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Abstract Aim We evaluated the morbidity and mortality associated with liver surgery in Japan and developed a risk model for liver resection using information from a national database. Methods We retrospectively reviewed 73 861 Japanese patients who underwent hepatectomy between 2014 and 2019, using information from the National Clinical Database (NCD) registrations. The primary endpoints were 30 days and in‐hospital mortality, and the secondary endpoints were postoperative complications. Logistic regression risk models for postoperative morbidity and mortality after hepatectomy were constructed based on preoperative clinical parameters and types of liver resection, and validated using a bootstrapping method. Results The 30‐day and in‐hospital mortality rates were 0.9% and 1.7%, respectively. Trisectionectomy, hepatectomy for gallbladder cancer, hepatectomy for perihilar cholangiocarcinoma, and poor activities of daily living were statistically significant risk factors with high odds ratios for both postoperative morbidity and mortality. Internal validations indicated that the c‐indices for 30‐day and in‐hospital mortality were 0.824 and 0.839, respectively. Conclusions We developed a risk model for liver resection by using a national surgical database that can predict morbidity and mortality based on preoperative factors.

Abstract Aim The existing predictive risk models for the surgical outcome of acute diffused peritonitis (ADP) need renovation by adding relevant variables such as ADP's definition or causative etiology to pursue outstanding data collection reflecting the real world. We aimed to revise the risk models predicting mortality and morbidities of ADP using the latest Japanese Nationwide Clinical Database (NCD) variable set. Methods Clinical dataset of ADP patients who underwent surgery, and registered in the NCD between 2016 and 2019, were used to develop a risk model for surgical outcomes. The primary outcome was perioperative mortality. Results After data cleanup, 45 379 surgical cases for ADP were derived for analysis. The perioperative and 30‐day mortality were 10.6% and 7.2%, respectively. The prediction models have been created for the mortality and 10 morbidities associated with the mortality. The top five relevant predictors for perioperative mortality were age >80, advanced cancer with multiple metastases, platelet count of

Abstract Background Anemia has negative effects on long‐term outcomes of rectal cancer patients; however, its status as a risk factor for severe complications is disputed. Perioperative risks may differ based on the severity of pre‐surgical anemia; nonetheless, no previous study has investigated these differences. This study identified risks of severe postoperative complications in rectal cancer patients based on severity of their pre‐surgical anemia. Materials and Methods This study enrolled patients who underwent low anterior resection for rectal cancer and were registered in the Japanese National Clinical Database (NCD) between 2017 and 2019. Anemia severity was categorized into three levels: mild, moderate, and severe. A logistic regression model was applied to calculate the risk‐adjusted odds ratio (OR) of severe complications after surgery. Results This study analyzed a cohort of 51 765 rectal cancer patients who underwent low anterior resection. Results showed that severe complications occurred in 10.9% of patients and were significantly more frequent in patients with anemia (13.6%) than those with normal hemoglobin levels (9.2%). Risk‐adjusted ORs of severe complications in the severe, moderate, and mild anemia groups versus the normal group for males were 1.19 (95% confidence interval [CI]: 0.89–1.58), 1.47 (1.34–1.62), and 1.21 (1.12–1.31), respectively. Those for females were 1.39 (0.90–2.15), 1.64 (1.37–1.97), and 1.36 (1.16–1.58), respectively. Conclusions According to this large cohort study, pre‐surgical anemia significantly increases the risk of severe postoperative complications in rectal cancer patients. Even mild anemia presents a significant risk.

Objectives: This study aims to investigate the factors influencing parental willingness in COVID-19 vaccination for children in Japan in light of the introduction of pediatric vaccines. Methods: An online survey was conducted in February 2022, coinciding with the imminent start of pediatric COVID-19 vaccinations in Japan. It assessed attitudes toward vaccine uptake and included questions about health-related attributes, psychological considerations, and sources of COVID-19 information. Data from 2,419 respondents who had children under the age of 12 were analyzed using multinomial logistic regression to identify factors associated with parental willingness towards COVID-19 vaccination for children. The outcomes were “agree” (in favor of vaccination), “not sure” (undecided), with “disagree” (against vaccination) as the reference category. Results: Among participants supportive of vaccination (“agree” compared to the “disagree” reference), salient determinants included: gender (Men in reference to women: odds ratio [OR] 1.54; 95 % confidence interval [CI] 1.11–2.15), highest educational level (Junior College/Vocational in reference to under high school: OR 0.61; 95 % CI 0.40–0.93, Bachelor’s /Master’s/Doctoral degree in reference to under high school: OR 0.59; 95 % CI 0.42–0.84), perception of benefits of COVID-19 vaccination (Significant in reference to Insignificant: OR 2.04; 95 % CI 1.26–3.28), perception of risks of COVID-19 vaccination (Significant in reference to Insignificant: OR 0.28; 95 % CI 0.19–0.42, Neutral in reference to Insignificant: OR 0.48; 95 % CI 0.33–0.71), the number of referenced information sources utilized for COVID-19 was associated with attitudes towards children’s vaccination (OR 1.02; 95 % CI 1.00–1.04). Conclusion: The study highlights the multifaceted factors influencing parents’ COVID-19 vaccination attitudes for their children, encompassing socioeconomic, health, psychological, and informational aspects. Factors like cautious information gathering, vaccine concerns and diverse referenced information sources impact willingness. To facilitate informed decision-making, essential measures include government risk communication, widespread vaccine information dissemination, and enhancing parents’ health information accessibility and evaluation skills are important.

Abstract Aim We explored institutional factors in Japan associated with lower operative mortality and failure‐to‐rescue (FTR) rates for eight major gastrointestinal procedures. Methods A 22‐item online questionnaire was sent to 2119 institutional departments (IDs) to examine the association between institutional factors and operative mortality and FTR rates. IDs were classified according to the number of annual surgeries, board certification status, and locality. In addition, the top 20% and bottom 20% of IDs were identified based on FTR rates and matched with the results of the questionnaire survey. Factors associated with operative mortality were selected by multivariate analysis. Results Of the 1083 IDs that responded to the questionnaire, 568 (213 382 patients) were included in the analysis. Operative morbidity, operative mortality, and FTR rates in the top 20% and bottom 20% of IDs were 13.1% and 8.4% (p

Abstract Aim The Coronavirus Disease 2019 (COVID‐19) pandemic affected the allocation of various medical resources to several areas, including intensive care units (ICUs). However, currently, its impact on the short‐term postoperative outcomes of gastrointestinal cancer surgeries remains unclear. We aimed to evaluate the impact of the pandemic on the incidence of complications occurring after low anterior resection in patients with rectal cancer in Japan. Methods Data from the Japanese National Clinical Database between 2018 and 2021 were retrospectively examined. The primary outcome of the study was the postoperative morbidity and mortality rates before and after COVID‐19 pandemic. Moreover, the postoperative ICU admission rate was assessed. Morbidity and mortality rates were also assessed using a standardized morbidity/mortality ratio (SMR, the ratio of the actual number of incidences to the expected number of incidences calculated by the risk calculator). Results This study included 74 181 patients, including 43 663 (58.9%) from COVID‐19 epidemic areas. The mean actual incidences of anastomotic leakage (AL) and pneumonia during the study period were 9.2% and 0.9%, respectively. The SMRs of these complications did not increase during the pandemic but those of AL declined gradually. The mean 30‐day mortality and operative mortality rates were 0.3% and 0.5%, respectively. Moreover, SMRs did not change significantly in the pandemic or regional epidemic status. The ICU admission rate temporarily decreased, especially in the epidemic areas. Conclusion Although the pandemic temporarily decreased the ICU admission rate, its impact on short‐term outcomes following low anterior resection in patients with rectal cancer was insignificant in Japan.

