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Current guidelines recommend colonoscopy within 24 hours for acute lower gastrointestinal bleeding (ALGIB); however, the evidence in support for colonic diverticular hemorrhage (CDH) indications remains insufficient. We use a nationwide database to investigate the effectiveness of early colonoscopy for CDH.We conducted a retrospective cohort study using the Japanese Diagnosis Procedure Combination inpatient database and identified patients who were admitted for CDH from 2010 to 2017. Patients who underwent colonoscopy on the same day of admission (early group) were compared with those who underwent colonoscopy on the next day of admission (elective group). The primary outcome was in-hospital mortality, and secondary outcomes were length of hospital stay, total hospitalization cost, fasting period, and the prevalence of re-colonoscopy, interventional radiology (IVR) or abdominal surgery. Propensity score matching was used to adjust for confounders.We identified 74,569 eligible patients. Patients were divided into the early (n=46,759) and elective (n=27,810) groups. After propensity score matching, 27,696 pairs were generated. In-hospital mortality did not significantly differ between the two groups (0.49% in the early group vs. 0.41% in the elective group; risk difference, 0.08%; 95% CI, -0.02 to 0.19; p=0.14). The early group had a significantly longer length of hospital stay, higher total hospitalization cost, longer fasting period, and higher prevalence of re-colonoscopy and abdominal surgery.The effectiveness of early colonoscopy conducted on the same day of admission for CDH could not be confirmed. Early colonoscopy may not result in favorable outcomes in CDH patients.

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.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 (100 mg/dL) at the initial health checkup. We identified the following ideal CVH metrics: non-smoking, body mass index of25 kg/mThe median age was 44 years, and 65.6% were men. An increasing number of non-ideal CVH metrics was associated with an elevated risk of prediabetes or diabetes. A non-ideal body mass index was most strongly associated with the risk of prediabetes or diabetes. The risk of developing prediabetes or diabetes rose as the number of non-ideal CVH metrics increased over 1 year.CVH metrics could stratify the risk of the annual development of prediabetes or diabetes. The risk of developing prediabetes or diabetes might be reduced by improving CVH metrics.

The acrylonitrile-co-methallyl sulfonate surface-treated (AN69ST) membrane has cytokine adsorption capacity and is used for treating sepsis. This study aimed to compare the effects of continuous renal replacement therapy (CRRT) using the AN69ST membrane with those of CRRT using other membranes for patients with pneumonia-associated sepsis.This retrospective, propensity score-matched, cohort study was based on a nationwide Japanese inpatient database. We included data from adults hospitalized with a primary diagnosis of pneumonia, who received CRRT using either the AN69ST membrane or another membrane within 2 days of admission, and who were discharged from the hospitals between September 2014, and March 2017. Propensity score matching was used to compare in-hospital mortality between the two groups.Eligible patients (N = 2393) were categorized into an AN69ST group (N = 631) and a non-AN69ST group (N = 1762). The overall in-hospital mortality rate was 38.9%. Among the 545 propensity-matched patient pairs, the in-hospital mortality rate was significantly lower in the AN69ST group than in the non-AN69ST group (35.8 vs. 41.8%, p = 0.046).Among patients with pneumonia-associated sepsis treated with CRRT, CRRT with the AN69ST membrane was associated with a significantly lower in-hospital mortality than CRRT with standard membranes.

Although many studies have investigated the relationship between patient outcomes and the level of nurse staffing, little is known about the association between increased night-shift nurse staffing and patient outcomes. In the Japanese universal health insurance system, a new scheme of additional financial incentives for acute care hospitals was launched in 2012 to increase the number of nurses during the night shift in general wards. The objective of this study was to investigate whether an additional financial incentive to increase night-shift nurse staffing in general wards was associated with better patient outcomes.Adoption of the above-mentioned scheme of additional financial incentives was used as a natural experiment, and the difference-in-differences method was conducted to evaluate the effect of the scheme. The study was performed using a nationwide inpatient database and hospital information in Japan.To conduct a difference-in-differences analysis, first, hospitals with and without increased night-shift nurse staffing were matched using propensity score matching. A patient-level difference-in-differences analysis was then conducted. The intervention group comprised the hospitals that adopted the new scheme of additional financial incentives. The outcome measures were in-hospital mortality, failure to rescue, and length of hospital stay.Subjects were 403,971 adult patients who underwent planned major surgeries in Japanese acute care hospitals from April 2012 to March 2018. The adjusted difference-in-differences estimates were not significant for in-hospital mortality (odds ratio: 0.83; 95% confidence interval: 0.68 to 1.01; p = 0.07) or failure to rescue (odds ratio: 0.92; 95% confidence interval: 0.73 to 1.14; p = 0.44). The adjusted difference-in-differences estimate for length of hospital stay was significant (percent change: -3.2%; 95% confidence interval: -6.1 to -0.3%; p = 0.029), indicating that the adoption of the scheme was associated with a decreased length of hospital stay.Increased night-shift nurse staffing was not associated with a decrease in in-hospital mortality or failure to rescue, but it was associated with a reduction in the length of hospital stay. It may be necessary to consider changes in policy content to make the policy more effective. The findings of this study are potentially useful for medical policymakers considering nurse staffing to decrease the length of stay, which may decrease costs.This study showed that increased night-shift nurse staffing was not associated with a decrease in in-hospital mortality or failure to rescue, but it was associated with a reduction in the length of hospital stay. The examination of the effectiveness of increasing nurse staffing during a specific shift in acute care hospitals is potentially useful for health policymakers worldwide in their considerations of future nurse staffing policies.

