Publishing type：Research paper (scientific journal)   Publisher：American Medical Association (AMA)  

Importance

Substantial heterogeneity exists in treatment recommendations across molecular tumor boards (MTBs), especially for biomarkers with low evidence levels; therefore, the learning program is essential.

Objective

To determine whether a learning program sharing treatment recommendations for biomarkers with low evidence levels contributes to the standardization of MTBs and to investigate the efficacy of an artificial intelligence (AI)–based annotation system.

Design, Setting, and Participants

This prospective quality improvement study used 50 simulated cases to assess concordance of treatment recommendations between a central committee and participants. Forty-seven participants applied from April 7 to May 13, 2021. Fifty simulated cases were randomly divided into prelearning and postlearning evaluation groups to assess similar concordance based on previous investigations. Participants included MTBs at hub hospitals, treating physicians at core hospitals, and AI systems. Each participant made treatment recommendations for each prelearning case from registration to June 30, 2021; participated in the learning program on July 18, 2021; and made treatment recommendations for each postlearning case from August 3 to September 30, 2021. Data were analyzed from September 2 to December 10, 2021.

Exposures

The learning program shared the methodology of making appropriate treatment recommendations, especially for biomarkers with low evidence levels.

Main Outcomes and Measures

The primary end point was the proportion of MTBs that met prespecified accreditation criteria for postlearning evaluations (approximately 90% concordance with high evidence levels and approximately 40% with low evidence levels). Key secondary end points were chronological enhancements in the concordance of treatment recommendations on postlearning evaluations from prelearning evaluations. Concordance of treatment recommendations by an AI system was an exploratory end point.

Results

Of the 47 participants who applied, 42 were eligible. The accreditation rate of the MTBs was 55.6% (95% CI, 35.3%-74.5%; P < .001). Concordance in MTBs increased from 58.7% (95% CI, 52.8%-64.4%) to 67.9% (95% CI, 61.0%-74.1%) (odds ratio, 1.40 [95% CI, 1.06-1.86]; P = .02). In postlearning evaluations, the concordance of treatment recommendations by the AI system was significantly higher than that of MTBs (88.0% [95% CI, 68.7%-96.1%]; P = .03).

Conclusions and Relevance

The findings of this quality improvement study suggest that use of a learning program improved the concordance of treatment recommendations provided by MTBs to central ones. Treatment recommendations made by an AI system showed higher concordance than that for MTBs, indicating the potential clinical utility of the AI system.

DOI： 10.1001/jamaoncol.2023.5120

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DOI： 10.1007/s42081-023-00206-1

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There are no validated biomarkers for schizophrenia (SCZ), a disorder linked to neural network dysfunction. We demonstrate that collapsin response mediator protein-2 (CRMP2), a master regulator of cytoskeleton and, hence, neural circuitry, may form the basis for a biomarker because its activity is uniquely imbalanced in SCZ patients. CRMP2's activity depends upon its phosphorylation state. While an equilibrium between inactive (phosphorylated) and active (nonphosphorylated) CRMP2 is present in unaffected individuals, we show that SCZ patients are characterized by excess active CRMP2. We examined CRMP2 levels first in postmortem brains (correlated with neuronal morphometrics) and then, because CRMP2 is expressed in lymphocytes as well, in the peripheral blood of SCZ patients versus age-matched unaffected controls. In the brains and, more starkly, in the lymphocytes of SCZ patients <40 y old, we observed that nonphosphorylated CRMP2 was higher than in controls, while phosphorylated CRMP2 remained unchanged from control. In the brain, these changes were associated with dendritic structural abnormalities. The abundance of active CRMP2 with insufficient opposing inactive p-CRMP2 yielded a unique lowering of the p-CRMP2:CRMP2 ratio in SCZ patients, implying a disruption in the normal equilibrium between active and inactive CRMP2. These clinical data suggest that measuring CRMP2 and p-CRMP2 in peripheral blood might reflect intracerebral processes and suggest a rapid, minimally invasive, sensitive, and specific adjunctive diagnostic aid for early SCZ: increased CRMP2 or a decreased p-CRMP2:CRMP2 ratio may help cinch the diagnosis in a newly presenting young patient suspected of SCZ (versus such mimics as mania in bipolar disorder, where the ratio is high).

DOI： 10.1073/pnas.2100032118

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：WILEY  

In modeling biological and ecological processes from data, it is essential to deal with data selection bias properly in order to obtain reliable and reasonable predictions. To incorporate the mechanism of selection bias into a statistical analysis, a propensity score (PS) is widely employed as an inverse probability weight in order to obtain a consistent estimation of a binary response variable of interest. However, the estimation performance often becomes unstable due to the mis-estimation of the PS. In order to obtain a consistent estimation as well as to stabilize the estimation performance, we propose a new regression model that incorporates the PS as an explanatory variable. Moreover, we show that the proposed model has a the property of double robustness, which enables us to obtain a consistent estimation of the response without suffering from selection bias if either the PS model or the proposed model is correctly specified. The robust bias correction model also accommodates heterogeneity of data distributions based on an asymmetric logistic model, which in turn improves model fitting and prediction accuracy. The PS in our regression model enables us to estimate consistently the global fish stock status even if the information of the stock status available is biased.

