• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.1-13
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• 2023

In the United States (US), due to the Common Rule, completely revised in 2017, single Institutional Review Board (IRB) review has become mandatory for government-sponsored multi-institutional research since 2020 regardless of the number of participating institutions. The goal of these changes is to reduce redundant reviews by the IRB at each institution and better protect research participants. In this paper, single IRB and Human Research Protection Program (HRPP) in the US and Korea were compared and considered, and their implications were discussed. A comparison of the HRPP evaluation and certification systems of the US and Korea includes that of SMART IRB in the US and Korea Central IRB, aiming at single IRB review for efficient review with support from the country and building a more efficient national human subject research network in the future. Its comparison and analysis will be helpful in deriving future tasks and development directions of single IRB and HRPP in Korea.

• 대한기관윤리심의기구협의회지
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• 제2권1호
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• pp.6-22
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• 2020

Purpose: Clinical studies require institutional review board (IRB) approval based on the ethical principle and regulations. While the number of clinical studies has been increased and diversified, duplicated IRB review for multi-center studies has become a major issue. Therefore, single IRB system has been suggested in revised Common Rule. This study aimed to identify and assess the current status of single IRB in Korea and the anticipated needs of single IRB from researchers and IRB member or administrators. Methods: We developed 14 questions including perceived advantages and disadvantages of single IRB, and anticipated problems. The online survey collected opinions on single IRB from researchers, IRB members and IRB administrators. We also interviewed five IRB administrators who have an experience of single IRB. Results: A total of 80 responses were analyzed in this study. Although efficiencies were suggested for the advantages of single IRB in terms of reducing burden of duplicated review, respondents also perceived that the different review criteria between single IRB and each IRB would be a major hurdle for adopting single IRB system. Therefore, the standardization of standard of procedures (SOP) and the standardization of IRB submission materials should be preceded. According to the small group experiences of single IRB in Korea, we also observed the similar anticipated problems of single IRB. Conclusion: Single IRB system has many advantages for conducting multi-center trial. However, many specialists still have a lot of concerns about introducing a single IRB system in Korea. Therefore, a gradual, step-by-step process for conducting a single IRB system in Korea will be needed. Many studies for improving currently suggested single IRB system and the improvement of awareness about the essential of single IRB system would be needed.

• 생물정신의학
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• 제19권4호
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• Clinics in Shoulder and Elbow
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• 제19권3호
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• pp.176-178
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• 2016

Panner's disease, osteonecrosis of the capitellum of the elbow, was first reported by Panner in 1927. The disease occurs mainly in boys between 6 and 15 years old and shows unilateral distribution. Pain, stiffness, localized tenderness over the lateral condyle of the elbow, and decreased range of motion are the typical clinical symptoms. Conservative treatment is generally recommended for patients in the early stage of this disease. A few cases of Panner's disease have been reported and few are related to long-term follow-up results. To the best of our knowledge, all reported cases were over six years. Therefore, we report on a five-year-old boy diagnosed as Panner's disease that showed resorption and regeneration of the humeral capitellum with no limitation of motion over three years. The current study was exempted from review by the institutional review board because it was a single retrospective case report. Informed consent was obtained from the patient's guardian.

• 혜화의학회지
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• 제25권1호
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• pp.1-13
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• 2016

Objectives : Lateral epicondylitis on elbow is one of the most common causes of elbow pain. Lateral epicondylitis can be managed with acupuncture, but the evidence for its effectiveness is uncertain. The purpose of this review is to investigate the trends of acupuncture treatments on lateral epicondylitis. Methods : We investigated the studies about acupuncture treatments for lateral epicondylitis via searching 5 Korean web databases(KTKP, RISS, OASIS, KCI, Kisti) The key search terms were 'Lateral epicondylitis', 'Tennis elbow', 'External epicondylitis'. 12 research papers(10 case reports, 1 RCT, 1NRCT) 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. The effectiveness of acupuncture treatment was classified. Results : 12 papers were published since 2003. The studies on acupuncture treatments about lateral epicondylitis were mainly published in The journal of pharmacopuncture. 10 case reports, 1 non-randomized controlled trials, 1 randomized controlled trials had been under research. In most of the research, the number of the cases were not enough. In 9 cases of the studies, various korean medicine treatments including acupuncture were used to treat the symptoms. In 3 cases of the studies single method was used to treat the symptoms. Visual analogue scale(VAS) and range of motion(ROM), grip strength were used as primary assessments. Among 12 clinical studies, 1 of them were accepted by institutional review board(IRB). Conclusions : In this study, we analyzed the trends of acupuncture treatments on lateral epicondylitis. Reviewing the domestic trends of studies on acupuncture treatments for lateral epicondylitis and examining the strong and weak points of those treatments are essential for the future studies.

