Impact of wound management strategies after revascularization for chronic limb-threatening ischemia.

OBJECTIVE: There is no established consensus or guidelines for wound management after revascularization for patients with chronic limb-threatening ischemia (CLTI) without severe infection. This study is designed to evaluate the clinical effect of the wound management strategy on toe wounds after revascularization for CLTI. METHODS: This retrospective cohort study was performed at eight institutions affiliated with Keio University School of Medicine in Japan and included 261 patients who underwent revascularization for CLTI between April 2019 and July 2021. We identified 132 patients with toe wounds from the database who had restored in-line blood flow to the foot. Patients were divided into two groups by the timing of toe resection after revascularization, which dictated the wound management policy. Group A (62 patients) underwent early toe amputation for suspected osteomyelitis, whereas group B (70 patients) underwent watchful waiting. The primary outcome was wound healing after revascularization; the secondary outcome was major amputation. We compared outcomes between groups A and B after propensity score matching. RESULTS: Using propensity score matching, each patient in group A (33 patients) was matched with a patient in group B (33 patients). Wound healing in matched group A was significantly better than that in matched group B (respectively: 1-year wound healing rate: 90.0% vs 68.2%, P < .001; median wound healing time: 65 days vs 258 days, P < .01). Although five major amputations were necessary in matched group B, none were required in matched group A (P = .05). The high rate of major amputations in group B was attributed to the sudden exacerbation of infection. Limb salvage rate in matched group A exceeded matched group B (100.0% vs 90.5%: 1-year limb salvage rate, P = .02). CONCLUSIONS: Early toe amputation for highly suspected osteomyelitis in patients with CLTI with toe wounds may expedite wound healing compared with watchful waiting, potentially avoiding unnecessary major amputation. Considering the wound management strategy is crucial when evaluating wound healing outcomes in patients with CLTI with revascularization.

Antifibrotics and mortality in idiopathic pulmonary fibrosis: external validity and avoidance of immortal time bias.

BACKGROUND AND OBJECTIVE: Pooled analyses of previous randomized controlled trials reported that antifibrotics improved survival in patients with idiopathic pulmonary fibrosis (IPF), but the results were only based on short-term outcome data from selected patients who met strict criteria. Observational studies/meta-analyses also suggested that antifibrotics improve survival, but these studies failed to control for immortal time bias that considerably exaggerates drug effects. Therefore, whether antifibrotics truly improve long-term survival in patients with IPF in the real world remains undetermined and requires external validity. METHODS: We used data from the Japanese National Claims Database to estimate the intention-to-treat effect of antifibrotics on mortality. To address immortal time bias, we employed models treating antifibrotic initiation as a time-dependent covariate and target trial emulation (TTE), both incorporating new-user designs for antifibrotics and treating lung transplantation as a competing event. RESULTS: Of 30,154 patients with IPF, 14,525 received antifibrotics. Multivariate Fine-Gray models with antifibrotic initiation as a time-dependent covariate revealed that compared with no treatment, nintedanib (adjusted hazard ratio [aHR], 0.85; 95% confidence interval [CI], 0.81-0.89) and pirfenidone (aHR, 0.89; 95% CI, 0.86-0.93) were associated with reduced mortality. The TTE model also replicated the associations of nintedanib (aHR, 0.69; 95% CI, 0.65-0.74) and pirfenidone (aHR, 0.81; 95% CI, 0.78-0.85) with reduced mortality. Subgroup analyses confirmed this association regardless of age, sex, and comorbidities, excluding certain subpopulations. CONCLUSIONS: The results of this large-scale real-world analysis support the generalizability of the association between antifibrotics and improved survival in various IPF populations.

Impact of preexisting interstitial lung disease on mortality in COVID-19 patients from the early pandemic to the delta variant epidemic: a nationwide population-based study.

