How to use the Harmonising Outcome Measures for Eczema Core Outcome Set for atopic dermatitis trials: a users’ guide

Thomas, Kim S; Howells, Laura; Leshem, Yael A; Simpson, Eric L; Apfelbacher, Christian; Spuls, Phyllis I; Gerbens, Louise A A; Jacobson, Michael E; Katoh, Norito; Williams, Hywel C; Stuart, Beth L

Abstract

Background
The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake.

Objectives
To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials.

Methods and results
We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD. It answers some of the common questions about using the HOME COS, how to access the outcome measurement instruments, what training/resources are needed to use them appropriately and clarifies when the COS is applicable. We also provide exemplar data to inform sample size calculations for eczema trials and encourage standardized data collection and reporting of the COS.

Conclusions
By encouraging adoption of the COS and facilitating consistent reporting of outcome data, it is hoped that the results of eczema trials will be more comprehensive and readily combined in meta-analyses and that patient care will subsequently be improved.

Citation

Thomas, K. S., Howells, L., Leshem, Y. A., Simpson, E. L., Apfelbacher, C., Spuls, P. I., …Stuart, B. L. (2024). How to use the Harmonising Outcome Measures for Eczema Core Outcome Set for atopic dermatitis trials: a users’ guide. British Journal of Dermatology, 190(4), 527-535. https://doi.org/10.1093/bjd/ljad497

• Journal Article Type: Article
• Acceptance Date: Dec 18, 2023
• Online Publication Date: Dec 20, 2023
• Publication Date: Apr 1, 2024
• Deposit Date: Jan 25, 2024
• Publicly Available Date: Jan 31, 2024
• Journal: British Journal of Dermatology
• Print ISSN: 0007-0963
• Electronic ISSN: 1365-2133
• Publisher: Oxford University Press (OUP)
• Peer Reviewed: Peer Reviewed
• Volume: 190
• Issue: 4
• Pages: 527-535
• DOI: https://doi.org/10.1093/bjd/ljad497
• Keywords: Dermatology
• Public URL: https://nottingham-repository.worktribe.com/output/28716314
• Publisher URL: https://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljad497/7484435