Integrated Risk Assessment Research Articles

Integrative molecular risk assessment of pre-malignant lesions on clinical resection samples for pancreatic neoplasia

Integrative molecular risk assessment of pre-malignant lesions on clinical resection samples for pancreatic neoplasia

IRA-3MSS: Integrated Risk Assessment Method for Three Management System Standards in the Field of Information Technology Service

IRA-3MSS: Integrated Risk Assessment Method for Three Management System Standards in the Field of Information Technology Service

ANALYSIS OF RISKS IN THE FINANCIAL SECURITY MANAGEMENT SYSTEM OF BUSINESS ENTITIES

Financial and economic activity is exposed to numerous systemic risks, which are a threat to the financial security of enterprises. The criterion for ensuring financial security is the appropriate level of the company's financial condition. The financial condition of the enterprise is a complex concept and is characterized by the system of indicators – financial coefficients: indicators of liquidity, financial stability, business activity, and management efficiency. The interrelationship and mutual determination between the indicators that cause the occurrence of risk when one of them changes is established.A range of factors that comprehensively characterize the financial and economic activity of the enterprise has been determined and developed risk analysis and assessment methodology, which includes the following stages: preparatory stage; construction of an algorithm for quantitative assessment of risk in the financial security system; interpretation of the results of an integrated risk assessment in the financial security system; determining the priorities of risk management in the system. The methods of financial analysis (horizontal, vertical, coefficient, analysis of business activity and financial stability) were applied and a quantitative assessment of risks was carried out. The indicators-coefficients of the enterprise's functioning are calculated and given an interpretation.The conclusion was formed that the construction of an effective risk management system and its universal functional component of risk analysis are current issues, as they allow to develop a set of measures to minimize threats and risks of conducting financial and economic activities of economic entities. Therefore, the correct assessment of risk with the help of the proposed methods and models of financial analysis for individual economic situations and business entities is effective and has value, as it gives the opportunity to make the optimal decision in specific situations and characterizes the criterion feature of financial security of industrial enterprises – liquidity, financial stability, business activity, profitability.

Novel Russian guidelines for the assessment and modification of cardiovascular risk in non-cardiac surgery

This year, new domestic recommendations for assessing and correcting the risk of cardiac complications during non-cardiac surgery have been published. These guidelines provide simple and practical key messages to facilitate decision-making in real-life clinical practice. The proposed algorithm for the management of patients before non-cardiac operations, focused on integral risk assessment, assessment of functional status and biomarkers. This review provides a summary of perioperative drug therapy, management of the most common CVDs, and focuses on specific care based on the risk of the patient's preexisting clinical conditions. Finally, the document includes practical recommendations for the management of postoperative complications, and also includes a new section on perioperative myocardial infarction/injury.

Assessing areas suitable for offshore wind energy considering potential risk to breeding seabirds in northern Japan

Offshore wind energy is expected to play a major role in realizing carbon neutrality. However, the installation of offshore wind turbines is of concern for breeding seabirds. Identifying areas with low potential risk for breeding seabirds in Japan is urgently needed. This study identified technically and legally potential areas for wind energy development that are suitable for breeding seabirds by integrating risk assessment models through a spatial approach using Geographic Information System (GIS). While many studies and the government have assessed the potential areas for offshore wind energy in northern Japan, this study shows that most of these legally potential areas overlap with major concern areas for breeding seabirds. Currently, Japanese rules do not sufficiently consider the risk to seabirds when zoning areas for installing offshore wind energy system. The results imply that the risk to breeding seabirds should be carefully examined when zoning areas for local offshore wind energy installations. The approach developed in this study is expected to aid in clearly identifying areas suitable for the installation of offshore wind turbines and minimize the impacts on breeding seabirds. It provides a balance between the expansion of offshore wind energy and conservation biology.

