Routine results of an algorithm for managing the production of blood components.

BACKGROUND AND OBJECTIVES: The variability in the number of donations together with a growing demand for platelet concentrates and plasma-derived medicines make us seek solutions aimed at optimizing the processing of blood. Some mathematical models to improve efficiencies in blood banking have been published. The goal of this work is to validate and evaluate an algorithm's impact in the production of blood components in the Blood and Tissues Bank of Aragon (BTBA). MATERIALS AND METHODS: A mathematical algorithm was designed, implemented and validated through simulations with real data. It was incorporated into the fractionation area, which uses the Reveos® fractionation system (Terumo BCT) to split blood into its components. After 9 months of daily routine validation, retrospective activity data from the Blood Bank and Transfusion Services before and during the use of the algorithm were compared. RESULTS: Using the algorithm, the outdating rate of platelet concentrates (PC) decreased by 87.8% in the blood bank. The average shelf life remaining of PC supplied to Transfusion Services increased by almost 1 day. As a consequence, the outdating rate in the Aragon Transfusion Network decreased by 33%. In addition, extra 100 litres of plasma were obtained in 9 months. CONCLUSIONS: The algorithm improves the blood establishment's workflow and facilitates the decision-making process in whole blood processing. It resulted in a decrease in PC outdating rate, increase in PC shelf life and finally an increase in the volume of recovered plasma, leading to significant cost savings.

Bayesian nonparametric inference for the overlap coefficient: With an application to disease diagnosis.

Diagnostic tests play an important role in medical research and clinical practice. The ultimate goal of a diagnostic test is to distinguish between diseased and nondiseased individuals and before a test is routinely used in practice, it is a pivotal requirement that its ability to discriminate between these two states is thoroughly assessed. The overlap coefficient, which is defined as the proportion of overlap area between two probability density functions, has gained popularity as a summary measure of diagnostic accuracy. We propose two Bayesian nonparametric estimators, based on Dirichlet process mixtures, for estimating the overlap coefficient. We further introduce the covariate-specific overlap coefficient and develop a Bayesian nonparametric approach based on Dirichlet process mixtures of additive normal models for estimating it. A simulation study is conducted to assess the empirical performance of our proposed estimators. Two illustrations are provided: one concerned with the search for biomarkers of ovarian cancer and another one aimed to assess the age-specific accuracy of glucose as a biomarker of diabetes.

Good Research Practice: Lessons from Animal Care and Use.

Animal care and use play a pivotal role in the research process. Ethical concerns on the use of animals in research have promoted the creation of a legal framework in many geographical areas that researchers must comply with, and professional organizations continuously develop recommendations on specific areas of laboratory animal science. Scientific evidence demonstrates that many aspects of animal care and use which are beyond the legal requirements have direct impact on research results. Therefore, the review and oversight of animal care and use programs are essential to identify, define, control, and improve all of these aspects to promote the reproducibility, validity, and translatability of animal-based research outcomes. In this chapter, we summarize the ethical principles driving legislation and recommendations on animal care and use, as well as some of these laws and international recommendations. Examples of the impact of specific animal care and use aspects on research, as well as systems of internal and external oversight of animal care and use programs, are described.

Long-term radiological assessment of a Mediterranean freshwater ecosystem surrounding a nuclear power plant.

The radionuclide concentration of man-made radionuclides on non-human biota in freshwater ecosystems has been extensively studied in environments affected by the Chernobyl and Fukushima accidents, in both humid continental and subtropical climates, respectively. However, there are very few studies that assess the long-term effects of operating nuclear facilities in Mediterranean environments. In the present study, a temporal analysis of the impact on carp, cattail, and bulrushes in the cooling pond of the currently operating Almaraz nuclear power plant was investigated for the period 2000-2020. The results do not show a general trend in man-made radionuclide concentrations. Instead, depending on their availability and the type of organism, trends decrease over time. This is also reflected in the effective half-lives obtained, which are lower than the physical half-life for some radionuclides. Transfer coefficients for the main man-made radionuclides detected were obtained, and it was found that these were significantly lower than the typical ranges found for benthic fish and vascular plants in freshwater ecosystems. Finally, the internal and external doses received by the carp have been evaluated using ERICA tool, and it has been observed that the main contribution to the total dose is due to the internal dose (0.65-7.04) × 10-4 µGy/h.

