Search results for: FDA adverse event reporting system

Authors: Farhad Arian Far, Anjanette Q. Eleazar, Francis Aldrine A. Uy, Mary Joyce Anne V. Uy

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The Unified Philippine Accident Reporting and Database System (UPARDS), is a newly developed system by Dr. Francis Aldrine Uy of the Mapua Institute of Technology. The main purpose is to provide an advanced road accident investigation tool, record keeping and analysis system for stakeholders such as Philippine National Police (PNP), Metro Manila Development Authority (MMDA), Department of Public Works and Highways (DPWH), Department of Health (DOH), and insurance companies. The system is composed of 2 components, the mobile application for road accident investigators that takes advantage of available technology to advance data gathering and the web application that integrates all accident data for the use of all stakeholders. The researchers with the cooperation of PNP’s Vehicle Traffic Investigation Sector of the City of Manila, conducted the field-testing of the application in fifteen (15) accident cases. Simultaneously, the researchers also distributed surveys to PNP, Manila Doctors Hospital, and Charter Ping An Insurance Company to gather their insights regarding the web application. The survey was designed on information systems theory called Technology Acceptance Model. The results of the surveys revealed that the respondents were greatly satisfied with the visualization and functions of the applications as it proved to be effective and far more efficient in comparison with the conventional pen-and-paper method. In conclusion, the pilot study was able to address the need for improvement of the current system.

Keywords: accident, database, investigation, mobile application, pilot testing

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Authors: Melanie Verhovnik

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Media shape the image of crime, peoples’ believes, attitudes and sometimes also behaviors. Media not only gives the impression that crime is increasing, it also suggest that very violent crime is more common than it actually is. It is also no wonder that humans are more afraid of being involved in a crime committed by strangers than committed by somebody they know – because this is the media construct. With the help of three case studies, the paper analyzes how media frames crime and criminals and gives valuable hints as to what better reporting could look like.

Keywords: court reporting, offenders in media, quantitative content analysis, victims in media

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Authors: Arvind Srivastav, Tarun Kanti Bhattacharyya

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The north-eastern, Himalayan, and Eastern Ghats Belt of India comprise of earthquake-prone, remote, and hilly terrains. Earthquakes have caused enormous damages in these regions in the past. A wireless sensor network based earthquake early warning system (EEWS) is being developed to mitigate the damages caused by earthquakes. It consists of sensor nodes, distributed over the region, that perform majority voting of the output of the seismic sensors in the vicinity, and relay a message to a base station to alert the residents when an earthquake is detected. At the heart of the EEWS is a low-power two-stage seismic sensor that continuously tracks seismic events from incoming three-axis accelerometer signal at the first-stage, and, in the presence of a seismic event, triggers the second-stage P-wave detector that detects the onset of P-wave in an earthquake event. The parameters of the P-wave detector have been optimized for minimizing detection time and maximizing the accuracy of detection.Working of the sensor scheme has been verified with seven earthquakes data retrieved from IRIS. In all test cases, the scheme detected the onset of P-wave accurately. Also, it has been established that the P-wave onset detection time reduces linearly with the sampling rate. It has been verified with test data; the detection time for data sampled at 10Hz was around 2 seconds which reduced to 0.3 second for the data sampled at 100Hz.

Keywords: earthquake early warning system, EEWS, STA/LTA, polarization, wavelet, event detector, P-wave detector

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Authors: Ming-Dong Wang, Abigail F. Ruby, Michelle E. Ross

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Methylphenidate is a first-line treatment drug for attention deficit hyperactivity disorder (ADHD), a common mental health disorder in children and adolescents. Over the last several decades, the rate of children and adolescents using ADHD medication has been increasing in many countries. A recent study found that the prevalence of ADHD medication use among children aged 3-18 years increased in 13 different world regions between 2001 and 2015, where the absolute increase ranged from 0.02 to 0.26% per year. The goal of this study was to examine the use of methylphenidate in Canadian children and its associated adverse reactions. Methylphenidate use information among young Canadians aged 0-14 years was extracted from IQVIA data on prescriptions dispensed by pharmacies between April 2014 and June 2020. The adverse reaction information associated with methylphenidate use was extracted from the Canada Vigilance database for the same time period. Methylphenidate use trends were analyzed based on sex, age group (0-4 years, 5-9 years, and 10-14 years), and geographical location (province). The common classes of adverse reactions associated with methylphenidate use were sorted, and the relative risks associated with methylphenidate use as compared with two second-line amphetamine medications for ADHD were estimated. This study revealed that among Canadians aged 0-14 years, every 100 people used about 25 prescriptions (or 23,000 mg) of methylphenidate per year during the study period, and the use increased with time. Boys used almost three times more methylphenidate than girls. The amount of drug used was inversely associated with age: Canadians aged 10-14 years used nearly three times as many drugs compared to those aged 5-9 years. Seasonal methylphenidate use patterns were apparent among young Canadians, but the seasonal trends differed among the three age groups. Methylphenidate use varied from region to region, and the highest methylphenidate use was observed in Quebec, where the use of methylphenidate was at least double that of any other province. During the study period, Health Canada received 304 adverse reaction reports associated with the use of methylphenidate for Canadians aged 0-14 years. The number of adverse reaction reports received for boys was 3.5 times higher than that for girls. The three most common adverse reaction classes were psychiatric disorders, nervous system disorders and injury, poisoning procedural complications. The number one commonly reported adverse reaction for boys was aggression (11.2%), while for girls, it was a tremor (9.6%). The safety profile in terms of adverse reaction classes associated with methylphenidate use was similar to that of the selected control products. Methylphenidate is a commonly used pharmaceutical product in young Canadians, particularly in the province of Quebec. Boys used approximately three times more of this product as compared to girls. Future investigation is needed to determine what factors are associated with the observed geographic variations in Canada.

