山名 隼人

Screening and brief interventions have been implemented in primary care settings to reduce excessive drinking. However, the effectiveness of screening and brief interventions within a health checkup setting is unclear. We assessed the effectiveness of general treatment for lifestyle-related diseases following screening for alcohol consumption at health checkups, using data on medical claims and health checkups. Participants were people with excessive drinking who met the threshold of recommendation to receive treatment for lifestyle-related diseases. We analyzed risky drinkers (drinking every day, 40-60 g/day for male and 20-60 g/day for female) and heavy drinkers (drinking every day, >60 g/day) separately. We performed one-to-one propensity score matching between people who received general outpatient treatment for lifestyle-related diseases and those who did not. Outcomes were drinking patterns (frequency and amount) and liver function at the next year's health checkup. Middle-aged males accounted for about 94% of the 23,347 participants. Eleven percent of the participants received treatment after the health checkup. After propensity score matching, among 1990 pairs of risky drinkers, those with treatment were significantly more likely to reduce their frequency of drinking (11.7% vs. 8.7%, p = 0.002) and showed lower transaminase values than those without treatment. In 575 pairs of heavy drinkers, there was no significant change in drinking patterns or liver function. Treatment in primary care after screening at health checkups was associated with the change in drinking behavior and improvement in liver condition among risky drinkers. More intensive intervention may be needed to reduce drinking in heavy drinkers.

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.

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.

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.

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.

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. This article is protected by copyright. All rights reserved.

It is important to educate caregivers in order to prevent infant injuries. However, there have been few studies on the effects of education on pregnant women. This study aimed to evaluate the effects of injury prevention group education on this group. Study participants were recruited from a group of pregnant mothers attending an antenatal class in Tokyo. Participants were assigned to either the intervention or control group based on the month in which they attended the existing antenatal class. Both groups received a leaflet on injury prevention, but only the intervention group received an additional short one-shot lecture. The implementation of each of the nine safety practices was assessed during home visits after childbirth. Of the 131 study participants (56 in the control group and 75 in the intervention group), 106 (80.9%) received home visits after birth. Mothers in the intervention group implemented three practices significantly more than those in the control group: Keep soft objects away from the baby's head (38.3% vs. 13.0%), Do not place your baby on a high surface (74.6% vs. 52.2%), and Use the baby carrier correctly (93.3% vs. 76.1%). In the future, we plan to follow up the participants to evaluate the program's long-term effects, and to continue to improve the program.

We investigated the association between exposure to eye drops prescribed for dry eye disease (DED) during pregnancy and adverse neonatal outcomes. Pregnant women with DED in the JMDC Claims Database (JMDC Inc., Tokyo, Japan) between 2005 and 2020 were included. According to their prescriptions during the first trimester, the women were classified into three exposed groups (hyaluronate 0.1% alone, hyaluronate 0.3% alone, and diquafosol alone) and an unexposed group (no eye drops for DED). We compared adverse neonatal outcomes (congenital anomalies, preterm birth, low birthweight, and composite outcome of these three) between the exposed and unexposed groups. We conducted a high-dimensional propensity score analysis using many variables in the database together with known potential confounders such as chronic comorbidities. We identified 4,808 eligible women, of whom 936 (19.5%) received eye drops for DED. Congenital anomalies occurred in 7.2% and 6.0%, preterm birth in 3.1% and 4.0%, low birthweight in 7.9% and 6.0%, and composite outcome in 14.9% and 12.3% of women in the hyaluronate 0.1% alone and unexposed groups, respectively. The high-dimensional propensity score analysis showed that hyaluronate 0.1% alone was not significantly associated with increases in congenital anomalies (risk difference, 0.4% [95% confidence interval, -1.9% to 2.7%]), preterm birth (-0.6% [-2.2% to 0.9%]), low birthweight (1.8% [-0.6% to 4.1%]), or composite outcome (1.9% [-1.3% to 5.1%]). Similar results were obtained in the hyaluronate 0.3% alone and diquafosol alone groups. Use of eye drops for DED in pregnant women was not associated with adverse neonatal outcomes.