Assessment of background dose rate on non-human biota in a Mediterranean terrestrial ecosystem.

The assessment of radiological impact to the environment is usually carried out by the dose rate estimation to hypothetical entities named Reference Animals and Plants (RAPs). There are many codes to carry out this assessment, which requires the definition of a scenario and using site-specific transfer parameters when possible. Transfer parameters present a geographical bias, as they are mostly derived from temperate and arctic climate datasets, but there is a scarcity of data for Mediterranean climates. In this study, a terrestrial Mediterranean scenario was defined using the distribution of activity concentrations of anthropogenic (90Sr, 137Cs) and naturally occurring radionuclides (40 K, 210Pb, 210Po, 226,228Ra, 235,238U, 232Th) in Cáceres province (Spain). Site-specific transfer factors, CRwo-media, defined as the ratio between the concentration in the whole organism and the medium (soil in this case) were considered. Dose rate assessments for terrestrial RAPs were carried out using Tier 3 in ERICA Tool, ranging 0.23-3.73 µGy/h which is below the screening level of 10 µGy/h. Therefore, no harmful effects are expected to occur. Internal dose rate predominates over external one because the main contributors are naturally occurring radionuclides (in most cases 40 K, 226,228Ra, 210Pb, 210Po), which are mostly α-emitting radionuclides. These results can be used for the evaluation of other radiological and nuclear installations in Mediterranean climates, as they set the background dose rate.

Reduction of natural radioactivity in groundwater with different salinity through adsorption of uranium and radium in filter materials.

In many small communities in the Mediterranean area, groundwater is usually the only water body available. Depending mainly on the surrounding geology, their concentration of naturally occurring radionuclides may pose a radiological hazard. Removal of uranium and radium from drinking water is the best way to avoid it, i.e., reverse osmosis (RO), but consuming a lot of energy. Thus, two modified drinking water treatment plants (DWTPs) using zeolites coated with manganese dioxide as adsorbent material were analyzed as an alternative to RO. Groundwater salinity can negatively affect this process. Radium removal decreased as water salinity increased; but it had a major impact on uranium, rendering the adsorption effectless in one DWTP. Waste management and how to avoid it from becoming radioactive are of major concern. Radium and uranium were associated to the reducible fraction in the filter material and also to the carbonate fraction in the case of uranium. Regeneration of the filter material using KCl solutions was able to remove 81% and 63% of uranium and radium, respectively.

Photoinduced Current Transient Spectroscopy on Metal Halide Perovskites: Electron Trapping and Ion Drift.

Metal halide perovskites (MHPs) are disruptive materials for a vast class of optoelectronic devices. The presence of electronic trap states has been a tough challenge in terms of characterization and thus mitigation. Many attempts based on electronic spectroscopies have been tested, but due to the mixed electronic-ionic nature of MHP conductivity, many experimental results retain a large ambiguity in resolving electronic and ionic charge contributions. Here we adapt a method, previously used in highly resistive inorganic semiconductors, called photoinduced current transient spectroscopy (PICTS) on lead bromide 2D-like ((PEA)2PbBr4) and standard "3D" (MAPbBr3) MHP single crystals. We present two conceptually different outcomes of the PICTS measurements, distinguishing the different electronic and ionic contributions to the photocurrents based on the different ion drift of the two materials. Our experiments unveil deep level trap states on the 2D, "ion-frozen" (PEA)2PbBr4 and set new boundaries for the applicability of PICTS on 3D MHPs.

