Search results for: FDA adverse event reporting system

Authors: Li Chen

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For an aerofoil or hydrofoil in high Reynolds number flows, broadband noise is generated efficiently as the result of the turbulence convecting over the trailing edge. This noise can be related to the surface pressure fluctuations, which can be predicted by either CFD or empirical models. However, in reality, the aerofoil or hydrofoil often operates at an angle of attack. Under this situation, the flow is subjected to an Adverse-Pressure-Gradient (APG), and as a result, a flow separation may occur. This study is to assess trailing-edge noise models for such flows. In the present work, the trailing-edge noise from a 2D airfoil at 6 degree of angle of attach is investigated. Under this condition, the flow is experiencing a strong APG, and the flow separation occurs. The flow over the airfoil with a chord of 300 mm, equivalent to a Reynold Number 4x10⁵, is simulated using RANS with the SST k-ɛ turbulent model. The predicted surface pressure fluctuations are compared with the published experimental data and empirical models, and show a good agreement with the experimental data. The effect of the APG on the trailing edge noise is discussed, and the associated trailing edge noise is calculated.

Keywords: aero-acoustics, adverse-pressure gradient, computational fluid dynamics, trailing-edge noise

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Authors: Adrian Forca, Simeon Cainday III

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The Electronic Payment Recording with Payment History Retrieval Module is developed intendedly for the College of Science and Technology. This system software innovates the manual process of recording the payments done in the department through the development of electronic payment recording system software shifting from the slow and time-consuming procedure to quick yet reliable and accurate way of recording payments because it immediately generates receipts for every transaction. As an added feature to its software process, generation of recorded payment report is integrated eliminating the manual reporting to a more easy and consolidated report. As an added feature to the system, all recorded payments of the students can be retrieved immediately making the system transparent and reliable payment recording software. Viewing the whole process, the system software will shift from the manual process to an organized software technology because the information will be stored in a logically correct and normalized database. Further, the software will be developed using the modern programming language and implement strict programming methods to validate all users accessing the system, evaluate all data passed into the system and information retrieved to ensure data accuracy and reliability. In addition, the system will identify the user and limit its access privilege to establish boundaries of the specific access to information allowed for the store, modify, and update making the information secure against unauthorized data manipulation. As a result, the System software will eliminate the manual procedure and replace with an innovative modern information technology resulting to the improvement of the whole process of payment recording fast, secure, accurate and reliable software innovations.

Keywords: collection, information system, manual procedure, payment

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Authors: Sadeem Aljamaan, Reem Hariri, Rahaf Alghamdi, Batool Alotaibi, Batool Alsenan, Lama Althunayyan, Areej Alnemer

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The aim of this study is to correlate between radiological findings and histopathological results in regard to the breast imaging-reporting and data system scores, size of breast masses, molecular subtypes and suspicious radiological features, as well as to assess the concordance rate in histological grade between core biopsy and surgical excision among breast cancer patients, followed by analyzing the change of concordance rate in relation to neoadjuvant chemotherapy in a Saudi population. A retrospective review was conducted over 6-year period (2017-2022) on all breast core biopsies of women preceded by radiological investigation. Chi-squared test (χ2) was performed on qualitative data, the Mann-Whitney test for quantitative non-parametric variables, and the Kappa test for grade agreement. A total of 641 cases were included. Ultrasound, mammography, and magnetic resonance imaging demonstrated diagnostic accuracies of 85%, 77.9% and 86.9%; respectively. magnetic resonance imaging manifested the highest sensitivity (72.2%), and the lowest was for ultrasound (61%). Concordance in tumor size with final excisions was best in magnetic resonance imaging, while mammography demonstrated a higher tendency of overestimation (41.9%), and ultrasound showed the highest underestimation (67.7%). The association between basal-like molecular subtypes and the breast imaging-reporting and data system score 5 classifications was statistically significant only for magnetic resonance imaging (p=0.04). Luminal subtypes demonstrated a significantly higher percentage of speculation in mammography. Breast imaging-reporting and data system score 4 manifested a substantial number of benign pathologies in all the 3 modalities. A fair concordance rate (k= 0.212 & 0.379) was demonstrated between excision and the preceding core biopsy grading with and without neoadjuvant therapy, respectively. The results demonstrated a down-grading in cases post-neoadjuvant therapy. In cases who did not receive neoadjuvant therapy, underestimation of tumor grade in biopsy was evident. In summary, magnetic resonance imaging had the highest sensitivity, specificity, positive predictive value and accuracy of both diagnosis and estimation of tumor size. Mammography demonstrated better sensitivity than ultrasound and had the highest negative predictive value, but ultrasound had better specificity, positive predictive value and accuracy. Therefore, the combination of different modalities is advantageous. The concordance rate of core biopsy grading with excision was not impacted by neoadjuvant therapy.

Keywords: breast cancer, mammography, MRI, neoadjuvant, pathology, US

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Authors: Arjun Chatterjee

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The India-China border clash in Galwan valley in June 2020, the first deadly skirmish between the two Asian giants in the Himalayan border area in over four decades, highlighted the need to examine the notion of ‘authenticity’ in journalistic practices. Information emanating from such remotely located, sparsely populated, and not well-demarcated international land borders have limited sources, restricted to official sources, which have their own narrative. Geopolitical goals and ambitions embolden narratives of nationalism in the media, and these often challenge the notion and understanding of authenticity in journalism. The Indian press, contrary to the Chinese press, which is state-owned, is diverse and also confrontational, where narratives of nationalism are differentially interpreted, embedded, and realised. This paper examines how authenticity has become a variable, rather than a constant, in conflict reporting of the Sino-Indian border clash and how authenticity is interpreted similarly or differently in conflict journalism. The paper reports qualitative textual analysis of two leading English language newspapers – The Times of India and The Hindu, and two mainstream regional language newspapers, Amar Ujala (Hindi) and Ananda Bazar Patrika (Bengali), to evaluate the ways in which representations of information function in conflict reporting and to recontextualize (and thus change or modify the meaning of) that which they represent, and with what political and cultural implications.

