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Background Recap of atopic eczema (RECAP) is a patient-reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self-reported and proxy-reported versions in English, Dutch and German. However, it is unclear whether the self-reported version shows adequate content validity when completed by young people (8-16 years) in these languages. Objectives To assess the content validity (comprehensibility, relevance and comprehensiveness) of the English, German and Dutch versions of the self-reported RECAP in young people with atopic eczema and to identify the most appropriate age cutoff for self-completion. Methods We conducted 23 semistructured cognitive interviews with young people aged 8-16 years, using the 'think-aloud' method. In Germany and the Netherlands, participants were recruited in dermatology clinics and in the UK through social media and existing mailing lists. Interviews were audio recorded, transcribed verbatim and analysed in the three languages, using a problem-focused coding manual. Transcripts were coded by two independent reviewers in each country. Themes were translated into English and compared across the three countries. Results Significant age-related comprehensibility issues with the last three items of the questionnaire occurred with young people aged 8-11 years, causing difficulties completing RECAP without help. However, older children had only minor problems and were able to complete the questionnaire by themselves. The self-reported version of RECAP has sufficient content validity for self-completion in young people aged 12 years and above. However, the German version with some translational adaptations may be appropriate for children from the age of 8 years. There may be some situations where the proxy version is needed for older children too. Conclusions The self-reported version of RECAP is appropriate for use from the age of 12 years. The proxy version can be used in children

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.

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the MIC of the POEM is 3 points. Further assessment of the minimally important change (MIC) of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. Objectives To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate to severe atopic eczema. Methods This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate to severe eczema. Results Data was collected from 300 children. The smallest detectable change was 2.12. The MIC estimates were 1.07 (0.2 SD) and 2.68 (0.5 SD) based on distribution-based methods, were 3.09 to 6.13 based on patient-reported anchor-based methods, and were 3.23 to 5.38 based on investigator-reported anchor-based methods. Conclusions We recommend the following thresholds are used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2.1 to 2.9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3 to 3.9, probably a clinically important change; 4+, very likely to be a clinically important change.

Objective: To inform the development of a core outcome set for eczema by engaging with people with eczema and parents of children with eczema to understand their experiences and understanding of the concept “eczema control”. Design: 37 participants took part in a total of 6 semi-structured online focus groups held in a typed chatroom with 5-7 participants per group. Three groups involved adults with eczema and three groups involved parents of children with eczema. Framework analysis was used for data analysis. Setting: A community-based sample was recruited from across the UK via social media and email. Participants: 19 adults aged 17-61 (15/19 female, 16/19 white) and 18 parents of children with eczema aged 9 months-17 years (9/18 female, 18/19 white). Results: Four main themes were identified. 1) “Commonalities and differences in the experiences of control”: a reduction in symptoms such as itch and sleep loss characterised eczema control, but what level was acceptable differed across participants. 2) “Eczema control goes beyond the skin”: psychological factors, social factors, the constant scratching and the impact on everyday activities are a variety of ways an individual can be impacted. 3) “Stepping up and down of treatment”: participants’ stepped-up treatment in response to loss of control, but several factors complicated this behaviour. Control needed to be maintained after stepped-up treatment ended to be acceptable. 4) “How to measure control”: self-report was generally preferred to allow frequent measurements and to capture unobservable features. Although most thought their eczema needed to be measured frequently, many also felt that this was not always realistic or desirable. Conclusions: Eczema “control” is a complex experience for people with eczema and parents of children with the condition. These experiences could have important implications on how long-term control should be measured in eczema clinical trials and clinical practice.

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the MIC of the POEM is 3 points. Further assessment of the minimally important change (MIC) of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. Objectives To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate to severe atopic eczema. Methods This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate to severe eczema. Results Data was collected from 300 children. The smallest detectable change was 2.12. The MIC estimates were 1.07 (0.2 SD) and 2.68 (0.5 SD) based on distribution-based methods, were 3.09 to 6.13 based on patient-reported anchor-based methods, and were 3.23 to 5.38 based on investigator-reported anchor-based methods. Conclusions We recommend the following thresholds are used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2.1 to 2.9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3 to 3.9, probably a clinically important change; 4+, very likely to be a clinically important change.

Objective: To inform the development of a core outcome set for eczema by engaging with people with eczema and parents of children with eczema to understand their experiences and understanding of the concept “eczema control”. Design: 37 participants took part in a total of 6 semi-structured online focus groups held in a typed chatroom with 5-7 participants per group. Three groups involved adults with eczema and three groups involved parents of children with eczema. Framework analysis was used for data analysis. Setting: A community-based sample was recruited from across the UK via social media and email. Participants: 19 adults aged 17-61 (15/19 female, 16/19 white) and 18 parents of children with eczema aged 9 months-17 years (9/18 female, 18/19 white). Results: Four main themes were identified. 1) “Commonalities and differences in the experiences of control”: a reduction in symptoms such as itch and sleep loss characterised eczema control, but what level was acceptable differed across participants. 2) “Eczema control goes beyond the skin”: psychological factors, social factors, the constant scratching and the impact on everyday activities are a variety of ways an individual can be impacted. 3) “Stepping up and down of treatment”: participants’ stepped-up treatment in response to loss of control, but several factors complicated this behaviour. Control needed to be maintained after stepped-up treatment ended to be acceptable. 4) “How to measure control”: self-report was generally preferred to allow frequent measurements and to capture unobservable features. Although most thought their eczema needed to be measured frequently, many also felt that this was not always realistic or desirable. Conclusions: Eczema “control” is a complex experience for people with eczema and parents of children with the condition. These experiences could have important implications on how long-term control should be measured in eczema clinical trials and clinical practice.

