• 제목/요약/키워드: Event Reporting

검색결과 110건 처리시간 0.025초

국내 사람유두종바이러스백신 접종 후 자발적 이상반응 보고사례의 Brighton Collaboration 기준 활용 가능성 연구 (Patterns of Spontaneous Adverse Events Reporting on Human Papillomavirus Vaccines according to the Applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017)

  • 김묘송;유승훈;박혜민;이민택;강예진;구현지;정선영
    • 한국임상약학회지
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    • 제30권1호
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    • pp.19-30
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    • 2020
  • Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

Window-Based Computer Code Package CONPAS for an Integrated Level 2 PSA

  • Ahn, Kwang-Il;Kim, See-Darl;Song, Yong-Mann;Jin, Young-Ho
    • 한국원자력학회:학술대회논문집
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    • 한국원자력학회 1996년도 춘계학술발표회논문집(2)
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    • pp.493-498
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    • 1996
  • A PC window-based computer code, CONPAS(CONtainment Performance Analysis System), has been developed to integrate the numerical, graphical and results-operation aspects of Level 2 probabilistic safety assessments (PSA) for nuclear power plants automatically. As a main logic for accident progression analysis, it employs a concept of the small containment phenomenological event tree(CPET) helpful to trace out visually individual accident progressions and of the large supporting event tree(LSET) for its detailed quantification. Compared with other existing computer codes for Level 2 PSA, the CONPAS code provides several advanced features: computational aspects including systematic uncertainty analysis, importance analysis, and sensitivity analysis, reporting aspects including tabling and graphic, and user-friend interface.

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MPEG-21 이벤트 리포팅 개요 및 동향 (Event Reporting Overview in MPEC-21)

  • 지경희;문남미;송영주;홍진우
    • 대한전자공학회:학술대회논문집
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    • 대한전자공학회 2003년도 하계종합학술대회 논문집 Ⅲ
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    • pp.1447-1450
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    • 2003
  • 이벤트 리포팅 기술요소는 MPEG-21 내에서 발생하는 모든 이벤트 및 상호작용에 대한 표준적인 측정방법 및 인터페이스를 제공한다는 점에서 그 중요성을 가진다. 본 논문에서는 MPEG-21 의 7 가지 주요 요소 중의 하나인 이벤트 리포팅에 대한 정의 및 필요성에 대해 알아보고, 이벤트 리포트 요구 및 이벤트 리포트로 나뉘는 이벤트 리포팅의 체계를 분석한다. 또한 MPEG-21의 이벤트 리포팅에 대한 표준화 동향을 분석하고, 이벤트 리포팅에 대한 향후 표준화 활동 방향을 제시한다.

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위성 운영을 위한 이벤트 시퀀스 기반의 자동 명령 추천 및 수행 시스템 (An Autonomous Command Recommend and Execution System for the Satellite Operation)

  • 양승은;정재엽;천이진
    • 항공우주기술
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    • 제13권2호
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    • pp.29-37
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    • 2014
  • 지상에서 위성의 상태를 파악하기 위해 텔레메트리, 위성 이벤트, 위성 오류 정보를 활용할 수 있다. 텔레메트리는 단순히 파라미터의 값을 나타내는 반면 이벤트 및 오류 정보는 특정 동작 및 상태를 명시적으로 나타낸다. 특히 이벤트는 지상 명령 수행 정보도 저장하므로 상태의 기록 뿐아니라 특정 조치의 내용도 포함한다. 기존에는 이러한 정보들을 지상에서 운영자가 취합 하여 위성의 상태 확인에만 수동적으로 사용 하였다. 그러나 최근 개발되는 위성의 수가 늘어나면서 지상에서 확인해야 할 정보의 양이 급격히 증가함에 따라 운영의 부담이 증가하고 있다. 또한 위성에 문제 발생 시 신속한 조치가 중요한데 운영자가 개발자에게 문제 보고 및 조치를 취하는 과정에서 시간 지연이 발생하게 된다. 이에 본 논문에서는 위성에서 연속적으로 발생하는 이벤트 시퀀스를 내용에 따라 구분하여 수집, 저장하여 특정 이벤트 발생 시 지상에서 취해야 할 동작을 추천 혹은 자동 수행하는 위성 운영 지원 시스템을 제안한다. 이는 이벤트 정보를 능동적으로 활용하는 시스템으로 지상과의 교신 시간이 제한적인 저궤도위성의 오류 자동 복구 절차에도 활용할 수 있다.

EMR의 자발적 약물부작용보고 시스템을 이용한 한약약물유해반응 분석 (Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records)

  • 김미경;한창호
    • 대한한의학회지
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    • 제36권1호
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    • pp.45-60
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    • 2015
  • Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

의약품의 시판후 조사제도 비교연구 (The Comparative Study on Post-Marketing Surveillance System for Pharmaceuticals)

  • 김인범;김홍진;손의동
    • 약학회지
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    • 제50권3호
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    • pp.145-153
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    • 2006
  • The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

국내 제조업의 아차사고 발굴활동 현황 및 인식에 관한 연구 (A Study on the Status and the Perception of Near Miss Reporting Activities in Domestic Manufacturing Industry)

