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Introduction: The association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and the risk of urogenital infections remains controversial. This study aimed to investigate the association between SGLT2 inhibitors and the incidence of perineal soft tissue infections, including Fournier's gangrene (FG), genital bacterial infections, and urinary tract infections (UTIs), using administrative claims data in Japan. Methods: In this retrospective cohort study, we utilized the JMDC Claims Database. The study included patients aged 18 years or older diagnosed with type 2 diabetes mellitus, identified by a diagnostic code, who received new prescriptions for SGLT2 inhibitors or dipeptidyl peptidase 4 (DPP-4) inhibitors between April 2014 and August 2020. Using one-to-one propensity score (PS) matching, we compared the incidence of perineal soft tissue infections, including FG, genital bacterial infection, and UTIs between groups treated with SGLT2 and DPP-4 inhibitors. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using the Cox proportional hazards model. Results: We identified 34,897 patients in the SGLT2 inhibitor group and 135,311 patients in the DPP-4 inhibitor group. After one-to-one PS matching, 31,665 pairs were generated. The mean age of the patients was 51 years, with approximately 70% being male. The use of SGLT2 inhibitors was associated with a decreased risk of UTI (HR 0.90, 95% CI 0.83–0.98) and an increased risk of genital bacterial infection (HR 1.23, 95% CI 1.03–1.46) compared to DPP-4 inhibitors. However, no significant association was observed with perineal soft tissue infection (HR 1.05, 95% CI 0.61–1.81). Conclusions: SGLT2 inhibitors were associated with a reduced risk of UTI and an increased risk of genital bacterial infection. They showed no significant association with perineal soft tissue infection when compared to DPP-4 inhibitors. Future research should explore broader demographics, focusing on the elderly and achieving gender balance, to gain a comprehensive understanding of infection risks. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

Although large-scale administrative databases may be useful for studies of infectious diseases, conventional databases lack microbiological data. To illustrate the applicability of the National Hospital Organization Clinical Data Archives, a novel database of electronic medical records in Japan, we conducted a descriptive study of the microbiological findings in patients with community-acquired pneumonia using the database. We identified patients aged ≥18 years who were hospitalized for community-acquired bacterial pneumonia between April 2016 and March 2019. We evaluated the results of bacterial culture and antibacterial susceptibility of specimens obtained on the first day of hospitalization, in addition to patient characteristics, diagnosis codes, and intravenous antibiotics administered. The analysis identified 2200 eligible patients from 15 hospitals. Sulbactam–ampicillin was the most frequently used initial antibiotic (32 %), followed by ceftriaxone (22 %) and tazobactam–piperacillin (19 %). Overall, 56 %, 95 %, 56 %, and 73 % of patients with pathogen-specific diagnosis codes in the database for Streptococcus pneumoniae , Haemophilus influenzae , Klebsiella pneumoniae , and Pseudomonas aeruginosa , respectively, also tested positive for the corresponding pathogen in their sputum or blood cultures. Antibacterial susceptibilities were consistent with a previous report from Japan; 81 % of S. pneumoniae cases were resistant to azithromycin, and 48 % of H. influenzae cases were resistant to ampicillin. These microbiological characteristics warrant the future use of this database for detailed real-world research on infectious diseases. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to elucidate the impact of periodontal therapy on glycaemic control in individuals with type 2 diabetes and various baseline blood glucose levels using a large‐scale claims database from Japan. Materials and Methods: Using the JMDC Claims Database, we identified individuals with type 2 diabetes who underwent health check‐ups in the fiscal years 2018 or 2019 and were followed up until the next year's health check‐up. We conducted a weighted cohort analysis using stabilized inverse probability weights for treatment and censoring to estimate the effect of periodontal therapy on changes in haemoglobin A1c levels within a year. Analysis was done for different baseline haemoglobin A1c categories: 6.5%–6.9%, 7.0%–7.9% and ≥8.0%. Results: Of the 4279 insured persons included in the study, 957 received periodontal therapy. Overall, there was a tendency towards improved glycaemic control among those who received periodontal therapy. Participants with baseline haemoglobin A1c levels of 7.0%–7.9% who received periodontal therapy exhibited significantly better glycaemic control compared with those without dental visits (difference; −0.094 [95% confidence interval: −0.181 to −0.007]). Conclusions: Periodontal therapy may improve glycaemic control in individuals with diabetes, especially in those with haemoglobin A1c levels ≥7.0%. [ABSTRACT FROM AUTHOR]

Objectives: Although amoxicillin is the first‐line prophylactic drug for impacted mandibular third molar extraction, third‐generation cephalosporins are widely prescribed in Japan. The lack of real‐world evidence may be one reason for this inappropriate use. We evaluated differences in the incidence of surgical site infection between amoxicillin and third‐generation cephalosporins for impacted mandibular third molar extraction. Methods: Using the JMDC Claims Database, we identified dental visits with fully or horizontally impacted mandibular third molar extraction from April 2015 to March 2020. One‐to‐one propensity‐score matching was conducted between amoxicillin and third‐generation cephalosporin groups. The incidence of surgical site infection following extraction was compared in the matched pairs using McNemar's test. Results: We identified 109,266 dental visits, including 39,514 (36.2%) patients who received amoxicillin and 69,752 (63.8%) patients who received third‐generation cephalosporins. In the 39,514 matched pairs, the incidence of surgical site infection was 3.5% (n = 1399) for amoxicillin group and 3.7% (n = 1467) for third‐generation cephalosporin group (p = 0.003). Conclusions: Amoxicillin was associated with a lower incidence of surgical site infection after impacted mandibular third molar extraction compared with third‐generation cephalosporins. This result supports current guidelines and strengthens the importance of disseminating and implementing antimicrobial resistance control in dentistry. [ABSTRACT FROM AUTHOR]

Aim: Kakkonto, a Japanese herbal kampo medicine, is empirically prescribed to improve milk stasis and ameliorate breast inflammation in patients with noninfectious mastitis. We investigated whether early use of kakkonto is associated with a reduction in antibiotic use and surgical drainage in patients with noninfectious mastitis. Methods: We identified 34 074 patients with an initial diagnosis of noninfectious mastitis within 1 year of childbirth between April 2012 and December 2022 using the nationwide administrative JMDC Claims Database. Patients were divided into the kakkonto (n = 9593) and control (n = 9648) groups if they received and did not receive kakkonto on the day of the initial diagnosis of noninfectious mastitis, respectively. Antibiotic administration and surgical drainage within 30 days after the initial diagnosis of noninfectious mastitis in the two groups were compared using propensity score‐stabilized inverse probability of treatment weighting analysis. Results: The frequency of antibiotic administration within 30 days after the initial diagnosis of noninfectious mastitis was significantly lower in the kakkonto group than in the control group (10% vs. 12%; odds ratio, 0.88 [95% confidence interval, 0.80–0.96]). The frequency of antibiotic administration during 1–3 and 4–7 days after the initial diagnosis were also significantly lower in the kakkonto group than in the control group. The frequency of surgical drainage did not differ significantly between the two groups. Conclusions: Kakkonto was associated with reduced administration of antibiotics for noninfectious mastitis, making it a potential treatment option for relieving breast inflammation and promoting antimicrobial stewardship. [ABSTRACT FROM AUTHOR]

