Reimagining India's National Telemedicine Service to improve access to care.

India's free-to-use National Telemedicine Service, eSanjeevani, has provided over 276 million consultations and shown promise to reduce systemic inequalities in access to care. However, recent reports of dropping footfall have raised questions about the potential of eSanjeevani to bridge service provision gaps in India. We reveal important problems linked to the design and practice of triage and tele-referral nationally within eSanjeevani, corroborated by the experience of one of the co-authors' practice of Obstetrics and Gynaecology on the platform since 2022. Some of these factors include sub-optimal integration of general practitioners within the tele-referral pathway; inadequate training of health-workers leading to inappropriate and ineffective consultations; outdated or absent technological support; the absence of mechanisms for re-referrals; and lack of feedback loops. We propose measures to re-imagine eSanjeevani to become a more effective tool towards improving public health outcomes and achieving universal health coverage in India.

Validation of the Ukrainian versions of two life purpose scales: Revised sense of purpose in life scale (SOPS-2U) and specific purpose orientations (SPO-U).

This work focused on the translation and evaluation of the psychometric properties of two widely used scales for assessing sense of purpose in life - the Revised Sense of Purpose Scale (SOPS-2) and the Specific Purpose Orientations (SPO) scale - in the Ukrainian language. The SOPS-2 consisted of 14 items measuring three dimensions of purpose: awakening to purpose, awareness of purpose, and altruistic purpose. Meanwhile, the SPO included 12 items assessing three types of purpose: others-growth, self-growth, and career-focused purpose orientations. Renamed as the Revised Sense of Purpose Scale - Ukrainian Version (SOPS-2U) and the Specific Purpose Orientations - Ukrainian Version (SPO-U), these two scales underwent a thorough translation process by two multilingual scholars proficient in both Ukrainian and English languages, employing the committee approach. Then through analyses of two datasets, the factorial validity, construct validity, and reliability of the SOPS-2U and SPO-U were established. These translated scales provide reliable and valid tools for assessing life purpose among Ukrainian-speaking adults.•Recognizing the profound impact of life purpose on adult wellbeing, the availability of a psychometrically robust measurement tool for assessing this construct in the Ukrainian language becomes crucial; thus, we translated and validated two such tools.•The Revised Sense of Purpose Scale - Ukrainian Version (SOPS-2U) is valid for assessing awakening to purpose, awareness of purpose, and altruistic purpose dimensions in Ukrainian adults.•The Specific Purpose Orientations - Ukrainian Version (SPO-U) can be used with Ukrainian adults to further examine the specific types of purpose, such as others-growth, self-growth, and career-focused purpose orientations.

Protocols versus practice: unravelling clinical checking variations in community pharmacies in England-a multi-method study.

BACKGROUND: Standardisation, a widely accepted concept for risk management, entails designing and implementing task-specific operating procedures. In community pharmacies, Standardised Operating Procedures (SOPs) are a mandatory requirement and are recognised as essential for upholding safety and quality. AIM: This study aimed to investigate community pharmacists' (CPs) compliance with SOPs when checking prescriptions, and the reasons for variations between standardised protocols and practice. METHOD: Eight sets of SOPs underwent hierarchical task analysis (HTA) to generate a normative description of clinical checking execution as per protocols. Subsequently, twelve CPs were engaged in a simulated clinical checking exercise, verbalising their thoughts while checking virtual prescriptions. Transcribed data underwent content analysis, aligned with a descriptive model to uncover engagement patterns, and disparities between SOPs and CPs' practices. Finally, a focus group discussion took place to contextualise the observed variations. RESULTS: HTA aided in constructing a clinical checking model with six primary subtasks and 28 lower subtasks. CPs often omitted subtasks during checks, diverging from prescribed protocols. These deviations, observed in controlled environment, reveal an ingrained aspect within the professional culture of pharmacists, where there may be a tendency not to strictly adhere to protocols, despite variations in work conditions. Contributing factors to this culture include the exercise of professional judgment, reliance on others, and prioritisation of patient preferences. CONCLUSION: This study highlights ongoing deviations from SOPs during clinical prescription checks in community pharmacies, suggesting a cultural tendency. Future research should delve into risk management strategies for these deviations and address the delicate balance between flexibility and stringent compliance.