Keywords: India-China, framing, conflict, media narratives, border dispute

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Authors: Azrul Azlan Iskandar Mirza

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The purpose of Funds Transfer Pricing (FTP) for Islamic Bank is to promote prudent liquidity risk-taking behavior of business units. The acquirer of stable deposits will be rewarded whilst a business unit that generates long-term assets will be charged for added liquidity funding risks. In the end, it promotes risk-adjusted pricing by incorporating profit rate risk and liquidity risk component in the product pricing. However, in the event of Shariah non-compliant (SNCE), FTP components will be examined in the rectification plan especially when Islamic banks need to purify the non-compliance income. The finding shows that the determination between actual and provision cost will defer the decision among Shariah committee in Islamic banks. This paper will review each of FTP components to ensure the classification of actual and provision costs reflect the decision on rectification process on SNCE. This will benefit future decision and its consistency of Islamic banks.

Keywords: fund transfer pricing, Islamic banking, Islamic finance, shariah non-compliant event

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Authors: Rodchares Hanrinth, Theerapong Srisil, Peeraya Sriphong, Pawich Paktipat

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The trigger tool is the low-cost, low-tech method to detect adverse events through clues called triggers. The Institute for Healthcare Improvement (IHI) has developed the Global Trigger Tool for measuring and preventing adverse events. However, this tool is not specific for detecting adverse drug events. The pharmacy-based trigger tool is needed to detect adverse drug events (ADEs). Group concept mapping is an effective method for conceptualizing various ideas from diverse stakeholders. This technique was used to identify a pharmacy-based trigger to detect adverse drug events (ADEs). The aim of this study was to involve the pharmacists in conceptualizing, developing, and prioritizing a feasible trigger tool to detect adverse drug events in a provincial hospital, the northeastern part of Thailand. The study was conducted during the 6-month period between April 1 and September 30, 2017. Study participants involved 20 pharmacists (17 hospital pharmacists and 3 pharmacy lecturers) engaging in three concept mapping workshops. In this meeting, the concept mapping technique created by Trochim, a highly constructed qualitative group technic for idea generating and sharing, was used to produce and construct participants' views on what triggers were potential to detect ADEs. During the workshops, participants (n = 20) were asked to individually rate the feasibility and potentiality of each trigger and to group them into relevant categories to enable multidimensional scaling and hierarchical cluster analysis. The outputs of analysis included the trigger list, cluster list, point map, point rating map, cluster map, and cluster rating map. The three workshops together resulted in 21 different triggers that were structured in a framework forming 5 clusters: drug allergy, drugs induced diseases, dosage adjustment in renal diseases, potassium concerning, and drug overdose. The first cluster is drug allergy such as the doctor’s orders for dexamethasone injection combined with chlorpheniramine injection. Later, the diagnosis of drug-induced hepatitis in a patient taking anti-tuberculosis drugs is one trigger in the ‘drugs induced diseases’ cluster. Then, for the third cluster, the doctor’s orders for enalapril combined with ibuprofen in a patient with chronic kidney disease is the example of a trigger. The doctor’s orders for digoxin in a patient with hypokalemia is a trigger in a cluster. Finally, the doctor’s orders for naloxone with narcotic overdose was classified as a trigger in a cluster. This study generated triggers that are similar to some of IHI Global trigger tool, especially in the medication module such as drug allergy and drug overdose. However, there are some specific aspects of this tool, including drug-induced diseases, dosage adjustment in renal diseases, and potassium concerning which do not contain in any trigger tools. The pharmacy-based trigger tool is suitable for pharmacists in hospitals to detect potential adverse drug events using clues of triggers.

Keywords: adverse drug events, concept mapping, hospital, pharmacy-based trigger tool

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Authors: Bryana Woodard, Monica Mitchell, Kasey Harry, Ebony Washington, Megan Harris, Marcia Boyd, Regina Lynch, Daphene Baines, Surbi Bankar

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Introduction: African Americans experience mental health illnesses (i.e., depression, anxiety, etc.) at higher rates than their white counterparts. Despite this, they utilize mental health resources less and have lower mental health literacy, perhaps due to cultural barriers- including but not limited to mistrust. Research acknowledges African Americans’ close ties to community networks, identifying these linkages as key to establishing comfort and trust. Similarly, the church has historically been a space that creates unity and community among African Americans. Studies show that longstanding academic-community partnerships with organizations, such as churches and faith-based entities, have the capability to effectively address health and mental health barriers and needs in African Americans. The importance of implementing faith-based approaches is supported in the literature, however few empirical studies exist. This project describes the First Ladies for Health and Cincinnati Children's Hospital Medical Center (CCHMC) Partnership (FLFH-CCHMC Partnership) and the implementation and assessment of an annual Mental Health Symposium, the overall aim of which was to increase mental health awareness and decrease stigma in African American communities. Methods: The specific goals of the FLFH Mental Health Symposium were to (1) Collaborate with trusted partners to build trust with community participants; (2) Increase mental health literacy and decrease mental health stigma; (3) Understand the barriers to improving mental health and improving trust; (4) Assess the short-term outcomes two months following the symposium. Data were collected through post-event and follow-up surveys using a mixed methods approach. Results: More than 100 participants attended each year with over 350 total participants over three years. 98.7% of participants were African American, 86.67% female, 11.6% male, and 11.6% LGBTQ+/non-binary; 10.5% of participants were teens, with the remainder aged 20 to 80 plus. The event was successful in achieving its goals: (1a) Eleven different speakers from 8 community and church organizations presented; (1b) 93% of participants rated the overall symposium as very good or excellent (2a) Mental health literacy significantly increased each year with over 90% of participants reporting improvement in their “understanding” and “awareness of mental health (2b) Participants 'personal stigma surrounding mental health illness decreased each year with 92.3% of participants reporting changes in their “willingness to talk about and share” mental health challenges; (3) Barriers to mental health care were identified and included social stigma, lack of trust, and the cost of care. Data were used to develop priorities and an action plan for the FLFH-CCHMC Mental Health Partnership; (4) Follow-up data showed that participants sustained benefits of the FLFH Symposium and took actionable steps (e.g., meditation, referrals, etc.). Additional quantitative and qualitative data will be shared. Conclusions: Lower rates of mental health literacy and higher rates of stigma among participants in this initiative demonstrate the importance of mental health providers building trust and partnerships in communities. Working with faith-based entities provides an opportunity to mitigate and address mental health equity in African American communities.

