How Should We Measure? A Review of Circular Cities Indicators

As the world continues to urbanize, it is necessary to identify and implement new urban development models and strategies in order to meet the challenges of sustainable development. As cities continue to face challenges in becoming fully circular, the need to establish a framework to measure the circular economy in urban areas grows. Many definitions for circular cities have been developed and addressed in recent years, as have numerous indicators. To make the transition to a circular city, we must integrate the findings and develop a general definition and measurement framework. This article aims at outlining a framework for circular cities indicators based on their key characteristics, as well providing directions for fostering circularity at the city level. To accomplish this goal, we conducted a systematic review and analyzed key papers published in the field of circular economy to determine how circular cities are measured. Choosing the right indicators to use for developing, monitoring, and evaluating circular cities is a difficult task for urban policymakers, managers, and planners. This highlights the significance of standardized frameworks for urban indicators. As a result, the authors propose a framework and highlight some key points about circular cities and smart urban metabolism

Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases

Studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology. A significant number of questions were related to the pediatric population and/or rare diseases. A total of 27 regulatory-led RWD studies have been conducted. Most studies were descriptive and aimed at estimating incidence and prevalence rates of clinical outcomes including adverse events or to evaluate medicines utilization. The review highlights key learnings to guide further efforts to enable the use and establish the value of real-world evidence (RWE) for regulatory decisions. For instance, there is a need to access additional fit-for-purpose and representative data, and to explore further means to provide timely evidence that meets regulatory timelines. The need for early interactions and close collaboration with study requesters, e.g., from the Agency's scientific Committees, to better understand the research question is equally important. Finally, the review provides our perspective on the way forward to maximize the potential of regulatory-led RWE generation

The Effect of Gd Impurities on the Physical Properties of Half-Metallic Ferromagnet Co2MnSiCo_2MnSi

In this paper we report our experimental and theoretical studies on the effect of Gd impurity on the physical properties of the Heusler half-metallic ferromagnet $Co_2MnSi$. The analysis of the band structures of the doped alloy shows that the half-metallic properties are completely conserved if Gd substitutes Mn atoms. This effect is not determined by the spin-orbit interaction, but through the coupling between the R(4f) spin with the Mn(3d) itinerant electron spins. We evaluate the strength of such a coupling by calculating, in an ab initio fashion, the total energy of $Co_{16}GdMn_7Si_8$ compound for a parallel and antiparallel f-d coupling. The obtained magnetic moments of Co or Mn sites are in good agreement with the experimental ones

Impact of different assumptions on estimates of childhood diseases obtained from health care data : A retrospective cohort study

PURPOSE: Accurate estimates of disease incidence in children are required to support pediatric drug development. Analysis of electronic health care records (EHR) may yield such estimates but pediatric-specific methods are lacking. We aimed to understand the impact of assumptions regarding duration of disease episode and length of run-in period on incidence estimates from EHRs. METHODS: Children aged 0 to 17 years (5-17 years for asthma) registered in the Integrated Primary Care Information database between 2002 and 2014 were studied. We tested the impact of the following: maximum duration of disease episode (0, 14, 30, 60, and 90 days) on recurrent diseases (acute otitis media [common] and acute pyelonephritis [rare]); and database run-in period on chronic diseases-asthma (common) and type 1 diabetes (DM) (rare). We calculated incidence rate ratios with 95% confidence intervals and stratified using 1-year age categories. RESULTS: Altogether, 503 495 children were registered. The incidence of acute otitis media was highest in <2-year-old children; using 30 days disease duration as reference, the rate increased with 8% if the duration was 14 days and decreased with 8% when extended to 60 days. Disease duration did not impact acute pyelonephritis (rare). No run-in (to exclude prevalent cases) versus 24-month run-in period overestimated the incidence rate for asthma and DM by a factor of 2. CONCLUSIONS: Analysis of EHR allows for estimation of disease incidence in children, but assumptions regarding episode length and run-in period impact the incidence estimates. Such assumptions may be routinely explored

