Mortality, Analgesic Use, and Care Requirements After Vertebral Compression Fractures: A Retrospective Cohort Study of 18,392 Older Adult Patients.

BACKGROUND: Vertebral compression fractures (VCFs) in older adults cause considerable health and socioeconomic burdens due to worsening ability to perform activities of daily living. The long-term effects of VCFs on patient outcomes, particularly prolonged analgesic use and functional decline, remain unknown. The aims of this study were to examine long-term clinical outcomes and to determine the risk factors for persistent pain and functional disability after VCFs. METHODS: This retrospective cohort study evaluated mortality, duration of analgesic use, and changes in care requirements in older adults with VCFs using claims data from a suburban prefecture in the Greater Tokyo Area. Patients were included if they were ≥65 years of age and had been diagnosed with a VCF between June 2014 and February 2019, as determined on the basis of International Classification of Diseases, Tenth Revision (ICD-10) codes; we also used claims data that could determine whether the patients underwent imaging examinations. Patients who discontinued outpatient visits within 1 month after the VCF diagnosis were excluded. RESULTS: We included 18,392 patients with VCFs and a mean age of 80 years. Seventy-six percent of patients were women, and the median follow-up period was 670 days. At the index VCF diagnosis, 3,631 patients (19.7%) were care-dependent. Overall, 968 patients (5.3%) died within 1 year. Among the 8,375 patients who received analgesics, 22% required analgesics for >4 months. Factors associated with prolonged analgesic use for >1 year were female sex (odds ratio [OR], 1.39 [95% confidence interval (CI), 1.16 to 1.65]) and VCFs in the thoracolumbar region (OR, 1.95 [95% CI, 1.50 to 2.55]) or lumbar region (OR, 1.59 [95% CI, 1.23 to 2.04]) (the reference was the thoracic region). The care needs of 1,510 patients (8.2%) increased within 1 year. Patients with a preexisting care dependency had a 10 times higher risk of increased care need (30.2% [1,060 of 3,509]) than those who had been independent at the time of the index diagnosis (3.0% [450 of 14,761]) (p < 0.001). CONCLUSIONS: Individuals with preexisting care dependency were more likely to experience functional decline following VCFs than those who were independent, which underscores the need for intensive and appropriate allocation of health-care resources to care-dependent patients. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Comparison of locoregional recurrence risk among nipple-sparing mastectomy, skin-sparing mastectomy, and simple mastectomy in patients with ductal carcinoma in situ: a single-center study.

BACKGROUND: In invasive breast cancer, there are no differences among the mid- and long-term oncological safety results of nipple-sparing mastectomy (NSM), skin-sparing mastectomy (SSM), and simple mastectomy (SM). There are several reports comparing NSM and SSM with SM in the context of ductal carcinoma in situ (DCIS); however, the eligibility criteria vary among institutions, and there are no reports that compare all three surgical methods simultaneously within the same institution. This study aimed to compare the local recurrence and survival rates of the three techniques (NSM, SSM, and SM) in Japanese patients undergoing mastectomy for DCIS. METHODS: Patients undergoing NSM, SSM, or SM at our institution between 2006 and 2015 were identified, and their outcomes were analyzed. RESULTS: The mean follow-up period was 80.4 months (standard deviation [SD]: 37.1 months). NSM was performed in 152 cases, SSM in 49, and SM in 44. Five of 245 patients developed local recurrences. Four of these patients had invasive cancer. The primary endpoints of 5-year cumulative local recurrence were 2.4% (95% confidence interval [CI]: 0.0-5.0) for NSM, 2.2% (95% CI: 0.0-6.3) for SSM, and 0% (95% CI: 0.0-0.0) for SM. There were no significant differences among the 5-year local recurrence rates. CONCLUSIONS: In this single-center, retrospective study, the oncological safety of SSM and NSM for DCIS was comparable to that of conventional SM.

Validation of the IOTA ADNEX Model Among Japanese Women Performed by Gynecology Trainees and Ultrasound Specialists: A Retrospective Diagnostic Accuracy Study.

