• Title/Summary/Keyword: IRB

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Clinical Study of Hematology Patients in Intensive Care Units (혈액종양 중환자실 환자의 임상적 고찰)

  • Lim, Jung In;Kim, Hyoung Soon;Ryu, Ri Ar;Kim, Eun Hee;Kong, Hyo Young
    • Journal of Korean Clinical Nursing Research
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    • v.20 no.3
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    • pp.384-394
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    • 2014
  • Purpose: To improve professional intensive care by analyzing admission causes, causes of death, disease conditions, and treatment processes in patients with hematological malignancies admitted to intensive care units (ICUs) in South Korea. Methods: This was a retrospective study approved by IRB, and conducted on admission with 559 adults, in the hematology ICU of a hospital located in Seoul. The study was carried out from April 2009 to March 2012. Data were analyzed using SAS. Results: Pneumonia was the most frequent cause of ICU admission and death, followed by sepsis. The condition at discharge was death (53.6%), recovery (39.9%), or hopeless (5.1%). Mortality of patients in states of incomplete remission was higher than that of patients with complete remission and of patients with multiple myeloma, severe aplastic anemia, and lymphoma. Conclusion: Results show that pneumonia and sepsis are the most frequent causes of ICU admission and for the death of patients with hematological malignancies. The most frequent status at discharge of patients with hematological malignancies was death (53.6%), with mortality of patients at Incomplete Remission status, of mechanically ventilated patients, and of patients on continuous renal replacement therapy (CRRT) being higher than others.

Analysis of Research Articles Published in the Journal of Korean Academy of Nursing Administration for 3 Years (2010~2012) (간호행정학회지 게재논문의 연구동향 분석(2010~2012년))

  • Jang, Keum Seong;Kim, Bok Nam;Kim, Yun Min;Kim, Jung Sook;Jeong, Seok Hee
    • Journal of Korean Academy of Nursing Administration
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    • v.19 no.5
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    • pp.679-688
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    • 2013
  • Purpose: The purpose of this study was to identify the major trends in research studies in the Journal of Korean Academy of Nursing Administration from 2010 to 2012. Methods: A review using analysis criteria developed by researchers was done of 132 studies published between 2010 and 2012. Research design, participants, research domain, and keywords were analyzed from the Journal of Korean Nursing Administration. Results: Job satisfaction, stress, organizational commitment, safety, turnover, nursing education, and performance were found to be major keywords. Of the research in the Journal, quantitative methods were used in 93.2% of studies. The major setting and participants were hospitals (58.2%) and nurses (65.5%) respectively. Prevalent analysis methods used were t-test, ANOVA, correlation, regression, chi-square, AMOS, and factor analysis. Major domains in the articles were: controlling, directing, staffing, nursing management education, and professionalism & legal principles. Conclusion: Through this study, the research trends in nursing administration were identified, but there is a need to include more of the following topics in future research: new concepts in nursing policy, enhanced deliberations of IRB, rationalization of the effects in sample size calculations, theoretical development of planning and organizing, and development of interventions for management support of the nursing management process.

Trends Analysis of Clinical Studies on Korean Medicine for Infertility (국내에서 수행된 난임 관련 한의학 치료 임상연구 경향 고찰)

  • So, Min-Ji;Lee, Yoon-Jae;Kim, Su-Hyun;Jang, Jun-Bock;Hwang, Deok-Sang;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.30 no.1
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    • pp.42-55
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    • 2017
  • Objectives: This study were investigated clinical studies published in international and Korea's journals to assess the effect of Korean Medicine for infertility. Methods: PubMed and Oriental Medicine Advanced Searching Integrated System (OASIS) were searched for this review up to Nov 2016.: using terms of 'infertility' and 'subfertile'. Results: Fifty clinical studies were finally selected. All studies were assessed as the noncomparative studies, and mainly case reports. The year of publication of literatures was the highest at from 2011 to 2015, accounted for 44%. Among 50 studies, there were 5 studies on males, 43 studies on females and 2 studies on both male and female. The number of subjects varies from 1 to 1277. The number of studies with subjects less than 10 was the greatest. Of all the studies, only three were institutional review board (IRB) approved. There were 9 studies that indicated whether the grant was supported. The duration of treatment was between 30 and 360 days, and most cases were within 180 days. Intervention methods were 100% for herb medicine, 40% added on acupuncture, and 29% added on moxibustion. Conclusions: Further clinical trials of well designed is needed to accumulate enough information to establish the evidence for Korean Medicine for infertility.