Abstract Background The coronavirus disease 2019 (COVID‐19) pandemic had resulted in either failure to provide required medical resources or delayed treatment for gastric cancer patients. This study aimed to investigate the impact of COVID‐19 on the incidence of postoperative complications using a nationwide Japanese database of patients undergoing distal gastrectomy for gastric cancer. Methods We collected the data of patients who underwent distal gastrectomy from January 2018 to December 2021 from the National Clinical Database (NCD), a web‐based surgical registration system in Japan. The number of surgical cases, the use of intensive care units, and the incidence of morbidity per month were analyzed. We also calculated the standardized mortality ratio (SMR), defined as the ratio of the number of observed patients to the expected number of patients calculated using the risk calculator established in the NCD, for several morbidities, including pneumonia, sepsis, 30‐day mortality, and surgical mortality. Results A decrease of 568 gastrectomies was observed from April 2020 to May 2020. Although the absolute number of patients admitted to intensive care units had declined since 2020, the proportion of patients admitted to the ICU did not change before and after the pandemic. Mortality and critical morbidity (such as pneumonia and sepsis) rates were not worse during the pandemic compared to pre‐pandemic periods per the SMR. Conclusions Surgical management was conducted adequately through the organized efforts of the entire surgery department in our country even in a pandemic during which medical resources and staff may have been limited.

Abstract Aim This study aimed to evaluate the impact of the coronavirus disease (COVID‐19) pandemic on elective endoscopic surgeries in Japan using the National Clinical Database. Methods We retrospectively analyzed the clinicopathological factors and surgical outcomes of laparoscopic cholecystectomy (LC), laparoscopic distal gastrectomy (LDG), and laparoscopic low anterior resection (LLAR) and compared the monthly numbers of each procedure performed in 2020 with those in 2018 and 2019. The degree of infection in prefectures was classified into low and high groups. Results In 2020, the number of LCs (except for acute cholecystitis) was 76 079 (93.0% of that in 2019), the number of LDGs was 14 271 (85.9% of that in 2019), and the number of LLARs was 19 570 (88.1% of that in 2019). Although the number of robot‐assisted LDG and LLAR cases increased in 2020, the growth rate was mild compared with that in 2019. There was little difference in the number of cases in the degree of infection in the prefectures. The numbers of LC, LDG, and LLAR cases decreased from May to June and recovered gradually. In late 2020, the proportion of T4 and N2 cases of gastric cancer and the number of T4 cases of rectal cancer increased compared with those in 2019. There was little difference between the proportions of postoperative complications and mortality in the three procedures between 2019 and 2020. Conclusion The number of endoscopic surgeries decreased in 2020 as a result of the COVID‐19 pandemic. However, the procedures were performed safely in Japan.

The increasing burden of lifestyle-related diseases highlights the need to address unhealthy dietary habits. This study aims to explore the latest dietary patterns in Japan following the COVID-19 pandemic, focusing on trends in health-promoting food choices. A web-based survey was conducted among 27,154 Japanese adults, selected via quota sampling to mirror national demographics. The study evaluated dietary diversity, measured through the Dietary Variety Score (Outcome 1), and the prioritization of nutritional and health considerations in food selection, assessed via a Likert scale (Outcome 2). Uniform Manifold Approximation and Projection (UMAP) and Ordering Points To Identify the Clustering Structure (OPTICS) algorithms were used to delineate patterns in health-centric food selections. OPTICS clustering revealed four distinct clusters for each outcome. Cluster 3, with a diverse diet, comprised older, predominantly female individuals with higher well-being and lower social isolation compared to Cluster 4, which lacked distinct dietary patterns. Cluster 3 also engaged more in snacking, treat foods, home cooking, and frozen meals. Similarly, a divide emerged between those prioritizing dietary considerations (Cluster C) and those indifferent to such aspects (Cluster D). The findings underscore the need for holistic post-COVID-19 public health initiatives addressing socioeconomic and cultural barriers to healthier dietary practices.

Abstract Aim This study aimed to investigate the effect of the coronavirus disease pandemic on the number of surgeries for gastroenterological cancer cases in Japan. Methods The data recorded in the National Clinical Database of Japan between 2018 and 2020 were utilized for this study. Five specific surgeries for primary cancers and surgery for acute diffuse peritonitis were considered the primary endpoints. We divided the study period into the prepandemic and postpandemic (after April 2020) periods and examined the number of surgeries in relation to clinical factors. Results Overall, 228 860 surgeries were analyzed. Among the five primary cancer surgeries, the number of distal gastrectomies for gastric cancer decreased the most (to 81.0% of the monthly number in the prepandemic period), followed by that of low anterior resections for rectal cancer (91.4%). In contrast, the number of pancreaticoduodenectomies for pancreatic cancer increased by 7.1%, while that of surgeries for peritonitis remained stable. This trend was observed nationwide. We also noted a marked reduction in the number of distal gastrectomy (to 72.5%), low anterior resection (84.0%), and esophagectomy (88.8%) procedures for T1 tumors. The noncurative resection rate and mortalities were low despite the increased proportion of T4 tumors and older patients. Conclusion A marked reduction in surgeries for gastric and rectal cancers with early T factors may reflect prioritization of surgeries and reduction in cancer screenings. Although the quality of the surgery was maintained in terms of reduced mortalities and morbidities, the long‐term effects of this pandemic should be monitored.

Abstract Aim The National Clinical Database (NCD) of Japan is a nationwide data entry system for surgery, and it marked its 10th anniversary in 2020. The aim was to present the 2020 annual report of gastroenterological surgery of the NCD. Methods The data of the surgical procedures stipulated by the training curriculum for board‐certified surgeons of the Japanese Society of Gastroenterological Surgery in the NCD from 2011 to 2020 were summarized. Results In total, 5 622 845 cases, including 593 088 cases in 2020, were extracted from the NCD. The total number of gastroenterological surgeries increased gradually in these 10 years, except for the year 2020 due to the COVID‐19 pandemic. The annual number of surgeries of each organ, except the pancreas and liver, decreased by 0.4%–13.1% in 2020 compared to 2019. The surgical patients were consistently aging, with more than 20% of all gastroenterological surgeries in 2020 involving patients aged 80 years or older. The participation of board‐certified surgeons increased for each organ (75.9%–95.7% in 2020). The rates of endoscopic surgery also increased constantly. Although the incidences of postoperative complications of each organ increased by 0.7%–7.9% in these 10 years, postoperative mortality rates decreased by 0.2%–1.5%. Conclusions We present here the short‐term outcomes of each gastroenterological operative procedure in 2020. This review of the 10‐years of NCD data of gastroenterological surgery revealed a consistent increase of the number of surgeries (except for in 2020), especially endoscopic procedures, and aging of the Japanese population. The good safety of Japanese gastroenterological surgeries was also indicated.

BackgroundSelf-tracking smartphone apps have emerged as promising tools to encourage healthy behaviors. In this longitudinal study, we used gym use data from members of a major fitness club that operates gyms throughout Japan from January 2014 to December 2019. ObjectiveOur objective was to assess the extent to which a health and fitness self-tracking mobile app introduced to gym members on January 1, 2018, contributed to their weight loss. The app allows users to input information regarding diet, sleep, weight, and gym exercise so that they can receive personalized feedback from an artificial intelligence chatbot to improve their health behaviors. MethodsWe used linear regression to quantify the association between app use and weight loss. The primary outcome of the study was the weight loss achieved by each gym user, which was calculated as the difference between their initial and final weights in kilograms, as recorded in the app. Individuals who did not attend the gym or failed to use the mobile app at least twice during the study period were excluded from the analysis. The model accounted for age, gender, distance between the gym and the member’s residence, average weekly number of times a member used the gym, user’s gym membership length in weeks, average weekly number of times a member input information into the app, and the number of weeks that the app was used at least once. ResultsData from 26,589 participants were analyzed. Statistically significant associations were detected between weight loss and 2 metrics related to app use: the average weekly frequency of use and the total number of weeks in which the app was used at least once. One input per week was found to be associated with a loss of 62.1 (95% CI 53.8-70.5) g, and 1 week of app use was associated with 21.7 (95% CI 20.5-22.9) g of weight loss from the day of the first input to that of the final input to the app. Furthermore, the average number of times that a member used the gym weekly was also shown to be statistically significantly associated with weight loss: 1 use per week was associated with 255.5 (95% CI 228.5-282.6) g of weight loss. ConclusionsThis empirical study demonstrated a significant association between weight loss among gym members and not only the frequency of weekly gym use but also the use of a health and fitness self-tracking app. However, further work is needed to examine the mechanisms through which mobile apps affect health behaviors and to identify the specific app features that are most effective in promoting weight loss.

