Search results for: FDA adverse event reporting system

Authors: Eunjoo Lee

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Background: As the number of surgeries increases, the incidence of adverse events is likely to become more prevalent. Patients who are somewhat knowledgeable about surgery-related adverse events are more likely to engage in safety initiatives to prevent them. Objectives: To evaluate the impact of a smartphone application developed during the study to enhance patients’ knowledge of surgery-related adverse events during hospitalization. Design: Non-randomized, one group, measured pre- and post-intervention. Participants: Thirty-six hospitalized patients admitted to the orthopedics unit of a general hospital in South Korea. Methods. First, a smartphone application to enhance patients’ knowledge of surgery-related adverse events was developed through an iterative process, which included a literature review, expert consultation, and pilot testing. The application was installed on participants’ smartphones, and research assistants taught the participants to use it. Twenty-five true/false questions were used to assess patients’ knowledge of preoperative precautions (eight items), surgical site infection (five items), Foley catheter management (four items), drainage management (four items), and anesthesia-related complications (four items). Results: Overall, the percentage of correct answers increased significantly, from 57.02% to 73.82%, although answers related to a few specific topics did not increase that much. Although the patients’ understanding of drainage management and the Foley catheter did increase substantially after they used the smartphone application, it was still relatively low. Conclusions: The smartphone application developed during this study enhanced the patients’ knowledge of surgery-related adverse events during hospitalization. However, nurses must make an additional effort to help patients to understand certain topics, including drainage and Foley catheter management. Relevance to clinical practice: Insufficient patient knowledge increases the risk of adverse events during hospitalization. Nurses should take active steps to enhance patients’ knowledge of a range of safety issues during hospitalization, in order to decrease the number of surgery-related adverse events.

Keywords: patient education, patient participation, patient safety, smartphone application, surgical errors

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Authors: Haouam Djemaa

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This study aimed to identify the possibility for applying fair value accounting by Algerian enterprises coted in capital maket (Algiers stock exchange). To achieve the objectives of this study, we made an interview with preparers of accounting information. The results document that enterprises are aware of fair value accounting in financial reporting because of its ability to provide useful accounting, but it depends on the availability of favorable circumstances for its application and this is what is missing in the Algerian environment.

Keywords: fair value, financial reporting, accounting information, valuation method

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Authors: Mahera Abdulrahman, Satish Chandrasekhar Nair

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Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight, particularly given the large unskilled-worker immigrant population and the elderly citizens utilizing health services. Examination of the structure, function, practices and outcomes of the human research ethics committees (HREC) was conducted using two survey instruments, reliable and validated. Results indicate that in the absence of a national ethics regulatory body, the individual emirate’s governed 21 HRECs covering health facilities and academic institutions in the UAE. Among the HRECs, 86% followed International Council for Harmonization-Good Clinical Practice guidelines, 57% have been in operation for more than five years, 81% reviewed proposals within eight weeks, 48% reviewed for clinical and scientific merit apart from ethics, and 43% handled more than 50 research proposals per year. However, researcher recognition, funding transparency, adverse event reporting systems were widespread in less than one-third of all HRECs. Surprisingly, intellectual property right was not included as a research output. Research was incorporated into the vision and mission statements of many (62%) organizations and, mechanisms such as research publications, collaborations, and recognitions were employed as key performance indicators to measure research output. In spite, resources to generate research output such as dedicated budget (19%), support staff (19%) and continuous training and mentoring program for medical residents and HREC members were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world, resources allocation for efficient, quality monitoring, continuous training, and the creation of a clinical research network are needed to strengthen the clinical research enterprise to scale up for the future. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors and the policy makers in the region.

Keywords: institutional review board, ethics committee, human research ethics, United Arab Emirates (UAE)

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Authors: Monika Szpringer, Aneta Pawlinska

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Adverse childhood experiences are linked to various types of health and adapt problems at different stages of life. They include various types of abuse, neglect, and dysfunctional environment. They have an unfavorable impact on the development of a child and his future functioning in society. Adolescents who were exposed to bad treatment may suffer from health problems during adulthood, like chronic diseases, psychological disorders, drug addiction, and suicide attempts. Objective: The aim of the project is to assess the relationship between adverse childhood experiences and the sense of efficacy and coping with emotions among teenagers aged 16-18 taking drugs. Material And Methods: The research was carried out in the period from March to December 2018 in Mazowieckie, Świętokrzyskie, Łódzkie, and Lubelskie Voivodship. The group consisted of 600 people aged 16-18 (M=16,58; SD=0, 78), men (63,2%) aged 16-18 (M=16,60;SD= 0,78) and women (35,5%) aged 16-18 (M16,55;SD=0,79). Participants included residents from Youth Educational Centers and Youth Sociotherapy Centers. Each participant filled in Author's Questionnaire, Adverse Childhood Questionnaire, then Courtland Emotional Control Scale-CECS and Generalized Self Efficacy Scale-GSES. Results and conclusions: The most common adverse experiences, according to teenagers, were family abuse, divorce/separation/parent's death, overuse of alcohol or drugs by an inmate, and emotional neglect. Adolescents who suffered from five to twelve adverse experiences had a higher level of depression's control. Adverse childhood experiences have an importance for the level of anger and depression's control among teenagers taking drugs. The greatest importance of the level of anger's control has emotional neglect. A higher level of emotional neglect is linked to a lower ability to control anger. The greatest importance of the level of depression's control has physical abuse and emotional neglect. The higher physical abuse during childhood, and the higher frequency of emotional neglect, the bigger the depression's control. The sense of efficacy in the group of people who suffered from one to four adverse experiences is close to the sense of efficacy that suffered people from five to twelve adverse experiences. The most important factor lowering the sense of one's efficacy was the intensification of sexual abuse. It was confirmed that the intensification and frequency of adverse childhood experiences were higher among women than men. Women also characterized lower anger control and greater depression's control. The authors’ own analyses confirmed the relationship between adverse childhood experiences and the sense of efficacy and coping with emotions among teenagers aged 16-18 taking drugs.

