Search results for: risk mitigation

Authors: Dianis Wulan Sari, Takeo Minematsu, Mikako Yoshida, Hiromi Sanada

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Introduction: Pruritus is diagnosed as itching without macroscopic abnormalities on skin. It is the most skin complaint of elderly people. In the present study, we conducted a dermatological study to examine the risk factors of pruritic skin and predicted how to prevent pruritus especially in the elderly population. Pruritus is caused several types of inflammation, including epidermal innate immunity based on keratinocyte responses and acquired immunity regulated by type 1 or 2 helper T (Th) cells. The triggers of pruritus differ among inflammation types, therefore we did separately assess the pruritus-associated factors of each inflammation type in an effort to contribute to the identification of intervention targets for preventing pruritus. Therefore, this study aimed to investigate the factors related with actual condition of pruritic skin by examine the skin properties. Method: This study was conducted in elderly population of Indonesian nursing home. Basic characteristics and behaviors were obtained by interview. The properties of pruritic skin were collected by examination of skin biomarker using skin blotting as novel method of non-invasive skin assessment method and examination of skin barrier function using stratum corneum hydration and skin pH. Result: The average age of participants was 74 years with independent status was 66.8%. Age (β = -0.130, p = 0.044), cumulative lifetime sun exposure (β = 0.145, p = 0.026), bathing duration (β = 0.151, p = 0.022), clothing change frequency (β = 0.135, p = 0.029), and clothing type (β = -0.139, p = 0.021) were risk factors of pruritic skin in multivariate analysis. Conclusion: Risk factors of pruritic skin in elderly population were caused by internal factors such as skin senescence and external factors such as sun exposure, hygiene care and skin care behavior.

Keywords: aging, hygiene care, pruritus, skin care, sun exposure

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Authors: Mushtaq Ahmad, Bashir Rahman, Taqweem-ul-Haq, Fazal Jalil, Aftab Ali Shah

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Single nucleotide polymorphisms (SNPs) in genes coding for microRNAs (miRNAs) play a pivotal role in the progression of breast cancer (BC). We investigated the association of miR-146a rs2910164 G/C polymorphism with the risk of BC in the Pakistani population. The miR-146a rs2910164 polymorphism was genotyped in 300 BC-cases and 300 age- and gender-matched healthy controls using T-ARMS-PCR. Genotype and allele frequencies were calculated, and the association between genotypes and the risk of BC was calculated by odds ratios (OR) and confidence intervals (95%). A significant difference in genotypic frequencies (χ2=63.10; p ≤ 0.0001) and allelic frequencies (OR=0.3955 (0.3132-0.4993); p ≤ 0.0001) was observed between cases and controls. Furthermore, we also found that miR-146 rs2910164 CC homozygote increased the risk of breast cancer in the dominant (OR=0.2397 (0.1629-0.3526); p=0.0001; GG vs GC+CC) and recessive (OR=2.803 (1.865- 4.213); P ≤ 0.0001; CC vs GC+GG) inheritance models. In summary, miR-146a rs2910164 G/C is significantly associated with BC in the Pakistani population. To our knowledge, this is the first study that assessed MIR146a rs2910164 G > C SNP in Pakistani population. By analyzing the secondary structure of MIR146A variant, a significant structural modification was noted. Study with a larger sample size is needed to further confirm these findings.

Keywords: breast cancer, MIR146A, microRNA, SNP

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Authors: Didier Birimwiragi Namogo

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The Kivu Lake Basin is located in the Western Branch of the East African Rift. In this basin is located a multitude of active faults, on which earthquakes occur regularly. The most recent earthquakes date from 2008, 2015, 2016, 2017 and 2019. The cities of Bukabu and Goma in DR Congo and Giseyi in Rwanda are the most impacted by this intense seismic activity in the region. The magnitude of the strongest earthquakes in the region is 6.1. The 2008 earthquake was particularly destructive, killing several people in DR Congo and Rwanda. This work aims to complete the distribution of seismicity in the region, deduce areas of weakness and establish a hazard map that can assist in seismic risk management. Using the local seismic network of the Goma Volcano Observatory, the earthquakes were relocated, and their focus mechanism was studied. The results show that most of these earthquakes occur on active faults described by Villeneuve in 1938. The alignment of the earthquakes shows a pace that follows directly the directions of the faults described by this author. The study of the focus mechanism of these earthquakes, also shows that these are in particular normal faults whose stresses show an extensive activity. Such study can be used for the establishment of seismic risk management tools.

Keywords: earthquakes, hazard map, faults, focus mechanism

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Authors: Julia Wong, Hua Beng Lim, Petrina Goh, Johanna Foo, Caleb Ng, Nurul ‘Aqilah Bte Mohd Taufek

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Animal-assisted therapy (AAT) utilizes human-animal interaction to achieve specific therapeutic goals, and its efficacy has been demonstrated across various settings overseas. The use of AAT in Singapore, however, is still limited. Ang Mo Kio-Thye Hua Kwan (AMKH) is one of the first community hospitals in Singapore to use AAT to complement its occupational therapy services with elderly patients. This study explored the perspectives of AMKH’s occupational therapists (OTs) in relation to AAT to understand barriers and enablers in implementing and practising AAT. We also examined how OTs at-large across practice settings perceive AAT. A mixed method design was used. 64 OTs at-large participated in on online survey, and 7 AMKH OTs were interviewed individually via Zoom. Survey results were analysed with descriptive and Mann-Whitney U tests. Interviews were thematically analysed. AMKH OTs perceived various benefits of AAT articulated in overseas studies in domains such as motivation and participation, emotional, social interaction, sensory tactile stimulation, and cognition. Interestingly, this perception was also supported by 67% of OTs who had responded to the survey, even though most of the OTs who had participated in the survey had no experience in AAT. Despite the perceived benefits of AAT, both OTs from AMKH and those at-large articulated concerns on risks pertaining to AAT (e.g., allergies, unexpected animal behaviour, infections, etc). However, AMKH OTs shared several ways to mitigate these risks, demonstrating their ability to develop a safe program. For e.g., volunteers and their dogs must meet specific recruitment criteria, stringent protocols are used to screen and match dogs with patients, and there are strict exclusion criteria for patients participating in AAT. AMKH OTs’ experience suggests that additional skills and knowledge are required to implement AAT, therefore, healthcare institutions should first consider improving their staff training and risk mitigation knowledge before implementing AAT. They can also refer to AMKH’s AAT protocols and those found in overseas studies, but institutions must adapt the protocols to fit their institutional settings and patients’ profiles.

