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This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future. [ABSTRACT FROM AUTHOR]

This paper discusses the variation between generic soil screening values (SSV) from 17 countries for 11 volatile organic contaminants (VOC). The variation between SSV was one to four orders-of- magnitude (OOM) depending on the SSV and landuse type. What would be the variation if parameter values are harmonized between member states? The effect of harmonization was visualized by firstly reviewing the technical derivation procedure for SSV for 7 SSV from five countries and collecting all parameter values that are involved in the deviation. The parameters were subdivided in scientific (e.g. algorithm plus its parameter values), political (e.g. toxicological reference) or geographical (e.g. building and soil properties) elements. Secondly, new SSV were calculated with progressively harmonized sets of scientific andlor political parameter values, while the geographical parameters varied. Thirdly, the variation between SSV was compared before and after harmonization. Results show that harmonizing algorithms plus other scientific and political parameters are suited for harmonization. The variation decreases to I OOM, after scientific and political parameters were harmonized. Geographical parameters seem to have less impact on the differences between SSV. So, should we harmonize the procedures for deriving SSV between EU member states? The need for discussing harmonization is also raised by the upcoming EU Soil Framework Directive. Clearly common generic SSV across all of Europe are not appropriate, since countries are allowed to include member state specific geographical and cultural elements and also political decision making. By harmonizing scientific andlor political parameters differences between SSV can be made more transparent between member states and it will encourage convergence in procedures among member states to ensure neutral conditions of competition and a coherent soil protection regime throughout Europe. To promote uniformity it is recommended to construct a toolbox for the calculation of human health risk exposure, carried by a European consensus, that includes different model algorithms for which fixed and flexible input parameters are made available. Fixed algorithm parameters are standardized and applied uniformly by all member states, e.g. physico- chemical parameters, while flexible input parameters permits member states to include region or country specific parameter values and policy decisions. [ABSTRACT FROM AUTHOR]

This paper proposes an enhanced algorithm to estimate the differential code biases (DCB) on three frequencies of the BeiDou Navigation Satellite System (BDS) satellites. By forming ionospheric observables derived from uncombined precise point positioning and geometry-free linear combination of phase-smoothed range, satellite DCBs are determined together with ionospheric delay that is modeled at each individual station. Specifically, the DCB and ionospheric delay are estimated in a weighted least-squares estimator by considering the precision of ionospheric observables, and a misclosure constraint for different types of satellite DCBs is introduced. This algorithm was tested by GNSS data collected in November and December 2013 from 29 stations of Multi-GNSS Experiment (MGEX) and BeiDou Experimental Tracking Stations. Results show that the proposed algorithm is able to precisely estimate BDS satellite DCBs, where the mean value of day-to-day scattering is about 0.19 ns and the RMS of the difference with respect to MGEX DCB products is about 0.24 ns. In order to make comparison, an existing algorithm based on IGG: Institute of Geodesy and Geophysics, China (IGGDCB), is also used to process the same dataset. Results show that, the DCB difference between results from the enhanced algorithm and the DCB products from Center for Orbit Determination in Europe (CODE) and MGEX is reduced in average by 46 % for GPS satellites and 14 % for BDS satellites, when compared with DCB difference between the results of IGGDCB algorithm and the DCB products from CODE and MGEX. In addition, we find the day-to-day scattering of BDS IGSO satellites is obviously lower than that of GEO and MEO satellites, and a significant bias exists in daily DCB values of GEO satellites comparing with MGEX DCB product. This proposed algorithm also provides a new approach to estimate the satellite DCBs of multiple GNSS systems. [ABSTRACT FROM AUTHOR]

This paper explores written calculation methods for division used by pupils in England (n = 276) and the Netherlands (n = 259) at two points in the same school year. Informal strategies are analysed and progression identified towards more structured procedures that result from different teaching approaches. Comparison of the methods used by year 5 (Group 6) pupils in the two countries shows greater success in the Dutch approach, which is based on careful progression from informal strategies to more structured and efficient procedures. This success is particularly notable for the girls in the sample. For the English pupils, whose written solutions largely involved the traditional algorithm, the discontinuity between the formal computation procedure and informal solution strategies presents difficulties. [ABSTRACT FROM AUTHOR]

