• 제목/요약/키워드: reporting

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의약품부작용보고시스템을 이용한 바레니클린의 이상사례 실마리정보 도출 (Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System)

  • 장민교;구현진;김준우;신광희
    • 한국임상약학회지
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    • 제32권1호
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    • pp.1-7
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    • 2022
  • Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

의약품부작용보고시스템을 이용한 메토클로프라미드의 이상사례 실마리정보 도출 (Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS))

  • 장민교;이영화;정현숙;신광희
    • 한국임상약학회지
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    • 제33권2호
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    • pp.122-127
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    • 2023
  • Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

Reporting Quality of Research Studies on AI Applications in Medical Images According to the CLAIM Guidelines in a Radiology Journal With a Strong Prominence in Asia

  • Dong Yeong Kim;Hyun Woo Oh;Chong Hyun Suh
    • Korean Journal of Radiology
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    • 제24권12호
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    • pp.1179-1189
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    • 2023
  • Objective: We aimed to evaluate the reporting quality of research articles that applied deep learning to medical imaging. Using the Checklist for Artificial Intelligence in Medical Imaging (CLAIM) guidelines and a journal with prominence in Asia as a sample, we intended to provide an insight into reporting quality in the Asian region and establish a journal-specific audit. Materials and Methods: A total of 38 articles published in the Korean Journal of Radiology between June 2018 and January 2023 were analyzed. The analysis included calculating the percentage of studies that adhered to each CLAIM item and identifying items that were met by ≤ 50% of the studies. The article review was initially conducted independently by two reviewers, and the consensus results were used for the final analysis. We also compared adherence rates to CLAIM before and after December 2020. Results: Of the 42 items in the CLAIM guidelines, 12 items (29%) were satisfied by ≤ 50% of the included articles. None of the studies reported handling missing data (item #13). Only one study respectively presented the use of de-identification methods (#12), intended sample size (#19), robustness or sensitivity analysis (#30), and full study protocol (#41). Of the studies, 35% reported the selection of data subsets (#10), 40% reported registration information (#40), and 50% measured inter and intrarater variability (#18). No significant changes were observed in the rates of adherence to these 12 items before and after December 2020. Conclusion: The reporting quality of artificial intelligence studies according to CLAIM guidelines, in our study sample, showed room for improvement. We recommend that the authors and reviewers have a solid understanding of the relevant reporting guidelines and ensure that the essential elements are adequately reported when writing and reviewing the manuscripts for publication.

Quality Reporting of Systematic Review and Meta-Analysis According to PRISMA 2020 Guidelines: Results from Recently Published Papers in the Korean Journal of Radiology

  • Ho Young Park;Chong Hyun Suh;Sungmin Woo;Pyeong Hwa Kim;Kyung Won Kim
    • Korean Journal of Radiology
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    • 제23권3호
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    • pp.355-369
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    • 2022
  • Objective: To evaluate the completeness of the reporting of systematic reviews and meta-analyses published in a general radiology journal using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Materials and Methods: Twenty-four articles (systematic review and meta-analysis, n = 18; systematic review only, n = 6) published between August 2009 and September 2021 in the Korean Journal of Radiology were analyzed. Completeness of the reporting of main texts and abstracts were evaluated using the PRISMA 2020 statement. For each item in the statement, the proportion of studies that met the guidelines' recommendation was calculated and items that were satisfied by fewer than 80% of the studies were identified. The review process was conducted by two independent reviewers. Results: Of the 42 items (including sub-items) in the PRISMA 2020 statement for main text, 24 were satisfied by fewer than 80% of the included articles. The 24 items were grouped into eight domains: 1) assessment of the eligibility of potential articles, 2) assessment of the risk of bias, 3) synthesis of results, 4) additional analysis of study heterogeneity, 5) assessment of non-reporting bias, 6) assessment of the certainty of evidence, 7) provision of limitations of the study, and 8) additional information, such as protocol registration. Of the 12 items in the abstract checklists, eight were incorporated in fewer than 80% of the included publications. Conclusion: Several items included in the PRISMA 2020 checklist were overlooked in systematic review and meta-analysis articles published in the Korean Journal of Radiology. Based on these results, we suggest a double-check list for improving the quality of systematic reviews and meta-analyses. Authors and reviewers should familiarize themselves with the PRISMA 2020 statement and check whether the recommended items are fully satisfied prior to publication.

