Search results for: clinical advice services
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 7548

Search results for: clinical advice services

6108 Multicenter Evaluation of the ACCESS HBsAg and ACCESS HBsAg Confirmatory Assays on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis B Surface Antigen

Authors: Vanessa Roulet, Marc Turini, Juliane Hey, Stéphanie Bord-Romeu, Emilie Bonzom, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Vanessa Viotti, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. has recently developed fully automated assays for the detection of HBsAg on a new immunoassay platform. The objective of this European multicenter study was to evaluate the performance of the ACCESS HBsAg and ACCESS HBsAg Confirmatory assays† on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer. Methods: The clinical specificity of the ACCESS HBsAg and HBsAg Confirmatory assays was determined using HBsAg-negative samples from blood donors and hospitalized patients. The clinical sensitivity was determined using presumed HBsAg-positive samples. Sample HBsAg status was determined using a CE-marked HBsAg assay (Abbott ARCHITECT HBsAg Qualitative II, Roche Elecsys HBsAg II, or Abbott PRISM HBsAg assay) and a CE-marked HBsAg confirmatory assay (Abbott ARCHITECT HBsAg Qualitative II Confirmatory or Abbott PRISM HBsAg Confirmatory assay) according to manufacturer package inserts and pre-determined testing algorithms. False initial reactive rate was determined on fresh hospitalized patient samples. The sensitivity for the early detection of HBV infection was assessed internally on thirty (30) seroconversion panels. Results: Clinical specificity was 99.95% (95% CI, 99.86 – 99.99%) on 6047 blood donors and 99.71% (95%CI, 99.15 – 99.94%) on 1023 hospitalized patient samples. A total of six (6) samples were found false positive with the ACCESS HBsAg assay. None were confirmed for the presence of HBsAg with the ACCESS HBsAg Confirmatory assay. Clinical sensitivity on 455 HBsAg-positive samples was 100.00% (95% CI, 99.19 – 100.00%) for the ACCESS HBsAg assay alone and for the ACCESS HBsAg Confirmatory assay. The false initial reactive rate on 821 fresh hospitalized patient samples was 0.24% (95% CI, 0.03 – 0.87%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS HBsAg assay had equivalent sensitivity performances compared to the Abbott ARCHITECT HBsAg Qualitative II assay with an average bleed difference since first reactive bleed of 0.13. All bleeds found reactive in ACCESS HBsAg assay were confirmed in ACCESS HBsAg Confirmatory assay. Conclusion: The newly developed ACCESS HBsAg and ACCESS HBsAg Confirmatory assays from Beckman Coulter have demonstrated high clinical sensitivity and specificity, equivalent to currently marketed HBsAg assays, as well as a low false initial reactive rate. †Pending achievement of CE compliance; not yet available for in vitro diagnostic use. 2023-11317 Beckman Coulter and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

Keywords: dxi 9000 access immunoassay analyzer, hbsag, hbv, hepatitis b surface antigen, hepatitis b virus, immunoassay

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6107 Perception and Attitudes of Medical Students towards Dermatology as a Future Specialty.

Authors: Rakan Alajmi, Rahaf Alnazzawi, Yara Aljefri, Abdullah Alafif, Ali Alraddadi, Awadh Alamri

Abstract:

Background: The distribution of physicians in different specialties across Saudi Arabia is determined by the career choices of medical students. Dermatology residency program is one of the highly competitive programs here in Saudi Arabia. Assessing and understanding the factors perceived to be attractive in choosing dermatology will aid the directors of the specialty programs to plan for a more balanced workforce distribution to better suit the needs of the specialties. Aim: The aim of our study is to determine and assess the factors perceived to be significantly attractive when choosing dermatology as a future specialty. Methods: The study is a cross-sectional study conducted in King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. A validated questionnaire was sent electronically to clinical year medical students. In addition to the questionnaire, gender, grade point average, preferred specialty, and other socio-demographic data were assessed. Results: A total of 121 clinical years medical students completed the questionnaire, 8 (6.6%) preferred dermatology as a specialty. 76 (62.8%) of the participants score a grade point average of more than 4.5 and 83 students (68.6%) chose their specialty during clinical years. The appeal of being a dermatologist (P= 0.047), the portrayal of different specialities in the media (P= 0.005), and the likelihood that dermatologists can influence patients’ lives (P=0.010) were shown to be significantly attractive factors. Conclusion: There are many factors that are affecting students’ choices when choosing a medical specialty. The appeal of being a dermatologist, the portrayal of different specialities in the media, and the likelihood that dermatologists can influence patients’ lives were shown to be significantly attractive factors when choosing dermatology as a future specialty. Recognizing medical students’ specialty perception will lead them to a proper specialty tailored to their needs.

Keywords: dermatology, career choice, medical specialties, student's perception

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6106 Correlation of Clinical and Sonographic Findings with Cytohistology for Diagnosis of Ovarian Tumours

Authors: Meenakshi Barsaul Chauhan, Aastha Chauhan, Shilpa Hurmade, Rajeev Sen, Jyotsna Sen, Monika Dalal

Abstract:

