Factors related to accurate clinicians' prediction of survival: an international multicenter study in East Asia.

PURPOSE: Recent guidelines for prognostic evaluation recommend clinicians' prediction of survival (CPS) for survival prediction in patients with advanced cancer. However, CPS is often inaccurate and optimistic. Studies on factors associated with overestimation or underestimation of CPS are limited. We aimed to investigate the factors associated with the overestimation and underestimation of CPS in patients with far-advanced cancer. METHODS: The current study was a secondary analysis of an international multicenter prospective cohort study, which enrolled newly admitted patients with advanced cancer in palliative care units (PCUs) in Japan, Korea, and Taiwan from 2017 to 2018. We obtained the temporal CPS at enrollment and performed multivariate logistic regression analysis to identify the factors associated with "underestimation (less than 33% of actual survival)" and "overestimation (more than 33% of actual survival)." RESULTS: A total of 2571 patients were assessed and admitted in 37 PCUs between January 2017 and September 2018. Older age (adjusted odds ratio [aOR] 1.01; 95% confidence interval [CI] 1.01-1.02; P < 0.01) and reduced oral intake (aOR 0.68; 95% CI 0.51-0.89; P < 0.01) were identified as significant factors associated with underestimation. Dyspnea (aOR 1.28; 95% CI 1.06-1.54; P = 0.01) and hyperactive delirium (aOR 1.34; 95% CI 1.05-1.72; P = 0.02) were identified as significant factors associated with overestimation. CONCLUSION: Older age was related to underestimation, while dyspnea and hyperactive delirium were related to overestimation of CPS for patients with weeks of survival. However, reduced oral intake was less likely to lead to underestimation.

Comparison of embolic risk in left ventricular thrombus between nonischemic and ischemic cardiomyopathy: A nationwide database analysis.

BACKGROUND: Left ventricular (LV) thrombus is not common but poses significant risks of embolic stroke or systemic embolism. However, the distinction in embolic risk between nonischemic cardiomyopathy (NICM) and ischemic cardiomyopathy (ICM) remains unclear. METHODS AND RESULTS: In total, 2738 LV thrombus patients from the JROAD-DPC (Japanese Registry of All Cardiac and Vascular Diseases Diagnosis Procedure Combination) database were included. Among these patients, 1037 patients were analyzed, with 826 (79.7%) having ICM and 211 with NICM (20.3%). Within the NICM group, the distribution was as follows: dilated cardiomyopathy (DCM; 41.2%), takotsubo cardiomyopathy (27.0%), hypertrophic cardiomyopathy (18.0%), and other causes (13.8%). The primary outcome was a composite of embolic stroke or systemic embolism (SSE) during hospitalization. The ICM and NICM groups showed no significant difference in the primary outcome (5.8% vs. 7.6%, p = 0.34). Among NICM, SSE occurred in 12.6% of patients with DCM, 7.0% with takotsubo cardiomyopathy, and 2.6% with hypertrophic cardiomyopathy. Multivariate logistic regression analysis for SSE revealed an odds ratio of 1.4 (95% confidence interval [CI], 0.7-2.7, p = 0.37) for NICM compared to ICM. However, DCM exhibited a higher adjusted odds ratio for SSE compared to ICM (2.6, 95% CI 1.2-6.0, p = 0.022). CONCLUSIONS: This nationwide shows comparable rates of embolic events between ICM and NICM in LV thrombus patients, with DCM posing a greater risk of SSE than ICM. The findings emphasize the importance of assessing the specific cause of heart disease in NICM, within LV thrombus management strategies.

National trends in treatments for ectopic pregnancy in Japan from 2010 to 2020: a retrospective observational study.