OBJECTIVES: This study aimed to validate the diagnostic accuracy of the International Ovarian Tumor Analysis (IOTA) Assessment of Different NEoplasias in the adneXa (ADNEX) model in Japanese women, population with a distinct adnexal mass distribution compared with European women, and to evaluate the model's utility by gynecology trainees and ultrasound specialists. METHODS: This single-center, retrospective study analyzed ultrasound data from January 2017 to March 2020 of 206 women with adnexal masses. Patients who underwent ultrasonography and serum CA-125 measurement and received postsurgery histological diagnosis were included. The ADNEX model's diagnostic performance was evaluated by two trainees and two specialists using the area under the receiver operating characteristic curve (AUC) and measures of accuracy, sensitivity, specificity, and predictive values for overall performance and each examiner. RESULTS: Of the 206 included Japanese women, the prevalence of malignancy was 30.1%, including borderline cases. The overall AUC for distinguishing malignancy was 0.848 (95% confidence interval [CI]: 0.817-0.880). The AUC for each examiner ranged from 0.791 to 0.898, with Specialist 2 showing the highest accuracy and sensitivity varying between 0.677 and 0.839. A moderate degree of agreement was noted among the four examiners (Fleiss' kappa was 0.586). The performance of trainees and specialists differed significantly in evaluating the solid tissue and the papillary projections in both malignant and benign groups (P < .001). CONCLUSIONS: The IOTA ADNEX model effectively differentiates benign and malignant adnexal masses in Japanese women. Although the accuracy matched up moderately among the four examiners, better accuracy is expected with training in evaluating solid tissue and papillary projections.

Safety of transbronchial lung cryobiopsy compared to transbronchial forceps biopsy in patients with diffuse lung disease: An observational study using a national database in Japan.

BACKGROUND: Transbronchial lung cryobiopsy (TBLC) is a new technique for obtaining high-quality and large-sized lung tissues, as compared to transbronchial forceps biopsy (TBFB), and is useful in the diagnosis of diffuse lung disease (DLD). We aimed to evaluate the safety of TBLC as compared to TBFB in DLD patients in Japan using a nationwide database. METHODS: Data were retrospectively collected from the Japanese Diagnosis Procedure Combination database from April 1, 2020 to March 31, 2022. Eligible patients (n = 9673) were divided into the following two groups: those who underwent TBFB (TBFB group, n = 8742) and TBLC (TBLC group, n = 931). To compare the outcomes between the two groups, a stabilized inverse probability of treatment weighting (IPTW) was applied using propensity scores. The primary outcome was in-hospital mortality, and the secondary outcomes were 28-day mortality, complications (mechanical ventilation, pneumothorax, and bleeding), and length of hospital stay after bronchoscopy. RESULTS: The crude in-hospital mortality rates were 3.2% and 0.9% in the TBFB and TBLC groups, respectively. The stabilized IPTW analysis showed no significant difference in the in-hospital mortality rates between the two groups; the odds ratio of the TBLC group as compared with the TBFB group was 0.73 (95% confidence interval: 0.34-1.60; p = 0.44). Moreover, the secondary outcomes did not significantly differ between the two groups. CONCLUSIONS: TBLC for DLD patients had a similar mortality and complication rates as TBFB.

Targeted vibratory therapy as a treatment for proprioceptive dysfunction: Clinical trial in older patients with chronic low back pain.

