Successive Harmonics Research Articles

Enhancing real world data interoperability in healthcare: A methodological approach to laboratory unit harmonization

ObjectiveThe primary aim of this study is to address the critical issue of non-standardized units in clinical laboratory data, which poses significant challenges to data interoperability and secondary usage. Despite UCUM (Unified Code for Units of Measure) offering a unique representation for laboratory test units, nearly 60% of laboratory codes in healthcare organizations use non-standard units. We sought to design, implement and test a methodology for the harmonization of units to the UCUM standards across a large research network. MethodsUsing dimensional analysis and a curated equivalence table, the proposed methodology harmonizes disparate units to UCUM standards. The process focused on identifying and converting non-UCUM conforming units, with the goal of enhancing data comparability and interoperability across different systems. ResultsThe methodology successfully achieved over 90% coverage of laboratory data with units in UCUM standards across the TriNetX research network, a significant improvement from baseline measurements. This enhancement in unit standardization directly contributed to increased interoperability of laboratory data, facilitating more reliable and comparable data analysis across various healthcare organizations. ConclusionThe successful harmonization of laboratory data units to UCUM standards represents a significant advancement in the field of biomedical informatics. By demonstrating a practical and effective approach to overcoming the challenges of non-standardized units, our study contributes to the broader efforts to improve data interoperability and usability for secondary purposes such as research and observational studies. Future work will focus on addressing the remaining gaps in unit standardization and exploring the implications of this methodology on clinical outcomes and research capabilities.

Harmonizing lightweight and ablation resistance: Design and performance of multilayer composite insulation materials for solid rocket motors

AbstractThe realization of lightweight insulation materials is often accompanied by a decrease in ablation performance. Coordinating the contradiction between lightweight and ablation resistance is the key to the development of thermal protection technology. Addressing the need for high‐performance insulation materials within solid rocket motors (SRMs) combustion chambers, we designed three multilayer composite structural insulation materials and studied their properties. The results show that among these constructed multilayer composites, the bilayer structure exhibited the lowest density at a mere 0.72 g/cm3, marking a 27% reduction compared to the basic structure. Remarkably, the bilayer configuration demonstrated superior ablation resistance, showcasing a 25% decrease in the line ablation rate in contrast to the basic structure after oxygen‐acetylene test. This achievement embodies the successful harmonization of lightweight properties with ablation resistance. Furthermore, based on the performance and microstructure of the char layer, a further analysis revealed the enhancement mechanism of ablative performance by the multilayer composite structure. It was found that the synergistic effect of the compact/porous structure of the char layer grants the bilayer structure thermal insulation material optimal ablative performance. This work provides strong support for improving the performance of SRMs.Highlights Insulation materials with multilayer composite structures are designed. The materials exhibit both lightweight and superior ablation resistance. Compact/porous char layers enhance material ablation performance.

The Implementation of Equidistance Line on Maritime Delimitation between Indonesia-Australia in Perth Treaty 1997

This article proposes some suggestions to the government in renegotiating the Perth Treaty to provide a solution for a definitive maritime boundary between Indonesia and Australia. Renegotiation of the Perth Treaty in terms of maritime delimitation between the two countries needs to be done in relation to the limitation of sovereignty of both countries. This treaty has never been ratified by both countries after the signing in 1998. The fundamental reason of Australia is associated with the independence of Timor-Leste in 1999 so that the rebus sic stantibus principle then applies. This research employed legal method to provide recommendations to the government as a basis for renegotiating the Perth Treaty according to international law. It also used a statutory and case approach. There are underlying reasons for the urgency of renegotiating the Perth Treaty using the median line with an equidistance line approach. The median line in UNCLOS 1982 has proven to provide progressive results regarding the maritime delimitation of countries. However the decisions of the International Court of Justice, resulted in various side effects with the use of the median line as a single effort to resolve maritime delimitation disputes. Therefore, a new solution is proposed, namely the median line with an equidistance line approach as the most effective method to create justice for each party. The equidistance line in international law serves as a legal resolution method, emerging from customary practices. It is recognized as new customary law for resolving maritime delimitation disputes between countries. Harmonisation of the median line concept using the equidistance line approach in resolving maritime delimitation disputes between Indonesia and Australia is a new approach that can be used based on the successful harmonisation of these two concepts in resolving delimitation disputes globally.