Ionic Field Screening in MAPbBr3 Crystals Revealed from Remnant Sensitivity in X-ray Detection.

Research on metal halide perovskites as absorbers for X-ray detection is an attractive subject due to the optimal optoelectronic properties of these materials for high-sensitivity applications. However, the contact degradation and the long-term instability of the current limit the performance of the devices, in close causality with the dual electronic-ionic conductivity of these perovskites. Herein, millimeter-thick methylammonium-lead bromide (MAPbBr3) single and polycrystalline samples are approached by characterizing their long-term dark current and photocurrent under X-ray incidence. It is shown how both the dark current and the sensitivity of the detectors follow similar trends at short-circuit (V = 0 V) after biasing. By performing drift-diffusion numerical simulations, it is revealed how large ionic-related built-in fields not only produce relaxations to equilibrium lasting up to tens of hours but also continue to affect the charge kinetics under homogeneous low photogeneration rates. Furthermore, a method is suggested for estimating the ionic mobility and concentration by analyzing the initial current at short-circuit and the characteristic diffusion times.

Coupling between Ion Drift and Kinetics of Electronic Current Transients in MAPbBr3 Single Crystals.

The optoelectronic properties of halide perovskite materials have fostered their utilization in many applications. Unravelling their working mechanisms remains challenging because of their mixed ionic-electronic conductive nature. By registering, with high reproducibility, the long-time current transients of a set of single-crystal methylammonium lead tribromide samples, the ion migration process was proved. Sample biasing experiments (ionic drift), with characteristic times exhibiting voltage dependence as ∝ V -3/2, is interpreted with an ionic migration model obeying a ballistic-like voltage-dependent mobility (BVM) regime of space-charge-limited current. Ionic kinetics effectively modify the long-time electronic current, while the steady-state electronic currents' behavior is nearly ohmic. Using the ionic dynamic doping model (IDD) for the recovering current at zero bias (ion diffusion), the ionic mobility is estimated to be ∼10-6 cm2 V-1 s-1. Our findings suggest that ionic currents are negligible in comparison to the electronic currents; however, they influence them via changes in the charge density profile.

Introduction to the EQIPD quality system.

While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.

The use of performance standards by AAALAC International to evaluate ethical review in European institutions.

During the past several decades, society has become increasingly concerned about the welfare of animals used in research. Today, the public asks scientists to justify the use of research animals and to be accountable for their welfare. Research institutions, government bodies and other regulatory authorities have developed mechanisms to ensure that researchers follow the principles of the 3Rs and use and care for research animals in an ethical manner. Additionally, organizations such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) have developed voluntary programs that can help researchers to ensure that they are caring for research animals appropriately. The author discusses how AAALAC International uses performance standards to evaluate the ethical review processes of European institutions.

Speciation of naturally occurring radionuclides in Mediterranean soils: bioavailabilty assessment.

Knowledge of soil-to-plant transfer processes is a key element that can have a significant health impact. Much effort has been taken to characterize the speciation of anthropogenic radionuclides released into the environment. However, the information about naturally occurring radionuclides is scarce. This work evaluate the potential risks of transference, that is, the bioavailability of the 234,238U, 226Ra, 228,230,232Th, and 210Po in three different soils collected in Mediterranean ecosystems. Chemical speciation of these radionuclides was carried out according to two different methods, Pavlotskaya and a modification of Tessier's protocol. Most of these radionuclides were associated to fractions strongly bound to soil particles and not able to be transferred. Increasing concentrations of U and Th extracted with increasing volume of NH4OAc 1 M were observed, until it reached saturation. Readily bioavailable fraction in both methods (either exchangeable or water soluble + exchangeable) decreased in the following order: 226Ra > 234,238 U > 228,230,232Th > 210Po. It was found that < 3% of the natural radionuclide concentration in soil are readily bioavailable for plant uptake in this region of Spain, and the resulting human health risk is negligible from natural radionuclide ingestion.