To describe and compare the postoperative adverse events and re-treatment for recurrence after laparoscopic and robotic-assisted sacrocolpopexy in Japanese patients with pelvic organ prolapse (POP).This was a retrospective cohort study using the DeSC database, which contains claims and medical check-up data provided by DeSC Healthcare Inc., Tokyo, Japan. We identified all patients who had undergone either laparoscopic or robotic-assisted sacrocolpopexy from April 2014 to May 2021. Patient backgrounds and postoperative outcomes were compared between the laparoscopic and robotic-assisted sacrocolpopexy groups. Moreover, the composite adverse event comprising vaginal erosion, postoperative urinary incontinence, postoperative dysuria, urinary tract injury, and abdominal incisional hernia was evaluated. Re-treatment for POP recurrence included pessary use and surgery for POP was also evaluated.Among 28 748 patients diagnosed with POP, 409 (1.4%) had undergone laparoscopic sacrocolpopexy and 52 (0.2%) had undergone robotic-assisted sacrocolpopexy. The prevalence of postoperative adverse events was 20.8% and 13.5% in the laparoscopic and robotic-assisted sacrocolpopexy groups, respectively (P = 0.270). One patient (1.9%) underwent surgery after robotic-assisted sacrocolpopexy, and none of the patients was administered pessaries postoperatively in both groups.In Japan, postoperative outcomes after laparoscopic and robotic-assisted sacrocolpopexy are similar and comparable to those reported in western countries.

To clarify the fetal safety of herbal Kampo medicines, including Hange-koboku-to, Koso-san, Nyoshin-san, Yokukansan, Yokukansan-kachinpi-hange, Saiko-keishikankyo-to, Keishi-karyukotu-borei-to, and Kanbaku-taisou-to, when administered to pregnant women with depression using a large healthcare administrative database.We extracted data from the JMDC Claims Database (2005-2018) for this retrospective cohort study of pregnant women aged 19 years or older admitted to obstetric clinics or hospitals for delivery. Participants were classified into four groups: those without depression, those diagnosed with depression without medication, those given Kampo medicines for depression, and those given western medicines for depression. Neonatal outcomes (congenital anomalies, low birth weight, and preterm birth) were considered as the safety outcome measures.We identified 179 707 eligible mothers. The adverse outcomes did not differ significantly between participants receiving Kampo medicine and those not diagnosed with depression during pregnancy. The proportion of low-birth-weight neonates did not differ significantly between the Kampo medicine and non-depression groups (adjusted odds ratio [aOR] 1.28; 95% confidence interval [CI] 0.86-1.91), but was significantly higher in the unmedicated depression group (aOR 1.31; 95% CI 1.07-1.61) and western medicine group (aOR 1.47; 95% CI 1.18-1.83).Kampo medicines are safe for treating depression during pregnancy without increasing the incidence of congenital anomalies, low birth weight, or preterm birth.

Direct oral anticoagulants (DOACs) have been used for both primary and secondary prevention of cerebral infarction in older patients with atrial fibrillation (AF). However, whether DOACs are more effective and safer than warfarin for secondary prevention of cerebral infarction in older patients with AF remains unclear.Using the Japanese Diagnosis Procedure Combination database, we identified patients with AF who were hospitalized for cerebral infarction from January 1, 2015 to March 31, 2019 and were aged ≥75 years at admission. We performed propensity score-stabilized inverse probability of treatment weighting analyses to balance measured confounders between patients with AF receiving DOACs and those receiving warfarin after discharge. The primary outcomes were 365-day readmission for (a) benefit: cerebral infarction or (b) harm: bleeding events after discharge. The secondary outcomes were 365-day readmission for intracranial bleeding or gastrointestinal bleeding after discharge as well as all-cause death during readmission. Using a Fine-Gray model, we compared the subdistribution hazard ratios (SHRs) of readmission between the DOAC group and warfarin group.We identified 101,389 eligible patients, including 80,726 patients receiving DOACs and 20,663 patients receiving warfarin. After the propensity score-stabilized inverse probability of treatment weighting, the adjusted SHRs of readmission (95% confidence interval [CI]) for cerebral infarction, bleeding events, and intracranial bleeding in the DOAC group as compared with the warfarin group were 0.76 (0.71-0.81), 0.78 (0.68-0.90), and 0.69 (0.57-0.82), respectively. There was no significant difference in readmission for gastrointestinal bleeding (SHR, 1.01; 95% CI, 0.72-1.41) between the DOAC and warfarin groups.In this retrospective nationwide study, DOACs were more effective and safer than warfarin for preventing reinfarction and bleeding events in patients with AF aged ≥75 years who have a history of cerebral infarction.

