• Title/Summary/Keyword: Event Reporting

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Standardization Technology of MPEG-21 Event Reporting (MPEG-21 Event Reporting 표준화 기술 연구)

  • 지경희;문남미;송영주;홍진우
    • Proceedings of the Korea Multimedia Society Conference
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    • 2004.05a
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    • pp.782-785
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    • 2004
  • ISO/1EC 21000-15 MPEG-21 이벤트 리포팅은 멀티미디어 프레임워크 내에서 보고 가능한 모든 이벤트 및 상호작용에 대한 표준적 측정방법 및 인터페이스를 제공하는 MPEG-21의 주요 요소 기술이다. 본 논문에서는 MPEG-21 이벤트 리포팅의 체계 및 DI로서의 구조, 피어 구조를 분석 제시한다. 나아가 현재 표준화 기술 동향을 분석함으로써 향후 이벤트 리포팅에 대한 표준화 방향을 제시하고자 한다.

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Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database (의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색)

  • Baek, Ji-Won;Yang, Bo Ram;Choi, Subin;Shin, Kwang-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.4
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    • pp.324-331
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    • 2021
  • To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

Investigating the Status of WHO VigiAccess Adverse Drug Event Reporting and Exploring its Potential for Application Using Anti-Obesity Agents as Examples (VigiAccess를 통한 WHO의 약물 이상사례 보고 현황 검색과 그 활용 가능성 탐색 : 비만 치료제를 중심으로)

  • Mikyung Kim
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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    • pp.55-74
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    • 2024
  • Objectives: This study reviewed the status of adverse event (AE) reporting in VigiAccess using anti-obesity agents as examples and explored the possibility of its use and future challenges. Methods: AE reports related to some representative drugs among herbal medicines (HMs), complex HM prescriptions, ingredients of supplements, and over-the-counter and prescription medicines were investigated using VigiAccess on February 1, 2024. Results: AE reports on prescription drugs were overwhelmingly higher than those on HMs or supplements. Although most reports were submitted from North America, reports on Ephedra sinica and green tea extract (GTE) were more from Asia and Europe, respectively. The female population reported more, and the difference in the sex ratio was the smallest for Ephedra spp. The age group was concentrated on young adults, but many older patients reported GLP-1 receptor agonist-related AEs. Symptoms related to the gastrointestinal and nervous systems were most commonly reported, but mental and cardiac disorders were common in Ephedra-type HMs. Hepatobiliary disorders are also commonly found in GTE-related reports. Conclusions: VigiAccess was useful for easily checking the global status of AE reporting for prescription drugs. However, several limitations were observed in using VigiAccess for HMs because of the few reports. Thus, it is necessary to increase the number of reports by education and to promote AE reporting among HM prescribers and users. The full range of HMs should be included in the pharmacovigilance system, and the coding and classification of HMs should be revised.

Effect of A Pharmacovigilance Practice Training Course for Future Doctors of Korean Medicine on Knowledge, Attitudes and Self Efficacy (약물감시 실습 교육이 한의과대학 학부생의 지식, 태도 및 자가 효능감에 미치는 효과)

  • Kim, Mikyung
    • The Journal of Korean Medicine
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    • v.41 no.1
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    • pp.21-44
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    • 2020
  • Objectives: This study was aimed to develop a pharmacovigilance practice training course for future doctors of Korean medicine, the graduate students of a college of Korean medicine, and to verify the educational effect of the curriculum. Methods: Fifty-six students were given a training course designed as follows: 1) pre-class homework (basic theory self-study, online course, causality assessment, and adverse event reporting simulation); 2) in-class: homework submission and case discussion; 3) after-class: homework revision and resubmission. An online survey to assess the change of the level of basic knowledge and attitudes toward pharmacovigilance, the willingness to report adverse events, and self-efficacy for the causality assessment and adverse event reporting was conducted before and after education. Results: The survey participation rate was 96.5% in pre-education and 64.3% in the post-education survey. After education, knowledge level was improved (mean score from 4.3±2.11 to 6.7±1.96 points, modal value from 3 to 8 points) and positive changes were observed in almost all questions on attitudes. In the post-education survey, more students felt that they could do causality assessment (from 13% to 80.5%), could report adverse events to the agency in charge (from 7.4% to 96.2%), and expressed their strong willingness to report adverse events in the future (from 77.8% to 88.9%) than in the pre-education survey. Conclusions: More schools of Korean medicine need to adopt pharmacovigilance training courses in their curriculum to foster future doctors of Korean medicine with pharmacovigilance capabilities. Such efforts will be the basis for achieving an evidence-based, safe use of herbal medicine.

