Till Örebro universitet

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative recommend long-term control of eczema is measured in all clinical trials over 3 months in duration, but prior to this work, no instrument had been identified as suitable for inclusion in the core outcome set.

Objective: To develop a ques-tionnaire to capture ‘eczema control’ from a patient/caregiver’s perspective.

Methods: A mixed-methods approach was used to develop and refine a conceptual framework, generate, refine and select items and initial testing of the items. Questionnaire con-tent was generated and refined via a focus group, expert panel meetings, cognitive interviews and an online survey with people with eczema/caregivers. Impact analysis and multivariable li-near regression were used for item selection. The distribution of scores and construct validity were assessed.

Results: Fourteen expert panel members (including patients, caregivers, healthcare professionals and methodologists) co-produced the instrument; with input from people with eczema/caregivers via a focus group (n = 6), cognitive interviews (n = 13) and an online survey (n = 330). Recap of atopic eczema (RECAP) is a seven-item questionnaire with a self-reported and caregiver-reported version. Initial testing suggested no floor or ceiling effects and good construct validity. Positive correlation with the Patient-Oriented Eczema Measure (POEM) was confirmed (r(258)=0.83, p < 0.001).

Conclusions: RECAP is appropriate and feasible for measuring eczema control in clinical trials. Testing of measurement properties and translation to other languages is ongoing. RECAP has been recommended for inclusion in the HOME core outcome set for clinical trials and the HOME clinical practice set.