DOI： 10.1002/ecs2.2038

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DOI： 10.1080/15598608.2015.1048396

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DOI： 10.3844/jmssp.2016.152.156

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DOI： 10.1016/j.spl.2015.02.023

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DOI： 10.3233/MAS-130286

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BACKGROUND AND AIM: Qualitative diagnosis of ulcerative colitis-associated neoplasia (UCAN) is crucial for surveillance colonoscopy in patients with ulcerative colitis (UC). Although the utility of magnifying endoscopy with narrow-band imaging (ME-NBI) in sporadic neoplasia diagnosis has been reported, its efficacy in UCAN remains unclear. This study aimed to evaluate the usefulness of ME-NBI for qualitative diagnosis of UCAN. METHODS: We generated 60 ME-NBI images (30 UCANs and 30 nonneoplasia lesions, including 10 polypoid and 20 nonpolypoid lesions) from patients with UC who underwent colonoscopy at our hospital between 2015 and 2023. Eleven endoscopists (seven experts and four trainees) independently assessed these images. Lesions were categorized into high- (≥ 80%), moderate- (50%-79%), and low- (< 50%) accuracy groups on the basis of the correct diagnostic rate. RESULTS: Overall sensitivity, specificity, and correct diagnostic rates were 66.5%, 79.0%, and 71.8%, respectively. Experts tended to exhibit higher specificity than trainees (83% vs. 70%). Polypoid lesions showed higher sensitivity (92% vs. 54%) and lower specificity (61% vs. 88%) than nonpolypoid lesions. Overall, the kappa value was 0.411. In UCAN, 37%, 37%, and 24% were classified into the high-, moderate-, and low-accuracy groups, respectively. All endoscopists assessed one case of UCAN in the low-accuracy group as a nonneoplastic vessel with a surface pattern. Only two nonneoplasias were identified as having nonneoplastic vessel and surface patterns by all endoscopists. CONCLUSIONS: This study demonstrated the usefulness of ME-NBI for qualitative diagnosis, along with its limitations. A unique endoscopic diagnostic algorithm for UCAN, incorporating ME-NBI and other modalities, is necessary.

DOI： 10.1111/jgh.16877

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AIM: Lymph node metastasis is an adverse prognostic factor in pancreatic ductal adenocarcinoma. However, it remains a challenge to predict lymph node metastasis using preoperative imaging alone. We used machine learning (combining preoperative imaging findings, tumor markers, and clinical information) to create a novel prediction model for lymph node metastasis in resectable pancreatic ductal adenocarcinoma. METHODS: The data of patients with resectable pancreatic ductal adenocarcinoma who underwent surgery between September 1991 and October 2022 were retrospectively examined. Machine-learning software (Statistical Package for the Social Sciences Modeler) was used to create a prediction model, and parameter tuning was performed to improve the model's accuracy. We also analyzed the contribution of each feature to prediction using individual conditional expectation and partial dependence plots. RESULTS: Of the 331 cases included in the study, 241 comprised the training cohort and 90 comprised the test cohort. After parameter tuning, the areas under the receiver operating characteristic curves for the training and test cohorts were 0.780 and 0.795, respectively. Individual conditional expectation and partial dependence plots showed that larger tumor size and carbohydrate antigen 19-9 and Duke pancreatic monoclonal antigen type 2 levels were associated with positive lymph node metastasis prediction in this model; neoadjuvant treatment was associated with negative lymph node metastasis prediction. CONCLUSION: Machine learning may contribute to the creation of an effective predictive model of lymph node metastasis in pancreatic ductal adenocarcinoma. Prediction models using machine learning may contribute to the development of new treatment strategies in resectable pancreatic ductal adenocarcinoma.

DOI： 10.1002/ags3.12836

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Introduction: In Japan, telemedicine has gradually expanded due to deregulation in response to the COVID-19 pandemic. However, its current status remains unclear, as it is primarily provided by general practitioners. This study aims to examine the use of telemedicine in sublingual immunotherapy (SLIT) for patients with Japanese cedar pollen allergy and/or house dust mite allergic rhinitis. Methods: We conducted a retrospective analysis of medical record data from seven otorhinolaryngology clinics and performed an exploratory evaluation between a group that combined telemedicine and in-person visits during the initial 6 months of SLIT and another group with only in-person visits. Results: Following propensity score matching, 51 and 82 patients were eligible for the telemedicine and in-person groups, respectively, with 33 cases in both groups. Both groups had similar characteristics after matching. No significant difference was found in the withdrawal rate at 6 months from the start of SLIT (6.1% and 9.1% in each group; p = 1.00), side effects, or treatment efficacy between the two groups. The average copayment for patients tended to be significantly higher in the telemedicine group after one, three, and 6 months following SLIT initiation. Discussion: The situation of patients who receive an appropriate combination of telemedicine and in-person visits is not significantly different from patients who receive in-person visits alone. This study may help indicate the actual status of telemedicine in Japan. Further investigation at more facilities is necessary in the future to dispel concerns in the practice setting.

