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The investment behaviour of individuals is unconsciously influenced by their thoughts, emotions, personal beliefs or past experiences to the degree that even individual investors with considerable knowledge may diverge from logic and reason. These influences, which can be classified as behavioural finance biases, may affect the manner in which risk is perceived and understood. This study aims to establish the relationship between the behavioural finance biases and the risk tolerance of individual investors within Gauteng, South Africa. This study also aims to identify the behavioural finance biases that drive individual investment decisions. Positive, statistically significant relationships were established between the behavioural finance biases and individual investor risk tolerance. Furthermore, the investment decisions of individual investors are driven to a rather great extent by the behavioural finance biases. The significance of these findings will contribute to facilitate the more practical and accurate profiling of individual investors’ risk tolerance to ensure the successful implementation of investment strategies not only within South Africa, but also internationally.Keywords: individual investors, risk tolerance, risk profiling, behavioural finance, investment decisions, Gauteng, South AfricaJEL Classifications: D81, G41DOI: https://doi.org/10.32479/ijefi.11451

Cybercrime becomes costlier than physical crime in developed economies. As a result, it has become the top priority in governance issues in financial institutions. As a developing nation in Bangladesh, the banking sector faces multi-dimensional challenges to adopt IT applications in banking with cybercrime. The paper examines what the banking industry faces cyber security risks and how the board members contribute to identify and mitigate the risk. Through an in-depth interview among the directors of commercial banks in Bangladesh, we identified the possible cyber risk and prepared the risk profile describing the sources, implications, severity of impact, likelihood of occurrence and ranked them. The result shows that the IT governance risk, IT investment risk, and information risk are most critical among the significant cyber security risks. The results of the study have important implications for both corporate boards and policymakers.

Background and purpose: A comprehensive individual toxicity risk profile is needed to improve radiation treatment optimisation, minimising toxicity burden, in head and neck cancer (HNC) patients. We aimed to develop and externally validate NTCP models for various toxicities at multiple time points.Materials and methods: Using logistic regression, we determined the relationship between normal tissue irradiation and the risk of 22 toxicities at ten time points during and after treatment in 750 HNC patients. The toxicities involved swallowing, salivary, mucosal, speech, pain and general complaints. Studied pre-dictors included patient, tumour and treatment characteristics and dose parameters of 28 organs. The resulting NTCP models were externally validated in 395 HNC patients.Results: The NTCP models involved 14 organs that were associated with at least one toxicity. The oral cavity was the predominant organ, associated with 12 toxicities. Other important organs included the parotid and submandibular glands, buccal mucosa and swallowing muscles. In addition, baseline toxicity, treatment modality, and tumour site were common predictors of toxicity. The median discrimination performance (AUC) of the models was 0.71 (interquartile range: 0.68-0.75) at internal validation and 0.67 (interquartile range: 0.62-0.71) at external validation.Conclusion: We established a comprehensive individual toxicity risk profile that provides essential insight into how radiation exposure of various organs translates into multiple acute and late toxicities. This comprehensive understanding of radiation-induced toxicities enables a new radiation treatment optimisation concept that balances multiple toxicity risks simultaneously and minimises the overall tox-icity burden for an individual HNC patient who needs to undergo radiation treatment. (C) 2021 The Author(s). Published by Elsevier B.V.

To improve our ability to extrapolate preclinical toxicity to humans, there is a need to understand and quantify the concordance of adverse events (AEs) between animal models and clinical studies. In the present work, we discovered 3011 statistically significant associations between preclinical and clinical AEs caused by drugs reported in the PharmaPendium database of which 2952 were new associations between toxicities encoded by different Medical Dictionary for Regulatory Activities terms across species. To find plausible and testable candidate off-target drug activities for the derived associations, we investigated the genetic overlap between the genes linked to both a preclinical and a clinical AE and the protein targets found to interact with one or more drugs causing both AEs. We discuss three associations from the analysis in more detail for which novel candidate off-target drug activities could be identified, namely, the association of preclinical mutagenicity readouts with clinical teratospermia and ovarian failure, the association of preclinical reflexes abnormal with clinical poor-quality sleep, and the association of preclinical psychomotor hyperactivity with clinical drug withdrawal syndrome. Our analysis successfully identified a total of 77% of known safety targets currently tested in in vitro screening panels plus an additional 431 genes which were proposed for investigation as future safety targets for different clinical toxicities. This work provides new translational toxicity relationships beyond AE term-matching, the results of which can be used for risk profiling of future new chemical entities for clinical studies and for the development of future in vitro safety panels.

Background Giant cell arteritis (GCA) is a disease that relapses often, and some patients run a refractory course. Although prompt recognition of resistant GCA is a major issue, there is no well-recognized, baseline risk factor for poor response to glucocorticoid (GC) treatment. Methods We included all patients consecutively diagnosed with GCA and homogeneously treated since 1976 in a single department and regularly followed-up for at least 18 months. Using a set of customized criteria defining response to GCs, we separated patients into highly responsive, usually responsive, dependent on GCs, and resistant to GCs. We determined which of the baseline variables were associated with GC-resistance and conducted factor analyses of mixed data and decision tree analyses. We also determined whether being GC-resistant was associated with poorer tolerance to GCs and higher death rates. Results In all, 455 patients were followed for 93.4 ± 67.6 (standard deviation) months; 41 (9%) and 21 (4.6%) patients developed GC-dependent and GC-resistant disease, respectively. Factor analyses suggested an association between clinical pattern and degree of responsiveness to GCs; The decision tree analyses, built on an age at GCA onset 〈 66 years and body weight 〉 71 kg, delineated a high risk profile (44% of the patients who featured both characteristics were GC-resistant vs. less than 3% who featured neither, p Conclusion Extra-cranial, large-vessel GCA may be associated with prolonged GC requirements. A simple combination of age and body weight defined a subgroup of patients at high risk for developing GC resistance. Our findings need confirmation in prospective controlled studies.