Keywords: adolescences, adverse childhood experiences, coping with emotions, drugs

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Authors: Michaela Vašková, Jiří Barta, Otakar J. Mika, Jan Hrdlička, Josef Kellner

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The paper is focused on the method to solutions the crisis situation in the Czech Republic associated with the mass methanol poisoning. The emphasis is put on tasks of individual state bodies and of Integrated Rescue System during the handling of the crisis. The theoretical part describes poisonings, ways of intoxication, types of intoxicants and cases of mass poisoning by dangerous substances in the world. The practical part describes the development, causes and solutions of extraordinary event, mass methanol poisoning in the Czech Republic. The main emphasis was put on the crisis management of the Czech Republic in solving this situation.

Keywords: crisis management, poisoning, methanol, hazardous substances, extraordinary event

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Authors: Abigail M. Csik, Gabriel A. Radvansky

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As people read through event-based narratives, they construct an event model that captures information about the characters, goals, location, time, and causality. For many reasons, memory for such narratives is represented at different levels, namely, the surface form, textbase, and event model levels. Rereading has been shown to decrease surface form memory, while, at the same time, increasing textbase and event model memories. More generally, distributed practice has consistently shown memory benefits over massed practice for different types of materials, including texts. However, little research has investigated distributed practice of narratives at different inter-study intervals and these effects on these three levels of memory. Recent work in our lab has indicated that there may be dramatic changes in patterns of forgetting around one week, which may affect the three levels of memory. The present experiment aimed to determine the effects of rereading on the three levels of memory as a factor of whether the texts were reread before versus after one week. Participants (N = 42) read a set of stories, re-read them either before or after one week (with an inter-study interval of three days, seven days, or fourteen days), and then took a recognition test, from which the three levels of representation were derived. Signal detection results from this study reveal that differential patterns at the three levels as a factor of whether the narratives were re-read prior to one week or after one week. In particular, an ANOVA revealed that surface form memory was lower (p = .08) while textbase (p = .02) and event model memory (p = .04) were greater if narratives were re-read 14 days later compared to memory when narratives were re-read 3 days later. These results have implications for what type of memory benefits from distributed practice at various inter-study intervals.

Keywords: memory, event cognition, distributed practice, consolidation

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Authors: Pachawo Bisani, Goodall Nyirenda

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The Malawi National Antiretroviral Therapy (NART) Electronic Medical Record (EMR) system was designed and developed with guidance from the Ministry of Health through the Department of HIV and AIDS (DHA) with the aim of supporting the management of HIV patient data and reporting in high prevalence ART clinics. As of 2021, the system has been scaled up to over 206 facilities across the country. The system is integrated with the clinical decision support system (CDSS) to assist healthcare providers in making a decision about an individual patient at a particular point in time. Despite NART EMR undergoing several evaluations and assessments, little has been done to evaluate the clinical decision support system in the NART EMR system. Hence, the study aimed to evaluate the use of CDSS in the NART EMR system in Malawi. The study adopted a mixed-method approach, and data was collected through interviews, observations, and questionnaires. The study has revealed that the CDSS tools were integrated into the ART clinic workflow, making it easy for the user to use it. The study has also revealed challenges in system reliability and information accuracy. Despite the challenges, the study further revealed that the system is effective and efficient, and overall, users are satisfied with the system. The study recommends that the implementers focus more on the logic behind the clinical decision-support intervention in order to address some of the concerns and enhance the accuracy of the information supplied. The study further suggests consulting the system's actual users throughout implementation.

Keywords: clinical decision support system, electronic medical record system, usability, antiretroviral therapy

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Authors: Ashok V. Sutagundar, Sunilkumar S. Manvi

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Energy, delay and bandwidth are the prime issues of wireless sensor network (WSN). Energy usage optimization and efficient bandwidth utilization are important issues in WSN. Event triggered data aggregation facilitates such optimal tasks for event affected area in WSN. Reliable delivery of the critical information to sink node is also a major challenge of WSN. To tackle these issues, we propose an event driven dynamic clustering and data aggregation scheme for WSN that enhances the life time of the network by minimizing redundant data transmission. The proposed scheme operates as follows: (1) Whenever the event is triggered, event triggered node selects the cluster head. (2) Cluster head gathers data from sensor nodes within the cluster. (3) Cluster head node identifies and classifies the events out of the collected data using Bayesian classifier. (4) Aggregation of data is done using statistical method. (5) Cluster head discovers the paths to the sink node using residual energy, path distance and bandwidth. (6) If the aggregated data is critical, cluster head sends the aggregated data over the multipath for reliable data communication. (7) Otherwise aggregated data is transmitted towards sink node over the single path which is having the more bandwidth and residual energy. The performance of the scheme is validated for various WSN scenarios to evaluate the effectiveness of the proposed approach in terms of aggregation time, cluster formation time and energy consumed for aggregation.