BACKGROUND: Ectopic pregnancy (EP) can be treated surgically or nonsurgically. In many countries, methotrexate is frequently used as a first-line medical treatment, and its effect is similar to that of surgery in selected patients. We aimed to investigate national trends in the treatment of EP in Japan. METHODS: We conducted a retrospective observational analysis between 2010 and 2020 using a nationwide claims database that included inpatient data. We identified female inpatients with EP aged 15 to 49 years old. We analysed year-to-year treatment trends for EP, as well as year-to-year trends in methotrexate administration, with a focus on the site of the pregnancy. Patients who received methotrexate were divided into two groups: Those with and those without surgery after methotrexate use. We compared the characteristics of these groups and calculated the methotrexate success rate. RESULTS: We identified 53,653 patients with EP. The proportion of patients undergoing surgery increased from 79% in 2010 to 83% in 2020, whereas the proportion of methotrexate therapy decreased from 8.1% in 2010 to 5.1% in 2020. Regarding methotrexate use for the site of the pregnancy, there was a significant downward trend in methotrexate therapy for tubal pregnancies. Notably, the methotrexate success rate was 84% during the study period. CONCLUSIONS: Surgery showed an increasing tendency over time, whereas methotrexate therapy showed a decreasing tendency for EP treatment in Japan. The efficacy of methotrexate in Japan was comparable to that observed in other countries.

Treatment for ectopic pregnancy includes surgical and non-surgical management. Medical treatment can be as effective as surgery in cases that meet certain criteria. Methotrexate, which is commonly employed as a medical treatment, is widely used in many countries outside Japan. However, reports on methotrexate therapy for ectopic pregnancy in Japan are limited, and the actual status of its use remains unknown. We investigated the treatment trends for ectopic pregnancy in Japan using nationwide inpatient data. The results demonstrated that surgeries increased from 79% in 2010 to 83% in 2020, while methotrexate therapy declined from 8.1% to 5.1%. Methotrexate therapy demonstrated an 84% success rate. Unlike many other countries, surgery became more prevalent while methotrexate therapy decreased for inpatients with ectopic pregnancy in Japan. The success rate of methotrexate in Japan was comparable to that in other countries. Thus, Japanese healthcare providers should consider using methotrexate therapy for appropriate cases and carefully choose the best treatment for each patient after discussing the treatment options with patients.

A significant outbreak of respiratory human adenovirus infections among children aged 3-6 years in Hokkaido, Japan, in 2023.

Human adenovirus (HAdV) infections present diverse clinical manifestations upon infecting individuals, with respiratory infections predominating in children. We surveyed pediatric hospitalizations due to respiratory HAdV infections across 18 hospitals in Hokkaido Prefecture, Japan, from July 2019 to March 2024, recording 473 admissions. While hospitalizations remained below five cases per week from July 2019 to September 2023, a notable surge occurred in late October 2023, with weekly admissions peaking at 15-20 cases from November to December. There were dramatic shifts in the age distribution of hospitalized patients: during 2019-2021, 1-year-old infants and children aged 3-6 years represented 51.4%-54.8% and 4.1%-13.3%, respectively; however, in 2023-2024, while 1-year-old infants represented 19.0%-20.1%, the proportion of children aged 3-6 years increased to 46.2%-50.0%. Understanding the emergence of significant outbreaks of respiratory HAdV infections and the substantial changes in the age distribution of hospitalized cases necessitates further investigation into the circulating types of HAdV in Hokkaido Prefecture and changes in children's neutralizing antibody titers against HAdV.

PSA doubling time 4.65 months as an optimal cut-off of Japanese nonmetastatic castration-resistant prostate cancer.

A multicenter study of nonmetastatic castration-resistant prostate cancer (nmCRPC) was conducted to identify the optimal cut-off value of prostate-specific antigen (PSA) doubling time (PSADT) that correlated with the prognosis in Japanese nmCRPC. Of the 515 patients diagnosed and treated for nmCRPC at 25 participating Japanese Urological Oncology Group centers, 450 patients with complete clinical information were included. The prognostic values of clinical factors were evaluated with respect to prostate specific antigen progression-free (PFS), cancer-specific survival (CSS), and overall survival (OS). The optimal cutoff value of PSADT was identified using survival tree analysis by Python. The Median PSA and PSADT at diagnosis of nmCRPC were 3.3 ng/ml, and 5.2 months, respectively. Patients treated with novel hormonal therapy (NHT) showed significantly longer PFS (HR: hazard ratio 0.38, p < 0.0001) and PFS2 (HR 0.45, p < 0.0001) than those treated with vintage nonsteroidal antiandrogen agent (Vintage). The survival tree identified 4.65 months as the most prognostic PSADT cutoff point. Among the clinical and pathological factors PSADT of < 4.65 months remained an independent prognostic factor for OS (HR 2.96, p = 0.0003) and CSS (HR 3.66, p < 0.0001). Current data represented optimal cut-off of PSADT 4.65 months for a Japanese nmCRPC.