Phenotype harmonization and analysis for The Populations Underrepresented in Mental illness Association Studies (the PUMAS Project).

The Populations Underrepresented in Mental illness Association Studies (PUMAS) project is attempting to remediate the historical underrepresentation of African and Latin American populations in psychiatric genetics through large-scale genetic association studies of individuals diagnosed with a serious mental illness [SMI, including schizophrenia (SCZ), schizoaffective disorder (SZA) bipolar disorder (BP), and severe major depressive disorder (MDD)] and matched controls. Given growing evidence indicating substantial symptomatic and genetic overlap between these diagnoses, we sought to enable transdiagnostic genetic analyses of PUMAS data by conducting phenotype alignment and harmonization for 89,320 participants (48,165 cases and 41,155 controls) from four cohorts, each of which used different ascertainment and assessment methods: PAISA n=9,105; PUMAS-LATAM n=14,638; NGAP n=42,953 and GPC n=22,624. As we describe here, these efforts have yielded harmonized datasets enabling us to analyze PUMAS genetic variation data at three levels: SMI overall, diagnoses, and individual symptoms. In aligning item-level phenotypes obtained from 14 different clinical instruments, we incorporated content, branching nature, and time frame for each phenotype; standardized diagnoses; and selected 19 core SMI item-level phenotypes for analyses. The harmonization was evaluated in PUMAS cases using multiple correspondence analysis (MCA), co-occurrence analyses, and item-level endorsement. We mapped >6,895 item-level phenotypes in the aggregated PUMAS data, in which SCZ (44.97%) and severe BP (BP-I, 31.53%) were the most common diagnoses. Twelve of the 19 core item-level phenotypes occurred at frequencies of > 10% across all diagnoses, indicating their potential utility for transdiagnostic genetic analyses. MCA of the 14 phenotypes that were present for all cohorts revealed consistency across cohorts, and placed MDD and SCZ into separate clusters, while other diagnoses showed no significant phenotypic clustering. Our alignment strategy effectively aggregated extensive phenotypic data obtained using diverse assessment tools. The MCA yielded dimensional scores which we will use for genetic analyses along with the item level phenotypes. After successful harmonization, residual phenotypic heterogeneity between cohorts reflects differences in branching structure of diagnostic instruments, recruitment strategies, and symptom interpretation (due to cultural variation).

A regulatory model for harmonizing tax collection across Nigerian states: The role of the joint tax board

Nigeria's decentralized tax system presents significant challenges to efficient tax administration, with disparities across states leading to issues such as double taxation, revenue leakage, and non-compliance. The need for a harmonized tax system has become more critical as the country seeks to improve its revenue generation and create a more conducive environment for businesses. This paper examines the role of the Joint Tax Board (JTB) in creating a regulatory model that harmonizes tax collection across Nigerian states. The study outlines the complexities of the current tax structure, highlighting the fragmentation between federal and state tax authorities. It also explores the successes and limitations of the JTB in coordinating tax policies, particularly with regard to the Personal Income Tax. Drawing on international examples of successful tax harmonization, the paper proposes a hybrid regulatory model that balances state autonomy with centralized coordination. Key principles for the proposed model include the standardization of tax policies, strengthening of enforcement mechanisms, and the adoption of modern technology to streamline tax administration. Furthermore, the paper discusses the challenges of implementing a harmonized tax system, such as political resistance from states, disparities in technological capacity, and weak enforcement mechanisms. Recommendations include legislative reforms to strengthen the powers of the JTB, capacity building for state tax authorities, and increased collaboration between federal and state governments. In conclusion, this study emphasizes the pivotal role of the JTB in driving tax harmonization and highlights the need for a unified tax system to promote economic growth and improve compliance in Nigeria. Keywords: Regulatory Model, Harmonizing, Tax Collection, Nigerian States, Role, Joint Tax Board.