Keywords: adverse reaction risk, methylphenidate, prescription trend, use variation

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Authors: Melissa Langevin, Natalie Ward, Colleen Fitzgibbons, Christa Ramsey, Melanie Hogue, Anna Theresa Lobos

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Description: Root Cause Analysis (RCA) is used by health care teams to examine adverse events (AEs) to identify causes which then leads to recommendations for prevention Despite widespread use, RCA has limitations. Best practices have not been established for implementing recommendations or tracking the impact of interventions after AEs. During phase 1 of this study, we used simulation to analyze two fictionalized AEs that occurred in hospitalized paediatric patients to identify and understand how the errors occurred and generated recommendations to mitigate and prevent recurrences. Scenario A involved an error of commission (inpatient drug error), and Scenario B involved detecting an error that already occurred (critical care drug infusion error). Recommendations generated were: improved drug labeling, specialized drug kids, alert signs and clinical checklists. Aim: Use simulation to optimize interventions recommended post critical event analysis prior to implementation in the clinical environment. Methods: Suggested interventions from Phase 1 were designed and tested through scenario simulation in the clinical environment (medicine ward or pediatric intensive care unit). Each scenario was simulated 8 times. Recommendations were tested using different, voluntary teams and each scenario was debriefed to understand why the error was repeated despite interventions and how interventions could be improved. Interventions were modified with subsequent simulations until recommendations were felt to have an optimal effect and data saturation was achieved. Along with concrete suggestions for design and process change, qualitative data pertaining to employee communication and hospital standard work was collected and analyzed. Results: Each scenario had a total of three interventions to test. In, scenario 1, the error was reproduced in the initial two iterations and mitigated following key intervention changes. In scenario 2, the error was identified immediately in all cases where the intervention checklist was utilized properly. Independently of intervention changes and improvements, the simulation was beneficial to identify which of these should be prioritized for implementation and highlighted that even the potential solutions most frequently suggested by participants did not always translate into error prevention in the clinical environment. Conclusion: We conclude that interventions that help to change process (epinephrine kit or mandatory checklist) were more successful at preventing errors than passive interventions (signage, change in memory aids). Given that even the most successful interventions needed modifications and subsequent re-testing, simulation is key to optimizing suggested changes. Simulation is a safe, practice changing modality for institutions to use prior to implementing recommendations from RCA following AE reviews.

Keywords: adverse events, patient safety, pediatrics, root cause analysis, simulation

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Authors: Anna Rudzińska, Katarzyna Szklener, Pola Juchaniuk, Anna Rodzajweska, Katarzyna Machulska-Ciuraj, Monika Rychlik- Grabowska, Michał łOziński, Agnieszka Kolak-Bruks, SłAwomir Mańdziuk

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Introduction: Immune checkpoint inhibition (ICI) belongs to the modern forms of anti-cancer treatment. Due to the constant development and continuous research in the field of ICI, many aspects of the treatment are yet to be discovered. One of the less researched aspects of ICI treatment is the influence of the adverse effects on the treatment success rate. It is suspected that adverse events in the course of the ICI treatment indicate a better response rate and correlate with longer progression-free- survival. Methodology: The research was conducted with the usage of the documentation of the Department of Clinical Oncology and Chemotherapy. Data of the patients with a lung cancer diagnosis who were treated between 2019-2022 and received ICI treatment were analyzed. Results: Out of over 133 patients whose data was analyzed, the vast majority were diagnosed with non-small cell lung cancer. The majority of the patients did not experience adverse effects. Most adverse effects reported were classified as grade 1 or grade 2 according to CTCAE classification. Most adverse effects involved skin, thyroid and liver toxicity. Statistical significance was found for the adverse effect incidence and overall survival (OS) and progression-free survival (PFS) (p=0,0263) and for the time of toxicity onset and OS and PFS (p<0,001). The number of toxicity sites was statistically significant for prolonged PFS (p=0.0315). The highest OS was noted in the group presenting grade 1 and grade 2 adverse effects. Conclusions: Obtained results confirm the existence of the prolonged OS and PFS in the adverse-effects-charged patients, mostly in the group presenting mild to intermediate (Grade 1 and Grade 2) adverse effects and late toxicity onset. Simultaneously our results suggest a correlation between treatment response rate and the toxicity grade of the adverse effects and the time of the toxicity onset. Similar results were obtained in several similar research conducted - with the proven tendency of better survival in mild and moderate toxicity; meanwhile, other studies in the area suggested an advantage in patients with any toxicity regardless of the grade. The contradictory results strongly suggest the need for further research on this topic, with a focus on additional factors influencing the course of the treatment.

Keywords: adverse effects, immunotherapy, lung cancer, PD-1/PD-L1 inhibitors

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Authors: Rafia Hassan, Ali Rizwan, Sadaf Farhan, Bushra Sabir

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The purpose of this study is to compare the conventional crop monitoring system with the satellite based crop monitoring system in Pakistan. This study is conducted for SUPARCO (Space and Upper Atmosphere Research Commission). The study focused on the wheat crop, as it is the main cash crop of Pakistan and province of Punjab. This study will answer the following: Which system is better in terms of cost, time and man power? The man power calculated for Punjab CRS is: 1,418 personnel and for SUPARCO: 26 personnel. The total cost calculated for SUPARCO is almost 13.35 million and CRS is 47.705 million. The man hours calculated for CRS (Crop Reporting Service) are 1,543,200 hrs (136 days) and man hours for SUPARCO are 8, 320hrs (40 days). It means that SUPARCO workers finish their work 96 days earlier than CRS workers. The results show that the satellite based crop monitoring system is efficient in terms of manpower, cost and time as compared to the conventional system, and also generates early crop forecasts and estimations. The research instruments used included: Interviews, physical visits, group discussions, questionnaires, study of reports and work flows. A total of 93 employees were selected using Yamane’s formula for data collection, which is done with the help questionnaires and interviews. Comparative graphing is used for the analysis of data to formulate the results of the research. The research findings also demonstrate that although conventional methods have a strong impact still in Pakistan (for crop monitoring) but it is the time to bring a change through technology, so that our agriculture will also be developed along modern lines.

