• Title/Summary/Keyword: Korean institutional review board

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An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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Effects of Customized Nutritional Education 'Change 10 Habits' Program According to Stage of Behavior Change in Mildly Obese Adults (경도비만 성인에서 행동변화단계에 따른 'Change 10 Habits' 개인별 영양교육의 효과)

  • Kim, Bo Hyung;Lim, Hyunjung
    • Journal of the Korean Dietetic Association
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    • v.21 no.3
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    • pp.215-226
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    • 2015
  • The prevalence of obesity is increasing worldwide and has become a serious epidemic health problem. We developed the 'Change 10 Habits' educational program based on obesity treatment and dietary guidelines and examined its effects on customized nutrition education in mildly obese adults. The study was approved by the Institutional Review Board. Study subjects were excluded if they had several major diseases, if had consumed an anti-obesity drug, or if they practiced an obesity-related program within 30 days. The subjects (n=87, $25{\leq}BMI$ <30) were each exposed to the customized nutrition education program with four lessons according to the stage of the transtheoretical model (TTM). The stage-matched program was administered for 12 weeks and was run by a clinical dietitian. Overall, subjects who were in the precontemplation/contemplation stage at baseline made progress in the preparation and action/maintenance stage after 12 weeks (P<0.05). For 'Alcohol is consumed, up to 2 drinks per day', the proportion of subjects who belonged in the action/maintenance stage increased from 34.5% to 49.4% at 12 weeks. In addition, scores of all items significantly increased after the program (P<0.05). 'Chew more than 10 times and eat slowly' score significantly increased from $3.9{\pm}2.4$ to $5.8{\pm}2.3$ (P<0.05). In conclusion, behavioral stage-matched nutrition education using the 'Change 10 Habits' program was effective in improving eating behaviors and enhancing healthy lifestyles in mildly obese adults.

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

  • Jo, Hoon-Seuk;Jeon, Soo-Hyung;Jeong, Jong-Hun;Kim, Kyu-Kon;Kim, Jong-Won
    • Journal of Sasang Constitutional Medicine
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    • v.25 no.4
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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.

A Pattern Identification Study on the Middle-Aged Women between Sasang Constitution using DSOM (한방진단시스템 DSOM을 활용한 사상체질에 따른 폐경(閉經)전후 중년여성(中年女性)의 변증연구(辨證硏究))

  • Lee, In-Seon;Jeon, Sooo-Hyung;Kim, Jong-Won
    • Journal of Sasang Constitutional Medicine
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    • v.25 no.4
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    • pp.320-329
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    • 2013
  • Objectives We carried out this study to know that there is any differences on the health condition of the middle aged women between Sasang coustitution. We used Diagnosis System of Oriental Medicine(DSOM) for diagnosis and determining pattern identification. Methods This research was approved by the Dongeui University Oriental Hospital Institutional Review Board (certificate no. 2011-06). From March 2012 to October 2012, we examined Kupperman's index, the MENQOL, DSOM, and Sasang Constitution of 291 women from the general population, with ages ranging from 40 to 60 years. And we compared the results statistically by the chi-square test and F-test. Results and Conclusions We excluded 4 Taeyangin to analyze because they were few, and analyzed 287 subjects which were 53 Soyangin, 131 Taeeumin, and 103 Soeumin. 1. The pathogenic factors that showed significant differences were deficiency of qi, insufficiency of Yin, heat on the frequency of the output and deficiency of qi, heat, phlegm on the mean of pathogenic factor score. Deficiency of qi was higher in Soeumin, insufficiency of Yin and heat were higher in Taeeumin, and phlegm was higher in Taeeumin and Soeumin. Overall, Soyangin tended to be lower than others on both the frequency of the output and the mean of pathogenic factor score. 2. The middle aged women with ages ranging from 40 to 60 years tended to be dryness, kidney, damp and became to be blood-deficiency, stagnation of qi, heart easily. Soyangin was more health than others, Taeeumin tended to be heat, phlegm, insufficiency of Yang, and Soeumin tended to be deficiency of qi.