Introduction: Ovarian masses are common forms of neoplasm in women and represent 2/3rd of gynaecological malignancies. A pre-operative suggestion of malignancy can guide the gynecologist to refer women with suspected pelvic mass to a gynecological oncologist for appropriate therapy and optimized treatment, which can improve survival. In the younger age group preoperative differentiation into benign or malignant pathology can decide for conservative or radical surgery. Imaging modalities have a definite role in establishing the diagnosis. By using International Ovarian Tumor Analysis (IOTA) classification with sonography, costly radiological methods like Magnetic Resonance Imaging (MRI) / computed tomography (CT) scan can be reduced, especially in developing countries like India. Thus, this study is being undertaken to evaluate the role of clinical methods and sonography for diagnosis of the nature of the ovarian tumor. Material And Methods: This prospective observational study was conducted on 40 patients presenting with ovarian masses, in the Department of Obstetrics and Gynaecology, at a tertiary care center in northern India. Functional cysts were excluded. Ultrasonography and color Doppler were performed on all the cases.IOTA rules were applied, which take into account locularity, size, presence of solid components, acoustic shadow, dopper flow etc . Magnetic Resonance Imaging (MRI) / computed tomography (CT) scans abdomen and pelvis were done in cases where sonography was inconclusive. In inoperable cases, Fine needle aspiration cytology (FNAC) was done. The histopathology report after surgery and cytology report after FNAC was correlated statistically with the pre-operative diagnosis made clinically and sonographically using IOTA rules. Statistical Analysis: Descriptive measures were analyzed by using mean and standard deviation and the Student t-test was applied and the proportion was analyzed by applying the chi-square test. Inferential measures were analyzed by sensitivity, specificity, negative predictive value, and positive predictive value. Results: Provisional diagnosis of the benign tumor was made in 16(42.5%) and of the malignant tumor was made in 24(57.5%) patients on the basis of clinical findings. With IOTA simple rules on sonography, 15(37.5%) were found to be benign, while 23 (57.5%) were found to be malignant and findings were inconclusive in 2 patients (5%). FNAC/Histopathology reported that benign ovarian tumors were 14 (35%) and 26(65%) were malignant, which was taken as the gold standard. The clinical finding alone was found to have a sensitivity of 66.6% and a specificity of 90.9%. USG alone had a sensitivity of 86% and a specificity of 80%. When clinical findings and IOTA simple rules of sonography were combined (excluding inconclusive masses), the sensitivity and specificity were 83.3% and 92.3%, respectively. While including inconclusive masses, sensitivity came out to be 91.6% and specificity was 89.2. Conclusion: IOTA's simple sonography rules are highly sensitive and specific in the prediction of ovarian malignancy and also easy to use and easily reproducible. Thus, combining clinical examination with USG will help in the better management of patients in terms of time, cost and better prognosis. This will also avoid the need for costlier modalities like CT, and MRI.

Keywords: benign, international ovarian tumor analysis classification, malignant, ovarian tumours, sonography

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6105 E-Business Role in the Development of the Economy of Sultanate of Oman

Authors: Mairaj Salim, Asma Zaheer

Abstract:

Oman has accomplished as much or more than its fellow Gulf monarchies, despite starting from scratch considerably later, having less oil income to utilize, dealing with a larger and more rugged geography, and resolving a bitter civil war along the way. Of course, Oman's progress in the past 30-plus years has not been without problems and missteps, but the balance is squarely on the positive side of the ledger. Oil has been the driving force of the Omani economy since Oman began commercial production in 1967. The oil industry supports the country’s high standard of living and is primarily responsible for its modern and expansive infrastructure, including electrical utilities, telephone services, roads, public education and medical services. In addition to extensive oil reserves, Oman also has substantial natural gas reserves, which are expected to play a leading role in the Omani economy in the Twenty-first Century. To reduce the country’s dependence on oil revenues, the government is restructuring the economy by directing investment to non-oil activities. Since the 21st century IT has changed the performing tasks. To manage the affairs for the benefits of organizations and economy, the Omani government has adopted E-Business technologies for the development. E-Business is important because it allows • Transformation of old economy relationships (vertical/linear relationships) to new economy relationships characterized by end-to-end relationship management solutions (integrated or extended relationships) • Facilitation and organization of networks, small firms depend on ‘partner’ firms for supplies and product distribution to meet customer demands • SMEs to outsource back-end process or cost centers enabling the SME to focus on their core competence • ICT to connect, manage and integrate processes internally and externally • SMEs to join networks and enter new markets, through shortened supply chains to increase market share, customers and suppliers • SMEs to take up the benefits of e-business to reduce costs, increase customer satisfaction, improve client referral and attract quality partners • New business models of collaboration for SMEs to increase their skill base • SMEs to enter virtual trading arena and increase their market reach A national strategy for the advancement of information and communication technology (ICT) has been worked out, mainly to introduce e-government, e-commerce, and a digital society. An information technology complex KOM (Knowledge Oasis Muscat) had been established, consisting of section for information technology, incubator services, a shopping center of technology software and hardware, ICT colleges, E-Government services and other relevant services. So, all these efforts play a vital role in the development of Oman economy.

Keywords: ICT, ITA, CRM, SCM, ERP, KOM, SMEs, e-commerce and e-business

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6104 Buddhism and Its Contribution to the World Culture

Authors: Utsha Barua Joy

Abstract:

Buddhism has been playing as a cultural mediator in the world Asia. Buddhism spread as a living spiritual tradition and philosophy and spread mostly as a part of the cultural heritage. Culture and religion concern and deal with some similar human issues in terms of the concept of values. This article mainly focuses on some pertinent issues. The Buddha created a revolutionary awareness in the history of mankind by giving equal status to all. With equality, man gets social, mental, economic, and political freedom. This article moreover discusses the concept of morality, educational system, and finally, missionary services. After the first rainy retreat, Buddha asked the monks to go from place to place and spread the Dharma for the welfare of mankind. Since then, all the monks took part in missionary work. Emperor Asoka’s missionary steps are the brightened example in the history of Buddhism. The goal of this article is to provide to the wise readers with a delineation of reference on how equality, morality, education system, and missionary services through Buddhism rendered great contribution to the cultural arena around the globe.

Keywords: equality, morality, educational system, missionary works

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6103 21st Century Biotechnological Research and Development Advancements for Industrial Development in India

Authors: Monisha Isaac

Abstract:

Biotechnology is a discipline which explains the use of living organisms and systems to construct a product, or we can define it as an application or technology developed to use biological systems and organisms processes for a specific use. Particularly, it includes cells and its components use for new technologies and inventions. The tools developed can be further used in diverse fields such as agriculture, industry, research and hospitals etc. The 21st century has seen a drastic development and advancement in biotechnology in India. Significant increase in Government of India’s outlays for biotechnology over the past decade has been observed. A sectoral break up of biotechnology-based companies in India shows that most of the companies are agriculture-based companies having interests ranging from tissue culture to biopesticides. Major attention has been given by the companies in health related activities and in environmental biotechnology. The biopharmaceutical, which comprises of vaccines, diagnostic, and recombinant products is the most reliable and largest segment of the Indian Biotech industry. India has developed its vaccine markets and supplies them to various countries. Then there are the bio-services, which mainly comprise of contract researches and manufacturing services. India has made noticeable developments in the field of bio industries including manufacturing of enzymes, biofuels and biopolymers. Biotechnology is also playing a crucial and significant role in the field of agriculture. Traditional methods have been replaced by new technologies that mainly focus on GM crops, marker assisted technologies and the use of biotechnological tools to improve the quality of fertilizers and soil. It may only be a small contributor but has shown to have huge potential for growth. Bioinformatics is a computational method which helps to store, manage, arrange and design tools to interpret the extensive data gathered through experimental trials, making it important in the design of drugs.

