Generalized Confidence Intervals for Ratios of Standard Deviations Based on Log-Normal Distribution when Times Follow Weibull Distributions.

Modern anesthetic drugs ensure the efficacy of general anesthesia. Goals include reducing variability in surgical, tracheal extubation, post-anesthesia care unit, or intraoperative response recovery times. Generalized confidence intervals based on the log-normal distribution compare variability between groups, specifically ratios of standard deviations. The alternative statistical approaches, performing robust variance comparison tests, give P-values, not point estimates nor confidence intervals for the ratios of the standard deviations. We performed Monte-Carlo simulations to learn what happens to confidence intervals for ratios of standard deviations of anesthesia-associated times when analyses are based on the log-normal, but the true distributions are Weibull. We used simulation conditions comparable to meta-analyses of most randomized trials in anesthesia, n ≈ 25 and coefficients of variation ≈ 0.30 . The estimates of the ratios of standard deviations were positively biased, but slightly, the ratios being 0.11% to 0.33% greater than nominal. In contrast, the 95% confidence intervals were very wide (i.e., > 95% of P ≥ 0.05). Although substantive inferentially, the differences in the confidence limits were small from a clinical or managerial perspective, with a maximum absolute difference in ratios of 0.016. Thus, P < 0.05 is reliable, but investigators should plan for Type II errors at greater than nominal rates.

Use of Real-World FHIR Data Combined with Context-Sensitive Decision Modeling to Guide Sentinel Biopsy in Melanoma.

Background: To support clinical decision-making at the point of care, the "best next step" based on Standard Operating Procedures (SOPs) and actual accurate patient data must be provided. To do this, textual SOPs have to be transformed into operable clinical algorithms and linked to the data of the patient being treated. For this linkage, we need to know exactly which data are needed by clinicians at a certain decision point and whether these data are available. These data might be identical to the data used within the SOP or might integrate a broader view. To address these concerns, we examined if the data used by the SOP is also complete from the point of view of physicians for contextual decision-making. Methods: We selected a cohort of 67 patients with stage III melanoma who had undergone adjuvant treatment and mainly had an indication for a sentinel biopsy. First, we performed a step-by-step simulation of the patient treatment along our clinical algorithm, which is based on a hospital-specific SOP, to validate the algorithm with the given Fast Healthcare Interoperability Resources (FHIR)-based data of our cohort. Second, we presented three different decision situations within our algorithm to 10 dermatooncologists, focusing on the concrete patient data used at this decision point. The results were conducted, analyzed, and compared with those of the pure algorithmic simulation. Results: The treatment paths of patients with melanoma could be retrospectively simulated along the clinical algorithm using data from the patients' electronic health records. The subsequent evaluation by dermatooncologists showed that the data used at the three decision points had a completeness between 84.6% and 100.0% compared with the data used by the SOP. At one decision point, data on "patient age (at primary diagnosis)" and "date of first diagnosis" were missing. Conclusions: The data needed for our decision points are available in the FHIR-based dataset. Furthermore, the data used at decision points by the SOP and hence the clinical algorithm are nearly complete compared with the data required by physicians in clinical practice. This is an important precondition for further research focusing on presenting decision points within a treatment process integrated with the patient data needed.

Market-based solution in China to finance the clean from the dirty.

Financial incentives play a key role in promoting renewable energy investments that can help China achieve the 'dual carbon' goal. The national emissions trading scheme (ETS) and the renewable energy portfolio standard (RPS) are two existing market-based policy instruments that can generate stable expected returns for low-carbon projects. This paper studies the interactive distribution effects of these two market-based instruments. We use the micro-level thermal power plant data to investigate the abatement effects of the national ETS, in which the details show that the existing rate-based ETS will result in higher negative impacts on power units, whose installed capacities are smaller than 400 MW. The interactive distribution effects between the two markets will occur when the permit allocation standards of the national ETS become stricter than the existing ones. Provinces in Eastern China and Northern China will face high pressure on costs in both ETS and RPS markets. When the levels of the permit allocation standards are set as 70% of the existing ones and the carbon price is assumed to be 200 yuan/ton in 2030, the annual market size of the national ETS will be nearly 100 billion yuan, and the annual market size is predicted to be 250 billion yuan. In the existing rate-based national ETS, the China Certified Emission Reduction (CCER) mechanism will have an offsetting effect, which should be taken into serious consideration during the policy-making processes in the future.

