RESUMO
Background: Emerging digital measures and clinical outcome assessments (COAs) leveraging digital health technologies (DHTs) could address the need for objective, quantitative measures of symptoms of atopic dermatitis (AD), such as nocturnal scratching. Development of such measures needs to be supported by evidence reflecting meaningfulness to patients. Objectives: To assess nocturnal scratching as a concept of interest associated with meaningful aspects of health of patients with AD (adults and children); and to explore patient-centred considerations for novel COAs measuring nocturnal scratch using DHTs. Methods: Phase 1 evaluated disease impacts on everyday life and the lived experience with nocturnal scratching through qualitative interviews of AD patients and caregivers. Phase 2 deployed a quantitative survey to a sample of AD patients as well as caregivers. Results: Four cohorts with various AD severity levels participated in Phase 1: (1) adults with AD (n = 15), (2) their caregivers/spouses/partners (n = 6), (3) children with AD (n = 14), and (4) their adult caregivers (n = 14). Findings were used to develop a conceptual model for nocturnal scratching as a potential concept of interest. The Phase 2 survey was completed by 1349 of 27640 invited adults with AD and caregivers of children with AD. The most burdensome aspects of AD reported were itchy skin and scratching. Overall, â¼65% of participants reported nocturnal scratching ≥1 day/week, resulting in â¼1-1.4 h of sleep lost per night. In all, 85%-91% of respondents considered it at least somewhat valuable that a treatment reduces night-time scratching. About 50% reported willingness to use technology to this end and â¼25% were unsure. Conclusion: Our results represented by the conceptual model confirm that nocturnal scratch is a concept of interest related to meaningful aspects of health for patients with AD and therefore is worth being captured as a distinct outcome for clinical and research purposes. DHTs are suitable tools presenting an important measurement opportunity to assess and evaluate occurrence, frequency, and other parameters of nocturnal scratching as a disease biomarker or COA of treatment efficacy.
RESUMO
BACKGROUND: Digital sensing solutions represent a convenient, objective, relatively inexpensive method that could be leveraged for assessing symptoms of various health conditions. Recent progress in the capabilities of digital sensing products has targeted the measurement of scratching during sleep, traditionally referred to as nocturnal scratching, in patients with atopic dermatitis or other skin conditions. Many solutions measuring nocturnal scratch have been developed; however, a lack of efforts toward standardization of the measure's definition and contextualization of scratching during sleep hampers the ability to compare different technologies for this purpose. OBJECTIVE: We aimed to address this gap and bring forth unified measurement definitions for nocturnal scratch. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
