Search

Abstract Background The micro-axial flow pump Impella, a new mechanical circulatory device for cardiogenic shock, is still only available in a limited number of hospitals, due to the facility certification requirements and insufficient evidence of the benefit of introducing Impella in hospitals. This study aimed to evaluate the impact of introducing Impella in hospitals on in-hospital mortality of patients treated with extracorporeal membrane oxygenation (ECMO). Methods Using a nationwide Japanese inpatient database, we identified patients who received ECMO during hospitalization between 1 April 2014 and 31 March 2021. A hospital-level propensity score–matched cohort was created matching hospitals that introduced Impella (exposure group) to those that did not introduce Impella (control group). The inclusion period in each hospital was divided into two time periods according to the time of Impella introduction in the exposure group and the corresponding hospital in the control group (before and after exposure). The primary outcome was in-hospital mortality. Uncontrolled and controlled interrupted time-series analyses involved before–after exposure comparison and exposure–control comparison. Results Out of 34,379 eligible patients, we created a matched cohort of 8351 patients from 86 hospitals with Impella introduction (exposure group) and 7230 patients from 86 hospitals without Impella introduction (control group). In-hospital mortality before and after exposure was 62.5% and 59.3, respectively, in the exposure group; and 66.8% and 63.7%, respectively, in the control group. Uncontrolled interrupted time-series analysis showed no significant level change or trend change in the before–after exposure comparison in both the exposure and the control groups. Controlled interrupted time-series analysis also showed no significant level change (−0.01%; 95% confidence intervals −5.36% to + 5.33%) or trend change (+ 0.10%, −0.30% to + 0.40%) after exposure in the exposure–control comparison. Conclusions This nationwide inpatient database study showed no association between Impella introduction in hospitals and in-hospital mortality of patients who underwent ECMO. Because this study confined itself to analze of the impact of the introduction of Impella solely at the hospital level, further detailed studies are warranted to assess its efficacy at the patient level.

Abstract Atypical haemolytic uremic syndrome (aHUS) is a rare disorder characterised by complement-mediated thrombotic microangiopathy (TMA). Despite clinical guidelines, the diagnosis and treatment of aHUS in its early stages remains challenging. This study examined the annual trends in aHUS clinical practices in Japan and explored factors influencing early diagnosis and treatment. Using data from the 2011–2020 Diagnosis Procedure Combination database, 3096 cases with the HUS disease code were identified, of which 217 were confirmed as aHUS and treated with eculizumab or plasma exchange. Early initiation, defined as starting eculizumab or plasma exchange within 7 days of admission, was the focus of the study. Our study revealed no significant changes over time in the number of aHUS diagnoses, cases treated with eculizumab, or early initiation cases. Early initiation cases underwent haemodialysis earlier and had ADAMTS13 activity measured earlier, shorter hospital stays, and lower hospitalisation costs than late initiation cases. In conclusion, we found no increase in the number of newly diagnosed aHUS cases or early treatment initiation over time. Early recognition of TMA and differentiation of the causative disease are crucial for identifying potential aHUS cases, which may lead to better patient prognoses.

Background: Legionella pneumonia, a severe form of pneumonia, is caused by Legionella bacteria. The epidemiology of Legionnaires’ disease in Japan, including seasonal trends, risk factors for severe disease, and fatality rates, is unclear. This study examined the epidemiology of Legionella pneumonia in Japan. Methods: This retrospective cohort study included data of adult patients hospitalized for Legionella pneumonia (identified using the International Classification of Diseases, 10th revision code, A481) in the Japanese Diagnosis Procedure Combination inpatient database, from April 2011 to March 2021. We performed multivariable logistic regression analysis to explore the prognostic factors of in-hospital mortality. Results: Of 7,370 enrolled hospitalized patients from 1,140 hospitals (male, 84.4%; aged >50 years, 87.9%), 469 (6.4%) died during hospitalization. The number of hospitalized patients increased yearly, from 658 in 2016 to 975 in 2020. Multivariable logistic regression analysis revealed that higher in-hospital mortality was associated with older age, male sex, lower body mass index, worsened level of consciousness, comorbidities (congestive heart failure, chronic renal diseases, and metastasis), hospitalization from November to May, and ambulance use. However, lower in-hospital mortality was associated with comorbidity (liver diseases), hospitalization after 2013, and hospitalization in hospitals with higher case volume. Conclusion: The characterized epidemiology of Legionella pneumonia in Japan revealed a high mortality rate of 6.4%. To the best of our knowledge, this is the first study to demonstrate a higher mortality rate in winter and in patients with congestive heart failure and metastasis. Further research is needed to understand the complex interplay between the prognostic factors of Legionella pneumonia.

Abstract Background Fluid resuscitation is fundamental in acute pancreatitis (AP) treatment. However, the optimal choice between normal saline (NS) and Ringer's solution (RS), and its impact on mortality in critically ill patients, remains controversial. This retrospective cohort study, utilizing a national Japanese inpatient database, investigates this question. Methods Using the Japanese Diagnosis Procedure Combination database between July 2010 and March 2021, we identified adult patients hospitalized in intensive care units (ICU) or high-dependency care units (HDU) for AP who survived at least three days and received sufficient fluid resuscitation (≥ [10 ml/kg/hr*1 h + 1 ml/kg/hr*71 h] ml) within three days of admission including emergency room infusions. Patients were classified into groups based on the predominant fluid type received: the NS group (> 80% normal saline) and the RS group (> 80% Ringer's solution). Propensity score matching was employed to reduce potential confounding factors and facilitate a balanced comparison of in-hospital mortality between the two groups. Results Our analysis included 8710 patients with AP. Of these, 657 (7.5%) received predominantly NS, and 8053 (92.5%) received predominantly RS. Propensity score matching yielded 578 well-balanced pairs for comparison. The NS group demonstrated significantly higher in-hospital mortality than the RS group (12.8% [474/578] vs. 8.5% [49/578]; risk difference, 4.3%; 95% confidence interval, 0.3% to 8.3%). Conclusions In patients admitted to ICU or HDU with AP receiving adequate fluid resuscitation, RS can be a preferred infusion treatment compared to NS.

ABSTRACT Aims/Introduction We assessed the modification effect of adherence to diabetes care on the association between HbA1c levels and the risk of coronavirus disease 2019 (COVID‐19) among individuals with diabetes using a population‐based database. Material and Methods We retrospectively identified individuals with diabetes during routine health checkups performed in 2019 in Japan using a population‐based claims database (JMDC, Tokyo, Japan). We assessed the risk of COVID‐19 infection in 2020 in relation to HbA1c levels during routine checkups, stratified by the presence/absence of follow‐up for diabetes care in 2019. Several sensitivity analyses were performed. Results We identified 65,956 individuals with an HbA1c ≥6.5% and fasting glucose ≥126 mg/dL in routine checkups, including 52,637 and 13,319 with and without at least one physician consultation for diabetes care in 2019, respectively. Although high HbA1c levels were associated with an increased risk of COVID‐19 infection in a dose‐dependent manner among individuals without diabetes care in 2019 (odds ratios, 1.53 and 2.17 in individuals with HbA1c of 7.0–7.9% and ≥8.0%, respectively) with a reference to HbA1c of 6.5–6.9%, individuals with diabetes care had no such trend in 2019 (odds ratios, 0.99 and 0.97 among individuals with HbA1c of 7.0–7.9% and ≥8.0%, respectively). Sensitivity analyses yielded consistent results when the variable definitions were changed and after multivariable adjustment with multiple imputation. Conclusions This population‐based study suggests that adherence to diabetes care may modify the association between HbA1c levels and the risk of COVID‐19 infection.

