The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care.

Contributors

Schmitt, J. Spuls, P. I. Thomas, K. S. Simpson, E. Furue, M. Deckert, S. Dohil, M. Apfelbacher, C. Singh, J. A. Chalmers, J. Williams, H. C.

Publication

Journal: J Allergy Clin Immunol
Volume: 134
Issue: 4
Pages: 800 - 7
Year: 2014
DOI: 10.1016/j.jaci.2014.07.043

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s): This study was funded by a grant from the National Institute of Health Research (RP-PG-0407-10177).


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
- Pharmaceutical industry representatives

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Nominal group technique (NGT)
- Systematic review

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