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Development of a core outcome set for hand eczema (HECOS)

Condition

Hand eczema

Background

Hand eczema is a complex, multifactorial and impairing skin disease. With a one-year prevalence of nearly 10% it is common in the general population. Moreover, occupational HE is one of the most common occupational diseases and makes up 40% of all occupational diseases in industrialised nations causing substantial psychological and economic burden for affected individuals and society. Considerable research efforts are therefore undertaken in order to develop and evaluate interventions aiming to prevent the development, recurrence or worsening of HE, or to ease its burden. 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. To help overcome these problems and enhance the efficiency of hand eczema research, the Hand Eczema Core Outcome Set (HECOS) initiative was formed.

Scope of the intended COS

  • Study types: RCTs and CCTs, excluding laboratory experiments and observational studies
  • Interventions: all interventions that aim to prevent or ease the burden of HE, without limitation (therapeutic: e.g. topical treatment, UV therapy, systemic treatment; prevention: e.g. education, behavioural approaches, gloves, barrier creams, moisturisers). For prevention studies, it is likely that the COS will need to be extended or modified.
  • Region: global scope

Methods

  • Outcome domain development
    • Identification of candidate outcome domains
      • Systematic scoping review to identify previously measured outcome domains in controlled or randomized-controlled trials published since 2000
      • Qualitative topic-guided patient interviews
      • Interviews with hand eczema experts
    • Consensus about core outcome domains
      • 3-round online Delphi survey
      • Face-to-face consensus meeting
      • Online approval by all panelists concerning consensus-meeting results
  • Outcome measurement instruments development
    • Identification of candidate outcome measurement instruments
      • Systematic scoping review to identify previously applied instruments in controlled or randomised-controlled trials published since 2000
      • Systematic review to identify empirical evidence supporting the validity of the instruments and to appraise the methodological quality of the validation studies by applying the COSMIN methodology
      • If required, own validation studies applying the COSMIN methodology
      • Best evidence synthesis to generate a short list of instruments that have the potential to be included in the COS
    • Consensus about core outcome measurement instruments
      • Online Delphi survey
      • Face-to-face consensus meetings with online approval by all panellists
  • Dissemination of the COS

Involvement of stakeholders

  • Stakeholders will be involved as members of the project group, as interviewees, and as panellists who participate in the consensus process (e-Delphi and face-to-face meetings)
  • From at least 4 continents and 15 countries
  • Patients will be contacted through patient associations, where existing, through university hospitals, through flyers at resident dermatologists, and through internet forums; specific eligibility criteria: chronic hand eczema diagnosed by a dermatologist
  • Hand eczema researchers and methodologists will be identified through previous collaboration, from relevant publications listed at PubMed, and at congresses.
  • Dermatologists who are not researchers will be contacted through national dermatologists associations.
  • HECOS is also going to involve pharma industry representatives, nurses, regulatory authorities/insurance representatives, and journal editors.

Current status

HECOS has been registered at www.comet-initiative.org. A systematic scoping review has identified outcome domains and outcome measurement instruments that have been applied outcomes in controlled or randomized-controlled trials published between 2000 and 2017 (https://doi.org/10.1111/cod.13212). We are currently planning patient interviews to identify relevant outcome domains from their perspective. The protocol for outcome domain development is about to be completed for review by CS-COUSIN. We plan to complete a long list of candidate outcome domains by October 2020 and to commence the e-Delphi consensus process in November 2020.

Funding

We have applied for funding by the EADV for conducting patient interviews in Germany, Croatia, Spain, and Denmark (no decision yet). No other funding has been applied for or granted so far.

Involved Countries

  • Asia
    • Singapore
  • Europe
    • Croatia
    • Denmark
    • Germany
    • The Netherlands
    • Spain
  • North America
    • Canada
  • HECOS welcomes and seeks participants from all countries to achieve a globally consented core outcome set.

Date of updates

  • 11/07/2019

Lead

  • Christian Apfelbacher, Institute of Social Medicine and Health Economy, Medical Faculty, Otto von Guericke University Magdeburg, Germany
  • Andrea Bauer, Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany

Project team members

  • Henriette Rönsch (coordinator), Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
  • Tove Agner, Bispebjerg Hospital, Dept. of Dermatology, University of Copenhagen, Denmark
  • Richard Brans, Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm) at the University of Osnabrück, Germany
  • Ana M Giménez-Arnau, Department of Dermatology, Hospital del Mar, Barcelona, Spain
  • Swen Malte John, Lower-Saxonian Institute of Occupational Dermatology (NIB), University of Osnabrück, Germany
  • 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, Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany
  • Jart AF Oosterhaven, Department of Dermatology, University of Groningen, University Medical Centre Groningen, The Netherlands
  • Marie-Louise A Schuttelaar, Department of Dermatology, University of Groningen, University Medical Centre Groningen, The Netherlands
  • Elke Weisshaar, Occupational Dermatology, Department of Dermatology, Ruprecht-Karls-University, Heidelberg, Germany
  • Yik Weng Yew, National Skin Centre, Institute of Dermatology, Singapore

Responsible member of Methods group (as assigned by CS-COUSIN)

  • Dr. Jan Kottner

Contact

henriette.roensch@tu-dresden.de

Published references

1. Ronsch H, Apfelbacher C, Brans R, Matterne U, Molin S, Ofenloch R, Oosterhaven JAF, Schuttelaar MLA, Weisshaar E, Yew YW, Bauer A. Which outcomes have been measured in hand eczema trials? A systematic review. Contact Dermatitis. 2019;80(4):201-207.

Additional resources