• Title/Summary/Keyword: reporting

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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.

A Study on the Improvement of the Reports on Details of Supply of Medical Device System Through Selective Application (선별적 적용을 통한 의료기기 공급내역보고 제도 개선 연구)

  • Hyun Ju Jeong;Soo Yeon Lim;Ju Wan Kim;Won Seuk Jang;Byeong-Ju Kwon
    • Journal of Biomedical Engineering Research
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    • v.44 no.5
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    • pp.315-323
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    • 2023
  • The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea (자발적 부작용 보고 데이터베이스를 이용한 DPP- IV inhibitor의 약물이상사례 분석)

  • Hyejung Pyo;Tae Young Kim;Su Been Choi;Hyeong Jun Jo;Hae Lee Kang;Jung Sun Kim;Hye Sun Gwak;Ji Min Han
    • Korean Journal of Clinical Pharmacy
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    • v.34 no.2
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    • pp.100-107
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    • 2024
  • Background: The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database. Methods: This study was conducted using AEs reported from January 2009 to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPP-IV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected. Results: Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of reported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, pharyngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15). Conclusions: Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.

Breast Imaging Reporting and Data System (BI-RADS): Advantages and Limitations (유방영상 판독과 자료체계: 장점과 한계)

  • Ji Soo Choi
    • Journal of the Korean Society of Radiology
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    • v.84 no.1
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    • pp.3-14
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    • 2023
  • Breast Imaging Reporting and Data System (BI-RADS) is a communication and data tracking system that standardizes and controls the quality of reporting by presenting lexicon descriptors, assessment categories, and recommendations for managing breast lesions. Using standardized terminology recommended by BI-RADS, radiologists can concisely and reproducibly communicate breast imaging results to clinicians. They can also provide the estimated malignant probability of the lesions found and guide management for them by determining the final assessment category. The limitations of BI-RADS 5th edition currently in use are that there are some areas for which standardized terminologies still need to be established, and that the diagnostic criteria of MRI assessment categories 3 and 4 are ambiguous compared to those for mammography or ultrasound. The next revision of BI-RADS is expected to include solutions for overcoming current limitations.

CT/MRI Liver Imaging Reporting and Data System (LI-RADS): Standardization, Evidence, and Future Direction (CT/MRI 간영상 판독과 자료체계: 표준화, 근거 및 발전방향)

  • Yeun-Yoon Kim;Jin-Young Choi
    • Journal of the Korean Society of Radiology
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    • v.84 no.1
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    • pp.15-33
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    • 2023
  • The liver imaging reporting and data system (LI-RADS) has been developed with the support of the American College of Radiology to standardize the diagnosis and evaluation of treatment response of hepatocellular carcinoma (HCC). The CT/MRI LI-RADS version 2018 has been incorporated in the American Association for the Study of Liver Diseases guidance. This review examines the effect of CT/MRI LI-RADS on the standardized reporting of liver imaging, and the evidence in diagnosing HCC and evaluating treatment response after locoregional treatment using CT/MRI LI-RADS. The results are compared with other HCC diagnosis guidelines, and future directions are described.

Implementation of Reporting Tool Supporting OLAP and Data Mining Analysis Using XMLA (XMLA를 사용한 OLAP과 데이타 마이닝 분석이 가능한 리포팅 툴의 구현)

  • Choe, Jee-Woong;Kim, Myung-Ho
    • Journal of KIISE:Computing Practices and Letters
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    • v.15 no.3
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    • pp.154-166
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    • 2009
  • Database query and reporting tools, OLAP tools and data mining tools are typical front-end tools in Business Intelligence environment which is able to support gathering, consolidating and analyzing data produced from business operation activities and provide access to the result to enterprise's users. Traditional reporting tools have an advantage of creating sophisticated dynamic reports including SQL query result sets, which look like documents produced by word processors, and publishing the reports to the Web environment, but data source for the tools is limited to RDBMS. On the other hand, OLAP tools and data mining tools have an advantage of providing powerful information analysis functions on each own way, but built-in visualization components for analysis results are limited to tables or some charts. Thus, this paper presents a system that integrates three typical front-end tools to complement one another for BI environment. Traditional reporting tools only have a query editor for generating SQL statements to bring data from RDBMS. However, the reporting tool presented by this paper can extract data also from OLAP and data mining servers, because editors for OLAP and data mining query requests are added into this tool. Traditional systems produce all documents in the server side. This structure enables reporting tools to avoid repetitive process to generate documents, when many clients intend to access the same dynamic document. But, because this system targets that a few users generate documents for data analysis, this tool generates documents at the client side. Therefore, the tool has a processing mechanism to deal with a number of data despite the limited memory capacity of the report viewer in the client side. Also, this reporting tool has data structure for integrating data from three kinds of data sources into one document. Finally, most of traditional front-end tools for BI are dependent on data source architecture from specific vendor. To overcome the problem, this system uses XMLA that is a protocol based on web service to access to data sources for OLAP and data mining services from various vendors.