Keywords: community psychology, faith-based, african-american, culturally competent care, mental health equity

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Authors: S. H. Iranmanesh, L. Aliabadi, A. Mollajan

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Integrated resilience engineering (IRE) is capable of returning banking systems to the normal state in extensive economic circumstances. In this study, information system of a large bank (with several branches) is assessed and optimized under severe economic conditions. Data envelopment analysis (DEA) models are employed to achieve the objective of this study. Nine IRE factors are considered to be the outputs, and a dummy variable is defined as the input of the DEA models. A standard questionnaire is designed and distributed among executive managers to be considered as the decision-making units (DMUs). Reliability and validity of the questionnaire is examined based on Cronbach's alpha and t-test. The most appropriate DEA model is determined based on average efficiency and normality test. It is shown that the proposed integrated design provides higher efficiency than the conventional RE design. Results of sensitivity and perturbation analysis indicate that self-organization, fault tolerance, and reporting culture respectively compose about 50 percent of total weight.

Keywords: banking system, Data Envelopment Analysis (DEA), Integrated Resilience Engineering (IRE), performance evaluation, perturbation analysis

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Authors: Faustina Masocha, Vusani Moyo

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For decades, dividend announcements have been presumed to contain important signals about the future prospects of companies. Similarly, the same has been presumed about management earnings announcements. Despite both dividend and earnings announcements being considered informative, a number of researchers questioned their credibility and found both to contain short-term signals. Pertaining to dividend announcements, some authors argued that although they might contain important information that can result in changes in share prices, which consequently results in the accumulation of abnormal returns, their degree of informativeness is less compared to other signaling tools such as earnings announcements. Yet, this claim in favor has been refuted by other researchers who found the effect of earnings to be transitory and of little value to shareholders as indicated by the little abnormal returns earned during the period surrounding earnings announcements. Considering the above, it is apparent that both dividends and earnings have been hypothesized to have a signaling impact. This prompts one to question which between these two signaling tools is more informative. To answer this question, two follow-up questions were asked. The first question sought to determine the event which results in the most effect on share prices, while the second question focused on the event that influenced trading volume the most. To answer the first question and evaluate the effect that each of these events had on share prices, an event study methodology was employed on a sample made up of the top 10 JSE-listed companies for data collected from 2012 to 2019 to determine if shareholders gained abnormal returns (ARs) during announcement dates. The event that resulted in the most persistent and highest amount of ARs was considered to be more informative. Looking at the second follow-up question, an investigation was conducted to determine if either dividends or earnings announcements influenced trading patterns, resulting in abnormal trading volumes (ATV) around announcement time. The event that resulted in the most ATV was considered more informative. Using an estimation period of 20 days and an event window of 21 days, and hypothesis testing, it was found that announcements pertaining to the increase of earnings resulted in the most ARs, Cumulative Abnormal Returns (CARs) and had a lasting effect in comparison to dividend announcements whose effect lasted until day +3. This solidifies some empirical arguments that the signaling effect of dividends has become diminishing. It was also found that when reported earnings declined in comparison to the previous period, there was an increase in trading volume, resulting in ATV. Although dividend announcements did result in abnormal returns, they were lesser than those acquired during earnings announcements which refutes a number of theoretical and empirical arguments that found dividends to be more informative than earnings announcements.

Keywords: dividend signaling, event study methodology, information content of earnings, signaling theory

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Authors: Suresh Sharma, Neeti Goutam

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In India abortions are legal and with the exceedingly liberal and broadened law that was passed in 1971, “Medical Termination of Pregnancy Act” had opened a new window to Women’s’ freedom and choice over their fertility. This paper would like to focus on the factors responsible for or leading to unsafe abortion as well as such high incidence of abortion in India which can help in understanding the ways in which we can prevent this apathy. To study the intricacies involved in delivering safety to womanhood in terms of safe abortion practice which includes more trained personnel, detailed explanation and consequences of conducting an abortion, fine reporting, awareness regarding family planning measures and not only pressurizing them to sterilize immediately after an abortion but also prior to that informing them and lastly easy accessibility of Contraceptives with a educated and brief information on that. Data has been drawn from various sources such as National Family Household Survey (1, 2, 3), Health Management Information System and Annual Health Survey. To safeguard the interest of women when it comes to complications resulting from unsafe abortions, Reproductive Health laid its strict adherence to it in its guidelines. The Government could induce more measures in terms of family planning measures and increase in the number of skilled medical health force, chiefly in rural areas to prevent the illegality of abortions. But before that fine reporting on the number of abortions performed will give an insight to this very issue only then policies and programs will work much better in favor of women.