Measuring the Impact of Incorporating Case Study Presentations Into Applied Biomedical Science Placement Workshops for Trainee Biomedical Scientists.

Introduction: Successfully completing the Institute of Biomedical Science (IBMS) registration portfolio is essential to becoming a Health and Care Professions Council (HCPC) registered Biomedical Scientist. In the West Midlands, a unique collaboration between four universities (Aston, Wolverhampton, Coventry, and Keele) and local NHS Trusts supports student placements and portfolio development. The universities support Training Officers in delivering components of the registration portfolio through the delivery of eight combined placement workshops. These have been designed to align to the IBMS registration portfolio and help students meet the HCPC Standards of Proficiency. This study aimed to evaluate the effectiveness of a redesigned workshop where students generated and presented medical case studies to peers, academics, and training leads. Materials and Methods: The three phases of the case study intervention included a pre-intervention survey, academic-led sessions focussing on medical case presentations and delivery of the presentation followed by a post-intervention survey. Results: Analysing survey responses pre- and post-intervention, students demonstrated enhanced confidence in their understanding of clinical conditions (p<0.0001), connecting lab findings to diseases, and in delivering a case presentation to their peers (p<0.001). Students reported an increased confidence in structuring case presentations and their critical thinking ability (p<0.0001). All students agreed engaging with the case study workshop improved their ability to communicate knowledge of scientific concepts orally. Thematic analysis revealed that the case presentation deepened students' understanding of multidisciplinary teams. 98% of respondents agreed patient communication should be integrated into Biomedical Sciences courses and 85% would like to see case study presentations embedded into the curriculum. Discussion: Combined placement workshops are an integral part of the Applied Biomedical Science placement journey. Case study presentations are clearly a valuable teaching and learning tool to nurture and develop key transferable skills and competencies in conjunction with Biomedical Science expertise. The collaborative approach in the West Midlands effectively prepares graduates with essential pathology knowledge, skills, and a completed IBMS registration portfolio. This study highlights a successful framework for a collaborative partnership with local NHS trusts that has allowed the completion of numerous pathology placements and could be adopted by other universities delivering accredited Biomedical Science courses.

Prodromal period of psychosis: diagnostic criteria.

OBJECTIVE: Aim: To study the psychopathological mechanisms of the development of the prodromal stage of psychosis in order to identify risk factors for the formation of psychosis. PATIENTS AND METHODS: Materials and Methods: In this research 137 patients with newly diagnosed psychosis were examined: 65 patients with a diagnosis of paranoid schizophrenia; 72 patients - with a diagnosis of acute polymorphic psychotic disorder. RESULTS: Results: According to the analysis of symptoms using the PANSS, the absence of signs of an anxious state, conceptual disorganization of thinking, emotional withdrowal are reliable signs of PPP in PS, and unusual thought content, absence of signs of stereotyped thinking, tension, anxiety, and hallucinations are reliable signs of PPP in APPD. According to the analysis of symptoms using the SOPS, unusual thought content/delusional ideas, bizarre thinking, social anhedonia, suspiciousness/persecutory ideas, decrease in expressiveness of emotions are reliable signs of PPP in PS, and bizarre thinking, impaired tolerance to normal stress, sleep disturbance, perceptual abnormalities/hallucinations, trouble with focus and attention are reliable signs of PPP in APPD. CONCLUSION: Conclusions: In the process of studying the clinical-psychopathological and pathopsychological aspects of the development of the PPP, a number of risk factors for the formation of psychosis were identified. We found that he most important diagnostic signs of PPP in PS patients are: stereotyped thinking, social isolation, disorganizational thinking disorders, passive-apathetic social detachment, suspiciousness. The most informative prodromal symptoms of HP in PS patients are: conceptual disorganization of thinking, bizzare thinking, social isolation, suspiciousness/persecutory ideas, reduced expression of emotions.

Development and validation of a human bronchial epithelial spheroid model to study respiratory toxicity in vitro.

