The Harmonising Outcome Measures for Eczema (HOME) initiative has recommended a Core Outcome Set (COS) for atopic eczema clinical trials. Adherence to this COS in future clinical trials of atopic eczema treatments will ensure outcomes are measured and reported consistently, thus allowing direct comparison and minimizing bias. The COS consists of domains (what should be measured) and instruments (howto measure it). In 2011 four core domains were agreed: (i) clinician-reported signs, (ii) patient-reported symptoms, (iii) dermatology-speciï¬c quality of life (QoL) and (iv) long-term control. The Eczema Area and Severity Index (EASI) (2013)and Patient-Oriented Eczema Measure (POEM) (2015) are the agreed instruments for signs and symptoms, respectively. EASI combines the severity of the signs of eczema with the extent to which the body is affected, and POEM is a seven-item questionnaire that captures the frequency of symptoms of eczema experienced over the previous week. Using the World Health Organization International Clinical Trials Registry Plat-form (WHO ICTRP), a network of international clinical trials registers, we sought to quantify uptake of the HOME core outcomes in clinical trials over time.
AimUsing the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), a network of international clinical trials registers, we sought to quantify uptake of the HOME core outcomes in clinical trials over time.
ContributorsR. Vincent J.R. Chalmers C. McWilliams K.S. Thomas S. Dodd N. Rogers M.J. Ridd J. Schmitt J.J. Kirkham
Disease Category: Skin
Disease Name: Eczema
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Any
- COS methods research
- COS uptake study
- Literature review
Included were Phase III/IV treatment trials involving adults and/or children with atopic eczema registered within the WHO ICTRP between 24 January 2005 and 16 June 2018.