BACKGROUND: COVID-19 patients with preexisting interstitial lung disease (ILD) were reported to have a high mortality rate; however, this was based on data from the early stages of the pandemic. It is uncertain how their mortality rates have changed with the emergence of new variants of concern as well as the development of COVID-19 vaccines and treatments. It is also unclear whether having ILD still poses a risk factor for mortality. As COVID-19 continues to be a major concern, further research on COVID-19 patients with preexisting ILD is necessary. METHODS: We extracted data on COVID-19 patients between January 2020-August 2021 from a Japanese nationwide insurance claims database and divided them into those with and without preexisting ILD. We investigated all-cause mortality of COVID-19 patients with preexisting ILD in wild-type-, alpha-, and delta-predominant waves, to determine whether preexisting ILD was associated with increased mortality. RESULTS: Of the 937,758 adult COVID-19 patients, 7,333 (0.8%) had preexisting ILD. The proportion of all COVID-19 patients who had preexisting ILD in the wild-type-, alpha-, and delta-predominant waves was 1.2%, 0.8%, and 0.3%, respectively, and their 60-day mortality was 16.0%, 14.6%, and 7.5%, respectively. The 60-day mortality significantly decreased from the alpha-predominant to delta-predominant waves (difference - 7.1%, 95% confidence intervals (CI) - 9.3% to - 4.9%). In multivariable analysis, preexisting ILD was independently associated with increased mortality in all waves with the wild-type-predominant, odds ratio (OR) 2.10, 95% CI 1.91-2.30, the alpha-predominant wave, OR 2.14, 95% CI 1.84-2.50, and the delta-predominant wave, OR 2.10, 95%CI 1.66-2.66. CONCLUSIONS: All-cause mortality rates for COVID-19 patients with preexisting ILD decreased from the wild-type- to the more recent delta-predominant waves. However, these patients were consistently at higher mortality risk than those without preexisting ILD. We emphasize that careful attention should be given to patients with preexisting ILD despite the change in the COVID-19 environment.

Denosumab-induced hypocalcemia in patients with solid tumors and renal dysfunction: a multicenter, retrospective, observational study.

BACKGROUND: Bone metastases are frequently observed in advanced cancer, and bone modifying agents are used to prevent or treat skeletal-related events. Zoledronic acid is contraindicated in patients with severe renal impairment (Ccr < 30 mL/min), but it is not completely known whether denosumab can be used in them. We aimed to determine the association between renal function and hypocalcemia development during denosumab treatment. METHODS: We included patients with solid cancer and bone metastases who started denosumab treatment between April 2017 and March 2019. They were classified into four groups based on creatinine clearance (Ccr; mL/min): normal (Ccr ≥ 80), mild (50 ≤ Ccr ˂80), moderate (30 ≤ Ccr ˂50), and severe (Ccr ˂30). Hypocalcemia was evaluated using the Common Terminology Criteria for Adverse Events (v5.0) based on the albumin-adjusted serum calcium levels; its incidence (stratified by renal function) and risk factors were investigated using a Chi-square test and logistic regression analysis. RESULTS: Of 524 patients (age: 69 ± 11 years; 303 men), 153 had a normal renal function and 222, 117, and 32 had mild, moderate, and severe renal dysfunction. The albumin-adjusted serum calcium level was higher than the measured (total) calcium level in most patients. The incidence of grade ≥ 1 hypocalcemia was 32.0% in the normal group and 37.4%, 29.9%, and 62.5% in the mild, moderate, and severe renal dysfunction groups, respectively. It was, therefore, higher in the severe renal dysfunction groups than in the normal group (P = 0.002). The incidence of grade ≥ 3 hypocalcemia did not differ significantly among the groups. Pre-treatment low serum calcium levels and severe renal dysfunction were risk factors for hypocalcemia. CONCLUSIONS: Evaluating denosumab-induced hypocalcemia required albumin adjustment, and its incidence was high among patients with severe renal dysfunction. Reduced serum calcium levels and severely impaired renal function were associated with an elevated hypocalcemia risk.

Risk factors for glioblastoma in adults in Japan: an exploratory cohort study based on the Shizuoka Kokuho Database, the Shizuoka study.