INTRODUCTION: Proprioceptive function declines with age, leading to falls, pain, and difficulties in performing activities of daily living among older adults. Although individuals with low back pain (LBP) exhibit decreased lumbosacral proprioception in various postures, the mechanism by which reduced proprioceptive function causes LBP remains uncertain. Vibratory stimulation may enhance proprioceptive function; however, its efficacy in treating LBP has not been investigated. Thus, we investigated the feasibility of improving proprioceptive function and its effect on alleviating chronic LBP in older patients through targeted vibratory therapy (TVT) administration. METHODS: This single arm designed trial included older patients aged >65 years with non-specific chronic LBP. TVT involved applying vibratory stimulation, matching the frequency of dysfunctional receptors, for 1 min daily over 14 days to activate proprioceptors; patients performed TVT three times daily at home. In cases of reduced proprioceptive function at multiple sites, TVT was aimed at the lowest frequency band value. LBP and proprioceptive function were evaluated at 2 weeks after TVT and at 2 weeks after the end of TVT in patients with declined proprioception in the trunk or lower extremities. RESULTS: Overall, 56 patients with chronic LBP were enrolled; 32 patients were recruited for treatment based on a proprioceptive dysfunction diagnosis and 24 patients were recruited with a normal diagnosis with no significant differences observed between the two sets of patients in sarcopenia-related factors and clinical proprioception-related characteristics. No patient had any adverse events. Two weeks after TVT, the numerical pain rating scale score improved to <3 points in 78.1% of patients, with 73.1% of patients achieving a score of ≤ 3 points. Proprioceptive function improved in 81.3% of cases, and engagement in activities of daily living improved significantly. CONCLUSIONS: TVT demonstrated efficacy in improving proprioception and alleviating LBP in older patients with impaired proprioceptive function without affecting non-targeted proprioceptors.

Association between Postoperative Adjuvant Vasodilator Therapy and In-Hospital Mortality for Non-Occlusive Mesenteric Ischemia: A Nationwide Observational Study.

BACKGROUND: Although several clinical guidelines recommend vasodilator therapy for non-occlusive mesenteric ischemia (NOMI) and immediate surgery when bowel necrosis is suspected, these recommendations are based on limited evidence. METHODS: In this retrospective nationwide observational study, we used information from the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2018 to identify patients with NOMI who underwent abdominal surgeries on the day of admission. We compared patients who received postoperative vasodilator therapy (vasodilator group) with those who did not (control group). Vasodilator therapy was defined as venous and/or arterial administration of papaverine and/or prostaglandin E1 within 2 days of admission. The primary outcome was in-hospital mortality. Secondary outcomes included the prevalence of additional abdominal surgery performed ≥3 days after admission and short bowel syndrome. RESULTS: We identified 928 eligible patients (149 in the vasodilator group and 779 in the control group). One-to-four propensity score matching yielded 149 and 596 patients for the vasodilator and control groups, respectively. There was no significant difference in in-hospital mortality between the groups (control vs. vasodilator, 27.5% vs. 30.9%; risk difference, 3.4%; 95% confidence interval, -4.9 to 11.6; p=0.42) and no significant difference in the prevalences of abdominal surgery, bowel resection ≥3 days after admission, and short bowel syndrome. CONCLUSIONS: Postoperative vasodilator use was not significantly associated with a reduction in in-hospital mortality or additional abdominal surgery performed ≥3 days after admission in surgically treated NOMI patients.

National trends in treatments for ectopic pregnancy in Japan from 2010 to 2020: a retrospective observational study.

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

Treatment for ectopic pregnancy includes surgical and non-surgical management. Medical treatment can be as effective as surgery in cases that meet certain criteria. Methotrexate, which is commonly employed as a medical treatment, is widely used in many countries outside Japan. However, reports on methotrexate therapy for ectopic pregnancy in Japan are limited, and the actual status of its use remains unknown. We investigated the treatment trends for ectopic pregnancy in Japan using nationwide inpatient data. The results demonstrated that surgeries increased from 79% in 2010 to 83% in 2020, while methotrexate therapy declined from 8.1% to 5.1%. Methotrexate therapy demonstrated an 84% success rate. Unlike many other countries, surgery became more prevalent while methotrexate therapy decreased for inpatients with ectopic pregnancy in Japan. The success rate of methotrexate in Japan was comparable to that in other countries. Thus, Japanese healthcare providers should consider using methotrexate therapy for appropriate cases and carefully choose the best treatment for each patient after discussing the treatment options with patients.

Normal saline versus Ringer's solution and critical-illness mortality in acute pancreatitis: a nationwide inpatient database study.

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

Reduction in the need for surgery and mortality after early administration of fibrinolytics following empyema drainage.