Keywords: animal-assisted therapy, dog-assisted therapy, occupational therapy, complementary therapy

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Authors: Leonard Simoni, Ilir Alimehmeti, Ervina Shirka, Endri Hasimi, Ndricim Kallashi, Verona Beka, Suerta Kabili, Artan Goda

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Background: Diabetes Mellitus type 2, small vessel calibre, stented length of vessel, complex lesion morphology, and prior bypass surgery have resulted risk factors for In-Stent Restenosis (ISR). However, there are some contradictory results about body mass index (BMI) as a risk factor for ISR. Purpose: We want to identify clinical, lesional and procedural factors that can predict clinical ISR in our patients. Methods: Were enrolled 759 patients who underwent first-time elective PCI with Bare Metal Stents (BMS) from September 2011 to December 2013 in our Department of Cardiology and followed them for at least 1.5 years with a median of 862 days (2 years and 4 months). Only the patients re-admitted with ischemic heart disease underwent control coronary angiography but no routine angiographic control was performed. Patients were categorized in ISR and non-ISR groups and compared between them. Multivariate analysis - Binary Logistic Regression: Forward Conditional Method was used to identify independent predictive risk factors. P was considered statistically significant when <0.05. Results: ISR compared to non-ISR individuals had a significantly lower BMI (25.7±3.3 vs. 26.9±3.7, p=0.004), higher risk anatomy (LM + 3-vessel CAD) (23% vs. 14%, p=0.03), higher number of stents/person used (2.1±1.1 vs. 1.75±0.96, p=0.004), greater length of stents/person used (39.3±21.6 vs. 33.3±18.5, p=0.01), and a lower use of clopidogrel and ASA (together) (95% vs. 99%, p=0.012). They also had a higher, although not statistically significant, prevalence of Diabetes Mellitus (42% vs. 32%, p=0.072) and a greater number of treated vessels (1.36±0.5 vs. 1.26±0.5, p=0.08). In the multivariate analysis, Diabetes Mellitus type 2 and multiple stents used were independent predictors risk factors for In-Stent Restenosis, OR 1.66 [1.03-2.68], p=0.039, and OR 1.44 [1.16-1.78,] p=0.001, respectively. On the other side higher BMI and use of clopidogrel and ASA together resulted protective factors OR 0.88 [0.81-0.95], p=0.001 and OR 0.2 [0.06-0.72] p=0.013, respectively. Conclusion: Diabetes Mellitus and multiple stents are strong predictive risk factors, whereas the use of clopidogrel and ASA together are protective factors for clinical In-Stent Restenosis. Paradoxically High BMI is a protective factor for In-stent Restenosis, probably related to a larger diameter of vessels and consequently a larger diameter of stents implanted in these patients. Further studies are needed to clarify this finding.

Keywords: body mass index, diabetes mellitus, in-stent restenosis, percutaneous coronary intervention

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Authors: Vaibhav Baliyan, Shweta Mehrotra, S. S. Parihar

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The agricultural productivity is challenged by climate change and depletion in natural resources, including water and land, which significantly affects the crop yield. Wheat is a thermo-sensitive crop and is prone to heat stress. High temperature decreases crop duration, yield attributes, and, subsequently, grain yield and biomass production. Terminal heat stress affects grain filling duration, grain yield, and yield attributes, thus causing a reduction in wheat yield. A field experiment was conducted at Indian Agricultural Research Institute, New Delhi, for two consecutive rabi seasons (2017-18 and 2018-19) on six varieties of wheat (early sown - HD 2967, HD 3086, HD 2894 and late sown - WR 544, HD 3059, HD 3117 ) with three moisture regimes (100%, 80%, and 60% ETc, and no irrigation) and six sowing dates in three replications to investigate the effect of different moisture regimes and sowing dates on growth, yield and water use efficiency of wheat for development of best management practices for mitigation of terminal heat stress. HD3086 and HD3059 gave higher grain yield than others under early sown and late sown conditions, respectively. Maximum soil moisture extraction was recorded from 0-30 cm soil depth across the sowing dates, irrigation regimes, and varieties. Delayed sowing resulted in reducing crop growth period and forced maturity, in turn, led to significant deterioration in all the yield attributing characters and, there by, reduction in yield, suggesting that terminal heat stress had greater impact on yield. Early sowing and irrigation at 80% ETc resulted in improved growth and yield attributes and water use efficiency in both the seasons and helped to some extent in reducing the risk of terminal heat stress of wheat grown on sandy loam soils of semi-arid regions of India.

Keywords: sowing, irrigation, yield, heat stress

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Authors: Maximilian Elsen, Frank Tietze

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The development and diffusion of green technologies are crucial for achieving our ambitious climate targets. The Paris Agreement commits its members to develop strategies for achieving net zero greenhouse gas emissions by the second half of the century. Governments, executives, and academics are working on net-zero strategies and the business of rating organisations on their environmental, social and governance (ESG) performance has grown tremendously in its public interest. ESG data is now commonly integrated into traditional investment analysis and an important factor in investment decisions. Creating these metrics, however, is inherently challenging as environmental and social impacts are hard to measure and uniform requirements on ESG reporting are lacking. ESG metrics are often incomplete and inconsistent as they lack fully accepted reporting standards and are often of qualitative nature. This study explores the use of patent data for assessing the environmental performance of companies by focusing on their patented inventions in the space of climate change mitigation and adaptation technologies (CCMAT). The present study builds on the successful identification of CCMAT patents. In this context, the study adopts the Y02 patent classification, a fully cross-sectional tagging scheme that is fully incorporated in the Cooperative Patent Classification (CPC), to identify Climate Change Adaptation Technologies. The Y02 classification was jointly developed by the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) and provides means to examine technologies in the field of mitigation and adaptation to climate change across relevant technologies. This paper develops sustainability-related metrics for firm-level patent portfolios. We do so by adopting a three-step approach. First, we identify relevant CCMAT patents based on their classification as Y02 CPC patents. Second, we examine the technological strength of the identified CCMAT patents by including more traditional metrics from the field of patent analytics while considering their relevance in the space of CCMAT. Such metrics include, among others, the number of forward citations a patent receives, as well as the backward citations and the size of the focal patent family. Third, we conduct our analysis on a firm level by sector for a sample of companies from different industries and compare the derived sustainability performance metrics with the firms’ environmental and financial performance based on carbon emissions and revenue data. The main outcome of this research is the development of sustainability-related metrics for firm-level environmental performance based on patent data. This research has the potential to complement existing ESG metrics from an innovation perspective by focusing on the environmental performance of companies and putting them into perspective to conventional financial performance metrics. We further provide insights into the environmental performance of companies on a sector level. This study has implications of both academic and practical nature. Academically, it contributes to the research on eco-innovation and the literature on innovation and intellectual property (IP). Practically, the study has implications for policymakers by deriving meaningful insights into the environmental performance from an innovation and IP perspective. Such metrics are further relevant for investors and potentially complement existing ESG data.