To clarify whether treatment with systemic corticosteroids at a certain dose was associated with better outcomes in patients with epiglottitis requiring airway management (tracheotomy or airway intubation).This was a retrospective cohort study on patients hospitalized for epiglottitis requiring airway management from a nationwide inpatient database (between July 2010 and March 2019). Patients treated with systemic corticosteroids equivalent to methylprednisolone ≥40 mg/d within 2 days of admission and patients who were not treated with corticosteroids within 2 days of admission were compared after inverse probability of treatment weighting using covariate balancing propensity score. The primary outcome was all-cause 30-day in-hospital mortality, and secondary outcomes included all-cause 7-day in-hospital mortality, length of hospital stay, and total medical cost.There were 1986 and 1771 patients in the corticosteroid and control groups, respectively. A total of 72 of 3757 (1.9%) patients died within 30 days of admission, including 17 of 1986 (0.9%) patients in the corticosteroid group and 55 of 1771 (3.1%) in the control group (weighted odds ratio, 0.28 [95% confidence interval, 0.11-0.70]; weighted risk difference, -2.2% [-3.2% to -1.3%]). Treatment with corticosteroids was associated with lower total medical costs (weighted median, $6,187 vs. $6,587; weighted difference, $-1,123 [-2,238 to -8]) but not all-cause 7-day in-hospital mortality (weighted odds ratio, 0.63 [0.22-1.82]; weighted risk difference, -0.3% [-0.9 to 0.2]) and length of hospital stay (weighted median, 13 vs. 13 days; weighted difference, -0.2 days [-2.1 to 1.8]).Systemic corticosteroids may be beneficial to patients with epiglottitis requiring airway management.3 Laryngoscope, 2022.

This study examined the association between adding nurse aides and patient mortality in acute care settings. We conducted a retrospective cohort study using a national healthcare administrative claims database. We identified patients who underwent planned surgery for six types of cancer from 2010 to 2017. Multivariable logistic analyses were used to examine the association between the nurse aide staffing level and patient outcomes. The primary outcomes were failure to rescue and 30-day hospital mortality. We examined 330 666 in-hospital patients. The median number of nurse aides per 100 occupied beds was 6.60 (interquartile range, 4.61-8.43). In the multivariable analysis, nurse aide staffing level was not significantly associated with failure to rescue or 30-day hospital mortality. The Japanese government provides economic incentives to hospitals that hire more nurse aides, expecting that a higher nurse aide staffing level will help licensed nurses concentrate on the tasks that need their specialties. However, our findings suggest that adding nurse aides may not be associated with lower rates of failure to rescue or 30-day hospital mortality in acute care settings.

Purpose Validating outcome measures is a prerequisite for using administrative databases for comparative effectiveness research. Although the Japanese Diagnosis Procedure Combination database is widely used in surgical studies, the outcome measure for postsurgical infection has not been validated. We developed a model to identify postsurgical infections using the routinely-collected Diagnosis Procedure Combination data. Methods We retrospectively identified inpatients who underwent surgery for gastric, colorectal, or liver cancer between April 2016 and March 2018 at four hospitals. Chart reviews were conducted to identify postsurgical infections. We used bootstrap analysis with backwards variable elimination to select independent variables from routinely-collected diagnosis and procedure data. Selected variables were used to create a score predicting the chart review-identified infections, and the performance of the score was tested. Results Among the 756 eligible patients, 102 patients (13%) had postoperative infections. Three variables were identified as predictors: diagnosis of infectious disease recorded as a complication arising after admission, addition of an intravenous antibiotic, and bacterial microscopy or culture. The prediction model had a C-statistic of 0.891 and pseudo-R2 of 0.380. A cut-off of 1 point of the score showed a sensitivity of 92% and specificity of 71%, and a cut-off of 2 points showed a sensitivity of 77% and specificity of 91%. Conclusions Our model using routinely-collected administrative data accurately identified postoperative infections. Further external validation would lead to the application of the model for research using administrative databases. This article is protected by copyright. All rights reserved.