OBJECTIVES: Renal failure and hepatic cirrhosis are mutually aggravating factors. However, no specific therapeutic strategies for hepatic encephalopathy (HE) and end-stage kidney disease have been established. The coexistence, with an extremely poor prognosis, makes randomized controlled trials unfeasible. We evaluated whether an infusion of branched-chain amino acids was associated with mortality in patients hospitalized for HE and end-stage kidney disease. DESIGN AND METHODS: Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified patients with HE and end-stage kidney disease who received hemodialysis 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 and those who did not. We conducted analyses using overlap weights based on propensity scores to compare in-hospital mortality between the groups. Sub-group analysis was conducted by stratifying patients by Child-Pugh class. RESULTS: We identified 553 eligible patients, including 503 patients who received branched-chain amino acid infusion and 50 who did not. The patients who received branched-chain amino acid infusion had lower mortality than those who did not (10.2% vs. 20.1%, relative risk 0.51, 95% confidence interval 0.27-0.95). Sub-group analysis showed that branched-chain amino acid infusion was associated with decreased in-hospital mortality in patients with Child-Pugh class C (16.2% vs. 39.0%, relative risk 0.41, 95% confidence interval 0.23-0.76). CONCLUSIONS: Branched-chain amino acid infusion may improve the prognosis of HE in patients with end-stage kidney disease, particularly those with lower liver function. Further research is necessary to provide a suitable treatment for HE in patients with end-stage kidney disease.

BACKGROUND: Many mechanically ventilated patients in Japan are treated in high-dependency care units (HDUs) rather than intensive care units (ICUs). HDUs can provide intermediate-level care with reduced costs; however, there is limited evidence on whether mechanically ventilated patients should be treated in the ICU or HDU. METHODS: This was a comparative effectiveness study using a nationwide administrative database in Japan. We identified mechanically ventilated patients with pneumonia in ICU or HDU on the day of admission in the Japanese Diagnosis Procedure Combination inpatient database from April 2014 to March 2019. The primary outcome was 30-day in-hospital mortality. Propensity score matching analysis was performed to compare this outcome between patients treated in the ICU and HDU. The robustness of the analyses was evaluated with multivariable regression, overlap weighting, and instrumental variable analyses. FINDINGS: Of 14,859 mechanically ventilated patients with pneumonia, 7,528 (51%) were treated in the ICU and 7,331 (49%) were treated in the HDU. After propensity score matching, patients treated in the ICU had significantly lower 30-day in-hospital mortality than did those treated in the HDU (24.0% vs. 31.2%; difference, -7.2%; 95% confidence interval, -10.0% to -4.4%). The multivariable regression, overlap weighting, and instrumental variable analyses showed a similar direction and magnitude of association. INTERPRETATION: Critical care for mechanically ventilated patients with pneumonia in the ICU was associated with a 7.2% decrease in 30-day in-hospital mortality vs. care in the HDU. Residual confounding may still play a role in the effect estimates. FUNDING: This study received funding from Ministry of Health, Labour and Welfare, Japan, and Ministry of Education, Culture, Sports, Science and Technology, Japan.

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 I 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 I allergy and endometriosis (IRR, 1.10; 95% confidence interval, 1.06 to 1.13) and between rheumatoid arthritis and endometriosis (IRR, 1.31; 95% confidence interval, 1.05 to 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. CONCLUSIONS: 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.

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.

OBJECTIVE: To investigate the association between exposure to topical ophthalmic antibiotics during pregnancy and adverse neonatal outcomes. METHODS: In this retrospective cohort study, we identified pregnant women with hordeola, chalazia, blepharitis, or bacterial conjunctivitis from 2005 to 2018 using the Japanese Medical Data Centre Claims Database. From the eligible women, we extracted women who were dispensed no topical antibiotics during the first trimester (non-antibiotic group), women who were dispensed topical fluoroquinolones alone at least once (fluoroquinolone alone group), and women who were dispensed any single type of antibiotic (single-antibiotic group). We compared the frequency of congenital anomalies (CA), preterm birth (PB), low birth weight (LBW), and the composite outcome of these three between the fluoroquinolone and non-antibiotic groups and between the single-antibiotic and non-antibiotic groups, using propensity score adjustment. RESULTS: A total of 891 eligible women were identified. In the fluoroquinolone (n = 409) and non-antibiotic (n = 309) groups, CA occurred in 6.8% and 6.8%, PB in 2.4% and 3.2%, LBW in 2.9% and 3.2%, and the composite outcome in 10.5% and 11.3%, respectively. Analysis using propensity score adjustment showed no significant difference between the groups in the frequency of CA (adjusted odds ratio, 1.15; 95% confidence interval, 0.61-2.18), PB (0.80; 0.30-2.17), LBW (1.08; 0.45-2.63), or the composite outcome (1.12; 0.67-1.87). Comparison of the single-antibiotic and non-antibiotic groups showed similar results. CONCLUSIONS: Topical ophthalmic antibiotics for hordeola, chalazia, blepharitis, or bacterial conjunctivitis during the first trimester were not associated with increased adverse neonatal outcomes.

