• 제목/요약/키워드: IRB (Institutional Review Board)

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

  • 소민지;이윤재;김수현;장준복;황덕상;김동일
    • 대한한방부인과학회지
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    • 제30권1호
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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.

동결견의 한의학적 치료에 대한 국내 연구 동향 (The Domestic Trends of Traditional Korean Medicine Treatments on Frozen Shoulder)

  • 손슬기;김종수;김신웅;문병헌;유수빈;이차로
    • 척추신경추나의학회지
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    • 제9권1호
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    • pp.55-65
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    • 2014
  • Objectives : The purpose of this review is to investigate the trends of traditional korean medicine treatments on frozen shoulder. Methods : We investigated the studies on traditional korean medicine treatments for frozen shoulder via searching 6 Korean web databases. As a result, 32 research papers were found to be analyzed according to their published year, the titles of journals, published institution, the types of study, the number of cases, the types of treatments, the instruments for assessment and ethical approvals. Results : 32 papers were published since 1989. The studies on traditional korean medicine treatments about frozen shoulder were mainly published in The journal of korean acupuncture & moxibustion medicine. 10 case series, 7 reviews, 6 non-randomized controlled trials, 5 randomized controlled trials and 4 case reports had been under research. In most of the research, the number of the cases were not enough. In 15 cases of the studies, various traditional korean medicine treatments were used to treat the symptoms. In 8 cases of the studies, one method was used to treat the symptoms. Range of motion(ROM) and visual analogue scale(VAS) were used as primary assessments. Among the 25 clinical studies, 5 of them were accepted by institutional review board(IRB). Conclusion : In this study, we analyzed the trends of traditional korean medicine treatments on frozen shoulder. Reviewing the domestic trends of studies on traditional korean medicine treatments for frozen shoulder and examining the strong and weak points of those treatments are essential for the future studies.

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소아승낙 현황조사와 소아청소년과/소아신경과 전문의를 대상으로 면담조사를 통한 소아승낙서 공통기준 수립 연구 (Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist)

  • 이윤진;이선주;강수진;이대호;배균섭;정종우;김병수;김진석;이명아
    • 대한기관윤리심의기구협의회지
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    • 제6권1호
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    • pp.5-16
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    • 2024
  • Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

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일본인용 사상체질진단지의 타당화 연구 (A Validation Study of the Sasang Constitution Questionnaire for Japanese(SSCQ-J))

  • 조훈석;전수형;정종훈;김규곤;김종원
    • 사상체질의학회지
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    • 제25권4호
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    • pp.289-296
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    • 2013
  • Objectives This study was aimed to validate Sasang Constitution Questionnaire for Japanese (SSCQ-J). Methods Sasang Constitution Questionnaire for Patients (SSCQ-P) was developed by joint researches between the Society of Sasang Constitutional Medicine and Korea Institute of Oriental Medicine. We translated SSCQ-P into Japanese and modified some items of that for Japanese. By getting approval from the Institutional Review Board(IRB)of School of Medicine, Keio University, we conducted a questionnaire survey of patients who visited Oriental Medicine Center from early January until mid-February 2011. The total of 364 patients filled out that Questionnaire and gave an interview with a Sasang constitution specialist. Using this Questionnaire data, we made Sasang constitutional classification functions and calculated diagnostic accuracy rate of SSCQ-J using discrimination analysis. Results 1. Male group's diagnostic accuracy rate of SSCQ-J was 77.01% and female was 78.10%. 2. Diagnostic accuracy of SSCQ-J was a little higher than SSCQ-P Conclusions 1. SSCQ-J can be considered to have good discriminant power compared with SSCQ-P 2. Further research with SSCQ-J will be helpful in the comparison study on the usual symptoms between Korean and Japanese as well as development of good discriminant function.

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

  • 강지숙;정여숙
    • 지역사회간호학회지
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    • 제19권3호
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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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Effects of Radiotherapy on the Risk of Developing Secondary Malignant Neoplasms in Hodgkin's Lymphoma Survivors

  • Abou-Antoun, Tamara;Mikhael, Rachelle;Massoud, Marcel;Chahine, Georges;Saad, Aline
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권2호
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    • pp.749-754
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    • 2016
  • Extended follow-up of Hodgkin lymphoma (HL) survivors indicates that these patients are at high risk of secondary malignant neoplasms (SMNs) contributing to increased morbidity and mortality. This study examined the characteristics of HL survivors who developed SMNs with the aim to report any correlation with radiotherapy (RT) dose. In this retrospective multi-center cohort study of HL patients treated between 1990 and 2011 at three major teaching hospitals in Lebanon, classification was into two groups including those treated with combined modality (RT and chemotherapy-CHT) and those treated with CHT alone. Approval from the University Institutional Review Board (IRB) was obtained. Of the 112 patients evaluated, 52.7% (59) received the combined modality while 47.3% (53) received CHT alone. There were 6 cases of SMNs in the combined modality cohort and 5 cases in the CHT cohort. The mean RT dose in the combined modality cohort was 34.5 Gray (Gy) ($SD{\pm}5.3$). A statistically significant increase (1.5 fold) in the risk of developing SMNs was observed among patients who received a dose higher than 41 Gy compared to a dose between 20 to 30 Gy (OR= 1.5; 95% confidence interval= 0.674 to 3.339, p=0.012). The risk of SMNs was not significantly higher among patients who received extended field compared to involved field RT (p=0.964). This study showed that the risk of developing SMNs is higher among patients treated with RT dose greater than 31 Gy, independent of the RT type used.

