• 대한기관윤리심의기구협의회지
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• 제1권2호
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• 한국임상약학회지
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• 제26권1호
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

• 재활치료과학
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• 제9권1호
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• pp.56-68
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• 2020

목적 : 본 연구는 치매로 인한 이상행동으로 인하여 음식물의 섭취에 영향을 보이는 환자들을 대상으로 행동관찰에 기반하여 식이 문제를 파악할 수 있는 국외의 체계화된 평가 도구들을 소개하고, 전문가 집단에 의한 내용타당도 검증을 통하여 한국화 하는 데 있다. 연구 방법 : 폭넓은 관련 문헌 검색에 기초한 수차례의 회의를 통하여 최종으로 한국판으로 개발할 평가도구 3종(Eating Behavior Scale; EBS, Edinburgh Feeding Evaluation in Dementia Scale; EdFED, Feeding Difficulty Index; FDI)을 선택하였다. 수정된 평가 도구 3종은 연구진들에 의하여 1차 번역되었으며, 9인으로 구성된 전문가팀을 대상으로 내용타당도지수(Content Validity Index; CVI)를 검증 하였다. 결과 : EBS 내용타당도 산출 결과 6개의 질문 항목 및 1개의 응답 항목 모두에서 CVI가 0.9 이상인 것으로 나타나 항목의 수정 없이 모든 항목을 한국판 EBS에 수록하였다. EdFED 내용타당도 산출 결과 11개의 질문 항목 모두에서 CVI값 0.9 이상인 것으로 나타나 항목의 수정 없이 모든 항목을 한국판 EdFED에 수록하였다. FDI의 내용타당도 산출 결과 19개의 질문 항목 모두에서 CVI값 0.8 이상인 것으로 나타나 항목의 수정 없이 모든 항목을 한국판 FDI에 수록하였다. 결론 : 국외에서 많이 활용되고 있는 치매 환자 대상의 행동 관찰기반 식이 평가도구 인 EBS, EdFED, FDI의 한국판을 개발하였다. 관찰기반의 한국판 평가 도구를 통하여 치매 환자들의 식이 관련 문제점들을 조기에 판단하고, 적절한 중재를 제공하는 것은 환자의 영양섭취 강화와 보호자의 부담 저하 측면에서 매우 중요하게 활용될 수 있을 것이다.

• 보건행정학회지
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• 제33권2호
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• pp.141-156
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• 2023

Background: As the population rapidly ages, older adults are increasingly likely to experience mobility problems. This study aims to explore the characteristics related to an elderly person's willingness to live in a nursing home if they have mobility problems Methods: This study analyzed data from 9,917 older adults (5,976 young-old and 3,941 old-old) obtained from the 2020 National Survey of Older Koreans. The dependent variable was the intended place of residence for older adults with mobility problems. Independent variables included various characteristics: (1) sociodemographic and social support, (2) health and functional status, and (3) residential environment. Rao-Scott chi-square tests and survey logistic regression analyses were performed for the young-old and old-old, respectively. Results: The intention to live in a nursing home was significantly different between the young-old (30.4%) and the old-old (34.7%) (p=0.009). According to fully adjusted multivariable analyses, for the young-old, the odds ratio of intending to live in a nursing home was significantly higher in social security benefit recipients (1.45; 95% confidence interval [CI], 1.06-1.97) compared to other individuals. The odds ratio was higher in unmarried (divorced, separated, widowed, or never-married) individuals for both young-old (1.41; 95% CI, 1.22-1.63) and old-old (1.34; 95% CI, 1.09-1.65) age groups, compared to their respective married counterparts. Conclusion: The results of this study suggest that in an aging society, health and social policies should be designed considering the different characteristics of the elderly to improve their health, function, and quality of life.

• 한국보건간호학회지
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• 제14권2호
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• pp.431-445
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• 2000