PURPOSE: To elucidate the risk factors associated with the onset of glioblastoma (GBM) utilizing a comprehensive administrative claims database from a major governmental district in Japan. METHODS: Using the Shizuoka Kokuho Database (SKDB) for the period from April 2012 to September 2021, we conducted a retrospective analysis of 1,465,353 participants, identifying GBM cases using specific Japanese disease codes in conjunction with associated treatments. Risk factors were assessed using both univariable and multivariable Cox proportional hazards models. RESULTS: Within the cohort, 182 participants (0.012%) received a GBM diagnosis during the study period, resulting in an incidence rate of 2.1 per 100,000 person-years. The multivariable analysis revealed that older age, male sex, and peripheral vascular disease (PVD) significantly influenced the risk of GBM onset. No clear link was found between allergic conditions and GBM risk, in contrast to some previous research. CONCLUSION: Employing a robust health insurance database, this study revealed significant associations between GBM and factors such as age, male sex, and PVD within the Japanese population. It provides key insights into GBM epidemiology and underscores the potential of health insurance databases for large-scale oncological research.

Human life expectancy and season of birth in Taiwan: A retrospective cohort study.

Prior research has indicated a correlation between the birth season and life expectancy; however, many of these studies did not sufficiently account for comorbidities. In this comprehensive investigation, we aimed to meticulously explore the association between the birth month and life expectancy, giving due consideration to comorbidities. We used a robust dataset derived from Taiwan's National Health Insurance Research Database (2000-2013), which allowed us to conduct a thorough examination. We divided our participants into four groups based on their season of birth: spring, summer, autumn, and winter. Propensity score matching was used to ensure an equitable distribution of demographic and clinical characteristics across the groups. Propensity scores were computed using logistic regression. Our model incorporated a broad range of demographic factors and comorbidities, providing rigorous adjustment for potential confounders. Our findings revealed a significantly increased risk of all-cause mortality among individuals born in spring, even after stringent adjustment for demographic factors and comorbidities. People born in spring demonstrated a 1.05-fold increase in the risk of all-cause mortality, with a hazard ratio of 1.05 and a 95% confidence interval of 1.01-1.09. Our study provides compelling evidence that helps understand the potential long-term impacts of a person's birth season, which acts as a proxy for pregnancy / early-life environmental exposure, on life expectancy. These findings underscore the crucial need for additional research to illuminate the underlying biological and environmental mechanisms linking the birth season and lifespan of a person. The elucidation of these links could guide the development of innovative health promotion and disease prevention strategies that are tailored to an individual's birth season.

Comorbidities associated with 2-year mortality in adults with cerebral palsy in Japan.

AIM: To clarify whether the Whitney Comorbidity Index (WCI) is useful in Asian adults with cerebral palsy (CP) and whether aspiration pneumonia and pressure ulcers improved the prognostic significance of the WCI. METHOD: This cohort study evaluated individuals aged at least 18 years with CP in Japan. We used Cox proportional hazards regression to analyse 2-year mortality rates. The predictive performance of the Charlson Comorbidity Index, Elixhauser Comorbidity Index, and WCI were compared as comorbidity assessment criteria. Aspiration pneumonia and pressure ulcers were added to the Cox models, and their impact on hazard ratios was determined. RESULTS: Of the 2232 adults with CP, 72 died during the 2 years. The model with a previously reported weighted WCI with aspiration pneumonia and pressure ulcers produced the best fit. Additionally, the hazard risk of 2-year mortality for an unweighted WCI score of at least 4 was 2.56; when CP-specific comorbidities were added, it increased to 8.94. INTERPRETATION: This study showed that the WCI can be used in Asian adults with CP. Furthermore, assessing patient age, aspiration pneumonia, and pressure ulcers in addition to the WCI increased the predictive value for mortality. Our findings indicate that the WCI can promote valid comparisons between international populations. WHAT THIS PAPER ADDS: The Whitney Comorbidity Index (WCI) is useful among adults with cerebral palsy, irrespective of ethnic differences. Assessment of aspiration pneumonia and pressure ulcers increased the WCI predictive value. The WCI helps identify adults with cerebral palsy at risk of adverse outcomes.