DOI： 10.1089/tmj.2024.0065

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DOI： 10.36648/1479-1064.32.2.11

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BACKGROUND: Anti-SS-A/Ro antibody (anti-SSA), the diagnostic marker of Sjögren's syndrome (SS), is often detected in systemic sclerosis (SSc). Some patients are diagnosed with SSc/SS overlap syndromes, while there are anti-SSA-positive SSc cases without SS. In this study, we investigated the clinical characteristics of SSc with anti-SSA and clarified the clinical impact of this antibody in SSc. METHODS: A retrospective chart review was conducted of 156 patients with SSc at Yokohama City University Hospital from 2018 to 2021. Clinical data, laboratory data, imaging, and autoantibody positivity status were collected and analysed to assess the association between these variables and anti-SSA using multivariable logistic regression analysis. RESULTS: This cohort included 18 men and 138 women with SSc (median age, 69.0 years). Thirty-nine patients had diffuse cutaneous SSc (dcSSc) (25%), and 117 patients had limited cutaneous SSc (75%). Forty-four patients were anti-SSA-positive. Among them, 24 fulfilled the SS criteria. Multivariable logistic regression revealed that anti-SSA was statistically associated with interstitial lung disease (ILD; odds ratio [OR] = 2.67; 95% confidence interval [CI], 1.14-6.3; P = 0.024). Meanwhile, anti-SSA positivity tended to increase the development of digital ulcer (OR = 2.18; 95% CI, 0.99-4.82, P = 0.054). In the comparative analysis of the autoantibody single-positive and anti-SSA/SSc-specific autoantibody double-positive groups, the anti-SSA single-positive group showed a significantly increased risk of ILD (OR = 12.1; 95% CI, 2.13-140.57; P = 0.003). Furthermore, patients with SSc and anti-SSA indicated that anti-SSA-positive SSc without SS was strongly associated with dcSSc when compared to that in patients with SS (OR = 6.45; 95% CI, 1.23-32.60; P = 0.024). CONCLUSIONS: Anti-SSA positivity increases the risk of organ involvement, such as ILD, in patients with SSc. Additionally, the anti-SSA-positive SSc without SS population may have more severe skin fibrosis than others. Anti-SSA may be a potential marker of ILD and skin severity in SSc.

DOI： 10.1186/s13075-024-03325-6

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BACKGROUND: This study investigated whether the chronic use of adaptive servo-ventilation (ASV) reduces all-cause mortality and the rate of urgent rehospitalization in patients with heart failure (HF). METHODS AND RESULTS: This multicenter prospective observational study enrolled patients hospitalized for HF in Japan between 2019 and 2020 who were treated either with or without ASV therapy. Of 845 patients, 110 (13%) received chronic ASV at hospital discharge. The primary outcome was a composite of all-cause death and urgent rehospitalization for HF, and was observed in 272 patients over a 1-year follow-up. Following 1:3 sequential propensity score matching, 384 patients were included in the subsequent analysis. The median time to the primary outcome was significantly shorter in the ASV than in non-ASV group (19.7 vs. 34.4 weeks; P=0.013). In contrast, there was no significant difference in the all-cause mortality event-free rate between the 2 groups. CONCLUSIONS: Chronic use of ASV did not impact all-cause mortality in patients experiencing recurrent admissions for HF.

DOI： 10.1253/circj.CJ-23-0827

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AIM: Peripheral artery disease (PAD) severely impairs patient prognosis and quality of life (QOL). Although lipoprotein apheresis (LA) has been applied to patients with PAD and elevated serum atherogenic lipoproteins, we hypothesized that LA can be effective for treating PAD even in patients with controlled serum lipoproteins through pleiotropic anti-atherosclerotic effects beyond lipoprotein removal. This study aimed to evaluate the efficacy of LA in patients with treatment-resistant PAD and controlled serum lipoproteins focusing on QOL. METHODS: In a single-arm prospective study, 30 patients with refractory PAD who had controlled serum lipoproteins underwent sequential LA sessions using dextran sulfate adsorption columns, aiming to complete 10 sessions. The ankle-brachial pressure index (ABI) and vascular QOL (VascuQOL) score were evaluated as the primary outcomes. Secondary outcomes included reactive hyperemia index (RHI) and biological antioxidant potential (BAP) as an endothelial function test and serum antioxidative-capacity evaluation, respectively. RESULTS: ABI significantly increased after LA sessions (pre-treatment 0.60±0.09 vs. post-treatment 0.65±0.13, p=0.023). Total VascuQOL score (3.7±1.1 vs 4.6±1.1, p＜0.001) and RHI (1.70±0.74 vs 2.34±1.76, p=0.023) significantly improved after the LA sessions. BAP tended to increase after the LA sessions, and the change reached statistical significance 3 months after treatment. CONCLUSION: ABI and QOL improved after a series of LA sessions in conventional treatment-resistant PAD patients with controlled serum lipoprotein levels. Increased antioxidative capacity and ameliorated endothelial function were observed after the LA treatment.

