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Survey of Conflict of Interest in the Clinical Research for IRB Members and Researchers (임상시험심사위원회 위원과 연구자를 대상으로 임상연구에서 이해상충에 대한 설문조사연구)

  • Maeng, Chi Hoon;Kang, Su Jin;Lee, Sun Ju;Yim, Hyeon Woo;Choe, Byung-in;Shin, Im Hee;Huh, Jung-Sik;Kwon, Ivo;Yoo, Soyoung;Lee, Mi-Kyung;Shin, Hee-Young;Kim, Duck-An
    • The Journal of KAIRB
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    • v.2 no.1
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    • pp.23-31
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    • 2020
  • Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

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Suicide Method, the Recent Stressors, Psychiatric Diagnosis of Suicide Attempters and Suicide Completers (자살시도자와 자살 사망자의 자살 방법, 스트레스 요인 및 정신과적 진단)

  • Sea Hyun O;Jihye Ahn;Seo Jihyo;Hyerin Gu;Minjeong Kim;Hyeyeon Jang;Seog Ju Kim
    • Sleep Medicine and Psychophysiology
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    • v.29 no.1
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    • pp.15-20
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    • 2022
  • Objectives: Suicide is the major public mental health concerns all over the world. The comparison of suicide attempters and suicide completers could be the fundamental evidence for the suicide prevention. The aim of this study is to explore the differences between suicide attempters and suicide completers in terms of the stressors, suicide methods, and psychiatric diagnosis. Methods: Two types of secondary data were collected for the analyses. Data of the suicide attempters (n = 680) were gathered by intensive reviewing the medical records of Samsung Medical Center, Seoul, Republic of Korea. Data of suicide completers (n = 11,722) were collected by the psychological autopsy data which were gathered by Korean Foundation for Suicide Prevention. Suicidal methods, psychiatric disorders and stressors before suicidal attempt were compared between suicide attempter and completers. Results: Suicide completers were older and male predominant compared to suicidal attempt. Hanging or gas intoxication were more commonly used in the suicide completion, while wrist cutting or drug intoxication were more common in suicide attempters. All types of stressors were found to be high in suicide completers than suicide attempters. However, the proportion of economic and physical stress were greater in suicide completers, while the proportion of family stress were greater in suicide attempters. According to the recorded diagnoses, the rates of depressive disorders, sleep-wake disorders, substance-related disorders were higher in suicide completers, while the rates of anxiety disorders and trauma- and stressor-related disorders, bipolar and related disorders and somatic symptom disorders were higher in suicide attempters. However, after controlling the gender and age, there were no significant differences in diagnosis between suicide attempters and suicide completers. Conclusion: These findings implicate that suicide attempters and completers differed in suicide methods and type of stress. The results suggests that economic stressors, physical illness might raise the risk of suicide completion.

Effect of Manganese Sulfate Concentration in Media on Production Speed of Insecticidal Crystal by Bacillus thuringiensis (배지 중 Manganese sulfate 농도가 Bacillus thuringiensis의 곤충독소 생성 시간에 미치는 영향)