Keywords: wireless sensor network, dynamic clustering, data aggregation, wireless communication

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Authors: Ernest Nweke

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Mongolia has made giant strides in the development of its auditing and accounting system from Soviet-style to a market-oriented system. High levels of domestic and foreign investment desired by the Mongolian government require that better and improved quality of corporate information and disclosure consistent with international standards be made available to investors. However, the Mongolian Certified Public Accountants (CPA) profession is still developing, and the quality of services provided by accounting firms in most cases do not comply with International Financial Reporting Standards (IFRS) framework approved by the government for use in financial reporting. Against this backdrop, Accounting and audit reforms, liberalization and deregulation, establishment of an efficient and effective professional monitoring and supervision regime are policy necessities. These will further enhance the Mongolian business environment, eliminate incompetence in the system, make the economy more attractive to investors and ultimately lift reporting standards and bring about improved accounting, auditing and disclosure practices among Mongolian firms. This paper examines the fundamental issues in the accounting and auditing environment in Mongolia and investigates the relationship between selected characteristics of Mongolian Stock Exchange (MSE) listed firms (profitability, leverage, firm size, firm auditor size, firm listing age, board size and proportion of independent directors) and voluntary accounting disclosures in their annual reports and accounts. The selected sample of firms for the research purpose consists of the top 20 indexes of the MSE, representing over 95% of the market capitalization. An empirical analysis of the hypothesized relationship was carried out using multiple regression in EViews analytical software. Research results lend credence to the fact that only a few of the company attributes positively impact voluntary accounting disclosures in Mongolian Stock Exchange-listed firms. The research is motivated by the absence of empirical evidence on the correlation between the quality of voluntary accounting disclosures made by listed companies in Mongolia and company characteristics and the findings thereof significantly useful to both firms and regulatory authorities. The concluding part of the paper precisely consists of useful research-based recommendations for listed firms and regulatory agencies on measures to put in place in order to enhance the quality of corporate financial reporting and disclosures in Mongolia.

Keywords: accounting, auditing, corporate disclosure, listed firms

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Authors: Dana Mohammed, Fatemah Abdullah, Hawraa Ali, Najat Al-Shaer, Rawan Al-Awadhi, , Magdy Helal

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We study the patient service performance at the emergency department of a major Kuwaiti public hospital, using discrete simulation and lean concepts. In addition to the common problems in such health care systems (over crowdedness, facilities planning and usage, scheduling and staffing, capacity planning) the emergency department suffered from several cultural and patient behavioural issues. Those contributed significantly to the system problems and constituted major obstacles in maintaining the performance in control. This led to overly long waiting times and the potential of delaying providing help to critical cases. We utilized the visual management tools to mitigate the impact of the patients’ behaviours and attitudes and improve the logistics inside the system. In addition a proposal is made to automate the date collection and communication within the department using RFID-based barcoding system. Discrete event simulation models were developed as decision support systems; to study the operational problems and assess achieved improvements. The simulation analysis resulted in cutting the patient delays to about 35% of their current values by reallocating and rescheduling the medical staff. Combined with the application of the visual management concepts, this provided the basis to improving patient service without any major investments.

Keywords: simulation, visual management, health care system, patient

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Authors: Jatuphum Ketchatturat

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Value-added assessment has been used for developing the model of monitoring and evaluation of student's learning achievement. The steps of model development consist of 1) study and analyisis of the school and the district report system of student achievement and progress, 2) collecting the data of student achievement to develop the value added indicator, 3) developing the system of value-added assessment by participatory action research approach, 4) putting the system of value-added assessment into the educational district of secondary school, 5) determining the quality of the developed system of value-added assessment. The components of the developed model consist of 1) the database of value-added assessment of student's learning achievement, 2) the process of monitoring and evaluation the student's learning achievement, and 3) the reporting system of value-added assessment of student's learning achievement.

Keywords: learning achievement, monitoring and evaluation, value-added assessment

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Authors: Ruel A. Welch

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Since the introduction of ServiceNow, the UK’s Science Museum Group’s (SMG) ICT service desk portal. There has not been an analysis of the tools available to SMG staff for just-in-time knowledge acquisition (knowledge management systems) and reporting ICT incidents with a focus on an aspect of professional identity, namely, gender. This study is conducted in the milieu of UK museums, galleries, arts, academic, charitable, and cultural heritage sectors. Numerous authors suggest that males and females experience ICT usage differently. Therefore, it is important for SMG to investigate the apparent disparities so that solutions can be derived to minimize this digital divide if one exists. It is acknowledged at SMG that there are challenges with keeping up with an ever-changing digital landscape. Subsequently, this entails the rapid upskilling of staff and developing an infrastructure that supports just-in-time technological knowledge acquisition and reporting technology-related issues. This problem was addressed by analyzing ServiceNow ICT incident reports and reports from knowledge articles from a six-month period from February to July. This study found a statistically significant relationship between gender and reporting an ICT incident. There is also a significant relationship between gender and the priority level of ICT incidents. Interestingly, there is no statistically significant relationship between gender and reading knowledge articles. Additionally, there is no statistically significant relationship between gender and reporting an ICT incident related to the knowledge article that was read by staff. The knowledge acquired from this study is useful to service desk management practice as it will help to inform the creation of future knowledge articles and ICT incident reporting processes.

