1.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.
2.Psychiatric adverse events associated with the COVID-19 vaccines approved in the Republic of Korea: a systematic review
Seungeun RYOO ; Miyoung CHOI ; Nam-Kyong CHOI ; Hyoung-Shik SHIN ; Jun Hee WOO ; Byung-Joo PARK ; Sanghoon OH
Osong Public Health and Research Perspectives 2024;15(2):107-114
This systematic review evaluated psychiatric adverse events (AEs) following vaccination against coronavirus disease 2019 (COVID-19). We included studies that reported or investigated psychiatric AEs in individuals who had received an approved COVID-19 vaccine in the Republic of Korea. Systematic electronic searches of Ovid-Medline, Embase, CENTRAL, and KoreaMed databases were conducted on March 22, 2023. Risk of bias was assessed using the Risk of Bias Assessment Tool for Non-randomized Studies 2.0. The study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023449422). Of the 301 articles initially selected, 7 were included in the final analysis. All studies reported on sleep disturbances, and 2 highlighted anxiety-related AEs. Sleep disorders like insomnia and narcolepsy were the most prevalent AEs, while depression was not reported. Our review suggests that these AEs may have been influenced by biological mechanisms as well as the broader psychosocial context of the COVID-19 pandemic. Although this study had limitations, such as a primary focus on the BNT162b2 vaccine and an observational study design, it offered a systematic, multi-vaccine analysis that fills a critical gap in the existing literature. This review underscores the need for continued surveillance of psychiatric AEs and guides future research to investigate underlying mechanisms, identify risk factors, and inform clinical management.
3.The COVID-19 Vaccine Safety Research Center: a cornerstone for strengthening safety evidence for COVID-19 vaccination in the Republic of Korea
Na-Young JEONG ; Hyesook PARK ; Sanghoon OH ; Seung Eun JUNG ; Dong-Hyun KIM ; Hyoung-Shik SHIN ; Hee Chul HAN ; Jong-Koo LEE ; Jun Hee WOO ; Jaehun JUNG ; Joongyub LEE ; Ju-Young SHIN ; Sun-Young JUNG ; Byung-Joo PARK ; Nam-Kyong CHOI
Osong Public Health and Research Perspectives 2024;15(2):97-106
The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in November 2021 to address the growing need for independent, in-depth scientific evidence on adverse events (AEs) following coronavirus disease 2019 (COVID-19) vaccination. This initiative was requested by the Korea Disease Control and Prevention Agency and led by the National Academy of Medicine of Korea. In September 2022, the COVID-19 Vaccine Safety Research Center was established, strengthening CoVaSC’s initiatives. The center has conducted various studies on the safety of COVID-19 vaccines. During CoVaSC’s second research year, from September 29, 2022 to July 19, 2023, the center was restructured into 4 departments: Epidemiological Research, Clinical Research, Communication & Education, and International Cooperation & Policy Research. Its main activities include (1) managing CoVaSC and the COVID-19 Vaccine Safety Research Center, (2) surveying domestic and international trends in AE causality investigation, (3) assessing AEs following COVID-19 vaccination, (4) fostering international collaboration and policy research, and (5) organizing regular fora and training sessions for the public and clinicians. Causality assessments have been conducted for 27 diseases, and independent research has been conducted after organizing ad hoc committees comprising both epidemiologists and clinical experts on each AE of interest. The research process included protocol development, data analysis, interpretation of results, and causality assessment. These research outcomes have been shared transparently with the public and healthcare experts through various fora. The COVID-19 Vaccine Safety Research Center plans to continue strengthening and expanding its research activities to provide reliable, high-quality safety information to the public.
4.A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee
Na-Young JEONG ; Hyesook PARK ; Sanghoon OH ; Seung Eun JUNG ; Dong-Hyun KIM ; Hyoung-Shik SHIN ; Hee Chul HAN ; Jong-Koo LEE ; Jun Hee WOO ; Byung-Joo PARK ; Nam-Kyong CHOI
Osong Public Health and Research Perspectives 2023;14(1):5-14
With the introduction of coronavirus disease 2019 (COVID-19) vaccines, the Korea Disease Control and Prevention Agency (KDCA) commissioned the National Academy of Medicine of Korea to gather experts to independently assess post-vaccination adverse events. Accordingly, the COVID-19 Vaccine Safety Research Committee (CoVaSC) was launched in November 2021 to perform safety studies and establish evidence for policy guidance. The CoVaSC established 3 committees for epidemiology, clinical research, and communication. The CoVaSC mainly utilizes pseudonymized data linking KDCA’s COVID-19 vaccination data and the National Health Insurance Service’s claims data. The CoVaSC’s 5-step research process involves defining the target diseases and organizing ad-hoc committees, developing research protocols, performing analyses, assessing causal relationships, and announcing research findings and utilizing them to guide compensation policies. As of 2022, the CoVaSC completed this research process for 15 adverse events. The CoVaSC launched the COVID-19 Vaccine Safety Research Center in September 2022 and has been reorganized into 4 divisions to promote research including international collaborative studies, long-/short-term follow-up studies, and education programs. Through these enhancements, the CoVaSC will continue to swiftly provide scientific evidence for COVID-19 vaccine research and compensation and may serve as a model for preparing for future epidemics of new diseases.