Penile prosthesis implantation is the gold standard of surgical therapy for patients with medication-refractory erectile dysfunction. However, this umbrella definition includes significant heterogeneity and associated risk profiles that should be candidly discussed and addressed perioperatively. Factors associated with operative success and patient satisfaction are often surgery specific; however, risk profiling via patient selection, preoperative optimization, proper device selection, and intraoperative consideration are highly correlated. Some examples of common risk profiles include comorbidity(ies) such as cardiovascular disease, diabetes mellitus, prior abdominal surgery, Peyronie's disease, and psychological risk factors. Similarly, integration of surgeon- and patient-amenable characteristics is key to decreasing risk of infection, complication, and need for revision. Finally, patient risk profiling provides a unique context for proper device selection and evidence-based intraoperative considerations.

Background: Echocardiography might enhance cardiovascular (CV) risk stratification beyond tools grading the risk for atherosclerotic CV diseases (ASCVD). We therefore studied the complementarity between the ASCVD risk score recommended by American cardiology societies and echocardiographic profiling in predicting adverse CV outcome in the community. Methods: 984 community-dwelling individuals between 40 and 79 years old (51.3% women) underwent CV risk profiling and echocardiography. We estimated their 10-year ASCVD risk from baseline risk factors using the Pooled Cohort Equations. Participants were categorized as at low (amp;lt;2.5%), borderline (2.5-amp;lt;7.5%) or intermediate-to-high (amp;gt;= 7.5%) ASCVD risk. Main outcome was the incidence of CV events collected on average 7.5 years later. Results: The probability for cardiac remodeling and/or dysfunction as assessed by echocardiography rose progressively with increasing 10-year ASCVD risk. During follow-up, 116 participants experienced at least one CV endpoint (15.8 events per 1000 person-years). With increasing 10-year ASCVD risk, the CV event rate increased stronger in participants with amp;gt;= 1 LV abnormality at baseline. Indeed, in individuals with an intermediate-to-high ASCVD risk and amp;gt;= 1 LV abnormality at baseline, the risk was significantly higher than the average population risk for a first CV event (HR: 3.00, P amp;lt; 0.001). Adding the presence of amp;gt;= 1 LV abnormality to a ASCVD risk score-based model yielded significant improvement in C-statistics (P = 0.024), integrated discrimination (P=0.0085) and net reclassification (P amp;lt; 0.001) for adverse CV events. Conclusions: Echocardiographic profiling enhanced CV risk stratification in individuals at intermediate-to-high ASCVD risk. Echocardiographic screening might supplement traditional ASCVD risk grading for CV disease prediction. (C) 2019 Elsevier B.V. All rights reserved. Funding Agencies|Fonds voor Wetenschappelijk Onderzoek Vlaanderen, Brussels, BelgiumFWO [11Z0916N, G0C5319N]

We envisage the development of new Brain Health Services to achieve primary and secondary dementia prevention. These services will complement existing memory clinics by targeting cognitively unimpaired individuals, where the focus is on risk profiling and personalized risk reduction interventions rather than diagnosing and treating late-stage disease. In this article, we review key potentially modifiable risk factors and genetic risk factors and discuss assessment of risk factors as well as additional fluid and imaging biomarkers that may enhance risk profiling. We then outline multidomain measures and risk profiling and provide practical guidelines for Brain Health Services, with consideration of outstanding uncertainties and challenges. Users of Brain Health Services should undergo risk profiling tailored to their age, level of risk, and availability of local resources. Initial risk assessment should incorporate a multidomain risk profiling measure. For users aged 39–64, we recommend the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Dementia Risk Score, whereas for users aged 65 and older, we recommend the Brief Dementia Screening Indicator (BDSI) and the Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI). The initial assessment should also include potentially modifiable risk factors including sociodemographic, lifestyle, and health factors. If resources allow, apolipoprotein E ɛ4 status testing and structural magnetic resonance imaging should be conducted. If this initial assessment indicates a low dementia risk, then low intensity interventions can be implemented. If the user has a high dementia risk, additional investigations should be considered if local resources allow. Common variant polygenic risk of late-onset AD can be tested in middle-aged or older adults. Rare variants should only be investigated in users with a family history of early-onset dementia in a first degree relative. Advanced imaging with 18-fluorodeoxyglucose positron emission tomography (FDG-PET) or amyloid PET may be informative in high risk users to clarify the nature and burden of their underlying pathologies. Cerebrospinal fluid biomarkers are not recommended for this setting, and blood-based biomarkers need further validation before clinical use. As new technologies become available, advances in artificial intelligence are likely to improve our ability to combine diverse data to further enhance risk profiling. Ultimately, Brain Health Services have the potential to reduce the future burden of dementia through risk profiling, risk communication, personalized risk reduction, and cognitive enhancement interventions.

