• Title/Summary/Keyword: Standard of Care

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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.

A Nutrition Intakes Survey of Pregnant Women in a Urban Area -Application of Convenient Method for the Study of Nutritionial Status- (일개 도시지역 임신부의 영양섭취에 관한 조사연구 -간이식 영양조사법 이용-)

  • Kim, In-Sook
    • Journal of Preventive Medicine and Public Health
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    • v.16 no.1
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    • pp.99-104
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    • 1983
  • Aiming at the total 200 pregnant women including 150 ones registered with the Health Center of Chung Ku District and 50 ones registered with the Health Center of Mapo District, we have conducted a research study of the socio-medical characteristics, maternal child health, and the status of nutritional intake which has utilized the application of convenient method for the study of nutritional status, during the period of April 20 to May 25, 1983. And we have obtained the following conclusions: 1. Regarding age distribution, the pregnant women aged from 26 to 30 were most numerous, which was 54.0%. The percentage of women who experienced the first pregnancy was 12.0% and the percentage of those who experienced the second pregnancy was 37.0%, which was the highest. Regarding the weeks of pregnancy of the pregnant women, the first trimesterr was 11.5%, the second trimester 30.0%, and the third trimester 58.6%. 2. Regarding academic achievements, the pregnant women who graduated from middle schools reached 43.5%, which was the highest percentage. Regarding economic status, the pregnant women who owned their own houses were only 21.0%. And the pregnant women whose monthly income was from 300,000 won to 400,000 won were 40%, which was the most numerous. 5. The women above 15 years old who experienced the first menstruation were 84.0%. And those who experienced abortion were totally 54.4%. and 35.5% among those women experienced artificial abortion. 4. 70.5% of the pregnant women said that their health condition was excellent, 24.5% felt subjective complaints, and 5.0% specially received medical consultation for their diseases. 5. 82.0% received prenatal care, but 60.5% regularly received prenatal care. 68.0% received the education for nutrition and only 19.5% regularly received the education for nutrition. 6. Regarding the family composition, the families consisting of two generations were 47.0%, which was the most numerous. 97.5% of the preparation for meals was conducted by housewives. They said that they did not lack time for meal preparation. 7. 94.9% of the pregnant women said that they had eaten as in ordinary times during their pregnancy. 25.5% said that there were tabooed foods. Tabooed foods are chiefly pork, chicken, milk, and eggs. 68.0% don't drink milk during pregnancy, 32.5% take the intake of vitamins, and 20.5% take iron supplement. 8. The average amounts of the intake of protein, fat, and carbohydrate of a pregnant women are 49.3gm, 29.4gm, and 205.1gm respectively, which showed the phenomenon in which the amount of the intake of nutrition increased as the weeks of pregnancy increased. The average amount of the intake of salt was 14.2gm. 9. Regarding the hemoglobin value of all pregnant women, those whose hemoglobin value was less than 11.0gm were 66.5%, those whose hemoglobin value was 11 to 12 gm were 16.5%. and those whose hemoglobin value was above 12gm were 17.0%. The pregnant women whose hemoglobin value was less than 11.0gm in the first trimester of pregnancy, in the second trimester, and in the trimester were 81.8%, 62.8%, and 64.9% respectively. This shows that the phenomenon of anemia increased as the weeks of pregnancy increased 10. Regarding physical development of a pregnant woman during prenatal period, the height and weight were $156.7cm{\pm}14.1$ and $51.1kg{\pm}58$ respectively. When the standard increase of a prenatal weigt gain is set as 100%, the women over the range of 100% were 28.0% and the women under the range of 80% were 37.0%.

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Status and prospects of Knowledge Information Security Industry (지식정보보안 산업의 현황과 전망)

  • Choi, Jeong-Il;Chang, Ye-Jin;Lee, Ok-Dong
    • Korean Security Journal
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    • no.39
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    • pp.269-294
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    • 2014
  • Korea is concerned with information security industry due to recent leak-out private information of 3 card companies. Executives are aware of damage from breach of security such as personal data spill, is more dangerous than any other financial risks. The information security industry, which was limited in physical security and network security formerly, is evolving into convergence security of public and facility security industry. The field of interest has also been changed into security of smart phone and intelligence image recently, from firewall or Anti-virus. The convergence security is originally about access control of facility, but recently its demand has been increased mostly by public institutions and major companies. The scope of the industry also varies from finance, education, distribution, national defense, medical care to automobile industry. The market of convergence security has been expanded and new various products and services of security of intelligent vehicle, 'U' healthcare, finance, smart grid and key industries are also developed. It is required to create and enhance of new curriculum and cultivate human resources for the development of knowledge information security industry. Raising standard of education and security consciousness of the nation is also necessary to strengthen the global competitiveness.