Incorporating ecosystem services into comparative vulnerability and risk assessments in the Pearl River and Yangtze River Deltas, China

Coastal river deltas face high risks from multiple natural hazards due to the combined effects of human activities, natural processes, and climate change. Vulnerability and risk assessments are essential for reducing and managing risks and, in the process, contribute to sustainable development. Despite adopting a social-ecological and multi-hazard perspective, previous risk assessments failed to achieve balanced consideration of both social and ecological sub-systems. To address this gap, we used an integrated risk assessment framework which incorporates the role of ecosystem services (ES) as a core component. A modular indicator library of ES indicators relevant to coastal river deltas was used to characterize multi-risks in the Pearl and Yangtze River deltas. Results indicate a higher risk level in the Pearl River Delta, with the key drivers of vulnerability and risk varying with scales. Visualizing hazard-prone and highly vulnerable areas facilitates the implementation of targeted management measures and policies to reduce disaster risks from natural hazards. Ecosystem services have been identified as important factors of the risk profiles, and their inclusion in risk reduction strategies ensures that policies can be put in place that allow ecosystems to provide services sustainably to communities.

Risk-based approach to setting sterile filtration microbial bioburden limits – Focus on biotech-derived products

Holistic concepts should be applied that reduce risks prior to final bioburden testing and sterile filtration, based on enhanced process and product attribute understanding, which could be key to successful bioburden risk management.Key findings of this paper include:oBioburden control and monitoring prior to filter sterilization is necessary for any thermolabile parenteral drug product that cannot be terminally sterilized in the final container. The bioburden limit applied prior to filter sterilization, as recommended in the 2019 EMA guideline “The sterilisation of the medicinal product, active substance, excipient and primary container”, can be interpreted as a specification (i.e., pass/fail criterion) regardless of the sterilizing filter capacity and risk mitigation measures applied during manufacture. It is proposed to interpret the guidance given by the EMA as an action limit of ≤10 CFU/100 mL.oPre-filtration and post-filtration risks and control measures are inter-correlated and should be addressed via an integrated risk assessment. This includes selection of sample test volume, acceptable bioburden levels and sterilizing filter area.oA holistic approach to bioburden risk is recommended, using a two-tier system for low bioburden monitoring prior to sterilization. A low alert level (product/facility history) and a higher action level, at or below the EMA criterion would be appropriate. It is proposed that any excursion warrants a thorough investigation and a case-by-case assessment for product quality impact rather than default rejection.oThe paper describes how detectable bioburden may be mitigated through subsequent effective sterilizing filtration, if the potential for bacterial by-products and their impact on safety and protein stability is assessed.oAs the manufacturing process is highly controlled to limit the potential for bioburden growth prior to filter sterilization, sample volumes less than 100 mL and alternative acceptance levels to ≤10 CFU/100 mL can be justified on the basis of the actual sample subject to testing. This is particularly relevant for small volume product batches.oTesting of bioburden prior to sterile filtration is not the only measure to control the microbial status and to generate sterile product but is a monitoring tool to verify efficacy of the control measures.

Design of experiments for the automated development of a multicellular cardiac model for high-throughput screening

Cardiovascular toxicity remains a major cause of drug attrition in early drug development, clinical trials, and post-market surveillance. In vitro assessment of cardiovascular liabilities often relies on single cell type-based model systems coupled with functional assays, like calcium flux and multielectrode arrays. Although these models offer high-throughput capabilities and demonstrate good predictivity for functional cardiotoxicities, they fail to consider the vital contribution of non-myocyte cells, thus limiting the potential for integrated risk assessment. Complex 3D hPSC-derived multicellular cardiac model systems have been growing in popularity; however, many of these models are limited to low-throughput with lengthy development timelines and high costs, which hampers their suitability to drug discovery.To optimize the development of an in vitro multicellular model system containing human-induced pluripotent stem-cell derived cardiomyocytes, endothelial cells and cardiac fibroblasts, we employed the Synthace platform, which enables scientists to express complex experimental intent in a simple format (e.g. Design of Experiments) and to translate this to automation protocols using no-code. Utilizing this approach, we systematically screened the impact of multiple cell culture parameters, including the co-culture of three cell types, on cardiac contractility, with minimal hands-on time. Our platform accelerates the assay development process, providing users with an efficient means to explore and optimize the experimental space for the development of multicellular models. This is particularly valuable in scenarios involving variable biological responses and limited understanding of underling mechanisms. Moreover, users can make better use of resources, streamline their workflows, and drive data-driven decision-making throughout the assay development journey.

Predictive Modeling and Integrated Risk Assessment of Postoperative Mortality and Pneumonia in Traumatic Brain Injury Patients through Clustering and Machine Learning: Retrospective Study.

