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There are currently no abstract classifiers, which can be used for new diagnostic test accuracy (DTA) systematic reviews to select primary DTA study abstracts from database searches. Our goal was to develop machine‐learning‐based abstract classifiers for new DTA systematic reviews through an open competition. We prepared a dataset of abstracts obtained through database searches from 11 reviews in different clinical areas. As the reference standard, we used the abstract lists that required manual full‐text review. We randomly splitted the datasets into a train set, a public test set, and a private test set. Competition participants used the training set to develop classifiers and validated their classifiers using the public test set. The classifiers were refined based on the performance of the public test set. They could submit as many times as they wanted during the competition. Finally, we used the private test set to rank the submitted classifiers. To reduce false exclusions, we used the Fbeta measure with a beta set to seven for evaluating classifiers. After the competition, we conducted the external validation using a dataset from a cardiology DTA review. We received 13,774 submissions from 1429 teams or persons over 4 months. The top‐honored classifier achieved a Fbeta score of 0.4036 and a recall of 0.2352 in the external validation. In conclusion, we were unable to develop an abstract classifier with sufficient recall for immediate application to new DTA systematic reviews. Further studies are needed to update and validate classifiers with datasets from other clinical areas. [ABSTRACT FROM AUTHOR]

Background: Although corticosteroid therapy with dose tapering is the most commonly used treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF), there is no consensus on the tapering regimen. This study aimed to investigate the association between early corticosteroid dose tapering and in-hospital mortality in patients with AE-IPF. Methods: In this retrospective cohort study, we analyzed the data of a cohort from eight Japanese tertiary care hospitals and routinely collected administrative data from a cohort from 185 Japanese hospitals. Patients with AE-IPF were classified into the early and non-early tapering groups depending on whether the maintenance dose of corticosteroids was reduced within two weeks of admission. Propensity score analysis with inverse probability weighting (IPW) was performed to estimate the effect of early corticosteroid dose tapering. Results: The multi-center cohort included 153 eligible patients, of whom 47 (31%) died, whereas the administrative cohort included 229 patients, of whom 51 (22%) died. Patients with early tapering tended to have a better prognosis than those without it (unadjusted hazard ratio [95% confidence interval] 0.41 [0.22–0.76] and 0.65 [0.36–1.18] in the multi-center and administrative cohorts, respectively). After IPW, the early tapering group had a better prognosis than the non-early tapering group (IPW-adjusted hazard ratio [95% confidence interval] 0.37 [0.14–0.99] and 0.27 [0.094–0.83] in the multi-center and administrative cohorts, respectively). Conclusion: Early corticosteroid dose tapering was associated with a favorable prognosis in patients with AE-IPF. Further studies are warranted to confirm the effects of early corticosteroid dose tapering in patients with AE-IPF. [ABSTRACT FROM AUTHOR]

See relatedReply [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to investigate the impact of social isolation and loneliness on the overall survival and death at home in patients with lung cancer.Methods: This prospective cohort study was conducted in a Japanese tertiary hospital. The enrollment period was from April 2018 to March 2020. Patients with pathologically diagnosed advanced lung cancer were included in this study. The primary outcome was overall survival, whereas the secondary outcome was death at home. The exposures were social isolation and loneliness.Results: A total of 211 patients were enrolled and divided into two groups and further into quartiles according to their social isolation and loneliness level, respectively. The hazard ratios of social isolation were 1.65 (95% confidence interval; 1.12 to 2.44) and 1.87 (95% confidence interval; 1.15 to 3.03) in the univariate analysis, while 1.40 (95% confidence interval; 0.92 to 2.13) in the multivariate analysis with complete case and multiple imputation. The odds ratio of death at home with social isolation was 3.47 (95% confidence interval; 1.08 to 11.1) in the multivariate analysis with multiple imputation. Loneliness was not associated with overall survival or death at home.Conclusions: Our study suggests that social isolation may be related to overall survival and death at home among patients with advanced lung cancer. More attention should be given to such patients at the time of diagnosis. [ABSTRACT FROM AUTHOR]

Background: We compared the prognostic value of serum high mobility group box 1 protein (HMGB1) and histone H3 levels with the International Society on Thrombosis and Haemostasis (ISTH) disseminated intravascular coagulation (DIC) scores for 28-day in-hospital mortality in patients with DIC caused by various underlying diseases. Methods: We conducted a multicenter prospective cohort study including two hematology departments, four emergency departments, and one general medicine department in Japan, between August 2017 and July 2021. We included patients diagnosed with DIC by the ISTH DIC scoring system. Results: Overall, 104 patients were included: 50 with hematopoietic disorders, 41 with infections, and 13 with the other diseases. The 28-day in-hospital mortality rate was 21%. The receiver operator characteristic (ROC) curve showed that a DIC score of 6 points, serum HMGB1 level of 8 ng/mL, and serum histone H3 level of 2 ng/mL were the optimal cutoff points. The odds ratios of more than these optimal cutoff points of the DIC score, serum HMGB1, and histone H3 levels were 1.58 (95% confidence interval [CI]: 0.60 to 4.17, p = 0.36), 5.47 (95% CI: 1.70 to 17.6, p = 0.004), and 9.07 (95% CI: 2.00 to 41.3, p = 0.004), respectively. The area under the ROC curve of HMGB1 (0.74, 95% CI: 0.63 to 0.85) was better than that of the ISTH DIC scores (0.55, 95% CI: 0.43 to 0.67, p = 0.03), whereas that of histone H3 was not (0.71, 95% CI: 0.60 to 0.82, p = 0.07). Calibration and net reclassification plots of HMGB1 identified some high-risk patients, whereas the ISTH DIC scores and histone H3 did not. The category-free net reclassification improvement of HMGB1 was 0.45 (95% CI: 0.01 to 0.90, p = 0.04) and that of histone H3 was 0.37 (95% CI: − 0.05 to 0.78, p = 0.08). Conclusions: Serum HMGB1 levels have a prognostic value for mortality in patients with DIC. This finding may help physicians develop treatment strategies. [ABSTRACT FROM AUTHOR]