Abstract Aim The National Health Insurance system has reimbursed robotic gastrointestinal surgery since April 2018 in Japan. Additionally, strict facility and surgeon standards were established by the government and the academic society. This study aimed to evaluate the prevalence and safety of robotic surgery using a Japanese nationwide web‐based database. Methods Patients who underwent the following robotic surgeries for malignant tumors in 2018 were included: esophagectomy (RE), total gastrectomy (RTG), distal gastrectomy (RDG), proximal gastrectomy (RPG), low anterior resection (RLAR), and rectal resections other than RLAR (RRR). The number of cases and surgical mortality rates each month were calculated to evaluate the prevalence and safety of robotic procedures. Results A total of 3281 patients underwent robotic gastrointestinal surgery. The monthly number of robotic surgeries nearly doubled in April 2018 when they were initially reimbursed by the National Health Insurance system. Operative mortality rates were 0.9%, 0.4%, 0.2%, and 2.8% for RE (n = 330), RTG (n = 239), RDG (n = 1167), and RPG (n = 109), respectively. No mortality was observed in RLAR (n = 1062) or RRR (n = 374). Conclusion Robotic surgery for gastrointestinal malignant tumors was safely introduced into daily clinical practice along with rigorous surgeon and facility standards in Japan.

Background: Increases in human mobility have been linked to rises in novel coronavirus disease 2019 (COVID-19) transmission. The pandemic era in Japan has been characterized by changes in inter-prefectural mobility across state of emergency (SOE) declarations and travel campaigns, but they have yet to be characterized. Methods: Using Yahoo Japan mobility data extracted from the smartphones of more than 10 million Japanese residents, we calculated the monthly number of inter-prefectural travel instances, stratified by residential prefecture and destination prefecture. We then used this adjacency matrix to calculate two network connectedness metrics, closeness centrality and effective distance, that reliably predict disease transmission. Results: Inter-prefectural mobility and network connectedness decreased most considerably during the first SOE, but this decrease dampened with each successive SOE. Mobility and network connectedness increased during the Go To Travel campaign. Travel volume between distant prefectures decreased more than travel between prefectures with geographic proximity. Closeness centrality was found to be negatively correlated with the rate of COVID-19 infection across prefectures, with the strength of this association increasing in tandem with the infection rate. Changes in effective distance were more visible among geographically isolated prefectures (Hokkaido and Okinawa) than among metropolitan, central prefectures (Tokyo, Aichi, Osaka, and Fukuoka). Conclusion: The magnitude of reductions in human mobility decreased with each subsequent state of emergency, consistent with pandemic fatigue. The association between network connectedness and rates of COVID-19 infection remained visible throughout the entirety of the pandemic period, suggesting that inter-prefectural mobility may have contributed to disease spread.

Abstract Background The risk of choking increases with aging, and the number of cases of choking-induced cardiac arrest is increasing. However, few studies have examined the prognosis of choking-induced cardiac arrest. The aim of this study was to reveal the rates of survival and dependence on devices in the long term after choking-induced cardiac arrest. Methods We analyzed data from the Shizuoka Kokuho Database, which consists of claims data of approximately 2.2 million people, from April 2012 to September 2018. We selected patients with choking-induced cardiac arrest who received cardiopulmonary resuscitation in the hospital. Patients were excluded if they were less than 20 years old, had an upper airway tumor, received ventilation assistance, or received enteral nutrition in the month prior to cardiac arrest. The primary outcome was death, and the secondary outcomes were the rates of survival at 3-months and independence on devices. Descriptive statistics are presented and compared among age groups (20–64 years, 65–74 years, 75–84 years, 85 years and older), and survival time analysis (Kaplan-Meier method) was performed. Results In total, 268 patients were analyzed, including 26 patients in the 20–64 age group, 33 patients in the 65–74 age group, 70 patients in the 75–84 age group, and 139 patients in the ≥85 age group. The overall 3-month survival rate was 5.6% (15/268). The 3-month survival rates were 3.8% (1/26) in the 20–64 age group, 15.2% (5/33) in the 65–74 age group, 8.6% (6/70) in the 75–84 age group, and 2.2% (3/139) in the ≥85 age group. The overall 12-month survival rate was 2.6% (7/268). Of the 7 patients who survived for 12 months, 3 received ventilation management and 5 received tube or intravenous feedings at 3 months. These survivors were still receiving ventilation assistance and tube feedings in the hospital and had not been discharged at 12 months. Conclusions The prognosis of choking-induced cardiac arrest was extremely poor when patients were not resuscitated before hospital arrival. Those who survived were mostly dependent on assistive devices. Additionally, none of the survivors dependent on assistive devices had discontinued the use of the devices at the long-term follow-up.

Abstract Background Elective laparoscopic surgery is now widely accepted in the treatment of abdominal diseases because of its minimal invasiveness and rapid postoperative recovery. It is also used in the emergency setting for the diagnosis and treatment of acute diffuse peritonitis regardless of the causative disease. However, the value of laparoscopy in acute diffuse peritonitis remains unclear. In this study we aimed to show trends in the use of laparoscopy over time and compare the real‐world performance of laparoscopic surgery with that of open surgery for acute diffuse peritonitis due to gastrointestinal perforation. Methods We extracted data from the National Clinical Database, a nationwide surgery registration system in Japan, for patients with a diagnosis of acute diffuse peritonitis due to gastroduodenal or colorectal perforation between 2016 and 2019. Trends in the use of laparoscopy over time were identified. Patient characteristics, laboratory findings, surgical findings, and postoperative complications were compared between laparoscopic surgery and open surgery. Results Patients in poor condition and those with abnormal laboratory findings tended to undergo open surgery. Anesthesia time and operating time were longer for laparoscopic surgery in patients with gastroduodenal perforation but shorter in those with colorectal perforation. Fewer complications occurred in patients who underwent laparoscopic surgery. The number of institutions where laparoscopic surgery was performed and the proportion of the use of laparoscopy at each institution increased over time. Conclusion The use of laparoscopy is becoming common in surgery for acute diffuse peritonitis due to gastrointestinal perforation. This approach may be a useful option for acute diffuse peritonitis.

In developing a formula for manual use in clinical settings, simplicity is as important as accuracy. Whole-liver (WL) mass is often estimated using demographic and anthropometric information to calculate the standard liver volume or recommended graft volume in liver transplantation. Multiple formulas for estimating WL mass have been reported, including those with multiple independent variables. However, it is unknown whether multivariable models lead to clinically meaningful improvements in accuracy over univariable models. Our goal was to quantitatively define clinically meaningful improvements in accuracy, which justifies an additional independent variable, and to identify an estimation formula for WL graft weight that best balances accuracy and simplicity given the criterion. From the Japanese Liver Transplantation Society registry, which contains data on all liver transplant cases in Japan, 129 WL donor-graft pairs were extracted. Among the candidate models, those with the smallest cross-validation (CV) root-mean-square error (RMSE) were selected, penalizing model complexity by requiring more complex models to yield a ≥5% decrease in CV RMSE. The winning model by voting with random subsets was fitted to the entire dataset to obtain the final formula. External validity was assessed using CV. A simple univariable linear regression formula using body weight (BW) was obtained as follows: WL graft weight [g] = 14.8 × BW [kg] + 439.2. The CV RMSE (g) and coefficient of determination (R2) were 195.2 and 0.548, respectively. In summary, in the development of a simple formula for manually estimating WL weight using demographic and anthropometric variables, a clinically acceptable trade-off between accuracy and simplicity was quantitatively defined, and the best model was selected using this criterion. A univariable linear model using BW achieved a clinically optimal balance between simplicity and accuracy, while one using body surface area performed similarly.

