Search

Simple Summary: Patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor gene (EGFR) Exon 20 insertion mutations (Exon20ins) used to have poor outcomes after the failure of platinum-based therapies. Amivantamab, a drug that targets two proteins involved in NSCLC (EGFR/MET), was developed and studied in the CHRYSALIS clinical trial. This paper summarizes an analysis comparing outcomes for amivantamab from CHRYSALIS to the outcomes for a mix of treatments that were used in real-world clinical practice (real-world physician's choice [RWPC]). RWPC data were collected from hospitals across Europe in the CATERPILLAR real-world evidence (RWE) study. The outcomes of 114 patients from CHRYSALIS were compared to 55 lines of treatment (LOTs) from CATERPILLAR-RWE, accounting for differences in patient characteristics between the two populations. Overall, the results show that amivantamab was at least twice as good as RWPC for platinum pre-treated patients in terms of tumor response and survival rates. Patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor gene (EGFR) Exon 20 insertions (Exon20ins) at the second line and beyond (2L+) have an unmet need for new treatment. Amivantamab, a bispecific EGFR- and MET-targeted antibody, demonstrated efficacy in this setting in the phase 1b, open-label CHRYSALIS trial (NCT02609776). The primary objective was to compare the efficacy of amivantamab to the choices made by real-world physicians (RWPC) using an external control cohort from the real-world evidence (RWE) chart review study, CATERPILLAR-RWE. Adjustment was conducted to address differences in prognostic variables between cohorts using inverse probability weighting (IPW) and covariate adjustments based on multivariable regression. In total, 114 patients from CHRYSALIS were compared for 55 lines of therapy from CATERPILLAR-RWE. Baseline characteristics were comparable between the amivantamab and IPW-weighted RWPC cohorts. For amivantamab versus RWPC using IPW adjustment, the response rate ratio for the overall response was 2.14 (p = 0.0181), and the progression-free survival (PFS), time-to-next-treatment (TTNT) and overall survival (OS) hazard ratios (HRs) were 0.42 (p < 0.0001), 0.47 (p = 0.0063) and 0.48 (p = 0.0207), respectively. These analyses provide evidence of clinical and statistical benefits across multiple outcomes and adjustment methods, of amivantamab in platinum pre-treated patients with advanced NSCLC harboring EGFR Exon20ins. These results confirm earlier comparisons versus pooled national registry data. [ABSTRACT FROM AUTHOR]

This systematic study aims at analyzing the differences between the approach of the European healthcare systems to the pharmaceutical market and the American one. This paper highlights the opportunities and the limitations given by the application of managed entry agreements (MEAs) in European countries as opposed to the American market, which does not regulate pharmaceutical prices. Data were collected from the Organisation for Economic Co-operation and Development (OECD), the European Medicines Agency, and the national healthcare agencies of US and European countries. A literature review was undertaken in PubMed, Scopus, MEDLINE, and Google for a period ten years (2010–2019). The period 2020–2021 was considered to compare health expenditure before and after the SARS-CoV-2 pandemic. Scarce information from national agencies has been given in terms of MEAs related to the COVID-19 pandemic. The comparison between the United States approach and the European one shows the importance of a market access regulation to reduce the cost of therapies, increasing the efficiency of national healthcare systems and the advantages in terms of quality and accessibility to the final users: patients. Nevertheless, it seems that the golden age of MEAs for Europe was during the examined period. Except for Italy, countries will move to other forms of reimbursements to obtain higher benefits, reducing the costs of an inefficient implementation and outcomes in the medium term. [ABSTRACT FROM AUTHOR]

