[The application of real-world evidence in drug regulatory decision-making]. / Die Anwendung von Real-world-Evidenz in Entscheidungsprozessen der Arzneimittelregulation.

Drug regulation is a system to support and protect public health. Drugs with market access must be effective, safe and of high quality. Therefore, drug regulatory decision-making by the competent authorities is made on a scientific basis. Real-world evidence (RWE) from real-world data (RWD) has so far predominantly been taken into account in a supportive manner in drug regulatory decision-making with regard to drug safety after marketing authorisation. The extensive potential of RWE for regulatory decision-making processes along the entire product life cycle has been increasingly used and further examined in recent years.This article provides an overview of current applications of RWE in drug regulatory decision-making processes. The potentials of RWE along with the hurdles to be addressed are described and examples of current projects on RWE research for drug regulation are given. The work is based on current international literature as well as examples from international and European initiatives and regulatory practice, which aim to support an increased use of RWD/RWE in regulatory decision-making processes. In order to be able to utilise the potential of RWE even more in the future, it is important to make relevant RWD sources more readily available through research projects and initiatives, to further develop evaluative methods and to establish the significance of RWE.

Experiences Shared by the (Future) Public Health Workforce during the COVD-19 Pandemic in Germany: Results of a Survey on Workload, Work Content, and Related Challenges among Students and Young Professionals.

Although previous studies have focused on the adverse effects of the COVID-19 pandemic on various professional groups (particularly in the health and nursing care sector), this study aims to close a research gap by assessing perspectives of students and young professionals in epidemiology and public health in Germany in terms of shifts in workload, work content, and related challenges caused by the pandemic. We conducted a cross-sectional survey between mid-February and mid-March 2022. Quantitative data were analyzed via standardized mean differences. Qualitative data based on answers to open-ended questions were analyzed via a qualitative content analysis. Overall, 172 individuals participated in this survey. Results indicate that students felt burdened the most by lack of exchange with other students and lecturers. Study participants employed in public health experienced changes in their employment because they had changes in their work content- and administration, which was accompanied by a high burden due to the workload. Multiple demands that can have an impact on both acquired skills and mental health during the professional qualification phase were mentioned by the participants. Therefore, more in-depth analyses are needed to investigate the impact the pandemic will have on the (future) public health workforce in the long run.

Association between Breakfast Skipping and Body Weight-A Systematic Review and Meta-Analysis of Observational Longitudinal Studies.

Globally, increasing rates of obesity are one of the most important health issues. The association between breakfast skipping and body weight is contradictory between cross-sectional and interventional studies. This systematic review and meta-analysis aims to summarize this association based on observational longitudinal studies. We included prospective studies on breakfast skipping and overweight/obesity or weight change in adults. The literature was searched until September 2020 in PubMed and Web of Science. Summary risk ratios (RRs) or ß coefficients with a 95% confidence interval (CI), respectively, were estimated in pairwise meta-analyses by applying a random-effects model. In total, nine studies were included in the systematic review and five of them were included in the meta-analyses. The meta-analyses indicated an 11% increased RR for overweight/obesity when breakfast was skipped on ≥3 days per week compared to ≤2 days per week (95% CI: 1.04, 1.19, n = two studies). The meta-analysis on body mass index (BMI) change displayed no difference between breakfast skipping and eating (ß = -0.02; 95% CI: -0.05, 0.01; n = two studies). This study provides minimal evidence that breakfast skipping might lead to weight gain and the onset of overweight and obesity.

Utilisation of medical rehabilitation services by persons of working age with a migrant background, in comparison to non-migrants: a scoping review.

In Germany, an ageing population is affected by societal and political changes due to demographic transition, e.g. by a prolonged working life for older employees. Demographic change also influences persons of higher working age with a migrant background. In 2018, 25% of all employees in Germany had a migrant background. Those affected by poor health at a higher working age can benefit from medical rehabilitation services, which aim to prevent early retirement and disabilities. So far, the utilisation of medical rehabilitation has been lower among persons of foreign nationality (often the only available proxy for migrant background), compared to that of Germans. The aim of this scoping review is to assess the utilisation of medical rehabilitation services by those with migrant background (PMB) and those without (non-PMB) and to identify the differences between these groups. We included 25 studies in our analysis, which were mainly secondary analyses of routine data and also a small number of primary studies. The results were inconsistent: studies published before 2018 showed a lower use of rehabilitation services for persons of foreign nationality compared to Germans. However, no differences were found between PMB and non-PMB in studies published in 2018 or later. PMB, as well as foreign nationals, showed poorer health before medical rehabilitation utilisation and had a higher chance of occupational disease and a lower education level. We identified a lower work-related performance, as well as barriers (e.g. information deficits) in the utilisation of rehabilitation services for groups of PMB. Our review is limited in that we cannot generalise our results to all PMB living in Germany. This is because of the heterogeneity, the limited number of studies and lack of representativeness in some studies. In many cases, studies only analyse the nationality, but they lack information about the second generation PMB. Future studies should survey the utilisation of medical rehabilitation services by migrant background rather than by nationality and focus on changes in the provision of rehabilitation measures following diversity-centred strategies.