Quality of life during usual epilepsy care for anxiety or depression symptoms: Secondary patient-reported outcomes in a randomized trial of remote assessment methods.

BACKGROUND AND OBJECTIVES: Anxiety and depression are highly prevalent and impactful in epilepsy. American Academy of Neurology quality measures emphasize anxiety and depression screening and quality of life (QOL) measurement, yet usual epilepsy care QOL and anxiety/depression outcomes are poorly characterized. The main objective was to assess 6-month QOL, anxiety and depression during routine care among adults with epilepsy and baseline anxiety or depression symptoms; these were prespecified secondary outcomes within a pragmatic randomized trial of remote assessment methods. METHODS: Adults with anxiety or depression symptoms and no suicidal ideation were recruited from a tertiary epilepsy clinic via an electronic health record (EHR)-embedded process. Participants were randomized 1:1 to 6 month outcome collection via patient portal EHR questionnaires vs. telephone interview. This report focuses on an a priori secondary outcomes of the overall trial, focused on patient-reported health outcomes in the full sample. Quality of life, (primary health outcome), anxiety, and depression measures were collected at 3 and 6 months (Quality of Life in Epilepsy-10, QOLIE-10, Generalized Anxiety Disorder-7, Neurological Disorders Depression Inventory-Epilepsy). Change values and 95 % confidence intervals were calculated. In post-hoc exploratory analyses, patient-reported anxiety/depression management plans at baseline clinic visit and healthcare utilization were compared with EHR-documentation, and agreement was calculated using the kappa statistic. RESULTS: Overall, 30 participants (15 per group) were recruited and analyzed, of mean age 42.5 years, with 60 % women. Mean 6-month change in QOLIE-10 overall was 2.0(95 % CI -6.8, 10.9), and there were no significant differences in outcomes between the EHR and telephone groups. Mean anxiety and depression scores were stable across follow-up (all 95 % CI included zero). Outcomes were similar regardless of whether an anxiety or depression action plan was documented. During the baseline interview, most participants with clinic visit EHR documentation indicating action to address anxiety and/or depression reported not being offered a treatment(7 of 12 with action plan, 58 %), and there was poor agreement between patient report and EHR documentation (kappa=0.22). Healthcare utilization was high: 40 % had at least one hospitalization or emergency/urgent care visit reported and/or identified via EHR, but a third (4/12) failed to self-report an EHR-identified hospitalization/urgent visit. DISCUSSION: Over 6 months of usual care among adults with epilepsy and anxiety or depression symptoms, there was no significant average improvement in quality of life or anxiety/depression, suggesting a need for interventions to enhance routine neurology care and achieve quality of life improvement for this group.

Assessment of cone-beam CT technical image quality indicators and radiation dose for optimal STL model used in visual surgical planning.