Abstract Background and Aim In Japan, the actual number of stoma constructions and stoma closures is not known. The aim of this study was to conduct a survey to determine the number of gastrointestinal stoma constructions and closures in Japan. Methods Enrolled participants comprised patients undergoing selected gastrointestinal surgeries who were recorded in the National Clinical Database. This database uses the “Common Items for Gastrointestinal Surgeons.” These procedures were formulated by the Japanese Society of Gastroenterological Surgery during 2013–2018. Results According to the National Clinical Database, a total of 154,323 gastrointestinal stomas were constructed between January 1, 2013 and December 31, 2018. By procedure, there were 78,723 cases of stoma construction, 39,653 of abdominoperineal resection, 2470 total pelvic exenteration procedures, and 33,572 Hartmann's procedures. The ratio of stoma closures to stoma constructions increased annually in patients under 70 y of age but not in older patients. Approximately 35% of total colectomies, 60% of proctocolectomies, and 20% of low anterior resections were accompanied by stoma construction. The number of patients with rectal cancer who underwent colostomy increased gradually during the study period and the number who underwent stoma construction increased among older patients. Conclusion The number of cases of gastrointestinal stoma construction has increased gradually in Japan, and the proportion of older patients is increasing each year. The purposes and surgical techniques for stoma construction are diverse and are expected to increase in Japan, a super‐aged society.

Objective: Pericardial effusion after cardiac surgery remains an important cause of morbidity and mortality. We describe the risk factors of pericardial effusion after congenital heart surgery through analyzing data from a nationwide, multi-institutional registry. Methods: The Japan Congenital Cardiovascular Surgery Database, which reflects routine clinical care in Japan, was used for this retrospective cohort study. Multivariable regression analysis was done after univariable comparison of patients with pericardial effusion and no pericardial effusion. Results: The study enrolled 64,777 patients registered with the Japan Congenital Cardiovascular Surgery Database between 2008 and 2016; 909 of these had postoperative pericardial effusion (1.4%) and were analyzed along with 63,868 patients without pericardial effusion. Univariable analysis found no difference between the groups in terms of gender, early delivery, or preoperative mechanical ventilatory support. In the pericardial effusion group, cardiopulmonary bypass use was lower (58.4% vs 62.1%), whereas the cardiopulmonary bypass time (176.9 vs 139.9 minutes) and aortic crossclamp time (75.1 vs 62.2 minutes) were longer, and 30-day mortality was higher (4.1% vs 2.2%). Multivariable analysis identified trisomy 21 (odds ratio, 1.54), 22q.11 deletion (odds ratio, 2.17), first-time cardiac surgery (odds ratio, 2.01), and blood transfusion (odds ratio, 1.43) as independent risk factors of postoperative pericardial effusion. In contrast, neonates, infants, ventricular septal defect, atrial septal defect, tetralogy of Fallot repair, and arterial switch operation were correlated with a low risk of pericardial effusion development. Conclusions: The incidence of postoperative pericardial effusion in congenital cardiac surgery was 1.4%. Trisomy 21, 22q.11 deletion, first-time cardiac surgery, and blood transfusion were identified as the principal factors predicting the need for pericardial effusion drainage.

Abstract Background Esophagectomy followed by gastric conduit reconstruction is a standard surgical procedure for esophageal cancer. However, there is no evidence of the superiority or inferiority of the posterior mediastinal (PM) versus the retrosternal (RS) reconstruction route with regard to short‐term outcomes after esophagectomy. We aimed to elucidate whether the reconstruction route can affect the short‐term outcomes after esophagectomy followed by gastric conduit reconstruction. Methods We reviewed the clinical data of patients who underwent esophagectomy between 2016 and 2018 from the Japanese National Clinical Database. This study included 9786 patients who underwent gastric conduit reconstruction through the PM or RS route with cervical anastomosis. Results Of the 9786 patients analyzed, 3478 and 6308 underwent gastric conduit reconstruction thorough the PM and RS routes, respectively. The incidence of anastomotic leak and surgical site infection (SSI) was significantly lower in the PM group than in the RS group (11.7% vs 13.8%, P = .005 and 8.4% vs 14.9%, P

Occult macular dystrophy (OMD) is the most prevalent form of macular dystrophy in East Asia. Beyond RP1L1, causative genes and mechanisms remain largely uncharacterised. This study aimed to delineate the clinical and genetic characteristics of OMD syndrome (OMDS). Patients clinically diagnosed with OMDS in Japan, South Korea, and China were enrolled. The inclusion criteria were as follows: (1) macular dysfunction and (2) normal fundus appearance. Comprehensive clinical evaluation and genetic assessment were performed to identify the disease-causing variants. Clinical parameters were compared among the genotype groups. Seventy-two patients with OMDS from fifty families were included. The causative genes were RP1L1 in forty-seven patients from thirty families (30/50, 60.0%), CRX in two patients from one family (1/50, 2.0%), GUCY2D in two patients from two families (2/50, 4.0%), and no genes were identified in twenty-one patients from seventeen families (17/50, 34.0%). Different severities were observed in terms of disease onset and the prognosis of visual acuity reduction. This multicentre large cohort study furthers our understanding of the phenotypic and genotypic spectra of patients with macular dystrophy and normal fundus. Evidently, OMDS encompasses multiple Mendelian retinal disorders, each representing unique pathologies that dictate their respective severity and prognostic patterns.

Abstract Background Japan strives to strengthen its development cooperation by mobilizing various resources to assist partner countries advance on Universal Health Coverage by 2030. However, the involvement and roles of various actors for health are not clear. This study is the first to map Japan’s publicly funded projects by both Official Development Assistance (ODA) and other non-ODA public funds, and to describe the intervention areas. Further, the policy implications for country-specific cooperation strategies are discussed. The development cooperation for health in Vietnam is used as a case in this study. Methods A cross-sectional analysis of the Japanese publicly funded health projects that were being implemented in Vietnam during December 2016 was conducted. A framework of analysis based on the World Health Organization six health systems building blocks was adopted. The projects’ qualitative information was also assessed. Results Overall, 68 projects implemented through Japanese public funding were analyzed. These 68 projects under 15 types of schemes were managed by seven different scheme-operating organizations and funded by five ministries. Of these 44 (64.7%) were ODA and 24 (35.3%) were non-ODA projects. Among the recategorized six building blocks of the health system, the largest proportion of projects was health service delivery (44%), followed by health workforces (25%), and health information systems (15%). Almost half the projects were implemented together with the central hospitals as Vietnamese counterparts, which suggests that this is one area in which the specificities of Japanese cooperation are demonstrated. No synergetic effects of potential collaboration or harmonization among Japanese funded projects were captured. Conclusions Several Japanese-funded projects addressed a wide range of health issues across all six building blocks of the health system in Vietnam. However, there is room for improvement in developing coordination and harmonization among the diversified Japanese projects. Establishing a country-specific mechanism for strategic coordination across Japanese ministries’ schemes can yield efficient and effective development cooperation for health. While Vietnam’s dependence on external funding is low, the importance of coordination across domestic actors of the donor countries can serve as an important lesson, especially in beneficiary countries with high external funding dependency.

Abstract Background Hemoglobin A1c (HbA1c) levels are routinely measured during health check-ups and are used as an indicator of glycemic control in Japan. However, only a few studies have followed up individuals to assess the risk of diabetes development and worsening based on HbA1c screening results. This study evaluated the relationship between HbA1c screening results and the risk of diabetes development and worsening. Methods Data were collected from the Shizuoka Kokuho Database, a Japanese administrative claims database of insured individuals aged > 40 years. We included individuals available for follow-up from April 2012 to March 2018 who had not received any diabetes treatment before March 2014. HbA1c screening results were categorized into 4 groups based on the HbA1c levels at the 2012 and 2013 health check-ups: group A, those whose HbA1c levels were 6.5% in 2012 but 6.5% in 2012 and 2013; and group D, those whose HbA1c levels were 6.5% in 2013. Logistic regression models were used to analyze diabetes development and worsening, defined as the initiation of diabetes treatment by March 2018 and the use of injection drugs by participants who initiated diabetes treatment by March 2018. Results Overall, 137,852 individuals were analyzed. After adjusting for covariates, compared with group A, group B was more likely to initiate treatment within 4 years (odds ratio: 22.64; 95% confidence interval: 14.66–34.99). In patients who initiated diabetes treatment by March 2018, injection drugs were less likely used by group D than by group A (odds ratio: 0.28; 95% confidence interval: 0.12–0.61). Conclusions Our study suggests that although HbA1c levels measured during health check-ups were correlated with the risk of diabetes development and worsening, HbA1c levels in a single year may not necessarily provide sufficient information to consider these future risks.

