Administrative Database In Japan Research Articles

Real-world evidence of FOLFIRI combined with anti-angiogenesis inhibitors or anti-EGFR antibodies for patients with early recurrence colorectal cancer after adjuvant FOLFOX/CAPOX therapy in Japan: A retrospective observational study using administrative database.

110 Background: Oxaliplatin-containing regimens (FOLFOX or CAPOX) are the most common adjuvant treatments after curative resection of colorectal cancer (CRC). However, real-world evidence (RWE) of treatment sequence/outcomes for patients with early recurrence CRC after receiving adjuvant chemotherapy are limited. Methods: This retrospective cohort study was based on an administrative database in Japan. The primary objective was to describe the treatment sequence for patients with early recurrence CRC and treated by combination of FOLFIRI and anti-angiogenesis inhibitors (AAIs) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) after adjuvant FOLFOX or CAPOX therapy. The study included patients with CRC who underwent surgical resection, started adjuvant chemotherapy ≤3 months (mo) after the first surgery, had early recurrence of CRC (defined as initiation of FOLFIRI + AAIs/anti-EGFR mAbs second line [2L] regimen) within 1 year after adjuvant chemotherapy ended. Patient characteristics at baseline of 2L (60 days prior to 2L initiation) and treatment sequence were summarized descriptively; time to discontinuation (TTD) for adjuvant and 2L therapy were analyzed using Kaplan-Meier method. Cox proportional hazard model was used to identify risk factors associated with TTD of 2L regimen. Results: The cohort included 832 patients: median (range) age was 67 (24-86) years, 56.4% males, 65.5% with left-sided CRC. Most patients received CAPOX (71.3%) as adjuvant therapy. Median (95% CI) duration of adjuvant therapy was 5.4 mo (5.3-5.5). As 2L therapy, 72.5% and 27.5% of patients received FOLFIRI + AAIs (AAIs group) and FOLFIRI + anti-EGFR mAbs (anti-EGFR group), respectively. Median TTD (95% CI) of the AAIs and anti-EGFR groups in 2L were 6.2 mo (5.8-6.9) and 6.1 mo (5.2-7.4), respectively. Among patients with recurrence within 6 mo (72.6%), the median TTD (95% CI) for AAIs and anti-EGFR groups were 6.1 mo (5.5- 6.5) and 5.8 mo (5.1-7.8), respectively. Among patients with recurrence during 6 to 12 mo (27.4%), the median TTD (95% CI) of AAIs and anti-EGFR groups were 8.1 mo (6.1-9.2) and 6.2 mo (4.6-8.0), respectively. Age ≥70 years was negatively associated with TTD of 2L, HR = 1.19 (95% CI: 1.02-1.39); p=0.03. Conclusions: This is the first RWE based on administrative data on treatment sequence/ outcomes for patients with early recurrence CRC treated by FOLFIRI + AAIs/anti-EGFR mAbs after adjuvant FOLFOX/CAPOX therapy in Japan. The treatment outcomes for patients with early recurrence CRC were similar to previous clinical trials in 2L advanced CRC. The results suggested that these two 2L regimens had similar TTD; however, the timing of relapse may influence the efficacy of AAIs and anti-EGFR mAbs.

Short-term outcomes of pancreatoduodenectomy in older individuals over a 9-year period using real-world data: A multilevel analysis based on a nationwide administrative database in Japan.

We aimed to evaluate the short-term outcomes of pancreatoduodenectomy (PD) in older individuals. Data from the Japanese Diagnosis Procedure Combination database on 62 275 patients who underwent PD from 1 April 2012 to 31 March 2020 were analyzed. Patients were divided into five age groups: <70, 70-74, 75-79, 80-84, and ≥85 years. The associations between postoperative outcomes and age were investigated using multilevel analysis. The mean differences in length of hospital stay and cost were also compared. The rate of PD in older individuals increased annually. Compared with the youngest age group (< 70 years), the incidence rate ratios for in-hospital mortality were 1.52 (95% confidence interval [CI]: 1.30-1.76), 2.07 (1.82-2.37), 2.29 (1.94-2.71), and 2.92 (2.20-3.87) in the 70-74, 75-79, 80-84, and ≥ 85-year-old age groups, respectively (all p < .001). Postoperative complications, length of postoperative hospital stay, and cost increased significantly with increasing age. These real-world data emphasize the higher levels of morbidity, mortality, and cost in older patients. Careful attention should be paid when considering the indication for PD in older individuals.