고관절 부분 치환술 시술정보 공개에 따른 재입원율, 입원일수 및 진료비의 변화 (The Change in Readmission Rate, Length of Stay and Hospital Charge after Performance Reporting of Hip Hemiarthroplasty)

  • 장원모;은상준;사공필용;이채은;오무경;오주환;김윤
    • Journal of Preventive Medicine and Public Health
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    • 제43권6호
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    • pp.523-534
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    • 2010
  • Objectives: We assessed impact of performance reporting information about the readmission rate, length of stay and cost of hip hemiarthroplasty. Methods: The data are from a nationwide claims database, National Quality Improvement Project database, of Health Insurance Review & Assessment Service in Korea. From January 2006 to April 2008, we received information of length of stay, readmission within 30 days, cost of 22 851 hip hemiarthroplasty episodes. Each episodes has retained the diagnoses of comorbidities and demographics. We used time-series analysis to assess the shifting of patients selections, between high volume (over 16 operations in a year) and low volume institutions, after performance reporting (December 2007). The changes of quality (readmission, length of stay) and cost were evaluated by multilevel analysis with adjustment of patient's factors and institutional factors after performance reporting. Results: As compared with the before performance reporting, the proportion of patients who choose the high volume institution, increased 3.45% and the trends continued 4 months at marginal significance (p = 0.059). After performance reporting, national average readmission rate, length of stay were decreased by 0.49 OR (95% CI=0.25 - 0.95) and 10% (${\beta}$=-0.102, p<0.01) and cost was not changed (${\beta}$=-0.01, p=0.27). The high volume institutions were more decreased than low volume in length of stay. Conclusions: After performance reporting, readmission rate, length of stay were decreased and the patient selections were marginally shifted from low volume institutions to high volume institutions.

허베이 스피리트호 기름유출사고를 통해 본 재난보도의 문제점 (Problems of Disaster Reporting in Korea - Case of Hebei Spirit Oil Spill in Taean-gun)

  • 박동균
    • 한국콘텐츠학회논문지
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    • 제9권5호
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    • pp.241-248
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    • 2009
  • 홍수, 지진, 폭설 등과 같은 자연재해나 대형사고 등에 대한 언론의 보도양태에 대한 분석연구들은 국내외를 막론하고 많이 이루어지지 못했다. 이러한 재난은 거의 매년 끊임없이 발생하고, 이에 대한 보도와 그에 대한 비판이 계속되었음에도 불구하고, 이러한 보도방식에 대한 학문적 비판과 대안이 미흡했다는 것은 큰 문제점이라고 할 수 있다. 이러한 맥락에서, 본 연구에서는 2007년 12일 충남 태안군에서 발생한 허베이 스피리트호 기름유출 사고에 대한 대응 및 복구과정에서 한국의 언론보도가 재난관리 과정상 제대로 역할을 수행했는지를 분석해 보고, 아울러 개선방안을 제시하였다. 허베이 스피리트호 기름유출사고를 통해 본 우리 나라의 재난보도의 문제점을 요약해 보면, 먼저 부정확한 보도가 다수 발생하여 피해자인 태안주민들을 더욱 곤경에 빠뜨리는 오류를 범하였다는 점이다. 또한, 사건 초기에 기름유출사고에 대한 잘못된 이름 짓기가 있었고, 재난보도의 근간이 피해자 중심이 아닌 독자 중심의 보도로 일관하였다는 점이다. 끝으로, 자원봉사에 대한 과잉보도로 인해 정작 사건의 본질과 피해당사자의 구호 등은 취재 및 보도에서 밀리는 현상이 초래되었다. 향후 재난보도는 피해자 중심의 보도, 방재 및 문제해결 보도 등의 취재를 지향하고, 아울러 재난전문 기자를 양성해야 한다.

