Defining and measuring ‘eczema control’: an international qualitative study to explore the views of those living with and treating atopic eczema

Abstract

Background Atopic eczema (also known as eczema) is a chronic, inflammatory skin condition that often afflicts patients’ health and well‐being. The Harmonising Outcome Measures for Eczema ( HOME ) initiative recommends that ‘long‐term control of eczema’ is measured in all clinical trials 3 months or longer in duration. However, little has been published on what eczema control means to those living with or treating atopic eczema. Objectives To (i) develop understanding of what eczema control means to patients, carers and clinicians and (ii) explore the feasibility and acceptability of different ways of measuring eczema control in the long term. Methods Online focus groups explored patients/carers experiences in the UK , the United States, the Netherlands, France, Sweden and Japan, and an international online survey gathered views of clinicians. The framework method was used to analyse the focus groups, and thematic analysis was used to analyse survey data. All findings were integrated into a theoretical framework to create overarching themes that cut across these diverse groups. Results Eight focus groups with patients (16 years+) and eight groups with carers of children took place ( N = 97). Sixty‐two people took part in the survey. Eczema control was described as a multifaceted construct involving changes in disease activity, the treatment and management of the condition and psychological, social and physical functioning. Patient/carer measurement allows personal accounts and frequent measurement, whilst clinician measurement was deemed less subjective. The burden on patients/carers and issues for analysing and interpreting data should be considered. Conclusions This study formed the basis of judging the content validity and feasibility of measurement instruments/methods to assess control of eczema in clinical trials. This online approach to an international qualitative study is an example of how core outcome set developers with limited resources can engage with multiple stakeholder groups on an international basis to inform consensus meeting discussions.

Development and initial testing of a new instrument to measure the experience of eczema control in adults and children: Recap of atopic eczema ( RECAP )

“…and K.S.T. through synthesizing findings from an international qualitative study, an international patient survey and a systematic literature review relating to the construct of interest.…”

“…Experiences of eczema control were mapped onto the theoretical framework used in previous concept elicitation studies . L.M.H.…”

“…Qualitative research involving people with eczema, their caregivers and healthcare professionals suggests that eczema control is a multifaceted construct involving changes in disease activity, the treatment and management of the condition and psychological, social and physical functioning . Measuring such a complex construct over time can be challenging, but instruments to capture long‐term control have been developed in other chronic diseases such as asthma and urticaria …”

Dupilumab Maintains Long-Term Disease Control in Adults with Moderate-to-Severe Atopic Dermatitis as Measured by Well-Controlled Weeks: Results From the LIBERTY AD CHRONOS Clinical Trial

“…Some of these outcome measures, however, are time consuming and involve calculations only used within a clinical trial setting. We aimed to assess disease control in adults with moderate-to-severe AD who had been enrolled in the phase 3 CHRONOS study [ 2 ] using a simple and pragmatic patient-reported outcome: the number of well-controlled weeks [ 3 – 5 ] ( Trial Registration: ClinicalTrials.gov Identifier: NCT02260986).…”

ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children

“…12 weeks), is recommended 32 . Long‐term control scores for use in clinical trials have recently been developed by international teams 33 …”