OBJECTIVES: Although intrapleural administration of fibrinolytics is an important treatment option for the management of empyema, the addition of fibrinolytics failed to reduce the need for surgery and mortality in previous randomized controlled trials. This study aimed to investigate the effects of administrating fibrinolytics in the early phase (within 3 days of chest tube insertion) of empyema compared with late administration or no administration. METHODS: We used the Japanese Diagnosis Procedure Combination Inpatient Database to identify patients aged ≥16 years who were hospitalized and underwent chest tube drainage for empyema. A 1:2 propensity score matching and stabilized inverse probability of treatment weighting were conducted. RESULTS: Among the 16 265 eligible patients, 3082 and 13 183 patients were categorized into the early and control group, respectively. The proportion of patients who underwent surgery was significantly lower in the early fibrinolytics group than in the control group; the odds ratio (95% confidence interval) was 0.69 (0.54-0.88) in the propensity score matching (P = 0.003) and 0.64 (0.50-0.80) in the stabilized inverse probability of treatment weighting analysis (P < 0.001). All-cause 30-day in-hospital mortality, length of hospital stay, duration of chest tube drainage, and total hospitalization costs were also more favourable in the early fibrinolytics group. CONCLUSIONS: The early administration of fibrinolytics may reduce the need for surgery and death in adult patients with empyema.

Treatment and Outcomes of 844 Cases of Pneumothorax in Heritable Connective Tissue Disorders.

BACKGROUND: Characteristics, practice patterns, and clinical outcomes of secondary spontaneous pneumothorax (SSP) with heritable connective tissue disorders (Marfan, Ehlers-Danlos, and Birt-Hogg-Dubé syndromes) are unclear. METHODS: A nationwide Japanese inpatient database that included data of 524 patients with SSP (884 hospitalizations) and 137,821 with primary spontaneous pneumothorax between July 2010 and March 2020 was used in this study. Hospitalization for SSP (n = 884) was categorized into surgical (n = 459) and nonsurgical (n = 425) groups, and the patient characteristics, treatment, and outcomes were compared between the groups. Multivariable analyses were performed to evaluate risk factors for pneumothorax recurrence. We also compared the characteristics of patients with different underlying heritable connective tissue disorders. RESULTS: Compared with the nonsurgical group, the surgical group had less frequent readmission for pneumothorax (26% vs 44%; hazard ratio, 0.47; 95% CI, 0.38-0.58). Young patients (2.46; 1.83-3.32) or those with Birt-Hogg-Dubé syndrome (2.53; 1.77-3.63) had a high risk of recurrence. Pneumothorax occurred frequently in teenagers with Marfan syndrome, in those aged 20 to 39 years with Ehlers-Danlos syndrome, and in those aged ≥40 years with Birt-Hogg-Dubé syndrome. CONCLUSIONS: Detailed information on the characteristics and clinical course of SSP in heritable connective tissue disorders will aid in the clinical decision-making process.

Hospital and regional variations in intensive care unit admission for patients with invasive mechanical ventilation.

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

Association between hospital palliative care team intervention volume and patient outcomes.

BACKGROUND: The benefits of palliative care in patients with advanced cancer are well established. However, the effect of the skills of the palliative care team (PCT) on patient outcomes remains unclear. Our aim was to evaluate the association between hospital PCT intervention volume and patient outcomes in patients with cancer. METHODS: A retrospective cohort study was conducted using a nationwide inpatient database in Japan. Patients with cancer receiving chemotherapy and PCT intervention from 2015 to 2020 were included. The outcomes were incidence of hyperactive delirium within 30 days of admission, mortality within 30 days of admission, and decline in activities of daily living (ADL) at discharge. The exposure of interest was hospital PCT intervention volume (annual number of new PCT interventions in a hospital), which was categorized into low-, intermediate-, and high-volume groups according to tertiles. Multivariate logistic regression and restricted cubic-spline regression were conducted. RESULTS: Of 29,076 patients, 1495 (5.1%), 562 (1.9%), and 3026 (10.4%) developed delirium, mortality, and decline in ADL, respectively. Compared with the low hospital PCT intervention volume group (1-103 cases/year, n = 9712), the intermediate (104-195, n = 9664) and high (196-679, n = 9700) volume groups showed significant association with lower odds ratios of 30-day delirium (odds ratio, 0.79 [95% confidence interval, 0.69-0.91] and 0.80 [0.69-0.93], respectively), 30-day mortality (0.73 [0.60-0.90] and 0.59 [0.46-0.75], respectively), and decline in ADL (0.77 [0.70-0.84] and 0.52 [0.47-0.58], respectively). CONCLUSION: Hospital PCT intervention volume is inversely associated with the odds ratios of delirium, mortality, and decline in ADL among hospitalized patients with cancer.

