TY - JOUR
T1 - Consensus on core domains for hand eczema trials
T2 - Signs, symptoms, control and quality of life
AU - Rönsch, Henriette
AU - Drewitz, Karl Philipp
AU - Atwater, Amber Reck
AU - Becker, Detlef
AU - Bentz, Philipp
AU - Brans, Richard
AU - Chong, Tricia
AU - Dickel, Heinrich
AU - Elsner, Peter
AU - Giménez-Arnau, Ana M.
AU - Guarneri, Fabrizio
AU - Guzmán Perera, María Graciela
AU - Ibrahim, Sarah
AU - Koumaki, Dimitra
AU - Koelbel, Jamie
AU - Larese Filon, Francesca
AU - Ljubojević Hadžavdić, Suzana
AU - Loman, Laura
AU - Matura, Mihaly
AU - Molin, Sonja
AU - Ofenloch, Robert
AU - Piontek, Katharina
AU - Spiewak, Radoslaw
AU - Strunk, Anne
AU - Reeder, Margo
AU - Reissig, David
AU - Rustemeyer, Thomas
AU - Schuttelaar, Marie Louise
AU - Simon, Dagmar
AU - Sloot, Manon
AU - Steiner, Markus F.C.
AU - Tongalaza, Saïda
AU - Valiukevičienė, Skaidra
AU - Waitek, Maurice
AU - Weisshaar, Elke
AU - Wöhrl, Stefan
AU - Wolff, Doreen
AU - Bauer, Andrea
AU - Apfelbacher, Christian
N1 - Publisher Copyright:
© 2025 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.
PY - 2025/9
Y1 - 2025/9
N2 - Background: Hand eczema (HE) is a common and complex skin disease. A uniform set of core outcomes and related measures for use in clinical trials is lacking, making it difficult to compare results across HE studies. Objective: To reach consensus on a set of core domains and subdomains that should be measured in future therapeutic HE trials. Methods: In 2024, we conducted a two-round online Delphi (eDelphi) survey among international HE experts, including physicians, patients and their relatives, researchers and industry representatives. A domain/subdomain was included in the core set when ≥80% of participants rated is as ‘critically important’; 50% agreement or less resulted in its exclusion. Results from 50% to 80% were deemed controversial and subject for further discussion. During a hybrid consensus meeting, the stakeholders reviewed, completed and, if necessary, revised the preliminary eDelphi consensus. Results: In the first and second round of the eDelphi, 208 and 134 persons, respectively, participated. Forty participants from 18 countries attended the consensus meeting. Consensus was reached to include the core domains ‘signs of HE’ (with five core subdomains), ‘symptoms of HE’ (two subdomains), ‘HE-related quality of life’ (four subdomains) and ‘HE control over time’ (four subdomains). The subdomains ‘desquamation/scaling’ and ‘emotional impact/mental health’ remained controversial. Consensus was reached that the domains ‘skin barrier function’ and ‘patient-reported treatment experience’ and 28 subdomains should not be part of the core outcome set.Conclusions: To produce comparable and meaningful results, future trials evaluating the effectiveness of HE treatments should measure signs and symptoms of HE, HE-related quality of life and HE control over time as core outcome domains. The next step of the HE core outcome set initiative (HECOS) is to identify appropriate measurement instruments.
AB - Background: Hand eczema (HE) is a common and complex skin disease. A uniform set of core outcomes and related measures for use in clinical trials is lacking, making it difficult to compare results across HE studies. Objective: To reach consensus on a set of core domains and subdomains that should be measured in future therapeutic HE trials. Methods: In 2024, we conducted a two-round online Delphi (eDelphi) survey among international HE experts, including physicians, patients and their relatives, researchers and industry representatives. A domain/subdomain was included in the core set when ≥80% of participants rated is as ‘critically important’; 50% agreement or less resulted in its exclusion. Results from 50% to 80% were deemed controversial and subject for further discussion. During a hybrid consensus meeting, the stakeholders reviewed, completed and, if necessary, revised the preliminary eDelphi consensus. Results: In the first and second round of the eDelphi, 208 and 134 persons, respectively, participated. Forty participants from 18 countries attended the consensus meeting. Consensus was reached to include the core domains ‘signs of HE’ (with five core subdomains), ‘symptoms of HE’ (two subdomains), ‘HE-related quality of life’ (four subdomains) and ‘HE control over time’ (four subdomains). The subdomains ‘desquamation/scaling’ and ‘emotional impact/mental health’ remained controversial. Consensus was reached that the domains ‘skin barrier function’ and ‘patient-reported treatment experience’ and 28 subdomains should not be part of the core outcome set.Conclusions: To produce comparable and meaningful results, future trials evaluating the effectiveness of HE treatments should measure signs and symptoms of HE, HE-related quality of life and HE control over time as core outcome domains. The next step of the HE core outcome set initiative (HECOS) is to identify appropriate measurement instruments.
UR - https://www.scopus.com/pages/publications/105003819310
U2 - 10.1111/jdv.20671
DO - 10.1111/jdv.20671
M3 - Article
AN - SCOPUS:105003819310
SN - 0926-9959
VL - 39
SP - 1588
EP - 1599
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
IS - 9
ER -