The use of laboratory animals in research has been extensively criticized. While most of the critique has been centered around the ethical aspect, also the economic and scientific aspects have been frequently mentioned as points of concern. As a result, the use of alternative methods has gradually become more enticing. The most used alternatives to laboratory animals are the 2D monolayer cell cultures. However, the limited translatability of these monolayer cell cultures to in vivo has led to the development of 3D cell cultures that are believed to better capture the in vivo physiology and pathology. Here we report on the development of a physiologically more relevant 3D cell model (spheroids) comprised of human bronchial epithelial (16HBE14o-) cells, for use in respiratory toxicity research. Culturing 16HBE14o-cells as hanging-drops led to the formation of stable spheroids which showed an increased expression of CLDN1 when compared to 2D monolayer cultured cells. In addition, cell-cycle analysis revealed an increased sub-G0 population and signs of G0/G1 arrest in spheroids. Afterwards, standard operating procedures (SOPs) were established, and existing protocols optimized, for compatibility with spheroids. Spheroids were successfully used to assess cytotoxicity, genotoxicity, apoptosis/necrosis, and oxidative stress after exposure to known cytotoxic or genotoxic compounds. The development of the bronchial epithelial spheroids and the establishment of SOPs can contribute to a more reliable toxicity assessment of chemicals and may aid in bridging the gap between in vivo and in vitro experiments.

DeXtrusion: automatic recognition of epithelial cell extrusion through machine learning in vivo.

Accurately counting and localising cellular events from movies is an important bottleneck of high-content tissue/embryo live imaging. Here, we propose a new methodology based on deep learning that allows automatic detection of cellular events and their precise xyt localisation on live fluorescent imaging movies without segmentation. We focused on the detection of cell extrusion, the expulsion of dying cells from the epithelial layer, and devised DeXtrusion: a pipeline based on recurrent neural networks for automatic detection of cell extrusion/cell death events in large movies of epithelia marked with cell contour. The pipeline, initially trained on movies of the Drosophila pupal notum marked with fluorescent E-cadherin, is easily trainable, provides fast and accurate extrusion predictions in a large range of imaging conditions, and can also detect other cellular events, such as cell division or cell differentiation. It also performs well on other epithelial tissues with reasonable re-training. Our methodology could easily be applied for other cellular events detected by live fluorescent microscopy and could help to democratise the use of deep learning for automatic event detections in developing tissues.

Comprehensive sentimental analysis of tweets towards COVID-19 in Pakistan: a study on governmental preventive measures.

Sentiments are the key factors that lead to influence our behavior. Sentiment analysis is a technique that analyzes people's behaviors, attitudes, and emotions toward a service, product, topic, or event. Since 2020, no country has remained untouched by COVID-19, and the governing bodies of most countries have been applying several anti-pandemic countermeasures to combat it. In this regard, it becomes tremendously important to analyze people's sentiments when tackling infectious diseases similar to COVID-19. The countermeasures taken by any country to control the pandemic leave a direct and crucial impact on each sector of public life, and every individual reacts to them differently. It is necessary to consider these reactions to implement appropriate messaging and decisive policies. Pakistan has done enough to control this virus's spread like every other country. This research aims to perform a sentimental analysis on the famous microblogging social platform, Twitter, to get insights into public sentiments and the attitudes displayed towards the precautionary steps taken by the Government of Pakistan in the years 2020 and 2021. These steps or countermeasures include the closure of educational institutes, suspension of flight operations, lockdown of business activities, enforcement of several standard operating procedures (SOPs), and the commencement of the vaccination program. We implemented four approaches for the analysis, including the Valence Aware Dictionary and sEntiment Reasoner (VADER), TextBlob, Flair, and Bidirectional Encoder Representations from Transformers (BERT). The first two techniques are lexicon-based. Flair is a pre-trained embedding-based approach, whereas BERT is a transformer-based model. BERT was fine-tuned and trained on a labeled dataset, achieving a validation accuracy of 92%. We observed that the polarity score kept varying from month to month in both years for all countermeasures. This score was analyzed with real-time events occurring in the country, which helped understand the public's sentiment and led to the possible formation of a notable conclusion. All implemented approaches showed independent performances. However, we noticed from the classification results of both TextBlob and the fine-tuned BERT model that neutral sentiment was dominant in the data, followed by positive sentiment.

Standard Operating Procedures (SOPs) for non-invasive multiple biomarkers detection in an academic setting: A critical review of the literature for the RENOVATE study protocol.