Background: The clinical effect of enteral administration of sleep-promoting medication (SPM) in mechanically ventilated patients remains unclear. This study aimed to investigate the relationship between enteral SPM administration and the intravenous sedative dose and examine the safety and cost of enteral SPM administration. Methods: This single-center retrospective cohort study was conducted in a Japanese tertiary hospital intensive care unit (ICU). The exposure was enteral SPM administration during mechanical ventilation. The outcome was the average daily propofol dose per body weight administered as a continuous sedative during mechanical ventilation. Patients were divided into three groups based on the timing of SPM administration at ICU admission: "administration within 48 hours (early administration [EA])," "administration after 48 hours (late administration [LA])," and "no administration (NA)." We used multiple linear regression models. Results: Of 123 included patients, 37, 50, and 36 patients were assigned to the EA, LA, and NA groups, respectively. The average daily propofol dose per body weight was significantly lower in the EA group than in the LA and NA groups (β -5.13 [95% confidence interval (CI) -8.93 to -1.33] and β -4.51 [95% CI -8.59 to -0.43], respectively). Regarding safety, enteral SPM administration did not increase adverse events, including self-extubation. The total cost of neuroactive drugs tended to be lower in the EA group than in the LA and NA groups. Conclusions: Early enteral SPM administration reduced the average daily propofol dose per body weight without increasing adverse events. [ABSTRACT FROM AUTHOR]

Ali-M3, an artificial intelligence program, analyzes chest computed tomography (CT) and detects the likelihood of coronavirus disease (COVID-19) based on scores ranging from 0 to 1. However, Ali-M3 has not been externally validated. Our aim was to evaluate the accuracy of Ali-M3 for detecting COVID-19 and discuss its clinical value. We evaluated the external validity of Ali-M3 using sequential Japanese sampling data. In this retrospective cohort study, COVID-19 infection probabilities for 617 symptomatic patients were determined using Ali-M3. In 11 Japanese tertiary care facilities, these patients underwent reverse transcription-polymerase chain reaction (RT-PCR) testing. They also underwent chest CT to confirm a diagnosis of COVID-19. Of the 617 patients, 289 (46.8%) were RT-PCR-positive. The area under the curve (AUC) of Ali-M3 for predicting a COVID-19 diagnosis was 0.797 (95% confidence interval: 0.762‒0.833) and the goodness-of-fit was P = 0.156. With a cut-off probability of a diagnosis of COVID-19 by Ali-M3 set at 0.5, the sensitivity and specificity were 80.6% and 68.3%, respectively. A cut-off of 0.2 yielded a sensitivity and specificity of 89.2% and 43.2%, respectively. Among the 223 patients who required oxygen, the AUC was 0.825. Sensitivity at a cut-off of 0.5% and 0.2% was 88.7% and 97.9%, respectively. Although the sensitivity was lower when the days from symptom onset were fewer, the sensitivity increased for both cut-off values after 5 days. We evaluated Ali-M3 using external validation with symptomatic patient data from Japanese tertiary care facilities. As Ali-M3 showed sufficient sensitivity performance, despite a lower specificity performance, Ali-M3 could be useful in excluding a diagnosis of COVID-19. [ABSTRACT FROM AUTHOR]

Recently, the creation of new heterogeneous catalysts using the unique electronic/geometric structures of small metal nanoclusters (NCs) has received considerable attention. However, to achieve this, it is extremely important to establish methods to remove the ligands from ligand‐protected metal NCs while preventing the aggregation of metal NCs. In this study, the ligand‐desorption process during calcination was followed for metal‐oxide‐supported 2‐phenylethanethiolate‐protected gold (Au) 25‐atom metal NCs using five experimental techniques. The results clearly demonstrate that the ligand‐desorption process consists of ligand dissociation on the surface of the metal NCs, adsorption of the generated compounds on the support and desorption of the compounds from the support, and the temperatures at which these processes occurred were elucidated. Based on the obtained knowledge, we established a method to form a metal‐oxide layer on the surface of Au NCs while preventing their aggregation, thereby succeeding in creating a water‐splitting photocatalyst with high activity and stability. [ABSTRACT FROM AUTHOR]

Recently, the creation of new heterogeneous catalysts using the unique electronic/geometric structures of small metal nanoclusters (NCs) has received considerable attention. However, to achieve this, it is extremely important to establish methods to remove the ligands from ligand‐protected metal NCs while preventing the aggregation of metal NCs. In this study, the ligand‐desorption process during calcination was followed for metal‐oxide‐supported 2‐phenylethanethiolate‐protected gold (Au) 25‐atom metal NCs using five experimental techniques. The results clearly demonstrate that the ligand‐desorption process consists of ligand dissociation on the surface of the metal NCs, adsorption of the generated compounds on the support and desorption of the compounds from the support, and the temperatures at which these processes occurred were elucidated. Based on the obtained knowledge, we established a method to form a metal‐oxide layer on the surface of Au NCs while preventing their aggregation, thereby succeeding in creating a water‐splitting photocatalyst with high activity and stability. [ABSTRACT FROM AUTHOR]

We performed this study to provide the latest evidence of the diagnostic accuracy of all Aspergillus antibodies for chronic pulmonary aspergillosis (CPA). In this meta‐analysis, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and other databases, until 19 March 2020, for studies that examined the diagnostic accuracy of each Aspergillus‐specific antibody for CPA and assessed the risk of bias using the revised Quality Assessment of Diagnostic Accuracy Studies‐2 tool. We integrated the results using a hierarchical summary receiver operating characteristic (HSROC) model and calculated the point estimates of specificity with sensitivity fixed at 0.90 using the HSROC curve. We identified 32 published and one unpublished studies, including 75 studies on five antibody test types: 18 of precipitin test (2810 participants), 46 of IgG (8197), three of IgA (283), six of IgM (733) and two of combined IgG and IgM (IgG + IgM) (920). The results of specificity with sensitivity fixed at 0.90 were as follows: precipitin test, 0.93 (95% credible intervals: 0.86, 1.00); IgG, 0.90 (0.86, 0.95); IgA, 0.74 (0.00, 1.00); IgM, 0.50 (0.37, 0.53); IgG + IgM, 0.47 (0.00, 1.00). However, the precipitin test showed imprecision and instability in the sensitivity analysis. Most studies had a high risk of bias due to the case‐control design. Although there is lack of applicability for malignancy or immunosuppressive patients, our study suggests a preference for IgG over other antibody tests in CPA screening. Particularly, IgG should be used as an adjunct when ruling out CPA. [ABSTRACT FROM AUTHOR]