Stability analysis of plasma waves driven by runaway electrons in tokamak hot plasmas

The local stability analysis of plasma waves driven by runaway electrons (REs) has been performed considering hot plasma Maxwellian background, with electron and ion temperatures of the order of 1 keV. It is shown that hot plasma waves, namely electron plasma waves (EPWs) and ion Bernstein waves (IBWs) can be driven unstable by RE at their coalescence frequency via Cherenkov resonance by RE with energy distribution peaked at about 8 MeV. A skew-normal distribution is used as a model of the RE energy distribution. The EPW and IBW couples of waves occur between any successive ion-cyclotron harmonics frequencies nf ci, above the lower hybrid resonance. At their confluence, the perpendicular group velocity vanishes and significant RF emissions are expected. The frequency gap between two successive confluences is ∼f ci. Groups of RF line emissions, separated by almost constant frequency gap ∼f ci/2 are detected during various quiescent runaway plasma discharges in the FTU tokamak. The analysis of a specific discharge suggests that the frequencies of the line emissions observed and the frequencies occurring at the EPW-IBW confluences are in reasonable agreement. A possible explanation of the line emissions with ∼f ci/2 gap in terms of nonlinear mode coupling is proposed.

Legal regulation of human protection against the effects of ionizing radiation (implementation of EU standards in the legislation of Ukraine)

The legal regulation of human protection against the effects of ionizing radiation (implementation of EU standards in the legislation of Ukraine) is considered. The legal aspects related to the change of the existing system of radiation protection of a person from the impact of ionizing radiation, which is based on the approach - «practice» and «intervention», to the modern European system of radiation protection, which is based on situational analysis and the key concept of the updated system, have been studied. what is the exposure situation, which is defined as one of three situations: planned situation, emergency exposure situation, existing exposure situation.
 According to the results of the study, the need for a comprehensive approach to the implementation of EU legislation in the legislation of Ukraine «on the example of the Council Directive 2013/59/Euratom» is substantiated. In particular, we believe that it is advisable to do this by one separate law, and not in parts, since without the implementation of the main provisions, the implementation of individual provisions leads to problems with their implementation. In our opinion, the Government of Ukraine should develop an «autonomous road map» for each EU directive, the implementation of which concerns the field of activity of more than one public administration body in the field of nuclear energy use, since some provisions of the Directive are not included in the draft laws on implementation, as they belong to spheres of administration of another state administration body. At the same time, aspects of the extensive legislation regulating relations regarding liquidation of the consequences of the Chernobyl accident should be reflected, in particular in the part of radiation protection, which cannot be reflected in the Directive, but belong to the scope of its regulation. Thus, it will simultaneously allow internal harmonization of legislation and avoid the situation of double interpretation of legislation, will contribute to overcoming contradictions, collisions and gaps in the current legislation of Ukraine.
 In some cases, it is important to carry out the synchronous development of other basic regulatory documents, in particular, new Radiation Safety Norms in order to make a harmonious transition from the existing to a new system of radiation protection of humans against the effects of ionizing radiation. In the future, this will contribute to a more successful systematization and harmonization of the entire array of normative legal acts of nuclear legislation in Ukraine.

Successful harmonization in EpiBioS4Rx biomarker study on post-traumatic epilepsy paves the way towards powered preclinical multicenter studies

ObjectiveProject 1 of the Preclinical Multicenter Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) consortium aims to identify preclinical biomarkers for antiepileptogenic therapies following traumatic brain injury (TBI). The international participating centers in Finland, Australia, and the United States have made a concerted effort to ensure protocol harmonization. Here, we evaluate the success of harmonization process by assessing the timing, coverage, and performance between the study sites. MethodWe collected data on animal housing conditions, lateral fluid-percussion injury model production, postoperative care, mortality, post-TBI physiological monitoring, timing of blood sampling and quality, MR imaging timing and protocols, and duration of video-electroencephalography (EEG) follow-up using common data elements. Learning effect in harmonization was assessed by comparing procedural accuracy between the early and late stages of the project. ResultsThe animal housing conditions were comparable between the study sites but the postoperative care procedures varied. Impact pressure, duration of apnea, righting reflex, and acute mortality differed between the study sites (p < 0.001). The severity of TBI on D2 post TBI assessed using the composite neuroscore test was similar between the sites, but recovery of acute somato-motor deficits varied (p < 0.001). A total of 99% of rats included in the final cohort in UEF, 100% in Monash, and 79% in UCLA had blood samples taken at all time points. The timing of sampling differed on day (D)2 (p < 0.05) but not D9 (p > 0.05). Plasma quality was poor in 4% of the samples in UEF, 1% in Monash and 14% in UCLA. More than 97% of the final cohort were MR imaged at all timepoints in all study sites. The timing of imaging did not differ on D2 and D9 (p > 0.05), but varied at D30, 5 months, and ex vivo timepoints (p < 0.001). The percentage of rats that completed the monthly high-density video-EEG follow-up and the duration of video-EEG recording on the 7th post-injury month used for seizure detection for diagnosis of post-traumatic epilepsy differed between the sites (p < 0.001), yet the prevalence of PTE (UEF 21%, Monash 22%, UCLA 23%) was comparable between the sites (p > 0.05). A decrease in acute mortality and increase in plasma quality across time reflected a learning effect in the TBI production and blood sampling protocols. SignificanceOur study is the first demonstration of the feasibility of protocol harmonization for performing powered preclinical multi-center trials for biomarker and therapy discovery of post-traumatic epilepsy.