OBJECTIVES: The aim of this study was to identify cone-beam computed tomography (CBCT) protocols that offer an optimal balance between effective dose (ED) and 3D model for orthognathic virtual surgery planning, using CT as a reference, and to assess whether such protocols can be defined based on technical image quality metrics. METHODS: Eleven CBCT (VISO G7, Planmeca Oy, Helsinki, Finland) scan protocols were selected out of 32 candidate protocols, based on ED and technical image quality measurements. Next, an anthropomorphic RANDO SK150 phantom was scanned using these 11 CBCT protocols and 2 CT scanners for bone quantity assessments. The resulting DICOM (Digital Imaging and Communications in Medicine) files were converted into Standard Tessellation Language (STL) models that were used for bone volume and area measurements in the predefined orbital region to assess the validity of each CBCT protocol for virtual surgical planning. RESULTS: The highest CBCT bone volume and area of the STL models were obtained using normal dose protocol (F2) and ultra-low dose protocol (J13), which resulted in 48% and 96% of the mean STL bone volume and 48% and 95% of the bone area measured on CT scanners, respectively. CONCLUSIONS: The normal dose CBCT protocol "F2" offered optimal bone area and volume balance for STL. The optimal CBCT protocol can be defined using contrast-to-noise ratio and modulation transfer function values that were similar to those of the reference CT scanners'. CBCT scanners with selected protocols can offer a viable alternative to CT scanners for acquiring STL models for virtual surgical planning at a lower effective dose.

Challenges and solutions to system-wide use of precision oncology as the standard of care paradigm.

The personalised oncology paradigm remains challenging to deliver despite technological advances in genomics-based identification of actionable variants combined with the increasing focus of drug development on these specific targets. To ensure we continue to build concerted momentum to improve outcomes across all cancer types, financial, technological and operational barriers need to be addressed. For example, complete integration and certification of the 'molecular tumour board' into 'standard of care' ensures a unified clinical decision pathway that both counteracts fragmentation and is the cornerstone of evidence-based delivery inside and outside of a research setting. Generally, integrated delivery has been restricted to specific (common) cancer types either within major cancer centres or small regional networks. Here, we focus on solutions in real-world integration of genomics, pathology, surgery, oncological treatments, data from clinical source systems and analysis of whole-body imaging as digital data that can facilitate cost-effectiveness analysis, clinical trial recruitment, and outcome assessment. This urgent imperative for cancer also extends across the early diagnosis and adjuvant treatment interventions, individualised cancer vaccines, immune cell therapies, personalised synthetic lethal therapeutics and cancer screening and prevention. Oncology care systems worldwide require proactive step-changes in solutions that include inter-operative digital working that can solve patient centred challenges to ensure inclusive, quality, sustainable, fair and cost-effective adoption and efficient delivery. Here we highlight workforce, technical, clinical, regulatory and economic challenges that prevent the implementation of precision oncology at scale, and offer a systematic roadmap of integrated solutions for standard of care based on minimal essential digital tools. These include unified decision support tools, quality control, data flows within an ethical and legal data framework, training and certification, monitoring and feedback. Bridging the technical, operational, regulatory and economic gaps demands the joint actions from public and industry stakeholders across national and global boundaries.

Rapid quality assessment and traceability of ginger powder from Northeast India and Indian market based on near infrared spectroscopic fingerprinting.

INTRODUCTION: Ginger (Zingiber officinale Rosc.) varies widely due to varying concentrations of phytochemicals and geographical origin. Rapid non-invasive quality and traceability assessment techniques ensure a sustainable value chain. OBJECTIVE: The objective of this study is the development of suitable machine learning models to estimate the concentration of 6-gingerol and check traceability based on the spectral fingerprints of dried ginger samples collected from Northeast India and the Indian market using near-infrared spectrometry. METHODS: Samples from the market and Northeast India underwent High Performance Liquid Chromatographic analysis for 6-gingerol content estimation. Near infrared (NIR) Spectrometer acquired spectral data. Quality prediction utilized partial least square regression (PLSR), while fingerprint-based traceability identification employed principal component analysis and t-distributed stochastic neighbor embedding (t-SNE). Model performance was assessed using RMSE and R2 values across selective wavelengths and spectral fingerprints. RESULTS: The standard normal variate pretreated spectral data over the wavelength region of 1,100-1,250 nm and 1,325-1,550 nm showed the optimal calibration model with root mean square error of calibration and R2 C (coefficient of determination for calibration) values of 0.87 and 0.897 respectively. A lower value (0.24) of root mean square error of prediction and a higher value (0.973) of R2 P (coefficient of determination for prediction) indicated the effectiveness of the developed model. t-SNE performed better clustering of samples based on geographical location, which was independent of gingerol content. CONCLUSION: The developed NIR spectroscopic model for Indian ginger samples predicts the 6-gingerol content and provides geographical traceability-based identification to ensure a sustainable value chain, which can promote efficiency, cost-effectiveness, consumer confidence, sustainable sourcing, traceability, and data-driven decision-making.