Validation of the Saga Fall Injury Risk Model.

Background: Predicting fall injuries can mitigate the sequelae of falls and potentially utilize medical resources effectively. This study aimed to externally validate the accuracy of the Saga Fall Injury Risk Model (SFIRM), consisting of six factors including age, sex, emergency transport, medical referral letter, Bedriddenness Rank, and history of falls, assessed upon admission. Methods: This was a two-center, prospective, observational study. We included inpatients aged 20 years or older in two hospitals, an acute and a chronic care hospital, from October 2018 to September 2019. The predictive performance of the model was evaluated by calculating the area under the curve (AUC), 95% confidence interval (CI), and shrinkage coefficient of the entire study population. The minimum sample size of this study was 2,235 cases. Results: A total of 3,549 patients, with a median age of 78 years, were included in the analysis, and men accounted for 47.9% of all the patients. Among these, 35 (0.99%) had fall injuries. The performance of the SFIRM, as measured by the AUC, was 0.721 (95% CI: 0.662-0.781). The observed fall incidence closely aligned with the predicted incidence calculated using the SFIRM, with a shrinkage coefficient of 0.867. Conclusions: The external validation of the SFIRM in this two-center, prospective study showed good discrimination and calibration. This model can be easily applied upon admission and is valuable for fall injury prediction.

Enhancing exercise tolerance in interstitial lung disease with high-flow nasal cannula oxygen therapy: A randomized crossover trial.

BACKGROUND AND OBJECTIVE: Interstitial lung disease (ILD) is characterized by dyspnoea on exertion and exercise-induced hypoxaemia. High-flow nasal cannula (HFNC) therapy reduces the respiratory workload through higher gas flow and oxygen supplementation, which may affect exercise tolerance. This study aimed to examine the effects of oxygen and gas flow rates through HFNC therapy on exercise tolerance in ILD patients. METHODS: We conducted three-treatment crossover study. All ILD patients performed the exercises on room air (ROOM AIR setting: flow, 0 L/min; fraction of inspired oxygen [FiO2], 0.21), HFNC (FLOW setting: flow 40 L/min, FiO2 0.21), and HFNC with oxygen supplementation (FLOW + OXYGEN setting: flow 40 L/min, FiO2 0.6). The primary endpoint was the endurance time, measured using constant-load cycle ergometry exercise testing at a peak work rate of 80%. RESULTS: Twenty-five participants (10 men, 71.2 ± 6.7 years) were enrolled. The increase in exercise duration between the ROOM AIR and FLOW was 46.3 s (95% CI, -6.1 to 98.7; p = 0.083), and the FLOW and FLOW + OXYGEN was 91.5 s (39.1-143.9; p < 0.001). The percutaneous oxygen saturation (SpO2) at rest was significantly higher with the FLOW + OXYGEN setting than with the ROOM AIR and FLOW settings, and the difference persisted during exercise. At equivalent time points during exercise, the SpO2 with the FLOW setting was significantly higher than that with the ROOM AIR setting. CONCLUSION: Oxygen supplementation in HFNC therapy improved exercise tolerance and SpO2. We found that gas flow alone did not improve exercise tolerance, but improved SpO2 during exercise.

Development of a predictive scoring system for vitamin D deficiency 'Vitamin D Deficiency Predicting Scoring (ViDDPreS)' based on the vitamin D status in young Japanese women: a nationwide cross-sectional study.