Keywords: biotechnology, advancement, agriculture, bio-services, bio-industries, bio-pharmaceuticals

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6102 The Impact of the Parking Spot’ Surroundings on Charging Decision: A Data-Driven Approach

Authors: Xizhen Zhou, Yanjie Ji

Abstract:

The charging behavior of drivers provides a reference for the planning and management of charging facilities. Based on the real trajectory data of electric vehicles, this study explored the influence of the surrounding environments of the parking spot on charging decisions. The built environment, the condition of vehicles, and the nearest charging station were all considered. And the mixed binary logit model was used to capture the impact of unobserved heterogeneity. The results show that the number of fast chargers in the charging station, parking price, dwell time, and shopping services all significantly impact the charging decision, while the leisure services, scenic spots, and mileage since the last charging are opposite. Besides, factors related to unobserved heterogeneity include the number of fast chargers, parking and charging prices, residential areas, etc. The interaction effects of random parameters further illustrate the complexity of charging choice behavior. The results provide insights for planning and managing charging facilities.

Keywords: charging decision, trajectory, electric vehicle, infrastructure, mixed logit

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6101 Impact of the COVID-19 Pandemic and Social Isolation on the Clients’ Experiences in Counselling and their Access to Services: Perspectives of Violence Against Women Program Staff - A Qualitative Study

Authors: Habiba Nahzat, Karen Crow, Lisa Manuel, Maria Huijbregts

Abstract:

Background and Rationale: The World Health Organization (WHO) declared COVID-19 a pandemic on March 11, 2020. Shortly after, the Ontario provincial and Toronto municipal governments also released multiple directives that led to the mass closure of businesses both in the public and private sectors. Recent research has identified connections between Intimate Partner Violence (IPV) and COVID-19 related stressors - especially because of lockdown and social isolation measures. Psychological impacts of lengthy seclusion coupled with disconnection from extended family and diminished support services can take a toll on families at risk and may increase mental health issues and the prevalence of IPV. Research Question: Thus, the purpose of the study was to understand the perspective of the Violence Against Women (VAW) program staff on the impact of the COVID-19 pandemic; we especially wanted to understand staff views of restrictions on clients’ counseling experiences and the ability to access services in general. The study also aimed to examine VAW program staff experiences regarding remote work and explore how the pandemic restriction measures affected the ability of their program operations to support their clients and each other. Method: A cross-sectional, descriptive qualitative study was conducted with a purposive sample of 9 VAW program staff – eight VAW counselors and one VAW manager. Prior to data collection, program staff collaborated in the development of the study purpose, interview questions and methodology. Ethics approval was obtained from the sponsoring organization’s Research Ethics Board. In-depth individual interviews were conducted with study participants using a semi-structured interview questionnaire. Brief demographic information was also collected prior to the interview. Descriptive statistics were used to analyze quantitative data and qualitative data was analyzed by thematic content analysis. Results: Findings from this study indicate that the COVID-19 pandemic restrictions had an adverse impact on clients seeking VAW services based on VAW staff perspectives. Program staff reported a perceived increase in abuse among women, especially in emotional and financial abuse and experiences of isolation and trauma. Findings further highlight the challenges women experienced when trying to access services in general as well as counseling and legal services. This was perceived to be more prominent among newcomers and marginalized women. The study also revealed client and staff challenges when participating in virtual counseling, their innovations and clients’ creativity in accessing needed counseling and how staff over time adapted to providing virtual support during the pandemic. Conclusion and Next Steps: This study builds upon existing evidence on the impact of COVID-19 restrictions on VAW and may inform future research to better understand the association between the COVID-19 pandemic restrictions and VAW on a broader scale and to inform and support possible short-term and long-term changes in the client experience and counselling practice.

Keywords: COVID-19, pandemic, virtual, violence against women (VAW)

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6100 The Effects of an Intervention Program on Psychosocial Factors and Consequences during the COVID-19 Pandemic in a Chilean Technology Services Company: A Quasi-Experimental Study

Authors: Julio Lavarello-Salinas, Verónica Kramm-Vergara, Pedro Gil-La Orden

Abstract:

During the COVID-19 pandemic, mental health became a relevant factor in people’s performance within organizations. The aim of this study was to analyze the effects of an organizational intervention program on the psychosocial factors of demands, resources, and the consequences of psychosocial risks in a technology services company during the COVID-19 pandemic. A quasi-experimental study was carried out with 105 employees who took part in an eight-week intervention program divided into two large stages. Pre- and post- measurements were collected using the UNIPSICO Questionnaire, considering its factors of demands, resources, and consequences of psychosocial risks. The Spanish Burnout Inventory (SBI) was also included. The results showed significant improvements in the perception of some psychosocial demand factors, all the resource factors, and all the consequences of psychosocial risks, except the guilt dimension of the SBI. Thus, we can conclude that the program was effective and that the study limitations should be improved in future studies.

Keywords: UNIPSICO questionnaire, occupational health, work stress, work psychosocial risk

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6099 Nurses' and Patients’ Perception about Care: A Comparative Study

Authors: Evangelia Kotrotsiou, Mairy Gouva, Theodosios Paralikas, Maria Fiaka, Styliani Kotrotsiou, Maria Malliarou

Abstract:

The purpose of this research is to investigate the way nurses perceive the care provided in comparison to the way patients perceive it, taking into account existing literature. As far as the sample of research is concerned, it has come from the population of nurses working in the General Hospital of Thessaloniki, St. Paul and the patients of its surgical clinic. In the present study, the sample consists of 100 nurses and 88 patients. The questionnaire used was the Caring Nurse-Patient Interactions Scale: 23-Item Version, created by Cossette et al. (2006). In the case of both patients and nurses, a high score was observed in relational care in the case of the frequency of nursing care in daily practice, as well as the satisfaction of providing nursing care. Overall, patients rated higher clinical care in the case of the frequency of nursing care in daily practice, as well as the satisfaction of the clinical care they were given. On the other hand, nurses rated higher comfort care in the case of the frequency of nursing care in everyday practice, as well as relational care in the area of the importance of nursing care in everyday practice.