Liquid biopsy has the potential to drastically change clinical practice, paving the way to a novel non-invasive approach for cancer diagnosis and treatment. One of the limitations for the implementation of liquid biopsy in clinical practice is the lack of shared and reproducible standard operating procedures (SOPs) for sample collection, processing and storage. Here, we present a critical review of the literature focusing on the available SOPs to guide liquid biopsy management in research settings and describe SOPs that our laboratory developed and employed in the context of a prospective clinical-translational trial (RENOVATE, NCT04781062). The main aim of this manuscript is to address common issues, towards the implementation of interlaboratory shared protocols for optimized preanalytical handling of blood and urine samples. To our knowledge, this work is one of the few up-to-date, freely available comprehensive reports on trial-level procedures for the handling of liquid biopsy.

Decision Making Within and Outside Standard Operating Procedures: Paradoxical Use of Operational Discretion in Firefighters.

OBJECTIVE: To understand how firefighters' use of rules (i.e., standard operating procedures [SOPs]) and deliberative decision making (i.e., operational discretion [OD]) interacts with acute stress. BACKGROUND: Current operational guidance for UK firefighters combines the provision of SOPs, for routine incidents, with the use of OD, under prescribed conditions (e.g., when there is a risk to human life). However, our understanding of the use of SOPs and OD is limited. METHODS: Incident commanders (ICs; n = 43) responded to simulated emergency incidents, which either licensed the use of OD or required use of a SOP. Video footage of IC behavior was used to code their response as involving a SOP or OD, while levels of acute stress were assessed using a blood-based measure and self-report. RESULTS: ICs were less likely to use OD selectively in the simulated emergency incident that licensed its use than in the one for which use of an SOP was appropriate; IC command level did not affect this pattern of results; and the incident that licensed OD resulted in more acute stress than the incident that required use of a SOP. CONCLUSION: SOPs and OD were not used in the manner prescribed by current operational guidance in simulated emergency incidents. APPLICATION: These results suggest that firefighter training in SOPs and OD should be augmented alongside personal resilience training, given the impact of stress on health and wellbeing, but also to improve the deployment of SOPs and OD under stress.

Patient Safety Culture in Latin American Hospitals: A Systematic Review with Meta-Analysis.

INTRODUCTION: Adverse events in hospitals are prevented through risk reduction and reliable processes. Highly reliable hospitals are grounded by a robust patient safety culture with effective communication, leadership, teamwork, error reporting, continuous improvement, and organizational learning. Although hospitals regularly measure their patient safety culture for strengths and weaknesses, there have been no systematic reviews with meta-analyses reported from Latin America. PURPOSE: Our systematic review aims to produce evidence about the status of patient safety culture in Latin American hospitals from studies using the Hospital Survey on Patient Safety Culture (HSOPSC). METHODS: This systematic review was guided by the JBI guidelines for evidence synthesis. Four databases were systematically searched for studies from 2011 to 2021 originating in Latin America. Studies identified for inclusion were assessed for methodological quality and risk of bias. Descriptive and inferential statistics, including meta-analysis for professional subgroups and meta-regression for subgroup effect, were calculated. RESULTS: In total, 30 studies from five countries-Argentina (1), Brazil (22), Colombia (3), Mexico (3), and Peru (1)-were included in the review, with 10,915 participants, consisting primarily of nursing staff (93%). The HSOPSC dimensions most positive for patient safety culture were "organizational learning: continuous improvement" and "teamwork within units", while the least positive were "nonpunitive response to error" and "staffing". Overall, there was a low positive perception (48%) of patient safety culture as a global measure (95% CI, 44.53-51.60), and a significant difference was observed for physicians who had a higher positive perception than nurses (59.84; 95% CI, 56.02-63.66). CONCLUSIONS: Patient safety culture is a relatively unknown or unmeasured concept in most Latin American countries. Health professional programs need to build patient safety content into curriculums with an emphasis on developing skills in communication, leadership, and teamwork. Despite international accreditation penetration in the region, there were surprisingly few studies from countries with accredited hospitals. Patient safety culture needs to be a priority for hospitals in Latin America through health policies requiring annual assessments to identify weaknesses for quality improvement initiatives.