OBJECTIVE: Vitamin D deficiency (VDD) is common among young women and causes various health problems, including those that occur during pregnancy and childbirth. Thus, we investigated the risk factors for VDD in young Japanese women and developed a simple risk scoring system called Vitamin D Deficiency Predicting Scoring (ViDDPreS). DESIGN: A cross-sectional study, using the following factors for multivariate logistic regression analysis to create the ViDDPreS score: residential area, season, cumulative ambient ultraviolet-B irradiation, BMI, vitamin D supplement use, sun exposure habits, frequency of habitual food intake and eating habits. The subjects were randomly divided into development and test sets for analysis. Serum 25-hydroxivitamin D concentration of less than 20 ng/ml was defined as VDD. SETTING: Four regions (Hokkaido/Tohoku, Kanto, Chubu/Kinki/Shikoku and Kyushu/Okinawa) in Japan. PARTICIPANTS: Five hundred and eighty-three healthy women aged 18-40 years. RESULTS: In the development set, the VDD group (68·4 %) had higher proportions of the following variables than the non-VDD group: residential area outside the Kanto region; blood samples obtained in winter; low BMI (<18·5 kg/m2); vitamin D supplement non-users; short time regularly spent outside on weekdays; intake of fish, vitamin D-abundant fish, dried fish and redfish less than once a week. VDD risk was classified as low, medium or high according to the ViDDPreS scores including these contributing factors, with a test set C-index of 0·671. CONCLUSION: We identified the risk factors for VDD in young Japanese women and developed a simple risk scoring system that enables us to assess VDD risk and aid in the development of appropriate prevention and treatment strategies for this population.

Peak expiratory flow predicts the occurrence of postoperative pneumonia after esophagectomy for esophageal cancer.

Expiratory flow is an important factor in the achievement of airway clearance that is required to prevent postoperative pneumonia (POP). Although peak expiratory flow (PEF) has been shown to predict the occurrence of POP in lung cancer patients after lobectomy, its predictive power in relation to esophagectomy for esophageal cancer remains unknown. This study assesses PEF as a predictor of POP in patients with esophageal cancer undergoing radical esophagectomy. We conducted a single-center, retrospective cohort study of patients who underwent radical esophagectomy with gastric tube reconstruction at our institution between January 2007 and December 2022. Preoperative pulmonary functions, including PEF, were assessed before surgery. Additionally, POP was diagnosed as a Clavien-Dindo classification of Grade II or higher. Survival and pneumonia incidence were compared using the Kaplan-Meier method. Logistic regression analysis was used to examine the relationship between these variables and POP. The study included 513 patients, of which 441 were men. POP occurred in 86 patients (16.7%). When all patients were stratified by %PEF into two groups, the group with %PEF lower that 80% had significantly poorer prognosis and higher incidence of pneumonia. Multivariable logistic regression analysis indicated that %PEF (OR: 0.986, 95%CI: 0.974-0.999, P = 0.030), along with age, BMI, preoperative treatment, and recurrent laryngeal nerve palsy were independent protective factors against POP. These results reveal that %PEF predicts the development of POP following esophagectomy for esophageal cancer.

[Optimal search conditions for identification of patients with chronic myeloid leukemia from Japanese National Health Insurance data].

This study investigated which conditions could be used to identify patients with chronic myeloid leukemia (CML) from a National Health Insurance claims dataset. During April 2012 and September 2018, 1,789,462 employees were enrolled in the dataset for Shizuoka Prefecture residents. The number of patients with the ICD-10 code for CML was 761. Among them, 246 who had been prescribed a tyrosine kinase inhibitor were considered as having true CML. The positive predictive value was calculated as 32.3% when CML was identified by ICD-10 code alone. Combination of ICD-10 code with prescribed drugs was required to accurately identify patients with CML from the insurance database.

Systemic inflammation score as a predictor of death within one year after esophagectomy.