In general the prevalence of old people is high and frequently have multiple diseases and symtoms requiring treatment. The nature of illness in the elderly has to be faced, and drugs do have an important part in the treatment of that illness. The purpose of this study were to describe health status and medication, and to provide some basic data for elderly's health education, especially for the right medication. Body mass index, self perceived health status, activities of daily living, disease and experience of past operation were surveyed to recognize the 249 elderly's actual health status. The degree of the elderly's understanding the way of medication, experience of side effects, experience of drug combination and incidence of drug adverse reaction along with drug combination were examined for medication. The aged $women(BMI; 10.7\pm13.3\%)$ overweighed the aged $men(BMI; 4.0\pm10.4\%)$. $69.0\%$ of them recognized their health good. Their activities of daily living were diminished following by the age group(p=0.0068) and relationship with self perceived health status were very significant(p=0.0005). They(192 elderly) suffered from multiple disease such as $osteoarthritis(49.5\%)$, $hypertension(32.0\%)$, gastric $disorder(16.1%)$, $diabetes(14.6\%)$, $osteomalacia(10.9\%)$, cardiovascular $disease(9.9\%)$, senile $cataract(5.7\%)$, skin $rash(5.2\%)$, liver $disease(4.2\%)$, kidney $disease(3.6\%)$, spinal cord $problem(3.6\%)$, respiratory $disease(2.1\%)$ $tuberculosis(1.0\%)\;etc(1.0\%).$ $28.3\%$ of them replied that they had an operation for appendictis senile cataract, peptic ulcer, spinal cord problem, pleurisy, hemorrhoid and the rest. Most of $them(87.4\%)$ knew the way very well how to use drugs, and $21.6\%$ of the replied 171 elderly experienced adverse drug reaction. Drug compliance rate were $high(83.6\%)$. In our study 56.9% of the 167 elderly took several medicine together. And $18.9\%$ of the 95 elderly who did drug combination had an experience of drug interaction. One person kept average 5.5 kinds of drugs at home among 243 elderly. They kept $digestives(79.4\%)$, $ointments(68.7\%)$, $vitamins(59.7\%)$, $analgesics(59.7\%)$, cold $medicines(45.3\%)$ antiarthritic $drugs(33.3\%)$, health $foods(27.7\%)$, antihypertensive $drugs(25.1\%)$, anti peptic ulcer $drugs(24.7\%)$, $laxatives(19.8\%)$, $antacids(16.5\%),\;antibiotics(l6.5\%)$, hypoglycemic $agents(10.3\%)$, cardiac $stimulants(7.0\%)$, $diuretics(4.5\%)$, antiarrhythmic $drugs(4.9\%)$, anti anginal $drugs(4.1\%)$, $hypnotics(3.3\%)$, $etc(38.3\%)$. With this result, we ascertain that polypharmacy in the elderly caused by multiple disease is common, which lead to drug interaction. So our task is to educate elderly how to use drugs in order to maximize their efficiency and to minimize their adverse effects.

• 여성건강간호학회지
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• 제4권3호
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• pp.309-321
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• 1998

The purpose of this study was to analyze the contents related to health in the three major monthly women's magazine that was printed from March, 1997 to February, 1998. The unit of analysis was the section of health, living life, and reaing child. The total number of related story of health was 317. The analysis was done according to the target, health management, topics and the informer by using frequency and number. The findings are as follows : 1. The contents were categorized by target people. The number of items for women was 113(35.6%), child(17.4%), family(15.5), husband(4.7%) and others(26.8%). Others were the contents that are impossible to classify. 2. The number of items of contents by health management was the related to health maintenance and promotion 120(47.8%), health care when they were deviated from health 26(10.3%), and those of both attributes 105(41.8%). 3. The number of items of contents by topics was the related to the occurrence, prevention and treatment of various kinds of disease 41(12..9%), diet 37(11.7%), academic information 11.3%, women's disease 10.4%, the effect of foods 6.0%, child's growth & development and child care 5.75, various kinds of therapy for health care 5.7%, sexual life 5.4% and exercise 4.7%. 4. The number of items of contents by informer was medical doctor 215(49%), lay person's case report or report of a struggle against a disease 12.3%, relevant organization of a related story(eg. family therapy research institute, physical therapist's or teacher's) 11.2%, and the contents of existing books or lecture 8.9%. Among those contents, only the one case from nurse or Korean nurses association as informer was founded, which is related to "skinship child care." In conclusion, this finding showed that women's magazine took a role as a important resource providing informations of health to women. it provides a challenge to the health professionals to have concerns on women's needs, and the content, source, and accuracy of the health related information and take part in the process producing information through such as screening and examining so as to give accurate information to women. Then women's magazine can take a role as a major resource for maintaining and promoting women's health. Finally, nurses's, who are professional health care providers, important and active role as informers toward the lay persons, especially for the women who are non-professional care givers at the family unit should be stressed. More active and continual monitoring and analyzing the contents related health in the mass media including magazine and Internet network in detail, and participating in establishing the system of adequate and precise information for women and lay persons from the nursing profession are required absolutely.

• 전자공학회논문지SC
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• 제43권3호
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• pp.60-66
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• 2006

본 논문은 photoplethysmography(PPG)와 Laser doppler(LD)를 이용하여 당뇨병 환자의 신경병증을 조기 진단하기 위한 시스템을 구성하여 손가락과 발가락의 혈류량을 측정하고 그 비율을 이용하는 방법을 제안하였다. 당뇨병 환자의 신경병증 진단을 위해 임상에서는 신경전도검사(NCV)가 사용되고 있으나 이 검사는 피부에 전기자극을 가하므로 환자에게 스트레스와 고통을 준다. 이에 본 논문에서는 고통이 전혀 없으며, 비관혈적이고 측정방법이 간단한 PPG와 LD를 이용하여 신경병증 진단법을 제안하였다. PPG가 LD에 비해 손가락 및 발가락의 혈류량 및 온도와의 상관관계, 민감도 및 특이도에서 더 우수하였다. 분석결과 50명의 신경병성 당뇨환자의 혈류비($0.96{\pm}0.20$)가 64명의 정상인의 혈류비($0.46{\pm}0.15$)에 비해 유의하게 높았다(p<0.000). 또한 신경병성 당뇨환자의 발가락 온도($30.5{\pm}1.4^{\circ}C$)가 정상인의 발가락 온도($29.3{\pm}2.0^{\circ}C$)에 비해 유의하게 높았다(p<0.000). 본 연구로부터 도출된 최적 혈류비(0.678)에 대한 측정 방법의 높은 민감도(95.3%)와 특이도(95.3%)를 확인하였다. 마지막으로 신경병성 당뇨환자 그룹의 경우 모두 손가락과 발가락의 온도차가 $4.5^{\circ}C$ 미만이었다.