Perioperative complications and cost of posterior decompression with fusion in thoracic spine for ossification of the posterior longitudinal ligament and ossification of the ligamentum flavum -a comparative study using a national inpatient database.

BACKGROUND: Although posterior decompression with fusion (PDF) are effective for treating thoracic myelopathy, surgical treatment has a high risk of various complications. There is currently no information available on the perioperative complications in thoracic ossification of the longitudinal ligament (T-OPLL) and thoracic ossification of the ligamentum flavum (T-OLF). We evaluate the perioperative complication rate and cost between T-OPLL and T-OLF for patients underwent PDF. METHODS: Patients undergoing PDF for T-OPLL and T-OLF from 2012 to 2018 were detected in Japanese nationwide inpatient database. One-to-one propensity score matching between T-OPLL and T-OLF was performed based on patient characteristics and preoperative comorbidities. We examined systemic and local complication rate, reoperation rate, length of hospital stays, costs, discharge destination, and mortality after matching. RESULTS: In a total of 2,660 patients, 828 pairs of T-OPLL and T-OLF patients were included after matching. The incidence of systemic complications did not differ significantly between the T-OPLL and OLF groups. However, local complications were more frequently occurred in T-OPLL than in T-OLF groups (11.4% vs. 7.7% P = 0.012). Transfusion rates was also significantly higher in the T-OPLL group (14.1% vs. 9.4%, P = 0.003). T-OPLL group had longer hospital stay (42.2 days vs. 36.2 days, P = 0.004) and higher medical costs (USD 32,805 vs. USD 25,134, P < 0.001). In both T-OPLL and T-OLF, the occurrence of perioperative complications led to longer hospital stay and higher medical costs. While fewer patients in T-OPLL were discharged home (51.6% vs. 65.1%, P < 0.001), patients were transferred to other hospitals more frequently (47.5% vs. 33.5%, P = 0.001). CONCLUSION: This research identified the perioperative complications of T-OPLL and T-OLF in PDF using a large national database, which revealed that the incidence of local complications was higher in the T-OPLL patients. Perioperative complications resulted in longer hospital stays and higher medical costs.

Development of parenting difficulties in infectious disease pandemic inventory.

BACKGROUND: The objective of this study was to develop the Parenting Difficulties in Infectious Disease Pandemic Inventory (PDIDPI) for the assessment of parenting difficulties during the coronavirus disease 2019 (COVID-19) pandemic and to examine its psychometric properties. METHODS: The 31-item PDIDPI was developed on the basis of the results of focus group interviews. An exploratory factor analysis using principal axis factoring was conducted to examine the PDIDPI factor structure. The internal consistency was assessed using Cronbach α values. The test-retest reliability was assessed using the intraclass correlation coefficient (ICC). The concurrent validity was established by examining the correlations of the PDIDPI with Fear of COVID-19 Scale and Center for Epidemiologic Studies Depression Scale (CESD) scores. RESULTS: We determined that the PDIDPI has seven factors: infection, school and learning, life change, care burden, daily living, health care, and emotion and behavior. The PDIDPI also had good internal consistency (α = 0.685-0.929) and acceptable test-retest reliability (ICC = 0.404-0.794). Regarding concurrent validity, the overall PDIDPI and its seven factors were all significantly associated with depression, determined by the CESD (r = 0.223-0.370), but not all factors were significantly associated with fear of COVID-19 (r = 0.082-0.203). CONCLUSIONS: Our findings support the psychometric properties of the PDIDPI, confirming its utility for evaluating the multifaceted challenges parents face in child management during the COVID-19 pandemic.