Abstract Background Most evidence of the waning of vaccine effectiveness is limited to a relatively short period after vaccination. Methods Data obtained from a linked database of healthcare administrative claims and vaccination records maintained by the municipality of a city in the Kanto region of Japan were used in this study. The study period extended from April 1, 2020, to December 31, 2022. The duration of the effectiveness of the COVID-19 vaccine was analyzed using a time-dependent piecewise Cox proportional hazard model using the age, sex and history of cancer, diabetes, chronic obstructive pulmonary disease, asthma, chronic kidney disease, and cardiovascular disease as covariates. Results Among the 174,757 eligible individuals, 14,416 (8.3%) were diagnosed with COVID-19 and 936 (0.54%) were hospitalized for COVID-19. Multivariate analysis based on the time-dependent Cox regression model with reference of non-vaccine group revealed a lower incidence of COVID-19 in the one-dose group (hazard ratio, 0.76 [95% confidence interval, 0.63–0.91]), two-dose (0.89 [0.85–0.93]), three-dose (0.80 [0.76–0.85]), four-dose (0.93 [0.88–1.00]), and five-dose (0.72 [0.62–0.84]) groups. A lower incidence of COVID-19-related hospitalization was observed in the one-dose group (0.42 [0.21–0.81]), two-dose (0.44 [0.35–0.56]), three-dose (0.38 [0.30–0.47]), four-dose (0.20 [0.14–0.28]), and five-dose (0.11 [0.014–0.86]) groups. Multivariable analyses based on the time-dependent piecewise Cox proportional hazard model with reference of non-vaccine group revealed significant preventive effects of the vaccine for 4 months for the incidence of COVID-19 and ≥ 6 months for hospitalization. Conclusions Vaccine effectiveness showed gradual attenuation with time after vaccination; however, protective effects against the incidence of COVID-19 and hospitalization were maintained for 4 months and ≥ 6 months, respectively. These results may aid in formulating routine vaccination plans after the COVID-19 pandemic.

Abstract Background Patients who receive invasive mechanical ventilation (IMV) in the intensive care unit (ICU) have exhibited lower in-hospital mortality rates than those who are treated outside. However, the patient-, hospital-, and regional factors influencing the ICU admission of patients with IMV have not been quantitatively examined. Methods This retrospective cohort study used data from the nationwide Japanese inpatient administrative database and medical facility statistics. We included patients aged ≥ 15 years who underwent IMV between April 2018 and March 2019. The primary outcome was ICU admission on the day of IMV initiation. Multilevel logistic regression analyses incorporating patient-, hospital-, or regional-level variables were used to assess cluster effects by calculating the intraclass correlation coefficient (ICC), median odds ratio (MOR), and proportional change in variance (PCV). Results Among 83,346 eligible patients from 546 hospitals across 140 areas, 40.4% were treated in ICUs on their IMV start day. ICU admission rates varied widely between hospitals (median 0.7%, interquartile range 0–44.5%) and regions (median 28.7%, interquartile range 0.9–46.2%). Multilevel analyses revealed significant effects of hospital cluster (ICC 82.2% and MOR 41.4) and regional cluster (ICC 67.3% and MOR 12.0). Including patient-level variables did not change these ICCs and MORs, with a PCV of 2.3% and − 1.0%, respectively. Further adjustment for hospital- and regional-level variables decreased the ICC and MOR, with a PCV of 95.2% and 85.6%, respectively. Among the hospital- and regional-level variables, hospitals with ICU beds and regions with ICU beds had a statistically significant and strong association with ICU admission. Conclusions Our results revealed that primarily hospital and regional factors, rather than patient-related ones, opposed ICU admissions for patients with IMV. This has important implications for healthcare policymakers planning interventions for optimal ICU resource allocation.

Abstract Background The risk of subsequent cardiovascular disease (CVD) is high in cancer survivors. Although metabolic syndrome is an established risk factor for CVD, its association with cancer survivors has not yet been established. This study aimed to clarify whether metabolic syndrome is associated with subsequent CVD risk in patients with cancer using a nationwide epidemiological dataset. Methods We retrospectively analysed 53 510 patients with a history of breast, colorectal, or stomach cancer, which is reportedly a major site for developing cancer in Japan. Study participants were categorized into two groups based on the presence of metabolic syndrome, defined using the Japanese criteria (high waist circumference and ≥2 metabolic parameters including elevated blood pressure, elevated triglycerides, reduced high‐density lipoprotein cholesterol, or elevated fasting plasma glucose). The clinical outcomes were collected between 2005 and 2021. The primary endpoint was defined as the composite CVD outcome, including myocardial infarction, angina pectoris, stroke, and heart failure. Results The median patient age was 54 years, and 37.5% of the patients were men. Metabolic syndrome was observed in 5558 (10.4%) patients. Over a mean follow‐up period of 973 ± 791 days, 3085 composite CVD outcomes were recorded. Multivariable Cox regression analyses showed that metabolic syndrome was associated with a greater risk of developing CVD events (HR = 1.29, 95% CI = 1.15–1.45). Metabolic syndrome was also associated with an increased risk of CVD in patients with a follow‐up period ≥1 year (HR = 1.33, 95% CI = 1.15–1.53). This relationship was also observed when metabolic syndrome was defined according to the International Diabetes Federation criteria (HR = 1.34, 95% CI = 1.21–1.49) and the National Cholesterol Education Program Adult Treatment Panel III criteria (HR = 1.32, 95% CI = 1.19–1.46). Subgroup analyses showed that the relationship between metabolic syndrome and incident CVD was more pronounced in the non‐obese participants than in the obese participants. Conclusions Metabolic syndrome is associated with a greater risk of developing CVD, even among cancer survivors.

Objectives Laboratory experiments have indicated that calcium channel blockers (CCBs) inhibit the entry and replication of influenza A virus in cells. However, no clinical studies have assessed the incidence of influenza among patients receiving CCBs. This study aimed to investigate the association between CCB use and the incidence of influenza among patients with hypertension using administrative claims data in Japan.Design Retrospective cohort study.Setting Administrative health insurance claims database of Kumamoto Prefecture, Japan.Participants 360 515 patients with hypertension (10th edition of the International Classification of Diseases code I10) who were prescribed CCBs and 171 142 patients who were prescribed angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) between 2012 and 2016.Primary outcome We compared the incidence of influenza between the CCB and ACEI/ARB groups using high-dimensional propensity-score (HD-PS) matching.Results A total of 166 814 HD-PS matched pairs were obtained. Before HD-PS matching, the CCB group had a significantly lower influenza incidence than the ACEI/ARB group in the overall analysis (2.4% vs 2.5%, p=0.007; risk ratio 0.95, 95% CI 0.92 to 0.99). However, no significant difference was observed between the two groups after HD-PS matching (2.4% vs 2.5%, p=0.067; risk ratio 0.96, 95% CI 0.92 to 1.00); only in 2012 did the CCB group have a significantly lower likelihood of influenza than the ACEI/ARB group.Conclusions No significant difference was observed in the influenza incidence between the CCB and ACEI/ARB groups. A direct comparative study between background-matched patients with and without CCBs is warranted to confirm the effect of CCBs on reducing the incidence of influenza.

Background: Although neonatal disseminated intravascular coagulation (DIC) is associated with high mortality and severe complications, few studies have reported its clinical course. We aimed to describe the characteristics, treatments, and outcomes of neonatal DIC by using a national inpatient database. Methods: Using the Japanese Diagnosis Procedure Combination database, we identified 5533 patients with neonatal DIC who were admitted to neonatal intensive care units between July 2010 and March 2020. We categorized the patients into those with asphyxia (n = 2911) and those without asphyxia (n = 2622). We investigated the patient characteristics, treatments, and outcomes. We further categorized neonates with asphyxia according to its severity. Results: The gestational age of neonates with asphyxia was significantly lower than that of neonates without asphyxia (P

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

Background The 2014 European Respiratory Society/American Thoracic Society guidelines defined severe asthma based on treatment intensity and estimated the proportion of severe asthma among all asthma cases to be 5–10%. However, data supporting the estimate and comprehensive and sequential data on asthma cases are scarce. We aimed to estimate the national prevalence and proportion of severe asthma during the last decade. Methods Using a Japanese national administrative database, which covers ≥99% of the population, we evaluated the prevalence and proportion of severe asthma in 2013, 2015, 2017 and 2019. Additionally, we elucidated the demographic characteristics, treatments and outcomes of patients with asthma. Results The national prevalence of mild–moderate and severe asthma in 2019 was 800 and 36 per 100 000 persons, respectively. While the prevalence of mild–moderate asthma remained almost constant in the study years, the prevalence of severe asthma decreased, resulting in a reduction in the proportion of severe asthma from 5.6% to 4.3%. Although treatment modalities have evolved, such as the increased use of combination inhalers and asthma biologics, approximately 15% of mild–moderate and 45% of severe asthma cases were still considered “uncontrolled”. The number of deaths from asthma decreased in patients with both mild–moderate and severe asthma. Conclusions This study revealed that the prevalence of severe asthma in Japan decreased during the study period and fell below 5% in the most recent data. Despite treatment evolution, a substantial proportion of patients with both mild–moderate and severe asthma still have poor asthma control.

