Established Risk Assessment Research Articles

P129 ASSESS THE ACCURACY OF FOUR RISK ASSESSMENT MODELS (RISKFRS, RISKWHO, RISKACC/AHA, AND RISKJBS) IN PREDICTING 10-YEAR CARDIOVASCULAR EVENT RISK IN INDIAN ACUTE MYOCARDIAL INFARCTION PATIENTS

Background: Despite numerous risk assessment models available for estimating the 10-year risk of cardiovascular (CV) events in individuals requiring primary prevention of CV disease, their applicability and accuracy in the Indian population remain inadequately studied. Objective of the study is to Assess and compare the predictive accuracy of four cardiovascular risk assessment models—RiskFRS, RiskWHO, RiskACC/AHA, and RiskJBS—in determining the 10-year cardiovascular event risk among Indian acute MI patients. Methods: In this study, 250 participants (mean age 59.4 ± 10.6 years; 205 males) without prior cardiovascular disease who experienced acute myocardial infarction (MI) were assessed using four established risk assessment models: Framingham Risk Score (RiskFRS), World Health Organization risk prediction charts (RiskWHO), American College of Cardiology/American Heart Association pooled cohort equations (RiskACC/AHA), and the 3rd Joint British Societies’ risk calculator (RiskJBS). These models estimated the participants’ predicted 10-year risk of cardiovascular events if assessed before the acute MI. Results: RiskWHO provided the lowest risk estimates, with 86.6% of patients estimated to have less than 20% 10-year risk. Conversely, RiskFRS and RiskACC/AHA yielded higher risk estimates (61.7% and 69.8% with less than 20% risk, respectively; p values <0.001 compared to RiskWHO). However, RiskJBS identified the highest proportion of patients as high-risk (only 44.1% at less than 20% risk, p values < 0.01 compared to all other three risk scores). Conclusions: In Indian patients experiencing acute MI, RiskJBS identifies a larger proportion of patients as ’high-risk’ compared to RiskWHO, RiskFRS, and RiskACC/AHA. However, further validation through large-scale prospective studies is necessary. These findings underscore the importance of tailoring risk assessment models to the unique characteristics of the Indian population and highlight the need for additional research to optimize cardiovascular risk prediction and management strategies in this demographic.

Revisiting the risk of introduction of Japanese encephalitis virus (JEV) into the United States – An updated semi-quantitative risk assessment

Japanese encephalitis virus (JEV) is associated with encephalitis in humans and reproductive and neurological illness in pigs. JEV has expanded beyond its native distribution in southeast Asia, with identifications in Europe (2010) and Africa (2016), and most recently, its spread into mainland Australia (2021−2022). The introduction of JEV into the United States (US) is a public health risk, and could also impact animal health and the food supply. To efficiently and cost-effectively manage risk, a better understanding of how and where diseases will be introduced, transmitted, and spread is required. To achieve this objective, we updated our group's previous qualitative risk assessment using an established semi-quantitative risk assessment tool (MINTRISK) to compare the overall rate of introduction and risk, including impacts, of JEV in seven US regions. The rate of introduction from the current region of distribution was considered negligible for the Northeast, Midwest, Rocky Mountain, West, Alaska, and Hawaii regions. The South region was the only region with a pathway that had a non-negligible rate of introduction; infected mosquito eggs and larvae introduced via imported used tires (very low; 95% uncertainty interval (UI) = negligible to high). The overall risk estimate for the South was very high (95% UI = very low to very high). Based on this risk assessment, the South region should be prioritized for surveillance activities to ensure the early detection of JEV. The assumptions used in this risk assessment, due to the lack of information about the global movement of mosquitoes, number of feral pigs in the US, the role of non-ardeid wild birds in transmission, and the magnitude of the basic reproduction ratio of JEV in a novel region, need to be fully considered as these impact the estimated probability of establishment.