The effectiveness of the 23-valent pneumococcal polysaccharide vaccine (PPV23) in preventing pneumonia in older adults remains controversial. Some studies have suggested differences in their effectiveness according to age or sex. We conducted an observational study using a database of vaccine subsidization data and health insurance claims for a city in Japan. Participants were residents from 2014 to 2018 turning 65, 70, 75, 80, 85, 90, or 95 years during a given fiscal year, and PPV23 during the first year of observation were identified. We matched vaccinated and non-vaccinated individuals of the same age using propensity scores for vaccination. The incidence of hospitalization with pneumonia was compared using the Fine-Gray regression model. We summarized the results for each age using random-effects meta-analysis and conducted a subgroup analysis by sex. A total of 102 136 participants were included, of whom 35% received PPV23. Propensity score matching selected 32 510 pairs of vaccinated and non-vaccinated individuals. Overall, PPV23 administration was associated with a decreased incidence of hospitalization with pneumonia (17.2 vs. 20.4 per 1000 person-years, sub-distribution hazard ratio: 0.84, 95% CI: 0.77 to 0.91). Vaccine effectiveness was the highest among those aged 70 years and decreased with increasing age. No statistically significant effect was observed in those aged 90 or 95 years. Vaccine effectiveness was observed in both males and females. PPV23 was associated with an overall decrease in hospitalization with pneumonia in older adults. However, vaccine effectiveness was significant in those aged 65 to 85 years but not in the older population. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Direct comparative effectiveness of booster doses of BNT162b2 and mRNA-1273 after BNT162b2 primary vaccination is unknown. Methods We investigated comparative effectiveness of BNT162b2 and mRNA-1273 booster dose using data from registry systems for vaccination and coronavirus disease 2019 (COVID-19) infection in a local city in Japan. We followed participants aged ≥16 years who completed the BNT162b2 primary vaccination between 22 November 2021, and 15 April 2022. We collected information on age, sex, vaccination status, vaccine type, and infection status. Age was categorized as 16–44, 45–64, 65–84, and ≥85 years. Vaccine effectiveness for mRNA-1273 and no booster vaccination against BNT162b2 was estimated using age-stratified Cox regression adjusted for age, sex, and days since the second vaccination. The estimated hazard ratios for mRNA-1273 and no booster vaccinations were integrated separately using random effects meta-analyses. Results During the study period, we identified 62 586 (40.4%), 51 490 (33.2%), and 40 849 (26.4%) participants who received BNT162b2, mRNA-1273, and no booster dose, respectively. The median age was 69, 71, and 47 years for BNT162b2, mRNA-1273, and no booster dose, respectively. The integrated hazard ratio with reference to BNT162b2 was 1.72 for no booster vaccination and 0.62 for mRNA-1273. The comparative effectiveness of mRNA-1273 was similar across age categories. Conclusions Both homologous and heterologous vaccinations are effective against Omicron variants. In the head-to-head comparison, the effect was stronger in people who received heterologous vaccination than in those who received homologous vaccination. These findings may help improve logistics and decision making in future vaccination programs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aim: Psychiatric disturbances are the major adverse effects of corticosteroids. There are no consistent conclusions regarding changes in steroid dosage and the incidence of psychiatric conditions, due in part to the lack of consistent evaluation criteria. The purpose of this research was to determine the incidence and dose‐dependency of psychiatric conditions as assessed by trained psychiatrists. Methods: A retrospective chart review was conducted at a university hospital in Japan. We identified inpatients receiving oral prednisolone treatment, who were referred to the consultation‐liaison psychiatry team from April 2015 to March 2018. Patients were divided into high‐dose (≥0.5 mg/kg/day) and low‐dose (<0.5 mg/kg/day) groups. We investigated the associations between steroid dosage and incidence of psychiatric conditions. Results: A total of 93 patients (35 in the high‐dose group, 58 in the low‐dose group) were included. Various psychiatric conditions, such as insomnia, delirium, depression, and psychosis, occurred during steroid therapy. The most common condition was insomnia (72%). We observed no significant differences in the patient background characteristics and the incidence of most psychiatric conditions between the high‐dose and low‐dose groups. However, there were more patients with delirium in the low‐dose group than in the high‐dose group. Conclusions: Based on the accurate assessment of psychiatric conditions by psychiatrists, our analysis suggests that, among inpatients referred to a consultation‐liaison psychiatry team, the incidence of psychiatric conditions, with the exception of delirium, is independent of the dose of oral prednisolone. [ABSTRACT FROM AUTHOR]

Background Malnutrition of inpatients is often overlooked and remains a serious concern. However, there are few studies on the relations between infused energy and amino acid intakes and clinical outcomes in older patients on parenteral nutrition. Objectives We aimed to determine the short-term outcomes of infused energy and amino acid intakes in older patients receiving parenteral nutrition. Methods We conducted a retrospective observational study using a national inpatient database covering >1000 hospitals in Japan. Participants were those who underwent central venous (CV) port insertion between 2011 and 2016, were aged ≥65 y, and did not have cancer. Based on the types and amounts of products used for enteral feeding and intravenous feeding on postoperative day (POD) 7 after CV port insertion, the infused energy and amino acid intakes were estimated. The primary end point was mortality on POD 90. Multivariable logistic regression was performed to investigate the relations of infused energy and amino acid intakes with mortality on POD 90. Results A total of 10,153 patients aged ≥65 y who underwent CV port insertion were included. The mortality rates at 90 d after central venous port insertion were 14.9% and 14.0% (risk difference, 0.9%; 95% CI: –0.5%, 2.3%; P  = 0.216) with infused energy intakes <20 and ≥20 kcal/kg, respectively, and 15.4% and 13.2% (risk difference, 2.2%; 95% CI: 0.9%, 3.6%; P  = 0.001) with infused amino acid intakes <0.8 and ≥0.8 g/kg, respectively. The differences were retained after adjustment for multiple variables including hospital, age, sex, BMI, emergency admission, and 27 major underlying diseases. The OR for the ≥0.8-g/kg group compared with the <0.8-g/kg group was 0.87 (95% CI: 0.77, 0.99; P  = 0.028). Conclusions A positive relation between infused amino acid intake and mortality was found in older patients receiving parenteral nutrition. [ABSTRACT FROM AUTHOR]

Problem: Immune responses were reported to be associated with the pathogenesis of endometriosis. However, previous studies of an association between allergic or autoimmune diseases and endometriosis have reported inconsistent results. We investigated the association between allergic or autoimmune diseases and the incidence of endometriosis. Method of study: Using a large‐scale health insurance claims database in Japan, we identified patients with endometriosis diagnosed between April 2011 and August 2018. For each case, we identified up to four controls with the same age and registration month. Conditional logistic regression analyses were conducted to evaluate the incidence rate ratio (IRR) of endometriosis in women with allergic diseases (asthma, allergic rhinitis, urticaria, atopic dermatitis, allergic conjunctivitis, and type 1 allergies combined), systemic lupus erythematosus, and rheumatoid arthritis compared with women without these diseases. Results: We identified 30 516 cases with endometriosis and 120 976 control participants. Mean age at registration was 30 years. There were significant positive associations between type 1 allergy and endometriosis (IRR, 1.10; 95% confidence interval, 1.06–1.13) and between rheumatoid arthritis and endometriosis (IRR, 1.31; 95% confidence interval, 1.05–1.64). Diagnosis of systemic lupus erythematosus was not associated with increased incidence of endometriosis. Among the different allergic diseases, allergic rhinitis, urticaria, and allergic conjunctivitis were associated with the increased incidence. Conclusion: Several allergic diseases were associated with an increased incidence of endometriosis. A higher incidence was also observed in patients with rheumatoid arthritis. Further studies are warranted to elucidate the influence of immune responses on the development of endometriosis. [ABSTRACT FROM AUTHOR]

