POEM a core instrument to measure symptoms in clinical trials: a HOME statement

Spuls, Ph.I. and Gerbens, L.A.A. and Simpson, E. and Apfelbacher, C.J. and Chalmers, J.R. and Thomas, K.S. and Prinsen, C.A.C. and Kobyletzki, L.B. von and Singh, J.A. and Williams, Hywel C. and Schmitt, J. (2016) POEM a core instrument to measure symptoms in clinical trials: a HOME statement. British Journal of Dermatology . ISSN 1365-2133

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Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and longterm control.

Objectives: The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials.

Methods: Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability, and feasibility to be considered for the final COS.

Results: At the 4th international HOME meeting there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87.5% agreed, 9.4% unsure, 3.1% disagreed).

Conclusions: All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM.

Item Type: Article
Additional Information: This is the peer reviewed version of the following article POEM a core instrument to measure symptoms in clinical trials: a HOME statement / Ph.I. Spuls, L.A.A. Gerbens, E. Simpson, C.J. Apfelbacher, J.R. Chalmers, K.S. Thomas, C.A.C. Prinsen, L.B. von Kobyletzki, J.A. Singh, H.C. Williams, J. Schmitt and The HOME initiative collaborators, which has been published in final form at http://dx.doi.org/10.1111/bjd.15179. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine
Identification Number: https://doi.org/10.1111/bjd.15179
Depositing User: Eprints, Support
Date Deposited: 05 Jan 2017 09:15
Last Modified: 26 Jan 2017 05:05
URI: http://eprints.nottingham.ac.uk/id/eprint/39586

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