Meta‐analyses examining dichotomous outcomes often include single‐zero studies, where no events occur in intervention or control groups. These pose challenges, and several methods have been proposed to address them. A fixed continuity correction method has been shown to bias estimates, but it is frequently used because sometimes software (e.g., RevMan software in Cochrane reviews) uses it as a default. We aimed to empirically compare results using the continuity correction with those using alternative models that do not require correction. To this aim, we reanalyzed the original data from 885 meta‐analyses in Cochrane reviews using the following methods: (i) Mantel–Haenszel model with a fixed continuity correction, (ii) random effects inverse variance model with a fixed continuity correction, (iii) Peto method (the three models available in RevMan), (iv) random effects inverse variance model with the treatment arm continuity correction, (v) Mantel–Haenszel model without correction, (vi) logistic regression, and (vii) a Bayesian random effects model with binominal likelihood. For each meta‐analysis we calculated ratios of odds ratios between all methods, to assess how the choice of method may impact results. Ratios of odds ratios <0.8 or <1.25 were seen in ~30% of the existing meta‐analyses when comparing results between Mantel–Haenszel model with a fixed continuity correction and either Mantel–Haenszel model without correction or logistic regression. We concluded that injudicious use of the fixed continuity correction in existing Cochrane reviews may have substantially influenced effect estimates in some cases. Future updates of RevMan should incorporate less biased statistical methods. [ABSTRACT FROM AUTHOR]

Objectives: Lymphovascular invasion (LVI) is a critical risk factor for lymph node metastasis (LNM), which requires additional surgery after endoscopic resection of T1 colorectal cancer (CRC). However, the impact of additional staining on estimating LNM is unclear. This systematic review aimed to evaluate the impact of additional staining on determining LNM in T1 CRC. Methods: We searched five electronic databases. Outcomes were diagnostic odds ratio (DOR), assessed using hierarchical summary receiver operating characteristic curves, and interobserver agreement among pathologists for positive LVI, assessed using Kappa coefficients (κ). We performed a subgroup analysis of studies that simultaneously included a multivariable analysis for other risk factors (deep submucosal invasion, poor differentiation, and tumor budding). Results: Among the 64 studies (18,097 patients) identified, hematoxylin–eosin (HE) and additional staining for LVI had pooled sensitivities of 0.45 (95% confidence interval [CI] 0.32–0.58) and 0.68 (95% CI 0.44–0.86), specificities of 0.88 (95% CI 0.78–0.94) and 0.76 (95% CI 0.62–0.86), and DORs of 6.26 (95% CI 3.73–10.53) and 6.47 (95% CI 3.40–12.32) for determining LNM, respectively. In multivariable analysis, the DOR of additional staining for LNM (DOR 5.95; 95% CI 2.87–12.33) was higher than that of HE staining (DOR 1.89; 95% CI 1.13–3.16) (P = 0.01). Pooled κ values were 0.37 (95% CI 0.22–0.52) and 0.62 (95% CI 0.04–0.99) for HE and additional staining for LVI, respectively. Conclusion: Additional staining for LVI may increase the DOR for LNM and interobserver agreement for positive LVI among pathologists. [ABSTRACT FROM AUTHOR]

With global warming and the depletion of fossil resources, our fossil-fuel-dependent society is expected to shift to one that instead uses hydrogen (H2) as clean and renewable energy. Water-splitting photocatalysts can produce H2 from water using sunlight, which are almost infinite on the earth. However, further improvements are indispensable to enable their practical application. To improve the efficiency of the photocatalytic water-splitting reaction, in addition to improving the semiconductor photocatalyst, it is extremely effective to improve the cocatalysts (loaded metal nanoclusters, NCs) that enable the reaction to proceed on the photocatalysts. We have thus attempted to strictly control metal NCs on photocatalysts by introducing the precise-control techniques of metal NCs established in the metal NC field into research on water-splitting photocatalysts. Specifically, the cocatalysts on the photocatalysts were controlled by adsorbing atomically precise metal NCs on the photocatalysts and then removing the protective ligands by calcination. This work has led to several findings on the electronic/geometrical structures of the loaded metal NCs, the correlation between the types of loaded metal NCs and the water-splitting activity, and the methods for producing high water-splitting activity. We expect that the obtained knowledge will lead to clear design guidelines for the creation of practical water-splitting photocatalysts and thereby contribute to the construction of a hydrogen-energy society. [ABSTRACT FROM AUTHOR]

Aim: We aimed to evaluate regional disparities in the proportion of the three main laparoscopic surgeries for benign gynecological diseases among 47 prefectures in Japan and their correlation with the number of laparoscopy‐qualified gynecologists per population. Methods: In this retrospective ecological study, we collected the data of patients from 47 prefectures in 2017 using "The National Database of Health Insurance Claims and Specific Health Checkups of Japan" Open Data from the Ministry of Health, Labor and Welfare in Japan. The primary outcome of the study was the proportion of laparoscopic surgeries conducted for benign gynecologic diseases (hysterectomy, myomectomy and surgery for the benign ovarian diseases). The main exposure was the number of laparoscopy‐qualified gynecologists per 100 000 females. Results: The average proportion of laparoscopic hysterectomies, myomectomies and surgeries for the benign ovarian disease were 38% (standard deviation (SD) 16, range 12–74), 48% (SD 18, range 9–81) and 60% (SD 11, range 36–79), respectively. Multiple regression analysis showed a significant correlation between the number of laparoscopy‐qualified gynecologists per 100 000 females and the proportion of the three main laparoscopic surgeries. Conclusion: There are obvious regional disparities in the proportion of the three main laparoscopic procedures for benign gynecological diseases among 47 prefectures. The number of laparoscopy‐qualified gynecologists correlated significantly with these regional disparities. The academic society should monitor these regional disparities and make an effort to reduce these regional disparities by increasing laparoscopy‐qualified gynecologists in areas where the widespread use of laparoscopic techniques is lagging. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to investigate the trends in overall hysterectomy and other alternative therapies for benign uterine diseases per population aged 40–54 years in Japan. Methods: We conducted a national representative cohort study in Japan. We obtained data from 'The National Database of Health Insurance Claims and Specific Health Checkups of Japan' Open Data. The primary outcome was the number of overall hysterectomies for benign gynecologic diseases per population aged 40–54 years, from 2014 to 2017 in Japan. The secondary outcome was the number of alternative surgical and drug therapies to hysterectomy per population. We also analyzed the correlation between the number of laparoscopy‐qualified gynecologists and the number of overall hysterectomies per population among 47 prefectures in 2017. Results: The number of overall hysterectomies for benign gynecological diseases per 100 000 females aged 40–54 years gradually increased from 320 in 2014 to 344 in 2017 (7.5% increase overall). Moreover, there was a significant increase in the use of levonorgestrel intrauterine systems. We could not explain the reason for this increase in the rate of overall hysterectomies by summarizing the increase or decrease of alternative therapies to hysterectomy. Multiple regression analysis showed a significant correlation between the number of laparoscopy‐qualified gynecologists and the number of overall hysterectomies among 47 prefectures. Conclusion: Despite the spread of alternative therapies to hysterectomy, there was an increasing trend for overall hysterectomies in Japan. The reason was not clear but may be related to the spread of laparoscopic hysterectomy. [ABSTRACT FROM AUTHOR]

