BACKGROUNDS: Incidence of malignant disease in older patients has been increasing. These geriatric patients have more comorbidities and frailty than younger patients, necessitating different approaches in evaluation and treatment. Geriatric surgery studies in Japan have followed those conducted in the US. The aims of this study were to compare trends in geriatric variables for patients who underwent gastroenterological surgeries between two countries, and to elucidate the characteristics of them. STUDY DESIGN: Geriatric variables and outcomes were analyzed via nationwide databases in both countries. Subjects were defined as patients with age ≥ 65 who underwent seven major gastroenterological surgeries for malignant disease. Basic statistical values were compared between them. RESULTS: A total of 2703 patients in the National Clinical Database (NCD) and 1342 patients in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) were included. Among preoperative comorbidities, dyspnea, hypertension, bleeding disorder, and emergency cases increased with age in both databases, while the rates of obesity and emergency cases were more frequent in NSQIP. Most postoperative complications were not significantly associated with age in either database. Geriatric-associated preoperative variables and outcomes varied with age in both countries. Cognitive variables (history of dementia, surrogate-signed consent, and delirium) were similar between the two databases. However, mobility elements (use of mobility aid, fall history, high fall risk, and new use of mobility aid) and postoperative functional dependency were more frequent in NSQIP than NCD. CONCLUSION: Geriatric-associated variables and outcomes changed similarly with age in both countries, while mobility and function were different between the two.

AIM: The use of minimally invasive surgery, including laparoscopic and robotic surgery, for gastrointestinal cancer has been rapidly increasing. This study aimed to clarify whether differences in minimally invasive surgery outcomes are associated with regional and patient characteristics. METHODS: A total of 123 771 right hemicolectomy and 126 965 low anterior resection cases performed between 2013 and 2019 were selected from the National Clinical Database for analysis. Patients were stratified by regional and economic variables, and open and minimally invasive surgical outcomes were evaluated. RESULTS: In secondary medical regions characterized by urban settings and numerous designated cancer care hospitals, the observed 30-day mortality of low anterior resections was lower only in the minimally invasive surgery group. For right hemicolectomies in regions with many designated cancer care hospitals, the observed incidence of postoperative complications was also lower in the minimally invasive group. Residents of high-income areas undergoing low anterior resection had a lower frequency of 30-day reoperation regardless of the type of surgery and a lower 30-day mortality in the minimally invasive group. For both right hemicolectomy and low anterior resection, patients with longer travel distances had fewer postoperative complications and lower 30-day reoperation rates in the minimally invasive group than in the open surgery group. CONCLUSION: This study found regional and patient characteristic disparities in minimally invasive surgical outcomes; national policies should be implemented to address these inequities.

AIM: The Japanese National Clinical Database, which covers more than 95% of the surgeries performed in Japan, is the largest nationwide database. This is the 2021 annual report of the Gastroenterological Section of the National Clinical Database, which aims to present the short-term outcomes of cases registered in 2021 and discuss significant changes and insights into gastroenterological surgeries observed over the decade. METHODS: We reviewed the data of patients registered in the National Clinical Database between 2012 and 2021. RESULTS: In total, 5 788 093 cases, including 597 780 cases in 2021, were extracted from the National Clinical Database. The number of surgeries resumed its original trend after a uniform decrease due to the coronavirus disease 2019 pandemic. The patient population continues to age, and the proportion of female patients is steadily increasing. The trend of surgeries being conducted in certified institutions with the involvement of board-certified surgeons is consistently rising. Moreover, the increasing trend of endoscopic surgery rate is still maintained. Although operative mortality is declining, the trend of increasing postoperative complications continues. Surgery on the esophagus, liver, and pancreas has shown substantial improvements in operative mortality, with a high participation rate of board-certified surgeons. Surgical procedures with a high incidence of emergency surgeries are characterized by low participation rates of board-certified surgeons, increased morbidity rates, and worse mortality outcomes. CONCLUSION: This overview of surgical patients in Japan, obtained using data extracted from the National Clinical Database, may serve as a critical cornerstone for the future development of gastroenterological surgery.

BACKGROUND: Saccular abdominal aortic aneurysms (AAAs) are considered to be at higher risk of rupture than fusiform AAAs, but not much is known about the extent of this risk. Therefore, this study aimed to compare the rupture presentation between fusiform and saccular AAAs. METHODS AND RESULTS: This is a retrospective cohort study on 27 290 patients who underwent primary endovascular repair for a degenerative AAA between 2016 and 2019, and who were registered in the National Clinical Database in Japan. At operation for nonruptured case, the aneurysm diameter was significantly smaller in saccular AAAs than in fusiform AAAs (median, 44.0 versus 51.0 mm; P<0.001). Similarly, aneurysm diameter at rupture was significantly smaller in saccular AAAs than in fusiform AAAs (median, 55.6 versus 68.0 mm; P<0.001). The likelihood of repair for rupture was significantly higher in saccular AAAs than in fusiform AAAs in the 40- to 54-mm diameter range, in which saccular morphology was found to be an independent risk factor for rupture against fusiform morphology by adjusting for sex and aneurysm diameter (odds ratio, 2.54 [95% CI, 1.75-3.69]). In addition, receiver-operating characteristic curve analysis revealed that the cutoff diameter to predict rupture was smaller in saccular AAAs than in fusiform AAAs (50.5 and 59.5 mm, respectively) based on the Youden index. CONCLUSIONS: Saccular AAAs presented at smaller diameters than fusiform AAAs in patients with ruptured AAAs treated with endovascular aortic repair, which supports the idea that saccular AAAs should be treated at smaller diameters.

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 < 0.001), 0.52% and 4.3% (p < 0.001), and 4.0% and 51.2% (p < 0.001), respectively. Based on the patients' background characteristics, the top 20% of IDs handled more advanced cases. No significant difference in locality was seen between better or worse hospital FTR rates, but fewer esophagectomies, hepatectomies, and pancreatoduodenectomies were performed in depopulated areas. Six items were found to be associated with operative mortality by multivariate logistic analysis. Only 50 (8.8%) IDs met all five factors related to better FTR rates. CONCLUSIONS: The present findings indicate that several hospital factors surrounding surgical treatment, characterized by abundant human resources, are closely related to better postoperative recovery from severe complications.