Frictional strength of siliciclastic sediment mixtures in fault stability assessment

Frictional strength of fault zones is a key parameter for evaluation of fault stability and reactivation. We measure friction using the direct shear test (DST) for (i) sand-clay mixes mimicking fault gouges, and (ii) strength of fault zone interfaces. The sand-clay mixing ratio is linked to the established Shale Gouge Ratio (SGR) used in fault seal analysis, suggesting an approach for linking the measured frictional properties to the established subsurface fault characterization methods and risk assessment. We use powdered caprock material from the Draupne Formation mixed with sand to prepare the fault gouge and discuss application of results for fault zones on the Horda Platform, Norwegian North Sea.Shearing of fault gouge show a systematic decrease in residual friction coefficient with increasing clay content from 0.6 (φ = 31°) in pure sand (SGR 0%) to 0.4 (φ = 22°) for clay rich mixtures (SGR 100%). Interface testing mimicking fault gouge on sand surface is less systematic and shows residual friction coefficients ranging from 0.53 to 0.6 (φ = 28–31°) for SGR 0–50%. Detailed interpretation of the shear testing results shows changes in drainage properties, volumetric changes during shearing and shear responses to normal stresses indicating threshold values for sand versus clay dominated material behaviour. However, the results are non-conclusive on the question if a linear variation of friction with clay content or a threshold between sand dominated versus clay dominated friction provides the best approach for linking friction to fault clay content.

Feasibility of universal breast cancer risk assessment in a diverse, publicly insured obstetrician gynecology clinic.

e13759 Background: Breast cancer is the most diagnosed cancer among women in the United States. Established breast cancer risk assessment (BCRA) tools can estimate a woman’s lifetime risk and inform the need for enhanced breast screening which can improve cancer-associated morbidity and mortality. Currently, critical disparities exist both in breast cancer prognosis and screening uptake. We aimed to evaluate the feasibility of routine BCRA in a diverse, publicly insured obstetrician gynecology clinic. Methods: All patients presenting to the obstetrician gynecology clinic were offered a BCRA using the Tyrer Cuzick (TC) risk model. Patients completed paper surveys and the information was input into the TC model to generate lifetime risk estimates. Printed evidence-based management guidelines were reviewed with and provided to those at ≥ 20% lifetime breast cancer risk and shared with the patient’s provider. Results: Between June 2023 and February 2024, 300 patients were approached and 208 (69.3%) completed the survey. One hundred seven (51.4%) survey respondents were presenting for obstetrical care and 101 (48.6%) for gynecologic care. Respondents had a median age of 33 years (IQR: 12). Ninety-six (46.2%) responding patients self-identified as Hispanic, 45 (21.6%) as Black, 25 (12.0%) as Asian, 28 (13.5%) as Non-Hispanic White, and 14 (6.7%) did not identify in these categories. One hundred eighty-nine (90.9%) survey respondents were publicly-insured. Ten (4.8%) patients were assisted by an interpreter. Overall, 12 (5.8%) patients had an elevated lifetime breast of breast cancer, defined as ≥ 20% based on the TC model (6 (50.0%) among obstetrical patients and 6 (50.0%) among gynecology patients). All patients at elevated risk were referred to a genetics clinic for counseling on options for enhanced breast surveillance. Conclusions: As leaders in women’s cancer care, gynecologic oncologists can lead and support programs to identify those women at highest risk for cancer, especially among historically underserved populations. Our feasibility study demonstrated that 69.3% of patients were willing to complete a BRCA and this tool identified 5.8% of patients to have a significantly elevated lifetime breast cancer risk. Providers should consider incorporating such tools in gynecologic oncology and obstetrical/gynecology clinics.

Flood Disaster Risk Assessment in Wuhan City Based on GIS Analysis and Indicator Ranking Using Random Forest

In recent years, with the acceleration of urbanization and the frequent occurrence of extreme weather globally, the risk of urban flood disasters has gradually increased, and its potential consequences are immeasurable. Therefore, conducting risk assessment of urban flood disasters is of great significance, as it is one of the foundations and decision-making means for Disaster Prevention and Mitigation, and has become a hot topic and trend in current research. This paper starts by exploring the concept and formation mechanism of urban flood disasters, taking Hazard Factors, Disaster-prone Environment sensitivity, Vulnerability of Exposed Bodies, and Disaster Prevention and Mitigation Capabilities as primary indicators. Based on this, a risk assessment index system is established with 14 secondary indicators, such as annual average rainfall, distance to water systems, elevation, and terrain undulation. The spatialization of each indicator data point is processed through ArcGIS10.7, and the importance of hazard and sensitivity indicators is ranked using the Random Forest algorithm. The indicators are then weighted using a combination of the Analytic Hierarchy Process (AHP) and the entropy method, and the combined weights of each assessment indicator are calculated. Taking Wuhan City as the research area, the weights of each indicator are input into the established risk assessment model. ArcGIS spatial analysis techniques and raster calculation functions are utilized to solve the fuzzy comprehensive evaluation of the assessment model, obtaining zoning maps of risk levels for hazard, sensitivity, vulnerability, disaster prevention, and mitigation capabilities, as well as the distribution of comprehensive risk levels. The validity and rationality of the model results are verified by actual disaster data, providing important reference for urban flood disaster prevention in the future.

