BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. OBJECTIVE: This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS. METHODS: Medline (1980–2021), EBSCO (1991–2021), and PubMed (1980–2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as the European Commission and the Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices and relevant national and international legislation, standards and guidelines concerning the topic were included in the review. RESULTS: The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world. CONCLUSION: Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results.

Abstract Limited evidence exists on the link between inflammation and epigenetic aging. We aimed to (a) assess the cross-sectional and prospective associations of 22 inflammation-related plasma markers and a signature of inflammaging with epigenetic aging and (b) determine whether epigenetic aging and inflammaging are independently associated with mortality. Blood samples from 940 participants in the Melbourne Collaborative Cohort Study collected at baseline (1990–1994) and follow-up (2003–2007) were assayed for DNA methylation and 22 inflammation-related markers, including well-established markers (eg, interleukins and C-reactive protein) and metabolites of the tryptophan–kynurenine pathway. Four measures of epigenetic aging (PhenoAge, GrimAge, DunedinPoAm, and Zhang) and a signature of inflammaging were considered, adjusted for age, and transformed to Z scores. Associations were assessed using linear regression, and mortality hazard ratios (HR) and 95% confidence intervals (95% CI) were estimated using Cox regression. Cross-sectionally, most inflammation-related markers were associated with epigenetic aging measures, although with generally modest effect sizes (regression coefficients per SD ≤ 0.26) and explaining altogether between 1% and 11% of their variation. Prospectively, baseline inflammation-related markers were not, or only weakly, associated with epigenetic aging after 11 years of follow-up. Epigenetic aging and inflammaging were strongly and independently associated with mortality, for example, inflammaging: HR = 1.41, 95% CI = 1.27–1.56, p = 2 × 10−10, which was only slightly attenuated after adjustment for 4 epigenetic aging measures: HR = 1.35, 95% CI = 1.22–1.51, p = 7 × 10−9). Although cross-sectionally associated with epigenetic aging, inflammation-related markers accounted for a modest proportion of its variation. Inflammaging and epigenetic aging are essentially nonoverlapping markers of biological aging and may be used jointly to predict mortality.

This book presents a critique of current English as a Business Lingua Franca (BELF) practices using research conducted in Bosnia and Herzegovina. The authors identify English communication behaviours that hinder or promote success in the workplace, and trace these back to curricula and teaching practices.

Abstract COVID-19 both creates and complicates public health challenges. Yet the pandemic also provides a unique lens for dissecting complex issues in global health that could benefit society in the long run. In this paper, we discuss the underlying reasons that can help explain the divergent COVID-19 control outcomes between Beijing and Shanghai—two advanced metropolitans that are similar in their municipal capacity, administrative capability and pandemic strategy. We hope insights of this investigation contribute to the development of disease prevention systems, such as context-specific and data-driven public health strategies that could yield optimal pandemic control outcomes with minimal unintended consequences, both amid and beyond COVID-19.

Background and purpose 40% of acute ischemic stroke patients treated by mechanical thrombectomy (MT) have a clinical history of atrial fibrillation (AF). The safety of bridging intravenous thrombolysis (IVT) (MT + IVT) is currently being discussed. We aimed to analyze the interaction between oral anticoagulation (OAC) status or AF with bridging IVT, regarding the occurrence of symptomatic intracranial hemorrhage (sICH) and functional outcome. Materials and Methods Multicentric observational cohort study (BEYOND-SWIFT registry) of consecutive patients undergoing MT between 2010 and 2018 (n = 2,941). Multinomial regression models were adjusted for prespecified baseline and plausible pathophysiological covariates identified on a univariate analysis to assess the association of AF and OAC status with sICH and good outcomes (90-day modified Rankin Scale score 0–2). Results In the total cohort (median age 74, 50.6% women), 1,347 (45.8%) patients had AF. Higher admission National Institutes of Health Stroke Scale (NIHSS) score (aOR 1.04 [95% 1.02–1.06], per point of increase) and prior medication with Vitamin K antagonists (VKA) (aOR 2.19 [95% 1.27–3.66]) were associated with sICH. Neither AF itself (aOR 0.71 [95% 0.41–1.24]) nor bridging IVT (aOR 1.08 [0.67–1.75]) were significantly associated with increased sICH. Receiving bridging IVT (aOR 1.61 [95% 1.24–2.11]) was associated with good 90-day outcome, with no interaction between AF and IVT (p = 0.92). Conclusion Bridging IVT appears to be a reasonable clinical option in selected patients with AF. Given the increased sICH risk in patients with VKA, subgroup analysis of the randomized controlled trials should analyze whether patients with VKA might benefit from withholding bridging IVT. Registration clinicaltrials.gov; Unique identifier: NCT03496064.

To investigate the association of different phenotypes, count, and locations of chronic covert brain infarctions (CBI) with long‐term mortality in patients with first‐ever manifest acute ischemic stroke (AIS) or transient ischemic attack (TIA). Additionally, to analyze their potential interaction with white matter hyperintensities (WMH) and predictive value in addition to established mortality scores.