DOI： 10.5551/jat.64639

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Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media LLC  

DOI： 10.1007/s12185-023-03700-0

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Other Link： https://link.springer.com/article/10.1007/s12185-023-03700-0/fulltext.html

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Introduction: This study aimed to identify immune mediators, including cytokines, chemokines, and growth factors, in the plasma for predicting treatment efficacy and immune-related adverse events (irAEs) in advanced urothelial carcinoma (aUC) treated with immune checkpoint inhibitors (ICIs). Methods: We enrolled 57 patients with aUC who were treated with the anti-programmed cell death protein 1 (PD-1) antibody pembrolizumab after the failure of platinum-based chemotherapy between February 2018 and December 2020. Plasma levels of 73 soluble immune mediators were measured before and 6 weeks after initiating pembrolizumab therapy. The association of estimated soluble immune mediators with clinical outcomes, including overall survival (OS), progression-free survival (PFS), anti-tumor responses, and irAEs, were statistically evaluated. Results: In the multivariate analysis, levels of 18 factors at baseline and 12 factors during treatment were significantly associated with OS. Regarding PFS, baseline levels of 17 factors were significantly associated with PFS. Higher levels of interleukin (IL)-6, IL-8, soluble tumor necrosis factor receptor 1 (sTNF-R1), and IL-12 (p40), both at baseline and post-treatment, were significantly associated with worse OS. Conversely, low IL-6 and high TWEAK levels at baseline were associated with irAEs. Among identified factors, interferon (IFN) γ and IL-12 (p40) were repeatedly identified; high baseline levels of these factors were risk factors for worse OS and PFS, as well as progressive disease. Notably, using correlation and principal component analysis, factors significantly associated with clinical outcomes were broadly classified into three groups exhibiting similar expression patterns. Discussion: Measuring plasma levels of soluble immune mediators, such as IL-6, IL-8, sTNF-R1, IFNγ, and IL-12 (p40), could be recommended for predicting prognosis and irAEs in ICI-treated patients with aUC.

DOI： 10.3389/fphar.2023.1269935

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Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media LLC  

DOI： 10.1007/s10877-023-01081-7

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Other Link： https://link.springer.com/article/10.1007/s10877-023-01081-7/fulltext.html

DOI： 10.3389/fimmu.2023.1227403

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DOI： 10.1002/cam4.6405

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DOI： 10.1186/s40560-023-00673-4

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DOI： 10.1111/den.14570

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Publishing type：Research paper (scientific journal)   Publisher：Wiley  

Abstract

Introduction

Conventionally, the recommended duration of adjuvant chemotherapy of colon cancer had been 6 months. The IDEA Collaboration suggested that shortening capecitabin and oxaliplatin (CAPOX) adjuvant chemotherapy may be possible. S‐1 and oxaliplatin (SOX) treatment is standard treatment in metastatic colorectal cancer in Japan. The aim of this study was to optimize treatment dosage and duration of adjuvant SOX in stage III colon cancer.

Methods

This trial was as open‐label multi‐center randomized phase II study. Patients with stage III colon cancer were randomly assigned to 3 months or 6 months of adjuvant SOX treatment in different doses: 130 mg/m² (3 months) or 100 mg/m² (6 months) of oxaliplatin. The primary endpoint was 3‐year disease‐free survival (DFS) and the null hypothesis for the primary endpoint was that the 3‐year DFS was ≤72% in each arm and was tested with a one‐sided significance level of 10%.

Results

Eighty‐two patients were assigned to the 6 months arm and 81 to the 3 months arm. The 3‐year DFS was 75.0% (80% CI 67.95–80.72, p = 0.282) in the 6 months arm and 76.9% (80% CI 70.1–82.38, p = 0.171) in the 3 months arm. Treatment completion rate and relative dose intensity (RDI) were higher in 3 months than 6 months arm. The adverse events (AE) were similar in both arms.

Conclusions

The 3‐year DFS was not significantly superior to null hypothesis in both 3 months and 6 months arms for the stage III colon cancer. Primary endpoint was not achieved. The SOX regimen was not feasible in long‐term outcomes.

DOI： 10.1002/ags3.12687

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DOI： 10.1111/1346-8138.16644

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BACKGROUND: Suicide remains one of the leading causes of death among adolescents. Although recent studies have suggested a strong association between auditory hallucinations and suicidal behaviors, little is known regarding the association between suicidal behaviors and visual hallucinations, which are also common among adolescent psychiatric patients. METHOD: A cross-sectional study of all first-time patients aged 10-15 years was conducted at three child and adolescent psychiatric outpatient facilities in Kanagawa Prefecture, Japan, from April 2015 to March 2018. Self-reported questionnaires were administered to evaluate auditory and visual hallucinations, suicide planning, and suicide attempts within the two weeks prior to the first visit. Our logistic regression model included three covariates (sex, age, and presence of major depressive episode) for adjustments. Among the 1285 respondents, 37 who had moderate or severe intellectual disability were excluded, leaving 1248 for analysis. RESULTS: Among the 1069 patients who completed questionnaire items on hallucinations, 230 (21.5%) experienced auditory or visual hallucinations. After controlling for all confounders, visual hallucinations, but not auditory hallucinations, were significantly associated with increased odds of suicide planning (odds ratio [OR] 2.5, 95% confidence interval [CI] 1.5-4.1). In contrast, auditory hallucinations, but not visual hallucinations, were significantly associated with increased odds of suicide attempts (OR 2.8, 95% CI 1.3-6.1). No interaction effects were observed between suicidal behaviors and auditory or visual hallucinations. CONCLUSIONS: Clinicians should consider the prevalence of both auditory and visual hallucinations among young adolescent patients, with emphasis on auditory hallucinations, given their association with suicide attempts.

