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Study Design:This was a retrospective observational study.Objectives:The objectives were to describe the prognosis of upper extremity function following cervical spinal cord injury (CSCI), and to identify prognostic factors for functional recovery.Setting:Spinal Injuries Center, Japan.Methods:Sixty patients with C3-4 CSCI without major bone injury participated in the study. Patients were treated nonsurgically and evaluated using the American Spinal Injury Association (ASIA) scales for the upper and lower extremities, their residual cervical motor functions, the modified Frankel grade and an upper extremity function scale. We compared the findings for the upper extremity function scale at 6 months with those for the residual cervical motor functions and modified Frankel grade obtained 3 days after injury.Results:Most patients with CSCI who could flex their hip and knee from a supine position (95%) or who showed some active elbow extension (86%) 3 days after their injury could use a spoon at 6 months. We compared patients who used their fingers at 6 months to those who could not, and observed significant differences in age and ASIA scores for the upper and lower extremities obtained 3 days after injury. A strong correlation was observed between the initial motor scores and the extent of functional recovery at 6 months.Conclusion:Hip and knee flexion from the supine position and elbow extension 3 days after injury significantly predicted a positive prognosis for upper extremity function. Younger age and higher ASIA motor scores obtained 3 days after injury were factors associated with neurological recovery. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of fremanezumab for migraine prevention., Design: Retrospective, single-center, real-world study., Setting: Regional tertiary headache center in Japan., Subjects: Adult individuals with migraine (n = 165, male = 17, female = 148; average age = 45.5 ± 16.0 years) who received fremanezumab between September 2021 and August 2022., Methods: Fremanezumab was administered subcutaneously at a monthly dose of 225 mg or quarterly dose of 675 mg based on patient preferences. Patients received fremanezumab treatment for up to 1 year unless it was discontinued. Monthly data were collected on migraine days, headache days, and days requiring acute medication., Results: Of the 165 patients, 125 (75.7%) received fremanezumab as their first anti-calcitonin gene-related peptide-related antibody drug. Significant reductions in monthly migraine days, headache days, and days requiring acute medication were observed in those with episodic and chronic migraines. The baseline monthly headache days was 8.1 ± 4.0 in the episodic migraine group, which reduced to 6.1 ± 4.8, 5.8 ± 4.4, 4.7 ± 3.6, and 4.6 ± 3.3 days at 1, 3, 6, and 12 months, respectively; in the chronic migraine group, the baseline monthly headache days was 20.9 ± 6.1, which reduced to 17.0 ± 8.9, 15.0 ± 9.2, 13.0 ± 7.7, and 12.0 ± 9.1 days at 1, 3, 6, and 12 months, respectively. Treatment benefits were enhanced after 6 months of administering fremanezumab in the chronic migraine group., Conclusions: In this real-world study of patients with migraine, fremanezumab appears to be effective and safe. Further studies are required to identify additional predictors of treatment success and failure with fremanezumab., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The natural history of branch-duct intraductal papillary mucinous cystic neoplasms (BD-IPMNs) in the pancreas remains unclear. This study aimed to answer this clinical question by focusing on the development of concomitant pancreatic ductal adenocarcinomas (cPDAC)., Methods: The Japan Pancreas Society conducted a prospective multicenter surveillance study of BD-IPMN every six months for five years. The primary endpoints were progression of BD-IPMN, progression to high-grade dysplasia/invasive carcinoma (HGD/IC), and cPDAC. Factors predicting the progression of BD-IPMN to HGD/IC and development of cPDAC were also assessed as secondary endpoints., Results: Among the 2104 non-operated patients, 348 (16.5 %) showed progression of primary BD-IPMN. Cumulative incidences of BD-IPMN with HGD/IC and cPDAC during the 5.17-year surveillance period were 1.90 % and 2.11 %, respectively, and standard incidence ratios of BD-IPMN with HGD/IC and cPDAC were 5.28 and 5.73, respectively. Of 38 cPDACs diagnosed during surveillance, 25 (65.8 %) were resectable. The significant predictive characteristics of BD-IPMN for progression to HGD/IC were larger cyst size (p = 0.03), larger main pancreatic duct size (p < 0.01), and mural nodules (p = 0.02). Significant predictive characteristics for the development of cPDAC were male sex (p = 0.03) and older age (p = 0.02), while the size of IPMN was not significant., Conclusion: Careful attention should be given to "dual carcinogenesis" during BD-IPMN surveillance, indicating the progression of BD-IPMN to HGD/IC and development of cPDAC distinct from BD-IPMN, although the establishment of risk factors that predict cPDAC development remains a challenge (UMIN000007349)., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The consensus-based TOKYO criteria were proposed as a standardized reporting system for endoscopic transpapillary biliary drainage. The primary objective was to address issues arising from the inconsistent reporting of stent outcomes across studies, which has complicated the comparability and interpretation of study results. However, the original TOKYO criteria were not readily applicable to recent modalities of endoscopic biliary drainage such as biliary drainage based on endoscopic ultrasound or device-assisted endoscopy. There are increasing opportunities for managing hilar biliary obstruction and benign biliary strictures through endoscopic drainage. Biliary ablation has been introduced to manage benign and malignant biliary strictures. In addition, the prolonged survival times of cancer patients have increased the importance of evaluating overall outcomes during the period requiring endoscopic biliary drainage rather than solely focusing on the patency of the initial stent. Recognizing these unmet needs, a committee has been established within the Japan Gastroenterological Endoscopy Society to revise the TOKYO criteria for current clinical practice. The revised criteria propose not only common reporting items for endoscopic biliary drainage overall, but also items specific to various conditions and interventions. The term "stent-demanding time" has been defined to encompass the entire duration of endoscopic biliary drainage, during which the overall stent-related outcomes are evaluated. The revised TOKYO criteria 2024 are expected to facilitate the design and reporting of clinical studies, providing a goal-oriented approach to the evaluation of endoscopic biliary drainage., (© 2024 The Author(s). Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Objective: To evaluate the efficacy and safety of 24-week cyclic administration of estetrol (E4) (15 mg)/drospirenone (DRSP) (3 mg) in Japanese patients with endometriosis., Design: A 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study., Setting: Twenty-five study centers in Japan., Patient(s): A total of 162 Japanese women diagnosed with endometriosis., Intervention(s): Participants were randomly allocated to the E4/DRSP group or the placebo group. In the E4/DRSP group, participants were orally administered one tablet containing E4 (15 mg) and DRSP (3 mg) daily for 24 days, followed by one placebo tablet for 4 days for a hormone-free interval, constituting a 1-cycle regimen. One placebo tablet was administered once daily for 28 days to participants in the placebo group. The treatments were continued for six cycles (24 weeks) throughout the confirmatory period., Main Outcome Measure(s): Changes in visual analogue scale (VAS) scores for the most severe pelvic pain (lower abdominal and back pain) from baseline to six treatment cycles at the end of the confirmatory study period., Result(s): Estetrol/drospirenone showed changes in the mean VAS scores for the most severe pelvic pain (-33.2 mm) from baseline to the end of the 6-cycle treatment. The between-group difference was significant (-8.5 mm; 2-sided 95% confidence interval, -16.1 to -0.9 mm), showing superiority to placebo. The responder rates, ≥30% and ≥50% reductions in the VAS scores from baseline, were higher in the E4/DRSP group than in the placebo group: 53.2% vs. 29.6% and 36.4% vs. 12.3%. Objective gynecological findings (induration of the cul-de-sac, pelvic tenderness, and limited uterine mobility) were significantly improved by E4/DRSP treatment, and the proportions of stable and worsened participants were significantly lower than in the placebo group. Estetrol/drospirenone decreased the size of endometriomas and improved quality of life, on the basis of quality of life-related questionnaires and global impression scores. No safety concerns were observed with E4/DRSP treatment. Few differences were observed in the proportion of participants with hemostasis parameters outside the reference range between the E4/DRSP and placebo groups., Conclusion(s): Estetrol/drospirenone effectively treats endometriosis-associated pain and improves gynecological findings. Estetrol/drospirenone may be a safe, new option for endometriosis treatment with a potentially decreased risk of thromboembolic events., Clinical Trial Registration Number: jRCT2011210027., Competing Interests: Declaration of Interests T.H. reports a medical writing and clinical trial advisory fee payment on the basis of the medical expert contract from Fuji Pharma Co., Ltd., and case study meeting fee payment on the basis of the medical expert contracts and medical writing fees for other clinical trials other than this manuscript in accordance with the medical expert contract from Fuji Pharma Co., Ltd. T.K. reports a medical writing and clinical trial advisory fee payment on the basis of the medical expert contract from Fuji Pharma Co., Ltd. A.H. reports a medical writing and clinical trial advisory fee payment on the basis of clinical biostatistics expert contract from Fuji Pharma Co., Ltd., and clinical biostatistics educational seminar fee payment on the basis of clinical biostatistics expert contract from Fuji Pharma Co., Ltd. T.T. reports salary and article processing charges from Fuji Pharma Co., Ltd. M.N. reports salary and article processing charges from Fuji Pharma Co., Ltd.; and patent filed with regard to the improvement of cul-de-sac induration, pelvic tenderness, and uterine mobility in subjects with endometriosis complicated by adenomyosis (Fuji Pharma Co., Ltd., and Mithra Pharmaceuticals). T.M. reports salary and article processing charges from Fuji Pharma Co., Ltd. M.H. reports salary and article processing charges from Fuji Pharma Co., Ltd.; and patent filed with regard to the improvement of cul-de-sac induration, pelvic tenderness, and uterine mobility in subjects with endometriosis complicated by adenomyosis (Fuji Pharma Co., Ltd., and Mithra Pharmaceuticals). J.-M.F. is a member of the Board at Mithra Pharmaceuticals and received financial support for the supervision of this study and consulting fees. Y.O. reports a medical writing and clinical trial advisory fee payment on the basis of the medical expert contract from Fuji Pharma Co., Ltd., and case study meeting fee payment on the basis of the medical expert contracts from Fuji Pharma Co., Ltd., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Amyotrophic lateral sclerosis (ALS) is a progressive, severe neurodegenerative disease caused by motor neuron death. Development of a medicine for ALS is urgently needed, and induced pluripotent cell-based drug repurposing identified a Src/c-Abl inhibitor, bosutinib, as a candidate for molecular targeted therapy of ALS. A phase 1 study confirmed the safety and tolerability of bosutinib in a 12-week treatment of ALS patients. The objectives of this study are to evaluate the efficacy and longer-term safety of bosutinib in ALS patients., Methods and Analysis: An open-label, multicentre phase 2 study was designed. The study consisted of a 12-week observation period, a 1-week transitional period, a 24-week study treatment period and a 4-week follow-up period. Following the transitional period, patients whose total Revised ALS Functional Rating Scale (ALSFRS-R) score declined by 1 to 4 points during the 12-week observation period were to receive bosutinib for 24 weeks. In this study, 25 ALS patients will be enrolled; patients will be randomly assigned to the following groups: 12 patients in the 200 mg quaque die (QD) group and 13 patients in the 300 mg QD group of bosutinib. The safety and exploratory efficacy of bosutinib in ALS patients for 24 weeks will be assessed. Efficacy using the ALSFRS-R score will be compared with the external published data from an edaravone study (MCI186-19) and registry data from a multicentre ALS cohort study, the Japanese Consortium for Amyotrophic Lateral Sclerosis Research., Ethics and Dissemination: This study was approved by the ethics committees of Kyoto University, Tokushima University, Kitasato University, Tottori University, Nara Medical University School of Medicine, Toho University and Hiroshima University. The findings will be disseminated in peer-reviewed journals and at scientific conferences., Trial Registration Number: jRCT2051220002; Pre-results, NCT04744532; Pre-results., Competing Interests: Competing interests: Kyoto University is the study sponsor. The study drug bosutinib and the pharmacokinetic analysis for only patient-experienced serious adverse events are supported by Pfizer JAPAN INC. under the Clinical Research Collaboration Agreement between Kyoto University and Pfizer JAPAN INC. RTak and NT received research funding and honoraria for lectures from Pfizer., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Postoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP., Methods: This multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C)., Discussion: The WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety., Trial Registration: This trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120)., (© 2024. The Author(s).)