目的:下肢切断後の転帰に関する大規模研究は少ない。また、下肢切断後の重要な転帰として再切断が挙げられるが、再切断に関するリスク因子は明らかになっていない。下肢切断後の在院死亡および再切断に関するリスク因子を明らかにするため本研究を行った。方法:本邦における入院患者データベースを用いて、下肢切断術を受けた患者13,774人の情報を抽出した。患者背景を分析し、多変量ロジスティック解析を用いて在院死亡および再切断に関連するリスク因子の解析を行った。結果:対象患者の平均年齢は72.4歳であり、63.1%(n=8.694)が男性であった。在院死亡率は10.8%(1,481/13,774人)であった。足部切断または下腿切断後の再手術率は10.1%(782/7,779人)であった(足部切断後では18.2%[391/2,148人]、下腿切断後では6.9%[391/5,631人])。再手術または在院死亡の有意なリスク因子は、高年齢、男性、末梢循環疾患、入院中のインスリンの使用、入院中の血液透析の実施、および多い併存疾患数であった。入院中の血液透析の実施が最も強いリスク因子であった(オッズ比:2.10、95%信頼区間:1.87〜2.35)。結論:下肢切断後の在院死亡率と再切断率は高く、下肢切断術を受けた患者がもつ慢性疾患の状態を反映しているものと考えられた。本研究にて明らかになった下肢切断後の在院死亡および再手術のリスク因子は、術後の予後の予測や切断高位の決定に寄与するものと考えられる。(著者抄録)

<sec><title>Introduction</title>Information on drug-induced interstitial lung disease (DILD) is limited due to its low incidence. This study investigated the frequencies of drug categories with potential risk in patients developing DILD during hospitalisation and analysed the risk of developing DILD associated with each of these drugs. </sec><sec><title>Methods</title>Using a Japanese national inpatient database, we identified patients without interstitial pneumonia on admission who developed DILD and required corticosteroid therapy during hospitalisation from July 2010 to March 2016. We conducted a nested case–control study; four controls from the entire non-DILD patient cohort were matched to each DILD case on age, sex, main diagnosis, admission year and hospital. We defined 42 classified categories of drugs with 216 generic names as drugs with potential risk of DILD, and we identified the use of these drugs during hospitalisation for each patient. We analysed the association between each drug category and DILD development using conditional logistic regression analyses. </sec><sec><title>Results</title>We retrospectively identified 2342 patients who developed DILD. After one-to-four case–control matching, 1541 case patients were matched with 5677 control patients. Six drug categories were significantly associated with the increased occurrence of DILD. These included epidermal growth factor receptor inhibitors (OR: 16.84, 95% CI 9.32 to 30.41) and class III antiarrhythmic drugs (OR: 7.01, 95% CI 3.86 to 12.73). Statins were associated with reduced risk of DILD (OR: 0.68, 95% CI 0.50 to 0.92). </sec><sec><title>Conclusions</title>We demonstrated significant associations between various drug categories and DILD. Our findings provide useful information on drug categories with potential risk to help physicians prevent and treat DILD. </sec>

