The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials
Open accessAbstract
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.
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The Harmonising Outcome Measures for Eczema initiative has established a core outcome set of tools and end points to be used in clinical trials for atopic dermatitis.
“The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of tools and end points to be used in clinical trials258–261 and are discussed in detail elsewhere37.”
From Atopic dermatitis: an expanding therapeutic pipeline for a complex disease (2022) · cites this paper as [258]
Step 2 identifies four core outcome domains for atopic eczema trials, and Step 3 reports that HOME selected EASI to measure clinical signs. But Step 3 says instruments for the other domains had not yet been agreed on, so the paper does not support the claim that a full set of tools had been established. Page numbers are unavailable in our copy. (LLM, conf=0.90)
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- Authors
- 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.
- Affiliations
- Zentrum für Evidenzbasierte Gesundheitsversorgung (DE)
- Amsterdam UMC Location University of Amsterdam (NL)
- University of Nottingham (GB)
- Oregon Health & Science University (US)
- Kyushu University (JP)
- University of California San Diego (US)
- University of Regensburg (DE)
- University of Alabama at Birmingham (US)
- Corresponding author
- Schmitt, Jochen
- ORCID
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2014-10
- Volume
- 134
- Issue
- 4
- Pages
- 800-807
- ISSN
- 0091-6749 (ISSN-L)
- OpenAlex
- W2029005903
- Cited by
- 319
- References
- 41
- Citations by year
- 2026: 14 · 2025: 14 · 2024: 27 · 2023: 30 · 2022: 37 · 2021: 38 · 2020: 27 · 2019: 27 · 2018: 23 · 2017: 31 · 2016: 29 · 2015: 18 · 2014: 3
- FWCI
- 4.47
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- University of Regensburg Publication Server (University of Regensburg) (acceptedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
- Repository@Nottingham (University of Nottingham) (submittedVersion)
- Funders
- National Institute for Health Research (RP-PG-0407-10177)
- Topics
- Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
- Keywords
- atopic dermatitis, core outcome set, Eczema Area and Severity Index, SCORAD, outcome measure standardization, measurement instrument validation, inter-rater reliability, intra-rater reliability
- MeSH terms
- Clinical Trials as Topic, Consensus Statements as Topic, Dermatitis, Atopic, Humans, International Cooperation, Research Design, Severity of Illness Index, Reproducibility of Results, Treatment Outcome, Evidence-Based Medicine, Quality Improvement
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