Quantity and Quality Assessment of Randomized Controlled Trials in the Journal of Oriental Rehabilitation Medicine (한방재활의학과학회지에 수록된 무작위대조시험 연구의 양적, 질적 평가)

  • Kwon, Dong-Hyun;Nam, Jong-Kyung;Jung, Min-Kyu;Kim, Ho-Jun;Lee, Myeong-Jong
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.4
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    • pp.91-103
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    • 2010
  • Objectives : The purpose of this study is to perform quantity and quality assessment of randomized controlled trials(RCTs) in the journal of oriental rehabilitation medicine(JORM). Methods : Upon extracting randomized controlled trial from all the articles published in the JORM from 1991 to 2009, assessments were made on the adequacy of the consolidated standards of reporting trials(CONSORT) checklist. The assessment were performed independently by two researchers, and adjustment of the differences were done by discussions. Results : Among the 824 articles from 1981 to 1999, 33 RCTs were selected. 4 RCTs were published from 1991 to 2002, and 29 RCTs were published from 2003 to 2009. Adequacy of the CONSORT checklist was 29.4%(27.3% from 1999 to 2005, 31.6% from 2006 to 2009). Conclusions : RCTs of the JORM consistently increased in quantity and quality. But researchers should make an effort to reporting more accurate.

Business Strategy, Corporate Governance and Sustainability Reporting: An Analysis of the Fit Contingency Approach

  • HERNAWATI, Erna
    • The Journal of Asian Finance, Economics and Business
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    • v.7 no.12
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    • pp.761-771
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    • 2020
  • This study discusses the role of Board Monitoring Effectiveness (BME) on managers' decisions regarding the business strategies that fit the external business environmental conditions by using a contingency analysis approach. Furthermore, this study will examine how fit strategies affect Sustainability Reporting (SR) of listed companies on the Indonesia Stock Exchange (IDX) from 2014 to 2017. This study uses Conditional Mixed Process (CMP) technique. This CMP method is claimed to be more efficient in analyzing the TSL models. This study found that in highly uncertain conditions, BME had a positive influence on the probability of managers to choose prospector and defender strategies rather than analyzers. These results indicate that BME shows positive impact on the contingency fit between business strategies and environmental uncertainty. In addition, the study documents that only prospectors have a positive impact on SR, however this study failed to document that defenders have positive impact on SR. Meanwhile the unexpected result is analyzers have a significantly positive effect on SR. This study is the first study to investigate the role of BME in contingency fit between business strategies and environmental uncertainties and how it produces effects up to the level of SR.

Predictors of Intention to Report Child Abuse among Nurses (간호사의 아동학대 신고의도 영향요인)

  • Kim, Jin-Sun;Park, Gyeong-Sook
    • Child Health Nursing Research
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    • v.11 no.2
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    • pp.211-220
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    • 2005
  • Purposes: The purposes of this study were to examine knowledge related to child abuse, attitudes toward child abuse, and intention to report child abuse and to identify the predictors of nurses' intention to report child abuse. Method: A descriptive-correlational study was conducted. Participants were 171 nurses who worked in the pediatric or emergency rooms in G city. Self-administered questionnaire was used for data collection. Descriptive statistics, t-test or ANOVA, Pearson correlation, and stepwise multiple regression analysis were used for data analysis. Results: Nurses had a limited knowledge related to child abuse. Nurses had negative attitudes toward child discipline, were inclined to punish the abuser, and had positive attitudes about professional responsibility for reporting child abuse. Nurses perceived difficulty in the actual behavior of reporting child abuse. Nurses' intention to report child abuse was predicted by nurses' attitudes to professional responsibility for reporting child abuse. Conclusions: Based on the findings of this study, educational programs need to be developed, implemented, and evaluated. The conclusion of this study is that supplementary education is needed for multidisciplinary decision making concerning the role of the nurses within the context of child abuse. Implications for nursing practice, education and research are discussed.

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Study on Antecedents and Consequences of Perceived Justice of the Performance Appraisals in Hospital Organization (병원 인사고과의 공정성지각 영향 요인에 관한 연구)

  • Lee, Chong-Hyo;Ahn, Sang-Yoon
    • Korea Journal of Hospital Management
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    • v.14 no.4
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    • pp.103-123
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    • 2009
  • The purpose of this study is to investigate antecedents and consequences of perceived justice of performance appraisals, which is classified as distributive and procedural justice, in hospital organization. The results of this study are summarized as follows. First, for distributive justice of performance appraisals, the influential factors are the pertinence of performance appraisal method, the opportunity of self-reporting, the availability of performance appraisal, and the feedback of performance appraisal. For the procedural justice of performance appraisals, they are the leadership style of performance appraisers, the ratee-rater exchange relationship, the pertinence of performance appraisal method, the opportunity of self-reporting, and the feedback of performance appraisal. Second, the perceived justice weakly affects outcome variables, organizational commitment and job satisfaction. By these results, the performance appraisal system needs to be changed in order to enhance distributive justice through the improvement of suitable methods of the performance appraisal, the opportunity of self-reporting, the availability of performance appraisal, and the feedback of performance appraisals. If it is difficult to increase the level of distributive justice due to the environmental restrictions in hospitals, the way to enhance the procedural justice more than the distributive one should be considered.

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