Keywords: nursing care, patient needs, patient satisfaction, care giving

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6098 Association of Vulnerability and Behavioural Outcomes of FSWs Linked with TI Prevention HIV Program: An Evidence from Cross-Sectional Behavioural Study in Thane District of Maharashtra

Authors: Jayanta Bora, Sukhvinder Kaur, Ashok Agarwal, Sangeeta Kaul

Abstract:

Background: It is important for targeted interventions to consider vulnerabilities of female sex workers (FSWs) such as poverty, work-related mobility and literacy for effective human immunodeficiency virus (HIV) prevention. This paper examines the association between vulnerability and behavioural outcomes among FSWs in Thane district, Maharashtra under USAID PHFI-PIPPSE project. Methods: Data were used from the Behavioural Tracking Survey, a cross-sectional behavioural study conducted in 2015 with 503 FSWs randomly selected from 12 TI-NGOs which were functioning and providing services to FSWs in Thane district prior to April 2014 in Thane district of Maharashtra. We have created the “vulnerability index”, a composite index of literacy, factors of dependence (alternative livelihood options, current debt), and aspects of sex work (mobility and duration in sex work) as a dependent variable. The key independent measures used were program exposure to intervention, service uptake, self-confidence, and self-identity. Bi-variate and multivariate logistic regressions were used to examine the study objectives. Results: A higher proportion of FSWs who were in the age-group 18–25 years from brothel/street /home/ lodge-based were categorized as highly vulnerable to HIV risk as compared to bar-based sex worker (74.1% versus 59.8%, P,0.002); regression analysis highlighted lower odds of vulnerability among FSWs who were aware of services and visited NGO clinic for medical check-up and counselling for STI [AOR= 0.092, 95% CI 0.018-0.460; P,0.004], However, lower odds of vulnerability on confident in supporting fellow sex worker in crisis [AOR= 0.601, 95% CI 0.476-0.758; P, 0.000] and were able to turn away clients when they refused to use a condom during sex [AOR= 0.524, 95% CI 0.342-0.802; P, 0.003]. Conclusion: The results highlight that FSWs associated with TIs and getting services are less vulnerable and highly empowered. As a result of behavioural change communication and other services provided by TIs, FSWs were able to successfully negotiate about condom use with their clients and manage solidarity in the crisis situation for fellow FSWs. Therefore, it is evident from study paper that TI prevention programs may transform the lives of masses considerably and may open a window of opportunity to infuse the information and awareness about HIV risk.

Keywords: female sex worker, HIV prevention, HIV service uptake, vulnerability

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6097 Effect of Powder Shape on Physical Properties of Porous Coatings

Authors: M. Moayeri, A. Kaflou

Abstract:

Decreasing the size of heat exchangers in industries is favorable due to a reduction in the initial costs and maintenance. This can be achieved generally by increasing the heat transfer coefficient, which can be done by increasing tube surface by passive methods named “porous coat”. Since these coatings are often in contact with the fluid, mechanical strength of coatings should be considered as main concept beside permeability and porosity in design, especially in high velocity services. Powder shape affected mechanical property more than other factors. So in this study, the Copper powder with three different shapes (spherical, dendritic and irregular) was coated on Cu-Ni base metal with thickness of ~300µm in a reduction atmosphere (5% H2-N2) and programmable furnace. The morphology and physical properties of coatings, such as porosity, permeability and mechanical strength were investigated. Results show although irregular particle have maximum porosity and permeability but strength level close to spherical powder, in addition, mentioned particle has low production cost, so for creating porous coats in high velocity services these powder recommended.

Keywords: porous coat, permeability, mechanical strength, porosity

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6096 Effect of Non-Genetic Factors and Heritability Estimate of Some Productive and Reproductive Traits of Holstein Cows in Middle of Iraq

Authors: Salim Omar Raoof

Abstract:

This study was conducted at the Al-Salam cows’ station for milk production located in Al-Latifiya district - Al-Mahmudiyah district (25 km south of Baghdad governorate) on a sample of (180) Holstein cows imported from Germany by Taj Al-Nahrain company in order to study the effect of the sequence, season and calving year on Total Milk Production (TMP). The lactation period (LP), calving interval, Services per conception and the estimate of the heritability of the studied traits. The results showed that the overall mean of TMP and LP were 3172.53 kg and 237.09-day respectively. The parity effect on TMP in Holstein cows was highly significant (P≤0.01). Total Milk production increased with the advance of parity and mostly reached its maximum value in the 4th and 3rd parity being 3305.87 kg and3286.35 kg per day, respectively. Season of calving has a highly significant (P≤0.01), effect on (TMP). Cows calved in spring had a highest milk production than those calved in other seasons. Season of calving had a highly significant (P≤0.01) effect on services per conception. The result of the study showed the heritability values for TMP, LP, SPC and CL were 0.21, 0.08, 0.08 and 0.07, respectively.

Keywords: cows, non genetic, milk production, heritability

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6095 Congenital Heart Defect(CHD) “The Silent Crises”; The Need for New Innovative Ways to Save the Ghanaian Child - A Retrospective Study

Authors: Priscilla Akua Agyapong

Abstract:

Background: In a country of nearly 34 million people, Ghana suffers from rapidly growing pediatric CHD cases and not enough pediatric specialists to attend to the burgeoning needs of these children. Most of the cases are either missed or diagnosed late, resulting in increased mortality. According to the National Cardiothoracic Centre, 1 in every 100,000 births in Ghana has CHD; however, there is limited data on the clinical presentation and its management, one of the many reasons I decided to do this case study coupled with the loss my 2 month old niece to multiple Ventricular Septal Defect 3 years ago due late diagnoses. Method: A retrospective cohort study was performed at the child health clinic of one of Ghana’s public tertiary Institutions using data from their electronic health record (EHR) from February 2021 to April 2022. All suspected or provisionally diagnosed cases were included in the analysis. Results: Records of over 3000 children were reviewed with an approximate male to female ratio of 1:1.53 cases diagnosed during the period of study, most of whom were less than 5 years of age. 25 cases had complete clinical records, with acyanotic septal defects being the most diagnosed. 62.5% of the cases were ventricular septal defects, followed by Patent Ductus Arteriosus (23%) and Atrial Septal Defects (4.5%). Tetralogy of Fallot was the most predominant and complex cyanotic CHD with 10%. Conclusion: The indeterminate coronary anatomy of infants makes it difficult to use only echocardiography and other conventional clinical methods in screening for CHDs. There are rising modernizations and new innovative ways that can be employed in Ghana for early detection, hence preventing the delay of a potential surgical repair. It is, therefore, imperative to create the needed awareness about these “SILENT CRISES” and help save the Ghanaian child’s life.