• 대한소아치과학회지
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• 제47권3호
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• pp.248-256
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• 2020

이 연구의 목적은 영유아구강검진의 효과를 치아우식 예방, 우식 치료행위, 치과진료비용이라는 다각적 관점에서 분석, 평가하는 것이다. 국민건강보험공단에서 제공하는 영유아검진코호트 데이터베이스를 활용하였고, 2008 - 2015년에 시행된 구강검진 1차 32,937건, 2차 22,608건, 3차 13,708건 및 2008년생과 2009년생 27,944명의 치과 진료 241,043건을 분석하였다. 2차와 3차 구강검진 결과를 통해 산출한 우식경험유치지수와 유치우식경험자율은 각각의 선행 구강검진 수검 횟수가 증가함에 따라 감소하였다. 유치의 급여 수복치료 및 치수치료, 유견치와 유구치의 조기 발치 시행 횟수는 구강검진 수검 횟수가 증가함에 따라 감소하였고, 전체 급여 치과진료비용 또한 수검 횟수가 증가함에 따라 감소하였다. 영유아구강검진은 치아우식을 예방하여 치아우식 관련 치료의 가능성을 줄이고, 따라서 치과진료비를 절감하는 효율적이고 경제적인 구강 건강 관리 방법이다.

• 대한방사선기술학회지:방사선기술과학
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• 제39권4호
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• pp.565-570
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• 2016

방사성 요오드($^{131}I$) 치료는 분화성 갑상선암 환자에서 재발을 감소시키고 생존률을 증가시키나, 환자에서 방출되는 방사능으로 인하여 피폭을 야기시킬 수 있으므로 환자로부터 발생되는 방사선량률을 측정하는 것이 방사선안전관리 측면에서 중요하다. 방사성 요오드($^{131}I$) 치료시 널리 사용되는 측정기 중 전리함과 GM계수관으로 측정된 방사선량률의 감도와 측정효율을 구하였다. 방사성 요오드($^{131}I$)를 150mCi 경구투여 받은 분화성 갑상선암 환자의 상복부로부터 1 m거리에서 경과 시간에 따라 방사선량률을 측정하였다. 시간에 따른 변화를 직접적으로 비교한 결과, 고선량률에서의 감도와 측정효율은 GM계수관보다 전리함이 높게 나타났고, 통계적으로 유의하였다(p<0.05). 저선량률에서의 감도와 측정효율은 GM계수관보다 전리함이 낮게 나타났지만 통계적으로 유의한 차이를 나타내지 않았다(p>0.05). 방사성 요오드($^{131}I$) 치료시에 검 교정이 완료된 전리함과 GM계수관으로 정확하고 신속한 방사선량률을 측정하여 환자에게 설명함으로써 방사성 요오드 치료 후 퇴원하는 환자에게 환자가족 또는 주변 사람들에게 미칠 수 있는 방사선피폭을 예측하고, 불필요한 예단을 줄여줄 수 있을 것이다.

• 대한치과교정학회지
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• 제36권6호
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• pp.434-441
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• 2006

교정 치료를 하고자 하는 가장 큰 동기 중의 하나는 좋은 안면을 얻고자 하는 것이므로 교정 치료 후 안면부에 나타나는 변화에 대한 환자들의 인지도를 이해하는 것은 교정 치료의 진단과 치료 계획 수립에 매우 중요한 일이다. 이에 본 연구는 정면 및 측모에서 하 안면부위의 입술의 위치와 안면 비대칭의 변화에 관하여 인지할 수 있는 최소한의 변화량을 알아보고자 근형 잡힌 비율을 지닌 가상의 정모와 측모 사진을 컴퓨터 영상으로 제작한 후 입술의 위치는 Ricketts의 E-line을 기준으로, 안면의 비대칭은 턱 끝의 중앙 지점을 기준으로 각각 1, 2, 3, 4 mm 변화시킨 디지털 영상을 이용하여 40명의 미술학도를 관찰자로 인지도 조사를 하였다. 연구 결과 환자가 입술의 위치와 비대칭의 변화를 인지하기 위해서는 측모에서 최소한 2 mm 이상, 정모에서 3 mm 이상의 변화가 필요하였으며 하 안면부 변화에 대한 인지도는 정모에서보다 측모 변화에 대한 인지도가 높았다. 또한 변화에 대한 사전 정보는 변화에 대한 인지율을 현저하게 높여 주었다.