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

CONTEXT: Guidelines worldwide recommend potassium replacement of 10-40 mmol/L in the initial fluid therapy for patients with diabetic ketoacidosis. However, evidence is lacking as to the association between infused potassium concentration and mortality. OBJECTIVE: We aimed to determine the association between infused potassium concentration and in-hospital mortality. METHODS: Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified inpatients admitted for treatment of diabetic ketoacidosis from July 2010 to March 2018. Patients with kidney dysfunction or serum potassium abnormalities were excluded. We evaluated the association of the potassium concentration in the total infused solutions in the first 2 days of hospitalization with 28-day in-hospital mortality using multivariable regression analysis with a cubic spline model. We also assessed the association between potassium concentration and occurrence of hyperkalemia. RESULTS: We identified 14,216 patients with diabetic ketoacidosis and observed 261 deaths. The quartile cut-points for potassium concentration were 7.7, 11.4, and 16.1 mmol/L. Within the range of approximately 10-40 mmol/L, potassium concentration was not associated with occurrence of hyperkalemia or death. Lower potassium concentrations were associated with higher 28-day in-hospital mortality; the odds ratio for patients receiving 8 mmol/L was 1.69 (95% CI: 1.03 to 2.78; reference: 20 mmol/L), and the odds ratio increased monotonically as potassium concentration decreased further. CONCLUSION: Patients receiving potassium replacement at concentrations of 10-40 mmol/L had similar in-hospital mortality rates, whereas lower concentrations were associated with higher mortality.

AIMS/INTRODUCTION: Discontinuation of diabetes care has been studied mostly in patients with prevalent diabetes and not in patients with newly diagnosed diabetes, whose dropout risk is highest. Because enrolling patients in a prospective study will influence adherence, we retrospectively examined whether guideline-recommended practices, defined as nutritional guidance or ophthalmological examination, can prevent patient discontinuation of diabetes care after its initiation. MATERIALS AND METHODS: We retrospectively identified adults with newly screened diabetes during checkups using a large Japanese administrative claims database (JMDC, Tokyo, Japan) that contains laboratory data and lifestyle questionnaires. We defined discontinuation of physician visits as a follow-up interval exceeding 6 months. We divided the patients into those who received guideline-recommended practices (nutritional guidance or ophthalmology consultation) within the same month as the first visit and those who did not. We calculated propensity scores and carried out inverse probability of treatment weighting analyses to compare discontinuation between the two groups. RESULTS: We identified 6,508 patients with at least one physician consultation for diabetes care within 3 months after their checkup, including 4,574 patients without and 1,934 with guideline-recommended practices. After inverse probability of treatment weighting, patients with guideline-recommended practices had a significantly lower proportion of discontinuation than those without (17.2% vs 21.8%; relative risk 0.79, 95% confidence interval 0.69-0.91). CONCLUSIONS: This study is the first to show that after adjustment for both patient and healthcare provider factors, guideline-recommended practices within the first month of physician consultation for diabetes care can decrease subsequent discontinuation of physician visits in patients with newly diagnosed diabetes.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: Prophylactic antibiotic use in patients undergoing TACE was associated with a reduced occurrence of liver abscess requiring procedural intervention.

AIM: To develop a procedure-based organ failure assessment model for intensive care unit (ICU) patients and to examine the ability of this model to predict in-hospital mortality, with reference to the Sequential Organ Failure Assessment (SOFA) score. METHODS: Using the Japanese nationwide Diagnosis Procedure Combination database, we identified patients aged ≥15 years who were admitted to the ICUs April 2018-March 2019. Since April 2018, Japanese health care providers have been required to input ICU patients' SOFA scores into this database. We extracted data on the following procedures on ICU admission: oxygen supplementation, invasive mechanical ventilation, blood transfusions, catecholamines, chest compression, extracorporeal membrane oxygenation, and renal replacement therapy. A procedure-based organ failure assessment model (Model 1) for in-hospital mortality was developed using therapeutic procedures for organ failure on the day of ICU admission in the derivation cohort. We also constructed a model using the SOFA score (Model 2). Discriminatory ability was assessed using area under the receiver operating characteristic curve (AUROC) in the validation cohort, and the discriminatory abilities of the models were compared. RESULTS: In total, 69,019 patients were included. Overall in-hospital mortality was 7.2%. The AUROCs for Model 1 (0.810) and Model 2 (0.817) in the validation cohort did not show a statistically significant difference (P = 0.20). CONCLUSION: The models established using procedure-based organ failure assessment showed no statistically significant differences from those using the SOFA score, suggesting that procedure records in administrative databases can be used for risk adjustment in clinical studies on ICU mortality.