Keywords: digital divide, ICT service desk practice, knowledge management systems, workplace learning

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Authors: Tarah Bouaricha

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The impact of worst natural disasters is analysed in terms of insured losses which happened between 2010 and 2014 on S&P insurance index. Event study analysis is used to test whether natural disasters impact insurance index stock market price. There is no negative impact on insurance stock market price around the disasters event. To analyse the reaction of insurance stock market, normal returns (NR), abnormal returns (AR), cumulative abnormal returns (CAR), cumulative average abnormal returns (CAAR) and a parametric test on AR and on CAR are used.

Keywords: study event, natural disasters, insurance, reinsurance, stock market

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Authors: Ashana Gupta

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Aim: In the UK, Botulinum Toxin (botox) is authorised for treating chronic myofascial pain secondary to masseter muscle hypertrophy (Fedorowicz et al. 2013). This audit aimed to ensure the Maxillofacial Unit is meeting the trust guidelines for the safe storage and disposal of botox. Method: The trust upholds a strict policy for botox handling. The audit was designed to optimise several elements including Staff awareness of regulations around botox handling A questionnaire was designed to test knowledge of advised storage temperatures, reporting of adverse events, disposal procedures and regulatory authorities. Steps taken to safely delivertoxin and eliminate unused toxin. A checklist was completed. These include marks for storagetemperature, identification checks, disposal of sharps, deactivation of toxin, and disposal. Results: All staff correctly stated storage requirements for toxin. 75% staff (n=8) were unsure about reporting and regulations. Whilst all staff knew how to dispose of vials, 0% staff showed awareness for the crucial step of deactivating toxin. All checklists (n=20) scored 100% for adequate storage, ID checks, and toxin disposal. However, there were no steps taken to deactivate toxin in any cases. Staff training took place with revision to clinical protocols. In line with Trust guidelines, an additional clinical step has been introduced including use of 0.5% sodium hypochlorite to deactivate botox. Conclusion: Deactivation is crucial to ensure residual toxin is not misused. There are cases of stolen botox within South-Tees Hospital (Woodcock, 2014). This audit was successful in increasing compliance to safe handling and disposal of botox by 100% and ensured our hospitalmeets Trust guidance.

Keywords: botulinum toxin, aesthetics, handling, disposal

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Authors: Kok Meng Ng, Sulung Veronica

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Electronic Dance Music (EDM), a musical event that so sought-after amongst the youth, is getting prevailed around the world. The emergence of this à la mode event has magnetized lots of attentions from the media as well as the public due to its high probabilities in creating social problems and menacing social harmony of one destination, for instance, two death cases occurred during the EDM events in Malaysia caused a feeling of consternation of the society. The arguments over the impacts of such events towards the society are endless. This paper focuses on the study of the impacts of EDM towards social harmony in Klang Valley area, Malaysia by scrutinizing the contradiction of statements from several experts and the local communities. This study sampled 15-20 people that represent different social background with face-to-face and online interview through snowball sampling method. This study helps to understand the social context as a whole based on the impacts of EDM events that take place in Malaysia. It also provides valuable information to EDMs’ organizer as well as local authorities for a proper event management to minimize EDM impacts towards society as part of the sustainable growth of the event industry.

Keywords: electronic dance music, social harmony, impacts, Klang Valley

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Authors: Ruairi J. McMillan

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Introduction: This critical analysis aims to ascertain how well neuroanatomical aetiologies are communicated within 20 case reports of aphasia. Neuroanatomical visualisations based on dissected brain specimens were produced and combined with white matter tract and vascular taxonomies of function in order to address the most consistently underreported features found within the aphasic case study reports. Together, these approaches are intended to integrate aphasiological knowledge from the past 20 years with aphasiological diagnostics, and to act as prototypal resources for both researchers and clinical professionals. The medico-legal precedent for aphasia diagnostics under Canadian, US and UK case law and the neuroimaging/neurological diagnostics relative to the functional capacity of aphasic patients are discussed in relation to the major findings of the literary analysis, neuroimaging protocols in clinical use today, and the neuroanatomical aetiologies of different aphasias. Basic Methodology: Literature searches of relevant scientific databases (e.g, OVID medline) were carried out using search terms such as aphasia case study (year) & stroke induced aphasia case study. A series of 7 diagnostic reporting criteria were formulated, and the resulting case studies were scored / 7 alongside clinical stroke criteria. In order to focus on the diagnostic assessment of the patient’s condition, only the case report proper (not the discussion) was used to quantify results. Statistical testing established if specific reporting criteria were associated with higher overall scores and potentially inferable increases in quality of reporting. Statistical testing of whether criteria scores were associated with an unclear/adjusted diagnosis were also tested, as well as the probability of a given criterion deviating from an expected estimate. Major Findings: The quantitative analysis of neuroanatomically driven diagnostics in case studies of aphasia revealed particularly low scores in the connection of neuroanatomical functions to aphasiological assessment (10%), and in the inclusion of white matter tracts within neuroimaging or assessment diagnostics (30%). Case studies which included clinical mention of white matter tracts within the report itself were distributed among higher scoring cases, as were case studies which (as clinically indicated) related the affected vascular region to the brain parenchyma of the language network. Concluding Statement: These findings indicate that certain neuroanatomical functions are integrated less often within the patient report than others, despite a precedent for well-integrated neuroanatomical aphasiology also being found among the case studies sampled, and despite these functions being clinically essential in diagnostic neuroimaging and aphasiological assessment. Therefore, ultimately the integration and specificity of aetiological neuroanatomy may contribute positively to the capacity and autonomy of aphasic patients as well as their clinicians. The integration of a full aetiological neuroanatomy within the reporting of aphasias may improve patient outcomes and sustain autonomy in the event of medico-ethical investigation.