Keywords: congenital heart defect(CHD), ventricular septal defect(VSD), atrial septal defect(ASD), patent ductus arteriosus(PDA)

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6094 Grape Seed Extract and Zinc Containing Multivitamin-Mineral Nutritional Food Supplement Protects Heart against Myocardial Ischemic-Reperfusion Injury in Wistar Rats

Authors: S. M. Satyam, K. L. Bairy, R. Pirasanthan, R. L. Vaishnav

Abstract:

Zincovit tablets have been used as nutritional food supplement over a prolonged period of time. The aim of the present study was to investigate the cardio-protective effect of combined formulation of grape seed extract and Zincovit tablets (40, 80 and 160 mg/kg) using a Langendorff model of ischemia-reperfusion in Wistar rats. Following 21 days of pre-treatment, combined formulation of grape seed extract and Zincovit tablets significantly attenuated ischemia-reperfusion induced cardiac injury in terms of increased coronary flow rate (p < 0.01), decreased creatine kinase activity in coronary effluent (p < 0.05), decreased MDA (p < 0.001), 4-HNE (p < 0.001) and increased protein thiol content (p < 0.01) in comparison with the untreated (control) group. This study opens an avenue to clinical studies to demonstrate the validity of this paradigm as a nutritional food supplement, which could improve the clinical outcome of patients subjected to percutaneous angioplasty.

Keywords: grape seed extract, myocardial ischemia-reperfusion injury, oxidative stress, Zincovit tablets

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6093 An Investigation of Customers’ Perception and Attitude towards Krung Thai Bank in Thailand

Authors: Phatthanan Chaiyabut

Abstract:

The purposes of this research were to identify the perception of customers towards Krung Thai Bank’s image and to understand the customer attitude towards Krung Thai Bank’s image in Bangkok, Thailand. This research utilized quantitative approach and used questionnaire as data collection tool. A sample size of 420 respondents was selected by simple random sampling. The findings revealed that the majority of respondents received information, news, and feeds concerning the bank through televisions the most. This information channel had significantly influenced on the customers and their decisions to utilize the bank’s products and services. From the information concerning the attitudes towards overall image of the bank, it was found that the majority respondents rated the bank’s image at the good level. The top three average attitudes included the bank’s images in supports government's monetary policies, being renowned and stable, and contributing in economical amendments and developments, with the mean average of 4.01, 3.96 and 3.81 respectively. The attitudes toward the images included a business leader in banking, marketing, and competitions. Offering prompt services, and provided appropriate servicing time were rated moderate with the attitudes of 3.36 and 3.30 respectively.

Keywords: attitude, image, Krung Thai Bank, perception

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6092 Knowledge Reactor: A Contextual Computing Work in Progress for Eldercare

Authors: Scott N. Gerard, Aliza Heching, Susann M. Keohane, Samuel S. Adams

Abstract:

The world-wide population of people over 60 years of age is growing rapidly. The explosion is placing increasingly onerous demands on individual families, multiple industries and entire countries. Current, human-intensive approaches to eldercare are not sustainable, but IoT and AI technologies can help. The Knowledge Reactor (KR) is a contextual, data fusion engine built to address this and other similar problems. It fuses and centralizes IoT and System of Record/Engagement data into a reactive knowledge graph. Cognitive applications and services are constructed with its multiagent architecture. The KR can scale-up and scaledown, because it exploits container-based, horizontally scalable services for graph store (JanusGraph) and pub-sub (Kafka) technologies. While the KR can be applied to many domains that require IoT and AI technologies, this paper describes how the KR specifically supports the challenging domain of cognitive eldercare. Rule- and machine learning-based analytics infer activities of daily living from IoT sensor readings. KR scalability, adaptability, flexibility and usability are demonstrated.

Keywords: ambient sensing, AI, artificial intelligence, eldercare, IoT, internet of things, knowledge graph

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6091 Effects of Ubiquitous 360° Learning Environment on Clinical Histotechnology Competence

Authors: Mari A. Virtanen, Elina Haavisto, Eeva Liikanen, Maria Kääriäinen

Abstract:

Rapid technological development and digitalization has affected also on higher education. During last twenty years multiple of electronic and mobile learning (e-learning, m-learning) platforms have been developed and have become prevalent in many universities and in the all fields of education. Ubiquitous learning (u-learning) is not that widely known or used. Ubiquitous learning environments (ULE) are the new era of computer-assisted learning. They are based on ubiquitous technology and computing that fuses the learner seamlessly into learning process by using sensing technology as tags, badges or barcodes and smart devices like smartphones and tablets. ULE combines real-life learning situations into virtual aspects and can be flexible used in anytime and anyplace. The aim of this study was to assess the effects of ubiquitous 360 o learning environment on higher education students’ clinical histotechnology competence. A quasi-experimental study design was used. 57 students in biomedical laboratory science degree program was assigned voluntarily to experiment (n=29) and to control group (n=28). Experimental group studied via ubiquitous 360o learning environment and control group via traditional web-based learning environment (WLE) in a 8-week educational intervention. Ubiquitous 360o learning environment (ULE) combined authentic learning environment (histotechnology laboratory), digital environment (virtual laboratory), virtual microscope, multimedia learning content, interactive communication tools, electronic library and quick response barcodes placed into authentic laboratory. Web-based learning environment contained equal content and components with the exception of the use of mobile device, interactive communication tools and quick response barcodes. Competence of clinical histotechnology was assessed by using knowledge test and self-report developed for this study. Data was collected electronically before and after clinical histotechnology course and analysed by using descriptive statistics. Differences among groups were identified by using Wilcoxon test and differences between groups by using Mann-Whitney U-test. Statistically significant differences among groups were identified in both groups (p<0.001). Competence scores in post-test were higher in both groups, than in pre-test. Differences between groups were very small and not statistically significant. In this study the learning environment have developed based on 360o technology and successfully implemented into higher education context. And students’ competence increases when ubiquitous learning environment were used. In the future, ULE can be used as a learning management system for any learning situation in health sciences. More studies are needed to show differences between ULE and WLE.

