• Title/Summary/Keyword: Risk-benefit

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Invasive Brain Stimulation and Legal Regulation: with a special focus on Deep Brain Stimulation (침습적 뇌자극기술과 법적 규제 - 뇌심부자극술(Deep Brain Stimulation)을 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.23 no.2
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    • pp.119-139
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    • 2022
  • Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

Adjuvant Chemotherapy in Patients with Node-Negative Non-Small Cell Lung Cancer with Satellite Pulmonary Nodules in the Same Lobe

  • Park, Jiyoun;Lee, Junghee;Jeon, Yeong Jeong;Shin, Sumin;Cho, Jong Ho;Kim, Hong-Kwan;Choi, Yong Soo;Kim, Jhingook;Zo, Jae Ill;Shim, Young Mog
    • Journal of Chest Surgery
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    • v.55 no.1
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    • pp.10-19
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    • 2022
  • Background: According to the eighth TNM (tumor-node-metastasis) staging system, the presence of separate tumor nodules in the same lobe is designated as a T3 descriptor. However, it remains unclear whether adjuvant chemotherapy confers survival advantages in this setting. Methods: We retrospectively identified 142 pathologic T3N0M0 patients with additional pulmonary nodules in the same lobe from a single-institutional database from 2004 to 2019. The main outcomes were overall survival and recurrence-free survival. Multivariable Cox regression was used to identify the benefit of adjuvant chemotherapy while adjusting for other variables. Results: Sixty-one patients received adjuvant chemotherapy (adjuvant group) and 81 patients did not receive adjuvant therapy after surgery (surgery-only group). There were no demonstrable differences between the 2 groups regarding hospital mortality and postoperative complications, indicating that treatment selection had not significantly occurred. However, the use of adjuvant chemotherapy was associated with improved 5-year overall survival (70% vs. 59%, p=0.006) and disease-free survival (60% vs. 46%, p=0.040). A multivariable Cox model demonstrated that adjuvant chemotherapy was associated with a survival advantage (adjusted hazard ratio, 0.54; p<0.001). In exploratory analyses of subgroups, the effect of adjuvant chemotherapy seemed to be insufficient in those with small main tumors (<4 cm). Conclusion: Adjuvant chemotherapy was associated with better survival in T3 cancers with an additional tumor nodule in the same lobe. However, the role of adjuvant chemotherapy in patient subgroups with small tumors or those without risk factors should be determined via large studies.

The Effect of Information Quality and Self-efficacy on Car-sharing Usage Intention (정보품질과 자기효능감이 카셰어링 재이용의도에 미치는 영향)

  • Liu, Bo;Byun, Sookeun
    • Journal of Service Research and Studies
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    • v.13 no.3
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    • pp.20-38
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    • 2023
  • Recently, car sharing has shown the most remarkable growth among sharing economy services. In the process of analyzing the intention to reuse the car sharing service, this study tried to reflect the unique characteristics of the service, which consists of non-face-to-face self-service, such as reservation, approval, handover, inspection, and return of the vehicle. Specifically, in addition to the perceived benefits and the perceived risks, we considered 'information quality' as a platform characteristic and 'self-efficacy' as a personal characteristic. To collect data, an online survey was conducted on adults with experience in car sharing, and a total of 320 responses were used for analysis. As a result of analyzing the structural equation model, it was found that information quality and self-efficacy increased the perceived benefits of services, and the higher the information quality, the higher the self-efficacy. On the other hand, the role of information quality and self-efficacy in lowering perceived risks was insignificant, and the intention to reuse services was more affected by perceived benefits than perceived risks. As a result of further analysis using Process Macro, it was found that the effect of self-efficacy on reuse intention was mediated by perceived benefits. It was analyzed that the indirect effects of information quality on reuse intention through perceived benefits or self-efficacy were all significant. These results suggest that providing timely, sufficient, and easy-to-understand information required by users on the platform improves self-efficacy and increases service reuse intention. In order to increase the number of service users, it is important for service providers not only to provide promotional activities such as offering attractive prices, but also to provide high-quality information so that users can use it more easily.

