Summary
Background
The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ...ensure cross‐trial comparison: clinical signs, symptoms, quality of life and long‐term control.
Objectives
The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials.
Methods
Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS.
Results
At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient‐Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed).
Conclusions
All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM.
What's already known about this topic?
There is insufficient high‐quality evidence for many of the treatments of atopic eczema (AE), which is partly due to the heterogeneity in outcomes used in clinical trials.
The Harmonising Outcome Measures for Eczema initiative defined ‘symptoms’ as one of the core outcome domains that should be measured in AE clinical trials.
What does this study add?
Consensus was reached on the Patient‐Oriented Eczema Measure (POEM) as the core instrument to measure symptoms.
This statement should promote awareness among all stakeholders.
What are the clinical implications of this work?
Not only itch and sleeplessness are symptoms important for patients with AE.
All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials.
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Linked Comment: Naldi. Br J Dermatol 2017; 176:852–853
Plain language summary available online
Background
The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed that quality of life should be measured in all atopic eczema clinical trials. Various candidate instruments exist ...for this domain but their content validity in atopic eczema is largely unclear.
Objective
To assess the content validity of quality‐of‐life candidate instruments for atopic eczema in infants, children and adults in order to aid the decision on what instrument to include in the core outcome set for the quality‐of‐life domain.
Methods
Six group discussions were conducted at the HOME VII Meeting in Tokyo. Each group was composed of 8–12 patients or parents of patients, clinicians, methodologists and pharmaceutical industry delegates and discussed one or two candidate instruments. The COSMIN criteria on relevance, comprehensiveness and comprehensibility were used to determine the overall content validity rating per instrument.
Results
Content validity of the Infant's Dermatitis Quality of Life Index, Children's Dermatology Life Quality Index and the Childhood Atopic Dermatitis Impact Scale (CADIS) long‐form was rated as sufficient (+). Results for the CADIS short‐form, DLQI and Skindex were inconsistent (±). DISABKIDS, Infants and Toddlers Dermatology Quality of Life and ABS‐A were classified as having insufficient content validity.
Conclusions
The content validity rating allowed for a comparison of all candidate instruments and informed the consensus‐seeking process regarding the core instrument for the quality‐of‐life domain.
Summary
Background
The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema (AE) clinical trials. Previous consensus meetings have ...agreed on preferred instruments for clinician‐reported signs (Eczema Area and Severity Index, EASI) and patient‐reported symptoms (Patient‐Oriented Eczema Measure, POEM). This paper reports consensus decisions from the HOME VII meeting.
Objectives
To complete the core outcome set for AE by agreeing on core outcome instruments for the domains of quality of life (QoL), long‐term control and itch intensity.
Methods
A face‐to‐face consensus meeting was held in Tokyo, Japan (8–10 April 2019) including 75 participants (49 healthcare professionals/methodologists, 14 patients, 12 industry representatives) from 16 countries. Consensus decisions were made by presentations of evidence, followed by whole and small group discussions and anonymous voting using predefined consensus rules.
Results
It was agreed by consensus that QoL should be measured using the Dermatology Life Quality Index (DLQI) for adults, the Children’s Dermatology Life Quality Index (CDLQI) for children and the Infant’s Dermatology Quality of Life Index (IDQoL) for infants. For long‐term control, the Recap of Atopic Eczema (RECAP) instrument or the Atopic Dermatitis Control Test (ADCT) should be used. Consensus was not reached over the frequency of data collection for long‐term control. The peak itch numerical rating scale (NRS)‐11 past 24 h was recommended as an additional instrument for the symptom domain in trials of older children and adults. Agreement was reached that all core outcome instruments should be captured at baseline and at the time of primary outcome assessment as a minimum.
Conclusions
For now, the core outcome set for clinical trials in AE is complete. The specified domains and instruments should be used in all new clinical trials and systematic reviews of eczema treatments.
What is already known about this topic?
Core outcomes sets improve the design and reporting of clinical trials, reduce selective outcome reporting bias and facilitate meta‐analysis of results in systematic reviews.
The HOME core outcome set for eczema recommends the inclusion of four core domains in all atopic eczema trials: clinician‐reported signs, patient‐reported symptoms, health‐related quality of life (HrQoL) and long‐term control.