Keywords: competence, higher education, histotechnology, ubiquitous learning, u-learning, 360o

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6090 Systems Strengthening for Sustainable Family Planning Service Provision in Uganda

Authors: D. Muyama, M. Luyiga, P. Buyungo, D. Chemonges, M. Namukwaya, L. Ssekabembe, B. Lukwago, D. Kyamagwa

Abstract:

Context: The study focuses on the sustainability of health interventions in Uganda, particularly in the private sector, beyond donor-funded project periods. The Population Services International (PSI) implemented the Women Health Project (WHP) to ensure continued access to quality family planning, cervical cancer screening, and post-abortion care services through private clinics. Research Aim: The aim of the study is to assess the continued access to quality family planning, cervical cancer screening, and post-abortion care services through the private sector after the closure or reduction in funding of the WHP. Methodology: PSI trained and mentored 83 clinics to establish functional systems in self-regulatory quality improvement, supply chain, referral, and demand creation. The clinics were also connected to the national reporting system and utilized Ministry of Health reporting tools. An assessment tool with six criteria was designed and used to evaluate the progress of the clinics. Clinics scoring 75% and above were considered independent and graduated from the program. Findings: Out of the 83 private clinics, 56 successfully met the graduation criteria and graduated from the program, while 25 lost interest and were gradually dropped. Two clinics failed to achieve the criteria due to leadership challenges. The 59 graduating clinics continued to provide high-quality family planning services, including IUD, implant, Depo-Provera, oral contraceptives, and post-abortion care. All graduating clinics were reassessed and found to still be capable of offering services, attributing their success to government stock availability and acquired skills through mentorships. The clinics expressed appreciation to PSI for the sustainable plan that allowed them to operate beyond the project period. Theoretical Importance: This study contributes to the understanding of sustainability planning and the importance of clinic owners' attitudes and buy-in for continued service provision. It emphasizes the implementation of sustainability plans through existing structures to leverage available resources and ensure continuity of care. Data Collection and Analysis Procedures: The study collected data through the assessment tool that evaluated the progress of clinics based on the established criteria. The tool was scored out of 100%, and clinics scoring above 75% were deemed independent. The findings were analyzed quantitatively to determine the success rate of clinics in meeting the graduation criteria. Questions Addressed: The study addresses the question of whether private clinics in Uganda can sustain the provision of family planning, cervical cancer screening, and post-abortion care services after the closure or reduction in funding of the WHP. Conclusion: The study concludes that the attitude and buy-in of clinic owners are essential for sustainability planning. Implementing sustainability plans through existing structures and leveraging available resources are crucial for the continuity of care after the end of a project or reduced funding. The findings highlight the importance of establishing sustainable plans to ensure continued access to essential health services beyond the project period. Contributions: This study contributes to the existing knowledge for programmers implementing or intending to implement donor-funded projects. It provides insights into designing sustainable plans that enable the independent operation of clinics even after the end of a project.

Keywords: graduation, family planning, systems strengthening, sustainability

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6089 Surgical Collaboration in Managing Spinal Cord Compression Due to a Pre-Vertebral Chordoma: A Case Report

Authors: Rose Virginy S. Bautista, Ida Marie Tabangay-Lim, Helen Bongalon-Amo, Jose Modesto B. Abellera

Abstract:

Chordomas, particularly those of the spine and the head and neck region, represent a rare and locally aggressive group of malignancies. The complexity of these tumors -given the rarity, location, and involvement of neurovascular structures- imposes a challenge in the diagnosis and management. We herein report a case of spinal cord compression due to a prevertebral cervical chordoma. The patient presented with a gradually enlarging lateral neck mass, with progressive bilateral extremity weakness and urinary incontinence; preoperative biopsy showed chordoma. A multidisciplinary approach for the management of this case was made, involving neurosurgery, head and neck surgery, and radiation oncology services. Surgical collaboration between the two cutting services was done to have a radical excision of the tumor and spinal cord decompression. The patient was then referred for adjuvant radiation therapy. With this collaborative treatment strategy, more comprehensive and quality care could be provided to our patients.

Keywords: chordoma, surgical collaboration, spinal cord compression, neurosurgery, head and neck surgery

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6088 Effect of Non-Genetic Factors and Heritability Estimate of Some Productive and Reproductive Traits of Holstein Cows in Middle of Iraq

Authors: Salim Omar Raoof

Abstract:

This study was conducted at the Al-Salam cows’ station for milk production located in Al-Latifiya district - Al-Mahmudiyah district (25 km south of Baghdad governorate) on a sample of (180) Holstein cows imported from Germany by Taj Al-Nahrain company, in order to study the effect of the sequence, season and calving year on Total Milk Production (TMP). the lactation period (LP), calving interval, Services per conception and the estimate the heritability of the studied traits. The results showed that the overall mean of TMP and LP were 3172.53 kg and237.09-day respectively. The parity effect on TMP in Holstein cows was highly significant (P≤0.01). total Milk production increased with the advanced of parity and mostly reached its maximum value in the 4th and 3rd parity being 3305.87 kg and3286.35 kg per day, respectively. Season of calving has a highly significant (P≤0.01) effect on (TMP). Cows calved in spring had a highest milk production than that calved in other seasons. Season of calving had highly significant (P≤0.01) effect on services per conception. The result of the study showed the heritability value for TMP, LP, SPC and CL were 0.21 ,0.08 ,0.08 and 0.07 respectively.

Keywords: Holstein, cows, milk production, non-genetic, hertability

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6087 Data Security: An Enhancement of E-mail Security Algorithm to Secure Data Across State Owned Agencies

Authors: Lindelwa Mngomezulu, Tonderai Muchenje

Abstract:

Over the decades, E-mails provide easy, fast and timely communication enabling businesses and state owned agencies to communicate with their stakeholders and with their own employees in real-time. Moreover, since the launch of Microsoft office 365 and many other clouds based E-mail services, many businesses have been migrating from the on premises E-mail services to the cloud and more precisely since the beginning of the Covid-19 pandemic, there has been a significant increase of E-mails utilization, which then leads to the increase of cyber-attacks. In that regard, E-mail security has become very important in the E-mail transportation to ensure that the E-mail gets to the recipient without the data integrity being compromised. The classification of the features to enhance E-mail security for further from the enhanced cyber-attacks as we are aware that since the technology is advancing so at the cyber-attacks. Therefore, in order to maximize the data integrity we need to also maximize security of the E-mails such as enhanced E-mail authentication. The successful enhancement of E-mail security in the future may lessen the frequency of information thefts via E-mails, resulting in the data of South African State-owned agencies not being compromised.

