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

Schmitt, Jochen; Spuls, Phyllis I.; Thomas, Kim S.; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A.; Chalmers, Joanne; Williams, Hywel C.

Authors

Jochen Schmitt

Phyllis I. Spuls

Eric Simpson

Masutaka Furue

Stefanie Deckert

Magdalene Dohil

Christian Apfelbacher

Jasvinder A. Singh

Joanne Chalmers

Profile image of HYWEL WILLIAMS

HYWEL WILLIAMS HYWEL.WILLIAMS@NOTTINGHAM.AC.UK
Professor of Dermato-Epidemiology



Abstract

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.

Journal Article Type Article
Acceptance Date Jul 25, 2014
Publication Date Oct 1, 2014
Deposit Date Sep 17, 2018
Electronic ISSN 1097-6825
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 134
Issue 4
Pages 800-807
DOI https://doi.org/10.1016/j.jaci.2014.07.043
Keywords Atopic dermatitis; clinical trials; eczema; Eczema Area and Severity Index; evidence-based medicine; outcomes research
Public URL https://nottingham-repository.worktribe.com/output/1105351
Publisher URL https://www.sciencedirect.com/science/article/pii/S0091674914010471
PMID 25282560
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