순환기 약물임상시험 대상자의 서면동의서 이해도와 참여결정후회도

윤은화,김정순,정인숙 한국의료윤리학회 2014 한국의료윤리학회지 Vol.17 No.3

This study was aimed to identify the objective understanding (OU) and subjective understanding (SU) of the informed consent and decisional regret (DR) and to determine the related factors to them in the cardiology clinical trials. The participants were 60 patients participating in the phase III clinical trials. Data was collected after giving informed consent form for OU and SU of the informed consent and 4 weeks after participating in the clinical trials for DR using self-reported questionnaires. Mean of OU, SU, and DR were 74.6, 58.6 and 42.9 based on 100 points, respectively. The predictors of OU were reading informed consent repeatedly (p=0.004), higher education than middle school (p<0.001), and time to giving information to consenting (p=0.034), and these variables explained 45.3% of OU variation. The predictors of SU were giving information by research nurses (p=0.025), higher education than middle school (p<0.001), making question before consenting (p=0.035), and these variables explained 48.8% of SU variation. The predictors of DR were giving information by research nurses (p=0.004), age (p=0.046), and these variables explained 23.6% of DR variation. SU showed negative correlation with DR (r=-0.34, p=0.008). In conclusion, the understanding of the informed consent, especially SU, was significantly lower and negatively correlated with DR. Therefore, it is needed to improve understanding of informed consent among participants in cardiology clinical trials to reduce DR. 본 연구는 순환기 약물임상시험 참여자를 대상으로 서면동의서 이해도와 임상시험 참여결정후회도, 그리고 각각에 관련된 요인을 파악하기 위한 단면조사연구이다. 연구대상자는 부산 시내에 위치한 3개의 임상시험 실시기관에서 실시하는 순환기 약물임상시험에 서면동의 후 참여하고 있는 대상자 60명이었다. 연구도구는 자기기입형 설문지로 서면동의의 질(객관적 이해도와 주관적 이해도)과 임상시험 참여결정후회도를 측정하는 문항으로 구성되었다. 자료수집은 2회로 나누어 실시하였는데, 1차 설문조사는 임상시험에 참여하기로 서면동의를 하고 아직 임상시험에 참여하지 않은 상태에서 이루어졌으며, 2차 설문조사는 1차 조사 4주 후에 임상시험 참여결정후회도를 조사하였다. 연구결과 객관적 이해도, 주관적 이해도, 참여결정후회도는 100점 기준으로 74.6점, 58.6점, 42.9점이었다. 객관적 이해도의 관련요인은 서면동의 전 설명문을 반복하여 읽은 경우(p=0.004), 교육수준이 중졸 이하에 비해 대재 이상인 경우(p<0.001), 중졸 이하에 비해 고졸인 경우(p=0.034), 그리고 서면동의서 설명에서 동의까지 걸린 시간이 30분을 초과하는 경우(p=0.022)였고, 이들 변수에 의한 설명력은 45.3%였다. 주관적 이해도의 관련요인은 서면동의서 주 설명자가 연구간호사인 경우(p=0.025), 교육수준이 중졸 이하에 비해 대재 이상인 경우(p<0.001), 중졸 이하에 비해 고졸인 경우(p=0.004), 그리고 서면동의 전 질문을 한 경우(p=0.035)였으며 이들 변수에 의한 설명력은 48.8%였다. 임상시험 참여결정후회도 관련요인은 서면동의서 주 설명자가 연구자인 경우(p=0.004), 연령이 65세 이상인 경우(p=0.046)였으며, 이들 변수에 의한 설명력은 23.6%였다. 서면동의서의 주관적 이해도는 임상시험 참여결정후회도와 유의한 음의 상관성(r=-0.34, p=0.008)을 보였다. 결론적으로 순환기약물 임상시험에 참여하는 대상자의 서면동의서 이해도는 낮은 수준이며, 특히 주관적 이해도가 매우 낮았다. 따라서 주관적 이해도를 개선함으로써 참여결정후회도를 낮출 필요가 있다.

