Evaluation of Parents' Use of a Child Health Care Information App and Their Health Literacy: Cross-Sectional Study.

Background: Recently, digital media, including internet websites and smartphone apps, have become popular resources for parents in searching for child health care information. Higher health literacy among parents in obtaining adequate health care information and making proper decisions may lead to improved child health outcomes and a reduction in the burden on health care professionals. However, few studies have examined the association between the provision of child health care information apps and parents' health literacy. Objective: This study aims to evaluate whether parents' use of an app that provides child health care information is associated with their health care knowledge, their health literacy, and emergency room visits for their children. Methods: Participants were recruited during checkups for their 1.5-year-old children at health centers within Saku City in 2022. Parents who agreed to participate were included in this study; individuals were excluded if they were not the mother or father of the child or did not have a smartphone. Participants were asked if they had used the Oshiete-Doctor app, which was distributed by Saku City free of charge to improve the home nursing skills of parents and guardians. Sociodemographic data of parents and children, data on health care knowledge about children, data on the frequency of emergency room visits in the past 6 months, and health literacy scores (HLSs) of parents (measured with the HLS-EU-Q47 [European Health Literacy Survey Questionnaire]) were collected from participants in this cross-sectional survey. Univariable and multivariable analyses were conducted to examine the associations of app use with health care knowledge, health literacy, and emergency room visits. Results: In total, 251 respondents completed the survey (response rate: 251/267, 94%). Although the proportion of health care workers was significantly higher among app users than among non-app users (P=.005), no other participant attributes were significantly associated with the use of the app. The proportions of participants with higher health care knowledge and participants with higher total HLSs were significantly higher among app users than among non-app users (P=.001 and P=.003, respectively). After adjusting for potentially confounding covariates, these proportions were still significantly higher among app users than among non-app users (P=.02 and P=.007, respectively). Emergency room visits were significantly more frequent among app users than among non-app users (P=.007) in the univariable analysis, but the association was not significant (P=.07) after adjusting for sociodemographic variables. Conclusions: This study showed a significant association between parents' use of a child health care information app and higher child health care knowledge and health literacy. The use of the app may lead to more appropriate health decisions and behaviors in children's health care. Future studies are needed to evaluate the association between app use and emergency room visits.

Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks.

Introduction: The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies in Europe. This research aimed to assess the impact of the regulation on national HTAs, the strategic implications for health technology developers, and its influence on price and reimbursement negotiations. Methods: A scoping literature review encompassing peer-reviewed literature as well as grey literature was conducted. Between February and March 2023, semi-structured interviews (n = 20) were performed with stakeholders from Belgian governmental institutions, European institutions, advanced therapy medicinal product developers, academics, and sickness funds. The interviews were analyzed using the framework analysis method. Results: Numerous steps, such as the development of implementing acts and procedural guidelines remain to be taken. At member state level, national/regional HTA bodies and payers must act to adopt the new concepts of Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) within their national legislation, as well as revise their timelines and prepare for interactions at a European level. Compiling a harmonized PICO (Population, Intervention, Comparator, and Outcome), adapting local procedures, and increasing capacity to actively take part in the JSC and JCA are seen as primary barriers by several stakeholders. Training and education will help HTA bodies, payers, and health technology developers to participate in the European processes. Conclusion: While practical and legal challenges were identified, recommendations (such as actively preparing for the upcoming changes and increasing capacity while providing training) were provided to adapt national and European procedures to the needs of the HTA Regulation 2021/2282. The importance of fostering collaborations and aligning local HTA procedures with the new way of working set out by the Regulation was demonstrated with this study.

Hydrophobic and Luminescent Polydimethylsiloxane PDMS-Y2O3:Eu3+ Coating for Power Enhancement and UV Protection of Si Solar Cells.

