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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Henriette Rönsch - , Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Karl Philipp Drewitz - , Otto-von-Guericke-Universität Magdeburg (Autor:in)
  • Amber Reck Atwater - , George Washington University (GWU), Distinctive Dermatology PLLC Vienna (Autor:in)
  • Detlef Becker - , Johannes Gutenberg-Universität Mainz (Autor:in)
  • Philipp Bentz - , Universität Heidelberg (Autor:in)
  • Richard Brans - , Universität Osnabrück (Autor:in)
  • Tricia Chong - , National Skin Centre, Singapore (Autor:in)
  • Heinrich Dickel - , Ruhr-Universität Bochum (Autor:in)
  • Peter Elsner - , SRH Wald-Klinikum Gera (Autor:in)
  • Ana M. Giménez-Arnau - , Universitat Pompeu Fabra (Autor:in)
  • Fabrizio Guarneri - , Università degli Studi di Messina (Autor:in)
  • María Graciela Guzmán Perera - , Hospital "Ángeles del Pedregal" (Autor:in)
  • Sarah Ibrahim - , University of Wisconsin-Madison (Autor:in)
  • Dimitra Koumaki - , Heraklion University Hospital (Autor:in)
  • Jamie Koelbel - , Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Francesca Larese Filon - , Università degli Studi di Trieste (Autor:in)
  • Suzana Ljubojević Hadžavdić - , University of Zagreb (Autor:in)
  • Laura Loman - , University of Groningen (Autor:in)
  • Mihaly Matura - , Umeå University, Universitetssjukhuset Örebro (Autor:in)
  • Sonja Molin - , Queen's University Kingston, Charité – Universitätsmedizin Berlin (Autor:in)
  • Robert Ofenloch - , Universität Heidelberg (Autor:in)
  • Katharina Piontek - , Otto-von-Guericke-Universität Magdeburg (Autor:in)
  • Radoslaw Spiewak - , Jagiellonian University in Kraków (Autor:in)
  • Anne Strunk - , Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Margo Reeder - , University of Wisconsin-Madison (Autor:in)
  • David Reissig - , Klinik und Poliklinik für Dermatologie, Institut und Poliklinik für Arbeits- und Sozialmedizin, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Thomas Rustemeyer - , Amsterdam University Medical Centers (UMC) (Autor:in)
  • Marie Louise Schuttelaar - , University of Groningen (Autor:in)
  • Dagmar Simon - , Universität Bern (Autor:in)
  • Manon Sloot - , University of Groningen (Autor:in)
  • Markus F.C. Steiner - , NHS Grampian (Autor:in)
  • Saïda Tongalaza - , Otto-von-Guericke-Universität Magdeburg (Autor:in)
  • Skaidra Valiukevičienė - , Lithuanian University of Health Sciences (Autor:in)
  • Maurice Waitek - , Universität Heidelberg (Autor:in)
  • Elke Weisshaar - , Universität Heidelberg (Autor:in)
  • Stefan Wöhrl - , Floridsdorfer Allergiezentrum (FAZ) (Autor:in)
  • Doreen Wolff - , Otto-von-Guericke-Universität Magdeburg (Autor:in)
  • Andrea Bauer - , Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Christian Apfelbacher - , Otto-von-Guericke-Universität Magdeburg (Autor:in)

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.

Details

OriginalspracheEnglisch
Seiten (von - bis)1588-1599
Seitenumfang12
FachzeitschriftJournal of the European Academy of Dermatology and Venereology
Jahrgang39
Ausgabenummer9
PublikationsstatusVeröffentlicht - Sept. 2025
Peer-Review-StatusJa

Externe IDs

PubMedCentral PMC12376261
Scopus 105003819310
ORCID /0000-0001-8649-9196/work/204618260
ORCID /0000-0002-4411-3088/work/204618953

Schlagworte

Ziele für nachhaltige Entwicklung

Schlagwörter

  • Humans, Quality of Life, Consensus, Eczema/therapy, Delphi Technique, Hand Dermatoses/therapy, Clinical Trials as Topic, Male, Female