Since Francis Fontan first introduced the eponymous technique, the Fontan procedure, this type of surgical palliation has allowed thousands of children affected by specific heart malformations to reach adulthood. Nevertheless, abdominal, thoracic, lymphatic and neurologic complications are the price that is paid by these patients. Our review focuses on Fontan-associated liver disease; the purpose is to summarize the current understanding of its physiopathology, the aim of follow-up and the specific radiologic follow-up performed in Europe. Finally, we as members of the Abdominal Task Force of the European Society of Paediatric Radiology propose a consensus-based imaging follow-up algorithm. [ABSTRACT FROM AUTHOR]

Aim: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) algorithm for the management of knee osteoarthritis (OA) is available worldwide from 2014, but in 2019 an update was published. Based on this algorithm, a Working Group (WG), including ESCEO members and Chinese experts, wished to see how the new ESCEO algorithm was perceived by Chinese experts in knee OA and how it was integrated into their clinical practice. Methods: A WG was held between members of the international ESCEO task force and a group of Chinese experts. Results: Non-pharmacological approach should be combined with pharmacological interventions. In step 1, symptomatic slow-acting drugs for osteoarthritis (SYSADOA) are the most important background drugs. Evidence, supported by high-quality research, is available only for crystalline glucosamine sulfate (pCGS) and chondroitin sulfate. Topical NSAIDs could be used as an additional option. In step 2, oral NSAIDs could be useful, but cardiovascular/renal/gastrointestinal profiles of the patients should be considered. Intra-articular hyaluronic acid and corticosteroids are alternative to oral NSAIDs, but the evidence is still limited. If steps 1 and 2 are not sufficient, weak opioids could be used. Overall, the conclusions of the ESCEO algorithm are accepted in China for products available in this country. The WG suggests the importance of economic studies, specifically made in China. Conclusion: This work provides evidence-based advice to establish a treatment algorithm in knee OA, for practical implementation in clinical practice in China. [ABSTRACT FROM AUTHOR]

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Objective: The long-term predictive value of the new proposed algorithm in the updated 2016 guidelines of the European Association of Cardiovascular Imaging to assess diastolic dysfunction (DD) in patients with heart failure with preserved ejection fraction (HFpEF) has not been validated.Methods: The analysis included 451 patients who were diagnosed with HFpEF as confirmed via echocardiography. The endpoints were mortality and hospitalization for HF. The Kaplan-Meier curves and Cox regression models were generated to determine the risk of all-cause mortality based on the 2016 and 2009 DD grading algorithm, respectively. We evaluated the net reclassification index of outcomes on the basis of 2009 DD grade after abiding by the 2016 recommendations.Results: After a follow-up of 2976 days, 119 patients (26.4%) died. According to the 2016 DD grading, grade III DD was associated with a significantly higher risk of mortality (hazard ratio [HR], 2.209; 95% CI 1.144-4.266) and HF hospitalization (HR, 2.047; 95% CI 1.348-3.870), as compared with grade I DD. Grade II DD was also associated with a higher risk of mortality (HR, 1.538; 95% CI 1.313-1.924). However, only grade III DD was independently associated with worse mortality based on 2009 DD grading. The net reclassification index for mortality increased significantly after grading by 2016 algorithm (10.6%, p < 0.001).Conclusions: The 2016 DD grading algorithm showed improved prognostic value of long-term mortality in patients with HFpEF. Based on the findings of the study, the appropriate grading of DD is important in the prognostication of patients with HFpEF.Key Points: • The application of the 2016 European Association of Cardiovascular Imaging recommendations diastolic dysfunction (DD) grading algorithm improves the predictive value for mortality. • Our analysis suggests DD grades II and III based on 2016 guidelines is associated with poor outcomes as compared with grade I. The echocardiographic indices of the new algorithm should be obtained and applied to effectively evaluate DD. [ABSTRACT FROM AUTHOR]