Introduction: Elite youth soccer players suffer increasing numbers of injuries owing to constantly increasing physical demands. Deficits in neuromuscular performance may increase the risk of injury. Injury risk factors need to be identified and practical cut-off scores defined. Therefore, the purpose of the study was to assess neuromuscular performance parameters within a laboratory-based injury risk screening, to investigate their association with the risk of non-contact lower extremity injuries in elite youth soccer players, and to provide practice-relevant cut-off scores.Methods: Sixty-two elite youth soccer players (age: 17.2 ± 1.1 years) performed unilateral postural control exercises in different conditions, isokinetic tests of concentric and eccentric knee extension and knee flexion (60°/s), isometric tests of hip adduction and abduction, and isometric tests of trunk flexion, extension, lateral flexion and transversal rotation during the preseason period. Non-contact lower extremities injuries were documented throughout 10 months. Risk profiling was assessed using a multivariate approach utilizing a Decision Tree model [Classification and Regression Tree (CART) method].Results: Twenty-five non-contact injuries were registered. The Decision Tree model selected the COP sway, the peak torque for knee flexion concentric, the functional knee ratio and the path of the platform in that hierarchical order as important neuromuscular performance parameters to discriminate between injured and non-injured players. The classification showed a sensitivity of 0.73 and a specificity of 0.91. The relative risk was calculated at 4.2, meaning that the risk of suffering an injury is four times greater for a player, who has been classified as injured by the Decision Tree model.Conclusion: Measuring static postural control, postural control under unstable condition and the strength of the thigh seem to enable a good indication of injury risk in elite youth soccer players. However, this finding has to be taken with caution due to a small number of injury cases. Nonetheless, these preliminary results may have practical implications for future directions in injury risk screening and in planning and developing customized training programs to counteract intrinsic injury risk factors in elite youth soccer players.

Introduction It is a fundamental good clinical practice in our medicolegal rights era to obtain standard, adequate, and transparent informed consent before any planned intervention. Currently, there are neither national approved vascular intervention-specific consents nor explicit guidelines for it. We aim to achieve a standardisation of perioperative risk profiling of infrainguinal bypass surgical consents and produce a model one. Method A retrospective analysis of 45 infrainguinal bypass consents (audit/reaudit) between (2013-2019) retrieved to evaluate quality and completeness against GMC 2008 guidance: "Consent: patients and doctors making decisions together". Data included basic consent requirements according to guidelines and specific risks of infrainguinal bypass. It was registered with the Trust Clinical Audit Department. Results (100%) of audit and reaudit consents documented the intended benefits of surgery. Inclusion into the National Vascular Registry (NVR) was achieved (0%) in audit vs (80%) in reaudit forms. Of the 19 documented postoperative complications, reaudit significant improvement observed in % of documenting 16 items with 9 complications recorded above 50%. The maximum number of audit documented risks was 15 (79%), the median 8 (42%), and the least was 3 (16%) compared to maximum 16 (84%), the median 10 (53%) and the least was 4 (21%) when reaudited, respectively. Conclusions Deficiencies in performing and adequately completing surgical consents still occur. Introducing a national pre-printed vascular intervention-specific consent is vital for accomplishing and maintaining a good clinical practice. It should include all complications with relative % risk to minimise errors, provide good quality consent, and promote clinical practice at a national level.

Introduction It is a fundamental good clinical practice in our medicolegal rights era to obtain standard, adequate, and transparent informed consent before any planned intervention. Currently, there are neither national approved vascular intervention-specific consents nor explicit guidelines for it. We aim to achieve a standardisation of perioperative risk profiling of carotid endarterectomy consents and produce a model one. Method A retrospective analysis of 65 carotid endarterectomy consents (audit/reaudit) between (2016-2019) retrieved to evaluate quality and completeness against GMC 2008 guidance: "Consent: patients and doctors making decisions together". Data included basic consent requirements according to guidelines and specific risks of carotid endarterectomy. It was registered with the Trust Clinical Audit Department. Results (90%) audit vs (87%) reaudit consents documented the intended benefits of surgery. Inclusion into the National Vascular Registry (NVR) was achieved (0%) in audit vs (60%) in reaudit forms. Of the 14 documented postoperative complications, reaudit significant improvement observed in % of documenting 12 items with 6 complications recorded above 50%. The maximum number of audit documented risks was 11 (79%), the median 6 (43%), and the least was 3 (21%) compared to maximum 13 (93%), the median 7 (50%) and the least was 5 (36%) when reaudited, respectively. Conclusions Deficiencies in performing and adequately completing surgical consents still occur. Introducing a national pre-printed vascular intervention-specific consent is vital for accomplishing and maintaining a good clinical practice. It should include all complications with relative % risk to minimise errors, provide good quality consent, and promote clinical practice at a national level.