Keywords: aphasia, language network, functional neuroanatomy, aphasiological diagnostics, medico-legal ethics

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Authors: Eko Budi Santoso

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There is a growing interest in Corporate Social Responsibility (CSR) issues in developing countries such as Indonesia. Firms disclose their CSR activities, and some provide assurance to gain recognition as socially responsible firms. However, several of those socially responsible firms involve in tax scandals and raise a question of whether CSR disclosure is used to disguise firm misconduct or as a reflection of socially responsible firms. Specifically, whether firms engage in CSR disclosure and its assurance also responsible for their tax matters. This study examines the association between CSR disclosure and tax aggressiveness and the role of sustainability reporting assurance to the association. This research develops a modified index according to global reporting initiatives to measure CSR disclosure and various measurement for tax aggressiveness. Using a sample of Indonesian go public companies issued CSR disclosure, the empirical result shows that there is an association between CSR disclosure and tax aggressiveness. In addition, results also indicate sustainability reporting assurance moderate those association. The findings suggest that stakeholder in developing countries should examine carefully firms with active CSR disclosure before label it as socially responsible firms. JEL Classification: M14

Keywords: CSR disclosure, tax aggressiveness, assurance, business ethics

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Authors: Ping Xu, Gregory T. Golm, Guanghan (Frank) Liu

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In the presence of competing events, traditional survival analysis may not be appropriate and can result in biased estimates, as it assumes independence between competing events and the event of interest. Instead, competing risk analysis should be considered to correctly estimate the survival probability of the event of interest and the hazard ratio between treatment groups. The COVID-19 pandemic has provided a potential source of competing risks in clinical trials, as participants in trials may experienceCOVID-related competing events before the occurrence of the event of interest, for instance, death due to COVID-19, which can affect the incidence rate of the event of interest. We have performed simulation studies to compare multiple competing risk analysis models, including the cumulative incidence function, the sub-distribution hazard function, and the cause-specific hazard function, to the traditional survival analysis model under various scenarios. We also provide a general recommendation on conducting competing risk analysis in randomized clinical trials during the era of the COVID-19 pandemic based on the extensive simulation results.

Keywords: competing risk, survival analysis, simulations, randomized clinical trial, COVID-19 pandemic

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Authors: Natascha C. D'Amico, Enzo Grossi, Giovanni Valbusa, Ala Malasevschi, Gianpiero Cardone, Sergio Papa

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Purpose: To characterize, through a radiomic approach, the nature of areas classified PI-RADS (Prostate Imaging Reporting and Data System) 3/5, recognized in multiparametric prostate magnetic resonance with T2-weighted (T2w), diffusion and perfusion sequences with paramagnetic contrast. Methods and Materials: 24 cases undergoing multiparametric prostate MR and biopsy were admitted to this pilot study. Clinical outcome of the PI-RADS 3/5 was found through biopsy, finding 8 malignant tumours. The analysed images were acquired with a Philips achieva 1.5T machine with a CE- T2-weighted sequence in the axial plane. Semi-automatic tumour segmentation was carried out on MR images using 3DSlicer image analysis software. 45 shape-based, intensity-based and texture-based features were extracted and represented the input for preprocessing. An evolutionary algorithm (a TWIST system based on KNN algorithm) was used to subdivide the dataset into training and testing set and select features yielding the maximal amount of information. After this pre-processing 20 input variables were selected and different machine learning systems were used to develop a predictive model based on a training testing crossover procedure. Results: The best machine learning system (three-layers feed-forward neural network) obtained a global accuracy of 90% ( 80 % sensitivity and 100% specificity ) with a ROC of 0.82. Conclusion: Machine learning systems coupled with radiomics show a promising potential in distinguishing benign from malign tumours in PI-RADS 3/5 areas.

Keywords: machine learning, MR prostate, PI-Rads 3, radiomics

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Authors: Abdel-Tawab H. Mossa

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Synthetic pesticides are widely used in large-scale worldwide for control pests in agriculture and public health sectors in both developed and developing countries. Although the positive role of pesticides, they have many adverse toxic effects on humans, animals, and the ecosystem. Therefore, in the last few years, scientists have been searching for new active compounds from natural resources as an alternative to synthetic pesticides. Currently, many commercial natural pesticides are available commercially worldwide. These products are recommended for uses in organic farmers and considered as safe pesticides. This paper focuses on the adverse effects of natural pesticides on mammals. Available commercial pesticides in the market contain essential oils (e.g. pepper, cinnamon, and garlic), plant extracts, microorganism (e.g. bacteria, fungi or their toxin), mineral oils and some active compounds from natural recourses e.g. spinosad, neem, pyrethrum, rotenone, abamectin and other active compounds from essential oils (EOs). Some EOs components, e.g., thujone, pulegone, and thymol have high acute toxicity (LD50) is 87.5, 150 and 980 mg/kg. B.wt on mice, respectively. Natural pesticides such as spinosad, pyrethrum, neem, abamectin, and others have toxicological effects to mammals and ecosystem. These compounds were found to cause hematotoxicity, hepato-renal toxicity, biochemical alteration, reproductive toxicity, genotoxicity, and mutagenicity. It caused adverse effects on the ecosystem. Therefore, natural pesticides in general not safe and have high acute toxicity and can induce adverse effects at long-term exposure.