Purpose: This prospective study explores high sensitivity C-reactive protein (hs-CRP) levels in relation to dietary patterns at two time points in European children.Methods: Out of the baseline sample of the IDEFICS study (n = 16,228), 4020 children, aged 2-9 years at baseline, with available hs-CRP levels and valid data from a food frequency questionnaire (FFQ) at baseline (T0) and 2 years later (T1) were included. K-means clustering algorithm based on the similarities between relative food consumption frequencies of the FFQ was applied. hs-CRP was dichotomized according to sex-specific cutoff points. Multilevel logistic regression was performed to assess the relationship between dietary patterns and hs-CRP adjusting for covariates.Results: Three consistent dietary patterns were found at T0 and T1: ‘animal protein and refined carbohydrate’, ‘sweet and processed’ and ‘healthy’. Children allocated to the ‘protein’ and ‘sweet and processed’ clusters at both time points had significantly higher odds of being in the highest category of hs-CRP (OR 1.47; 95% CI 1.03-2.09 for ‘animal protein and refined carbohydrate’ and OR 1.44; 95% CI 1.08-1.92 for ‘sweet and processed’) compared to the ‘healthy’ cluster. The odds remained significantly higher for the ‘sweet and processed’ pattern (OR 1.39; 95% CI 1.05-1.84) when covariates were included.Conclusions: A dietary pattern characterized by frequent consumption of sugar and processed products and infrequent consumption of vegetables and fruits over time was independently related with inflammation in European children. Efforts to improve the quality of the diet in childhood may prevent future diseases related with chronic inflammation. [ABSTRACT FROM AUTHOR]

Objective: Our aim was to determine the prevalence of tuberculosis (TB), the number needed to screen (NNS), and the diagnostic accuracy of chest X-ray (CXR) screening to detect active pulmonary TB during the 2015 European refugee crisis.Materials and Methods: We evaluated data of all refugees who underwent CXR screening in a single-centre of one German metropolitan area in 2015. We determined the prevalence of TB, NNS, and accuracy of CXR to detect active pulmonary TB. Reference method for active TB was the database of all definite TB cases registered at the Department of Public Health.Results: A total of 17,487 immigrants underwent single-centre CXR screening in 2015; prevalence of definite pulmonary TB was 0.103%. The NNS for detecting one case of active pulmonary TB was 1749. CXR had a sensitivity of 55.6% [95% confidence interval (CI) 30.8-78.5%) and a specificity 98.3% (CI 98.1-98.5%) to reveal one case of active TB.Conclusion: Our single-centre study indicates that chest X-ray screening for TB during the 2015 European refugee crisis was of low yield due the low prevalence of TB and high number needed to screen, thus implicating the need for improved screening algorithms adapted to the overwhelming number of refugees.Key Points: • Prevalence of pulmonary tuberculosis (TB) among refugees in 2015 was low (0.103%). • The number needed to screen to detect one case of active pulmonary TB was 1749. • Tuberculosis X-ray screening resulted in a low sensitivity and high specificity. • Tuberculosis X-ray screening during the European refugee crisis is of low yield. • Improved screening algorithms are needed due to the overwhelming the number of refugees. [ABSTRACT FROM AUTHOR]

Objective: Our aim was to estimate the prevalence-based cost of illness imposed by nocturia (≥2 nocturnal voids per night) in Germany, Sweden, and the UK in an average year.Methods: Information obtained from a systematic review of published literature and clinicians was used to construct an algorithm depicting the management of nocturia in these three countries. This enabled an estimation of (1) annual levels of healthcare resource use, (2) annual cost of healthcare resource use, and (3) annual societal cost arising from presenteeism and absenteeism attributable to nocturia in each country.Results: In an average year, there are an estimated 12.5, 1.2, and 8.6 million patients ≥20 years of age with nocturia in Germany, Sweden, and the UK, respectively. In an average year in each country, respectively, these patients were estimated to have 13.8, 1.4, and 10.0 million visits to a family practitioner or specialist, ~91,000, 9000, and 63,000 hospital admissions attributable to nocturia and 216,000, 19,000, and 130,000 subjects were estimated to incur a fracture resulting from nocturia. The annual direct cost of healthcare resource use attributable to managing nocturia was estimated to be approximately €2.32 billion in Germany, 5.11 billion kr (€0.54 billion) in Sweden, and £1.35 billion (€1.77 billion) in the UK. The annual indirect societal cost arising from both presenteeism and absenteeism was estimated to be approximately €20.76 billion in Germany and 19.65 billion kr (€2.10 billion) in Sweden. In addition, in the UK, the annual indirect cost due to absenteeism was an estimated £4.32 billion (€5.64 billion).Conclusions: Nocturia appears to impose a substantial socioeconomic burden in all three countries. Clinical and economic benefits could accrue from an increased awareness of the impact that nocturia imposes on patients, health services, and society as a whole. [ABSTRACT FROM AUTHOR]