Abstract The COVID-19 pandemic has highlighted the global need for reliable models of disease spread. We propose an AI-augmented forecast modeling framework that provides daily predictions of the expected number of confirmed COVID-19 deaths, cases, and hospitalizations during the following 4 weeks. We present an international, prospective evaluation of our models’ performance across all states and counties in the USA and prefectures in Japan. Nationally, incident mean absolute percentage error (MAPE) for predicting COVID-19 associated deaths during prospective deployment remained consistently

Summary: Background: Percutaneous coronary intervention (PCI) is increasingly performed via transradial access (TRA). This study aimed to investigate the clinical and economic benefits of TRA compared with transfemoral access (TFA) under universal healthcare coverage system in Japan. Methods: A total of 36,153 patients (acute coronary syndrome [ACS], 15,266; stable ischemic heart disease [SIHD], 20,052) across 714 institutions in the Japanese nationwide PCI registry (J-PCI) in 2015 were analyzed (mean age 69.9 ± 11.1 years and 23.6% female). Cost was defined as the total amount of healthcare resources used to care for the patient during hospitalization. Propensity score matching analysis was conducted to balance the baseline characteristics of patients undergoing TRA and TFA. Findings: The median total cost of PCI was JPY 1,341,176 (interquartile range, 959,052), with higher expenses for ACS (JPY 1,772,116 [1,117,107]) compared with SIHD (JPY 1,119,153 [540,440]) patients. Most patients underwent PCI via TRA (73.8%), and after propensity score matching, TRA was associated with a reduced risk of in-hospital death and bleeding (0.88% vs. 1.91% [P < 0.0001] and 2.18% vs. 4.53% [P < 0.0001] in ACS, and 0.10% vs. 0.28% [P = 0.070] and 0.53% vs. 1.72% [P < 0.0001] in SIHD, respectively), which led to lower costs in both ACS (JPY 1,699,279 [1,164,554] for TRA vs. JPY 1,931,255 [1,070,222] for TFA; P < 0.0001), and SIHD (JPY 1,102,352 [505,904] for TRA vs. JPY 1,311,525 [706,450] for TFA; P < 0.0001) patients. Interpretation: In this direct cost analysis of a nationwide registry, the use of TRA was associated with cost saving for both ACS and SIHD patients. Funding: This study was funded by the Japan Society for the Promotion of Science (grant nos. 20H03915, 16H05215, 16KK0186, 20K22883, and 21K08064), Japan Agency for Medical Research and Development [AMED] (grant number 16lk1010004h0002), and the National Clinical Database. The J-PCI registry is led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics.

Abstract Background We aimed to present the 2019 annual report of the gastroenterological section of the National Clinical Database (NCD). Methods We reviewed 609,589 cases recorded in 2019 and 5,029,764 cases registered from 2011 to 2019 for the 115 selected gastroenterological surgical procedures. Results The main features of gastroenterological surgery in Japan were similar to those described in the 2018 annual report, namely, that 1) operative numbers gradually increased in all procedures, except gastrectomy and hepatectomy, which decreased in these years; 2) in all eight major gastroenterological surgeries, the age distribution tended toward older patients; 3) the morbidity of esophagectomy, hepatectomy, and pancreaticoduodenectomy increased, but mortality was minimized in all procedures; 4) all eight major gastroenterological procedures have increasingly been performed under laparoscopy; and 5) board‐certified surgeons were increasingly involved. These trends in recent years were more prominent in 2019. Conclusions Thanks to the continuous cooperation and dedication of the surgeons, medical staff, and surgical clinical reviewers who registered the clinical data into the NCD, it is possible to understand the comprehensive landscape of surgery in Japan and to disclose new evidence in this field. The Japanese Society of Gastroenterological Surgery will continue to promote the value of this database and encourage the use of feedback and clinical studies using the NCD, now and in the future. Generating further approaches to surgical quality improvement are important directions for future research.

Abstract Aim Preoperative inflammation‐based Glasgow prognostic score (GPS) is a useful tool for predicting long‐term prognosis in cancer patients. However, its association with postoperative short‐term outcomes remains unknown. The aim of this study is to investigate the association between GPS and postoperative morbidity and mortality among patients undergoing surgery for various gastrointestinal malignancies. Methods Using the Japanese National Clinical Database, we analyzed the records of 312 357 patients with gastrointestinal malignancy who underwent six typical elective surgeries, including esophagectomy, distal gastrectomy, total gastrectomy, right hemicolectomy, low anterior resection, and pancreaticoduodenectomy, between January 2015 and December 2018. We assigned GPS of 0, 1, or 2 to patients with no, one, or both decreased albumin and elevated C‐reactive protein levels, respectively. We investigated the relationship of GPS with operative morbidity and mortality for each procedure with adjustments for patients' demographics, preoperative status, comorbidities, and cancer stages. Results Crude operative morbidity was significantly higher for GPS 1 and 2 than GPS 0 patients in all procedures except pancreaticoduodenectomy. The postoperative length of hospital stay was significantly longer for GPS 1 and 2 patients in all procedures (P

Abstract Aims/Introduction Increased incidence of hospitalization for heart failure (HHF) among patients with diabetes is increasingly being reported. We investigated the incidence of adverse cardiovascular events including HHF among patients with type 2 diabetes mellitus, and the potential clinical improvement with sodium–glucose cotransporter 2 inhibitors (SGLT2i) using a contemporary administrative claims database from a large governmental district of Japan. Materials and Methods We included initiators of any oral glucose‐lowering drugs between 2013 and 2018. We estimated the 5‐year cumulative incidence of hospitalization for HF, myocardial infarction and stroke, treating death as a competing risk. We evaluated the possible impact of introducing SGLT2i to the potential recipients of the drug, using the inclusion criteria from Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA‐REG OUTCOME) and Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction 58 (DECLARE‐TIMI 58) trials, assuming the same risk reduction as theirs. Results Among 23,340 drug initiators (54.0% men, and 6.4% aged >85 years), the 5‐year cumulative incidence was 5.4% (95% confidence interval 4.9–5.9%) for HHF, 1.9% (95% confidence interval 1.7–2.2%) for myocardial infarction admission and 6.1% (95% confidence interval 5.7–6.6%) for stroke admission. Among 6,192 patients with laboratory test data, 651 (10.5%) and 2,680 (43.3%) patients met the EMPA‐REG‐like and DECLARE‐like criteria, respectively. The 5‐year cumulative incidence among the 2,849 patients meeting either of the criteria was estimated to decrease from 97.1 to 75.6 events through 75% adoption of SGLT2i. Conclusions The incidence of HHF was similar to that of stroke. A significant portion of our cohort met the inclusion criteria for major randomized clinical trials for SGLT2i, and estimated reduction in the HHF events was substantial.

Background The Tokyo 2020 Summer Olympic Games (23 July–8 August 2021) were held in the middle of Japan’s fifth wave of COVID-19, when the number of cases was on the rise, and coincided with the fourth state of emergency implemented by the host city, Tokyo.Aim This study aimed to assess whether the hosting of the Games was associated with a change in the number of COVID-19 cases in Japan using a synthetic control method.Methods A weighted average of control countries with a variety of predictors was used to estimate the counterfactual trajectory of daily COVID-19 cases per 1 000 000 population in the absence of the Games in Japan. Outcome and predictor data were extracted using official and open sources spanning several countries. The predictors comprise the most recent country-level annual or daily data accessible during the Games, including the stringency of the government’s COVID-19 response, testing capacity and vaccination capacity; human mobility index; electoral democracy index and demographic, socioeconomic, health and weather information. After excluding countries with missing data, 42 countries were ultimately used as control countries.Results The number of observed cases per 1 000 000 population on the last day of the Games was 109.2 (7-day average), which was 115.7% higher than the counterfactual trajectory comprising 51.0 confirmed cases per 1 000 000 population. During the Olympic period (since 23 July), the observed cumulative number of cases was 61.0% higher than the counterfactual trajectory, comprising 143 072 and 89 210 confirmed cases (p=0.023), respectively. The counterfactual trajectory lagged 10 days behind the observed trends.Conclusions Given the increasing likelihood that new emerging infectious diseases will be reported in the future, we believe that the results of this study should serve as a sentinel warning for upcoming mega-events during COVID-19 and future pandemics.