An Ethical Consideration on the Standard Operating Procedure Operation Status and the Ethical Review of the Vulnerable Research Subjects of Institutional Review Board, a Medical Institution in Korea (우리나라 의료기관 Institutional Review Board의 취약한 연구 대상자 관련 표준운영지침서 운영 현황과 윤리적 고찰)

  • Eun Hwa Byun;Byung In Choe
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.21-32
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    • 2023
  • Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

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Factors Influencing Individual's Intention to Provide MyData: Focusing on the Moderating Effects of Individual Capabilities and Institutional Type (개인의 마이데이터 제공의도에 영향을 미치는 요인: 개인역량과 기관유형의 조절효과를 중심으로)

  • Dong Keun Park;Sung-Byung Yang;Sang-Hyeak Yoon
    • Knowledge Management Research
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    • v.24 no.1
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    • pp.73-97
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    • 2023
  • Recently, the MyData market has been growing as the importance of data and issues related to personal information protection have drawn much attention together. MyData refers to the concept of guaranteeing an individual's right to personal information and providing and utilizing one's data according to individual consent. MyData service providers can combine and analyze customer information to provide personalized services. In the early days, the MyData business was activated mainly by private companies and the financial industry, but recently, public institutions are also actively taking advantage of MyData. Meanwhile, the importance of an individual's intention to provide MyData for the success of MyData businesses continues to increase, but research related to this is lacking. Moreover, existing studies have been mainly conducted on individual benefits of MyData; there are not enough studies in which both public benefit and perceived risk factors are considered at the same time. In this regard, this study intends to derive factors affecting the intention to provide MyData based on the privacy calculus model, examine their influencing mechanism, and further verify the moderating effects of individual capabilities and institutional type. This study can find academic significance in that it expanded and demonstrated the privacy calculus model in the context of MyData providing intention. In addition, the results of this study are expected to offer practical guidelines for developing and managing new services in MyData businesses.

Korean representation of biotechnology : For college students and lay adults (생명공학에 대한 한국인들의 표상: 대학생들과 일반 성인들을 중심으로)

  • Kyo-Heon Kim
    • Korean Journal of Culture and Social Issue
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    • v.8 no.1
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    • pp.165-187
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    • 2002
  • This study examines Korean representation of the biotechnology and psychological factors which can influence lay people's perception and attitude about biotechnology. Korean college students(N=433) and lay adults(N=90) whom had college education participated in the study. Participants of the study 1 were asked to list words which comes to mind when associate with the biotechnology in broad sense, and several specific applications in health, medicines, agriculture and research. Participants of the study 2 were asked to list possible benefits and costs of biotechnology and their specific applications. In study 3, Participants responded the questionnaires about perceptions and attitudes of biotechnology. Korean people associated the biotechnology with its costs or risks and benefits. Korean college students mainly got the informations of the biotechnology from TV, newspapers, or internet. They trusted the scientist group and NGO group on their judgements about the assessment of risk and benefit of the biotechnology. College students showed the positive attitude with the applications in medicines and negative attitude with the applications in agriculture and public using of individual's genetic information. The radicalism, sensitivity in behavioral activation system, and trust/cynicism were to be found as a significant influencing factor for interest/knowledge and behavioral intention in related with biotechnology. Finally, more extensive knowledge of biotechnology did not lead to greater acceptance of it.

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An Overview of Readjustment Measures Against the Banking Industry's Non-Performing Loans (은행부실채권(銀行不實債權) 정리방안(整理方案)에 대한 고찰(考察))

  • Kim, Joon-kyung
    • KDI Journal of Economic Policy
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    • v.13 no.1
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    • pp.35-63
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    • 1991
  • Currently, Korea's banking industry holds a sizable amount of non-performing loans which stem from the government-led bailout of many troubled firms in the 1980s. Although this burden was somewhat relieved with the aid of banks' recapitalization in the booming securities market between 1986-88, the insolvent credits still resulted in low profitability in the banking sector and have been detrimental to the progress of financial liberalization and internationalization. This paper surveys the corporate bailout experiences of major advanced countries and Korea in the past and derives a rationale for readjustment measures against non-performing loans, in which rescue plans depend on the nature of the financial system. Considering the features of Korea's financial system and the banking sector's recent performance, it discusses possible means of liquidation in keeping with the rationale. The conflict of interests among parties involved in non-performing loans is widely known as one of the major constraints in writing off the loans. Specifically, in the case of Korea, the government's excessive intervention in allocating credits has preempted the legitimate role of the banking sector, which now only passively manages its past loans, and has implicitly confused private with public risk. This paper argues that to minimize the incidence of insolvent loan readjustment, the government's role should be reduced and that the correspondent banks should be more active in the liquidation process, through the market mechanism, reflecting their access to detailed information on the troubled firms. One solution is that banks, after classifying the insolvent loans by the lateness or possibility of repayment, would swap the relatively sound loans for preferred stock and gradually write off the bad ones by expanding the banks' retained earnings and revaluing the banks' assets. Specifically, the debt-equity swap can benefit both creditors and debtors in the sense that it raises the liquidity and profitability of bank assets and strengthens the debtor's financial structure by easing the debt service burden. Such a creditor-led or market-led solution improves the financial strength and autonomy of the banking sector, thereby fostering more efficient resource allocation and risk sharing.

