1.Professional biobanking education in Korea based on ISO 20387
Jong Ok KIM ; Chungyeul KIM ; Sangyong SONG ; Eunah SHIN ; Ji-Sun SONG ; Mee Sook ROH ; Dong-chul KIM ; Han-Kyeom KIM ; Joon Mee KIM ; Yeong Jin CHOI
Journal of Pathology and Translational Medicine 2025;59(1):11-25
To ensure high-quality bioresources and standardize biobanks, there is an urgent need to develop and disseminate educational training programs in accordance with ISO 20387, which was developed in 2018. The standardization of biobank education programs is also required to train biobank experts. The subdivision of categories and levels of education is necessary for jobs such as operations manager (bank president), quality manager, practitioner, and administrator. Essential training includes programs tailored for beginner, intermediate, and advanced practitioners, along with customized training for operations managers. We reviewed and studied ways to develop an appropriate range of education and training opportunities for standard biobanking education and the training of experts based on KS J ISO 20387. We propose more systematic and professional biobanking training programs in accordance with ISO 20387, in addition to the certification programs of the National Biobank and the Korean Laboratory Accreditation System. We suggest various training programs appropriate to a student’s affiliation or work, such as university biobanking specialized education, short-term job training at unit biobanks, biobank research institute symposiums by the Korean Society of Pathologists, and education programs for biobankers and researchers. Through these various education programs, we expect that Korean biobanks will satisfy global standards, meet the needs of users and researchers, and contribute to the advancement of science.
2.Professional biobanking education in Korea based on ISO 20387
Jong Ok KIM ; Chungyeul KIM ; Sangyong SONG ; Eunah SHIN ; Ji-Sun SONG ; Mee Sook ROH ; Dong-chul KIM ; Han-Kyeom KIM ; Joon Mee KIM ; Yeong Jin CHOI
Journal of Pathology and Translational Medicine 2025;59(1):11-25
To ensure high-quality bioresources and standardize biobanks, there is an urgent need to develop and disseminate educational training programs in accordance with ISO 20387, which was developed in 2018. The standardization of biobank education programs is also required to train biobank experts. The subdivision of categories and levels of education is necessary for jobs such as operations manager (bank president), quality manager, practitioner, and administrator. Essential training includes programs tailored for beginner, intermediate, and advanced practitioners, along with customized training for operations managers. We reviewed and studied ways to develop an appropriate range of education and training opportunities for standard biobanking education and the training of experts based on KS J ISO 20387. We propose more systematic and professional biobanking training programs in accordance with ISO 20387, in addition to the certification programs of the National Biobank and the Korean Laboratory Accreditation System. We suggest various training programs appropriate to a student’s affiliation or work, such as university biobanking specialized education, short-term job training at unit biobanks, biobank research institute symposiums by the Korean Society of Pathologists, and education programs for biobankers and researchers. Through these various education programs, we expect that Korean biobanks will satisfy global standards, meet the needs of users and researchers, and contribute to the advancement of science.
3.Professional biobanking education in Korea based on ISO 20387
Jong Ok KIM ; Chungyeul KIM ; Sangyong SONG ; Eunah SHIN ; Ji-Sun SONG ; Mee Sook ROH ; Dong-chul KIM ; Han-Kyeom KIM ; Joon Mee KIM ; Yeong Jin CHOI
Journal of Pathology and Translational Medicine 2025;59(1):11-25
To ensure high-quality bioresources and standardize biobanks, there is an urgent need to develop and disseminate educational training programs in accordance with ISO 20387, which was developed in 2018. The standardization of biobank education programs is also required to train biobank experts. The subdivision of categories and levels of education is necessary for jobs such as operations manager (bank president), quality manager, practitioner, and administrator. Essential training includes programs tailored for beginner, intermediate, and advanced practitioners, along with customized training for operations managers. We reviewed and studied ways to develop an appropriate range of education and training opportunities for standard biobanking education and the training of experts based on KS J ISO 20387. We propose more systematic and professional biobanking training programs in accordance with ISO 20387, in addition to the certification programs of the National Biobank and the Korean Laboratory Accreditation System. We suggest various training programs appropriate to a student’s affiliation or work, such as university biobanking specialized education, short-term job training at unit biobanks, biobank research institute symposiums by the Korean Society of Pathologists, and education programs for biobankers and researchers. Through these various education programs, we expect that Korean biobanks will satisfy global standards, meet the needs of users and researchers, and contribute to the advancement of science.