Inferior alveolar nerve cutting; legal liability versus desired patient outcomes

  • Kim, Soung Min;Lee, Jong Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.43 no.5
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    • pp.318-323
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    • 2017
  • Objectives: Mandibular angle reduction or reduction genioplasty is a routine well-known facial contouring surgery that reduces the width of the lower face resulting in an oval shaped face. During the intraoral resection of the mandibular angle or chin using an oscillating saw, unexpected peripheral nerve damage including inferior alveolar nerve (IAN) damage could occur. This study analyzed cases of damaged IANs during facial contouring surgery, and asked what the basic standard of care in these medical litigation-involved cases should be. Materials and Methods: We retrospectively reviewed a total of 28 patients with IAN damage after mandibular contouring from August 2008 to July 2015. Most of the patients did not have an antipathy to medical staff because they wanted their faces to be ovoid shaped. We summarized three representative cases according to each patient's perceptions and different operation procedures under the approvement by the Institutional Review Board of Seoul National University. Results: Most of the patients did not want to receive any further operations not due to fear of an operation but because of the changes in their facial appearance. Thus, their fear may be due to a desire for a better perfect outcome, and to avoid unsolicited patient complaints related litigation. Conclusion: This article analyzed representative IAN cutting cases that occurred during mandibular contouring esthetic surgery and evaluated a questionnaire on the standard of care for the desired patient outcomes and the specialized surgeon's position with respect to legal liability.

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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Comparison of Salivary Stress Hormone Levels between Periodontitis Patients and Healthy Subjects in Korea

  • Lee, Sol;Heo, Narae;Heo, Seok-Mo
    • The Journal of the Korean dental association
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    • v.54 no.11
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    • pp.897-906
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    • 2016
  • Objectives: Periodontitis is multifactorial disease mainly caused by microbial community. Recently, some research has been conducted to find other possible risk factors including stress hormones related to periodontitis. Psychological stress can affect the periodontal health by a variety of biological mechanisms. This study compared the stress hormone levels in healthy subjects and patients with periodontal disease using saliva in order to investigate the association between periodontitis and stress. Methods: The human saliva was collected from 38 periodontally healthy individuals and 34 patients with chronic periodontitis under Institutional Review Board. Their age was 20-60 years ($40.3{\pm}10.45$). From these samples, determination of salivary levels of cortisol and Dehydroepiandrosterone (DHEA) performed by enzyme immunoassay kit (Salimetrics Europe, Suffolk, UK). The independent t-test and Mann-Whitney test for trend was applied using IBM SPSS statistics version 12.0 Program to analyze statistically significant differences. Results: Salivary cortisol levels of periodontitis patients were higher than those levels of healthy subjects (P < 0.001), while salivary DHEA levels of periodontitis patients were not significantly different (P = 0.431). Salivary cortisol/DHEA ratio of periodontitis patients was higher than those levels of healthy subjects (P < 0.001). Conclusions: Our study demonstrates the high levels of cortisol concentrations and cortisol/DHEA ratio in saliva of periodontitis patients than those of healthy subjects. Since cortisol levels and cortisol/DHEA ratio can be significant factors related to the severity of periodontal disease, our study would be helpful for early diagnosis and treatment of periodontal disease.

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A Comparative Study of Methods of Measurement of Peripheral Pulse Waveform

  • Kang, Hee-Jung;Lee, Yong-Heum;Kim, Kyung-Chul;Han, Chang-Ho
    • The Journal of Korean Medicine
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    • v.30 no.3
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    • pp.98-105
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    • 2009
  • Objective: Increased aortic and carotid arterial augmentation index (AI) is associated with the risk of cardiovascular disease. The most widely used approach for determining central arterial AI is by calculating the aortic pressure waveform from radial arterial waveforms using a transfer function. But how the change of waveform by applied pressure and the pattern of the change rely on subject's characteristics has not been recognized. In this study, we use a new method for measuring radial waveform and observe the change of waveform and the deviation of radial AI in the same position by applied pressure. Method: Forty-six non-patient volunteers (31 men and 15 women, age range 21-58 years) were enrolled for this study. Informed consent in a form approved by the institutional review board was obtained in all subjects. Blood pressure was measured on the left upper arm using an oscillometric method, radial pressure waves were recorded with the use of an improved automated tonometry device. DMP-3000(DAEYOMEDI Co., Ltd. Ansan, Korea) has robotics mechanism to scan and trace automatically. For each subject, we performed the procedure 5 times for each applied pressure level. We could thus obtain 5 different radial pulse waveforms for the same person's same position at different applied pressures. All these processes were repeated twice for test reproducibility. Result: Aortic AI, peripheral AI and radial AI were higher in women than in men (P<0.01), radial AI strongly correlated with aortic AI, and radial AI was consistently approximately 39% higher than aortic AI. Relationship between representative radial AI of DMP-3000 and peripheral AI of SphygmoCor had strongly correlation. And there were three patterns in change of pulse waveform. Conclusion: In this study, it is revealed the new device was sufficient to measure how radial AI and radial waveform from the same person at the same time change under applied pressure and it had inverse-proportion to applied pressure.

