Clinical hand eczema trials measure a variety of outcome domains to determine the success of interventions. This considerably limits the comparability and overall confidence in the study results, and thereby the strength of recommendations for clinical practice.
HECOS aims to develop two core outcome sets for the standardised evaluation of therapeutic and preventive interventions, respectively, in future hand eczema trials and reviews. These sets will define the minimum that should be measured and reported in controlled and randomised-controlled trials of hand eczema interventions.
Both sets will be developed with similar methods, following the CS-COUSIN guideline.
The COS will enhance the methodological quality, comparability, and usefulness of hand eczema trials for clinical decision making and also reduce the effort of planning, conducting, and reporting individual hand eczema studies, reviews and meta-analyses.
- 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)
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- 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.