OBJECTIVE: Infective native aneurysms (INAs) of the abdominal aorta and iliac arteries are uncommon, but potentially fatal. Endovascular aneurysm repair (EVAR) has recently been introduced as a durable treatment option, with outcomes comparable to those yielded by conventional open repair (OR). However, due to the rarity of the disease, the strengths and limitations of each treatment remain uncertain. The present study aimed to separately assess post-OR and post-EVAR outcomes and to clarify factors affecting short-term and late prognosis following each treatment. METHODS: Using a nationwide clinical registry, we investigated 600 patients treated with OR and 226 patients treated with EVAR for INAs of the abdominal aorta and/or common iliac artery. The relationships between preoperative/operative factors and postoperative outcomes, including 90-day and 3-year mortality and persistent/recurrent aneurysm-related infection, were examined. RESULTS: Prosthetic grafts were used in > 90% of patients treated with OR, and in situ and extra-anatomic arterial reconstruction was performed in 539 and 57 patients, respectively. Anemia and imaging findings suggestive of aneurysm-enteric fistula were independently associated with poor outcomes in terms of both 3-year mortality (hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.01-2.62; P=0.046, and HR, 2.24; 95% CI, 1.12-4.46; P=0.022, respectively) and persistent/recurrent infection (odds ratio [OR], 2.16; 95% CI, 1.04-4.49; P=0.039, and OR, 4.96; 95% CI, 1.81-13.55; P=0.002, respectively) after OR, whereas omental wrapping/packing and antibiotic impregnation of the prosthetic graft for in situ reconstruction contributed to improved 3-year survival (HR, 0.60; 95% CI, 0.39-0.92; P=0.019, and HR, 0.53; 95% CI, 0.32-0.88; P=0.014, respectively). Among patients treated with EVAR, abscess formation adjacent to the aneurysm was significantly associated with the occurrence of persistent/recurrent infection (OR, 2.24; 95% CI, 1.06-4.72; P=0.034) whereas an elevated white blood cell count was predictive of 3-year mortality (HR, 1.77; 95% CI, 1.00-3.13; P=0.048). CONCLUSIONS: Profiles of prognostic factors differed between OR and EVAR in the treatment of INAs of the abdominal aorta and common iliac artery. OR may be more suitable than EVAR for patients with abscess formation.

Background Self-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. Objective Our 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. Methods We 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. Results Data 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. Conclusions This 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.

In the 23rd Nationwide Follow-up Survey of Primary Liver Cancer in Japan, data from 20,889 newly registered patients and 42,274 previously registered follow-up patients were compiled from 516 institutions over a 2-year period from 1 January 2014 to 31 December 2015. Basic statistics compiled for patients newly registered in the 23rd survey was cause of death, past medical history, clinical diagnosis, imaging diagnosis, treatment-related factors, pathological diagnosis, recurrence status, and autopsy findings. Compared with the previous 22nd survey, the population of patients with hepatocellular carcinoma (HCC) was older at the time of clinical diagnosis, had more female patients, had more patients with non-B non-C HCC, had smaller tumor diameter, and was more frequently treated with hepatectomy. Cumulative survival rates were calculated for HCC, intrahepatic cholangiocarcinoma (ICC), and combined hepatocellular cholangiocarcinoma (combined HCC and ICC) by treatment type and background characteristics for patients newly registered between 2004 and 2015 whose final outcome was survival or death. Median overall survival and cumulative survival rates for HCC were calculated by dividing patients by combinations of background factors (number of tumors, tumor diameter, Child-Pugh grade, or ALBI grade) and by treatment type (hepatectomy, radiofrequency ablation therapy [RFA], transcatheter arterial chemoembolization [TACE], hepatic arterial infusion chemotherapy [HAIC] and systemic therapy). The same values were also calculated according to registration date by dividing patients newly registered between 1978 and 2015 into five time period groups. The data obtained from this nationwide follow-up survey are expected to contribute to advancing clinical research and treatment of primary liver cancer in the world. This article is protected by copyright. All rights reserved.

OBJECTIVE: Surgical treatment is an established method for popliteal artery entrapment syndrome (PAES), which, however, mainly derives from single-centre experiences where PAES cases are centralised and treated periodically. This study evaluated clinical outcomes of surgical treatment for PAES in a clinical setting where PAES cases are not centralised. METHODS: Multicentre, retrospective cohort study using a national clinical registry. From a Japanese nationwide clinical registry, data for patients who underwent surgical treatment for PAES between 2013 and 2018, including 58 limbs from 41 institutes, were retrieved and evaluated. Patency was analysed using Kaplan-Meier curves. RESULTS: Mean patient age was 36 ± 19 years, 78% were male, and the incidence of PAES was 0.24 limbs/centre/year, reflecting a clinical setting where PAES cases are not centralised. The most frequent arterial symptom was intermittent claudication (90%). Computed tomography was performed in 57 limbs (98%) for the diagnosis, however active manoeuvres such as dorsiflexion and plantarflexion during the examination was performed in only 13 limbs (22%), and occlusion of the popliteal artery was present in 38 limbs (66%) at diagnosis. Regarding surgical treatment, myotomy alone was performed in only seven limbs (12%), and other limbs received revascularisation. Mean follow up was 26 ± 20 months, and surgical treatment was effective as it relieved symptoms in >96% of limbs, with 5-year primary and secondary patency of the surgical treatment for PAES of 72% and 93%, respectively. CONCLUSION: Results of surgical treatment were acceptable even in a clinical setting where PAES cases are not centralised. However, a low incidence of active manoeuvres performed during the examination and a high incidence of occlusion at diagnosis suggests there may be a possibility of delayed diagnosis or underdiagnosis of PAES in Japan, and increased awareness for PAES is warranted.

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.