Prenatal hypertension as the risk of eclampsia, HELLP syndrome, and critical obstetric hemorrhage

Critical bleeding is a common cause of maternal mortality in obstetric patients. However, the non-obstetric factors underlying critical obstetric bleeding remain uncertain. Therefore, this study aimed to clarify the impact of chronic hypertension on obstetric hemorrhage by evaluating a nationwide administrative database in Japan. Women who gave birth between 2018 and 2022 were enrolled. The primary outcome was critical hemorrhage requiring massive red blood cell (RBC) transfusion during childbirth. In total, 354, 299 eligible women were selected from the database. The maternal mortality rate was >1.0% among those who received a massive RBC transfusion (≥4000 cc), and this amount was used as the cutoff of the outcome. Critical hemorrhage was less frequent with elective Caesarean section (CS) compared with vaginal childbirth or emergent CS (odds ratio [OR], 0.38; 95% confidence interval, 0.30–0.47). Multiple logistic regression analysis adjusting for these obstetric risks revealed that a higher maternal age (adjusted OR [aOR] per 1 year, 1.07 [1.05–1.09]); oral medications with prednisolone (aOR, 2.5 [1.4–4.4]), anti-coagulants (aOR, 10 [5.4–19]), and anti-platelets (aOR, 2.9 [1.3–6.4]); and a prenatal history of hypertension (aOR, 2.5 [1.5–4.4]) and hypoproteinemia (aOR, 5.8 [1.7–20]) are the risks underlying critical obstetric hemorrhage. Prenatal history of hypertension was significantly associated with obstetric disseminated intravascular coagulation (OR, 1.9 [1.5–2.4]); Hemolysis, Elevated Liver enzymes, and Low platelet count (HELLP) syndrome (OR, 3.3 [2.7–4.2]); and eclampsia (OR, 6.1 [4.6–8.1]). In conclusion, a maternal prenatal history of hypertension is associated with the development of HELLP syndrome, eclampsia, and resultant critical hemorrhage.The incidence of HELLP syndrome and eclampsia increased more than fivefold in the presence of prenatal hypertension. However, the likelihood of subsequently developing DIC or experiencing critical bleeding did not change by the presence of prenatal hypertension.

Increasing daily duration of rehabilitation for inpatients with sporadic inclusion body myositis may contribute to improvement in activities of daily living: A nationwide database cohort study

To analyse the association between the daily duration of rehabilitation for inpatients with sporadic inclusion body myositis and improvement in activities of daily living, using a Japanese nationwide inpatient administrative claims database. Data were extracted regarding inpatients with sporadic inclusion body myositis who had undergone rehabilitation between 1 April 2018 and 31 March 2021. The mean daily duration of rehabilitation was categorized into 2 groups: > 1.0 h (longer rehabilitation) and ≤ 1.0 h (shorter rehabilitation). The main outcome was improvement in activities of daily living from admission to discharge, measured using the Barthel Index. For the main analysis, a generalized linear model was used. In total, 424 patients with sporadic inclusion body myositis met the eligibility criteria for inclusion in the study. The main analysis found a significant difference in improvement in activities of daily living between the longer rehabilitation and shorter rehabilitation groups after adjusting for confounders (risk ratio (95% confidence interval), 1.37 (1.06-1.78)). A longer daily duration of rehabilitation results in improved activities of daily living for inpatients with sporadic inclusion body myositis.

Incremental medical cost of delirium in elderly patients with cognitive impairment: analysis of a nationwide administrative database in Japan

ObjectivesDelirium is a neuropsychiatric disorder that commonly occurs in elderly patients with cognitive impairment. The economic burden of delirium in Japan has not been well characterised. In this study, we...

Changes in operative trends and short-term outcomes of surgery for congenital biliary dilatation in adults using real-world data: A multilevel analysis based on a nationwide administrative database in Japan.