Abstract Since the start of the coronavirus disease 2019 (COVID-19) pandemic, it has remained unknown whether conventional risk prediction tools used in intensive care units are applicable to patients with COVID-19. Therefore, we assessed the performance of established risk prediction models using the Japanese Intensive Care database. Discrimination and calibration of the models were poor. Revised risk prediction models are needed to assess the clinical severity of COVID-19 patients and monitor healthcare quality in ICUs overwhelmed by patients with COVID-19.

Abstract Aim We aimed to investigate whether later weekdays are related to worse short‐term outcomes after elective right hemicolectomy for colon cancer. Methods We retrospectively analyzed adult patients who underwent elective right hemicolectomy for colon cancer between 2012 and 2017. Records lacking details about surgical mortality were excluded, and multiple imputation was performed for other missing data (variables). The primary endpoint was surgical mortality, defined as the sum of 30‐day mortality and in‐hospital deaths within 90 days postoperatively. Using 22 clinical variables, hierarchal logistic regression modeling with clustering of patients from the same institutes was performed. Results Of the 112 658 patients undergoing elective right hemicolectomy for colon cancer, the 30‐day mortality and surgical mortality were 0.6% and 1.1%, respectively. Surgery on Friday was less frequent, accounting for 17.1% of all cases. The occurrence of severe postoperative complications, anastomotic leakage, or unadjusted odds ratio for surgical mortality did not show significant differences between weekdays. A hierarchal logistic regression model identified 19 independent factors for surgical mortality. Adjusted odds ratios for surgical mortality were 1.01 (95% confidence interval: 0.83‐1.22, P = .915), 0.86 (95% confidence interval: 0.71‐1.05, P = .144), 0.86 (95% confidence interval: 0.71‐1.05, P = .408), and 0.83 (95% confidence interval: 0.68‐1.03, P = .176) for Tuesday, Wednesday, Thursday, and Friday, respectively, showing no significant differences. Conclusion This study did not identify an evident difference in surgical mortality between weekdays; a safe elective right hemicolectomy for colon cancer is being offered throughout the week in Japan.

Abstract Background and Aim In 2015, the Japanese Society of Gastroenterological Surgery (JSGS) initiated data verification in the gastroenterological section of the National Clinical Database (NCD) and reported high accuracy of data entry. Remote audits were introduced for data validation on a trial basis in 2016 and formally accepted into use in 2017‐2018. The aim of this study was to audit the data quality of the NCD gastroenterological section for 2016‐2018 and to confirm the high accuracy of data in remote audits. Methods Each year, 45‐46 hospitals were selected for audit. Twenty cases were randomly selected in each hospital, and the accuracy of patient demographic and surgical outcome data (46 items) was compared with the corresponding medical records obtained by visiting the hospital (site‐visit audit) or by mailing data from the hospital to the JSGS office (remote audit). Results A total of 136 hospitals were included, of which 88 (64.7%) had a remote audit, and 124 936 items were evaluated with an overall data accuracy of 98.1%. There was no significant difference in terms of data accuracy between site‐visit audit and remote audit. Accuracy, sensitivity, and specificity of mortality were 99.7%, 89.7%, 100% for site‐visit audits and 99.8%, 97.3%, 100% for remote audits, respectively. Mean time spent on data verification per case of remote audits was shorter than that of site‐visit audits (10.0 minutes vs 13.7 minutes, P

Abstract Aim We evaluated the association of profiles of institutional departments with operative outcomes of eight major gastroenterological procedures. Methods We administered a 15‐item online survey to 2634 institutional departments in 2016 to investigate the association of questionnaire responses with operative mortality for the procedures. The proportions of conditions met were listed according to institutional volume and classified according to annual operative cases in 1464 departments. Group A included departments with annual performance of

Abstract Background The effect of antithrombotic drugs on intraoperative operative blood loss volume in patients undergoing emergency surgery for generalized peritonitis is not well defined. The purpose of this study was to investigate the effect of antithrombotic drugs on intraoperative blood loss in patients with generalized peritonitis using a nationwide surgical registry in Japan. Method This retrospective cohort study used a nationwide surgical registry data from 2011 to 2017 in Japan. Propensity score matching for the use of antithrombotic drugs was used for the adjustment of age, gender, comorbidities, frailty, preoperative state, types of surgery, surgical approach, laboratory data, and others. The main outcome was intraoperative blood loss: comparison of intraoperative blood loss, ratio of intraoperative blood loss after adjusted for confounding factors, and variable importance of all covariates. Results A total of 70,105 of the eligible 75,666 patients were included in this study, and 2947 patients were taking antithrombotic drugs. Propensity score matching yielded 2864 well-balanced pairs. The blood loss volume was slightly higher in the antithrombotic drug group (100 [10–349] vs 70 [10–299] ml). After adjustment for confounding factors, the use of antithrombotic drugs was related to a 1.30-fold increase in intraoperative blood loss compared to non-use of antithrombotic drugs (95% CI, 1.16–1.45). The variable importance revealed that the effect of the use of antithrombotic drugs was minimal compared with surgical approach or type of surgery. Conclusion This study shows that while taking antithrombotic drugs is associated with a slight increase in intraoperative blood loss in patients undergoing emergency surgery for generalized peritonitis, the effect is likely of minimal clinical significance.

Understanding COVID-19 risk perception may help inform public health messaging aimed at encouraging preventive measures and improving countermeasures against the pandemic. We conducted an online survey of 29,708 Japanese adults in February 2021 and estimated the associations between COVID-19 risk perception and a broad array of individual factors. Two logistic regressions were constructed to estimate factors associated with the risk perception of COVID-19 (defined as responding that one might become infected within the next 6 months), and of severe illness among those who responded that they might become infected (defined as responding that one would become severely ill). After adjusting for covariates, those with a higher perceived risk of the COVID-19 vaccine had higher odds of risk perception for both infection and severe illness. Interestingly, those with higher odds of risk perception of being infected were more likely to report obtaining their information from healthcare workers whereas those with lower odds were more likely to report obtaining their information from the Internet or the government; those with lower odds of risk perception of being severely ill were more likely to report obtaining their information from the Internet. The higher the trust level in the government as a COVID-19 information source, the lower the odds of both risk perception of being infected and becoming severely ill. The higher the trust levels in social networking services as a COVID-19 information source, the higher the odds of risk perception of becoming severely ill. Public health messaging should address the factors identified in our study.

Summary: Background: Coronavirus disease 2019 (COVID-19) has negatively affected access to healthcare systems and treatment timelines. This study was designed to explore the impact of the COVID-19 pandemic on patients who underwent percutaneous coronary intervention (PCI). Methods: From January 2019 to December 2020, 489,001 patients from 1068 institutions were registered in the Japanese nationwide PCI (J-PCI) registry. We constructed generalized linear models to assess the difference in the daily number of patients and in-hospital outcomes between 2019 and 2020. Findings: In total, 207 institutions (19·3%) had closed or restricted access during the first COVID-19 outbreak in May 2020; the number of closed or restricted institutions had plateaued at a median of 121 institutions (11·3%). The daily case volume of PCI significantly decreased in 2020 (by 6·7% compared with that in 2019; 95% confidence interval [CI], 6·2–7·2%; p

To provide insight into the mortality burden of coronavirus disease (COVID-19) in Japan, we estimated the excess all-cause deaths for each week during the pandemic, January–May 2020, by prefecture and age group. We applied quasi-Poisson regression models to vital statistics data. Excess deaths were expressed as the range of differences between the observed and expected number of all-cause deaths and the 95% upper bound of the 1-sided prediction interval. A total of 208–4,322 all-cause excess deaths at the national level indicated a 0.03%–0.72% excess in the observed number of deaths. Prefecture and age structure consistency between the reported COVID-19 deaths and our estimates was weak, suggesting the need to use cause-specific analyses to distinguish between direct and indirect consequences of COVID-19.