Keywords: e-mail security, cyber-attacks, data integrity, authentication

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6086 Integrating AI into Breast Cancer Diagnosis: Aligning Perspectives for Effective Clinical Practice

Authors: Mehrnaz Mostafavi, Mahtab Shabani, Alireza Azani, Fatemeh Ghafari

Abstract:

Artificial intelligence (AI) can transform breast cancer diagnosis and therapy by providing sophisticated solutions for screening, imaging interpretation, histopathological analysis, and treatment planning. This literature review digs into the many uses of AI in breast cancer treatment, highlighting the need for collaboration between AI scientists and healthcare practitioners. It emphasizes advances in AI-driven breast imaging interpretation, such as computer-aided detection and diagnosis (CADe/CADx) systems and deep learning algorithms. These have shown significant potential for improving diagnostic accuracy and lowering radiologists' workloads. Furthermore, AI approaches such as deep learning have been used in histopathological research to accurately predict hormone receptor status and categorize tumor-associated stroma from regular H&E stains. These AI-powered approaches simplify diagnostic procedures while providing insights into tumor biology and prognosis. As AI becomes more embedded in breast cancer care, it is crucial to ensure its ethical, efficient, and patient-focused implementation to improve outcomes for breast cancer patients ultimately.

Keywords: breast cancer, artificial intelligence, cancer diagnosis, clinical practice

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6085 Findings from an Access Improvement Project for Antiretroviral Therapy Uptake through Traditional Birth Attendants at Mother Theresa Hospital, Lagos, Nigeria

Authors: Daniel Afolayan, Christina Olawepo, Francis Olowookanga, Nguhemen Tingir, Olawale Fadare, John Oko

Abstract:

In Nigeria, traditional birth attendants (TBAs) can play an important role in the prevention of mother-to-child transmission of HIV. However, their role in improving access to antiretroviral therapy (ART) is unclear. Catholic Caritas Foundation of Nigeria (Caritas Nigeria) is an implementing agency supporting increased access to HIV testing and treatment services in Lagos state through health facilities including Mother Theresa Hospital. Despite intra-facility testing and community outreaches, ART uptake at Mother Theresa Hospital, Lagos was low with 6 individuals on antiretroviral drugs 3 months post-activation. This study explored improving access to ART through linkages with TBAs for ART uptake at the facility. Plan-Do-Study-Act model was used. The goal was to improve uptake of ART from 6 to 80 in 5 months (end of project year). Scanning revealed a network of 15 TBAs with potential as satellites for HIV testing. Caritas Nigeria linked the facility with 15 TBAs who were provided with HIV test kits and trained on HIV testing services for provider-initiated testing and outreaches. Weekly reports and referrals of positives were received, tracked and feedback given on testing yield. These TBAs serve individuals of various age and gender at their trado-medical centres. At the end of 5 months, HIV testing increased by 10,575 (78% from TBAs) and HIV positives obtained improved by 77 (44.2% from TBAs). 55 new individuals were enrolled and commenced on ART (61.8% from TBAs). There was a successful linkage of all clients with escort services due to incentives. Total uptake of ART was 61 (76.3% of target). Structured partnerships between TBAs and HIV care and treatment centers should be strengthened to improve access to ART.

Keywords: access improvement, antiretroviral therapy, traditional birth attendants, uptake

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6084 Tourism Development and Its Role in the Urban Expansion of Al-Khomse City, Libya

Authors: Khaled Klib, Yousri Azzam, Ibrahim Maarouf

Abstract:

Tourism is one of the most important and fastest growing economic activities in the world, which has a prominent role in the growth and development of countries and has become increasingly important as business and trade after the World War II. The tourism development is one of the most important aspects of urban development, which aims to plan and develop tourist attractions and improve the urban environment within cities. Tourism development has become a priority for the urban development policy of cities, particularly those which have many tourist potentials. Complementary services, such as infrastructure, roads’ networks, transportation, and communications are needed for these potentials to function properly. In order to achieve these functionalities, also a new planning for the new areas as an expansion is required, or developing and renovating the existing urban areas according to pre-prepared plans to avoid random expansion of the urban structure of the city. This paper aims to determine the tourist attractions of Al-Khomse city, by reviewing the most important tourist attractions such as the Roman city (Leptis Magna), the geographical location on the Mediterranean coast, the temperate climate and diversity of the natural environment. The paper also examines the reality of the infrastructure and tourist services in the city and its suitability to serve the tourism sector. The paper also includes a proposed for tourism development in the city as one of the city's urban expansion trends, which can guide the development strategy in the future. The paper concludes with a vision for the tourism development areas as one of the trends for urban expansion in the future. The paper also concludes tourism development will have an effective role in the growth and development of urban, economic and social, in addition to preserving the natural environment. The paper recommended the need to emphasize the role of tourism development as one of the pillars and trends for the development policy and expansion of Al-Khomse city, preservation of tourist attractions and natural resources and developing infrastructure and tourist services such as accommodation, entertainment, mobility, and accessibility.

Keywords: tourism, tourist attractions, tourism development, urban expansion

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6083 Pulmonary Complications of Dengue Infection

Authors: Shilpa Avarebeel

Abstract:

Background: India is one of the seven identified countries in South-East Asia region, regularly reporting dengue infection and may soon transform into a major niche for dengue epidemics. Objective: To study the clinical profile of dengue in our setting with special reference to respiratory complication. Study design: Descriptive and exploratory study, for one year in 2014. All patients confirmed as dengue infection were followed and their clinical profile, along with outcome was determined. Study proforma was designed based on the objective of the study and it was pretested and used after modification. Data was analyzed using statistical software SPSS-Version 16. Data were expressed as mean ±S .D for parametric variables and actual frequencies or percentage for non-parametric data. Comparison between groups was done using students’ t-test for independent groups, Chie square test, one-way ANOVA test, Karl Pearson’s correlation test. Statistical significance is taken at P < 0.05. Results: Study included 134 dengue positive cases. 81% had dengue fever, 18% had dengue hemorrhagic fever, and one had dengue shock syndrome. Most of the cases reported were during the month of June. Maximum number of cases was in the age group of 26-35 years. Average duration of hospital stay was less than seven days. Fever and myalgia was present in all the 134 patients, 16 had bleeding manifestation. 38 had respiratory symptoms, 24 had breathlessness, and 14 had breathlessness and dry cough. On clinical examination of patients with respiratory symptoms, all twenty-eight had hypoxia features, twenty-four had signs of pleural effusion, and four had ARDS features. Chest x-ray confirmed the same. Among the patients with respiratory symptoms, the mean platelet count was 26,537 c/cmm. There was no statistical significant difference in the platelet count in those with ARDS and other dengue complications. Average four units of platelets were transfused to all those who had ARDS in view of bleeding tendency. Mechanical ventilator support was provided for ARDS patients. Those with pleural effusion and pulmonary oedema were given NIV (non-invasive ventilation) support along with supportive care. However, steroids were given to patients with ARDS and 10 patients with signs of respiratory distress. 100%. Mortality was seen in patients with ARDS. Conclusion: Dengue has to be checked for those presenting with fever and breathlessness. Supportive treatments remain the cornerstone of treatment. Platelet transfusion has to be given only by clinical judgment. Steroids have no role except in early ARDS, which is controversial. Early NIV support helps in speedy recovery of dengue patients with respiratory distress.

Keywords: adult respiratory distress syndrome, dengue fever, non-invasive ventilation, pulmonary complication

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6082 Interpersonal Emotion Regulation in Adolescence: An Enhanced Critical Incident Study

Authors: Setareh Shayanfar

Abstract:

Given the increasing importance of peer relationships during adolescence, the present study aimed to examine peer interactions that facilitate or hinder adolescents’ regulation of negative emotions. Using the Enhanced Critical Incident Technique, 1-hour semi-structured interviews were conducted with 16 junior high school adolescents. Participants were asked to recall situations when they experienced strong negative emotions during the past school year, indicate the peer interactions that helped or hindered their emotion regulation, and identify prospective interactions with the potential to help regulate their emotions. Data analysis extracted 182 critical incidents, including 109 helping incidents, 45 hindering incidents, and 28 wish list items, which generated 10 categories nested within four overarching themes: Positive Personal Support included (a) supportive presence, (b) expressing concern, (c) empathizing, and (d) encouraging and cheering up; while Strategy Transmission included (e) sharing perspective, and (f) giving advice; Activated Support included (g) taking action, and (h) distracting; while Negative Personal Interactions included (i) withdrawing and (j) punishing. Implications for mental health and service providers, as well as recommendations for future research, are presented.

Keywords: adolescence, emotion regulation, enhanced critical incident technique, peers

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6081 Revolutionizing Autonomous Trucking Logistics with Customer Relationship Management Cloud

Authors: Sharda Kumari, Saiman Shetty

Abstract:

Autonomous trucking is just one of the numerous significant shifts impacting fleet management services. The Society of Automotive Engineers (SAE) has defined six levels of vehicle automation that have been adopted internationally, including by the United States Department of Transportation. On public highways in the United States, organizations are testing driverless vehicles with at least Level 4 automation which indicates that a human is present in the vehicle and can disable automation, which is usually done while the trucks are not engaged in highway driving. However, completely driverless vehicles are presently being tested in the state of California. While autonomous trucking can increase safety, decrease trucking costs, provide solutions to trucker shortages, and improve efficiencies, logistics, too, requires advancements to keep up with trucking innovations. Given that artificial intelligence, machine learning, and automated procedures enable people to do their duties in other sectors with fewer resources, CRM (Customer Relationship Management) can be applied to the autonomous trucking business to provide the same level of efficiency. In a society witnessing significant digital disruptions, fleet management is likewise being transformed by technology. Utilizing strategic alliances to enhance core services is an effective technique for capitalizing on innovations and delivering enhanced services. Utilizing analytics on CRM systems improves cost control of fuel strategy, fleet maintenance, driver behavior, route planning, road safety compliance, and capacity utilization. Integration of autonomous trucks with automated fleet management, yard/terminal management, and customer service is possible, thus having significant power to redraw the lines between the public and private spheres in autonomous trucking logistics.

Keywords: autonomous vehicles, customer relationship management, customer experience, autonomous trucking, digital transformation

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6080 The Adequacy of Antenatal Care Services among Slum Residents in Addis Ababa, Ethiopia

Authors: Yibeltal T. Bayou, Yohana S. Mashalla, Gloria Thupayagale-Tshweneagae

Abstract:

Background: Maternal mortality has been shown to be lower in urban areas than in rural areas. However, disparities for the fast-growing population of urban poor who struggle as much their rural counterparts to access quality healthcare are masked by the urban averages. The aim of this paper is to report on the findings of antenatal adequacy among slum residents in Addis Ababa, Ethiopia. Methods and Materials: A quantitative and cross-sectional community-based study design was employed. A stratified two-stage cluster sampling technique was used to determine the sample and data was collected using structured questionnaire administered to 837 women aged 15-49 years. Binary logistic regression models were employed to identify predictors of adequacy of antenatal care. Results: The majority of slum residents did not have adequate antenatal care services i.e., only 50.7%, 19.3% and 10.2% of the slum resident women initiated early antenatal care, received adequate antenatal care service contents and had overall adequate antenatal care services. Pregnancy intention, educational status and place of ANC visits were important determinant factors for adequacy of ANC in the study area. Women with secondary and above educational status were 2.9 times more likely to have overall adequate care compared to those with no formal education. Similarly, women whose last pregnancy was intended and clients of private healthcare facilities were 1.8 and 2.8 times more likely to have overall adequate antenatal care compared to those whose last pregnancy was unintended and clients of public healthcare facilities respectively. Conclusion: In order to improve ANC adequacy in the study area, the policymaking, planning, and implementation processes should focus on the poor adequacy of ANC among the disadvantaged groups in particular and the slum residents in general.

Keywords: Addis Ababa, adequacy of antenatal care, slum residents, maternal mortality

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6079 Delivering Safer Clinical Trials; Using Electronic Healthcare Records (EHR) to Monitor, Detect and Report Adverse Events in Clinical Trials

Authors: Claire Williams

Abstract:

Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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