Investigating the temporal and spatial evolution of bank performance and its impact pathways in the context of financial technology development.

Financial technology transforms humans and businesses as globalization and the digital economy accelerate. This affects bank performance. Thus, studying whether financial technology affects bank performance is crucial to enhancing living standards and business development. This article examines the development and interaction between financial technology and bank performance from 2012 to 2021 using standard deviation ellipses, kernel density estimation, Moran's index, and spatial econometric models. The research found that (1) financial technology development improves regional bank performance. In contrast, control variables like economic development, urbanization, tax burden, capital adequacy ratio, net interest margin, and loan-to-deposit ratio also affect bank performance. (2) From 2012 to 2021, Chinese bank performance initially grew, then declined, while financial technology declined slowly and improved rapidly. Financial technology and bank performance development were highest in the eastern coastal regions and lowest in the northwest and northeast. (3) China's financial technology and bank performance had high-high or low-low spatial agglomeration. (4) Financial technology and control variables have a spatial spillover effect on bank performance, so their development in one region can affect neighboring regions. This article provides recommendations for governments and banks based on these findings.

Risk Assessment Predicts Most of the Salmonellosis Risk in Raw Chicken Parts is Concentrated in Those Few Products with High Levels of High-Virulence Serotypes of Salmonella.

Salmonella prevalence declined in U.S. raw poultry products since adopting prevalence-based Salmonella performance standards, but human illnesses did not reduce proportionally. We used Quantitative Microbial Risk Assessment (QMRA) to evaluate public health risks of raw chicken parts contaminated with different levels of all Salmonella and specific high- and low-virulence serotypes. Lognormal Salmonella level distributions were fitted to 2012 USDA-FSIS Baseline parts survey and 2023 USDA-FSIS HACCP verification sampling data. Three different Dose-Response (DR) approaches included (i) a single DR for all serotypes, (ii) DR that reduces Salmonella Kentucky ST152 virulence, and (iii) multiple serotype-specific DR models. All scenarios found risk concentrated in the few products with high Salmonella levels. Using a single DR model with Baseline data (µ = -3.19, σ = 1.29 Log CFU/g), 68% and 37% of illnesses were attributed to the 0.7% and 0.06% of products with >1 and >10 CFU/g Salmonella, respectively. Using distributions from 2023 HACCP data (µ = -5.53, σ = 2.45), 99.8% and 99.0% of illnesses were attributed to the 1.3% and 0.4% of products with >1 and >10 CFU/g Salmonella, respectively. Scenarios with serotype-specific DR models showed more concentrated risk at higher levels. Baseline data showed 92% and 67% and HACCP data showed >99.99% and 99.96% of illnesses attributed to products with >1 and >10 CFU/g Salmonella, respectively. Regarding serotypes using Baseline or HACCP input data, 0.002% and 0.1% of illnesses were attributed to the 0.2% and 0.4% of products with >1 CFU/g of Kentucky ST152, respectively, while 69% and 83% of illnesses were attributed to the 0.3% and 0.6% of products with >1 CFU/g of Enteritidis, Infantis, or Typhimurium, respectively. Therefore, public health risk in chicken parts is concentrated in finished products with high levels and specifically high levels of high-virulence serotypes. Low-virulence serotypes like Kentucky contribute few human cases.

Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models-a New Method Based on Metropolis-Hastings Algorithm.