Medical benefits of peripherally acting mu-opioid receptor antagonists other than improving opioid-induced constipation remain unclear. Our aim was to evaluate the association between the use of naldemedine and incidence of hyperactive delirium in cancer patients receiving chemotherapy and opioid therapy.We conducted a propensity score-matched analysis using a nationwide inpatient database in Japan. Cancer patients receiving both inpatient chemotherapy and opioid therapy from June 1, 2017, to March 31, 2018, were included. Patients receiving naldemedine were matched to control patients by propensity score. Our primary outcome was the incidence of hyperactive delirium during hospitalization, and secondary outcomes were the length of hospital stay, hospital costs, in-hospital mortality, and incidence of ileus.Of 34,031 patients receiving inpatient chemotherapy and opioid therapy, 1905 (5.6%) were included in the naldemedine group. After one-to-four propensity score matching, 1904 patients were included in the naldemedine group and 7616 in the control group. Naldemedine users had significantly reduced incidence of hyperactive delirium compared with the control patients (19.4% vs 23.3%; risk difference, -3.9 [95% confidence interval, -5.9 to -1.9]; risk ratio, 0.83 [0.75-0.92]; p0.001; subdistribution hazard ratio, 0.85 [0.75-0.97]; p = 0.015). The median length of hospital stay was significantly shorter in the naldemedine group compared with the control group (12 days [interquartile range, 6-23] vs 14 days [6-26]; p = 0.001). The median hospital costs were also significantly lower in the naldemedine group compared with the control group (US $6179 [3351-10,026] vs US $6576 [3436-11,107]; p 0.001). No significant differences were found for in-hospital mortality or incidence of ileus between the groups.Our findings suggest that the use of naldemedine may have benefits in preventing hyperactive delirium, shortening hospital stay, and decreasing hospital costs in cancer patients receiving chemotherapy and opioid therapy.

Objective Pregnant women may develop disseminated intravascular coagulation (DIC), possibly resulting in massive maternal haemorrhage and perinatal death. The Japan guideline recommends use of antithrombin III (ATIII) for DIC in obstetrics; however, its effect remains uncertain. The present study aimed to investigate the effect of ATIII for DIC in obstetrics, using a national inpatient database in Japan. Design Nationwide observational study. Setting Japan. Population We used the Diagnosis Procedure Combination inpatient database to identify patients who delivered at hospital and were diagnosed with DIC from July 2010 to March 2018. Methods Propensity score matching analyses were performed to compare in-hospital maternal mortality and hysterectomy during hospitalisation between users and non-users of ATIII on the day of delivery. Main outcome measures In-hospital mortality, hysterectomy. Results A total of 9920 patients were enrolled, including 4329 patients (44%) who used ATIII and 5511 patients (56%) who did not use ATIII. One-to-one propensity score matching created 3290 pairs. In-hospital maternal mortality did not differ significantly between the propensity-matched groups (0.3% in the ATIII group versus 0.5% in the control group; odds ratio 0.73; 95% CI 0.35-1.54). A significantly lower proportion of patients in the ATIII group, compared with those in the control group, underwent hysterectomy during hospitalisation (5.3% versus 8.7%; absolute risk difference -2.9%; 95% CI -4.2 to -1.6%). Conclusions Although the present study did not show a mortality-reducing effect of ATIII for patients with DIC in obstetrics, it may have clinical benefit in terms of reducing the number of patients undergoing hysterectomy. Tweetable abstract This study did not show mortality-reducing effect of antithrombin III for patients with DIC in obstetrics.

Aim Despite advances in the management of liver diseases and changes in the etiology of cirrhosis, few studies have updated the prognosis of cirrhosis. This study aimed to clarify the recent prognosis of cirrhosis and identify risk factors for death. Methods In this retrospective observational study by the Hepatic Disease Network of the National Hospital Organization in Japan, chart reviews were performed to follow patients with cirrhosis beginning in 2011. We conducted Kaplan-Meier survival time analyses stratified by Child-Pugh classification and albumin-bilirubin grade. Cox regression analysis was used to identify risk factors for death. Results We identified 444 eligible patients from 25 hospitals, including 303 (68%), 110 (25%), and 31 (7%) patients with Child-Pugh classes A, B, and C, respectively. Hepatitis C virus infection was the cause of cirrhosis for 63% of the patients. The 1-year and 5-year cumulative survival rates of patients with Child-Pugh classes A, B, and C were 90% and 61%, 78% and 42%, and 65% and 25%, respectively. The 1-year and 5-year cumulative survival rates of patients with albumin-bilirubin grades 1, 2, and 3 were 98% and 80%, 91% and 56%, and 58% and 23%, respectively. Cirrhosis classification (Child-Pugh and albumin-bilirubin), age, liver cancer, and untreated esophageal varices were associated with increased hazard of death. Conclusions Little improvement was observed in the prognosis of cirrhosis compared with previous reports, and the prognosis of Child-Pugh class C cirrhosis remained poor. Untreated esophageal varices were identified as a risk factor for death.