The Association Between Patient Safety Culture and Accreditation at Primary Care Centers in Kuwait: A Country-Wide Multi-Method Study.

Purpose: A culture of patient safety is essential for the continual improvement of service and reducing errors. This study aims to examine how the scores of patient safety culture items impact accreditation compliance percentages in primary care settings in Kuwait. Methods: A cross-sectional and a retrospective quantitative approaches were used on 5288 employees at 75 primary healthcare centers across Kuwait. Patient safety culture questionnaires were distributed to clinical and administrative staff with at least one year of experience. We also examined the percentages of compliance with accreditation standards by the studied centers. Participant socio-demographic and setting demographic data were studied using univariate (means, standard deviations, frequencies, percentages) and bivariate (Student's t-tests, ANOVA F-tests, Mann-Whitney U-test, Kruskal-Wallis H-test, Spearman correlation) analyses to examine how trends in the patient safety culture items and accreditation compliance differ across the primary healthcare center demographic groups. The relationship between patient safety culture composites and percentages of accreditation compliance was investigated. To predict the factors for accreditation compliance, we used multivariate regression analysis. Results: The responses of 5288 employees (response rate= 76.5%) from 75 centers were included. Our analysis revealed that the demographics of the setting affected the accreditation compliance percentage more than the percentages of patient safety culture positive ratings. Furthermore, the composites "Patient Care Tracking/Follow-up", "Communication about Error", "Organizational Learning" and "Overall Perceptions of Patient Safety & Quality" had statistically significant weak-to-moderate positive correlations (r = 0.272-0.373) with percentage scores for compliance with various accreditation standards. Regression analysis indicated that the patient safety culture items accounted for 35% to 38% of the variability in accreditation compliance scores. Conclusion: The safety practices adopted by a primary healthcare center reflect its culture, and this has an impact on its accreditation performance. Our interpretation of the findings is expected to help healthcare leaders to better understand the relationship between safety culture and performance and to develop realistic reform strategies.

Strategic job market-guided development of pharmacy bachelor's curriculum and its importance in maintaining the profession viability in the Middle Eastern countries: Colleges of pharmacy in the UAE as a model.

The Middle East has high youth population; however, it is challenged by uncertain economic situation. Higher education plays a crucial role in the development of nations by equipping generations with the knowledge and skill through cumulative curriculum development. Like other professions, pharmacy is a dynamic field of study where continuous improvements are required to keep the viability of the profession and endow future generations with up to date skills. This article describes a strategy for pharmacy curriculum development considering four layers. The strategy starts from the understanding of the current situation in a university, looking into national, international accreditations and job market. The strategy covers development from program to subject's level. The strategy is applied to pharmacy programs in the UAE. Upon analysis, several recommendations were obtained for curriculum improvements. At individual university level, there is a need to work on clinical oriented topics in the curriculum to fit with international accreditation and country's vision. Details on this can be taken form deeper analysis of job market and stakeholders in the UAE. On the national level, unifications of total credit hours for the degree across universities needs to be envisaged with limits on contact experiential hours. The strategy has the potential of extrapolating to other Middle Eastern countries.

The Open Cryotop System Is Effective for the Simultaneous Vitrification of a Large Number of Porcine Embryos at Different Developmental Stages.

The Superfine Open Pulled Straw (SOPS) system is the most commonly used method for vitrification of pig embryos. However, this system only allows the vitrification of four to seven embryos per straw. In this study, we investigated the effectiveness of the open (OC) and closed (CC) Cryotop® systems to simultaneously vitrify a larger number of porcine embryos. Morulae, early blastocysts and full blastocysts were vitrified with the open Cryotop® (n = 250; 20 embryos per device) system, the closed Cryotop® (n = 158; 20 embryos per device) system and the traditional superfine open pulled straw (SOPS; n = 241; 4-7 embryos per straw) method. Fresh embryos from each developmental stage constituted the control group (n = 132). Data expressed as percentages were compared with the Fisher's exact test. The Kruskal-Wallis test was used to analyze the effect of the different vitrification systems on the embryo quality parameters and two-by-two comparisons were accomplished with the Mann-Whitney U test. Differences were considered statistically significant when p < 0.05. Vitrified and control embryos were incubated for 24 h and examined for viability and quality. At the warming step, the embryo recovery rate for the CC system was 51%, while all embryos were recovered when using OC and SOPS. There were no differences between the vitrification and control groups in the postwarming viability of full blastocysts. In contrast, morulae and early blastocysts that were vitrified-warmed with the SOPS system had lower viability (p < 0.01) compared to those from the OC, CC and control groups. The embryonic viability was similar between the OC and control groups, regardless of the developmental stage considered. Moreover, the embryos from the OC group had comparable total cell number and cells from the inner cell mass and apoptotic index than the controls. In conclusion, the OC system is suitable for the simultaneous vitrification of 20 porcine embryos at different developmental stages and provides comparable viability and quality results to fresh embryos subjected to 24 h of in vitro culture.

