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생명과학Ⅰ 방어 작용 단원의 백워드 설계 수업 방법 모색
하민영(Min-Young Ha),천재순(Jaesun Chun) 학습자중심교과교육학회 2021 학습자중심교과교육연구 Vol.21 No.8
본 연구는 2015 개정 교육과정의 변화와 요구에 맞추어 성취기준의 효율적인 실현을 위한 생명 과학Ⅰ 방어 작용 단원의 백워드 설계 수업 방법 및 수업 프로그램을 제시하는 것을 목적으로 한다. 2015 개정 교육과정의 생명과학 Ⅰ교과에서 방어 작용 단원을 선정하고, Bloom의 신교육목표분류체계를 이용하여 성취기준을 분석하였으며 교과서 분석을 통해 핵심 개념을 추출하였다. 분석한 내용을 바탕으로 백워드 설계 수업 템플릿을 작성하였고, 이를 바탕으로 수행과제 및 평가기준이 포함된 구체적인 교수-학습 지도안을 작성하였다. 타당성 확보를 위해 완성된 최종 수업 프로그램은 전문가 집단이 검토하였고, 그 결과를 CVI(Content Validity Index) 값으로 산출하였다. 생명과학Ⅰ 방어 작용 단원의 성취기준의 분석 결과, 지식 차원에서 ‘개념적 지식’ 차원이 약 42.9%이며, 인지과정 차원에서는 ‘이해하기’ 차원이 약 71.4%로 가장 많은 비중을 차지하였다. 완성된 프로그램의 전문가 타당성 검토 결과, 타당도 평균값은 3.86, CVI 값은 1로 전반적으로 프로그램이 타당하였다. 이러한 프로그램의 개발은 2015 개정 교육과정 성취기준의 실현과 더불어 교육과정상에서 요구되는 지식, 기능, 가치 및 태도의 균형 있는 학습을 위한 방안이 되며 진정한 과정 중심 평가의 구체적인 대안이 될 것이다. The purpose of this study is to develop and verify the validity of a backward design-based instructional program for the Life Sciences I defense action unit for efficient realization of achievement standards in line with the changes and demands of the 2015 revised curriculum. In the 2015 revised curriculum Life Science Ⅰ, the defense action unit was selected, the achievement criteria were analyzed using Bloom s taxonomy of educational objectives, and the key concepts were extracted through textbook analysis. Based on the analyzed contents, a backward design instruction template was prepared, and based on this, a specific teaching-learning guidance plan including performance tasks and evaluation criteria was prepared. Based on the analyzed contents, a backward design instruction template was prepared, and based on this, a specific teaching-learning guidance plan including performance tasks and evaluation criteria was prepared. The final instructional program completed to secure validity was reviewed by a group of experts, and the result was calculated as a CVI (Content Validity Index) value. As a result of the analysis of the achievement criteria of the defense action unit of Life Science I, the “conceptual knowledge” level was about 42.9% in terms of knowledge, and the “understanding” level was about 71.4% in the cognitive process level for most part. As a result of expert feasibility review of the completed program, the average validity value was 3.86 and the CVI value was 1. Overall, the program was valid. The development of these this programs will be a plan for the realization of the 2015 revised curriculum achievement standards and a balanced learning of knowledge, skills, values, and attitudes required in the curriculum, and will be a concrete alternative to genuine process-based evaluation.
미국, 유럽, 한국의 실사용데이터/실사용근거를 활용한 연구설계 및 데이터분석의 최신 가이드라인 비교 및 향후 발전방향 고찰
전민정,하민영,성희진,이혜성,송재환,신주영 대한약물역학위해관리학회 2023 약물역학위해관리학회지 Vol.15 No.1
After enacting the 21st Century Cures Act of 2016, real-world data (RWD) and realworld evidence (RWE) have been increasingly used to support drug development and approval worldwide. The importance of RWD/RWE is growing for decisionmaking, while the reliability of RWD/RWE is still a concern regarding the quality of data, reproducibility, and transparency. Regulatory agencies have published diverse guidelines to encourage the appropriate use of RWD/RWE, but there are differences in practical information detailing methodological and analytic approaches among countries. We compared guidelines focusing on study design and data analysis for RWD/RWE in the United States, Europe, South Korea from 2017 to 2022. We summarized RWD/RWE guidelines according to the timeline and conducted a GAP analysis from the following perspectives: (1) the roadmap for the use of RWD/RWE; (2) the current guideline for study design and data analysis; (3) features of guideline. Based on our findings, we suggest a future direction for developing governance in terms of study design and data analysis to enhance the utilization of RWD/RWE in South Korea.
데이터 접근, 연계, 검증을 위한 미국, 유럽, 한국의 현황 및 국내 개선사항 제언
신주영,전민정,하민영,이채영,김송희,오인선,성희진 대한약물역학위해관리학회 2023 약물역학위해관리학회지 Vol.15 No.1
21st Century Cures Act of 2016 sparked interest in real-world data (RWD) and real-world evidence (RWE) worldwide. South Korea published several RWD/RWE guidelines as well as the United States and Europe did to keep up with global trend. The Ministry of Food and Drug Safety published ‘Comprehensive Drug Safety Management Plan Phase I’ and it set the road map direction for the next five years as post-marketing pharmacovigilance and adverse effect analysis system operation using big data in 2020. Through this, it is expected to pay more attention to the possibility of RWD/RWE's use as a drug safety management tool in South Korea. To enhance the usage of RWD in South Korea, we need to understand current status of RWD platforms and policies. We investigated current status of systems and policies for health data access, linkage, and validation of the United States, Europe, and South Korea. Based on our research, we also suggest a new integration platform for data access, linkage, and validation to enhance the utilization of RWD/RWE in South Korea
약국 이상사례 보고 데이터를 활용한 졸피뎀 이상사례 현황
신주영,황성환,하민영,이채영,이모세,김영욱,이정민 대한약물역학위해관리학회 2023 약물역학위해관리학회지 Vol.15 No.2
Zolpidem is a non-benzodiazepine drug that is known for its relative safety benefit compared to traditional benzodiazepines. However, adverse events (AEs) on the central nervous system such as somnambulism, nightmares, and hallucinations have been consistently reported following its use. This study aimed to identify the AEs related to zolpidem in South Korea. To detect signals of AEs of zolpidem by data mining using the Korean Pharmaceutical Association adverse event reporting system (KPA) database. Methods: We evaluated KPA database from April 2013 to December 2021, a nationwide drug database reported from pharmacy, analyzing AEs reported for zolpidem. We compared the distribution of patient age and sex, frequent AEs, serious adverse events, and causality assessment were performed according to the KPA database system. To identify zolpidem-related AEs, we conducted disproportionality analysis. Estimating reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE by using logistic regression. Results: A total of 155,771 AEs were reported in the KPA database, out of which 1,529 (0.01%) were related to zolpidem. The analysis revealed that dizziness (86 cases, 5.69%) and headache (72 cases, 4.76%) were the most frequently reported adverse events. Notably, somnambulism (ROR: 143.75, 95% CI, 109.17–189.28) was reported more frequently in association with zolpidem than with any other drugs. Additionally, 13 cases of serious AEs were reported. Conclusion: We identified 3 signals out of 5 most frequent AEs. It is necessary to monitor for these AEs related to zolpidem for appropriate and safe use