Keywords: area frame, crop reporting service, CRS, sample frame, SRS/GIS, satellite remote sensing/ geographic information system

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Authors: Jawid Ahmad Baktash, Mursal Dawodi, Tomokazu Nagata

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With the rapid growth of Cloud Computing, Formal Methods became a good choice for the refinement of message specification and verification for Dynamic Routing in Cloud Computing. Cloud-based Dynamic Routing is becoming increasingly popular. We propose feedback in Formal Methods for Dynamic Routing and Cloud Computing; the model and topologies show how to send messages from index zero to all others formally. The responsibility of proper verification becomes crucial with Dynamic Routing in the cloud. Formal Methods can play an essential role in the routing and development of Networks, and the testing of distributed systems. Event-B is a formal technique that consists of describing the problem rigorously and introduces solutions or details in the refinement steps. Event-B is a variant of B, designed for developing distributed systems and message passing of the dynamic routing. In Event-B and formal methods, the events consist of guarded actions occurring spontaneously rather than being invoked.

Keywords: cloud, dynamic routing, formal method, Pro-B, event-B

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Authors: Nazia Nazir

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Background: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study was to observe the effect of adding dexmedetomidine to bupivacaine for the supraclavicular block. Methods (Design): In this randomized, double-blind study, seventy ASA I & II patients of either sex undergoing elective surgeries on the upper limb were given supraclavicular block under ultrasound guidance. Group C (n=35), received 38 mL 0.25% bupivacaine + 2mL normal saline and group D received 38 mL 0.25% bupivacaine + 1 µg/kg dexmedetomidine (2mL). Patients were observed for onset, duration of motor and sensory block, duration of analgesia, sedation score, hemodynamic changes and any adverse events. Results: In group D the onset was faster (P < 0.001), duration of sensory and motor block, as well as duration of analgesia, was prolonged as compared to group C (P < 0.0001). There was significant drop in heart rate (HR) from the baseline in group D (P < 0.05) at 30, 60, 90 and 120 min, however, none of the patients dropped HR below 50/min. Mean arterial Pressure (MAP) remained unaffected. The patients in group D were effectively sedated than those in group C (P < 0.05). No adverse event was reported in either group. Conclusion: Dexmedetomidine as adjuvant to bupivacaine in supraclavicular block resulted in faster action, prolonged motor and sensory block, prolonged analgesia with hemodynamic stability and adequate sedation.

Keywords: Analgesia, bupivacaine, dexmedetomidine, supraclavicular block

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Authors: Megumi Nishida, Naoya Motegi, Takurou Kikuchi, Tomoko Tokumura

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In recent years, power system has been changed and flexible power pricing system such as demand response has been sought in Japan. The demand response system is simple in the household sector and the owner, decision-maker, can gain the benefits of power saving. On the other hand, the execution of the demand response in the office building is more complex than household because various people such as owners, building administrators and occupants are involved in making decisions. While the owners benefit from the demand saving, the occupants are forced to be exposed to demand-saved environment certain benefits. One of the reasons is that building systems are usually centralized control and each occupant cannot choose either participate demand response event or not, and contribution of each occupant to demand response is unclear to provide incentives. However, the recent development of IT and building systems enables the personalized control of office environment where each occupant can control the lighting level or temperature around him or herself. Therefore, it can be possible to have a system which each occupant can make a decision of demand response participation in office building. This study investigates the personal behavior upon demand response requests, under the condition where each occupant can adjust their brightness individually in their workspace. Once workers participate in the demand response, their task lights are automatically turned off. The participation rates in the demand response events are compared between four groups which are divided by different motivation, the presence or absence of incentives and the way of participation. The result shows that there are the significant differences of participation rates in demand response event between four groups. The way of participation has a large effect on the participation rate. ‘Opt-out’ group, where the occupants are automatically enrolled in a demand response event if they don't express non-participation, will have the highest participation rate in the four groups. The incentive has also an effect on the participation rate. This study also reports that the impact of low illumination office environment on the occupants, such as stress or fatigue. The electrocardiogram and the questionnaire are used to investigate the autonomic nervous activity and subjective symptoms about the fatigue of the occupants. There is no big difference between dim workspace during demand response event and bright workspace in autonomic nervous activity and fatigue.

Keywords: demand response, illumination, questionnaire, electrocardiogram

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Authors: Bel G Raggad

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An e-Learning setting is a distributed computing environment where information resources can be connected to any public network. Public networks are very unsecure which can compromise the reliability of an e-Learning environment. This study is only concerned with the intrusion detection aspect of e-Learning security and how incident responses are planned. The literature reported great advances in intrusion detection system (ids) but neglected to study an important ids weakness: suspected events are detected but an intrusion is not determined because it is not defined in ids databases. We propose an incident response generator (DIRG) that produces incident responses when the working ids system suspects an event that does not correspond to a known intrusion. Data involved in intrusion detection when ample uncertainty is present is often not suitable to formal statistical models including Bayesian. We instead adopt Dempster and Shafer theory to process intrusion data for the unknown event. The DIRG engine transforms data into a belief structure using incident scenarios deduced by the security administrator. Belief values associated with various incident scenarios are then derived and evaluated to choose the most appropriate scenario for which an automatic incident response is generated. This article provides a numerical example demonstrating the working of the DIRG system.