We aimed to evaluate the operative trends and compare the short-term outcomes between open and laparoscopic surgery for congenital biliary dilatation (CBD) in adults using real-world data from Japan. Data from the Japanese Diagnosis Procedure Combination database on 941 patients undergoing surgery for CBD at 357 hospitals from April 1, 2016, to March 31, 2021, were analyzed. The patients were divided into two groups: open surgery (n=764) and laparoscopic surgery (n=177). We performed a retrospective analysis via a multilevel analysis of the short-term surgical outcomes and costs between open and laparoscopic surgery. The rate of laparoscopic surgery has been increasing annually and had almost doubled to 25% by 2021. There were no significant differences in the in-hospital mortality rate or postoperative morbidity between the two groups. The length of anesthesia was significantly longer in the laparoscopic than open surgery group (8.80 vs 6.16 hours, p < .001). The time to removal of the abdominal drain and length of hospital stay were significantly shorter in the laparoscopic than open surgery group (6.12 vs 8.35 days, p=.001 and 13.57 vs 15.79 days, p < .001, respectively). The coefficient for cost was 463 235 yen (95% confidence interval, 289 679-636 792) higher in laparoscopic than open surgery (p < .001). The short-term results were comparable between laparoscopic and open surgery for CBD. Further investigation is needed to validate our findings and long-term outcomes.

Characteristics of Japanese patients with non-dialysis-dependent chronic kidney disease initiating treatment for anemia: a retrospective real-world database study

Objective Anemia is a common complication of chronic kidney disease (CKD). The aim of this study was to evaluate hemoglobin levels at the initiation of erythropoiesis stimulating agent (ESA) therapy in patients with non-dialysis-dependent CKD (NDD-CKD) and anemia using a large-scale administrative database in Japan. Methods The longitudinal data of adult patients who initiated ESA therapy between April 2008 and December 2018 were extracted from a hospital-based administrative database. The primary outcome was hemoglobin level at the initiation of ESA therapy, whereas the exploratory outcome was hemoglobin level recorded 6 months after the onset of the ESA therapy. Results A total of 4939 patients were included in the primary analysis. The mean hemoglobin level at the initiation of ESA therapy was 9.1 g/dL, which was lower than the level (11 g/dL) recommended for the initiation of treatment by the current Japanese treatment guidelines. Moreover, 42.1% and 15.0% of the patients had hemoglobin levels <9.0 and <8.0 g/dL, respectively, at the initiation of ESA therapy. In 2964 patients for whom hemoglobin levels at 6 months after the initiation of ESA therapy were available, the mean hemoglobin level increased to 10.3 g/dL, and 61.9% and 31.1% of these patients had hemoglobin levels ≥10.0 and ≥11.0 g/dL, respectively. Conclusion This real-world database study revealed that hemoglobin levels at the initiation of ESA therapy in new users of ESA were lower than those recommended by treatment guidelines in Japan.

Association between heat exposure and hospitalization for diabetic ketoacidosis, hyperosmolar hyperglycemic state, and hypoglycemia in Japan.

An increase in extreme heat events has been reported along with global warming. Heat exposure in ambient temperature is associated with all-cause diabetes mortality and all-cause hospitalization in diabetic patients. However, the association between heat exposure and hospitalization for hyperglycemic emergencies, such as diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and hypoglycemia is unclear. The objective of our study is to clarify the impact of heat exposure on the hospitalization for DKA, HHS, and hypoglycemia. Data of daily hospitalizations for hyperglycemic emergencies (i.e., DKA or HHS) and hypoglycemia was extracted from a nationwide administrative database in Japan and linked with temperature in each prefecture in Japan during 2012-2019. We applied distributed lag non-linear model to evaluate the non-linear and lagged effects of heat exposure on hospitalization for hyperglycemic emergencies. The pooled relative risk for hyperglycemic emergencies of heat effect (the 90th percentile of temperature with reference to the 75th percentile of temperature) and extreme heat effect (the 99th percentile of temperature with reference to the 75th percentile of temperature) over 0-3 lag days was 1.27 (95%CI: 1.16-1.39) and 1.64 (95%CI: 1.38-1.93), respectively. The pooled relative risk for heat effect on hospitalization for hypoglycemia and extreme heat effect over 0-3 lag days was 1.33 (95%CI: 1.17-1.52) and 1.65 (95%CI: 1.29-2.10), respectively. These associations were consistent by type of hyperglycemic emergencies and type of diabetes and were generally consistent by regions. Heat exposure was associated with hospitalizations for DKA, HHS and hypoglycemia. These results may be useful to guide preventive actions for the risk of fatal hyperglycemic emergencies and hypoglycemia.

Cost-effectiveness analysis of trastuzumab monotherapy versus adjuvant chemotherapy plus trastuzumab in elderly patients with HER2-positive early breast cancer.

