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The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)

  • Lee, Jiyoun
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.163-207
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    • 2020
  • Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

The Impact of Antibiotic Burden on the Selective Resistance of Gram Negative Bacteria in Children (소아청소년에서의 항생제 사용량 변화에 따른 그람음성 균주의 항생제 내성률 변화 양상)

  • Park, Sera;Lee, Euntaek;So, Hye Jin;Yoo, Ree Nar;Lee, Jina
    • Pediatric Infection and Vaccine
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    • v.28 no.2
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    • pp.82-91
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    • 2021
  • Background: The purpose of this study was to investigate the association between antibiotic use and the antimicrobial resistance of gram-negative bacteria isolated from blood cultures in a pediatric population. Methods: From January 2014 to June 2018, the antibiotic resistance pattern of Acinetobacter baumannii, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa obtained from bacteremic patients aged ≤18 years hospitalized at Asan Medical Center Children's Hospital was analyzed and the parenteral antibiotic consumption data were retrieved. Results: During the study period, the blood culture was positive for K. pneumoniae (6.4%; 105/1,628), E. coli (5.6%; 91/1,628), P. aeruginosa (3.3%; 54/1,628), and A. baumannii (2.5%; 41/1,628), and the extended-spectrum antibiotic resistance rate of gram-negative bacteria was consistently high. The overall resistance rate of E. coli and K. pneumoniae to extendedspectrum cephalosporin was 49.3% and 54.4%, respectively. Carbapenem-resistant E. coli was first detected in 2014; its overall resistance rate to carbapenem was 5.3%. There was a linear correlation between the usage of 3rd generation cephalosporin and the resistance of A. baumannii (r2=0.96, P=0.004) and carbapenem usage and the resistance of K. pneumoniae (r2=0.79, P=0.045). Conclusions: A positive linear correlation was observed between antibiotic resistance and the corresponding antibiotic usage in 3rd generation cephalosporin resistant A. baumannii and carbapenem resistant K. pneumoniae. The judicious use of antibiotics in healthcare settings is important to minimize selection for extended-spectrum β-lactamase (ESBL) and carbapenem resistance in gram-negative bacteria.

Health and nutrition intake status of the Korean elderly according to their food security level: data from the 7th Korea National Health and Nutrition Examination Survey (KNHANES VII), 2016-2018 (식품안정성 수준에 따른 한국노인의 건강상태와 영양섭취현황: 제7기 (2016-2018) 국민건강영양조사 자료 활용)

  • Maeng, Ahreum;Lee, Jeehyun;Yoon, Eunju
    • Journal of Nutrition and Health
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    • v.54 no.2
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    • pp.179-198
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    • 2021
  • Purpose: This study examined general characteristics, health status, accessibility to medical services, health-related quality of life, dietary behavior, and energy and nutrient intakes of the elderly at different levels of food security utilizing data from the 7th Korea National Health and Nutrition Examination Survey (2016-2018). Methods: The elderly subjects (1,721 males and 2,271 females) were divided into 3 groups (secure, mildly insecure, moderately/severely insecure) according to their food security levels. Health and nutrient status was determined using energy intake, nutrient density, the prevalence of insufficient nutrient intake, dietary behavior, and health status. Results: The elderly with food insecurities had a lower self-evaluated health status and a higher prevalence of physician-diagnosed chronic diseases such as arthritis, osteoarthritis, rheumatoid arthritis, osteoporosis for males, and hypertension, stroke, arthritis, and osteoarthritis for females. The associated financial burden was the major reason for not accessing medical services in the food insecure group. Furthermore, the food insecure group had a higher risk of impaired health-related quality of life compared to the secure group. The proportion of subjects with an energy intake below the estimated energy requirement was higher in the food insecure group and a significantly higher prevalence of insufficient intake was observed for all the nutrients (proteins, vitamin A, vitamin B1, vitamin B2, niacin, vitamin C, calcium, and iron) assessed in this study compared to the food secure group. Conclusion: This study suggests that food insecurity poses a challenge to the health and nutritional status of the elderly population in Korea and needs proper management. It would be helpful to develop food and nutrition assistance programs to ensure the food stability of the elderly population and assure quality to address gaps in their nutrient intake.