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports

INTRODUCTION: As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE: Our objective was to provide an overview of adverse drug events associated with asthma medications in children from a spontaneous reports database and to identify new signals. METHODS: Spontaneous reports concerning asthma drugs were obtained from EudraVigilance, the European Medicine Agency's database for suspected adverse drug reactions. For each drug-event combination, we calculated the proportional reporting ratio (PRR) in the study period 2011-2017. Signals in children (aged 0-17 years) were compared with signals in the whole population. Analyses were repeated for different age categories, by sex and by therapeutic area. RESULTS: In total, 372,345 reports in children resulted in 385 different signals concerning asthma therapy. The largest group consisted of psychiatric events (65 signals). Only 30 signals were new, with seven, including herpes viral infections, associated with omalizumab. Stratification by age, sex and therapeutic area provided additional new signals, such as hypertrichoses with budesonide and encephalopathies with theophylline. Of all signals in children, 60 (16%) did not appear in the whole population. CONCLUSIONS: The majority of signals regarding asthma therapy in children were already known, but we also identified new signals. We showed that signals can be masked if age stratification is not conducted. Further exploration is needed to investigate the risk and causality of the newly found signals

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports

INTRODUCTION: As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE: Our objective was to provide an overview of adverse drug events associated with asthma medications in children from a spontaneous reports database and to identify new signals. METHODS: Spontaneous reports concerning asthma drugs were obtained from EudraVigilance, the European Medicine Agency's database for suspected adverse drug reactions. For each drug-event combination, we calculated the proportional reporting ratio (PRR) in the study period 2011-2017. Signals in children (aged 0-17 years) were compared with signals in the whole population. Analyses were repeated for different age categories, by sex and by therapeutic area. RESULTS: In total, 372,345 reports in children resulted in 385 different signals concerning asthma therapy. The largest group consisted of psychiatric events (65 signals). Only 30 signals were new, with seven, including herpes viral infections, associated with omalizumab. Stratification by age, sex and therapeutic area provided additional new signals, such as hypertrichoses with budesonide and encephalopathies with theophylline. Of all signals in children, 60 (16%) did not appear in the whole population. CONCLUSIONS: The majority of signals regarding asthma therapy in children were already known, but we also identified new signals. We showed that signals can be masked if age stratification is not conducted. Further exploration is needed to investigate the risk and causality of the newly found signals

Sarkad, Gyula, Békéscsaba 10. évfolyamos fiatalok életvitelének vizsgálata

Purpose: In order to identify challenges in pediatric pharmacoepidemiological safety studies, we assessed the characteristics of such (published) studies. Methods: Relevant articles from inception to 2013 were retrieved from Embase and Medline. We sequentially screened titles, abstracts and full texts with independent validation. We systematically collected data regarding general information, study methods and results. Results: Out of 4825 unique articles, 268 full texts (5.6%) were retained; 147 (54.9%) pertained to drugs rather than vaccines. Considering the 268 studies, 202 (75.4%) concerned children and adolescents (2 to 11 years) and 14 (5.3%) included preterm newborns. Most studies originated from North America (154 [57.5%]) or Europe (92 [34.3%]). Only 47 studies (17.5%) were privately funded. The majority (174 [64.9%]) were cohort studies. Out of 268 studies, 196 (73.1%) collected data retrospectively; paper medical charts were the most common data source for the exposures (85 [31.7%]) and outcomes (122 [45.5%]). Only 3 (2.0%) drug-only studies investigated rarely used drugs. Considering all 268 studies, only 27 (10.1%) reported sample size or power calculation. Most (75 [51.0%]) drug-only studies corrected confounding by multivariate modeling unlike stratification in 66 (55.9%) vaccine-only studies. Considering 75 child-only studies without any statistically significant result, 41 (54.7%) did not discuss lack of power. Conclusions: Although the field of pediatric pharmacoepidemiology is steadily developing evaluation seldom includes neonates, is mainly focused on few drug classes and safety outcomes and concerns mainly drug use in developed countries. Small study size is a specific challenge in pediatrics. Reporting should be improved. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd