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The HOME Core outcome set for clinical trials of atopic dermatitis.

Authors :
Williams HC
Schmitt J
Thomas KS
Spuls PI
Simpson EL
Apfelbacher CJ
Chalmers JR
Furue M
Katoh N
Gerbens LAA
Leshem YA
Howells L
Singh JA
Boers M
Source :
The Journal of allergy and clinical immunology [J Allergy Clin Immunol] 2022 Jun; Vol. 149 (6), pp. 1899-1911. Date of Electronic Publication: 2022 Mar 26.
Publication Year :
2022

Abstract

Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a "road map," Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool.<br /> (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1097-6825
Volume :
149
Issue :
6
Database :
MEDLINE
Journal :
The Journal of allergy and clinical immunology
Publication Type :
Academic Journal
Accession number :
35351441
Full Text :
https://doi.org/10.1016/j.jaci.2022.03.017