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.
- Christian Apfelbacher (lead), Institute of Social Medicine and Health Economy, Medical Faculty, Otto von Guericke University Magdeburg, Germany
- Andrea Bauer (lead), Henriette Rönsch (coordinator), Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany
- Tove Agner, Bispebjerg Hospital, Dept. of Dermatology, University of Copenhagen, Denmark
- Richard Brans, Anna-Sophie Buse, Andreas Hansen, Swen Malte John, Institute for Health Research and Education, Department of Dermatology, Environmental Medicine and Health Theory, University of Osnabrueck; Institute for interdisciplinary Dermatological Prevention and Rehabilitation at the University of Osnabrück
- Ana M Giménez-Arnau, Department of Dermatology, Hospital del Mar, Barcelona, Spain
- Jelena Macan, Institute for Medical Research and Occupational Health (IMI), Zagreb, Croatia
- Sonja Molin, Division of Dermatology, Department of Medicine, Queen’s University, Kingston, Canada
- Robert Ofenloch, Elke Weisshaar, Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany
- Jart AF Oosterhaven, Marie-Louise A Schuttelaar, Department of Dermatology, University of Groningen, University Medical Centre Groningen, The Netherlands
- Yik Weng Yew, National Skin Centre, Institute of Dermatology, Singapore
Methodological support: Dr Jan Kottner (www.cs-cousin.org)
Disease Category: Skin
Disease Name: Eczema
Age Range: 18
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Nominal group technique (NGT)
- Systematic review
The COS development follows the CS-COUSIN guideline.
As a first step, a list of candidate outcome domains will be derived from a systematic literature review concerning previously measured outcomes in HE trials, from qualitative patient interviews, and from expert interviews. This is followed by a consensus study about core outcome domains, which will be conducted by an online 3-round Delphi survey and a face-to-face meeting, applying pre-defined consensus-criteria.
After a set of core outcome domains has been defined, HECOS is going to identify corresponding outcome measurement instruments through a systematic literature review and appraise their quality. If needed, HECOS will conduct validation studies. The core outcome measurement instruments will be defined through a consensus study.
HECOS involves hand eczema and methods experts as well as patients and further stakeholders with an interest in the initiative.