  • 이석기;박정철
    • 한국융합학회논문지
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    • 제12권12호
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    • pp.287-294
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    • 2021
  • 아차사고란 재해가 일어날 수 있는 상황이 발생하였으나 인원의 부상이나 자산의 손상 등 직접적인 손실로 이어지지 않은 사건을 의미한다. 재해 방지에 있어 아차사고의 중요성은 충분히 강조되어 왔지만, 아차사고를 발굴하기 위한 활동과 그에 대한 인식에 대해서는 알려진 것이 많지 않다. 본 연구는 국내 제조업 사업장들의 아차사고 관련 활동 현황을 조사하고, 이러한 활동이 산업재해의 발생 및 안전문화와 어떠한 관련이 있는지 밝히는 것을 목표로 한다. 이를 위해 제조업 사업장을 대상으로 설문조사를 실시하여 그 결과를 분석하였다. 분석 결과, 아차사고 발굴활동을 수행하는 사업장은 조사대상의 56%로 절반을 약간 넘는 것으로 나타났으며, 발굴활동을 수행하는 사업장과 그렇지 않은 사업장의 아차사고에 대한 인식 수준에는 상당한 차이가 있었다. 또한, 아차사고의 건수는 아차사고 발굴에 대한 포상 여부에 따라 차이가 있는 것으로 나타났다. 아차사고 발굴활동의 실시 여부와 산업재해 발생 이력 간에는 관계를 발견할 수 없었지만, 안전문화 수준은 발굴활동을 수행하는 사업장이 수행하지 않는 사업장에 비해 더 높은 것으로 나타났다. 본 연구는 국내 제조업 사업장의 아차사고에 대한 인식과 발굴활동의 개략적인 현황을 파악했다는 데 의의가 있으며, 이를 기초로 추후 아차사고 발굴활동과 재해 발생 간의 연관관계검증 및 아차사고 발굴활동의 효과 제고를 위한 후속 연구가 필요할 것으로 보인다.

삼중화된 회로에서의 결함 감지를 위한 방법에 관한 연구 (A Study on Fault Detection Scheme on TMRed Circuits)

  • 강동수;이종길;장경선
    • 한국정보과학회:학술대회논문집
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    • 한국정보과학회 2011년도 한국컴퓨터종합학술대회논문집 Vol.38 No.1(B)
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    • pp.313-316
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    • 2011
  • SRAM-based FPGAs are very sensitive to single event upset(SEU) induced by space irradiation. To mitigate SEU effects, space applications employ some mitigation schemes. The triple modular redundancy(TMR) is a well-known mitigation scheme. It uses one or three voters as well as three identical blocks performing the same work. The voters can mask out one error in the outputs from the three replicated blocks. One SEU error in TMRed circuits can be masked but it needs to be detected for some reasons such as to analyze the SEU effects in the satellite or to recover the circuits from the error before additional error occur. In this paper, we developed a fault detection circuit and reporting system to detect a fault on the TMRed circuits. To verify our error detection circuit and reporting circuit, we performed an irradiation test at MC-50 Cyclotron. Experimental results showed that error detection circuit can detect a fault on the TMRed test circuit in radiation environment.

응급실 내 1급 응급구조사의 폭력경험과 대처 및 반응 (Violence experiences, coping, and response of paramedics in the emergency room)

  • 한승은;이경열
    • 한국응급구조학회지
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    • 제22권2호
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    • pp.51-65
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    • 2018
  • Purpose: The purpose of this study was to investigate experiences of violence with patients or family members by paramedics working at emergency rooms. Methods: A questionnaire was administered from June 1 to 31, 2017 to 225 paramedics working at 27 emergency medical centers. The collected data were analyzed with SPSS statistics ver 24.0 program. Results: Within the past year, 208(92.9%) of 224 participants experienced violence among whom 202(90.2%) experienced verbal abuse, 193(86.2%) experienced physical threat, 89(39.7%) experienced physical violence, and 52(23.2%) experienced sexual violence. The level of violence response depending on the overlapping experience of violence type showed significant difference from emotional response (p= .001), social response (p= .001), physical response (p= .004), and overall violence response (p= .001). Conclusion: In conclusion, paramedics are frequently exposed to violence in the emergency rooms, of which they mostly experience verbal abuse. In addition, because the reporting system in the event of violence and the coping process are not well-informed, paramedics are unable to sufficiently utilize the reporting system and programs established within the institution. Therefore, the support of the legal system is needed to create a safe working environment for the medical staff who work in the emergency medical centers.

Convergence with International Financial Reporting Standard and Its Effect on Stock Return: Evidence from Malaysia

  • ZAKARIA, Zukarnain;SORAYA, Evi Oktoviana;ISMAIL, Mohd Roslan
    • The Journal of Asian Finance, Economics and Business
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    • 제8권12호
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    • pp.153-158
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    • 2021
  • Convergence is the process of gradual adoption of a certain accounting standard issued by different regulatory bodies. The aim is to achieve uniformity and standardization across borders to open opportunities for international investment and collaboration. The implementation of IFRS, in theory, encourages more transactions by presenting financial statements in a simple and understandable manner for all investors and other businesses interested in the company. Using event study methodology, this study investigates whether Malaysian companies' adoption of IFRS is recognized by the investment community. A total of 89 public listed companies in Bursa Malaysia are involved in this study. The results show that about 62.8 percent of the companies that adopted IFRS-based financial statements experienced an increase in their average abnormal return after the announcement. However, the paired sample test results show that only 5.6 percent out of 89 companies studied experience a significant difference in abnormal return before and after the announcement. The inexistence of the average abnormal return difference between before and after the announcement may indicate that IFRS-based financial statements do not have any new market informational content. This study found little evidence to show that convergence with IFRS affects the company's stock price in Malaysia.