Identification of cost-effective biosecurity measures to reduce Salmonella along the pork production chain.

The continued occurrence of salmonellosis cases in Europe attributed to the consumption of pork products highlights the importance of identifying cost-effective interventions. Certain biosecurity measures (BSMs) may be effective in reducing the prevalence of specific pathogens along the pork production chain and their presence in food products. The objective of this study was to identify pathogen-specific, cost-effective BSMs to reduce Salmonella at different stages of the pork production chain in two European countries - Austria (AT) and the United Kingdom (UK). For this purpose, a cost-benefit analysis was conducted based on the epidemiological output of an established quantitative microbiological risk assessment that simulated the implementation effect of the BSMs based on their risk ratios. For each of the BSMs, the associated costs and benefits were assessed individually and country-specifically. For both AT and UK, nine different BSMs were evaluated assuming a countrywide implementation rate of 100%. The results showed that four BSMs were cost-effective (benefit-cost ratio > 1) for AT and five for the UK. The uncertainty regarding the cost-effectiveness of the BSMs resulted from the variability of individual risk ratios, and the variability of benefits associated with the implementation of the BSMs. The low number of cost-effective BSMs highlights the need for holistic risk-based models and economic assessments. To increase the willingness to implement BSMs and maximize the benefits for stakeholders, who carry the majority of the implementation costs, epidemiological assessments of BSM effectiveness should consider the impact on several relevant pathogens simultaneously.

Geochemical baseline establishment, pollution level and health risk assessment of soil heavy metals in the upper Xiaowen River Basin, Shandong Province, China.

This study analyzed the distribution and content of eight heavy metals (Cu, Pb, Zn, Ni, Cr, As, Cd, and Hg) in 221 surface soil samples from the upper reaches of the Xiaowen River. Environmental geochemical baselines were established for the eight heavy metals, and the pollution status was assessed on the basis of these baselines and the soil background value of Weifang City. The calculation results of Nemerow pollution index and the potential ecological hazard index (PEHI)-Ri showed that the overall pollution degree and ecological hazard in the study area were at a slight level. 49% (calculated by baseline value) and 24% (calculated by background value of Weifang City) samples were at moderate or above pollution level. 9% (calculated by baseline value) and 42% (calculated by background value) samples were at the level of moderate potential ecological hazards or above. According to the calculation results of Igeo and PEHI-Ei, the main pollutant in the study area was Hg, followed by Cd. 3% (calculated by baseline value) and 12% (calculated by background value) of Hg samples were at moderate or above contamination levels. 5% (calculated by baseline value) and 38% (calculated by background value) of Hg samples were at the level of strong potential ecological hazard or above. The western, central, and eastern parts of the study area were mainly the primary areas of pollution and ecological hazards. The non-carcinogenic risk was at an acceptable level, the carcinogenic risk was at a tolerable level, and the main risk pathway was oral intake, with Cr being the main contributor. Source apportionment indicated that soil heavy metals primarily originate from soil parent material, transportation, agricultural fertilization, and industrial emissions (waste gas, waste water and solid waste).

Reputational risks management and mitigation: Empirical evidence from the wedding organizer sector

Purpose – The purpose of this research is to identify and determine reputation risk mitigation strategies that may arise in the business processes of wedding activities at Lifetime Organizer Bogor. A poor reputation for a wedding organizer can drive consumers to switch to competitors with a better reputation. Therefore, effective reputation risk management is crucial for wedding organizers.Design/methodology/approach – This study employs the Risk Assessment Godfrey method and Flanagan & Norman Risk Response Analysis. Risks are identified through direct observation at multiple weddings organized by Lifetime Organizer, in-depth interviews with the owner and field coordinators, and the distribution of questionnaires to partner vendors and consumers of Lifetime Organizer. The risk assessment is calculated using a comprehensive approach that combines qualitative and quantitative elements, facilitated by questionnaires, and processed through geometric mean calculations.Findings – The findings in this study contain mitigation action strategies for risks with high and extreme risk levels. These mitigation strategies are organized based on implementation that aligns with the company's needs and resources, thereby enabling the company to proactively prevent the occurrence of such risks.Research limitations/implications – In this study, the identified risks pertain to factors that may influence the company's reputation. Since reputation is a subjective perception held by individuals, it introduces subjectivity in the process of identifying and evaluating risks. It is anticipated that in future research endeavors, this aspect will be duly considered and addressed.Practical implications – The research holds significant practical implications for wedding organizers, providing a tailored approach to reputation risk management. The proposed strategies, informed by the risk assessment framework, empower companies to navigate the dynamic event planning industry effectively, fostering long-term success and resilience.Originality/value – This study contributes novelty by adapting and applying established risk assessment methods to the specific context of the wedding planning industry in Indonesia. The findings offer a unique perspective on reputation risk management, providing valuable insights for both industry practitioners and researchers in developing countries.