Enrichment culture evaluation and characterization of Streptococcus agalactiae among pregnant women in Japan.

Introduction. Maternal screening tests and prophylactic antibiotics are important to prevent neonatal and infant group B streptococcal (GBS) infections.Hypothesis/Gap Statement. The performance of enrichment broth media for GBS screening that are available in Japan is unclear. Whole-genome data of GBS isolates from pregnant women in Japan is lacking.Aim. The aim of this study was to compare the protocol performance of six enrichment broths and two subculture agar plates, which were all available in Japan, for GBS detection. In addition, we showed whole-genome data of GBS isolates from pregnant women in Japan.Methodology. We collected 133 vaginal-rectal swabs from pregnant women visiting clinics and hospitals in Nagasaki Prefecture, Japan, and compared the protocol performance of 6 enrichment broths and 2 subculture agar plates. All GBS isolates collected in this study were subjected to whole-genome sequencing analysis.Results. We obtained 133 vaginal-rectal swabs from pregnant women at 35-37 weeks of gestation from 8 private clinics and 2 local municipal hospitals within Nagasaki Prefecture, Japan. The detection rate of the protocol involving the six enrichment broths and subsequent subcultures varied between 95.5 and 100 %, depending on the specific choice of enrichment broth. The GBS carriage rate among pregnant women in this region was 18.8 %. All 25 isolates derived from the swabs were susceptible to penicillin, whereas 48 and 36 % of the isolates demonstrated resistance to erythromycin and clindamycin, respectively. The distribution of serotypes was highly diverse, encompassing seven distinct serotypes among the isolates, with the predominant serotype being serotype V (n = 8). Serotype V isolates displayed a tendency towards increased resistance to erythromycin and clindamycin, with all resistant isolates containing the ermB gene.Conclusion. There was no difference in performance among the culture protocols evaluated in this study. GBS strains isolated from pregnant women appeared to have greater genomic diversity than GBS strains detected in neonates/infants with invasive GBS infections. To confirm this result, further studies with larger sample sizes are needed.

Associations between modifiable risk factors and hepatocellular carcinoma: a trans-ancestry Mendelian randomization study.

BACKGROUND: Potentially modifiable risk factors for hepatocellular carcinoma (HCC) have been investigated in observational epidemiology studies in East Asian and European populations, whereas the causal associations of most of these risk factors remain unclear. METHODS: We collected genome-wide association summary statistics of 22 modifiable risk factors in East Asians and 33 risk factors in Europeans. Genetic summary statistics of HCC were sourced from the Biobank Japan study (1,866 cases and 195,745 controls) for East Asians, and the deCODE genetics study (406 cases and 49,302 controls) and the UK Biobank (168 cases and 372 016 controls) for Europeans. Two-sample Mendelian randomization (MR) analyses were performed independently for East Asian and European populations. RESULTS: In East Asians, genetically predicted alcohol frequency, ever drinkers, aspartate aminotransferase (AST), hypothyroidism, chronic hepatitis B, and chronic hepatitis C, metabolic dysfunction-associated steatotic liver disease (MASLD), and autoimmune hepatitis were significantly associated with an increased HCC risk (P < 0.05/22). Among European population, alanine transaminase, AST, MASLD, percent liver fat, and liver iron content were significantly associated with a higher risk of HCC (P < 0.05/33). The replication dataset and meta-analysis further confirmed these results. CONCLUSIONS: Although East Asian and European populations have different factors for HCC, their common modifiable risk factors AST and MASLD for HCC, offer valuable insights for targeted intervention strategies to mitigate society burden of HCC.

Long-term evacuation and obesity: a 12-year follow-up comparative study of residents inside and outside Katsurao Village after the Fukushima nuclear disaster.