This study harnessed machine learning to forecast postoperative mortality (POM) and postoperative pneumonia (PPN) among surgical traumatic brain injury (TBI) patients. Our analysis centered on the following key variables: Glasgow Coma Scale (GCS), midline brain shift (MSB), and time from injury to emergency room arrival (TIE). Additionally, we introduced innovative clustered variables to enhance predictive accuracy and risk assessment. Exploring data from 617 patients spanning 2012 to 2022, we observed that 22.9% encountered postoperative mortality, while 30.0% faced postoperative pneumonia (PPN). Sensitivity for POM and PPN prediction, before incorporating clustering, was in the ranges of 0.43-0.82 (POM) and 0.54-0.76 (PPN). Following clustering, sensitivity values were 0.47-0.76 (POM) and 0.61-0.77 (PPN). Accuracy was in the ranges of 0.67-0.76 (POM) and 0.70-0.81 (PPN) prior to clustering and 0.42-0.73 (POM) and 0.55-0.73 (PPN) after clustering. Clusters characterized by low GCS, small MSB, and short TIE exhibited a 3.2-fold higher POM risk compared to clusters with high GCS, small MSB, and short TIE. In summary, leveraging clustered variables offers a novel avenue for predicting POM and PPN in TBI patients. Assessing the amalgamated impact of GCS, MSB, and TIE characteristics provides valuable insights for clinical decision making.

Translation of international frameworks and national policies on climate change, land degradation, and biodiversity to develop integrated risk assessment for watershed management in Indonesia

The international conventions on environments, i.e., biodiversity (United Nations Convention on Biodiversity - UNCBD), land degradation (United Nations Convention to Combat Desertification - UNCCD), and climate change (United Nations Framework Convention on Climate Change - UNFCCC) stipulates country-level policies, programs, and actions in sustaining environmental well-being. This study attempts to connect the three conventions ratified into national regulations in Indonesia. The connection is framed to develop indicators and their attributes for measuring health or risk levels of watershed functions and services to the present challenges. The risk assessment is formulated based on a set of risk components and indicators developed with referring to Ministry of Forestry Regulation No. 60/2014 about the classification of watershed health conditions, Ministry of Forestry Regulation No. 29/2009 about biodiversity, and Ministry of Environment and Forestry Regulation No. 7/2018 about climate change risk assessment. The formulation grouped the risk indicators into biophysical, socio-economic, and governance. The risk assessment is applied to the Way Khilau watershed of Lampung, Indonesia, to measure the risk levels and identify the contributing indicators that should be considered for designing adaptation options. Under the current conditions, the Way Khilau watershed has a score of about 123.25 or 0.77, which will be exacerbated by future climate change. The risk level can reach a score of 138 or 0.89, nearly approaching the upper threshold. This risk level urges the policymakers and stakeholders to take adaptation actions to maintain the functions and services of the Why Khilau watershed.

Methodology for Assessing the Risks of Regional Competitiveness Based on the Kolmogorov–Chapman Equations

The relevance of research on competitiveness at the meso level is related to the contemporary views of a region as an essential element of the economic space. The development of forecasting and analytical methods at the regional level of the economy is a key task in the process of strategic decision making. This article proposes a method of quantitative assessment of the risks of regional competitiveness. The novelty of this approach is based on both a fixed-point risk assessment and scenario-based predictive analysis. A hierarchical structure of indicators of competitiveness of regions is offered. A method based on the Kolmogorov–Chapman equations was used for the predictive estimation of risks of regional competitiveness. The integrated risk assessment is performed using the modified fuzzy ELECTRE II method. A web application has been implemented to assess the risks of competitiveness of Russian regions. The functionality of this application provides the use of multi-criteria decision-making methods based on a fuzzy logic approach to estimate risks at a specified time, calculating the probability of risk events and their combinations in the following periods and visualizing the results. Approbation of the technique was carried out for 78 Russian regions for various scenarios. The analysis of the results obtained provides an opportunity to identify the riskiest factors of regional competitiveness and to distinguish regions with different risk levels.