π‐Stacked polymers, which consist of layered π‐electron systems in a polymer, can be expected to be used in molecular electronic devices. However, the construction of a stable π‐stacked structure in a polymer is considerably challenging because it requires sophisticated designs and precise synthetic methods. Herein, we present a novel π‐stacked architecture based on poly(quinolylene‐2,3‐methylene) bearing alanine derivatives as the side chain, obtained through the living cyclo‐copolymerization of an o‐allenylaryl isocyanide. In the resulting polymer, the neighboring quinoline rings of the main chain form a layered structure with π–π interactions, which is stabilized by intramolecular hydrogen bonds. The vicinal quinoline units form two independent helices and the whole molecule is a twisted‐tape structure. This structure is established on the basis of UV/CD spectra, theoretical calculations, and atomic‐force microscopy. [ABSTRACT FROM AUTHOR]

π‐Stacked polymers, which consist of layered π‐electron systems in a polymer, can be expected to be used in molecular electronic devices. However, the construction of a stable π‐stacked structure in a polymer is considerably challenging because it requires sophisticated designs and precise synthetic methods. Herein, we present a novel π‐stacked architecture based on poly(quinolylene‐2,3‐methylene) bearing alanine derivatives as the side chain, obtained through the living cyclo‐copolymerization of an o‐allenylaryl isocyanide. In the resulting polymer, the neighboring quinoline rings of the main chain form a layered structure with π–π interactions, which is stabilized by intramolecular hydrogen bonds. The vicinal quinoline units form two independent helices and the whole molecule is a twisted‐tape structure. This structure is established on the basis of UV/CD spectra, theoretical calculations, and atomic‐force microscopy. [ABSTRACT FROM AUTHOR]

Background: The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials supporting recent anticancer drugs approved by the FDA, with a focus on immune checkpoint inhibitors (ICPis).Methods: We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed the clinical trials performed for each drug indication and matched each trial with publications in the literature. The primary benchmark was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model that was adjusted for clustering within drug indications and individual covariates.Results: Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in the time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8-1.7; P = 0.55). However, findings related to non-ICPis investigated specifically in randomized phase 2 or phase 3 trials were significantly more likely to be published earlier than those related to ICPis (adjusted HR, 7.4; 95% CI, 1.8-29.5; P = 0.005).Conclusion: One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2 years post-FDA approval. We found no evidence that the drug type was associated with the time to overall trial publication. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis examined the efficacy of neuromuscular electrical stimulation (NMES) on lower limb muscle strength and health-related quality of life (HR-QOL) after thoracic and abdominal surgery. We searched the Cochrane Central Register of Controlled Trials, MEDLINE via PubMed, Excerpta Medica Database via Elsevier, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, World Health Organization International Clinical Trials Registry Platform via their dedicated search portal, and ClinicalTrials.gov on November 2021 and updated in April 2023 to identify randomized controlled trials that examined the effects of NMES after thoracic and abdominal surgery. The primary outcomes were lower limb muscle strength, HR-QOL, and adverse events. We used the Cochrane Risk of Bias Tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach to assess the certainty of evidence. A total of 18 randomized control trials involving 915 participants, including 10 on cardiovascular surgery, two on pulmonary surgery, five on digestive system surgery, and one on other surgery, were included. NMES slightly increased lower limb muscle strength and adverse events in cardiovascular surgery. Adverse events (hypotension, pain, and muscle discomfort) occurred in seven patients. HR-QOL was measured in two studies on cardiovascular surgery, but these were not pooled due to concept heterogeneity. Overall, NMES slightly increases lower limb muscle strength after cardiovascular surgery without serious adverse events. However, higher-quality randomized control trials in thoracic and abdominal surgeries are needed. [ABSTRACT FROM AUTHOR]

Purpose: The immune-related response criteria (irRC) were proposed to incorporate pseudo-progression. However, the association between the irRC and overall survival (OS) has yet to be evaluated in non-small cell lung cancer (NSCLC). Therefore, the purpose of this study is to evaluate the concordance between the response evaluation criteria in solid tumors (RECIST) version 1.1 and the irRC in patients with NSCLC treated with nivolumab, as well as, to determine the relationship between these two response criteria and OS.Methods: We conducted a retrospective cohort study of 143 patients at three tertiary care hospitals in Japan between January and December 2016 (UMIN000022014).Results: The weighted kappa statistic for the two response criteria was 0.72 (95% confidence interval (CI) 0.66-0.76). The Harrell's C-index was 0.74 (95% CI 0.68-0.80) for the RECIST and 0.74 (95% CI 0.68-0.80) for the irRC, respectively. The difference between the two criteria was - 0.002 (95% CI - 0.05 to 0.04). The Moreau, O'Quigley, and Lellouch statistic was 0.03 for the RECIST and 0.17 for the irRC, respectively.Conclusion: We demonstrated a good concordance between the RECIST and the irRC for predicting OS in patients with NSCLC treated with nivolumab. [ABSTRACT FROM AUTHOR]

Objective There are several prognostic indices (PIs) to predict overall survival (OS) in malignant pleural mesothelioma (MPM) patients. Before using a clinical prediction model in the actual clinical setting, empiric evaluation of its performance based on datasets that were not used to develop the model (i.e., external validation) is essential. The purpose of this study was to conduct an external validation of the PIs for MPM. Materials and methods A retrospective cohort study was performed on MPM patients treated at 2 tertiary hospitals in Japan between 2007 and 2015. The primary outcome was OS. Harrell’s c-index, and was calculated to examine the discrimination of three models. The bootstrapping technique was used to evaluate optimism. Results The participants comprised 183 patients who underwent surgical treatment (n = 61), chemotherapy (n = 101), and best supportive care (BSC, n = 21). The median OS rates were 1014 days for surgery, 690 days for chemotherapy, and 545 days for best supportive care (BSC). The respective discriminations (95% confidence interval) of the Eastern Cooperative Oncology Group Performance Status, the European Organisation for Research and Treatment of Cancer index, regimen, PS, histology or stage (rPHS) index, and Tagawa index for the OS of MPM patients were 0.532 (0.444–0.620), 0.560 (0.472–0.648), 0.584 (0.452–0.716), and 0.525 (0.453–0.596) for surgery; 0.632 (0.539-0.724), 0.622 (0.548–0.696), 0.677 (0.587–0.766), and 0.545 (0.436–0.653) for chemotherapy; and 0.504 (0.365–0.644), 0.583 (0.456-–0.710), 0.704 (0.508–0.899), and 0.583 (0.436–0.730) for BSC. Conclusions Each PI showed poor discrimination for MPM patients who underwent surgical treatment. The rPHS index showed moderate discrimination for patients given chemotherapy and BSC. [ABSTRACT FROM AUTHOR]