The standard errors (SE) of the maximum likelihood estimates (MLE) of the population parameter vector in nonlinear mixed effect models (NLMEM) are usually estimated using the inverse of the Fisher information matrix (FIM). However, at a finite distance, i.e. far from the asymptotic, the FIM can underestimate the SE of NLMEM parameters. Alternatively, the standard deviation of the posterior distribution, obtained in Stan via the Hamiltonian Monte Carlo algorithm, has been shown to be a proxy for the SE, since, under some regularity conditions on the prior, the limiting distributions of the MLE and of the maximum a posterior estimator in a Bayesian framework are equivalent. In this work, we develop a similar method using the Metropolis-Hastings (MH) algorithm in parallel to the stochastic approximation expectation maximisation (SAEM) algorithm, implemented in the saemix R package. We assess this method on different simulation scenarios and data from a real case study, comparing it to other SE computation methods. The simulation study shows that our method improves the results obtained with frequentist methods at finite distance. However, it performed poorly in a scenario with the high variability and correlations observed in the real case study, stressing the need for calibration.

Enhancing pneumococcal bacteraemia diagnosis: A comparative assessment of culture-independent assays (MALDI-TOF-MS Sepsityper® module and a lateral flow inmunochromatography test).

INTRODUCTION: Pneumococcal bacteraemia is a major contributor to global morbidity and mortality. Traditional culture-based methods lack sensitivity and are time-consuming. This study aimed to assess the effectiveness of two culture-independent assays, the MALDI-TOF-MS Sepsityper® module and the lateral flow inmunochromatography test (LFICT) with the Standard F® Streptococcus pneumoniae, directly from positive blood culture (BC) bottles. METHODS: A prospective study was conducted from December 2021 to July 2022. For all BC positives for S. pneumoniae a double centrifugation protocol was implemented. The resulting pellet was subsequently processed using both techniques. RESULTS: The LFICT showed exceptional performance with 100% sensitivity and specificity, outperforming the MALDI-TOF-MS Sepsityper® module, which achieved 85.2% sensitivity and 100% specificity. Nevertheless, the combination of these assays offers a robust and comprehensive approach to diagnosis. CONCLUSIONS: The simultaneous use of both techniques offers a promising alternative that can be integrated into routine practices directly from BC samples.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

BACKGROUND: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

[Guidelines for economic evaluation of post-marketing Chinese patent medicine].

With the premise of drug safety and effectiveness, pharmacoeconomic evaluation can provide optimal solutions for diversified decision-making application scenarios from different research perspectives while maximizing the rational utilization of existing healthcare resources. Chinese patent medicine is an essential component of pharmaceutical utilization in China and a significant part of healthcare expenditure in China. However, the economic evaluation of post-marketing Chinese patent medicine is lacking. These evaluations often lack standardization, exhibit varying quality, and are unable to effectively support healthcare decisions, indicating a need for improvement in overall quality. Given this situation, this project has gathered leading experts from China and has strictly adhered to the requirements of the group standards set by the China Association of Traditional Chinese Medicine in developing Guidelines for economic evaluation of post-marketing Chinese patent medicine, aiming to provide methodological guidance for the post-market pharmacoeconomic evaluation of Chinese patent medicine, enhancing the standardization of pharmacoeconomic evaluations of Chinese patent medicine and the scientific validity of research results, and thereby elevating the overall quality of pharmacoeconomic evaluations for post-marketing Chinese patent medicine. The guidelines adhere to the framework provided by relevant laws and regulations in China and technical guidance documents. It is based on guidance from traditional Chinese medicine(TCM) theories, focusing on the unique characteristics of TCM. It covers various aspects of pharmacoeconomic evaluation, including fundamental principles, research topic selection, research question definition, study design type selection, cost identification and measurement, health outcomes, and evaluation methods. The guidelines offer methodological recommendations and decision guidance to address common issues and challenges in the pharmacoeconomic evaluation of post-marketing Chinese patent medicine.

An Assessment of the Fire Safety Standards in Iranian Homes and Equipment As They Relate to Fire Accidents.