Interstitial Pneumonitis Following Sequential Administration of Programmed Death-1/Programmed Death-Ligand1 Inhibitors and Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors For Non-Small Cell Lung Cancer: A Matched-Pair Cohort Study Using a Nationwide Inpatient Database.

BACKGROUND: It is unclear whether the sequential administration of programmed death (PD)-1/programmed death-ligand 1 (PD-L1) inhibitors and epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is associated with the development of severe interstitial pneumonitis (IP). PATIENTS AND METHODS: We identified 69,107 eligible patients with non-small cell lung cancer (NSCLC) from a Japanese national inpatient database, who initiated EGFR-TKI therapy. The study population was divided into the PD-1/PD-L1 inhibitor and non-prior PD-1/PD-L1 groups based on PD-1/PD-L1 administration before EGFR-TKI therapy. We conducted 1:4 matched-pair cohort analyses (n = 9,725) to compare the incidence of IP and in-hospital mortality within 90 days of administration of EGFR-TKI between the two groups after adjusting for the clinical background. Furthermore, we performed subgroup analyses categorized according to the duration of prior PD-1/PD-L1 inhibitor use. RESULTS: IP occurred in 4.4% of patients in the matched-pair cohort. PD-1/PD-L1 inhibitor-use before EGFR-TKI therapy was significantly associated with IP (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.34-2.38) and in-hospital mortality (OR, 2.10; 95% CI, 1.72-2.55). Prior PD-1/PD-L1 inhibitor use in an interval of <6 months before EGFR-TKI administration was associated with a higher risk of IP than EGFR-TKI administration without prior PD-1/PD-L1 inhibitor. In-hospital mortality was higher in patients with prior PD-1/PD-L1 inhibitor use than that in those without prior PD-1/PD-L1 inhibitor use, irrespective of the treatment duration. CONCLUSION: Sequential use of PD-1/PD-L1 inhibitors and EGFR-TKIs in patients with non-small cell lung cancer was significantly associated with IP compared to EGFR-TKIs without prior PD-1/PD-L1 inhibitor administration.

Exploring the efficacy of routine antimicrobial therapy in severe fever with thrombocytopenia syndrome: Overlap weighting analysis using a nationwide inpatient database.

BACKGROUND: Severe fever with thrombocytopenia syndrome (SFTS) is an infectious disease that presents a formidable challenge due to the absence of established therapeutic strategies that are explicitly tailored to its management. This study aimed to assess the impact of routine antimicrobial therapy on patients diagnosed with SFTS in Japan. We conducted a comprehensive retrospective cohort analysis using extensive data from a national inpatient database. METHODS: This study scrutinized data from adult patients with SFTS and categorized them based on whether they received antimicrobial treatment within the initial 2 days of hospital admission. A meticulous evaluation was carried out on a range of outcomes, such as in-hospital mortality rates, overall costs associated with hospitalization, and length of hospital stay. Overlap weighting was applied along with multivariate regression models to enhance the reliability of the findings through confounder adjustment. The outcomes showed no significant improvement in the prognosis of patients with SFTS who received routine antimicrobial therapy. The use of antimicrobials did not yield statistically significant improvements in in-hospital mortality rates or other secondary outcomes, suggesting that such therapeutic interventions may not be necessary during the early stages of hospital admission. CONCLUSION: In our study, administration of antimicrobials within 2 days of admission for SFTS did not affect prognosis. The standard use of antimicrobial treatments may be an issue that should be reconsidered.

Body mass index and survival among patients with advanced biliary tract cancer: a single-institutional study with nationwide data-based validation.