BACKGROUND: After radical resection for esophageal cancer, death within 1 year of surgery can occur due both to recurrence and to other diseases, even after postoperative complications have been overcome. This study identified risk factors for early death within 1 year of esophagectomy for reasons other than death in hospital in patients undergoing esophagectomy for esophageal cancer or esophagogastric junction cancer. METHODS: We reviewed 366 patients who underwent esophagectomy without adjuvant treatment between January 2009 and July 2022 for thoracic esophageal cancer or esophagogastric junction cancer. Patients who died within 1 year excluding in-hospital death were compared with those who did not. Multivariable logistic regression analysis was used to identify predictors of death within 1 year after surgery. RESULTS: Death within 1 year occurred in 32 of 366 patients, 24 from primary disease and 8 from other diseases. Deaths within 1 year were significantly older than the other cases, had significantly lower % vital capacity (%VC), and occurred significantly more often in cases in advanced stages of disease. In a multivariable analysis, a systemic inflammation score (SIS) based on serum albumin level and lymphocyte-to-monocyte ratio was identified as an independent predictor of death within 1 year. As SIS increased, %VC decreased significantly, and CRP level and neutrophil-lymphocyte ratio increased significantly. There was no relationship between SIS and pN. Death within 1 year increased as SIS increased (p = 0.001 for trend). CONCLUSION: SIS assessment undertaken before beginning esophageal cancer treatment is a useful predictor of death within 1 year of surgery.

Novel Strategy for the Management of Cervical Multicystic Diseases.

PURPOSE: To investigate the clinical practices of diagnosing multicystic cervical lesions as a means to develop a more appropriate diagnostic algorithm for gastric-type adenocarcinoma (GAS) and its precursors. METHODS: Clinical information for 159 surgically treated patients for multicystic disease of the uterine cervix was collected from 15 hospitals. We performed a central review of the MRI and pathological findings. The MRI findings were categorized into four types including two newly proposed imaging features based on the morphology and distribution of cysts, and the diagnosis accuracy was assessed. Among the four MRI types, types 1 and 2 were categorized as benign lesions that included LEGH; type 3 were precancerous lesions (with an assumption of atypical LEGH); and type 4 were malignant lesions. RESULTS: The central pathological review identified 56 cases of LEGH, seven with GAS, four with another form of carcinoma, and 92 with benign disease. In clinical practice, over-diagnosis of malignancy (suspicion of MDA) occurred for 12/19 cases (63.2%) and under-diagnosis of malignancy occurred for 4/11 (36%). Among the 118 patients who had a preoperative MRI and underwent a hysterectomy, type 3 or 4 MRI findings in conjunction with abnormal cytology were positively indicative of premalignancy or malignancy, with a sensitivity and specificity of 61.1% and 96.7%, respectively. CONCLUSIONS: Although the correct preoperative diagnosis of cervical cancer with a multicystic lesion is challenging, the combination of cytology and MRI findings creates a more appropriate diagnostic algorithm that significantly improves the diagnostic accuracy for differentiating benign disease from premalignancy and malignancy.

Risk factors, treatment and survival rates of late-onset acquired haemophilia A: A cohort study from the Shizuoka Kokuho Database.

INTRODUCTION: Acquired haemophilia A (AHA) is a rare disease. The risk factors have yet to be studied. AIM: We aimed to identify risk factors for late-onset AHA in Japan. METHODS: A population-based cohort study was conducted using data from the Shizuoka Kokuho Database. The study population was defined as individuals aged ≥60 years. Cause-specific Cox regression analysis was performed to calculate hazard ratios. RESULTS: Of 1,160,934 registrants, there were 34 patients with newly diagnosed AHA. The mean follow-up period was 5.6 years, and the incidence of AHA was 5.21 per million person-years. Myocardial infarction, diabetes mellitus, solid tumors, antimicrobial agents, phenytoin and anti-dementia drugs, which showed significant differences in the univariate analysis, were excluded from the multivariable analysis because of the small number of cases. Multivariable regression analysis showed that the presence of Alzheimer's disease (hazard ratio [HR]:4.28, 95% confidence interval [CI]:1.67-10.97) and rheumatic disease (HR:4.65, 95% CI:1.79-12.12) increased the risk of AHA development. CONCLUSION: We found that comorbid Alzheimer's disease is a risk factor of AHA incidence in the general population. Our findings provide insight into the etiology of AHA, and the proof of the coexistence of Alzheimer's disease may support the recent notion that Alzheimer disease is an autoimmune disease.

Clinical trial assessing the safety of edoxaban with concomitant chemotherapy in patients with gynecological cancer-associated thrombosis (EGCAT study).