This paper presents a comparative analysis of various capacity mechanisms that are either in force or under approval in key countries/regions in Europe and the US. A detailed analysis on the necessities that led to the establishment of the capacity mechanisms, along with various fundamental technical and operational features associated with the design and operation of different capacity mechanisms, mainly in Europe (Italy, France, Germany, Belgium, Poland, Great Britain, Ireland, Cyprus) and complementarily in the US (PJM, New England), are presented. This analysis is complemented by a real-life application regarding the long-term capacity remuneration mechanism that is expected to be established in Greece in the near future. A detailed simulation of the envisaged capacity mechanism auctions under differentiated scenarios has been performed, regarding the future Greek power system operating conditions during the forthcoming decade (2022–2031). Test results illustrate that the outcome of the auctions is heavily dependent on the future energy generation mix and the market participants' bidding strategy. Whereas, the total cost that will have to be undertaken by the electricity supply companies and, ultimately, by the end-consumers for the financing of the proposed capacity mechanism lies in the range of 5.5–8.7 €/MWh for the entire study period. [ABSTRACT FROM AUTHOR]

Simple Summary: This research delves into the realm of pancreatic cystic neoplasms (PCNs), specifically focusing on a subtype with a high malignancy potential that is known as intraductal papillary mucinous neoplasms (IPMNs). By analyzing data from 113 patients across two European medical centers, this study assesses the effectiveness of two key guidelines, the Fukuoka consensus guidelines and the European evidence-based guidelines, in diagnosing severe disease stages in IPMNs. The findings reveal comparable diagnostic accuracies between the guidelines, highlighting the importance of personalized patient care and the potential indicators for surgical intervention. This study underscores the need for continuous research to refine these guidelines to improve patient outcomes and deepen our understanding of PCNs. Through this research, the authors seek to contribute to more accurate diagnosis and treatment strategies, ultimately influencing the broader medical community's approach to managing these complex cystic formations in the pancreas. This study addresses the critical need for the accurate diagnosis and management of intraductal papillary mucinous neoplasms (IPMNs), which are pancreatic cystic neoplasm types holding a substantial potential for malignancy. It evaluates the diagnostic effectiveness of the Fukuoka consensus guidelines and the European evidence-based guidelines in detecting high-grade dysplasia/invasive carcinoma in IPMNs, utilizing a retrospective analysis of 113 patients from two European medical centers. The methods include a comparative analysis of clinical, radiological, and endoscopic ultrasonography data, alongside an assessment of guideline-driven diagnostic performance. The results demonstrate that both guidelines offer similar accuracy in identifying severe disease stages in IPMNs, with certain clinical markers—such as jaundice, solid mass presence, and an increase in CA 19-9 levels—being pivotal in predicting the need for surgical intervention. This study concludes that while both guidelines provide valuable frameworks for IPMN management, there is an inherent need for further research to refine these protocols and improve patient-specific treatment strategies. This research contributes to the ongoing discourse on optimizing diagnostic and treatment paradigms for pancreatic cystic neoplasms, aiming to enhance clinical outcomes and patient care in this challenging medical field. [ABSTRACT FROM AUTHOR]

Self-management interventions (SMIs) offer a promising approach to actively engage patients in the management of their chronic diseases. Within the scope of the COMPAR-EU project, our goal is to provide evidence-based recommendations for the utilisation and implementation of SMIs in the care of adult individuals with type 2 diabetes mellitus (T2DM). A multidisciplinary panel of experts, utilising a core outcome set (COS), identified critical outcomes and established effect thresholds for each outcome. The panel formulated recommendations using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, a transparent and rigorous framework for developing and presenting the best available evidence for the formulation of recommendations. All recommendations are based on systematic reviews (SR) of the effects and of values and preferences, a contextual analysis, and a cost-effectiveness analysis. The COMPAR-EU panel is in favour of using SMIs rather than usual care (UC) alone (conditional, very low certainty of the evidence). Furthermore, the panel specifically is in favour of using ten selected SMIs, rather than UC alone (conditional, low certainty of the evidence), mostly encompassing education, self-monitoring, and behavioural techniques. The panel acknowledges that, for most SMIs, moderate resource requirements exist, and cost-effectiveness analyses do not distinctly favour either the SMI or UC. Additionally, it recognises that SMIs are likely to enhance equity, deeming them acceptable and feasible for implementation. [ABSTRACT FROM AUTHOR]