BACKGROUND: The registration committee for esophageal cancer in the Japan Esophageal Society (JES) has collected the patients' characteristics, treatment, and outcomes of patients who underwent any treatment during 2015 in Japan. METHODS: We analyzed patients' data who had visited the participating hospitals in 2015. We collected the data using the National Clinical Database with a web-based data collection system. We used the Japanese Classification of Esophageal Cancer 10th edition by JES and the TNM classification by the Union of International Cancer Control (UICC) for cancer staging. RESULTS: A total of 9368 cases were registered from 355 institutions in Japan. Squamous cell carcinoma and adenocarcinoma accounted for 86.7% and 7.4%, respectively. The 5-year survival rates of patients treated by endoscopic resection, concurrent chemoradiotherapy, radiotherapy alone, and esophagectomy were 87.2%, 33.5%, 24.2%, and 59.9%, respectively. Esophagectomy was performed in 5172 cases. Minimally invasive approaches were selected for 60.6%, and 54.4% underwent thoracoscopic esophagectomy. The operative mortality (within 30 days after surgery) was 0.79% and the hospital mortality was 2.3%. The survival curves showed an excellent discriminatory ability both in the clinical and pathologic stages by the JES system. The survival of pStage IV was better than IIIC in the UICC system because pStage IV included the patients with supraclavicular lymph node metastasis (M1 LYM). CONCLUSION: We hope this report improves all aspects of diagnosing and treating esophageal cancer in Japan.

Background: Research characterizing changes of heart with respect to vaccine intention is scarce, and very little research considers those who were initially vaccine willing but became hesitant. Here, we sought to assess the factors related to reversals of vaccine willingness. Methods: We conducted a longitudinal, national survey on vaccination intention among Japanese adults aged 20 years or older, with the first questionnaire performed in February-March 2021 (N = 30,053) and the follow-up in February 2022 (N = 19,195, response rate 63.9%). The study population comprised those who reported vaccine willingness in the first survey, with the outcome variable being development of vaccine hesitancy at follow-up. We performed a regression analysis of vaccination status using sociodemographic, health-related, psychologic/attitudinal, and information-related variables as predictors. We used the sparse group minimax concave penalty (MCP) to select the optimum group of covariates for the logistic regression. Findings: Of 11,118 (57.9%) respondents who previously expressed interest in vaccination, 10,684 (96.1%) and 434 (3.9%) were in the vaccine willing and hesitant groups, respectively. Several covariates were found to significantly predict vaccine hesitancy, including marital status, influenza vaccine history, COVID-19 infection/testing history, engagement in COVID-19 preventive measures, perceived risks/benefits of the COVID-19 vaccine, and attitudes regarding vaccination policies and norms. The use of certain information sources was also associated with vaccine hesitancy. Interpretation: Sociodemographic, health-related, psychologic/attitudinal, and information-related variables predicted the development of vaccine hesitancy among those with prior willingness. Most of these predictors were also associated with vaccination status. Funding: The present work was supported in part by a grant from the Kanagawa Prefectural Government of Japan and by AIST government subsidies.

Background: Vaccine hesitancy is a global public health threat. We present unique data that characterises those who experienced reversals of COVID-19 vaccination hesitancy in Japan. Methods: We administered a questionnaire on vaccination intention among 30053 Japanese adults aged 20 years or older before the COVID-19 vaccination was available to the general population (first survey) and conducted a follow-up survey on vaccination status one year later in February 2022 (second survey). Those who responded in the first survey that they did not intend to be vaccinated or were unsure and then responded in the second survey that they were vaccinated or intend to be vaccinated were asked about the reasons for their change of heart. Based on previous literature and expert opinion, 31 reasons for changing vaccination intention were compiled and respondents were asked to choose which among them applied to themselves, with multiple responses possible. Based on the results of those responses, each individual was then clustered using the Uniform Manifold Approximation and Projection (UMAP) dimensionality reduction technique and Ordering Points To Identify the Clustering Structure (OPTICS) algorithm. We then identified unique characteristics among each of the sub-populations (clusters). Findings: In the second survey we received 19195 responses (response rate 63.9%), of which 8077 responded 'no' or 'not sure' in the first survey regarding their intention to be vaccinated. Of these, 5861 responded having received or intending to receive the vaccine (72.6%). We detected six and five sub-populations (clusters) among the 'no' group and 'not sure' group, respectively. The clusters were characterized by perceived benefits of vaccination, including the COVID-19 vaccine, awareness of the COVID-19 vaccination status of those close to them, recognition of the social significance of COVID-19 vaccination for the spread of infection, and dispelled concerns about short-term adverse reactions and the safety of the COVID-19 vaccine. Work and personal relationship reasons were also found to be a unique overarching reason for vaccination changes of heart only among those who did not intend to vaccinate. Interpretation: Those who changed their intention to accept COVID-19 vaccination as well as their unique characteristics as detailed in this study will be important entry points when discussing how to promote vaccination to those who are hesitant to vaccinate in the future. Funding: The present work was supported in part by a grant from the Kanagawa Prefectural Government of Japan and by AIST government subsidies.

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.

BACKGROUND: The registration committee for esophageal cancer in the Japan Esophageal Society (JES) has collected the patients' characteristics, treatment, and outcomes annually. METHODS: We analyzed the data of patients who had visited the participating hospitals in 2014. We collected the data with a web-based data collection system using the National Clinical Database. We used the Japanese Classification of Esophageal Cancer 10th edition by JES and the TNM classification 7th edition by the Union of International Cancer Control (UICC) for cancer staging. RESULTS: A total of 9026 cases were registered from 344 institutions in Japan. Squamous cell carcinoma and adenocarcinoma accounted for 87.9% and 7.1%, respectively. The 5-year survival rates of patients treated using endoscopic resection, concurrent chemoradiotherapy, radiotherapy alone, and esophagectomy were 87.1%, 33.7%, 25.3%, and 59.3%, respectively. Esophagectomy was performed in 5204 cases. Concerning the approach used for esophagectomy, 48.1% of the cases were treated thoracoscopically. The operative mortality (within 30 days after surgery) was 0.75%, and the hospital mortality was 2.0%. The survival curves showed an excellent discriminatory ability both in the clinical and pathologic stages by the JES system. The survival of pStage IV was better than IIIC in the UICC system, because pStage IV included the patients with supraclavicular lymph-node metastasis (M1 LYM). CONCLUSION: We hope that this report contributes to improving all aspects of diagnosing and treating esophageal cancer in Japan.

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.