The Influences of Physical Health, Cognitive Symptom and Nutritional Status on the Depression of the Elderly Dwelling in a Big City (대도시 노인의 질병, 주관적 신체증상 및 영양상태가 우울에 미치는 영향)

  • Kang, Ji-Sook;Chung, Yeo-Sook
    • Research in Community and Public Health Nursing
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    • v.19 no.3
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    • pp.378-387
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    • 2008
  • Purpose: The purposes of this study were to investigate factors related to the depression of the elderly dwelling in a big city, and to explore the influence of physical health, cognitive symptom and nutritional status on the elders' depression. Methods: After the approval of the Institutional Review Board (IRB) and obtaining the participants' consent form, a face to face and private interview was conducted with each participant from Mar, 2007 to Aug, 2007 by trained graduate level students. A total of 201 elders aged over 65 years participated in the study. The questionnaire consisted of K GDS, PHQ 15 and Nutritional Screening Initiative (NSI). Collected data were analyzed with the SPSS 13.0 program, which was used for frequency, percentage, mean, standard deviation, Pearson correlation coefficients, and multiple regression. Results: The major findings of this study were as follows. 1) 28.4% of the subjects belonged to the depression group, 78.1% had one or more diseases, 85.6% had experienced somatic symptoms, and 49.7% belonged to the nutritional risk group. 2) Older age, lower educational level, more pocket money a larger number of diseases, more severe cognitive symptoms and poorer nutritional status were significantly related to a higher depression score. 3) Significant factors influencing depression were nutritional status, cognitive symptoms and the number of diseases, which explained 38.1% of the variance of elderly depression, and nutritional status was the most influencing factor. Conclusion: The finding of this study gives useful information for developing assessment tools and interventions for elders' depression.

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Institutional Review Board and Research Ethics (기관생명윤리위원회(IRB)와 연구윤리)

  • Kim, Jongbin;Kim, Jongsoo
    • Journal of the korean academy of Pediatric Dentistry
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    • v.41 no.2
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    • pp.187-192
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    • 2014
  • Research ethics is the basic attitude for researchers. Thanks to our predecessors we are able to conduct systematic studies. The current trend of results and the amount of study-oriented assessments make the side effect that researchers conduct SCI (Science Citation Index) studies. Since the Declaration of Helsinki, the importance of the right, safety and welfare for human participants have improved. In the present study, I looked into other countries' standpoints concerning the subject of the responsibilities for research ethics and compared them with Korean's standpoint. Recently, the Ministry of Health and Welfare revised the laws for bioethics and safety. In the point of bioethics, I checked out the function, exemption and process of the Institutional Review Board for the future researcher. It is suggested to use the research note to verify a study procedure and protect oneself from research misconducts.

Analysis of Plasma Proteome before and after Oral Administration of Acidic Polysacharide from Panax Ginseng, Double-blind, Placebo-controlled, Randomised Trial (인삼 다당체 경구 투여 전 ${\cdot}$ 후 혈장의 proteome 분석;무작위배정, 이중 맹검, 위약비교시험)

  • Lee, Seon-Goo;Cho, Young-Ho;Kang, Tae-Gyu;Yang, Ha-Young;Yoo, Byong-Chul;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.21 no.5
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    • pp.1185-1193
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    • 2007
  • Ginsing polysaccharide, known to have an immune regulating effect, was administered to 23 randomly selected healthy male subjects with a mean age of 23 years in accordance with an IRB approval. Then, these subjects underwent physico-chemical tests and serum proteome was analyzed from the blood sample taken from these subjects. Analyses of proteome involved image analysis, protein sections and protein identification in sequence after two-dimensional electrophoresis was carried out. During the physico-chemical test, 4 subjects were excluded from the study. In the proteome analysis, identified were 5 spots such as SP40, 40, Cytokeratin 9, hypothetical protein LOC544932, Apolipoprotein E ,similar to Human albumin, which showed differences in the amount of protein expression. In conclusion, changes of 5 proteins were remarkable before and after administration of ginsing polysaccharides. In certain cases, hepatic and renal slight injury occurred. Thus, further clinical study on dosage regimen would be necessary for securing the basis for concentration-dependent effectiveness and safety.

