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Age related, structured educational programmes for the management of atopic dermatitis in children and adolescents: multicentre, randomised controlled trial.

ABSTRACT: To determine the effects of age related, structured educational programmes on the management of moderate to severe atopic dermatitis in childhood and adolescence.Multicentre, randomised controlled trial.Seven hospitals in Germany.Parents of children with atopic dermatitis aged 3 months to 7 years (n = 274) and 8-12 years (n = 102), adolescents with atopic dermatitis aged 13-18 years (n = 70), and controls (n = 244, n = 83, and n = 50, respectively).Group sessions of standardised intervention programmes for atopic dermatitis once weekly for six weeks or no education (control group).Severity of eczema (scoring of atopic dermatitis scale), subjective severity (standardised questionnaires), and quality of life for parents of affected children aged less than 13 years, over 12 months.Significant improvements in severity of eczema and subjective severity were seen in all intervention groups compared with control groups (total score for severity: age 3 months to 7 years - 17.5, 95% confidence intervals - 19.6 to - 15.3 v - 12.2, - 14.3 to - 10.1; age 8-12 years - 16.0, - 20.0 to - 12.0 v - 7.8, - 11.4; - 4.3; and age 13-18 years - 19.7, - 23.7 to - 15.7 v - 5.2, - 10.5 to 0.1). Parents of affected children aged less than 7 years experienced significantly better improvement in all five quality of life subscales, whereas parents of affected children aged 8-12 years experienced significantly better improvement in three of five quality of life subscales.Age related educational programmes for the control of atopic dermatitis in children and adolescents are effective in the long term management of the disease.

SUBMITTER: Staab D

PROVIDER: S-EPMC1444870 | biostudies-other | 2006 Apr

REPOSITORIES: biostudies-other

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Age related, structured educational programmes for the management of atopic dermatitis in children and adolescents: multicentre, randomised controlled trial.

Staab Doris D Diepgen Thomas L TL Fartasch Manigé M Kupfer Jörg J Lob-Corzilius Thomas T Ring Johannes J Scheewe Sibylle S Scheidt Reginald R Schmid-Ott Gerhard G Schnopp Christina C Szczepanski Rüdiger R Werfel Thomas T Wittenmeier Marita M Wahn Ulrich U Gieler Uwe U

BMJ (Clinical research ed.) 20060401 7547

<h4>Objective</h4>To determine the effects of age related, structured educational programmes on the management of moderate to severe atopic dermatitis in childhood and adolescence.<h4>Design</h4>Multicentre, randomised controlled trial.<h4>Setting</h4>Seven hospitals in Germany.<h4>Participants</h4>Parents of children with atopic dermatitis aged 3 months to 7 years (n = 274) and 8-12 years (n = 102), adolescents with atopic dermatitis aged 13-18 years (n = 70), and controls (n = 244, n = 83, and ...[more]

PMID: 16627509

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Project description:Atopic dermatitis (AD) may affect academic performance through multiple pathways, including poor concentration associated with itching, sleep deprivation, or adverse effects of medications. Because educational attainment is associated with health and well-being, any association with a prevalent condition such as AD is of major importance. To examine whether a childhood diagnosis of AD is associated with lower educational attainment. This population-based cohort study used linked routine health care data from January 1, 1977, to June 30, 2017 (end of registry follow-up), in Denmark. The study population included all children born in Denmark on June 30, 1987, or earlier with an inpatient or outpatient hospital clinic diagnosis of AD recorded before their 13th birthday (baseline) and a comparison cohort of children from the general population matched by birth year and sex. A secondary analysis included exposure-discordant full siblings as a comparison cohort to account for familial factors. Data were analyzed from September 11, 2019, to January 21, 2021. Hospital-diagnosed AD. Estimated probability or risk of not attaining specific educational levels (lower secondary, upper secondary, and higher) by 30 years of age among children with AD compared with children in the matched general population cohort. Corresponding risk ratios (RRs) were computed using Poisson regression that was conditioned on matched sets and adjusted for age. The sibling analysis was conditioned on family and adjusted for sex and age. The study included a total of 61 153 children, 5927 in the AD cohort (3341 male [56.4%]) and 55 226 from the general population (31 182 male [56.5%]). Compared with matched children from the general population, children with AD were at increased risk of not attaining lower secondary education (150 of 5927 [2.5%] vs 924 of 55 226 [1.7%]; adjusted RR, 1.50; 95% CI, 1.26-1.78) and upper secondary education (1141 of 5777 [19.8%] vs 8690 of 52 899 [16.4%]; RR, 1.16; 95% CI, 1.09-1.24), but not higher education (2406 of 4636 [51.9%] vs 18 785 of 35 408 [53.1%]; RR, 0.95; 95% CI, 0.91-1.00). The absolute differences in probability were less than 3.5%. The comparison of 3259 children with AD and 4046 of their full siblings yielded estimates that were less pronounced than those in the main analysis (adjusted RR for lower secondary education, 1.29 [95% CI, 0.92-1.82]; adjusted RR for upper secondary education, 1.05 [95% CI, 0.93-1.18]; adjusted RR for higher education, 0.94 [95% CI, 0.87-1.02]). This population-based cohort study found that hospital-diagnosed AD was associated with reduced educational attainment, but the clinical importance was uncertain owing to small absolute differences and possible confounding by familial factors in this study. Future studies should examine for replicability in other populations and variation by AD phenotype.

