• The Journal of KAIRB
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• v.2 no.1
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• pp.6-22
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• 2020

Purpose: Clinical studies require institutional review board (IRB) approval based on the ethical principle and regulations. While the number of clinical studies has been increased and diversified, duplicated IRB review for multi-center studies has become a major issue. Therefore, single IRB system has been suggested in revised Common Rule. This study aimed to identify and assess the current status of single IRB in Korea and the anticipated needs of single IRB from researchers and IRB member or administrators. Methods: We developed 14 questions including perceived advantages and disadvantages of single IRB, and anticipated problems. The online survey collected opinions on single IRB from researchers, IRB members and IRB administrators. We also interviewed five IRB administrators who have an experience of single IRB. Results: A total of 80 responses were analyzed in this study. Although efficiencies were suggested for the advantages of single IRB in terms of reducing burden of duplicated review, respondents also perceived that the different review criteria between single IRB and each IRB would be a major hurdle for adopting single IRB system. Therefore, the standardization of standard of procedures (SOP) and the standardization of IRB submission materials should be preceded. According to the small group experiences of single IRB in Korea, we also observed the similar anticipated problems of single IRB. Conclusion: Single IRB system has many advantages for conducting multi-center trial. However, many specialists still have a lot of concerns about introducing a single IRB system in Korea. Therefore, a gradual, step-by-step process for conducting a single IRB system in Korea will be needed. Many studies for improving currently suggested single IRB system and the improvement of awareness about the essential of single IRB system would be needed.

• Pediatric Infection and Vaccine
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• v.31 no.1
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• pp.46-54
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• 2024

Purpose: This study aimed to identify the pathogens of bloodstream infection in children with underlying hemato-oncologic diseases, analyze susceptibility patterns, compare temporal trends with those of previous studies, and assess empirical antimicrobial therapy. Methods: Retrospective review study of children bacteremia in hemato-oncologic diseases was conducted at Seoul National University Bundang Hospital from January 2013 to July 2023. Results: Overall, 98 episodes of bacteremia were observed in 74 patients. Among pathogens isolated, 57.1% (n=56) were Gram-positive bacteria, 38.8% (n=38) were Gram-negative bacteria, and 4.1% (n=4) were Candida spp. The most common Gram-positive bacteria were coagulase-negative staphylococci (n=21, 21.4%) and Staphylococcus aureus, (n=14, 14.3%) whereas the most common Gram-negative bacteria were Klebsiella pneumoniae (n=16, 16.3%) and Escherichia coli (n=10, 10.2%). The susceptibility of Gram-positive bacteria to penicillin, oxacillin, and vancomycin was 11.5%, 32.7%, and 94.2%, respectively and the susceptibility of Gram-negative bacteria to cefotaxime, piperacillin/tazobactam, imipenem, gentamicin, and amikacin was 68.6%, 80%, 97.1%, 82.9%, and 91.4%, respectively. Methicillin-resistant S. aureus was detected in 1 strain and among Gram-negative strains, extended spectrum β-lactamase accounted for 28.9% (12/38). When analyzing the antibiotic susceptibility and empirical antibiotics, the mismatch rate was 25.5% (n=25). The mortality rate of children within 30 days of bacteremia was 7.1% (n=7). Conclusions: Empirical antibiotic therapy for bacteremia in children with hemato-oncologic diseases should be based on the local antibiogram in each institution and continuous monitoring is necessary.

• Korean Journal of Radiology
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• v.22 no.6
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• pp.983-993
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• 2021

Objective: To investigate the image quality of ultralow-dose CT (ULDCT) of the chest reconstructed using a cycle-consistent generative adversarial network (CycleGAN)-based deep learning method in the evaluation of pulmonary tuberculosis. Materials and Methods: Between June 2019 and November 2019, 103 patients (mean age, 40.8 ± 13.6 years; 61 men and 42 women) with pulmonary tuberculosis were prospectively enrolled to undergo standard-dose CT (120 kVp with automated exposure control), followed immediately by ULDCT (80 kVp and 10 mAs). The images of the two successive scans were used to train the CycleGAN framework for image-to-image translation. The denoising efficacy of the CycleGAN algorithm was compared with that of hybrid and model-based iterative reconstruction. Repeated-measures analysis of variance and Wilcoxon signed-rank test were performed to compare the objective measurements and the subjective image quality scores, respectively. Results: With the optimized CycleGAN denoising model, using the ULDCT images as input, the peak signal-to-noise ratio and structural similarity index improved by 2.0 dB and 0.21, respectively. The CycleGAN-generated denoised ULDCT images typically provided satisfactory image quality for optimal visibility of anatomic structures and pathological findings, with a lower level of image noise (mean ± standard deviation [SD], 19.5 ± 3.0 Hounsfield unit [HU]) than that of the hybrid (66.3 ± 10.5 HU, p < 0.001) and a similar noise level to model-based iterative reconstruction (19.6 ± 2.6 HU, p > 0.908). The CycleGAN-generated images showed the highest contrast-to-noise ratios for the pulmonary lesions, followed by the model-based and hybrid iterative reconstruction. The mean effective radiation dose of ULDCT was 0.12 mSv with a mean 93.9% reduction compared to standard-dose CT. Conclusion: The optimized CycleGAN technique may allow the synthesis of diagnostically acceptable images from ULDCT of the chest for the evaluation of pulmonary tuberculosis.