Meta-análisis de la escala de capital intelectual: implicaciones para hacer frente a la pandemia del COVID-19

Introducción: la medición del capital intelectual como activo intangible se ha establecido a partir de una escala de seis dimensiones relacionada con formación, academia, laboral, profesional, sindical y organizativa. La pandemia ha generado estudios que muestran diferencias significativas entre estas dimensiones, abriendo la discusión sobre la validez metaanalítica. Objetivo: realizar una revisión documental, sistemática y metaanalítica, con una muestra de artículos publicados entre 2014 y 2021 en revistas indexadas en repositorios internacionales. Materiales y métodos: se realizó un estudio documental, sistemático y metaanalítico sobre una muestra de artículos publicados en repositorios internacionales en los últimos dos años. Se utilizó la Escala de Capital Intelectual, considerando sus dimensiones reportadas en la literatura. Resultados: se estableció la estructura y los umbrales de los efectos aleatorios, calculados mediante la ecuación para establecer el parámetro delta, considerando sus intervalos de confianza para la corrección de errores de muestreo y estimación, así como las diferencias entre grupos. Conclusión: se recomienda extender la revisión de la literatura hasta agosto de 2021, para poder contrastar ambas revisiones, y establecer así la validez metaanalítica de la escala, y discutir sus implicaciones en la era COVID-19.

Introduction: the measurement of intellectual capital as an intangible asset has been established from a scale of six dimensions related to training, academia; labor, professional, union, and organizational. The pandemic has generated studies that show significant differences between these dimensions, opening the discussion on meta-analytic validity. Objective: to carry out a documentary, systematic and meta-analytical review with a sample of articles published from 2014 to 2021 in journals indexed in international repositories. Materials and methods: a documentary, systematic and meta-analytical study was carried out on a sample of articles published in international repositories in the last two years. The Intellectual Capital Scale was used, considering its dimensions reported in the literature. Results: the structure and thresholds of the random effects were established, calculated by means of the equation to establish the delta parameter, considering their confidence intervals for correction of sampling and estimation errors, as well as differences between groups. Conclusion: it is recommended to extend the review of the literature until August 2021 in order to be able to contrast both reviews to establish the meta-analytic validity of the scale and discuss its implications in the COVID-19 era.

Anthropogenic and naturally occurring radionuclide content in near surface air in Cáceres (Spain).

The anthropogenic (137Cs, 90Sr, 239+240Pu and 241Am) and naturally occurring radionuclide (40K, 234,238U, 228,230,232Th, 226Ra and 210Pb) content in near surface air present seasonal variations related to natural processes, such as soil erosion, resuspension of fine particles of soil and radon exhalation from soil (210Pb). The objective is to analyze seasonal variations of their concentrations and compare with radiological events (Fukushima fallout and wild fire) in a location without any known source of anthropogenic radionuclides. The 210Pb, 40K, and 137Cs presented annual variations, with maximum activity levels in summer. Solar radiation and rainfall were correlated with 210Pb and 40K. The 234,238U, 228,230,232Th, 226Ra, 137Cs and 90Sr presented positive correlation with monthly mean values of temperature. The ratio 90Sr/137Cs was within the range of those reported for soils in Spain. Finally, the maximal effective dose rate was estimated to be 37 and 88 µSv/y for infants and adults, respectively, well below 1 mSv/y reference level. The main contributor to effective dose was 210Pb, about 92%, followed by: 210Pb â‰« 228,230,232Th > 226Ra, 234,238U > 7Be, 239+240Pu > 40K, 90Sr > 137Cs > 22Na.

Challenges and Opportunities in Implementation: The AAALAC International Perspective.