Research Status and Development Prospect of Wellbore Integrity in China

Summary As the exploration and development of oil and gas move into increasingly challenging locations and harsher environments, well integrity becomes more difficult to maintain. High temperatures, pressures, and corrosion can all contribute to wellbore integrity failure. Such failures can have significant financial and environmental consequences, including gas leakage and fluid spills. In this paper, we review the development and technical advancements of wellbore integrity research both in China and abroad and look forward to the development direction of wellbore integrity in China. We provide basic background knowledge for those interested in wellbore integrity and also share the progress and development direction of integrity research for wellbore integrity researchers. Through research and analysis, some conclusions can be drawn. Countries around the world are actively studying wellbore integrity and have developed a large number of standards, especially the United States and Norway, which have the most standards. The most common way to analyze wellbore integrity is to first divide the entire wellbore into different wellbore barrier units according to different standards, such as ISO 16530-1, and then study risk factors and integrity management measures in different units. Mainstream research is mostly carried out around the integrity of casing, cement, and tubing, and many achievements have been made, but the study of packer and downhole safety valve is still on the way. Wellbore integrity risk assessment aims to quantify potential risks and establish risk levels to support decision-making for on-site wellbore integrity control. This is achieved by identifying factors affecting wellbore integrity, establishing an evaluation index system and processing evaluation indicators to determine failure probability and impact consequences. The resulting risk value can be divided into different areas using the “as low as reasonably practicable principle” or a risk matrix graph. However, due to the complexity of the factors involved and the subjectivity of risk classification rules, there are still challenges in promoting the evaluation model and reducing errors in the evaluation results. China should actively promote interdisciplinary integration and respond to the call for “dual carbon goals” to break through the current bottleneck in wellbore integrity research. This can be achieved by promoting the development of quantitative wellbore integrity risk assessment methods, developing supporting evaluation software based on big data, and by tackling the integrity challenges faced by different types of wells and promoting the development of wellbore integrity discipline.

Integrative risk assessment method via combining geostatistical analysis, random forest, and receptor models for potentially toxic elements in selenium-rich soil

Revealing the spatial features and source of associated potentially toxic elements (PTEs) is crucial for the safe use of selenium (Se)-rich soils. An integrative risk assessment (GRRRA) approach based on geostatistical analysis (GA), random forest (RF), and receptor models (RMs) was first established to investigate the spatial distribution, sources, and potential ecological risks (PER) of PTEs in 982 soils from Ziyang City, a typical natural Se-rich area in China. RF combined with multiple RMs supported the source apportionment derived from the RMs and provided accurate results for source identification. Then, quantified source contributions were introduced into the risk assessment. Eighty-three percent of the samples contain Cd at a high PER level in local Se-rich soils. GA based on spatial interpolation and spatial autocorrelation showed that soil PTEs have distinct spatial characteristics, and high values are primarily distributed in this research areas. Absolute principal component score/multiple line regression (APCS/MLR) is more suitable than positive matrix factorization (PMF) for source apportionment in this study. RF combined with RMs more accurately and scientifically extracted four sources of soil PTEs: parent material (48.91%), mining (17.93%), agriculture (8.54%), and atmospheric deposition (24.63%). Monte Carlo simulation (MCS) demonstrates a 47.73% probability of a non-negligible risk (RI > 150) caused by parent material and 3.6% from industrial sources, respectively. Parent material (64.20%, RI = 229.56) and mining (16.49%, RI = 58.96) sources contribute to the highest PER of PTEs. In conclusion, the GRRRA method can comprehensively analyze the distribution and sources of soil PTEs and effectively quantify the source contribution to PER, thus providing the theoretical foundation for the secure utilization of Se-rich soils and environmental management and decision making.

An integrated risk assessment framework for multiple natural disasters based on multi-dimensional correlation analysis

An integrated risk assessment framework for multiple natural disasters based on multi-dimensional correlation analysis

Impacts of Agricultural Pesticide Contamination: An Integrated Risk Assessment of Rural Communities of Eswatini.