• The Korea Journal of Herbology
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• v.39 no.3
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• pp.107-114
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• 2024

Objective : Cicadae Periostracum (CP), which is the discarded shell of the Cryptotympana atrata (Fabricius, 1775), is a recognized component of oriental medicine for treatment sore throat, itching, shock, sedation, edema. However, the safety and toxicity of CP have not yet been established. It has been reported that symptoms of addiction or side effects may occur in patients who take high doses of CP or who are hypersensitive to it. Therefore, we investigated the acute toxicity of an CP extracts in Sprague-Dawley (SD) rats. Methods : To study acute toxicity, five SD rats of each sex per group were treated with CP extracts at single doses of 0, 500, 1000, or 2000 mg/kg administrated by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. At the end of 14-day observation period, all animals were sacrificed and complete hematological and macroscopic examinations were performed. Results : There were no dead animal and test article-related effects on body weight change or the gross finding. No toxicologically significant results were observed between control and treated groups in hematology. Although salivation related to stress at the highest dose was observed in clinical signs immediately after administration, it is considered to have no toxicological significance. Conclusion : As the results, we did not find any adverse effect at the dose levels of 500, 1000, or 2000 mg/kg in rats. The minimal lethal dose was considered to be over 2000 mg/kg body weight in rats.

• Quality Improvement in Health Care
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• v.30 no.1
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• pp.120-131
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• 2024

Purpose: This study aimed to evaluate the impact of implementing a clinical pathways (CPs) on the clinical outcomes and costs of patients undergoing breast cancer surgery. Methods: This retrospective cohort study included patients who were newly diagnosed with primary breast cancer at the Samsung Medical Center between 2014 and 2019 (N=8482; 2931 patients in the pre-path and 5551 patients in the post-path). Clinical outcomes included reoperation during hospitalization, readmission, and emergency room visits within 30 days of discharge. The cost data for each unit were obtained from an activity-based management accounting system. We performed an interrupted time series analysis. Results: The post-path period showed a significantly shorter hospital length of stay (LOS) than the pre-path period (6.3 days in pre-path vs. 5.0 days in post-path; -1.3 days' difference; p=.001), and fewer reoperations during hospitalization and within 30 days after discharge than the pre-path period. After adjusting for inflation rates and relative value scores, the model demonstrated savings of $146 per patient in the post-path for total costs, and $537 per patient for patient out-of-pocket costs (p=.001). Conclusion: CPs can help reduce costs without compromising the quality of care by reducing the number of reoperations, readmissions, and complications.

• Korean Journal of Radiology
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• v.24 no.4
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• pp.362-370
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• 2023

Objective: To report the clinical and radiological characteristics of patients with underlying B-cell lymphoma and coronavirus disease 2019 (COVID-19) showing migratory airspace opacities on serial chest computed tomography (CT) with persistent COVID-19 symptoms. Materials and Methods: From January 2020 to June 2022, of the 56 patients with underlying hematologic malignancy who had undergone chest CT more than once at our hospital after acquiring COVID-19, seven adult patients (5 female; age range, 37-71 years; median age, 45 years) who showed migratory airspace opacities on chest CT were selected for the analysis of clinical and CT features. Results: All patients had been diagnosed with B-cell lymphoma (three diffuse large B-cell lymphoma and four follicular lymphoma) and had received B-cell depleting chemotherapy, including rituximab, within three months prior to COVID-19 diagnosis. The patients underwent a median of 3 CT scans during the follow-up period (median 124 days). All patients showed multifocal patchy peripheral ground glass opacities (GGOs) with basal predominance in the baseline CTs. In all patients, follow-up CTs demonstrated clearing of previous airspace opacities with the development of new peripheral and peribronchial GGO and consolidation in different locations. Throughout the follow-up period, all patients demonstrated prolonged COVID-19 symptoms accompanied by positive polymerase chain reaction results from nasopharyngeal swabs, with cycle threshold values of less than 25. Conclusion: COVID-19 patients with B-cell lymphoma who had received B-cell depleting therapy and are experiencing prolonged SARS-CoV-2 infection and persistent symptoms may demonstrate migratory airspace opacities on serial CT, which could be interpreted as ongoing COVID-19 pneumonia.