Qualitative Study on Experiences of Responding to COVID-19 of Therapists in Long-term Care Hospitals (요양병원 치료사의 코로나19 대응 경험에 대한 질적 연구)

  • Bae, Won-Jin;Park, Ju-Young
    • Journal of Korea Entertainment Industry Association
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    • v.15 no.4
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    • pp.337-347
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    • 2021
  • This study is a qualitative study conducted to provide basic data for therapists working in long-term care hospitals to improve their countermeasure strategies for new infectious diseases and improvement of the treatment room infection management system, and to help therapists understand their infection management work. Colaizzi's phenomenological research method was applied as the research method. Telephone interviews were conducted with nine occupational therapists and physical therapists working in nursing hospitals. The contents of the interview were recorded with the consent of the study subjects, and additional confirmation was received by email. The recorded content was analyzed after transcription, and the meaning and nature of the experience coping with COVID-19 were described. The content was organized into 6 themes, 17 main meaning and 49 meaning units. In accordance with the COVID-19 situation, the infection control system has been strengthened by reinforcing infection control education in nursing hospitals, practicing infection control, and supervising infection control outside business hours. It was found that the treatment environment was changed due to the restriction of treatment activities by practicing distancing in the treatment room, adjusting rest and meal times during working hours, and strengthening infection control. In addition, the therapist's role has been expanded and the paradigm of treatment has changed, such as considering the untact intervention, and they have experienced cohort quarantine, pre-tested for COVID-19, vaccinations, and side effects from COVID-19. However, due to the infection work, the therapist's work burden is increased, and the person is experiencing fear, depression, and work stress from the spread of COVID-19. They were also aware of the need for nursing hospital care personnel support, such as guaranteeing rest after vaccination and providing infection control tools and equipment. The results of this study are expected to be used as basic data for human and physical support for the development of infectious disease response strategy programs in nursing hospital treatment rooms and for infection control in nursing hospitals.

A Study on the Web Novel Writer's Identity as a Media Content Producer: An In-Depth Interview and Self-description (미디어 콘텐츠 생산자로서 웹소설 작가의 정체성 연구: 심층 인터뷰와 자기기술지를 중심으로)

  • Kim, Mi-Sook
    • The Journal of the Korea Contents Association
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    • v.22 no.10
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    • pp.658-675
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    • 2022
  • With the advent of the OTT platform, the world has become an era in which the same media content is shared and reacted in real time by being grouped into one culture. This study attempts a producer study of web novel writers, who are producers of the web novel market that is expanding into webtoons, dramas, and movies with IP (intellectual property rights) of the original story at a time when Korean K-content such as "Squid Game" and "Weird Lawyer Woo Young-woo" leads the global market. In this study, web novel writers were viewed as producers of commercial media content, not just 'Novelist', and their identities and characteristics of the labor process were examined. Web novel writers began writing web novels as a side job or two jobs, and cited the fact that they can make profits alone without barriers to entry and without incurring capital or facility costs. Although there is no barrier to entry, most writers experience severe failure in their first work, which is attributed to the misunderstanding that the word "writer" is someone who writes what they want in any genre. Web novels are different, so writers go through the process of realizing that in order to succeed by writing web novels, they must be thoroughly in the audience's shoes and write them according to the trends and codes they want. Web novel writers expressed their identity as "story sellers," "story producers," "people who can produce IP alone," and "people who satisfy fantasies that cannot be achieved in reality," and in common, there was a strong sense of being a person who provides stories and makes profits or sales. Regarding the burden of writing a huge amount of web novels, the writer with a high income expressed a generous position that "the income is higher than the effort," but ordinary writers complained of difficulties in the hard work, saying, "It seems like I am working hard on writing that I have to write constantly.

A fundamental study on the automation of tunnel blasting design using a machine learning model (머신러닝을 이용한 터널발파설계 자동화를 위한 기초연구)