  • Ro-Un Lee;Do Gyung Oh;Eun-Sun Jeong;Jung-Beom Kim
    • Journal of Food Hygiene and Safety
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    • v.38 no.3
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    • pp.170-175
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    • 2023
  • In this study, the effect of MnSO4 on the insecticidal crystal (IC) produced by Bacillus thuringiensis for a rapid detection medium was analyzed. The strains used included one B. thuringiensis reference (KCTC 1511) and nine wild-type strains. The IC in B. thuringiensis was detected following the method published by the Ministry of Food and Drug Safety in Korea. In the nutrient agar to which 0.005% MnSO4 was added, IC was observed on two of the three plates after 48 hours of incubation and on all three plates after 120 hours. In AK agar, IC was observed on one and two of the three plates after 48 and 96 hours of incubation, respectively. These results indicated that 0.005% MnSO4 nutrient agar is more appropriate than AK agar for production of IC in B. thuringiensis. The effect of various MnSO4 concentrations on IC production was studied after 24 hours of incubation. IC was produced on 1 of the 10 plates with 0.000% MnSO4 nutrient agar, 2 of the 10 plates with 0.001% MnSO4 nutrient agar, and 3 of the 10 plates with 0.002% MnSO4 nutrient agar. IC was not observed for the other nutrient agars containing 0.003%-0.009% MnSO4. These results indicated that nutrient agar with 0.002% MnSO4 led to the most rapid production of IC by B. thuringiensis after 24 hours of incubation. However, the conditions for IC production by B. thuringiensis depended on the incubation conditions and strain activity. Therefore, further studies are needed to verify the effects of 0.002% MnSO4 on the production of IC by various Bacillus thuringiensis strains.

Effects of Thermotherapy for Life Care in the Elderly with Chronic Neck Pain (만성 목통증 노인환자의 라이프케어를 위한 온열치료의 효과 연구)

  • Lee, Jong-Min;Shin, Ho-Jin;Kim, Sung-Hyeon;Roh, Young-Chae;Jung, Kyoung-Sim;Hahm, Suk-Chan;Lee, Sung-Jae
    • Journal of Korea Entertainment Industry Association
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    • v.13 no.8
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    • pp.635-645
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    • 2019
  • Non-specific chronic neck pain (CNP) is a prevalent disorder and often accompany with pain, fatigue, reduced range of motion (ROM), and hand function. Although various types of drug are commonly used to manage the symptoms following CNP, there is a need for therapeutic exercise and alternative medicine interventions that have few side effects or are easy to apply. Present study investigated the effects of salt pack and neck exercise for life care of the elderly with non-specific CNP. Sixteen patients with non-specific CNP were recruited and randomly assigned into two groups: the intervention group (n=8) or the control group (n=8). All patients performed neck self-exercise for 30 min/day, 5 times a week for 1 week. And the subjects in the intervention group additionally received salt hot pack for 20 min per session. Visual analogue scale (VAS) and pain pressure threshold (PPT) using algometer were used to assess pain intensity (primary outcome). ROM of shoulder joint and grip strength were measured to test shoulder and hand function (secondary outcome). There were significant improvements in the intervention group (p<.05), while the subjects in the control group did not show a significant change after intervention (p>.05). Also, the intervention group show significant differences in VAS and PPT compared to the control group (p<.05). Thus, our results demonstrated that salt pack and neck exercise have a positive effect for life care in elderly patients with non-specific CNP.

Analyze Technologies and Trends in Commercialized Radiology Artificial Intelligence Medical Device (상용화된 영상의학 인공지능 의료기기의 기술 및 동향 분석)

  • Chang-Hwa Han
    • Journal of the Korean Society of Radiology
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    • v.17 no.6
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    • pp.881-887
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    • 2023
  • This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.

Literature Review on Applying Digital Therapeutic Art Therapy for Adolescent Substance Addiction Treatment (청소년 마약류 중독 치료를 위한 디지털치료제 예술치료 적용을 위한 문헌연구)