Climate change will have a great impact on the hottest climates of southern Europe and the existing residential stock will be extremely vulnerable to these future climatic conditions. Therefore, there is an urgent need to update this building stock considering imminent global warming by applying climatic files that predict future conditions in building performance simulations. This research makes use of the two most applied tools (Meteonorm and CCWorldWeatherGen) for generating future climate hourly datasets for 2050 and 2080 in southern Spain. The results predicted for outdoor and indoor thermal conditions and cooling and heating demands are evaluated for two different scale simulation models: a test cell and a multi-family building located in southern Spain. The main aim of this work is the development of a comparative analysis of the results to highlight their potential differences and raise awareness of the influence of the climate data projection method on the simulation outcome. The results show that the projection method selected for producing future climatic files has relevant effects on the analysis of thermal comfort and energy demand, but it is considerably reduced when an annual evaluation is developed. [ABSTRACT FROM AUTHOR]

The aim of our long-term research program is to improve the quality and quantity of amaranth production through mutation breeding using γ-radiation. In this paper, we present the characterization of the new variety 'Zobor' of A. hypochondriacus × A. hybridus developed by radiation-induced mutagenesis of hybrid K-433. Multiyear phenotypic characterization of an important yield parameter (1000-seed weight) showed that the studied mutant variety 'Zobor' has an advantage in seed weight over the nonirradiated control seeds of K-433 with predictable performance of this yield trait. 'Zobor' exhibited changes in seed morphometric parameters, starch particle size, and pasting properties with no change in amylose content and swelling power. Moreover, the seeds of 'Zobor' showed the significantly highest folate content among selected amaranth varieties. The mutant variety could, therefore, be interesting for the development of functional foods and as a low-management crop, attractive for cultivation in Europe. [ABSTRACT FROM AUTHOR]

(1) Alcohol consumption contributes to the development of numerous diseases and is a big organizational burden on emergency departments (EDs). (2) We examined data on alcohol-related ED admissions in Poznan, Poland between 1 April 2019 and 31 March 2022. A total of 2290 patients' records were collected and analysed. The main goal was to determine the impact that these visits had on the functioning of the ED and the hospital. (3) The alcohol-related admission rate was significantly higher in males (78.95% vs. 21.05%), and the median blood alcohol concentration (BAC) level was 2.60 (1.78–3.38) ‰. Most of the visits took place at weekends and in the evening. Patients with higher BAC tended to stay longer in the ED, but had a lower chance of being admitted. A majority of patients required radiology and laboratory testing, 20.44% needed psychiatric examination, and 19.69% suffered trauma, mainly to the head. (4) Injuries and mental problems were the most common medical emergencies. This study presents trends in alcohol-related ED attendances, examines reasons for visits, and makes an attempt to assess overall burden on EDs. [ABSTRACT FROM AUTHOR]

Tanning beds have been classified as carcinogenic to humans. As a result, many countries have enacted laws regulating the use of commercial tanning beds, including bans for minors. However, there is no international overview of the current legal status of access restrictions for minors that provides details on their specific design regarding age limits and possible exceptions to the statutory regulation. Therefore, we performed a comprehensive web search of current tanning bed legislation for minors on the three continents North America, Australia, and Europe. Our findings regarding the existence and concrete design of access restrictions are presented graphically, using maps. We found a wide variety of different legislations. In Australia, a total ban on tanning beds exists, while in New Zealand, tanning bed use is banned for minors. In Europe, about half of the countries have implemented a strict ban for minors. In North America, we found differences in the age limit for access restrictions between the states, provinces, and territories for those regions that implemented a ban for minors. In the United States, some states have rather "soft bans" that allow use by minors with different types of parental consent. The patchwork in legislation calls for harmonization. Therefore, our comparison is an important starting point for institutions such as the World Health Organization or the European Commission to advance their goals toward a harmonization of tanning bed legislation in general and for minors in particular. [ABSTRACT FROM AUTHOR]