Objectives: The aim is to access the real-world clinical management of physicians who treat Takayasu arteritis (TAK) and giant cell arteritis (GCA) after the publication of the Japanese Circulation Society (JCS) 2017 Guidelines for the Management of Vasculitis Syndrome., Methods: This descriptive, cross-sectional study utilized self-administered electronic questionnaires, which were answered in February 2022 by physicians treating TAK or GCA and registered with Macromill Inc., Results: The 329 survey respondents were enrolled. The 2017 JCS Guidelines were the most commonly referenced information source for resolving clinical questions, accessed by 70% of respondents. Ophthalmoscopy was performed in only 50% of patients with TAK and in 70% for GCA. The median percentages of patients who underwent 18F-fluorodeoxyglucose-positron emission tomography/computed tomography for TAK and GCA patients were 23% and 20% at diagnosis, respectively, and 10% each at follow-up within 12 months. Tocilizumab was the most frequently used medication in combination with glucocorticoids for both TAK and GCA, especially in remission induction therapy for relapsed patients., Conclusions: The majority of physicians treating TAK and GCA referred to the 2017 JCS guidelines. This report clarified the current clinical practice for large vessel vasculitis in Japan, providing information for the next revision of the guidelines., (© Japan College of Rheumatology 2024. Published by Oxford University Press. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site–for further information please contact journals.permissions@oup.com.)

Aims: This study aimed to describe baseline characteristics and adherence among patients with transthyretin amyloid cardiomyopathy (ATTR-CM) treated with tafamidis (VYNDAQEL®) in Japan using the Japanese Medical Data Vision (MDV) database., Methods and Results: This study was a non-interventional, retrospective cohort study of adult (≥18 years old) patients in the Japanese MDV claims database diagnosed with ATTR-CM and with at least two tafamidis prescriptions of dose strength 4 × 20 mg/day between 1 March 2019 and 31 August 2021. The date of the first prescription was defined as the index date, with follow-up time defined as the time between the first and last prescription plus the days' supply from the last refill. Baseline characteristics were assessed during a 12 month pre-index period. Adherence was measured using two metrics: (i) the modified medication possession ratio (mMPR), calculated by taking the sum of days supplied for all fills within the follow-up period, divided by the number of days of follow-up, and reported as a percentage, with patients classified as adherent with an mMPR of ≥80%, and (ii) the proportion of days covered (PDC), calculated by taking the total number of days' supply dispensed during the follow-up period divided by the number of days of follow-up, adjusting for any days' supply overlap. A total of 210 patients were identified; the mean (standard deviation) age of the cohort was 77 (5.9) years, and the majority (89%) were male. The most common baseline cardiovascular comorbidities were heart failure (85%), ischaemic heart disease (66%), hypertensive diseases (49%), and diabetes (35%); 75% of patients received heart failure medications in the 12 months prior to index, with the most common being beta-blockers (49%), diuretics (48%), angiotensin receptor blockers (30%), angiotensin-converting enzyme inhibitors (22%), and sodium-glucose cotransporter-2 inhibitors (8.1%). Over an average 14 month follow-up, mean mMPR was 96% with a median of 100% [inter-quartile range (IQR): 97-101%]; 93% of patients were adherent (defined as an mMPR ≥ 80%). In the same follow-up period, mean PDC was 93.6% with a median of 99% (IQR: 93-100%). Persistence was high with 78% of patients having a 0 day gap between prescription refills., Conclusions: This study found high adherence rates to tafamidis in this real-world Japanese patient population. Adherence rates in this study were similar to those reported by the tafamidis clinical trial and a previously published US commercial claims adherence analysis. Further studies should be conducted to assess the impact of real-world adherence on real-world outcomes., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: This study was conducted to verify the effectiveness of Anterior Support Screw (AS2) for unstable femoral trochanteric fractures., Design: A multicenter, prospective, randomized controlled trial SETTING: This study was conducted across 15 academic medical centers in Japan PATIENTS/PARTICIPANTS: We enrolled 240 cases of femoral trochanteric fractures with posterior crushing and intramedullary displacement of proximal bone fragments across 15 institutions in Japan., Intervention: All patients were subjected to a reduction in which the anterior cortex was brought into contact. The patients were randomly assigned to the anterior support screw group (AS2 group) and the non-screw group (control group)., Main Outcome Measurements: Two computed-tomography (CT) scans were taken immediately after surgery and early postoperative period (day 14-21) to investigate the reduction loss rate of the anterior cortex and sliding distances in the early postoperative period., Results: The reduction loss rate was 4.5 % in the AS2 group and 16.8 % in the control group, indicating a significantly lower reduction loss rate in the AS2 group (p = 0.003). The average sliding distance was 1.8 mm in the AS2 group and 2.8 mm in the control group, indicating a significantly shorter sliding distance in the AS2 group (p < 0.0001)., Conclusion: Adding a screw in front of the intramedullary nail significantly reduces reduction loss, and maintains anterior bony contact. This study also showed that these screws suppress the sliding distance during the postoperative period., Level of Evidence: Therapeutic Level I., Competing Interests: Declaration of competing interest In this study, Zimmer Biomet and its affiliates were involved in preparing research implementation plans, research management, and statistical analysis. Each research institution receives research funds from Zimmer Biomet in return for the data provided., (Copyright © 2024. Published by Elsevier Ltd.)

