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.

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.

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.

Background: Disruption of the rotator cuff muscles compromises concavity compression force, which leads to superior migration of the humeral head and loss of stability. A novel idea of using the magnetic force to achieve shoulder stabilization in massive rotator cuff tears (MRCTs) was considered because the magnets can stabilize two separate entities with an attraction force. This study aimed to investigate the biomechanical effect of the magnetic force on shoulder stabilization in MRCTs. Methods: Seven fresh frozen cadaveric specimens were used with a customized shoulder testing system. Three testing conditions were set up: condition 1, intact rotator cuff without magnets; condition 2, an MRCT without magnets; condition 3, an MRCT with magnets. For each condition, anterior-posterior translation, superior translation, superior migration, and subacromial contact pressure were measured at 0°, 30°, and 60° of abduction. The abduction capability of condition 2 was compared with that of condition 3. Results: The anterior-posterior and superior translations increased in condition 2; however, they decreased compared to condition 2 when the magnets were applied (condition 3) in multiple test positions and loadings (p <0.05). Abduction capability improved significantly in condition 3 compared with that in condition 2, even for less deltoid loading (p < 0.05). Conclusions The magnet biomechanically played a positive role in stabilizing the shoulder joint and enabled abduction with less deltoid force in MRCTs. However, to ensure that the magnet is clinically applicable as a stabilizer for the shoulder joint, it is necessary to thoroughly verify its safety in the human body and to conduct further research on technical challenges.

Purpose: This study examined the radiological and clinical outcomes of internal fixation using a reconstruction plate and 21G circumferential wire in comminuted midshaft clavicular fractures. Materials and Methods: A retrospective cohort study was performed on 51 patients between 2005 and 2019. Thirty-two patients underwent internal fixation with a reconstruction plate and a 21G circumferential wire with minimal soft tissue detachment, and 19 patients underwent surgery without a wire. The patients were assessed with the radiographic parameters, the University of California at Los Angeles (UCLA) score, and the visual analogue scale (VAS) pain score. Based on this, patients who operated without a circumferential wire were set as the control group, and the differences in bone union between the two groups were compared. Results: Thirty-two patients were followed-up for an average of 65 weeks, and 19 patients in the control group were followed-up for an average of 56 weeks. The radiological evaluation confirmed the anatomical reduction and bone union in all 32 patients. No case of nonunion was present. The UCLA score was 32.38 on average and 33.11 in the control group (p=0.395). The VAS score was 1.00 on average and 0.84 in the control group (p=0.668). A significant difference in the bony union time was observed between the group who underwent internal fixation with a reconstruction plate and a 21G circumferential wire with minimal soft tissue detachment, and the control group (p=0.015). On the other hand, there was no statistical significance when other variables were controlled (p=0.107). Conclusion For displaced midshaft clavicular fractures, internal fixation using a reconstruction plate and 21G circumferential wire maintained accurate anatomical reduction. The satisfactory clinical and radiological results mean that internal fixation using a reconstruction plate and 21G circumferential wire may be a good option for surgical treatment.

This study provides a statistical analysis of 1,226 cases of death occurring in Area 8, Seoul Metropolitan Police Agency (Gangseo, Yangcheon, and Guro Police Stations) from January 1 to December 31, 2017. There were 427 postmortem inspection cases in Gangseo, 393 in Yangcheon, 377 in Guro, and 29 in other areas. The number of autopsy cases was 69 in Gangseo, 70 in Yangcheon, 86 in Guro, and seven in other areas. According to the postmortem inspection reports, there were 593 cases of natural death and 336 cases of unnatural death, while in 297 cases the cause of death was unknown. Of the 297 unknown cases, autopsy rates from each police station were as follows: 54 of 99 cases (54.5%) in Gangseo, 60 of 101 cases (59.4%) in Yangcheon, 67 of 93 cases (72.0%) in Guro, and in all four cases (100%) from other areas. Unnatural deaths included 215 cases of suicide, nine cases of homicide, and 64 accidental death, while 48 cases were undetermined. Among the unnatural deaths, the cause of death included 138 cases of hanging, 72 cases of falls from a height, and 32 cases of poisoning. Since this statistical study is based on actual postmortem inspection data for 1,226 cases of death in the eight areas of Seoul (excluding deaths from traffic accidents), it raises issues relating to the current postmortem inspection system, and can be used as reference material for a comprehensive overview of causes of death.