Analysis of Important Medical Adverse Events and Signals Related with Cyclosporine and Tacrolimus Using the FDA Adverse Event Reporting System (FAERS) Database (FDA 부작용 보고 시스템 데이터베이스를 이용한 Cyclosporine과 Tacrolimus의 주요 약물이상사례 및 실마리 정보 분석)

  • Seung Hyeon Cha;Ji Hyeon Im;Yun-Kyoung Song
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.4
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    • pp.352-361
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    • 2022
  • Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

Analysis of Global Media Reporting Trends for K-fashion -Applying Dynamic Topic Modeling- (K 패션에 대한 글로벌 미디어 보도 경향 분석 -다이내믹 토픽 모델링(Dynamic Topic Modeling)의 적용-)

  • Hyosun An;Jiyoung Kim
    • Journal of the Korean Society of Clothing and Textiles
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    • v.46 no.6
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    • pp.1004-1022
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    • 2022
  • This study seeks to investigate K-fashion's external image by examining the trends in global media reporting. It applies Dynamic Topic Modeling (DTM), which captures the evolution of topics in a sequentially organized corpus of documents, and consists of text preprocessing, the determination of the number of topics, and a timeseries analysis of the probability distribution of words within topics. The data set comprised 551 online media articles on 'Korean fashion' or 'K-fashion' published on Google News between 2010 and 2021. The analysis identifies seven topics: 'brand look and style,' 'lifestyle,' 'traditional style,' 'Seoul Fashion Week (SFW) event,' 'model size,' 'K-pop,' and 'fashion market,' as well as annual topic proportion trends. It also explores annual word changes within the topic and indicates increasing and decreasing word patterns. In most topics, the probability distribution of the word 'brand' is confirmed to be on the increase, while 'digital,' 'platform,' and 'virtual' have been newly created in the 'SFW event' topic. Moreover, this study confirms the transition of each K-fashion topic over the past 12 years, along with various factors related to Hallyu content, traditional culture, government support, and digital technology innovation.

Stock Reaction to the Implementation of Extensible Business Reporting Language

  • JUNUS, Onong;IRWANTO, Andry
    • The Journal of Asian Finance, Economics and Business
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    • v.8 no.1
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    • pp.675-685
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    • 2021
  • The purpose of this study is to examine the reaction of stock prices on the implementation of Extensible Business Reporting Language (XBRL) in companies listed on the Indonesia Stock Exchange (IDX). Using the event study method and calculating abnormal returns of the 2015 financial statements of 462 companies listed on the IDX, findings showed that 49 companies have not applied the XBRL format in their financial statements. Based on the results of the Average Abnormal Return (AAR) and Cumulative Average Abnormal Return (CAAR) values, using the one-sample test, investors react to shares in companies that have not implemented XBRL and who have implemented XBRL; however, based on the independent t-test based on average values there are differences between companies that have not applied XBRL and those who have implemented XBRL. This research only looks at the one-year implementation of XBRL in financial reporting (2015), then the research does not separate which companies are on time in the delivery of financial statements to the public through the IDX website. Our research contributes to the understanding of the use of XBRL in corporate financial reporting because before the XBRL financial reporting format was published, the company had published a financial statement format based on the legal provisions of financial statements in Indonesia.

Effect of Patient Safety Training Program of Nurses in Operating Room

  • Zhang, Peijia;Liao, Xin;Luo, Jie
    • Journal of Korean Academy of Nursing
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    • v.52 no.4
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    • pp.378-390
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    • 2022
  • Purpose: This study developed an in-service training program for patient safety and aimed to evaluate the impact of the program on nurses in the operating room (OR). Methods: A pretest-posttest self-controlled survey was conducted on OR nurses from May 6 to June 14, 2020. An in-service training program for patient safety was developed on the basis of the knowledge-attitude-practice (KAP) theory through various teaching methods. The levels of safety attitude, cognition, and attitudes toward the adverse event reporting of nurses were compared to evaluate the effect of the program. Nurses who attended the training were surveyed one week before the training (pretest) and two weeks after the training (posttest). Results: A total of 84 nurses participated in the study. After the training, the scores of safety attitude, cognition, and attitudes toward adverse event reporting of nurses showed a significant increase relative to the scores before the training (p < .001). The effects of safety training on the total score and the dimensions of safety attitude, cognition, and attitudes toward nurses' adverse event reporting were above the moderate level. Conclusion: The proposed patient safety training program based on KAP theory improves the safety attitude of OR nurses. Further studies are required to develop an interprofessional patient safety training program. In addition to strength training, hospital managers need to focus on the aspects of workflow, management system, department culture, and other means to promote safety culture.

Development of Event Corrective Action Supporting System (ECAS) in Nuclear Power Plant (원전 사고처리 지원시스템(ECAS) 개발)

  • Choi, Young Hwan;Kim, Yopng Mi;Ko, Han Ok
    • Transactions of the Korean Society of Pressure Vessels and Piping
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    • v.5 no.2
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    • pp.40-44
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    • 2009
  • In this study, Event Corrective Action Supporting System (ECAS) is developed for the accident evaluation in nuclear power plant. The ECAS system can be used in supporting regulator and/or operator under event situation in nuclear power plants. The ECAS system consists of 5 modules including failure location module, failure analysis module, failure integrity evaluation module, system vulnerability evaluation module, and reporting and operating experience feedback module. The ECAS system will be used as sub module of Knowledge-Based Event Evaluation Network (K-EvENT) which is developing for the against the accident in nuclear power plants.

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Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting (의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이)

  • Lee, Ye Jin;Yoon, Chiho;Choi, Soo Jeong;Kang, Youngjoon;Kim, Jin Kuk;Kwon, Bum Sun;Lee, You Kyoung;Nam, Ki Chang
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.171-178
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    • 2019
  • This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.