Solar cells have been developed as a highly efficient source of alternative energy, collecting photons from sunlight and turning them into electricity. On the other hand, ultraviolet (UV) radiation has a substantial impact on solar cells by damaging their active layers and, as a result, lowering their efficiency. Potential solutions include the blocking of UV light (which can reduce the power output of solar cells) or converting UV photons into visible light using down-conversion optical materials. In this work, we propose a novel hydrophobic coating based on a polydimethylsiloxane (PDMS) layer with embedded red emitting Y2O3:Eu3+ (quantum yield = 78.3%) particles for UV radiation screening and conversion purposes. The favorable features of the PDMS-Y2O3:Eu3+ coating were examined using commercially available polycrystalline silicon solar cells, resulting in a notable increase in the power conversion efficiency (PCE) by ~9.23%. The chemical and UV stability of the developed coatings were assessed by exposing them to various chemical conditions and UV irradiation. It was found that the developed coating can endure tough environmental conditions, making it potentially useful as a UV-protective, water-repellent, and efficiency-enhancing coating for solar cells.

Size-Dependent High-Pressure Behavior of Pure and Eu3+-Doped Y2O3 Nanoparticles: Insights from Experimental and Theoretical Investigations.

We report a joint high-pressure experimental and theoretical study of the structural, vibrational, and photoluminescent properties of pure and Eu3+-doped cubic Y2O3 nanoparticles with two very different average particle sizes. We compare the results of synchrotron X-ray diffraction, Raman scattering, and photoluminescence measurements in nanoparticles with ab initio density-functional simulations in bulk material with the aim to understand the influence of the average particle size on the properties of pure and doped Y2O3 nanoparticles under compression. We observe that the high-pressure phase behavior of Y2O3 nanoparticles depends on the average particle size, but in a different way to that previously reported. Nanoparticles with an average particle size of ~37 nm show the same pressure-induced phase transition sequence on upstroke and downstroke as the bulk sample; however, nanoparticles with an average particle size of ~6 nm undergo an irreversible pressure-induced amorphization above 16 GPa that is completed above 24 GPa. On downstroke, 6 nm nanoparticles likely consist of an amorphous phase.

Measuring Respirable Crystalline Silica (Quartz) from Powdery Materials through Sedimentation and X-ray Diffractometry.

When possible, choosing materials with a low quartz content is the most effective and cost-efficient way to prevent the respirable quartz exposure of workers and other end users of powdery products. Therefore, methods are needed to analyze low amounts of quartz from powdery products, such as sand, gravel, plaster, cement, and concrete. To this end, we present a method to analyze respirable dust and quartz from powdered materials, such as construction products. The method includes separation of the respirable dust fraction by liquid sedimentation, followed by gravimetric analysis and determination of the crystalline silica content by X-ray diffractometry. While also aiding in the development of less harmful products, analysis of the quartz concentration of powdery products is statutory in Eu countries, excluding natural products not chemically modified. According to EU Regulation No. 1272/2008, products must be classified if they contain harmful substances in concentrations above 0.1 wt.%, and clauses pertaining to cancerous properties and harmfulness to lungs should be included. Also, mineral producers in the EU recommend that products containing respirable quartz should be labelled based on their quartz concentration, provided the concentration exceeds 1 wt.%. The present method meets these needs. The analysis can be performed in parallel from 50 to 1000 mg (dry weight) of powdery materials. The quantitative limit of determination was 10 µg per sample, corresponding to 0.01 wt.%, and the linear range 0.02-10 wt.% (10-5000 µg quartz per sample, Pearson correlation coefficient 0.99). The accuracy of the method was 82% and the repeatability 11%.

Cultured meat in the European Union: Legislative context and food safety issues.

The current food system, which is responsible for about one third of all global gas emissions, is considered one of the main causes of resource depletion. For this reason, scientific research is investigating new alternatives capable of feeding an ever-growing population that is set to reach 9-11 billion by 2050. Among these, cell-based meat, also called cultured meat, is one possible solution. It is part of a larger branch of science called cellular agriculture, whose goal is to produce food from individual cells rather than whole organisms, tracing their molecular profile. To date, however, cultured meat aroused conflicting opinions. For this reason, the aim of this review was to take an in-depth look at the current European legislative framework, which reflects a 'precautionary approach' based on the assumption that these innovative foods require careful risk assessment to safeguard consumer health. In this context, the assessment of possible risks made it possible not only to identify the main critical points during each stage of the production chain (proliferation, differentiation, scaffolding, maturation and marketing), but also to identify solutions in accordance with the recommendations of the European Food Safety Authority (EFSA). Further, the main challenges related to organoleptic and nutritional properties have been reviewed.. Finally, possible future markets were studied, which would complement that of traditional meat, implementing the offer for the consumer, who is still sceptical about the acceptance of this new product. Although further investigation is needed, the growing demand for market diversification and the food security opportunities associated with food shortages, as well as justifying the commercialisation of cultured meat, would present an opportunity to position cultured meat as beneficial.

