Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting

K S Thomas; C A Apfelbacher; J R Chalmers; E Simpson; P I Spuls; L A A Gerbens; H C Williams; J Schmitt; M Gabes; L Howells; B L Stuart; E Grinich; T Pawlitschek; T Burton; L Howie; A Gadkari; L Eckert; T Ebata; M Boers; H Saeki; T Nakahara; N Katoh

doi:10.1111/bjd.19673

Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting

Br J Dermatol. 2020 Nov 11. doi: 10.1111/bjd.19673. Online ahead of print.

Authors

K S Thomas¹, C A Apfelbacher², J R Chalmers¹, E Simpson³, P I Spuls⁴, L A A Gerbens⁴, H C Williams¹, J Schmitt⁵, M Gabes⁶, L Howells¹, B L Stuart⁷, E Grinich⁸, T Pawlitschek⁸, T Burton⁹, L Howie¹⁰, A Gadkari¹¹, L Eckert¹², T Ebata¹³, M Boers¹⁴, H Saeki¹⁵, T Nakahara¹⁶, N Katoh¹⁷

Affiliations

¹ Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
² Institute of Social Medicine and Health Systems Research (ISMHSR), Otto von Guericke University Magdeburg, Magdeburg, Germany.
³ Department of Dermatology, Oregon Health & Science University, Portland, Oregon, USA.
⁴ Department of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
⁵ Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Dresden, Germany.
⁶ Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
⁷ Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
⁸ School of Medicine, Department of Dermatology, Oregon Health & Science University, Portland, Oregon, USA.
⁹ Patient Representative (independent), Nottingham, United Kingdom.
¹⁰ Global Parents for Eczema Research, Brisbane, Australia.
¹¹ Health Economics and Outcomes Research, Boehringer Ingelheim Inc, Germany.
¹² Global Dupixent Business Partner, sanofi GHEVA, 1 av. Pierre Brossolette, 91 380, Chilly Mazatin, France.
¹³ Chitofuna Dermatology Clinic, Tokyo, Japan.
¹⁴ Department of Epidemiology and data Science; Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.
¹⁵ Department of Dermatology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
¹⁶ Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
¹⁷ Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.

PMID: 33179283
DOI: 10.1111/bjd.19673

Abstract

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema clinical trials. Previous consensus meetings have agreed upon preferred instruments for clinician-reported signs (Eczema Area and Severity Index - EASI) and patient-reported symptoms (Patient-Oriented Eczema Measure - POEM). This paper reports consensus decisions from the HOME VII meeting.

Objective: To complete the core outcome set for atopic eczema by agreeing upon core outcome instruments for the domains of quality of life, long-term control and itch intensity.

Methods: Face-to-face consensus meeting held in Tokyo, Japan (8^th to 10^th April, 2019) including 74 participants (47 healthcare professionals/methodologists, 14 patients, 13 industry representatives), from 16 countries. Consensus decisions were made by presentations of evidence, followed by whole and small group discussions and anonymous voting using pre-defined consensus rules.

Results: It was agreed by consensus that quality of life should be measured using the Dermatology Life Quality Index (DLQI) for adults, the Children's Dermatology Life Quality Index (CDLQI) for children, and the Infant's Dermatology Quality of Life Index (IDQoL) for infants. For long-term control, the Recap of Atopic Eczema (RECAP) instrument or the Atopic Dermatitis Control Test (ADCT) should be used. Consensus was not reached over the frequency of data collection for long-term control. The peak itch numerical rating scale(NRS)-11 past 24 hours was recommended as an additional instrument for the symptom domain in trials of older children and adults. Agreement was reached that all core outcome instruments should be captured at baseline and at the time of primary outcome assessment as a minimum.

Conclusions: For now, the core outcome set for clinical trials in atopic eczema is complete. The specified domains and instruments should be used in all new clinical trials and systematic reviews of eczema treatments.