Abstract Aim Appendicitis is divided into two categories: complicated appendicitis (CA) and uncomplicated appendicitis (UA). In pediatric patients with CA, the use of interval appendectomy (IA), which is non‐operative management followed by elective surgery, has decreased the number of postoperative complications. Before discussing the merit of IA for adult patients, we need to clarify whether the frequency and seriousness of the complication rate after emergency surgery is higher for CA than for UA. Methods This retrospective cohort study included adult patients who underwent appendectomy and who were registered in the National Clinical Database (NCD) from 2014 to 2016. Patients with CA who underwent emergency appendectomy comprised the CA group. Patients with UA comprised the UA group. Patients with chronic or recurrent appendicitis who underwent elective appendectomy comprised the elective appendectomy (EA) group. Primary outcomes were all morbidity, serious morbidity, and mortality within 30 days after appendectomy. Results We included 109 256 patients in the study: 14 798 CA, 86 876 UA, and 7582 EA patients. Compared with the UA group, the rates of all morbidity, serious morbidity, and mortality were significantly higher in the CA group. All morbidity, serious morbidity, and mortality rates were significantly lower in the EA group than in the other two groups. Conclusions We confirmed that emergency surgery for CA places the patient at relatively higher risk. We also showed that the risk associated with EA is significantly lower than that for the other methods.

Abstract Background The Acute Physiology and Chronic Health Evaluation (APACHE) III-j model is widely used to predict mortality in Japanese intensive care units (ICUs). Although the model’s discrimination is excellent, its calibration is poor. APACHE III-j overestimates the risk of death, making its evaluation of healthcare quality inaccurate. This study aimed to improve the calibration of the model and develop a Japan Risk of Death (JROD) model for benchmarking purposes. Methods A retrospective analysis was conducted using a national clinical registry of ICU patients in Japan. Adult patients admitted to an ICU between April 1, 2018, and March 31, 2019, were included. The APACHE III-j model was recalibrated with the following models: Model 1, predicting mortality with an offset variable for the linear predictor of the APACHE III-j model using a generalized linear model; model 2, predicting mortality with the linear predictor of the APACHE III-j model using a generalized linear model; and model 3, predicting mortality with the linear predictor of the APACHE III-j model using a hierarchical generalized additive model. Model performance was assessed with the area under the receiver operating characteristic curve (AUROC), the Brier score, and the modified Hosmer–Lemeshow test. To confirm model applicability to evaluating quality of care, funnel plots of the standardized mortality ratio and exponentially weighted moving average (EWMA) charts for mortality were drawn. Results In total, 33,557 patients from 44 ICUs were included in the study population. ICU mortality was 3.8%, and hospital mortality was 8.1%. The AUROC, Brier score, and modified Hosmer–Lemeshow p value of the original model and models 1, 2, and 3 were 0.915, 0.062, and < .001; 0.915, 0.047, and < .001; 0.915, 0.047, and .002; and 0.917, 0.047, and .84, respectively. Except for model 3, the funnel plots showed overdispersion. The validity of the EWMA charts for the recalibrated models was determined by visual inspection. Conclusions Model 3 showed good performance and can be adopted as the JROD model for monitoring quality of care in an ICU, although further investigation of the clinical validity of outlier detection is required. This update method may also be useful in other settings.

Abstract The international spread of COVID-19 infection has attracted global attention, but the impact of local or domestic travel restriction on public transportation network remains unclear. Passenger volume data for the domestic public transportation network in Japan and the time at which the first confirmed COVID-19 case was observed in each prefecture were extracted from public data sources. A survival approach in which a hazard was modeled as a function of the closeness centrality on the network was utilized to estimate the risk of importation of COVID-19 in each prefecture. A total of 46 prefectures with imported cases were identified. Hypothetical scenario analyses indicated that both strategies of locking down the metropolitan areas and restricting domestic airline travel would be equally effective in reducing the risk of importation of COVID-19. While caution is necessary that the data were limited to June 2020 when the pandemic was in its initial stage and that no other virus spreading routes have been considered, domestic travel restrictions were effective to prevent the spread of COVID-19 on public transportation network in Japan. Instead of lockdown that might seriously damage the economy, milder travel restrictions could have the similar impact on controlling the domestic transmission of COVID-19.

Abstract Background Since there was no previous report, we analyzed the relationship between French Risk Stratification parameters in pulmonary arterial hypertension (PAH) and mean pulmonary arterial pressures (mPAP) using Japan PH Registry (JAPHR) national-wide cohort. Methods We enrolled 108 patients with PAH from JAPHR from previous reported cohort and analyzed the relations between French Risk Stratification scores and hemodynamic improvements. Results The ratio meeting 0 to 4 French Risk Stratification score was 21.3%, 31.5%, 32.4%, 13.0%, and 1.9% at baseline, and 6.5%, 23.2%, 33.3%, 23.2%, 13.9% at follow-up, respectively. The improvements in the number of criteria met were associated both with mPAP at follow-up (p = 0.03) and with the improvements in mPAP (p

Abstract Aim The advantages of laparoscopic right hemicolectomy over open surgery for colon cancer in general clinical practice are debated, as evidenced by the continued use of open surgery in a significant proportion of patients worldwide. This study aimed to assess and compare the clinical outcome of laparoscopic and open right hemicolectomy for colon cancer using data from the Japanese National Clinical Database. Methods A total of 72 299 patients who underwent laparoscopic (n = 46 084) and open (n = 26 215) right hemicolectomy for colon cancer between 2014 and 2018 were enrolled in this retrospective study. Short‐term outcome was compared between groups using propensity score matching analysis. Results The incidence of overall postoperative morbidity ≥ Clavien‐Dindo classification grade 3 was significantly higher in the open surgery group than the laparoscopic group (4.7% vs 3.2%, P

Summary: Background: Optimizing media campaigns for those who were unsure or unwilling to take coronavirus disease (COVID-19) vaccines is required urgently to effectively present public health messages aimed at increasing vaccination coverage. We propose a novel framework for selecting tailor-made media channels and their combinations for this task. Methods: An online survey was conducted in Japan during February to March, 2021, with 30,053 participants. In addition to their sociodemographic characteristics, it asked the attitude toward vaccination and information sources (i.e., media channels) for COVID-19 issues. Multinomial logic regression was fitted to estimate the combinations of the media channels and their odds ratio (OR) associated with vaccination attitudes. Findings: The proportion of respondents who were unsure or unwilling to take the vaccination was skewed toward younger generation: 58.1% were aged under 35, while 28.1% were 65 years or older. Media channels such as “Non-medical and Non-TV” and “Non-medical and Non-government” were associated with the unsure group: OR (95% Confidence intervals, (CI)) = 1.75 (1.62, 1.89) and 1.53 (1.44, 1.62), respectively. In addition, media channels such as “Newspapers or the Novel Coronavirus Expert Meeting”, “Medical or Local government”, and “Non-TV” were associated with the unwilling group: OR (95% CI) were 2.00 (1.47, 2.75), 3.13 (2.58, 3.81), and 2.25 (1.84, 2.77), respectively. Interpretation: To effectively approach COVID-19 vaccine unsure and unwilling groups, generation-specific online and offline media campaigns should be optimized to the type of vaccine attitude. Funding: Funded by the Ministry of Health, Labour and Welfare of Japan (H29-Gantaisaku-ippan-009) and the Japan Agency for Medical Research and Development (AMED) (JP20fk0108535).

BackgroundConfounding by indication is a serious threat to comparative studies using real world data. We assessed the utility of automated data-adaptive analytic approach for confounding adjustment when both claims and clinical registry data are available.MethodsWe used a comparative study example of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) in 2005-2008 when CAS was only indicated for patients with high surgical risk. We included Medicare beneficiaries linked to the Society for Vascular Surgery's Vascular Registry >65 years old undergoing CAS/CEA. We compared hazard ratios (HRs) for death while adjusting for confounding by combining various 1) Propensity score (PS) modeling strategies (investigator-specified [IS-PS] vs. automated data-adaptive [ada-PS]); 2) data sources (claims-only, registry-only and claims-plus-registry); and 3) PS adjustment approaches (matching vs. quintiles-adjustment with/without trimming). An HR of 1.0 was used as a benchmark effect estimate based on CREST trial.ResultsThe cohort included 1,999 CAS and 3,255 CEA patients (mean age 76). CAS patients were more likely symptomatic and at high surgical risk, and experienced higher mortality (crude HR = 1.82 for CAS vs. CEA). HRs from PS-quintile adjustment without trimming were 1.48 and 1.52 for claims-only IS-PS and ada-PS, 1.51 and 1.42 for registry-only IS-PS and ada-PS, and 1.34 and 1.23 for claims-plus-registry IS-PS and ada-PS, respectively. Estimates from other PS adjustment approaches showed similar patterns.ConclusionsIn a comparative effectiveness study of CAS vs. CEA with strong confounding by indication, ada-PS performed better than IS-PS in general, but both claims and registry data were needed to adequately control for bias.