Natural hazard risk analysis in the framework of water safety plans.

The available literature on natural hazard risk analysis focused on the implementation of water safety plans (WSPs) is surprisingly quite poor, despite the significant increase in the number and severity of disasters and adverse effects on drinking water supply systems generated by natural hazards. At the same time, WSPs that conveniently account for natural hazards with a comprehensive approach 'from source to tap' are still scarce as they typically occur at larger spatial scales and adequate prevention, mitigation and adaptation require efficient inter-institutional collaborations. The aim of this paper is to highlight the main bottlenecks for water utilities to include natural hazards in the development of their WSPs. The research adopted a stakeholders-oriented approach, involving a considerable number of water utilities (168), water sectoral agencies (15) and institutions (68) across the Adriatic-Ionian Region through a stepwise process that generated joint SWOT analysis, the development of a decision support system (DSS) focused on WSPs procedures and tabletop exercises. The final outcomes generated strategic documents (REWAS - Adrion Road map for resilient water supply) that highlighted the necessity for efficient cross-sectoral and inter-institutional cooperation in the development of well-founded and robust WSPs to address natural hazard risk analysis for water supply systems (DWSS).

Solidarity as a Political Determinant of Health: Insights from EU Competition Policy.

CONTEXT: The connection between law and political determinants of health is not well-understood, but nevertheless it is suggested that the two are inseparable, and that this represents an "upstream" level with scope for influencing other determinants of health (particularly social). Solidarity underpins European healthcare systems and given its clear link with redistribution, can be seen as a means to address health inequities. As such, solidarity may be seen as a political determinant of health in the specific context of EU competition policy. METHODS: A range of EU case law, Treaty provisions, and Commission publications relating to EU competition policy are analysed. FINDINGS: Solidarity is typically juxtaposed as antithetical to competition, thus underpins exceptions to the applicability of the prohibitions on anticompetitive agreements, abuse of dominance, and state aid. Case law indicates a further dynamic between definitions of solidarity at EU and national levels. CONCLUSIONS: This analysis leads to two groups of considerations when framing solidarity as a political determinant of health in the EU competition policy context: firstly, the predominance of solidarity suggests it may shape competition reforms, and secondly the EU-Member State dynamic which indicates less EU-level reach into national competition reforms in healthcare than may be expected.

The EU as Active and Passive Political Determinant of Forced Migrants' Health: Insights from the Case of Germany.

CONTEXT: This article examines the EU's function as political determinant of health (PDoH) in national-level regulation of forced migrants' access to health(care), with a focus on Germany. It sheds light on the role the EU has come to play - and been assigned - in national policymaking under the impression of different crises. METHODS: By applying the concepts of claims and frames/framing, the article examines in a document analysis how and to what end(s) 'the EU' as a polity as well as specific EU legislation were invoked in German draft legislation. FINDINGS: Increasing Europeanisation in the areas of health and migration has not only forced national legislators to adapt legislation in order to abide to EU rules and standards, but has also prompted governmental actors to shift responsibility for policy reforms to the EU - even in cases where not all of these reforms were legally required. CONCLUSIONS: The EU's role as PDoH must be considered from two angles: the Union's active potential to determine public health through its policies and laws; and its passive, to some extent involuntary, potential to do so through the strategic invoking of EU norms, rules and (in)competences by actors across the EU multilevel-governance system.

HERA-lding More Integration in Health? Examining the Discursive Legitimation of the European Commission's New Health Emergency Preparedness and Response Authority.