Background and aim The effect of tranexamic acid (TXA) remains unknown in patients with colonic diverticular bleeding, which is one of the most common causes of lower gastrointestinal bleeding. We investigated the efficacy of TXA for patients with colonic diverticular bleeding. Methods We performed a nationwide observational study using the Japanese Diagnosis Procedure Combination database and identified patients who were admitted for diverticular bleeding from 2010 to 2018. Patients who received TXA on the day of admission comprised the TXA group, and the remaining patients comprised the control group. The primary outcome was in-hospital mortality. Secondary outcomes included severe bleeding, blood transfusion within 7 days of admission, length of stay, and hospitalization costs. Propensity score matching was performed to compare outcomes between the two groups. Results Overall, 78 291 patients met our eligibility criteria, and 30 526 matched pairs were created by one-to-one propensity score matching. After matching, there was no significant difference in in-hospital mortality between the two groups (odds ratio [OR], 1.07; 95% confidence interval [CI], 0.88-1.30); however, TXA administration was associated with significantly lower proportions of severe bleeding events (OR, 0.93; 95% CI, 0.89-0.99), blood transfusions (OR, 0.88; 95% CI, 0.84-0.92), shorter length of stay (difference, -0.23 days; 95% CI, -0.01 to -0.44 days), and lower total hospitalization costs (difference, -$233; 95% CI, -$153 to -$314). Conclusions Although TXA was not significantly associated with lower in-hospital mortality, it may reduce severe bleeding, blood transfusions, length of stay, and hospitalization costs.

Background Semisolid nutrients have been widely used to prevent complications related to enteral nutrition (EN) in Japan. However, there are few data on the effect of feeding semisolid nutrient preparations. We compared 30-day readmission rates of gastrostomy tube-fed patients who had been prescribed semisolid vs liquid nutrients on discharge. Methods This is a retrospective observational study using a Japanese nationwide inpatient database of data entered between June 2014 and March 2018. We identified patients aged ≥18 years who had received EN through gastrostomy during hospitalization. Patients were classified as having been prescribed semisolid vs liquid EN on discharge. After one-to-one propensity score matching, all-cause 30-day readmission rates were compared between the 2 groups. Results In total, 5331 patients were identified, including a semisolid-nutrients group (n = 2089) and a liquid-nutrients group (n = 3242). Propensity score matching created 1912 pairs. The 30-day readmission rates were 15.6% and 13.9% in the semisolid-nutrients and liquid-nutrients groups, respectively. No significant difference was observed between the groups (risk difference, 1.7%; 95% CI, -0.6 to 4.0%; P = .14). Conclusion All-cause 30-day readmission of patients receiving gastrostomy tube feeding did not differ between those prescribed semisolid vs liquid nutrients on discharge. Randomized controlled trials are needed to accurately determine the effect of semisolid nutrients on clinical outcomes.

Aim Previous randomized controlled trials of branched-chain amino acid infusion for hepatic encephalopathy involved a small number of patients, and the effectiveness of branched-chain amino acid infusion has not been clarified. We evaluated whether branched-chain amino acid infusion in addition to lactulose treatment was associated with short-term outcomes in a large population of patients. Methods Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified inpatients with hepatic encephalopathy who received lactulose within 2 days of admission from July 2011 to March 2017. We divided the patients into those who received branched-chain amino acid infusion within 2 days of admission in addition to lactulose treatment and those who did not. We conducted propensity-score inverse probability of treatment weighting analyses to compare in-hospital mortality, consciousness at discharge, in-hospital complications, length of stay, and total hospitalization costs between the groups. Results We identified 8051 patients with hepatic encephalopathy treated with lactulose, including 7560 patients who received lactulose plus branched-chain amino acid infusion and 491 who received lactulose alone. The lactulose plus branched-chain amino acid infusion group had a significantly lower mortality than the lactulose alone group (9.6% vs. 15.0%, odds ratio 0.60, 95% confidence interval 0.44-0.82). The lactulose plus branched-chain amino acid infusion group also had a lower proportion of patients with impaired mental status at discharge, and lower total hospitalization costs than the lactulose alone group. Conclusions Branched-chain amino acid infusion together with lactulose may improve the prognosis of hepatic encephalopathy.