Keywords: climate change mitigation, innovation, patent portfolios, sustainability

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Authors: S. Alireza Mirghasemi, Shervin Rashidinia, Mohammad Saleh Sadeghi, Mohsen Talebizadeh, Narges Rahimi Gabaran, Seyed Shahin Eftekhari, Sara Shahmoradi

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Avascular necrosis of femoral head is a pathologic condition that the main cause is decreased blood supply of femoral head. Among predisposing risk factors, chronic use of corticosteroids, alcoholism, smocking and hip traumas have more important role. Also we can mention OCP consumption as a risk factor among less common predisposing factors that lead to AVNF, in this study we introduce another cause of AVNF with a period of treatment with moderate dose of corticosteroids accompanied by OCP as a probable facilitating factor that leads to AVNF.

Keywords: AVN, corticosteroids consumption, femoral head osteonecrosis, OCP

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Authors: Adjebli Ahmed, Messis Abdelaziz, Ayeche Riad, Tighilet Karim, Talbi Melissa, Smaili Yanis, Lehri Mokrane, Louardiane Mustapha

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Colorectal cancer is one of the most common types of cancer worldwide, and its incidence has been increasing in recent years. Data and fecal samples from colorectal cancer patients were collected at the Amizour Public Hospital's oncology department (Bejaia, Algeria). Microbiological and cohort study were conducted at the Biological Engineering of Cancers laboratory at the Faculty of Medicine of the University of Bejaia. All the data showed that patients aged between 50 and 70 years were the most affected by colorectal cancer, while the age categories of [30-40] and [40-50] were the least affected. Males were more likely to be at risk of contracting colorectal cancer than females. The most common types of colorectal cancer among the studied population were sigmoid cancer, rectal cancer, transverse colon cancer, and ascending colon cancer. The hereditary factor was found to be more dominant than other risk factors. Bacterial identification revealed the presence of certain pathogenic and opportunistic bacterial genera, such as E. coli, K. pneumoniae, Shigella sp, and Streptococcus group D. These results led us to conclude that dysbiosis of the intestinal microbiome is strongly present in colorectal cancer patients at the EPH of Amizour.

Keywords: microbiome, colorectal cancer, risk factors, bacterial identification

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Authors: Todor Bačkalić, Marinko Maslarić, Milosav Georgijević, Sanja Bojić

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Water transport could be the backbone of the future European combined transport system. The future transport policy in landlocked countries from the Danube Region has to be based on inland waterway transport (IWT). The development of the container transport on inland waterways depends directly on technical-exploitative characteristics of the network of inland waterways. Research of navigational abilities of inland waterways is the basic step in transport planning. The size of the vessel’s draught (T) is the limiting value in project tasks and it depends on the depth of the waterway. Navigation characteristics of rivers have to be determined as precise as possible, especially from the aspect of determination of the possible draught of vessels. This article outlines a rationale, why it is necessary to develop competence about infrastructure risk in water transport. Climate changes are evident and require special attention and global monitoring. Current risk assessment methods for Inland waterway transport just consider some dramatic events. We present a new method for the assessment of risk and vulnerability of inland waterway transport where river depth represents a crucial part. The analysis of water level changes in the lower Danube was done for two significant periods (1965-1979 and 1998-2012).

Keywords: container vessel, draught, probability, the Danube

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Authors: Nawaf A. Alqahtani, Ali M. Alqahtani, Khalid A. Alqahtani, Huda S. Abdullfattah, Ebtehal A. Alessa, Khalid S. Al Gelban, Ossama A. Mostafa

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Background: The internet is an exciting medium that is becoming an essential part of everyday life. Although the internet is fully observed in Saudi Arabia, young people may be vulnerable to problematic internet use, possibly leading to addiction. Aim of study: To explore the magnitude of internet addiction (IA) among medical students associated risk factors and its impact on students' academic achievement. Subjects and Methods: A cross sectional study was conducted in 2014 on 571 medical students (293 males and 278 females) at the College of Medicine, King Khalid University, Abha, Saudi Arabia. Data Collection was done through using the Arabic version of the Compulsive Internet Use Scale and a checklist of demographic characteristics. Results: Age of participants ranged from 19 to 26 years (Mean+SD: 21.9+1.5 years). Internet access was available to 97.4% of students at home and to 80.2% of students at their mobile phones. The most frequently accessed websites by medical students were the social media (90.7%), scientific website (50.4%) and the news websites (31.3%). IA was mild in 47.8% of medical students while 5.8% had moderate IA. None of the students had severe IA. Prevalence of IA was significantly higher among female medical students (p=0.002), availability of internet at home (p=0.022), and availability of internet at the students' mobile phone (p=0.041). The mean General Point Average (GPA) was highest among students with mild IA (4.0+0.6), compared with 3.6+0.6 among those with moderate addiction, and 3.9+0.6 among those who did not show IA. Differences in mean GPA according to grade of IA were statistically significant ((P=0.001). Conclusions: Prevalence of IA is high among medical students in Saudi Arabia. Risk factors for IA include female gender, availability of internet at home or at the mobile phone. IA has a significant impact on students' GPA. Periodic screening of medical students for IA and raising their awareness toward the possible risk of IA are recommended.

Keywords: internet addiction, medical students, risk factors, Saudi Arabia

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Authors: Harini Chakkera

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Background: Inpatient hyperglycemia is an established independent risk factor among several patient cohorts with hospital readmission. This has not been studied after kidney transplantation. Nearly one-third of patients who have undergone a kidney transplant reportedly experience 30-day readmission. Methods: Data on first-time solitary kidney transplantations were retrieved between September 2015 to December 2018. Information was linked to the electronic health record to determine a diagnosis of diabetes mellitus and extract glucometeric and insulin therapy data. Univariate logistic regression analysis and the XGBoost algorithm were used to predict 30-day readmission. We report the average performance of the models on the testing set on five bootstrapped partitions of the data to ensure statistical significance. Results: The cohort included 1036 patients who received kidney transplantation, and 224 (22%) experienced 30-day readmission. The machine learning algorithm was able to predict 30-day readmission with an average AUC of 77.3% (95% CI 75.30-79.3%). We observed statistically significant differences in the presence of pretransplant diabetes, inpatient-hyperglycemia, inpatient-hypoglycemia, and minimum and maximum glucose values among those with higher 30-day readmission rates. The XGBoost model identified the index admission length of stay, presence of hyper- and hypoglycemia and recipient and donor BMI values as the most predictive risk factors of 30-day readmission. Additionally, significant variations in the therapeutic management of blood glucose by providers were observed. Conclusions: Suboptimal glucose metrics during hospitalization after kidney transplantation is associated with an increased risk for 30-day hospital readmission. Optimizing the hospital blood glucose management, a modifiable factor, after kidney transplantation may reduce the risk of 30-day readmission.