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the MIC of the POEM is 3 points. Further assessment of the minimally important change (MIC) of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. Objectives To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate to severe atopic eczema. Methods This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate to severe eczema. Results Data was collected from 300 children. The smallest detectable change was 2.12. The MIC estimates were 1.07 (0.2 SD) and 2.68 (0.5 SD) based on distribution-based methods, were 3.09 to 6.13 based on patient-reported anchor-based methods, and were 3.23 to 5.38 based on investigator-reported anchor-based methods. Conclusions We recommend the following thresholds are used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2.1 to 2.9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3 to 3.9, probably a clinically important change; 4+, very likely to be a clinically important change.

Objective: To inform the development of a core outcome set for eczema by engaging with people with eczema and parents of children with eczema to understand their experiences and understanding of the concept “eczema control”. Design: 37 participants took part in a total of 6 semi-structured online focus groups held in a typed chatroom with 5-7 participants per group. Three groups involved adults with eczema and three groups involved parents of children with eczema. Framework analysis was used for data analysis. Setting: A community-based sample was recruited from across the UK via social media and email. Participants: 19 adults aged 17-61 (15/19 female, 16/19 white) and 18 parents of children with eczema aged 9 months-17 years (9/18 female, 18/19 white). Results: Four main themes were identified. 1) “Commonalities and differences in the experiences of control”: a reduction in symptoms such as itch and sleep loss characterised eczema control, but what level was acceptable differed across participants. 2) “Eczema control goes beyond the skin”: psychological factors, social factors, the constant scratching and the impact on everyday activities are a variety of ways an individual can be impacted. 3) “Stepping up and down of treatment”: participants’ stepped-up treatment in response to loss of control, but several factors complicated this behaviour. Control needed to be maintained after stepped-up treatment ended to be acceptable. 4) “How to measure control”: self-report was generally preferred to allow frequent measurements and to capture unobservable features. Although most thought their eczema needed to be measured frequently, many also felt that this was not always realistic or desirable. Conclusions: Eczema “control” is a complex experience for people with eczema and parents of children with the condition. These experiences could have important implications on how long-term control should be measured in eczema clinical trials and clinical practice.

Background The Patient Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the MIC of the POEM is 3 points. Further assessment of the minimally important change (MIC) of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. Objectives To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate to severe atopic eczema. Methods This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate to severe eczema. Results Data was collected from 300 children. The smallest detectable change was 2.12. The MIC estimates were 1.07 (0.2 SD) and 2.68 (0.5 SD) based on distribution-based methods, were 3.09 to 6.13 based on patient-reported anchor-based methods, and were 3.23 to 5.38 based on investigator-reported anchor-based methods. Conclusions We recommend the following thresholds are used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2.1 to 2.9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3 to 3.9, probably a clinically important change; 4+, very likely to be a clinically important change.

Background: Eczema is a chronic, itchy skin condition with onset typically in early childhood. Clinical trials compare health-related outcomes between two or more groups receiving different interventions. The Harmonising Outcome Measures in Eczema (HOME) initiative is an international collaboration working together to develop a core outcome set of outcome measures to be included in all eczema clinical trials to improve the comparability of outcome measures across trials. Aims & objectives: This thesis aims to inform two of the outcome domains recommended for measurement in eczema clinical trials by the HOME initiative group: long-term control of eczema and patient-reported symptoms. For the long-term control of eczema domain, the key objectives were to understand the concept of long-term control of eczema from key stakeholders’ perspectives and to develop an instrument to measure eczema control. For the patient-reported symptoms domain the key objectives were to explore the measurement model of the Patient-Oriented Eczema Measure (POEM) and inform interpretability of the scores of the POEM. Methods: To understand the concept of long-term control of eczema from key stakeholders’ perspectives, qualitative methods using online focus groups with people with eczema and caregivers of children with eczema across six countries, and an online survey of the HOME membership was conducted. To develop an instrument to measure eczema control, development of a conceptual framework, focus groups, expert panel design and feedback, cognitive interviews, and piloting of items was conducted. The measurement model of the POEM was explored using thought experiments and theoretical discourse. Anchor-based and distribution-based statistical approaches to examining the minimally important change score and the smallest detectable change were used to assess the interpretability of the POEM scores. Results: With regards to progressing the long-term control of eczema domain of the HOME initiati

Objective: To inform the development of a core outcome set for eczema by engaging with people with eczema and parents of children with eczema to understand their experiences and understanding of the concept “eczema control”. Design: 37 participants took part in a total of 6 semi-structured online focus groups held in a typed chatroom with 5-7 participants per group. Three groups involved adults with eczema and three groups involved parents of children with eczema. Framework analysis was used for data analysis. Setting: A community-based sample was recruited from across the UK via social media and email. Participants: 19 adults aged 17-61 (15/19 female, 16/19 white) and 18 parents of children with eczema aged 9 months-17 years (9/18 female, 18/19 white). Results: Four main themes were identified. 1) “Commonalities and differences in the experiences of control”: a reduction in symptoms such as itch and sleep loss characterised eczema control, but what level was acceptable differed across participants. 2) “Eczema control goes beyond the skin”: psychological factors, social factors, the constant scratching and the impact on everyday activities are a variety of ways an individual can be impacted. 3) “Stepping up and down of treatment”: participants’ stepped-up treatment in response to loss of control, but several factors complicated this behaviour. Control needed to be maintained after stepped-up treatment ended to be acceptable. 4) “How to measure control”: self-report was generally preferred to allow frequent measurements and to capture unobservable features. Although most thought their eczema needed to be measured frequently, many also felt that this was not always realistic or desirable. Conclusions: Eczema “control” is a complex experience for people with eczema and parents of children with the condition. These experiences could have important implications on how long-term control should be measured in eczema clinical trials and clinical practice.