Keywords: abortion, MTP act, India, women

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Authors: Nipawan Tharasak, Sajeewan Darbavasu

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This research aims 1) to study the opinion, problems and obstacles to internal educational quality assurance system for individual and the university levels, 2) to propose an approach to the development of quality assurance system of Suan Sunandha Rajabhat University. A study of problems and obstacles to internal educational quality assurance system of the university conducted with sample group consisting of staff and quality assurance committee members of the year 2010. There were 152 respondents. 5 executives were interviewed. Tool used in the research was document analysis. The structure of the interview questions and questionnaires with 5-rate scale. Reliability was 0.981. Data analysis were percentage, mean and standard deviation with content analysis. Results can be divided into 3 main points: (1) The implementation of the internal quality assurance system of the university. It was found that in overall, input, process and output factors received high scores. Each item is considered, the preparation, planning, monitoring and evaluation. The results of evaluation to improve the reporting and improvement according to an evaluation received high scores. However, the process received an average score. (2) Problems and obstacles. It was found that the personnel responsible for the duty still lack understanding of indicators and criteria of the quality assurance. (3) Development approach: -Staff should be encouraged to develop a better understanding of the quality assurance system. -Database system for quality assurance should be developed. -The results and suggestions should be applied in the next year development planning.

Keywords: development system, internal quality assurance, education, educational quality assurance

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Authors: Abdoullah Nyassi, Golam Sarwar, Sarra Baldeh, Mamadou S. K. Jallow, Bai Lamin Dondeh, Isaac Osei, Grant A. Mackenzie

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A randomized controlled trial is the "gold standard" for evaluating the efficacy of an intervention. Large-scale, cluster-randomized trials are expensive and difficult to conduct, though. To guarantee the validity and generalizability of findings, high-quality, dependable, and accurate data management systems are necessary. Robust data management systems are crucial for optimizing and validating the quality, accuracy, and dependability of trial data. Regarding the difficulties of data gathering in clinical trials in low-resource areas, there is a scarcity of literature on this subject, which may raise concerns. Effective data management systems and implementation goals should be part of trial procedures. Publicizing the creative clinical data management techniques used in clinical trials should boost public confidence in the study's conclusions and encourage further replication. In the ongoing pneumococcal vaccine schedule study in rural Gambia, this report details the development and deployment of multi-data management systems and methodologies. We implemented six different data management, synchronization, and reporting systems using Microsoft Access, RedCap, SQL, Visual Basic, Ruby, and ASP.NET. Additionally, data synchronization tools were developed to integrate data from these systems into the central server for reporting systems. Clinician, lab, and field data validation systems and methodologies are the main topics of this report. Our process development efforts across all domains were driven by the complexity of research project data collected in real-time data, online reporting, data synchronization, and ways for cleaning and verifying data. Consequently, we effectively used multi-data management systems, demonstrating the value of creative approaches in enhancing the consistency, accuracy, and reporting of trial data in a poor resource setting.

Keywords: data management, data collection, data cleaning, cluster-randomized trial

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Authors: Marie-Eve Joret, Marijn Van Vliet, Flavio Camarrone, Marc M. Van Hulle

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Event-related potentials (ERPs) provide evidence that the human brain can process and understand music at a pre-attentive level. Music-specific ERPs include the Early Right Anterior Negativity (ERAN) and a late Negativity (N5). This study aims to further investigate this issue using two types of syntactic manipulations in music: mild violations, containing no out-of-key tones and strong violations, containing out-of-key tones. We will examine whether both manipulations will elicit the same ERPs.

Keywords: ERAN ERPs, Music, N5, P3, ERPs, Music, N5 component, P3 component

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Authors: Tanakrit Doltanakarn

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Introduction: These days, cannabis is being accepted in many countries due to the fact that cannabis could be use in medical. The medical cannabis is used to treat and reduce the pain many diseases. For example, neuropathic pain, Parkinson, autism disorders, cancer pain reduce the adverse effect of chemotherapy, diabetes, and migraine. Active ingredients in cannabis that modulate patients' perceptions of their conditions include Δ9‐tetrahydrocannabinol (THC), cannabidiol (CBD), flavonoids, and terpenes. However, there is an adverse effect of cannabis, cardiovascular effects, psychosis, schizophrenia, mood disorder, and cognitive alternation. These effects are from the THC and CBD ingredients in the cannabis. The metabolize processes of delta-9 THC to 11-OH-delta 9 -THC (inactive form), THC were cause of adverse effects. Interestingly, the distributions of CYP2C9 gene (CYP2C9*2 and CYP2C9*3, poor metabolizer) that might affect incidences of adverse effects in patients who treated with medical cannabis. Objective: The aim of this study we want to investigate the association between genetic polymorphism of CYP2C9 frequency and Thai patients who treated with medical cannabis. Materials and Methods:We recruited sixty-five unrelated Thai patients from the College of Pharmacy, Rangsit University. DNA were extracted using Genomic DNA Mini Kit. Genotyping of CYP2C9*2 (430C>T, rs1799853) and CYP2C9*3 (1075A>C, rs1057910) were genotyped by the TaqMan Real-time PCR assay. Results: Among these 31 medicals cannabis-induced ADRs patients, they were diagnosed with 22 (33.85%) tachycardia and 3 (4.62%) arrhythmia. There were 34 (52.31%) medical cannabis-tolerant controls who were included in this study.40 (61.53%) Thai patients were female, and 25 (38.46%) were male, with median age of 57 (range 27 – 87) years. In this study, we found none of the medical cannabis-induced ADRs carried CYP2C9*2 variant along with medical cannabis-tolerant control group. CYP2C9*3 variant (intermediate metabolizer, IM) was found just only one of thirty-one (3.23%) in the medical cannabis-induced ADRs and two of thirty-fourth (5.88%) in the tolerant controls. Conclusions: Thus, the distribution of CYP2C9 alleles offer a comprehensive view of pharmacogenomics marker in Thai population that could be used as a reference for worldwide to investigate the pharmacogenomics application.