Revitalization of tourism and hospitality sector: preempting pandemics through lessons learned.

The devastating effects of the COVID-19 pandemic have left many repercussions for the tourism industry to preempt any future catastrophe of this nature. The research aims to propose recommendations for the post-COVID-19 business world to revitalize and reclaim their market space and win back their volumes without any fear of indefinite closures and continued lockdowns in the industry. Drawing from the literature, the study assumed revitalization through responsiveness, use of advanced technology, customers' and employees' willingness, enhanced skills, adherence to standard operating procedures and protective measures, and restructuring via a public-private partnership. For the purpose, survey method was employed to collect data from the industry. After confirmation of the reliability and validity, the regression analyses supported effective revitalization through government responsiveness, use of digital technology, psychological recouping of customers' willingness, enhancing technical skills through training, strict adherence to protective measures, and destination restructuring and reorganization through a public-private partnership. The study proclaimed that Pakistan's tourism and hospitality sector development has evolved through the COVID-19 situation, and is likely to revamp and revitalize into a sustainable business. Once achieving sustainability, the revamped industry will likely to increase revenue, generate employment, and alleviate poverty through thriving public-private partnerships, community involvement, and community well-being without compromising people's health.

Impact of Sports Psychology, Human Behavior, and Advertisement on the sales of player's shirts and drinks / Impacto de la Psicología del Deporte, el Comportamiento Humano y la Publicidad en las ventas de camisetas y bebidas de los jugadores

Growing health concerns and being overweight as a result of excessive consumption of soft drink have become a major concern around the world. The primary purpose of this research study is to measure the effect of sports psychology, human behavior, and advertisement on the sale of player's shirts and drinks. This research study uses primary data analysis, collected through a questionnaire including specific questions related to the independent and dependent variables understudy. In this research study, sports psychology, human behavior, and advertisement are consider independent variables, and sales of player's shirts and sales of drinks are the dependent variables. For measuring data analysis, the study uses chi-square analysis, descriptive statistical analysis, regression analysis, least-square analysis and other histogram graphs. According to the overall study results, it has been found that sport psychology shows a positive and insignificant impact on the sale of players' shirts. On the other hand, human behavior is found to have a negative but significant impact on the sale of players' shirts. In other words, sport psychology has a negative effect on the sale of drinks, and human behavior has a positive effect on drinks sales. This study has important implications for marketers and policy-makers concerned with public health in general, and obesity reduction in particular. Through social marketing, soft drink marketers may incorporate obesity-reduction activities. This study proposes a conceptual framework soft drink anti-consumption behavior, emphasizing health concerns and exploring the impact of sociocultural variables on anti-consumption.(AU)

Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial.

Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.

FAIRification of nanosafety data to improve applicability of (Q)SAR approaches: A case study on in vitro Comet assay genotoxicity data.