Analysis of the harmonization of contract law Ukraine with the law of the European Union

The introduction of European norms into national legislation can cause certain problems and disagreements.The reasons that can lead to such disagreements, which are mentioned in the statement of the problem, are primarily cultural and historical differences. Countries have their own cultural and historical characteristics that affect their legal systems. European norms may not always take these differences into account, which may lead to differences in the interpretation and application of the law.The reason is the needs and peculiarities of the national economy, because each country has its own economic structure and needs. European norms may not take into account the specifics of the national economy, which may lead to disagreements and cause difficulties in the implementation of certain provisions.European norms may be formulated ambiguously or leave certain aspects uncertain. This can lead to differences in the interpretation and application of the law, as well as to different approaches in court decisions, which is legal ambiguity.Time constraints and the accelerated process of harmonization are also one of the reasons due to differences between Ukrainian and European law. The implementation of European norms can take place at a fast pace, which can make it difficult to adapt and ensure full compliance with national legislation. This can lead to ambiguities and inappropriateness in the legal system.And integration with European law can create challenges in ensuring a unified mechanism for control and dispute resolution. Differences in the interpretation and application of European norms can create problems in resolving disputes between the parties. Therefore, the lack of a single control mechanism is also a reason.Ukrainian contract law needs legislative adaptation. After all, the implementation of European norms requires significant changes in national legislation. This can cause difficulties and require time and resources to implement the necessary reforms.One of the reasons is the lack of full compliance. Ukraine may have difficulties in achieving full compliance with European norms due to various factors, such as backwardness in the development of the legal system, corruption, insufficient legal culture, etc. This can lead to unresolved issues and disagreements with European law.The next reason is the implementation of requirements and standards. Harmonization of contract law with European norms requires the introduction of new requirements and standards. This can be a challenge for government bodies, lawyers, courts and other participants of the legal system, who must familiarize themselves with the new rules, acquire the necessary skills and abilities to apply them.Harmonization of contract law to European standards may also require significant financial costs. This is due to the need for reforms, training of specialists, development and implementation of new laws and legal instruments. The government and other stakeholders must commit sufficient resources to ensure successful harmonization, which is a challenge.The reason for the discrepancy between domestic and European law is the interaction with other branches of law. Harmonization of contract law can affect other areas of law, such as economic, civil and labor law.Changes in one area may necessitate changes in the corresponding areas, which may cause complications and disagreements in their interaction.Harmonization of contract law requires broad public support and involvement. This means the need to inform citizens, businesses and other interested parties about the changes, hold consultations and take into account their opinions and suggestions. Support and involvement of society is needed. Despite these challenges, the harmonization of contract law of Ukraine with European law remains important and necessary. This will contribute to the creation of a single legal space, increased protection of the rights of citizens and enterprises, development of trade and investments, and improvement of justice.However, it is important to take into account the specificities and needs of the country when implementing European norms, ensuring a balance between global standards and national realities.