BACKGROUND: Gynecological cancer is one of the highest risk factors for cancer-associated thrombosis (CAT). Although low-molecular-weight heparin (LMWH) is recommended as an anticoagulant for treating CAT, recent studies have shown that direct oral anticoagulants (DOACs) are an acceptable alternative. Patients with cancer require a series of chemotherapies concomitantly with DOAC administration; however, the extent to which these drugs influence DOAC blood concentrations is unknown. In this study, we measured the plasma concentration of edoxaban during chemotherapy for gynecological cancers to determine its safety. METHODS: Patients histologically diagnosed with ovarian or uterine corpus cancer and CAT were recruited after primary surgery and before the initiation of postoperative adjuvant chemotherapy, including paclitaxel. Patients were administered edoxaban (30 or 60 mg) orally for CAT. The plasma concentrations of edoxaban and active factor Xa were determined and their percentage change before and after chemotherapy was calculated. Additionally, blood coagulation tests were analyzed. RESULTS: Sixteen patients with gynecological cancer (12 with ovarian cancer and 4 with uterine corpus cancer) were enrolled. Among these, 15 samples were collected one day after chemotherapy initiation. During chemotherapy, the trough concentration of edoxaban changed from 17.6 ± 10.6 to 20.0 ± 15.6 ng/ml, and the mean percentage change in edoxaban concentration was 14.5%. Therefore, the trough concentrations of edoxaban, which represent excretion capacity, were not significantly increased by chemotherapy with paclitaxel. The area under the plasma edoxaban concentration-time curve and the active factor Xa concentration were also unaffected. CONCLUSION: Patients with CAT and ovarian or uterine corpus cancer administered edoxaban orally showed no significant increase in the trough concentration of edoxaban while undergoing chemotherapy. This suggests the safety of edoxaban use during the treatment of gynecological cancers. TRIAL REGISTRATION: EGCAT study; Japan Registry of Clinical Trials, jRCTs051190024.

Factors associated with incidence of acute kidney injury: a Japanese regional population-based cohort study, the Shizuoka study.

BACKGROUND: Acute kidney injury (AKI) is a globally critical issue. Most studies about AKI have been conducted in limited settings on perioperative or critically ill patients. As a result, there is little information about the epidemiology and risk factors of AKI in the general population. METHODS: We conducted a population-based cohort study using the Shizuoka Kokuho Database. We included subjects with records of health checkup results. The observation period for each participant was defined as from the date of insurance enrollment or April 2012, whichever occurred later, until the date of insurance withdrawal or September 2020, whichever was later. Primary outcome was AKI associated with admission based on the ICD-10 code. We described the incidence of AKI and performed a multivariate analysis using potential risk factors selected from comorbidities, medications, and health checkup results. RESULTS: Of 627,814 subjects, 8044 were diagnosed with AKI (incidence 251 per 100,000 person-years). The AKI group was older, with more males. Most comorbidities and prescribed medications were more common in the AKI group. As novel factors, statins (hazard ratio (HR) 0.84, 95% confidence interval (CI) 0.80-0.89) and physical activity habits (HR 0.79, 95% CI 0.75-0.83) were associated with reduced incidence of AKI. Other variables associated with AKI were approximately consistent with those from previous studies. CONCLUSIONS: The factors associated with AKI and the incidence of AKI in the general Japanese population are indicated. This study generates the hypothesis that statins and physical activity habits are novel protective factors for AKI.

A Simple and Accurate Model for Predicting Fall Injuries in Hospitalized Patients: Insights from a Retrospective Observational Study in Japan.