(Quantitative) structure-activity relationship ([Q]SAR) methodologies are widely applied to predict the (eco)toxicological effects of chemicals, and their use is envisaged in different regulatory frameworks for filling data gaps of untested substances. However, their application to the risk assessment of nanomaterials is still limited, also due to the scarcity of large and curated experimental datasets. Despite a great amount of nanosafety data having been produced over the last decade in international collaborative initiatives, their interpretation, integration and reuse has been hampered by several obstacles, such as poorly described (meta)data, non-standard terminology, lack of harmonized reporting formats and criteria. Recently, the FAIR (Findable, Accessible, Interoperable, and Reusable) principles have been established to guide the scientific community in good data management and stewardship. The EU H2020 Gov4Nano project, together with other international projects and initiatives, is addressing the challenge of improving nanosafety data FAIRness, for maximizing their availability, understanding, exchange and ultimately their reuse. These efforts are largely supported by the creation of a common Nanosafety Data Interface, which connects a row of project-specific databases applying the eNanoMapper data model. A wide variety of experimental data relating to characterization and effects of nanomaterials are stored in the database; however, the methods, protocols and parameters driving their generation are not fully mature. This article reports the progress of an ongoing case study in the Gov4nano project on the reuse of in vitro Comet genotoxicity data, focusing on the issues and challenges encountered in their FAIRification through the eNanoMapper data model. The case study is part of an iterative process in which the FAIRification of data supports the understanding of the phenomena underlying their generation and, ultimately, improves their reusability.

Structural Modeling on the Determinants of Effectiveness of SOPs Containing COVID-19 in Mass Gatherings.

The study is aimed to analyze the determinants of the effectiveness of SOPs in mass gatherings for containing COVID-19. The overall design of the study involves a literature review, data collection by field survey, structural modeling, and analysis. The study is built on the experts' opinion of a focus group (representing people who recently participated in and are responsible for mass gatherings). The study uses the discussion of the literature review to identify the determinants, interpretive structural modeling (ISM) for developing and analyzing a structural model, and Matrice d'Impacts Croises Multiplication Appliquée a un Classement (MICMAC) for corroboration of results of the ISM/classification of determinants. From the literature review, a list of determinants is generated and verified by a panel of experts. The results of the ISM revealed that the determinants "legal environment of the country," "practicability of SOPs," "perceived benefit of adapting SOPs," and "possibilities of avoiding gathering" occupied the top of the model, therefore, they are less critical determinants, whereas "nature of gathering" occupied the bottom of the model, and is thus the most critical determinant. The remaining determinants form the middle of the model, and are therefore moderately severe. The results of MICMAC show that the determinant "perceived benefit of adapting SOPs" is dependent, "nature of gathering" is independent, and all others are linked. The results of MICMAC implicitly substantiate the findings of the ISM. The overall results of the study show that "nature of gathering" is the key determinant. This research does not require a priori theory since it is a theory-building study that uses an inductive approach. It is based on real data and it is useful for local authorities, organizers, participants (attendees/visitors) of mass gatherings, health officials/regulators, researchers, and the community at large. This study has fundamental importance for planning and preparing for such events while ensuring the minimum risk of COVID-19 transmission.

A Plan for Emergency Shutdown and Reopening for a Consortium of Biobanks.

Background: The AIDS and Cancer Specimen Resource (ACSR) is a network of four regional biospecimen repositories and a technical core in the United States and South Africa. Its mission is to acquire, store, and distribute HIV-associated malignancy specimens and related clinical data to support translational research. At the outset of the COVID-19 pandemic, it became apparent that existing ACSR Standard Operating Procedures (SOPs) were not sufficient to ensure long-term maintenance and integrity of inventories during periods of extended shutdown. The ACSR needed an administrative SOP for situations pertaining to epidemics/pandemics. The ACSR Quality Working Group (QWG), comprised of representatives from each of the five ACSR sites and an external member who directs a large university medical center biorepository, addressed the issue. Methods: To understand the individual problems the sites faced, questions were developed to query each of the six QWG sites' contingency plans to cover this type of emergency, the amount of work allowed onsite and by whom, the challenges sites experienced, and the lessons learned to assist with future similar situations, while remaining consistent with the existing IRB protocols. Results: Reported challenges spanned all activities of classical biobanks and differed within the geographical locations of the sites and the local COVID-19 infection rate. Review of the responses to the questions revealed that the general shutdown of society external to the biorepositories presented them with a homogeneous collection of problems, limitations, and needs. This led to creating an SOP that addresses planning for pandemic emergencies, scaling down of activities, shutting down, and reopening plans. Conclusions: The ACSR QWG sites now have a structured response SOP for their sites, including guidance on how to develop and implement an emergency shutdown and reopening plan. The complete SOP is publicly available on the ACSR website.