Keywords: kidney, transplant, diabetes, insulin

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Authors: Puntarikorn Rungrattanakasin

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Objectives: To develop the trigger tool to warn about the risk of bleeding as an adverse event from warfarin drug usage during admission in Medical Wards of Chumphae Hospital. Methods: A retrospective study was performed by reviewing the medical records for the patients admitted between June 1st,2020- May 31st, 2021. ADEs were evaluated by Naranjo’s algorithm. The international normalized ratio (INR) and events of bleeding during admissions were collected. Statistical analyses, including Chi-square test and Reciever Operating Characteristic (ROC) curve for optimal INR threshold, were used for the study. Results: Among the 139 admissions, the INR range was found to vary between 0.86-14.91, there was a total of 15 bleeding events, out of which 9 were mild, and 6 were severe. The occurrence of bleeding started whenever the INR was greater than 2.5 and reached the statistical significance (p <0.05), which was in concordance with the ROC curve and yielded 100 % sensitivity and 60% specificity in the detection of a bleeding event. In this regard, the INR greater than 2.5 was considered to be an optimal threshold to alert promptly for bleeding tendency. Conclusions: The INR value of greater than 2.5 (>2.5) would be an appropriate trigger tool to warn of the risk of bleeding for patients taking warfarin in Chumphae Hospital.

Keywords: trigger tool, warfarin, risk of bleeding, medical wards

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Authors: Aisha F. Bushager

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Today we are more exposed than ever to cyber threats and attacks at personal, community, organizational, national, and international levels. More aspects of our lives are operating on computer networks simply because we are living in the fifth domain, which is called the Cyberspace. One of the most sensitive areas that are vulnerable to cyber threats and attacks is the Electronic Banking (e-Banking) area, where the banking sector is providing online banking services to its clients. To be able to obtain the clients trust and encourage them to practice e-Banking, also, to maintain the services provided by the banks and ensure safety, cyber security and risks control should be given a high priority in the e-banking area. The aim of the study is to carry out risk assessment on the e-banking services and determine the cyber threats, cyber attacks, and vulnerabilities that are facing the e-banking area specifically in the Kingdom of Bahrain. To collect relevant data, structured interviews were taken place with e-banking experts in different banks. Then, collected data where used as in input to the risk management framework provided by the National Institute of Standards and Technology (NIST), which was the model used in the study to assess the risks associated with e-banking services. The findings of the study showed that the cyber threats are commonly human errors, technical software or hardware failure, and hackers, on the other hand, the most common attacks facing the e-banking sector were phishing, malware attacks, and denial-of-service. The risks associated with the e-banking services were around the moderate level, however, more controls and countermeasures must be applied to maintain the moderate level of risks. The results of the study will help banks discover their vulnerabilities and maintain their online services, in addition, it will enhance the cyber security and contribute to the management and control of risks that are facing the e-banking sector.

Keywords: cyber security, e-banking, risk assessment, threats identification

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Authors: A. Falenski, A. Kaesbohrer, M. Filter

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Introduction: Risk assessments can be performed in various ways and in different degrees of complexity. In order to assess risks associated with imported foods additional information needs to be taken into account compared to a risk assessment on regional products. The present review is an overview on currently available best practise approaches and data sources used for food import risk assessments (IRAs). Methods: A literature review has been performed. PubMed was searched for articles about food IRAs published in the years 2004 to 2014 (English and German texts only, search string “(English [la] OR German [la]) (2004:2014 [dp]) import [ti] risk”). Titles and abstracts were screened for import risks in the context of IRAs. The finally selected publications were analysed according to a predefined questionnaire extracting the following information: risk assessment guidelines followed, modelling methods used, data and software applied, existence of an analysis of uncertainty and variability. IRAs cited in these publications were also included in the analysis. Results: The PubMed search resulted in 49 publications, 17 of which contained information about import risks and risk assessments. Within these 19 cross references were identified to be of interest for the present study. These included original articles, reviews and guidelines. At least one of the guidelines of the World Organisation for Animal Health (OIE) and the Codex Alimentarius Commission were referenced in any of the IRAs, either for import of animals or for imports concerning foods, respectively. Interestingly, also a combination of both was used to assess the risk associated with the import of live animals serving as the source of food. Methods ranged from full quantitative IRAs using probabilistic models and dose-response models to qualitative IRA in which decision trees or severity tables were set up using parameter estimations based on expert opinions. Calculations were done using @Risk, R or Excel. Most heterogeneous was the type of data used, ranging from general information on imported goods (food, live animals) to pathogen prevalence in the country of origin. These data were either publicly available in databases or lists (e.g., OIE WAHID and Handystatus II, FAOSTAT, Eurostat, TRACES), accessible on a national level (e.g., herd information) or only open to a small group of people (flight passenger import data at national airport customs office). In the IRAs, an uncertainty analysis has been mentioned in some cases, but calculations have been performed only in a few cases. Conclusion: The current state-of-the-art in the assessment of risks of imported foods is characterized by a great heterogeneity in relation to general methodology and data used. Often information is gathered on a case-by-case basis and reformatted by hand in order to perform the IRA. This analysis therefore illustrates the need for a flexible, modular framework supporting the connection of existing data sources with data analysis and modelling tools. Such an infrastructure could pave the way to IRA workflows applicable ad-hoc, e.g. in case of a crisis situation.

Keywords: import risk assessment, review, tools, food import

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Authors: Siqing Guan, Fumiyo Oshima, Eiji Shimizu, Nozomi Tomita, Toru Takahashi, Hiroaki Kumano

