Abstract
BackgroundEczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals, and researchers) but no validated instruments for the domain have been identified.
Objectiveto develop a measurement instrument to capture a patient’s perspective of eczema control that is suitable for use in eczema clinical trials.
MethodsBest practice for development of a patient‐reported outcome was followed. A mixed‐methods approach was used to develop and refine a conceptual framework, generate, refine and select items and to test the distribution and construct validity of the final scale. The mixed‐methods approach involved expert panel meetings (including patient representatives, healthcare professionals and methodologists), and data collection using a focus group, cognitive interviews and an online survey with people with eczema/caregivers. Multivariable linear regression was used in the item selection process.
ResultsFourteen expert panel members 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). The resulting instrument, Recap of atopic eczema (RECAP), is a seven‐item questionnaire that captures eczema control via self or caregiver report. The development process aimed to ensure good content validity and feasibility. Initial testing suggested no floor or ceiling effects and good construct validity. Hypothesised correlation with the Patient‐Oriented Eczema Measure was confirmed (r(258) = 0.83, p < 0.001).
ConclusionRECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required.
Objectiveto develop a measurement instrument to capture a patient’s perspective of eczema control that is suitable for use in eczema clinical trials.
MethodsBest practice for development of a patient‐reported outcome was followed. A mixed‐methods approach was used to develop and refine a conceptual framework, generate, refine and select items and to test the distribution and construct validity of the final scale. The mixed‐methods approach involved expert panel meetings (including patient representatives, healthcare professionals and methodologists), and data collection using a focus group, cognitive interviews and an online survey with people with eczema/caregivers. Multivariable linear regression was used in the item selection process.
ResultsFourteen expert panel members 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). The resulting instrument, Recap of atopic eczema (RECAP), is a seven‐item questionnaire that captures eczema control via self or caregiver report. The development process aimed to ensure good content validity and feasibility. Initial testing suggested no floor or ceiling effects and good construct validity. Hypothesised correlation with the Patient‐Oriented Eczema Measure was confirmed (r(258) = 0.83, p < 0.001).
ConclusionRECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required.
| Original language | English |
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| Number of pages | 13 |
| Journal | British Journal of Dermatology |
| Early online date | 3 Dec 2019 |
| DOIs | |
| Publication status | E-pub ahead of print - 3 Dec 2019 |