Keywords: medical cannabis, adverse effect, CYP2C9, thai patients

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Authors: Cristina Schreiner, Romeo Ciobanu, Marius Pislaru

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This paper aims to build a system based on fuzzy models that can be implemented in the assessment of ecological systems, to determine appropriate methods of action for reducing adverse effects on environmental and implicit the population. The model proposed provides new perspective for environmental assessment, and it can be used as a practical instrument for decision-making.

Keywords: ecosystem model, environmental security, fuzzy logic, sustainability of habitable regions

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Authors: Patompong Satapornpong, Therdpong Tempark, Pawinee Rerknimitr, Jettanong Klaewsongkram, Chonlaphat Sukasem

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Dapsone (4, 4’-diaminodiphenyl sulfone, DDS) is broadly used for the treatment of inflammatory diseases and infections such as; leprosy, Pneumocystis jiroveci pneumonia in patients with HIV infection, neutrophilic dermatoses, dermatitis herpetiformis and autoimmune bullous disease. The severe cutaneous adverse drug reactions (SCARs) including, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) are rare but severe life-threatening adverse drug reactions. Dapsone is one of many culprit drugs induced SJS, TEN and DRESS. Notwithstanding, to our knowledge, there are no studies of the association of HLA class I alleles and dapsone-induced SCARs in non-leprosy Thai patients. This investigation was a prospective cohort study, which performed in a total of 45 non-leprosy patients. Fifteen patients of dapsone-induced SCARs were classified as following the RegiSCAR criteria, and 30 dapsone-tolerant controls were exposed to dapsone more than 6 months without any evidence of cutaneous reactions. The genotyping of HLA-A, -B and –C were performed using sequence-specific oligonucleotides (PCR-SSOs). The Ethics Committee of Ramathibodi hospital, Mahidol University, approved this study. Among all HLA class I alleles, HLA-A*24:07, HLA-B*13:01, HLA-B*15:02, HLA-C*03:04 and HLA-C*03:09 were significantly associated with dapsone-induced SCARs (OR = 10.55, 95% CI = 1.06 – 105.04, p = 0.0360; OR = 56.00, 95% CI = 8.27 – 379.22, p = 0.0001; OR = 7.00, 95% CI = 1.17 – 42.00, p = 0.0322; OR = 6.00, 95% CI = 1.24 – 29.07, p = 0.0425 and OR = 17.08, 95% CI = 0.82 – 355.45, p = 0.0321, respectively). Furthermore, HLA-B*13:01 allele had strong association with dapsone-induced SJS-TEN and DRESS when compared with dapsone-tolerant controls (OR = 42.00, 95% CI = 2.88 – 612.31, p = 0.0064 and OR = 63.00, 95% CI = 7.72 – 513.94 and p = 0.0001, respectively). Consequently, HLA-B*13:01 might serve as a pharmacogenetic marker for screening before initiating the therapy with dapsone for prevention of dapsone-induced SCARs.

Keywords: dapsone-induced SCARs, HLA-B*13:01, HLA class I alleles, severe cutaneous adverse reactions, Thai

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Authors: Lubowa Samuel

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Health information systems, often known as HIS, are critical components of the healthcare system to improve health policies and promote global health development. In a broader sense, HIS as a system integrates data collecting, processing, reporting, and making use of various types of data to improve healthcare efficacy and efficiency through better management at all levels of healthcare delivery. The aim of this study is to assess the adoption of health information systems (HIS) in a resource-constrained country drawing from the Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) model. The results indicate that the user's perception of the technology and the poor information technology infrastructures contribute a lot to the low adoption of HIS in resource-constrained countries.

Keywords: health information systems, resource-constrained countries, health information systems

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Authors: Alireza Ghaffari, Hassan Saghi

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Project management is more complex than managing the day-to-day affairs of an organization. When the project dimensions are broad and multiple projects have to be monitored in different locations, the integrated management becomes even more complicated. One of the main concerns of project managers is the integrated project management, which is mainly rooted in the lack of accurate and accessible information from different projects in various locations. The collection of dispersed information from various parts of the network, their integration and finally the selective reporting of this information is among the goals of integrated information systems. It can help resolve the main problem, which is bridging the information gap between executives and senior managers in the organization. Therefore, the main objective of this study is to design and implement an important subset of a project management information system in order to successfully control the cost of construction projects so that its results can be used to design raw software forms and proposed relationships between different project units for the collection of necessary information.

Keywords: financial performance, cost subsystem, PMIS, project management

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Authors: Grant Bifolchi

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As global environmental problems continue to have highly adverse effects, finding long-term, sustainable solutions to combat ecological distress are of growing paramount concern. Ghost Gear—also known as abandoned, lost or otherwise discarded fishing gear (ALDFG) and derelict fishing gear (DFG)—represents one of the greatest threats to the world’s oceans, posing a significant hazard to human health, livelihoods, and global food security. In fact, according to the UN Food and Agriculture Organization (FAO), abandoned, lost and discarded fishing gear represents approximately 10% of marine debris by volume. Around the world, many governments, governmental and non-profit organizations are doing their best to manage the reporting and retrieval of nets, lines, ropes, traps, floats and more from their respective bodies of water. However, these organizations’ ability to effectively manage files and documents about the environmental problem further complicates matters. In Ghost Gear monitoring and management, organizations face additional complexities. Whether it’s data ingest, industry regulations and standards, garnering actionable insights into the location, security, and management of data, or the application of enforcement due to disparate data—all of these factors are placing massive strains on organizations struggling to save the planet from the dangers of Ghost Gear. In this 90-minute educational session, globally recognized Ghost Gear technology expert Grant Bifolchi CET, BBA, Bcom, will provide real-world insight into how governments currently manage Ghost Gear and the technology that can accelerate success in combatting ALDFG and DFG. In this session, attendees will learn how to: • Identify specific technologies to solve the ingest and management of Ghost Gear data categories, including type, geo-location, size, ownership, regional assignment, collection and disposal. • Provide enhanced access to authorities, fisheries, independent fishing vessels, individuals, etc., while securely controlling confidential and privileged data to globally recognized standards. • Create and maintain processing accuracy to effectively track ALDFG/DFG reporting progress—including acknowledging receipt of the report and sharing it with all pertinent stakeholders to ensure approvals are secured. • Enable and utilize Business Intelligence (BI) and Analytics to store and analyze data to optimize organizational performance, maintain anytime-visibility of report status, user accountability, scheduling, management, and foster governmental transparency. • Maintain Compliance Reporting through highly defined, detailed and automated reports—enabling all stakeholders to share critical insights with internal colleagues, regulatory agencies, and national and international partners.