• Journal of Acupuncture Research
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• 제32권3호
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• pp.147-161
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• 2015

Objectives : The purpose of this study was to review the effectiveness of acupuncture and moxibustion therapy for the treatment of acute herpes zoster. Methods : Data was collected by two researchers. Clinical trials on PubMed were retrieved using MeSH terms including "herpes zoster" combined with "acupuncture therapy", "moxibustion", "bloodletting", "electroacupuncture", and related keywords. We excluded irrelevant studies and included randomized and non-randomized controlled trials, case series and case reports. Finally, we selected a total of thirteen studies and conducted a literature analysis and an object quality assessment. Results : Twelve of thirteen studies were about acupuncture and moxibustion combined therapy. Only one study suggested that a single acupuncture therapy is expected to be equally as effective as a common western medicine therapy. There was some evidence related to the effectiveness of moxibustion, venesection and electroacupuncture, but it dealt with combining therapy and was insufficient, and with an inclusion of potential risk factors. Only one study was conducted under approval from an institutional review board. No severe treatment-related adverse events were observed. A quality assessment suggested that there was some weakness in the areas of blinding and concealment. Conclusions : There is some evidence that suggests the effectiveness and safety of acupuncture and moxibustion combined therapy as a treatment for acute herpes zoster.

• Integrative Medicine Research
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• 제6권3호
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• pp.317-324
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• 2017

Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

• 한방비만학회지
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• 제8권2호
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• pp.49-62
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• 2008

Objectives Physical activity is known to be beneficial to prevent weight gain and to be physically healthy. In this study, we tried to find out the relationship between body composition with physical activity. Methods International Physical Activity Questionnaire(IPAQ)-short form was given to premenopausal women aged 20~55 and BMI${\geq}23\;kg/m^2$. Subcutaneous and visceral adipose tissue of the subjects by CT scanning was obtainedin a single slice. They were given written consent and this study is performed under the permission of institutional review board of Kyung Hee East-west Neo Medical Center. Results The mean of physical activity of total subjects was 1935.18 MET-min/week(n=63). When three groups of physical activity pattern(inactive, minimally active, and HEPA(Health-enhancing physical activity) active) was analyzed, all of them were heavily relied on the activity intensities of walking. The VSR(visceral/Subcutaneous adipose tissue Ratio) was correlated with total physical activity in vigorous activity group. Conclusions The physical activity of Korean obese and overweight women was on the average, but the vigorous activity is thought to be necessary. The vigorous physical activity was related with visceral adipose tissue.

• Clinical and Experimental Pediatrics
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• 제56권7호
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• pp.291-297
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• 2013

Purpose: The aim of this study was to investigate prophylactic treatment effects in Korean patients with severe hemophilia A. Methods: A prospective study of 32 severe hemophilia A patients was conducted with the approval of the Institutional Review Board at the Eulji University Hospital. Two patients received primary prophylaxis; whereas, the other 30 patients were divided into 2 groups-secondary prophylaxis (n=15) and on-demand (n=15)-on the basis of their consent for secondary prophylaxis. A 20-25 IU/kg dose of factor VIII concentrate was administered to the primary and secondary prophylaxis group patients every 3 days for 1 year. The prophylactic effect was evaluated by observing changes in the Pettersson scores, annual number of total and joint bleeds, and factor VIII consumption for 1 year. Results: No moderate or severe bleeding was observed, and the Pettersson scores remained unchanged during the prophylaxis period in the patients who received primary prophylactic treatment. After the treatment was changed from on-demand to secondary prophylaxis, the annual number of total and joint bleeds in the secondary prophylaxis group decreased by $64.4%{\pm}13.0%$ and $70.0%{\pm}15.2%$, respectively. The average increase in Pettersson scores within 1 year was $0.5{\pm}0.8$ and $1.3{\pm}1.1$ in the secondary prophylaxis and on-demand groups, respectively. Prophylactic effects were also observed in patients >17 years who had nearly the same initial Pettersson scores. Conclusion: Intermediate-dose prophylactic treatment may delay hemarthropathy progression and prevent its occurrence in Korean severe hemophilia A patients.

• 성인간호학회지
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• 제27권6호
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• pp.665-672
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• 2015

Purpose: The aims of current study were to assess the inhaler competency and medication adherence, and to identify association of inhaler competency with medication adherence in patients with obstructive lung disease. Methods: We did a secondary analysis of the Hanyang Obstructive Pulmonary Evaluation data in a single institution from June 2014 to April 2015 after an approval of Institutional Review Board. A total of 150 patients with asthma or chronic obstructive lung disease participated in the study. Inhaler competency was evaluated accuracy in each step for using metered dose inhaler. Medication adherence was calculated using actually dispensed doses based on the prescribed inhaler doses. Results: Older adults (${\geq}65$) had lower competency in using inhaler (66.7 vs 83.3, z=-4.52, p<.001) and poorer medication adherence (67.7 vs 91.8, $x^2=14.06$, p<.001) than adults (<65). Inhaler competency was associated with medication adherence (p=.26, p=.001). Surprisingly, more than 50% of patients were current smokers. Conclusion: Inhaler competency and medication adherence were lower in older adults with obstructive lung disease than those in adult-age patients. Therefore, an individual education program for older patients should be developed to improve the rates of proper use of inhalers. Nursing management for obstructive lung disease should focus on developing behavioral intervention strategies for smoking cessation.