한국과 중국의 양금기보법 비교연구: 개량양금 기술표현체계 개발을 전제로

윤은화 ( Yin Hua Yin ),양미지 ( Mi Ji Yang ) 세계음악학회 2015 음악과 문화 Vol.32 No.-

The Yang geum mentioned Guracheolsahyeongeum (歐邏鐵絃琴) by Yeonam Park, Ji-won in Western Yang guem. Originally,Yang geum was a sort of Dulcimer. It has been translated and spread to the world under the names such as Tympanon, Harkvert, Cembalo and Yangqin. Actually new traditional music composition skills in Korea are represented and required in several ways through the Modernized Yang Geum, but the real state of a study on sign system of the modernized Yang Geum`` new performing technique is poor. Accordingly, this study was made to develop a newly improved Yang Geum``s performing technique sign system by searching the existing Chinese Yangqin, Korean Traditional Yang Geum and Modernized Yang Geum``s performing technique sign systems. Yang Geum has been actively played, studied and improved as a folk musical instrument of the world, while the Korean Yang Geum research has continued to have little on traditional music. The Korean Traditional Yang Geum is dominated mainly by one-handed technique, whose tune is frequently changed by environment. And popular acceptance is poor due to the limit of the instrument noisy tuning. As a result, China``s Modernized Yang Geum Performing Technique Sign has been systematically studied for a long time and organized and mentioned on the first top part of any manual. This notated a special technique playing in commonly used sign when playing the Modernized Yang Geum Performing that led to the correct Modernized Yang Geum performing expression. First, the Chinese Modernized Yang Geum is composed by staff notation and number notation, and the correct technique training is good by the notation system of performing technique. Second, the Korean Traditional Yang Geum is composed by staff notation(except jungganbo), and the notation sign system ofjungganbo was used by the notation sign system of performing technique when having reverse score of staff notation. Third, Korea``s 18strings Modernized Yang Geum improved the musical instrument by magnifying the register of the Korean Traditional Yang Geum and the notation system was notated by the staff notation of the West. The notation sign systems of performing technique includes left hand slapping · Zither Stick · vibrato · rolling the stick · One-time pushing · twice pushing · pushing from the bottom sound · glissando · grace note · continuation technique · chord technique · barrier slapping technique · left-hand technique · right-hand technique · arpeggio · banchegui technique · staccato · tremolo · two voice tremolo · vibrato · mute technique. However, several performing techniques by composers are reported cause chaos, and even the same performing notation is differently indicated to have poor precision shown. Fourth, Korea``s 43strings Modernized Yang Geum is a musical instrument improved by the North Korea``s Yang Geum with all techniques of the existing instrument 18strings Modernized Yang Geum accepted that led not only to Korean music but to several musics. This allowed the suspension of the existing 18strings Improved Yang Geum to be expanded, the traditionality and merits of the existing Modernized Yang Geum to be preserved by improving the musical instruments such as pedaling, the new Modernized Yang Geum performing technique to be expanded according the demand of a new era, and several technique expressions to be progressively presented. As a result, the Korean Modernized Yang Geum``s new performing technique sign systempresented the pedal, Goejo rate, performing technique of two stick, semitone technique expression system by expanding the existing Modernized Yang Geum performing technique except the rolling the stick, arpeggio, tremolo, vibrato. Like this, 43strings Modernized Yang Geum is the musical instrument improved to play several musics not only of the existing 18strings Modernized Yang Geum performing techniques but also new traditional music, which seems to be the beginning to raise importance of the future new traditional music Yang Geum``simportance used.