Keywords: ghost gear, ALDFG, DFG, abandoned, lost or otherwise discarded fishing gear, data, technology

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Authors: Mohd Zamri Che Wanik

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This paper presents the management of the Fault Ride Through event within a Solar Farm during a grid fault. The modeling and simulation of a photovoltaic (PV) with battery energy storage connected to the power network will be described. The modeling approach and the study analysis performed are described. The model and operation scenarios are simulated using a digital simulator for different scenarios. The dynamic response of the system when subjected to sudden self-clearance temporary fault is presented. The capability of the PV system and battery storage riding through the power system fault and, at the same time, supporting the local grid by injecting fault current is demonstrated. For each case, the different control methods to achieve the objective of supporting the grid according to grid code requirements are presented and explained. The inverter modeling approach is presented and described.

Keywords: faut ride through, solar farm, grid code, power network

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Authors: S. L. Tulasi Devi, Shivam Azad

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The primary objective of this study is to analyze the impact of green bond issuance on the stock prices of respective Indian companies. An event study methodology has been employed to study the effect of green bond issuance. For in-depth study and analysis, this paper used different window frames, including 15-15 days, 10-10 days, 7-7days, 6-6 days, and 5-5 days. Further, for better clarity, this paper also used an uneven window period of 7-5 days. The period of study covered all the companies which issued green bonds during the period of 2017-2022; Adani Green Energy, State Bank of India, Power Finance Corporation, Jain Irrigation, and Rural Electrification Corporation, except Indian Renewable Energy Development Agency and Indian Railway Finance Corporation, because of data unavailability. The paper used all three event study methods as discussed in earlier literature; 1) constant return model, 2) market-adjusted model, and 3) capital asset pricing model. For the fruitful comparison between results, the study considered cumulative average return (CAR) and buy and hold average return (BHAR) methodology. For checking the statistical significance, a two-tailed t-statistic has been used. All the statistical calculations have been performed in Microsoft Excel 2016. The study found that all other companies have shown positive returns on the event day except for the State Bank of India. The results demonstrated that constant return model outperformed compared to the market-adjusted model and CAPM. The p-value derived from all the methods has shown an almost insignificant impact of the issuance of green bonds on the stock prices of respective companies. The overall analysis states that there’s not much improvement in the market efficiency of the Indian Stock Markets.

Keywords: green bonds, event study methodology, constant return model, market-adjusted model, CAPM

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Authors: John Allbutt, Andrew Murray, Jonathan Ling, Thomas M. Heffernan

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Ultra-endurance events place unique physical and psychological pressures on participants. In this study, we examined the psychologically challenging aspects of taking part in a 3000 mile transatlantic rowing race using a qualitative approach. To date, more people have been into space than have rowed an ocean and only one psychological study has been conducted on this experience which had a specific research focus. The current study was a qualitative study using semi-structured interviews. Participants were an opportunity sample of seven competitors from a recent ocean rowing race. Participants were asked about the psychological aspects of the event after it had finished. The data were analysed using thematic analysis. Several themes emerged from the analysis. These related to: 1) preparation; 2) bodily aches/pains, 3) race setbacks; 4) boat conditions; 5) interpersonal factors and communication; 6) strategies for managing stress and interpersonal tensions. While participants were generally very positive about the event, the analysis showed that they experienced significant psychological challenges during their voyage. Competitors paid considerable attention to preparing for the physical challenges of the event. However, not all prospective competitors gave the same time to preparing for psychological factors or were aware how they might play out during their voyage. All Atlantic rowing crews should be aware of the psychological challenges they face, and have strategies in place to help cope with the psychological strain of taking part.

Keywords: confinement experiences, ocean rowing, stress, ultra-endurance sport

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Authors: Xenia I. Loizidou, Anthi Gavriel, Demetra Petsa

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The tourism industry is a significant contributor to Cyprus's Gross Domestic Product. However, as the main tourism product is 'sun and sea', the industry is significantly unsustainable, with the majority of tourists (approx. 90%) concentrated in coastal areas over a short period of time, causing negative environmental, social, and economic impacts. The newly established Cypriot Deputy Ministry of Tourism aims to diversify the Cypriot tourism industry by focusing on the development of niche tourism products that will elongate the touristic season and divert visitors to inland mountainous and rural areas. In this respect, conference and event tourism is an ideal product for development. The current paper presents the results of fieldwork carried out between January and March 2020 in Cyprus, with key stakeholders within the conference and event tourism sector. The work consisted of a survey and semi-structured interviews to determine the current level of sustainability within the conference tourism sector, the main barriers to the sector's development, as well as key stakeholder insights and suggestions for measures to improve the sector's sustainability. The results suggest that there is a general lack of understanding of the negative economic, environmental and social impacts associated with the organization of conventional conferences and events, compared to the positive impacts of sustainable conferences/events. There also seems to be a lack of awareness of actions that can be taken to make the conference and event sector more sustainable. Incentives, marketing, branding, and training are identified as some of the effective means to improve the sustainability of the Cypriot conference and event sector, as is the development of country-wide sustainability policy and a review and enforcement of national waste management legislation. The research outputs will be utilized for the development of targeted toolkits, training, and awareness-raising activities that will drive Cyprus towards becoming an international sustainable tourism destination.

