Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

Aim

The aims of the HOME II consensus meeting were to:
• Refine or confirm the preliminary core set of outcome domains for atopic eczema trials derived from the Delphi procedure
• Define minimum criteria for the recommendation of instruments to measure specific core outcome measures in clinical trials of interventions for atopic eczema
• Prioritize research into outcome measures for atopic eczema

Contributors

Schmitt, J. Spuls, P. Boers, M. Thomas, K. Chalmers, J. Roekevisch, E. Schram, M. Allsopp, R. Aoki, V. Apfelbacher, C. Bruijnzeel-Koomen, C. Bruin-Weller, M. Charman, C. Cohen, A. Dohil, M. Flohr, C. Furue, M. Gieler, U. Hooft, L. Humphreys, R. Ishii, H. A. Katayama, I. Kouwenhoven, W. Langan, S. Lewis-Jones, S. Merhand, S. Murota, H. Murrell, D. F. Nankervis, H. Ohya, Y. Oranje, A. Otsuka, H. Paul, C. Rosenbluth, Y. Saeki, H. Schuttelaar, M. L. Stalder, J. F. Svensson, A. Takaoka, R. Wahlgren, C. F. Weidinger, S. Wollenberg, A. Williams, H.

Publication

Journal: Allergy
Volume: 67
Issue: 9
Pages: 1111 - 7
Year: 2012
DOI: 10.1111/j.1398-9995.2012.02874.x

Further Study Information

Current Stage: Not Applicable
Date: June 2011
Funding source(s): Study participants funded their own travel and accommodation. Some patient representatives’ costs were covered by academic colleagues (Professors Furue, Takaoka and Williams). Venue, voting system and catering costs were covered by Dr Spuls, Academic Medical Centre, Amsterdam. The HOME initiative is partially supported through an independent research programme commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0407-10177). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.


Health Area

Disease Category: Skin

Disease Name: Eczema

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting

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