In this study, we aimed to examine the clinical value of the pleural effusion (PE) biomarkers, soluble mesothelin-related peptide (SMRP), cytokeratin 19 fragment (CYFRA 21–1) and carcinoembryonic antigen (CEA), and the utility of combining chest computed tomography (CT) findings with these biomarkers, in diagnosing malignant pleural mesothelioma (MPM). We conducted a retrospective cohort study in a single center. Consecutive patients with undiagnosed pleural effusions who underwent PE analysis between September 2014 and August 2016 were reviewed. This study included 240 patients (32 with MPM and 208 non-MPM). SMRP and the CYFRA 21-1/CEA ratio had a sensitivity and specificity for diagnosing MPM of 56.3% and 86.5%, and 87.5% and 74.0%, respectively. Using receiver operating characteristics (ROC) curve analysis of the ability of these markers to distinguish MPM from all other PE causes, the area under the ROC curve (AUC) for SMRP and the CYFRA 21-1/CEA ratio was 0.804 and 0.874, respectively. The sensitivity and specificity of SMRP combined with the CYFRA 21-1/CEA ratio were 93.8% and 64.9%, respectively. The sensitivity of the combination of SMRP, the CYFRA 21-1/CEA ratio, and the presence of Leung’s criteria (a chest CT finding that is suggestive of malignant pleural disease) was 93.8%. In conclusion, the combined PE biomarkers had a high sensitivity for diagnosing MPM, although the addition of chest CT findings did not improve the sensitivity of SMRP combined with the CYFRA 21-1/CEA ratio. Combination of these biomarkers helped to rule out MPM effectively among patients at high risk of suffering MPM and would be valuable especially for old frail patients who have difficulty in undergoing invasive procedures such as thoracoscopy. [ABSTRACT FROM AUTHOR]

The RECORD statement - checklist of items, extended from the STROBE statement, that should be reported in observational studies using routinely collected health data. Reference 1 Anan K, Kataoka Y, Ichikado K, Kawamura K, Johkoh T, Fujimoto K, Tobino K, Tachikawa R, Ito H, Nakamura T, Kishaba T, Inomata M, Kamitani T, Yamazaki H, Ogawa Y, Yamamoto Y. Early corticosteroid dose tapering in patients with acute exacerbation of idiopathic pulmonary fibrosis. [Extracted from the article]

PURPOSE: This systematic review aimed to investigate the efficacy of telemedicine (TM) using videoconferencing systems in outpatient care for patients with cancer. METHODS: We searched six electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, ICTRP, and ClinicalTrials.gov) through June 2021 to identify randomized controlled trials that evaluated the use of TM using videoconferencing systems compared with usual face-to-face care in outpatient care for patients with cancer. We assessed the certainty of evidence on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation. RESULTS: From the 2,400 articles screened, six randomized controlled trials were eligible for this study. Two studies evaluated the use of TM in cancer follow-up and four investigated psychotherapy for cancer. TM using videoconferencing systems may result in no differences in primary outcomes such as patient satisfaction (standardized mean difference, 0.11; 95% CI, –0.18 to 0.40) and outpatient attendance complete proportion (risk difference, 0.02%; 95% CI, –0.04 to 0.09), and secondary outcomes such as medical professional satisfaction, time devoted to outpatient care, and depression score. The certainty of evidence for these outcomes was low. Although the average money spent on outpatient visit was a primary outcome, the level of evidence was uncertain. CONCLUSION: Our results suggest that TM using videoconferencing systems in outpatient care for patients with cancer may be as effective as usual face-to-face care. Use of TM more frequently may be considered for patients with cancer who are expected to obtain benefit from TM using videoconference systems. Telemedicine using videoconferencing in outpatient care for patients with cancer may be as effective as usual care. [ABSTRACT FROM AUTHOR]

Attenuated total reflection infrared (ATR-IR) spectroscopy was performed on glycerol/water solutions in order to gain a better understanding of the strong hydrogen bonding of glycerol as a humectant. The OH stretching band after eliminating the contribution of glycerol OH in the glycerol/water solutions was decomposed using three Gaussian components. With increasing glycerol concentrations up to 50 volume %, the decrease of the 3428 cm–1component (middle H-bond component) and the increase of the 3562 cm–1component (longer H-bond component) suggested the breaking of H bonds among water molecules. On the other hand, the 3242 cm–1component (shorter H-bond component) remained unchanged. It was expected that water molecules surrounding glycerol molecules are retained by strong H bonding between H atoms of water and O atoms in C–O of glycerol when aqueous solutions containing glycerol are introduced in human skin. [ABSTRACT FROM AUTHOR]

Keywords: catalysts; metal clusters; nanostructures; photocatalysts; water splitting EN catalysts metal clusters nanostructures photocatalysts water splitting 21074 21074 1 09/16/21 20210920 NES 210920 B A ligand-desorption process b during calcination was followed for metal-oxide-supported 2-phenylethanethiolate-protected gold 25-atom metal nanoclusters (NCs) using five experimental techniques by Yuichi Negishi and co-workers in their Research Article on page 21340. Inside Cover: Creation of High-Performance Heterogeneous Photocatalysts by Controlling Ligand Desorption and Particle Size of Gold Nanocluster (Angew. Based on the obtained knowledge, a method to form a metal-oxide layer on the surface of Au NCs while preventing their aggregation was established, and thereby a water-splitting photocatalyst with high activity and stability was created. [Extracted from the article]

Innentitelbild: Creation of High-Performance Heterogeneous Photocatalysts by Controlling Ligand Desorption and Particle Size of Gold Nanocluster (Angew. Keywords: catalysts; metal clusters; nanostructures; photocatalysts; water splitting EN catalysts metal clusters nanostructures photocatalysts water splitting 21242 21242 1 09/16/21 20210920 NES 210920 B Die Ligandendesorption b bei der Kalzinierung von Metalloxid-gestützten 2-Phenylethanthiolat-geschützten 25-atomigen Gold-Nanoclustern wurde von Yuichi Negishi und Mitarbeitern im Forschungsartikel auf S. 21510 mit fünf experimentellen Techniken untersucht. Catalysts, metal clusters, nanostructures, photocatalysts, water splitting. [Extracted from the article]