Integrated Bayesian Network and Strongest Path Method (BN-SPM) for effective multi-hazard risk assessment of interconnected infrastructure systems

This study proposes an integrated framework based on Bayesian Network (BN) and Strongest Path Method (SPM) to provide a robust assessment of the natural hazard risks to interconnected infrastructure systems. Leveraging Bayesian inference, the BN transforms prior failure probabilities into posterior ones, while SPM prioritizes network entities based on global impact, global vulnerability, and risk indices, calculated from key parameters including the likelihood of failure, degree of impact, and degree of dependence. The proposed integrated BN-SPM model calculates risk indices for complex interconnected networks with conditional dependencies on external nodes, such as multi-hazard, or mitigation and redundancy strategies, without predetermined parameters. Using this framework we evaluate diverse scenarios in Saint Lucia, encompassing non-hazard condition, flooding hazards, and presumptive strategies like mitigation and redundancy. The high likelihood of failure and complex interdependencies heighten risks even under non-hazard condition. Particularly, the Hewanorra International Airport (HIA) emerges as the most vulnerable entity. The established risk assessment framework offers the potential for application in evaluating risks within complex interconnected systems such as power grids, transportation networks, and communication systems facing various multi-hazard scenarios. This framework also assesses the implementation of mitigation and redundancy strategies, reducing the risk index within the affected network domain.

Effect of China national centralized drug procurement policy on anticoagulation selection and hemorrhage events in patients with AF in Suining.

Background: Launched in March 2019, the National Centralized Drug Procurement (NCDP) initiative aimed to optimize the drug utilization framework in public healthcare facilities. Following the integration of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) into the procurement catalog, healthcare establishments in Suining swiftly transitioned to the widespread adoption of NOACs, beginning 1 March 2020. Objective: This study aims to comprehensively assess the impact of the NCDP policy on the efficacy of anticoagulation therapy, patient medication adherence, and the incidence of hemorrhagic events in individuals with non-valvular atrial fibrillation (NVAF) residing in Suining. The analysis seeks to elucidate the broader impacts of the NCDP policy on this patient demographic. Methods: This study analyzed patient hospitalization records from the Department of Cardiology at Suining County People's Hospital, spanning 1 January 2017, to 30 June 2022. The dataset included demographic details (age, sex), type of health insurance, year of admission, hospitalization expenses, and comprehensive information on anticoagulant therapy utilization. The CHA2DS2-VASc scoring system, an established risk assessment tool, was used to evaluate stroke risk in NVAF patients. Patients with a CHA2DS2-VASc score of 2 or higher were categorized as high-risk, while those with scores below 2 were considered medium or low-risk. Results: 1. Treatment Cost Analysis: The study included 3,986 patients diagnosed with NVAF. Following the implementation of the NCDP policy, a significant increase in the average treatment cost for hospitalized patients was observed, rising from 8,900.57 ± 9,023.02 CNY to 9,829.99 ± 10,886.87 CNY (p < 0.001). 2. Oral Anticoagulant Utilization: Overall, oral anticoagulant use increased from 40.02% to 61.33% post-NCDP (p < 0.001). Specifically, NOAC utilization among patients dramatically rose from 15.41% to 90.99% (p < 0.001). 3. Hemorrhagic Events: There was a significant decrease in hemorrhagic events following the NCDP policy, from 1.88% to 0.66% (p = 0.01). Hypertension [OR = 1.979, 95% CI (1.132, 3.462), p = 0.017], history of stroke [OR = 1.375, 95% CI (1.023, 1.847), p = 0.035], age ≥65years [OR = 0.339, 95% CI (0.188, 0.612), p < 0.001], combination therapy of anticoagulants and antiplatelets [OR = 3.620, 95% CI (1.752, 7.480), p < 0.001], hepatic and renal insufficiency [OR = 4.294, 95% CI (2.28, 8.084), p < 0.001], and the NCDP policy [OR = 0.295, 95% CI (0.115, 0.753), p = 0.011] are significant risk factors for bleeding in patients with atrial fibrillation. 4. Re-hospitalization and Anticoagulant Use: Among the 219 patients requiring re-hospitalization, there was a notable increase in anticoagulant usage post-NCDP, from 36.07% to 59.82% (p < 0.001). NOACs, in particular, saw a substantial rise in usage among these patients, from 11.39% to 80.92% (p < 0.001). 5. Anticoagulant Type Change: The NCDP policy [OR = 28.223, 95% CI (13.148, 60.585), p < 0.001] and bleeding events [OR = 27.772, 95% CI (3.213, 240.026), p = 0.003] were significant factors influencing the alteration of anticoagulant medications in patients. Conclusion: The NCDP policy has markedly improved anticoagulation management in patients with AF. This policy has played a crucial role in enhancing medication adherence and significantly reducing the incidence of hemorrhagic events among these patients. Additionally, the NCDP policy has proven to be a key factor in guiding the selection and modification of anticoagulant therapies in the AF patient population.

