Objective:Etanercept monotherapy has been studied and approved for treatment of polyarticular juvenile idiopathic arthritis (JIA). The following study evaluates the safety and efficacy of combination therapy of etanercept and methotrexate compared to etanercept monotherapy in JIA.Methods:We perfomed an open, non-randomised study on patients who had previously failed to respond to at least one disease-modifying antirheumatic drug (DMARD). A total of 722 patients with JIA in whom at least 1 item of follow-up data was recorded were identified; of these, 118 patients treated with further slow acting drugs were excluded. In all, 504 patients were treated with a combination of etanercept and methotrexate. A total of 100 patients treated with etanercept only were in the control group. Efficacy was calculated using the American College of Rheumatology paediatric scores for 30, 50 and 70% improvement (PedACR30/50/70). Adverse events (AEs) and serious adverse events (SAEs) were reported.Results:After 12 months 55 patients in the monotherapy group and 376 patients in the etanercept and methotrexate group were available for comparison. For the intention to treat analysis, 65 patients discontinuing treatment prematurely were included. All activity parameters decreased significantly in both treatment groups. After 12 months 81%/74%/62% of patients of the etanercept and methotrexate group and 70%/63%/45% of patients of the etanercept monotherapy group achieved PedACR30/50/70 scores, respectively (p<0.05 for PedACR30, p<0.01 for PedACR70). The likelihood of achieving a PedACR70 increased with combination therapy with an odds ratio of 2.1 (95% CI 1.2 to 3.5). In total, 25 infectious and 23 non-infectious SAEs including 3 malignancies occurred in the etanercept and methotrexate group, and 1 infectious and 3 non-infectious SAEs occurred in the single etanercept group.Conclusions:The patients’ disease activity improved during etanercept monotherapy and etanercept and methotrexate combination therapy. Tolerability in both treatment groups was comparable.

Objective: To assess the short-term impact of a nutritional intervention aimed at reducing childhood overweight in German pre-school children. Design: Using a cluster-randomized study design with waiting-list controls, we tested a 6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods. At baseline, 6 and 12 months, a parent-completed questionnaire assessed fruit and vegetable intakes (primary outcomes) and water and sugared drinks consumption (secondary outcomes). Direct measurement assessed BMI, skinfold thickness and waist-to-height-ratio. An intention-to-treat analysis used random-effects panel regression models to assess the intervention effect, adjusted for each child's age, gender, immigrant background and maternal education. Setting: Eighteen pre-schools from three south German regions. Subjects: Healthy children aged 3-6 years. Results: Three hundred and seventy-seven (80 %) eligible pre-school children participated in the study. Of these, 348 provided sufficient data for analysis. The sample mean age was 4?26 (SD 0?78) years; the majority (53?2 %) were boys. Children's fruit and vegetable intakes increased significantly (P , 0?001 and P , 0?05, respectively); no significant changes in the consumption of water, sugared drinks or anthropometric measurements were noted. Conclusions: Nutritional interventions in pre-schools have the potential to change eating behaviours in young children, which in the long term might reduce risk for developing overweight.