4.Clinical significance and outcomes of adult living donor liver transplantation for acute liver failure: a retrospective cohort study based on 15-year single-center experience
Geun-hyeok YANG ; Young-In YOON ; Shin HWANG ; Ki-Hun KIM ; Chul-Soo AHN ; Deok-Bog MOON ; Tae-Yong HA ; Gi-Won SONG ; Dong-Hwan JUNG ; Gil-Chun PARK ; Sung-Gyu LEE
Annals of Surgical Treatment and Research 2024;107(3):167-177
Purpose:
This study aimed to describe adult living donor liver transplantation (LDLT) for acute liver failure and evaluate its clinical significance by comparing its surgical and survival outcomes with those of deceased donor liver transplantation (DDLT).
Methods:
We retrospectively reviewed the medical records of 267 consecutive patients (161 LDLT recipients and 106 DDLT recipients) aged 18 years or older who underwent liver transplantation between January 2006 and December 2020.
Results:
The mean periods from hepatic encephalopathy to liver transplantation were 5.85 days and 8.35 days for LDLT and DDLT, respectively (P = 0.091). Among these patients, 121 (45.3%) had grade III or IV hepatic encephalopathy (living, 34.8% vs. deceased, 61.3%; P < 0.001), and 38 (14.2%) had brain edema (living, 16.1% vs. deceased, 11.3%; P = 0.269) before liver transplantation. There were no significant differences in in-hospital mortality (living, 11.8% vs. deceased, 15.1%; P = 0.435), 10-year overall survival (living, 90.8% vs. deceased, 84.0%; P = 0.096), and graft survival (living, 83.5% vs. deceased, 71.3%;P = 0.051). However, postoperatively, the mean intensive care unit stay was shorter in the LDLT group (5.0 days vs. 9.5 days, P < 0.001). In-hospital mortality was associated with vasopressor use (odds ratio [OR], 3.40; 95% confidence interval [CI], 1.45–7.96; P = 0.005) and brain edema (OR, 2.75; 95% CI, 1.16–6.52; P = 0.022) of recipient at the time of transplantation. However, LDLT (OR, 1.26; 95% CI, 0.59–2.66; P = 0.553) was not independently associated with in-hospital mortality.
Conclusion
LDLT is feasible for acute liver failure when organs from deceased donors are not available.
5.Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset
Ki Hyeong LEE ; Byoung Chul CHO ; Myung-Ju AHN ; Yun-Gyoo LEE ; Youngjoo LEE ; Jong-Seok LEE ; Joo-Hang KIM ; Young Joo MIN ; Gyeong-Won LEE ; Sung Sook LEE ; Kyung-Hee LEE ; Yoon Ho KO ; Byoung Yong SHIM ; Sang-We KIM ; Sang Won SHIN ; Jin-Hyuk CHOI ; Dong-Wan KIM ; Eun Kyung CHO ; Keon Uk PARK ; Jin-Soo KIM ; Sang Hoon CHUN ; Jangyoung WANG ; SeokYoung CHOI ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(1):48-60
Purpose:
This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC).
Materials and Methods:
Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS).
Results:
In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib.
Conclusion
Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.
6.The Moderating Effect of Resilience on the Relationship Between the Relevance to Victims With Post-Trauma Psychiatric Symptoms of Community Residents After Seoul Halloween Crowd Crush
Se Youl KIM ; Sra JUNG ; Mi Yeon LEE ; Kang-Seob OH ; Young-Chul SHIN ; Dong-Won SHIN ; Junhyung KIM ; Eun Soo KIM ; Sun Wook JUNG ; Kwang-yeol LEE ; Nahyun OH ; Sung Joon CHO ; Sang-Won JEON
Psychiatry Investigation 2024;21(11):1183-1192
Objective:
This study aimed to examine the psychiatric impact of the Seoul Halloween crowd crush on individuals related to the victims compared to the general population. It also explores the moderating effect of resilience on the relationship between trauma exposure and psychiatric symptoms.
Methods:
In total, 2,220 participants completed various post-incident questionnaires (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Hwa-byung symptom scale, post-traumatic stress disorder checklist for DSM-5, and Brief Resilience Scale) 30 days after the incident. Moderation analyses were conducted using the PROCESS macro in the statistical package for the social sciences.
Results:
Individuals related to the victims exhibited higher symptom severity and a greater risk for clinically significant levels of depression, anxiety, anger, and post-traumatic stress disorder (PTSD) (odds ratio=3.28, 3.33, 1.51, and 4.39 respectively). The impact of relevance to victims on anxiety and PTSD symptoms was moderated by resilience, with a stronger effect observed for individuals with low resilience (β=3.51, 95% confidence interval [CI] 2.78–4.24 for anxiety and β=14.53, 95% CI 12.43–16.63 for PTSD) than for those with high resilience (β=1.69, 95% CI 0.72–2.65 for anxiety and β=8.33, 95% CI 5.56–11.09 for PTSD).
Conclusion
When related to the victims, it was found that not only PTSD, but also depression, anxiety, and anger could intensify. Resilience emerged as a potential buffer against these adverse effects, emphasizing its significance in mitigating the psychiatric impact of community trauma.