Marked reductions in mean annual rainfall associated with climate change in Eswatini in Southern Africa have encouraged the recycling of irrigation water and the increased use of pesticides in agricultural production, raising concerns about potential ecological and health risks due to long-term exposure to pesticide residues in soil and irrigation water. This probabilistic integrated risk assessment used liquid chromatography with tandem mass spectrometry to analyze the concentrations of four commonly used agricultural pesticides (ametryn, atrazine, pendimethalin, and 2,4-dichlorophenoxyacetic acid (2,4-D)) in irrigation water and topsoil samples from farmlands in Eswatini to assess potential ecological and health risks due to exposure. The concentrations of these pesticides ranged from undetectable to 0.104 µg/L in irrigation water and from undetectable to 2.70 µg/g in soil. The probabilistic multi-pathway and multi-route risk assessments conducted revealed hazard indices exceeding 1.0 for all age groups for ametryn and atrazine, suggesting that the daily consumption of recycled irrigation water and produce from the fields in this area may pose considerable health risks. The indices pertaining to ecological risks had values less than 0.1. Adaptation measures are recommended to efficiently manage pesticide use in agriculture, and further research will ensure that agriculture can adapt to climate change and that the general public and ecosystem are protected.

Integrating risk assessment methods for carbon storage: A case study for the quest carbon capture and storage facility

This paper documents how tools developed by the National Risk Assessment Partnership (NRAP) complement the Bowtie risk assessment approach through the demonstration of a risk-based Area of Review (AoR) determination for the Quest Carbon Capture and Storage (CCS) facility near Edmonton, Alberta with the NRAP Open-Source Integrated Assessment Model (NRAP Open-IAM). The Bowtie risk assessment for the Quest CCS site was developed by Shell Canada Ltd., who operates the asset on behalf of the Athabasca Oil Sand Project — a joint venture, owned by Canadian Natural Resources Ltd, Chevron Canada and Shell Canada Ltd. The Quest Bowtie treats site risk comprehensively – considering a large set of technical and project risks (e.g., operational risks, above ground infrastructure, public perception, etc.). NRAP tools, methods, and analyses are focused on quantitative assessment of subsurface technical risks. NRAP-Open-IAM was used to evaluate potential groundwater impacts at the Quest site, i.e., a sufficient change above background groundwater quality levels to be measurable, should CO2 and/or brine leak from the reservoir via a faulty and/or compromised wellbore. Our results show there is a low potential for groundwater impact and support a further reduction (from ∼460 to 100 km2) to the established AoR for the Quest site. Integrating both approaches early in the site characterization period could significantly benefit commercial-scale projects by drastically reducing the region over which leakage risks (e.g., legacy wells) need to be evaluated, i.e., the AoR. This is especially true for brownfield sites, which could contain hundreds to thousands of legacy wells. Further, basing monitoring network design on those regions where impacts are most likely to occur has the potential to facilitate more efficient deployment of monitoring technologies and improve the likelihood of detecting a leak should one occur.

Mycotoxins and Maize Value Chain: Multi-Matrix and Multi-Analyte Tools towards Global Feed and Food Safety

Maize value chains represent invaluable end-consumer products in food systems worldwide. Mycotoxin contamination along these chains causes severe economic and health impacts from the plant, animal and human safety points of view. This work aimed to develop a single standardized methodology that fulfilled extraction and detection procedures for 22 mycotoxins in maize chain matrices. The main goal concerned the validation of a QuEChERS-based ultra-high-performance liquid chromatography coupled to the tandem mass spectrometry (UHPLC-MS/MS) method in compliance with established performance criteria for mycotoxin determination. Validation parameters encompassing specificity/selectivity, linearity, precision, recovery, Limits of Detection (LOD) and Limits of Quantification (LOQ) were evaluated, and acceptable data were found for all the mycotoxins in the matrices under study, namely, seeds, flowering plants, silage and feed. The applied method presented LODs and LOQs lower than 40.3 and 42.1 ng g−1, respectively, and recoveries ranging from 80.7 to 118.1%, with precision values below 20.5%. A first-time full analytical procedure in a multi-matrix and multi-analyte approach was successfully validated, representing a valuable control tool for mycotoxin monitoring in maize chains. This approach will ultimately allow a response to the need for integrated risk assessments encompassing full, comprehensive analysis of whole food chains in compliance with the maximum levels established in European regulations, and the establishment of accurate solutions in each chain-specific critical point, helping to provide more sustainable, safer and healthy food systems.

