Purpose: The purpose of this study was to explore and assess the experiences of cancer patients and their caregivers who had been admitted to comprehensive nursing care service wards. Methods: Data were collected from 10 patients and 10 caregivers by in-depth interviews. The data were analyzed using content analysis of Downe-Wamboldt. Results: Three categories and seven subcategories were extracted. 1) Realizing institutional limitations of comprehensive nursing care service: ‘Wishing for precise operating systems based on patient severity,’ ‘Anticipating active caregiver participation in treatment process,’ ‘Requiring a countermeasure for safety accidents,’ 2) Professional nursing service which provides relief: ‘Patient-centered professional nursing service,’ ‘Inpatient service that provides relief for patients and caregivers,’ 3) Anticipating continuous use of the service: ‘Inpatient service which users are willing to reuse,’ ‘Wishing for expansion and reinforcement of the service.’ Conclusion Cancer patients and their caregivers experienced institutional limitations while satisfied with professional nursing service and willing to reuse the service. To improve this situation, institutional support such as separate wards for severe patients, measures for active caregiver participation and prevention of safety accidents, and adequate staffing would be helpful for relatively severe level cancer patients and their caregivers.

Purpose: The purpose of this study was to explore and assess the experiences of cancer patients and their caregivers who had been admitted to comprehensive nursing care service wards. Methods: Data were collected from 10 patients and 10 caregivers by in-depth interviews. The data were analyzed using content analysis of Downe-Wamboldt. Results: Three categories and seven subcategories were extracted. 1) Realizing institutional limitations of comprehensive nursing care service: ‘Wishing for precise operating systems based on patient severity,’ ‘Anticipating active caregiver participation in treatment process,’ ‘Requiring a countermeasure for safety accidents,’ 2) Professional nursing service which provides relief: ‘Patient-centered professional nursing service,’ ‘Inpatient service that provides relief for patients and caregivers,’ 3) Anticipating continuous use of the service: ‘Inpatient service which users are willing to reuse,’ ‘Wishing for expansion and reinforcement of the service.’ Conclusion Cancer patients and their caregivers experienced institutional limitations while satisfied with professional nursing service and willing to reuse the service. To improve this situation, institutional support such as separate wards for severe patients, measures for active caregiver participation and prevention of safety accidents, and adequate staffing would be helpful for relatively severe level cancer patients and their caregivers.

Purpose: The purpose of this study was to explore and assess the experiences of cancer patients and their caregivers who had been admitted to comprehensive nursing care service wards. Methods: Data were collected from 10 patients and 10 caregivers by in-depth interviews. The data were analyzed using content analysis of Downe-Wamboldt. Results: Three categories and seven subcategories were extracted. 1) Realizing institutional limitations of comprehensive nursing care service: ‘Wishing for precise operating systems based on patient severity,’ ‘Anticipating active caregiver participation in treatment process,’ ‘Requiring a countermeasure for safety accidents,’ 2) Professional nursing service which provides relief: ‘Patient-centered professional nursing service,’ ‘Inpatient service that provides relief for patients and caregivers,’ 3) Anticipating continuous use of the service: ‘Inpatient service which users are willing to reuse,’ ‘Wishing for expansion and reinforcement of the service.’ Conclusion Cancer patients and their caregivers experienced institutional limitations while satisfied with professional nursing service and willing to reuse the service. To improve this situation, institutional support such as separate wards for severe patients, measures for active caregiver participation and prevention of safety accidents, and adequate staffing would be helpful for relatively severe level cancer patients and their caregivers.

Background: Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined. Methods: This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months. Conclusion This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
Equipment and Supplies ; Equipment Safety ; In Vitro Techniques ; Indicators and Reagents ; Korea* ; Licensure ; Magnets ; Needles

This study was carried out to reduce children's sugar, natrium and fat intakes and establish their healthy lifestyle. To achieve these goals, we developed an educational web site and an e-learning system. The targets of this web site are children, parents and educators. This site has various information about sugar, natrium and fat, and has special menus for each target: such as the 'Let's study' for children, 'Guides for child's eating' for parents, and 'Educational softwares, Lesson plans/materials, and Textbooks/Teaching guides' for educators. We developed three nutrient characters and applied them to the web site. We provided information in the form of texts, images, flash and sounds. This site has special boards in 'Nutrition cafe' menu to interchange information or their successful stories between the connecters. We developed an e-learning system with two courses. One is for junior elementary students and the other is for senior students. Children can study each nutrient step by step in a course according to their academic ability and concern. Also, they can evaluate their academic achievement in this system, which was uploaded into 'Let's study' in children menu in the web site. Conclusively this web site and e-learning system could contribute to reducing children's sugar, natrium and fat intakes by helping children study them systematically and effectively by on-line system. We expect this e-learning system would be a new nutrition education system to make nutrition education more active.
Achievement ; Child ; Humans ; Life Style ; Online Systems ; Parents

This study was conducted to reduce sodium (Na) intake and to establish healthy dietary lifestyles of children. To achieve these goals, we searched, collected, and analyzed the materials related to the Na education, based on which the research personnel-professors and graduate students in nutrition and child education and elementary school teachers discussed to figure out major topics, objectives, and detailed contents and activities appropriate for Na intake reduction. Also a survey was done on the sodium intake and nutrition knowledge of the elementary students. We also organized an advisory committee composed of 15 professionals in related fields to discuss the adequacy and validity of the specific contents. Finally, we systematically organized the contents and developed children's textbooks and teacher's guidebooks. Considering the different cognitive development stages of junior and senior elementary students, we developed two different textbooks for each of them which are easy to read and understand, fun to play with lots of activities, and designed to practice into daily life. The contents cover three major topics-the concept of Na, Na in food, Na in life and are composed of 6 units in total. To help teachers understand and instruct, teacher's guidebook contains an overview of the education, specific information and practical guidelines for each class. We developed these education materials with the aim of lowering children's Na consumption and eventually promoting their health welfare; hopefully we expect these materials would be useful for children's nutritional education in the field.
Advisory Committees ; Child ; Humans ; Life Style ; Sodium

BACKGROUND: Because doxylamine succinate (DS) is an over-the-counter medicine, it can be obtained easily and is frequently used in suicidal attempts. Patients usually recover without serious complications, but occasionally rhabdomyolysis and even death can occur in DS intoxication. In this study, the authors tried to find out the independent predictors of high peak serum CK levels, i.e. probable rhabdomyolysis in DS intoxication. METHODS: The medical records of 41 patients who visited a hospital for DS intoxication from January 1, 2002 to April 30, 2003, were reviewed retrospectively. RESULTS: In the group of DS only, initial occult blood of urine (P=0.003), initial WBC count (P=0.003) and confusion (P=0.007) were the best predictors of the peak serum CK level (2=0.724). In the group of DS with other drugs intoxication, initial creatinine level (P=0.003) and initial occult blood of urine (P=0.007) were the best predictors of the peak serum CK level (r2=0.784). In the cases of rhabdomyolysis patients, the time taken for the CK level to be increased over 1,000 IU/L was 1.9level to be increased over 1,000 IU/L was 1.9+/-0.6 days. CONCLUSION: In DS only intoxication, occult blood in initial urine analysis, initial high WBC count and confusion can be thought of as useful clinical predictors for high peak serum CK level case. In DS with other drugs intoxication, initial creatinine level and initial occult blood of urine can be considered as the best predictors. More than 2 days will be needed for the observation of serious complications in DS intoxication.
Creatinine ; Doxylamine* ; Humans ; Medical Records ; Occult Blood ; Retrospective Studies ; Rhabdomyolysis ; Succinic Acid