CONTEXT: Since COVID-19, the European Commission (EC) has sought to expand its activities in health through the development of a 'European Health Union' and within it, the Health Emergencies Preparedness and Response Authority (HERA). METHODS: We applied a discourse analysis on documents establishing HERA to investigate how the creation of this institution was legitimated by the EC. We focused on how it framed health emergencies; how it framed the added value of HERA; and how it linked HERA to existing EU activities and priorities. FINDINGS: Our analysis demonstrates that security-based logics have been central to the EC's legitimation of HERA - in alignment with a 'securitization of health' occurring worldwide in recent decades. This legitimation can be understood as part of the EC's effort to promote future integration in health in the absence of new competencies. CONCLUSIONS: Securitization has helped the EC raise its profile in health politically, without additional competencies, thereby laying the groundwork for potential future integration. Looking at the discursive legitimation of HERA sheds light not only on whether the EC is expanding its health powers, but also how it strategizes to do so. HERA, while constrained, allows the EC to further deepen security-driven integration in health.

Europium-based ß-hydroxyketone complexes: synthesis, optoelectronic, thermal and computational analyses.

Six red-light-emitting Eu(III) complexes having a ß-hydroxyketone as ligand and heterocyclic ring containing compounds as ancillary ligands were synthesized to explore their use in displays and optoelectronics. The coordinating behavior of complexes was determined by various techniques such as FTIR (Fourier transform infrared), 1H-NMR (Nuclear magnetic resonance), and 13C-NMR that establishes a bonding of ligand and ancillary ligand with the Eu(III) ion. Morphology and purity were investigated through XRD (X-ray diffraction), SEM (scanning electron microscopy) and EDS (energy-dispersive X-ray spectroscopy) analyses that suggest semicrystalline and pure complex formation. Thermal analysis of complexes by TGA/DTG (thermogravimetric/derivative thermogravimetric) indicates that complexes are stable upto 200 ºC temperature making them suitable for use in display devices. Analysis of the photophysical properties was carried out in both solid and solution states using PL (photoluminescence) studies, color parameters, J-O (Judd-Ofelt) analysis and bandgap. Most emissive transition (5D0 → 7F2) is responsible for the red emission in the complexes. The CIE (Commission International de I'Eclairage) coordinates of complexes also indicate the red emission on UV excitation. The bandgap which was obtained in the range of 2.54-3.02 eV reveals the semiconducting behavior of complexes. Values of J-O parameters and Ω2 in the complexes reflect asymmetric chemical environment around Eu (III) and less covalence and the Ω4 indicates that complexes are less rigid. Bandgap calculated through DFT (density function theory) for complexes is in range of 2.37-2.77 eV, and intensity parameters (J-O), energy transfer rates, and spherical coordinates were determined by LUMPAC software. The computational data are in good harmony with the experimental data. Further biological aspects of complexes were studied using antioxidant and antimicrobial studies.

Access in all areas? a round up of developments in market access and health technology assessment: part 4.

In this latest update, we look at recent developments in market access including the pricing agreement of Libmeldy® by the Beneluxa Initiative, the financial impact of managed entry agreements in Italy and the restructuring of Agenzia Italiana del Farmaco (AIFA). We also highlight the collaboration between FINOSE and the New Expensive Drug (NED) section of the Nordic Pharmaceutical Forum.

Computational and optoelectronic investigations of red-emissive europium (III) ß-diketonate with n-donor ligands for display applications.

Europium complexes exhibiting red luminescence were prepared by employing ß-diketone as main ligand and 1,10-phenanthroline as an additional ligand. Various methods, including 1H NMR, IR spectroscopy and analysis of optical band gap were employed to examine these complexes. The luminescent photophysical properties were investigated using PL spectroscopy and theoretical calculations were conducted to explore radiative transitions probabilities and Judd-Ofelt (J-O) parameters for transitions of type 5D0 → 7F2, 4. J-O parameters were determined using the JOES computer program and results were in good agreement with the outcomes obtained experimentally. The luminescence analysis results have verified the vibrant, single-color red emission of the prepared complexes. The band gap of ternary europium complexes, determined optically, electronically, and theoretically, falls within the range of 3-4 eV. This similarity indicates that these complexes are potentially suitable as semiconductor materials. The results from absorption, electrochemical and photophysical analyses indicate the potential use of synthesized complexes in lighting and display applications.