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An Analytic Case Study on the Management of an Upper-level General Hospital(2010-2012)

  • Park, Hyun-Suk;Lee, Jung-Min;Baek, Hong-Suck;Lee, Jun-Ho;Park, Sang-Sub
    • Journal of Korean Clinical Health Science
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    • v.2 no.1
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    • pp.1-16
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    • 2014
  • Purpose. For a more efficient hospital management, this study aims to provide basic data so that the hospital management and staff in charge of hospital administration may systematically classify and collect hospital information, by analyzing the ordinary characters of an upper-level general hospital system and its common-type balance sheet, common-type profit and loss statement and financial ratio. Methods. By using information about an upper-level general hospital in C Province, provided by Alio(www.alio.go.kr), a public organization information provision site, Health Insurance Review & Assessment Service(www.hira.or.kr) and Ministry of Health and Welfare(www.mw.go.kr), this study analyzed 3 year's data from 2010 to 2012 and provided basic data by analyzing the ordinary characters of an upper-level general hospital system, and its common-type balance sheet, common-type profit and loss statement and financial ratio. Results. After analyzing the ordinary characters, common-type balance sheet, common-type proft and loss statement and financial ration of this general hospital, based on the 2010 to 2012 data, this study came to the following conclusions. Firstly, out of all the 1,069 hospital staff, there were 272 doctors working for 24 medical departments, out of whom the majority was 33 physicians. Most of the nurses were third-class ones, and about 2,000 outpatients and 600 inpatients on average were treated per day. Secondly, as a result of analyzing the common-type balance sheet, this study discovered that intangible assets out of fixed assets accounted for 41%, the majority, out of which usable and profitable donation asset buildings were of great importance, and the liquid assets increased more in 2012 than 2011. In the financial structure, the ratio of liquid liabilities was over 50% out of all the liabilities in 2012, and the ratio of purchase payables was high as well. The ratio of fixed liabilities reached up to 40%, out of which the retirement benefit appropriation fund was quite high. The capital was over 80%, but the surplus was in a deficit state. Compared to the capital, the ratio of total liabilities was about 90%, which indicates the financial structure of this general hospital was vulnerable. Thirdly, as a result of analyzing the common-type profit and loss statement, this study found out that the medical profits from inpatients were higher than profits from outpatients. The material cost was related to the medical quality of this general hospital, and it was as high as 30% out of the total costs and was about 45% of the labor cost. This general hospital showed 10% in the ratio of non-medical profits, and it seemed because of government subsidies. The ratios of medical profits and current net income were gradually changing for the better in 2012, compared to 2011. Lastly, as a result of analyzing the financial ratio, it was found that the liquidity ratio kept decreasing, from 110.7% in 2010 and 102.0% in 2011 to 77.2% in 2012. Besides, it was analyzed that the liquidity ratio and the net working capital ratio greatly decreased, while the quick ratio and the liquid ratio kept decreasing. Conclusions. 1. It is necessary to take the risk management into more consideration, and particularly, it is needed to differentiate and manage the levels of risk in detail. 2. By considering the fact that investments into hospital infrastructures were mostly based on liabilities, it is needed to deal with the scale of losses when evaluating risks. 3. By reflecting the character that investments into hospital infrastructures were based on liabilities, it is necessary to consider the ratio of ordinary profits as well as the ratio of operating profits to sales, and it is also important to consider sales productivity factors, such as the sales amount per a sickbed, by comparing them with other hospitals. As for limitations of this study, there may be some problems in terms of data interpretation because of the lack of information about the number of inpatients and the number of outpatients per year, which are needed for the break-even point analysis. Besides, to suggest a direction for the improvement of hospital management through analyses, non-financial factors should be reflected, such as the trend of economy, medical policies, and politic backgrounds. However, this study only focused on the common-type balance sheet, common-type profit and loss statement and financial ratio, so this study is actually limited to generalizing all the factors by analyzing public data only.