Keywords: natural pesticides, toxicity, safety, genotoxicity, ecosystem, biochemical

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Authors: Fan Ye

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Adverse weather conditions, particularly those with low visibility, are critical to the driving tasks. However, the direct relationship between visibility distances and traffic flow/roadway safety is uncertain due to the limitation of visibility data availability. The recent growth of deployment of Road Weather Information Systems (RWIS) makes segment-specific visibility information available which can be integrated with other Intelligent Transportation System, such as automated warning system and variable speed limit, to improve mobility and safety. Before applying the RWIS visibility measurements in traffic study and operations, it is critical to validate the data. Therefore, an attempt was made in the paper to examine the validity and viability of RWIS visibility data by comparing visibility measurements among RWIS, airport weather stations, and weather information recorded by police in crash reports, based on Ohio data. The results indicated that RWIS visibility measurements were significantly different from airport visibility data in Ohio, but no conclusion regarding the reliability of RWIS visibility could be drawn in the consideration of no verified ground truth in the comparisons. It was suggested that more objective methods are needed to validate the RWIS visibility measurements, such as continuous in-field measurements associated with various weather events using calibrated visibility sensors.

Keywords: RWIS, visibility distance, low visibility, adverse weather

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Authors: Sarika Gupta, Harshika Khanna, Ajay K Verma, Surya Kant

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Background: Drug-resistant tuberculosis (DR-TB) is a growing health challenge to global TB control efforts. Pediatric DR-TB is one of the neglected infectious diseases. In our previously published report, we have notified an increased prevalence of DR-TB in the pediatric population at a tertiary health care centre in North India which was estimated as 17.4%, 15.1%, 18.4%, and 20.3% in (%) in the year 2018, 2019, 2020, and 2021. Limited evidence exists about a pattern of drug resistance, side effect profile and programmatic outcomes of Paediatric DR-TB treatment. Therefore, this study was done to find out the pattern of resistance, side effect profile and treatment outcome. Methodology: This was a prospective cohort study conducted at the nodal drug-resistant tuberculosis centre of a tertiary care hospital in North India from January 2021 to December 2022. Subjects included children aged between 0-18 years of age with a diagnosis of DR-TB, on the basis of GeneXpert (rifampicin [RIF] resistance detected), line probe assay and drug sensitivity testing (DST) of M. tuberculosis (MTB) grown on a culture of body fluids. Children were classified as monoresistant TB, polyresistant TB (resistance to more than 1 first-line anti-TB drug, other than both INH and RIF), MDR-TB, pre-XDR-TB and XDR-TB, as per the WHO classification. All the patients were prescribed DR TB treatment as per the standard guidelines, either shorter oral DR-TB regimen or a longer all-oral MDR/XDR-TB regimen (age below five years needed modification). All the patients were followed up for side effects of treatment once per month. The patient outcomes were categorized as good outcomes if they had completed treatment and cured or were improving during the course of treatment, while bad outcomes included death or not improving during the course of treatment. Results: Of the 50 pediatric patients included in the study, 34 were females (66.7%) and 16 were male (31.4%). Around 33 patients (64.7%) were suffering from pulmonary TB, while 17 (33.3%) were suffering from extrapulmonary TB. The proportions of monoresistant TB, polyresistant TB, MDR-TB, pre-XDR-TB and XDR-TB were 2.0%, 0%, 50.0%, 30.0% and 18.0%, respectively. Good outcome was reported in 40 patients (80.0%). The 10 bad outcomes were 7 deaths (14%) and 3 (6.0%) children who were not improving. Adverse events (single or multiple) were reported in all the patients, most of which were mild in nature. The most common adverse events were metallic taste 16(31.4%), rash and allergic reaction 15(29.4%), nausea and vomiting 13(26.0%), arthralgia 11 (21.6%) and alopecia 11 (21.6%). Serious adverse event of QTc prolongation was reported in 4 cases (7.8%), but neither arrhythmias nor symptomatic cardiac side effects occurred. Vestibular toxicity was reported in 2(3.9%), and psychotic symptoms in 4(7.8%). Hepatotoxicity, hypothyroidism, peripheral neuropathy, gynaecomastia, and amenorrhea were reported in 2 (4.0%), 4 (7.8%), 2 (3.9%), 1(2.0%), and 2 (3.9%) respectively. None of the drugs needed to be withdrawn due to uncontrolled adverse events. Conclusion: Paediatric DR TB treatment achieved favorable outcomes in a large proportion of children. DR TB treatment regimen drugs were overall well tolerated in this cohort.