BackgroundThe prevalence of diabetes has risen fast with a considerable weighted prevalence of undiagnosed diabetes or uncontrolled diabetes. Then it becomes more necessary to timely screen out and monitor high-risk populations who are likely to be ignored during the COVID-19 pandemic. To classify and find the common risks of undiagnosed diabetes and uncontrolled diabetes, it’s beneficial to put specific risk control measures into effect for comprehensive primary care. Especially, there is a need for accurate yet accessible prediction models.ObjectiveBased on a cross-sectional study and secondary analysis on the health examination held in Changchun City (2016), we aimed to evaluate the factors associated with hyperglycemia, analyze the management status of T2DM, and determine the best cutoff value of incidence of diabetes in the first-degree relatives to suggest the necessity of early diagnosis of diabetes after first screening.ResultsA total of 5658 volunteers were analyzed. Prevalence of T2DM and impaired fasting glucose were 8.4% (n=477) and 11.5% (n=648), respectively. There were 925 participants (16.3%) with a family history of T2DM in their first-degree relatives. Multivariable analysis demonstrated that family history was associated with hyperglycemia. Among the 477 patients with T2DM, 40.9% had not been previously diagnosed. The predictive equation was calculated with the following logistic regression parameters with 0.71 (95% CI: 0.67–0.76) of the area under the ROC curve, 64.0% of sensitivity and 29% of specificity (P < 0.001): P = \frac{1}{1 + e^{-z}}, where z = -3.08 + [0.89 (Family history-group) + 0.69 (age-group)+ 0.25 (BMI-group)]. Positive family history was associated with the diagnosis of T2DM, but not glucose level in the diagnosed patients. The best cutoff value of incidence of diabetes in the first-degree relatives was 9.55% (P < 0.001).ConclusionsFamily history of diabetes was independently associated with glucose dysfunction. Classification by the first-degree relatives with diabetes is prominent for targeting high-risk population. Meanwhile, positive family history of diabetes was associated with diabetes being diagnosed rather than the glycemic control in patients who had been diagnosed. It’s necessary to emphasize the linkage between early diagnosis and positive family history for high proportions of undiagnosed T2DM.

Background: Agonal breathing is a relatively common symptom that follows cardiac arrest when the brainstem function is preserved. Agonal breathing is associated with favorable survival in patients experiencing out-of-hospital cardiac arrest (OHCA). While previous studies focused on agonal breathing observed in the pre-hospital setting for all study subjects, we focused on agonal breathing observed upon hospital arrival. In this multicenter prospective study, we aimed to assess the prognosis of patients exhibiting agonal breathing upon hospital arrival were compared. We hypothesized that agonal breathing at hospital arrival would be associated with favorable neurological outcomes among patients with OHCA. Methods: The data on incidence of agonal breathing were prospectively collected for all evaluable participants in a multicenter, observational study in Japan (SOS-KANTO [Survey of Survivors after Out-of-Hospital Cardiac Arrest in Kanto Area] 2017 Study). Groups with and without agonal breathing were compared upon hospital arrival. Propensity-score with inverse probability of treatment weighting (IPTW) analysis was performed to adjust for confounding factors. The primary outcome was a favorable neurological outcome (Cerebral Performance Category 1–2) at 1 month. Results: A total of 6,457 participants out of the 9,909 registered in SOS-KANTO 2017 (in which 42 facilities participated) were selected for the current study. There were 128 patients (2.0%) in the with-agonal breathing group and 6,329 (98.0%) in the withoutagonal breathing group. The primary outcome was 1.1% in the with-agonal breathing group and 0.6% in the without-agonal breathing group (risk difference, 0.55; 95% confidence interval, 0.23–0.87) after IPTW analysis. Conclusion: In this multicenter prospective study, agonal breathing at hospital arrival was significantly associated with better neurological outcomes and increased survival at 1 month. Thus, agonal breathing at hospital arrival may be a useful prognostic predictor for patients experiencing OHCA.

Aim: This study aimed to assess the association between gasping and survival among out-of-hospital cardiac arrest (OHCA) patients requiring extracorporeal cardiopulmonary resuscitation (ECPR). Methods: This prospective, multicenter, observational study was conducted between 2019 and 2021. We categorized adult patients requiring ECPR into those with or without gasping prior to hospital arrival. The primary outcome was the 30-day survival. We performed multivariable logistic regression analyses fitted with generalized estimating equations and subgroup analyses based on the initial rhythm and age. Results: Of the 9,909 patients with OHCA requiring ECPR, 332 were enrolled in the present study, including 92 (27.7%) and 240 (72.3%) with and without gasping, respectively. The 30-day survival was higher in patients with gasping than in those without gasping (35.9% [33/92] vs. 16.2% [39/240]). In the logistic regression analysis, gasping was significantly associated with improved 30-day survival (adjusted odds ratio: 3.01; 95% confidence interval, 1.64–5.51). Subgroup analyses demonstrated similar trends in patients with an initial non-shockable rhythm and older age. Conclusions: Gasping was associated with improved survival in OHCA patients requiring ECPR, even those with an initial non-shockable rhythm and older age. Clinicians may select the candidates for ECPR appropriately based on the presence of gasping.

Abstract Background Clinical guidelines recommend early mobilization and rehabilitation (EMR) for patients who are critically ill. However, various barriers impede its implementation in real-world clinical settings. In 2018, the Japanese universal healthcare coverage system announced a unique financial incentive scheme to facilitate EMR for patients in intensive care units (ICU). This study evaluated whether such an incentive improved patients’ activities of daily living (ADL) and reduced their hospital length of stay (LOS). Methods Using the national inpatient database in Japan, we identified patients admitted to the ICU, who stayed over 48 hours between April 2017 and March 2019. The financial incentive required medical institutions to form a multidisciplinary team approach for EMR, development and periodic review of the standardized rehabilitation protocol, starting rehabilitation within 2 days of ICU admission. The incentive amounted to 34.6 United States Dollars per patient per day with limit 14 days, structured as a per diem payment. Hospitals were not mandated to provide detailed information on individual rehabilitation for government, and the insurer made payments directly to the hospitals based on their claims. Exposure was the introduction of the financial incentive defined as the first day of claim by each hospital. We conducted an interrupted time-series analysis to assess the impact of the financial incentive scheme. Multivariable radon-effects regression and Tobit regression analysis were performed with random intercept for the hospital of admission. Results A total of 33,568 patients were deemed eligible. We confirmed that the basic assumption of ITS was fulfilled. The financial incentive was associated with an improvement in the Barthel index at discharge (0.44 points change in trend per month; 95% confidence interval = 0.20–0.68) and shorter hospital LOS (− 0.66 days change in trend per month; 95% confidence interval = − 0.88 – -0.44). The sensitivity and subgroup analyses showed consistent results. Conclusions The study suggests a potential association between the financial incentive for EMR in ICU patients and improved outcomes. This incentive scheme may provide a unique solution to EMR barrier in practice, however, caution is warranted in interpreting these findings due to recent changes in ICU care practices.

Background: Despite the widespread practice of Japanese traditional Kampo medicine, the characteristics of patients receiving various Kampo formulations have not been documented in detail. We applied a machine learning model to a health insurance claims database to identify the factors associated with the use of Kampo formulations. Methods: A 10% sample of enrollees of the JMDC Claims Database in 2018 and 2019 was used to create the training and testing sets, respectively. Logistic regression analyses with lasso regularization were performed in the training set to construct models with prescriptions of 10 commonly used Kampo formulations in 1 year as the dependent variable and data of the preceding year as independent variables. Models were applied to the testing set to calculate the C-statistics. Additionally, the performance of simplified scores using 10 or 5 variables were evaluated. Results: There were 338,924 and 399,174 enrollees in the training and testing sets, respectively. The commonly prescribed Kampo formulations included kakkonto, bakumondoto, and shoseityuto. Based on the lasso models, the C-statistics ranged from 0.643 (maoto) to 0.888 (tokishakuyakusan). The models identified both the common determinants of different Kampo formulations and the specific characteristics associated with particular Kampo formulations. The simplified scores were slightly inferior to full models. Conclusion: Lasso regression models showed good performance for explaining various Kampo prescriptions from claims data. The models identified the characteristics associated with Kampo formulation use.