Introduction Early identification of patients (pts) with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) at high risk for treatment failure may allow for interventions to improve outcomes; however, known prognostic factors are inadequate. Circulating tumor DNA (ctDNA) has demonstrated the ability to identify previously untreated DLBCL pts at high risk of relapse (Kurtz et al. 2018). We assessed the potential for ctDNA to identify pts with R/R DLBCL receiving bendamustine and rituximab (BR) +/- polatuzumab (pola) at higher risk for disease progression. Methods GO29365 (NCT02257567) is a Phase Ib/II study comparing pola+BR versus BR in pts with transplant-ineligible R/R DLBCL and enrolled 80 pts (n=40 per randomized arm). The primary efficacy objective was independent review committee (IRC)-assessed complete response (CR) rate at primary response assessment (PRA, 6-8 weeks after Cycle 6, Day 1 or last dose of study drug). ctDNA was measured in available cohort samples using a customized DLBCL panel on a modified ctDNA CAPP-Seq workflow developed based on the prototype assay reported in Kurtz et al. 2018, with improvement of sensitivity and specificity. ctDNA was reported as mean mutant molecules per mL (MMPM). Plasma depleted whole blood from baseline was used as a source of germline DNA to filter non-tumor-specific variants. A total of 43 samples were available at baseline; eight pts without a paired germline were excluded from efficacy and correlative analyses. Of the 35 samples (n=21 Pola+BR; n=14 BR) with available germline data, paired samples were available for 25 pts at PRA. Detectable ctDNA (+/-) was determined using empirical p-values ( Results Intent-to-treat and biomarker evaluable populations were similar in demographics and efficacy, but there was a higher proportion of pola+BR versus BR pts assayed (60% vs 40%). Analyses are reported for the pooled arms, but results were consistent across both arms. ctDNA was detected in all available baseline (n=43) samples (95% CI: 92-100). Baseline ctDNA levels were correlated with known prognostic factors including International Prognostic Index (IPI), lactate dehydrogenase (LDH), Ann Arbor stage and number of prior therapies (Figure 1A). Higher ctDNA levels at baseline were negatively prognostic; when stratifying pts by median ctDNA levels the hazard ratio (HR) for PFS was 0.16 (95% CI: 0.07-0.41; Figure 1B); OS HR 0.23 (95% CI: 0.10-0.52). Similar results were observed for other quartile stratifications. This significant trend was maintained when adjusted in multivariate analysis for treatment, IPI >3, and LDH > upper limit of normal with an adjusted HR for PFS of 0.24 (95% CI: 0.07-0.81) and for OS an adjusted HR of 0.30 (95% CI: 0.09-0.97). Similar to the first-line setting (Kurtz et al. 2018), on-treatment log fold-changes in ctDNA trended with PRA response (Figure 1C); pts with a CR had a significantly greater average decrease in MMPM across timepoints than non-CR pts (Wilcoxon p-value Conclusions Baseline ctDNA levels were correlated with standard clinical risk factors, and were shown to have independent prognostic value for response, PFS and OS in R/R DLBCL pts treated with BR +/- pola. The degree of ctDNA change upon treatment was also correlated with response, but association with PFS needs further investigation with a larger sample size. This provides early evidence that ctDNA can be used to improve identification of R/R DLBCL pts at high risk for disease progression/relapse. Figure Disclosures Herrera: AstraZeneca: Research Funding; Karyopharm: Consultancy; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy, Research Funding; Immune Design: Research Funding; Seattle Genetics: Consultancy, Research Funding; Gilead Sciences: Consultancy, Research Funding; Pharmacyclics: Research Funding; Merck: Consultancy, Research Funding; Bristol Myers Squibb: Consultancy, Other: Travel, Accomodations, Expenses, Research Funding. Tracy:F. Hoffmann-La Roche: Current Employment, Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment. Croft:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months. Opat:Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZenca: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Beigene: Research Funding; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Mundipharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Epizyme: Research Funding; F. Hoffman-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel accomodations, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Ray:F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment. Musick:F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company; Roche/Genentech, Inc.: Current Employment. Paulson:F. Hoffmann-La Roche Ltd.: Current Employment, Current equity holder in publicly-traded company. Sehn:Chugai: Consultancy, Honoraria; Servier: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Teva: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding; MorphoSys: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Lundbeck: Consultancy, Honoraria; Karyopharm: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Kite: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Acerta: Consultancy, Honoraria; Genentech, Inc.: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria; Apobiologix: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Verastem Oncology: Consultancy, Honoraria; TG therapeutics: Consultancy, Honoraria. Jiang:F. Hoffmann-La Roche: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment.

International mail articles present an important potential vector for biosecurity and other regulatory risk. Border intervention is a key element in Australia’s biosecurity strategy. Arriving international mail articles are inspected and those that are intercepted with biosecurity risk material are documented, including the address to which the article was to be delivered. Knowledge about patterns in the intended destinations of mail article permits more detailed biosecurity intervention. We used geo-location software to identify the delivery address of mail articles intercepted with biosecurity risk material from 2008–2011. We matched these addresses with demographic data that were recorded at a regional level from the Australian Bureau of Statistics 2011 Census and used random forest statistical analyses to correlate various demographic fields at the regional level with the counts of seized mail articles. The analysis of the seizure counts against demographic characteristics suggests a high correlation between having higher numbers of university students that speak a particular language in a region and higher quantities of intercepted mail articles destined for that region. We also explore metropolitan and regional patterns in the destinations of seized materials. These results can be used to provide information on policy and operational actions to try to reduce the rate at which mail articles that contain biosecurity risk material are sent to Australia.

We evaluated the outcomes and adverse events after fetoscopic laser surgery (FLS) for twin–twin transfusion syndrome (TTTS) using the Solomon technique in comparison to the selective technique. A retrospective analysis of a single-center consecutive cohort of FLS-treated TTTS using the selective (January 2010 to July 2014) and Solomon (August 2014 to December 2017) techniques was performed. Among 395 cases, 227 underwent selective coagulation and 168 underwent the Solomon technique. The incidence rates of recurrent TTTS (Solomon vs. selective: 0% vs. .9%, p = .510) and twin anemia–polycythemia sequence (.6% vs. .4%, p = .670) were very low in both groups. The incidence rates of placental abruption (Solomon vs. selective: 10.7% vs. 3.5%, p = .007) and preterm premature rupture of the membranes (pPROM) with subsequent delivery before 32 weeks (20.2% vs. 7.1%, p < .001) were higher in the Solomon group. The median birth recipient weight was significantly smaller in the Solomon group (1790 g vs. 1933 g, p = .049). The rate of survival of at least one twin was significantly higher in the Solomon group (98.2% vs. 93.8%, p = .046). The Solomon technique and total laser energy were significant risk factors for pPROM (odds ratio: 2.64, 1.07, 95% CI [1.32, 5.28], [1.01, 1.13], p = .006, p = .014, respectively). These findings suggest that the Solomon technique led to superior survival outcomes but increased risks of placental abruption, pPROM and fetal growth impairment. Total laser energy was associated with the occurrence of pPROM. Close attention to adverse events is required for perinatal management after FLS to treat TTTS using the Solomon technique.