Mixed-species malaria infections are often unrecognized or underestimated. We hereby report the first described case of mixed infection with Plasmodium falciparum and Plasmodium ovale malaria in a returned traveller in Korea. In August 2016, a 25-year-old returned traveller from Cameroon and Democratic Republic of Congo presented with fever. He was diagnosed as P. falciparum malaria and successfully treated with artesunate. And 5 weeks after the completion of treatment, he presented with fever and diagnosed as P. ovale infection. P. ovale infection is a rare cause of malaria and often shows delayed presentation due to its dormant liver stage as hypnozoites. At re-presentation, the immunochromatographic test and microscopic examinations of our patient did not reveal P. ovale, which was only detected via polymerase chain reaction (PCR) assay. This case highlights the importance of considering malaria infection even in persons who have previously received malaria treatment. It also shows the usefulness of PCR testing for diagnosing P. ovale infections, which often present with a low level of parasitaemia.
Adult ; Cameroon ; Coinfection* ; Congo ; Fever ; Humans ; Korea* ; Liver ; Malaria ; Plasmodium falciparum* ; Plasmodium ovale* ; Plasmodium* ; Polymerase Chain Reaction

This study provides a statistical analysis of 1,226 cases of death occurring in Area 8, Seoul Metropolitan Police Agency (Gangseo, Yangcheon, and Guro Police Stations) from January 1 to December 31, 2017. There were 427 postmortem inspection cases in Gangseo, 393 in Yangcheon, 377 in Guro, and 29 in other areas. The number of autopsy cases was 69 in Gangseo, 70 in Yangcheon, 86 in Guro, and seven in other areas. According to the postmortem inspection reports, there were 593 cases of natural death and 336 cases of unnatural death, while in 297 cases the cause of death was unknown. Of the 297 unknown cases, autopsy rates from each police station were as follows: 54 of 99 cases (54.5%) in Gangseo, 60 of 101 cases (59.4%) in Yangcheon, 67 of 93 cases (72.0%) in Guro, and in all four cases (100%) from other areas. Unnatural deaths included 215 cases of suicide, nine cases of homicide, and 64 accidental death, while 48 cases were undetermined. Among the unnatural deaths, the cause of death included 138 cases of hanging, 72 cases of falls from a height, and 32 cases of poisoning. Since this statistical study is based on actual postmortem inspection data for 1,226 cases of death in the eight areas of Seoul (excluding deaths from traffic accidents), it raises issues relating to the current postmortem inspection system, and can be used as reference material for a comprehensive overview of causes of death.
Accidental Falls ; Autopsy ; Cause of Death ; Homicide ; Humans ; Poisoning ; Police ; Seoul ; Statistics as Topic ; Suicide

This nationwide, prospective cohort study evaluated pulmonary function and radiological sequelae according to infection severity in 73 survivors from the 2015 Middle East respiratory syndrome (MERS) outbreak in Korea. Patients with severe pneumonia in MERS-coronavirus infection had more impaired pulmonary function than those with no or mild pneumonia at the 1-year follow-up, which was compatible with the radiological sequelae. Severe pneumonia significantly impairs pulmonary function and makes long radiological sequelae in MERS.
Cohort Studies ; Coronavirus ; Coronavirus Infections* ; Follow-Up Studies ; Humans ; Korea ; Middle East* ; Pneumonia* ; Prospective Studies ; Survivors

BACKGROUND: Rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP) is one of the effective chemotherapeutic regimens for patients with advanced stage marginal zone lymphoma (MZL). However, prognostic factors that affect the outcome of treatment for MZL are not well understood. METHODS: Between August 2006 and June 2013, patients with newly diagnosed stage III and IV MZL treated with R-CVP as a first-line therapy from 15 institutions were retrospectively analyzed. Patients' clinical and laboratory data at diagnosis were collected by review of medical records. RESULTS: A total of 80 patients were analyzed. Bone marrow involvement was observed in 30% cases. Twelve patients (15%) had nodal MZL, and 41.3% patients exhibited multiple mucosa-associated lymphoma tissue sites. Overall response rate was 91.3%, including 73.8% achieving complete response. Advanced MZL patients treated with R-CVP showed a 3-year progression-free survival (PFS) rate of 69.6%. Prognostic markers significantly affecting PFS in univariate analysis were platelet to lymphocyte ratio (PLR, <95 vs. ≥95, P=0.014), serum albumin (≤3.9 vs. >3.9 g/dL, P=0.008), and the International Prognostic Index (IPI) score (1 vs. 2–4, P=0.032). In multivariate analysis, only PLR (<95 vs. ≥95, HR 0.367, 95% CI, 0.139–0.971, P=0.043) was an independent risk factor for PFS. CONCLUSION: PLR ≥95 at diagnosis is an independent prognostic marker for PFS in advanced stage MZL patients treated with R-CVP. This marker may aid clinicians in predicting the response to R-CVP chemotherapy in stage III and IV MZL patients.
Blood Platelets* ; Bone Marrow ; Cyclophosphamide* ; Diagnosis ; Disease-Free Survival ; Drug Therapy ; Drug Therapy, Combination* ; Humans ; Lymphocytes* ; Lymphoma* ; Medical Records ; Multivariate Analysis ; Prednisone* ; Prognosis ; Retrospective Studies ; Risk Factors ; Rituximab* ; Serum Albumin ; Vincristine*