Improving regulatory efficiency for biotechnology products.

Small procedural changes in how regulatory agencies implement biotech policies can make significant differences in improving regulatory efficiency. This paper discusses how science based, crop specific guidance documents can improve dossier content and the review and approval of biotech varieties. In addition, we describe how the adoption of established risk assessment methodology and applying policy-linked decision making at the agency level can boost both efficiency and developer, public and government confidence in agency decision making and in biotech crops.

A case study of risk analysis due to lightning for wind power plants

This paper briefly describes the Portuguese Lightning Location System, and presents an overview of wind energy in Portugal. The method for risk assessment due to lightning flashes to earth, proposed by the International Electrotechnical Commission, IEC, is used. A wind power plant is characterized for a case study, and the standard IEC 62305-2 is applied. Results obtained are able to support the advantage for investors to take into account the lighting activity in the region where the wind power plant shall be installed. Also, the use of a well established risk assessment method allows the adoption of adequate protection measures.

Securing Cloud-Assisted Connected and Autonomous Vehicles: An In-Depth Threat Analysis and Risk Assessment.

As threat vectors and adversarial capabilities evolve, Cloud-Assisted Connected and Autonomous Vehicles (CCAVs) are becoming more vulnerable to cyberattacks. Several established threat analysis and risk assessment (TARA) methodologies are publicly available to address the evolving threat landscape. However, these methodologies inadequately capture the threat data of CCAVs, resulting in poorly defined threat boundaries or the reduced efficacy of the TARA. This is due to multiple factors, including complex hardware-software interactions, rapid technological advancements, outdated security frameworks, heterogeneous standards and protocols, and human errors in CCAV systems. To address these factors, this study begins by systematically evaluating TARA methods and applying the Spoofing, Tampering, Repudiation, Information disclosure, Denial of service, and Elevation of privileges (STRIDE) threat model and Damage, Reproducibility, Exploitability, Affected Users, and Discoverability (DREAD) risk assessment to target system architectures. This study identifies vulnerabilities, quantifies risks, and methodically examines defined data processing components. In addition, this study offers an attack tree to delineate attack vectors and provides a novel defense taxonomy against identified risks. This article demonstrates the efficacy of the TARA in systematically capturing compromised security requirements, threats, limits, and associated risks with greater precision. By doing so, we further discuss the challenges in protecting hardware-software assets against multi-staged attacks due to emerging vulnerabilities. As a result, this research informs advanced threat analyses and risk management strategies for enhanced security engineering of cyberphysical CCAV systems.

Strategies to Improve Perioperative Palliative Care Integration for Seriously Ill Veterans.

