Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey.

Autor: Rönsch H; Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany., Schiffers F; Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany., Ofenloch R; Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany., Weisshaar E; Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany., Buse AS; Department of Dermatology, Environmental Medicine and Health Theory, University of Osnabrück, Osnabrück, Germany.; Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm), University of Osnabrück, Osnabrück, Germany., Hansen A; Department of Dermatology, Environmental Medicine and Health Theory, University of Osnabrück, Osnabrück, Germany.; Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm), University of Osnabrück, Osnabrück, Germany., John SM; Department of Dermatology, Environmental Medicine and Health Theory, University of Osnabrück, Osnabrück, Germany.; Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm), University of Osnabrück, Osnabrück, Germany., Giménez Arnau AM; Department of Dermatology, Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain., Pesqué D; Department of Dermatology, Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain., Agner T; Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark., Nørreslet LB; Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark., Loman L; Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Romeijn GLE; Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Schuttelaar MLA; Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Košćec Bjelajac A; Occupational Health and Environmental Medicine Unit, Institute for Medical Research and Occupational Health, Zagreb, Croatia., Macan J; Occupational Health and Environmental Medicine Unit, Institute for Medical Research and Occupational Health, Zagreb, Croatia., Bauer A; Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany., Apfelbacher CJ; Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University, Magdeburg, Germany.
Jazyk: angličtina
Zdroj: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2023 Jun; Vol. 37 (6), pp. 1199-1206. Date of Electronic Publication: 2023 Feb 15.
DOI: 10.1111/jdv.18923
Abstrakt: Background: Hand eczema (HE) is a common skin disease characterized by itch, pain and visible skin changes such as fissures, erythema and vesicles. It is not yet clear which outcome domains are most important for patients. The Hand Eczema Core Outcome Set (HECOS) initiative is developing a consented set of core domains and suitable measurement instruments for the future application in all HE trials. This includes an online Delphi survey about core domains, which requires a 'Long List' of all domains that might be important to measure.
Objectives: To compile a 'Long List' of candidate outcome domains for therapeutic HE trials with suggestions from patients and experts.
Methods: First, 60 patients with chronic HE were interviewed at seven study sites in Croatia, Denmark, Germany, the Netherlands and Spain. Patients were asked about domains that were important from their perspectives. Second, 185 HE experts were invited by email to complete an online survey. With an open question, they were asked to suggest up to six domains.
Results: Suggestions were provided by 58 patients and 82 experts. Most patients and experts suggested to measure the domains 'signs', 'symptoms' and 'HE-related quality of life'. Specifically, >25% of patients said that less itch, pain or fissures indicated a successful treatment. Among experts, >25% suggested 'itch' and 'ability to work' as core sub-domains. Further outcomes from the domains 'HE control over time', 'patient-reported treatment experience' and 'skin barrier function' were mentioned.
Conclusion: 'Itch' was rated high among patients with HE and professional HE experts. While patients emphasized fissures as important, experts underlined the ability to work. This investigation allowed us to define a 'Long List' of 7 candidate outcome domains with 58 sub-domains. From this list, a panel of stakeholders will select core domains during an online Delphi survey.
(© 2023 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
Databáze: MEDLINE
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