Fire accidents and burns are one of the leading causes of death and disability worldwide. This study was conducted with the aim of studying the etiology of fire accidents as well as investigating the fire safety standards of both homes and equipment in Iran. Samples included patients with flame burns who consented to answer the questions. Questions covered five areas: patient demographics, epidemiological characteristics of burns, the fire safety status of the home, the fire safety status of the equipment, and the mechanism of the accident. In this study, the mean extent of the burns was 18.07 ± 14.29% of body surface area and was significantly related to the age grouping of the patients. The highest total body surface area (TBSA) was observed in patients between 19 to 39 years. The most common cause of flame injuries was gas explosions (36.81%). The interviews revealed that most of the houses were not equipped with smoke detectors or fire extinguishers. The extent of burns was significantly higher in patients living in unequipped homes (P = 0.047). Cooking equipment was often involved in the accidents (38.1%). Considering the low home fire safety and the role of equipment misuse and damaged equipment use in the occurrence of accidents, it seems that installing fire alarms and firefighting equipment, proper training on how to work with and maintain the equipment, using cooking and heating equipment correctly along with discontinuing use if damaged would all be effective and are highly suggestive to reduce fire injuries.

Les incendies et les brûlures sont une cause majeure de décès et de handicap dans le monde. Les buts de cette étude était d'identifier les causes d'incendie en Iran et d'évaluer la sécurité des maison et des équipements en Iran. Nous avons interrogé des victimes d'incendie acceptant de répondre à nos questions, qui relevaient de 5 sujets: démographie des patients, caractéristiques des brûlures, sécurité- incendie de leur domicile ainsi que des équipements et mécanisme de l'incendie. La surface brûlée était de 18,07 +/- 14,29%, significativement corrélée à l'âge de la victime, la surface maximale étant observée dans le groupe 19-39 ans. Une explosion de gaz était la cause la plus fréquente de déclenchement de l'incendie (36,81%) et les équipements de cuisson étaient impliqués dans 38% des cas. La plupart des habitations ne se pas équipées de détecteurs de fumées (DAAF) ni d'extincteurs, les brûlures étant plus étendues en l'absence de tels matériels (p= 0,047). Il est donc nécessaire de promouvoir l'installation de DAAF et d'extincteurs, de développer l'éducation à l'utilisation et à l'entretien des appareils de chauffage comme de cuisson, de décourager l'utilisation de ces appareils quand ils sont endommagés afin de réduire le risque d'incendie de domicile.

Inconsistencies in the EU regulatory risk assessment of PFAS call for readjustment.

Recognition of per- and polyfluoroalkyl substances (PFAS) as widespread environmental pollutants and a consequent risk to human health, has recently made the European Union (EU) adopt several regulatory measures for their management. The coherence of these measures is challenged by the diversity and the ubiquitous occurrence of PFAS, which also complicates the EU's endeavor to advance justified, harmonized, and transparent approaches in the regulatory assessment of chemical risks. Our study critically reviews the European approach for the risk assessment of PFAS, by applying a comparative analysis of the current and pending regulatory thresholds issued for these chemicals in water bodies, drinking water, and certain foodstuffs. Our study shows that the level of health protection embedded in the studied thresholds may differ by three orders of magnitude, even in similar exposure settings. This is likely to confuse the common understanding of the toxicity and health risks of PFAS and undermine reasonable decision-making and the equal treatment of different stakeholders. We also indicate that currently, no consensus exists on the appropriate level of required health protection regarding PFAS and that the recently adopted tolerable intake value in the EU is too cautious. Based on our analysis, we propose some simple solutions on how the studied regulations and their implicit PFAS thresholds or their application could be improved. We further conclude that instead of setting EU-wide PFAS thresholds for all the environmental compartments, providing the member states with the flexibility to consider case-specific factors, such as regional background concentrations or food consumption rates, in their national regulatory procedures would likely result in more sustainable management of environmental PFAS without compromising the scientific foundation of risk assessment, the legitimacy of the EU policy framework and public health.