Abstract Background In the chain of survival for Out-of-hospital cardiac arrest (OHCA), each component of care contributes to improve the prognosis of the patient with OHCA. The SARS-CoV-2 (COVID-19) pandemic potentially affected each part of care in the chain of survival. The aim of this study was to compare prehospital care, in-hospital treatment, and outcomes among OHCA patients before and after the COVID-19 pandemic. Methods We analyzed data from a multicenter prospective study in Kanto area, Japan, named SOS-KANTO 2017. We enrolled patients who registered during the pre-pandemic period (September 2019 to December 2019) and the post-pandemic period (June 2020 to March 2021). The main outcome measures were 30-day mortality and the proportion of favorable outcomes at 1 month, and secondary outcome measures were changes in prehospital and in-hospital treatments between the pre- and post-pandemic periods. Results There were 2015 patients in the pre-pandemic group, and 5023 in the post-pandemic group. The proportion of advanced airway management by emergency medical service (EMS) increased (p

Background Although there have been studies that compared outcomes of patients with acute myocardial infarction (AMI) across countries, little focus has been placed on institutional variance of outcomes. The aim of the present study was to compare institutional variance in mortality following percutaneous coronary intervention (PCI) for AMI and factors explaining this variance across different health systems.Methods Data on inpatients who underwent PCI for AMI in 2016 were obtained from the National Health Insurance Data Sharing Service in Korea, the Diagnosis Procedure Combination (DPC) Study Group Database in Japan, and the National Health Insurance Research Database (NHIRD) in Taiwan. Multilevel analyses with inpatient mortality as the outcome and the hierarchical structure of patients nested within hospitals were conducted, adjusting for common patient-level and hospital-level variables. We compared the intraclass correlation coefficient (ICC) and the proportion of variance explained by hospital-level characteristics across the three health systems.Results There were 17 351 patients from 160 Korean hospitals, 29 804 patients from 660 Japanese hospitals, and 10 863 patients from 104 Taiwanese hospitals included in the analysis. Inpatient mortality rates were 6.3%, 7.3%, and 6.0% in Korea, Japan, and Taiwan, respectively. After adjusting for patient and hospital characteristics, Taiwan had the lowest variation in mortality (ICC, 1.8%), followed by Korea (2.2%) and then Japan (4.5%). The measured hospital characteristics explained 38%, 19%, and 9% of the institutional variance in Korea, Taiwan, and Japan, respectively.Conclusion Korea, Japan, and Taiwan had similarly uniform outcomes across hospitals for patients undergoing PCI for AMI. However, Japan had a relatively large institutional variance in mortality and a lower proportion of variation explainable by hospital characteristics, compared with Korea and Taiwan.

Objectives: The effectiveness of monotherapy and combination therapy with quinolones and macrolides for treating Legionnaires’ disease remains uncertain; this study aimed to assess the comparative effectiveness of three treatment approaches. Methods: Using a nationwide inpatient database, we analyzed 3560 eligible patients hospitalized for Legionnaires’ disease between April 1, 2014, and March 31, 2021; patients were divided into combination therapy, quinolone monotherapy, and macrolide monotherapy groups according to the antibiotics administered within 2 days of admission. We compared in-hospital mortality, total hospitalization costs, and length of stay across these groups using multiple propensity score analysis with inverse probability of treatment weighting. Results: Of the 3560 patients, there were 564 (15.8%), 2221 (62.4%), and 775 (21.8%) patients in the combination therapy, quinolone monotherapy, and macrolide monotherapy groups, respectively. No significant differences were observed in in-hospital mortality between combination therapy and quinolone monotherapy groups, and between combination therapy and macrolide monotherapy groups. There were no significant differences in total hospitalization costs or length of stay among the three groups. Conclusion: The study suggests that there may not be a significant advantage in using a combination of quinolones and macrolides over monotherapy for the treatment of Legionnaires’ disease. Given the potential for increased side effects, careful consideration is advised when choosing this combination therapy.

Background There are few data on sex differences in the association between schizophrenia and the development of cardiovascular disease (CVD). We sought to clarify the relationship of schizophrenia with the risk of developing CVDs and to explore the potential modification effect of sex differences. Methods and Results We conducted a retrospective analysis using the JMDC Claims Database between 2005 and 2022. The study population included 4 124 508 individuals aged 18 to 75 years without a history of CVD or renal replacement therapy. The primary end point is defined as a composite end point that includes myocardial infarction, angina pectoris, stroke, heart failure, atrial fibrillation, and pulmonary thromboembolism. During a mean follow‐up of 1288±1001 days, we observed 182 158 composite end points. We found a significant relationship of schizophrenia with a greater risk of developing composite CVD events in both men and women, with a stronger association observed in women. The hazard ratio for the composite end point was 1.63 (95% CI, 1.52–1.74) in women and 1.42 (95% CI, 1.33–1.52) in men after multivariable adjustment (P for interaction=0.0049). This sex‐specific difference in the association between schizophrenia and incident CVD was consistent for angina pectoris, heart failure, and atrial fibrillation. Conclusions Our analysis using a large‐scale epidemiologic cohort demonstrated that the association between schizophrenia and subsequent CVD events was more pronounced in women than in men, suggesting the clinical importance of addressing schizophrenia and tailoring the CVD prevention strategy based on sex‐specific factors.

Aim: To assess the association between body mass index (BMI) and neurological outcomes among patients with out-of-hospital cardiac arrest (OHCA). Methods: This prospective, multicenter, observational study conducted between 2019 and 2021 included adults with OHCA who were hospitalized after return of spontaneous circulation. Based on the BMI, the patients were categorized as underweight (BMI

Abstract Background The organ dysfunction that is associated with death in COVID-19 patients has not been determined in multicenter epidemiologic studies. In this study, we evaluated the major association with death, concomitant organ dysfunction, and proportion of multiple organ failure in deaths in patients with COVID-19, along with information on organ support. Methods We performed an observational cohort study using the Japanese multicenter research of COVID-19 by assembling a real-world data (J-RECOVER) study database. This database consists of data on patients discharged between January 1 and September 31, 2020, with positive SARS-CoV-2 test results, regardless of intensive care unit admission status. These data were collected from the Diagnosis Procedure Combination and electronic medical records of 66 hospitals in Japan. The clinician identified and recorded the organ responsible for the death of COVID-19. Results During the research period, 4,700 patients with COVID-19 were discharged from 66 hospitals participating in the J-RECOVER study; of which, 272 patients (5.8%) from 47 institutions who died were included in this study. Respiratory system dysfunction (87.1%) was the leading association with death, followed by cardiovascular (4.8%), central nervous (2.9%), gastrointestinal (2.6%), and renal (1.1%) dysfunction. Most patients (96.7%) who died of COVID-19 had respiratory system damage, and about half (48.9%) had multi-organ damage. Of the patients whose main association with death was respiratory dysfunction, 120 (50.6%) received mechanical ventilation. Conclusion This study showed that although respiratory dysfunction was the most common association with death in many cases, multi-organ dysfunction was associated with death due to COVID-19.