This report assesses peer‐reviewed and grey literature on risk communication concepts and practices, as requested by the European Commission to support the implementation of a ‘General Plan for Risk Communication’, i.e. an integrated framework for EU food safety risk assessors and risk managers at Union and national level, as required by the revised EU General Food Law Regulation. We conducted a scoping review of social research studies and official reports in relation to risk communication in the following areas: understanding and awareness of risk analysis roles and tasks, reducing misunderstanding of the different meaning of the terms ‘hazard’ and ‘risk’, tackling misinformation and disinformation, enhancing confidence in EU food safety, taking account of risk perceptions, key factors in trade‐offs about risks, audience segmentation and tools, channels and mechanisms for coordinated risk communications. We structured our findings as follows: i) definitions of key concepts, ii) audience analysis and information requirements, iii) risk profiling, models and mechanisms, iv) contributions to communication strategies. We make several recommendations for consideration by the Commission, both in terms of actions to support the design and implementation of the general plan, and research needs that we consider crucial to further inform appropriate risk communication in the EU. EFSA carried out a targeted consultation of experts and a public consultation open to all interested parties including the general public, in preparing and finalising this report., This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.e190401/full and http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.e190402/full

Commercial shipping is the primary pathway of introduction for aquatic nonindigenous species, mainly through the mechanisms of ballast water and biofouling. In response to this threat, regulatory programs have been established across the globe to regulate and monitor commercial merchant and passenger vessels to assess compliance with local requirements to reduce the likelihood of NIS introductions. Resource limitations often determine the inspection efforts applied by these regulatory agencies to reduce NIS introductions. We present a simple and adaptable model that prioritizes vessel arrivals for inspection using proxies for potential propagule pressure, namely a ships’ wetted surface area as a proxy for the likelihood of biofouling-mediated potential propagule pressure and ballast water discharge volume as a proxy for ballast water-mediated potential propagule pressure. We used a California-specific dataset of vessels that arrived at California ports between 2015 and 2018 to test the proposed model and demonstrate how a finite set of inspection resources can be applied to target vessels with the greatest potential propagule pressure. The proposed tool is adaptable by jurisdiction, scalable to different segments of the vessel population, adjustable based on the vector of interest, and versatile because it allows combined or separate analyses of the PPP components. The approach can be adopted in any jurisdiction across the globe, especially jurisdictions without access to, or authority to collect, risk profiling data or direct measurements for all incoming vessel arrivals.

Introduction: We investigated relationships among genetic determinants of Alzheimer's disease (AD), amyloid/tau/neurodegenaration (ATN) biomarkers, and risk of dementia.Methods: We studied cognitively normal individuals with subjective cognitive decline (SCD) from the Amsterdam Dementia Cohort and SCIENCe project. We examined associations between genetic variants and ATN biomarkers, and evaluated their predictive value for incident dementia. A polygenic risk score (PRS) was calculated based on 39 genetic variants. The APOE gene was not included in the PRS and was analyzed separately.Results: The PRS and APOE ε4 were associated with amyloid-positive ATN profiles, and APOE ε4 additionally with isolated increased tau (A-T+N-). A high PRS and APOE ε4 separately predicted AD dementia. Combined, a high PRS increased while a low PRS attenuated the risk associated with ε4 carriers.Discussion: Genetic variants beyond APOE are clinically relevant and contribute to the pathophysiology of AD. In the future, a PRS might be used in individualized risk profiling.

The study by Sehrawat et al. made an important observation that extracellular vesicles (EVs) and sphingolipid cargoes can distinguish alcoholic hepatitis from decompensated cirrhosis. The authors suggest that an EV value of 1.56 × 1011 /mL will help in differentiating alcoholic hepatitis and also predict 90-day survival, permitting risk profiling and thus having important clinical implications.(1).

Objectives To delineate laboratory-confirmed bloodstream infection (LCBI), analyze risk factors for its occurrence and predictors for its short-term mortality in systemic lupus erythematosus (SLE) patients. Methods A single center, retrospective, case-controlled study was performed in 159 SLE patients (2013–2019) to identify risk factors of LCBI by comparing patients with LCBI (n = 39) to those without infection (n = 120). The predictors associated with 30-day mortality in LCBI patients were also analyzed. Results Altogether 40 bacteria strains were isolated in 39 LCBI patients with a predominance of the gram-negative bacilli (24 strains, 60.0%). Escherichia coli and Staphylococcus aureus were the leading Gram-negative and Gram-positive microorganisms, respectively. Occurrence of LCBI was independently predicted by: SLE disease duration >4 years, SLEDAI score >4 points, glucocorticoids dose >7.5 mg/d and the previous or concomitant occurrence of autoimmune hemolytic anemia (AIHA) or thrombotic microangiopathy (TMA). Based on the identified risk factors, we developed a matrix model for the risk of future LCBI. The 30-day mortality (39 cases) was 23.1% and healthcare-associated LCBI was a predictor for 30-day mortality in SLE patients compared with community-acquired LCBI. Conclusion Longer duration, higher disease activity and glucocorticoids dose, and occurrence of AIHA or TMA were risk factors of LCBI in SLE and its poor short-term prognosis may attribute to healthcare-associated LCBI.

Assessing the baseline knowledge status and expectations of the target population of any health promotion and secondary prevention program is essential to the success of such intervention. To obtain this information about the Hong Kong population a priori to implementing these preventive strategies for oral cancer in addition to determining the willingness of potential screening participants to take risk-profiling assessments, a cross-sectional survey was conducted between November 2019 and March 2020. A total of 964 residents between the ages 18 and 86 years were invited to participate in this study across the three geographical areas in Hong Kong. Most participants self-reported being aware of oral cancer (86.3%), although the proportion of those with substantial knowledge on salient risk factors and early identifiable signs were very low (2.9%). Age and level of education were the only demographic characteristics associated with the knowledge status. The proportion of participants willing to attend community screening and partake in risk profiling assessment was high (83.9% and 80.9% respectively). Willingness to attend community screening was directly associated with respondents’ self-reported oral cancer awareness status (OR: 1.9, 95% CI: 1.22–2.96). Also, we observed that those participants who were willing to attend screening are more inclined to take risk prediction assessments that those not willing to attend. These findings have showcased the need to intensify health promotion via personal skills development to encourage early disease presentation and will assist in the planning of these programs accordingly in the Hong Kong population.

