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Fernando J Martinez,1 Alberto Papi,2 Tobias Welte3,4 ,† Dave Singh,5 Dmitry V Galkin,6 Alessandro Guasconi,7 Stefania Pirondi,7 George Georges,7 Joseph Imperato,8 Ruben Hermans9 1Weill Cornell Medicine, New York–Presbyterian Hospital, New York, NY, USA; 2Research Center on Asthma and COPD, Department of Medical Sciences, University of Ferrara, Ferrara, Italy; 3Pneumonology and Infectiology, Member of the German Center of Lung Research, Hannover Medical School, Hannover, Germany; 4Biomedical Research in End Stage and Obstructive Lung Disease, German Center for Lung Research, Hannover Medical School, Hannover, Germany; 5Medicines Evaluations Unit, University of Manchester, Manchester University Foundation Hospitals Trust, Manchester, UK; 6Global Clinical Development, Chiesi USA, Cary, NC, USA; 7Global Clinical Development, Chiesi Farmaceutici, S.p.A, Parma, Italy; 8Medical Affairs, IQVIA Inc, New York, NY, USA; 9Medical Affairs, IQVIA Inc, London, UK†Prof. Tobias We 50% in 2020 compared with 2019. The proportions of patients with an exacerbation increased in most countries in 2021. Across each country, seasonal exacerbation increases seen during autumn and winter in pre-pandemic years were absent during the first year of the pandemic. The percentage of patients filling COPD prescriptions across each country increased by 4.53– 22.13% in 2019 to 9.94– 34.17% in 2021.Conclusion: Early, steep declines in exacerbation rates occurred in 2020 versus 2019 across all five countries and were accompanied by a loss of the seasonal pattern of exacerbation.Keywords: COPD exacerbation, chronic obstructive pulmonary disease, COVID-19, electronic health records, real-world study

Kai-Michael Beeh,1 Piotr Kuna,2 Massimo Corradi,3 Isabelle Viaud,4 Alessandro Guasconi,4 George Georges4 1Insaf Respiratory Research Institute, Wiesbaden, Germany; 2Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Łódź, Poland; 3Department of Medicine and Surgery, University of Parma, Parma, Italy; 4Global Clinical Development, Chiesi Farmaceutici SpA, Parma, ItalyCorrespondence: Kai-Michael BeehInsaf Respiratory Research Institute, Wiesbaden, GermanyTel +49 611 9854347Email k.beeh@insaf-wi.deBackground: Three 52-week studies in COPD have assessed the efficacy and safety of single-inhaler extrafine formulation triple therapy combining beclomethasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) delivered via pressurized metered-dose inhaler (pMDI). BDP/FF/G is now being developed for delivery via multi-dose dry-powder inhaler (DPI; NEXThaler). This study aimed to demonstrate non-inferiority of BDP/FF/G DPI vs pMDI for lung function.Methods: Multicenter, randomized, double-blind, double-dummy, active-controlled, three-way cross-over study in patients with COPD and post-bronchodilator forced expiratory volume in 1 second (FEV1) 30– 80% predicted. Patients received BDP/FF/G 100/6/10μg via DPI and pMDI, and BDP/FF 100/6μg via pMDI, all two inhalations twice daily for four weeks, with treatments separated by two-week washout. The two co-primary objectives were to demonstrate non-inferiority between the two BDP/FF/G formulations for FEV1 area under the curve between 0 and 12 hours post-dose (AUC0-12h) normalized by time and trough FEV1 at 24 hours, both on Day 28. EudraCT 2017– 004405-41.Results: Of 449 patients screened, 366 were randomized, with 342 (93.4%) completing all three treatment periods. The primary objectives were met, with changes from baseline in FEV1 AUC0– 12h and trough FEV1 on Day 28 similar for the two BDP/FF/G formulations, and the confidence intervals for the difference lying entirely within the pre-specified non-inferiority criterion (– 50mL): – 20 (– 35, – 6) mL and 3 (– 15, 20) mL for AUC0– 12h and trough FEV1, respectively. BDP/FF/G pMDI and DPI were statistically superior to BDP/FF for these endpoints (p< 0.001). A similar proportion of patients experienced adverse events with each treatment (15.5%, 18.7% and 15.4% with BDP/FF/G DPI and pMDI, and BDP/FF, respectively); the majority were mild or moderate, with few related to treatment.Conclusion: Extrafine BDP/FF/G DPI and pMDI demonstrated similar efficacy and safety in patients with COPD, supporting the DPI formulation as a valid alternative.Keywords: adrenergic beta-2 receptor agonists, muscarinic antagonists, steroids, respiratory function tests, chronic obstructive pulmonary disease