Co-existence and harmonisation of different legal traditions in South Africa

This essay introduces a contemporary description of the mixed jurisdiction of South Africa. It depicts how in South Africa co-existence, harmonization and resistance are found in different fields of law and identifies both pitfalls and benefits of mixity. Several components are introduced: civil law, English common law, local customary law, the Bill of Rights and international legal instruments. The successful harmonisation of civil and common law is ascribed to introduction of the English administration of justice. The British institutions, structure and process placed the focus on legal procedure and succeeded to avoid conflict between different legal cultures as economic transactions ignored different value systems and doctrine. The same model was, however, not applied in respect of indigenous customary law, where from the onset choices between values and doctrine were cast in stone with the consequent conflicts. The new constitution of 1996 is transformative and the courts are instructed to develop common law and indigenous law to promote the rights, values, spirit and purport of the Bill of Rights. Thus, in all fields of private law court decisions attempt to realise such transformation by harmonising constitutional values with legal tradition while strong impetus has been provided by legislation. As it appears that the need for harmonisation between civil and common law is experienced mainly in the commercial field, the question arises whether civil law jurisdictions can transform themselves into a mixed jurisdiction by way of legal transplants to facilitate the global market. Mixed legal systems developed mostly as the result of colonial history. Civil law and common law were able to mix because the common law court system and procedure made it possible for English trained judges to successfully merge certain areas of private law, primarily in the commercial field. This means that the court system and the law of procedure, but especially training, qualification and selection of judges are of paramount importance.

HarmonizR enables data harmonization across independent proteomic datasets with appropriate handling of missing values

Dataset integration is common practice to overcome limitations in statistically underpowered omics datasets. Proteome datasets display high technical variability and frequent missing values. Sophisticated strategies for batch effect reduction are lacking or rely on error-prone data imputation. Here we introduce HarmonizR, a data harmonization tool with appropriate missing value handling. The method exploits the structure of available data and matrix dissection for minimal data loss, without data imputation. This strategy implements two common batch effect reduction methods—ComBat and limma (removeBatchEffect()). The HarmonizR strategy, evaluated on four exemplarily analyzed datasets with up to 23 batches, demonstrated successful data harmonization for different tissue preservation techniques, LC-MS/MS instrumentation setups, and quantification approaches. Compared to data imputation methods, HarmonizR was more efficient and performed superior regarding the detection of significant proteins. HarmonizR is an efficient tool for missing data tolerant experimental variance reduction and is easily adjustable for individual dataset properties and user preferences.

The Use of Multicriteria Inference Method to Identify and Classify Selected Combustion Engine Malfunctions Based on Vehicle Structure Vibrations.

Internal combustion engines are among the most commonly used propulsion units for drive systems in various industries such as land transportation, maritime transportation, and power generation. Their operation involves a continuous change of technical condition as a result of not only the combustion process but also their operation under conditions of variable load or ambient impact. It is therefore important to monitor the technical condition of internal combustion engines to ensure high performance and reliability over their lifetime. The article presents the test results obtained from incorrect operation of an internal combustion engine as a result of forced failures of the ignition and injection system. On this basis, a multicriteria comparison of the signal analysis of engine block vibrations was made, after the transformation of the signal from the time domain to the frequency domain, by using the induction technique obtained from the operation of decision tree algorithms. For this purpose, the amplitude spectrum in the frequency domain, scaled to absolute values of discretization for which teaching and testing data tables were created for successive harmonics, was determined for the engine block vibration signal being tested. On the basis of the developed algorithm using decision trees, a multicriteria data table was analyzed for which a compatibility path for the analyzed engine block vibration signal is created. In this way, it is confirmed with a specified degree of effectiveness, depending on the point of operation of the engine resulting from its crankshaft speed, that there is a possibility of detecting a preset ignition or injection system malfunction in the technical condition of the internal combustion engine with a probability up to about 72%.

Commutability Assessment of Candidate External Quality Assessment Materials for Aminotransferase Activity Measurements Based on Different Approaches in China.

BackgroundUsing commutable external quality assessment (EQA) materials is important for monitoring successful harmonization efforts. We assessed the commutability of four human serum pool (HSP) preparations to identify candidate EQA materials for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activity measurement.MethodsOne set each of 85 clinical samples (CSs) was collected for ALT and AST activity measurement. The 15 candidate EQA materials included four types of HSP preparations (A to D): materials A, C, and D contained human original recombinant (HOR) aminotransferases; materials B was mixed leftover samples. The CSs and 15 candidate EQA materials were analyzed using seven routine assays, and the ln-transformed results were analyzed in 21 assay pairs. Commutability was assessed using Deming regression, with a 95% prediction interval (CLSI approach) and the difference in bias with an error component model (International Federation of Clinical Chemistry and Laboratory Medicine [IFCC] approach).ResultsFor ALT, all materials were commutable for 14–21 assay pairs according to the CLSI and IFCC approaches. For AST, B01–03 showed commutability for 14–21 assay pairs, and C01–03 and D01–03 showed commutability for no less than 10 assay pairs according to the two approaches. A01–06 were commutable for 9–16 assay pairs according to the CLSI approach, but for 6–9 assay pairs according to the IFCC approach.ConclusionsMixed leftover samples showed desirable commutability characteristics as candidate EQA materials for routine aminotransferase activity measurements. Human serum bases supplemented with HOR were commutable for most routine ALT activity measurements.