Keywords: pediatric, drug-resistant, tuberculosis, adverse events, treatment

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Authors: André Rui Coelho Fernandes, Mariana Rufino, Divakar Hamal, Amr Sousa, Emma Fossett, Kamalpreet Cheema

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Aim: A single patella tendon rupture is relatively uncommon, but a simultaneous bilateral event is a rare occurrence and has been scarcely reviewed in the literature. This review was carried out to analyse the existing literature on this event, with the aim of proposing a standardised approach to the diagnosis and management of this injury. Methods: A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Three independent reviewers conducted searches in PubMed, OvidSP for Medline and Embase, as well as Cochrane Library using the same search strategy. From a total of 183 studies, 45 were included, i.e. 90 patellas. Results: 46 patellas had a Type 1 Rupture equating to 51%, with Type 3 being the least common, with only 7 patellas sustaining this injury. The mean Insall-Salvio ratio for each knee was 1.62 (R) and 1.60 (L) Direct Primary Repair was the most common surgical technique compared to Tendon Reconstruction, with End to End and Transosseous techniques split almost equally. Brace immobilisation was preferred over cast, with a mean start to weight-bearing of 3.23 weeks post-op. Conclusions: Bilateral patellar tendon rupture is a rare injury that should be considered in patients with knee extensor mechanism disruption. The key limitation of this study was the low number of patients encompassed by the eligible literature. There is space for a higher level of evidence study, specifically regarding surgical treatment choice and methods, as well as post-operative management, which could potentially improve the outcomes in the management of this injury.

Keywords: trauma and orthopaedic surgery, bilateral patella, tendon rupture, trauma

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Authors: Jerry Q. Cheng

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Currently, in analyzing large-scale recurrent event data, there are many challenges such as memory limitations, unscalable computing time, etc. In this research, a divide-and-conquer method is proposed using parametric frailty models. Specifically, the data is randomly divided into many subsets, and the maximum likelihood estimator from each individual data set is obtained. Then a weighted method is proposed to combine these individual estimators as the final estimator. It is shown that this divide-and-conquer estimator is asymptotically equivalent to the estimator based on the full data. Simulation studies are conducted to demonstrate the performance of this proposed method. This approach is applied to a large real dataset of repeated heart failure hospitalizations.

Keywords: big data analytics, divide-and-conquer, recurrent event data, statistical computing

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Authors: Santi Gopal Maji, R. A. J. Syngkon

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The changing attitude of the corporate enterprises from maximizing economic benefit to corporate sustainability after the publication of Brundtland Report has attracted the interest of researchers to investigate the sustainability practices of firms and its impact on financial performance. To enrich the empirical literature in Asian context, this study examines the disclosure pattern of corporate sustainability and the influence of sustainability reporting on financial performance of firms from four Asian countries (Japan, South Korea, India and Indonesia) that are publishing sustainability report continuously from 2009 to 2016. The study has used content analysis technique based on Global Reporting Framework (3 and 3.1) reporting framework to compute the disclosure score of corporate sustainability and its components. While dichotomous coding system has been employed to compute overall quantitative disclosure score, a four-point scale has been used to access the quality of the disclosure. For analysing the disclosure pattern of corporate sustainability, box plot has been used. Further, Pearson chi-square test has been used to examine whether there is any difference in the proportion of disclosure between the countries. Finally, quantile regression model has been employed to examine the influence of corporate sustainability reporting on the difference locations of the conditional distribution of firm performance. The findings of the study indicate that Japan has occupied first position in terms of disclosure of sustainability information followed by South Korea and India. In case of Indonesia, the quality of disclosure score is considerably less as compared to other three countries. Further, the gap between the quality and quantity of disclosure score is comparatively less in Japan and South Korea as compared to India and Indonesia. The same is evident in respect of the components of sustainability. The results of quantile regression indicate that a positive impact of corporate sustainability becomes stronger at upper quantiles in case of Japan and South Korea. But the study fails to extricate any definite pattern on the impact of corporate sustainability disclosure on the financial performance of firms from Indonesia and India.

Keywords: corporate sustainability, quality and quantity of disclosure, content analysis, quantile regression, Asian countries

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Authors: Ioannis Andrianakis, Manolis Falelakis, Maria Pavlidou, Konstantinos Papakonstantinou, Ermioni Avramidou, Dimitrios Kalogiannis, Nikolaos Milios, Katerina Bountakidou, Kiriakos Chatzidimitriou, Panagiotis Panagiotopoulos

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Artistic events, such as concerts and performances, are challenging to organize because they involve many people with different skill sets. Small and medium venues often struggle to afford the costs and overheads of booking and hosting remote artists, especially if they lack sponsors or subsidies. This limits the opportunities for both venues and artists, especially those outside of big cities. However, more and more research shows that audiences prefer smaller-scale events and concerts, which benefit local economies and communities. To address this challenge, our project “PerformAnts: Digital Event Manager-Organizer” aims to develop a smart digital tool that automates and optimizes the processes and costs of live shows and tours. By using machine learning, applying best practices and training users through workshops, our platform offers a comprehensive solution for a growing market, enhances the mobility of artists and the accessibility of venues and allows professionals to focus on the creative aspects of concert production.

Keywords: event organization, creative industries, event promotion, machine learning

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Authors: Johannes Atug, Andreas Radke, Mitchell Tseng, Gunther Reinhart

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In modern supply chains, large numbers of SKU (Stock-Keeping-Unit) need to be timely managed, and any delays in noticing disruptions of items often limit the ability to defer the impact on customer order fulfillment. However, in supply chains of IoT-connected enterprises, the ERP (Enterprise-Resource-Planning), the MES (Manufacturing-Execution-System) and the SCADA (Supervisory-Control-and-Data-Acquisition) systems generate large amounts of data, which generally glean much earlier notice of deviations in the business process steps. That is, analyzing these streams of data with process mining techniques allows the monitoring of the supply chain business processes and thus identification of items that deviate from the standard order fulfillment process. In this paper, a framework to enable event-based SCM (Supply-Chain-Management) processes including an overview of core enabling technologies are presented, which is based on the RAMI (Reference-Architecture-Model for Industrie 4.0) architecture. The application of this framework in the industry is presented, and implications for SCM in industry 4.0 and further research are outlined.