For sustainability environment: some determinants of greenhouse gas emissions from the agricultural sector in EU-27 countries.

Climate events significantly affect the lives of not only humanity but also all living things. Just as transformation in the ecosystem affects sectors, all sectors also transform the ecosystem. It is stated that the agricultural sector is at the root of the deterioration in the ecosystem due to the effect of intensive agriculture after the green revolution. It can be stated that, with an understanding far from the concept of sustainability, the foodstuffs and their waste produced in the agricultural sector are considered among the causes of climate change, which is now concentrated on the whole world in the third millennium. In this study, the effect of N2O gas released from produce residues and the release of enteric fermentation on the level of CO2 released from agricultural-food systems was investigated using advanced econometric models. The findings reveal that both factors are effective. However, it can be stated that the effect of N2O gas released from the produce residues is greater. Suggestions such as improving feed rations and maintaining herd management strategies within certain patterns to reduce the level of enteric fermentation may contribute to the process. In produce residue management, turning waste into compost and expanding bioenergy power plants will ensure both waste disposal and resource continuity in generating energy. Otherwise, the decreasing resources in the world may come to an end, and there will be disruptions and problems in the agricultural sector, as in all sectors. Considering the increasing world population, it is inevitable that food supply security may be endangered and the hunger problem may reach an irreversible level.

Phthalates and substitute plasticizers: Main achievements from the European human biomonitoring initiative HBM4EU.

Phthalates and the substitute plasticizer DINCH belong to the first group of priority substances investigated by the European Human Biomonitoring Initiative (HBM4EU) to answer policy-relevant questions and safeguard an efficient science-to-policy transfer of results. Human internal exposure levels were assessed using two data sets from all European regions and Israel. The first collated existing human biomonitoring (HBM) data (2005-2019). The second consisted of new data generated in the harmonized "HBM4EU Aligned Studies" (2014-2021) on children and teenagers for the ten most relevant phthalates and DINCH, accompanied by a quality assurance/quality control (QA/QC) program for 17 urinary exposure biomarkers. Exposures differed between countries, European regions, age groups and educational levels. Toxicologically derived Human biomonitoring guidance values (HBM-GVs) were exceeded in up to 5% of the participants of the HBM4EU Aligned Studies. A mixture risk assessment (MRA) including five reprotoxic phthalates (DEHP, DnBP, DiBP, BBzP, DiNP) revealed that for about 17% of the children and teenagers, health risks cannot be excluded. Concern about male reproductive health emphasized the need to include other anti-androgenic substances for MRA. Contaminated food and the use of personal care products were identified as relevant exposure determinants paving the way for new regulatory measures. Time trend analyses verified the efficacy of regulations: especially for the highly regulated phthalates exposure dropped significantly, while levels of the substitutes DINCH and DEHTP increased. The HBM4EU e-waste study, however, suggests that workers involved in e-waste management may be exposed to higher levels of restricted phthalates. Exposure-effect association studies indicated the relevance of a range of endpoints. A set of HBM indicators was derived to facilitate and accelerate science-to-policy transfer. Result indicators allow different groups and regions to be easily compared. Impact indicators allow health risks to be directly interpreted. The presented results enable successful science-to-policy transfer and support timely and targeted policy measures.

Urinary phthalate/DINCH metabolites associations with kisspeptin and reproductive hormones in teenagers: A cross-sectional study from the HBM4EU aligned studies.