Background Clinical features and complications of subcutaneous implantable cardioverter‐defibrillator (S‐ICD) implantation for Brugada syndrome have not been well studied. Methods We used the Japanese Diagnosis Procedure Combination database to retrospectively investigate patients who had undergone ICD implantation between April 2016 and March 2017. We compared the characteristics and in‐hospital complications of patients with Brugada syndrome implanted with S‐ICD or transvenous (TV)‐ICD. Results We extracted 3090 patients who received ICD implantation. Among them, we identified 278 Brugada patients. The mean age was 43 ± 14.4 years and 262 (94%) were male. Of these 278 patients, 136 (49%) received S‐ICD and 142 (51%) received TV‐ICD. TV‐ICD recipients had a history of atrial fibrillation more frequently compared with S‐ICD recipients. The median (interquartile range) of length of hospital stay was not significantly different between patients with S‐ICD and TV‐ICD (13 days [10‐20.5] vs 12 days [10‐18], respectively). The prevalence of in‐hospital complications after ICD implantation was similar between the two groups. There were no patients with cardiac tamponade, hemothorax, pneumothorax, cardiovascular event, stroke, and death following the procedure during hospitalization in either group. Conclusions Short‐term safety of S‐ICD implantation may be identical to that of TV‐ICD. Large prospective studies are warranted to compare the effects and long‐term safety of S‐ICD compared with TV‐ICD., In the present study, we aimed to compare the patient characteristics and in‐hospital complication of patients with Brugada syndrome implanted with subcutaneous implantable cardioverter‐defibrillator S‐ICD (S‐ICD) or transvenous (TV)‐ICD. From the Japanese nationwide inpatient database, we extracted 3090 patients who received ICD implantation. The present study is the first to describe patient characteristics and in‐hospital complication of TV‐ICD and S‐ICD in patients with Brugada syndrome in Japan.

Objectives To investigate whether Japanese Kampo medicines, including Sho-hange-kabukuryou-to, Touki-syakuyaku-san, and Hange-kouboku-to, are safe for fetuses, and whether these medicines reduce hospitalizations and medical costs in pregnant women with hyperemesis gravidarum. Methods We used the Japan Medical Data Center database to extract data for pregnant women (aged ≥19 years) admitted to obstetric clinics or hospitals for delivery between January 1, 2005, and December 31, 2016. Eligible patients were classified into three groups: Kampo medicines for hyperemesis gravidarum, other medicines for hyperemesis gravidarum, and without hyperemesis gravidarum. Safety outcome measures were neonatal outcomes (congenital anomalies, low birthweight, and preterm birth), and effectiveness measures were mother's unplanned hospitalization for hyperemesis gravidarum and total medical costs within 20 weeks of gestation. Results We identified 121 287 eligible mothers. No significant differences in the safety measures were observed among the groups. The Kampo medication group had a significantly lower proportion of mothers with unplanned hospital admission (odds ratio 0.80, 95% confidence interval [CI] 0.69-0.92) and lower total costs (coefficient [US$] 12.8, 95% CI -23.2 to -2.4) than the other medication group. Conclusion Kampo medicines may reduce unplanned admissions and medical costs among pregnant women with hyperemesis gravidarum. UMIN Clinical Trials Registry: R000037298 UMIN000032706.

Aim Clinical guidelines for acute lower gastrointestinal bleeding (LGIB) recommend non‐endoscopic treatment when endoscopic treatment is difficult or the patient is hemodynamically unstable. The aim of this study was to investigate whether angiography should be prioritized as initial treatment for severe LGIB patients over colonoscopy. Methods We undertook a retrospective cohort study using the Japanese Diagnosis Procedure Combination inpatient database. We compared adult patients who underwent colonoscopy or angiography within 1 day of admission for severe LGIB from 2010 to 2017. The primary outcome was in‐hospital mortality. Secondary outcomes included surgery carried out within 1 day after admission and surgery carried out between 2 and 7 days of admission. Propensity score‐matched analyses were undertaken to adjust for confounders. Results We identified 6,546 eligible patients. The patients were divided into the colonoscopy group (n = 5,737) and angiography group (n = 809). After one‐to‐four propensity score matching, we compared 3,220 and 805 patients who underwent colonoscopy and angiography, respectively. The angiography group was not significantly associated with reduced in‐hospital mortality compared with the colonoscopy group. In contrast, the number of patients who underwent surgery within 1 day of admission was significantly lower in the angiography group than in the colonoscopy group. Conclusions The present study revealed that in‐hospital mortality did not significantly differ between colonoscopy and angiography, even in severe LGIB patients. Although this study was unable to identify which subgroups should undergo angiography for primary hemostasis, angiography might be a better option than colonoscopy for initial hemostasis in more severe cases of LGIB., The present study aimed to determine which initial treatment for severe LGIB patients should be prioritized ‐ angiography or colonoscopy. No significant difference was observed for in‐hospital mortality between the treatment groups in severe LGIB patients.