Growing value of data standardization: Allotrope Foundation Connect Workshop Proceedings.

Recent Allotrope Foundation (AF) Connect Workshops (2021-2023) showcased some of the latest advancements in data standardization for analytical data in the pharmaceutical industry. These workshops demonstrated the adaption of two key technologies, the Allotrope Data Format (ADF) and the Allotrope Simple Model (ASM), which streamline instrument data representation and terminology to enhance interoperability across systems. Notably, ASM has facilitated broader adoption of the standard. The increasing significance of data-driven decision-making in the life sciences is underscored by the evolving landscape of open-source solutions and commercial implementations, as demonstrated by industry leaders adopting these standards. Here, we highlight selected examples that illustrate the collective efforts of the community in advancing data standards and data management in the life sciences.

Blindness and visual impairment: quality of life and accessibility in the city of Turin.

Purpose: Despite the increase in socio-health conditions and, in general, the focus on health worldwide, many diseases still adversely affect the quality of life (QoL), including those causing vision loss. The main purpose of this study was to evaluate the QoL of people with visual impairments through a questionnaire and identify issues concerning everyday life in the urban and extra-urban areas of Turin. Patients and methods: A personalized questionnaire including 25 questions was distributed to 100 enrolled patients. It was designed by integrating the most widely used questionnaires related to the QoL of people with visual impairment with questions concerning the city of Turin. The inclusion criteria were any degree of visual impairment (from mild defect to complete blindness), according to Law n. 138/2001 classification. The exclusion criteria were mental disability and residence in care homes. Finally, statistical analysis was performed. Pearson's Chi-Square test was used to evaluate the strength of the association between two qualitative variables in different sections of the questionnaire. The results were classified as statistically significant with a p-value of ≤0.05 or borderline (0.05 < p-value<0.10). Results: Based on responses to question 7 (Q7), 67% of selected patients stated that sight markedly influences their QoL. Moreover, 49% of patients responding to question 12 considered themselves almost completely dependent on other people regarding mobility and movement in and around Turin. In total, 57% used public transport (Q13); however, 50% of them found it challenging to access (Q14). Personal aids (e.g., white cane and magnifying glasses) were adopted only by 51% (Q15), and 63% of patients responding to question 18 suggested a refinement of urban aids (e.g., road signs). Of the 53 patients, 30 patients (56.6%) considered Turin a livable city for visually impaired people (Q19); however, 44 patients (84.6%) reported no significant improvements in Turin's urban logistics during the last 5 years and highlighted the urgent need to improve urban aids (Q21). Furthermore, the statistical associations studied showed that the loss of vision plays a significant role in influencing the perception of one's QoL (association of questions 7 and 8, X2 = 112.119, Cramer's V = 0.548, p-value <0.001). In addition, it is more difficult for visually impaired patients living outside the city to move outdoors (Chi-Square = 10.637, Cramer's V = 0.326, p - 245 value = 0.031) and to cross the street (Chi-Square = 14.102, Cramer's V = 0.376, p-250 value = 0.007). Finally, those who feel independent perceive their lives to be more fulfilling (Chi-Square = 268, X2 = 37.433; Cramer's V = 0.306, p value = 0.002). Conclusion: Our study showed how vision loss plays a remarkable role in influencing the perception of one's QoL. Furthermore, it highlighted how the implementation of mobility and the use of personal aids for living in a city, such as Turin, were associated with a better perception of QoL by visually impaired patients. However, it is necessary to improve urban technological development according to the needs of people with visual disability.

Regulating seafarers' welfare: an examination of the protection of Filipino seafarers' well-being through a legal analysis of the POEA-Standard Employment Contract.

