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

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

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.

Aim

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.

Contributors

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

Publication

Journal: British Journal of Dermatology
Volume:
Issue:
Pages: -
Year: 2023
DOI: 10.1093/bjd/ljad497

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors

Health Area

Disease Category: Skin

Disease Name: Eczema

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Commentary

Method(s)

- Other

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