Keywords: conference, event, sustainability, tourism

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Authors: Ratchaneewan Salao, Steven W. Edwards, Kiatichai Faksri, Kanin Salao

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Background: A two-dose regimen of COVID-19 vaccination (inactivated whole virion SARS-CoV-2 and adenoviral vector) has been widely used. Side effects are very low, but several adverse effects have been reported. Methods: A 40-year-old female patient, with a previous history of thyroid goitre, developed severe neck pain, headache, nausea and fatigue 7-days after receiving second vaccination with Vaxzevria® (Oxford-AstraZeneca). Clinical and laboratory findings, including thyroid function tests and ultrasound of thyroid glands, were performed. Results: Her left thyroid gland was multinodular enlarged, and severely tender on palpation. She had difficulty in swallowing and had tachycardia but no signs of hyperthyroidism. Laboratory results supported a diagnosis of subacute thyroiditis. She was prescribed NSAID (Ibuprofen 400 mg) and dexamethasone for 3-days and her symptoms resolved. Conclusions: Although this is an extremely rare event, physicians may encounter more cases of this condition due to the extensive vaccination program using this combination of vaccines.

Keywords: SARS-CoV-2, adenoviral vector vaccines, vaccination, subacute thyroiditis

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Authors: Olukayode Bamgbose, Feyisola Agboola, Adewale M. Taiwo, Olanrewaju Olujimi Oluwole Terebo, Azeez Soyingbe, Akeem Bamgbade

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The present study evaluated the contents and health risk assessment of metals determined in milk and milk product samples collected from the Abeokuta market. Forty-five milk and milk product (yoghurt) samples were digested and analysed for selected metals using Atomic Absorption Spectrophotometric method. Health risk assessment was evaluated for hazard quotient (HQ), hazard index (HI), and cancer risk (CR). Data were subjected to descriptive and inferential statistics. The concentrations of Zn, which ranged from 3.24±0.59 to 4.35±0.59 mg/kg, were the highest in the samples. Cr and Cd were measured below the detection limit of the analytical instrument, while the Pb level was higher than the Codex Alimentarius Commission value of 0.02 mg/kg, indicating unsafe for consumption. However, the HQ of Pb and other metals in milk and milk product samples was less than 1.0, thereby establishing no adverse health effects for Pb and other metals. The distribution pattern of metals in milk and milk product samples followed the decreasing order of Zn > Fe > Ni > Co > Cu > Mn > Pb > Cd/Cr. The CR levels of meals were also less than the permissible limit of 1.0 x 10-4, establishing no possible development of cancer. Keywords: adverse effects, cancer, metals, milk, milk product, the permissible limit.

Keywords: adverse effects, cancer, metals, milk, milk product, permissible limit

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Authors: Awad Khireldin, Colin Law

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Runways are the major infrastructure of airports around the world. Efficient operations of runways are key to ensure that airports are running smoothly with minimal delays. There are many factors that affect the efficiency of runway operations, such as the aircraft wake separation, runways system configuration, the fleet mix, and the runways separation distance. This paper aims to address how to maximize runway operations using a Discrete Event Simulation model. A case study of Cairo International Airport (CIA) is developed to maximize the utilizing of three parallel runways using a simulation model. Different scenarios have been designed where every runway could be assigned for arrival, departure, or mixed operations. A benchmarking study was also included to compare the actual to the proposed results to spot the potential improvements. The simulation model shows that there is a significant difference in utilization and delays between the actual and the proposed ones, there are several recommendations that can be provided to airport management, in the short and long term, to increase the efficiency and to reduce the delays. By including the recommendation with different operations scenarios, such as upgrading the airport slot Coordination from Level 1 to Level 2 in the short term. In the long run, discuss the possibilities to increase the International Air Transport association (IATA) slot coordination to Level 3 as more flights are expected to be handled by the airport. Technological advancements such as radar in the approach full airside simulation model could improve the airport performance where the airport is recommended to review the standard operations procedures with the appropriate authorities. Also, the airport can adopt a future operational plan to accommodate the forecasted additional traffic density in case of adding a fourth terminal building to increase the airport capacity.

Keywords: airport performance, runway, discrete event simulation, capacity, airside

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Authors: Yin Yuanling

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A Deep Feedback Recurrent Neural Network (DFRNN) and Bidirectional Long Short-Term Memory (BiLSTM) are designed to address the problem of low accuracy of traditional relationship extraction models. This method combines a deep feedback-based recurrent neural network (DFRNN) with a bi-directional long short-term memory (BiLSTM) approach. The method combines DFRNN, which extracts local features of text based on deep feedback recurrent mechanism, BiLSTM, which better extracts global features of text, and Self-Attention, which extracts semantic information. Experiments show that the method achieves an F1 value of 76.69% on the CEC dataset, which is 0.0652 better than the BiLSTM+Self-ATT model, thus optimizing the performance of the deep learning method in the event relationship extraction task.

