Objective: This study aimed to develop a reliable and valid Mixed State Severity Index (MSSI) to assess mood instability in patients with mood disorders and determine cutoff scores. Methods: Twenty-one items were selected based on Koukopoulos’ criteria for mixed depressive episode, historically referred to as agitated depression, and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision mixed features criteria. The MSSI was administered to 242 patients (major depressive disorder [n=92], bipolar disorder [BD] I [n=78], and BD II [n=72]) and 726 controls. Results: The MSSI demonstrated high internal consistency (α=0.78–0.90). Exploratory factor analysis revealed a stable four-factor structure. Based on receiver operating characteristic analysis, optimal cutoff scores were identified to distinguish mood disorder groups from controls, ranging from 19.5 to 27.5 depending on diagnosis. Conclusion The MSSI is a reliable and valid instrument for assessing the severity of mixed features in patients with mood disorders. The established cutoff scores enhance its clinical utility, providing robust diagnosis and treatment planning support.

Purpose: Axillary surgery is increasingly omitted in patients with early-stage breast cancer undergoing upfront surgery, as supported by trials such as SOUND and INSEMA. However, in the neoadjuvant setting, the omission of axillary surgery has only been explored in small single-arm studies involving highly selected patients with confirmed breast pathologic complete response (pCR). The NeoNAUTILUS trial aimed to evaluate the oncologic safety of omitting sentinel lymph node biopsy (SLNB) in patients with a high probability of achieving an axillary pCR (ypN0) following neoadjuvant systemic therapy (NST), regardless of breast pCR status. Methods NeoNAUTILUS is a prospective, multicenter, randomized, controlled, noninferiority trial conducted at 12 tertiary centers in Korea. Eligible participants were women with clinical T1–T3, N0, or selected N1 invasive breast cancer, who completed NST and were candidates for breast-conserving surgery (BCS). Prior to enrollment, all patients underwent axillary ultrasound after NST completion to exclude suspicious lymph nodes. Patients with clinical N0 disease of any subtype were eligible for inclusion. Patients with clinical N1 disease with human epidermal growth factor receptor 2-positive or triple-negative tumors may be included if their primary tumor demonstrates a > 30% reduction on magnetic resonance imaging after NST. Participants were randomized 1:1 to undergo BCS with or without SLNB, stratified by clinical nodal status and tumor subtype. Patients were randomized and remained blinded until surgery. The primary endpoint is the 5-year invasive disease-free survival. A total of 464 patients are expected to be enrolled over 3 years, with a 5-year follow-up period.Discussion: NeoNAUTILUS is the first randomized trial to assess the omission of axillary surgery after NST based on the predicted nodal response, independent of breast pCR. This study may redefine axillary management in the neoadjuvant setting by identifying patients who can safely avoid SLNB, thereby reducing surgical morbidity without compromising oncologic outcomes.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Purpose: In total mastectomy (TM), sentinel lymph node biopsy (SLNB) is recommended but can be omitted for breast-conserving surgery (BCS) in patients with ductal carcinoma in situ (DCIS). However, concerns regarding SLNB-related complications and their impact on quality of life exist. Consequently, further research is required to evaluate the role of axillary surgeries, including SLNB, in the treatment of TM. We aimed to explore the clinicopathological factors and outcomes associated with axillary surgery in patients with a final diagnosis of pure DCIS who underwent BCS or TM. Methods: We retrospectively analyzed large-scale data from the Korean Breast Cancer Society registration database, highlighting on patients diagnosed with pure DCIS who underwent surgery and were categorized into two groups: BCS and TM. Patients were further categorized into surgery and non-surgery groups according to their axillary surgery status. The analysis compared clinicopathological factors and outcomes according to axillary surgery status between the BCS and TM groups. Results: Among 18,196 patients who underwent surgery for DCIS between 1981 and 2022, 11,872 underwent BCS and 6,324 underwent TM. Both groups leaned towards axillary surgery more frequently for large tumors. In the BCS group, clinical lymph node status was associated with axillary surgery (odds ratio, 11.101; p = 0.003). However, in the TM group, no significant differences in these factors were observed. Survival rates did not vary between groups according to axillary surgery performance. Conclusion The decision to perform axillary surgery in patients with a final diagnosis of pure DCIS does not affect the prognosis, regardless of the breast surgical method.Furthermore, regardless of the breast surgical method, axillary surgery, including SLNB, should be considered for high-risk patients, such as those with large tumors. This may reduce unnecessary axillary surgery and enhance the patients’ quality of life.

