A patient-centred conceptual model of nocturnal scratch and its impact in atopic dermatitis: A mixed-methods study supporting the development of novel digital measurements.

Autor: Cesnakova L; Digital Medicine Society (DiMe) Boston Massachusetts USA., Meadows K; Health Outcomes Insights Ltd. Faringdon Oxfordshire UK., Avey S; Janssen Research & Development LLC Raritan New Jersey USA., Barrett J; Health Outcomes Insights Ltd. Faringdon Oxfordshire UK., Calimlim B; AbbVie, Inc. North Chicago Illinois USA., Chatterjee M; Janssen Research & Development LLC Raritan New Jersey USA., Goss S; AbbVie, Inc. North Chicago Illinois USA., Keyloun KR; AbbVie, Inc. North Chicago Illinois USA., Lambert J; UCB Pharma Brussels Belgium., Northcott CA; Pfizer, Inc. Cambridge Massachusetts USA., Patalano F; Novartis Pharma AG Basel Switzerland., Sirbu D; UCB Pharma Brussels Belgium., Begolka WS; National Eczema Association Novato California USA., Thyssen N; UCB Pharma Brussels Belgium., Zorman S; Novartis Pharma AG Basel Switzerland.; ActiGraph LLC Pensacola Flordia USA., Goldsack JC; Digital Medicine Society (DiMe) Boston Massachusetts USA.
Jazyk: angličtina
Zdroj: Skin health and disease [Skin Health Dis] 2023 Jul 01; Vol. 3 (5), pp. e262. Date of Electronic Publication: 2023 Jul 01 (Print Publication: 2023).
DOI: 10.1002/ski2.262
Abstrakt: 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, ∼65% of participants reported nocturnal scratching ≥1 day/week, resulting in ∼1-1.4 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 ∼25% 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.
Competing Interests: Lucia Cesnakova and Jennifer C. Goldsack are employees of the Digital Medicine Society, the sponsor of this study. The other authors are employees of their respective organizations. Carrie A. Northcott, Doina Sirbu and Jérémy Lambert are shareholders of their respective organizations.
(© 2023 Digital Medicine Society (DiME). Skin Health and Disease published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)
Databáze: MEDLINE
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