INTRODUCTION: The ACS NSQIP Surgical Risk Calculator (SRC) assesses risk to support goal-concordant care. While it accurately predicts US outcomes, its performance internationally is unknown. This study evaluates SRC accuracy in predicting mortality following low anterior resection (LAR) and pancreaticoduodenectomy (PD) in NSQIP patients and accuracy retention when applied to native Japanese patients (National Clinical Database, NCD). METHODS: NSQIP (41,260 LAR; 15,114 PD) and NCD cases (61,220 LAR; 27,901 PD) from 2015 to 2017 were processed through the SRC mortality model. Country-specific calibration and discrimination were assessed with and without an intercept correction applied to the Japanese data. RESULTS: The SRC exhibited acceptable calibration for LAR and PD when applied to NSQIP data but miscalibration for NCD data. A simple correction to the model intercept, motivated by lower mortality rates in the Japanese data, successfully remediated the miscalibration. CONCLUSIONS: The SRC may inaccurately predict surgical risk when applied to the native Japanese population. An intercept correction method is suggested when miscalibration is encountered; it is simple to implement and may permit effective international use of the SRC.

PURPOSE: This study compared the quality of healthcare before and after implementation of a policy restructuring the healthcare delivery system and estimated the impact of centralization. METHODS: We used the National Clinical Database to study patients undergoing esophagectomies from 2011 to 2016. We compared the effect of centralization based on the patient background, surgical mortality, and year of surgery. Difference-in-difference methods based on the generalized estimating equation logistic regression model were used for before-and-after comparisons after adjusting for patient-level expected surgical mortality. RESULTS: In total, 34,640 cases were identified. More cases with risk factors were noted in ultra-low-volume hospitals, where 38.4% of cases in underpopulated areas were treated, than in higher volume facilities, and the operative mortality, readmission within 30 days and length of stay were worse among patients treated in these hospitals. In centralized prefectures, the number of cases per hospital increased over time (7.2 in 2011 to 9.5 in 2016) while the crude operative mortality tended to decrease (3.4% in 2011 to 1.8% in 2016). The difference-in-difference estimator was 0.856 (95% confidence interval: 0.639-1.147, p = 0.298). CONCLUSION: The centralization of ultra-low-volume hospitals did not lead to a deterioration in the quality of care but rather an improving trend.

In the 22nd Nationwide Follow-up Survey of Primary Liver Cancer in Japan, data from 21,155 newly registered patients and 43,041 previously registered follow-up patients were compiled from 538 institutions over a 2-year period from 1 January 2012 to 31 December 2013. Basic statistics compiled for patients newly registered in the 22nd survey was cause of death, past medical history, clinical diagnosis, imaging diagnosis, treatment-related factors, pathological diagnosis, recurrence status, and autopsy findings. Compared with the previous 21st survey, the population of patients with hepatocellular carcinoma (HCC) was older at the time of clinical diagnosis, had more female patients, had more patients with non-B non-C HCC, had smaller tumor diameter, and was more frequently treated with hepatectomy. Cumulative survival rates were calculated for HCC, intrahepatic cholangiocarcinoma, and combined hepatocellular cholangiocarcinoma (combined HCC and intrahepatic cholangiocarcinoma) by treatment type and background characteristics for patients newly registered between 2002 and 2013 whose final outcome was survival or death. Median overall survival and cumulative survival rates for HCC were calculated by dividing patients by combinations of background factors (number of tumors, tumor diameter, or Child-Pugh grade) and by treatment type (hepatectomy, radiofrequency ablation therapy, transcatheter arterial chemoembolization, hepatic arterial infusion chemotherapy and systemic therapy). The same values were also calculated according to registration date by dividing patients newly registered between 1978 and 2013 into five time period groups. The data obtained from this nationwide follow-up survey are expected to contribute to advancing clinical research and treatment of primary liver cancer in the world. This article is protected by copyright. All rights reserved.

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 <40 cases of the eight procedures, B 40-79 cases, C 80-199 cases, D 200-499 cases, and E ≥ 500 cases. We evaluated the number of conditions met for 10 of 15 items that could be improved by efforts of institutional departments, to assess whether the profiles of institutional departments had impacts on operative mortality. We built a multivariable logistic regression model for operative mortality with facilities categorized based on the number of conditions met and procedure-specific predicted mortality as explanatory variables using generalized estimating equation to account for facility-level clustering. We also examined how operative outcomes differed between facilities meeting nine or more conditions and those that did not. Results: We recognized meeting nine out of the 10 conditions as being a good indicator for having appropriate structural and process measures for gastroenterological surgery. The facilities meeting nine or more of the conditions had better operative mortality for all eight procedures. Conclusions: Our findings reveal that the profiles of institutional departments can reflect the outcomes of gastroenterological surgery in Japan.

BACKGROUND: The National Clinical Database (NCD) nationwide registry program of gastric cancer started in 2018. The purpose of this study was to report the treatment results of the NCD registry in the form of treatment results of the real world in Japan. METHODS: Patients' characteristics, tumor features, treatments, and outcomes were collected using a web-based data entry system. We analyzed the initial NCD database for data on surgically treated gastric cancer patients in 2011. RESULTS: A total of 30,257 patients with malignant gastric tumors were enrolled by the NCD registry program from 501 hospitals in all 47 prefectures. Of these, the status of data entry was not approved in 8.8% of the registered data, and follow-up information was missing in 1.2% of the approved cases. Excluding 1777 cases, which were not resected for primary gastric cancer, 25,306 resected cases included 44.4% of stomach surgeries recorded in the NCD. The 5 year survival rate of the resected cases was 71.3% and the operative mortality rate was 0.41%. The stage-specific 5 year survival rates were as follows: 89.6% for stage IA, 83.8% for stage IB, 77.3% for stage IIA, 69.1% for stage IIB, 58.7% for stage IIIA, 44.1% for stage IIIB, 30.1% for stage IIIC, and 13.4% for stage IV. CONCLUSIONS: The NCD gastric cancer registry program demonstrated validity for database construction. The gastric cancer registry is expected to become a nationwide registry with the dissemination of data entry system and method in the NCD.