Treatment of latent tuberculosis infection is recommended in patients receiving biologics. However, evidence is weak regarding the efficacy of treatment regimens in this population, and the real-world practice pattern has not been elucidated. Using a large-scale health insurance claims database in Japan, we identified patients who started treatment of immune-mediated inflammatory diseases with tumor necrosis factor inhibitors or other biologics. Treatment with isoniazid within 12 months of starting a biologic was summarized to evaluate the duration of treatment for latent tuberculosis infection and the time between start of isoniazid and initiation of a biologic. Among 2064 patients starting biologics, 10% received treatment for latent tuberculosis infection with isoniazid. Among the patients with biologics and isoniazid, isoniazid was started in the same month as initiating biologics or 1 month before in 82%. In addition to the recommended 6- and 9-month treatments, 20% of patients were receiving isoniazid at 12 months after starting treatment and 20% received a prescription for 350 days or more. In patients starting biologics, treatment for latent tuberculosis infection was provided for different durations, including not only the recommended periods but also longer periods. Research on safety and effectiveness of the treatment in this population is necessary. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the association between cumulative visits for care of minor injuries and risk of traumatic brain injuries in children aged ≤36 months.Methods: We conducted a retrospective analysis of children born from 2009 to 2012, using a health insurance claims database in Japan. We investigated the total number of visits where children aged 0-36 months presented for treatment of minor injuries such as superficial injuries, fractures, burns and foreign body ingestions. Logistic regression analysis was used to evaluate the association between the cumulative number of visits for treatment of minor injuries and traumatic brain injuries in children aged ≤36 months.Results: A total of 91 011 children were included in the analysis, 51% of whom were boys. Traumatic brain injuries were identified in 0.7% of these children. Cumulative visits for care of minor injuries among children aged 0-36 months were significantly associated with traumatic brain injuries by 36 months of age, with an odds ratio of 2.12 (95% confidence interval: 1.68-2.68) for multiple visits.Conclusion: Cumulative visits for treatment of minor injuries during the first 36 months of life were associated with increased risk of traumatic brain injuries by 36 months of age. [ABSTRACT FROM AUTHOR]

Objectives: We examined the advantages of tubeless percutaneous nephrolithotomy (PCNL) and totally tubeless PCNL over standard PCNL. Materials and Methods: Using a nationwide inpatient database in Japan, we gathered data on patients undergoing PCNL from July 2010 to March 2016 and extracted eligible patients who were candidates for tubeless PCNL. Eligible patients were divided into 4 groups: tubeless, totally tubeless, standard, and standard PCNL with ureteral stent (US). Multivariable analyses compared postoperative hospital stay, duration of analgesic use, urinary tract infection (UTI), and blood transfusion among the 4 groups. Results: Analyses were conducted on patients in the standard (n = 954), tubeless (n = 98), totally tubeless (n = 146), and standard PCNL with US (n = 389) groups. Postoperative hospital stay was significantly shorter in the tubeless group than in the standard group (1.6 days [–2.9 to 0.4]). With reference to the standard PCNL group, there was no significant difference in the number of days of analgesic use or the proportions of postoperative UTIs or blood transfusion among the groups. Postoperative UTIs developed significantly more often in women than in men regardless of the PCNL method. Conclusions: Our multivariable analyses showed that tubeless PCNL was associated with shorter postoperative hospital stays, but totally tubeless PCNL was not. [ABSTRACT FROM AUTHOR]

The risk of hepatitis B virus (HBV) reactivation has increased owing to advances in the immunosuppressive therapy field. However, the HBV reactivation incidence among patients with previously resolved HBV (prHBV) infection during immunosuppressive therapy for rheumatoid arthritis (RA) remains unclear. The objective of this work is to describe the validity of detecting prHBV infection from administrative data through comparisons with chart abstraction and determine the incidence of HBV reactivation during immunosuppressive therapy for RA in Japan. In this retrospective cohort study, data on selected patients were extracted from administrative claims data. To identify patients with prHBV infection and de novo hepatitis, and HBsAg carriers, we conducted chart abstraction. The incidence rate of de novo hepatitis was 1.23 of 100 person‐years. The positive predictive value (PPV) and its 95% confidence interval (CI) of administrative data for the identification of suspected prHBV infections was 85.8% (95% CI: 81.7%‐89.3%). This study evaluated the PPV of the algorithm of HBV‐DNA testing with immunosuppressive therapy performed four times or more per year for the detection of prHBV infection from administrative data. Additionally, we determined the incidence rate of HBV reactivation among preHBV infections during immunosuppressive therapy for RA to be 1.23 of 100 person‐years. [ABSTRACT FROM AUTHOR]

Background: Tracheostomy is often performed in patients with severe burns who are undergoing prolonged mechanical ventilation. However, the appropriate timing of tracheostomy and its effect on mortality remain unknown. The aim of this study was to determine whether tracheostomy can reduce mortality in patients with severe burns.Methods: Using the Japanese Diagnosis Procedure Combination database from April 2010 to March 2014, we extracted data on adult patients with severe burns (burn index score of ≥15) who started mechanical ventilation within 3days of admission. We estimated the hazard ratio for 28-day in-hospital mortality associated with tracheotomy performed from day 5 to 28. We adjusted for baseline and time-dependent confounders using inverse probability of treatment weighting methods and fitted a marginal structural Cox proportional hazard model.Results: We identified 680 eligible patients (94 in the tracheostomy group, 2289 person-days; 586 in the non-tracheostomy group, 11,197 person-days). Patients who underwent a tracheostomy had worse prognostic factors for mortality. After adjustment for these factors, the hazard ratio for 28-day mortality associated with tracheostomy compared with non-tracheostomy was 0.73 (95% confidence interval, 0.39-1.34).Conclusions: There was no significant association between 28-day in-hospital mortality and early tracheostomy in adult patients with severe burns. [ABSTRACT FROM AUTHOR]

Purpose: Despite extensive research on enteral nutrition (EN) for patients in shock, it remains unclear whether this should be postponed in patients with cardiogenic or obstructive shock requiring venoarterial extracorporeal membrane oxygenation (VA-ECMO). In this study, we aimed to compare outcomes of early and delayed EN for patients with cardiogenic or obstructive shock requiring VA-ECMO.Methods: In this retrospective database study drawing on the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2016, we identified patients with cardiogenic or obstructive shock who had received VA-ECMO for more than 2 days. We allocated the patients to two groups: those who received EN within 2 days (early) or 3 days or more (delayed) after starting VA-ECMO. We then used a marginal structural model to analyze associations between early EN and various outcomes, including in-hospital mortality and 28-day mortality.Results: We identified 1769 eligible patients during the 69-month study period, 220 of whom (12%) received early EN. After using a marginal structural model to adjust for baseline and time-dependent confounders, we found that the early EN group showed significantly lower in-hospital mortality [hazard ratio 0.78, 95% confidence interval (95% CI) 0.62-0.98, P = 0.032] and lower 28-day mortality (hazard ratio 0.74, 95% CI 0.56-0.97, P = 0.031) than the delayed EN group.Conclusions: According to this retrospective database study, early EN is not associated with harm but rather with lower mortality in patients with cardiogenic or obstructive shock requiring at least 2 days of VA-ECMO. [ABSTRACT FROM AUTHOR]