Keywords: cyber-physical production systems, event-based monitoring, supply chain management, RAMI (Reference-Architecture-Model for Industrie 4.0)

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Authors: Abdulaziz Alakeel, Roaa Alamri, Abdulrahman Alomair, Mohammed Fouda

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Introduction: Ibrutinib is a selective, potent, and irreversible small-molecule inhibitor of Bruton's tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue (CYS-481) at the active site of Btk, leading to inhibition of Btk enzymatic activity. The drug is indicated to treat certain type of cancers such as mantle cell lymphoma (MCL), chronic lymphocytic leukaemia and Waldenström's macroglobulinaemia (WM). Cardiac failure is a condition referred to inability of heart muscle to pump adequate blood to human body organs. There are multiple types of cardiac failure including left and right-sided heart failure, systolic and diastolic heart failures. The aim of this review is to evaluate the risk of cardiac failure associated with the use of ibrutinib and to suggest regulatory recommendations if required. Methodology: Signal Detection team at the National Pharmacovigilance Center (NPC) of Saudi Food and Drug Authority (SFDA) performed a comprehensive signal review using its national database as well as the World Health Organization (WHO) database (VigiBase), to retrieve related information for assessing the causality between cardiac failure and ibrutinib. We used the WHO- Uppsala Monitoring Centre (UMC) criteria as standard for assessing the causality of the reported cases. Results: Case Review: The number of resulted cases for the combined drug/adverse drug reaction are 212 global ICSRs as of July 2020. The reviewers have selected and assessed the causality for the well-documented ICSRs with completeness scores of 0.9 and above (35 ICSRs); the value 1.0 presents the highest score for best-written ICSRs. Among the reviewed cases, more than half of them provides supportive association (four probable and 15 possible cases). Data Mining: The disproportionality of the observed and the expected reporting rate for drug/adverse drug reaction pair is estimated using information component (IC), a tool developed by WHO-UMC to measure the reporting ratio. Positive IC reflects higher statistical association while negative values indicates less statistical association, considering the null value equal to zero. The results of (IC=1.5) revealed a positive statistical association for the drug/ADR combination, which means “Ibrutinib” with “Cardiac Failure” have been observed more than expected when compared to other medications available in WHO database. Conclusion: Health regulators and health care professionals must be aware for the potential risk of cardiac failure associated with ibrutinib and the monitoring of any signs or symptoms in treated patients is essential. The weighted cumulative evidences identified from causality assessment of the reported cases and data mining are sufficient to support a causal association between ibrutinib and cardiac failure.

Keywords: cardiac failure, drug safety, ibrutinib, pharmacovigilance, signal detection

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Authors: Arun Prasad Jaganathan

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In today's dynamic industrial world, traditional task allocation methods often fall short in adapting to evolving operational conditions. This paper introduces an AI-enabled task assistance and management system designed to overcome the limitations of conventional approaches. By using artificial intelligence (AI) and machine learning (ML), the system intelligently interprets user instructions, analyzes tasks, and allocates resources based on real-time data and environmental factors. Additionally, geolocation tracking enables proactive identification of potential delays, ensuring timely interventions. With its transparent reporting mechanisms, the system provides stakeholders with clear insights into task progress, fostering accountability and informed decision-making. The paper presents a comprehensive overview of the system architecture, algorithm, and implementation, highlighting its potential to revolutionize task management across diverse industries.

Keywords: artificial intelligence, machine learning, task allocation, operational efficiency, resource optimization

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Authors: Karen J. Polvado, Betty Bowles, Jansen Lauren, Gibson Martha, Robin Lockhart

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The purpose of this study was to identify motivation to participate in the Hotter ‘n Hell Hundred (HHH) bicycling event, and the participants’ demographics, health risk factors, and preparation to ride in the event. A convenience sample of adults pre-registered for non-competitive cycling events (N = 7,472) were requested to complete a survey. Of these, 2,645 (35%) responded. Questions identified the participants’ demographics, preparation, previous experience with HHH, and motives for riding. The HHH attracted riders of all ages (18-80), genders, ethnicities, and educational levels. The majority were males, 40-59 years old, married, college graduates, and identified themselves as non-Hispanic whites. The majority (68%) reported no existing medical conditions, and were normal weight (70%), although 52% had been overweight or obese in the past. Preparation to ride in the HHH varied from riding more than five times a week for the last year, to riding 1-2 times per week one month before the event. Most (93%) had ridden in the HHH an average of 5 times. Motivations to ride included: personal challenge (75%); to experience the HHH ride (57%); a chance to ride with family/friends/coworkers (52%); improving health (47%); fun (33%); challenge by others (15%); part of a weight loss plan (11%); training for another event (10%); and raising money for a cause (2%). The motivation to participate appeared to move from extrinsic to intrinsic motivation as age increased. Exploration of the exercise habits and motivations of older adults (70+) is suggested by this study.

Keywords: cycling, motivation, physical activity, training

Procedia PDF Downloads 276