BACKGROUND: Exposure to phthalate/DINCH metabolites can induce human reproductive toxicity, however, their endocrine-disrupting mechanisms are not fully elucidated. OBJECTIVE: To investigate the association between concentrations of phthalate/DINCH metabolites, serum kisspeptin, and reproductive hormones among European teenagers from three of the HBM4EU Aligned Studies. METHODS: In 733 Belgian (FLEHS IV study), Slovak (PCB cohort follow-up), and Spanish (BEA study) teenagers, ten phthalate and two DINCH metabolites were measured in urine by high-performance liquid chromatography-tandem mass spectrometry. Serum kisspeptin (kiss54) protein, follicle-stimulating hormone (FSH), total testosterone (TT), estradiol (E2), and sex hormone-binding globulin (SHBG) levels were measured by immunosorbent assays. Free Androgen Index (FAI) was calculated as a proxy of free testosterone. Adjusted sex-stratified linear regression models for individual studies, mixed effect models (LME) accounting for random effects for pooled studies, and g-computation and Bayesian kernel machine regression (BKMR) models for the phthalate/DINCH mixture were performed. RESULTS: The LME suggested that each IQR increase in ln-transformed levels of several phthalates was associated with lower kisspeptin [MnBP: %change (95%CI): -2.8 (-4.2;-0.4); MEHP: -1.4 (-3.4,0.2)] and higher FSH [∑DINP: 11.8 (-0.6;25.1)] levels in females from pooled studies. G-computation showed that the phthalates/DINCH mixture was associated with lower kisspeptin [-4.28 (-8.07;-0.34)] and higher FSH [22.13 (0.5;48.4)] also in females; BKMR showed similar although non-significant pattern. In males, higher phthalates metabolites [MEHP: -12.22 (-21.09;-1.18); oxo-MEHP: -12.73 (-22.34;-1.93)] were associated with lower TT and FAI, although higher DINCH [OH-MINCH: 16.31 (6.23;27.35), cx-MINCH: 16.80 (7.03;27.46), ∑DINCH: 17.37 (7.26;29.74)] were associated with higher TT levels. No mixture associations were found in males. CONCLUSION: We observed sex-specific associations between urinary concentrations of phthalate/DINCH metabolites and the panel of selected effect biomarkers (kisspeptin and reproductive hormones). This suggests that exposure to phthalates would be associated with changes in kisspeptin levels, which would affect the HPG axis and thus influence reproductive health. However, further research is needed, particularly for phthalate replacements such as DINCH.

Consumers confused 'Where to dispose biodegradable plastics?': A study of three waste streams.

Biodegradable plastics, either fossil- or biobased, are often promoted due to their biodegradability and acclaimed environmental friendliness. However, as demonstrated by previous literature, considerable confusion exists about the appropriate source separation and waste management of these plastics. Present study investigated this confusion based on manual sorting analyses of waste sampled from packaging waste (P), biowaste (B) and residual waste (R) in an urban area of Austria. The results were evaluated relative to near-infrared sensor-based sorting trials conducted in a German urban area. Although existing literature has focused on waste composition analyses (mostly in stand-alone studies) of the three waste streams, the present study focused on identifying the specific types of biodegradable plastic items found in each of these streams. Supermarket carrier bags (P = 90, B = 14, R = 33) and dustbin bags (P = 2, B = 46, R = 6) were found in all three waste streams in the Austrian urban area. Similarly, in the German urban area dustbin bags (P = 1, B = 106, R = 3) were the common items. The results indicate that certain bioplastic items were present in more than one bin; thus, hinting that consumers are not necessarily aware of how-to source-separate the biodegradable plastics. This suggests that neither consumers nor current waste management systems are fully 'adapted' to bioplastics, and the management of these plastics' waste is currently not optimal.

Have the non-technical summaries of animal experiments in Europe improved? An update.

Following a review of the Directive 2010/63/EU on the protection of animals used for scientific purposes in the European Union (EU), non-technical project summaries (NTS) of all approved projects must be published in a central database using a standard template. Our initial review of the NTS reported in ALTEX in 2018 had found the NTS to be deficient in their accessibility and quality, notably the adverse effects section where the harms to the animals are meant to be described. Here we repeat our review to see if these legislative changes have improved the accessibility and quality of the NTS. As before we focused on the NTS from the United Kingdom (UK) and Germany; even though the UK has left the EU it is using the same template. We found significant improvement in the reporting of five of the six elements we identified as essential to the predicted harms section. However, there was no significant improvement in the reporting of adverse effects. Only 41% of German NTS and 48% of UK NTS are fully reporting this important element of the predicted harms section. In our view, researchers need support in describing the impact of their research on the animals and to assist here we include a checklist for competent authorities and a list of suggested terminology for standard administration and sampling procedures. Unless the NTS improve further, their utility as a tool for sharing of good practices in the 3Rs or to support evidence-based policy making will remain limited.