Objectives It is unclear whether mandatory health examination is effective for employees who are already being treated for chronic diseases. We focused on patients being treated for hypertension and evaluated the association between employer‐based health examination attendance and diabetes treatment initiation. Methods Using a database that stores health insurance claims and health examination results of subscribers enrolled in society‐managed health insurance plans in Japan, we identified employees aged 40‐59 years who were being treated for hypertension when starting diabetes treatment from April 2012 to December 2016. A case‐crossover analysis was conducted using 90, 180, and 270 days prior to diabetes treatment initiation as reference points and 90 days after the mandatory health examination as the exposure period. We conducted a subgroup analysis by hemoglobin A1c (HbA1c) level and frequency of outpatient blood glucose testing before the mandatory health examination. Results We identified 1464 individuals starting treatment for diabetes while on antihypertensive drugs. The overall odds ratio for starting diabetes treatment within 90 days of the health examination was 1.89 (95% confidence interval: 1.70‐2.10). The subgroup analysis showed that this odds ratio increased as HbA1c level increased and as blood glucose testing frequency decreased. Conclusions Among employees starting treatment for diabetes while being treated for hypertension, employer‐based mandatory health examination attendance was associated with initiation of diabetes treatment. The health examinations may be functioning as a complement to screening in outpatient settings.

Background Sugammadex is used as a reversal drug during anesthesia. Although several case reports have described anaphylaxis following sugammadex infusion, little is known about the relationship between sugammadex and anaphylaxis, particularly in pediatric patients. Aims The aim of this retrospective study was to investigate the association between sugammadex and in-hospital anaphylaxis in pediatric patients who underwent general anesthesia. Methods We identified patients who underwent general anesthesia in a Japanese national inpatient database between July 2010 and March 2016. We conducted 1-4 case-control matching between patients with and without perioperative anaphylaxis. We calculated the adjusted odds ratio for sugammadex use and occurrence of anaphylaxis, using a conditional logistic regression analysis with adjustment for duration of anesthesia, antibiotics, and blood transfusions. Results Among 835 405 patients who underwent general anesthesia, we identified 149 (0.018%) patients with anaphylactic shock and 472 (0.056%) with a combination of anaphylaxis associated signs/symptoms and skin lesions. Sugammadex use was not significantly associated with anaphylactic shock (odds ratio, 0.80; 95% confidence interval, 0.53-1.21; P = .29) or the combination of anaphylaxis associated signs/symptoms and skin lesions (odds ratio, 1.25; 95% confidence interval, 0.97-1.60; P = .08). Conclusion The present study showed no significant association between sugammadex and perioperative anaphylaxis in pediatric patients who underwent general anesthesia.

Objectives To investigate factors associated with lower likelihood of discharge to home from geriatric intermediate care facilities in Japan. Design Retrospective cohort study. Setting We used data from the nationwide long-term care (LTC) insurance claims database (April 2012-March 2014). Participants Study participants were 342,758 individuals newly admitted to 3,459 geriatric intermediate care facilities during the study period. Measurements The primary outcome was discharge to home. We performed a multivariable competing-risk Cox regression with adjustment for resident-, facility-, and region-level characteristics. Resident level of care needs and several medical conditions were included as time-varying covariates. Death, admission to a hospital, and admission to another LTC facility were treated as competing risks. Results During the 2-year follow-up period, 19% of participants were discharged to home. In the multivariable competing-risk Cox regression, the following factors were significantly associated with lower likelihood of discharge to home: older age, higher level of care need, having several medical conditions, private ownership of the facility, more beds in the facility, and more LTC facility beds per 1,000 adults aged 65 and older in the region. Conclusion Only 19% of residents were discharged to home. Our results are useful for policy-makers to promote discharge to home of older adults in geriatric intermediate care facilities.