Clinician‐reported signs should be captured using the Eczema Area and Severity Index (EASI) and patient‐reported symptoms using the Patient‐Oriented Eczema Measure (POEM).
What does this study add?
The HOME core outcome set is now complete and recommended core outcome instruments have been agreed on for all four domains.
Core outcome instruments for HrQoL: Dermatology Life Quality Index (DLQI) for adults, Children’s Dermatology Life Quality Index (CDLQI) for children and Infant’s Dermatology Quality of Life Index (IDQoL) for infants.
Core outcome instruments for long‐term control: either the Recap of Atopic Eczema (RECAP) or the Atopic Dermatitis Control Test (ADCT).
In addition, itch intensity should be measured using the peak NRS‐11 past 24 h for trials including older children and adults.
What are the clinical implications of this work?
If all future trials of eczema treatments include the HOME core outcome instruments, then trial results will be more readily incorporated into meta‐analyses in systematic reviews and clinical care will be informed by the best available evidence.
Linked Comment: D.F. Murrell and C.F. Paul. Br J Dermatol 2021; 185:13–14.
To cite this article: Apfelbacher CJ, Diepgen TL, Schmitt J. Determinants of eczema: population-based cross-sectional study in Germany. Allergy 2011; 66: 206-213. ABSTRACT: Background: Eczema is a ...chronic inflammatory skin disease and is among the most frequent chronic conditions in childhood and adolescence. It is the aim of this study to investigate determinants of eczema in German children and adolescents. Methods: Data were drawn from the public use files of the German Interview and Examination Survey for Children and Adolescents (KIGGS), a nationwide cross-sectional representative survey conducted between 2003 and 2006, including 17 641 children aged 0-17 (response rate: 66.6%). We investigated the association of a broad set of environmental and lifestyle exposures with ever physician-diagnosed eczema by means of univariable analyses and multivariable logistic regression modelling. Results: The weighted prevalence of ever physician-diagnosed eczema was 13.2% 95% confidence interval (CI) 12.5-13.9%. In multivariable analysis, significant positive associations of parental allergies (OR 1.94, 95% CI 1.72-2.19), parent-reported infection after birth (OR 1.45, 95% CI 1.05-2.00) and parent-reported jaundice after birth (OR 1.27, 95% CI 1.04-1.54) were revealed. Being a migrant (OR 0.63, 95% CI 0.49-0.80) and keeping a dog (OR 0.78, 95% CI 0.64-0.96) showed significant inverse associations with eczema. Other lifestyle (alcohol consumption during pregnancy) and environmental factors (mould on the walls, pets, origin from East/West Germany) were not significantly related to eczema. Conclusions: This study suggests that a family history of allergies is the strongest determinant of eczema. Perinatal health problems were associated with eczema, pointing to the importance of early life factors in the manifestation of eczema.
Summary
Background
Eczema 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.
Objectives
To develop a measurement instrument to capture a patient's perspective of eczema control that is suitable for use in eczema clinical trials.
Methods
Best practice for the 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 and caregivers. Multivariable linear regression was used in the item selection process.
Results
Fourteen expert panel members co‐produced the instrument, with input from people with eczema and 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. Hypothesized correlation with the Patient‐Oriented Eczema Measure was confirmed r(258) = 0·83, P < 0·001.
Conclusions
RECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required.
Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418–419.
What's already known about this topic?
Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers).
Qualitative studies suggest eczema control is a multifaceted and individual experience and no instrument has been identified that captures eczema control in this way.
What does this study add?
We have developed Recap of atopic eczema (RECAP), a seven‐item questionnaire to capture the experience of eczema control in all ages and eczema severities; there are two versions: a self‐reported version for adults and older children with eczema, and a caregiver‐reported version for younger children with eczema.
Designed with input from people with eczema, caregivers and healthcare professionals to ensure good content validity.
Initial testing of score distributions and construct validity suggests good measurement properties.
What are the clinical implications of the work?
The RECAP instrument is appropriate and feasible for measuring eczema control in clinical trials and may also be useful in routine practice.
Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418–419.
Plain language summary available online
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