We aimed to explore the association between short-term exposure to temperature variability (TV), and cardiovascular hospitalization stratified by the presence of comorbid diabetes. We collected data on nationwide hospitalization for cardiovascular diseases and daily weather conditions during 2011–2018 in Japan. TV was calculated as the standard deviation of daily minimum and maximum temperatures within 0–7 lag days. We applied a two-stage time-stratified case-crossover design to estimate the association between TV and cardiovascular hospitalization with and without comorbid diabetes, adjusting for temperature and relative humidity. Furthermore, specific cardiovascular disease causes, demographic characteristics, and seasons were used for stratification. In 3,844,910 hospitalizations for cardiovascular disease, each 1 °C increase in TV was associated with a 0.44% (95% CI: 0.22%, 0.65%) increase in the risk of cardiovascular admission. We observed a 2.07% (95% CI: 1.16%, 2.99%) and 0.61% (95% CI: −0.02%, 1.23%) increase per 1 °C in risk of heart failure admission in individuals with and those without diabetes, respectively. The higher risk among individuals with diabetes was mostly consistent in the analyses stratified by age, sex, body mass index, smoking status, and season. Comorbid diabetes may increase susceptibility to TV in relation to acute cardiovascular disease hospitalization. [ABSTRACT FROM AUTHOR]

Abstract: 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. [ABSTRACT FROM AUTHOR]

Clinical evidence on prophylactic antibiotics for transarterial chemoembolization (TACE) to prevent liver abscess is limited because liver abscess is a rare event. This study aimed to analyse the association between prophylactic antibiotic use for TACE and the occurrence of liver abscess after TACE. Using the nationwide Diagnosis Procedure Combination database in Japan, we retrospectively identified patients who underwent TACE for hepatic cancer between July 2010 and March 2017. The primary outcome was liver abscess requiring procedural intervention within 30 days of TACE. Secondary outcomes included 30-day in-hospital mortality and length of stay. Propensity score matching was performed to adjust for potential confounding factors and compare outcomes between patients with and without prophylactic antibiotics. Among 167 544 eligible patients, 134 712 received antibiotics and 32 832 did not. In the matched cohort of 29 211 pairs, the proportion of patients with liver abscess requiring procedural intervention was significantly lower in the antibiotics group than in the no-antibiotics group (0.08% vs. 0.22%, p 0.001; relative risk (95% confidence interval), 0.35 (0.22–0.57); absolute risk reduction, 0.0014 (0.0008–0.0021); and number needed to treat, 696 (476–1223)). There was no significant difference in 30-day in-hospital mortality between the groups. The length of stay was longer in the antibiotics group than in the no-antibiotics group (median, 10 vs. 9 days, p < 0.001). Prophylactic antibiotic use in patients undergoing TACE was associated with a reduced occurrence of liver abscess requiring procedural intervention. [ABSTRACT FROM AUTHOR]

• The association between weight loss and subsequent functional decline is unclear. • Older individuals with ≥1 % weight loss were at risk of functional decline. • Monitoring weight change could identify older adults at risk of functional decline. The association between weight loss and subsequent functional decline is uncertain. The study aims to elucidate the association between weight loss over a year and subsequent functional decline requiring assistance in performing their activities of daily living in older individuals. The study used data from the publicly funded Long-Term Care Insurance service in Japan, which provides coverage for long-term care services for individuals unable to perform activities of daily living due to physical or cognitive impairment. The study enrolled people born in or before 1949, who underwent health checkups in both 2014 and 2015. The participants were followed from 2015 to the worsening of functional decline requiring long-term care services, death, or February 28, 2019, whichever occurred first. The risk of subsequent functional decline in each weight loss category was estimated using a Cox regression model adjusted for age, sex, baseline body mass index, smoking, and Charlson comorbidity index. We identified 67,452 eligible individuals from the database. The median follow-up period was 1,284 days. The hazard ratios (95 % confidence interval) of functional decline for -1 %, -2 %, -3 %, -4 %, and ≤-5% weight change compared to 0 % weight change were 1.17 (1.03−1.32), 1.26 (1.11−1.43), 1.29 (1.12−1.49), 1.61 (1.39−1.87), and 1.79 (1.58−1.99), respectively. Older people with weight loss of 1 % or more were at risk of functional decline. Close weight monitoring may serve as an easy and inexpensive means of identifying older individuals at risk of functional decline. [ABSTRACT FROM AUTHOR]

Substantial evidence suggests that non-optimal temperatures can increase the risk of cardiovascular disease (CVD) mortality and morbidity; however, limited studies have reported inconsistent results for hospital admissions depending on study locations, which also lack national-level investigations on cause-specific CVDs. We performed a two-stage meta-regression analysis to examine the short-term associations between temperature and acute CVD hospital admissions by specific categories [i.e., ischemic heart disease (IHD), heart failure (HF), and stroke] in 47 prefectures of Japan from 2011 to 2018. First, we estimated the prefecture-specific associations using a time-stratified case-crossover design with a distributed lag nonlinear model. We then used a multivariate meta-regression model to obtain national average associations. During the study period, a total of 4,611,984 CVD admissions were reported. We found cold temperatures significantly increased the risk of total CVD admissions and cause-specific categories. Compared with the minimum hospitalization temperature (MHT) at the 98th percentile of temperature (29.9 °C), the cumulative relative risks (RRs) for cold (5th percentile, 1.7 °C) and heat (99th percentile, 30.5 °C) on total CVD were 1.226 [95% confidence interval (CI): 1.195, 1.258] and 1.000 (95% CI: 0.998, 1.002), respectively. The RR for cold on HF [RR = 1.571 (95% CI: 1.487, 1.660)] was higher than those of IHD [RR = 1.119 (95% CI: 1.040, 1.204)] and stroke [RR = 1.107 (95% CI: 1.062, 1.155)], comparing to their cause-specific MHTs. We also observed that extreme heat increased the risk of HF with RR of 1.030 (95% CI: 1.007, 1.054). Subgroup analysis showed that the age group ≥85 years was more vulnerable to these non-optimal temperature risks. This study indicated that cold and heat exposure could increase the risk of hospital admissions for CVD, varying depending on the cause-specific categories, which may provide new evidence to reduce the burden of CVD. [Display omitted] • Association of temperature and CVD admissions was estimated across Japan. • Cold increased the risk of CVD admissions and cause-specific categories, whereas only significant heat risk on HF was observed. • Older people were more vulnerable to the risks for non-optimal temperatures on CVD admissions. [ABSTRACT FROM AUTHOR]

• Duration of influenza vaccine effect in the elderly is currently unclear. • This cohort study used healthcare claims data and vaccination records. • Influenza vaccines showed moderate effectiveness in the Japanese elderly. • Vaccine effectiveness showed a trend of gradual attenuation. • Vaccine protection against incidence was maintained for 4–5 months post-vaccination. The immune response to influenza vaccination in the elderly is likely to be lower than that in young adults. Clinical protection may not persist year-round in the elderly. However, the effectiveness of influenza vaccine in the elderly has not been adequately studied, especially in terms of the duration of effectiveness. We used a linked database of healthcare administrative claims data and vaccination records maintained by the municipality of a city in Kanto region of Japan. We studied individuals who were aged 65 years or older at baseline and were followed up between April 1, 2014 to March 31, 2020. The duration of influenza vaccine effectiveness by age category was analyzed using a time-dependent piecewise Cox proportional hazard model with time-dependent vaccine status, prior season vaccination and covariates confirmed in the baseline period (age, sex, cancer, diabetes, chronic obstructive pulmonary diseases, asthma, chronic kidney diseases, and cardiovascular diseases). We identified an analysis population of 83,146 individuals, of which 7,401 (8.9%) had experienced influenza and 270 (0.32%) underwent influenza-related hospitalization. Individuals who were vaccinated during the first season (n = 47,338) were older than non-vaccinated individuals (n = 35,808) (average age, 75.8 vs. 74.1 years, respectively). The multivariable analysis showed a lower incidence of influenza in vaccinated individuals (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.43–0.51; P < 0.001), while the incidence of hospitalization for influenza did not differ significantly by vaccination status (HR, 0.79; 95% CI, 0.53–1.18; P = 0.249). Protective effectiveness against incidence was maintained for 4 or 5 months after vaccination in those aged 65–69 and 80-years, 5 months in 70–79 years. Our study identified moderate vaccine effectiveness in preventing the incidence of influenza in the Japanese elderly. Vaccine effectiveness showed a trend of gradual attenuation. Clinicians should suspect influenza infection even in those vaccinated, especially in elderly individuals who had received vaccination more than 4 or 5 months previously. [ABSTRACT FROM AUTHOR]