Background: Lymph node metastasis (LNM) occurs in 20–25% of patients with T2 colorectal cancer (CRC). Identification of risk factors for LNM in T2 CRC may help identify patients who are at low risk and thereby potential candidates for endoscopic full-thickness resection. We examined risk factors for LNM in T2 CRC with the goal of establishing further criteria of the indications for endoscopic resection. Methods: MEDLINE, CENTRAL, and EMBASE were systematically searched from inception to November 2023. Studies that investigated the association between the presence of LNM and the clinical and pathological factors of T2 CRC were included. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Certainty of evidence (CoE) was assessed using the GRADE approach. Results: Fourteen studies (8349 patients) were included. Overall, the proportion of LNM was 22%. The meta-analysis revealed that the presence of lymphovascular invasion (OR, 5.5; 95% CI 3.7–8.3; high CoE), high-grade tumor budding (OR, 2.4; 95% CI 1.5–3.7; moderate CoE), poor differentiation (OR, 2.2; 95% CI 1.8–2.7; moderate CoE), and female sex (OR, 1.3; 95% CI 1.1–1.7; high CoE) were associated with LNM in T2 CRC. Lymphatic invasion (OR, 5.0; 95% CI 3.3–7.6) was a stronger predictor of LNM than vascular invasion (OR, 2.4; 95% CI 2.1–2.8). Conclusions: Lymphovascular invasion, high-grade tumor budding, poor differentiation, and female sex were risk factors for LNM in T2 CRC. Endoscopic resection of T2 CRC in patients with very low risk for LNM may become an alternative to conventional surgical resection. Trial registration: PROSPERO, CRD42022316545. [ABSTRACT FROM AUTHOR]

Background and Aims: Relapse is common in alcohol dependence (AD) and alcohol use disorder (AUD), so alcohol reduction therapy should be measured over as long a period as possible; however, existing reviews do not consider the duration of treatment and therefore alcohol reduction therapy may not have been appropriately evaluated. This review evaluated the efficacy and safety of alcohol reduction pharmacotherapy in patients with AD or AUD according to the duration of treatment. Methods: We conducted a systematic review and network meta‐analysis of randomized controlled trials (RCTs) that assessed 15 pharmacological agents. MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, the ClinicalTrials.gov and the International Clinical Trials Registry Platform were searched for eligible trials through to May 2021. Outcomes were heavy drinking days (HDD), total alcohol consumption (TAC), any adverse event and days without drinking. Results: Fifty‐five RCTs (n = 8891) were included. Nalmefene was superior to placebo for reducing HDD (standard mean difference [SMD] −0.28, 95% confidence interval [CI] −0.37, −0.18) and TAC (SMD −0.25, 95% CI −0.35, −0.16) in the long‐term, but not in the short‐term. Topiramate was superior to placebo for reducing HDD (SMD −0.35, 95% CI −0.59, −0.12) and days without drinking (SMD 0.46, 95% CI 0.11, 0.82), and baclofen was superior for reducing TAC (SMD −0.70, 95% CI −1.29, −0.11), in the short‐term. The frequency of adverse events was higher with nalmefene and topiramate than with placebo. Conclusion: Nalmefene, topiramate and baclofen may be effective as alcohol reduction pharmacotherapy; however, only nalmefene has demonstrated long‐term efficacy, and nalmefene and topiramate have a significantly higher frequency of adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

• This study investigated the difference between COVID-19 RCT in medRxiv and in PubMed. • SPIN in the conclusion was more frequently seen in reports in medRxiv than PubMed. • Readers should pay attention to the overstatements in preprints of COVID-19 RCT. [ABSTRACT FROM AUTHOR]

This article is a letter to the editor addressing concerns about a review article on the topic of "Second curettage versus conventional chemotherapy in avoiding unnecessary chemotherapy and reducing the number of chemotherapy courses for patients with gestational trophoblastic neoplasia." The authors raise concerns about potential overestimation of results due to the inclusion of two reports from the same study in the meta-analysis. They also question the comprehensiveness of the literature search and the inclusion of studies with a high risk of bias. Additionally, the authors point out inaccuracies in the reported denominator for the outcome of "avoiding unnecessary chemotherapy" and the deviation from the original protocol. The authors declare no conflict of interest. [Extracted from the article]

Aims/Introduction: This systematic review and meta‐analysis aimed to investigate the efficacy and safety of acceptance and commitment therapy (ACT) for people with type 2 diabetes mellitus. Materials and Methods: Several electronic databases were examined on 16 January 2021, including PubMed, CENTRAL, PsycINFO, International Clinical Trials Registry Platform and ClinicalTrials.gov. Randomized controlled trials were included to compare ACT with usual treatment for people with type 2 diabetes reported in any language. Primary outcome measures were glycated hemoglobin, self‐care ability assessed by the summary of diabetes self‐care activities and all adverse events. The secondary outcome measure was acceptance assessed by the acceptance and action diabetes questionnaire. Results: Of 678 publications initially identified, three trials were included in the meta‐analysis. ACT resulted in a reduction in glycated hemoglobin (mean difference −0.62 points lower in the intervention group; 95% confidence interval −1.07 to −0.16; I2 = 0%; low‐quality evidence). In addition, ACT increased the score of the summary of diabetes self‐care activities (mean difference 8.48 points higher in the intervention group; 95% confidence interval 2.16–14.80; high‐quality evidence). Adverse events were not measured in all trials. ACT increased scores of the acceptance and action diabetes questionnaire (mean difference 5.98 points higher in the intervention group; 95% confidence interval, 1.42–10.54; I2 = 43%; low‐quality evidence). Conclusions: ACT might reduce glycated hemoglobin, and increase self‐care ability and acceptance among people with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Frontispiz: Construction of Helically Stacked -Electron Systems in Poly(quinolylene-2,3-methylene) Stabilized by Intramolecular Hydrogen Bonds Keywords: allenes; cyclo-copolymerization; helical polymers; isocyanide; -stacked polymers EN allenes cyclo-copolymerization helical polymers isocyanide -stacked polymers 1 1 1 06/17/20 20200622 NES 200622 B Helikale Polymere b Die Synthese eines neuartigen Typs -gestapelter Polymere wird von N. Kanbayashi, K. Onitsuka et al. in der Zuschrift auf S. 10372 beschrieben. Allenes, cyclo-copolymerization, helical polymers, isocyanide, -stacked polymers. [Extracted from the article]