In elderly patients with human epidermal growth factor 2-positive breast cancer, adjuvant chemotherapy was associated with decreased quality of life, with relatively small benefits for prognosis. We examined the cost-effectiveness of trastuzumab monotherapy versus adjuvant chemotherapy plus trastuzumab in elderly patients with human epidermal growth factor 2-positive breast cancer. A Markov model was developed to evaluate the costs and benefits of trastuzumab monotherapy over adjuvant chemotherapy plus trastuzumab for elderly patients with human epidermal growth factor 2-positive breast cancer. We built the model with a yearly cycle over a 20-year time horizon and five health states: disease-free, relapse, post-relapse, metastasis and death. The parameters in the model were based on a previous randomized controlled trial and a nationwide administrative database in Japan. The incremental cost-effectiveness ratio, expressed as Japanese yen per the quality-adjusted life-years, was estimated from the perspective of health care payers. One-way deterministic sensitivity analysis and probabilistic sensitivity analysis with Monte-Carlo simulations of 10 000 samples were conducted. The incremental cost-effectiveness ratio of trastuzumab monotherapy over adjuvant chemotherapy plus trastuzumab was $\sim$1.8 million Japanese yen /quality-adjusted life-year. The one-way deterministic sensitivity analysis showed that transition probability from disease-free to metastasis status and cost of metastasis status had the greatest influence on the incremental cost-effectiveness ratio. More than half the estimates in the probabilistic sensitivity analysis were located below a threshold of willingness-to-pay of 5 million Japanese yen /quality-adjusted life-year. In this first comparative cost-effectiveness analysis of adjuvant chemotherapy plus trastuzumab versus trastuzumab monotherapy in the elderly, the latter was found favorable for elderly patients with human epidermal growth factor 2-positive breast cancer.

Association Between Intensive Care Unit Admission Practices and Outcomes in Patients with Isolated Traumatic Subarachnoid Hemorrhage: A Nationwide Inpatient Database Analysis in Japan.

Patients with traumatic brain injury associated with intracranial hemorrhage are commonly admitted to the intensive care unit (ICU); however, the need for ICU care for patients with isolated traumatic subarachnoid hemorrhage (tSAH) remains unclear. We aimed to investigate the association between the ICU admission practices and outcomes in patients with isolated tSAH. This observational study used a nationwide administrative database in Japan. We identified patients with isolated tSAH from the Japanese Diagnostic Procedure Combination inpatient database from July 1, 2010, to March 31, 2020. The primary outcome was in-hospital mortality, whereas the secondary outcomes were neurosurgical interventions, activities of daily living at discharge, and total hospitalization cost. We performed a risk-adjusted mixed-effect regression analysis to evaluate the association between hospital-level ICU admission rates and study outcomes. The ICU admission rates were categorized into quartiles: lowest, middle-low, middle-high, and highest. Moreover, we assessed the robustness of the results with a patient-level instrumental variable analysis. Of the 61,883 patients with isolated tSAH treated at 962 hospitals, 16,898 (27.3%) patients were admitted to the ICU on the day of admission. Overall, 2465 (4.0%) patients died in the hospital, and 783 (1.3%) patients underwent neurosurgical interventions. There was no significant difference between the lowest and highest ICU admission quartile in terms of in-hospital mortality (3.7% vs. 4.3%; adjusted odds ratio 0.93; 95% confidence interval [CI] 0.78-1.10), neurosurgical interventions, and activities of daily living at discharge. However, the total hospitalization cost in the lowest ICU admission quartile was significantly lower than that in the highest quartile (US $3032 vs. $4095; adjusted difference US $560; 95% CI 33-1087). The patient-level instrumental variable analysis did not reveal a significant difference in in-hospital mortality between the patients who were admitted to the ICU and those who were not (risk difference 0.2%; 95% CI - 0.1 to 0.5). There was no significant association between the ICU admission practices and outcomes in patients with isolated tSAH, whereas higher ICU admission rates were associated with significantly higher hospitalization costs. Our results provide an opportunity for improved health care allocation in the management of patients with isolated tSAH.