Keywords: decision support system, distributed computing, e-Learning security, incident response, intrusion detection, security risk, statefull inspection

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Authors: Kathleen Joy Hingan, Jessiraye Luienne Catubigan, Carlo Mercado, Janisse RañEses

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In this research, the researchers wanted to explore how specialists and resident doctors in the fields of surgery, and obstetrics and gynecology handle their medical errors. They are interested in understanding the factors that contributed to the disclosure of medical error, the feelings after the occurrence of an error, and the way they coped with it given the power relations in place. The researchers conducted semi-structured interviews, transcribed the recordings, and analyzed the transcripts using thematic analysis. They found that doctors disclosed to their superiors and co-residents to cope with and to learn from the errors. In terms of disclosure to patients, the participants told them about the adverse event, but not about the error because of fear for themselves, their colleagues, their institution, and their patient. Doctors also performed compensatory actions to make up for the error and the nondisclosure of its occurrence. These actions functioned as a form of damage control too. Resident doctors and specialists receive different sanctions because of the power structures in the system.

Keywords: coping, disclosure, doctors, interviews, medical errors, thematic analysis

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Authors: Ramona Zharfpeykan, Paul Rouse

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Organizational sustainability is important to both organizations themselves and their stakeholders. Despite its increasing popularity and increasing numbers of organizations reporting sustainability, research on evaluating and comparing the sustainability performance of companies is limited. The aim of this study was to develop models to measure sustainability performance for both cross-sectional and longitudinal comparisons across companies in the same or different industries. A secondary aim was to see if sustainability reports can be used to evaluate sustainability performance. The study used both a content analysis of Australian sustainability reports in mining and metals and financial services for 2011-2014 and a survey of Australian and New Zealand organizations. Two methods ranging from a composite index using uniform weights to data envelopment analysis (DEA) were employed to analyze the data and develop the models. The results show strong statistically significant relationships between the developed models, which suggests that each model provides a consistent, systematic and reasonably robust analysis. The results of the models show that for both industries, companies that had sustainability scores above or below the industry average stayed almost the same during the study period. These indices and models can be used by companies to evaluate their sustainability performance and compare it with previous years, or with other companies in the same or different industries. These methods can also be used by various stakeholders and sustainability ranking companies such as the Global Reporting Initiative (GRI).

Keywords: data envelopment analysis, sustainability, sustainability performance measurement system, sustainability performance index, global reporting initiative

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Authors: Noriko Hanakawa, Masaki Obana

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A simulation tool has been proposed for big-scale projection mapping events. The tool has four main functions based on Mapbox and Unity utilities. The first function is building a 3D model of real cities by MapBox. The second function is a movie projection to some buildings in real cities by Unity. The third function is a movie sending function from a PC to a virtual projector. The fourth function is mapping movies with fitting buildings. The simulation tool was adapted to a real projection mapping event that was held in 2019. The event has been finished. The event had a serious problem in the movie projection to the target building. The extra tents were set in front of the target building. The tents became the obstacles to the movie projection. The simulation tool can be reappeared the problems of the event. Therefore, if the simulation tool was developed before the 2019 projection mapping event, the problem of the tents’ obstacles could be avoided with the simulation tool. In addition, we confirmed that the simulation tool is useful to make a plan of future projection mapping events in order to avoid obstacles of various extra equipment such as utility poles, planting trees, monument towers.

Keywords: projection mapping, projector position, real 3D map, avoiding obstacles

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Authors: Suriyani Ariffin, Nor Aziah Alias, Khairil Iskandar Othman, Haslinda Yusoff

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An Integrated Cumulative Grade Point Average (iCGPA) is a mechanism and strategy to ensure the curriculum of an academic programme is constructively aligned to the expected learning outcomes and student performance based on the attainment of those learning outcomes that is reported objectively in a spider web. Much effort and time has been spent to develop a viable mechanism and trains academics to utilize the platform for reporting. The question is: How well do learners conceive the idea of their achievement via iCGPA and whether quality learner attributes have been nurtured through the iCGPA mechanism? This paper presents the architecture of an integrated CGPA mechanism purported to address a holistic evaluation from the evaluation of courses learning outcomes to aligned programme learning outcomes attainment. The paper then discusses the students’ understanding of the mechanism and evaluation of their achievement from the generated spider web. A set of questionnaires were distributed to a group of students with iCGPA reporting and frequency analysis was used to compare the perspectives of students on their performance. In addition, the questionnaire also explored how they conceive the idea of an integrated, holistic reporting and how it generates their motivation to improve. The iCGPA group was found to be receptive to what they have achieved throughout their study period. They agreed that the achievement level generated from their spider web allows them to develop intervention and enhance the programme learning outcomes before they graduate.

Keywords: learning outcomes attainment, iCGPA, programme learning outcomes, spider web, iCGPA reporting skills

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Authors: Sachin Singh, Thomas Penzel, Dinesh Nandan

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Accurate identification of Sleep Apnea Hypopnea Syndrom Diagnosis is difficult problem for human expert because of variability among persons and unwanted noise. This paper proposes the diagonosis of Sleep Apnea Hypopnea Syndrome (SAHS) using airflow, ECG, Pulse and SaO2 signals. The features of each type of these signals are extracted using statistical methods and ANN learning methods. These extracted features are used to approximate the patient's Apnea Hypopnea Index(AHI) using sample signals in model. Advance signal processing is also applied to snore sound signal to locate snore event and SaO2 signal is used to support whether determined snore event is true or noise. Finally, Apnea Hypopnea Index (AHI) event is calculated as per true snore event detected. Experiment results shows that the sensitivity can reach up to 96% and specificity to 96% as AHI greater than equal to 5.