Seriously ill patients are at higher risk for adverse surgical outcomes. Palliative care (PC) interventions for seriously ill surgical patients are associated with improved quality of patient care and patient-centered outcomes, yet, they are underutilized perioperatively. To identify strategies for improving perioperative PC integration for seriously ill Veterans from the perspectives of PC providers and surgeons. We conducted semistructured, in-depth individual and group interviews with Veteran Health Administration PC team members and surgeons between July 2020 and April 2021. Participants were purposively sampled from high- and low-collaboration sites based on the proportion of received perioperative palliative consults. We performed a team-based thematic analysis with dual coding (inter-rater reliability above 0.8). Interviews with 20 interdisciplinary PC providers and 13 surgeons at geographically distributed Veteran Affairs sites converged on four strategies for improving palliative care integration and goals of care conversations in the perioperative period: 1) develop and maintain collaborative, trusting relationships between palliative care providers and surgeons; 2) establish risk assessment processes to identify patients who may benefit from a PC consult; 3) involve both PC providers and surgeons at the appropriate time in the perioperative workflow; 4) provide sufficient resources to allow for an interdisciplinary sharing of care. The study demonstrates that individual, programmatic, and organizational efforts could facilitate interservice collaboration between PC clinicians and surgeons.

ERGONOMIC RISK ASSESSMENT IN CERTAIN INDUSTRIAL FIELDS USING THE QEC AND RULA METHODS

In many industrial activities carried out by workers, some parts of the human body or even the body as a whole are overused to a degree that can affect the health of the workers. Established ergonomic risk assessment methods include QEC and RULA, and these methods aim to assess the risk factors that may cause workers to develop WMSDs. The purpose of this study is to evaluate the ergonomic risks related to workers' bodily postures when they work on conveyor belts. By using the QRC and RULA methods comparatively, it is possible to see which of the two tools are more suitable for evaluation in this type of activity and which of the two methods offers a more accurate diagnosis. The ERGOWORK version 2.7B software application was used for data entry and processing, which implements both methods. Based on the results obtained, conclusions and recommendations were drawn regarding the workers' workstations, and these can be materialized in the redesign of the work equipment and/or the replacement of the worker, in the execution of certain operations, by automatic machines.

Risk assessment of norovirus and hepatitis A virus in strawberries imported into China.

Norovirus (NoV) and hepatitis A virus (HAV) pose a considerable health risk worldwide. In recent years, many cases of virus infection caused by virus-contaminated strawberries have occurred worldwide. This study applied a critical control point system to analyze the main hazards during the production and marketing of strawberries imported into China and explore the key control points in the whole process. To further evaluate the risks in the supply chain, the established quantitative microbial risk assessment (QMRA) was used to determine the probability that residents would be infected with viruses after consuming imported strawberries. It was found that the risk of virus contamination from imported strawberries was low, and the virus contamination mainly results from water resources and personnel. This research helps the regulatory authorities formulate strategies to ensure the long-term microbial safety of imported strawberries. In addition, the methods may prove useful in evaluating the risks of other agricultural produce.

Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing.

This article provides a strategy by which a manufacturing process with a Biosafety Level 2 (BL2) designation can be downgraded to Biosafety Level 1 (BL1). The principles of the downgrading process are based on the robust contamination controls in clinical and commercial manufacturing, which typically are not part of Research and Development processes. These strict requirements along with the application of current Good Manufacturing Practice (cGMP) principles provide a framework by which processes can be suitably managed and controlled to mitigate biohazard risk, specifically for cell lines that may be contaminated with human pathogenic viral agents. We demonstrate how a risk assessment guide was used to define the risk profile of a theoretical process with a human cell line intended for clinical/commercial application. Based on the risk assessment, key BL2 elements were identified as suitable for downgrading, including facility containment controls, emergency spill response plans, and storage and shipping requirements. For various reasons, some aspects of the systems were deemed unsuitable for downgrading due to the severity of the control risk and, therefore, remained at BL2. We have used an established risk assessment guide to show how cGMP compliments and augments biosafety containment. We provide justification for downgrading from BL2 to BL1 for clinical and commercial cell and gene therapy manufacturing with human cell lines.

Combining sarcopenia and ASA status to inform emergency laparotomy outcomes: could it be that simple?