Influence of inpatient rehabilitation after crisis in patients with myasthenia gravis: A retrospective cohort study using a nationwide administrative database in Japan

BackgroundGrowing evidence indicates that carefully programmed rehabilitation can improve symptoms in patients with myasthenia gravis (MG). However, evidence on rehabilitation to aid in recovery from a myasthenic crisis is lacking. This study aimed to examine the association between inpatient rehabilitation and recovery in the activities of daily living (ADL) after a myasthenic crisis. MethodsWe retrospectively identified patients hospitalized due to myasthenic crisis in a nationwide administrative database in Japan. Patients were divided into two groups based on the intensity of rehabilitation after weaning from mechanical ventilation. We evaluated the influence of rehabilitation on recovery in the ADL by comparing the two groups in Kaplan–Meier and Cox proportional hazard model analyses. ResultsWe extracted the data of 437 cases treated from April 1, 2016 to March 31, 2020. High-intensity rehabilitation was associated with delayed recovery in the ADL on Kaplan–Meier analysis (p = 0.024, log-rank test). A similar result was obtained after adjusting for covariates in the Cox proportional hazard model analysis (hazard ratio: 0.69; 95% confidence interval: 0.48–0.99; p = 0.043). ConclusionsHigh-intensity rehabilitation performed in current inpatient settings may not contribute to recovery in the ADL after a myasthenic crisis in patients with MG. Despite this study's large sample size, further research is necessary to reach firm conclusions.

Evaluation of cholecystectomy in older individuals using real-world data: a multilevel analysis based on a nationwide administrative database in Japan.

In the present study, we aimed to evaluate the clinical outcomes of cholecystectomy in older individuals. In this retrospective study, data from the Japanese Diagnosis Procedure Combination database on 96,620 patients who had undergone cholecystectomy at 1060 hospitals from 2018 to 2020 were analyzed. Patients were divided into five age groups: < 75, 75-79, 80-84, 85-89, and ≥ 90years. Associations between postoperative outcomes and age group were investigated by logistic regression analysis. Mean differences between age groups in time to postoperative recovery and cost were also compared. Older patients had higher rates of poor scores for activities of daily living and preoperative comorbidity. Compared with the youngest age group (< 75years), the odds ratios for in-hospital mortality were 3.00 (95% confidence interval, 1.74-5.19), 7.54 (4.73-12.01), 13.47 (8.21-22.14), and 27.64 (15.56-49.09), in the 75-79, 80-84, 85-89, and ≥ 90-year-old age group, respectively (all p < 0.001). Furthermore, the length of postoperative hospital stay and rates of postoperative complications, postoperative reintubation, and reoperation with general anesthesia increased significantly in parallel with increasing age, the highest rates being in the ≥ 90year-old age group. Our real-world data highlight the worse postoperative outcomes, including a higher mortality rate, in older patients undergoing cholecystectomy. Care should be taken when considering the indications for surgery in such patients.

A new scoring system for predicting in-hospital death after lung cancer surgery (the SABCIP score) using a Japanese nationwide administrative database.

BackgroundWe aimed to develop and validate a new risk scoring tool for predicting in‐hospital mortality after lung cancer surgery.MethodsWe retrospectively identified patients admitted for lung cancer surgery from a nationwide administrative database in Japan and randomly divided them into derivation and validation cohorts. In the derivation cohort, we performed logistic regression analysis to determine predictive variables and developed a risk scoring tool by proportionally weighting the regression coefficients and assigning points to each variable. In both cohorts, we evaluated the predictive performance of the score using the c‐index and showed the in‐hospital mortality at each risk score.ResultsIn total, 64 175 patients (32 170 and 32 005 patients in the derivation and validation cohort, respectively) were enrolled, including 115 (0.4%) and 119 (0.4%) in‐hospital patient deaths in the derivation and validation cohorts, respectively. Following the multivariate regression analysis, we selected six variables to create the SABCIP score, a risk scoring tool named after the parameters on which it is based, namely male sex, age ≥ 75 years, body mass index <18.5, clinical stage ≥3, interstitial lung disease, and procedure type (sleeve resection, chest wall resection, or pneumonectomy). The c‐index of the score was 0.82 and 0.80 in the derivation and validation cohorts, respectively, which represents a better or equal discrimination performance compared with previous scoring tools. In‐hospital mortality increased as the score increased in both cohorts.ConclusionThe SABCIP score is a simple and useful predictor of in‐hospital mortality in patients after lung cancer surgery.

Recent trends in glaucoma surgery: a nationwide database study in Japan, 2011-2019.