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The Study on Identifying the Components of Community Pharmacy Externship Based on Korean Community Pharmacists' Consensus (약학교과과정의 개국약국실습 방향에 관한 연구)

  • Kim, Sung Hyun;Oh, Jung Mi
    • Korean Journal of Clinical Pharmacy
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    • v.9 no.2
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    • pp.109-118
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    • 1999
  • The need for and components of a contemporary community pharmacy externship for pharmacy students have not been clearly identified in Korea. Mail survey was performed among 20 college of pharmacy deans and 800 community pharmacists to analyze the current status and develop a consensus regarding major focus area and criteria of community pharmacy externship to be implemented under the separation of dispensary from medical practice in year 2000. Mail survey yielded $80\%\;and\;23.5\%$ response rate for pharmacy school deans and community pharmacists, respectively. Of the 16 pharmacy schools that responded 14 said they have externship program in hospital pharmacy, and only 8 pharmacy schools responded of having externship program for community pharmacy. However, these community pharmacy programs lacked criteria and standard guideline for the externship. The results of survey revealed that community pharmacy externship program for students should be organized and directed toward developing expert knowledge and skills in pharmacy practice activities, clinical services, communications, pharmacy management, and professionalism. Pharmacy practice components should include competencies and skills in computer application, prescription processing, dispensing, pharmaceutical compounding, Narcotics Control Law application, maintenance and provision of drug information, and laws and regulations. Clinical service components should include the ability to identify patient's drug-related problems, provide long-term patient care and appreciate drug therapy services. Communication skills should be taught to effectively express his/her professional opinion, deduce the needs of others, utilize appropriate techniques and media to communicate ideas and conduct a patient interview and to obtain patient drug history. Pharmacy management skills should be taught to be efficient in medical insurance and drug control process. It was found that professionalism, morality, pharmacy practice experience, ability to provide clinical services, collect and provide drug information and regality are important criteria of preceptors. Externship sites should possess the ability to stock various drugs, access and provide diverse pharmacy services and should have private patient counseling area. Most pharmacists agreed that top 200 drugs' generic and brand name, indications, dosage, side effects, and contraindication should be instructed during the externship. It was also found that student and preceptor should be evaluated for their performances during the externship. This information will be incorporated into teaming objectives for students and to develop Academic Extemship Program Guidelines.

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An Empirical Study for Model Development Concerning Advance Directive (사전의료지시서(Advance Directives) 모형 개발을 위한 실증 연구)

  • Hong, Seongae
    • 한국노년학
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    • v.30 no.4
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    • pp.1197-1211
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    • 2010
  • This research was concucted to present a model of advance directives(AD) when a patient, who is in consciousness, shows a preference for an end of life care as an act of preparing for an uncertain situation that may arise in the forseeable future. The subjects of the research are 383 doctors/nurese and adults, who live in six cities and provinces, to investigate the status of AD, attitude regarding a meaningless life-prolonging treatment, and moreover, an understanding of and a preference for AD. The research was done by the well-structured questionnaire. Also, SPSS 14.0 is used to analyse the collected data, focused on frequency analysis, avearage and standard deviation, X2 test. As the results of the study, the most of the surveyed doctors/nurese knew DNR orders and AD and a few of them used DNR orders and AD practically. Also, the result shows that there is a negative conception of meaningless life-prolonging treatment among the responents, in addition, most of them agreed upon the idea of introducing AD to Korea, filling it out and making it legally effective. As a method of making AD out, the respondents wanted to use a form that mixed living will with an Power of Attorney in a document. Also, considering the appropriate time, respondents prefered when they are diagnosed with terminal illness. At the moment, the introductory model for AD, which is suitable for the Korean culture and current situation is presented based on the result of this research. In the future, other researches should deal with specific measures that can lead to a social consensus to adopt AD in Korea.

Development of Task Guidelines for Hospice Team Members (호스피스 팀 구성원의 직무지침 개발)