The current study aimed to investigate the Autism Diagnostic Interview-Revised (ADI-R) algorithms for toddlers and young preschoolers (Kim and Lord, J Autism Dev Disord 42(1):82-93, ) in a non-US sample from ten sites in nine countries (n = 1,104). The construct validity indicated a good fit of the algorithms. The diagnostic validity was lower, with satisfactorily high specificities but moderate sensitivities. Young children with clinical ASD and lower language ability were largely in the mild-to-moderate or moderate-to-severe concern ranges of the ADI-R, nearly half of the older and phrase speech ASD-group fell into the little-to-no concern range. Although broadly the findings support the toddler algorithms, further work is required to understand why they might have different properties in different samples to further inform research and clinical use. [ABSTRACT FROM AUTHOR]

Hypertension is a major modifiable risk for the development of cardiovascular, cerebrovascular and renal diseases. Thus, effective treatment of high blood pressure is an important strategy for reducing disease burden; however, in spite of the availability of numerous effective therapies only 30-40 % of patients with hypertension achieve the recommended blood pressure goals of <140/90 mmHg. Lack of adherence to therapy and reluctance to intensify therapy are cited frequently to explain the discrepancy between potential and attained outcomes. Adherence is closely related to the tolerability, effectiveness and complexity of therapy. Therapeutic inertia may be influenced by concerns over tolerability, as well as the lack of clear preferences for therapies when managing patients with risk factors and comorbidities. Effective and well-tolerated single pill combination therapies are now available that improve adherence and simplify treatment. The combination of a renin-angiotensin system blocker with a calcium channel blocker and a diuretic improves adherence to therapy. We have devised a practical tool for orienting the application of well-tolerated single pill 2/3 drug fixed dose combination therapies in clinical situations commonly encountered when treating hypertensive patients. This approach employs the angiotensin receptor blocker olmesartan alone or in combinations with amlodipine and/or hydrochlorothiazide. This platform is based on clinical evidence, guidelines, best practice, and clinical experience where none of these is available. We believe it will increase the percentage of hypertensive patients who achieve blood pressure control when applied as part of an integrative approach that includes regular follow-up and instruction on lifestyle changes. [ABSTRACT FROM AUTHOR]

Summary: Guidance is provided in a European setting on the assessment and treatment of postmenopausal women at risk of fractures due to osteoporosis. Introduction: The International Osteoporosis Foundation and European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis published guidance for the diagnosis and management of osteoporosis in 2008. This manuscript updates these in a European setting. Methods: Systematic literature reviews. Results: The following areas are reviewed: the role of bone mineral density measurement for the diagnosis of osteoporosis and assessment of fracture risk, general and pharmacological management of osteoporosis, monitoring of treatment, assessment of fracture risk, case finding strategies, investigation of patients and health economics of treatment. Conclusions: A platform is provided on which specific guidelines can be developed for national use. [ABSTRACT FROM AUTHOR]

As a main contribution we present a new approach for studying the problem of optimal partial hedging of an American contingent claim in a finite and complete discrete-time market. We assume that at an early exercise time the investor can borrow the amount she has to pay for the option holder by entering a short position in the numéraire asset and that this loan in turn will mature at the expiration date. We model and solve a partial hedging problem, where the investor's purpose is to find a minimal amount at which she can hedge the above-mentioned loan with a given probability, while the potential shortfall is bounded above by a certain number of numéraire assets. A knapsack problem approach and greedy algorithm are used in solving the problem. To get a wider view of the subject and to make interesting comparisons, we treat also a closely related European case as well as an American case where a barrier condition is applied. [ABSTRACT FROM AUTHOR]

