• 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.

• Journal of the Korean Society for Aeronautical & Space Sciences
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• v.50 no.4
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• pp.259-267
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• 2022

The existing method of deriving the fail-safe design requirements for the domestic developed rotary-wing aircraft system may miss the factors that cause critical system function failures, when being applied to the latest integrated avionics system. It is because the existing method analyzes the severity effect of the failures caused by a single item. To solve the issue, we present a systematic analysis procedure for deriving fail-safe design requirements of system architecture by utilizing functional hazard assessment and development assurance level analysis of SAE ARP4754A, international standard for complex system development. To demonstrate that our proposed procedure can be a solution for the aforementioned issue, we set up experimental environments that include common factors that can cause critical function failures of a system, and we conducted a cross-validation with the existing method. As a result, we showed that the proposed procedure can identify the potential critical common factors that the existing method have missed, and that the proposed procedure can derive fail-safe design requirements to control the common factors.

• Structural Engineering and Mechanics
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• v.87 no.3
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• pp.283-296
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• 2023

Free-vibration and buckling analyses of plate problems are investigated with the aid of the strain gradient notation finite element method (SGN-FEM). As SGN-FEM employs physically interpretable polynomials in developing finite elements, parasitic shear sources, which are the cause of shear locking, can be precisely identified and subsequently eliminated. This allows two mutually complementary objectives to be defined in this work, namely, evaluate the efficiency of free-vibration and buckling results provided by corrected models, and study the severity of parasitic shear effects on plate models performance. Parasitic shear are flexural terms erroneously present in shear strain polynomials. It is reviewed here that six parasitic shear terms arise during the formulation of the four-node Mindlin plate element. Two parasitic shear terms have been identified in the in-plane shear strain polynomial while other two have been identified in each of the transverse shear strain polynomials. The element is corrected a-priori, i.e., during development, by simply removing the spurious terms from the shear strain polynomials. The computational implementation of the element in its two versions, namely, containing the parasitic shear terms (PS) and corrected for parasitic shear (SG), allows for assessments of the accuracy of results and of the deleterious effects of parasitic shear in free vibration and buckling analyses. This assessment of the parasitic shear effects is a novelty of this work. Validation of the SG model is done comparing its results with analytical results and results provided by other numerical procedures. Analyses are performed for square plates with different thickness-to-length ratios and boundary conditions. Results for thin plates provided by the PS model do not converge to the correct solutions, which indicates that parasitic shear must be eliminated. That is, analysts should not rely on refinement alone. For thick plates, PS model results can be considered acceptable as deleterious effects are really critical in thin plates. On the other hand, results provided by the SG model converge well for both thin and thick plates. The effectiveness of the SG model is established via high-accuracy results obtained in several examples. It is concluded that corrected SGN-FEM models are efficient alternatives for free-vibration and buckling analysis of Mindlin plate problems, and that precise elimination of parasitic shear is a requirement for sound analyses.

• Journal of Korea Water Resources Association
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• v.56 no.8
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• pp.485-496
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• 2023

Recently, South Korea has been making efforts to mitigate the risk of water scarcity during droughts by utilizing various drought response measures in dam operations. While various studies have been conducted on this topic, there is currently a lack of research on the economic effects of drought response measures. In this study, we evaluated the economic effects of drought response measures on nationwide multipurpose dams by using a long-term simulated inflow model based on ARIMA and Copula and a dam operation model that reflects drought response measures. The results showed that the expected benefits per unit flow rate were highest for coordinated operation and alternative water supply measures, at KRW 1,176 and KRW 1,139, respectively, while the benefits of emergency water supply utilization and water supply adjustment were estimated at KRW 956 and KRW 875, respectively. Additionally, when we examined the changes in the economic benefits of drought response measures based on the assumption of increased drought severity in the future, the changes in the drought risk resulting from reduced inflow increased the economic benefits of all drought response measures. The economic benefits of water supply adjustment increased by 2.6% compared to the baseline, while the economic benefits of coordinated operation and alternative water supply measures increased by 11.7% compared to the baseline. This suggests that dam-network-based measures, such as coordinated operation and alternative water supply measures, are crucial as drought risk increases. This study is expected to serve as a fundamental reference for selecting and utilizing drought response measures in the future.