5.National Academy of Medicine of Korea (NAMOK) Key Statements on COVID-19
Hyoung-Shik SHIN ; Hyesook PARK ; Jun Soo KWON ; Hyun NAMGOONG ; Seong-Jun KIM ; June Myung KIM ; Kyong Ran PECK ; Kyungwon LEE ; Jong-koo LEE ; JinHan LEE ; Hee Chul HAN ; SungJin HONG ; Byung-Joo PARK ; Tae Hwan LIM ; Eung Soo HWANG ; Jun Hee WOO ; NAMOK COVID-19 Committee
Journal of Korean Medical Science 2021;36(41):e287-
6.The Effect of Breastfeeding on Prevention of Maternal Hypertension: Systematic Review
Hyeji JEON ; Sung Hong JOO ; Anna CHOI ; Jung Yeol HAN ; Eui Shik JEONG ; Hye Jung SHIN ; Jae Youn KIM
Journal of the Korean Society of Maternal and Child Health 2019;23(3):185-190
PURPOSE: The purpose of this study is to clarify the relevance of breastfeeding and its preventive effect on maternal hypertension as well as to evaluate the theoretical mechanism behind of it through systematic evaluation of existing articles. METHODS: For systematic evaluation of literatures in recent 5 years, 5 most suitable articles were selected with the key words, (breastfeeding or breastfeed or lactation) AND (hypertension or high blood pressure or hypertensive disorders) from PubMed, EMBASE, and Cochran Library, and carefully reviewed by 2 researchers. RESULTS: Breastfeeding women have less frequently developed hypertension in their later life. Depending on the duration of breastfeeding, compared to nonbreastfeeding women, breastfeeding women's odds ratio for developing hypertension are 0.87 (95% confidence interval [CI], 0.76–0.99), 0.83 (95% CI, 0.68–1.00), and 0.79 (95% CI, 0.65–0.97) each for 0–6 months, 6–12 months, and greater than 12 months of breastfeeding. As the number of breastfeeding children increases, the incidence of maternal hypertension decreases. In addition, both partial and exclusive breastfeeding lower the risk of developing maternal hypertension. Though the mechanism of prophylactic effect of breastfeeding on hypertension is not conclusive, reset hypothesis, oxytocin release, the increase of ghrelin and protein peptide YY, as well as epigenetic programming are considered to be relevant to the etiology of the condition. CONCLUSION: Breastfeeding prevents maternal hypertension later in life. Studies show dose-response relationship of breastfeeding as the duration matters. In addition, both partial and exclusive breastfeeding have preventive effect on maternal hypertension. Numerous mechanisms are continuously being reported and further studies are needed for clarification.
Breast Feeding
;
Child
;
Epigenomics
;
Female
;
Ghrelin
;
Humans
;
Hypertension
;
Incidence
;
Odds Ratio
;
Oxytocin
;
Peptide YY
7.Current Awareness and Use of the Strain Echocardiography in Routine Clinical Practices: Result of a Nationwide Survey in Korea.
Ju Hee LEE ; Jae Hyeong PARK ; Seung Woo PARK ; Woo Shik KIM ; Il Suk SOHN ; Jung Yeon CHIN ; Jung Sun CHO ; Ho Joong YOUN ; Hae Ok JUNG ; Sun Hwa LEE ; Seong Hwan KIM ; Wook Jin CHUNG ; Chi Young SHIM ; Jin Won JEONG ; Eui Young CHOI ; Se Joong RIM ; Jang Young KIM ; Kye Hun KIM ; Joon Han SHIN ; Dae Hee KIM ; Ung JEON ; Jung Hyun CHOI ; Yong Jin KIM ; Seung Jae JOO ; Ki Hong KIM ; Kyoung Im CHO ; Goo Yeong CHO
Journal of Cardiovascular Ultrasound 2017;25(3):91-97
BACKGROUND: Because conventional echocardiographic parameters have several limitations, strain echocardiography has often been introduced in clinical practice. However, there are also obstacles in using it in clinical practice. Therefore, we wanted to find the current status of awareness on using strain echocardiography in Korea. METHODS: We conducted a nationwide survey to evaluate current use and awareness of strain echocardiography from the members of the Korean Society of Echocardiography. RESULTS: We gathered total 321 questionnaires from 25 cardiology centers in Korea. All participants were able to perform or interpret echocardiographic examinations. All participating institutions performed strain echocardiography. Most of our study participants (97%) were aware of speckle tracking echocardiography and 185 (58%) performed it for clinical and research purposes. Two-dimensional strain echocardiography was the most commonly used modality and left ventricle (LV) was the most commonly used cardiac chamber (99%) for clinical purposes. Most of the participants (89%) did not think LV strain can replace LV ejection fraction (LVEF) in their clinical practice. The common reasons for not performing routine use of strain echocardiography was diversity of strain measurements and lack of normal reference value. Many participants had a favorable view of the future of strain echocardiography. CONCLUSION: Most of our study participants were aware of strain echocardiography, and all institutions performed strain echocardiography for clinical and research purposes. However, they did not think the LV strain values could replace LVEF. The diversity of strain measurements and lack of normal reference values were common reasons for not using strain echocardiography in clinical practice.