Salman H Siddiqui,1,2 Ian D Pavord,3,4 Neil C Barnes,5,6 Alessandro Guasconi,7 Sally Lettis,8 Steven Pascoe,9 Stefano Petruzzelli7 1University of Leicester, Leicester, UK; 2National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK; 3Respiratory Theme, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, University of Oxford, Oxford, UK; 4Respiratory Medicine Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK; 5Glaxo Smith Kline, Brentford, London, UK; 6Barts and The London School of Medicine and Dentistry, London, UK; 7Chiesi Farmaceutici SpA, Parma, Italy; 8GSK, Uxbridge, London, UK; 9GSK, King of Prussia, PA, USA Background: Growing evidence suggests that blood eosinophil count is associated with patient responsiveness to inhaled corticosteroids (ICS). We performed post hoc predictive modeling on data from the FORWARD study and two replicate studies by Dransfield, to evaluate the relationships between baseline eosinophil count and the effect of ICS on exacerbations and lung function in patients with COPD. Methods: The studies assessed ICS/long-acting β2 agonist (LABA) combinations vs LABA alone. Using data from each study, we modeled COPD exacerbation rates, predose FEV1, and St George’s Respiratory Questionnaire score ([FORWARD only]) over a continuous range of eosinophils (0–1,000 eosinophils/µL in FORWARD, 0–993 eosinophils/µL in Dransfield). Results: In all studies, ICS/LABA reduced exacerbations versus LABA alone across all eosinophil levels, with progressively greater reductions at increasing baseline blood eosinophil counts. In FORWARD, annual exacerbation rates ranged from 0.78 to 0.83 per year between 0 and 1,000 eosinophils/µL in the ICS/LABA arm, and from 0.81 to 1.54 per year in the LABA-only arm. In the Dransfield studies, exacerbation rates ranged from 0.54 to 1.02 per year in the ICS/LABA arm between 0 and 993 eosinophils/µL, and from 0.56 to 1.75 per year in the LABA-only arm. Change in FEV1 was not associated with eosinophil count in ICS-treated patients in FORWARD, whereas an increased treatment benefit in terms of FEV1 was observed at higher eosinophil levels in the Dransfield studies. ICS/LABA led to greater improvements in St George’s Respiratory Questionnaire total scores compared to LABA alone in patients in FORWARD with ≥67 eosinophils/µL. Conclusion: Higher blood eosinophil count in patients with COPD is associated with an increased beneficial effect from ICS in terms of exacerbation reduction. Further prospective data are required to assess the role of blood eosinophils as a biomarker for therapeutic recommendations. Keywords: lung function, FEV1, COPD, ICS

Microsporidia, fungal-related single-cell parasites, infect a broad range of vertebrates and invertebrates. The most identified species of Microsporidia in humans are Enterocytozoon bieneusi and Encephalitozoon intestinalis, which have emerged as [...]

Background. Caregiver affiliate stigma concerning neurodegenerative disorders (NDDs) profoundly affects caregivers' well-being, though its full impact remains to be fully elucidated. Objectives. This scoping review aims to consolidate the current knowledge on caregiver affiliate stigma related to NDDs, explore its connection to caregiver psychosocial well-being, and pinpoint the gaps in the existing research. Methods. Adhering to the PRISMA-ScR guidelines, a comprehensive search of five databases was conducted for peer-reviewed, English language studies focusing on caregiver-affiliated stigma in relation to NDDs. Results. The initial search yielded 9033 articles, with 19 meeting the inclusion criteria after rigorous screening. Bronfenbrenner's ecological systems theory was employed to analyze various stigma conceptualizations, including public, courtesy, affiliate, and family stigma. Analysis revealed a correlation between elevated levels of affiliate stigma and increased caregiver burden, deteriorated mental health outcomes, and diminished quality of life. The internalization of stigma was found to vary across demographic groups, influenced by factors such as education level and social support. The review also highlighted the mediating role of coping strategies and the protective function of social support against stigma internalization. Conclusions, These findings underscore the necessity for targeted, culturally sensitive interventions that address caregiver affiliate stigma across multiple ecological levels. This review contributes to a more nuanced understanding of caregiver affiliate stigma in relation to NDDs, laying the groundwork for future research and intervention development aimed at enhancing caregiver well-being in diverse cultural contexts. [ABSTRACT FROM AUTHOR]