DOI： 10.1111/camh.12504

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Continuous monitoring of the respiratory rate is crucial in an acute care setting. Contact respiratory monitoring modalities such as capnography and thoracic impedance pneumography are prone to artifacts, causing false alarms. Moreover, their cables can restrict patient behavior or interrupt patient care. A microwave Doppler sensor is a novel non-contact continuous respiratory rate monitor. We compared respiratory rate measurements performed with a microwave Doppler sensor mounted on the ceiling of an intensive care unit with those obtained by conventional methods in conscious and spontaneously breathing patients. Participants' respiratory rate was simultaneously measured by visual counting of chest wall movements for 60 s; a microwave Doppler sensor; capnography, using an oxygen mask; and thoracic impedance pneumography, using electrocardiogram electrodes. Bland-Altman analysis for repeated measures was performed to calculate bias and 95% limits of agreement between the respiratory rate measured by visual counting (reference) and that measured by each of the other methods. Among 52 participants, there were 336 (microwave Doppler sensor), 275 (capnography), and 336 (thoracic impedance pneumography) paired respiratory rate data points. Bias (95% limits of agreement) estimates were as follows: microwave Doppler sensor, 0.3 (- 6.1 to 6.8) breaths per minute (bpm); capnography, - 1.3 (- 8.6 to 6.0) bpm; and thoracic impedance pneumography, 0.1 (- 4.4 to 4.7) bpm. Compared to visual counting, the microwave Doppler sensor showed small bias; however, the limits of agreement were similar to those observed in other conventional methods. Our monitor and the conventional ones are not interchangeable with visual counting.Trial registration number: UMIN000032021, March/30/2018.

DOI： 10.1007/s10877-021-00733-w

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AIM: To compare the mid-term oncological results between patients with low rectal cancer who underwent minimally invasive laparoscopic surgery (MILS) and those who underwent open surgery (OS). PATIENTS AND METHODS: Overall, 262 matched patients who underwent primary resection for low rectal cancer between 2000 and 2019 were divided into MILS (n=131; n=107, conventional laparoscopic surgery; n=24, robotic surgery) and OS (n=131) groups. The short- and mid-term outcomes were compared. RESULTS: Similar baseline characteristics were noted. The operative time was longer and blood loss was lesser in the MILS group; the conversion rate was 3.8%. The incidence of postoperative complications was similar. The 2-year cumulative incidence of local recurrence was noted to be much lower in the MILS group (1.9%) than in the OS group (8.4%). MILS had a significantly low hazard ratio (0.208, p=0.036). CONCLUSION: MILS has potential benefits in reducing local recurrence of low rectal cancer.

DOI： 10.21873/anticanres.15042

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Background: Community-acquired pneumonia is one of the most common diseases in elderly persons and usually results in a prolonged hospital stay. Discharge planning plays an important role in reducing the length of hospitalization. This study was designed to determine whether early screening for risk factors for delayed discharge could improve the quality of discharge planning. Methods: This retrospective, observational study was conducted in two medical facilities from January 2016 to December 2018. Hospital A used a screening tool on admission (screening group): screening for risk factors for delayed discharge and initiating discharge planning immediately for those for whom it was applicable, and discharge planning in the stable phase for those for whom it was not applicable; and Hospital B initiated discharge planning without screening (usual group). Propensity score-matched pneumonia patients in the two groups were then compared. The primary outcome was length of hospital stay. Results: A total of 648 patients were enrolled in this study. After adjusting for age, sex, aspiration, comorbidity, pneumonia severity index, and key person, 118 pairs underwent analysis. Length of stay was significantly different (20 days vs 13 days, p<0.001) between the groups. There were no differences in duration of antibiotic treatment, in-hospital mortality, and 30-day readmission (9 days vs 9 days, p=0.744; 10 (8.5%) vs 10 (8.5%), p=1.000; 10 (8.5%) vs 9 (7.6%), p=0.811, respectively). Conclusion: Early screening for delayed discharge improved the quality of discharge planning by reducing the length of stay in pneumonia patients.

DOI： 10.2147/CIA.S296390

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The aim of the present study was to investigate the psychological effects of the COVID-19 outbreak and associated factors on hospital workers at the beginning of the outbreak with a large disease cluster on the Diamond Princess cruise ship. This cross-sectional, survey-based study collected demographic data, mental health measurements, and stress-related questionnaires from workers in 2 hospitals in Yokohama, Japan, from March 23, 2020, to April 6, 2020. The prevalence rates of general psychological distress and event-related distress were assessed using the 12-item General Health Questionnaire (GHQ-12) and the 22-item Impact of Event Scale-Revised (IES-R), respectively. Exploratory factor analysis was conducted on the 26-item stress-related questionnaires. Multivariable logistic regression analysis was performed to identify factors associated with mental health outcomes for workers both at high- and low-risk for infection of COVID-19. A questionnaire was distributed to 4133 hospital workers, and 2697 (65.3%) valid questionnaires were used for analyses. Overall, 536 (20.0%) were high-risk workers, 944 (35.0%) of all hospital workers showed general distress, and 189 (7.0%) demonstrated event-related distress. Multivariable logistic regression analyses revealed that 'Feeling of being isolated and discriminated' was associated with both the general and event-related distress for both the high- and low-risk workers. In this survey, not only high-risk workers but also low-risk workers in the hospitals admitting COVID-19 patients reported experiencing psychological distress at the beginning of the outbreak.