MANAGEMENT TECHNOLOGIES FOR ENHANCING INTEGRATED PROCESSES IN THE CUSTOMS AND LOGISTICS SERVICES SECTOR

The article discusses the issues of modern electronic technologies implementation in managing integrated processes in the customs and logistics services sector in Ukraine. It is argued that collection and processing of large amounts of information are hardly possible without the use of latest information technology advancements. It has been verified that to operate effectively, the "Electronic Customs" should involve close interaction between all its subsystems, such as electronic declaration; electronic document management; risk analysis and risk management; transit control delivery; single interdepartmental automated system for collecting, storing and processing information; implementation of fully automated government control; unified database of regulatory and reference documentation used for customs purposes; information support for audit and law enforcement activities. The research findings have revealed a number of benefits of using the electronic declaration pattern, in particular, it contributes to boosting trade, reducing the time period for customs control, eliminating of subjective factors while handling customs procedures through the use of online prior notification and preliminary electronic customs declaration in the frameworks of customs clearance of goods and customs documents and goods delivery. Ultimately, building a multifunctional integrated system of "Electronic Customs" is focused towards better facilitating and enhancing the customs units performances by speeding up customs control and customs clearance procedures, improving the public service quality in the area government customs regulation, mitigating the risk of any illegal actions and corruption along with ensuring and enhancing the customs services security in Ukraine, contributing to further development, adaptation and successful harmonization of information systems of the State Customs Service of Ukraine to the European Union standards and good practice.

Harmonising Road Transport Legislation in the SADC Region for Crime Prevention

The Southern African Development Community (SADC) is an organisation that aims to facilitate cooperation between the governments of its Member States through a set of goals. SADC uses protocols as an instrument of coordination of its Member States on Transport, Communications and Meteorology endeavours to harmonise various aspects of traffic and transportation in the region. The researcher relies on carrying out an extensive literature review, consulting secondary data, official government publications and review of case studies. This article is informed by both the routine activity theory and situational crime prevention theory. It was found that the SADC regional body still has several barriers to overcome before a successful harmonisation stage to prevent crime will be achieved by Member States. Regional cooperation is needed amongst Member States to prevent organised borderless crime like human trafficking, drugs trafficking, fraud and money laundering, car-hijacking and terrorism.

Recent insights into Fc-mediated effector responses to HIV-1.

Recent work defining Fc-mediated effector functions for both viral control and protection against infection is summarized and considered along with new strategies to drive robust Fc-mediated responses. In new human and nonhuman primate (NHP) vaccine trials as well as studies of natural infection, Fc-mediated effector responses have sometimes been observed to correlate with decreased risk of infection or with better clinical outcomes, suggesting a potential role for these responses in HIV-1 prevention and therapy. Recent highlights include use of antibody-dependent cellular cytotoxicity-sensitizing CD4-induced mimetic compounds, novel V1V2 immunogens, passive transfer studies, and vaccine regimens that successfully elicited Fc-mediated responses and were reported to decrease risk of infection in challenge studies in NHPs. Lastly, detailed studies of IgG3 forms of HIV-specific antibodies have reported that both neutralizing and Fc-mediated responses can be increased relative to the more prevalent IgG1 subclass. Successful harmonization of neutralizing and Fc-mediated responses may make key contributions to the goal of reducing HIV-1 infection via active and passive vaccination. New studies continue to highlight the importance of Fc-mediated antibody responses as correlates of decreased risk of infection and suggest enhanced phagocytosis is a potential mechanism of reduced risk of infection associated with human IgG3 responses. Results from recent studies may help guide the rational design of therapies and vaccines that aim to specifically leverage antibody effector function.

Positron emission tomography PET/CT harmonisation study of different clinical PET/CT scanners using commercially available software.