Aims: In recent years, there has been remarkable development in machine learning (ML) models, showing a trend towards high prediction performance. ML models with high prediction performance often become structurally complex and are frequently perceived as black boxes, hindering intuitive interpretation of the prediction results. We aimed to develop ML models with high prediction performance, interpretability, and superior risk stratification to predict in-hospital mortality and worsening heart failure (WHF) in patients with acute heart failure (AHF)., Methods and Results: Based on the Kyoto Congestive Heart Failure registry, which enrolled 4056 patients with AHF, we developed prediction models for in-hospital mortality and WHF using information obtained on the first day of admission (demographics, physical examination, blood test results, etc.). After excluding 16 patients who died on the first or second day of admission, the original dataset (n = 4040) was split 4:1 into training (n = 3232) and test datasets (n = 808). Based on the training dataset, we developed three types of prediction models: (i) the classification and regression trees (CART) model; (ii) the random forest (RF) model; and (iii) the extreme gradient boosting (XGBoost) model. The performance of each model was evaluated using the test dataset, based on metrics including sensitivity, specificity, area under the receiver operating characteristic curve (AUC), Brier score, and calibration slope. For the complex structure of the XGBoost model, we performed SHapley Additive exPlanations (SHAP) analysis, classifying patients into interpretable clusters. In the original dataset, the proportion of females was 44.8% (1809/4040), and the average age was 77.9 ± 12.0. The in-hospital mortality rate was 6.3% (255/4040) and the WHF rate was 22.3% (900/4040) in the total study population. In the in-hospital mortality prediction, the AUC for the XGBoost model was 0.816 [95% confidence interval (CI): 0.815-0.818], surpassing the AUC values for the CART model (0.683, 95% CI: 0.680-0.685) and the RF model (0.755, 95% CI: 0.753-0.757). Similarly, in the WHF prediction, the AUC for the XGBoost model was 0.766 (95% CI: 0.765-0.768), outperforming the AUC values for the CART model (0.688, 95% CI: 0.686-0.689) and the RF model (0.713, 95% CI: 0.711-0.714). In the XGBoost model, interpretable clusters were formed, and the rates of in-hospital mortality and WHF were similar among each cluster in both the training and test datasets., Conclusions: The XGBoost models with SHAP analysis provide high prediction performance, interpretability, and reproducible risk stratification for in-hospital mortality and WHF for patients with AHF., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: The fecal immunochemical test (FIT) is used for colorectal cancer (CRC) screening. Patients on antithrombotic drugs (ATs) are often screened for CRC, but the effect of ATs on FIT results is controversial., Methods: We divided individuals with FIT-positive results into two groups, patients treated with and without ATs, and retrospectively compared invasive CRC rates, advanced neoplasia detection rates (ANDRs), adenoma detection rates (ADRs), and polyp detection rates (PDRs) between the two groups. We evaluated the factors influencing the FIT positive predictive value (PPV) using propensity matching, adjusting for age, sex, and bowel preparation., Results: We enrolled 2327 individuals (54.9% male; mean age, 66.7  ±  12.7 years). We grouped 463 individuals into the AT user group and 1864 into the nonuser group. Patients in the AT user group were significantly older and more likely to be male. After propensity score matching for age, sex, and Boston bowel preparation scale, the ADR and PDR in the AT user group were significantly lower than those in the nonuser group. Univariate logistic analysis revealed that multiple AT use (odds ratio [OR]: .39, p < 0.001) had the lowest OR for FIT PPV, followed by age- and sex-adjusted factors for the ADR and any AT use (OR: .67, p = 0.0007). No significant factors related to AT use were observed among age-adjusted predictive factors for invasive CRC, but warfarin use was a borderline significant positive predictive factor (OR: 2.23, p = 0.059)., Conclusion: AT use may not affect the PPV for detecting invasive CRC in patients with positive FIT results, but warfarin may have an impact., (© 2023 John Wiley & Sons Australia, Ltd.)

Purpose: This study investigated the impact of sidedness of colorectal cancer (CRC) in elderly patients on the prognosis., Methods: In a sub-analysis of a multicenter case-control study of CRC patients who underwent surgery at ≥ 80 years old conducted in Japan between 2003 and 2007, both short- and long-term outcomes were compared between right-sided colon cancers (RCCs) and left-sided colorectal cancers (LCCs). RCCs were defined as those located from the cecum to the transverse colon., Results: Among the 1680 patients who underwent curative surgery, 812 and 868 had RCCs and LCCs, respectively. RCCs were more frequent than LCCs in those who were female, had renal comorbidities, and had a history of abdominal surgery. Regarding tumor characteristics, RCCs were larger, invaded more deeply, and were diagnosed as either mucinous or signet ring-cell carcinoma more frequently than LCCs. Regarding the prognosis, patients with RCCs had a significantly longer cancer-specific survival (CS-S) and cancer-specific relapse-free survival (CS-RFS) than those with LCCs. Furthermore, sidedness was determined to be an independent prognostic factor for CS-S and CS-RFS., Conclusion: RCCs, which accounted for half of the cases in patients ≥ 80 years old, showed better long-term outcomes than LCCs., (© 2024. The Author(s).)

Background: In 2018, diagnostic criteria were introduced for IgG4-related periaortitis/periarteritis and retroperitoneal fibrosis (PA/RPF). This study assessed the existing criteria and formulated an improved version., Methods and Results: Between August 2022 and January 2023, we retrospectively analyzed 110 Japanese patients diagnosed with IgG4-related disease (IgG4-RD) involving cardiovascular and/or retroperitoneal manifestations, along with 73 non-IgG4-RD patients ("mimickers") identified by experts. Patients were stratified into derivation (n=88) and validation (n=95) groups. Classification as IgG4-RD or non-IgG4-RD was based on the 2018 diagnostic criteria and various revised versions. Sensitivity and specificity were calculated using experts' diagnosis as the gold standard for the diagnosis of true IgG4-RD and mimickers. In the derivation group, the 2018 criteria showed 58.5% sensitivity and 100% specificity. The revised version, incorporating "radiologic findings of pericarditis", "eosinophilic infiltration or lymphoid follicles", and "probable diagnosis of extra-PA/-RPF lesions", improved sensitivity to 69.8% while maintaining 100% specificity. In the validation group, the original and revised criteria had sensitivities of 68.4% and 77.2%, respectively, and specificities of 97.4% and 94.7%, respectively., Conclusions: Proposed 2023 revised IgG4-related cardiovascular/retroperitoneal disease criteria show significantly enhanced sensitivity while preserving high specificity, achieved through the inclusion of new items in radiologic, pathological, and extra-cardiovascular/retroperitoneal organ categories.

Background: Despite the widespread use of PROPATEN ® , a bioactive heparin-bonded expanded polytetrafluoroethylene graft, in bypass surgery, there are only a few reports of long-term results. We evaluated the long-term results of PROPATEN ® use for above-knee femoropopliteal bypass (AKFPB)., Methods and Results: After PROPATEN ® -based AKFPB, patients were prospectively registered at 20 Japanese institutions between July 2014 and October 2017 to evaluate long-term results. During the median follow-up of 76 months (interquartile range 36-88 months) for 120 limbs (in 113 patients; mean [±SD] age 72.7±8.1 years; 66.7% male; ankle-brachial index [ABI] 0.45±0.27; lesion length 26.2±5.7 cm; chronic limb-threatening ischemia in 45 limbs), there were 8 major amputations; however, clinical improvement was sustained (mean [±SD] ABI 0.87±0.23) and the Rutherford classification grade improved in 105 (87.5%) limbs at the latest follow-up. At 8 years, the primary patency, freedom from target-lesion revascularization, secondary patency, survival, and amputation-free survival, as estimated by the Kaplan-Meier method, were 66.3±4.8%, 71.5±4.4%, 86.5±3.4%, 53.1±5.0%, and 47.4±5.3%, respectively., Conclusions: This multicenter prospective registry-based analysis showed sustained excellent clinical improvement and secondary patency for up to 8 years following PROPATEN ® -based AKFPB. PROPATEN ® constitutes a durable and good revascularization option for complex superficial femoral artery lesions, especially when endovascular treatment is inappropriate or an adequate venous conduit is unavailable.

Galcanezumab, a monoclonal antibody targeting the calcitonin gene-related peptide pathway (CGRP mAb), acts peripherally due to its large size. However, recent studies have suggested that CGRP mAbs may also have a central mode of action. This study aimed to evaluate the central effects of galcanezumab on migraine central sensitization.This prospective real-world study was conducted at three headache centers in Japan between May 2021 and May 2022. Patients treated with galcanezumab for migraines were included in the study. The primary outcome was the change in the validated Central Sensitization Inventory (CSI) score from baseline to six months of treatment. We also assessed changes in the Allodynia Symptom Checklist (ASC-12) score. Eighty-six patients with migraine (73 female and 13 male) were analyzed. At 6 months, CSI and ASC-12 scores were significantly reduced compared to baseline (CSI: 36.0 vs. 29.3, p < 0.001; and ASC-12: 5.55 vs. 4.26, p < 0.01). Furthermore, these effects were observed as early as three months of treatment. In this study, we demonstrated the real-world efficacy of galcanezumab in improving central sensitization in migraine, with significant effects seen in the early phase of treatment. Trial registration: This study was registered with UMIN-CTR on May 2, 2021 (UMIN000044096)., (© 2024. The Author(s).)

Background: Undetectable circulating tumor DNA (ctDNA) is an obstacle to performing comprehensive genomic profiling in daily practice to identify genomic alterations. We investigated the associations between clinicopathological factors and undetectable ctDNA using a commercially available comprehensive genomic profiling assay in metastatic prostate cancer., Patients and Methods: Patients treated with systemic treatment for metastatic prostate cancer were included. ctDNA was analyzed by FoundationOne ® Liquid CDx at enrollment. The associations between clinicopathological characteristics and ctDNA detection were analyzed., Results: The number of bone metastasis was associated with ctDNA detection (odds ratio [95% confidence interval], 13.6 [1.71-108], P = 0.014). An algorithm predicting ctDNA detection using clinicopathological parameters was created. If ≥ 4 bone metastases were observed, ctDNA detection was estimated to be 98.9%. Among the patients with < 4 bone metastases, if two or three features among ISUP grade group 5, PSA level ≥ 10 ng/ml, and castration resistance were present, the ctDNA detection rate was 96.7% while the ctDNA detection rate was 86.3% if no or only one feature was present., Conclusions: An algorithm created in this study is helpful in determining when to undertake comprehensive genomic profiling assay using blood., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Acute kidney injury (AKI) is a serious complication of cirrhosis. This study analyzed the prognostic effect of AKI in patients with cirrhosis and its risk factors, particularly in relation to amino acid imbalance., Methods: This retrospective study reviewed 808 inpatients with cirrhosis at two institutes in Gifu, Japan. AKI was diagnosed according to the recommendations of the International Club of Ascites. Amino acid imbalance was assessed by measuring serum branched-chain amino acid (BCAA) levels, tyrosine levels, and the BCAA-to-tyrosine ratio (BTR). Factors associated with mortality and AKI development were assessed using the Cox proportional hazards regression model with AKI as a time-dependent covariate and the Fine-Gray competing risk regression model, respectively., Results: Of the 567 eligible patients without AKI at baseline, 27% developed AKI and 25% died during a median follow-up period of 4.7 years. Using a time-dependent covariate, AKI development (hazard ratio [HR], 6.25; 95% confidence interval [CI], 3.98-9.80; p < 0.001) was associated with mortality in patients with cirrhosis independent of potential covariates. In addition, alcohol-associated/-related liver disease, metabolic dysfunction-associated steatohepatitis, Child-Pugh score, and BTR (subdistribution HR 0.78; 95% CI 0.63-0.96; p = 0.022) were independently associated with AKI development in patients with cirrhosis. Similar results were obtained in the multivariate model that included BCAA and tyrosine levels instead of BTR., Conclusions: AKI is common and associated with mortality in Japanese patients with cirrhosis. An amino acid imbalance is strongly associated with the development of AKI in patients with cirrhosis., (© 2024. The Author(s).)