DOI： 10.1371/journal.pone.0245294

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DOI： 10.1097/MJT.0000000000001321

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INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) pathogenesis involves abnormal metabolism of cholesterol and hepatic accumulation of toxic free-cholesterol. Elobixibat (EXB) inhibits the ileal bile acid (BA) transporter. EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol. In this randomised, double-blind, placebo-controlled, parallel-group, phase IIa study, we aim to provide a proof-of-concept assessment by evaluating the efficacy and safety of EXB in combination with CTM in patients with NAFLD. METHODS AND ANALYSIS: A total of 100 adult patients with NAFLD, diagnosed based on low-density lipoprotein cholesterol (LDL-C) level of >120 mg/dL and liver fat content of ≥8% by MRI-based proton density fat fraction (MRI-PDFF), who meet the inclusion/exclusion criteria will be enrolled. The patients will be randomly assigned to receive the combination therapy of 10 mg EXB and 9 g CTM powder (4 g CTM), 10 mg EXB monotherapy, 9 g CTM powder monotherapy or a placebo treatment (n=25 per group). Blood tests and MRIs will be performed 16 weeks following treatment initiation. The primary study endpoint will be the absolute LDL-C level change at week 16 after treatment initiation. The exploratory endpoint will include absolute changes in the liver fat fraction as measured by MRI-PDFF. This proof-of-concept study will determine whether the combination therapy of EXB and CTM is effective and safe for patients with NAFLD. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of Yokohama City University Hospital before participant enrolment. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. TRIAL REGISTRATION NUMBER: NCT04235205.

DOI： 10.1136/bmjopen-2020-037961

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Purpose: Among senior community-acquired pneumonia (CAP) survivors, functional status after hospitalization is often decreased. This study investigated the change of functional status affecting delayed discharge. Patients and Methods: This retrospective observational study was conducted in two medical facilities from January 2016 to December 2018. Hospitalized CAP patients >64 years old were divided into two groups: an early group discharged ≤1 week after ending antibiotic treatment and a delayed group discharged >1 week after ending antibiotic treatment. The primary outcome was decline in functional status. Results: The early group comprised 170 patients and the delayed group comprised 155 patients (median age: 78 vs 82 years; p = 0.007). Distribution of the causative microorganisms and initial prescription of antibiotics showed no significant differences in the two groups (p=0.38; p=0.83, respectively) More patients showed decline in functional status in the delayed group than the early group (16 (9.4%) vs 49 (31.6%), p<0.001), even if rehabilitation was more frequently conducted (77 (45.3%) vs 118 (76.1%); p<0.001). Higher medical expenses were observed in the delayed group ($8631 vs $3817, respectively; p<0.001). Multivariable regression analysis of factors contributing delayed discharge revealed that decreased functional status, pneumonia severity index (PSI) categories, rehabilitation enrolled, aspiration and age were independently associated with delayed discharge (odds ratio 4.31, 95% confidence interval (CI) 2.32-7.98; 2.34, 95% CI 1.43-3.82; 15.96, 95% CI 4.56-55.82 (PSI V vs II); 2.48, 95% CI 1.11-5.98; and 1.03, 95% CI 1.01-1.06; respectively). Conclusion: Functional status decline was independently associated with extended hospitalization.

DOI： 10.2147/CIA.S267349

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BACKGROUND: Low population density may be associated with high mortality in acute myocardial infarction (AMI) patients. The purpose of this study was to investigate the effect of population density and hospital primary percutaneous coronary intervention (PCI) volume on AMI in-hospital mortality in Japan.Methods and Results:This is a retrospective study of 64,414 AMI patients transported to hospital by ambulances. The main outcome measure was in-hospital mortality. The median population density was 1,147 (interquartile range, 342-5,210) persons/km2. There was a significant negative relationship between population density and in-hospital mortality (OR for a quartile down in population density 1.086, 95% CI 1.042-1.132, P<0.001). Patients in less densely populated areas were more often transported to hospitals with a lower primary PCI volume, and they had a longer distance to travel. By using multivariable analysis, primary PCI volume was found to be significantly associated with in-hospital mortality, but distance to hospital was not. When divided into the low- and high-volume hospitals, using the cut-off value of 115 annual primary PCI procedures, the increase in in-hospital mortality associated with low population density was observed only in patients hospitalized in the low-volume hospitals. CONCLUSIONS: Increased in-hospital mortality related to low population density was observed only in AMI patients who were transported to the low primary PCI volume hospitals, but not in those who were transported to high-volume hospitals.