Knowledge, Attitude, Practice and Related Factors about Low Salt Diet in University Students (대학생의 저염식이에 대한 지식, 태도, 행위와 관련요인)

  • Woo, Sang Jun;Cho, Yoo Hyang;Chung, Younghae;Park, Young Hee
    • The Journal of Korean Society for School & Community Health Education
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    • v.16 no.2
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    • pp.89-100
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    • 2015
  • Objectives: This study was carried out to measure knowledge, attitude, and practice and related factors of low-salt diet among university students. Methods: Data from a convenience sample of 251 nursing and engineering students of two universities in south-western part of Korea were collected during March 16~20, 2015 using a self-reporting questionaire and urine test. The instruments developed by Lee and Song(1999) were used to measure knowledge and practice, and Ahn(2013) for attitude toward low-salt diet. A spot urine salt stick($SaltSinal^{(R)}$) was also used to evaluate practice of low-salt diet. Data were analyzed using SPSS 21.0, and t-tests, ANOVA, Pearson correlation, and Scheffe test were used. The study was IRB approved. Results: Knowledge, attitude, and practice of low-salt diet was low and spot urine salt level was high among university students. Knowledge and attitude were higher and spot urine salt level was lower among nursing students. Knowledge and attitude were related to gender and drinking. Living arrangement, monthly allowance, smoking, frequency of eating-out, frequency of breakfast were shown not to be related to knowledge and attitude. None of the variable investigated were significantly related to practice of low-salt diet. However, spot urine salt was related with gender, living arrangement, and smoking. Conclusions: A rigorous health education is necessary in order to lower dietary salt among university students. Considering frequent eating-out among university students, it is also very important to lower salt amount in foods sold on- and off-campus.

Factors Related to Sexual Function in Men with Rectal Cancer (직장암 남성의 성기능 관련 요인)

  • Woo, Sang Jun;Lee, Eun Sook;Kim, Hyeong Rok;Kim, Chang Hyun
    • The Journal of Korean Society for School & Community Health Education
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    • v.20 no.3
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    • pp.91-100
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    • 2019
  • Purpose: The purpose of this study was to investigate the sexual function of male patients receiving rectal cancer and to analyze the factors related to sexual function. Methods: This study included 71 male patients undergoing outpatient treatment after surgery at C University Hospital, Chonnam, Korea from April 1 to September 1, 2014. The sexual function of males with colorectal cancer was calculated using the Korean Translation of International Index of Erectile Function(IIEF). Data analysis was performed using t-test, ANOVA, and regression analysis. The study was IRB approved. Results: The sexual function index scores of the subjects were 33.28±19.47 points. Regression analysis showed that sexual function increased as the duration after operation increased(p=.001), higher location of cancer(p=.007), age decreased(p=.013). The explanatory power (adj. R2) of the analysis model was 0.186. Conclusion: Sexual function of males with rectal cancer differed according to duration after operation, and location of cancer, age. Therefore, medical staff think that it can be used as basic data for appropriate education and counseling by age, time, and type of treatment to improve sexual function of men with rectal cancer.

Gastroepiploic Artery Preservation with Glycerol as a Training Model for Microvascular Anastomosis (미세혈관문합술의 연습 모델로서 글리세롤 처리된 위대망동맥의 활용)

  • Park, Chan Young;Chang, Hak;Chung, Jin Haeng;Heo, Eun Ju;Minn, Kyung Won;Yoo, Moon Won;Yang, Han Kwang
    • Archives of Plastic Surgery
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    • v.35 no.5
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    • pp.626-629
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    • 2008
  • Purpose: We investigate the possibility of vessel preservation with glycerol and evaluate the potential of preserved gastroepiploic artery as a tool for the microsurgical practice. Methods: In 5 early gastric cancer patients, IRB(No. C-0603-040-170), we gained gastroepiploic artery specimens(5 segments, about 10 cm) after gastrectomy. Each segment was rinsed in a normal saline and subsequently placed in a bottle, containing 50 mL anhydrous glycerol (87%). The bottles were refrigerated at $4^{\circ}C$, the longest preservation time being 5 months. Results: At first glance, no fragmentation was detected and the surface of vessel seemed mild sclerotic. In histological examination, vascular structures remained intact though preservation with glycerol led to a mild atrophy of the smooth muscle in the tunica media. Especially, we found out the elastic fibers and endothelial lining of the intima were preserved until 5 months. Adequate status for using microsurgical practice was also maintained and leakage test was performed successfully with gentian violet ink. Conclusion: Based on the results obtained in this study, the gastroepiploic artery preservation with glycerol as a training model for microvascular anastomosis is a technically very simple procedure and useful for the novice microsurgeon.

Evaluation of Good Clinical Practice(GCP) Implementability at the Designated Clinical Trial Hospitals (임상시험 지정병원의 "의약품 임상시험 관리기준(KGCP)" 수행 가능성 평가에 관한 연구)

  • Jang, Sun-Mee;Lee, Eui-Kyung;Park, Byung-Joo;Huh, Soon-Im
    • Quality Improvement in Health Care
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    • v.2 no.1
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    • pp.86-109
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    • 1995
  • Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

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