Keywords: event relations, deep learning, DFRNN models, bi-directional long and short-term memory networks

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Authors: Reena K., Mamatha H. G., Somshekarayya, P. Kumar

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Objectives: The annual proficiency testing of intermediate reference laboratories is conducted by the National Reference Laboratory (NRL) to assess the efficiency of the laboratories to correctly identify Mycobacterium tuberculosis and to determine its drug susceptibility pattern. The proficiency testing results from 2013 to 2017 were analyzed to determine laboratories that were consistent in reporting quality results and those that had difficulty in doing so. Methods: A panel of twenty cultures were sent out to each of these laboratories. The laboratories were expected to grow the cultures in their own laboratories, set up drug susceptibly testing by all the methods they were certified for and report the results within the stipulated time period. The turnaround time for reporting results, specificity, sensitivity positive and negative predictive values and efficiency of the laboratory in identifying the cultures were analyzed. Results: Most of the laboratories had reported their results within the stipulated time period. However, there was enormous delay in reporting results from few of the laboratories. This was mainly due to improper functioning of the biosafety level III laboratory. Only 40% of the laboratories had 100% efficiency in solid culture using Lowenstein Jensen medium. This was expected as a solid culture, and drug susceptibility testing is not used for diagnosing drug resistance. Rapid molecular methods such as Line probe assay and Genexpert are used to determine drug resistance. Automated liquid culture system such as the Mycobacterial growth indicator tube is used to determine prognosis of the patient while on treatment. It was observed that 90% of the laboratories had achieved 100% in the liquid culture method. Almost all laboratories had achieved 100% efficiency in the line probe assay method which is the method of choice for determining drug-resistant tuberculosis. Conclusion: Since the liquid culture and line probe assay technologies are routinely used for the detection of drug-resistant tuberculosis the laboratories exhibited higher level of efficiency as compared to solid culture and drug susceptibility testing which are rarely used. The infrastructure of the laboratory should be maintained properly so that samples can be processed safely and results could be declared on time.

Keywords: annual proficiency testing, drug susceptibility testing, intermediate reference laboratory, national reference laboratory

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Authors: Fiona Jensen, Barb Goodwin, Nancy Kleiman, Rhonda Usunier

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Background: Clinical simulation is now a common component in many health profession curricula in preparation for clinical practice. In the Rady Faculty of Health Sciences (RFHS) college leads in simulation and interprofessional (IP) education, planned an eight hour simulated hospital day shift, where seventy students from six health professions across two campuses, learned with each other in a safe, realistic environment. Learning about interprofessional collaboration, an expected competency for many health professions upon graduation, was a primary focus of the simulation event. Method: Faculty representatives from the Colleges of Nursing, Medicine, Pharmacy and Rehabilitation Sciences (Physical Therapy, Occupation Therapy, Respiratory Therapy) and Pharmacy worked together to plan the IP event in a simulation facility in the College of Nursing. Each college provided a faculty mentor to guide the same profession students. Students were placed in interprofessional teams consisting of a nurse, physician, pharmacist, and then sharing respiratory, occupational, and physical therapists across the team depending on the needs of the patients. Eight patient scenarios were role played by health profession students, who had been provided with their patient’s story shortly before the event. Each team was guided by a facilitator. Results and Outcomes: On the morning of the event, all students gathered in a large group to meet mentors and facilitators and have a brief overview of the six competencies for effective collaboration and the session objectives. The students assuming their same profession roles were provided with their patient’s chart at the beginning of the shift, met with their team, and then completed professional specific assessments. Shortly into the shift, IP team rounds began, facilitated by the team facilitator. During the shift, each patient role-played a spontaneous health incident, which required collaboration between the IP team members for assessment and management. The afternoon concluded with team rounds, a collaborative management plan, and a facilitated de-brief. Conclusions: During the de-brief sessions, students responded to set questions related to the session learning objectives and expressed many positive learning moments. We believe that we have a sustainable simulation IP collaborative learning opportunity, which can be embedded into curricula, and has the capacity to grow to include more health profession faculties and students. Opportunities are being explored in the RFHS at the administrative level, to offer this event more frequently in the academic year to reach more students. In addition, a formally structured event evaluation tool would provide important feedback and inform the qualitative feedback to event organizers and the colleges about the significance of the simulation event to student learning.

Keywords: simulation, collaboration, teams, interprofessional

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Authors: M. Reza Roshandel, Tannaz Aghaei Badr, Batoul Khoundabi, Sara C. Lewis, Soroush Rais-Bahrami, John Sfakianos, Reza Mehrazin, Ash K. Tewari

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Introduction: Prostate biopsy is the most reliable diagnostic method for choosing the appropriate management of prostate cancer. However, discrepancies between Gleason grade groups (GG) of different biopsies remain a significant concern. This study aims to assess the association of the radiological factors with GG discrepancies in patients with index Prostate Imaging Reporting and Data System (PI-RADS) 3 lesions, using radical prostatectomy (RP) specimens as the most accurate and informative pathology. Methods: This single-institutional retrospective study was performed on a total of 2289 consecutive prostate cancer patients with combined targeted and systematic prostate biopsy followed by radical prostatectomy (RP). The database was explored for patients with the index PI-RADS 3 lesions version 2 and 2.1. Cancers with PI-RADS 4 or 5 scoring were excluded from the study. Patient characteristics and radiologic features were analyzed by multivariable logistic regression. Number-density of lesions was defined as the number of lesions per prostatic volume. Results: Of the 151 prostate cancer cases with PI-RADS 3 index lesions, 27% and 17% had upgrades and downgrades at RP, respectively. Analysis of grade changes showed no significant associations between discrepancies and the number or the number density of PI-RADS 3 lesions. Moreover, the study showed no significant association of the GG changes with race, age, location of the lesions, or prostate volume. Conclusions: This study demonstrated that in PI-RADS 3 cancerous nodules, the chance of the pathology changes in the final pathology of RP specimens was low. Furthermore, having multiple PI-RADS 3 nodules did not change the conclusion, as the possibility of grade changes in patients with multiple nodules was similar to those with solitary lesions.

Keywords: prostate, adenocarcinoma, multiparametric MRI, Gleason score, robot-assisted surgery

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