• Journal of Animal Science and Technology
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• v.65 no.6
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• pp.1180-1193
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• 2023

Most carcass and meat quality traits are moderate to highly heritable, indicating that they can be improved through selection. Genetic evaluation for these types of traits is performed using performance data obtained from commercial and progeny testing evaluation. The performance data from commercial farms are available in large volume, however, some drawbacks have been observed. The drawback of the commercial data is mainly due to sorting of animals based on live weight prior to slaughter, and this could lead to bias in the genetic evaluation of later measured traits such as carcass traits. The current study has two components to address the drawback of the commercial data. The first component of the study aimed to estimate genetic parameters for carcass and meat quality traits in Korean Hanwoo cattle using a large sample size of industry-based carcass performance records (n = 469,002). The second component of the study aimed to describe the impact of sorting animals into different contemporary groups based on an early measured trait and then examine the effect on the genetic evaluation of subsequently measured traits. To demonstrate our objectives, we used real performance data to estimate genetic parameters and simulated data was used to assess the bias in genetic evaluation. The results of our first study showed that commercial data obtained from slaughterhouses is a potential source of carcass performance data and useful for genetic evaluation of carcass traits to improve beef cattle performance. However, we observed some harvesting effect which leads to bias in genetic evaluation of carcass traits. This is mainly due to the selection of animal based on their body weight before arrival to slaughterhouse. Overall, the non-random allocation of animals into a contemporary group leads to a biased estimated breeding value in genetic evaluation, the severity of which increases when the evaluation traits are highly correlated.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.4
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• pp.109-124
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• 2023

Objectives This study aims to find out effect of Korean medicine treatment on managing thoracolumbar compression fractures through retrospective observational study. Methods Among hospitalized patients at the Department of Korean Medicine Rehabilitation from January 1st, 2018 to February 28th, 2023, a total of 24 inpatients who were diagnosed with thoracolumbar compression fractures and received Korean medicine treatment were included in this study. Numeric rating scale (NRS) was used for pain assessment and clinical variables such as sex, symptoms, age, thoracolumbar injury classification and severity (TLICS) scores were collected. For subgroup analysis to analyze factors affecting treatment response, we divided patients into responders and non-responders according to NRS change. For statistical analysis, we compared before/after hospitalization and analyzed distinct features between two groups. Results Most of the patients were in their 70s and 83.33% were female. Average hospitalization period was 24.54±11.91 days. All patients had back pain as their chief complaint and only 2 patients received surgeries. In TLICS, only 1 patient got score 6, which represented surgery indication. After Korean medicine treatment, NRS of almost every patient got lower significantly at the time of discharge (3.02±1.93) than admission (5.52±1.95). Comparing two groups, responders had lower NRS at the time of discharge and TLICS score of them were lower than non-responders. Conclusions Our results show that Korean medicine treatment for thoracolumbar compression fractures was effective in reducing pain. There were distinct clinical features such as age, past history, surgeries between those with significant improvement in pain scores and those who did not.

• Health Policy and Management
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• v.34 no.2
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• pp.106-119
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• 2024

Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of this study is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and some European countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholar by using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements on advance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promote the communication and coordination of responses, and expedited drug regulatory processes. Similarly, Canada established the Multi-Stakeholder Steering Committee on drug shortages by involving representatives from central and local governments and private sectors. Canada also adopted a tiered approach to the communication of drug shortages based on the assessment of the severity of the shortage problem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agency and the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countries reviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. The efforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmental coordination and development of guidelines.

• The Journal of Korean Medicine
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• v.44 no.4
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• pp.41-58
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• 2023