Keywords: neural network, AHI, statistical methods, autoregressive models

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Authors: Martin Surya Mulyadi, Rosinta Ria Panggabean

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The terms of intellectual capital emerge as the economic activity shift from the agricultural economy to knowledge economy and it will allow corporations to earn competitive advantage to its competitors. Considering its importance, many researches have a focus on how corporations disclose its intellectual capital. This intellectual capital research mainly focuses on developed country with only several researchers conducted this research in developing the country. While there are several intellectual capital researches in developing country, to authors’ best knowledge, there is no intellectual capital reporting research in Indonesia published internationally. This research will focus on two industries that acknowledge having a high reliance on intellectual capital: finance industry and the pharmaceutical industry. Our research found that Indonesian corporations in these industries are aware of the importance of intellectual capital, and variations of this disclosure exist within the industry.

Keywords: Developed country, Indonesia, Intellectual Capital, Intellectual Capital Reporting

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Authors: Sana Masmoudi Mardassi, Yosra Makni Fourati

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Regulators highlight the importance of the Audit Committee (AC) as a key internal corporate governance mechanism. One of the most important roles of this committee is to oversee the financial reporting process. The purpose of this paper is to examine the link between the characteristics of an audit committee and the financial reporting quality by investigating whether the characteristics of audit committees are associated with improved financial reporting quality, especially the Real Earnings Management. In the current study, a panel data from 80 nonfinancial companies listed on the Amsterdam Stock Exchange during the period between 2010 and 2017 were used. To measure audit committee characteristics, four proxies have been used, specifically, audit committee independence, financial expertise, gender diversity and AC meetings. For this research, a linear regression model was used to identify the influence of a set of board characteristics of the audit committee on real earnings management after controlling for firm audit committee size, leverage, size, loss, growth and board size. This research provides empirical evidence of the association between audit committee independence, financial expertise, gender diversity and meetings and Real Earnings Management (REM) as a proxy of financial reporting quality. The study finds that independence and AC Gender diversity are strongly related to financial reporting quality. In fact, these two characteristics constrain REM. The results also suggest that AC- financial expertise reduces to some extent, the likelihood of engaging in REM. These conclusions provide support then to the audit committee requirement under the Dutch Corporate Governance Code rules regarding gender diversity and AC meetings.

Keywords: audit committee, financial expertise, independence, real earnings management

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Authors: Wanda Luen-Wun Siu, Xiaowen Zhang

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This paper offered the primary methodical proof on how CSR reporting related to enterprise earnings in listed firms in China in light of most evidence focusing on cross-sectional data or data in a short span of time. Using full economic and business panel data on China’s publicly listed enterprise from 2006 to 2020 over two decades in the China Stock Market and Accounting Research database, we found initial evidence of significant direct relations between CSR reporting and firm corporate performance in both state-owned and privately owned firms over this period, supporting the stakeholder theory. Results also revealed that state-owned enterprises performed as well as private enterprises in the current period. But private enterprises performed better than state-owned enterprises in the subsequent years. Moreover, the release of social responsibility reports had a more significant impact on the financial performance of state-owned and private enterprises in the current period than in the subsequent periods. Specifically, CSR release was not significantly associated with the financial performance of state-owned enterprises on the lag of the first, second, and third periods. But it had an impact on the lag of the first, second, and third periods among private enterprises. Such findings suggested that CSR reporting helped improve the corporate financial performance of state-owned and private enterprises in the current period, but this kind of effect was more significant among private enterprises in the lag periods.

Keywords: China’s listed firms, CSR reporting, financial performance, panel analysis

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Authors: Remya Radhakrishnan, Hema Perinbanathan, Anukriti Rath, Reshmi Ramachandran, Rohith Thazhathuvetil Sasindrababu, Maria Karizhenskaia

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Childhood adversities have lasting effects on health and well-being. This abstract explores the connection between adverse childhood experiences (ACEs) and health consequences, including substance abuse and obesity. Understanding the impact of childhood trauma and emphasizing the importance of culturally sensitive treatments and focused interventions help to mitigate these effects. Research consistently shows a strong link between ACEs and poor health outcomes. Our team conducted a comprehensive literature review of depression and anxiety in Canadian children and youth, exploring diverse treatment methods, including medical, psychotherapy, and alternative therapies like art and music therapy. We searched Medline, Google Scholar, and St. Lawrence College Library. Only original research papers, published between 2012 and 2023, peer-reviewed, and reporting on childhood adversities on health and its treatment methods in children and youth in Canada were considered. We focused on their significance in treating depression and anxiety. According to the study's findings, the prevalence of adverse childhood experiences (ACEs) is still a significant concern. In Canada, 40% of people report having had multiple ACEs, and 78% report having had at least one ACE, highlighting the persistence of childhood adversity and indicating that the issue is unlikely to fade off in the near future. Likewise, findings revealed that individuals who experienced abuse, neglect, or violence during childhood are likelier to engage in harmful behaviors like polydrug use, suicidal ideation, and victimization and suffer from mental health problems such as depression and post-traumatic stress disorder (PTSD).