Background: Systemic edema is an adverse effect of docetaxel chemotherapy and causes distress to patients, including those receiving this agent for breast cancer. However, its characteristics and factors related to its effect on quality of life (QoL) have not been adequately investigated. In this study, we assessed systemic edema quantitatively, explored related factors, and evaluated QoL in patients receiving docetaxel for breast cancer. Methods: The study had a prospective cohort design and included 37 patients with no known history of swelling who were treated with docetaxel between September 2019 and April 2022. Patients were examined at the start, middle, and end of their course of treatment and 1 and 2 months later. Body water content, body mass, fat mass, and muscle mass were quantified using bioelectrical impedance analysis. Systemic edema was evaluated with reference to the Common Terminology Criteria for Adverse Events. The timing of development of systemic edema at any anatomical site that was grade 2 or worse was recorded. QoL was assessed using the Quality of Life-Anti Cancer Drug scale. Nutrition was evaluated using the Brief-type self-administered diet history questionnaire. Multivariable logistic regression analysis was performed to identify related factors. QoL was also compared between patients with edema and those without edema. Results: Systemic edema developed in 67% of the study participants and was most prevalent at the end of treatment. Body fat mass (adjusted odds ratio [aOR] 0.802, 95% confidence interval [CI] 0.651–0.988, p = 0.038), disease stage (aOR 3.279, 95% CI 0.493–21.793, p = 0.219), and history of alcohol consumption (aOR 0.141, 95% CI 0.013–1.521, p = 0.106) were identified as risk factors for docetaxel-induced edema. Participants who developed systemic edema experienced more physical, vital, and emotional distress 1 month after treatment than those who did not. There was no association between systemic edema and nutrition. Conclusions: Systemic edema may develop after treatment with docetaxel and increase distress in patients with a high body fat mass. Patients at risk of systemic edema should be informed in advance about the potential frequency, location, and timing of its onset and encouraged to self-manage this condition. [ABSTRACT FROM AUTHOR]

Background: Video-assisted thoracoscopic surgery is a widely recommended treatment for empyema in advanced stages. However, only a few studies have evaluated prognostic factors among patients with empyema who underwent video-assisted thoracoscopic surgery. Furthermore, no studies have evaluated predictors of direct discharge home. Patients and Methods: This multicenter retrospective cohort study included 161 patients with empyema who underwent video-assisted thoracoscopic surgery in five acute-care hospitals. The primary outcome was the probability of direct discharge home. The secondary outcome was the length of hospital stay after surgery. We broadly assessed pre-operative factors and performed univariable logistic regression for the direct discharge home and univariable gamma regression for the length of hospital stay after surgery. Results: Of the 161 included patients, 74.5% were directly discharged home. Age (>70 years; −24.3%); altered mental status (−33.4%); blood urea nitrogen (>22.4 mg/dL; −19.4%); and pleural pH (<7.2; −17.6%) were associated with high probabilities of not being directly discharged home. Fever (15.2%) and albumin (> 2.7 g/dL; 20.2%) were associated with high probabilities of being directly discharged home. The median length of stay after surgery was 19 days. Age (>70 years; 6.2 days); altered mental status (5.6 days); purulence (2.7 days); pleural thickness (>2 cm; 5.1 days); bronchial fistula (14.6 days); albumin (>2.7 g/dL; 3.1 days); and C-reactive protein (>20 mg/dL; 3.6 days) were associated with a longer post-operation hospital stay. Conclusions: Physicians should consider using these prognostic factors to predict non-direct discharge to the home for patients with empyema. [ABSTRACT FROM AUTHOR]

Objective: The risk of atherosclerotic cardiovascular disease (ASCVD) is estimated using the American College of Cardiology (ACC)/American Heart Association (AHA) Pooled Cohort Equations (PCEs). However, the accuracy of this tool remains controversial, particularly among patients who are recommended statin therapy according to the ACC/AHA guidelines. We performed external validation of PCEs among patients eligible for statin therapy using data from the systolic blood pressure intervention trial (SPRINT). Results: Our study included 4057 patients from among the 9361 patients in SPRINT. The mean patient age was 64.5 years, and the median predicted 10-year risks of ASCVD were 17.2% and 12.3% for men and women, respectively. Over a median follow-up of 3.3 years, 133 primary events (including 23 cardiovascular deaths) were noted, whereas 304 events were predicted by the PCEs. The PCEs demonstrated poor calibration (Hosmer–Lemeshow test, p < 0.001) and overestimated the probability consistently. Additionally, they showed moderate discrimination [area under the curve: 0.65 (95% confidence interval, 0.60–0.69)]. This study demonstrates that PCEs might overestimate the risk of ASCVD in patients who are recommended statin therapy. [ABSTRACT FROM AUTHOR]

Pre-emptive kidney transplantation (PEKT), i.e., transplantation performed before initiation of maintenance dialysis, is considered an ideal renal replacement therapy because there is no exposure to long-term dialysis therapy. Therefore, we summarized advantages/disadvantages of PEKT to assist in deciding whether kidney transplantation should be performed pre-emptively. This study was registered with PROSPERO, CRD42021269163. Observational studies comparing clinical outcomes between PEKT and non-PEKT were included; those involving only pediatric recipients or simultaneous multi-organ transplantations were excluded. The PubMed/MEDLINE, Cochrane Library, and Ichushi-Web databases were searched on 1 August 2021. Studies were pooled using the generic inverse-variance method with random effects model, and risk of bias was assessed using ROBINS-I. Seventy-six studies were included in the systematic review (sample size, 23–121,853; enrollment year, 1968–2019). PEKT patients had lower all-cause mortality (adjusted HR: 0.78 [95% CI 0.66–0.92]), and lower death-censored graft failure (0.81 [0.67–0.98]). Unadjusted RRs for the following outcomes were comparable between the two patient groups: cardiovascular disease, 0.90 (0.58–1.40); biopsy-proven acute rejection, 0.75 (0.55–1.03); cytomegalovirus infection, 1.04 (0.85–1.29); and urinary tract infection, 0.89 (0.61–1.29). Mean differences in post-transplant QOL score were comparable in both groups. The certainty of evidence for mortality and graft failure was moderate and that for other outcomes was very low following the GRADE classification. The present meta-analysis shows the potential benefits of PEKT, especially regarding patient and graft survival, and therefore PEKT is recommended for adults with end-stage kidney disease. [ABSTRACT FROM AUTHOR]