Objectives: This retrospective observational study aimed to investigate the efficacy and safety of Cheongpebaedok-tang, a traditional Korean herbal medicine, provided via telemedicine to patients with asymptomatic to mild COVID-19 in Korea. Methods: From February to April 2020, a retrospective analysis investigated COVID-19 patients treated via Korean telemedicine. The study involved asymptomatic to mild cases receiving Cheongpebaedok-tang more than three times, along with continuous Korean medicine care in convalescence. Diagnoses and treatment adhered to the telemedicine guidelines of the Association of Korean Medicine, with varied Cheongpebaedok-tang prescriptions based on symptom severity. Symptom evaluation involved a detailed assessment using a 15-item tool at initial and final sessions. Results: The study included 27 patients, with a mean age of 48.7 ± 2.3 years (mean ± standard error). Patients began self-administering oral Cheongpebaedok-tang for an average of 19.4 ± 1.8 days after the date of COVID-19 diagnosis confirmation and continued the medication for 15.8 ± 1.2 days. The reported side effects of the Cheongpebaedok-tang included palpitations (11.1%), insomnia (7.4%), dizziness (3.7%), and diarrhea (3.7%). All side effects disappeared after adjusting the prescription according to standard treatment guidelines. The occurrence of all COVID-19-related adverse symptoms, except fatigue and myalgia, decreased. Fatigue was the most common chronic symptom persisting after 6 months (51.9%), followed by ocular symptoms (37.0%) and sore throat (22.2%). Conclusions: This study implies Cheongpebaedok-tang may offer a potentially safe, symptom-alleviating approach for managing mild COVID-19 cases via telemedicine, although further comprehensive research is warranted.

• Journal of the Korean Society of Marine Environment & Safety
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• v.30 no.2
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• pp.200-208
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• 2024

The occurrence a fire on a training ship with a large number of people on board can lead to severe casualties. Hence the Seafarers' Act and Safety Life At Sea(SOLAS) emphasizes the importance of the abandon ship drill. Therefore, in this study, the training ship of Mokpo National Maritime University, Segero, which has a large number of people on board, was selected as the target ship and the likelihood and severity of fire accidents on each deck were predicted through the preliminary hazard analysis(PHA) qualitative risk assessment. Additionally, assuming a fire in a high-risk area, a simulation of evacuation time and population density was performed to quantitatively predict the risk. The the total evacuation time was predicted to be the longest at 501s in the meal time scenario, in which the population distribution was concentrated in one area. Depending on the scenario, some decks had relatively high population densities of over 1.4pers/m², preventing stagnation in the number of evacuees. The results of this study are expected to be used as basic data to develop training scenarios for training ships by quantifying evacuation time and population density according to various evacuation scenarios, and the research can be expanded in the future through comparison of mathematical models and experimental values.

• Korean Journal of Radiology
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• v.25 no.7
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• pp.673-683
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• 2024

Objective: To evaluate the role of visual and quantitative chest CT parameters in assessing treatment response in patients with severe asthma. Materials and Methods: Korean participants enrolled in a prospective multicenter study, named the Precision Medicine Intervention in Severe Asthma study, from May 2020 to August 2021, underwent baseline and follow-up chest CT scans (inspiration/expiration) 10-12 months apart, before and after biologic treatment. Two radiologists scored bronchiectasis severity and mucus plugging extent. Quantitative parameters were obtained from each CT scan as follows: normal lung area (normal), air trapping without emphysema (AT without emph), air trapping with emphysema (AT with emph), and airway (total branch count, Pi10). Clinical parameters, including pulmonary function tests (forced expiratory volume in 1 s [FEV1] and FEV1/forced vital capacity [FVC]), sputum and blood eosinophil count, were assessed at initial and follow-up stages. Changes in CT parameters were correlated with changes in clinical parameters using Pearson or Spearman correlation. Results: Thirty-four participants (female:male, 20:14; median age, 50.5 years) diagnosed with severe asthma from three centers were included. Changes in the bronchiectasis and mucus plugging extent scores were negatively correlated with changes in FEV1 and FEV1/FVC (ρ = from -0.544 to -0.368, all P < 0.05). Changes in quantitative CT parameters were correlated with changes in FEV1 (normal, r = 0.373 [P = 0.030], AT without emph, r = -0.351 [P = 0.042]), FEV1/FVC (normal, r = 0.390 [P = 0.022], AT without emph, r = -0.370 [P = 0.031]). Changes in total branch count were positively correlated with changes in FEV1 (r = 0.349 [P = 0.043]). There was no correlation between changes in Pi10 and the clinical parameters (P > 0.05). Conclusion: Visual and quantitative CT parameters of normal, AT without emph, and total branch count may be effective for evaluating treatment response in patients with severe asthma.