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 < 0.001). Conclusion: The audits showed that NCD data are reliable and characterized by high accuracy. Remote audits may substitute site-visit audits.

BACKGROUND: Primary infected aneurysms of the abdominal aorta and iliac arteries are potentially life-threatening. However, because of the rarity of the disease, its pathogenesis and optimal treatment strategy remain poorly defined. METHODS: A nationwide retrospective cohort study investigated patients who underwent surgical treatment for a primary infected abdominal aortic and/or common iliac artery (CIA) aneurysm between 2011 and 2017 using a Japanese clinical registry. The study evaluated the relationships between preoperative factors and postoperative outcomes including 90-day and 3-year mortality, and persistent or recurrent aneurysm-related infection. Propensity score matching was used to compare survival between patients who underwent in situ prosthetic grafting and those who had endovascular aneurysm repair (EVAR). RESULTS: Some 862 patients were included in the analysis. Preceding infection was identified in 30.2 per cent of the patients. The median duration of postoperative follow-up was 639 days. Cumulative overall survival rates at 30 days, 90 days, 1 year, 3 years and 5 years were 94.0, 89.7, 82.6, 74.9 and 68.5 per cent respectively. Age, preoperative shock and hypoalbuminaemia were independently associated with short-term and late mortality. Compared with open repair, EVAR was more closely associated with persistent or recurrent aneurysm-related infection (odds ratio 2.76, 95 per cent c.i. 1.67 to 4.58; P < 0.001). Propensity score-matched analyses demonstrated no significant differences between EVAR and in situ graft replacement in terms of 3-year all-cause and aorta-related mortality rates (P = 0.093 and P =0.472 respectively). CONCLUSION: In patients undergoing surgical intervention for primary infected abdominal aortic and CIA aneursyms, postoperative survival rates were encouraging. Eradication of infection following EVAR appeared less likely than with open repair, but survival rates were similar in matched patients between EVAR and in situ graft replacement.

In the 21st Nationwide Follow-up Survey of Primary Liver Cancer in Japan, data from 22,134 new patients and 41,956 previously followed patients were compiled from 546 institutions over a 2-year period from 1 January 2010 to 31 December 2011. Basic statistics compiled for patients newly registered in the 21st survey were cause of death, medical history, clinical diagnosis, imaging diagnosis, treatment-related factors, pathological diagnosis, recurrence status, and autopsy findings. Compared with the previous 20th survey, the population of patients with hepatocellular carcinoma (HCC) was older at the time of clinical diagnosis, had more female patients, had more patients with non-B non-C HCC, had smaller tumor diameter, and was more frequently treated with hepatectomy and with radiofrequency ablation. Cumulative survival rates were calculated for HCC, intrahepatic cholangiocarcinoma, and combined hepatocellular cholangiocarcinoma (combined HCC and intrahepatic cholangiocarcinoma) by treatment type and background characteristics for patients newly registered between 1998 and 2011 whose final outcome was survival or death (excluding unknown). Cumulative survival rates for HCC were calculated by dividing patients by combinations of background factors (number of tumors, tumor diameter, and Child-Pugh grade) and by treatment type (hepatectomy, local ablation therapy, transcatheter arterial chemoembolization, and hepatic arterial infusion chemotherapy). The same values were also calculated according to registration date by dividing patients newly registered between 1978 and 2011 into four time-period groups. The data obtained from this nationwide follow-up survey are expected to contribute to advancing clinical research and treatment of primary liver cancer.

<title>Abstract</title> <sec> <title>Background</title> Quantifying the risks and benefits of revascularization for chronic limb-threatening ischaemia (CLTI) is important. The aim of this study was to create a risk prediction model for treatment outcomes 30 days after revascularization in patients with CLTI. </sec> <sec> <title>Methods</title> Consecutive patients with CLTI who had undergone revascularization between 2013 and 2016 were collected from the JAPAN Critical Limb Ischemia Database (JCLIMB). The cohort was divided into a development and a validation cohort. In the development cohort, multivariable risk models were constructed to predict major amputation and/or death and major adverse limb events using least absolute shrinkage and selection operator logistic regression. This developed model was applied to the validation cohort and its performance was evaluated using c-statistic and calibration plots. </sec> <sec> <title>Results</title> Some 2906 patients were included in the analysis. The major amputation and/or mortality rate within 30 days of arterial reconstruction was 5.0 per cent (144 of 2906), and strong predictors were abnormal white blood cell count, emergency procedure, congestive heart failure, body temperature of 38°C or above, and hemodialysis. Conversely, moderate, low or no risk in the Geriatric Nutritional Risk Index (GNRI) and ambulatory status were associated with improved results. The c-statistic value was 0.82 with high prediction accuracy. The rate of major adverse limb events was 6.4 per cent (185 of 2906), and strong predictors were abnormal white blood cell count and body temperature of 38°C or above. Moderate, low or no risk in the GNRI, and age greater than 84 years were associated with improved results. The c-statistic value was 0.79, with high prediction accuracy. </sec> <sec> <title>Conclusion</title> This risk prediction model can help in deciding on the treatment strategy in patients with CLTI and serve as an index for evaluating the quality of each medical facility. </sec>

BACKGROUND: Esophageal cancer is the eighth most common cause of cancer mortality in Japan. More than 11,000 people had died from esophageal cancer in 2018. The Japan Esophageal Society has collected the data on patients' characteristics, performed treatment, and outcomes annually. METHODS: We analyzed the data of patients who had first visited the participating hospitals in 2013. In 2019, the data collection method was changed from an electronic submission to a web-based data collection using the National Clinical Database (NCD). Japanese Classification of Esophageal Cancer 10th by the Japan Esophageal Society (JES) and UICC TNM Classification 7th were used for cancer staging RESULTS: A total of 8019 cases were registered from 334 institutions in Japan. Squamous cell carcinoma and adenocarcinoma accounted for 87.8% and 6.3%, respectively. The 5-year survival rates of patients treated using endoscopic resection, concurrent chemoradiotherapy, radiotherapy alone, or esophagectomy were 88.3%, 32.4%, 24.4%, and 59.3%, respectively. Esophagectomy was performed in 4910 cases. The operative and the hospital mortality rates were 0.77% and 1.98%, respectively. The survival curves showed a good discriminatory ability both in the clinical and pathologic stages by the JES system. The 5-year survival rate of patients with pStage IV in the UICC classification that included patients with supraclavicular node metastasis was better than that of patients with pStage IVb in JES classification. CONCLUSION: We hope this report contributes to improving all aspects of the diagnosis and treatment of esophageal cancer in Japan.