To effectively manage patients of different vulnerabilities to falls and pressure injury entails understanding the risk drivers and predicting risk profiles in real-time, thus, we determined the core drivers of patients’ proneness to these risks while developing a machine learning strategy for their real-time prediction in acute care hospital. By implementing a multivariate logistic analysis, the risk drivers and injury risk probabilities were obtained while establishing a comparative machine learning technique for patients’ risk-profiling. We observed Multi sclerosis & motor neuron disease (MSN) and Fall during current admission (FDA) as pronounced risk drivers, and Extra Tree Classifier (ETC) and Random Forest (RF) as the best algorithms with prediction accuracy of 90.6% - 99.8%. With a cost saving of 2.3% - 38.89%, our framework will provide an efficient technique for cost-effective management of inpatients susceptible to falls and pressure injury risks on admission.

Contains fulltext : 229568.pdf (Publisher’s version ) (Open Access) INTRODUCTION: Cervical cancer affects half a million women worldwide annually. Given the association between high-risk human papillomavirus (hrHPV) infection and carcinogenesis, hrHPV DNA testing became an essential diagnostic tool. However, hrHPV alone does not cause the disease, and, most importantly, many cervical lesions regress to normal in a year because of the host immune system. Hence, the low specificity of hrHPV DNA tests and their inability to predict the outcome of infections have triggered a further search for biomarkers. AREAS COVERED: We evaluated the latest viral and cellular biomarkers validated for clinical use as primary screening or triage for cervical cancer and assessed their promise for prevention as well as potential use in the future. The literature search focused on effective biomarkers for different stages of the disease, aiming to determine their significance in predicting the outcome of hrHPV infections. EXPERT OPINION: Biomarkers such as p16/Ki-67, hrHPV genotyping, hrHPV transcriptional status, and methylation patterns have demonstrated promising results. Their eventual implementation in the screening programs may support the prompt diagnosis of hrHPV infection and its progression to cancer. These biomarkers will help in making clinical management decisions on time, thus, saving the lives of hrHPV-infected women, particularly in developing countries.

Private higher learning institution is vulnerable towards heavy dependence in students’ tuition fees to sustain operation, thus the default in tuition payments is among its most critical risk. In this work, the statistics-based scoring method is adopted to provide risk assessment that offers risk profiling for every students, specifically on their ability to pay tuition fees. Risk mitigation and preventive measure are also proposed in this work.

This is a commentary on the manuscript by Mpody C, Arends J, Aldrink J, et al., titled "Prognostic Profiling of Children with Serious Post-Operative Complications: A Novel Probability Model for Failure to Rescue".

Background: Prediction of patient outcomes following allogeneic hematopoietic stem cell transplantation (HSCT) remains a tenacious problem. An important limitation of current prediction models is the heterogeneity in outcome even among similar cases. We introduce a novel approach to individualizing estimates of leukemia-free survival (LFS) in acute leukemia patients undergoing haploidentical (haplo) HSCT. Methods: Data were obtained from the registry of the European Society for Blood and Marrow Transplantation for all cases of haplo HSCT for acute leukemia performed between 2011 and 2017. Patients receiving ex-vivo T-cell depleted grafts were excluded. Acute myeloid leukemia patients were classified by clinical disease ontogeny (de novo vs. secondary), cytogenetics, and FLT3-ITD/NPM1mut status; acute lymphoblastic leukemia patients by disease status and the presence of the Philadelphia chromosome. Common patient and transplantation parameters including recipient age, Karnofsky performance status (KPS), time from diagnosis to transplantation, conditioning and graft-versus-host disease (GvHD) prophylaxis were included. Data were split into training and geographic validation sets. Results: A total of 2,001 patients was included in the training set and another 270 in the validation cohort. In the training set, the median age was 50 years; 68% of patients were in complete remission, and 69% had a KPS ≥ 90; 87% received post-transplant cyclophosphamide and 13% antithymocyte globulin for GvHD prophylaxis. To provide the clinician insight on outcomes of similar patients, we developed a descriptive tool to visually explore outcomes of cases with comparable features. We next generated 50 random survival forest models for the prediction of 1-year LFS. In contrast to single point-estimates, the ensemble of 50 models generates a prediction interval accounting for predictive uncertainty. There was heterogeneity of variable importance between models, with either disease status or KPS leading in all models (Figure A). The model was well calibrated (Figure B); the median c-statistic was 0.64 on the validation set. An online interface presents the individual outcomes of the fifteen patients most similar to the index case, the prediction interval, and a visualization of all 50 survival forest predictions. Predictions for a sample patient are shown in Figure (C). Conclusions: We present the first system for individualized prediction of leukemia-free survival following T-cell replete haplo transplantation. A key, novel component of the model, distinguishing it from standard risk scores, is that it provides a measure of predictive certainty. This is essential for judging the robustness of prediction. Our approach is applicable to other clinical settings and can be used for designing risk-guided interventions and for informing patients and clinicians. Figure Disclosures Labopin: Jazz Pharmaceuticals: Honoraria. Blaise:Jazz Pharmaceuticals: Honoraria. Sica:F. Hoffmann-La Roche Ltd: Other: All authors received support for third-party writing assistance, furnished by Scott Battle, PhD, provided by F. Hoffmann-La Roche, Basel, Switzerland., Research Funding. Mohty:Stemline: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; GSK: Consultancy, Honoraria, Research Funding, Speakers Bureau.