BACKGROUND: Excess body weight may modulate the progression of various cancer types. The prognostic relevance of body mass index (BMI) has not been fully examined in patients with biliary tract cancer. METHODS: Using a single-institutional cohort of 360 patients receiving gemcitabine-based chemotherapy for advanced biliary tract cancer, we examined the association of BMI with overall survival (OS). Using the Cox regression model with adjustment for potential confounders, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for OS according to BMI. The findings were validated using a Japanese nationwide inpatient database including 8324 patients treated at 201 hospitals. RESULTS: In the clinical cohort, BMI was not associated with OS (Ptrend = 0.34). Compared to patients with BMI = 18.5-24.9 kg/m2, patients with BMI < 18.5 kg/m2 and ≥ 25.0 kg/m2 had adjusted HRs for OS of 1.06 (95% CI, 0.78-1.45) and 1.01 (95% CI, 0.74-1.39), respectively. There was no evidence on a non-linear relationship between BMI and OS (Pnonlinearity = 0.63). In the nationwide cohort, the null findings were validated (Ptrend = 0.18) with adjusted HRs of 1.07 (95% CI, 0.98-1.18) for BMI < 18.5 kg/m2 and 1.05 (95% CI, 0.96-1.14) for BMI ≥ 25.0 kg/m2 (vs. BMI = 18.5-24.9 kg/m2). In the clinical cohort, BMI was not associated with progression-free survival (Ptrend = 0.81). CONCLUSIONS: BMI was not associated with survival outcomes of patients with advanced biliary tract cancer. Further research is warranted incorporating more detailed body composition metrics to explore the prognostic role of adiposity in biliary tract cancer.

Association of Novel Antihyperglycemic Drugs Versus Metformin With a Decrease in Asthma Exacerbations.

BACKGROUND: Similar to metformin, dipeptidyl peptidase-4 inhibitors (DPP-4 Is), glucagon-like peptidase 1 receptor agonists (GLP-1 RAs), and sodium glucose co-transporter-2 inhibitors (SGLT-2 Is) may improve control of asthma owing to their multiple potential mechanisms, including differential improvements in glycemic control, direct anti-inflammatory effects, and systemic changes in metabolism. OBJECTIVE: To investigate whether these novel antihyperglycemic drugs were associated with fewer asthma exacerbations compared with metformin in patients with asthma comorbid with type 2 diabetes. METHODS: Using a Japanese national administrative database, we constructed 3 active comparators-new user cohorts of 137,173 patients with a history of asthma starting the novel antihyperglycemic drugs and metformin between 2014 and 2022. Patient characteristics were balanced using overlap propensity score weighting. The primary outcome was the first exacerbation requiring systemic corticosteroids, and the secondary outcomes included the number of exacerbations requiring systemic corticosteroids. RESULTS: DPP-4 Is and GLP-1 RAs were associated with a higher incidence of exacerbations requiring systemic corticosteroids compared with metformin (DPP-4 Is: 18.2 vs 17.4 per 100 person-years, hazard ratio: 1.09, 95% confidence interval [CI]: 1.05-1.14; GLP-1 RAs: 24.9 vs 19.0 per 100 person-years, hazard ratio: 1.14, 95% CI: 1.01-1.28). In contrast, the incidence of exacerbations requiring systemic corticosteroids was similar between the SGLT-2 Is and metformin groups (17.3 vs 18.1 per 100 person-years, hazard ratio: 1.00, 95% CI: 0.97-1.03). While DPP-4 Is and GLP-1 RAs were associated with more exacerbations requiring systemic corticosteroids, SGLT-2 Is were associated with slightly fewer exacerbations requiring systemic corticosteroids (53.7 vs 56.6 per 100 person-years, rate ratio: 0.95, 95% CI: 0.91-0.99). CONCLUSIONS: While DPP-4 Is and GLP-1 RAs were associated with poorer control of asthma compared with metformin, SGLT-2 Is offered asthma control comparable to that of metformin.

Successful Management With Continuous Negative Abdominal Pressure Therapy in a Severely Obese Patient With Inhalation Burn-Induced Severe Respiratory Failure Requiring Veno-Venous Extracorporeal Membrane Oxygenation: A Case Report.