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Risk factors for social anxiety in autism spectrum conditions involve executive attention, emotion regulation, and thought regulation as processes of cognitive dysregulation. Social camouflaging behaviors as strategies used to mask and/or compensate for autism characteristics during social interactions in autism spectrum conditions have also been emphasized. However, the role of cognitive dysregulation and social camouflaging related to social anxiety in autism spectrum conditions has not been clarified. Whether these factors are specific to social anxiety in autism spectrum conditions or common to social anxiety independent of autism spectrum conditions needs to be clarified. Here, we explored risk factors specific to social anxiety in autism spectrum conditions and general risk factors for social anxiety independent of autism spectrum conditions. From the Japanese participants in early adulthood (age=18~39) of the online survey in Japan, those who exceeded the Japanese version Autism-Spectrum Quotient cutoff (33 points or more )were divided into the autism spectrum conditions group (ASC; N=255, mean age=32.08, SD age=5.16)and those who did not exceed the cutoff were divided into the non-autism spectrum conditions group (Non-ASC; N=255, mean age=31.70, SD age=5.09). Using the Japanese versions of the Social Phobia Scale, the Social Interaction Anxiety Scale, and the Short Fear of Negative Evaluation Scale, a composite score for social anxiety was calculated using a method of principal. We also measured emotional control difficulties using the Difficulties in Emotion Regulation Scale, executive attention using the Effortful Control Scale for Adults, rumination using the Rumination-Reflection Questionnaire, and worry using the Penn State Worry Questionnaire. This study was passed through the review of the Ethics Committee. No conflicts of interest. Multiple regression analysis with forced entry method was used to predict social anxiety in the ASC and non-ASC groups separately, based on executive attention, emotion dysregulation, worry, rumination, and social camouflage. In the ASC group, emotion dysregulation (β=.277, p<.001), worry (β=.162, p<.05), assimilation (β=.308, p<.001) and masking (β=.275, p<.001) were significant predictors of social anxiety (F (7,247) = 45.791, p <.001, R2=.565). In the non-ASC groups,emotion dysregulation (β=.171, p<.05), worry (β=.344，p <.001), assimilation (β=.366,p <.001) and executive attention (β=-.132,p <.05) were significant predictors of social anxiety (F (7,207) =47.333, p <.001, R2=.615).The findings suggest that masking was shown to be a risk factor for social anxiety specific to autism spectrum conditions, while emotion dysregulation, worry, and assimilation were shown to be common risk factors for social anxiety, regardless of autism spectrum conditions. In addition, executive attention is a risk factor for social anxiety without autism spectrum conditions.

Keywords: autism spectrum, cognitive control, social anxiety, social camouflaging

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Authors: Ilse Kreme

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To the best of this author’s knowledge, no studies have been identified on the connection between a refusal to engage in health-protective behaviors and a basic understanding of viral biology among community college students, faculty, and staff during the COVID-19 pandemic. Lack of scientific knowledge could prevent understanding of why these behaviors are important to prevent the community spread of COVID-19, even when they are not shown to offer much individual protection. In this study, a possible correlation was examined between a basic knowledge level of viral disease that comes from having taken a college biology course and disease perceptions of COVID-19. In particular, disease risk perception, disease severity percept and mask-wearing behaviors were examined as they correlated with having taken an undergraduate biology course. The effect of covariates of age, gender, and education level were investigated along with the main dependent variables. A representative sample of the population included students, faculty, and staff at Paradise Valley Community College (PVCC) in Phoenix, Arizona. Participants were recruited by an email sent to all students, faculty, and staff at PVCC using an all-college email distribution. Disease risk and severity perception were assessed with the Brief Illness Perception Questionnaire 5 (BIP-Q5), which was modified to include questions measuring participant age, education level, and whether they took or ever took a college biology course. Two additional questions measured compliance of willingness to wear a face mask. The results showed an effect of gender on mask-wearing behavior and a correlation between having taken a biology course and disease severity perception. No differences were seen in mask-wearing behavior and disease risk perception as a result of having taken a biology course. These findings suggest that taking an undergraduate biology course leads to a greater awareness of COVID-19 disease severity through an understanding of the basic biological principles of viral disease transmission. The results can be used to modify existing health education strategies. Further research is needed on how to best reach target audiences in all education brackets.

Keywords: COVID-19, education, gender, mask wearing, disease risk perception, disease severity perception

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Authors: Jeongwoo Lee

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Children are the most vulnerable travelers and they are at risk for pedestrian injury. Creating a safe route to school is important because walking to school is one of the main opportunities for promotion of needed physical exercise among children. This study examined how the built environmental attributes near an elementary school influence traffic accidents among school-aged children. The study used two complementary data sources including the locations of police-reported pedestrian crashes and the built environmental characteristics of school areas. The environmental attributes of road segments were collected through GIS measurements of local data and actual site audits using the inventory developed for measuring pedestrian-crash risk scores. The inventory data collected at 840 road segments near 32 elementary schools in the city of Ulsan. We observed all segments in a 300-meter-radius area from the entrance of an elementary school. Segments are street block faces. The inventory included 50 items, organized into four domains: accessibility (17items), pleasurability (11items), perceived safety from traffic (9items), and traffic and land-use measures (13items). Elementary schools were categorized into two groups based on the distribution of the pedestrian-crash hazard index scores. A high pedestrian-crash zone was defined as an school area within the eighth, ninth, and tenth deciles, while no pedestrian-crash zone was defined as a school zone with no pedestrian-crash accident among school-aged children between 2013 and 2016. No- and high pedestrian-crash zones were compared to determine whether different settings of the built environment near the school lead to a different rate of pedestrian-crash incidents. The results showed that a crash risk can be influenced by several environmental factors such as a shape of school-route, number of intersections, visibility and land-use in a street, and a type of sidewalk. The findings inform policy for creating safe routes to school to reduce the pedestrian-crash risk among children by focusing on school zones.

Keywords: active school travel, school zone, pedestrian crash, safety route to school

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Authors: S. Albert, R. Cossu, A. Grinham, C. Heatherington, C. Wilson

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Shipping trends suggest increasing vessel size and draught visiting Australian ports highlighting potential challenges to port infrastructure and requiring optimization of shipping channels to ensure safe passage for vessels. The Port of Brisbane in Queensland, Australia has an 80 km long access shipping channel which vessels must transit 15 km of relatively shallow coffee rock (generic class of indurated sands where sand grains are bound within an organic clay matrix) outcrops towards the northern passage in Moreton Bay. This represents a risk to shipping channel deepening and maintenance programs as the dredgeability of this material is more challenging due to its high cohesive strength compared with the surrounding marine sands and potential higher acid sulfate risk. In situ assessment of acid sulfate sediment for dredge spoil control is an important tool in mitigating ecological harm. The coffee rock in an anoxic undisturbed state does not pose any acid sulfate risk, however when disturbed via dredging it’s vital to ensure that any present iron sulfides are either insignificant or neutralized. To better understand the potential risk we examined the reduction potential of coffee rock across the entire dredge cycle in order to accurately portray the true outcome of disturbed acid sulfate sediment in dredging operations in Moreton Bay. In December 2014 a dredge trial was undertaken with a trailing suction hopper dredger. In situ samples were collected prior to dredging revealed acid sulfate potential above threshold guidelines which could lead to expensive dredge spoil management. However, potential acid sulfate risk was then monitored in the hopper and subsequent discharge, both showing a significant reduction in acid sulfate potential had occurred. Additionally, the acid neutralizing capacity significantly increased due to the inclusion of shell fragments (calcium carbonate) from the dredge target areas. This clearly demonstrates the importance of assessing potential acid sulfate risk across the entire dredging cycle and highlights the need to carefully evaluate sources of acidity.