Cardiology
;
Echocardiography*
;
Heart Ventricles
;
Korea*
;
Reference Values
8.The efficacy and safety of pegylated liposomal doxorubicin monotherapy and combination therapy with carboplatin in Korean patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer: a single-institution experience.
Young Jae LEE ; Yong Man KIM ; Shin Wha LEE ; Jeong Yeol PARK ; Dae Yeon KIM ; Dae Shik SUH ; Jong Hyeok KIM ; Young Tak KIM ; Joo Hyun NAM
Obstetrics & Gynecology Science 2017;60(5):433-439
OBJECTIVE: This study aimed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) with or without carboplatin in Korean patients with recurrent ovarian cancer (ROC), fallopian tube, or primary peritoneal cancer. METHODS: This retrospective study included 52 patients with ROC, fallopian tube, or primary peritoneal cancer who received PLD (50 mg/m²) between 1(st) December 2014 and 31(th) July 2016. RESULTS: The mean number of chemotherapy cycles was 3.8 (range, 2 to 9) in the PLD monotherapy group and 7 (range, 2 to 13) in the PLD combined with carboplatin (PLD-C) group. In overall response rates and clinical beneficial rates, PLD monotherapy group shows 5.0% and 17.5%, and PLD-C group shows 33.3% and 75.0%. The mean progression-free survival (PFS) was 5 and 13 months in the PLD monotherapy and PLD-C groups, respectively. At 6 months after treatment initiation, absence of disease progression was confirmed in 6 (15%) and 10 (83.3%) patients in the PLD monotherapy and PLD-C groups. Hematological adverse events (e.g., neutropenia and thrombocytopenia) were more common in the PLD-C group (P<0.001, P=0.004). The incidence of anemia and non-hematological adverse events, including mucositis, hand-foot syndrome, and allergic reactions, was similar in both groups. CONCLUSION: This study demonstrated the efficacy and safety of PLD monotherapy and PLD-C combination in Korean patients with ROC. This study would be helpful to consider the degree of worry about side effects and treatment expectations after treatment. Further retrospective studies with larger samples are required to confirm the efficacy of PLD monotherapy in Asian patients with platinum-resistant ROC.
Anemia
;
Asian Continental Ancestry Group
;
Carboplatin*
;
Disease Progression
;
Disease-Free Survival
;
Doxorubicin*
;
Drug Therapy
;
Fallopian Tubes*
;
Female
;
Hand-Foot Syndrome
;
Humans
;
Hypersensitivity
;
Incidence
;
Mucositis
;
Neutropenia
;
Ovarian Neoplasms
;
Retrospective Studies
9.Erratum: Author correction.
Young Jae LEE ; Yong Man KIM ; Hyun Jin KIM ; Sung Wook CHOI ; Shin Wha LEE ; Jeong Yeol PARK ; Dae Yeon KIM ; Dae Shik SUH ; Jong Hyeok KIM ; Young Tak KIM ; Joo Hyun NAM
Obstetrics & Gynecology Science 2017;60(6):621-621
The Editorial Office of Obstet Gynecol Sci would like to correct the author list.
10.Evaluation of effects of olfactory and auditory stimulation on separation anxiety by salivary cortisol measurement in dogs.
Journal of Veterinary Science 2016;17(2):153-158
Separation anxiety (SA) is a serious behavioral problem in dogs. In this study, salivary cortisol was studied to determine if the owner's odor or voice could reduce SA in dogs. Twenty-eight dogs with SA were divided into three groups: group 1 (control), group 2 (with owner's clothes during the separation period; SP) and group 3 (a recording of the owner's voice was played during SP). The dog's saliva was collected after the owner and their dog were in the experimental room for 5 min (PRE). The dog was then separated from the owner for 20 min and saliva collected four times at intervals of 5 min (SP1-4). Finally, the owner was allowed back into the room to calm the dog for 5 min, after which saliva was collected (POST). Evaluation of salivary cortisol concentrations by ELISA revealed that the ratios of SP1 concentration to PRE or POST concentrations were significantly higher in group 1 than in group 2 or 3. Additionally, the concentrations of SP1-PRE and SP1-POST among groups differed significantly. These findings indicate that the owner's odor or voice may be helpful to managing stress in dogs with SA.
Acoustic Stimulation*
;
Animals
;
Anxiety, Separation*
;
Clothing
;
Dogs*
;
Enzyme-Linked Immunosorbent Assay
;
Hydrocortisone*
;
Odors
;
Physiology
;
Problem Behavior
;
Saliva
;
Voice

Result Analysis
Print
Save
E-mail