Aim To investigate infl uence of neutrophil-to-lymphocyte ratio (NLR) and proatherogenic risk factors to improve the accuracy of pneumonia severity index (PSI) in the prediction of community acquired pneumonia (CAP) outcome in healthy individuals. Methods A retrospective observational cross-sectional study conducted at the Clinic for Pulmonary Diseases and Tuberculosis "Podhrastovi", University Clinical Centre Sarajevo, included 83 patients with the diagnosis of CAP during the period March 2019-March 2021. Once diagnosed with CAP, PSI score was calculated and according to its value the need for hospital treatment was identifi ed. Patients were divided in two groups: low risk of CAP (PSI <90), and high risk of CAP (PSI> 90). Results The overall average hospital stay was 22.76±10.154 days. In the patients diagnosed with CAP, a positive correlation was established between the following parameters PSI score and age (r=0.670; p<0.01), C-reactive protein-CRP (rho=0.287; p<0.01), leukocytes (rho=0.406; p<0.01), NLR (rho=0.313; p<0.01) and platelet to lymphocyte ratio (PLR) (0.296; p<0.05). CRP, leukocytes, NLR and PLR were statistically signifi cantly higher in patients with high risk of CAP compared to patients with low risk of CAP. Diastolic blood pressure, lymphocytes, eosinophils were signifi cantly lower in patients with high risk of CAP (p<0.05;) compared to patients with low risk of CAP (p<0.01). The optimal cut-off value of NLR for CAP patients was 3.089 with an estimated area under curve (AUC) of 0.664. Conclusion Proatherogenic parameters such as age, systolic blood pressure and leukocytes in combination with neutrophil-lymphocyte count ratio could improve accuracy of the pneumonia severity index in community acquired pneumonia outcome.

Background: Conflicting data exist on traditional lipid profiles in patients with Alzheimer’s disease (AD) and vascular dementia (VD), whereas scarce number of studies evaluated non-traditional lipid profiles in patients with AD and VD. Studies have shown that ethnic background may affect lipid profile. Objective: The aim of the present study was to conduct comparative assessment of traditional and non-traditional lipid profiles in Bosnian patients with AD and VD. Methods: A controlled, cross-sectional study was performed with 66 patients with AD, 50 patients with VD, and 60 control subjects. The Montreal Cognitive Assessment (MoCA) test was used for an evaluation of the global cognitive function. The Hachinski ischemic score was used to distinguish patients with VD from those with AD. Plasma total cholesterol (TC), high-density lipoprotein -cholesterol (HDL-C), and triglycerides (TG) levels were determined using standard enzymatic colorimetric techniques, whereas the Friedewald formula was used to calculate low-density lipoprotein-cholesterol (LDL-C) levels. The non-traditional lipid indices such as TG/HDL-C, TC/HDL-C, and LDL-C/HDL-C ratio were separately calculated. The differences between the groups were analyzed with ANOVA followed by the Tuckey posthoc test or with the Kruskal Wallis test followed by the Mann-Whitney test. Results: Results of the present study have shown that patients in AD group had significantly lower level of TC, TG, LDL-C, VLDL-C, Non-HDL-C and significantly lower atherogenic index compared to the control group (CG) and compared to the VD patients. Significant difference in values of TG and VLDL-C was observed between VD and the CG, whereas no significant difference in values of TC, LDL-C, atherogenic index and Non-HDL-C was observed between these two groups. Our results have also shown that TG/HDL-C, TC/HDL-C, and LDL-C/HDL-C ratios were significantly lower in AD patients compared to the VD and CG. Moreover, TG/HDL-C ratio was significantly lower in VD compared to the CG. However, a significant difference in TC/HDL-C and LDL-C/HDL-C was not observed between VD and the CG. Conclusion: Based on the results of the present study it can be deduced that there is a difference in traditional and non-traditional lipid profiles between AD and VD patients of Bosnian descent. Obtained results suggest that lipids are decreased in AD and in VD to a certain extent. However, since there is an inconsistence in literature whether there is an association between cholesterol and cognition, large prospective studies are required to elucidate this controversy.

Vehicle automation and connectivity bring new opportunities for safe and sustainable mobility in urban and highway networks. Such opportunities are however not directly associated with traffic flow improvements. Research on exploitation of connected and automated vehicles (CAVs) toward a more efficient traffic currently remains at a theoretical level, and/or based on simulation models with limited reliability. Furthermore, testing CAVs in the real world is still costly and very challenging from an implementation perspective. A possible alternative is to use automated robots. By designing and testing both the low- and the high-level controllers of CAVs, it is indeed possible to reach a better understanding of the challenges that future vehicles will need to face. Robotic applications can effectively test these challenges within a wide variety of research communities—for example, via robotic competitions. Along this direction, the Joint Research Centre has organized the first European robotic traffic competition for automated miniature vehicles. Each team participated with four robots and was judged based on a set of indicators that assess the collective behaviors of the vehicles. Results show the suitability of the methodology with different teams proposing completely different approaches to deal with the challenge and thus achieving different results. Future competitions may further raise awareness about the possibility of using CAVs to improve traffic and to engage with a broader community to design systems that are really capable of achieving this goal.