  • Kim, Yangkyun;Lee, Je-Kyum;Lee, Sean Seungwon
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.24 no.5
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    • pp.431-449
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    • 2022
  • As many tunnels generally have been constructed, various experiences and techniques have been accumulated for tunnel design as well as tunnel construction. Hence, there are not a few cases that, for some usual tunnel design works, it is sufficient to perform the design by only modifying or supplementing previous similar design cases unless a tunnel has a unique structure or in geological conditions. In particular, for a tunnel blast design, it is reasonable to refer to previous similar design cases because the blast design in the stage of design is a preliminary design, considering that it is general to perform additional blast design through test blasts prior to the start of tunnel excavation. Meanwhile, entering the industry 4.0 era, artificial intelligence (AI) of which availability is surging across whole industry sector is broadly utilized to tunnel and blasting. For a drill and blast tunnel, AI is mainly applied for the estimation of blast vibration and rock mass classification, etc. however, there are few cases where it is applied to blast pattern design. Thus, this study attempts to automate tunnel blast design by means of machine learning, a branch of artificial intelligence. For this, the data related to a blast design was collected from 25 tunnel design reports for learning as well as 2 additional reports for the test, and from which 4 design parameters, i.e., rock mass class, road type and cross sectional area of upper section as well as bench section as input data as well as16 design elements, i.e., blast cut type, specific charge, the number of drill holes, and spacing and burden for each blast hole group, etc. as output. Based on this design data, three machine learning models, i.e., XGBoost, ANN, SVM, were tested and XGBoost was chosen as the best model and the results show a generally similar trend to an actual design when assumed design parameters were input. It is not enough yet to perform the whole blast design using the results from this study, however, it is planned that additional studies will be carried out to make it possible to put it to practical use after collecting more sufficient blast design data and supplementing detailed machine learning processes.

A Study on the Major Issues and Legislative Considerations of CCTV Installation in an Operating Room (수술실 CCTV 설치의 쟁점과 입법방향에 관한 소고(小考))

  • Kim, Sungeun;Choe, A Reum;Bae, Kyounghee
    • The Korean Society of Law and Medicine
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    • v.22 no.2
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    • pp.111-138
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    • 2021
  • 'Unlicensed medical practice by a non-medical practitioner' often represented by surrogate surgery or so-called 'ghost surgery,' causes irreparable damage to life or body, and therefore calls for very strict and effective controls. The 'bill on installment of CCTVs in an operating room' to prevent unlicensed surrogate surgery has been discussed for a long time, but due to numerous issues and heated confrontations, it has been pending in the National Assembly. Nevertheless, it is expected that the bill will be discussed again in earnest in the National Assembly because surrogate surgery and factory-type cosmetic surgery, which has been performed mainly in the field of cosmetic surgery, has also been occurring in the field of therapeutic surgery. In general, an operating room is considered as being locked or closed, as well as disallowing implicit complicity among insiders. Hence, if the insiders conspire to commit or cover up an illegal act, or if a surgeon performs rapid cosmetic surgery and then leaves the recipient (or medical institution) so as to perform more operations for profit - even if it is legitimate practice - it may result in serious consequences in terms of the recovery of a patient. In this case, installation of CCTVs can be of great help in identifying an illegal act and assessing any occurrence of negligence. On the other hand, while the fundamental purpose of therapeutic surgery is to restore a patient's life or body - that is, lifesaving - installation of CCTVs may base the relationship between a surgeon and a patient on distrust and surveillance, so it may increase the number of requests for CCTV footage or lead to more disputes, as well as placing a burden on the surgeon when best results are not achieved for a patient. As a result, the surgeon may choose non-invasive treatment contrary to conscience instead of risky but necessary surgery, or he/she may have significant difficulty in determining the timing of surgery, which may limit the provision of effective surgical medical care. Then, in terms of the relationship between a surgeon and patient, and in the long run, there could be significant disadvantages for the public and patients if CCTV footage is allowed. In this paper, we review domestic and overseas cases and issues regarding installation of CCTVs in an operating room, and present various viewpoints and suggestions to promote legislation with minimized legal problems and side effects, thereby contributing to protection of the lives and health of the public, patients, and recipients of surgery.

Association Between Suicide and Diet (자살과 식단의 연관성)

  • Eunji, Lim;Bong-Jo, Kim;Cheol-Soon, Lee;Boseok, Cha;So-Jin, Lee;Jae-Won, Choi;Young-Ji, Lee;Nuree, Kang;Dongyun, Lee
    • Korean Journal of Psychosomatic Medicine
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    • v.30 no.2
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    • pp.73-79
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    • 2022
  • Objectives : Suicide is a global social problem. Social burden caused by suicide is gradually increasing. Various efforts have been made to prevent suicide. Lifestyle changes to western style, especially diet changes, have increased the risk for suicide. Therefore, in this study, we discussed diet as an adjuvant treatment for suicide. Methods : In this review, we summarized the biochemical mechanism of suicide, and diet as a risk factor for suicide and diet as a protective factor through a web search. Results : In this study, biochemical mechanisms for suicide were reviewed and diet as a risk factor and diet as a protective factor for suicide were investigated. It was confirmed that neurotoxic effects such as oxidative stress and inflammation in the neural system could increase the risk of suicide. Based on results of previous studies on the relationship between suicide and diet, it was found that heavy use of alcohol, coffee, carbonated soft drink, and fast food were risk factors for suicide. Protective factors for suicide included antioxidants such as vitamin C, carotene, and anti-inflammatory agents such as omega-3 fatty acids found in seafood in large amounts. Conclusions : The only treatment for suicide is prevention. In this context, effectiveness, accessibility, and safety are important for preventing for suicide. Antioxidants and anti-inflammatory agents that are relatively safe and readily available to the public could be effective adjuvant treatments to decrease the risk of suicide. In addition, it is necessary to educate the public on reducing diets that could increase the risk of suicide