Background/objectives: The Berlin-Frankfurt-Münster (BFM)-S classification is a crucial prognostic indicator in children experiencing first-relapsed acute lymphoblastic leukemia (ALL). Early molecular response to therapy, evaluated by measurable/minimal residual disease (MRD), has a significant impact on the survival of patients with childhood ALL. Applying risk stratification based on the BFM-S classification and MRD response after induction, the first nationwide prospective multicenter study, ALL-R08, was conducted in children with first-relapsed ALL in Japan., Methods: The ALL-R08 study comprised two parts: ALL-R08-I, an observational study aimed at obtaining an overall picture of outcomes in first-relapsed childhood ALL, and ALL-R08-II, a clinical trial for the non-T-ALL S2 risk group. In ALL-R08-II, patients with an MRD level of ≥10 -3 at the end of induction therapy were assigned to undergo allogeneic hematopoietic stem cell transplantation (allo-HCT), whereas those with an MRD level less than 10 -3 and isolated extramedullary relapse continued to receive chemotherapy., Results: In total, 163 patients were enrolled in the ALL-R08 study, and 82 and 81 patients were enrolled in the ALL-R08-I and the ALL-R08-II, respectively. In ALL-R08-I, the probability of 3-year event-free survival (EFS) for patients with S1, S2, S3, S4, and post-HCT groups was 83% ± 15%, 37% ± 11%, 28% ± 8%, 14% ± 7%, and 0%, respectively. In the ALL-R08-II trial, 3-year EFS in patients with post-induction MRD less than 10 -3 and ≥10 -3 was 70% ± 9% (n = 27) and 68% ± 8% (n = 31) (p = .591), respectively., Conclusions: ALL-REZ BFM-type treatment is equally effective for children with first-relapsed ALL treated according to the Japanese frontline protocols and for children with first-relapsed ALL treated according to the BFM-type frontline protocols., (© 2024 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)

Virome analysis was performed on 174 grape genetic resources from the National Agriculture and Food Research Organization, Japan. A total of 20 bulk samples was prepared by grouping the vines into batches of 6-10 plants. Each of the bulk samples was analyzed using high-throughput sequencing, which detected 27 viruses and 5 viroids, including six viruses and one viroid reported in Japan for the first time (grapevine viruses F, L, and T, grapevine Kizil Sapak virus, grapevine Syrah virus 1, grapevine satellite virus, and grapevine yellow speckle viroid 2). In addition, a novel vitivirus was detected with a maximum nucleotide sequence identity of only 58% to its closest relative, grapevine virus A (GVA). The genome of this novel virus was 7,461 nucleotides in length and encoded five open reading frames showing the typical genomic structure of vitiviruses. Phylogenetic trees of vitiviruses placed it in a distinct position nearest to GVA or grapevine virus F (GVF) in genomes and amino acids of deduced replication-associated protein (RAP) and coat protein (CP). The amino acid sequence identities of RAP and CP with GVA, GVF, and other vitiviruses were a maximum of 53% and 73%, respectively, which were significantly below the species demarcation threshold of 80% in the genus. The low identity and phylogenetic analyses indicate the discovery of a novel vitivirus species provisionally named grapevine virus P., Competing Interests: Declarations Conflict of interest The author belongs to NARO. The author has no conflict of interest. Research involving human participants and animals This article does not contain any studies with human participants or animals performed by the author., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

While many studies have described the association between cognitive decline and eating habits, little attention has been paid to its association with cheese intake. In this epidemiological study of 1035 community-dwelling women aged ≥ 65, we investigated the association between intake/type of cheese and cognitive function. The anthropometry, functional ability, and the frequency of food intake, including cheese, were assessed. The mini-mental state examination (MMSE) was used to assess cognitive function, and a score of 20-26 was operationally defined as mild cognitive decline. We found that the MMSE score was significantly different between the presence of cheese intake and not (cheese intake: 28.4 ± 1.9; non-cheese intake: 27.6 ± 2.4) and between those who consumed Camembert cheese and those who did not (Camembert cheese: 28.7 ± 1.4; others: 28.3 ± 2.0). After adjusting for confounders, multiple logistic regression identified four independent variables significantly associated with mild cognitive decline: Camembert cheese intake (odds ratio = 0.448, 95% confidence interval = 0.214-0.936), age, usual walking speed, and repetitive saliva swallowing test scores. Our results, while based on cross-sectional data from Japanese community-dwelling older women, identified the significant inverse association between Camembert cheese intake and mild cognitive decline.

Background/aims: We assessed the associations between retinopathy of prematurity (ROP) and continuous measurements of oxygen saturation (SpO 2 ), and developed a risk prediction model for severe ROP using birth data and SpO 2 data., Methods: This retrospective study included infants who were born before 30 weeks of gestation between August 2009 and January 2019 and who were screened for ROP at a single hospital in Japan. We extracted data on birth weight (BW), birth length, gestational age (GA) and minute-by-minute SpO 2 during the first 20 days from the medical records. We defined four SpO 2 variables using sequential measurements. Multivariate logistic regression was used to develop a model that combined birth data and SpO 2 data to predict treatment-requiring ROP (TR-ROP). The model's performance was evaluated using the area under the receiver operating characteristic curve (AUC)., Results: Among 350 infants, 83 (23.7%) required ROP treatment. The SpO 2 variables in infants with TR-ROP differed significantly from those with non-TR-ROP. The average SpO 2 and high SpO 2 showed strong associations with GA (r=0.73 and r=0.70, respectively). The model incorporating birth data and the four SpO 2 variables demonstrated good discriminative ability (AUC=0.83), but it did not outperform the model incorporating BW and GA (AUC=0.82)., Conclusion: Data obtained by continuous SpO 2 monitoring demonstrated valuable associations with severe ROP, as well as with GA. Differences in the distribution of average SpO 2 and high SpO 2 between infants with TR-ROP and non-TR-ROP could be used to establish efficient cut-off values for risk determination., Competing Interests: Competing interests: None declared. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Macular edema is a known side effect of taxane-based anticancer drugs. We retrospectively investigated data from 11 centers between January 2016 and December 2021. Among 14,260 patients, 30 (0.21%) developed macular edema; from these, the number of cases associated with nab-paclitaxel was 16 (0.43%), significantly higher than the number of cases associated with paclitaxel or docetaxel (P < 0.01). Visual acuity (VA) and retinal choroidal change were examined in 27 patients, with a follow-up of at least 3 months. The patients' mean age was 67.2 years; 14 (51.3%) were male and four (14.8%) had unilateral onset. The mean interval between anticancer drug initiation and the first ophthalmology visit was 290.1 days. Among the 20 patients who discontinued anticancer drugs, VA and edema significantly improved 2 months after discontinuation (LogMAR VA: 0.50 vs. 0.28, central retinal thickness: 472.7 µm vs. 282.5 µm, both P < 0.01). No significant changes were observed in the central choroidal thickness. A correlation was found between duration of taxane treatment and VA immediately before discontinuation of anticancer drugs (β = 0.00050; 95% confidence interval: 0.00036-0.00097; P < 0.05). Although taxane-induced macular edema is reversible, slower anticancer drug discontinuation worsened VA, highlighting the need for regular ophthalmologic evaluation during treatments., (© 2024. The Author(s).)

Serving size may be the appropriate reference for calculating food nutritional value. We aimed to assess the nutritional values of Japanese foods based on serving sizes rather than per 100 g by adapting the Meiji Nutritional Profiling System (Meiji NPS). Given the variability in serving sizes across countries, we used Japanese serving sizes to calculate the Meiji NPS scores. We confirmed the convergent validity of the Meiji NPS scores per serving size with the Nutrient-Rich Food Index 9.3 using Spearman's correlation coefficients (r = 0.51, p < 0.001). Food groups recommended by official guidelines, such as pulses, nuts and seeds, fish and seafood, fruits, vegetables, and milk and milk products, scored relatively high. Furthermore, the nutrient density scores of food items with small serving sizes, such as mushrooms, algae, seasonings, and fats and oils, were moderated when calculated by per serving size, despite having considerably higher or lower scores per 100 g. These results indicate that calculating NPS per serving size allows for the assessment of the nutritional value of food items in accordance with actual consumption quantities. Therefore, the Meiji NPS calculated per serving size, alongside the per 100 g version, may be useful for dietary management depending on specific purposes.