Background and objective Although oral care may have salutary effects among frail elderly people, access to dental care is often limited in long-term care facilities. In 2009, the Japanese long-term care insurance system introduced an additional reimbursement scheme for enhanced oral care supervised by dentists in nursing facilities. The aim of this study was to examine whether enhanced oral care provided by trained nursing facility staff members is sufficient to improve health outcomes among nursing facility residents. Design, setting, and participants This was a quasi-experimental study using a nationwide long-term care database. Using facility-level propensity score matching, we identified 170,874 residents in 742 facilities that provided enhanced oral care and 167,546 residents in 742 control facilities that provided only standard care from 2009 to 2012. We used a resident-level difference-in-differences approach to analyze the impact of enhanced oral care on health outcomes among nursing facility residents. Results After controlling for resident characteristics and background time trends, no significant differences were found between residents admitted to the facilities with and without enhanced oral care in the incidence of critical illness, transfer to a hospital, mortality, or costs. Yearly change in the odds of discharge to home was significantly increased for residents with enhanced oral care (odds ratio = 1.07; 95% confidence interval: 1.02–1.12; P = .008). Conclusion The results suggest that enhanced oral care provided by trained nursing facility staff members may improve the general condition of elderly residents in nursing facilities and promote their discharge to home. [ABSTRACT FROM AUTHOR]

Purpose: Perinatal mood disorders affect both parents, impacting their children negatively. Little is known on the association between parental perinatal mood disorders and pediatric outcomes in Japan considering relevant covariates. Our objective was to investigate the association between paternal and maternal perinatal mood disorders and adverse physical and psychological child outcomes by the age of 36 months, adjusting for covariates such as the child's sex, age of parent at child's birth, perinatal mood disorders of the other parent, and perinatal antidepressant use., Methods: We identified parents in the JMDC Claims Database in Japan from 2012 to 2020. Perinatal mood disorders were defined using International Classification of Diseases, 10th codes for mood disorders during the perinatal period combined with psychiatric treatment codes. We evaluated the association between parental perinatal mood disorders and pediatric adverse outcomes by the age of 36 months using Cox proportional hazard models adjusted for the covariates., Results: Of the 116,423 father-mother-child triads, 2.8% of fathers and 2.3% of mothers had perinatal mood disorders. Paternal perinatal mood disorders were not significantly associated with adverse child outcomes. After adjusting for paternal perinatal mood disorders and antidepressant use, maternal perinatal mood disorders were associated with delayed motor development, language development disorders, autism spectrum disorders, and behavioral and emotional disorders (adjusted hazard ratio [95% confidence interval]: 1.65 [1.01-2.69], 2.26 [1.36-3.75], 4.16 [2.64-6.55], and 6.12 [1.35-27.81], respectively)., Conclusions: Paternal perinatal mood disorders were not associated with adverse child outcomes in this population. Maternal perinatal mood disorders were associated with multiple child outcomes., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature.)

Background: To clarify the risk of adverse ocular events following influenza vaccination., Methods: This self-controlled case series study used a claims database linked to vaccination records of a large city in Japan between April 2014 and September 2021. Individuals aged ≥ 65 years who developed adverse ocular events during the follow-up period were included. The exposure was influenza vaccination. The primary outcome was defined as the occurrence of at least one of the following five eye diseases: uveitis, scleritis, retinal vein occlusion, retinal artery occlusion, or optic neuritis. Conditional Poisson regression was used to estimate the within-subject incidence rate ratio of ocular adverse events during the risk period (0-56 days after vaccination) compared to the control period., Results: A total of 4,527 cases were eligible for the study (median age, 74 years; male, 42%). The incidence rate ratio for the outcome during the risk period was 0.99 (95% confidence interval, 0.87 to 1.14). No increased risk was observed for individual components of the outcome either; the incidence rate ratio was 0.94 (0.78 to 1.13) for uveitis, 1.17 (0.86 to 1.59) for scleritis, 0.98 (0.76 to 1.27) for retinal vein occlusion, 0.89 (0.42 to 1.87) for retinal artery occlusion, and 0.87 (0.44 to 1.70) for optic neuritis., Conclusions: This self-controlled case series showed no apparent increase in the risk of adverse ocular events after influenza vaccination among older adults. These results mitigate the concerns of older adults who may hesitate to receive influenza vaccination for fear of adverse ocular events., Abbreviation: HR = hazard ratio; CI = confidence interval; RVO = retinal vein occlusion; SCCS = self-controlled case series.

Aim: The importance of comprehensive geriatric assessment (CGA) is increasing in aging societies worldwide. However, there are few comprehensive studies on CGA, resulting in a limited understanding of its implementation rate, temporal changes and factors associated with its implementation. We aimed to investigate the implementation status of CGA and its regional variance in Japan., Methods: Using the Diagnosis Procedure Combination database, we investigated CGA trends, and identified the patient, hospital and regional factors associated with its implementation. We identified patients aged ≥65 years who were admitted for the first time between 2016 and 2020 with a diagnosis of stroke, heart failure, pneumonia, bone fracture or colorectal cancer. We examined the CGA implementation rate according to patient and hospital characteristics. We also investigated temporal changes and tendencies to carry out CGA in different prefectures., Results: A total of 1 974 817 patients were analyzed, of whom 570 696 (28.9%) underwent CGA. The implementation trend increased steadily from 25.3% in fiscal year 2016 to 33.4% in fiscal year 2019. The implementation rate also increased with patient age (30.3% in patients aged ≥95 years). Regional variations in its implementation status were observed, with a higher tendency to be implemented in areas near major metropolitan regions. A trend toward carrying out CGA for colorectal cancer, but not for other diseases, has been observed in eastern Japan., Conclusion: Although CGA is increasingly carried out, considerable regional differences remain in its implementation status. Initiatives to reduce variations are necessary. Geriatr Gerontol Int 2024; 24: 904-911., (© 2024 The Author(s). Geriatrics & Gerontology International published by John Wiley & Sons Australia, Ltd on behalf of Japan Geriatrics Society.)

Objective: The study aimed to investigate treatment options for older women with pelvic organ prolapse (POP) and postoperative outcomes based on their long-term care (LTC) status., Methods: We used the medical and LTC insurance claims databases of Tochigi Prefecture in Japan, covering 2014 to 2019. We included women 65 years and older with POP and evaluated their care status and treatment, excluding women with an observation period <6 months. Among women with a postsurgical interval ≥6 months, we compared care level changes and deaths within 6 months and complications within 1 month postoperatively between those with and without LTC using Fisher exact test., Results: We identified 3406 eligible women. Of the 447 women with LTC and 2959 women without LTC, 16 (3.6%) and 415 (14.0%), respectively, underwent surgery. Among 393 women with a postsurgical interval ≥6 months, 19 (4.8%) required LTC at surgery. Two of the 19 women with LTC (10.5%) and eight of 374 women without LTC (2.1%) experienced worsening care-needs level. No deaths were recorded. Urinary tract infection (UTI) was significantly more frequent in women with LTC than in women without LTC (36.8% vs 8.6%). Other complications were rare in both groups., Conclusion: The proportion of patients who underwent surgery for POP was lower in women with LTC than in women without LTC. Postoperative UTI was common and 11% had a worsening care-needs level postoperatively, whereas other complications were infrequent. Further detailed studies would contribute to providing optimal treatment to enhance patients' quality of life., (© 2024 International Federation of Gynecology and Obstetrics.)