A study on the nutrient intake of the elderly in Korea based on activity limitations: data from the 2019 Korea National Health and Nutrition Examination Survey (활동제한에 따른 한국 노인의 식생활 및 영양섭취 평가: 2019년 국민건강영양조사 자료를 이용하여)

  • Kim, Soyoung;Lee, Youngmi
    • Journal of Nutrition and Health
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    • v.55 no.5
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    • pp.543-557
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    • 2022
  • Purpose: Conditions that limit activity constitute one of the important factors that threaten the health of the elderly. This study sought to analyze the dietary habits and nutritional intake status of the Korean elderly who were faced with activity limitations. Methods: Utilizing data from the 2019 Korea National Health and Nutrition Examination Survey, we classified 1,383 elderly people aged 65 and over into 2 groups: those with activity limitations (n = 222, LG) and those without (n = 1,161, NG). We conducted a comparative analysis of the general characteristics, dietary habits, intake of major food groups, energy, and major nutrients. The nutrient adequacy ratio (NAR), index of nutritional quality (INQ), and healthy eating practices were also analyzed. Complex sampling analysis was utilized for all the analyses with energy intake and socio-demographic variables adjusted. Results: The average age (73.8 years) of members of the LG was higher than those of the NG (72.6 years; p = 0.010). A higher percentage of participants in the LG lived alone (28.1%) compared to those in NG (17.2%; p = 0.004). The LG participants tended to regard their health status as "bad" or "very bad" (62.7%) more often than those in the NG (19.3%; p < 0.001). The LG subjects ate breakfast less frequently (p = 0.054) and ate out significantly less often than the NG subjects (p < 0.001). The LG subjects ate more grain (p = 0.001), fewer seeds (p = 0.014) and vegetables (p = 0.039). Carbohydrate made up a large percentage of their energy intake (p = 0.026). The LG subjects had significantly lower NARs of energy (p = 0.021), protein (p = 0.031), and riboflavin (p = 0.037). The LG participants also had a significantly lower rate of healthy eating practices (22.7%) compared to those in the NG (37.8%; p < 0.001). Conclusion: Activity-limited elderly, despite their need for appropriate dietary management, were poorly nourished. They were likely to live alone, thereby making it hard to provide them with social support. Hence, there is a need to provide nutrition education and policy support for the elderly bearing the burden of limited activity.

Liability for Damages Due to Violation of Supervisory Duty by the Legal Guardian of the Mental Patient (정신질환자 보호의무자의 감독의무 위반으로 인한 손해배상책임 -대법원 2021. 7. 29. 선고 2018다228486 판결의 검토-)

  • Dayoung Jeong
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.133-170
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    • 2022
  • Supreme Court 2018Da228486, on July 29, 2021, ruled Article 750 of the Civil Act as the basis for liability for damages due to the violation of the supervisory duty of the responsible mental patient. This judgment recognizes that the legal guardian is liable for tort due to neglect of the responsibility of supervision under Article 750 of the Civil Act because the duty of protection bears the duty of supervision over the mental patient under the law. However, unlike the case of Article 755 Paragraph 1, which explicitly requires a legal obligation to supervise, Article 750 only stipulates general tort liability. Thus, to admit tort liability under Article 750, it is not necessary that the basis of the supervisory duty by the law. In this case, the supervisory duty may also be acknowledged according to customary law or sound reasoning. The duty of supervision of a legal guardian is not a general duty to prevent all consequences of the behavior of a mental patient but a duty within a reasonably limited scope. Therefore, the responsibility of the burden of care should be acknowledged only when the objective circumstances in which it is appropriate to hold the legal guardian for the acts of the mental patient are admitted. Under the Act on the improvement of mental health and the support for welfare services for mental patients, a legal guardian cannot even be granted the supervisory duty to prevent the mental patient from harming others.