Classical swine fever (CSF) re-emerged in Japan in 2018 for the first time in 26 years. The disease has been known to be caused by a moderately pathogenic virus, rather than the highly pathogenic virus that had occurred in the past. However, the underlying pathophysiology remains unknown. This study conducted an experimental challenge on specific pathogen-free (SPF) pigs in a naïve state for 2, 4, and 6 weeks and confirmed the disease state during each period by clinical observation, virus detection, and pathological necropsy. We revealed the pathological changes and distribution of pathogens and virus-specific antibodies at each period after virus challenge. These results were comprehensively analyzed and approximately 70% of the pigs recovered, especially at 4- and 6-week post-virus challenge. This study provides useful information for future countermeasures against CSF by clarifying the pathogenicity outcomes in unvaccinated pigs with moderately pathogenic genotype 2.1 virus., (© 2024 The Author(s). Microbiology and Immunology published by The Societies and John Wiley & Sons Australia, Ltd.)

To elucidate the seroprevalence and rate of asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Japanese children, serological analysis was performed using serum samples collected from March 2020 to February 2023. A total of 1493 serum samples were collected during the first study period (March 2020 to February 2021). None of the serum samples was positive for SARS-CoV-2 antibody. In the second period (March 2021 to February 2022), seven of the 1055 patients (0.7%) experienced SARS-CoV-2 infection. The third period (March 2022 to February 2023) was divided into three terms: from March to June 30, 2022; from July to October 2022; and from November 2022 to February 2023. The seroprevalence gradually increased throughout this period, with rates of 6.0%, 18.6%, and 30.4% in the three terms, respectively. Pediatric cases of asymptomatic SARS-CoV-2 infection occurred after the surge of Omicron variants. Since none of the SARS-CoV-2 antibody-positive patients had a previous history of coronavirus disease 2019, the seroprevalence rate in this study may represent the rate of asymptomatic infection., (© 2024 Wiley Periodicals LLC.)

Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for treatment of symptomatic patients with peripheral artery disease (PAD) and complex femoropopliteal (FP) lesions was assessed in a real-world Japanese practice setting. Methods : A prospective, multicenter, postmarket surveillance study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results : A total of 321 patients were enrolled and were a mean age of 73.9 ± 8.7 years; 77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean lesion length was 23.6 ± 6.6 cm and the frequency with TASC II C/D lesions and chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, respectively. The mean ankle-brachial index was 0.92 ± 0.15 and the mean improvement in Rutherford class was 2.3 ± 1.4, which was maintained through 5 years. The rate of cumulative device- or procedure-related SAEs through 5 years was 19.9% with only 9.3% of those occurring after the first year. No stent fractures were observed through 5 years by x-ray evaluation. Conclusion : The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese patients with PAD. ( ClinicalTrials.gov Identifier: NCT04706273) ., Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Osamu Iida – advisory boards: Boston Scientific, Cordis; consultant: Boston Scientific, Otsuka Medical; honorarium: Boston Scientific Japan, Becton Dickinson, Cordis, W. L. Gore, Medtronic Japan, Terumo Co., Ltd. Takao Ohki – consultant: W. L. Gore. Yoshimitsu Soga – honorarium: Boston Scientific, Cordis, Kaneka Medics, Medtronic Japan, Terumo Co., Ltd. Tatsuya Nakama – advisory boards: Asahi Intecc; consultant: Becton Dickinson, Boston Scientific, COOK Medical, Century Medical Inc., Cordis, NIPRO, OrbusNeichi; honorarium: Abbott Vascular, KANEKA, Medtronic, Terumo Co., Ltd. Terutoshi Yamoaka – consultant: JAPAN LIFELINE; honorarium: W. L. Gore, Boston Scientific Japan, Kaneka Medix. Kazuki Tobita – honorarium: W. L. Gore, Boston Scientific, Medtronic, Terumo, Kaneka Medics, Becton Dickinson. The other authors have no conflicts of interest to declare.

Introduction: Migraine-related stigma (MiRS) and social burden is increasingly recognized. We assessed perspectives and attitudes toward migraine in people with and without migraine in Japan., Methods: OVERCOME (Japan) was a cross-sectional, population-based web survey of people with and without migraine (July-September 2020). People with migraine were individuals who met the modified International Classification of Headache Disorders criteria or had self-reported physician-diagnosed migraine. People without migraine were selected per quota sampling to represent the Japanese adult population. People with migraine reported their experiences on stigma and social burden and answered how frequently they experienced stigma using the MiRS questionnaire. Associations between MiRS and disability and MiRS and interictal burden were examined using the migraine disability assessment and Migraine Interictal Burden Scale-4. People without migraine reported their experiences and attitudes toward people with migraine by answering an 11-item attitudinal migraine questionnaire., Results: A total of 17,071 and 2008 people with and without migraine, respectively, completed the survey. Overall, 11,228 (65.8%) respondents with migraine reported that they have never experienced stigma or burden; however, of the 12,383 employed respondents, 5841 (47.2%) reported that their current employers are not "extremely" or "very" understanding about their conditions. Moreover, ∼30%-40% of respondents "sometimes," "often," or "very often" hid their migraine from others. The proportion of respondents who experienced stigma often or very often, as assessed by MiRS, was 16.5%; this increased with the increasing number of monthly migraine headache days. The proportion of respondents with moderate-to-severe disability and interictal burden increased with increasing stigma. Among respondents without migraine, the proportion holding a stigmatizing attitude toward those with migraine was low (<15%); ∼80% had never experienced work- or family-related stigma or burden., Conclusion: MiRS and burden exist but may be hidden and underrecognized in Japan. Disease awareness and education may be important to prevent and reduce stigma and burden., (© 2024 The Author(s). Brain and Behavior published by Wiley Periodicals LLC.)

Background & Aims: Despite previously reported treatment strategies for nonfunctioning small (≤20 mm) pancreatic neuroendocrine neoplasms (pNENs), uncertainties persist. We aimed to evaluate the surgically resected cases of nonfunctioning small pNENs (NF-spNENs) in a large Japanese cohort to elucidate an optimal treatment strategy for NF-spNENs., Methods: In this Japanese multicenter study, data were retrospectively collected from patients who underwent pancreatectomy between January 1996 and December 2019, were pathologically diagnosed with pNEN, and were treated according to the World Health Organization 2019 classification. Overall, 1490 patients met the eligibility criteria, and 1014 were included in the analysis cohort., Results: In the analysis cohort, 606 patients (59.8%) had NF-spNENs, with 82% classified as grade 1 (NET-G1) and 18% as grade 2 (NET-G2) or higher. The incidence of lymph node metastasis (N1) by grade was significantly higher in NET-G2 (G1: 3.1% vs G2: 15.0%). Independent factors contributing to N1 were NET-G2 or higher and tumor diameter ≥15 mm. The predictive ability of tumor size for N1 was high. Independent factors contributing to recurrence included multiple lesions, NET-G2 or higher, tumor diameter ≥15 mm, and N1. However, the independent factor contributing to survival was tumor grade (NET-G2 or higher). The appropriate timing for surgical resection of NET-G1 and NET-G2 or higher was when tumors were >20 and >10 mm, respectively. For neoplasms with unknown preoperative grades, tumor size >15 mm was considered appropriate., Conclusions: NF-spNENs are heterogeneous with varying levels of malignancy. Therefore, treatment strategies based on tumor size alone can be unreliable; personalized treatment strategies that consider tumor grading are preferable., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Fremanezumab is an effective treatment for episodic (EM) and chronic migraine (CM) patients in Japan, but its cost effectiveness remains unknown. The objective of this study was to determine the cost effectiveness of fremanezumab compared with standard of care (SOC) in previously treated EM and CM patients from a Japanese healthcare perspective., Methods: Estimated regression models were implemented in a probabilistic Markov model to inform effectiveness and health-related quality-of-life data for fremanezumab and SOC. The model was further populated with data from the literature. The adjusted Japanese healthcare perspective included productivity losses. The main model outcomes were quality-adjusted life-years (QALYs), costs (2022 Japanese Yen [¥]), and incremental outcomes including the incremental cost-effectiveness ratio (ICER). Analyses were performed separately for the EM and CM patients and combined. Costs and effects were discounted at an annual rate of 2.0%., Results: The mean QALYs over a 25-year time horizon for the EM and CM populations combined were 13.03 for SOC and 13.15 for fremanezumab. The associated costs were ¥27,550,292 for SOC and ¥28,371,048 for fremanezumab. QALYs were higher and costs lower for EM patients compared with CM patients for both fremanezumab and SOC. The deterministic ICERs of fremanezumab versus SOC were ¥6,334,861 for EM, ¥7,393,824 for CM, and ¥6,530,398 for EM and CM combined. Indirect costs and choice of mean migraine days model distribution had a substantial impact on the ICER., Conclusion: Using fremanezumab in a heterogeneous mixture of Japanese EM and CM patients resulted in a reduction of monthly migraine days and thus more QALYs compared with SOC. The cost effectiveness of fremanezumab versus SOC in EM and CM patients resulted in an ICER of ¥6,530,398, from an adjusted Japanese public healthcare perspective., (© 2024. The Author(s).)

