Purpose: This 6-year post-marketing surveillance (PMS) study was conducted in South Korea to evaluate the real-world safety and effectiveness of eribulin in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Materials and Methods: During the study period (17 August 2012 to 16 August 2018), case-report files (CRFs) of patients receiving eribulin were collected. The main study endpoint was to assess the safety of eribulin. Evaluation of the effectiveness of eribulin was an exploratory endpoint. Patients were followed for 1 year after eribulin initiation. Results: CRFs were collected from 64 investigators at 64 sites for 1,079 patients. The safety analysis set (SAS) included 1,001 eribulin recipients; effectiveness was assessed in 244 patients. In the SAS, patients were predominantly female (99.6%), with a median age of 53.0 years, and diagnosed with metastatic breast cancer (92.0%). Eribulin was administered as a median 4th line chemotherapy. A total of 2,124 treatment-emergent adverse events (TEAEs) were reported in 661 patients (66.0%). Neutropenia was the most common TEAE (32.5% of patients), occurring at a median of 9-11 days from initial eribulin administration. Overall response and disease control rates were 31.7% and 95.6%, respectively, and the median duration of eribulin use (time to treatment failure) was 3.0 months. Conclusion This large real-world PMS analysis in patients with advanced or metastatic breast cancer demonstrated the effectiveness of eribulin and found no new safety concerns relative to safety information from prior clinical and real-world studies, and approvals in South Korea and other countries.

Purpose: This study aims to develop and implement an economic evaluation using a micro-costing approach to provide a precise and transparent analysis of the direct costs of cystoscopic procedures in Korean hospitals. The study seeks to identify key cost components and evaluate whether current reimbursement rates accurately reflect these direct costs. Materials and Methods: Significant variations in cost items were identified across different studies. An economic evaluation was conducted using a micro-costing methodology for the cost analysis of cystoscopic procedures, developed through literature review, data collection from studies, and expert consultations. Results: Gangnam Severance Hospital (GSH) performed 2,188 cystoscopic procedures, including 1,847 cystoscopies and 341 JJ stent removals, with average costs of $100.8 and $110.6, respectively. At National Health Insurance Service Ilsan Hospital (NHIMC), 1,463 procedures were performed, including 1,167 cystoscopies and 296 JJ stent removals, with average costs of $119.2 and $125.3. Cystoscopy costs at GSH were driven by reprocessing ($45.8, 45.4%) and equipment ($33.1, 32.9%), while NHIMC’s were $52.5 (44.0%) for equipment and $48.7 (40.8%) for reprocessing. Both hospitals incurred financial losses, with NHIS (National Health Insurance Service) covering only about 71.7% and 60.6% of costs for cystoscopy, and 71.0% and 62.7% for JJ stent removal. Conclusions The significant discrepancy between HIRA (Health Insurance Review & Assessment Service)’s estimated costs and those identified here suggests that current fees for cystoscopic procedures may be underestimated and require reassessment.Given the results, reevaluating these rates is essential to ensure fair compensation for healthcare providers and to deliver optimal patient care.

Purpose: Several studies have compared various methods of treatment for displaced femoral neck fractures (FNF), including multiple cannulated screw fixation, in young and active patients. However, there have been few studies on the cephalomedullary nail with additional cannulated screw fixation in displaced FNF. Therefore, the aim of this study is to evaluate the outcomes of the cephalomedullary nail technique with either a cannulated screw or multiple cannulated screw fixation in displaced FNF. Materials and Methods: Among 69 consecutive patients who underwent internal fixation for displaced FNF, 64 were included. Patients were divided into two groups. Patients in Group 1 underwent fixation utilizing a cephalomedullary nail with an additional screw. Group 2 patients underwent fixation utilizing a cephalomedullary nail with additional multiple cannulated screws. Radiologic and clinical outcomes were assessed at the final follow-up clinical appointment. Results: No significant difference was found in basic characteristics such as mean age, male to female ratio, and fracture classification between the study groups. The mean time to ambulation after surgery was significantly shorter in Group 1 (P<0.001).There was no statistically significant difference between the two groups in procedure-specific complication rate. However, the immobilization-related complication rate was significantly higher in Group 2 (P=0.017). Conclusion In terms of enabling early ambulation in young and active patients, the cephalomedullary nailing with additional cannulated screws has the advantage in the management of displaced FNF. Furthermore, early ambulation lowers the rate of immobilization-related complications and shortens hospital stays.