The Council for Scientific and Industrial Research (CSIR) has recently launched a state-of-the-art online climate risk profiling and adaptation tool to assist municipalities across South Africa to assess their risk and vulnerabilities, and respond by adapting settlements to climate change. The Green Book looks forwards to the year 2050 by projecting settlement growth combined with quantitative, scientific evidence of the likely impacts that climate change will have on South African towns and cities and its key resources. The tool provides appropriate adaptation measures to be considered for implementation towards the development of climate resilient settlements. The ultimate goal of the Green Book is to contribute to resilient, sustainable and liveable South African settlements through climate change adaptation. Co-funded by the Canadian International Development Research Centre and the CSIR and produced in collaboration with South Africa’s National Disaster Management Centre, the Green Book is the result of a 3-year initiative. More than 50 researchers and numerous stakeholders and reviewers were involved in producing the Green Book and reviewing its findings.

[The Research Foundation Review 2018 summarizes the offerings from the CFA Institute Research Foundation over the past year—books, literature reviews, workshop presentations, and other relevant material.

This paper looks at the use of risk profiles by law enforcement in the age of Big Data. First, the paper discusses different use-types of risk profiling. Subsequently, the paper deals with the following three categories of challenges of risk profiling: (a) false positives (and to some extent false negatives) as well as incorrect data and erroneous analysis, (b) discrimination and stigmatization, (c) and maintaining appropriate procedural safeguards. Based on the hypothesis of risk profiling creating challenges, this paper addresses the question whether we need transparency of risk profiling by law enforcement actors, from the perspective of protecting fundamental rights of those affected by the use of risk profiles. The paper explores tackling these challenges from the angle of transparency, introducing Heald’s varieties of transparency as a theoretical model.

An emerging objective in the IBD community is to gear the findings from genome-wide association studies towards achieving precision medicine. The main goal of this new model of disease management is to adapt clinical practice to the needs of each patient. This includes, among others, obtaining more detailed characterizations of disease presentation at diagnosis, better prediction of disease prognosis that permits to anticipate and adapt management to variations in symptomatology, and tailoring treatment to individual needs. In this chapter, we will introduce the methodology for estimation of disease risk using genetic data from individuals and discuss the potential and main challenges for using genomic risk profiling as a predictive tool that can pave the way for adoption of precision medicine-based approaches in the clinical management of IBD.

AIM Centenarians represent a biological model of successful aging because they escaped/postponed most invalidating age-related diseases, such as cardiovascular diseases. The aim of the present study was to clarify whether a favorable cardiovascular risk profile increases the survival chances in long-lived people. METHODS A total of 355 community-dwelling nonagenarians and centenarians living in Southern Italy were recruited in the study. Patients were classified as at low and high cardiovascular risk on the basis of serum cholesterol, diabetes, hypertension and smoking status. The relationship between cardiovascular risk factors and 10-year mortality was investigated by Cox regression analysis. Splines-based hazard ratio curves were also estimated for total cholesterol, low-density lipoprotein cholesterol, and systolic and diastolic blood pressure. RESULTS Low levels of selected cardiovascular risk factors usually associated with lower mortality in adults do not increase survival chances among oldest-old individuals. In particular, after adjusting for age, sex, and cognitive, functional and nutritional status, serum cholesterol >200 mg/dL increased the survival chances during the follow-up period (hazard ratio 0.742, 95% CI 0.572-0.963). CONCLUSIONS The present results showed that in nonagenarians and centenarians, the clinical and prognostic meaning associated with traditional cardiovascular risk factors is very different from younger populations. Consequently, considering the increase of this population segment, further studies are required to confirm these results and to translate them into clinical practice/primary care. Geriatr Gerontol Int 2019; 19: 165-170.

Summary Accurate prediction of long-term outcomes remains a challenge in the care of cancer patients. Due to the difficulty of serial tumor sampling, previous prediction tools have focused on pretreatment factors. However, emerging non-invasive diagnostics have increased opportunities for serial tumor assessments. We describe the Continuous Individualized Risk Index (CIRI), a method to dynamically determine outcome probabilities for individual patients utilizing risk predictors acquired over time. Similar to “win probability” models in other fields, CIRI provides a real-time probability by integrating risk assessments throughout a patient’s course. Applying CIRI to patients with diffuse large B cell lymphoma, we demonstrate improved outcome prediction compared to conventional risk models. We demonstrate CIRI’s broader utility in analogous models of chronic lymphocytic leukemia and breast adenocarcinoma and perform a proof-of-concept analysis demonstrating how CIRI could be used to develop predictive biomarkers for therapy selection. We envision that dynamic risk assessment will facilitate personalized medicine and enable innovative therapeutic paradigms.

Actinic keratoses (AKs) represent in-situ squamous cell carcinomas that potentially invade subepidermal structures and may metastasize. Until now, it is unpredictable to determine which AK lesions show this aggressive behavior. As AKs usually occur in large sun exposed areas, field-directed treatments have become the standard treatment regimen. Among these, conventional photodynamic therapy (cPDT) with 5-aminolaevulinic acid (ALA) or methyl-aminolevulinate (MAL) using red light is particularly effective in the treatment of AKs, but acceptance of the therapy is impaired by severe pain during treatment. Daylight PDT (dPDT) has demonstrated to be an equally effective alternative treatment option which is less painful. Recent attempts to determine the risk of AKs that demonstrate particular aggressive biological behavior by implementation of clinical and histological characteristics of AKs have not lead to conclusive results. Therefore, a look at the molecular biology of AKs could serve as a useful tool to develop a risk profiling for separation of those patients that are of particular risk to develop invasive tumor and, by this, to facilitate a more effective and adapted treatment option.