Background and Aim: Screening for tuberculosis before treating with biologic agents is recommended in patients with immune-mediated inflammatory diseases (IMIDs). We conducted this study to identify adherence to the recommended practice in a real-world setting in Japan. Methods: We used a community-based insurance claims database in a city in the Greater Tokyo Area in Japan. Between July 2012 and January 2019, we enrolled patients with IMIDs in the age range 15 to 74 years who had initiated biologic therapy. Tuberculosis screening was defined as (a) interferon-γ release assay and/or a tuberculin skin test (IGRA/TST) and (b) IGRA/TST and X-ray and/or CT scan (X-ray/CT) within 2 months before starting biologic agents. We analyzed the proportions of patients who underwent tuberculosis screening and their association with the patient- and treatment-related factors and treatment for latent tuberculosis infection (LTBI). Results: Of 421 patients presumed to have initiated biologic therapy, 202 (48%) underwent IGRA/TST and 169 (40%) underwent IGRA/TST and X-ray/CT. Patients aged 65 to 74 years were more likely to undergo tuberculosis screening than those aged 45 to 64 years. Compared to infliximab, IGRA/TST was less frequently performed in patients treated with etanercept, adalimumab, golimumab, abatacept, and tocilizumab. Treatment for LTBI was provided to 67 (16%) patients. Proportions of patients receiving LTBI treatment did not significantly differ according to the screening status. Conclusion: There was low adherence to the recommendations for tuberculosis screening and prophylactic treatment before biologic therapy. It is necessary to continue alerting clinical practitioners to the importance of screening for tuberculosis and treatment for LTBI.

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.

PURPOSE: The risks of topical ophthalmic corticosteroids during pregnancy remain unclear. This study investigated the association between exposure to topical ophthalmic corticosteroids during pregnancy and adverse neonatal outcomes. DESIGN: Retrospective, cohort, database study. METHODS: Pregnant women with allergic conjunctivitis in the JMDC claims database (JMDC, Tokyo, Japan) between 2005 and 2018 were included. Adverse neonatal outcomes (congenital anomalies [CA], preterm birth [PB], low birthweight [LB], and the composite of these 3 outcomes) were compared between mothers who did and did not receive topical ophthalmic corticosteroids during the first trimester. Controls were women who were not prescribed topical ophthalmic corticosteroids during the first trimester. First, propensity scores were calculated with known confounders, including disorders during pregnancy, other chronic comorbidities, and use of antihistamines. Logistic regression was then conducted with propensity score adjustment. RESULTS: A total of 6,847 eligible women were identified of whom 898 (13%) had received topical ophthalmic corticosteroids. CA occurred in 5.5% and 4.9%, respectively; PB in 3.4% and 3.9%, respectively; LB in 5.9% and 7.0%, respectively; and the composite outcome in 11.7% and 11.7% of unexposed and exposed mothers, respectively. Corticosteroid eye drops were not significantly associated with an increase in CA (adjusted odds ratio [aOR], 0.78; 95% confidence interval [CI], 0.54-1.14; P = .20); PB (aOR, 1.23; 95% CI, 0.80-1.88; P = .35); LB (aOR, 1.17; 95% CI, 0.84-1.61; P = .35), or composite outcome (aOR, 0.95; 95% CI, 0.73-1.22; P = .68). CONCLUSIONS: The use of topical ophthalmic corticosteroids in pregnant women with allergic conjunctivitis was not associated with any increase in CA, PB, or LB.

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.