Keywords: acid sulfate, coffee rock, indurated sand, dredging, maintenance dredging

Procedia PDF Downloads 346

Authors: Jiemiao Chen, Shuoxun Xu

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The main goal of our research is to apply the Vine copula measuring dependency between price, temperature, and precipitation indices to calculate a fair crop insurance premium. This research is focused on Worth, Iowa, United States, over the period from 2000 to 2020, where the farmers are dependent on precipitation and average temperature during the growth period of corn. Our proposed insurance considers both the natural risk and the price risk in agricultural production. We first estimate the distributions of crops using parametric methods based on Goodness of Fit tests, and then Vine Copula is applied to model dependence between yield price, crop yield, and weather indices. Once the vine structure and its parameters are determined based on AIC/BIC criteria and forecasting price and yield are obtained from the ARIMA model, we calculate this crop insurance premium using the simulation data generated from the vine copula by the Monte Carlo Simulation method. It is shown that, compared with traditional crop insurance, our proposed insurance is more fair and thus less costly for the farmers and government.

Keywords: vine copula, weather index, crop insurance premium, insurance risk management, Monte Carlo simulation

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Authors: Mark De Ste Croix, Jonathan Hughes, Francisco Ayala, Michal Lehnert

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There are well-known challenges to implementing injury prevention training for youth players but no data are available on the knowledge and understanding of deliverers of such programmes at grass root level. To increase adoption and adherence to such programmes coach knowledge and understanding of injury risk and prevention is essential. Therefore, the purpose of this study was to examine grass-root coaches knowledge and understanding of injury risk and prevention in youth players. 68 grass root coaches (18 females and 50 males) who were attending a one-day injury prevention workshop completed a modified validated questionnaire exploring knowledge and understanding of injury risk and prevention in youth players. Only 59% of coaches agreed that youth players are at a high risk of suffering an injury. There were high levels of agreement that injuries can have negative impacts on team performance (75%) and can cause physical problems in later life (85%), however only around half of coaches felt that injuries affect youth players current quality of life (59%). There was strong agreement that it is possible to prevent injuries in youth players (84%), but coaches were generally unaware of programs to help prevent injuries (84%), and only 9% used some form of injury prevention program. Despite this, nearly all coaches felt that their coaching could benefit from a greater understanding of growth and maturation (91%), injury prevention programmes (91%) and specific exercises (93%) for youth athletes. 17% of coaches rated their knowledge of injury prevention as good/very good at the start of the workshop and this increased to 94% at the end of the workshop. 62% of coaches identified their attitude towards injury prevention as indifferent at the start of the workshop compared with only 1% at the end. Only 14% of coaches at the start of the workshop were confident to deliver an injury prevention session but 83% stated they were confident by the end of the workshop. Finally, 98% of coaches felt that the workshop provided them with the confidence and the knowledge to deliver an injury prevention session and 98% suggested that they would implement injury prevention into their coaching. These data suggest that there is a lack of understanding of grass root coaches that children are a high-risk group for injuries, and that such injuries impact on current quality of life. Despite understanding that injuries can be prevented most grass root coaches do not have the knowledge to implement injury prevention into their coaching and very few do. There is a common consensus amongst these coaches that a greater understanding of such programmes will enhance their coaching. The injury prevention workshop appears to have increased the knowledge and changed the attitude of coaches towards injury prevention. All coaches felt that the workshop provided them with the tools to adopt, implement and deliver injury prevention in their coaching. These data highlight that there is a clear need for education regarding injury risk and prevention to be embedded within the coach education pathway, especially at grass root level.

Keywords: coach education, injury prevention, knowledge, and understanding, youth

Procedia PDF Downloads 152

Authors: Maria Trimintziou, Michael Sakellariou, Prodromos Psarropoulos

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Nowadays, the exploitation of hydrocarbons reserves in deep seas and oceans, in combination with the need to transport hydrocarbons among countries, has made the design, construction and operation of offshore pipelines very significant. Under this perspective, it is evident that many more offshore pipelines are expected to be constructed in the near future. Since offshore pipelines are usually crossing extended areas, they may face a variety of geohazards that impose substantial permanent ground deformations (PGDs) to the pipeline and potentially threaten its integrity. In case of a geohazard area, there exist three options to proceed. The first option is to avoid the problematic area through rerouting, which is usually regarded as an unfavorable solution due to its high cost. The second is to apply (if possible) mitigation/protection measures in order to eliminate the geohazard itself. Finally, the last appealing option is to allow the pipeline crossing through the geohazard area, provided that the pipeline will have been verified against the expected PGDs. In areas with moderate or high seismicity the design of an offshore pipeline is more demanding due to the earthquake-related geohazards, such as landslides, soil liquefaction phenomena, and active faults. It is worthy to mention that although worldwide there is a great experience in offshore geotechnics and pipeline design, the experience in seismic design of offshore pipelines is rather limited due to the fact that most of the pipelines have been constructed in non-seismic regions (e.g. North Sea, West Australia, Gulf of Mexico, etc.). The current study focuses on the seismic design of offshore pipelines against active faults. After an extensive literature review of the provisions of the seismic norms worldwide and of the available analytical methods, the study simulates numerically (through finite-element modeling and strain-based criteria) the distress of offshore pipelines subjected to PGDs induced by active seismic faults at the seabed. Factors, such as the geometrical properties of the fault, the mechanical properties of the ruptured soil formations, and the pipeline characteristics, are examined. After some interesting conclusions regarding the seismic vulnerability of offshore pipelines, potential cost-effective mitigation measures are proposed taking into account constructability issues.

Keywords: offhore pipelines, seismic design, active faults, permanent ground deformations (PGDs)

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Authors: Euan Donley

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Emergency Departments (EDs) are heavily burdened as presentation rates continue to rise. To improve patient flow National Emergency Access Targets (NEAT) were introduced. NEAT implements timelines for ED presentations, such as discharging patients within four hours of arrival. Mental health patients use EDs more than the general population and are generally more complex in their presentations. The aim of this study is to examine the impact of NEAT on psychiatric risk assessment of mental health patients in the ED. Seventy-eight mental health clinicians from 7 Victoria, Australia, hospital EDs participated in a mixed method analysis via anonymous online survey. NEAT was considered helpful as mental health patients were seen quicker, were less likely to abscond, could improve teamwork amongst ED staff, and in some cases administrative processes were better streamlined. However, clinicians felt that NEAT was also responsible for less time with patients and relatives’, resulted in rushed assessments, placed undue pressure on mental health clinicians, was not conducive to training, and the emphasis on time was the wrong focus for patient treatment. The profile of a patient typically likely to be treated within NEAT timelines showed a perfect storm of luck and compliance. If a patient was sober, medically stable, referred early, did not require much collateral information and did not have distressed relatives, NEAT was more likely to be met. Organisationally participants reported no organisational change or training to meet NEAT. Poor mental health staffing, multiple ED presentations and a shortage of mental health beds also hamper meeting NEAT. Findings suggest participants were supportive of NEAT in principle, but a demanding workload and organisational barriers meant NEAT had an overall negative effect on psychiatric risk assessment of mental health patients in ED.

