The HOME Core outcome set for clinical trials of atopic dermatitis

Williams, Hywel C.; Schmitt, Jochen; Thomas, Kim S.; Spuls, Phyllis I.; Simpson, Eric L.; Apfelbacher, Christian J.; Chalmers, Joanne R.; Furue, Masutaka; Katoh, Norito; Gerbens, Louise A.A.; Leshem, Yael A.; Howells, Laura; Singh, Jasvinder A.; Boers, Maarten

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.

• Journal Article Type: Article
• Acceptance Date: Mar 11, 2022
• Online Publication Date: Mar 26, 2022
• Publication Date: 2022-06
• Deposit Date: Mar 18, 2022
• Publicly Available Date: Mar 27, 2023
• Journal: Journal of Allergy and Clinical Immunology
• Print ISSN: 0091-6749
• Electronic ISSN: 1097-6825
• Peer Reviewed: Peer Reviewed
• Volume: 149
• Issue: 6
• Pages: 1899-1911
• DOI: https://doi.org/10.1016/j.jaci.2022.03.017
• Keywords: Immunology; Immunology and Allergy
• Public URL: https://nottingham-repository.worktribe.com/output/7610732
• Publisher URL: https://www.jacionline.org/article/S0091-6749(22)00389-X/pdf
• Related Public URLs: https://www.sciencedirect.com/science/article/abs/pii/S009167492200389X
• Additional Information: Authors on behalf of the HOME Initiative.