Dental Hygienist-Led Dental Hygiene Process of Care for Self-Support Program Participants in Gangneung (강릉시 자활근로사업 참여자 대상 치위생 과정 사례보고)

  • Yoo, Sang-Hee;Kwak, Seon-Hui;Lee, Sue-Hyang;Song, Ga-In;Bae, Soo-Myoung;Shin, Sun-Jung;Shin, Bo-Mi
    • Journal of dental hygiene science
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    • v.18 no.6
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    • pp.327-339
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    • 2018
  • This study aimed to provide basic data for establishing the clinical basis for dental hygienist-led dental hygiene process of care by identifying multiple risk factors for self-support program participants in Gangneung city; we also compared oral health status and behavioral changes through customized oral health care. Four dental hygienists who were evaluated for degree of conformity provided dental hygiene process of care to eight self-support program participants who were selected as having an oral health risk among people in the self-support center. The clinical indicators measured during dental hygiene assessment and evaluation and behavioral changes due to dental hygiene intervention were compared and analyzed. With respect to clinical indicators, at the time of probe, the retention rate of patients with gingival bleeding decreased from 61.4% to 14.7% after intervention (p=0.004). Furthermore, the retention rate of patients with a periodontal pocket >4 mm decreased from 15.6% to 5.8% (p=0.001). The average modified O'Leary index of the patients improved from 23 to 40 (p=0.002). Previously, all eight subjects used the vertical or horizontal method of brushing; after dental hygiene care interventions regarding method and frequency of toothbrushing, use of oral care products, and individual interventions, they started using the rolling or Bass method of toothbrushing. Four of eight subjects reported using interdental toothbrushes after intervention. As a result of applying the change model to the transtheoretical behavior change of the subject, the result of strengthening the health behavior was confirmed. For promotion of oral health by the prevention-centered incremental oral health care system, dental hygienist-led dental hygiene management and maintenance is essential. It is thought that continuous research, such as for feasibility evaluation, cost benefit analysis, and preparation of legal systems, is needed to establish and activate dental hygiene management.

A Study on Consumer's Emotional Consumption Value and Purchase Intention about IoT Products - Focused on the preference of using EEG - (IoT 제품에 관한 소비자의 감성적 소비가치와 구매의도에 관한 연구 - EEG를 활용한 선호도 연구를 중심으로 -)

  • Lee, Young-ae;Kim, Seung-in
    • Journal of Communication Design
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    • v.68
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    • pp.278-288
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    • 2019
  • The purpose of this study is to analyze the effects of risk and convenience on purchase intention in the IOT market, and I want to analyze the moderating effect of emotional consumption value. In this study, two products were selected from three product groups. There are three major methods of research. First, theoretical considerations. Second, survey analysis. Reliability analysis and factor analysis were performed using descriptive statistics using SPSS. Third, we measured changes of EEG according to in - depth interview and indirect experience. As a result of the hypothesis of this study, it was confirmed that convenience of use of IoT product influences purchase intention. Risk was predicted to have a negative effect on purchase intentions, but not significant in this study. This implies that IoT products tend to be neglected in terms of monetary loss such as cost of purchase, cost of use, and disposal cost when purchasing. In-depth interviews and EEG analysis revealed that there is a desire to purchase and try out the IoT product due to the nature of the product, the novelty of new technology, and the vague idea that it will benefit my life. The aesthetic, symbolic, and pleasure factors, which are sub - elements of emotional consumption value, were found to have a great influence. This is consistent with previous research showing that emotional consumption value has a positive effect on purchase intention. In-depth interviews and EEG analyzes also yielded the same results. This study has revealed that emotional consumption value affects the intention to purchase IoT products. It seems that companies producing IoT products need to concentrate on marketing with more emotional consumption value.