To clarify recent trends in glaucoma surgery in Japan, including minimally invasive glaucoma surgery. Retrospective cohort study. We used the Diagnostic Procedure Combination database, a nationwide administrative database in Japan. Patients who underwent glaucoma-related procedures were included. We calculated the number of surgeries stratified by procedures and age categories. We also investigated the number of glaucoma-related procedures in combination with cataract surgery. From fiscal years 2011 to 2019, we identified 134,331 glaucoma-related procedures at 720 hospitals. The total number of glaucoma-related procedures increased by 215% from 6516 in 2011 to 20,569 in 2019. The numbers of filtering surgeries, trabeculotomies, and glaucoma drainage devices with plates [GDD(p +)] procedures significantly increased (P = 0.002, 0.002, and 0.006, respectively), whereas the number of cyclocryotherapy procedures significantly decreased (P = 0.002). The number of iStent procedures increased by 49% from 371 in 2018 to 551 in 2019. The ≥ 65year age group accounted for > 80% of the iStent procedures. In the 0 to 14year age group, trabeculotomy accounted for about 70% of the procedures, and the GDD(p +) procedure became the second most common procedure after trabeculotomy because of the decrease in filtering surgeries. Among combination surgeries, trabeculotomy was most frequently performed. The proportion of combination surgery increased, especially in trabeculotomy. The total number of glaucoma-related procedures increased throughout the observation period. Before 2017 filtering surgery was the most common procedure, whereas trabeculotomy was most common after 2018. The proportion of trabeculotomies performed in combination with cataract surgery continuously increased.

Risk factors for in‐hospital mortality in patients with advanced lung cancer with interstitial pneumonia undergoing systemic chemotherapy: A retrospective and observational study using a nationwide administrative database in Japan

BackgroundThe safety profile of systemic chemotherapy for lung cancer patients with interstitial pneumonia (IP) in clinical practice remains unclear. Using Diagnostic Procedure Combination (DPC) data from the Japanese administrative database, we investigated the mortality of hospitalized lung cancer patients with IP as they underwent a course of systemic chemotherapy nationwide.MethodsThe DPC data of patients with stage IIIB or IV lung cancer as defined by the Union for International Cancer Control Tumor‐Nodes‐Metastases 6th and 7th editions from April 2014 to March 2016 were obtained. Among those patients, only patients with concomitant IP and receiving systemic chemotherapy without radiotherapy were included.ResultsAmong 1524 included patients, 70 (4.6%) died in the hospital. Multivariate analysis revealed that low activities of daily living (ADL) scores on admission (hazard ratio [HR] 2.26, 95% confidence interval [CI] 1.24–4.12, p = 0.008) and high‐dose corticosteroid therapy following chemotherapy (HR 2.62, 95% CI 1.44–4.77, p = 0.002) were strongly associated with in‐hospital mortality. It was determined that patients possibly received high‐dose corticosteroids for IP exacerbations; these patients had a higher in‐hospital mortality rate of 67.7% (21/31 patients) and a significantly shorter median survival time of 55 days (95% CI 31–69 days, p < 0.001) than those who did not receive high‐dose corticosteroids.ConclusionAcute exacerbation of IP treated with systemic high‐dose corticosteroids is significantly associated with in‐hospital mortality, and a low ADL score on admission is a risk factor for in‐hospital mortality in lung cancer patients with IP who undergo systemic chemotherapy.

Risk of major congenital malformations associated with first-trimester exposure to propulsives: A health administrative database study in Japan.

To evaluate the risk of major congenital malformations (MCMs) associated with first-trimester exposure to propulsives with a special focus on domperidone using a large administrative database in Japan. A large claims database was used from January 2005 to August 2016. The dates of pregnancy onset and delivery were estimated using the developed algorithms. MCMs were defined according to the International Classification of Diseases, 10th revision codes. We compared the infants' risk of overall MCMs between women with or without first-trimester prescriptions of propulsives and estimated the odds ratios (ORs) with unadjusted and adjusted analyses. We also compared the risk of overall MCMs between women with domperidone prescriptions and those with other propulsive prescriptions during the first trimester. Among 38 270 women, propulsives were prescribed to 3197 women (8.4%) in the first trimester, including domperidone to 371 women (1.0%). Propulsive prescriptions in the first trimester were not significantly associated with an increased risk of overall MCMs (adjusted OR [aOR] 1.030, 95% confidence interval [CI] 0.843-1.257). Compared to the prescription of other propulsives in the first trimester, the prescription of domperidone in the first trimester was not associated with an increased risk of overall MCMs (aOR 0.724, 95% CI 0.363-1.447). The first-trimester prescription of propulsives, including domperidone, was not associated with an increased risk of overall MCMs.