Keywords: assessment, emergency, risk, psychiatric

Procedia PDF Downloads 502

Authors: Armel Zacharie Ekoa Bessa, Annick Kwewouo Janpou

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Sediments collected along the beaches of the Atlantic Ocean in Africa were analyzed by geochemical proxies such as the ICP-MS technique to determine their heavy metal contamination and related ecological risks. Several metals were selected and show a decreasing trend: Fe > Mn > Ni > Cu > Co > Zn > Cr > Cd. Several pollution indices have been calculated, including the enrichment factor (EF), whose values are generally higher than 1. 5; the geo-accumulation index (I-geo), with values of some elements (Co, Ni and Cu) in the sediments of the study area being higher than 0, and other metals (Zn, Cr, Fe and Mn) being lower than 0; the contamination factor (CF), where the values of all the selected elements are between 1 and 3; and the pollution load index (PLI), where the values in almost all the study sites are higher than 1. These results show moderate contamination of the investigated sediments with heavy metals. The potential ecological risk assessment (Eri and RI) suggests that this part of the African coast is a low to a slight risk area. Statistical analyses indicate that heavy metals have shown fairly similar trends with anthropogenic and natural sources. This study shows that this coastal area is not highly concentrated in heavy metals and reveals that the Atlantic coast of Africa would be moderately polluted by the metals studied, with a low to moderate ecological risk.

Keywords: heavy metals, pollution, atlantic ocean, sediments

Procedia PDF Downloads 59

Authors: Terri Cole, Fay Sweeting

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Abuse of position for sexual gain by police is defined as behavior involving individuals taking advantage of their role to pursue a sexual or improper relationship. Previous research has considered whether it involves ‘bad apples’ - individuals with poor moral ethos or ‘bad barrels’ – broader organizational flaws which may unconsciously allow, minimize, or do not effectively deal with such behavior. Low level sexual misconduct (e.g., consensual sex on duty) is more common than more serious offences (e.g., rape), yet the impact of such behavior can have severe implications not only for those involved but can also negatively undermine public confidence in the police. This ongoing, collaborative research project has identified variables from 514 historic case files from 35 UK police forces in order to identify potential risk indicators which may lead to such behavior. Quantitative analysis using logistic regression and the Cox proportion hazard model has resulted in the identification of specific risk factors of significance in prediction. Factors relating to both perpetrator background such as a history of intimate partner violence, debt, and substance misuse coupled with in work behavior such as misusing police systems increase the risk. Findings are able to provide pragmatic recommendations for those tasked with identifying potential or investigating suspected perpetrators of misconduct.

Keywords: abuse of position, forensic psychology, misconduct, sexual abuse

Procedia PDF Downloads 178

Authors: Claude Nsobya, Alice Moncaster, Karen Potter, Jed Ramsay

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The shift in Flood Risk Governance (FRG) has moved away from traditional approaches that solely relied on centralized decision-making and structural flood defenses. Instead, there is now the adoption of integrated flood risk management measures that involve various actors and stakeholders. This new approach emphasizes people-centered approaches, including adaptation and learning. This shift to a diversity of FRG approaches has been identified as a significant factor in enhancing resilience. Resilience here refers to a community's ability to withstand, absorb, recover, adapt, and potentially transform in the face of flood events. It is argued that if the FRG merely focused on the conventional 'fighting the water' - flood defense - communities would not be resilient. The move to these people-centered approaches also implies that communities will be more involved in FRG. It is suggested that effective flood risk governance influences resilience through meaningful community involvement, and effective community engagement is vital in shaping community resilience to floods. Successful community participation not only uses context-specific indigenous knowledge but also develops a sense of ownership and responsibility. Through capacity development initiatives, it can also raise awareness and all these help in building resilience. Recent Flood Risk Management (FRM) projects have thus had increasing community involvement, with varied conceptualizations of such community engagement in the academic literature on FRM. In the context of overland floods, there has been a substantial body of literature on Flood Risk Governance and Management. Yet, groundwater flooding has gotten little attention despite its unique qualities, such as its persistence for weeks or months, slow onset, and near-invisibility. There has been a little study in this area on how successful community involvement in Flood Risk Governance may improve community resilience to groundwater flooding in particular. This paper focuses on a case study of a flood risk management project in the United Kingdom. Buckinghamshire Council is leading Project Groundwater, which is one of 25 significant initiatives sponsored by England's Department for Environment, Food and Rural Affairs (DEFRA) Flood and Coastal Resilience Innovation Programme. DEFRA awarded Buckinghamshire Council and other councils 150 million to collaborate with communities and implement innovative methods to increase resilience to groundwater flooding. Based on a literature review, this paper proposes a new paradigm for effective community engagement in Flood Risk Governance (FRG). This study contends that effective community participation can have an impact on various resilience capacities identified in the literature, including social capital, institutional capital, physical capital, natural capital, human capital, and economic capital. In the case of social capital, for example, successful community engagement can influence social capital through the process of social learning as well as through developing social networks and trust values, which are vital in influencing communities' capacity to resist, absorb, recover, and adapt. The study examines community engagement in Project Groundwater using surveys with local communities and documentary analysis to test this notion. The outcomes of the study will inform community involvement activities in Project Groundwater and may shape DEFRA policies and guidelines for community engagement in FRM.