Objective The effect of Rikkunshito, a Japanese herbal Kampo medicine, on chemotherapy-induced nausea and vomiting (CINV) has been evaluated in several small prospective studies, with mixed results. We retrospectively evaluated the antiemetic effects of Rikkunshito in patients undergoing cisplatin-based chemotherapy using a large-scale database in Japan. Methods The Diagnosis Procedure Combination inpatient database from July 2010 to March 2019 was used to compare adult patients with malignant tumors who had received Rikkunshito on or before the day of cisplatin administration (Rikkunshito group) and those who had not (control group). Antiemetics on days 2 and 3 and days 4 and beyond following cisplatin administration were used as surrogate outcomes for CINV. Patient backgrounds were adjusted using the stabilized inverse probability of treatment weighting, and outcomes were compared using univariable regression models. Results We identified 669 and 123,378 patients in the Rikkunshito and control groups, respectively. There were significantly fewer patients using intravenous 5-HT 3 -receptor antagonists in the Rikkunshito group (odds ratio, 0.38; 95% confidence interval, 0.16-0.87; p=0.023) on days 2 and 3 of cisplatin-based chemotherapy. Conclusion The reduced use of antiemetics on day 2 and beyond of cisplatin administration suggested a beneficial effect of Rikkunshito in palliating the symptoms of CINV.

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.

Purpose: Large-scale administrative health care databases are increasingly being utilized for research. However, there has not been much literature that validated administrative data in Japan; a previous review identified six validation studies published between 2011 and 2017. We conducted a literature review of studies that assessed the validity of Japanese administrative health care data., Methods: We searched for studies published by March 2022 that compared individual-level administrative data with a reference standard from another data source, as well as studies that validated administrative data using other data within the same database. The eligible studies were also summarized based on characteristics which included data types, settings, reference standard used, numbers of patients, and conditions validated., Results: There were 36 eligible studies, including 29 that used external reference standard and seven that validated administrative data using other data within the same database. Chart review was the reference standard in 21 studies (range of the numbers of patients, 72-1674; 11 studies conducted in single institutions and nine studies in 2-5 institutions). Five studies used a disease registry as the reference standard. Diagnoses of cardiovascular diseases, cancer, and diabetes were frequently evaluated., Conclusions: Validation studies are being conducted at an increasing rate in Japan, although most of them are small scale. Further large-scale comprehensive validation studies are necessary to effectively utilize the databases for research., (© 2023 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

Background: Validating the information recorded in administrative databases is essential. However, no study has comprehensively validated the accuracy of Japanese Diagnosis Procedure Combination (DPC) data on various respiratory diseases. Therefore, this study aimed to evaluate the validity of diagnoses of respiratory diseases in the DPC database., Methods: We conducted chart reviews of 400 patients hospitalized in the departments of respiratory medicine in two acute-care hospitals in Tokyo, between April 1, 2019 and March 31, 2021, and used them as reference standards. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of DPC data on 25 respiratory diseases were determined., Results: Sensitivity ranged from 22.2% (aspiration pneumonia) to 100% (chronic eosinophilic pneumonia and malignant pleural mesothelioma) and was <50% for eight diseases, while specificity was >90% for all diseases. PPV ranged from 40.0% (aspiration pneumonia) to 100% (coronavirus disease 2019, bronchiectasis, chronic eosinophilic pneumonia, pulmonary hypertension, squamous cell carcinoma, small cell carcinoma, lung cancer of other histological types, and malignant pleural mesothelioma) and was >80% for 16 diseases. Except for chronic obstructive pulmonary disease (82.9%) and interstitial pneumonia (other than idiopathic pulmonary fibrosis) (85.4%), NPV was >90% for all diseases. These validity indices were similar in both hospitals., Conclusions: The validity of diagnoses of respiratory diseases in the DPC database was high in general, thereby providing an important basis for future studies., Competing Interests: Conflict of Interest The authors declare no conflicts of interest., (Copyright © 2023 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.)

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., (© 2023 The Author(s); Published by Kerman University of Medical Sciences This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Objective: 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., Methods: 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., Results: 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)., Conclusion: Kampo medicines are safe for treating depression during pregnancy without increasing the incidence of congenital anomalies, low birth weight, or preterm birth., (© 2022 International Federation of Gynecology and Obstetrics.)

Objective: It remains unclear which factors contribute to dysphagia recovery after an acute stroke. This study aimed to identify factors associated with complete oral intake recovery in patients with post-stroke dysphagia., Methods: Data were obtained from the Diagnosis Procedure Combination database, which is a nationwide database of administrative claims and discharge abstracts in Japan. We selected patients admitted within 3 days of stroke onset and conducted multivariable logistic regression analysis. Total oral intake within 30 days of admission was the primary outcome measure., Results: A total of 151,302 patients were included, and total oral intake was observed in 48% of them within 30 days of admission. Total oral intake was significantly associated with age, sex, stroke subtype, consciousness disturbance, low body mass index, multiple comorbidities, and the modified Rankin Scale before stroke onset. In addition, males had worse outcomes than females (odds ratio, 0.75; 95% confidence interval, 0.73-0.77, p < 0.001), and intracerebral and subarachnoid hemorrhagic stroke subtypes were associated with non-recovery., Conclusion: This study identified several prognostic factors for total oral intake in patients with acute stroke. These results may be useful for predicting a patient's dysphagia prognosis at the time of admission and designing a nutritional management plan for patients with acute stroke., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: To evaluate the validity of operative information recorded in the Diagnosis Procedure Combination (DPC) database, a national inpatient database including administrative claims data., Methods: We reviewed the medical charts of 1221 patients who underwent one of six surgeries (breast, esophageal, gastric, thyroid cancer surgery, appendectomy, or inguinal hernia repair) at a surgery department of a university hospital from April 2016 to March 2019. We compared operative information (type, date, laterality of procedure; type of anesthesia; transfusion; and duration of anesthesia) recorded in the DPC database with the information recorded in the medical charts., Results: The DPC data for type, date, laterality of surgery, and type of anesthesia were accurate in 99% of the reviewed patients. The sensitivity and specificity for identifying whether a patient received a transfusion procedure were 97.5% and 99.6%, respectively. Data regarding the duration of anesthesia in the DPC database were identical to those in medical chart records in 1114 of 1216 cases that received general or spinal anesthesia (91.5%). The duration of anesthesia in the DPC data was 53 min longer on average than the recorded operative time in the medical charts., Conclusion: The DPC database had high validity for operative information., (© 2022. The Author(s) under exclusive licence to Springer Nature Singapore Pte Ltd.)

