Different potencies of topical corticosteroids for a better treatment strategy in children with atopic dermatitis (The Rotterdam Eczema study): Protocol for an observational cohort study with an embedded randomised open-label controlled trial

Introduction Topical corticosteroids (TCS) of different potencies are the main treatment to control atopic dermatitis (AD). The Dutch guideline on AD for general practitioners (GPs) recommends a stepwise approach in which treatment steps are tailored to the severity of the disease, starting with the lowest possible potency of TCS. However, it remains unclear whether the recommended stepwise approach is most efficient. This randomised open-label controlled trial aims to determine whether a potent TCS is more effective than a low-potency TCS in the initial treatment of children with a moderate flare-up of AD in primary care. In the observational cohort, the overall aim is to determine the frequency, burden and determinants of flare-ups of AD during follow-up. Methods and analysis The study is an observational cohort study with an embedded pragmatic randomised controlled, open-label trial. Eligible are patients diagnosed with AD (aged 12 weeks to 18 years) who visited the GP for AD or received repeated prescriptions for AD in the previous 12 months; follow-up of the cohort is 1 year. Children are enrolled in the trial if they have a flare-up of AD during follow-up in the cohort. Eligible children are randomised to the intervention group (with a potent TCS once daily) or to the GP guideline group (with a low potency TCS once daily). Primary outcome is the difference in average subjective disease severity over 24 weeks follow-up in the trial, measured with the patient-oriented eczema measure. As secondary outcome, the Eczema Area and Severity Index is measured. Ethics and dissemination This study tests the hypothesis that immediate treatment with a potent TCS during a flare-up of AD leads to faster and more efficacious results as compared with starting with a TCS with low potency with less overall use of TCS. The study protocol is approved by the Medical Ethics Committee (MEC) of the Erasmus Medical Center Rotterdam, the Netherlands (MEC-2017-328). The results of the study will be published in international peer-reviewed journals and presented at national and international conferences. Trial registration number NTR: 6679; Pre-results

Atopic Dermatitis in Children in the General Population: Baseline Characteristics, Medication Use, and Severity Measures in the Rotterdam Eczema Study

Background : Real-life data on severity and treatments in children with atopic dermatitis (AD) are needed to evaluate self-management. Objectives : To determine severity and use of topical treatments in children with AD in the general population. Furthermore, we aim to determine agreement and correlation between objective and subjective AD severity measures. Methods : Data were used from the Rotterdam Eczema Study, an observational prospective cohort study with an embedded pragmatic open-label randomized controlled trial. Descriptive statistics were used for baseline characteristics, medication use, and severity. Strength of agreement and correlation were determined using kappa analysis and Pearson correlation. Results : In total, 367 children (mean age 5.7 years) were recruited. The mean eczema area and severity index (EASI) score was 2.1 (±3.2) and mean patient-oriented eczema measure (POEM) score was 10.3 (±6.1). The majority applied emollients on a daily basis (54.9%) and had not used topical corticosteroids (TCSs) over the past week (51%). Based on severity banding of POEM and EASI, 49.9% and 24.9% of the children were undertreated, respectively. No evidence was found for an agreement between EASI and POEM (kappa 0.028, n = 178, P = 0.451). A moderate correlation between POEM, EASI, infants' dermatitis quality of life index, and children's dermatology life quality index was found. POEM showed higher correlation with quality of life (QoL) than EASI. Conclusion : Emollients were used sufficiently in the study population. Based on signs or symptoms, 24.9% and 49.9% of children are undertreated, respectively. POEM scores correlated better with QoL than with EASI scores. We argue that EASI underestimates severity of AD, and treatment based on EASI scores may lead to undertreatment of AD. Treating physicians should be aware of suboptimal use of TCSs

Perceived adherence and associated barriers to the national atopic dermatitis guideline: A survey among general practitioners

AbstractBackground General practitioners (GPs) have an important role in managing patients with atopic dermatitis (AD). Although pivotal, adherence to dermatological guidelines in general practice has not been assessed.Objectives To assess GPs’ perceived adherence and barriers to the Dutch AD guideline.Methods A survey was conducted among 391 GPs in the Netherlands between December 2021 and May 2022. GPs rated their perceived adherence and perceived barriers concerning five key recommendations of the AD guideline, following an existing framework. The correlation between perceived adherence and barriers was investigated using Spearman’s rank correlation.Results A total of 213 GPs (54%) participated. Perceived adherence rates varied across recommendations (43.7% to 98.1%). Lowest adherence was reported for recommendations concerning topical corticosteroids (TCS). Across all recommendations, patient factors (65.6%; SD 11.6) and lack of applicability to specific patient groups (29.5%; SD 10.5) were reported most frequently as barriers. The overall correlation between adherence and barriers was strongest for knowledge (ρ .55; SD .10) and attitude-related factors (range: ρ .40--.62).Conclusion GPs’ perceived adherence and barriers vary substantially across recommendations of the AD guideline. In particular, GPs reported lower adherence to recommendations concerning TCS. Next to patient-related factors, strong correlations between adherence perceived by GPs and knowledge and attitude-related barriers suggest the importance of addressing these factors as well to improve adherence