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

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  • Henriette Rönsch
  • Frederike Schiffers
  • Robert Ofenloch
  • Elke Weisshaar
  • Anna Sophie Buse
  • Andreas Hansen
  • Swen Malte John
  • Ana M. Giménez Arnau
  • David Pesqué
  • Agner, Tove
  • Line Brok Nørreslet
  • Laura Loman
  • Geertruida L. E. Romeijn
  • Marie L. A. Schuttelaar
  • Adrijana Košćec Bjelajac
  • Jelena Macan
  • Andrea Bauer
  • Christian J. Apfelbacher

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.

OriginalsprogEngelsk
TidsskriftJournal of the European Academy of Dermatology and Venereology
Vol/bind37
Udgave nummer6
Sider (fra-til)1199-1206
Antal sider8
ISSN0926-9959
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
We thank all patients and experts who provided their suggestions of candidate outcome domains. We are very grateful for the contributions of the CHEPEP study staff, who conducted, transcribed and translated the patient interviews at the study centres, and Matthes Schaefer, Magdeburg, who assisted with the online expert survey. We also thank the further HECOS steering group members for their valuable contributions, especially concerning the categorization of the ‘Long List’ of outcomes, and Sabine Puhlfürst, Magdeburg, for her assistance in organizing the virtual meetings of the steering group. Open Access funding enabled and organized by Projekt DEAL.

Publisher Copyright:
© 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.

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