Rehabilitation medicine in Korea has improved significantly; however, the rehabilitation medical delivery system still lacks well-established continuity and comprehensiveness. Since 2000, Japan has implemented a convalescent rehabilitation ward system, with continuous improvements in policies and criteria based on clinical needs. This study compared the rehabilitation systems of Korea and Japan, focusing on institutional standards and the scope of target patients in order to explore directions for enhancing the Korean system.Current Concepts: Japan applies a multi-tiered reporting system for rehabilitation wards, categorizing wards and adjusting reimbursements based on performance indicators such as functional improvement rates, discharge-tohome rates, and rehabilitation effectiveness indices. Additionally, Japan’s policies encompass a broad range of target diseases and flexible admission criteria, improving accessibility. In Korea, the scope of target diseases is relatively narrow, limiting opportunities for patients to receive appropriate rehabilitation treatment.Discussion and Conclusion: Korea could benefit from adopting a multitiered system and performance-based reimbursement structure, as seen in Japan’s model. Expanding the range of eligible conditions and reviewing certification requirements can enhance the accessibility and quality of rehabilitation services. These changes are expected to foster an environment in which patients can receive timely and comprehensive rehabilitation care, thereby facilitating physical recovery and reintegration into society.

Rehabilitation medicine in Korea has improved significantly; however, the rehabilitation medical delivery system still lacks well-established continuity and comprehensiveness. Since 2000, Japan has implemented a convalescent rehabilitation ward system, with continuous improvements in policies and criteria based on clinical needs. This study compared the rehabilitation systems of Korea and Japan, focusing on institutional standards and the scope of target patients in order to explore directions for enhancing the Korean system.Current Concepts: Japan applies a multi-tiered reporting system for rehabilitation wards, categorizing wards and adjusting reimbursements based on performance indicators such as functional improvement rates, discharge-tohome rates, and rehabilitation effectiveness indices. Additionally, Japan’s policies encompass a broad range of target diseases and flexible admission criteria, improving accessibility. In Korea, the scope of target diseases is relatively narrow, limiting opportunities for patients to receive appropriate rehabilitation treatment.Discussion and Conclusion: Korea could benefit from adopting a multitiered system and performance-based reimbursement structure, as seen in Japan’s model. Expanding the range of eligible conditions and reviewing certification requirements can enhance the accessibility and quality of rehabilitation services. These changes are expected to foster an environment in which patients can receive timely and comprehensive rehabilitation care, thereby facilitating physical recovery and reintegration into society.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Rehabilitation medicine in Korea has improved significantly; however, the rehabilitation medical delivery system still lacks well-established continuity and comprehensiveness. Since 2000, Japan has implemented a convalescent rehabilitation ward system, with continuous improvements in policies and criteria based on clinical needs. This study compared the rehabilitation systems of Korea and Japan, focusing on institutional standards and the scope of target patients in order to explore directions for enhancing the Korean system.Current Concepts: Japan applies a multi-tiered reporting system for rehabilitation wards, categorizing wards and adjusting reimbursements based on performance indicators such as functional improvement rates, discharge-tohome rates, and rehabilitation effectiveness indices. Additionally, Japan’s policies encompass a broad range of target diseases and flexible admission criteria, improving accessibility. In Korea, the scope of target diseases is relatively narrow, limiting opportunities for patients to receive appropriate rehabilitation treatment.Discussion and Conclusion: Korea could benefit from adopting a multitiered system and performance-based reimbursement structure, as seen in Japan’s model. Expanding the range of eligible conditions and reviewing certification requirements can enhance the accessibility and quality of rehabilitation services. These changes are expected to foster an environment in which patients can receive timely and comprehensive rehabilitation care, thereby facilitating physical recovery and reintegration into society.