DOI： 10.1253/circj.CJ-19-0869

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BACKGROUND: Use of the antipsychotic drug olanzapine by patients with schizophrenia is associated with autonomic nervous system (ANS) dysfunction. It is presumed that there are interindividual differences in ANS dysfunction that correspond to pharmacogenetics. In this study, we investigated whether genetic polymorphisms in ABCB1, CYP1A2, and UGT1A4 are associated with this observed ANS dysfunction. METHODS: A total of 91 schizophrenia patients treated with olanzapine monotherapy participated in this study. A power spectral analysis of heart rate variability was used to assess ANS activity. The TaqMan system was used to genotype seven single nucleotide polymorphisms (SNPs) in CYP1A2 (rs2069514 and rs762551), UGT1A4 (rs2011425), and ABCB1 (rs1045642, rs1128503, rs2032582, rs2235048). RESULTS: Sympathetic nervous activity was significantly higher in individuals with the UGT1A4 rs2011425 G allele than in those with the UGT1A4 rs2011425 non-G allele (sympathetic activity, p = .001). Furthermore, sympathetic nervous activity was also significantly associated with UGT1A4 rs2011425 genotype as revealed by multiple regression analysis (sympathetic activity, p = .008). CONCLUSIONS: We suggest that the UGT1A4 rs2011425 polymorphism affects olanzapine tolerability because it is associated with the observed side effects of olanzapine in schizophrenia patients, namely sympathetic dysfunction.

DOI： 10.1186/s12888-020-02492-5

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To estimate pregnancy complications in women newly diagnosed with gestational diabetes mellitus (GDM) according to the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria and verify the validity of introducing the IADPSG criteria in Japan. This retrospective study included data from women with singleton delivery at 22 weeks or later at a tertiary hospital during 2000-2009. We compared pregnancy outcomes between women who would now be diagnosed with GDM according to the IADPSG criteria but not by the old JSOG criteria (IGT group, n = 503) and women with normal glucose tolerance according to both the criteria (NGT group, n = 2,789). Multivariate analysis was performed and adjusted for background factors. Maternal age at delivery and pre-pregnancy BMI were significantly higher in the IGT group than in the NGT group, while gestational weeks at delivery did not differ between the groups. No difference was observed in the rates of GDM-related composite complications (defined as cases with at least one of the following: macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, or neonatal respiratory distress syndrome) at 11.9% and 8.8% (adjusted odds ratio (OR) 1.30, 95% confidence interval (CI) 0.90-1.87, p = 0.16). Pregnancy outcomes did not differ significantly between the IGT and NGT groups, except for frequencies of total neonatal admissions at 10.5% and 7.1%, respectively (adjusted OR 1.55, 95% CI 1.12-2.13, p < 0.01).

DOI： 10.1507/endocrj.EJ19-0279

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Background/Aims: Strategies for an effective intervention after chronic kidney disease (CKD) screening have not been well examined. We describe the rationale and design of a protocol of a pragmatic randomized controlled trial (RCT) to test the effect of a behavioral intervention using the nudge approach in behavioral economics on CKD patients' visiting behaviors to physicians and change in their kidney function after CKD screening. Methods: The RCT will include CKD patients (N = 4500) detected at screening (estimated glomerular filtration rate [eGFR] <60 mL/min/1.74 m2 or urine protein ≥1+), aged 40-63 years. The two intervention groups will receive a "usual letter" and "nudge-based letter," while the control group will only receive a conventional follow-up. Our primary outcome is proportion of patients' visiting physicians for 6 months after the intervention; the secondary outcome is change in the eGFR at 2 years after the intervention. Results: We developed an efficient intervention program after CKD screening and designed the pragmatic RCT to assess its effectiveness in the real world. Our trial is unique in that it investigates the effect of the nudge approach in behavioral economics. By the end of 2018, we have enrolled 1,692 participants, and randomized 677 participants into the usual letter group, 677 participants into the nudge-based letter group, and 338 participants into the control group. We have confirmed that health checkup data could identify a large number of eligible participants. Conclusion: The trial's results will contribute to filling in the gap between screening and subsequent medical interventions for preventing CKD progression.

DOI： 10.1016/j.conctc.2019.100429

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BACKGROUND: The tumor, node, metastasis classification system for staging esophageal cancer does not include tumor volume although it may be an important prognostic factor. We evaluated the prognostic value of tumor volume in esophageal cancer. METHODS: We performed a retrospective study in patients with histologically confirmed primary esophageal cancer who underwent curative esophagectomy at our facility between April 1992 and December 2013. The Tumor Depth Parameter (TDP) was defined as mucosa = 1, submucosa = 2, muscularis propria = 3, adventitia = 4, and invasion into adjacent organs = 5. The pathological Tumor Volume Index (TVI) was defined as the major axis × the minor axis × TDP. The appropriate tumor diameter and TVI cutoff values were determined by the Youden index obtained from the receiver operating characteristic curve. Prognostic factors for overall survival were evaluated by univariate analysis and Cox proportional hazards regression models. RESULTS: We enrolled 302 patients. In the univariate analysis, patient age and sex, thoracoscopic surgery, tumor depth of invasion and diameter, lymph node metastasis, and the TVI were significantly associated with overall survival. In our multivariate analysis, patient age and sex, thoracoscopic surgery, lymph node metastasis, and the TVI were independently associated with overall survival. CONCLUSIONS: The pathological TVI was an independent prognostic factor in patients with esophageal carcinoma and could be included in the staging system of esophageal cancer.