7.Brain Frailty and Outcomes of Acute Minor Ischemic Stroke With Large-Vessel Occlusion
Je-Woo PARK ; Joon-Tae KIM ; Ji Sung LEE ; Beom Joon KIM ; Joonsang YOO ; Jung Hoon HAN ; Bum Joon KIM ; Chi Kyung KIM ; Jae Guk KIM ; Sung Hyun BAIK ; Jong-Moo PARK ; Kyusik KANG ; Soo Joo LEE ; Hyungjong PARK ; Jae-Kwan CHA ; Tai Hwan PARK ; Kyungbok LEE ; Jun LEE ; Keun-Sik HONG ; Byung-Chul LEE ; Dong-Eog KIM ; Jay Chol CHOI ; Jee-Hyun KWON ; Dong-Ick SHIN ; Sung Il SOHN ; Sang-Hwa LEE ; Wi-Sun RYU ; Juneyoung LEE ; Hee-Joon BAE
Journal of Clinical Neurology 2024;20(2):175-185
Background:
and Purpose The influence of imaging features of brain frailty on outcomes were investigated in acute ischemic stroke patients with minor symptoms and large-vessel occlusion (LVO).
Methods:
This was a retrospective analysis of a prospective, multicenter, nationwide registry of consecutive patients with acute (within 24 h) minor (National Institutes of Health Stroke Scale score=0–5) ischemic stroke with anterior circulation LVO (acute minor LVO). Brain frailty was stratified according to the presence of an advanced white-matter hyperintensity (WMH) (Fazekas grade 2 or 3), silent/old brain infarct, or cerebral microbleeds. The primary outcome was a composite of stroke, myocardial infarction, and all-cause mortality within 1 year.
Results:
In total, 1,067 patients (age=67.2±13.1 years [mean±SD], 61.3% males) were analyzed. The proportions of patients according to the numbers of brain frailty burdens were as follows: no burden in 49.2%, one burden in 30.0%, two burdens in 17.3%, and three burdens in 3.5%. In the Cox proportional-hazards analysis, the presence of more brain frailty burdens was associated with a higher risk of 1-year primary outcomes, but after adjusting for clinically relevant variables there were no significant associations between burdens of brain frailty and 1-year vascular outcomes. For individual components of brain frailty, an advanced WMH was independently associated with an increased risk of 1-year primary outcomes (adjusted hazard ratio [aHR]=1.33, 95% confidence interval [CI]=1.03–1.71) and stroke (aHR=1.32, 95% CI=1.00–1.75).
Conclusions
The baseline imaging markers of brain frailty were common in acute minor ischemic stroke patients with LVO. An advanced WMH was the only frailty marker associated with an increased risk of vascular events. Further research is needed into the association between brain frailty and prognosis in patients with acute minor LVO.
8.Psychological Distress Trends and Effect of Media Exposure Among Community Residents After the Seoul Halloween Crowd Crush
Sun Wook JUNG ; Sra JUNG ; Mi Yeon LEE ; Kang-Seob OH ; Young-Chul SHIN ; Dong-Won SHIN ; Eun Soo KIM ; Se Youl KIM ; Kwang-yeol LEE ; Nahyun OH ; Sung Joon CHO ; Sang-Won JEON
Journal of Korean Medical Science 2024;39(33):e233-
Background:
It is unclear how exposure to and perception of community trauma creates a mental health burden. This study aimed to examine the psychological distress trends among community residents in acute stress reaction, acute stress disorder, and post-traumatic stress disorder phases following the Seoul Halloween crowd crush.
Methods:
A three-wave repeated cross-sectional survey was conducted with participants after the incident. Analysis of covariance (ANCOVA) with post hoc Bonferroni test was adopted to examine temporal changes in psychological distress and psychological outcomes resulting from media impacts. A two-way ANCOVA was adopted to examine the interaction effects of time and relevance to victims on psychological distress.
Results:
A total of 807, 1,703, and 2,220 individuals participated in the three waves. Anxiety (estimated mean [standard error of the mean]: 2.28 [0.03] vs. 2.12 [0.02] vs. 2.03 [0.02]; P < 0.001), depression (2.22 [0.03] vs. 2.01 [0.02] vs. 1.90 [0.02]; P < 0.001), and anger (2.70 [0.03] vs. 2.66 [0.02] vs. 2.49 [0.02]; P < 0.001) gradually improved. However, sense of safety initially worsened and did not recover well (2.96 [0.03] vs. 2.75 [0.02] vs. 2.77 [0.02];P < 0.001). The interaction effect of time and relevance to the victim were significant in depression (P for interaction = 0.049), anger (P for interaction = 0.016), and sense of safety (P for interaction = 0.004). Among participants unrelated to the victim, those exposed to graphics exhibited higher levels of anxiety (2.09 [0.02] vs. 1.87 [0.07]; P = 0.002), depression (1.99 [0.02] vs. 1.83 [0.07]; P = 0.020), and anger (2.71 [0.03] vs. 2.47 [0.08]; P = 0.003) at W2 and higher anger (2.49 [0.02] vs. 2.31 [0.06]; P = 0.005) at W3.