Accurate disclosure of financial conflicts of interest (COI) among clinical practice guideline (CPG) developers is critical to ensure the quality of CPGs. However, there is limited evidence on the impact of underreporting COIs on the quality of CPGs. This study aimed to examine the proportion of underreported COI disclosures in the development of Japanese CPGs and to estimate the association between underreported COIs and CPG quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II. Twenty-three Japanese CPGs published in 2019 and their 1114 developers were included in the study. The results show that underreporting of COIs occurred in 52% of the included CPGs and 8% of all CPG developers. Underreporting COI disclosures was negatively associated with low-quality CPG (Odds ratio [OR], 0.57; 95% confidence interval [CI]: 0.11, 3.04). On the other hand, CPGs that had more than 13% of CPG developers with voting rights on recommendation decisions and underreporting of COI disclosures were positively associated with low quality (OR, 1.78; 95% CI: 0.25, 12.45). For individual CPG developers with voting rights for recommendation decisions, the presence of a COI was positively associated with low quality (OR, 1.11; 95% CI: 0.71, 1.75). This study demonstrates that the involvement and underreporting of COIs did not seriously distort the CPG development process. However, the COI-related factors of CPG developers with voting rights for recommendation decisions may be associated with low CPG quality. [ABSTRACT FROM AUTHOR]

Comment & Response B To the Editor b We have some concerns about the recent study[1] that reported that 0.05% atropine lowered the incidence of myopia in healthy children compared with placebo. First, the authors found no significant difference in the incidence of myopia between 0.01% atropine eyedrops and placebo and postulated that 0.01% atropine might not yield therapeutic benefits. In the pilot study, the myopia incidence rates for 0.05% atropine, 0.01% atropine, and placebo were 6.6%, 14.6%, and 20.0%, respectively. [Extracted from the article]

Background: While conducting systemic reviews, searching for ongoing or unpublished trials is critical to address publication bias. As of April 2019, records of ongoing or unpublished randomized and/or quasi-randomized controlled trials registered in the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov are available in the Cochrane Central Register of Controlled Trials (CENTRAL). These records registered in CENTRAL include studies published since the inception of ICTRP and ClinicalTrials.gov . Whether systematic reviewers can search CENTRAL to identify ongoing or unpublished trials instead of ICTRP and ClinicalTrials.gov is unknown.Methods: This was a cross-sectional study. A consecutive sample of ongoing or unpublished studies published from June 1, 2019 to December 27, 2019 was selected from the Cochrane Reviews. The sensitivity and the number needed to read (NNR) were assessed from among the studies selected from CENTRAL instead of ICTRP and ClinicalTrials.gov and also assessed the characteristics of studies not identified by searching CENTRAL.Results: In total, 247 records from 50 Cochrane reviews were included; of these, 200 were identified by searching CENTRAL, whereas the remaining 47 records were not. The sensitivity of searching CENTRAL was 0.81 (95% confidence interval [CI]: 0.76, 0.85). The NNR was 115 (95% CI: 101, 133). The 47 unidentified studies were registered through ClinicalTrials.gov or ICTRP. Sixteen unidentified studies were not indexed in CENTRAL.Conclusions: For systematic reviewers, searching CENTRAL could not substitute for searching ClinicalTrials.gov and/or ICTRP. Systematic reviewers should not only search CENTRAL but also ICTRP and ClinicalTrials.gov to identify unpublished trials.Trial Registration: A pre-specified protocol was applied to conduct this study. The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR).Trial Registration Number: UMIN000038981 . [ABSTRACT FROM AUTHOR]

The effectiveness of systemic steroid therapy on mortality in patients with pneumonic chronic obstructive pulmonary disease (COPD) exacerbation is unclear. We evaluated the association between systemic steroid therapy and 30-day mortality after adjusting for known confounders, using data from the Health, Clinic, and Education Information Evaluation Institute in Japan, which longitudinally followed up patients in the same hospital. We selected patients aged ≥40 years admitted for pneumonic COPD exacerbation. The exclusion criteria were censoring within 24 h, comorbidity with other respiratory diseases, and daily steroid use. Systemic steroid therapy was defined as oral/parenteral steroid therapy initiated within two days of admission. The primary outcome was the 30-day mortality rate. To account for known confounders, each patient was assigned an inverse probability of treatment weighting. The outcome was evaluated using logistic regression. Among 3,662 patients showing pneumonic COPD exacerbation, 30-day mortality in the steroid therapy and non-steroid therapy groups was 27.6% (169/612) and 21.9% (668/3,050), respectively. Systemic steroid therapy indicated a slightly higher estimated probability of 30-day mortality (difference in the estimated probabilities, 2.65%; 95% confidence interval, -1.23 to 6.54%, p-value = 0.181). Systemic steroid therapy within two days of admission was associated with higher 30-day mortality rates in pneumonic COPD exacerbation. Further validation studies based on chart reviews will be needed to cope with residual confounders. [ABSTRACT FROM AUTHOR]

Background: Because of limitations in previous randomised controlled trials and observational studies, the effectiveness of immediate video-assisted thoracoscopic surgery (VATS) for patients with empyema in real-world settings remains unclear. Objective: This study aimed to evaluate whether immediate VATS improves clinical outcomes in patients with empyema. Methods: This multicentre retrospective cohort study included 744 patients with physician-diagnosed empyema from six hospitals between 2006 and 2021. The exposure was VATS performed within 3 days of empyema diagnosis, the primary outcome was 30-day mortality, and secondary outcomes were 90-day mortality, length of hospital stay, and time from diagnosis to discharge. We used propensity score weighting to account for potential confounders. For outcome analyses, we used logistic regression for mortality outcomes and gamma regression for the number of days. Results: Among the 744 patients, 53 (7.1%) underwent VATS within 3 days, and 691 (92.9%) initially received conservative treatment. After propensity score weighting, the differences in 30- and 90-day mortalities between the immediate VATS and initial conservative treatment groups were 1.18% (95% confidence interval [CI], −10.7 to 13.0%) and −0.08% (95% CI, −10.3 to 10.2%), respectively. The differences in length of hospital stay and time from diagnosis to discharge were −3.22 (95% CI, −6.19 to −0.25 days) and −5.04 days (95% CI, −8.19 to −1.90 days), respectively. Conclusions: Our real-world study showed that immediate VATS reduced the length of hospital stay and the time from diagnosis to discharge. Considering the small sample and differences in protocols between countries, further large-scale studies are warranted. [ABSTRACT FROM AUTHOR]

Prof. Setsuro Fujii achieved significant results in the field of drug discovery research in Japan. He developed nine well-known drugs: FT, UFT, S-1 and FTD/TPI are anticancer drugs, while cetraxate hydrochloride, camostat mesilate, nafamostat mesilate, gabexate mesilate and pravastatin sodium are therapeutic drugs for various other diseases. He delivered hope to patients with various diseases across the world to improve their condition. Even now, drug discovery research based on Dr. Fujii's ideas is continuing. [ABSTRACT FROM AUTHOR]