DOI： 10.1245/s10434-019-07308-9

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PURPOSE: Capeox is widely used as an adjuvant chemotherapy regimen of colorectal cancer that does not require central vein catheter insertion. However, oxaliplatin-related vascular pain with peripheral administration is a major adverse event. We assessed the preventive effect of Celecoxib on oxaliplatin-related vascular pain. METHODS: A multicenter study of the Yokohama Clinical Oncology Group (YCOG) in Japan. This study was an open label, randomized non-comparative phase II study between Capeox without Celecoxib (C+ Group) and with it (C- group). The primary endpoint was the appearance frequency of grade ≥ 2 vascular pain according to the Verbal Rating Scale (VRS). RESULTS: Between October 2012 and February 2014, 81 patients were recruited to this study and randomly divided into 2 groups: 38 patients in the C- group and 39 patients in the C+ group. Four cases were excluded at the analysis stage because they had not received the allocated intervention. The rate of grade ≥ 2 vascular pain was 55.3% in the C- group and 53.8% in the C+ group (p = 1.000). CONCLUSIONS: Celecoxib was unable to prevent oxaliplatin-related vascular pain in this study. However, it may be able to decrease the vascular pain that patients already have.

DOI： 10.1007/s00280-018-3739-9

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OBJECTIVE: Cesarean delivery at a preterm gestational age has been related to maternal complications such as bleeding and infection. However, previous reports are conflicting, and there is no consensus on the matter. We aimed to clarify the adverse effect of preterm cesarean delivery with an emphasis on maternal bleeding. STUDY DESIGN: We conducted a retrospective study comparing the frequency of maternal adverse outcome between preterm emergency cesarean delivery and term emergency cesarean delivery. Nine hundred and forty seven preterm cases and 1056 full-term cases were included in the study. We analyzed the frequency of abnormal bleeding defined as 1500 mL or more as primary outcome, blood transfusion rate, and rate of postoperative administration of antibiotics as secondary outcome. Logistic regression analysis was performed for confounding variables; age at delivery, primiparity, obesity, prior history of uterine surgery, abnormal placental position, abnormal glucose tolerance, hypertension during pregnancy, early rupture of membranes, and general anesthesia use during operation. As secondary analysis, to study the effects of method of incision, we compared adverse outcomes among classical cesarean delivery, inverted T incision, and upper segment incision within preterm emergency cesarean delivery. RESULTS: Preterm cesarean delivery had significantly higher rates of abnormal bleeding, transfusion and use of antibiotics than term cesarean delivery. Among the preterm delivery, classical incision was related to increased rate of blood transfusion and need for antibiotic treatment. CONCLUSION: Preterm cesarean delivery increases the risk of maternal bleeding. This should be considered especially in the setting of early preterm birth.

DOI： 10.1016/j.ejogrb.2018.12.033

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BACKGROUND/AIM: Nanoparticle albumin-bound (nab)-paclitaxel has demonstrated antitumor activity against advanced gastric cancer. However, gastric cancer patients can be difficult to treat with the recommended dose because of the high incidence of adverse toxicities. The aim of this study was to evaluate the safety and effectiveness of low-dose nab-paclitaxel in a multicenter, single-arm, phase II study. PATIENTS AND METHODS: Treatment included low doses of 180 mg/m2 nab-paclitaxel administered on day 1 of each 21-day cycle. The primary endpoint was defined as the overall response rate (ORR). The secondary endpoints included progression-free survival (PFS), safety, and overall survival (OS). A total of 34 patients were enrolled in the full-analysis set. RESULTS: The ORR was 5.9%. The median PFS and OS were 2.4 months and 9.2 months, respectively. The most common grade 3/4 toxicities were anemia (8.8%), neutropenia (5.9%), appetite loss (5.9%) and peripheral sensory neuropathy (5.9%). No treatment-related deaths occurred. CONCLUSION: The tri-weekly low dose of nab-paclitaxel therapy is effective towards advanced gastric cancer patients with good tolerability and an acceptable margin of safety.

DOI： 10.21873/anticanres.13068

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BACKGROUND: Patients with schizophrenia have a higher mortality risk than the general population. Additionally, the autonomic nervous system (ANS) activity of patients with schizophrenia is lower and more dysfunctional than that of the general population. Nonetheless, the association between ANS dysfunction and mortality in schizophrenia is unclear. The aim of this study was to investigate the association between ANS activity and mortality in schizophrenia and to evaluate the predictive values of heart rate variability for long-term survival. METHODS: This study involves the 10-year follow-up of a sample population consisting of 59 Japanese inpatients with schizophrenia between 60 and 70 years of age from 2007 to 2016. The ANS activity of all patients was evaluated using heart rate variability in 2007. RESULTS: Fifty-three participants could be followed up because they stayed in the hospital during the follow-up period. Of these patients, 11 died during follow-up. Their mean age at death was 70.55 ± 3.45 years. The parasympathetic activity of nonsurvivors was significantly lower than that of survivors, and multiple logistic regression analysis showed a significant association between death and parasympathetic activity. CONCLUSION: We suggest that decreased parasympathetic activity could be associated with 10-year all-cause mortality in older schizophrenic patients.

DOI： 10.1016/j.comppsych.2018.08.002

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