All countries of the European Union (EU) are required to publish "non-technical summaries" (NTS) of research projects that use animals. To improve transparency, the public must have access to NTS and understand their content. Our previous review found that the information provided in the NTS was lacking in many cases. This is preventing a full understanding of what animals experience during experiments. In particular, NTS often failed to fully describe what procedures the animals would be subjected to, how often they would take place, how long they would last, and the harm they would cause. Here we repeat our review to see if recent legislative changes, including the requirement for NTS to be published in a central database using a standard template, have made a difference. While there has been some improvement in reporting, many NTS still fail to adequately describe the harm that animals will experience.

Novel Eu-dipeptide assemblies for a fluorescence sensing strategy to ultrasensitive determine trace sulfamethazine.

Self-assembled Eu-dipeptide (tryptophan-phenylalanine) microparticles with multi-emission fluorescence was prepared and modified with a single-stranded DNA corresponding to the sulfamethazine (SMZ) adapter (Eu-PMPs@cDNA). Aptamer-functionalized magnetic Fe3O4 (MNPs@aptamer) was used to specifically bind the target SMZ. Using Eu-PMPs@cDNA as fluorescent signal probe and MNPs@aptamer as catcher, a noncompetitive fluorescence sensing strategy was developed for determination of SMZ with good sensitivity, accuracy, selectivity, and stability. Under the optimized conditions, fluorescence increases linearly in the 0-20 ng/mL SMZ concentration range, and the detection limit is 0.014 ng/mL. The fluorescence sensing method was applied to analysis of water and fish muscle samples, and recoveries ranged from 81.78 to 119.46 % with relative standard deviations below 4.2 %. This study offered a reliable and sensitive fluorescence sensing strategy for SMZ determination in food samples, which owns great potential for wide-ranging application in harmful compounds assay by simply changing the type of aptamer and its complementary single-stranded DNA.

Developing generic templates to shape the future for conducting integrated research platform trials.

BACKGROUND: Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice-scientific guideline, first published in 2002 and last updated in 2016. This document provides an international ethical and scientific quality standard for designing and conducting trials that involve the participation of human subjects. Recently, there has been heightened awareness of the importance of integrated research platform trials (IRPs) designed to evaluate multiple therapies simultaneously. The use of a single master protocol as a key source document to fulfill trial conduct obligations has resulted in a re-examination of the templates used to fulfill the dynamic regulatory and modern drug development environment challenges. METHODS: Regulatory medical writing, biostatistical, and other members of EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) developed the suite of templates for IRPs over a 3.5-year period. Stakeholders contributing expertise included academic hospitals, pharmaceutical companies, non-governmental organizations, patient representative groups, and small and medium-sized enterprises (SMEs). RESULTS: The suite of templates for IRPs based on TransCelerate's Common Protocol Template (CPT) and statistical analysis plan (SAP) should help authors navigate relevant guidelines as they create study design content relevant for today's IRP studies. It offers practical suggestions for adaptive platform designs which offer flexible features such as dropping treatments for futility or adding new treatments to be tested during a trial. The EU-PEARL suite of templates for IRPs comprises a preface, followed by the actual resource. The preface clarifies the intended use and underlying principles that inform resource utility. The preface lists references contributing to the development of the resource. The resource includes TransCelerate CPT guidance text, and EU-PEARL-derived guidance text, distinguished from one another using shading. Rationale comments are used throughout for clarification purposes. In addition, a user-friendly, functional, and informative Platform Trials Best Practices tool to support the setup, design, planning, implementation, and conduct of complex and innovative trials to support multi-sourced/multi-company platform trials is also provided. Together, the EU-PEARL suite of templates and the Platform Trials Best Practices tool constitute the reference user manual. CONCLUSIONS: This publication is intended to enhance the use, understanding, and dissemination of the EU-PEARL suite of templates for designing IRPs. The reference user manual and the associated website ( http://www.eu-pearl ) should facilitate the designing of IRP trials.