Keywords: adverse childhood experiences (ACEs), obesity, post-traumatic stress disorder (PTSD), resilience, substance abuse, trauma-informed care

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Authors: Seyedmohsen Mortazavi

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The purpose of this research is to investigate the personality types of internal auditors on the quality of financial reporting in companies admitted to the Tehran Stock Exchange. Personality type is one of the issues that emphasizes the field of auditors' behavior, and this field has attracted the attention of shareholders and stock companies today, because the auditors' personality can affect the type of financial reporting and its quality. The research is applied in terms of purpose and descriptive and correlational in terms of method, and a researcher-made questionnaire was used to check the research hypotheses. The statistical population of the research is all the auditors, accountants and financial managers of the companies admitted to the Tehran Stock Exchange, and due to their large number and the uncertainty of their exact number, 384 people have been considered as a statistical sample using Morgan's table. The researcher-made questionnaire was approved by experts in the field, and then its validity and reliability were obtained using software. For the validity of the questionnaire, confirmatory factor analysis was first examined, and then using divergent and convergent validity; Fornell-Larker and cross-sectional load test of the validity of the questionnaire were confirmed; Then, the reliability of the questionnaire was examined using Cronbach's alpha and composite reliability, and the results of these two tests showed the appropriate reliability of the questionnaire. After checking the validity and reliability of the research hypotheses, PLS software was used to check the hypotheses. The results of the research showed that the personalities of internal auditors can affect the quality of financial reporting; The personalities investigated in this research include neuroticism, extroversion, flexibility, agreeableness and conscientiousness, all of these personality types can affect the quality of financial reporting.

Keywords: flexibility, quality of financial reporting, agreeableness, conscientiousness

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Authors: M. Reni Sagayaraj, S. Anand Gnana Selvam, R. Reynald Susainathan

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In this paper we study that the catastrophic events arrive independently at the service facility according to a Poisson process with rate λ. The nature of a catastrophic event is that upon its arrival at a service station, it destroys all the customers there waiting and in the service. We will derive the net profit associated with queuing system and obtain its probability of the busy period.

Keywords: queueing system, net-profit, busy period, catastrophical events

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Authors: Roberta Guerra, Juan Pablo Pozo Hernandez

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Surface sediments from the coastal lagoon of Pialassa Piomboni in the NW Adriatic Sea were collected and analysed and the potential ecological risks in the area were assessed based on the acid-volatile sulphide (AVS) model. The AVS levels are between 0.03 and 8.8 µmol g-1, with the average at 3.1 µmol g-1. The simultaneously extracted metals (∑SEM), which is the molar sum of Cd, Cu, Ni, Pb, and Zn, range from 0.3 to 6.6 µmol g-1, with the average at 1.7 µmol g-1. Most of the high ∑SEM concentrations are located in the southern area of the lagoon. [SEM]Zn had the comparatively high mean concentration (1.4 µmol g-1), and a maximum value of 6.1 µmol g-1, respectively. Concentrations of [SEM]Cd, [SEM]Cu, [SEM]Ni, and [SEM]Pb were consistently lower, with maximum values of 0.007 µmol g-1, 1.4 µmol g-1, 0.3 µmol g-1 and 0.2 µmol g-1, respectively. Compared to other metals, [SEM]Zn was the dominant component in all samples and accounted for approximately 31 - 93% of the ∑SEM, whereas the contribution of Cd – the most toxic metal studied – to ∑SEM was no more than 1%. According to the USEPA evaluation method, the sediment samples can be divided into the three following categories: category 1, adverse biological effects on aquatic life may be expected when ([SEM]–[AVS])/fOC > 3000; category 2, adverse effects on aquatic life are uncertain when ([SEM]–[AVS])/fOC = 130 to 3,000; and category 3, no indication of adverse effects when ([SEM]–[AVS])/fOC < 130. Most of the surface sediments of the Pialassa Piomboni lagoon (>90%) had no adverse biological effects according to the criterion proposed by the USEPA; while adverse effects were uncertain in few stations (~2%).

Keywords: sediment quality, heavy metals, coastal lagoon, bioavailability, SEM, AVS

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Authors: Amber Dhoot, Tarush Gupta, Andrea Gurr, William Jenkins, Sandro Pietrunti, Alexis Tang

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Background: The COVID-19 pandemic has driven pharmacovigilance towards a new paradigm. Nowadays, more people than ever before are recognising and reporting adverse reactions from medications, treatments, and vaccines. In the modern era, with over 3.8 billion users, social media has become the most accessible medium for people to voice their opinions and so provides an opportunity to engage with more patient-centric and accessible pharmacovigilance. However, the pharmaceutical industry has been slow to incorporate social media into its modern pharmacovigilance strategy. This project aims to make social media a more effective tool in pharmacovigilance, and so reduce drug costs, improve drug safety and improve patient outcomes. This will be achieved by firstly uncovering and categorising the barriers facing the widespread adoption of social media in pharmacovigilance. Following this, the potential opportunities of social media will be explored. We will then propose realistic, practical recommendations to make social media a more effective tool for pharmacovigilance. Methodology: A comprehensive systematic literature review was conducted to produce a categorised summary of these barriers. This was followed by conducting 11 semi-structured interviews with pharmacovigilance experts to confirm the literature review findings whilst also exploring the unpublished and real-life challenges faced by those in the pharmaceutical industry. Finally, a survey of the general public (n = 112) ascertained public knowledge, perception, and opinion regarding the use of their social media data for pharmacovigilance purposes. This project stands out by offering perspectives from the public and pharmaceutical industry that fill the research gaps identified in the literature review. Results: Our results gave rise to several key analysis points. Firstly, inadequacies of current Natural Language Processing algorithms hinder effective pharmacovigilance data extraction from social media, and where data extraction is possible, there are significant questions over its quality. Social media also contains a variety of biases towards common drugs, mild adverse drug reactions, and the younger generation. Additionally, outdated regulations for social media pharmacovigilance do not align with new, modern General Data Protection Regulations (GDPR), creating ethical ambiguity about data privacy and level of access. This leads to an underlying mindset of avoidance within the pharmaceutical industry, as firms are disincentivised by the legal, financial, and reputational risks associated with breaking ambiguous regulations. Conclusion: Our project uncovered several barriers that prevent effective pharmacovigilance on social media. As such, social media should be used to complement traditional sources of pharmacovigilance rather than as a sole source of pharmacovigilance data. However, this project adds further value by proposing five practical recommendations that improve the effectiveness of social media pharmacovigilance. These include: prioritising health-orientated social media; improving technical capabilities through investment and strategic partnerships; setting clear regulatory guidelines using multi-stakeholder processes; creating an adverse drug reaction reporting interface inbuilt into social media platforms; and, finally, developing educational campaigns to raise awareness of the use of social media in pharmacovigilance. Implementation of these recommendations would speed up the efficient, ethical, and systematic adoption of social media in pharmacovigilance.

