• Journal of Food Hygiene and Safety
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• v.30 no.3
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• pp.217-226
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• 2015

This study was conducted to establish a standardized process for developing food safety health indicators. With this aim, we proposed a standardized process, accessed the validity of the suggested process by performing simulations, and provided a method to utilize the indicators. Developing process for domestic environmental health indicators was benchmarked to propose a standardized process for developing food safety health indicators, and DPSEEA framework was applied to the development of indicators. The suggested standardized process consists of an exploitation stage and a management stage. In the exploitation stage, a total of 6 procedures (initial indicators suggestion, candidate indicators selection, data availability assessment, feasibility assessment, pilot study, and final indicator selection) are conducted, and the indicators are routinely calculated and officially announced in the management stage. The exploitation stage is operated by an interaction between a task force team who manages the overall process, and an advisory committee (minimum of 4 in academia, 2 in research, 4 in specialists of Ministry of Food and Drug Safety) who reviews and performs evaluations on the indicators. The standardized process was simulated with 45 initial indicators, and total of 4 indicators (17 detailed indicators) were selected: 'Proportion of domestic fruit/vegetable receiving 'acceptable' in the evaluation of pesticide/herbicide residues', 'Food-borne disease outbreaks', 'Food-borne legal infectious disease incidence', 'Salmonellosis incidence'. Synthetic food safety health index was derived by calculating percent difference with the data from 2010 to 2012. Results showed that when comparing the year 2010 to 2011, and 2011 to 2012, the overall food safety status improved by 10.37% and 9.87%, respectively. In addition, the contribution of indicators to the overall food safety status can be determined by looking into the individual indicators, and the synthetic index may be illustrated to enhance the ease of interpretation to the public and policy makers. In overall, food health safety indicators can be useful in many ways and therefore, attention should be drawn to conduct further studies and establish related legislations.

• Journal of Korean Medical Science
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• v.33 no.49
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• pp.323.1-323.12
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• 2018

Background: Vitamin K antagonist (VKA) to prevent thromboembolism in non-valvular atrial fibrillation (NVAF) patients has limitations such as drug interaction. This study investigated the clinical characteristics of Korean patients treated with VKA for stroke prevention and assessed quality of VKA therapy and treatment satisfaction. Methods: We conducted a multicenter, prospective, non-interventional study. Patients with $CHADS_2{\geq}1$ and treated with VKA (started within the last 3 months) were enrolled from April 2013 to March 2014. Demographic and clinical features including risk factors of stroke and VKA treatment information was collected at baseline. Treatment patterns and international normalized ratio (INR) level were evaluated during follow-up. Time in therapeutic range (TTR) > 60% indicated well-controlled INR. Treatment satisfaction on the VKA use was measured by Treatment Satisfaction Questionnaire for Medication (TSQM) after 3 months of follow-up. Results: A total of 877 patients (age, 67; male, 60%) were enrolled and followed up for one year. More than half of patients (56%) had $CHADS_2{\geq}2$ and 83.6% had $CHA_2DS_2-VASc{\geq}2$. A total of 852 patients had one or more INR measurement during their follow-up period. Among those patients, 25.5% discontinued VKA treatment during follow-up. Of all patients, 626 patients (73%) had poor-controlled INR (TTR < 60%) measure. Patients' treatment satisfaction measured with TSQM was 55.6 in global satisfaction domain. Conclusion: INR was poorly controlled in Korean NVAF patients treated with VKA. VKA users also showed low treatment satisfaction.

• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.881-887
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• 2023

This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.