Objective: The Scales for Outcomes in Parkinson’s Disease–Cognition (SCOPA-Cog) was developed to assess cognition in patients with Parkinson’s disease (PD). In this study, we aimed to evaluate the validity and reliability of the Korean version of the SCOPACog (K-SCOPA-Cog). Methods: We enrolled 129 PD patients with movement disorders from 31 clinics in South Korea. The original version of the SCOPA-Cog was translated into Korean using the translation-retranslation method. The test–retest method with an intraclass correlation coefficient (ICC) and Cronbach’s alpha coefficient were used to assess reliability. Spearman’s rank correlation analysis with the Montreal Cognitive Assessment-Korean version (MOCA-K) and the Korean Mini-Mental State Examination (K-MMSE) were used to assess concurrent validity. Results: The Cronbach’s alpha coefficient was 0.797, and the ICC was 0.887. Spearman’s rank correlation analysis revealed a significant correlation with the K-MMSE and MOCA-K scores (r = 0.546 and r = 0.683, respectively). Conclusion Our results demonstrate that the K-SCOPA-Cog has good reliability and validity.

Purpose: This study measured the physeal fracture gap on preoperative ankle computed tomography (CT) to predict the periosteal entrapment that requires an open reduction in distal tibia triplane fractures. Materials and Methods: This study retrospectively reviewed patients who had undergone internal fixation for a triplane fracture from April 2004 to September 2022. The demographic data, including age,body mass index, and past medical history, were analyzed. In the radiographic evaluations, ankle CT and ankle simple radiographs, including anteroposterior (AP), lateral, and mortise views, were taken preoperatively. Postoperatively, simple ankle radiographs were obtained periodically, including AP, mortise, and lateral views. The physeal fracture gap was measured on ankle CT, and the larger gap between the coronal and sagittal view of CT was selected. The residual physeal gap <2 mm was considered an adequate reduction. Results: Of 17 cases, three demonstrated successful reduction using closed reduction techniques. Periosteal entrapment was observed in 14 cases open reduction cases. In all three closed reduction cases, the physeal gap estimated on preoperative ankle CT was under 3 mm with a mean gap of 2.4±0.2 mm (range, 2.1-2.5 mm). In the remaining 14 open reduction cases, the measured physeal gap was over 3 mm, averaging 5.0±2.7 mm (range, 3.1-12.2 mm). There was a significant difference in the preoperative physeal gap between the two groups (p<0.01). Overall, good reduction was achieved in all 17 cases; the postoperative physeal gap was under 2 mm with a mean of 1.0±0.5 mm (closed reduction group, 0.5±0.2 mm; open reduction group, 1.1±0.5 mm). Conclusion Open reduction is strongly recommended for triplane fractures with a physeal fracture gap of 3 mm or more in preoperative ankle CT, suggesting the possibility of an entrapped periosteum in the fracture gap.

Background: Osteochondral autologous transplantation (OAT) has been widely used in the treatment of osteochondral lesion of the talus (OLT). Previous studies have reported successful outcomes following the use of osteochondral autogenous grafts from the intercondylar notch of the knee or a non-weight-bearing region of the femoral condyle. However, donor-site morbidity of the knee joint has been observed in several cases. This study aimed to investigate the outcomes and safety of OAT with autografts from the ipsilateral lateral talar articular facet as an alternative donor site for medial OLT. Methods: Among 40 patients who underwent OAT, 29 patients were excluded. Eleven patients who underwent OAT with an osteochondral graft harvested from the ipsilateral lateral talar articular facet from 2011 to 2022 were retrospectively analyzed. The size of OLT was measured on ankle magnetic resonance imaging, including coronal length, sagittal length, depth, and area. Clinical outcomes were evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale and a visual analog scale (VAS). Weight-bearing ankle radiographs were obtained postoperatively and at 1 year after surgery. Results: The average follow-up time after surgery was 64.7 months (range, 14–137 months). The average diameter of lesions was 8.8 mm (range, 8–9.9 mm). The average size of lesions was 51.2 mm2 (range, 33.6–71.3 mm2 ) , and all lesions included subchondral cysts. The average depth of lesions was 7.3 mm (range, 6.2–9.1 mm). Graft sizes ranged from 8 to 10 mm in diameter (8 mm, n = 1; 10 mm, n = 10) All measured clinical outcomes improved postoperatively, including the AOFAS scores (preoperative, 55.4 ± 9.0;1-year follow-up, 92.1 ± 7.6; p = 0.001) and VAS scores (preoperative, 5.5 ± 0.7; 1-year follow-up, 1.9 ± 0.8; p = 0.001). All weightbearing ankle radiographs of the graft and donor sites did not reveal arthritic change in the ankle joint, lateral talar dome collapse, and graft-site delayed union or nonunion at 1 year after surgery. Conclusions For a single medial OLT, harvesting autografts from the ipsilateral lateral talar articular facet without knee donorsite morbidities can be a good alternative in OAT for OLT.