Aims/introduction: To conduct a multicenter survey of visually impaired patients with diabetes mellitus (DM) and to identify the physical and ocular characteristics that lead to blindness in Japan., Materials and Methods: Visually impaired patients with diabetes mellitus in Japan were divided into blind and low-vision groups according to the World Health Organization classification. Data on parameters related to diabetes mellitus and ocular complications in the right and left eyes were collected from 19 highly advanced medical facilities and compared between the two groups., Results: Among 408 visually impaired persons (blind group: 257, low-vision group: 151), 72.1% were under 70 years of age. The rates of neovascular glaucoma (NVG) (right eye, P = 0.041; left eye, P = 0.0031) or proliferative diabetic retinopathy (PDR) (right eye: P = 0.014, left eye: P = 0.0047) and the rate of proliferative membrane beyond half of the retinal area (right eye: P = 0.0263, left eye: P = 0.037) were significantly higher in the blind group. The direct cause of visual impairment was retinal atrophy, common in both groups. Neovascular glaucoma and diabetic macular edema were equally prevalent in the blind and low-vision groups, respectively., Conclusions: In Japan, blind patients with diabetes mellitus are characterized by severe conditions such as neovascular glaucoma and progressive proliferative diabetic retinopathy upon their initial visit to an advanced care facility. These results highlight the importance of monitoring retinopathy through regular ophthalmological examinations, internal medicine, and appropriate therapeutic intervention., (© 2024 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Purpose: The present study aimed to investigate the current situation of radiation protection education for designated radiation workers in hospitals., Methods: A web-based questionnaire survey was conducted at 1,883 hospitals nationwide with 200 or more beds., Results: Responses from 186 hospitals were included in the analysis. Seven hospitals (6.7%) regulated by the Act on the Regulation of Radioisotopes and six hospitals (7.4%) regulated by only the Ordinance on Prevention of Ionizing Radiation Hazards did not implement radiation protection education. In approximately 6% of the hospitals, designated radiation workers-including physicians, nurses, and radiological technologist-did not attend the education program. The education program attendance rate of physicians was lower than that of nurses. In more than 90% of the hospitals, the frequency of the periodical education program was once every year and lecture time spanned one or less than one hour. The topics of lecture in more than 90% of the hospitals were health effects of radiation and methods of radiation protection for occupational exposure. The radiological technologist was the instructor of the education program in approximately 70% of the hospitals., Conclusion: The implementation of radiation protection for designated radiation workers varied from hospital to hospital, and some hospitals did not comply with laws and regulations. Effective and efficient radiation protection education models should be implemented in hospitals.

Background: Per the biopsychosocial model, pain, especially chronic low back pain, which often presents with nonspecific pain, requires a comprehensive approach involving social factors. However, the association of social factors, including social isolation and loneliness, with this condition remains unclear. This study examined the cross-sectional association of social isolation and loneliness with chronic low back pain among older adults., Methods: We recruited functionally independent older adults through a mail survey in 2019 from the Japan Gerontological Evaluation Study (JAGES). Chronic low back pain was defined as low back pain lasting more than 3 months. Social isolation was identified based on face-to-face and non-face-to-face interactions ("not isolated," "isolated tendency," and "isolated"). Loneliness was assessed using the University of California, Los Angeles Loneliness Scale ("not lonely," "lonely tendency," and "lonely")., Results: Consequently, 21,463 participants were analyzed (mean age: 74.4 years; 51.5% females); 12.6% reported chronic low back pain. Multivariable Poisson regression analysis revealed that loneliness was significantly associated with the likelihood of chronic low back pain; compared with "not lonely", the prevalence ratio (PR) was 1.14 (95% confidence interval [CI], 1.05-1.25) for "lonely tendency" and 1.40 (95% CI, 1.27-1.54) for "lonely." Social isolation was not associated; compared with "not isolated," the PR was 0.96 (95% CI, 0.88-1.05) for "isolated tendency" and 0.99 (95% CI, 0.89-1.10) for "isolated." A positive multiplicative interaction between social isolation and loneliness for chronic low back pain was found., Conclusion: Lonelier individuals were more likely to experience chronic low back pain, and those with loneliness and social isolation were synergistically more likely for this condition.

Background: Saccular abdominal aortic aneurysms (AAAs) are considered to be at higher risk of rupture than fusiform AAAs, but not much is known about the extent of this risk. Therefore, this study aimed to compare the rupture presentation between fusiform and saccular AAAs., Methods and Results: This is a retrospective cohort study on 27 290 patients who underwent primary endovascular repair for a degenerative AAA between 2016 and 2019, and who were registered in the National Clinical Database in Japan. At operation for nonruptured case, the aneurysm diameter was significantly smaller in saccular AAAs than in fusiform AAAs (median, 44.0 versus 51.0 mm; P <0.001). Similarly, aneurysm diameter at rupture was significantly smaller in saccular AAAs than in fusiform AAAs (median, 55.6 versus 68.0 mm; P <0.001). The likelihood of repair for rupture was significantly higher in saccular AAAs than in fusiform AAAs in the 40- to 54-mm diameter range, in which saccular morphology was found to be an independent risk factor for rupture against fusiform morphology by adjusting for sex and aneurysm diameter (odds ratio, 2.54 [95% CI, 1.75-3.69]). In addition, receiver-operating characteristic curve analysis revealed that the cutoff diameter to predict rupture was smaller in saccular AAAs than in fusiform AAAs (50.5 and 59.5 mm, respectively) based on the Youden index., Conclusions: Saccular AAAs presented at smaller diameters than fusiform AAAs in patients with ruptured AAAs treated with endovascular aortic repair, which supports the idea that saccular AAAs should be treated at smaller diameters.

A neutrophilic iron-oxidizing and -reducing bacterium, strain MIZ03 T , was previously isolated from a wetland in Ibaraki, Japan. Here, we report the detailed characteristics of this strain. It was motile with a single polar flagellum, and Gram-stain-negative. It could grow not only chemolithoautotrophically but also chemoorganotrophically by aerobic respiration and fermentation. Major cellular fatty acids were C 16 : 1  ω 7 c /C 16 : 1  ω 6 c , and C 16 : 0 . Phylogenetic analyses indicated that strain MIZ03 T belonged to the genus Rhodoferax . This strain was closely related to Rhodoferax ferrireducens with 98.5 % of 16S rRNA gene sequence similarity. Based on its phenotypic and genomic based characteristics, we conclude that strain MIZ03 T represents a new species in the genus Rhodoferax . We propose the name Rhodoferax lithotrophicus sp. nov. to accommodate this strain. The type strain is MIZ03 T (=JCM 34246 T =DSM 113266 T ). We also propose the name Rhodoferax koreensis sp. nov., of which the type strain is DCY110 T (=KCTC 52288 T =JCM 31441 T ), for the effectively, but not yet validly, published name ' Rhodoferax koreense '.

Aim: Efforts to combat frailty and preserve good health in older adults have highlighted oral frailty as an early indicator of overall frailty. Individuals showing oral frailty are at an elevated risk of insufficient nutritional intake compared with those without oral frailty; however, underlying mechanisms remain poorly explored. In this cross-sectional study, we aimed to examine the link between oral frailty and undernutrition, especially regarding poor appetite and low dietary diversity., Methods: The analysis included 2727 late-stage older adults (mean age 79.9 ± 4.3 years) who underwent dental checkups in a prefecture in Japan from 2016 to 2020. The examination involved a questionnaire survey (covering basic information, frailty screening index, appetite index: Simplified Nutritional Appetite Questionnaire; and dietary variety: Dietary Variety Score) and a measurement survey (including intraoral confirmation, oral diadochokinesis and masticatory efficiency test). Individuals with three or more indications of poor oral function, identified through oral function assessment, were defined as showing oral frailty. Binomial logistic regression and path analyses examined associations among oral frailty, Simplified Nutritional Appetite Questionnaire and Dietary Variety Score., Results: Among those analyzed, 1208 (44.3%) participants were categorized into the oral frailty group. Binomial logistic regression analysis showed that Simplified Nutritional Appetite Questionnaire (odds ratio for oral frailty per 1-point increase 0.88, 95% confidence interval 0.84-0.93) and Dietary Variety Score (odds ratio 0.95, 95% confidence interval 0.92-0.98) were significantly associated with oral frailty. The path analysis showed individual associations between each examined factor., Conclusions: Oral frailty was associated with decreased appetite and dietary variety in late-stage older adults. Geriatr Gerontol Int 2024; 24: 626-633., (© 2024 Japan Geriatrics Society.)

Aim: To investigate the distribution of nurse practitioners (NPs) across Japan and their perceived facilitators and barriers to NP implementation in Japan., Background: NP certification examinations have been conducted in Japan since 2011, and by 2020, there were 487 NPs in the country. The momentum of NP implementation is slower in Japan compared with other countries., Methods: A cross-sectional descriptive study, following the STROBE guidelines, was conducted. Web-based survey questionnaires, developed by the authors, were administered to 248 NPs whose email addresses were maintained by the certification management body., Results: Valid responses were obtained from 101 NPs (response rate: 40.7%), of which 34% were male. The respondents had more than 12 years of registered nurse experience on an average before enrolling in the graduate NP program. 53% were employed as NPs from the beginning, while 25% were initially employed as registered nurses and later advanced to NPs, and 11% still worked as RNs. A majority worked in hospitals with beds. Many NPs perceived the lack of NP national licensure and reimbursement benefits as barriers to NP implementation, whereas recognition from superiors and organizations was considered facilitators., Conclusions: Despite their small numbers in Japan, NPs take on crucial tasks and contribute to the appropriate distribution of medical resources. The NP licensure system and recognition from superiors and organizations may be necessary to promote NP roles in Japan., Implications for Nursing and Health Policy: Some certified NPs still work as registered nurses. Recognition from nursing and organization administrators is critical to implementing NPs. To this end, a reimbursement system benefiting the organizations and a legislation facilitating NP employment are required., (© 2022 The Authors. International Nursing Review published by John Wiley & Sons Ltd on behalf of International Council of Nurses.)