Abstract Background Emergency gastrointestinal surgery, although rare, is known for its high mortality and morbidity. However, the risks of emergency surgery for gastrointestinal cancer have not been investigated in depth. This study aimed to investigate the impact of emergency surgery on mortality and morbidity in patients with gastrointestinal cancers and to identify associated risk factors. Methods We extracted data from the National Clinical Database, a nationwide surgery registration system in Japan, for patients with gastrointestinal cancer who underwent esophageal resection, total gastrectomy, distal gastrectomy, right hemicolectomy, or low anterior resection between 2012 and 2017. The impacts of emergency surgery on 30‐day mortality and incidence of overall postoperative complications were compared with those of non‐emergency surgery. Risk factors for mortality and overall postoperative complications were then sought in patients who underwent emergency surgery. Results Thirty‐day mortality and incidence of overall postoperative complications were significantly higher in emergency surgeries for gastric, colon, and rectal cancers than in non‐emergency surgeries (odds ratios 4.86‐6.98 and 1.68‐2.18, respectively; all P

Background: The World Health Organization declared the novel coronavirus outbreak (COVID-19) to be a pandemic on March 11, 2020. Large-scale monitoring for capturing the current epidemiological situation of COVID-19 in Japan would improve preparation for and prevention of a massive outbreak. Methods: A chatbot-based healthcare system named COOPERA (COvid-19: Operation for Personalized Empowerment to Render smart prevention And care seeking) was developed using the LINE app to evaluate the current Japanese epidemiological situation. LINE users could participate in the system either though a QR code page in the prefectures’ websites or a banner at the top of the LINE app screen. COOPERA asked participants questions regarding personal information, preventive actions, and non-specific symptoms related to COVID-19 and their duration. We calculated daily cross correlation functions between the reported number of infected cases confirmed using polymerase chain reaction and the symptom-positive group captured by COOPERA. Results: We analyzed 206,218 participants from three prefectures reported between March 5 and 30, 2020. The mean age of participants was 44.2 (standard deviation, 13.2) years. No symptoms were reported by 96.93% of participants, but there was a significantly positive correlation between the reported number of COVID-19 cases and self-reported fevers, suggesting that massive monitoring of fever might help to estimate the scale of the COVID-19 epidemic in real time. Conclusions: COOPERA is the first real-time system being used to monitor trends in COVID-19 in Japan and provides useful insights to assist political decisions to tackle the epidemic.

Abstract Background Demographic changes in the pattern of disease burden, escalating health expenditures and inequitable access to healthcare are global challenges. Irrespective of their level of development, all countries need to reform their health systems to prepare for the future emerging health needs, in order to meet their commitments of health systems strengthening, universal health coverage (UHC) and explicit targets in the Sustainable Development Goals (SDGs). Summary We propose three core principles for the future health system as described herein. A health system is not simply a ‘cure delivery machine’ but part of a ‘social security system’ that engages all stakeholders through a shared vision and value of health and well-being, not merely an absence of diseases. The future health system shall provide people-centred, affordable care, tailored to the individual’s needs, accessible at any time and any place, and reflect the notion of leaving no one behind through a life course approach — underpinned by the SDGs. Information and communications technology (ICT) offers the potential to facilitate the realisation of these principles by improving the information flow between different parts of the health system through electronic means. We introduce Japan’s new data platform — Person-centred Open PLatform for wellbeing (PeOPLe) — planned to be introduced in 2020 as one example of an ICT-based intervention to realise the three proposed principles. PeOPLe integrates data collected throughout the life course to enable all people to receive affordable, personalised health and social care at any time and any place throughout their lifetime. Furthermore, we discuss the applicability of these principles and PeOPLe to the health systems context of Thailand and the Philippines, including elaborations on ICT transformation challenges. Conclusion Current rising momentum and scale for ICTs in the UHC era offers a great opportunity to make a difference for countries. The PeOPLe concept is not only relevant to resource-rich countries; its applicability to other Asian countries could be feasible though it will need to be adapted to the various country contexts. We hope that this paper contributes to wider discussion around policy choices of ICT application for future health systems strengthening and UHC in order to achieve the SDGs.

Abstract The National Clinical Database (NCD) of Japan grew rapidly, harvesting over 11 million cases of data between 2011 and 2018 from more than 5000 facilities. This is the Report of the NCD based upon gastrointestinal surgery information in 4 420 175 cases from 2011 to 2018. More than 70% of all gastrointestinal surgeries were performed at certified institutions, and the percentage of surgeries performed at certified institutions was particularly high for the esophagus (93.8% in 2018), liver (89.4%), pancreas (91.3%), and spleen (86.9%). Also, more than 70% of the surgeries were performed with the participation of the board‐certified surgeon. As the patients have been getting older, the morbidities have been increasing. However, the mortalities have been kept at a low level. The rates of endoscopic surgery have been increasing year by year, especially high in low anterior resection (67.0%) and esophagectomy (61.0%). Nationwide, this database is surely expecting to ensure the quality of board certification system and surgical outcomes in gastroenterological surgery.

Abstract Aim To investigate the effectiveness of the institutional medical structure and of the implemented clinical practice guidelines for improving colon cancer surgical outcomes. Methods We conducted a web‐based questionnaire survey among departments registered at the National Clinical Database in Japan from October 2014 to January 2015 to assess the association between quality indicators (QIs), including structure and process indicators (clinical practice guideline adherence), and the risk‐adjusted odds ratio for operative mortality (AOR) after right hemicolectomy for colorectal cancer during the study period. Results Among the 2064 departments registering at least one colorectal surgery during the study period, we obtained responses from 814 departments (39.4%). Our analysis on data from 22 816 patients with right hemicolectomy demonstrated that three structural QIs (certification of training hospitals by the Japanese Society of Gastroenterological Surgery and the presences of board‐certified gastroenterological and colorectal surgeons) were associated with significantly lower AOR (P

Background/Aims 5-Aminosalicylic acid (ASA) causes intolerance reactions in some patients. This study was performed to examine the prognosis of patients with ulcerative colitis (UC) and 5-ASA intolerance, and to evaluate the potential interaction between 5-ASA intolerance and the intestinal microbiota. Methods We performed a retrospective cohort study of patients with UC who visited participating hospitals. The primary endpoint was to compare the incidence of hospitalization within 12 months between the 5-ASA intolerance group and the 5-ASA tolerance group. The secondary endpoint was to compare the risk of adverse clinical outcomes after the start of biologics between the 2 groups. We also assessed the correlation between 5-ASA intolerance and microbial change in an independently recruited cohort of patients with UC. Results Of 793 patients, 59 (7.4%) were assigned to the 5-ASA intolerance group and 734 (92.5%) were assigned to the 5-ASA tolerance group. The admission rate and incidence of corticosteroid use were significantly higher in the intolerance than tolerance group (P< 0.001). In 108 patients undergoing treatment with anti-tumor necrosis factor biologics, 5-ASA intolerance increased the incidence of additional induction therapy after starting biologics (P< 0.001). The 5-ASA intolerance group had a greater abundance of bacteria in the genera Faecalibacterium, Streptococcus, and Clostridium than the 5-ASA tolerance group (P< 0.05). Conclusions In patients with UC, 5-ASA intolerance is associated with a risk of adverse clinical outcomes and dysbiosis. Bacterial therapeutic optimization of 5-ASA administration may be important for improving the prognosis of patients with UC.