안전신고 제도(안전신문고) 도입에 따른 효과 분석 (Analysis of Effects on Adoption of a Safety e-Reporting System)

  • 이준;조상명;박은미;이상화
    • 한국방재안전학회논문집
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    • 제12권4호
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    • pp.27-41
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    • 2019
  • 본 연구는 안전 신문고 제도의 효과를 분석하기 위해 2014년 9월 ~ 2019년 7월까지 접수된 안전신고 데이터 분석을 수행하고 해당 데이터를 통해 안전신고 성과를 측정할 수 있는 항목을 선정하여 4대 불법 주정차 주민신고제 도입에 대한 효과, 도로교통사고 기반의 원단위법을 이용한 효과 분석을 수행하였다. 2019년 10월까지 49개 기초자치단체의 4대 불법 주정차 주민 신고제 도입 후 약 60% 정도 단속 단가가 감소되었으며, 단속인력에 대한 신고 1건의 가치는 21만 3천원/건으로 도출되었다. 과태료 부과 등을 통한 세수 확보를 건당 편익으로 산정하면 약 6만 2천원/건 정도 추정되었다. 이 둘을 합하면 4대 불법 주정차 주민신고 가치는 총 27만 5천원/건으로 도출되었다. 안전신문고의 신고 유형은 대부분 교통 및 시설로 이를 대표적인 신고가치로 정의하고 연도별 총 편익을 산정한 결과, 2014년부터 2019년까지 안전신문고로 접수된 신고건수는 1,164,439건, 2019년 4월 이후 7월까지 신고 된 4대 불법 주정차 신고건수는 502,721건으로 지난 5년간 총 편익을 산정하면 약 2,734억여 원이다.

기업건전성평가에 미치는 내부통제정보의 유용성에 관한 실증분석 연구 (An Empirical Analysis about the usefulness of Internal Control Information on Corporate Soundness Assessment)

  • 유길현;김대룡
    • 디지털융복합연구
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    • 제14권8호
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    • pp.163-175
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    • 2016
  • 본 연구는 기업의 내부통제 취약점 유무가 금융기관의 기업건전성 평가 분류와 유의적으로 작용하는지를 실증 분석함으로써, 기업에게는 효율적인 내부통제제도 형성유인을 제공하고 금융기관에게는 내부회계관리제도에 따른 정보유용성을 실증적으로 확인해 보는데 있다. 분석대상은 2008년부터 2013년까지 K_금융기관과 거래실적이 있는 유가증권 및 코스닥 상장기업과 자산 1,000억 원 이상의 비상장기업이다. 분석결과, 내부회계관리제도에 따른 내부통제 취약점 비보고기업은 평균적으로 'BBB' 신용등급을 받는데 반하여, 보고기업은 'CCC'등급을 받고 있으며, 자산 건전성 분류 역시 통계적으로 유의하게 비보고기업은 '정상'으로, 보고기업은 '요주의' 기업으로 분류되고 있다. 따라서 내부통제의 취약점 보고정보는 기업이 형성하는 재무자료의 신뢰성을 저하시켜 기업에게는 낮은 신용등급의 원인으로, 금융기관에게는 자산부실화 예방을 위한 충당금 추가 적립, 높은 대출금리 요구의 유인이 될 수 있다는 점을 시사한다. 내부회계관리제도에 따른 내부통제의 취약점 보고가 기업신용평가나 자산건전성 분류 등 기업 건전성에 대한 금융기관의 평가에 유의한 정보로써 활용될 수 있다는 점을 제시하고 있는 것이 본 연구의 주요의의이다.