Abstract Background Previous studies have reported conflicting results regarding fresh frozen plasma (FFP)-to-red blood cell (RBC) ratio and platelet-to-RBC ratio on outcomes for massive transfusion for trauma. Moreover, nationwide data on massive transfusion practices for trauma in the real-world clinical setting are scarce. This study aimed to examine the nationwide practice patterns and trends in massive transfusion for trauma in Japan using a national administrative, inpatient database. Method We identified patients who underwent emergency hospitalization for trauma and received massive transfusion, defined as administration of at least 20 units of RBC within the first 2 days of admission, using the nationwide inpatient database, which covers approximately 90% of all tertiary emergency hospitals in Japan, between 2011 and 2020. Trends in the incidence and practice patterns of massive transfusion were described by calendar year. The association of practice patterns with mortality or adverse events was tested. Results A total of 3,530,846 trauma hospitalizations were identified, of which 5247 (0.15%) received massive transfusion. A significant declining trend was observed in the incidence of massive transfusion in trauma hospitalizations from 0.24% in 2011 to 0.10% in 2020 (P for trend

Abstract The aim of this study was to compare in-hospital mortality of three procedures –halo-vest immobilization, anterior spinal fixation (ASF), and posterior spinal fixation (PSF)– in the treatment of elderly patients with isolated C2 odontoid fracture. We extracted data for elderly patients who were admitted with C2 odontoid fracture and treated with at least one of the three procedures (halo-vest immobilization, ASF, or PSF) during hospitalization. We conducted a generalized propensity score-based matching weight analysis to compare in-hospital mortality among the three procedures. We further investigated independent risk factors for in-hospital death. The study involved 891 patients (halo-vest, n = 463; ASF, n = 74; and PSF, n = 354) with a mean age of 78 years. In-hospital death occurred in 45 (5.1%) patients. Treatment type was not significantly associated with in-hospital mortality. Male sex (odds ratio 2.98; 95% confidence interval 1.32–6.73; p = 0.009) and a Charlson comorbidity index of ≥ 3 (odds ratio 9.18; 95% confidence interval 3.25–25.92; p

Abstract Background The prognosis for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is poor, and there is no established treatment. Hence, we aimed to investigate the effectiveness of a polymyxin B-immobilised fibre column (PMX) for the treatment of AE-IPF. Methods Data were retrospectively collected from the Japanese Diagnosis Procedure Combination database from 1 July 2010 to 31 March 2018. We identified adult patients with idiopathic pulmonary fibrosis who received high-dose methylprednisolone (mPSL) therapy and mechanical ventilation upon admission. Eligible patients (n = 5616) were divided into those receiving PMX treatment combined with high-dose mPSL (PMX group, n = 199) and high-dose mPSL alone (mPSL alone group, n = 5417). To compare outcomes between the two groups, we applied a stabilised inverse probability of treatment weighting (IPTW) using propensity scores. The primary outcome was in-hospital mortality, and the secondary outcomes were 14- and 28-day mortality and length of hospital stay. Results The in-hospital mortality rates of the PMX and mPSL alone groups were 79.9% and 76.4%, respectively. The results did not significantly differ between the two groups after performing a stabilised IPTW. The odds ratio of the PMX group compared with the mPSL alone group was 1.56 (95% confidence interval 0.80–3.06; p = 0.19). The 14- and 28-day mortality and length of hospital stay (secondary outcomes) also did not significantly differ between the two groups. Conclusions In AE-IPF patients using mechanical ventilation, the treatment outcome was not significantly better for PMX combined with high-dose mPSL than for high-dose mPSL alone.

Abstract This study aimed to determine whether obesity and disease outcomes are associated in patients with critically-ill coronavirus disease 2019 (COVID-19) requiring invasive mechanical ventilation (IMV). This retrospective observational study using Japanese multicenter registry data included COVID-19 patients who required IMV and were discharged between January and September 2020. The patients were divided into the obese (body mass index [BMI] ≥ 25 kg/m2) and nonobese (BMI

Abstract Background Hepatorenal syndrome (HRS) is a life-threatening complication of end-stage liver disease. This study aimed to clarify the status of HRS in Japan by analyzing the Japanese Diagnosis Procedure Combination database. Methods Patients hospitalized for cirrhosis and HRS from July 2010 to March 2019 were sampled. They were divided into two groups according to their prognosis upon discharge: the transplant-free survival group and the death or liver transplantation group. The two groups’ baseline patient characteristics and treatments were compared. Results The mean age of the 1,412 participants was 67.3 years (standard deviation: 12.3 years), and 65.4% were male. The Child–Pugh grades was B and C in 18.8% and 81.2%, respectively. Hepatocellular carcinoma was present in 27.1% of the patients, and the proportion of spontaneous bacterial peritonitis was 2.3%. Albumin, noradrenaline, and dopamine were administered to 57.9%, 8.0%, and 14.9% of the patients, respectively; 7.0% of the patients underwent renal replacement therapy; and 5.0% were admitted to the intensive care unit. Intravenous antibiotics were administered to 30.8% of the patients. A total of 925 patients (65.5%) died or underwent liver transplantation. In addition to a higher proportion of patients with poor baseline liver function, the death or liver transplantation group included more males, patients with hepatocellular carcinoma, and those with spontaneous bacterial peritonitis. Conclusions HRS in Japan has a high mortality rate. Albumin was administered to over 50% of participants. Although noradrenaline is recommended in Japanese clinical guidelines, dopamine was more frequently used as a vasoconstrictor in clinical practice.

Living-donor lobar lung transplantation (LDLLT) is a well-established surgical procedure with favorable outcomes; however, the frequency of readmission and costs in LDLLT are poorly understood. Here, we aimed to compare health care costs and readmissions at 90 days and 1 year after the index discharge in LDLLT and cadaveric lung transplantation (CLT) and evaluate the reasons for readmission and in-hospital mortality. In this retrospective cohort study, we used the Diagnosis Procedure Combination database, a nationwide inpatient database in Japan to obtain initial lung transplantation data for all patients from July 2010 to March 2020. Multivariable Poisson or multiple regression analyses after multiple imputation was performed to compare the cumulative number of readmissions and costs between patients receiving LDLLT and CLT. Among 514 recipients, 115 (22%) underwent LDLLT and 399 (78%) received CLT. Overall, in-hospital mortality after transplantation was 4.5%. The LDLLT group showed a significantly lower crude readmission rate (90 days, 22% vs 37%, p = 0.004; 1 year, 48% vs 62%, p = 0.031) and median readmission cost (90 days, United States dollar (USD) 0 vs 0, p = 0.003; 1 year, USD 1178 vs 4714, p = 0.005) than the CLT group. Multivariable regression analyses showed that the LDLLT group had a lower risk of readmission (incidence rate ratio, 0.59; 95% confidence interval, 0.38-0.92; p = 0.020) and lower costs at 90 days (difference, USD −11,629; 95% confidence interval, −5682 to −17,462; p

Abstract Background Plasma exchange (PEX) has been the primary treatment for immune-mediated thrombotic thrombocytopenic purpura (iTTP) since the 1990s. Daily PEX is recommended in international guidelines, but PEX was only reimbursed up to three times weekly under the Japanese national health insurance system until March 2018. This study was conducted to analyze practice patterns and outcomes in patients with TTP in Japan. Methods We used the Japanese Diagnosis Procedure Combination inpatient database, including data from approximately 1,200 acute care hospitals. We identified all hospitalized adult patients who were diagnosed with TTP on admission from July 2010 to March 2017 and who received at least one PEX during hospitalization, which we defined as TTP treated with PEX. We revealed patient characteristics, treatment patterns, and outcomes. Results There were 1,559 patients with TTP treated with PEX. The median age was 64 (interquartile range [IQR] 46–74) years. There were slightly more women (59%) than men enrolled into this study. The median PEX frequency within 7 days of the initial PEX was three (IQR 2–5) times. The median total PEX number during hospitalization was six (IQR 3–10), while the median PEX duration was 10 (IQR 4–22) days. The median time from admission to the initial PEX was 4 (IQR 2–11) days. Overall, in-hospital mortality was 32%. Thirty-three percent (144/437) of hospitals reported only one case of TTP during the study period. Conclusions Our data demonstrated that clinical practice in Japan considerably varied and its standardization is warranted.