  • Jiwon Kim;Daniel H. Byun
    • Trans-
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    • v.16
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    • pp.1-31
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    • 2024
  • The advent of digital media has facilitated easy access for adolescents to environments conducive to the purchase of narcotics. In particular, there's an increasing trend in the purchase and consumption of narcotics mediated through Social Network Services (SNS) and messenger services. Adolescents, sensitive to such environments, are at risk of experiencing neurological and mental health issues due to narcotic addiction, increasing their exposure to criminal activities, hence necessitating national-level management and support. Consequently, the quest for sustainable treatment methods for adolescents exposed to narcotics emerges as a critical challenge. In the context of high relapse rates in narcotic addiction, the necessity for cost-effective and user-friendly treatment programs is emphasized. This study conducts a literature review aimed at utilizing digital platforms to create an environment where adolescents can voluntarily participate, focusing on the development of therapeutic content through art. Specifically, it reviews societal perceptions and treatment statuses of adolescent drug addiction, analyzes the impact of narcotic addiction on adolescent brain activity and cognitive function degradation, and explores approaches for developing digital therapeutics to promote the rehabilitation of the addicted brain through analysis of precedential case studies. Moreover, the study investigates the benefits that the integration of digital therapeutic approaches and art therapy can provide in the treatment process and proposes the possibility of enhancing therapeutic effects through various treatment programs such as drama therapy, music therapy, and art therapy. The application of art therapy methods is anticipated to offer positive effects in terms of tool expansion, diversification of expression, data acquisition, and motivation. Through such approaches, an enhancement in the effectiveness of treatments for adolescent narcotic addiction is anticipated. Overall, this study undertakes foundational research for the development of digital therapeutics and related applications, offering economically viable and sustainable treatment options in consideration of the societal context of adolescent narcotic addiction.

Development of Rabbit Brain Tumor Model Using VX2 Cells and Verification with the MRI in Neuroradiologic Research (Neuroradiology 연구를 위한 VX2 세포를 이용한 토끼 뇌종양 모델 제작과 MRI를 이용한 검증)

  • Yong-Woo Kim;Seon Hee Choi;Hak Jin Kim
    • Journal of the Korean Society of Radiology
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    • v.84 no.2
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    • pp.441-453
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    • 2023
  • Purpose To evaluate the development, location, and volume of a VX2 carcinoma using four inoculation methods in a rabbit brain. Materials and Methods Inoculation of a VX2 cell suspension was performed 1) on the appointed day, 2) seven days after storing a VX2 carcinoma in a freezer or 3) seven days after storing a VX2 carcinoma in a deep freezer after sacrificing the donor rabbits. 4) Without sacrificing the rabbits, the VX2 cell suspension was obtained using a gun biopsy, inoculation was performed on the appointed day. MR imaging was performed 10 days after inoculation. Brain tissues were obtained the day after. The development, location, and volume of the tumor were evaluated. Results Seventeen of the 18 rabbits inoculated on the appointed day developed tumors (average tumor volume, 106.32 mm3). One of five inoculated seven days after storing the VX2 tumor in the freezer, and three of five inoculated seven days after storing the VX2 tumor in the deep freezer developed tumors. Inoculation with a VX2 cell suspension obtained with a gun biopsy from five rabbits revealed development of tumors in only two rabbits. The tumors mostly developed in the superficial cortex. Conclusion TVX2 rabbit brain tumor model is easy to develop and revealed variable reproducibility. This model can be applicable in radiologic imaging, treatment planning, interventional treatment and drug delivery research. VX2 cell can be successfully innoculated into the brain using variable methods under researcher's variable conditions.

Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study

  • Young Choi;Byounghyun Lim;Song-Yi Yang;So-Hyun Yang;Oh-Seok Kwon;Daehoon Kim;Yun Gi Kim;Je-Wook Park;Hee Tae Yu;Tae-Hoon Kim;Pil-Sung Yang;Jae-Sun Uhm;Jamin Shim;Sung Hwan Kim;Jung-Hoon Sung;Jong-il Choi;Boyoung Joung;Moon-Hyoung Lee;Young-Hoon Kim;Yong-Seog Oh;Hui-Nam Pak;CUVIA-REGAB Investigators
    • Korean Circulation Journal
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    • v.52 no.9
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    • pp.699-711
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    • 2022
  • Background and Objectives: We investigated whether extra-pulmonary vein (PV) ablation targeting a high maximal slope of the action potential duration restitution curve (Smax) improves the rhythm outcome of persistent atrial fibrillation (PeAF) ablation. Methods: In this open-label, multi-center, randomized, and controlled trial, 178 PeAF patients were randomized with 1:1 ratio to computational modeling-guided virtual Smax ablation (V-Smax) or empirical ablation (E-ABL) groups. Smax maps were generated by computational modeling based on atrial substrate maps acquired during clinical procedures in sinus rhythm. Smax maps were generated during the clinical PV isolation (PVI). The V-Smax group underwent an additional extra-PV ablation after PVI targeting the virtual high Smax sites. Results: After a mean follow-up period of 12.3±5.2 months, the clinical recurrence rates (25.6% vs. 23.9% in the V-Smax and the E-ABL group, p=0.880) or recurrence appearing as atrial tachycardia (11.1% vs. 5.7%, p=0.169) did not differ between the 2 groups. The post-ablation cardioversion rate was higher in the V-Smax group than E-ABL group (14.4% vs. 5.7%, p=0.027). Among antiarrhythmic drug-free patients (n=129), the AF freedom rate was 78.7% in the V-Smax group and 80.9% in the E-ABL group (p=0.776). The total procedure time was longer in the V-Smax group (p=0.008), but no significant difference was found in the major complication rates (p=0.497) between the groups. Conclusions: Unlike a dominant frequency ablation, the computational modeling-guided V-Smax ablation did not improve the rhythm outcome of the PeAF ablation and had a longer procedure time.

The Use of Analgesics in the Last 24 hours of Life of Patients with Advanced Cancer : A Comparison of Medical Physicians and Surgeons (말기 암 환자의 마지막 24시간 동안 진통제 사용의 분석 : 내과의사와 외과의사의 비교)

  • Choi, Youn-Seon;Kim, Jong-Min;Lee, Young-Mee;Lim, Jong-Kuk;Lee, Tai-Ho;Hong, Myung-Ho
    • Journal of Hospice and Palliative Care
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    • v.1 no.1
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    • pp.47-55
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    • 1998
  • Background : It is almost important therapy modality to control pain for the terminal cancer patients for the last 24 hours because those terminally illed patient deserved to have pain free and peaceful time before death. Physician who is deal with terminal cancer patients for their last 24 hours does not need to worry about drug addiction or other untoward side reactions of pain medications. The purpose of this study was to evaluate if terminally illed cancer patient was given pain medication properly and sufficiently and if there was any different behavior to control pain of terminal cancer patients between medical physicians and surgeons in terms of type, amount and administration route and frequency. Methods : A retrospective chart audit of analgesic type, amount and administration route was performed on the medical recorders of 160 hospitalized terminal cancer patients who had died in the Korea University Medical Center Anam Hospital during the period of July 1, 1994 to June 30, 1995. Patients were classified into 103 patients were cared for by medical physicians and 57 patients were cared for by surgeons. After then, we analysed the difference of pain control pattern between them. Different types and amount of analgesics were converted to a common standard, an oral morphine equivalents(OME) relative to 1mg of oral morphine. Results : 1) The total number of patients was 160, male 102 cases(63.8%), and the female was 58 cases(36.2%) respectively. 2) The mean age was 56.4(${\pm}14.62$) years old and mean admission period was 27.8 days(${\pm}34.85$). 3) The frequent cancer site was stomach 42 cases(26.315), lung and liver 29 cases(18.1%) each, pancreas 10 cases(6.2%) in order 4) 125 out of 160 subjects (78.13%) complained pain, and 66 out of 103(64.08%) and 31 out of 57(54.39%) were treated with analgesics to relieve pain. 50 out of 97(51.55%) were able to continue on oral medication. 5) 86 cases(53.75%) were well oriented 24 hours prior to death. 6) The frequent analgesics for regular basis were long acting form of oral morphine 34 cases(Medical phsicians 24, Surgeons 10), intravenous morphine 26 cases(Medical physicians 20, Surgeons 6) in order, and the most common p.r.n.(pro re nata) analgesics used was intravenous morphine. 7) The mean amount of analgesics on regular basis was 115.41 OME by medical physicians and 52.7 OME by surseons(P<0.05). The mean amount of p.r.n. analgesics was significantly larger in patients are for by surgeons(66.64 OME) than medical physicians 23.49 OME(P<0.01). 8) The mean frequency of administrated number of p.r.n. analgesics was 0.62 times/day on medical part and 1.88 times/day on surgical part (P<0.001). Conclusion : Of the 97 patients with advanced cancer, 51.55% were able to take oral medications in the last day of life. The parenteral analgesics were more frequently used in the patients cared for by surgeons than medical physicians. Over the half of terminal cancer patients were well oriented in the last day of life. Doctor's knowledge and attitude towards pain is very important to mange the pain, effectively.