OBJECTIVES: To investigate the effect of geriatric variables on five newly added outcomes and create risk models for predicting these outcomes. SUMMARY BACKGROUND DATA: Because there is a current lack of geriatric research focusing on geriatric outcomes using a national surgical database in Japan, there is a need to investigate outcomes associated with major gastroenterological surgery using these data. METHODS: This multicenter prospective cohort study was conducted at 26 surgery departments across 21 institutions in Japan using the National Clinical Database (NCD) surgical registry. In total, 22 new geriatric variables were imported from the ACS NSQIP geriatric pilot study. The following five geriatric outcomes were defined: 1) postoperative delirium, 2) physical function on postoperative day 30, 3) fall risk on discharge, 4) discharge other than home with social service, and 5) functional decline on discharge, and geriatric risk prediction models for major gastroenterological surgery were created. RESULTS: Between January 2018 and December 2018, data on 3,981 procedures from seven major gastroenterological surgeries were collected and analyzed. Older age and preoperative geriatric variables (Origin status from home, History of dementia, Use of mobility aid, Fall history, and Not competent on admission) were strongly associated with postoperative outcomes. Geriatric risk prediction models for these outcomes were created, with C-statistic values ranging from 0.74 to 0.90, demonstrating model validity and sufficiency of fit. CONCLUSIONS: The risk models for the newly defined five geriatric outcomes that we created can be used in the decision-making process or provision of care in geriatric patients.

OBJECTIVES: There is growing concern regarding quality of work life (QWL) among care staff in nursing homes. However, little is known about the impact of QWL on nursing home residents' functional performance. Recent literature suggests that job satisfaction and happiness of healthcare workers reflect their perceived QWL and impact the quality of their care. This study examined the association between job satisfaction and global happiness with change in functional performance of severely disabled elderly residents in nursing homes. DESIGN: A retrospective cohort study of nursing home residents combined with a questionnaire survey of their care staff. SETTING: Eighteen nursing homes in Japan. PARTICIPANTS: Data were collected from 1000 residents with a required care level of 3-5 and from 412 care staff in nursing homes between October 2017 and March 2018. OUTCOMES AND EXPLANATORY VARIABLES: Functional performance was structurally assessed with ICF (International Classification of Functioning, Disability and Health) staging, composed of 52 items concerning activities of daily life, cognitive function and social participation, at baseline and 6 months later. Deterioration and improvement of functional performance were dichotomously defined as such change in any of the items. QWL of care staff was evaluated with a questionnaire including questions about job satisfaction and global happiness. RESULTS: Functional performance deteriorated and improved in 23.0% and 12.7% of residents, respectively. Global happiness of care staff was associated with lower probability of residents' deterioration (adjusted OR, 0.61; CI 0.44 to 0.84). There was no significant correlation between job satisfaction or happiness of care staff and improvement of residents' functional performance. CONCLUSION: These results suggest that QWL of care staff is associated with changes in functional performance of elderly people with severe disabilities in nursing homes.

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.

OBJECTIVE: To examine whether there is an association between prehospital transfer distance and surgical mortality in emergency thoracic aortic surgery. METHODS: A retrospective cohort study using a national clinical database in Japan was conducted. Patients who underwent emergency thoracic aortic surgery from January 1, 2014, to December 31, 2016, were included. Patients with type B dissection were excluded. A multilevel logistic regression analysis was performed to examine the association between prehospital transfer distance and surgical mortality. In addition, an instrumental variable analysis was performed to address unmeasured confounding. RESULTS: A total of 12,004 patients underwent emergency thoracic aortic surgeries at 495 hospitals. Surgical mortality was 13.8%. The risk-adjusted mortality odds ratio for standardized distance (mean 12.8 km, standard deviation 15.2 km) was 0.94 (95% confidence interval, 0.87-1.01; P = .09). Instrumental variable analysis did not reveal a significant association between transfer distance and surgical mortality as well. CONCLUSIONS: No significant association was found between surgical mortality and prehospital transfer distance in emergency thoracic aortic surgery cases. Suspected cases of acute thoracic aortic syndrome may be transferred safely to distant high-volume hospitals.

In the 20th Nationwide Follow-up Survey of Primary Liver Cancer in Japan, data from 21 075 new patients and 40 769 previously followed patients were compiled from 544 institutions over a 2-year period from 1 January 2008 to 31 December 2009. Compared with the previous 19th survey, the population of patients with hepatocellular carcinoma (HCC) was older at the time of clinical diagnosis, included more female patients, included more patients with non-B non-C HCC, had smaller tumor diameters and more frequently received radiofrequency ablation as local ablation therapy. Cumulative survival rates were calculated for HCC, intrahepatic cholangiocarcinoma, and combined hepatocellular cholangiocarcinoma (combined HCC and intrahepatic cholangiocarcinoma) by treatment type and by background characteristics for patients newly registered between 1998 and 2009 whose final outcome was survival or death. Cumulative survival rates for HCC were calculated by dividing patients by combinations of background factors (number of tumors, tumor diameter, and Child-Pugh grade) and by treatment types (hepatectomy, local ablation therapy, and transcatheter arterial chemoembolization). Cumulative survival rates and median overall survival in patients treated by resection, transcatheter arterial chemoembolization, and local ablation therapy were calculated. The same values were also calculated by the registration date by dividing patients newly registered between 1978 and 2009 into four time period groups . The results of the analysis show that the prognosis of HCC is improving dramatically. It is expected that the data obtained from this nationwide follow-up survey will contribute to advancing clinical research, including the design of clinical trials, as well as the treatment strategy of primary liver cancer in the clinical practice setting.