Introduction: To describe patterns in antibiotic prophylaxis for tooth extraction following the 2016 Japanese National Action Plan on Antimicrobial Resistance., Methods: Using a health insurance claims database, we retrospectively identified tooth extraction visits by patients aged ≥18 years from September 2015 to August 2018 and classified patients as undergoing extraction of a fully impacted or horizontally impacted mandibular wisdom tooth, being at risk of infective endocarditis or surgical site infection, or being at low risk. Antibiotic use and type of antibiotics prescribed on the day of tooth extraction were evaluated across the study period, with stratification by tooth extraction category and facility type (hospital or dental clinic)., Results: We identified 662,435 patients with tooth extraction. The mean age was 42.7 years, and 57% were male. Twelve percent underwent wisdom tooth extraction, 32% were high risk, and 10% visited hospitals. The proportion of antibiotic use was 83% overall and 82% among low-risk patients. This proportion remained similar throughout the study period. A shift from third-generation cephalosporins to amoxicillin was observed from 2015 to 2018: the proportion prescribed third-generation cephalosporins decreased from 58% to 34% in hospitals and from 57% to 56% in clinics, and the proportion prescribed amoxicillin increased from 16% to 37% in hospitals and from 6% to 10% in clinics., Conclusions: The pattern of prophylactic antibiotic use for tooth extraction gradually changed after the initiation of the National Action Plan. Further efforts are required to reduce potentially inappropriate prescriptions for low-risk patients, especially in dental clinics., (Copyright © 2021 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Background: Dental claims data have been used for epidemiological studies without establishing the validity of the recorded diagnoses or procedures. The present study aimed to examine the accuracy of diagnoses, procedures, operation time, and the number of teeth recorded in dental claims data., Methods: We reviewed the charts of 200 patients who visited and 100 patients who were hospitalized in the Department of General Dentistry, Orthodontics, and Oral and Maxillofacial Surgery in an academic hospital between August 2012 and December 2017. The sensitivity and specificity of the dental claims data for five diseases and 15 procedures were evaluated. We assessed the difference in the number of teeth and duration of general anesthesia between claims data and chart reviews., Results: Sensitivity was more than 86% for six out of seven diagnoses except for pericoronitis (67%). Specificity ranged from 72% (periodontal disease) to 100% (oral cancer for inpatient). The sensitivity of procedures ranged from 10% (scaling for inpatient) to 100%, and the specificity ranged from 6% (food intake on the day of the surgery) to 100%. The mean (standard deviation [SD]) number of teeth in the chart review was 22.6 (6.8), and in the dental claims was 21.6 (8.6). The mean (SD) operation time was 171.2 (120.3) minutes, while the duration of general anesthesia was 270.9 (171.3) minutes., Conclusions: The present study is the first study to validate dental claims data, and indicates the extent of usefulness of each diagnosis and procedure for future dental research using administrative data., (© 2021. The Author(s).)

Background: In Japan, the Diagnosis Procedure Combination (DPC) data have been used as a nationwide administrative hospital discharge database for clinical studies. However, few studies have evaluated the validity of recorded diagnoses of cancer in the database., Methods: We compared the DPC data with hospital-based cancer registries in Osaka Prefecture, Japan to assess the validity of the recorded cancer diagnoses in the DPC data. Fifteen types of cancer were included in the analysis. Cancer stage with tumor-node-metastasis (TNM) classification was assessed for eight cancer types with >400 patients. We evaluated concordance and positive predictive value of cancer diagnosis, and concordance of cancer stage between the DPC data and the hospital-based cancer registry., Results: In total, we identified 29,180 eligible patients. The five types of cancer with the highest number of patients were as follows: 6,765 (23.2 %) colorectal, 6,476 (22.2 %) stomach, 4,862 (16.7 %) breast, 4,445 (15.2 %) lung, and 2,257 (7.7 %) liver. Concordance of diagnosis ranged from 63.9 %-99.5 %, and twelve of the fifteen types of cancers had concordance of over 90 %. Positive predictive values of diagnosis ranged from 86.8 %-100 %. Regarding cancer stage, the overall degree of concordance was 67.2 % in all patients and the concordance was over 70 % in four types of cancers., Conclusions: The DPC data had high validity of cancer diagnosis. However, the potential impact of the misclassifications and low concordance in cancer stage among specific type of cancers in the DPC data should be considered., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Little is known about hip fracture inpatient care in East Asia. This study examined the characteristics of patients, hospitals, and regions associated with delivery of hip fracture surgeries across Japan, Korea, and Taiwan. We also analyzed and compared how the resource use and a short-term outcome of the care in index hospitals varied according to factors in the respective health systems., Methods: We developed comparable, nationwide, individual-level health insurance claims datasets linked with hospital- and regional-level statistics across the health systems using common protocols. Generalized linear multi-level analyses were conducted on length of stay (LOS) and total cost of index hospitalization as well as inpatient death., Results: The majority of patients were female and aged 75 or older. The standardized LOS of the hospitalization for hip fracture surgery was 32.5 (S.D. = 18.7) days in Japan, 24.7 (S.D. = 12.4) days in Korea, and 7.1 (S.D. = 2.9) days in Taiwan. The total cost per admission also widely varied across the systems. Hospitals with a high volume of hip fracture surgeries had a lower LOS across all three systems, while other factors associated with LOS and total cost varied across countries., Conclusion: There were wide variations in resource use for hip fracture surgery in the index hospital within and across the three health systems with similar social health insurance schemes in East Asia. Further investigations into the large variations are necessary, along with efforts to overcome the methodological challenges of international comparisons of health system performance., (© 2021. The Author(s).)

Objective Maoto is a traditional Japanese Kampo formula used to treat influenza. However, clinical evidence for maoto has been limited to small-scale studies of its effect in alleviating symptoms. The present study evaluated whether or not the addition of maoto to a neuraminidase inhibitor was associated with a reduction in hospitalization following influenza. Methods Using the JMDC Claims Database, we identified outpatients <60 years old who were diagnosed with influenza by an antigen test from September 2013 to August 2018. One-to-five propensity score matching was conducted between patients who received maoto in addition to a neuraminidase inhibitor and those who received a neuraminidase inhibitor alone. Hospitalization within seven days of the influenza diagnosis was compared in the matched groups using the Mantel-Haenszel test. Results We identified 1.79 million cases of influenza from the database in the 5-year study period. Maoto was prescribed for 3.9% of the 1.67 million cases receiving a neuraminidase inhibitor. In the 64,613 propensity score-matched groups of patients, the 7-day hospitalization rate was 0.116% (n=75) for patients with maoto and 0.122% (n=394) for patients without maoto. The difference between these treatment groups was nonsignificant (common odds ratio, 0.95; 95% confidence interval, 0.74 to 1.22; p=0.695). Conclusion The addition of maoto to a neuraminidase inhibitor was not associated with a decrease in hospitalization among nonelderly patients with influenza. Further research is necessary to clarify the indication and efficacy of maoto.

Objective Kampo is a traditional Japanese medicine using formulae of natural agents. Although Kampo is widely practiced, information regarding the current prescriptions of Kampo formulations is lacking. The aim of the study was to describe the outpatient use of Kampo formulations in the current Japanese health insurance system. Methods From the JMDC Claims Database, we identified subscribers with outpatient prescriptions of Kampo extract formulations between April 2017 and March 2018. Prescription records were summarized at the individual level to describe the pattern of each formula's use, such as the frequency of prescription and the number of days within a year that were covered by the prescriptions. We also examined whether or not Kampo formulations were prescribed in combination with other drugs. Results Of the 4.5 million subscribers, 13.5% received prescriptions of Kampo extracts within 1 year, and 54% of Kampo users were women. The most commonly prescribed Kampo formulae included kakkonto, shoseiryuto, and maoto, which were used for the short term covering a median of 5 to 7 days. There were also several formulae that were prescribed for longer periods. The median numbers of days covered by kamishoyosan and keishibukuryogan were 60 and 56, respectively. Kampo formulations were used in combination with Western drugs in 85% of prescriptions. Conclusion Kampo formulations are commonly prescribed under the Japanese insurance system and are frequently used in combination with Western drugs. The pattern of prescriptions varied across different formulae.