Objective: Evacuation, owing to a disaster, impacts various aspects of an individual's life, including health status. This study aimed to determine the prevalence of obesity among residents of Katsurao Village, Fukushima Prefecture, after the evacuation order due to the Fukushima nuclear disaster in 2011 was lifted in 2016 and to compare the prevalence of obesity by place of residence (inside or outside the village). Methods: The number of examinees, sex, age, place of residence, body mass index (BMI), exercise habits, smoking habits, drinking habits, and dietary status were extracted from the results of health checkups since 2016. We compared the BMI of the indigenes of Katsurao Village by place of residence (inside or outside the village) over time. Results: Although 7 years have passed since 2016, ~70% of the registered residents of Katsurao Village still live outside the village. The obesity rates have consistently been higher among people living outside the village compared to those inside, and the place of residence was the only factor significantly associated with obesity. Conclusion: The findings of this study suggest early intervention is necessary to prevent health risks associated with disaster evacuation if the evacuation period is prolonged.

Postdischarge functional outcomes in older patients with acute heart failure in Japan: the Longevity Improvement & Fair Evidence study.

BACKGROUND: The association between care needs level (CNL) at hospitalisation and postdischarge outcomes in older patients with acute heart failure (aHF) has been insufficiently investigated. METHODS: This population-based cohort study was conducted using health insurance claims and CNL data of the Longevity Improvement & Fair Evidence study. Patients aged ≥65 years, discharged after hospitalisation for aHF between April 2014 and March 2022, were identified. CNLs at hospitalisation were classified as no care needs (NCN), support level (SL) and CNL1, CNL2-3 and CNL4-5 based on total estimated daily care time as defined by national standard criteria, and varied on an ordinal scale between SL&CNL1 (low level) to CNL4-5 (fully dependent). The primary outcomes were changes in CNL and death 1 year after discharge, assessed by CNL at hospitalisation using Cox proportional hazard models. RESULTS: Of the 17 724 patients included, 7540 (42.5%), 4818 (27.2%), 3267 (18.4%) and 2099 (11.8%) had NCN, SL&CNL1, CNL2-3 and CNL4-5, respectively, at hospitalisation. One year after discharge, 4808 (27.1%), 3243 (18.3%), 2968 (16.7%), 2505 (14.1%) and 4200 (23.7%) patients had NCN, SL&CNL1, CNL2-3, CNL4-5 and death, respectively. Almost all patients' CNLs worsened after discharge. Compared to patients with NCN at hospitalisation, patients with SL&CNL1, CNL2-3 and CNL4-5 had an increased risk of all-cause death 1 year after discharge (hazard ratio [95% confidence interval]: 1.19 [1.09-1.31], 1.88 [1.71-2.06] and 2.56 [2.31-2.84], respectively). CONCLUSIONS: Older patients with aHF and high CNL at hospitalisation had a high risk of all-cause mortality in the year following discharge.

Cutaneous fusarium disease and leukaemias: A systematic review.

The present study analyses the clinical characteristics of patients diagnosed with cutaneous fusarium through a systematic review of cases reported in literature. A total of 39 cases were included, of which 53% were men, 30% were women, and in 17% the sex was not specified. The age ranged from 5 to 85 years. Most cases were reported in Brazil, followed by Japan and United States of America. The most common agent was Fusarium solani, in 37.5% of the patients. Most of the affected individuals had acute myeloid leukaemia and some of the predisposing factors, which included induction chemotherapy, febrile neutropenia, and bone marrow transplantation. The clinical topography of the lesions was located in 27.5% and disseminated in 72.5%, with the most observed clinical feature outstanding the presence of papules and nodules with central necrosis in 47% of the cases. Longer survival was demonstrated in those treated with more than three antifungals. It is concluded that cutaneous fusarium is a complex and challenging clinical entity, infection in patients with leukaemias underscores the need for thorough care to decrease morbidity and mortality.

Association between Postoperative Adjuvant Vasodilator Therapy and In-Hospital Mortality for Non-Occlusive Mesenteric Ischemia: A Nationwide Observational Study.