Since 2013, the Japanese Society for Vascular Surgery started the project of nationwide registration and tracking database for patients with critical limb ischemia (CLI) treated by vascular surgeons. The purpose of this project is to clarify the current status of the medical practice for the patients with CLI to contribute to the improvement of the quality of medical care. This database, called JAPAN Critical Limb Ischemia Database (JCLIMB), is created on the National Clinical Database (NCD) and collects the data of patients' background, therapeutic measures, early results, and long-term prognosis as long as five years after the initial treatment. The limbs managed conservatively are also registered in JCLIMB, together with those treated by surgery and/or endovascular treatment. The basic and early prognostic data of CLI, registered during the four years from 2013 to 2016, have been reported as annual reports. In this paper, for the purpose of clarifying the picture of clinical practice of CLI in Japan, we have compiled these data over the past four years. (This is a translation of Jpn J Vasc Surg 2019; 28: 219-247.).

Background: The Japanese National Clinical Database (NCD) is a large-scale, nationwide, web-based data entry system that is linked to the surgical board certification system and covers almost all surgical cases carried out in Japan. Aim: To evaluate outcomes according to the gastroenterological section of the NCD. Methods: The 115 surgical procedures stipulated by the "Training Curriculum for Board-Certified Surgeons in Gastroenterology" were registered from 2011 to 2017. The number of surgeries, preoperative comorbidities, and short-term outcomes were compared between registration periods. Results: In total, 3 818 414 cases have been registered. More than 70% of all surgeries were carried out at certified institutions. The annual number of cases has been increasing year after year, and the aged population has also been increasing. Although the rates of preoperative comorbidities and postoperative complications have been increasing, the postoperative mortality rate has remained relatively low; in 2017, the 30-day mortality rate was 1.0% among those who underwent esophagectomy, 0.7% among those who underwent distal gastrectomy, 1.1% among those who underwent total gastrectomy, 1.3% among those who underwent right hemicolectomy, 0.5% among those who underwent low anterior resection, 1.3% among those who underwent hepatectomy, and 1.3% among those who underwent pancreaticoduodenectomy. The annual rate of endoscopic surgery dramatically increased over 7 years between 2011 and 2017, especially for low anterior resection (29.5%-62.6%) and esophagectomy (31.0%-56.1%). Conclusion: This database is expected to ensure the quality of the board-certification system and surgical outcomes in gastroenterological surgery.

PURPOSES: To evaluate the reliability of data collected from the gastroenterological section of the National Clinical Database of Japan (NCD), which began registrations in 2011 with ten surgical subspecialty societies. METHODS: During 2014 and 2015, 1,136,700 cases involving 115 procedures at 4374 hospitals were registered in the gastroenterological surgery section of the NCD. After a test audit using the 2014 data, 17 hospitals were selected for the first audit and data verification for 2015. The data accuracy of patient demographics, surgical outcomes, and processes was assessed using 45 items from the cases registered, in comparison with the medical records. RESULTS: In the first audit of the 2015 data, case registration accuracy verification involved 338 patients (99.4% of the extracted cases). The data accuracy with the maximum postoperative variables was > 95%. Accuracy of the mortality and status 30 days after the surgery was high (> 99%) with a sensitivity of 1.00 and a specificity of 1.00. Among the six complications studied, the recorded cases had high specificity but lower sensitivity (0.70-0.89). CONCLUSIONS: We verified the data from the gastroenterological section of the NCD and found high accuracy of data entry.

Since 2013, the Japanese Society for Vascular Surgery has started the project of nationwide registration and tracking database for patients with critical limb ischemia (CLI) who are treated by vascular surgeons. The purpose of this project is to clarify the current status of the medical practice for the patients with CLI to contribute to the improvement of the quality of medical care. This database, called JAPAN Critical Limb Ischemia Database (JCLIMB), is created on the National Clinical Database (NCD) and collects data of patients' background, therapeutic measures, early results, and long term prognosis as long as five years after the initial treatment. The limbs managed conservatively are also registered in JCLIMB, together with those treated by surgery and/or EVT. In 2016, 1,092 CLI limbs (male 755 limbs: 70%) were registered by 91 facilities. ASO has accounted for 98% of the pathogenesis of these limbs. In this manuscript, the background data, the early prognosis, and 6-months' prognosis of the registered limbs are reported. (This is a translation of Jpn J Vasc Surg 2019; 28: 1-27.).

BACKGROUND: The current status and adoption of cancer-related clinical practice guidelines in Japan has not been elucidated yet. The purpose of this study was to propose roles and suggestions to develop future cancer-related clinical guidelines. METHODS: A questionnaire consisting of four domains with a total of 17 questions was developed. We distributed the questionnaire to 28 specific academic organizations in Japan which have developed any cancer-related clinical practice guidelines and which were funded by the Ministry of Health, Labor, and Welfare. RESULTS: Most organizations have investigated nationwide dissemination and adoption of clinical practice guidelines. The rate of adoption in clinical practice was estimated at approximately ≥ 70%. However, organizations with smaller budgets reported surveying approximately 60% of the time, whereas the ones with larger budgets reported approximately 100% success in surveying about their guidelines. The presidents of the organizations agreed that a new organization operated directly by the national government was necessary. CONCLUSION: In Japan, to develop cancer-related clinical practice guidelines, a study of clinical validation is necessary. Sufficient funds must be available to support the project to maintain and revise the guidelines. Furthermore, legal and ethical issues should be solved before establishing any registry system.

PURPOSE: The aim of this study was to examine the quality of data from the National Clinical Database (NCD) via a comparison with regional government report data and medical charts. METHODS: A total of 1,165,790 surgical cases from 3007 hospitals were registered in the NCD in 2011. To evaluate the NCD's data coverage, we retrieved regional government report data for specified lung and esophageal surgeries and compared the number with registered cases in the NCD for corresponding procedures. We also randomly selected 21 sites for on-site data verification of eight demographic and surgical data components to assess the accuracy of data entry. RESULTS: The numbers of patients registered in the NCD and regional government report were 46,143 and 48,716, respectively, for lung surgeries and 7494 and 8399, respectively, for esophageal surgeries, leading to estimated coverages of 94.7% for lung surgeries and 89.2% for esophageal surgeries. According to on-site verification of 609 cases at 18 sites, the overall agreement between the NCD data components and medical charts was 97.8%. CONCLUSION: Approximately, 90-95% of the specified lung surgeries and esophageal surgeries performed in Japan were registered in the NCD in 2011. The NCD data were accurate relative to medical charts.