BACKGROUND: The Philippines is the global maritime industry's single biggest source of seafarers. This article examines how the Philippines protects the welfare of its seafarers working on board ocean-going vessels. MATERIALS AND METHODS: We employed a multi-method approach to better understand the POEA-SEC as a regulatory instrument. First, we analysed Philippine legislation and regulations that are shaping the employment, welfare, and working conditions of Filipino seafarers. Second, we examined the Philippine Overseas Employment Administration Standard Employment Contract (POEA-SEC) which requires that minimum standards of employment for seafarers are met. We use legal analysis to examine three specific provisions that pertain to their well-being: duration of employment, monetary considerations, and working conditions in terms of hours of work and rest periods. Third, we analysed interview and focus group data on the experiences of Filipino seafarers on board ships in respect of the POEA-SEC's efficacy in protecting their well-being. RESULTS: Analysis of the policy environment for Filipino seafarers shows how the interests of powerful actors have taken precedence over those of Filipino seafarers. Seafarers' experiences suggest that they cannot be reached by the contract, whether symbolic or otherwise. The contract fails to address seafarer issues, such as security of tenure, excessive working hours resulting in fatigue, stress and anxiety. CONCLUSIONS: The POEA-SEC falls short as a legal document to address occupational, health and safety issues, which contribute to the detriment of seafarers' health and well-being. This indicates that the Philippine government cannot fully protect its seafarers.

Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya-individually randomised superiority trial.

BACKGROUND: Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress. Despite antenatal services providing a pivotal platform to address women's mental health needs, PND treatment remains inaccessible in many LMICs. The World Health Organization advocates interpersonal psychotherapy (IPT) for treating depression. While research from high-income countries has established the efficacy of IPT and group-IPT (g-IPT) for PND, its effectiveness within the LMIC context and its potential benefits for child development remain uncharted. This study seeks to gauge the potency of g-IPT for women with PND in two LMICs. METHODS: This multi-site randomised controlled trial is a continuation of two preceding phases-conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, characterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to determine if culturally tailored g-IPT, administered within community settings in both countries, outperforms HQ-SC in influencing child developmental outcomes, maternal depression, and the quality of the mother-child bond. DISCUSSION: The SUMMIT trial, designed with pragmatism, possesses the magnitude to evaluate g-IPT within two LMIC frameworks. It seeks to enlighten policymakers, service commissioners, professionals, and users about g-IPT's potential to alleviate maternal PND and bolster child developmental outcomes in LMICs. Additionally, the trial will generate valuable data on the clinical and economic merits of high-quality standard care. TRIAL REGISTRATION: ISRCTN, ISRCTN15154316. Registered on 27 September 2023, https://doi.org/10.1186/ISRCTN15154316.

Iron Oxide (Magnetite)-Based Nanobiomaterial with Medical Applications-Environmental Hazard Assessment Using Terrestrial Model Species.

Nanobiomaterials (NBMs) have tremendous potential applications including in cancer diagnosis and treatment. However, the health and environmental effects of NBMs must be thoroughly assessed to ensure safety. Fe3O4 (magnetite) nanoparticles coated with polyethylene glycol (PEG) and poly (lactic-co-glycolic acid) (PLGA) were one of the focus NBMs within the EU project BIORIMA. Fe3O4 PEG-PLGA has been proposed to be used as a contrast agent in magnetic resonance imaging for the identification of solid tumors and has revealed low cytotoxicity in several cell lines. However, the effects of Fe3O4 PEG-PLGA have not been assessed in terrestrial environments, the eventual final sink of most materials. In the present study, the effects of Fe3O4 PEG-PLGA and its precursor, (un-coated) Fe3O4 NMs, were assessed in soil model invertebrates Enchytraeus crypticus (Oligochaeta) and Folsomia candida (Collembola). The endpoints were survival, reproduction, and size, based on the standard OECD test (28 days) and its extension (56 days). The results showed no toxicity for any of the endpoints evaluated, indicating that the NBM Fe3O4 PEG-PLGA poses no unacceptable risk to the terrestrial environment.