Objectives: Frailty is a significant cause of adverse health events including long-term care and hospitalization. Although information and communication technology (ICT) has become an integral part of modern life, it remains unclear whether ICT use is associated with frailty., Design: A cross-sectional study (Integrated Longitudinal Studies on Aging in Japan, ILSA-J)., Setting and Participants: Aged 75 and older data from the ILSA-J in 2017 (n = 2893)., Methods: ICT use was measured using the technology usage sub-items of the Japan Science and Technology Agency Index of Competence. Specifically, the use of mobile phones, ATMs, DVD players, and sending e-mails were rated as "yes" (able to do) or "no" (unable to do), with the first quintile (≤1 point) defined as ICT non-users. Frailty was assessed using the Japanese version of the Cardiovascular Health Study criteria based on the phenotype model (e.g., weight loss, slowness, weakness, exhaustion, and low activity). Further, multivariate logistic regression analysis analyzed its association with ICT use. Subgroup analyses were stratified according to gender, years of education, and living arrangements., Results: Higher ICT use was not associated with frailty after adjusting for covariates (odds ratio [OR]: 0.53; 95%CI 0.39-0.73). Similar associations were found in the sub-groups of women (OR 0.45, 95%CI 0.30-0.66), <13 years of education (OR 0.48, 95%CI 0.34-0.67), living alone (OR 0.46, 95%CI 0.27-0.79), and living together (OR 0.57, 95%CI 0.38-0.85). No association existed between using ICT and frailty in the sub-groups of men and ≥13 years of education., Conclusions and Implications: Higher ICT use is associated with the absence of frailty in individuals 75 years and older. Such benefits may be particularly pronounced in women, those with lower levels of education, and older adults living alone or with others., (© 2024. The Author(s).)

Purpose: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients., Methods: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate., Results: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD., Conclusion: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months., Level of Evidence: Level 3, Cohort study., Clinical Trial Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018., (© 2024. The Author(s).)

Background: This phase 2b/3, randomized, placebo-controlled trial explored the efficacy and evaluated the safety of ensitrelvir. This trial involved individuals with asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and patients with mild symptoms of coronavirus disease 2019 (COVID-19)., Methods: The trial was conducted at 57 medical institutions in Japan, South Korea, and Vietnam (study period: January 6-August 14, 2022). Eligible participants were randomized (1:1:1) to the ensitrelvir 125-mg, ensitrelvir 250-mg, or placebo group, received the allocated intervention orally, and were followed up until Day 28. Participants self-rated the severity of 14 typical COVID-19 symptoms and recorded the data in an electronic diary., Results: In total, 572 participants (194, 189, and 189 in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively) were included in the intention-to-treat population. Ensitrelvir 125-mg group observed a 77% reduction in the risk of developing any of the 14 COVID-19 symptoms or fever and a 29% reduction in the risk of worsening of such symptoms or fever versus placebo (statistically nonsignificant). The viral RNA, viral titer, and time to infectious viral clearance observed a statistically significant decrease versus placebo. Most treatment-related adverse events (TEAEs) were mild to moderate in severity, and the most common TEAE observed across groups was a decrease in high-density lipoprotein., Conclusions: Our exploratory results suggest a potential reduction in the risk of development or worsening of COVID-19 symptoms with ensitrelvir. Ensitrelvir showed antiviral efficacy and was well tolerated., Trial Registration: Japan Registry of Clinical Trials identifier: jRCT2031210350., (© 2024 The Author(s). Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Background: Asparaginase is essential for treating T-cell acute lymphoblastic leukemia (T-ALL). Despite the ongoing debate on whether T-ALL and T-cell lymphoblastic lymphoma (T-LBL) are the same disease entity or two distinct diseases, patients with T-LBL often receive the same or similar treatment protocols as those with T-ALL., Methods: The outcomes of patients with or without L-asparaginase discontinuation were retrospectively analyzed among four national protocols: Japan Association of Childhood Leukemia Study (JACLS) ALL-02 and ALL-97 for T-ALL and Japanese Pediatric Leukemia/Lymphoma Study Group ALB-NHL03 and JACLS NHL-98 for T-LBL. The hazard ratio (HR) was calculated with the Cox regression model by considering L-asparaginase discontinuation as a time-dependent variable., Results: In total, 199 patients with T-ALL, and 133 patients with T-LBL were included. L-asparaginase discontinuation compromised event-free survival (EFS) of T-ALL patients (ALL-02: HR 3.32, 95% confidence interval [CI] 1.40-7.90; ALL-97: HR 3.39, 95%CI 1.19-9.67). Conversely, EFS compromise was not detected among T-LBL patients (ALB-NHL03: HR 1.39, 95%CI 0.41-4.68; NHL-98: HR 0.92, 95%CI 0.11-7.60)., Conclusion: The effects of L-asparaginase discontinuation differed between T-ALL and T-LBL. We assume that the differential impact results from (1) the inherent differential response to L-asparaginase between them and/or (2) a less stringent assessment of early treatment response in T-LBL than in T-ALL. Given the poor salvage rate of refractory or relapsed T-ALL and T-LBL, optimization of the frontline therapy is critical, and the current study provides a new suggestion for further treatment modifications. However, larger studies in contemporary intensified treatment protocols are required., (© 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.)

Objective: In this study, we examine how advancements in novel antirheumatic drugs affect the clinicopathologic features of lymphoproliferative disorder (LPD) in patients with rheumatoid arthritis (RA)., Methods: In this multicenter study across 53 hospitals in Japan, we characterized patients with RA who developed LPDs and visited the hospitals between January 1999 and March 2021. The statistical tools used included Fisher's exact test, the Mann-Whitney U-test, the log-rank test, logistic regression analysis, and Cox proportional hazards models., Results: Overall, 752 patients with RA-associated LPD (RA-LPD) and 770 with sporadic LPD were included in the study. We observed significant differences in the clinicopathologic features between patients with RA-LPD and those with sporadic LPD. Histopathological analysis revealed a high frequency of LPD-associated immunosuppressive conditions. Furthermore, patients with RA-LPD were evaluated based on the antirheumatic drugs administered. The methotrexate (MTX) plus tacrolimus and MTX plus tumor necrosis factor inhibitor (TNFi) groups had different affected site frequencies and histologic subtypes than the MTX-only group. Moreover, MTX and TNFi may synergistically affect susceptibility to Epstein-Barr virus infection. In case of antirheumatic drugs administered after LPD onset, tocilizumab (TCZ)-only therapy was associated with lower frequency of regrowth after spontaneous regression than other regimens., Conclusion: Antirheumatic drugs administered before LPD onset may influence the clinicopathologic features of RA-LPD, with patterns changing over time. Furthermore, TCZ-only regimens are recommended after LPD onset., (© 2024 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

In early spring 2018, significant mosaic disease symptoms were observed for the first time on barley leaves ( Hordeum vulgare L., cv. New Sachiho Golden) in Takanezawa, Tochigi Prefecture, Japan. This cultivar carries the resistance gene rym3 (rym; resistance to yellow mosaic). Through RNA-seq analysis, Barley yellow mosaic virus (BaYMV-Takanezawa) was identified in the roots of all five plants (T01-T05) in the field. Phylogenetic analysis of RNA1, encompassing known BaYMV pathotypes I through V, revealed that it shares the same origin as isolate pathotype IV (BaYMV-Ohtawara pathotype). However, RNA2 analysis of isolates revealed the simultaneous presence of two distinct BaYMV isolates, BaYMV-Takanezawa-T01 (DRR552862, closely related to pathotype IV) and BaYMV-Takanezawa-T02 (DRR552863, closely related to pathotype III). The amino acid sequences of the BaYMV-Takanezawa isolates displayed variations, particularly in the VPg and N-terminal region of CP, containing mutations not found in other domains of the virus genome. Changes in the CI (RNA1 amino acid residue 459) and CP (RNA1 amino acid residue 2138) proteins correlated with pathogenicity. These findings underscore the importance of monitoring and understanding the genetic diversity of BaYMV for effective disease management strategies in crop breeding.

Spontaneous intracerebral hemorrhage (SICH) remains a devastating form of stroke. Prior use of antiplatelets or warfarin before SICH is associated with poor outcomes, but the effects of direct oral anticoagulants (DOACs) remain unclear. This study aimed to clarify trends in prior antithrombotic use and to assess the associations between prior use of antithrombotics and in-hospital mortality using a multicenter prospective registry in Japan. In total, 1085 patients were analyzed. Prior antithrombotic medication included antiplatelets in 14.2%, oral anticoagulants in 8.1%, and both in 1.8%. Prior warfarin use was significantly associated with in-hospital mortality (odds ratio [OR] 5.50, 95% confidence interval [CI] 1.30-23.26, P < 0.05) compared to no prior antithrombotic use. No such association was evident between prior DOAC use and no prior antithrombotic use (OR 1.34, 95% CI 0.44-4.05, P = 0.606). Concomitant use of antiplatelets and warfarin further increased the in-hospital mortality rate (37.5%) compared to warfarin alone (17.2%), but no such association was found for antiplatelets plus DOACs (8.3%) compared to DOACs alone (11.9%). Prior use of warfarin remains an independent risk factor for in-hospital mortality after SICH in the era of DOACs. Further strategies are warranted to reduce SICH among patients receiving oral anticoagulants and to prevent serious outcomes., (© 2024. The Author(s).)