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Development of smart education-based teaching and learning plans and a smart textbook for 'healthy diet and meal plans' unit in 「Technology·Home Economics」 (중학교 「기술·가정」의 '건강한 식생활과 식사 구성' 단원에 적용한 스마트 교수·학습 과정안과 교재 개발)

  • Choi, Song Eun;Chae, Jung-Hyun
    • Journal of Korean Home Economics Education Association
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    • v.26 no.4
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    • pp.85-114
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    • 2014
  • The main purpose of this study was to develop teaching and learning plans and a smart textbook for food and nutrition education in Home Economics focusing on 'healthy diet and meal plans' unit in "Technology home Economics" textbooks for 7th graders to evaluate the effectiveness of the instruction conducted with the smart textbook. The content of the study to achieve the purpose is as follows: First, design a smart education-based teaching and learning curriculum for food and nutrition education in Home Economics, focusing on 'healthy diet and meal plans' unit. Second, develop a smart textbook for food and nutrition education based on the teaching and learning curriculum, using a smart content authoring tool. Third, evaluate the effectiveness of the instruction after applying the curriculum in real classroom situations. The results of this study were as follows: First, teaching and learning plans and materials were developed for two units, 'issues regarding teenagers' diet' and 'implementation of a healthy and balanced diet', under 'teenagers' life'. The first unit, 'issues regarding teenagers' diet', dealt with topics such as teenagers' dietary behaviors, nutrition, and health. Learning objectives for this unit were to help students identify and evaluate their own dietary behaviors. The second unit, 'implementation of a healthy and balanced diet', encouraged students to diagnose problems with their diet and plan nutrient rich meals. The objectives for this unit were to help students implement a healthy and balanced diet by providing them with nutrition and dietary guidelines for Koreans, sample meal plans, and guidelines for developing healthy eating habits for teenagers. In order to develop a teaching and learning plans to achieve these objectives, teaching and learning materials including inquiry tasks, materials for group activities, multimedia, applications and various pop-up learning materials were developed. Second, a smart textbook using DocZoom, which was a smart content authoring tool was developed. The textbook dealt with issues regarding teenagers' diet and implementation of a healthy and balanced diet. Multimedia material used in the textbook come from the Ministry of Food and Drug Safety's food and nutrition education web sites and other sources. To develop student-oriented material, relevant video clips were added to the smart textbook to motivate students and enhance their interest in the course. Third, the outcome of this study indicated that the instruction using teaching and learning plans and learning materials with the smart textbook was effective for enhancing students' interest in Home Economics classes (t-value=-3.99, p<.001), creating enthusiasm for learning(t-value = -2.61, p<.05), encouraging self-directed and independent learning(t-value = -4.77, p<.001), and improving students' interest in food and nutrition courses(t-value = -3.83, p<.001). The students' evaluation of the instruction were as follows: the instruction using teaching and learning plans and learning materials with smart textbooks, instead of paper textbooks, helped them save time looking for learning materials; students evaluated that it was easier for them to see and understand video clips and charts. In addition, most students answered that instruction with smart textbooks were more fun and convenient, and they agreed that the courses enhanced their learning experience.

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