What is long-term control of atopic eczema?:International qualitative studies and results of the HOME V consensus meeting O27

The Harmonising Outcome Measures for Eczema (HOME) initiative is a multidisciplinary, evidence-based international group developing a core outcome set for atopic eczema trials. HOME has previously recommended four essential domains to be measured; signs, symptoms, quality of life and long-term control, with Eczema Area and Severity Index (EASI) and Patient-Oriented Eczema Measure (POEM) as the instruments to measures signs and symptoms, respectively. The aim of the current study was to define the domain of long-term control, and achieve consensus on what instrument(s) should be used to measure it. Two qualitative studies were conducted by the long-term control working group: online focus groups involving patients and carers, and an online qualitative survey of the HOME membership. These were analysed thematically and combined to provide evidence on what long-term control of atopic eczema means to patients, carers and clinicians. A face-to-face consensus meeting (HOME V) was held on 12-14 June 2017 in Nantes, France, involving moderated small interactive groups and whole-group discussions with anonymous voting. The HOME roadmap and COSMIN and COMET guidelines on outcome measurement instrument selection were followed. Discussions and voting on the definition of long-term control and the face validity and feasibility of different ways of measuring long-term control were informed by these two international qualitative studies and other published evidence (systematic reviews and validation studies). Focus groups involving 99 patients and carers were conducted in the U.K., the U.S.A., the Netherlands, France, Sweden and Japan. The HOME survey included 62 responses, mainly clinicians, representing 16 countries. Patients, carers and clinicians considered long-term control to involve several related concepts: level of disease activity, impact on daily life, and treatment required (such as reducing treatment or using only maintenance treatment). Issues highlighted to consider when measuring long-term control included capturing the perspective of patients, carers and clini-cians, burden of data collection, interpretability and including an objective assessment. The consensus meeting in Nantes was attended by 81 participants from 13 countries. There was consensus (91% of participants voted in favour) that the long-term-control domain consists of repeated measures of the agreed core domains [clinician-reported signs, patient-reported symptoms (including itch intensity) and quality of life] plus a patient global assessment. Pending further discussions, the existing recommended instruments for signs and symptoms (EASI and POEM) should be used. HOME recommends that long-term control of atopic eczema is captured in trials by repeated measures of the existing core domains plus a patient global assessment. Further work is required on the timing of assessments and to determine the patient global assessment instrument