Keywords: adverse drug reaction, drug safety, pharmacovigilance, social media

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Authors: Wanchalerm Patanacharoenwong, Panaya Sudta, Prachya Bumrungkun

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The paper focuses on the development of a system that combines Internet of Things (IoT) technologies and deep learning algorithms for anomaly detection in residential Electric Vehicle (EV) charging in smart cities. With the increasing number of EVs, ensuring efficient and reliable charging systems has become crucial. The aim of this research is to develop an integrated IoT and deep learning system for detecting anomalies in residential EV charging and enhancing EV load profiling and event detection in smart cities. This approach utilizes IoT devices equipped with infrared cameras to collect thermal images and household EV charging profiles from the database of Thailand utility, subsequently transmitting this data to a cloud database for comprehensive analysis. The methodology includes the use of advanced deep learning techniques such as Recurrent Neural Networks (RNN) and Long Short-Term Memory (LSTM) algorithms. IoT devices equipped with infrared cameras are used to collect thermal images and EV charging profiles. The data is transmitted to a cloud database for comprehensive analysis. The researchers also utilize feature-based Gaussian mixture models for EV load profiling and event detection. Moreover, the research findings demonstrate the effectiveness of the developed system in detecting anomalies and critical profiles in EV charging behavior. The system provides timely alarms to users regarding potential issues and categorizes the severity of detected problems based on a health index for each charging device. The system also outperforms existing models in event detection accuracy. This research contributes to the field by showcasing the potential of integrating IoT and deep learning techniques in managing residential EV charging in smart cities. The system ensures operational safety and efficiency while also promoting sustainable energy management. The data is collected using IoT devices equipped with infrared cameras and is stored in a cloud database for analysis. The collected data is then analyzed using RNN, LSTM, and feature-based Gaussian mixture models. The approach includes both EV load profiling and event detection, utilizing a feature-based Gaussian mixture model. This comprehensive method aids in identifying unique power consumption patterns among EV owners and outperforms existing models in event detection accuracy. In summary, the research concludes that integrating IoT and deep learning techniques can effectively detect anomalies in residential EV charging and enhance EV load profiling and event detection accuracy. The developed system ensures operational safety and efficiency, contributing to sustainable energy management in smart cities.

Keywords: cloud computing framework, recurrent neural networks, long short-term memory, Iot, EV charging, smart grids

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Authors: Hamidreza Babaali, Alireza Mojtahedi, Nasim Soori, Saba Soori

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Hydraulic jump is one of the effective ways of energy dissipation in stilling basins that the ‎energy is highly dissipated by jumping. Adverse slope surface at the end stilling basin is ‎caused to increase energy dissipation and stability of the hydraulic jump. In this study, the adverse slope ‎has been added to end of United States Bureau of Reclamation (USBR) II stilling basin in hydraulic model of Nazloochay dam with scale 1:40, and flow simulated into stilling basin using Flow-3D ‎software. The numerical model is verified by experimental data of water depth in ‎stilling basin. Then, the parameters of water level profile, Froude Number, pressure, air ‎entrainment and turbulent dissipation investigated for discharging 300 m³/s using K-Ɛ and Re-Normalization Group (RNG) turbulence ‎models. The results showed a good agreement between numerical and experimental model‎ as ‎numerical model can be used to optimize of stilling basins.‎

Keywords: experimental and numerical modelling, end adverse slope, flow ‎parameters, USBR II stilling basin

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Authors: Vincenzo Russo, Rosella Giacometti

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The paper aims to assess the insurance industry's resilience under Solvency II against adverse scenarios. Starting from the economic balance sheet available under Solvency II for insurance and reinsurance undertakings, we assume that assets and liabilities follow a bivariate geometric Brownian motion (GBM). Then, using the results available under Margrabe's formula, we establish an analytical solution to calibrate the volatility of the asset-liability ratio. In such a way, we can estimate the probability of default and the probability of breaching the undertaking's Solvency Capital Requirement (SCR). Furthermore, since estimating the volatility of the Solvency Ratio became crucial for insurers in light of the financial crises featured in the last decades, we introduce a novel measure that we call Resiliency Ratio. The Resiliency Ratio can be used, in addition to the Solvency Ratio, to evaluate the insurance industry's resilience in case of adverse scenarios. Finally, we introduce a simplified stress test tool to evaluate the economic balance sheet under stressed conditions. The model we propose is featured by analytical tractability and fast calibration procedure where only the disclosed data available under the Solvency II public reporting are needed for the calibration. Using the data published regularly by the European Insurance and Occupational Pensions Authority (EIOPA) in an aggregated form by country, an empirical analysis has been performed to calibrate the model and provide the related results at the country level.