BACKGROUND While several predictive models for falls have been reported such as we reported in 2020, those for fall "injury" have been unreported. This study was designed to develop a model to predict fall injuries in adult inpatients using simple predictors available immediately after hospitalization. MATERIAL AND METHODS This was a single-center, retrospective cohort study. We enrolled inpatients aged ≥20 years admitted to an acute care hospital from April 2012 to March 2018. The variables routinely obtained in clinical practice were compared between the patients with fall injury and the patients without fall itself or fall injury. Multivariable analysis was performed using covariables available on admission. A predictive model was constructed using only variables showing significant association in prior multivariable analysis. RESULTS During hospitalization of 17 062 patients, 646 (3.8%) had falls and 113 (0.7%) had fall injuries. Multivariable analysis showed 6 variables that were significantly associated with fall injuries during hospitalization: age (P=0.001), sex (P=0.001), emergency transport (P<0.001), medical referral letter (P=0.041), history of falls (P=0.012), and abnormal bedriddenness ranks (all P≤0.001). The area under the curve of this predictive model was 0.794 and the shrinkage coefficient was 0.955 using the same data set given above. CONCLUSIONS We developed a predictive model for fall injuries during hospitalization using 6 predictors, including bedriddenness ranks from official Activities of Daily Living indicators in Japan, which were all easily available on admission. The model showed good discrimination by internal validation and promises to be a useful tool to assess the risk of fall injuries.

A single institution's experience with minimally invasive surgery for ovarian cancer, and a systematic meta-analysis of the literature.

BACKGROUND: This study assesses the feasibility of minimally invasive surgery (MIS) for well-selected epithelial ovarian cancer (EOC) patients. METHODS: We performed a review of data prospectively collected from a single center from 2017 to 2022. Only patients with histologically confirmed EOC, with a tumor diameter of less than 10 cm, were eligible. We also performed a meta-analysis of similar studies comparing the outcomes of laparoscopy and laparotomy. We used MINORS (Methodological Index for Non-Randomized Studies) to assess the risk of bias and calculated the odds ratio or mean difference. RESULTS: Eighteen patients were included; 13 in re-staging group, four in PDS group, and one in IDS group. All achieved complete cytoreduction. One case was converted to laparotomy. The median number of removed pelvic lymph nodes was 25 (range 16-34), and 32 (range 19-44) for para-aortic nodes. There were two (15.4%) intraoperative urinary tract injuries. The median follow-up was 35 months (range 1-53). Recurrence was observed in one case (7.7%). Thirteen articles for early-stage ovarian cancer were included in our meta-analysis. Analysis of the pooled results found that MIS had a higher frequency of spillage (OR, 2.15; 95% CI 1.27-3.64). No differences were observed in recurrence, complications, or up-staging. CONCLUSIONS: Our experience supports the possibility of conducting MIS for EOC in well-selected patients. Except for spillage, our meta-analysis findings are consistent with previous reports, the majority of which were also retrospective. Ultimately, randomized clinical trials will be needed to authenticate the safety.

Identification of asthma cases in Japan using health insurance claims data: Positive and negative predictive values of proposed discrimination criteria: A single-center study.

BACKGROUND: Asthma cases have been increasingly investigated using claims data. However, the validity of defining asthma cases using health insurance claims in Japan is unclear. This study aims to assess the positive and negative predictive values of our proposed discrimination criteria for asthma. METHODS: We developed discrimination criteria for asthma based on both the International Statistical Classification of Diseases and Related Health Problems (ICD)-10 disease codes for asthma and health insurance claims data for prescriptions and the treatment of asthma. Inclusion criteria were patients aged ≥16 years with at least one health insurance claim from April 2018 to March 2019 in all departments of our hospital. Physician-diagnosed asthma documented in the charts was used as the reference standard. Positive and negative predictive values of the discrimination criteria for physician-diagnosed asthma were estimated and compared with those estimated from discrimination criteria based solely on ICD-10 codes. RESULTS: The new discrimination criteria had a high positive predictive value (PPV) of 86.0%, which was significantly higher than the PPV for the criteria defined solely by the ICD-10 codes (61.5%) (P < 0.01). The negative predictive values for both criteria were 100%. Allergic rhinitis and chronic cough were frequently misclassified as asthma using the discrimination criteria based solely on ICD-10 codes but were more likely to be appropriately classified using our proposed criteria. CONCLUSIONS: Our proposed criteria adequately identified asthma subjects using health insurance claims data in Japan with a high PPV. Further studies are needed for external validation of these criteria.