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Introduction: A well-trained and experienced staff in epidemiological studies is essential for the quality of the study implementation and the data and analyses collected from it. A broad understanding of Good Epidemiological Practice (GEP) can increase the motivation of staff to collect evaluable data. There are no special training opportunities for non-academic staff. This report describes the development and evaluation of an “EPI Study Nurse” (ESN) pilot course to train staff in epidemiological studies. Project description: The development of a concept for a pilot course was initiated by a project group from the study centers of the German National Cohort (NAKO) in early 2020. It was carried out in close collaboration with the Robert Koch Institute (RKI) and the professional societies “Deutsche Gesellschaft für Sozialmedizin und Prävention” (DGSMP), “Deutsche Gesellschaft für Epidemiologie” (DGEpi), and “Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V.” (GMDS). A training plan with 12 modules covering the relevant contents of the GEP was defined and a timetable was drawn up. Those responsible for the modules and teachers as well as participants in the pilot course were recruited through inquiries from the institutions mentioned above. After each module, the expectations and satisfaction of participants and teachers were surveyed. The pilot course was financed by the participating institutions from their own resources. Discussion: The pilot phase of the continuing education course was successfully implemented within one year (2022–2023) (preparation of a curriculum, registration of participants and recruitment of lecturers, organisation and execution of the course and final examination) and evaluated. A particular challenge was the definition of the module-specific timeframes for the lectures and group work as well as the targeted consideration of the different levels of experience of the participants. For future courses, it must be taken into account that administrative tasks in particular require considerable human resources (e.g., creating the curriculum, organizing and moderating the course) and financial resources (e.g., fees, travel expenses). The project was approved as part of the application for the third funding phase of the NAKO (June 2024 – April 2028) and the courses will be offered once a year.
Importance:Severe burn injury triggers systemic inflammation that can lead to multiple organ dysfunctions and death. High-dose intravenous vitamin C has been proposed to mitigate these effects, but strong evidence in patients with burn injury is lacking. Objective:To evaluate the efficacy of high-dose intravenous vitamin C in patients with severe burn injury. Design, Setting, and Participants:Randomized, double-blind, placebo-controlled phase 3 trial conducted across 24 burn centers in North, Central, and South America; Europe; and Asia. Adults (≥18 years) with deep second- and/or third-degree burns covering 20% or more of total body surface area and requiring skin grafting were enrolled between August 18, 2020, and September 12, 2025. Final follow-up was completed in March 2026. The trial was stopped early after the first prespecified interim analysis for futility/harm. Interventions:Patients were randomly assigned (1:1) to receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours) or matched placebo. Main Outcomes and Measures:The primary outcome was a composite of 28-day mortality and persistent organ dysfunction (defined as dependence on mechanical ventilation, kidney replacement therapy, or vasopressor/inotrope support at day 28). The main secondary outcome was time to discharge alive from hospital within 90 days. Results:Among 238 patients enrolled (mean age, 48.9 [SD, 19.1] years; 79% male; mean total body surface area, 37.0% [SD, 14.6%]), 120 were assigned to vitamin C and 118 to placebo. The primary composite outcome occurred in 49 patients (40.8%) in the vitamin C group and 35 patients (29.7%) in the placebo group (adjusted risk ratio [RR], 1.28 [95% CI, 0.99-1.65]; P = .06), crossing the prespecified futility/harm threshold and prompting early trial termination. Time to discharge alive from hospital within 90 days was not improved (adjusted subdistribution hazard ratio, 0.85 [95% CI, 0.62-1.16]; P = .31). Twenty-eight-day mortality was higher in the vitamin C group (15.0% vs 7.6%; adjusted RR, 1.96 [95% CI, 1.32-2.90]; P = .001), as was hospital mortality (23.3% vs 16.1%; adjusted RR, 1.44 [95% CI, 1.03-2.00]; P = .03). Conclusions and Relevance:Among patients with severe burn injury, high-dose intravenous vitamin C did not reduce 28-day mortality and persistent organ dysfunction and is possibly harmful. Trial Registration:ClinicalTrials.gov Identifier: NCT04138394.
Macrophages play a central role in tuberculosis, both in bacterial persistence and tissue pathology. Body weight and a dysregulated lipid metabolism profoundly affect disease progression and survival. Yet, the relationship between lipid metabolism and mycobacterial immunity is still poorly understood. Accordingly, this study investigated the influence of cholesterol and lipoproteins on macrophage responses to mycobacteria, in particular the formation of multinucleated giant cells (MGC), which are key components of granulomas and involved in the containment of mycobacteria. We found that low-density lipoprotein (LDL) cholesterol was essential for the transformation of macrophage progenitors into MGCs in vitro, independent of the oxidation status. In contrast to these direct lipid effects on macrophage transformation, a lipid-rich diet to mice, which is known to elevate cholesterol levels in the blood, did not prime the MGC forming potential of bone-marrow progenitor cells. In conclusion, LDL promotes the mycobacteria-specific macrophage transformation, however, this effect appears to depend on tissue lipid availability rather than priming in the bone marrow.