Cholesterol crystal embolization (CCE) is a rare, mainly iatrogenic condition. The proportion of CCE after cardiovascular procedures has not been fully elucidated. The purpose of this study was to determine the proportion of CCE diagnosed after cardiovascular procedures and to identify risk factors for CCE occurrence. Data on patients aged older than 40 years who underwent cardiovascular procedures between July 2010 and March 2017 were extracted from the Japanese Diagnosis Procedure Combination database. Inpatients diagnosed with CCE within 1 year after procedures in the same hospital were identified. Logistic regression analysis was performed to identify factors associated with the occurrence of CCE. There were 962 patients with CCE in 2,190,300 patients who underwent cardiovascular procedures. The overall proportion of CCE after cardiovascular procedures was 4.4 per 10,000 patients (95% confidence interval 4.1-4.7). The overall in-hospital mortality among patients with CCE was 11% (107/962). Older age, male sex, smoking, heart failure, peripheral vascular disease, cerebrovascular disease, renal insufficiency, diabetes mellitus, hypertension, and aortic aneurism and dissection were significantly associated with the higher occurrence of CCE. Compared with cardioangiography, several procedures were significantly associated with higher occurrence of CCE, including intra-aortic balloon pumping, percutaneous transluminal angioplasty of the renal artery, and transcatheter aortic valve implantation or balloon aortic valvuloplasty. CCE is rare but remains a severe complication of cardiovascular procedures. Atherosclerotic risk factors and certain cardiovascular procedures were associated with CCE.

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., (© 2020 The Authors. Journal of Occupational Health published by John Wiley & Sons Australia, Ltd on behalf of The Japan Society for Occupational Health.)

Objectives: Current clinical guidelines discourage long-term prescription of benzodiazepines and Z-drugs (BZD); however, the practice continues to exist. The aim of this study was to investigate the proportion of long-term BZD prescriptions and its risk factors., Design: Retrospective cohort study using a health insurance database., Setting: Japan., Participants: A total of 86 909 patients were identified as outpatients aged 18 to 65 years who started BZD between 1 October 2012 and 1 April 2015. After excluding patients who underwent surgery on the day of first BZD prescription (n=762) and patients without 8 months follow-up (n=12 103), 74 044 outpatients were analysed., Main Outcome Measures: We investigated the proportion of long-term prescriptions for ≥8 months among new BZD users. We assessed patient demographics, diagnoses, characteristics of the initial BZD prescription and prescribers as potential predictors of the long-term BZD prescription. Multivariable logistic regression was performed to assess the association between long-term prescription and potential predictors., Results: Of the new BZD users, 6687 (9.0%) were consecutively prescribed BZD for ≥8 months. The long-term prescription was significantly associated with mood and neurotic disorder, cancer, prescription by psychiatrists, multiple prescriptions, hypnotics and medium half-life BZD in the initial prescription., Conclusion: Despite the recent clinical guidelines, 9% of new BZD users were given prescriptions for more than 8 months. Physicians should be aware of risk factors when prescribing BZDs for the first time., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There was no established disability predictive measurement for patients with trauma that could be used in administrative claims databases. The aim of the present study was to develop and validate a diagnosis-based disability predictive index for severe physical disability at discharge using the International Classification of Diseases, 10th revision (ICD-10) coding., Methods: This retrospective observational study used the Diagnosis Procedure Combination database in Japan. Patients who were admitted to hospitals with trauma and discharged alive from 01 April 2010 to 31 March 2015 were included. Pediatric patients under 15 years old were excluded. Data for patients admitted to hospitals from 01 April 2010 to 31 March 2013 was used for development of a disability predictive index (derivation cohort), while data for patients admitted to hospitals from 01 April 2013 to 31 March 2015 was used for the internal validation (validation cohort). The outcome of interest was severe physical disability defined as the Barthel Index score of <60 at discharge. Trauma-related ICD-10 codes were categorized into 36 injury groups with reference to the categorization used in the Global Burden of Diseases study 2013. A multivariable logistic regression analysis was performed for the outcome using the injury groups and patient baseline characteristics including patient age, sex, and Charlson Comorbidity Index (CCI) score in the derivation cohort. A score corresponding to a regression coefficient was assigned to each injury group. The disability predictive index for each patient was defined as the sum of the scores. The predictive performance of the index was validated using the receiver operating characteristic curve analysis in the validation cohort., Results: The derivation cohort included 1,475,158 patients, while the validation cohort included 939,659 patients. Of the 939,659 patients, 235,382 (25.0%) were discharged with severe physical disability. The c-statistics of the disability predictive index was 0.795 (95% confidence interval [CI] 0.794-0.795), while that of a model using the disability predictive index and patient baseline characteristics was 0.856 (95% CI 0.855-0.857)., Conclusions: Severe physical disability at discharge may be well predicted with patient age, sex, CCI score, and the diagnosis-based disability predictive index in patients admitted to hospitals with trauma., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Introduction: To develop and validate a new trauma mortality prediction scoring system based on International Statistical Classification of Diseases (ICD)-10 codes, using a Japanese administrative claims and discharge abstract database., Methods: This retrospective observational study used the Japanese Diagnosis Procedure Combination database. Injuries were categorised into 33 groups with 5 additional groups based on injury sites and types. A multivariable logistic regression analysis was performed for in-hospital mortality in a derivation cohort after adjusting for the 38 groups, patient's sex, age and Charlson Comorbidity Index score. Each variable was assigned a score that was equal to the value of the regression coefficient. The new severity score was defined as the sum of the scores. The new scoring system was tested in a validation cohort., Results: The mortality rates were 2.4% (9270/393 395) and 2.5% (8778/349 285) in the derivation and validation cohorts, respectively. The area under the receiver operating curve (AUROC) of the new scoring system was 0.887 (95% CI 0.884 to 0.890) in the validation cohort. Subgroup analyses showed that the scoring system retained high predictive performance both for patients <65 years (AUROC 0.934, 95% CI 0.928 to 0.939) and for elderly patients at the age of ≥65 years (AUROC 0.825, 95% CI 0.820 to 0.829)., Conclusions: A new ICD-10-based injury severity scoring system was developed and validated. Further studies are required to validate the scoring system in other databases., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objectives: Comorbidity measures are widely used in administrative databases to predict mortality. The Japanese Diagnosis Procedure Combination database is unique in that secondary diagnoses are recorded into subcategories, and procedures are precisely recorded. We investigated the influence of these features on the performance of mortality prediction models., Study Design and Setting: We obtained data of adult patients with main diagnosis of acute myocardial infarction, congestive heart failure, acute cerebrovascular disease, gastrointestinal hemorrhage, pneumonia, or septicemia during a 1-year period. Multiple models were constructed representing different subcategories from which Charlson and Elixhauser comorbidities were extracted. Prevalence of comorbidities and C statistics of logistic regression models predicting in-hospital mortality was compared. Associations between four procedures (computed tomography, oxygen administration, urinary catheter, and vasopressors) and mortality were also evaluated., Results: C statistics of the model using all secondary diagnoses (Charlson: 0.717; Elixhauser: 0.762) were greater than those using a limited subcategory to strictly specify comorbidities (Charlson: 0.708; Elixhauser: 0.744). However, misidentification of complications and main diagnoses as comorbidities was observed in the all-diagnosis model. The four procedures were associated with mortality., Conclusion: Subcategorized diagnoses allowed correct identification of comorbidities and procedures predicted mortality. Incorporation of these two features should be considered for other administrative databases., (Copyright © 2015 Elsevier Inc. All rights reserved.)