Objectives:Harmonisation is the process whereby standardised uptake values from different scanners can be made comparable. This PET/CT pilot study aimed to evaluate the effectiveness of harmonisation of a modern scanner with image reconstruction incorporating resolution recovery (RR) with another vendor older scanner operated in two-dimensional (2D) mode, and for both against a European standard (EARL). The vendor-proprietary software EQ•PET was used, which achieves harmonisation with a Gaussian smoothing. A substudy investigated effect of RR on harmonisation.Methods:Phantom studies on each scanner were performed to optimise the smoothing parameters required to achieve successful harmonisation. 80 patients were retrospectively selected; half were imaged on each scanner. As proof of principle, a cohort of 10 patients was selected from the modern scanner subjects to study the effects of RR on harmonisation.Results:Before harmonisation, the modern scanner without RR adhered to EARL specification. Using the phantom data, filters were derived for optimal harmonisation between scanners and with and without RR as applicable, to the EARL standard. The 80-patient cohort did not reveal any statistically significant differences. In the 10-patient cohort SUVmax for RR > no RR irrespective of harmonisation but differences lacked statistical significance (one-way ANOVA F(3.36) = 0.37, p = 0.78). Bland-Altman analysis showed that harmonisation reduced the SUVmax ratio between RR and no RR to 1.07 (95% CI 0.96–1.18) with no outliers.Conclusions:EQ•PET successfully enabled harmonisation between modern and older scanners and against the EARL standard. Harmonisation reduces SUVmax and dependence on the use of RR in the modern scanner.Advances in knowledge:EQ•PET is feasible to harmonise different PET/CT scanners and reduces the effect of RR on SUVmax.

From Medical Imaging to Radiomics: Role of Data Science for Advancing Precision Health.

Treating disease according to precision health requires the individualization of therapeutic solutions as a cardinal step that is part of a process that typically depends on multiple factors. The starting point is the collection and assembly of data over time to assess the patient’s health status and monitor response to therapy. Radiomics is a very important component of this process. Its main goal is implementing a protocol to quantify the image informative contents by first mining and then extracting the most representative features. Further analysis aims to detect potential disease phenotypes through signs and marks of heterogeneity. As multimodal images hinge on various data sources, and these can be integrated with treatment plans and follow-up information, radiomics is naturally centered on dynamically monitoring disease progression and/or the health trajectory of patients. However, radiomics creates critical needs too. A concise list includes: (a) successful harmonization of intra/inter-modality radiomic measurements to facilitate the association with other data domains (genetic, clinical, lifestyle aspects, etc.); (b) ability of data science to revise model strategies and analytics tools to tackle multiple data types and structures (electronic medical records, personal histories, hospitalization data, genomic from various specimens, imaging, etc.) and to offer data-agnostic solutions for patient outcomes prediction; (c) and model validation with independent datasets to ensure generalization of results, clinical value of new risk stratifications, and support to clinical decisions for highly individualized patient management.

Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.

Notwithstanding successful harmonization efforts, the global regulatory framework governing product safety is complex and continually evolving, as evidenced by additional regional guidance and regulations. In this regulatory review, we provide an overview from both global and regional perspectives. A historical perspective, with a focus on recent developments, enables identification of important long–term trends, such as a shift from single–case medical review of serious adverse events to an interdisciplinary evaluation of aggregate data for the purpose of judging product causality and informing benefit–risk assessments. We will show how these trends lead to opportunities for closer interdisciplinary collaboration, for bridging the gap between preand postmarketing surveillance, and for a more proactive determination of patient populations with a positive benefit–risk profile for product use. We will conclude by pointing to ongoing and future work that seeks to provide specific solutions for ongoing aggregate safety evaluation.

Technologies of tutorial assistance in the visual activity distance education for the bachelors-designers

The article discusses the innovative approaches in the distance form of training the bachelors-designers, the direction of the tutorial assistance vector and the ways of realizing the creative potential of students in visual activity. Emphasis is placed on the innovative approaches and technologies in distant training the bachelors-designers, on the extracurricular activities of the students using telecommunications and information technologies, the tutoring technology as the most acceptable technology and a humane form of pedagogical interaction, creating the conditions for self-development and self-realization of students. The assessment criteria are defined as the products of visual activity in the process of distant training, and the products of art as a result of this activity. The conditions for successful self-realization and harmonization of the students in the visual activity distant training process.