Keywords: flood risk governance, community, resilience, groundwater flooding

Procedia PDF Downloads 51

Authors: Pratima Pokharel

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When sewer overflow due to rainfall in urban areas, this leads to public health risks when an individual is exposed to that contaminated floodwater. Nevertheless, it is still unclear the extent to which the infections pose a risk to public health. This study analyzed reported diarrheal cases by month and age in Bangkok, Thailand. The results showed that the cases are reported higher in the wet season than in the dry season. It was also found that in Bangkok, the probability of infection with diarrheal diseases in the wet season is higher for the age group between 15 to 44. However, the probability of infection is highest for kids under 5 years, but they are not influenced by wet weather. Further, this study introduced a vulnerability that leads to health risks from urban flooding. This study has found some vulnerability variables that contribute to health risks from flooding. Thus, for vulnerability analysis, the study has chosen two variables, economic status, and age, that contribute to health risk. Assuming that the people's economic status depends on the types of houses they are living in, the study shows the spatial distribution of economic status in the vulnerability maps. The vulnerability map result shows that people living in Sukhumvit have low vulnerability to health risks with respect to the types of houses they are living in. In addition, from age the probability of infection of diarrhea was analyzed. Moreover, a field survey was carried out to validate the vulnerability of people. It showed that health vulnerability depends on economic status, income level, and education. The result depicts that people with low income and poor living conditions are more vulnerable to health risks. Further, the study also carried out 1D Hydrodynamic Advection-Dispersion modelling with 2-year rainfall events to simulate the dispersion of fecal coliform concentration in the drainage network as well as 1D/2D Hydrodynamic model to simulate the overland flow. The 1D result represents higher concentrations for dry weather flows and a large dilution of concentration on the commencement of a rainfall event, resulting in a drop of the concentration due to runoff generated after rainfall, whereas the model produced flood depth, flood duration, and fecal coliform concentration maps, which were transferred to ArcGIS to produce hazard and risk maps. In addition, the study also simulates the 5-year and 10-year rainfall simulations to show the variation in health hazards and risks. It was found that even though the hazard coverage is very high with a 10-year rainfall events among three rainfall events, the risk was observed to be the same with a 5-year and 10-year rainfall events.

Keywords: urban flooding, risk, hazard, vulnerability, health risk, framework

Procedia PDF Downloads 51

Authors: Abdullah Almilaibary, Jeremy Jolley, Mark Hayter

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Background: Despite recent progress in enhancing the accessibility of HIV-related health services worldwide, opportunities to diagnose patients are often missed due to genuine barriers at different levels. The aim of the study is to explore the factors that affect the utilization of HIV testing services by young people aged 17-25 in Saudi Arabia. Methods: A non-experimental descriptive cross-sectional design was used to predict factors that influenced HIV testing among Umm- Al Qura University students aged 17-25 years. A newly developed self-completed online questionnaire was used and the study sample was drawn using a convenience sampling technique. The questionnaire consisted of 52 items divided into three scales: 12 items for HIV/AIDS-related knowledge, 3 items for risk perception, and 37 items for attitudes toward HIV testing. Five experts in the field of HIV/AIDS validated the contents of the questionnaire and agreed that the items included were related to the construct being measured. The reliability of the questionnaire was also assessed using a test/re-test strategy with 27 participants recruited from the population under study. The reliability assessment revealed that the questionnaire was consistent as Cronbach’s Alpha was 0.80 for HIV/ADS knowledge, 0.88 for risk perception and 0.78 for attitudes towards HIV testing. The data were collected between 14th of July and 14th of October 2014. Results: 394 participants completed the questionnaires: 116 (29.4%) male and 278 (70%) female. 50.5% of the participants were aged 20 to 22 years, 34.8% were 17-19 years and 14.7% were aged between 23-25 years; about 93% of the participants were single. Only 20 (6%) participants had previously been tested for HIV. The main reasons for not being tested for HIV were: exposure to HIV was considered unlikely (48%), HIV test was not offered (36%) and unawareness of HIV testing centres (16%). On HIV/AIDS-related knowledge, the male participants scored higher than the females as the mean score for males was (M = 6.4, SD = 2.4) while for females it was (M 5.7, SD 2.5). In terms of risk perception, female participants appeared to have lower levels of risk perception than male participants, with the mean score for males being (M 11.7, SD 2.5) and (M 10.5, SD 2.4) for females. The female participants showed slightly more positive attitudes towards HIV testing than male participants: the mean score for males was (M = 108.14, SD = 17.9) and was (M = 111.32, SD = 17.3) for females. Conclusions: The data reveal that misconceptions about HIV/AIDS in Saudi Arabia are still a challenge. Although the attitudes towards HIV testing were reasonably positive, the utilization of the HIV test was low. Thus, tailoring HIV/AIDS preventive strategies in Saudi Arabia should focus on the needs of young people and other high risk groups in the country.

Keywords: attitude toward hiv testing, hiv testing, hiv/aids related knowledge, risk perception

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Authors: Amy Halseth, Kevin Shan, Kye Gilder, John Buse

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The study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥ 2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focus on weight change. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age 61 yrs, mean BMI 37.3 kg/m2; 85.2% had type 2 diabetes, 32.1% had CV disease, 17.4% had both. At 52 wks, ITT-LOCF analysis showed greater least squares mean percent change in weight (LSM%ΔBW) with NB (-3.1%; 95% CI -4.8, -1.4) vs PBO (-0.3%; 95% CI -1.9, 1.4). Both groups demonstrated greater weight loss while on-treatment (NB [-7.3%], PBO [-3.9%]). Odds ratios of 5% and 10% weight loss were 3.3 and 4.1 (ITT-LOCF), respectively, in NB over PBO. At 104 wks, on-treatment LSM%ΔBW was -6.3% with NB (n=1137) vs -3.5% with PBO (n=741). Major reasons for NB withdrawal were adverse events (AE, 29%) and patient decision (21%), with GI disorders being the most common. Weight loss with NB in this study, in an older population predominantly with diabetes and elevated CV risk, was somewhat lower than that observed in overweight/obese participants without diabetes and similar to participants with diabetes in Phase 3 studies.

Keywords: contrave, mysimba, obesity, pharmacotherapy, weight loss

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Authors: Ping Jiang, Yunyan Xing, Dian Zhang, Bo Guo

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The reliability qualification test (RQT) is widely used in product development to qualify whether the product meets predetermined reliability requirements, which are mainly described in terms of reliability indices, for example, MTBF (Mean Time Between Failures). It is widely exercised in product development. In engineering practices, RQT plans are mandatorily referred to standards, such as MIL-STD-781 or GJB899A-2009. But these conventional RQT plans in standards are not preferred, as the test plans often require long test times or have high risks for both producer and consumer due to the fact that the methods in the standards only use the test data of the product itself. And the standards usually assume that the product is exponentially distributed, which is not suitable for a complex product other than electronics. So it is desirable to develop an RQT plan derivation method that safely shortens test time while keeping the two risks under control. To meet this end, for the product whose lifetime follows Weibull distribution, an RQT plan derivation method is developed. The merit of the method is that expert judgment is taken into account. This is implemented by applying the Bayesian method, which translates the expert judgment into prior information on product reliability. Then producer’s risk and the consumer’s risk are calculated accordingly. The procedures to derive RQT plans are also proposed in this paper. As extra information and expert judgment are added to the derivation, the derived test plans have the potential to shorten the required test time and have satisfactory low risks for both producer and consumer, compared with conventional test plans. A case study is provided to prove that when using expert judgment in deriving product test plans, the proposed method is capable of finding ideal test plans that not only reduce the two risks but also shorten the required test time as well.

Keywords: expert judgment, reliability qualification test, test plan derivation, producer’s risk, consumer’s risk

Procedia PDF Downloads 116