ABSTRACT Aims/Introduction Little is known about the relationship between cardiovascular health (CVH) metrics and the risk of developing prediabetes or diabetes. We examined the association of CVH metrics with the annual risk of developing prediabetes or diabetes. Materials and Methods We carried out this study including 403,857 participants aged 18–71 years with available data on fasting plasma glucose (FPG) data for five consecutive years and with normal FPG (

Abstract Background Children with community-acquired septic shock can rapidly deteriorate and die in acute-care hospitals. This study aimed to describe the mortality, timing, and risk factors in children with community-acquired septic shock. Methods This is a retrospective cohort study using a national inpatient database in Japan. The study population included children (age

Abstract Background Current guidelines recommend systemic thrombolysis as the first-line reperfusion treatment for patients with high-risk pulmonary embolism (PE) who present with cardiogenic shock but do not require venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, little is known about the optimal reperfusion treatment in high-risk PE patients requiring VA-ECMO. We aimed to evaluate whether systemic thrombolysis improved high-risk PE patients’ outcomes who received VA-ECMO. Methods This was a retrospective cohort study using the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2021. We identified patients who were diagnosed with PE and received VA-ECMO on the day of admission. Patients who received systemic thrombolysis with monteplase or urokinase within two days of initiating VA-ECMO were defined as the thrombolysis group and the remaining patients as the control group. The primary outcome was in-hospital mortality and secondary outcomes were favorable neurological outcomes, length of hospital stay, VA-ECMO duration, total hospitalization cost, major bleeding, and blood transfusion volume. Propensity-score inverse probability of treatment weighting (IPTW) was performed to compare the outcomes between the groups. Results Of 1220 eligible patients, 432 (35%) received systemic thrombolysis within two days of initiating VA-ECMO. Among the unweighted cohort, patients in the thrombolysis group were less likely to have poor consciousness at admission, out-of-hospital cardiac arrest, and left heart catheterization. After IPTW, the patient characteristics were well-balanced between the two groups The crude in-hospital mortality was 52% in the thrombolysis group and 61% in the control group. After IPTW, in-hospital mortality did not differ significantly between the two groups (risk difference: − 3.0%, 95% confidence interval: − 9.6% to 3.5%). There were also no significant differences in the secondary outcomes. Sensitivity analyses showed a significant difference in major bleeding between the monteplase and control groups (risk difference: 6.9%, 95% confidence interval: 1.7% to 12.1%), excluding patients who received urokinase. There were no significant differences in the other sensitivity and subgroup analyses except for the total hospitalization cost. Conclusions Systemic thrombolysis was not associated with reduced in-hospital mortality or increased major bleeding in the high-risk PE patients receiving VA-ECMO. However, systemic thrombolysis with monteplase was associated with increased major bleeding.

Abstract Background Although weight loss in heart failure (HF) is a detrimental condition known as cachexia, weight gain caused by fluid retention should also be considered harmful. However, studies with sufficient number of patients examining the impact of weight change and its interval on in‐hospital mortality in HF have not been conducted thus far. We sought to elucidate the association of weight change with in‐hospital mortality in patients with HF. Methods This retrospective observational study used data from the Diagnosis Procedure Combination database, a nationwide inpatient health claims database in Japan. In total, 48 234 patients repeatedly hospitalized for HF (median 82 [74–87] years; 46.4% men) between 2010 and 2018 were included. Weight change was derived from body weight at the first and second admissions. Results The median weight change and interval between two hospitalizations were −3.1 [−8.3 to −1.8] % and 172 [67–420] days, with 66.9% of overall cohort experiencing any weight loss. As a result of multivariable‐adjusted logistic regression analysis, weight loss +5.0% were associated with increased in‐hospital mortality (adjusted odds ratio [OR] [95% confidence interval]: 1.46 [1.31–1.62], P

Background: The guidelines for the requirement of Legionella urinary antigen tests on admission for patients hospitalized with community-acquired pneumonia differ in Japan, the United States, and Europe. We aimed to evaluate the association between the timing of Legionella urinary antigen testing and inhospital mortality in patients with atypical pneumonia. Methods: We identified 654,708 patients with atypical pneumonia from July 2010 to March 2021 using the Japanese national inpatient database. The patients were divided into groups that underwent Legionella urinary antigen tests on the day of admission (test group, n = 229,649) and those that underwent testing after the day of admission or were untested (control group, n = 425,059). A propensity score-stabilized inverse probability of treatment weighting analysis was performed to compare inhospital mortality, length of hospital stay, and total hospitalization costs between the two groups. Odds ratios (ORs) or differences and their 95% confidence intervals (CIs) were calculated using generalized linear models. Results: The tested group had a significantly lower 30-day inhospital mortality than that of the control group (7.7% vs. 9.0%; OR: 0.83 [95% CIs, 0.81–0.86]). The tested group also had a significantly shorter length of stay (difference, −2.3 [−2.6 to − 2.0] days and total hospitalization costs (−396 [−508 to − 285] US dollars) than that of the control group. Conclusions: Legionella urinary antigen testing upon admission is associated with better outcomes in patients with atypical pneumonia. Legionella urinary antigen testing performed on the day of admission is recommended for hospitalized patients with atypical pneumonia.

Abstract Background An increasing number of studies are evaluating the safety of intravenous sedation compared with that of general anesthesia; however, data on bleeding complications after pediatric percutaneous renal biopsy performed under intravenous sedation or general anesthesia are lacking. We aimed to examine differences in bleeding complications between intravenous sedation and general anesthesia in pediatric patients. Methods Data of pediatric patients aged ≤ 15 years undergoing percutaneous kidney biopsy for kidney disease between July 2007 and March 2019 were retrieved from a national inpatient database in Japan. We examined differences in bleeding complications after renal biopsy performed under intravenous sedation, defined by the absence of the record of general anesthesia with intubation but by the presence of intravenous sedation during biopsy, and general anesthesia, defined by the presence of the record of general anesthesia with intubation during biopsy, among pediatric patients admitted for percutaneous renal biopsy. We performed binomial regression using overlap weights based on propensity scores for patients receiving intravenous sedation. Analyses stratified by age or sex, a sensitivity analysis using generalized estimating equations considering cluster effects by hospital among a propensity score-matched cohort, and another sensitivity analysis using the instrumental variable method were performed to confirm the robustness of the results. Results We identified 6,560 biopsies performed in 5,999 children aged 1–15 years from 328 hospitals and 178 events. Only three severe complications and no death were observed. No significant difference in the proportion of bleeding complications was observed between procedures performed under intravenous sedation and those performed under general anesthesia (unadjusted proportions, 2.8% and 2.3%; adjusted proportions, 2.5% and 2.2%), with an unadjusted relative risk of 1.21 (95% confidence interval, 0.80–1.81) and adjusted relative risk of 1.13 (95% confidence interval, 0.74–1.73). Both age- and sex-stratified analyses yielded similar results. The analysis using generalized estimating equation and the instrumental variable method showed relative risks of 0.95 (95% confidence interval, 0.48–1.88) and 1.18 (95% confidence interval, 0.74–1.89), respectively. Conclusion This retrospective cohort study using a national database revealed that the risk of biopsy-related bleeding was comparable between intravenous sedation and general anesthesia during pediatric percutaneous kidney biopsy, suggesting that intravenous sedation alone and general anesthesia may have a similar bleeding risk in pediatric percutaneous kidney biopsies.

Introduction: Recent studies have shown worse post-operative outcomes following several surgeries in underweight or obese patients. However, the association between body mass index (BMI) and short-term outcomes following thyroid cancer surgery remains unclear because of the small number of patients, deficit s in background data known as risk factors (e.g. cancer stage, operative procedure, intraoperative device use and hospital volume) and categorisation of BMI. Methods: We identified patients who underwent thyroidectomy for different iated thyroid cancer from July 2010 to March 2017 using a Japanese nationwide inpatient database. We used restricted cubic spline (RCS) analyses to investigate potential non-linear associations between BMI (without categorisation) and outcomes: post-operative complications (local and general), duration of anaesthesia, post-operative length of hospital stay and hospitalisation costs. The analyses were adjusted for demographic and clinical backgrounds including the above-stated factors. We also performed multivariable regression analyses for the outcomes with categorisation of BMI. Results: Among 59,671 eligible patients, the median BMI was 22.9 kg/m2 (interquartile range (IQR), 20.7–25.6 kg/m2). In total, 3860 patients (6.5%) had local complications and 787 patients (1.3%) had general complications. Although the re were no significant associations with local complications, such as bleeding, recurrent laryngeal nerve paralysis and surgical site infection, the occurrence of general complications was significantly associated with higher BMI. BMI showed a linear as sociation with the duration of anaesthesia and U-shaped associations with post-operative length of stay and hospitalisation costs. The lowest points of the U-shaped curves occurred at a BMI of approximately 24 kg/m2. The multivariate regression analyses showed consistent results with the RCS analyses.