  • Ro, You-Ja;Han, Sung-Suk;Yoo, Yang-Sook;Yong, Jin-Sun
    • Journal of Hospice and Palliative Care
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    • v.4 no.1
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    • pp.26-40
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    • 2001
  • Purpose : The purpose of this study was to develop task guidelines for hospice team members. The task range of all personnel who work for hospice institutions was identified, and a tool describing roles and tasks of the hospice team members was developed based on review of related literature, both domestic and international. Methods : The content validity of the tool was assured by an expert panel through two phases of discussion. The first phase of the study included a survey conducted from December 1999 to January 2000 for a total of 126 hospice experts and practitioners affiliated with domestic hospice institutions. The second phase of the study included 35 subjects. The data were collected using a survey when the investigators visited each hospice institution. The data were analyzed using descriptive statistics. Results : 1) In the first phase of the study, all items scored over 80 points in CVI were selected as the roles and tasks of hospice coordinator, nurse, pastor, social worker, pharmacist, nutritionist, therapist, volunteer, and nurse aide. However, two items were excluded because they scored below 80 points: an item describing eligibility of a physician, a person who has a license for managing anesthetic agents was scored as 78.6 points, and an item describing the eligibility of the team leader of volunteers, a person educated at the graduate level was scored as 74.7 points. 2) In the second phase of the study, all items scored over 80 points in CVI were selected as the roles and tasks of hospice nurse, pastor, social worker, pharmacist, nutritionist, therapist, volunteer, and nurse aide. Of the roles of the hospice coordinator, however, the item scored as 77.9 points, assess and plan a patients physical, social, emotional, and spiritual status, and, of the roles of the team leaders of volunteers, the item scored as 78.6, attend a team meeting once a week and participate in building an standard nursing plan for patients were included in the tool since they scored over 80 points in the first phase of the study. Conclusion : The developed task guideline should be further modified and revised based on the findings of a preliminary application in the actual field. There is also a need of continuous research for developing more culturally-appropriate task guidelines for hospice team members.

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Development of a Method of Cybersickness Evaluation with the Use of 128-Channel Electroencephalography (128 채널 뇌파를 이용한 사이버멀미 평가법 개발)

  • Han, Dong-Uk;Lee, Dong-Hyun;Ji, Kyoung-Ha;Ahn, Bong-Yeong;Lim, Hyun-Kyoon
    • Science of Emotion and Sensibility
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    • v.22 no.3
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    • pp.3-20
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    • 2019
  • With advancements in technology of virtual reality, it is used for various purposes in many fields such as medical care and healthcare, but as the same time there are also increasing reports of nausea, eye fatigue, dizziness, and headache from users. These symptoms of motion sickness are referred to as cybersickness, and various researches are under way to solve the cybersickness problem because it can cause inconvenience to the user and cause adverse effects such as discomfort or stress. However, there is no official standard for the causes and solutions of cybersickness at present. This is also related to the absence of tools to quantitatively measure the cybersickness. In order to overcome these limitations, this study proposed quantitative and objective cybersickness evaluation method. We measured 128-channel EEG waves from ten participants experiencing visually stimulated virtual reality. We calculated the relative power of delta and alpha in 11 regions (left, middle, right frontal, parietal, occipital and left, right temporal lobe). Multiple regression models were obtained in a stepwise manner with the motion sickness susceptibility questionnaire (MSSQ) scores indicating the susceptibility of the subject to the motion sickness. A multiple regression model with the highest under the area ROC curve (AUC) was derived. In the multiple regression model derived from this study, it was possible to distinguish cybersickness by accuracy of 95.1% with 11 explanatory variables (PD.MF, PD.LP, PD.MP, PD.RP, PD.MO, PA.LF, PA.MF, PA.RF, PA.LP, PA.RP, PA.MO). In summary, in this study, objective response to cybersickness was confirmed through 128 channels of EEG. The analysis results showed that there was a clearly distinguished reaction at a specific part of the brain. Using the results and analytical methods of this study, it is expected that it will be useful for the future studies related to the cybersickness.

Hypofractionated Radiotherapy for Breast Cancers - Preliminary Results from a Tertiary Care Center in Eastern India

  • Nandi, Moujhuri;Mahata, Anurupa;Mallick, Indranil;Achari, Rimpa;Chatterjee, Sanjoy
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.6
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    • pp.2505-2510
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    • 2014
  • Background: The standard radiotherapy (RT) fractionation practiced in India and worldwide is 50Gy in 25 fractions over 5 weeks to the chest wall or whole breast followed by tumour bed boost in case of breast conservation (BCS). A body of validated data exists regarding hypofractionation in breast cancer. We here report initial results for 135 patients treated at our center with the START-B type of fractionation. Materials and Methods: From May 2011 till July 2012, women with all stages of breast cancer (excluding metastatic), who had undergone BCS or mastectomy were planned for 40Gy in 15 fractions over 3weeks to chest wall/whole breast and supraclavicular fossa (where indicated) followed by tumour bed boost in BCS patients. Planning was done using Casebow's technique. The primary end point was to assess the acute toxicity and the cosmetic outcomes. Using cosmetic scales; patients were assessed during radiotherapy and at subsequent follow up visits with the radiation oncologist. Results: Of the 135 patients, 62 had undergone BCS and 73 mastectomy. Median age of the population was 52 years. Some 80% were T1&T2 tumours in BCS whereas most patients in mastectomy group were T3&T4 tumours (60%). 45% were node negative in BCS group whilst it was 23% in the mastectomy group. Average NPI scores were 3.9 and 4.9, respectively. Most frequently reported histopathology report was infiltrating ductal carcinoma (87%), grade III being most common (58%), and 69% were ER positive tumours, and 30% were Her 2 Neu positive. Triple negative tumours accounted for 13% and their mean age was young (43 yrs.) The maximum acute skin toxicity at the end of treatment was Grade 1 in 94% of the mastectomy grouppatients and 71% in BCS patients. Grade 2 toxicity was 6% in mast group and 23% in BCS group. Grade 3 was 6% in BCS group, no grade 3 toxicity in mastectomy patients and there was no grade 4 skin toxicity in any case. Post RT at 1 month; 39% of BCS patients had persisting Grade I skin reaction which was only 2% in mastectomy patients. At 3 months post RT, 18% patients had persisting hyperpigmentation. At 6 months 8% patients had persisting erythema in the BCS group only. Some 3% BCS and 8% mastectomy patients had lymph edema till the date of evaluation. Cosmetic outcome in BCS patients remained good to excellent 6 months post surgery and radiotherapy. 1 patient of BCS and 3 patients of mast had developed metastatic disease at the time of evaluation. Conclusions: Hypofractionated RT is well tolerated in Indian population with reduced acute skin toxicity and good cosmetic outcome. Regimens such as these should be encouraged in other centers to increase machine output time. The study is on-going to assess long term results.