Introduction The purpose of this study is to determine if the risk of receiving a blood transfusion during hip fracture hospitalization can be predicted by a validated risk profiling score (Score for Trauma Triage in Geriatric and Middle Aged (STTGMA)). Materials and Methods A consecutive series of 1449 patients 55 years and older admitted for a hip fracture at one academic medical center were identified from a trauma database. The STTGMA risk score was calculated for each patient. Patients were stratified into risk groups based on their STTGMA score quantile: minimal risk (0–50%), low risk (50–80%), moderate risk (80–95%), and high risk (95–100%). Incidence and volume of blood transfusions were compared between risk groups. Results There were 562 (38.8%) patients who received a transfusion during their admission. 58.3% of patients in the high risk group received a transfusion during admission compared to 31.2% of minimal risk group patients, 42.6% of low risk group patients, and 50.0% of moderate risk group patients ( p < 0.001). STTGMA was predictive of first transfusion incidence in both the preoperative and postoperative periods. There was no difference in mean total transfusion volume between the four risk groups. Conclusion The STTGMA model is capable of risk stratifying hip fracture patients more likely to receive blood transfusions during hospitalization. Surgeons can use this tool to anticipate transfusion requirements.

Enhanced ways to cope with climate change and environmental change are being made at various levels across the world. In the southern African region, despite the regions’ potential for economic growth, several disasters associated with climate stresses (particularly evidence made for repeated floods and droughts) can retard economic growth, development and livelihood security. In this paper, disaster inventories are argued to be useful ways of revealing nuanced analyses of extreme climate events and other challenges such as the spatial–temporal distribution of events and their impacts, particularly for vulnerable people groups. Despite repeated calls for vigilance about current and future climate variations and environmental change impacts, there are few detailed regional and country-specific inventories of disasters and records of subsequent humanitarian responses that record both impacts and possible implications of disaster events in the region. This paper draws together those data that do exist and offers a review of the occurrences, impacts and past responses to humanitarian crises in the region (for 14 countries over the period of 2000–2012). From this research a number of critical areas are profiled: first, the convergence of compound and complex shocks that occur simultaneously and/or sequentially is compounding disaster risks—including those associated with climate challenges. A review of international and regional UN agency, NGO and governmental reports all illustrates the need to articulate between internationally significant, ‘signature’ events and smaller, sub-national events with a higher recurrence interval that may be just as damaging to local communities. Second, the reach of disaster impacts is changing with the region becoming increasingly more mobile in terms of the movement patterns of people within countries and across borders, which brings with it new compound and complex threats such as cholera and measles outbreaks. Third, the nature of the changing disaster profile is placing strain on countries and the region. Sub-national disaster response due to personnel capacity limitations, at the national and municipal levels, is unable to effectively respond to and reduce risks associated with various shocks. In the paper, by providing an inventory of disasters and humanitarian responses in the southern African region, we point to the changing regional and national dimensions of the region’s disaster risk profile that, we suggest, will require a variety of responses.

Background and aims: Subclinical atherosclerosis assessed by sonographic intima-media-thickness measurement of the carotid artery (cIMT) is considered to be an early precursor of cardiovascular disease already in childhood. Structural analysis of the carotid intimal layer (carotid intima-media-roughness, cIMR) improves cardiovascular risk profiling for the adult patient and has been shown to be increased also in paediatric patients with elevated cardiovascular risk. To date, normal values for the paediatric age are lacking. Thus, we present normative data for a paediatric age group. Methods: 602 healthy German school children (age 8-18 y) were studied, and cIMT and cIMR calculated;reference values were given for three age groups (group 1: 8-10.99 years;group 2: 11-13.99 years;group 3: 14-17.99 years). Results: cIMT values were: 0.48 +/- 0.03 mm for girls and boys in age group 1, 0.49 +/- 0.03 mm for girls and boys in age group 2;and 0.45 +/- 0.03 mm for girls and 0.49 +/- 0.03 mm for boys in age group 3;cIMR was 0.04 +/- 0.01 mm for both sexes in age group 1 and 3;while in age group 2, both sexes showed a cIMR of 0.03 +/- 0.01 mm. Physical fitness was significantly negatively correlated with cIMR (r = -0.212, p < 0.0001) and a strong predictor for cIMR increase. Conclusions: The normative data of cIMR for a paediatric age group presented here allow for the identification of patients at elevated cardiovascular risk. By including cIMR as surface analysis of the arterial wall, the individual risk stratification may be improved compared to thickness-analysis of the Intima-Media-Layer (cIMT) also at a paediatric age. (C) 2016 Published by ELSEVIER.

This paper addresses the problem of trust in Modeling and Simulation (M&S) technologies, and uncertainty in applications to homeland security. The key goal of this paper is an extension of the notion of trusted M&S techniques for traveler risk assessment in mass-transit applications such as e-borders. Theories of uncertainty suggest that different understandings of uncertainty result in different mechanisms of its reduction. We show that a taxonomy of uncertainty that is accepted in philosophical studies, as well as the NATO methodology of uncertainty assessment (known as the Admiralty Code), can be useful in M&S. This paper overviews various approaches to M&S and focuses on a framework that is based on multi-source fusion mechanisms using Dempster–Shafer (DS) theory. The DS metric is useful for the development of simulators, recommender machines, and risk profilers when expert knowledge is given in an imprecise form. The difference between the Bayesian and DS metrics is introduced via a demonstrative experiment from the area of traveler risk assessment using a biometric-enabled watchlist.