Project description:BackgroundRuxolitinib cream is a topical formulation of ruxolitinib, an inhibitor of Janus kinase 1 and Janus kinase 2.ObjectiveWe aimed to determine the safety, tolerability, and bioavailability of 1.5% ruxolitinib cream under maximum-use conditions in patients with atopic dermatitis. Efficacy was evaluated as an exploratory objective.MethodsEligible patients aged ≥ 12-65 years with atopic dermatitis, an Investigator's Global Assessment score ≥ 2, and ≥ 25% affected body surface area were enrolled in an open-label, maximum-use phase I study conducted in the USA and Canada. Patients applied 1.5% ruxolitinib cream twice daily to lesions identified at baseline for the first 28 days and continued use only on active lesions for an additional 28 days (extension period). Safety was assessed by frequency, duration, and severity of treatment-emergent adverse events. Plasma concentrations of ruxolitinib and pharmacokinetic parameters were assessed as secondary endpoints.ResultsOverall, 41 patients (median age, 17 years; 51% male) were enrolled and 37 (90.2%) entered the extension period, all of whom completed the study. Treatment-emergent adverse events were reported in 13 patients (31.7%). Treatment-related adverse events were reported in four patients (9.8%). The mean (standard deviation) steady-state plasma concentration was 104 (309) nM during the first 28 days, well below the half-maximal inhibitory concentration of Janus kinase-mediated myelosuppression in the bone marrow (281 nM), and decreased further during the extension period. Higher plasma concentrations were detected in a few patients who were treated for a very high affected body surface area. At day 56, 94.6% of patients achieved ≥ 75% improvement in the Eczema Area and Severity Index.ConclusionsUnder maximum-use conditions, ruxolitinib cream was generally well tolerated, with approximately one-third of patients experiencing treatment-emergent adverse events and few treatment-related adverse events. The mean steady-state plasma concentration of ruxolitinib was well below the level expected to affect bone marrow production of blood cells, with a small number of patients exhibiting higher plasma concentrations. In addition, ruxolitinib cream showed a high level of efficacy in patients with atopic dermatitis involving ≥ 25% affected body surface area.ClinicaltrialsGov identifierNCT03920852.

Project description:IntroductionPatient education serves an essential purpose in the long-term management of allergic diseases as a secondary prevention approach. However, evidence on using education for primary prevention is limited. This study aims to evaluate the effect of an educational intervention, that is, the Preventive Antenatal Educational Program on Allergic Diseases (PAEPAD), on infantile allergic disease incidences compared with the standard care.Methods and analysisThis is a single-centre randomised controlled trial of expecting mother-children dyads in Daxing Teaching Hospital of Beijing, China. A total of 2266 expecting mothers will be recruited. Expecting mothers enlisted in the birth registry of Daxing Teaching Hospital of Capital Medical University and intend to give birth at this location will be screened for eligibility. Women aged≥18 years with less than 14+6 weeks of pregnancy who intends to remain resident in Daxing district for at least 2 years postpartum will be entered into the run-in phase. Randomisation will take place at 30 weeks of gestation. Women at high risk for miscarriage or intend to have abortions will be excluded. The participants will be allocated into two groups (ie, the PAEPAD and the standard care group) by random allocation (1:1). The PAEPAD group will receive a multidisciplinary education of neonatal care, including standard education as the control group and additional information on skincare of infants, sun protection, topical corticosteroids and an overview of atopic dermatitis (AD), whereas the standard care group will receive the standard neonatal care education carried out by obstetricians. Participants will be followed for 2 years. The primary outcome will be infantile AD cumulative incidence at 2 years postpartum. Secondary outcomes will include other AD outcomes, atopic march outcomes, knowledge outcomes and other maternal and neonatal outcomes. Data collection will be carried out using both electronic and paper questionnaires. Biological samples will also be collected longitudinally.Ethics and disseminationThe study design was approved by the ethical committee of Capital Medical University Daxing Teaching Hospital, Beijing, China. The trial results will be published in peer-reviewed journals and at conferences.Trial registration numberChiCTR registry (Trial ID: ChiCTR2000040463).

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Age related, structured educational programmes for the management of atopic dermatitis in children and adolescents: multicentre, randomised controlled trial.

Publications

Age related, structured educational programmes for the management of atopic dermatitis in children and adolescents: multicentre, randomised controlled trial.

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