• Journal of the Korean Society of Radiology
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• v.84 no.1
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• pp.51-74
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• 2023

Multiple myeloma, which is a proliferative disease of plasma cells that originate from a single clone, is the second most common hematologic malignancy following non-Hodgkin lymphoma. In the past, its diagnosis was made based on clinical findings (so-called "CRAB") and a skeletal survey using radiographs. However, since the implementation of the International Myeloma Working Group's revised guideline regarding the radiologic diagnosis of multiple myeloma, whole-body (WB) MRI has emerged to play a central role in the early diagnosis of multiple myeloma. Diffusion-weighted imaging and fat quantification using Dixon methods enable treatment response assessment by MRI. In keeping with the trend, a multi-institutional and multidisciplinary consensus for standardized image acquisition and reporting known as the Myeloma Response Assessment and Diagnostic System (MY-RADS) has recently been proposed. This review aims to describe the clinical application of WB-MRI based on MY-RADS in multiple myeloma, discuss its limitations, and suggest future directions for improvement.

• The Korean Journal of Medicine
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• v.99 no.2
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• pp.84-95
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• 2024

In Harrison's Principles of Internal Medicine, human understanding is emphasized as one of three necessary characteristics that a physician must have. Inflammation, which is caused by inflammatory inducers (inf-ids), is a fundamental feature of disease at the cellular and molecular levels. Inflammation protects the body, but excessive or prolonged inflammation can be damaging and can cause disease. Humans are repeatedly exposed to external and internal environmental factors that generate inf-ids throughout their lives. External environmental factors include microbial and non-microbial inf-ids, as well as stressors that inevitably arise during social interactions. Internal environmental factors include the adaptive physiological response that is present from birth. Inf-ids may also be produced by the four-step habit loop, which consists of a cue (e.g., stressor), emotions, routine act (adaptive response), and a reward. Immune cells in the circulatory system and in tissues may have positive and negative effects in inflammatory responses. However, low-grade inflammation may be difficult to detect. We propose a model of disease development that integrates external and internal environmental factors from the perspective of human understanding.

• The Korean journal of internal medicine
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• v.39 no.3
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• pp.501-512
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• 2024

Background/Aims: Optimal risk stratification based on simplified geriatric assessment to predict treatment-related toxicity and survival needs to be clarified in older patients with diffuse large B-cell lymphoma (DLBCL). Methods: This multicenter prospective cohort study enrolled newly diagnosed patients with DLBCL (≥ 65 yr) between September 2015 and April 2018. A simplified geriatric assessment was performed at baseline using Activities of Daily Living (ADL), Instrumental ADL (IADL), and Charlson's Comorbidity Index (CCI). The primary endpoint was event-free survival (EFS). Results: The study included 249 patients, the median age was 74 years (range, 65-88), and 125 (50.2%) were female. In multivariable Cox analysis, ADL, IADL, CCI, and age were independent factors for EFS; an integrated geriatric score was derived and the patients stratified into three geriatric categories: fit (n = 162, 65.1%), intermediate-fit (n = 25, 10.0%), and frail (n = 62, 24.9%). The established geriatric model was significantly associated with EFS (fit vs. intermediate-fit, HR 2.61, p < 0.001; fit vs. frail, HR 4.61, p < 0.001) and outperformed each covariate alone or in combination. In 87 intermediate-fit or frail patients, the relative doxorubicin dose intensity (RDDI) ≥ 62.4% was significantly associated with worse EFS (HR, 2.15, 95% CI 1.30-3.53, p = 0.002). It was related with a higher incidence of grade ≥ 3 symptomatic non-hematologic toxicities (63.2% vs. 27.8%, p < 0.001) and earlier treatment discontinuation (34.5% vs. 8.0%, p < 0.001) in patients with RDDI ≥ 62.4% than in those with RDDI < 62.4%. Conclusions: This model integrating simplified geriatric assessment can risk-stratify older patients with DLBCL and identify those who are highly vulnerable to standard dose-intensity chemoimmunotherapy.

• Journal of Hospice and Palliative Care
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• v.19 no.1
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• pp.61-69
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• 2016

Purpose: It is important to alleviate care burden for terminal cancer patients and their families. This study investigated the factors associated with care burden among family caregivers (FCs) of terminally ill cancer patients. Methods: We analyzed data from 289 FCs of terminal cancer patients who were admitted to palliative care units of seven medical centers in Korea. Care burden was assessed using the Korean version of Caregiver Reaction Assessment (CRA) scale which comprises five domains. A multivariate logistic regression model with stepwise variable selection was used to identify factors associated with care burden. Results: Diverse associating factors were identified in each CRA domain. Emotional factors had broad influence on care burden. FCs with emotional distress were more likely to experience changes to their daily routine (adjusted odds ratio (aOR), 2.54; 95% confidence interval (CI), 1.29~5.02), lack of family support (aOR, 2.27; 95% CI, 1.04~4.97) and health issues (aOR, 5.44; 2.50~11.88). Family functionality clearly reflected a lack of support, and severe family dysfunction was linked to financial issues as well. FCs without religion or comorbid conditions felt more burdened. The caregiving duration and daily caregiving hours significantly predicted FCs' lifestyle changes and physical burden. FCs who were employed, had weak social support or could not visit frequently, had a low self-esteem. Conclusion: This study indicates that it is helpful to understand FCs' emotional status and family functions to assess their care burden. Thus, efforts are needed to lessen their financial burden through social support systems.