Conclusion
Community residents indirectly exposed to trauma also experienced psychological distress in the early stages after the incident. A significant impact of media which might have served as a conduit for unfiltered graphics and rumors was also indicated.
9.A Causality Assessment Framework for COVID-19 Vaccines and Adverse Events at the COVID-19 Vaccine Safety Research Center
Seyoung KIM ; Jeong Ah KIM ; Hyesook PARK ; Sohee PARK ; Sanghoon OH ; Seung Eun JUNG ; Hyoung-Shik SHIN ; Jong Koo LEE ; Hee Chul HAN ; Jun Hee WOO ; Byung-Joo PARK ; Nam-Kyong CHOI ; Dong-Hyun KIM
Journal of Korean Medical Science 2024;39(26):e220-
During the coronavirus disease 2019 (COVID-19) pandemic, conclusively evaluating possible associations between COVID-19 vaccines and potential adverse events was of critical importance. The National Academy of Medicine of Korea established the COVID-19 Vaccine Safety Research Center (CoVaSC) with support from the Korea Disease Control and Prevention Agency to investigate the scientific relationship between COVID-19 vaccines and suspected adverse events. Although determining whether the COVID-19 vaccine was responsible for any suspected adverse event necessitated a systematic approach, traditional causal inference theories, such as Hill's criteria, encountered certain limitations and criticisms. To facilitate a systematic and evidence-based evaluation, the United States Institute of Medicine, at the request of the Centers for Disease Control and Prevention, offered a detailed causality assessment framework in 2012, which was updated in the recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) in 2024.This framework, based on a weight-of-evidence approach, allows the independent evaluation of both epidemiological and mechanistic evidence, culminating in a comprehensive conclusion about causality. Epidemiological evidence derived from population studies is categorized into four levels—high, moderate, limited, or insufficient—while mechanistic evidence, primarily from biological and clinical studies in animals and individuals, is classified as strong, intermediate, weak, or lacking. The committee then synthesizes these two types of evidence to draw a conclusion about the causal relationship, which can be described as “convincingly supports” (“evidence established” in the 2024 NASEM report), “favors acceptance,” “favors rejection,” or “inadequate to accept or reject.” The CoVaSC has established an independent committee to conduct causality assessments using the weightof-evidence framework, specifically for evaluating the causality of adverse events associated with COVID-19 vaccines. The aim of this study is to provide an overview of the weight-ofevidence framework and to detail the considerations involved in its practical application in the CoVaSC.
10.Clinical Burden of Aripiprazole Once-Monthly in Patients With Schizophrenia Receiving Antipsychotic Polypharmacy
Jiwan MOON ; Hyeryun YANG ; Sra JUNG ; Soo Bong JUNG ; Jhin-Goo CHANG ; Won-Hyoung KIM ; Sang Min LEE ; Jangrae KIM ; Minji BANG ; Min-Kyoung KIM ; Eun Soo KIM ; Dong-Won SHIN ; Kang Seob OH ; Sang Won JEON ; Junhyung KIM ; Young Chul SHIN ; Sung Joon CHO
Journal of the Korean Society of Biological Psychiatry 2024;31(2):34-39
Objectives:
This study aimed to assess the clinical burden, a critical determinant of medication adherence in patients with schizophrenia, after the administration of Aripiprazole once-monthly (AOM).
Methods:
This study was a retrospective, non-interventional, multicenter, naturalistic observational study conducted through the analysis of participants’ electronic medical records. Study participants were recruited from eight sites. Data were collected at baseline, defined as the time of AOM administration, and at 1, 3, 6, 9, and 12 months thereafter. The primary outcome measure was the change in the Clinical Global Impression-Clinical Benefit (CGI-CB) score over 12 months, and the secondary outcome measure was the change in the Clinical Global Impression-Improvement (CGI-I) score.
Results:
The data of 139 participants were analyzed, revealing a statistically significant decrease of 26.8% in CGI-CB scores and 13.4% in CGI-I scores over 12 months. Upon comparison between adjacent visit intervals, significant reductions were observed for both measures between month 3 and month 6.
Conclusions
This study is the first multicenter investigation to simultaneously evaluate the clinical efficacy and tolerability of transitioning to AOM in the context of polypharmacy. The study suggested that AOM may contribute to reducing the clinical burden, thereby improving the quality of life for patients with schizophrenia.

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