BACKGROUND/AIMS: To investigate the association between exposure to intraocular pressure (IOP)-lowering medications during pregnancy and neonatal adverse outcomes. METHODS: This retrospective, cohort study used the JMDC Claims Database (JMDC, Tokyo, Japan), 2005-2018. We extracted data on pregnant women with glaucoma, including dispensation of (1) any IOP-lowering medications, (2) only prostaglandin analogues (PGs) and 3) only beta-blockers, during the first trimester. We compared frequency of congenital anomalies (CA), preterm birth (PB), low birth weight (LBW) and the composite outcome of these three measures, between the women with and without IOP-lowering medications. We calculated propensity scores (PSs) using logistic regression in which use of IOP-lowering medications was regressed against known confounders (disorders during pregnancy and other chronic comorbidities). We then conducted logistic regression in which neonatal adverse outcomes were regressed against use of IOP-lowering medications with adjustment for the PS. RESULTS: We identified 826 eligible women, 91 (11%) of whom had received any IOP-lowering medications. CA occurred in 9.9% and 6.4%, PB in 2.2% and 4.5%, LBW in 9.9% and 6.0% and composite outcome in 17.6% and 13.3% of mothers with and without IOP-lowering medications, respectively. After adjustment for PS, IOP-lowering medications were not significantly associated with more frequent CA (adjusted OR (aOR), 1.43; 95% CI, 0.66 to 3.12), PB (aOR, 0.45; 95% CI, 0.10 to 1.97), LBW (aOR, 2.11; 95% CI, 0.98 to 4.57) or composite outcome (aOR, 1.40; 95% CI, 0.78 to 2.53). Results were similar regarding PGs only and beta-blockers only. CONCLUSIONS: IOP-lowering medications during the first trimester were not significantly associated with increase in CA, PB or LBW.

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.

BACKGROUND: Surgical procedure for symptomatic spinal metastasis is expected to improve the quality of life. Factors related to short-term perioperative mortality after surgery for spinal metastasis may be different from those related to long-term mortality, which have classically been used to determine the indication for surgery. The purposes of this study were to evaluate factors related to the 30-day mortality after surgery for spinal metastasis and create an integer risk scoring system. METHODS: Using the Diagnosis Procedure Combination database from 2010 to 2016, we extracted data of patients who underwent surgical procedure for spinal metastasis. Multivariable logistic regression analysis was performed to clarify the association between patient backgrounds and the 30-day postoperative mortality. We created a risk scoring system using regression coefficients to estimate the 30-day mortality for each patient. RESULTS: Among 3524 patients, the 30-day mortality was 2.6%. Factors associated with a higher 30-day mortality were male sex (odds ratio, 2.50 [95% confidence interval, 1.45-4.31]), emergency admission (1.80 [1.11-2.92]), rapid growth tumors (3.83 [2.49-5.90]), and non-skeletal metastasis (2.27 [1.42-3.64]). In patients with the maximum risk score of five, the 30-day mortality was 16.2%. CONCLUSIONS: Factors related to the 30-day mortality were male sex, emergency admission, rapid growth tumors, and non-skeletal metastasis. These findings provide spine surgeons and patients knowledge of the potential risk of short-term perioperative mortality and allow them to consider the risk of surgery.

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: Comprehensive geriatric assessment (CGA) is a multidimensional and multidisciplinary method to identify geriatric conditions among older patients. The aim of the present study was to examine the associations between CGA and short-term outcomes among older adult inpatients with stroke. Methods: The study was a nationwide, retrospective cohort study. We used the Diagnosis Procedure Combination database, a national Japanese inpatient database, to identify older adult stroke patients from 2014 to 2017. The associations between CGA and in-hospital mortality, length of hospital stay, readmission rate, rehabilitation intervention, and introduction of home health care were evaluated using propensity score matching and instrumental variable analysis. Findings: We identified 338,720 patients, 21·3% of whom received CGA. A propensity score-matched analysis of 53,861 pairs showed that in-hospital mortality was significantly lower in the CGA group than in the non-CGA group (3·6% vs. 4·1%, p < 0·001). The rate of long-term hospitalization (> 60 days) was significantly lower in the CGA group than in the non-CGA group (8·7% vs. 10·1%, p < 0·001), and the rates of rehabilitation intervention (30·3% vs. 24·9%, p < 0·001) and home health care (8·3% vs. 7·6%, p = 0·001) were both higher in the CGA group than in the non-CGA group. Instrumental variable analysis showed similar results. Interpretation: CGA was significantly associated with the examined short-term outcomes. These findings from Japan, one of the most aged countries worldwide, highlight the possible benefits of CGA for short-term outcomes and can be of use for health policy in other international contexts. Funding: This work was supported by grants from the Ministry of Health, Labour and Welfare, Japan (19AA2007 and H30-Policy-Designated-004) and the Ministry of Education, Culture, Sports, Science and Technology, Japan (17H04141).

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.

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.

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.