Abstract We aimed to evaluate the association between ICU patient volume before the COVID-19 pandemic and the outcomes of ventilated COVID-19 patients. We analyzed ventilated patients with COVID-19 aged > 17 years and enrolled in the J-RECOVER study, a retrospective multicenter observational study conducted in Japan between January and September 2020. Based on the number of patients admitted to the ICU between January and December 2019, the top third institutions were defined as high-volume centers, the middle third ones as middle-volume centers, and the bottom third ones as low-volume centers. The primary outcome measure was in-hospital mortality. Multivariate logistic regression analysis for in-hospital mortality and ICU patient volume was performed after adjusting for multiple propensity scores. Among 461 patients, 158, 158, and 145 patients were admitted to low-volume (20 institutions), middle-volume (14 institutions), and high-volume (13 institutions) centers, respectively. Admission to middle- and high-volume centers was not significantly associated with in-hospital death compared with admission to low-volume centers (adjusted odds ratio, 1.11 [95% confidence interval (CI): 0.55–2.25] and adjusted odds ratio, 0.81 [95% CI: 0.31–1.94], respectively). In conclusion, institutional intensive care patient volume prior to the COVID-19 pandemic was not significantly associated with in-hospital death in ventilated COVID-19 patients.

Background: Detailed data on intensive care unit (ICU) occupancy in Japan are lacking. Using a nationwide inpatient database in Japan, we aimed to assess ICU bed occupancy to guide critical care utilization planning. Methods: We identified all ICU patients admitted from January 1, 2015 to December 31, 2018 to ICU-equipped hospitals participating in the Japanese Diagnosis Procedure Combination inpatient database. We assessed the trends in daily occupancy by counting the total number of occupied ICU beds on a given day divided by the total number of licensed ICU beds in the participating hospitals. We also assessed ICU occupancy for patients with mechanical ventilation, patients with extracorporeal membrane oxygenation, and patients without life-supportive therapies. Results: Over the 4 study years, 1,379,618 ICU patients were admitted to 495 hospitals equipped with 5,341 ICU beds, accounting for 75% of all ICU beds in Japan. Mean ICU occupancy on any given day was 60%, with a range of 45.0% to 72.5%. Mean ICU occupancy did not change over the 4 years. Mean ICU occupancy was about 9% higher on weekdays than on weekends and about 5% higher in the coldest season than in the warmest season. For patients with mechanical ventilation, patients with extracorporeal membrane oxygenation, and patients without life-supportive therapies, mean ICU occupancy was 24%, 0.5%, and 30%, respectively. Conclusion: Only one-fourth of ICU beds were occupied by mechanically ventilated patients, suggesting that the critical care system in Japan has substantial surge capacity under normal temporal variation to care for critically ill patients.

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic has disrupted critical care services worldwide. Examining how critical care systems responded to the COVID-19 pandemic on a national level will be useful in setting future critical care plans. The present study aimed to describe the utilization of critical care services before and during the COVID-19 pandemic using a nationwide Japanese inpatient administrative database. Methods All patients admitted to an intensive care unit (ICU) or a high-dependency care unit (HDU) from February 9, 2019, to February 8, 2021, in the Japanese Diagnosis Procedure Combination inpatient database were included. February 9, 2020, was used as the breakpoint separating the periods before and during COVID-19 pandemic. Hospital and patient characteristics were compared before and during the COVID-19 pandemic. Change in ICU and HDU bed occupancy before and during the COVID-19 pandemic was evaluated using interrupted time-series analysis. Results The number of ICU patients before and during the COVID-19 pandemic was 297,679 and 277,799, respectively, and the number of HDU patients was 408,005 and 384,647, respectively. In the participating hospitals (383 ICU-equipped hospitals and 460 HDU-equipped hospitals), the number of hospitals which increased the ICU and HDU beds capacity were 14 (3.7%) and 33 (7.2%), respectively. Patient characteristics and outcomes in ICU and HDU were similar before and during the COVID-19 pandemic except main etiology for admission of COVID-19. The mean ICU bed occupancy before and during the COVID-19 pandemic was 51.5% and 47.5%, respectively. The interrupted time-series analysis showed a downward level change in ICU bed occupancy during the COVID-19 pandemic (− 4.29%, 95% confidence intervals − 5.69 to − 2.88%), and HDU bed occupancy showed similar trends. Of 383 hospitals with ICUs, 232 (60.6%) treated COVID-19 patients in their ICUs. Their annual hospital case volume of COVID-19 ICU patients varied greatly, with a median of 10 (interquartile range 3–25, min 1, max 444). Conclusions The ICU and HDU bed capacity did not increase while their bed occupancy decreased during the COVID-19 pandemic in Japan. There was no change in clinicians’ decision-making to forego ICU/HDU care for selected patients, and there was no progress in the centralization of critically ill COVID-19 patients.

Objectives: This study aim to evaluate the effectiveness of fluoroquinolone (FQ) antimicrobial therapy in combination with tetracyclines (TCs) in patients with Japanese spotted fever (JSF) using a nationwide inpatient database in Japan.Methods: We identified hospitalized patients diagnosed with JSF who were enrolled in the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2021. Patients who received FQ plus TC on the day of admission were compared with patients who received TC alone on the day of admission, using inverse probability of treatment weighting. The primary outcome was in-hospital mortality. Secondary outcomes were in-hospital complications, total hospitalization costs, and length of hospital stay.Results: We identified 1060 eligible patients. Of these, 434 (41%) received FQ plus TC on the day of admission and 626 (59%) received TC alone on the day of admission. Inverse probability of treatment weighting showed no statistically significant differences between the groups in in-hospital mortality, in-hospital complications, total hospitalization costs, and length of hospital stay.Conclusion: This study did not show any significantly improved effectiveness using FQ antimicrobials in combination with TCs for treating JSF. Clinicians may need to be cautious in administering FQ and TC antimicrobials concomitantly in routine practice.

Background: Psoriasis is a known risk factor for acute myocardial infarction (AMI). However, the associations between psoriasis and short-term outcomes of AMI remain controversial. Objective: To compare the short-term outcomes of AMI patients with and without psoriasis accounting for patient background characteristics and site-specific effects. Methods: We identified patients with AMI between July 2010 and March 2020, using a Japanese national inpatient database. We matched patients with and without psoriasis to generate a 1:10 matched-pair cohort matched for sex, hospital, and fiscal year at admission. Multivariable regression analyses with adjustment for background characteristics including age and Killip class at admission were conducted to compare short-term outcomes of AMI. Results: In this study of AMI patients with psoriasis (n = 455) and without psoriasis (n = 438,534), 30-day in-hospital mortality was 5.6%. Patients with psoriasis had higher proportions of comorbidities than patients without psoriasis. Multivariable regression analyses in the matched-pair cohort revealed that psoriasis was significantly associated with decreased 30-day in-hospital mortality (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.08-0.85). Limitations: Retrospective study design without data on psoriasis severity. Conclusion: The matched-pair cohort analyses with adjustment for patient background characteristics and site-specific effects revealed decreased in-hospital mortality in AMI patients with psoriasis.

