Jochen Schmitt and Hywel Williams: Harmonising outcome measures for eczema in clinical trials and routine care

comet Eczema (synonymous with atopic dermatitis and atopic eczema) affects about one in five preschool children, up to one in eight adolescents, and approximately 3% of adults. The constant itching caused by eczema frequently leads to sleep problems and other limitations in the lives of the patients and their families.

A major problem that currently hinders the ability to interpret or compare published research in eczema is the profusion of different outcome measures. In a systematic review of ways to measure the severity of eczema, we identified 20 different instruments, most of which have never been validated adequately or did not perform adequately when tested in validation studies.(1) Standardizing outcomes for future eczema trials is an important step to help comparative effectiveness research and evidence-based care of people with eczema.

In order to tackle the multiplicity of current eczema outcomes, we undertook an international multi-professional Delphi exercise to develop consensus-based sets of core outcome domains for eczema for “controlled trials” and “clinical recordkeeping”.(2) The Delphi panel included consumers, clinical experts, regulatory agency representatives, and the editors of the most influential dermatological journals. They identified symptoms, physician-assessed clinical signs and a measurement for long-term control of flares as the preliminary core set of outcome domains for eczema trials. The main result of the Delphi exercise was to reinforce the need to measure symptoms of eczema regularly in clinical practice. (2) There has been considerable interest and support from the international community for the Delphi study.

In order to harness this interest, the Harmonising Outcome Measures for Eczema (HOME) initiative was founded in July 2010 with a group of about 40 clinical researchers and outcomes research methodologists at the International Symposium on Atopic Dermatitis/ New Trends in Allergy meeting in Munich. (3) At this meeting, the majority of participants expressed a clear interest in proceeding further into working together on identifying core outcomes for eczema research and on other eczema outcomes research issues. The group agreed to continue collaboratively with the HOME initiative, planning for a 2-day workshop to be held every 2 years.

HOME is linked with other current outcomes research initiatives such the COMET (Core Outcome Measures in Effectiveness Trials) Initiative and the OMERACT (Outcome Measures in Rheumatology) Initiative for joint diseases. The HOME-2 meeting will be held in Amsterdam on June 6 and 7, 2011, hosted by Dr. Phyllis Spuls and colleagues.

The main goal of the meeting will be the identification of internationally accepted and appropriate scales to measure core outcome domains and items in clinical trials and recordkeeping in eczema. We feel that the scenario “recordkeeping in daily practice” is important in addition to the scenario “clinical trial” in order to allow and propagate translation of trial evidence into clinical practice, and therefore clinical interpretability.

Although HOME-2 will be a working meeting, it will also be interesting and good fun, and we are delighted that Maarten Boers – one of the founding members of OMERACT, will be there to guide us as we start our venture. HOME-2 is directed to all those interested in eczema outcome measures and evidence-based dermatology, including patient representatives, clinicians, methodologists, and regulatory agency representatives with special interest in eczema. Further information about the HOME-2 meeting and the HOME-initiative more generally may be found on

 Reference List

 1.  Schmitt J, Langan SM, Williams HC. What are the best outcome measurements for atopic eczema? – A systematic review . J Allergy Clin Immunol 2007;120:1389-98.

 2.  Schmitt J, Langan S, Stamm T, Williams HC. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective delphi consensus process. J Invest Dermatol 2011;131:623-30.

 3.  Schmitt J,.Williams HC. Harmonising Outcome Measures for Eczema (HOME). Report from the first international consensus meeting (HOME 1), 24 July 2010, Munich, Germany. Br.J.Dermatol. 2011; 163:1166-8.

Jochen Schmitt leads a research group on health services research at the Interdisciplinary Allergy Centre, University of Dresden, Germany.

Hywel Williams is the director of the Centre of Evidence-Based Dermatology at the University of Nottingham.