BACKGROUND: Although several clinical guidelines recommend vasodilator therapy for non-occlusive mesenteric ischemia (NOMI) and immediate surgery when bowel necrosis is suspected, these recommendations are based on limited evidence. METHODS: In this retrospective nationwide observational study, we used information from the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2018 to identify patients with NOMI who underwent abdominal surgeries on the day of admission. We compared patients who received postoperative vasodilator therapy (vasodilator group) with those who did not (control group). Vasodilator therapy was defined as venous and/or arterial administration of papaverine and/or prostaglandin E1 within 2 days of admission. The primary outcome was in-hospital mortality. Secondary outcomes included the prevalence of additional abdominal surgery performed ≥3 days after admission and short bowel syndrome. RESULTS: We identified 928 eligible patients (149 in the vasodilator group and 779 in the control group). One-to-four propensity score matching yielded 149 and 596 patients for the vasodilator and control groups, respectively. There was no significant difference in in-hospital mortality between the groups (control vs. vasodilator, 27.5% vs. 30.9%; risk difference, 3.4%; 95% confidence interval, -4.9 to 11.6; p=0.42) and no significant difference in the prevalences of abdominal surgery, bowel resection ≥3 days after admission, and short bowel syndrome. CONCLUSIONS: Postoperative vasodilator use was not significantly associated with a reduction in in-hospital mortality or additional abdominal surgery performed ≥3 days after admission in surgically treated NOMI patients.

External Validation and Update of the Risk Prediction Model for Denosumab-Induced Hypocalcemia Developed From a Hospital-Based Administrative Database.

PURPOSE: Denosumab is used to treat patients with bone metastasis from solid tumors, but sometimes causes severe hypocalcemia, so careful clinical management is important. This study aims to externally validate our previously developed risk prediction model for denosumab-induced hypocalcemia by using data from two facilities with different characteristics in Japan and to develop an updated model with improved performance and generalizability. METHODS: In the external validation, retrospective data of Kameda General Hospital (KGH) and Miyagi Cancer Center (MCC) between June 2013 and June 2022 were used and receiver operating characteristic (ROC)-AUC was mainly evaluated. A scoring-based updated model was developed using the same data set from a hospital-based administrative database as previously employed. Selection of variables related to prediction of hypocalcemia was based on the results of external validation. RESULTS: For the external validation, data from 235 KGH patients and 224 MCC patients were collected. ROC-AUC values in the original model were 0.879 and 0.774, respectively. The updated model consisting of clinical laboratory tests (calcium, albumin, and alkaline phosphatase) afforded similar ROC-AUC values in the two facilities (KGH, 0.837; MCC, 0.856). CONCLUSION: We developed an updated risk prediction model for denosumab-induced hypocalcemia with small interfacility differences. Our results indicate the importance of using data from plural facilities with different characteristics in the external validation of generalized prediction models and may be generally relevant to the clinical application of risk prediction models. Our findings are expected to contribute to improved management of bone metastasis treatment.

[CURRENT STATUS OF SCHOOL LUNCHES RELATED TO FOOD ALLERGY AND UNMET NEEDS OF TEACHERS IN MIYAGI PREFECTURE].

BACKGROUND: The number of students with food allergies is on the increase, while the problems and burdens of school teachers and staff are not yet clear. Our study was designed to identify the unmet needs of school teachers and staff dealing with food allergy in school lunches. METHODS: A written questionnaire was sent by mail to 600 elementary and junior high schools in Miyagi Prefecture. RESULTS: Responses were received from 169 schools. The prevalence of food allergy was 5.6% and the EpiPen possession rate was 0.36%. The most common problems perceived by teachers and staff were the "increase in the number of students with food allergies" and the "diversification of causative foods". Other problems included "uncertainty of foods to be removed" and "insufficient collaboration among teachers, guardians, and doctors," which could be improved by the medical providers. In the free descriptions, many respondents complained of an excessive workload and the mental burden of never making a mistake or missing anything. CONCLUSION: Our survey revealed that while there is a public demand for safe school lunches, the teachers and staff dealing with this demand are under considerable strain. It is necessary to consider reducing the burden, and a sustainable system needs to be established.

Assessment of the Safety of Exposure to Cefcapene Pivoxil during the First Trimester of Pregnancy: A Prospective Cohort Study in Japan.