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BackgroundWith rates of childhood obesity increasing, physical activity (PA) promotion especially in young children has assumed greater importance. Given the limited effectiveness of most interventions to date, new approaches are needed. The General Systems theory suggests that involving parents as intervention targets may be effective in fostering healthier life styles in children. We describe the development of a parent-focused participatory intervention and the procedures used to evaluate its effectiveness in increasing daily PA in preschoolers.Methods/DesignThirty-seven South German preschools were identified for this study and agreed to participate. Using a two-armed, controlled cluster-randomized trial design we test a participatory intervention with parents as the primary target group and potential agents of behavioural change. Specifically, the intervention is designed to engage parents in the development, refinement and selection of project ideas to promote PA and in incorporating these ideas into daily routines within the preschool community, consisting of children, teachers and parents. Our study is embedded within an existing state-sponsored programme providing structured gym lessons to preschool children. Thus, child-based PA outcomes from the study arm with the parent-focused intervention and the state-sponsored programme are compared with those from the study arm with the state-sponsored programme alone. The evaluation entails baseline measurements of study outcomes as well as follow-up measurements at 6 and 12 months. Accelerometry measures PA intensity over a period of six days, with the mean over six days used as the primary outcome measure. Secondary outcomes include childrens' BMI, a sum of averaged skin fold thickness measurements across multiple sites, and PA behaviour. Longitudinal multilevel models are used to assess within-subject change and between-group differences in study outcomes, adjusted for covariates at the preschool and individual levels. Teacher qualitative interviews monitor the intervention implementation process.DiscussionParticipatory approaches that actively involve parents have the potential to promote PA in ways that might be better tailored to local needs and more sustainable. Our mixed methods approach to assess the intervention efficacy and implementation employing both quantitative and qualitative measures within a cluster-randomized controlled trial may serve as a framework for evaluating public health interventions in preschool settings.Trial Registrationclinicaltrials.gov No: NCT00987532

The main strategy for combatting SARS-CoV-2 infections in 2020 consisted of behavioural regulations including contact reduction, maintaining distance, hand hygiene, and mask wearing. COVID-19-related risk perception and knowledge may influence protective behaviour, and education could be an important determinant. The current study investigated differences by education level in risk perception, knowledge and protective behaviour regarding COVID-19 in Germany, exploring the development of the pandemic over time. The COVID-19 Snapshot Monitoring study is a repeated cross-sectional online survey conducted during the pandemic in Germany from 3 March 2020 (waves 1–28: 27,957 participants aged 18–74). Differences in risk perception, knowledge and protective behaviour according to education level (high versus low) were analysed using linear and logistic regression. Time trends were accounted for by interaction terms for education level and calendar week. Regarding protective behaviour, interaction terms were tested for all risk perception and knowledge variables with education level. The strongest associations with education level were evident for perceived and factual knowledge regarding COVID-19. Moreover, associations were found between low education level and higher perceived severity, and between low education level and lower perceived probability. Highly educated men were more worried about COVID-19 than those with low levels of education. No educational differences were observed for perceived susceptibility or fear. Higher compliance with hand washing was found in highly educated women, and higher compliance with maintaining distance was found in highly educated men. Regarding maintaining distance, the impact of perceived severity differed between education groups. In men, significant moderation effects of education level on the association between factual knowledge and all three protective behaviours were found. During the pandemic, risk perception and protective behaviour varied greatly over time. Overall, differences by education level were relatively small. For risk communication, reaching all population groups irrespective of education level is critical.

Objective: To estimate the indirect lifetime cost of childhood overweight and obesity for Germany. Methods: The lifetime cohort model consisted of two parts: (a) Model I used data from the German Interview and Examination Survey for Children on prevalence of BMI categories during childhood to evaluate BMI trajectories before the age of 18; and (b) Model II estimated lifetime excess indirect cost based on the history of childhood BMI. Indirect costs were defined as the opportunity cost of lost productivity due to mortality and morbidity and were identified through a systematic literature review. Results: Our analysis showed that the majority of children with overweight and obesity remained in the same BMI category during their adult life, resulting in significant indirect lifetime costs. We estimated that overweight and obesity during childhood resulted in an excess lifetime cost per person of e4,209 (men) and e2,445 (women). For the current prevalent German population, the excess lifetime cost was e145 billion. Conclusions: Our study showed that childhood obesity results in significant economic burden on the society. Therefore, cost-effective strategies targeted at reducing the prevalence of obesity during the early years of life can significantly reduce both healthcare and nonhealthcare costs over the lifetime.

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The evidence on the aetiology of DP is fragmentary and heterogeneous. In addition, factors possibly relevant to the development of DP have not been appreciated in the scientific discussion.