Prevention through Activity in Kindergarten Trial (PAKT): A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children

BACKGROUND: Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent. METHODS/DESIGN: The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT), 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20,000 inhabitants) or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry) and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro) between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body adiposity (BMI, skin folds), media use (questionnaire), blood pressure, number of accidents and infections (questionnaire), increases in specific motor skills (throwing, balancing, complex motor performance, jumping) and in flexibility. DISCUSSION: If this trial proofs the effectiveness of the multilevel kindergarten based physical activity intervention on preschooler's activity levels and motor skills, the programme will be distributed nationwide in Germany

Sequential and Multiple Testing for Dose-Response Analysis

For the analysis of dose-response relationship under the assumption of ordered alternatives several global trend tests are available. Furthermore, there are multiple test procedures which can identify doses as effective or even as minimally effective. In this paper it is shown that the principles of multiple comparisons and interim analyses can be combined inflexible and adaptive strategies for dose-response analyses; these procedures control the experimentwise error rate. © 2000, Drug Information Association. All rights reserved

Influence of EPs 7630 on Antipyretic Comedication and Recovery from Acute Tonsillopharyngitis in Children: A Meta-analysis of Randomized, Placebo-Controlled, Clinical Trials

Objective Acute tonsillopharyngitis (ATP) is a common, seasonal infection of predominantly viral origin. Management is aimed at shortening the course of the disease and restoring the comfort of the patient. We performed a meta-analysis to investigate whether treatment with the Pelargonium sidoides extract EPs 7630 reduces the use of antipyretic comedication (i.e., acetaminophen) in children suffering from ATP. Methods Studies were identified from clinical trial registries and medical literature. Randomized, placebo-controlled, clinical trials investigating EPs 7630 in children with ATP and reporting the coadministration of paracetamol were eligible. Based on the raw data of eligible trials, we analyzed cumulative paracetamol use, as well as the ability to attend school at the end of treatment. Three trials including a total of 345 children aged 6 to 10 years and suffering from non-beta -hemolytic streptococcal ATP were identified and eligible. Children were administered EPs 7630 or placebo for 6 days. Results Compared with placebo, EPs 7630 reduced the cumulative paracetamol dose by an average of 449mg (95% confidence interval [CI]: 252-646mg; p <0.001). A total of 19.1% (EPs 7630) and 71.5% (placebo) of children were still unable to attend school at the end of the treatment (risk ratio=0.28; 95% CI: 0.16-0.48; p <0.001). Conclusion Our meta-analysis demonstrates that EPs 7630 reduced the use of antipyretic comedication and accelerated recovery

Die Vierfeldtafel bis N=80

No abstract available

Aspirin, paracetamol (acetaminophen) and caffeine for the treatment of acute migraine attacks: A systemic review and meta-analysis of randomized placebo-controlled trials

Background and purpose Many migraine patients rely on over-the-counter analgesics for the treatment of migraine attacks. Fixed-dose combinations of aspirin, paracetamol and caffeine (APC) have been used for treating migraine in many countries for a long time. We performed a meta-analysis for the comparison of APC versus placebo, which has not been done to date. Methods Randomized, blinded, placebo-controlled, parallel-group studies using APC to treat a migraine attack were included in a meta-analysis. We calculated the rate ratio (RRs) associated with APC versus placebo. Results Seven studies were included, with 3306 participants (2147 treated with APC and 1159 treated with placebo). For the primary efficacy outcome, being pain-free at 2 h, APC was superior to placebo (19.6% vs. 9.0%, RR 2.2, 95% confidence interval [CI] 1.4-3.3). For the co-primary efficacy outcome, pain relief at 2 h, APC was superior to placebo (54.3% vs. 31.2%, RR 1.7, 95% CI 1.6-1.9). Adverse events were more frequent in the APC than the placebo groups (10.9% vs. 7.8%, RR 1.7, 95% CI 1.3-2.2). Conclusions Results showed that APC is superior to placebo in the treatment of acute migraine attacks. Efficacy, measured by pain-free response and pain relief at 2 h, was clinically relevant

Interdisciplinary CME: is the need evident? Results of the evaluation of CME articles in the Journal of the German Medical Association

Background. Medicine has become more and more specialised over the last decades, which in turn has increased the need for interdisciplinary information exchange. The aim of this study is to describe the extent of the need for interdisciplinary knowledge transfer in a contemporary medical specialist population. Methods. We analysed reading by medical specialty of 53 accredited continuing medical education (CME) articles published in Deutsches Ärzteblatt (“Journal of the German Medical Association”), which is available to all German physicians. Results. In all, 86,340 physicians participated 1,007,923 times by reading one or more of the 53 articles. In fewer than 50% of all cases, 89.5% of all participants read content belonging to their specialty (rated by self-assessment). The highest percentage of interdisciplinary use of print CME was found in the group of physicians working neither in ambulatory care nor in hospitals, that is, those physicians working in the public health area, with public authorities, etc. Linear regression analysis in the biggest group of specialists (internal medicine) showed a tendency for more interdisciplinary use in the group of younger participants, female physicians, and those working in ambulatory care. Conclusion. This study demonstrates a somewhat unexpectedly high interdisciplinary use of medical information from freely available CME articles. The extent of interdisciplinary use of information most probably reflects an individual need of similar magnitude. These findings should stimulate CME providers more often to plan interdisciplinary CME independent of the mode of presentation

First-line therapy for non-transplant eligible patients with multiple myeloma: direct and adjusted indirect comparison of treatment regimens on the existing market in Germany

The purpose of this study was to compare approved first-line therapies for patients with multiple myeloma. A systematic literature search for phase III randomized controlled trials (RCTs) comparing first-line chemotherapies approved in Germany and recommended by guidelines at the time of study design was conducted. Random-effects meta-analysis (MA) was used for direct and the Bucher method for adjusted indirect treatment comparison. One RCT comparing melphalan and prednisone plus bortezomib (VMP) vs. melphalan and prednisone (MP) and six RCTs comparing MP plus thalidomide (MPT) vs. MP were analysed. For MPT vs. MP, an individual patient data (IPD) MA was used for sensitivity analyses. VMP and MPT were superior to MP regarding efficacy endpoints (VMP vs. MP, overall survival (OS): hazard ratio (HR) 0.70, 95 % confidence interval (CI) 0.57-0.86; progression-free survival (PFS): HR 0.56, 0.39-0.79; complete response (CR), risk-ratio (RR) for non-response: 0.70, 0.65-0.75; MPT vs. MP, OS: HR 0.83, 0.66-1.03; PFS: HR 0.67, 0.56-0.81; CR, RR for non-response 0.92, 0.88-0.95); but had a higher risk of developing any grade 3-4 adverse events (AEs) (VMP vs. MP: RR 1.13, 1.06-1.20; MPT vs. MP: RR 2.06, 1.43-2.98). The indirect comparison of VMP vs. MPT via MP showed a statistically not significant advantage for VMP regarding survival outcomes (OS: HR 0.85, 0.63-1.14; PFS: HR 0.83, 0.56-1.23) and a significant advantage regarding CR (RR for non-response 0.76, 0.70-0.83) and AEs (RR 0.55, 0.38-0.80). Treatment comparisons using results of IPD MA yielded similar effect sizes. VMP and MPT seem more effective than MP, VMP was superior to MPT regarding response criteria and AEs. Our results may best be confirmed by a head-to-head trial of VMP vs. MPT