원소분석용 알루미나 분말 인증표준물질의 개발과 활용

이경석,김은화,고청아,김태규,윤일선 한국분석과학회 2020 학술대회논문집 Vol.2020 No.11

까마귀쪽나무 열매와 잎의 항염증 효과 비교 연구

남궁승,장선아,손은화,박종필,손은수,구현정,윤원종,권정은,정용준,맹학,한효상,강세찬 한국자원식물학회 2015 한국자원식물학회지 Vol.28 No.2

The present study aimed to investigate comparative anti-inflammatory effects of Litsea japonica fruit and leaf extract considering the balance of safety and efficacy. Dose response studies were performed to determine the inhibitory effects of 70% EtOH extract of leaf (L70%) on the pro-inflammatory enzymes expression, COX-2/PGE2 and NO/iNOS, and pro-inflammatory cytokines production, IL-1β, IL-6, and TNF-α in lipopolysaccharide (LPS)-stimulated RAW 264.7 cells. We also examined comparative effects of 30 and 70% EtOH extract of fruits (F30% and F70%) at low concentration (10 ㎍/㎖) in the same conditions. L70% at 50 and 100 ㎍/㎖ showed inhibitory effects on almost all the inflammatory mediators we examined except for COX-2 regulation, but there were no effects at 10 ㎍/㎖. Since 100 ㎍/㎖ of L70% have 18.2% cytotoxicity, we compared the effects of fruit extract, F30% and F70% at 10 ㎍/㎖ on the regulation of NO/iNOS, PGE2, IL-1β, IL-6, and TNF-α and obtained that fruit extacts are more efficacious and safe than leaf. This study suggests that the 30% EtOH fraction of L. japonica fruit could be a good candidate for development as a functional food supplement in the prevention of inflammatory disorders. 본 연구에서는 까마귀쪽나무 잎과 열매 추출물의 항염증 활성을 비교하고자 마우스 대식세포주인 RAW 264.7 cell에서LPS에 의해 유도된 COX-2/PGE2와 iNOS/NO 및 염증성 cytokine 인 TNF-α, IL-1β, IL-6의 생성 억제 정도를 확인하였다. 그 결과, 동일한 농도 조건(10 ㎍/㎖)에서 까마귀쪽나무의 열매 추출물이 잎 추출물에 비해 NO, PGE2, iNOS, 염증성 cytokine인TNF-α, IL-1β, IL-6의 생성량 모두에서 억제 효능이 우수하게나타났다. 따라서 까마귀쪽나무가 보여주는 항염증 효과적 측면과 안전성의 두가지 측면을 고려할 때, 까마귀쪽나무의 열매추출물이 저농도에서 잎 추출물보다 항염증 효과가 우수하거나동등하며, 그 안전성이 크다고 판단됨으로 까마귀쪽나무의 열매추출물이 항염증 효능을 가진 기능성 식품 소재로써 개발 가능성이 있음을 제시한다.

시험자와 의뢰자의 임상연구코디네이터의 근무환경과활용방안에 대한 인식

정인숙,최상민,윤지향,윤은화 대한임상약리학회 2012 Translational and Clinical Pharmacology Vol.20 No.1

Background: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. Methods: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and χ2 test or t test. Results: Among investigators and sponsors, 56.1 % and 95.0 % perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5 % of investigators and 68.8 % of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4 % of investigators perceived lack of experienced CRCs and 84.8 % of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6 % of investigators and 58.0 % of sponsors. Conclusion: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs. Background: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. Methods: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and χ2 test or t test. Results: Among investigators and sponsors, 56.1 % and 95.0 % perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5 % of investigators and 68.8 % of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4 % of investigators perceived lack of experienced CRCs and 84.8 % of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6 % of investigators and 58.0 % of sponsors. Conclusion: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.

시험자와 의뢰자의 임상연구코디네이터의 근무환경과 활용방안에 대한 인식

정인숙,최상민,윤지향,윤은화,Jeong, Ihn-Sook,Choe, Sang-Min,Yoon, Ji-Hyang,Yun, Eun-Hwa 대한임상약리학회 2012 臨床藥理學會誌 Vol.20 No.1

Background: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. Methods: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and ${\chi}^2$ test or t test. Results: Among investigators and sponsors, 56.1% and 95.0% perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5% of investigators and 68.8% of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4% of investigators perceived lack of experienced CRCs and 84.8% of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6% of investigators and 58.0% of sponsors. Conclusion: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.