Chest radiography (CR) has been used as a screening tool for lung cancer and the use of low-dose computed tomography (LDCT) is not recommended in Japan. We need to reconsider whether CR really contributes to the early detection of lung cancer. In addition, we have not well discussed about other major thoracic disease detection by CR and LDCT compared with lung cancer despite of its high frequency. We review the usefulness of CR and LDCT as veridical screening tools for lung cancer and other thoracic diseases. In the case of lung cancer, many studies showed that LDCT has capability of early detection and improving outcomes compared with CR. Recent large randomized trial also supports former results. In the case of chronic obstructive pulmonary disease (COPD), LDCT contributes to early detection and leads to the implementation of smoking cessation treatments. In the case of pulmonary infections, LDCT can reveal tiny inflammatory changes that are not observed on CR, though many of these cases improve spontaneously. Therefore, LDCT screening for pulmonary infections may be less useful. CR screening is more suitable for the detection of pulmonary infections. In the case of cardiovascular disease (CVD), CR may be a better screening tool for detecting cardiomegaly, whereas LDCT may be a more useful tool for detecting vascular changes. Therefore, the current status of thoracic disease screening is that LDCT may be a better screening tool for detecting lung cancer, COPD, and vascular changes. CR may be a suitable screening tool for pulmonary infections and cardiomegaly., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Among venous thromboembolism, pulmonary thromboembolism (PTE) is one of the most serious postoperative complications. Deep venous thrombosis (DVT) is the main cause. Considering the unknown prevalence of DVT and PTE in the postoperative period of cardiovascular surgery in Japan, we investigated the incidence in consecutive patients who underwent cardiovascular surgery., Methods: A total of 225 patients who underwent cardiovascular surgery at four hospitals consented to participate in the study. We assessed DVT using lower extremity venous ultrasound preoperatively and postoperatively. Seven patients with preexisting DVT were excluded. Postoperative antithrombotic therapy was administered at the discretion of the attending physician at each institution. The postoperative intermittent pneumatic compression therapy followed the standard prophylaxis protocol at each institution. Patients were grouped into DVT and non-DVT cohorts for comparison. Continuous variables were expressed as means ± standard deviations and compared by the t-test., Results: The analysis of lower extremity venous ultrasound images indicated that DVT developed in 16 of the 218 study patients (DVT, 7.3%). No patient had PTE. Procedure-related data revealed significantly higher total blood transfusion (DVT group: 61.2 ± 49.9 IU vs. non-DVT group: 27.7 ± 30.2 IU: p  = 0.018, effect size = 1.048) in the DVT group. The multivariate logistic regression predictor of DVT based on preoperative, intraoperative, and postoperative factors was blood transfusion ( p  = 0.005, 95% confidence interval 1.010-1.059, odds ratio 1.034)., Conclusions: The incidence of postoperatively developed DVT was 7.3% in this study., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Aim: This cross-sectional study evaluated vaginal health and hygiene practices among reproductive and perimenopausal women in Japan using an online-based questionnaire., Methods: The questionnaire included 11 well-structured questions concerning vulvovaginal symptoms and hygiene care practices. Participants' responses were anonymized and analyzed descriptively. The relationships of age, family income, occupation, and childbearing with women's concerns regarding vaginal or vulvar problems were analyzed by chi-square tests., Results: About 80% of women in their 20s to 50s in Japan reported experiencing vulvovaginal symptoms. Women in their 40s had significantly fewer symptoms than women in their 20s (p = 0.04), and women in their 50s had significantly fewer symptoms than all other age groups (20s, 30s, and 40s) (p < 0.001). Among symptomatic women, 77.5% did not discuss their symptoms with anyone else and only 10% visited doctors. About 12.5% of women reported taking special care of their vagina or vulva regularly, whereas 38.2% expressed a desire to try some form of care but had not yet done so. Of the women who did not take special care of their vagina or vulva, 46.2% lacked knowledge about proper care, 42.2% did not want to spend money on care, 30.5% did not want to discuss care with others, and 21.3% were psychologically reluctant., Conclusion: Determination of the prevalence of vulvovaginal symptoms among Japanese women can enhance understanding of this prevalent condition and its impact on women's health. These findings may help formulate effective public health interventions and promote better hygienic practices, thus improving the well-being of women in Japan., (© 2024 The Authors. Journal of Obstetrics and Gynaecology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Obstetrics and Gynecology.)

Objectives: Endoscopic submucosal dissection (ESD) for superficial esophageal squamous cell carcinoma (ESCC) is performed for the treatment of lesions with varied backgrounds and factors. However, the predictive factors associated with the technical difficulty of ESD remain unknown in patients with varied lesions. Therefore, this study aimed to identify the predictive factors associated with the technical difficulty of ESD for ESCC using a retrospective cohort., Methods: This multicenter, retrospective study was conducted in 10 hospitals in Japan. Consecutive patients who underwent esophageal ESD between January 2013 and December 2019 were enrolled. Lesions of subepithelial tumors, adenocarcinoma, and adenoma were excluded. Difficult lesions were defined as ESD requiring a long procedure time (≥120 min), perforation development, piecemeal resection, or discontinued ESD. In the present study, the clinical factors were assessed to identify the technical difficulty of ESD using univariate and multivariate analyses., Results: Among 1708 lesions treated with esophageal ESD, eight subepithelial tumors, 44 adenocarcinomas, and two adenomas were excluded. Finally, 1505 patients with 1654 lesions were analyzed, and 217 patients with 217 lesions (13.1%) were classified as patients with difficult lesions. In multivariate analysis, the predictive factors associated with the technical difficulty of ESD were as follows: tumors with varices, tumors with diverticulum, antiplatelet use (discontinued), circumference of tumor (≥1/2), preoperative tumor size ≥30 mm, trainee, and nonhigh-volume center., Conclusion: This multicenter retrospective study identified the predictive factors associated with the technical difficulty of ESD for ESCC with varied backgrounds and factors., (© 2023 Japan Gastroenterological Endoscopy Society.)

Background: Donepezil has been approved in Japan for the treatment of dementia with Lewy bodies (DLB) based on clinical trials showing its beneficial effects on cognitive impairment. This phase IV study evaluated the efficacy of donepezil by focusing on global clinical status during a 12-week double-blind phase., Methods: Patients with probable DLB were randomly assigned to the placebo (n = 79) or 10 mg donepezil (n = 81) groups. The primary endpoint was changes in global clinical status, assessed using the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus). We also assessed four CIBIC-plus domains (general condition, cognitive function, behaviour, and activities of daily living) and changes in cognitive impairment and behavioural and neuropsychiatric symptoms measured using the Mini-Mental State Examination (MMSE) and the Neuropsychiatric Inventory (NPI), respectively., Results: Although donepezil's superiority was not shown in the global clinical status, a significant favourable effect was detected in the cognitive domain (P = 0.006). MMSE scores improved in the donepezil group after adjustments in post hoc analysis (MMSE mean difference, 1.4 (95% confidence interval (CI), 0.42-2.30), P = 0.004). Improvements in NPIs were similar between the groups (NPI-2: -0.2 (95% CI, -1.48 to 1.01), P = 0.710; NPI-10: 0.1 (95% CI, -3.28 to 3.55), P = 0.937)., Conclusion: The results support the observation that the efficacy of 10 mg donepezil in improving cognitive function is clinically meaningful in DLB patients. The evaluation of global clinical status might be affected by mild to moderate DLB patients enrolled in this study. No new safety concerns were detected., (© 2024 The Authors. Psychogeriatrics published by John Wiley & Sons Australia, Ltd on behalf of Japanese Psychogeriatric Society.)

Objective: Poor-grade subarachnoid hemorrhage (SAH) accounts for 20% of all SAH and is associated with poor outcomes. The first step in improving outcomes is to analyze the factors that contribute to poor outcomes., Methods: This was a multicenter, retrospective, observational, cohort study. Data fields included demographic, clinical, radiological, and outcome data for all spontaneous patients with SAH treated at 4 hospitals in Aomori Prefecture in Japan. Patients with modified Rankin Scale score 0-2 at discharge were defined as the good outcome group, and those with modified Rankin Scale score 3-6 were defined as the poor outcome group, and comparisons were made between the 2 groups., Results: There were 329 eligible patients with poor-grade SAH, 41 with good outcome group, and 288 with poor outcome group. On multivariate analysis of the outcome, conservative treatment (P < 0.001), Fisher group 4 (P < 0.007), age ≥65 years (P = 0.011), and Hunt and Kosnik grade V on admission (P = 0.021) were significant factors contributing to a poor outcome., Conclusions: Nonelderly patients who are not in grade V and Fisher group 4 should undergo aneurysm treatment as soon as possible because they are more likely to have a good outcome, whereas elderly patients in grade V and Fisher group 4 are unlikely to benefit from aneurysm treatment at present. The development of a treatment for early brain injury may be important to improve the outcomes of patients with poor-grade SAH., (Copyright © 2024 Elsevier Inc. All rights reserved.)