Continuous negative abdominal pressure (CNAP) therapy effectively provides respiratory support in patients with respiratory failure and severe obesity; however, its use in clinical practice remains limited. In this case, we report a significant improvement in the respiratory condition of a patient with severe obesity and inhalation burns following the application of CNAP in addition to venovenous extracorporeal membrane oxygenation (V-V ECMO) and mechanical ventilation. The patient was able to wean off these devices successfully. This case highlights the potential of CNAP therapy as an adjunct treatment for severe respiratory failure, particularly in obese patients for whom conventional interventions are insufficient.

Current Clinical Practice of Laboratory Testing of the Hemostasis and Coagulation System in Patients with Sepsis: A Nationwide Observational Study in Japan.

Introduction: The clinical benefit of hemostasis molecular indicators such as thrombin-antithrombin complex (TAT), soluble fibrin (SF), and prothrombin fragment 1 + 2 (F1+2) for the diagnosis of disseminated intravascular coagulation (DIC) is reported. Recently, novel DIC diagnostic criteria that adopt them were proposed in Japan. Despite the theoretical understanding of their function, the practical use of these markers remains unclear. The present study aimed to provide a descriptive overview of current clinical practice regarding the measurement of hemostasis markers in sepsis management in Japan. Methods: This retrospective observational analysis used the Japanese Diagnosis Procedure Combination inpatient database containing data from more than 1500 acute-care hospitals in Japan. We identified adult patients hospitalized for sepsis between April 2018 and March 2021. Descriptive statistics for measuring several hemostasis laboratory markers were summarized using patient disease characteristics, hospital characteristic, and geographical location. Results: This study included 153,474 adult sepsis patients. Crude in-hospital mortality was 30.0%. Frequency of measurement of fibrinogen, fibrin degradation products (FDP), and D-dimer in sepsis patients on admission was 43.2%, 36.1%, and 46.4%, respectively. Novel and specific hemostasis molecular markers such as TAT, SF, and F1+2 were seldom measured (1.9%, 1.7%, and 0.02%, respectively). Hemostasis molecular markers were more frequently measured with progression of thrombocytopenia. Measurement of these clinically favorite hemostasis markers was influenced not only by disease characteristics but also hospital characteristic or geographical location. Conclusions: Hemostasis molecular markers such as TAT, SF, and F1+2 were rarely measured in clinical settings. Although adopted by several DIC scoring systems, neither fibrinogen, FDP, nor D-dimer was routinely measured.

Safety of pyrazinamide in elderly patients with tuberculosis in Japan: A nationwide cohort study.

BACKGROUND AND OBJECTIVE: Pyrazinamide (PZA) is the standard first-line treatment for tuberculosis (TB); however, its safety in elderly patients has not been thoroughly investigated. METHODS: This retrospective study used data from the Japanese Diagnosis Procedure Combination inpatient database. We identified patients who were admitted for TB between July 2010 and March 2022. Patients were categorized into HRE (isoniazid, rifampicin and ethambutol) and HREZ (isoniazid, rifampicin, ethambutol and PZA) groups. Primary outcomes included in-hospital mortality and overall adverse events (characterized by a composite of hepatotoxicity, gout attack, allergic reactions and gastrointestinal intolerance). Secondary outcomes included the length of hospital stay, 90-day readmission and use of drugs related to the primary outcome adverse events. Data were analysed using propensity score matching; we also conducted a subgroup analysis for those aged ≥75 years. RESULTS: Among 19,930 eligible patients, 8924 received HRE and 11,006 received HREZ. Propensity score matching created 3578 matched pairs with a mean age of approximately 80 years. Compared with the HRE group, the HREZ group demonstrated a higher proportion of overall adverse events (3.1% vs. 4.7%; p < 0.001), allergic reactions (1.4% vs. 2.5%; p < 0.001) and antihistamine use (21.9% vs. 27.6%; p < 0.001). No significant differences were observed regarding in-hospital mortality, hepatotoxicity or length of hospital stay between the groups. Subgroup analysis for those aged ≥75 years showed consistent results. CONCLUSION: Medical practitioners may consider adding PZA to an initial treatment regimen even in elderly patients with TB.