The need and benefit of the Harmonising Outcome Measures for Eczema user’s guide

Atopic dermatitis (AD) is a complex chronic relapsing pruritic inflammatory skin disease that can significantly impact a person’s quality of life and lead to psychosocial stress and functional disturbances in performing daily life activities.1 The heterogeneity of the presenting symptoms of AD and associated life impact makes determining which outcomes to capture in clinical trials a challenge. To address the need for standardization of the measurement and reporting of outcomes in AD clinical trials, the Harmonising Outcome Measures for Eczema (HOME) initiative produced a core outcome set (COS),2 which was completed in 2022.2 A COS is a set of outcomes which includes the measurement instruments to capture the outcomes that should be reported in all clinical trials and applicable research studies for a condition. The HOME AD COS contains five outcome measures that should be captured and reported in all AD clinical trials and research studies assessing clinically relevant outcomes. The four outcome domains and the instruments to measure them that should be reported in all trials are signs measured by the Eczema Area and Severity Index, symptoms measured by the Patient-Oriented Eczema Measure and the Numerical Rating Scale itch peak 24 h, quality of life measured by the Dermatology Life Quality Index (adults), the Children’s Dermatology Life Quality Index (children) and the Infants’ Dermatitis Quality of Life Index (infants), and eczema control measured by the Atopic Dermatitis Control Tool or Recap of Atopic Eczema.2,3 While completing the HOME COS was a momentous achievement, work is needed to ensure that it is widely and properly adopted; an analysis of randomized trials for systemic treatments for AD found that even when COS items were measured, very few trials reported results according to HOME recommendations.4