Humans ; Adolescent ; Pandemics ; Substance-Related Disorders/epidemiology* ; Smoking ; Ethanol ; Republic of Korea/epidemiology* ; Alcohol Drinking/epidemiology*

Background/Aims: The use of a self-expandable metal stent (SEMS) is recommended for unresectable malignant biliary obstruction (MBO). Stent-related adverse events might differ according to the position of the stent through the ampulla of Vater (AOV). We retrospectively evaluated SEMS patency and adverse events according to the position of the SEMS. Methods: In total, 280 patients who underwent endoscopic SEMS placement due to malignant distal biliary obstruction were analyzed retrospectively. Suprapapillary and transpapillary SEMS insertions were performed on 51 patients and 229 patients, respectively. Results: Between the suprapapillary group (SPG) and transpapillary group (TPG), the stent patency period was not significantly different (median [95% confidence interval]: 107 days [82.3 to 131.7] vs 120 days [99.3 to 140.7], p=0.559). There was also no significant difference in the rate of adverse events. In subgroup analysis, the stent patency for an MBO located within 2 cm from the AOV was found to be significantly shorter than that for an MBO located more than 2 cm from the AOV in the SPG (64 days [0 to 160.4] vs 127 days [82.0 to 171.9], p<0.001) and TPG (87 days [52.5 to 121.5] vs 130 [97.0 to 162.9], p<0.001). Patients with an MBO located within 2 cm from the AOV in both groups had a higher percentage of duodenal invasion (SPG: 40.0% vs 4.9%, p=0.002; TPG: 28.6% vs 2.9%, p<0.001) than patients with an MBO located more than 2 cm from the AOV. Conclusions The SPG and TPG showed similar results in terms of stent patency and rate of adverse events. However, patients with an MBO located within 2 cm from the AOV had a higher percentage of duodenal invasion with shorter stent patency than those with an MBO located more than 2 cm from the AOV, regardless of stent position.

Antithrombotic therapy is a cornerstone of acute ischemic stroke (AIS) management and secondary stroke prevention. Since the first version of the Korean Clinical Practice Guideline (CPG) for stroke was issued in 2009, significant progress has been made in antithrombotic therapy for patients with AIS, including dual antiplatelet therapy in acute minor ischemic stroke or high-risk transient ischemic stroke and early oral anticoagulation in AIS with atrial fibrillation. The evidence is widely accepted by stroke experts and has changed clinical practice. Accordingly, the CPG Committee of the Korean Stroke Society (KSS) decided to update the Korean Stroke CPG for antithrombotic therapy for AIS. The writing members of the CPG committee of the KSS reviewed recent evidence, including clinical trials and relevant literature, and revised recommendations. A total of 35 experts were invited from the KSS to reach a consensus on the revised recommendations. The current guideline update aims to assist healthcare providers in making well-informed decisions and improving the quality of acute stroke care. However, the ultimate treatment decision should be made using a holistic approach, considering the specific medical conditions of individual patients.

Background/Aims: Treatment decisions for locally advanced head and neck squamous cell carcinoma (LA-HNSCC) are complicated, and multi-modal treatments are usually indicated. However, it is challenging for older patients to complete treatments. Thus, we investigated disease characteristics, real-world treatment, and outcomes in older LA-HNSCC patients. Methods: Older patients (aged ≥ 70 years) were selected from a large nationwide cohort that included 445 patients with stage III–IVB LA-HNSCC from January 2005 to December 2015. Their data were retrospectively analyzed and compared with those of younger patients. Results: Older patients accounted for 18.7% (83/445) of all patients with median age was 73 years (range, 70 to 89). Proportions of primary tumors in the hypopharynx and larynx were higher in older patients and older patients had a more advanced T stage and worse performance status. Regarding treatment strategies of older patients, 44.5% of patients received concurrent chemoradiotherapy (CCRT), 41.0% underwent surgery, and 14.5% did not complete the planned treatment. Induction chemotherapy (IC) was administered to 27.7% (23/83) of older patients; the preferred regimen for IC was fluorouracil and cisplatin (47.9%). For CCRT, weekly cisplatin was prescribed 3.3 times more often than 3-weekly cisplatin (62.2% vs. 18.9%). Older patients had a 60% higher risk of death than younger patients (hazard ratio, 1.6; p = 0.035). Oral cavity cancer patients had the worst survival probability. Conclusions Older LA-HNSCC patients had aggressive tumor characteristics and received less intensive treatment, resulting in poor survival. Further research focusing on the older population is necessary.