then developed ontologies for the digital measurement of sleep scratching.

In all, 29 studies defined inflammation-related scratching between 1996 and 2021. When cross-referenced with the results of search terms describing the sleep period, only 2 of these scratch-related papers also described sleep-related variables. From these search results, we developed an evidence-based and patient-centric definition of nocturnal scratch: an action of rhythmic and repetitive skin contact movement performed during a delimited time period of intended and actual sleep that is not restricted to any specific time of the day or night. Based on the measurement properties identified in the searches, we developed ontologies of relevant concepts that can be used as a starting point to develop standardized outcome measures of scratching during sleep in patients with inflammatory skin conditions.

This work is intended to serve as a foundation for the future development of unified and well-described digital health technologies measuring nocturnal scratching and should enable better communication and sharing of results between various stakeholders taking part in research in atopic dermatitis and other inflammatory skin conditions.

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Clinical Trials, Digital Measures Best Practices

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