In spite of the increasing trend for local authorities and international organization to follow the same ethical principles, the regulatory framework on the protection, care, and use of research animals is still heterogeneous. Differences across geopolitical areas exist not only at the legal level but, more important, also at the level of implementation of the existing regulations. In this diverse landscape, AAALAC International uses performance standards to assure harmonization of accredited animal care and use programs globally. Accredited programs must first comply with applicable legislation, which may establish different baseline levels, on top of which performance standards are to be applied for the different animal care and use program areas. To achieve this goal, AAALAC International has given its Council on Accreditation an international composition and perspective that allows better interpretation of the different scenarios. There are a number of challenges and opportunities that may impact the implementation of existing legislation and the accreditation of animal care and use programs across countries. Challenges may relate to financial constraints, administrative burden, or differences between compliance and best practices. Opportunites may be represented by other fields of animal research, the level of development of research in some countries, or increasing interinstitutional collaborations. A description of these challenges and opportunities in North America, Europe, and the Pacific Rim from the AAALAC International perspective is discussed in this article.

Current concepts of Harm-Benefit Analysis of Animal Experiments - Report from the AALAS-FELASA Working Group on Harm-Benefit Analysis - Part 1.

International regulations and guidelines strongly suggest that the use of animal models in scientific research should be initiated only after the authority responsible for the review of animal studies has concluded a well-thought-out harm-benefit analysis (HBA) and deemed the project to be appropriate. Although the process for conducting HBAs may not be new, the relevant factors and algorithms used in conducting them during the review process are deemed to be poorly defined or lacking by committees in many institutions. This paper presents the current concept of HBAs based on a literature review. References on cost or risk benefit from clinical trials and other industries are also included. Several approaches to HBA have been discovered including algorithms, graphic presentations and generic processes. The aim of this study is to better aid and harmonize understanding of the concepts of 'harm', 'benefit' and 'harm-benefit analysis'.

Recommendations for Addressing Harm-Benefit Analysis and Implementation in Ethical Evaluation - Report from the AALAS-FELASA Working Group on Harm-Benefit Analysis - Part 2.

International regulations and guidelines strongly suggest that the use of animal models in scientific research should be initiated only after the authority responsible for the review of animal studies has concluded a well-thought-out harm-benefit analysis (HBA) and deemed the project to be appropriate. The AALAS-FELASA working group on HBA has performed a literature review and based on this review, proposed a method for HBA. Examples of the working group's approach are included in this report.

Approaches to animal research project evaluation in Europe after implementation of Directive 2010/63/EU.

Directive 2010/63/EU requires the evaluation and authorization of all research projects and training activities involving the use of animals and defines some components and expertise necessary for the evaluation process. Adoption of Directive 2010/63/EU provided an opportunity to harmonize project evaluation processes across Europe, but thus far, member states have used a variety of approaches in the transposition and implementation of Directive 2010/63/EU. The authors discuss and compare the project evaluation systems being implemented in five European Union member states (France, Germany, Spain, the Netherlands and the UK).

A novel device based on smart textile to control heart's activity during exercise.

In recent years, several systems have been developed to control cardiac function during exercise, and some are also capable of recording RR data to provide heart rate variability (HRV) analyses. In this study we compare time between heart beats and HRV parameters obtained with a smart textile system (GOW; Weartech sl., Spain) and an electrocardiogram machine commonly used in hospitals during continuous cycling tests. Twelve cardiology patients performed a 30-min cycling test at stable submaximal intensity. RR interval data were recorded during the test by both systems. 3-min RR segments were taken to compare the time intervals between beats and HRV variables using Bland-Altman analyses and intraclass correlation coefficients. Limits of agreement (LoAs) on RR intervals were stable at around 3 ms (widest LoAs -5.754 to 6.094 ms, tightest LoAs -2.557 to 3.105 ms, medium LoAs -3.638 ± 0.812 to 3.145 ± 0.539 ms). HRV parameters related to short-term change presented wide LoAs (RMSSD -0.17 to 18.41 %, HF -17.64 to 33.21 %, SD1 -0.50 to 17.54 %) as an effect of the error measurement of the GOW system. The GOW system is a valid tool for controlling HR during physical activity, although its use as a clinical tool for HRV cannot be supported.