Risk assessment for emergency laparotomy (EL) is important for guiding decision-making and anticipating the level of perioperative care in acute clinical settings. While established tools such as the American College of Surgeons National Surgical Quality Improvement Program calculator (ACS-NSQIP), the National Emergency Laparotomy Audit Risk Prediction Calculator (NELA) and the Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity calculation (P-POSSUM) are accurate predictors for mortality, there has been increasing recognition of the benefits from including measurements for frailty in a simple and quantifiable manner. Psoas muscle to 3rd lumbar vertebra area ratio (PM:L3) measured on CT scans was proven to have a significant inverse association with 30-, 90- and 365-day mortality in EL patients. A retrospective analysis was conducted of 500 patients admitted to four Australian hospitals who underwent EL during 2016-2017, and had contemporaneous abdomino-pelvic CT scans. Radiological sarcopenia was measured as PM:L3 ratios. ASC-NSQIP, NELA and P-POSSUM were retrospectively calculated. Univariate and multivariate logistic regression modelling was used to assess these ratios and scores, as well as American Society of Anaesthesiologists (ASA) classification separated into ASA I-III and IV/V (simplified ASA), as potential predictors of 30-, 90- and 365-day mortality. PM:L3, simplified ASA, ACS-NSQIP, NELA and P-POSSUM were each statistically significant predictors of 30-day, 90-day and 365-day mortality (P < 0.001). Logistic regression models of 30-, 90- and 365-day mortality combining PM:L3 (P = 0.001) and simplified ASA (P < 0.001) exhibited AUCs of 0.838 (0.780, 0.896), 0.805 (0.751, 0.860) and 0.775 (0.729, 0.822), respectively, which were comparable to that of ACS-NSQIP and NELA. Combining the semi-physiological parameter ASA classification with PM:L3 provides a quick and simple alternative to the more complex established risk assessment scores and is superior to PM:L3 alone.

Association of umbilical cord serum TARC/CCL17 with childhood allergies: A birth cohort study

BackgroundEarly identification of infants at high risk of allergies can improve the efficacy of preventive interventions. However, an established quantifiable risk assessment method in the early postnatal period does not exist. TARC (or CCL17) is a Th2 chemokine used as an activity marker for atopic dermatitis (AD). Therefore, we evaluated the association between cord blood TARC (cTARC) and the development of allergic diseases in childhood. MethodsThis is a high-risk birth cohort for allergy, consisting of children with a family history of allergy. We collected 263 pairs of maternal and child cord blood samples perinatally and child blood samples at ages 1, 2, and 5 years. TARC and allergen-specific immunoglobulin E levels were measured, and the relationship between allergic diseases was analyzed. ResultsThe median cTARC was 989 pg/mL (interquartile range [IQR]: 667–1430 pg/mL). The cTARC levels in children who developed AD were higher than those in children who did not develop AD, and the association strengthened with younger age (median [IQR] at 1 year: 1285 [816–1965] vs. 933 [662–1330] pg/mL, p < 0.01; at 2 years: 1114 [787–1753] vs. 950 [660–1373] pg/mL, p = 0.02). In the multivariate analysis, cTARC was associated with AD, egg white sensitization, food allergy, allergic rhinitis, and Japanese cedar pollen sensitization. ConclusionscTARC was associated with the development of allergic diseases and allergen sensitization in early childhood. These results suggest that, infantile AD-mediated atopic march starts during fetal life, and this immune status is reflected in the cTARC at birth.

Comparison of Lactate Clearance with Established Risk Assessment Tools in Predicting Outcomes in Acute Upper Gastrointestinal Bleeding

Early risk stratification is mandatory in acute upper gastrointestinal bleeding (AUGIB) to guide optimal treatment. Numerous risk scores were introduced, but lack of practicability led to limited use in daily clinical practice. Lactate clearance is an established risk assessment tool in a variety of diseases, such as trauma and sepsis. Therefore, this study compares the predictive ability of pre-endoscopic lactate clearance and established risk scores in patients with AUGIB at the University Hospital of Cologne. Active bleeding was detected in 27 (25.2%) patients, and hemostatic intervention was performed in 35 (32.7%). In total, 16 patients (15%) experienced rebleeding and 12 (11.2%) died. Initially, lactate levels were elevated in 64 cases (59.8%), and the median lactate clearance was 18.7% (2.7-48.2%). Regarding the need for endoscopic intervention, the predictive ability of Glasgow Blatchford Score, pre-endoscopic Rockall score, initial lactate and lactate clearance did not differ significantly, and their area under the receiver operating characteristic curves were 0.658 (0.560-0.747), 0.572 (0.473-0.667), 0.572 (0.473-0.667) and 0.583 (0.483-0.677), respectively. Similar results were observed in relation to rebleeding and mortality. In conclusion, lactate clearance had comparable predictive ability compared to established risk scores. Further prospective research is necessary to clarify the potential role of lactate clearance as a reliable risk assessment tool in AUGIB.