Unstructured mesh models can resolve the model domain with a variable and very fine mesh resolution. Nevertheless, tuning the model setup is still required (for example because of parametrized sub-grid processes). Adjoint models are commonly used to calculate sensitivities of ocean models and optimize their parameters so that better agreement is achieved between model simulations and observations. One major obstacle in developing an adjoint model is the need to update the reverse code after each modification of the forward code, which is not always straightforward. Automatic differentiation is a tool to generate the adjoint model code without user input. So far this method has mainly been used for structured mesh ocean models. We present here an unstructured mesh, adjoint, tidal model using this technique, and discuss the sensitivities of the misfit between simulated and observed elevations with respect to open boundary values, the bottom friction coefficient and the bottom topography. The forward model simulates tides on the European Continental Shelf and we show that the tidal model dynamics in the adjoint simulations can be used to define regions, where parameters or mesh has to be optimized. We analyze the dependence of the sensitivities on the wave type and mesh resolution to specify whether the model misfit originates from physical or numerical model deficiencies. In the sensitivity patterns, it is possible to identify islands not resolved in the mesh. We propose to refine the mesh prior to the parameter optimization. [ABSTRACT FROM AUTHOR]

Background: The new REACH legislation requires assessment of a large number of chemicals in the European market for several endpoints. Developmental toxicity is one of the most difficult endpoints to assess, on account of the complexity, length and costs of experiments. Following the encouragement of QSAR (in silico) methods provided in the REACH itself, the CAESAR project has developed several models. Results: Two QSAR models for developmental toxicity have been developed, using different statistical/ mathematical methods. Both models performed well. The first makes a classification based on a random forest algorithm, while the second is based on an adaptive fuzzy partition algorithm. The first model has been implemented and inserted into the CAESAR on-line application, which is java-based software that allows everyone to freely use the models. Conclusions: The CAESAR QSAR models have been developed with the aim to minimize false negatives in order to make them more usable for REACH. The CAESAR on-line application ensures that both industry and regulators can easily access and use the developmental toxicity model (as well as the models for the other four endpoints). [ABSTRACT FROM AUTHOR]

A new multi-trajectory highly vectorizable Gear chemical-transport model is discussed and tested against measurements from 25 sites in Europe for a two-week summer period. The simulations are compared with measurement data and with results of a Quasi-Steady-State Approximation (QSSA) based Lagrangian model using the EMEP mechanism.The model is developed from the Lagrangian EMEP model. The Regional Atmospheric Chemistry Mechanism (RACM) is used as the model’s chemical mechanism. To solve the stiff chemical rate equations, a sparse-matrix highly vectorizable Gear algorithm is used. The meteorological data used to run the model are obtained from the HIgh Resolution Limited Area Model (HIRLAM).The vectorized Gear based model improves the accuracy of the numerical solution for the chemistry compared with the QSSA based model. The differences between the two models are explained by alternative approaches of the chemical modules employed in the model: a Gear algorithm versus a QSSA solver, photolysis rate parameters in RACM are calculated from a radiation transfer code versus parameterized photolysis rate parameters used in the Lagrangian EMEP model, the RACM versus the EMEP atmospheric chemical mechanisms and two methods of aggregating the emissions of Volatile Organic Compounds (VOC). Photolysis rate parameters calculated from radiation codes (which are more accurate than simple parameterizations) and the Gear algorithm (which is a benchmark solver compared with the QSSA solver) are recommended for atmospheric chemistry modeling because of the high sensitivity of ozone concentrations to the chemical reaction scheme and to the photolysis rates (Stockwell and Goliff, 2004). [ABSTRACT FROM AUTHOR]

We extend Free Disposable Hull (FDH) efficiency analysis towards the general directional distance function framework. The profit interpretation of directional distance functions is extended to the non-convex FDH technologies. In addition, we derive an efficient enumerative algorithm for computing distance measures in Free Disposable Hull (FDH) technologies, which applies to the entire (infinitely large) family of directional distance functions. A simple numerical example and an application to European commercial banks illustrate the algorithm. [ABSTRACT FROM AUTHOR]