Intensive care unit versus high-dependency care unit for mechanically ventilated patients with pneumonia: a nationwide comparative effectiveness study

BackgroundMany 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. MethodsThis 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. FindingsOf 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. InterpretationCritical 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. FundingThis study received funding from Ministry of Health, Labour and Welfare, Japan, and Ministry of Education, Culture, Sports, Science and Technology, Japan.

Potent Acid Suppression With Vonoprazan vs Proton Pump Inhibitors Does Not Have Higher Association With Clostridioides difficile Infection.

Proton pump inhibitors (PPIs) are associated with the onset of Clostridioides difficile infection (CDI). Although a new potassium-competitive acid blocker, vonoprazan, consistently shows a more potent acid inhibitory effect in comparison to PPIs, the risk of CDI in vonoprazan-treated patients relative to those treated with PPIs is unknown. In this retrospective case-control study, using a nationwide hospital-based administrative database in Japan, we investigated the association of the onset of CDI in patients treated with vonoprazan. A CDI case was defined as a case in which a patient was diagnosed and treated for CDI. For each CDI case, 3 non-CDI patients were extracted as controls. Information on the usage of acid suppressants in the 2 months before the onset of CDI and other confounding factors was collected. Relative associations of gastric acid suppressants with the onset of CDI were estimated. A total of 4,466 CDI cases and 13,220 of non-CDI controls were extracted. A multivariate conditional regression analysis revealed that PPI or vonoprazan use was modestly, but significantly associated with CDI (odds ratio [95% confidence interval]: PPI, 1.3 [1.2-1.4]; vonoprazan, 1.4 [1.2-1.7]). With PPI users as a reference, vonoprazan did not show a stronger association with CDI (odds ratio [95% confidence interval]: 1.07 [0.91-1.26]). We found a significant positive association between vonoprazan use and CDI; however, the magnitude of the association was not beyond that in PPI users. This is the first report on any potential adverse effects of vonoprazan.

Effects of polymyxin B hemoperfusion in patients with sepsis requiring continuous hemodiafiltration: Analysis of a nationwide administrative database in Japan.

This study investigated sepsis patients' current status with continuous hemodiafiltration (CHDF) with or without polymyxin B hemoperfusion (PMX). We identified 17 367 adult sepsis patients treated with CHDF and PMX using the Japanese diagnosis procedure combination (DPC) database from April 2016 to March 2019. More than half of the patients in this category resulted in death in the hospital, which means that patients in this group were critically ill. Among the patients who received CHDF, the 28-day survival rate of PMX-treated patients was significantly higher than that of non-treated patients, after adjusting the patient background by propensity score matching (69.5% vs. 65.4%, p< 0.0001). Furthermore, the length of hospital stay and intensive care unit stay was significantly shorter in PMX-treated patients than that of non-treated patients. These results suggest that PMX may provide benefits to patients with severe sepsis requiring CHDF.

Snowfall reduces the risk of chronic subdural hematoma onset: Analysis of an administrative database in Japan.

Background: Chronic subdural hematoma (CSDH) is a frequently observed disease in neurosurgical practice. Although first snowfall has been considered to increase the onset of CSDH, few reports have assessed the relationship between snowfall and CSDH. In this study, we aimed to investigate the relationship between CSDH onset and first snowfall events.Methods: This retrospective study was based on the Japanese Diagnosis Procedure Combination inpatient database from July 1, 2010, to March 31, 2016, and on the global observation of snowfall events in Japan obtained from the Japan Meteorological Agency. We used a binomial approximation to evaluate the average number of CSDH patients after first snowfall events compared with that before first snowfall events. We calculated the odds ratio of CSDH onset on the first snowfall.Results: We identified 8526 CSDH patients from the database. A total of 5573 (65.4%) were observed before first snowfall events, and 2953 (34.6%) after first snowfall events. The first snowfall of winter was significantly associated with a reduction in the occurrence of CSDH (odds ratio, 0.53; 95% confidence interval; 0.51–0.55). In subgroup analysis, only the first snowfall in October was not associated with reduction in the occurrence of CSDH.Conclusion: First snowfall events did not affect the onset of CSDH in Japan.