Search

The conduct of clinical trials in paediatrics is essential to improve drug therapy in children. In Europe, paediatric clinical trials have been supported by the European Paediatric Regulation since 2007, but there is still a great need for high-quality clinical trials. The personnel and time required to conduct clinical trials in accordance with EU Regulations 536/2014 and 745/2017 is considerably higher compared to other studies, such as observational studies. It is important that this additional workload for the trial centre is fully compensated, also taking into account EU state aid rules. In paediatric trials, it is necessary to take into account the special requirements of paediatric and adolescent medicine when calculating the additional costs. Within the framework of the pan-European paediatric study network c4c/GermanNetPaeT, a working group dealt with specific aspects of cost calculation in order to support paediatric study centres in internal cost calculation as well as in the subsequent preparation of financing requirements for industrial sponsors or public funders. In several workshops the working group developed a cost calculation template with the content derived from the "Joint recommendations for a total services account as a factor in simplifying contracts" of the Deutsche Hochschulmedizin (DHM, German University Medicine), the Netzwerk der Koordinierungszentren für Klinische Studien (KKS Network, Network of Coordinating Centres for Clinical Trials) and the Verband Forschender Arzneimittelhersteller (vfa, German Association of Research-Based Pharmaceutical Companies). By estimating the specific time required for measures and investigations as part of a sample study, the background to the increased time required was discussed and a list with aspects to be considered for cost calculation was compiled together with the study centres. The paediatrics-specific aspects mentioned in detail are intended to increase understanding of the particular problem of higher costs for clinical trials involving children and adolescents and the need for correspondingly appropriate remuneration. This transparent and comprehensible presentation of the higher financial requirements for both the study centres and the financial supporters is intended to promote the high-quality conduct of clinical trials in paediatric study centres in the long term., Competing Interests: The authors declare that they have no competing interests., (Copyright © 2024 Ahne et al.)

Depressive symptoms in patients with coronary heart disease (CHD) predict adverse outcomes regarding e.g. cardiovascular complications. We trained women with CHD to support female peers through telephone-based counseling and tested whether depressive symptoms can be reduced, and perceived social support can be improved by the intervention over six months. 108 women with CHD and self-reported depressive or anxiety symptoms were included in a randomized controlled trial. The intervention group was offered immediate telephone-based peer support for six months, while the waiting list control group received the intervention with a 6-months delay. Primary outcomes were depressive symptoms and perceived social support immediately after the intervention period and at 6-months-follow-up. 40% of the women made use of the peer support. During the first six months, both groups showed a reduction in depressive symptoms (IIG: t(169) = -1.79, p = .08; WCG: t(169) = -2.76, p = .007) and a significant improvement in social support (IIG: t(175) = 3.54, p < .001; WCG: t(175) = 3.36, p < .001). We found no significant group × time interactions. There was no influence of telephone-based peer support on depressive symptoms and social support. We discuss potential causes for both lack of specific treatment effects and the general improvement over time in both groups.

Background: Risk factor control is essential in limiting the progression of coronary heart disease, but the necessary active patient involvement is often difficult to realise, especially in patients suffering psychosocial risk factors (e.g. distress). Blended collaborative care has been shown as an effective treatment addition, in which a (non-physician) care manager supports patients in implementing and sustaining lifestyle changes, follows-up on patients, and integrates care across providers, targeting both, somatic and psychosocial risk factors., Aims: The aim of this study was to test the feasibility, acceptance and effect of a six-month blended collaborative care intervention in Germany., Methods: For our randomised controlled pilot study with a crossover design we recruited coronary heart disease patients with ⩾1 insufficiently controlled cardiac risk factors and randomised them to either immediate blended collaborative care intervention (immediate intervention group, n =20) or waiting control (waiting control group, n =20)., Results: Participation rate in the intervention phase was 67% ( n =40), and participants reported high satisfaction ( M= 1.63, standard deviation=0.69; scale 1 (very high) to 5 (very low)). The number of risk factors decreased significantly from baseline to six months in the immediate intervention group ( t (60)=3.07, p =0.003), but not in the waiting control group t (60)=-0.29, p =0.77). Similarly, at the end of their intervention following the six-month waiting period, the waiting control group also showed a significant reduction of risk factors ( t (60)=3.88, p <0.001)., Conclusion: This study shows that blended collaborative care can be a feasible, accepted and effective addition to standard medical care in the secondary prevention of coronary heart disease in the German healthcare system.

The prevalence of obesity-related nonalcoholic fatty liver disease (NAFLD) is rising. NAFLD may result in nonalcoholic steatohepatitis (NASH), progressing to liver cirrhosis. Weight loss is recommended to treat obesity-related NASH. Lifestyle intervention may improve NASH; however, pertinent trials have so far focused on overweight patients, whereas patients with obesity are at highest risk of developing NAFLD. Furthermore, reports of effects on liver fibrosis are scarce. We evaluated the effect of lifestyle intervention on NAFLD in a real-life cohort of morbidly obese patients. In our observational study, 152 patients underwent lifestyle intervention, with a follow-up of 52 weeks. Noninvasive measures of obesity, metabolic syndrome, liver steatosis, liver damage, and liver fibrosis were analyzed. Treatment response in terms of weight loss was achieved in 85.1% of patients. Dysglycemia and dyslipidemia improved. The proportion of patients with fatty liver dropped from 98.1 to 54.3% ( P < 0.001). Weight loss >10% was associated with better treatment response ( P = 0.0009). Prevalence of abnormal serum transaminases fell from 81.0 to 50.5% ( P < 0.001). The proportion fibrotic patients, as determined by the NAFLD fibrosis score, dropped from 11.8 to 0% ( P < 0.05). Low serum levels of adiponectin correlated with degree of liver damage, i.e., serum liver transaminases ( r = -0,32, P < 0.05). Serum levels of adiponectin improved with intervention. In conclusion, lifestyle intervention effectively targeted obesity and the metabolic syndrome. Liver steatosis, damage and fibrosis were ameliorated in this real-life cohort of morbidly obese patients, mediated in part by changes in the adipokine profile. Patients with weight loss of >10% seemed to benefit most. NEW & NOTEWORTHY We demonstrate new evidence that lifestyle intervention is effective in treating NAFLD in the important group of patients with (morbid) obesity. Although current guidelines on the therapy of NASH recommend weight loss of 5-7%, weight reduction >10% may be favorable in morbid obesity. Serum levels of adipokines correlate with liver damage, which is indicative of their pathogenetic importance in human NASH. Our study adds to the limited body of evidence that NAFLD-associated liver fibrosis may resolve with lifestyle intervention.