Keywords: Solvency II, solvency ratio, volatility of the asset-liability ratio, probability of default, probability to breach the SCR, resilience ratio, stress test

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Authors: Neil Singla, Derek Muse, Karen DiDonato, Pamela Palmer

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Introduction: Pain is the most common reason people visit emergency rooms. Studies indicate however, that Emergency Department (ED) physicians often do not provide adequate analgesia to their patients as a result of gender and age bias, opiophobia and insufficient knowledge of and formal training in acute pain management. Novel classes of analgesics have recently been introduced, but many patients suffer from acute pain in settings where the availability of intravenous (IV) access may be limited, so there remains a clinical need for rapid-acting, potent analgesics that do not require an invasive route of delivery. A sublingual sufentanil tablet (SST), dispensed using a single-dose applicator, is in development for treatment of moderate-to-severe acute pain in a medically-supervised setting. Objective: The primary objective of this study was to demonstrate the repeat-dose efficacy, safety and tolerability of sufentanil 20 mcg and 30 mcg sublingual tablets compared to placebo for the management of acute pain as determined by the time-weighted sum of pain intensity differences (SPID) to baseline over the 12-hour study period (SPID12). Key secondary efficacy variables included SPID over the first hour (SPID1), Total pain relief over the 12-hour study period (TOTPAR12), time to perceived pain relief (PR) and time to meaningful PR. Safety variables consisted of adverse events (AE), vital signs, oxygen saturation and early termination. Methods: In this Phase 2, double-blind, dose-finding study, an equal number of male and female patients were randomly assigned in a 2:2:1 ratio to SST 20 mcg, SS 30 mcg or placebo, respectively, following bunionectomy. Study drug was dosed as needed, but not more frequently than hourly. Rescue medication was available as needed. The primary endpoint was the Summed Pain Intensity Difference to baseline over 12h (SPIDI2). Safety was assessed by continuous oxygen saturation monitoring and adverse event reporting. Results: 101 patients (51 Male/50 Female) were randomized, 100 received study treatment (intent-to-treat [ITT] population), and 91 completed the study. Reasons for early discontinuation were lack of efficacy (6), adverse events (2) and drug-dosing error (1). Mean age was 42.5 years. For the ITT population, SST 30 mcg was superior to placebo (p=0.003) for the SPID12. SPID12 scores in the active groups were superior for both male (ANOVA overall p-value =0.038) and female (ANOVA overall p-value=0.005) patients. Statistically significant differences in favour of sublingual sufentanil were also observed between the SST 30mcg and placebo group for SPID1(p<0.001), TOTPAR12(p=0.002), time to perceived PR (p=0.023) and time to meaningful PR (p=0.010). Nausea, vomiting and somnolence were more frequent in the sufentanil groups but there were no significant differences between treatment arms for the proportion of patients who prematurely terminated due to AE or inadequate analgesia. Conclusions: Sufentanil tablets dispensed sublingually using a single-dose applicator is in development for treatment of patients with moderate-to-severe acute pain in a medically-supervised setting where immediate IV access is limited. When administered sublingually, sufentanil’s pharmacokinetic profile and non-invasive delivery makes it a useful alternative to IM or IV dosing.

Keywords: acute pain, pain management, sublingual, sufentanil

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Authors: Daniela Gradinaru, Iuliana Georgescu, Loredana Hutanu (Toma), Mihai-Bogdan Afrasinei

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This article aims to analyze the situation of Romanian companies from an environmental point of view. Environmental issues are addressed very often nowadays, and they reach and affect every domain, including the economical one. Implementing an environmental management system will not only help the companies to comply with laws and regulations, but, above all, will offer them an important competitive advantage.

Keywords: environmental management system, environmental reporting, environmental expenses, sustainable development

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Authors: Ibrahim Abouelkhir

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Background: Prior to this project, the number of CT aorta requests from our Emergency Department (ED) was reported by the radiology department to be high with a low positive event rate: only 1- 2% of CT aortas performed were positive for acute aortic syndrome. This trend raised concerns about the time required to process and report these scans, potentially impacting the timely reporting of other high-priority imaging, such as trauma-related scans. Other harms identified were unnecessary radiation, patients spending longer in ED contributing to overcrowding, and, most importantly, the patient not getting the right care the first time. The radiology department also raised the problem of reporting bias because they expected our CT aortas to be normal. Aim: The main aim of this project was to reduce the number of unnecessary CT aortas requested, which would be shown by 1. Number of CT aortas requested and 2. Positive event rate. Methodology: This was a quality improvement project carried out in the ED at Frimley Park Hospital, UK. Starting from 1 st January 2024, we recorded the number of days required to reach 35 CT aorta requests. We looked at all patients presenting to the ED over the age of 16 for whom a CT aorta was requested by the ED team. We looked at how many of these scans were positive for acute aortic syndrome. The intervention was a change in practice: all CT aortas should be approved by an ED consultant or ST4+ registrar (5th April 2024). We then reviewed the number of days it took to reach a total of 35 CT aorta requests following the intervention and again reviewed how many were positive. Results: Prior to the intervention, 35 CT Aorta scans were performed over a 20-day period. Following the implementation of the ED senior doctor vetting process, the same number of CT Aorta scan requests was observed over 50 days - more than twice the pre-intervention period. This indicates a significant reduction in the rate of CT Aorta scans being requested. During the pre-intervention phase, there were two positive cases of acute aortic syndrome. In the post-intervention period, there were zero. Conclusion: The mandatory review of CT Aorta scan requested by the ED consultant effectively reduced the number of scans requested. However, this intervention did not lead to an increase in positive scan results. We noted that post-intervention, approximately 50% of scans had been approved by registrar-grade doctors and, only 50% had been approved by ED consultants, and the majority were not in-person reviews. We wonder if restricting the approval to consultant grade only might improve the results, and furthermore, in person reviews should be the gold standard.

Keywords: quality improvement project, CT aorta scans, emergency department, radiology department, aortic dissection, scan request vetting, clinical outcomes, imaging efficiency

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