간호사가 인식한 조직의 특성과 투약오류보고장애요인간의 정준상관관계 (Canonical correlation between organizational characteristics and barrier to medication error reporting of nurses)

  • 김민정;김명수
    • 한국산학기술학회논문지
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    • 제15권2호
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    • pp.979-988
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    • 2014
  • 본 연구는 간호사들이 인식한 안전 분위기와 업무환경을 포함한 조직의 특성과 투약오류보고장애요인간의 관련성을 검증하기 위한 연구이다. 수정된 안전 분위기, 업무환경, 투약오류보고장애 문항을 활용하여 7개 병원의 334명의 간호사들을 대상으로 하여 조사하였다. 자료수집기간은 2012년 9월 한달 간이었고, 서술적 통계, Pearson correlation coefficient, canonical correlation을 적용하였다. 조직의 특성은 투약오류보고장애와 세 가지 유의한 상관이 있었다. 첫 번째 정준상관계수는 .50(Wilks' ${\lambda}$=0.61, df=32, p<.001)이었고, 두 번째는 .35(Wilks' ${\lambda}$=0.81, df=21, p<.001), 세 번째는 .22(Wilks' ${\lambda}$=0.93, df=12, p=.018)이었다. 첫 번째 정준상관은 높은 안전 분위기와 업무환경이 오류보고에의 두려움을 제외한 투약오류보고와 관련이 있었다. 두 번째 식은 '의료인간의 안전 분위기'의 높은 지각과 높은 '병원에의 간호사 참여'와 '인적 자원의 적절성'은 낮은 '불안감'과 '행정자들의 반응'과 관련이 있었다. 투약오류보고장애를 위한 전략과 안전 분위기와 업무환경과 같은 조직의 특성의 진보가 적용되어야 한다.

CARE 지침에 따른 2018~2021년 동의신경정신과학회지 증례 보고의 질 평가 (Assessing the Quality of Reporting for Case Reports in Journal of Oriental Neuropsychiatry from Year 2018 to 2021 Using CARE Guideline)

  • 최성열
    • 동의신경정신과학회지
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    • 제33권2호
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    • pp.143-156
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    • 2022
  • Objectives: The purpose of this study was to evaluate the quality of reporting for case reports published in Journal of Oriental Neuropsychiatry from year 2018 to 2021 compared with year 2013 to 2017 in order to recommend ways to improve the quality of case reports published in the future. Methods: To evaluate the quality of case reports identified by electronic searching in Oriental medicine Advanced Searching Integrated System (OASIS) and by hand searching from archives on peer review system of Journal of Oriental Neuropsychiatry using CAse REport (CARE) guideline. The researcher assessed the quality of reporting based on the CARE guideline as 'Sufficient', 'Not-Sufficient', 'Not-Applicable', and 'Not-Reported' for case reports published from 2018 to 2021 in Journal of Oriental Neuropsychiatry. In addition, it was compared with previous case reports published from 2013 to 2017. Results: Finally, 17 case reports were included for the assessment. General quality of reporting for case reports published from year 2018 to 2021 was improved compared with that of previous case reports published in 2018. The maximum value (46.4%→60.7%, 14.3% increase), the minimum value (22.2%→32.1%, 9.9% increase), and the median value (39.3%→50.0%, 10.7% increase) of the report rate evaluated as 'Sufficient' were generally improved. The maximum value (53.6%→50.0%, 3.6% decrease), minimum value (25.9%→21.4%, 4.5% decrease), and median value (35.7%→32.1%, 3.6% decrease) of the report rate evaluated as 'Not-Sufficient', the maximum value of the report rate evaluated as 'Not-reported' (40.7%→25.9%, 14.8% decrease), the minimum value (14.7%→10.7% decrease), and the intermediate value (14.7% decrease) were also generally improved. Four items (8b, 8d, 10c, and 13) were evaluated as 'Not-Reported'. These items seem to be items that need urgent improvement along with 8c, which showed a significant decrease in reporting rate. Conclusions: There are needs to improve the quality of case reports in Journal of Oriental Neuropsychiatry by comparing case reports published from year 2013 to 2017 with case reports published from year 2018 to 2021. To improve the quality of case reporting, sufficient education at the academic level should be provided on thesis preparation methods. It is also necessary to develop a tool for evaluating the quality of case reporting that reflects characteristics of Korean Medicine.