Background The impact of major changes in the treatment practice of pulmonary embolism (PE), such as limited indications for systemic thrombolysis and the introduction of direct oral anticoagulants, is not well documented. This study aimed to describe annual trends in the treatment patterns and outcomes in patients with PE. Methods and Results Using the Japanese Diagnosis Procedure Combination inpatient database from April 2010 to March 2021, we identified hospitalized patients with PE. Patients with high‐risk PE were defined as those admitted for out‐of‐hospital cardiac arrest or who received cardiopulmonary resuscitation, extracorporeal membrane oxygenation, vasopressors, or invasive mechanical ventilation on the day of admission. The remaining patients were defined as patients with non–high‐risk PE. The patient characteristics and outcomes were reported with fiscal year trend analyses. Of 88 966 eligible patients, 8116 (9.1%) had high‐risk PE, and the remaining 80 850 (90.9%) had non–high‐risk PE. Between 2010 and 2020, in patients with high‐risk PE, the annual proportion of extracorporeal membrane oxygenation use significantly increased from 11.0% to 21.3%, whereas that of thrombolysis use significantly decreased from 22.5% to 15.5% (P for trend

Abstract Aim Although major complication rates following percutaneous liver biopsy (PLB) have been reported to be higher in children than in adults, scarce data are available regarding pediatric patients stratified by native and transplanted liver. We aimed to assess the factors associated with major complications after percutaneous biopsy of native or transplanted liver using a nationwide inpatient database. Methods Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified pediatric patients who underwent PLB between 2010 and 2018. We described major complication rates and analyzed factors associated with major complications following PLB, stratified by native and transplanted liver. Results We identified 3584 pediatric PLBs among 1732 patients from 239 hospitals throughout Japan during the study period, including 1310 in the native liver and 2274 in the transplanted liver. Major complications following PLB were observed in 0.5% (n = 18) of the total cases; PLB in the transplanted liver had major complications less frequently than those in the native liver (0.2% vs. 1.0%, p = 0.002). The occurrence of major complications was associated with younger age, liver cancers, unscheduled admission, anemia or coagulation disorders in cases with native liver, while it was associated with younger age alone in cases with transplanted liver. Conclusions The present study, using a nationwide database, found that major complications occurred more frequently in pediatric cases with native liver and identified several factors associated with its major complications.

Abstract Little is known regarding the relationship between self-reported gait speed and the subsequent risk of heart failure (HF) and cardiovascular disease (CVD). We sought to clarify the clinical utility of self-reported gait speed in primary CVD prevention settings. This is an observational cohort study using the JMDC Claims Database, which is an administrative health claims database. Data were collected between January 2005 and April 2020. Medical records of 2,655,359 participants without a prior history of CVD were extracted from the JMDC Claims Database. Gait speed was assessed using information from questionnaires provided at health check-ups, and study participants were categorized into fast or slow gait speed groups. The primary outcome was HF. The secondary outcomes included myocardial infarction (MI), angina pectoris (AP), and stroke. The median age was 45.0 years, and 55.3% of participants were men. 46.1% reported a fast gait speed. The mean follow-up period was 1180 ± 906 days. HF, MI, AP, and stroke occurred in 1.9%, 0.2%, 1.9%, and 1.0% of participants, respectively. Multivariable Cox regression analyses showed that, compared with slow gait speed, fast gait speed was associated with a lower incidence of HF, MI, AP, and stroke. The discriminative predictive ability for HF significantly improved by adding self-reported gait speeds to traditional risk factors (net reclassification improvement 0.0347, p

We sought to clarify the incidence of major adverse cardiac events (MACE) after the initiation of immune checkpoint inhibitors (ICIs). We analyzed the JMDC Claims Database between 2005 and 2021. The study included 2972 patients with no history of cardiovascular disease and a prescription for an ICI. The primary outcome was the incidence of MACE, including myocarditis, pericarditis, Takotsubo cardiomyopathy, atrio-ventricular block, heart failure, myocardial infarction, and stroke. The median age of study participants was 59 (Q1-Q3 53–65) years, and 2163 participants (72.8%) were male. Lung cancer was the most common cancer site (n = 1603). Among ICIs, programmed cell death-1 (PD-1) was most frequently used, and a combination ICI treatment was conducted in 110 patients (3.7%). During a mean follow-up of 358 ± 327 days, 419 MACE events were recorded. The incidence rate of myocarditis, pericarditis, Takotsubo cardiomyopathy, atrio-ventricular block, heart failure, myocardial infarction, and stroke was 3.4, 142.3, 10.3, 17.2, 1191.2, 55.2, and 278.5 per 10,000 person-years, respectively. The incidence of cardiovascular events was higher within 180 days after the initial prescription of ICI. The continuation rate of ICI after MACE was 38.4%. In conclusion, our analysis of a nationwide epidemiological dataset demonstrated the incidence of MACE after the initiation of ICI treatment. The incidence of heart failure was higher than expected, and the continuation rate of ICI treatment after MACE was low. Our results indicated the importance of monitoring and prevention of cardiovascular events in cancer patients requiring ICI treatment.

Background Limited evidence is available on sex differences about the association between hypertension and incident atrial fibrillation (AF). Methods and Results We used a nationwide health checkup and claims database to analyze 3 383 738 adults (median age, 43 (36–51) years, 57.4% men). We investigated the relationship between hypertension and incident AF in men and women using a Cox regression model. We used restricted cubic spline functions to identify the association of blood pressure (BP) as a continuous parameter with incident AF. We categorized the men and women into 4 groups according to the 2017 American College of Cardiology/American Heart Association BP guidelines. During a mean follow‐up of 1199±950 days, 13 263 AF diagnoses were recorded. The incidence (95% CI) of AF was 15.8 (15.5–16.1) per 10 000 person‐years in men and 6.1 (5.9–6.3) per 10 000 person‐years in women. Compared with normal BP, elevated BP, stage 1 hypertension, and stage 2 hypertension were associated with an increased risk AF in both men and women. However, the hazard ratios were greater in women than in men, and the P value for interactions in the multivariable model was 0.0076. The models using restricted cubic spline showed that the risk of AF associated with elevated systolic BP increased steeply above an approximate threshold of systolic BP of 130 mm Hg in men and 100 mm Hg in women. Although our primary findings were consistent across subgroup analyses, this association was most significant in younger individuals. Conclusions Although the incidence of AF was higher in men, the association between hypertension and incident AF was more pronounced in women than in men, suggesting a potential sex difference in the relationship between hypertension and incident AF.

Abstract This study compared hand function and the cost-effectiveness of treatment between collagenase Clostridium histolyticum (CCH) injection and limited fasciectomy for patients with Dupuytren’s contracture (DC). The CeCORD-J study is a prospective, multicenter, non-randomized controlled, observational study of two parallel groups. Participants were DC patients with multiple affected fingers, including flexion contracture of the proximal interphalangeal (PIP) joint. The primary outcome was the Hand10 score, as a patient-reported outcome measure (PROM). We set secondary outcomes of EQ-5D-5L (QOL) score, degree of extension deficit, and direct cost. Propensity score adjustment was used to balance differences in patient characteristics between groups. Participants comprised 52 patients in the Collagenase group and 26 patients in the Surgery group. There were no significant differences in the Hand10 and QOL scores between the two groups at 26 weeks. Mean direct cost was 248,000 yen higher in the Surgery group than in the Collagenase group. Extension deficit angle of the PIP joint was significantly larger in the Collagenase group at 26 weeks. Although the Collagenase group showed dominance in cost-effectiveness, there was no significant difference between the two groups in hand function at 26 weeks.

Abstract Background Some academic organizations recommended that physicians intubate patients with COVID-19 with a relatively lower threshold of oxygen usage particularly in the early phase of pandemic. We aimed to elucidate whether early intubation is associated with decreased in-hospital mortality among patients with novel coronavirus disease 2019 (COVID-19) who required intubation. Methods A multicenter, retrospective, observational study was conducted at 66 hospitals in Japan where patients with moderate-to-severe COVID-19 were treated between January and September 2020. Patients who were diagnosed as COVID-19 with a positive reverse-transcription polymerase chain reaction test and intubated during admission were included. Early intubation was defined as intubation conducted in the setting of ≤ 6 L/min of oxygen usage. In-hospital mortality was compared between patients with early and non-early intubation. Inverse probability weighting analyses with propensity scores were performed to adjust patient demographics, comorbidities, hemodynamic status on admission and time at intubation, medications before intubation, severity of COVID-19, and institution characteristics. Subgroup analyses were conducted on the basis of age, severity of hypoxemia at intubation, and days from admission to intubation. Results Among 412 patients eligible for the study, 110 underwent early intubation. In-hospital mortality was lower in patients with early intubation than those with non-early intubation (18 [16.4%] vs. 88 [29.1%]; odds ratio, 0.48 [95% confidence interval 0.27–0.84]; p = 0.009, and adjusted odds ratio, 0.28 [95% confidence interval 0.19–0.42]; p