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Visualization of unstructured personal narratives of perterm birth using text network analysis (텍스트 네트워크 분석을 이용한 조산 경험 이야기의 시각화)

  • Kim, Jeung-Im
    • Women's Health Nursing
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    • v.26 no.3
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    • pp.205-212
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    • 2020
  • Purpose: This study aimed to identify the components of preterm birth (PTB) through women's personal narratives and to visualize clinical symptom expressions (CSEs). Methods: The participants were 11 women who gave birth before 37 weeks of gestational age. Personal narratives were collected by interactive unstructured storytelling via individual interviews, from August 8 to December 4, 2019 after receiving approval of the Institutional Review Board. The textual data were converted to PDF and analyzed using the MAXQDA program (VERBI Software). Results: The participants' mean age was 34.6 (±2.98) years, and five participants had a spontaneous vaginal birth. The following nine components of PTB were identified: obstetric condition, emotional condition, physical condition, medical condition, hospital environment, life-related stress, pregnancy-related stress, spousal support, and informational support. The top three codes were preterm labor, personal characteristics, and premature rupture of membrane, and the codes found for more than half of the participants were short cervix, fear of PTB, concern about fetal well-being, sleep difficulty, insufficient spousal and informational support, and physical difficulties. The top six CSEs were stress, hydramnios, false labor, concern about fetal wellbeing, true labor pain, and uterine contraction. "Stress" was ranked first in terms of frequency and "uterine contraction" had individual attributes. Conclusion: The text network analysis of narratives from women who gave birth preterm yielded nine PTB components and six CSEs. These nine components should be included for developing a reliable and valid scale for PTB risk and stress. The CSEs can be applied for assessing preterm labor, as well as considered as strategies for students in women's health nursing practicum.

A Statistical Analysis of the General Anesthesia for Dental Treatment to Children with Developmental Disability (장애 환자의 소아치과 치료 시 전신마취에 대한 통계적 고찰)

  • Choi, Young-Kyoo;Lee, Sung-Min;Kim, Dong-Ok
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.2 no.2 s.3
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    • pp.101-106
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    • 2002
  • Background: The management of the behavior of handicapped children when providing required dental care is often a problem, whether in the dental office or in a hospital setting. Because of the high incidence of poor cooperation, many of these patients are scheduled for dental care under general anesthesia with preoperative medical assessment. The purpose of this study was to carry out a clinico-statistical survey on dental treatment for handicapped children under general anesthesia. Methods: After approval from the institutional review board, the medical records of 64 handicapped children between 1997 and 2002 were reviewed to determine the patient profiles, anesthesia management, and complications. The charts of these patients, who underwent dental examination, scaling and prophylaxis, and restoration and extraction of teeth under general anesthesia, were reviewed. Results: The mean age was 12.8 years old, and males (53%) predominated females (47%). Twenty-four patients had mental retardation, twelve had autism, six had cerebral palsy, 4 had behavior disorder, others had heart disease, convulsive disorder, etc. Sixty-two had intravenous thiopental with neuromuscular blocker, 2 had intravenous ketamine induction. Nasotracheal intubation was uneventful in 55 patients, nine had orotracheal intubation because of difficult visualization of the larynx. Twenty-one patients experienced postoperative complications in the recovery room, including epistaxis, nasal obstruction, vomiting, airway obstruction, respiratory depression. Conclusions: General anesthesia is a very effective way of completing the dental treatments for disabled children. We emphasize the need to train anesthesiologists in the care of disabled patients.

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