편타성 손상으로 인해 발생된 경부통의 한의학적 치료에 대한 국내 연구 동향 (The Domestic Trends of Korean Medical Treatments for Neck Pain Caused by Whiplash Injury)

  • 정성현;이현호;이기언;최지훈;김동후;이종하
    • 한방재활의학과학회지
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    • 제27권4호
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    • pp.11-19
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    • 2017
  • Objectives We attempted to investigate the trends of Korean Medical treatments for neck pain caused by whiplash injury by analyzing domestic clinical studies. Methods We searched for studies listed on Korean electronic databases (KTKP, OASIS, RISS, KMbase, NDSL, KCI, and National Assembly Library). Clinical studies were chosen according to the inclusion criteria. Subsequently, we compared and analyzed the data. Results The search yielded 35 studies, of which there were 12 randomized controlled trials (RCTs), 15 non-randomized controlled trials (NRCTs), 6 case reports, and 2 before-after studies. Among these, 54.7% of participants were in the acute stage of the damage period. Pharmacopuncture was used the most in main treatment methods. Only 14.3% of studies mentioned approval by an institutional review board (IRB) and only 8.6% of studies considered side effects. Conclusions There is some evidence that Korean Medical treatment is effective for neck pain caused by whiplash injury. Since all studies, however, were exposed to the risk of bias. Therefore, future studies of a higher quality are required.

일부 치위생학과 학생들의 학습태도 및 강의형태에 따른 학습매체 만족도 조사 (Satisfaction with instruction medium according to learner attitude and lecture mode in the dental hygiene students)

  • 심선주;홍수민;하정은;박정란
    • 한국치위생학회지
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    • 제15권5호
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    • pp.841-847
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    • 2015
  • Objectives: The purpose of the study was to investigate the satisfaction with instruction medium according to learner attitude and lecture mode in the dental hygiene students. Methods: A web-based self-reported questionnaire was complected by 155 dental hygiene students in Cheonan from May 26 to June 5, 2015. The questionnaire consisted of general characteristics of the subjects, school adaptation, interest to learn, effort to learn, faculty centered lecture, learner centered lecture, self-directed learning, motivation to learn, characteristics of each subject, and satisfaction with lecture mode. The study was approved by institutional review board (IRB) by Baekseok University. Chi-square test and multivariate logistic regression were used to evaluate the satisfaction to medium of instruction according to explanation factors. Results: The lecture mode, opportunity and motivation to learn, interest to learn and effort to learn were the significant factors to satisfaction with instruction medium. In multivariate logistic regression model, the adjusted odds ratio was 6.28 for the opportunity to learn and 4.87 for the interesting to learn. Conclusions: The satisfaction with instruction medium is the most important factor that decides the lecture mode and learner attitude including opportunity to learn and concern to learn.

치과공포감과 주관적인 구강건강관련 삶의 질과의 관련성 (Relationship between dental fear and subjective oral health-related quality of life)

  • 이경희;김소라;구지혜;김찬주;최다혜
    • 한국치위생학회지
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    • 제15권4호
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    • pp.695-703
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    • 2015
  • Objectives: The purpose of the study is to investigate the relationship between dental fear and subjective oral health-related quality of life. Methods: A self-reported questionnaire was filled out by 320 subjects in Seoul and Gyeonggido from June to August, 2014 after permission from Institutional Review Board (IRB). Except incomplete 9 copies, 311 data were analyzed using SPSS WIN 19.0 program. The questionnaire consisted of five questions of the general characteristics of the subjects, twelve questions of oral health related quality of life, eighteen questions of dental fear, and one question of awareness toward subjective health status. Results: The explanation power of subjective oral health-related quality of life on dental fear was 26.2 percent. As the subjective oral health-related quality of life increased by 1 point, the dental fear decreased at the rate of 0.645 (p<0.001). Conclusions: Higher subjective oral health-related quality of life will diminish the dental fear. Regular dental checkups and preventive treatment are very important to enhance the oral health-related quality of life in those who visit the dental clinic.

치매노인의 불안, 우울, 삶의 질에 대한 치매노인의 주관적 측정과 간병인의 측정간의 차이 연구 (Comparison between Perception of Dementia Patients' and Caregivers' Assessment on Patients' Anxiety, Depression, and Quality of Life)

  • 신경림;강윤희;정덕유;김려화;황선아
    • 성인간호학회지
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    • 제20권5호
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    • pp.804-814
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    • 2008
  • Purpose: The objectives of this study were to examine the difference between scores assigned by dementia patients and their caregivers to the patients' anxiety, depression, and quality of life. Methods: After obtaining Institutional Review Board(IRB) approval, face-to-face interview with the patients and their caregivers respectively was conducted by trained graduate-level nursing students from December 2007 to February 2008. Patients' anxiety, depression, and quality of life were measured by patients and their caregivers. The data obtained were analyzed using the SPSS/WIN 14.0 program, which was used for frequency, percentage, mean, standard deviation, t-test, and Pearson's correlation. Results: Significant relationships were reported between the depression rated by patients and that rated by their caregivers(r = .37, p = .019). In addition, there was no difference between the quality of life rated by patients and that rated by their caregivers(t = -7.11, p = .479). However, there was no significant relationship between the anxiety rated by patients and that rated by their caregivers(r = .21, p = .195). Conclusion: There were no differences on level of depression and quality of life of dementia patients measured by dementia patients and caregivers, However, dementia patients' anxiety level has discrepancy between them.

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