Simple Summary: Pancreatic cancer is one of the deadliest cancers due to its subtle onset and advanced stage at diagnosis. With most patients having inoperable cancer at diagnosis, survival rates remain low despite existing treatments. Our review aims to map and summarize current studies on FGFR inhibitors, a promising new treatment targeting specific cancer pathways. We found that while there are many preclinical studies, clinical research is still emerging, focusing mainly on the efficacy and safety of these treatments. Although FGFR alterations are relatively rare in pancreatic cancer, the few available real-life data are promising. Future research should aim to better identify the genetic drivers of this cancer and gather more data on long-term outcomes. This could lead to improved treatments and better survival rates for patients with pancreatic cancer. Pancreatic cancer is a highly lethal disease, often diagnosed at advanced stages, with a 5-year overall survival rate of around 10%. Current treatments have limited effectiveness, underscoring the need for new therapeutic options. This scoping review aims to identify and summarize preclinical and clinical studies on FGFR (Fibroblast Growth Factor Receptor) inhibitors, including tyrosine kinase inhibitors (TKIs) and FGFR-specific inhibitors, in pancreatic cancer with FGFR alterations. We included studies analyzing efficacy, safety, and survival outcomes in various populations. A comprehensive search across major databases identified 73 relevant studies: 32 preclinical, 16 clinical, and 25 from gray literature. The clinical trials focused primarily on efficacy (20 studies) and safety (14 studies), with fewer studies addressing survival outcomes. FGFR1 was the most studied alteration, followed by FGFR2 and FGFR4. Although FGFR alterations are relatively rare in pancreatic cancer, the available data, including promising real-life outcomes, suggest significant potential for FGFR inhibitors. However, more extensive research is needed to identify the correct genetic drivers and gather robust survival data. Ongoing and future trials are expected to provide more comprehensive insights, potentially leading to improved targeted therapies for pancreatic cancer patients with FGFR alterations. [ABSTRACT FROM AUTHOR]

The question of European trade unions' approach towards vocational training is an interesting example of a broader issue, involving both the role played by non-governmental actors in shaping the social dimension of the integration process, and the need to develop a social dialogue in the Community. In this context, the establishment of Cedefop in 1975 can be considered one of the main achievements of the protracted pressure and requests from the European trade unions to be better represented in the EC and to develop a series of initiatives aimed at shaping a common European social policy in the field of employment and vocational training. (Contains 10 footnotes.)

Artificial Intelligence (AI) is defined as "the capacity of a computer, robot, programmed device, or software application to perform operations and tasks analogous to learning and decision making in humans, such as speech recognition or question answering. Chat Generative Pre-Trained Transformer (ChatGPT) represent an example of this promising technology as it is designed to communicate and interact with people similarly to a human being". The introduction of any form of AI based technologies could be beneficial in nursing education and healthcare provision. A questionnaire co-created with ChatGPT was administered to nursing students, nurses and educators aiming at exploring how those technologies would impact on the world of healthcare and education. 176 participants were recruited. Data analysis showed that the perceived potential benefits of introducing AI include: improved quality of nursing care, of the diagnostic process and of job satisfaction. Conversely, some of the risks would be: limited opportunities to critical thinking and reduction of interaction and collaboration. [ABSTRACT FROM AUTHOR]

We report a case of Enterocytozoon bieneusi infection in a pediatric hematopoietic stem cell transplant recipient in Argentina. Spores were visualized in feces using Calcofluor White and modified trichrome stainings. PCR and sequencing identified E. bieneusi genotype D in fecal samples and liver samples, confirming extraintestinal dissemination of the parasite. [ABSTRACT FROM AUTHOR]