Cefcapene pivoxil hydrochloride is an antibiotic often used by women who are or may be pregnant. However, the safety of exposure to it during the first trimester of pregnancy has not been assessed. In this study, we aimed to clarify the effects of exposure during the first trimester of pregnancy on maternal and fetal outcomes. Data were obtained from pregnant women who were counseled on drug use during pregnancy at two Japanese facilities from April 1988 to December 2017. The incidence of major malformations in singleton pregnancy was compared between neonates born to women who took cefcapene pivoxil hydrochloride (n = 270) and control drugs (n = 1594) during their first trimester. The adjusted odds ratio of the incidence of major malformations was calculated using multivariate logistic regression analysis adjusted for smoking during pregnancy and maternal age. The incidence of major malformations was 2.6% in the cefcapene pivoxil hydrochloride group and 1.8% in the control group. There were no significant differences in the incidence between the cefcapene pivoxil hydrochloride and control groups (adjusted odds ratio: 1.48 [95% confidence interval: 0.64-3.42], p = 0.36). This prospective cohort study showed that exposure to cefcapene pivoxil hydrochloride during the first trimester of pregnancy was not associated with increased risk of major malformations in infants. Our findings will help healthcare providers in choosing appropriate medicines.

Prevalence of food allergy increased 1.7 times in the past 10 years among Japanese patients below 6 years of age.

BACKGROUND: While food allergy (FA) has been increasingly recognized as a growing public health burden worldwide, epidemiological studies on FA in Japan are limited. METHODS: This was a noninterventional, observational study using the administrative claims data from 2010 to 2019 (10 years). Patients with physician-diagnosed FA in Japan (prevalent cohort) were divided into high-risk or low-risk cohorts using adrenaline prescription. The high-risk cohort was further divided into anaphylaxis or nonanaphylaxis cohort based on the occurrence of anaphylaxis or a serious allergic reaction (SAR) during 1 year after adrenaline prescription. The primary objective was to examine yearly prevalence of FA. The secondary objectives were to describe demographics/clinical characteristics and healthcare resource utilization (HCRU), to evaluate the number of occurrences of anaphylaxis/SAR in the high-risk cohort, and the impact of anaphylaxis/SAR on HCRU. RESULTS: The overall standardized prevalence rate was 0.325% (95% confidence interval [CI], 0.311-0.339) in 2010 and 0.797% (95% CI, 0.790-0.804) in 2019 and predominant in patients age <6 years (preschool; 3.377% [95% CI, 3.229-3.525] in 2010 and 5.726% [95% CI, 5.663-5.789] in 2019). Majority of FA patients (>80%) were children/adolescent throughout the 10 years. While high-risk cohort was a relatively minor population (8.5% in the prevalent cohort in 2019), the occurrence of anaphylaxis/SAR in the high-risk cohort was 227,690/100,000 patient-years. Multivariate analysis showed a significant increase in HCRU variables in the anaphylaxis versus nonanaphylaxis cohort (e.g., 2.08 [95% CI, 2.05-2.11] times more FA-related outpatient visits). CONCLUSIONS: Prevalence of FA increased in a statistically significant way from 2010 to 2019; 1.7-fold increase was observed in patients <6 years old. Patients in the high-risk cohort appear to have suffered from frequent anaphylaxis/SAR, highlighting an unmet medical need for FA patients at "high-risk," considering the unavailability of approved medications to prevent anaphylaxis/SAR.

Predictors of Complete Oral Intake in Patients With Stroke After Tracheostomy.

