Background: Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema. Methods/design: This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property. Discussion: The proposed systematic review will yield a comprehensive assessment of measurement properties of existing QoL instruments in infants, children, and adolescents with eczema. The results will serve as a basis to recommend a QoL measurement instrument for infants, one for children, and one for adolescents for use in future clinical trials. Systematic review registration: PROSPERO CRD42015023483
Background: Eczema, asthma and hay fever are global health problems and their prevalence has increased considerably over the last decades. All appear to share an underlying atopic diathesis but their aetiology is considered to be multifactorial. They have been linked to decreases in health related quality of life (HRQoL) in adults, children/adolescents and/or parents of children. Research also suggests an association of the three conditions with mental health, which in turn is related to HRQoL decreases. We aimed to assess whether the impact of any of the three conditions on HRQoL is modified by presence of mental health problems. Methods: The impact of occurrence of the three conditions within the past four weeks and 12 months on HRQoL, as measured by the ‘Quality of Life in Children – Revised’ (KINDL-R) questionnaire was analysed by use of the complex sample general linear model in a population-based sample (N = 6518) of children and adolescents aged 11 – 17. Analyses were adjusted for the other atopic conditions, sociodemographic and clinical variables and stratified for mental health as measured by the Strengths and Difficulties Questionnaire (SDQ) (normal n = 5697, borderline n = 609, abnormal n = 193). Results: Eczema and hay fever within the past four weeks were significantly associated with decreased total or certain subscales of KINDL-R after adjusting for all other variables when no mental health abnormalities were present while asthma was associated with better HRQoL in these individuals. However, when mental health problems were present, eczema was positively associated with several subscales and the positive impact of asthma was stronger. The presence of mental health problems accentuated the negative relationship between hay fever and HRQoL (stronger negative impact). However, due to decreasing numbers in the group with mental health problems only few associations reached statistical significance. Conclusions: While the results suggest mental health to have a modifying effect on the relationship between some atopic conditions and HRQoL caution needs to be exercised in interpreting the results: First, the groups with borderline or abnormal mental health were comparably smaller than the group with normal mental health. In the group with normal mental health small effects were more likely to become significant than in the other two groups. Secondly some problems regarding the validity of the self-report SDQ still remain.