Development of Multichannel On-line Thermometry System (다 채널 직결 온도측정 시스템의 설계 및 제작)

  • Shin, Sei-One;Shin, Hyun-Jin;Kim, Myung-Se;Kim, Sung-Kyu
    • Journal of Yeungnam Medical Science
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    • v.16 no.2
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    • pp.193-199
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    • 1999
  • Background: Measurement of body temperature is an important parameter in patient management in many clinical conditions. Failure to reach minimal acceptable body temperature standards has been associated with physiological derangements and has necessitated the application of additional therapy. The authors developed a new, simple, accurate thermometry system, which could be used to undertake precise temperature measurement for various clinical conditions. Materials and Methods: A new thermometry system using a specially designed temperature detecting and display system was developed. This system contains a temperature detecting sensor(LM 35CZ), which enables multiple serial checking of heat, data collection and processing computer, and 3-dimensional display system. It provides real time volumetric visualization of temperature distribution of a defined volume and stores and prints the data. Results: With this system, temperature can be measured at multiple interesting sites simultaneously, demonstrated as a 3-dimensional temperature distribution and stored. In well-controlled, systematic experiments a significant correlation has been observed between standard temperature and temperature using this system at various measuring points. Conclusion: This thermometry system is a real-time measurement system, which can demonstrate 3-dimensional heat distribution in experimental phantom and human body and can be used for diagnosing abnormal clinical conditions. In addition, this system reduces the nursing staff work load, providing them more time for long term care to patients.

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Individualized Chemotherapy for Metastatic Gastric Cancer: Retrospective Data from a University Hospital in Brazil

  • Aguiar, Pedro Nazareth Junior;Ribas, Christian;Forones, Nora Manoukian
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.13
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    • pp.5289-5296
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    • 2015
  • Background: Despite the decreased incidence, gastric cancer is still a frequent cause of cancer related death. The 1st line 2 or 3 drugs regimen is still a debatable issue. HER2 targeted therapy has emerged as the standard of care, but it is unavailable in the Brazilian Public Health System. The end-point of this trial was overall survival (OS) in patients with metastatic gastric cancer treated in a public university hospital in Brazil. The secondary end-points were efficacy and safety of regimens with 2 (F+P) or 3 (EOX) drugs to develop an institutional guideline to facilitate optimal treatments. Materials and Methods: In this retrospective study, 1st line regimens were evaluated for OS and PFS stratified by age and ECOG using Cox regression. Results: 47 patients were treated over the last 3 years. In 1st line, 29 were treated with F+P (mean 59.3 years, 34.5% ECOG 2 and a mean of 5.69 cycles) and 16 with EOX (mean 47 years, 18.8% ECOG 2 and a mean of 5.44 cycles). The median OS was 13.8 months (95%CI 10.7-16.9). Response was evaluated in 40 cases and was 64.3% for EOX and 37.5% for F+P (p=0.25). The median PFS was 9.5 months for EOX and 5.6 months for F+P (HR 0.85, 95%CI 0.41-1.74). However, among patients with ECOG 2 mPFS was 3.70 vs 5.40 months, respectively (p=0.86). Regimens showed similar manageable adverse events. A total of 34 patients suffered progression and 14 received $2^{nd}$ line therapy. Diffuse histology (HR 1.89, 95%CI 1.22-2.88), achieving 2nd line (HR: 0.25, 95%CI 0.11-0.58) and treatment response (HR 0.23, 95%CI 0.12-0.47) were OS prognostic factors. Conclusions: Patients treated in our hospital had outcomes compatible with the literature. The regimen choice should be related to patient features. Second line treatment should be considered.