BACKGROUND: Tracheostomy procedures inhibit swallowing, although details of subsequent recovery of oral intake remain unknown. This retrospective cohort study aimed to investigate factors influencing dysphagia improvement in patients with subacute stroke after tracheostomy. METHODS AND RESULTS: The study included 117 patients who underwent tracheostomy after subacute stroke, cerebral hemorrhage, or endogenous subarachnoid hemorrhage and received care at 2 convalescent rehabilitation wards in urban and suburban Japan between 2015 and 2022. The primary outcome measure was the achievement of complete oral intake. Patient demographics, Functional Independence Measure scores, body mass index, food intake level scale scores, and the presence of severe white matter hyperintensities on imaging were retrospectively collected from medical records. Statistical analysis involved univariate logistic regression to identify potential predictors and multivariate logistic regression to refine the model while accounting for multicollinearity. In total, 47% of patients achieved complete oral intake on discharge. Sex, days from onset to admission, Functional Independence Measure motor and cognitive scores, body mass index, food intake level scale scores, and severe white matter hyperintensities were identified as potential predictors in the univariate analysis. However, multivariate logistic regression identified only food intake level scale scores (odds ratio [OR], 3.687 [95% CI, 1.519-8.949]; P=0.004) and severe white matter hyperintensities (OR, 0.302 [95% CI, 0.096-0.956]; P=0.042) as significant predictors of complete oral intake. CONCLUSIONS: In patients with subacute stroke undergoing tracheostomy, the level of oral intake on admission and severe white matter hyperintensities on imaging may be better predictors of complete oral intake. However, prospective studies with larger sample sizes and more comprehensive data are warranted to confirm these findings.

Clinical features associated with NeoRAS wild-type metastatic colorectal cancer A SCRUM-Japan GOZILA substudy.

"NeoRAS WT" refers to the loss of RAS mutations (MTs) following first-line treatment in metastatic colorectal cancer (mCRC). We evaluate the incidence and clinicopathological characteristics of NeoRAS WT mCRC using next-generation sequencing of plasma circulating tumor DNA. Patients with mCRC enrolled in the GOZILA study initially diagnosed with tissue RAS MT mCRC and received subsequent systemic therapy are eligible. NeoRAS WT is defined as the absence of detectable RAS MT in plasma and assessed in all eligible patients (Group A) and in a subgroup with at least one somatic alteration detected in plasma (Group B). Overall, 478 patients are included. NeoRAS WT prevalence is 19.0% (91/478) in Group A and 9.8% (42/429) in Group B. Absence of liver or lymph node metastasis and tissue RAS MTs other than KRAS exon 2 MTs are significantly associated with NeoRAS WT emergence. Overall, 1/6 and 2/6 patients with NeoRAS WT treated with anti-EGFR monoclonal antibodies (mAbs) show partial response and stable disease for ≥6 months, respectively. NeoRAS WT mCRC is observed at a meaningful prevalence, and anti-EGFR mAb-based therapy may be effective.

The integrated incretin effect is reduced by both glucose intolerance and obesity in Japanese subjects.

Introduction: Incretin-based drugs are extensively utilized in the treatment of type 2 diabetes (T2D), with remarkable clinical efficacy. These drugs were developed based on findings that the incretin effect is reduced in T2D. The incretin effect in East Asians, whose pancreatic ß-cell function is more vulnerable than that in Caucasians, however, has not been fully examined. In this study, we investigated the effects of incretin in Japanese subjects. Methods: A total of 28 Japanese subjects (14 with normal glucose tolerance [NGT], 6 with impaired glucose tolerance, and 8 with T2D) were enrolled. Isoglycemic oral (75 g glucose tolerance test) and intravenous glucose were administered. The numerical incretin effect and gastrointestinally-mediated glucose disposal (GIGD) were calculated by measuring the plasma glucose and entero-pancreatic hormone concentrations. Results and discussion: The difference in the numerical incretin effect among the groups was relatively small. The numerical incretin effect significantly negatively correlated with the body mass index (BMI). GIGD was significantly lower in participants with T2D than in those with NGT, and significantly negatively correlated with the area under the curve (AUC)-glucose, BMI, and AUC-glucagon. Incretin concentrations did not differ significantly among the groups. We demonstrate that in Japanese subjects, obesity has a greater effect than glucose tolerance on the numerical incretin effect, whereas GIGD is diminished in individuals with both glucose intolerance and obesity. These findings indicate variances as well as commonalities between East Asians and Caucasians in the manifestation of incretin effects on pancreatic ß-cell function and the integrated capacity to handle glucose.