Implementation of the HOME core outcome set for clinical trials of atopic eczema—barriers and opportunities: the HOME IX meeting report

Jacobson, M. E.; Thomas, K. S.; Apfelbacher, C. J.; Leshem, Y. A.; Williams, H. C.; Gerbens, L. A. A.; Spuls, P. I.; Schmitt, J.; Howells, L.; Katoh, N.; Simpson, E. L.; On behalf of the Harmonising Outcome Measures for Eczema (HOME) Initiative

Abstract

The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2days (September 25–26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria:< 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets.

Citation

Jacobson, M. E., Thomas, K. S., Apfelbacher, C. J., Leshem, Y. A., Williams, H. C., Gerbens, L. A. A., …On behalf of the Harmonising Outcome Measures for Eczema (HOME) Initiative. (2023). Implementation of the HOME core outcome set for clinical trials of atopic eczema—barriers and opportunities: the HOME IX meeting report. Archives of Dermatological Research, 315, 2617-2622. https://doi.org/10.1007/s00403-023-02647-w

• Journal Article Type: Article
• Acceptance Date: May 17, 2023
• Online Publication Date: Jul 11, 2023
• Publication Date: 2023
• Deposit Date: Jun 14, 2023
• Publicly Available Date: Jul 12, 2024
• Journal: Archives of Dermatological Research
• Print ISSN: 0340-3696
• Electronic ISSN: 1432-069X
• Publisher: Springer Science and Business Media LLC
• Peer Reviewed: Peer Reviewed
• Volume: 315
• Pages: 2617-2622
• DOI: https://doi.org/10.1007/s00403-023-02647-w
• Keywords: Core Outcome Sets; Atopic Eczema; Core Outcome Set Implementation; Harmonising Outcome Measures for Eczema Initiative
• Public URL: https://nottingham-repository.worktribe.com/output/21909642
• Publisher URL: https://link.springer.com/article/10.1007/s00403-023-02647-w
• Additional Information: Authors on behalf of the Harmonising Outcome Measures for Eczema (HOME) Initiative.