Background: The optimal colloid solution for the treatment of ovarian hyperstimulation syndrome (OHSS) remains to be established. Objective: We aimed to compare artificial colloids (AC) with human albumin (HA) for the treatment of OHSS. Materials and Methods: In this retrospective cohort study, data for OHSS participants were collected from a national inpatient database in Japan. The participants received intravenous fluid management with AC (n = 156) or HA (n = 127). We compared the two groups in terms of the length of stay, development of post-treatment complications, and termination surgery. Results: In multivariable linear regression analyses for log-transformed length of stay with reference to the OHSS participants receiving AC, the regression coefficient (95% confidence interval) in participants receiving HA was 0.03 (-0.04-0.09, p = 0.42). Thromboembolism occurred in two participants in the HA group and three participants in the AC group. Two participants in the HA group suffered renal failure during hospitalization. No participants underwent termination surgery in the two groups. Conclusion: The present results showed comparable efficacy between AC and HA for the treatment of OHSS. There were no significant differences in post-treatment complications between the two groups.

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.

PURPOSE: Patients with symptomatic COPD are recommended to use inhaled bronchodilators containing long-acting muscarinic receptor antagonists (LAMAs). However, bronchodilators may cause gastrointestinal adverse effects due to anticholinergic reactions, especially in advanced-age patients with COPD. Dai-kenchu-to (TU-100, Da Jian Zhong Tang in Chinese) is the most frequently prescribed Japanese herbal Kampo medicine and is often prescribed to control abdominal bloating and constipation. The purpose of this study was to evaluate the role of Dai-kenchu-to as a supportive therapy in advanced-age patients with COPD. PATIENTS AND METHODS: We used the Japanese Diagnosis Procedure Combination inpatient database and identified patients aged ≥75 years who were hospitalized for COPD exacerbation. We then compared the risk of re-hospitalization for COPD exacerbation or death between patients with and without Dai-kenchu-to using 1-to-4 propensity score matching. A Cox proportional hazards model was used to compare the two groups. We performed subgroup analyses for patients with and without LAMA therapy. RESULTS: Patients treated with Dai-kenchu-to had a significantly lower risk of re-hospitalization or death after discharge; the HR was 0.82 (95% CI, 0.67-0.99) in 1-to-4 propensity score matching. Subgroup analysis of LAMA users showed a significant difference in re-hospitalization or death, while subgroup analysis of LAMA non-users showed no significant difference. CONCLUSION: Our findings indicate that Dai-kenchu-to may have improved the tolerability of LAMA in advanced-age patients with COPD and, therefore, reduced the risk of re-hospitalization or death from COPD exacerbation. Dai-kenchu-to may be recommended as a useful supportive therapy for advanced-age patients with COPD.

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.

INTRODUCTION: A reliable scoring system that predicts the walking ability of hip fracture patients would be useful for clinicians. Here we developed a scoring system for hip fracture patients and evaluated its predictive ability. HYPOTHESIS: We hypothesized that age, sex, presence of dementia, walking ability before the injury, fracture type, serum hemoglobin level, serum albumin level and interval in days between admission and surgery would be the predictive factors of the walking ability at discharge. MATERIAL AND METHODS: Data from 409 patients who underwent hip fracture surgery were included. We analyzed factors that affected walking ability and developed a scoring system that predicts the probability of walking unaided or with a cane at discharge. RESULTS: The mean age of the patients was 81.3 years. A total of 164 (40%) patients could walk unaided or with a cane at discharge. Multivariate logistic regression analysis showed that the obstructive factors for the ability to walk unaided or with a cane at discharge were older age (odds ratio [OR]=0.962, p=0.002), dementia (OR=0.126, p<0.001), use of a cane before injury (OR=0.396, p<0.001), trochanteric fracture (OR=0.571, p=0.027) and low serum albumin level (OR=4.15, p<0.001) at admission. The scoring system used the following formula: Score=5-0.04×age+albumin-2(with dementia)- 1(with use of a cane before injury)-1(with trochanteric fracture). The C-statistics for the scoring system was 0.81 (95% confidence interval, 0.77-0.85). DISCUSSION: This newly developed scoring system of information at admission predicted the discharge mobility of hip fracture patients. In addition to the previously known risk factors, serum albumin level at admission was detected as a new predictor for mobility at discharge. LEVEL OF PROOF: IV, retrospective study.