Background Associations between underweight/obesity and manifestations of influenza infection remain unclear, especially in children. This study investigated the dose-response relationships between weight status and clinical outcomes among children hospitalized with influenza-related respiratory infections. Methods We obtained hospital discharge records of inpatients aged under 18 years with diagnoses of bronchitis/pneumonia and influenza, using a Japanese national inpatient database. The patients were classified as underweight, normal-weight, overweight, or obese groups using weight-for-length, weight-for-height, and body-mass-index for age following World Health Organization criteria. We compared need for intensive care, 30-day readmission, mean total hospitalization costs, and length of hospital stay across the four groups using multivariable regression models and restricted cubic spline functions. Results Overall, 27 771 patients were identified, including 2637 underweight, 19 701 normal-weight, 2675 overweight, and 2758 obese patients. The underweight group showed a significantly higher 30-day readmission (adjusted odds ratio, 1.68; 95% confidence interval, 1.28-2.18) and a longer length of stay (adjusted difference, 0.23 days; 95% confidence interval, 0.12-0.23 days) than the normal-weight group did. No significant differences in the need for intensive care or hospitalization costs were observed across the four weight status groups. The threshold for a statistically significant association between weight status and 30-day readmission was a z-score for weight-for-length, weight-for-height, or BMI for age of -0.95 (17th percentile). Conclusion These findings demonstrated that underweight status is a risk factor for repeated hospital admissions because of influenza-related respiratory infections in children.

Aim Tuberculosis screening is recommended for patients with immune-mediated inflammatory diseases (IMIDs) prior to anti-tumor necrosis factor (TNF) therapy. However, adherence to the recommended practice is unknown in the current clinical setting in Japan. Methods We used a large-scale health insurance claims database in Japan to conduct a longitudinal observational study. Of more than two million beneficiaries in the database between 2013 and 2014, we enrolled those with IMIDs aged 15–69 years who had initiated anti-TNF therapy. We defined tuberculosis screening primarily as tuberculin skin test and/or interferon-gamma release assay (TST/IGRA) within 2 months before commencing anti-TNF therapy. We analyzed the proportions of the patients who had undergone tuberculosis screening and the associations with primary disease, type of anti-TNF agent, methotrexate prescription prior to anti-TNF therapy, and treatment for latent tuberculosis infection (LTBI). Results Of 385 patients presumed to have initiated anti-TNF therapy, 252 (66%) had undergone tuberculosis screening by TST/IGRA (22% TST, 56% IGRA, and 12% both TST and IGRA), and 231 (60%) had undergone TST/IGRA and radiography. Patients with psoriasis tended to be more likely to undergo tuberculosis screening than those with other diseases; however, this association was not statistically significant. Treatment for LTBI was provided to 43 (11%) patients; 123 (32%) received neither TST/IGRA nor LTBI treatment. Conclusions Tuberculosis screening was often not performed prior to anti-TNF therapy despite the guidelines’ recommendations; thus, patients could be put at unnecessary risk of reactivation of tuberculosis.

Background Asthma and obesity are common health problems in children. This study investigated the impact of obesity on children hospitalized with acute asthma exacerbation. Methods We obtained the hospital discharge records of inpatients aged 3-8 years with a diagnosis of asthma using a national inpatient database in Japan. The patients were classified into underweight, normal weight, overweight, and obese groups using weight for height and body mass index for age provided by the World Health Organization. We compared 30-day re-admission, need for intensive care, mean total hospitalization costs, and length of hospital stay between the 4 groups using multivariable regression models. Results Overall, 38 679 patients were identified, including 3177 underweight, 28 904 normal weight, 3334 overweight, and 3264 obese patients. The obese group showed significantly higher 30-day re-admission (adjusted odds ratio, 1.26; 95% confidence interval, 1.03-1.54) and longer length of stay (adjusted difference, 0.12 days; 95% confidence interval, 0.10-0.20 days) than the normal weight group. The threshold was a 91st percentile of weight for length or body mass index for the relationship with 30-day re-admission. No significant difference was observed between the 4 groups regarding the need for intensive care and total hospitalization costs. Conclusion These findings demonstrated that obesity was a risk factor for repeated admissions caused by asthma in children, indicating the importance for the prevention of pediatric obesity.

Background and Aim Because of the rarity of invasive treatment for hepatocellular carcinoma (HCC) in patients on hemodialysis (HD) for end-stage renal disease (ESRD), the risks associated with radiofrequency ablation (RFA) in such patients remain uncertain. We used a nationwide database to investigate in-hospital mortality and hemorrhagic complications following RFA in patients on HD for ESRD. Methods Using the Japanese Diagnosis Procedure Combination database, we enrolled patients on HD for ESRD who underwent RFA for HCC. For each patient, we randomly selected up to four non-dialyzed patients using a matched-pair sampling method based on patient age, sex, treatment hospital, and treatment year. In-hospital mortality and hemorrhagic complications were compared between dialyzed and non-dialyzed patients following RFA. Results We compared matched-pair samples of 437 dialyzed and 1345 non-dialyzed patients. In patients on HD for ESRD, mortality was significantly lower in those aged ≤70 years than in older patients (P = 0.02). In-hospital mortality was significantly higher in dialyzed ESRD patients than in non-dialyzed patients (1.1% vs 0.15%, respectively; odds ratio = 7.77, P