Contamination profile and risk assessment of per- and polyfluoroalkyl substances in Guanting Reservoir, a former drinking water source with degraded water quality

The water quality of Guanting Reservoir couldn't meet the requirement of the standard for drinking water sources in China from 1997 since its pollution. The present work studied the pollution characteristics of per- and polyfluoroalkyl substances (PFASs) in water and sediments in Guanting Reservoir, 4 tributaries and WWTPs by high-performance liquid chromatography-negative electrospray ionization-tandem mass spectrometry (HPLC/ESI-MS/MS). The sources and risks of the identified PFASs were analyzed. There were 11 PFASs detected in the Guanting Reservoir, the average PFASs concentration was 267.89 ng/L in water and 2.17 ng/g in sediment, respectively, which are higher than those in other water sources within and outside China. Perfluorooctanoic acid (PFOA) was the main pollutant in both water and sediments, and it has potential ecological risk (0.1 < RQ < 1) in both water and sediment samples as well as potential health risk with HR value ranges in 0.25–0.64 in water in Guanting Reservoir. Sanggan River and Yongding River are the main input sources of PFASs pollution, and the direct emission from industrial production and the degradation of precursors have been shown to make a great contribution to the PFASs in Guanting Reservoir. The results suggest that continuous monitoring and integrated risk assessment in Guanting Reservoir catchment and more attention should be paid on the pollution control from Sangan River and Yongding River.

Environmental Modeling for Radiation Safety

The newly launched IAEA project MEREIA (MEthods for Radiological and Environmental Impact Assessment; 2021- 2025), MEREIA continues some activities of previous IAEA exercises in the field of radioecological modelling and focuses on areas where the probabilistic approach determines the predictive capability of environmental models. The program offered the opportunity to set up well-designed and verified scenarios to collect and compare exposures predicted by particular models based on this scenario and then perform a validation study of contributing models. It consists of the comparison of model prediction with observed data or in the case where there is a lack of measurement data to perform a comparison within model prognoses. The previous international works have brought significant improvement in environmental modeling in terms of better understanding and mathematical description of complex physical and chemical phenomena that occur in various environmental media and also have promoted new areas for experimental investigations. The new experimental results yielded updated handbooks of a large number of environmental parameters for less-known elements. Moreover, the principal objective of the activities in environmental modelling was an integrated risk assessment of the reference group of population and biota associated with radionuclides releases from various kinds of nuclear facilities as from different types and power nuclear reactors, radioactive waste disposal and more complex nuclear research facility. This reflects recent international recommendations to extend protection against radiation hazards of humans to wildlife flora and fauna. However, the statistics supported knowledge on some essential environmental parameters still remain small. Therefore, one could be aware of some limitations of the probabilistic approach that required advanced methods of probabilistic prognosis Monte Carlo.

Integrating resilience in the multi-hazard sustainable design of buildings

Recent natural disasters and climate change-induced extremes emphasize the urgent need to enhance the overall resilience of society by addressing the various hazards that buildings may face. Current design approaches recognize the need for integrated risk assessments, but studies primarily focus on existing buildings and single hazards, neglecting the impact of multiple hazards and resilience quantifications. However, it is crucial to consider multi-hazard scenarios and quantify economic, environmental, and resilience losses to pursue effective solutions from the early-stage design of both new buildings and retrofitting interventions. This paper presents a practical multi-criteria approach to support design decisions for enhanced safety, sustainability, and resilience of buildings against earthquakes and heatwaves. The proposed approach is applied to a commercial building with various seismic-resistant and energy-efficient facades. Non-linear seismic assessments are conducted to predict the potential impact concerning repair costs, carbon emissions, and the resilience loss at the design-level earthquake. Additionally, a whole life-cycle analysis and dynamic energy simulations are performed to calculate the financial and carbon losses resulting from power consumption and the ability of the building to maintain energy efficiency under extreme heat. Finally, the study employs a multi-matrix decision-making approach based on integrated economic, environmental, and resilience losses to guide the design selection. The results demonstrate that earthquake-resistant facades can significantly reduce financial losses by over 50%, with seismic resilience playing a crucial role in the final decision. This approach facilitates more effective investment decisions for building projects, enabling the quantification of the effectiveness of integrated strategies in reducing overall potential losses.