Consensus on core domains for hand eczema trials: Signs, symptoms, control and quality of life

Henriette Rönsch, Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Karl Philipp Drewitz, Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University, Magdeburg, Germany.
Amber Reck Atwater, Department of Dermatology, George Washington University, Washington, DC, USA.
Detlef Becker, Department of Dermatology, University of Mainz, Mainz, Germany.
Philipp Bentz, Division of Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany.
Richard Brans, Department of Dermatology, Environmental Medicine and Health Theory, Osnabrück University, Osnabrück, Germany.
Tricia Chong, National Skin Centre, Singapore, Singapore.
Heinrich Dickel, Department of Dermatology, Venereology and Allergology, St. Josef Hospital, University Medical Center, Ruhr University Bochum, Bochum, Germany.
Peter Elsner, SRH Hospital Gera, Gera, Germany.
Ana M. Giménez-Arnau, Department of Dermatology, Hospital del Mar Research Institute, Universitat Pompeu Fabra, Barcelona, Spain.
Fabrizio Guarneri, Dermatology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
María Graciela Guzmán Perera, Dermatology Department, Hospital Angeles del Pedregal, Mexico City, Mexico.
Sarah Ibrahim, Department of Dermatology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Dimitra Koumaki, Dermatology Department, University Hospital of Heraklion, Heraklion, Crete, Greece.
Jamie Koelbel, Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Francesca Larese Filon, Clinical Unit of Occupational Medicine, University of Trieste, Trieste, Italy.
Suzana Ljubojević Hadžavdić, Department of Dermatology and Venereology, University Hospital Center Zagreb, School of Medicine University of Zagreb, Zagreb, Croatia.
Laura Loman, Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Mihaly Matura, Departments of Dermatology, Norrlands University Hospital, Umeå, Sweden.
Sonja Molin, Division of Dermatology, Queen's University, Kingston, Ontario, Canada.
Robert Ofenloch, Division of Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany.
Katharina Piontek, Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University, Magdeburg, Germany.
Radoslaw Spiewak, Department of Experimental Dermatology and Cosmetology, Jagiellonian University Medical College, Krakow, Poland.
Anne Strunk, Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Margo Reeder, Department of Dermatology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
David Reissig, Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Thomas Rustemeyer, Department of Dermatology, Allergology and Occupational Dermatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Marie-Louise Schuttelaar, Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Dagmar Simon, Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Manon Sloot, Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Markus F. Steiner, NHS Grampian, Occupational Health Service, Aberdeen, UK.
Saïda Tongalaza, Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University, Magdeburg, Germany.

Document Type

Journal Article

Publication Date

4-25-2025

Journal

Journal of the European Academy of Dermatology and Venereology : JEADV

DOI

10.1111/jdv.20671

Abstract

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.

Department

Dermatology

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