• 한국임상약학회지
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• 제20권2호
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• pp.114-119
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• 2010

Objectives: We developed a registry guidance to provide a standard for data collection, analysis and methodical management of information on the influence of drug exposure on pregnant women and fetus. Methods: We surveyed guidances and regulations of clinical trials and the pharmaceutical affairs law, compared them with Pregnancy Exposure Registry of other countries and in addition, investigated related references. We found the flaws of the present registry and supplemented it based on better results from other countries. Results: We developed a concrete and detailed report that included pregnancy drug exposure cases necessary for close monitoring, types and characteristics of data on pregnancy drug exposure, the requirements of registry data, and essential items needed to be researched. Conclusions: Information on pregnancy drug exposure in Korea can be effectively collected by using this report which provides a comprehensive assess to drug's influence on pregnant women and fetus, and in addition, accurate information about safety and effectiveness of drug use in pregnant women and fetus can be obtained by sharing data globally and managing it synthetically and systematically.

• 지역사회간호학회지
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• 제32권4호
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• pp.518-528
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• 2021

Purpose: This study was conducted to explore the healthcare experience of residents participating in the Community-Based Hypertension and Diabetes Registry Program. Methods: This study used qualitative content analysis. Data were collected from in depth interviews of fifteen participants, who either participated in the program hosted by the Training Center for Hypertension and Diabetes for more than two years or participated in an intensive one-on-one education program. Results: The results showed that the core theme in healthcare of participants was 'Proactive healthcare with attention and systematic guidance of experts'. The positive reinforcement of staffs and the improvement of self-efficacy through effective close management were found to be positive influencing factors of participation. The theme consisted of the following categories: 'Participation in the program with positive expectations on healthcare', 'Interest in body and health', 'Vitality in life', 'Confidence in dealing with disease', 'Thankfulness for close care and attention', and 'Desire for continuous care'. Conclusion: When establishing policies on managing chronic diseases, a strategy that reflects the results of the study is required. It is necessary to build up emotional relationship among stakeholders, and expand opportunities for close healthcare such as one-on-one customized training, and mutual cooperation with various organizations in the local community.

• 항공우주시스템공학회지
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• 제12권4호
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• pp.1-8
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• 2018

형식증명승인은 외국 감항당국으로부터 형식증명을 받은 후 국내로 도입되는 항공기, 엔진, 프로펠러에 대한 형식설계 검증을 통해 항공기의 안전성을 확인하는 것을 말한다. 우리나라는 항공안전법 제21조 "형식증명승인"에 따라 국내로 수입되는 항공기에 대한 설계 적합성을 확인하고 있다. 최근 미국, 중국, 싱가포르 등으로 구성된 Validation Principles Working Group은 위험평가 기반의 형식증명승인 모델을 개발하였으며 국제 표준화를 위해 노력하고 있다. 이에 따라, 위험평가기반의 형식증명승인 모델을 분석하고, 우리나라의 형식증명승인 제도의 개선방향을 고찰하였다.

• Korean Journal of Radiology
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• 제24권8호
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• pp.729-738
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• 2023

Objective: When multiple surveillance mammograms are performed within an annual interval, the current guidance for oneyear follow-up to determine breast cancer status results in shared follow-up periods in which a single breast cancer diagnosis can be attributed to multiple preceding examinations, posing a challenge for standardized performance assessment. We assessed the impact of using follow-up periods that eliminate the artifactual inflation of second breast cancer diagnoses. Materials and Methods: We evaluated surveillance mammograms from 2007-2016 in women with treated breast cancer linked with tumor registry and pathology outcomes. Second breast cancers included ductal carcinoma in situ or invasive breast cancer diagnosed during one-year follow-up. The cancer detection rate, interval cancer rate, sensitivity, and specificity were compared using different follow-up periods: standard one-year follow-up per the American College of Radiology versus follow-up that was shortened at the next surveillance mammogram if less than one year (truncated follow-up). Performance measures were calculated overall and by indication (screening, evaluation for breast problem, and short interval follow-up). Results: Of 117971 surveillance mammograms, 20% (n = 23533) were followed by another surveillance mammogram within one year. Standard follow-up identified 1597 mammograms that were associated with second breast cancers. With truncated follow-up, the breast cancer status of 179 mammograms (11.2%) was revised, resulting in 1418 mammograms associated with unique second breast cancers. The interval cancer rate decreased with truncated versus standard follow-up (3.6 versus 4.9 per 1000 mammograms, respectively), with a difference (95% confidence interval [CI]) of -1.3 (-1.6, -1.1). The overall sensitivity increased to 70.4% from 63.7%, for the truncated versus standard follow-up, with a difference (95% CI) of 6.6% (5.6%, 7.7%). The specificity remained stable at 98.1%. Conclusion: Truncated follow-up, if less than one year to the next surveillance mammogram, enabled second breast cancers to be associated with a single preceding mammogram and resulted in more accurate estimates of diagnostic performance for national benchmarks.