Since 2013, the Japanese Society for Vascular Surgery has started the project of nationwide registration and tracking database for patients with critical limb ischemia (CLI) who are treated by vascular surgeons. The purpose of this project is to clarify the current status of the medical practice for the patients with CLI to contribute to the improvement of the quality of medical care. This database, called JAPAN Critical Limb Ischemia Database (JCLIMB), was created on the National Clinical Database and collects data of patients' background, therapeutic measures, early results, and long term prognosis as long as five years after the initial treatment. The limbs managed conservatively are also registered in JCLIMB, together with those treated by surgery and/or endovascular treatment. In 2015, 1138 CLI limbs (male, 796 limbs [70%]) were registered by 92 facilities. Arteriosclerosis obliterans has accounted for 98% of the pathogenesis of these limbs. In this manuscript, the background data and the early prognosis of the registered limbs are reported. (This is a translation of Jpn J Vasc Surg 2018; 27: 155-185.).

BACKGROUND: Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. METHODS: We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. RESULTS: We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. CONCLUSIONS: Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.

The National Clinical Database (NCD) of Japan started its registration in 2011 and over 9 000 000 cases from more than 5000 facilities were registered over a 6-year period. This is the report of NCD based upon gastrointestinal surgery information in excess of 3 200 000 cases from 2011 to 2016 adding data of complications. About 70% of all gastrointestinal surgeries were carried out at certified institutions, and the percentage of surgeries done at certified institutions was particularly high for the esophagus (92.4% in 2016), liver (88.4%), pancreas (89.8%), and spleen (86.8%). The percentage of anesthesiologist participation was more than 90% for almost all organs, except 85.7% for the rectum and anus. Approximately, more than two-thirds of the surgeries were carried out with the participation of a board-certified surgeon. Although patients have been getting older, mortalities have not been increasing. There were differences in the incidence of complications according to organ site and procedure. Remarkably, mortality rates of low anterior resection were very low, and those of hepatectomy and acute diffuse peritonitis surgery have been gradually decreasing. Although the complication rates were gradually increasing for esophagectomy or pancreaticoduodenectomy, the mortality rates for these procedures were decreasing. Nationwide, this database is expected to ensure the quality of the board-certification system and surgical outcomes in gastroenterological surgery.

一般社団法人National Clinical Database(NCD)のデータベース事業であり、2014年に施行・登録された消化器外科手術情報を追加し作成されたAnnual Report 2015について報告した。115の消化器外科専門医術式、および医療水準評価術式として定めた8術式の、2011年〜2014年までのデータを対象に経年的変化を検討した。消化器外科専門医115術式に関しては、NCDに登録された総数は2056325例で、臓器別では小腸・結腸(36.1%)が最も多かった。男女比は全体で約6:4で、全体の16.0%が80歳以上であった。手術は全体の約7割が認定施設で行われ、麻酔科医関与の比率は91.2%であった。次いで、主たる8術式に関しては、2014年の症例数での検討で、男女比は全ての術式で男性が多く、結腸右半切除術、急性汎発性腹膜炎手術で80歳以上の比率が高かった。概ね7割以上が認定施設で行われ、麻酔科医関与の比率は全ての術式で90%以上であった。

2014年10月〜2015年1月に実施したNational Clinical Database(NCD)施設診療科調査の結果を報告した。有効回答は診療科5672ヶ所中2097ヶ所(37.0%)より得られた。診療を行っている疾患およびNCDに登録している領域で最も多いのは食道癌であった。NCDに関する認知度については、「科のほぼすべての医師が知っている」と回答した診療科が最も多かった。症例登録の入力時期は「入力情報がある程度確定した後に入力している」が最も多かった。2011年度調査結果と比較すると、入力にかかわる職種については、診療科に所属する医師や事務専門職の関与が増加していた。入力手順に関しては、電子カルテなどの診療情報システムの活用が増加していた。診療提供体制に関しては、ガイドラインに準じた診療内容を「施設として推奨し、判断を統一している」と回答する割合が多かった。心臓領域におけるカンファレンスの開催状況については、「症例検討カンファレンス」は9割以上の診療科で週1回以上開催されており、「ハートチームカンファレンス」は6割以上の診療科で週1回以上開催されている結果であった。

Since 2013, the Japanese Society for Vascular Surgery (JSVS) has started the project of nationwide registration and a tracking database for patients with critical limb ischemia (CLI) who are treated by vascular surgeons. The purpose of this project is to clarify the current status of the medical practice for patients with CLI to contribute to the improvement of the quality of medical care. This database, called JAPAN Critical Limb Ischemia Database (JCLIMB), is created on the National Clinical Database (NCD) and collects data of patients' background, therapeutic measures, early results, and long term prognosis as long as five years after the initial treatment. The limbs managed conservatively are also registered in JCLIMB, together with those treated by surgery and/or EVT. In 2013, 1207 CLI limbs (male 874 limbs: 72%) were registered by 87 facilities. ASO has accounted for 98% of the pathogenesis of these limbs. In this manuscript, the background data and the early prognosis of the registered limbs are reported. (This is a translation of Jpn J Vasc Surg 2016; 25: 215-232.).

Since 2013, the Japanese Society for Vascular Surgery (JSVS) has started the project of nationwide registration and a tracking database for patients with critical limb ischemia (CLI) who are treated by vascular surgeons. The purpose of this project is to clarify the current status of the medical practice for patients with CLI to contribute to the improvement of the quality of medical care. This database, called JAPAN Critical Limb Ischemia Database (JCLIMB), is created on the National Clinical Database (NCD) and collects data of patients' background, therapeutic measures, early results, and long-term prognosis as long as 5 years after the initial treatment. The limbs managed conservatively are also registered in JCLIMB, together with those treated by surgery and/or endovascular treatment (EVT). In 2014, 1347 CLI limbs (male 936 limbs: 69%) were registered by 95 facilities. Arteriosclerosis obliterans (ASO) has accounted for 97% of the pathogenesis of these limbs. In this manuscript, the background data and the early prognosis of the registered limbs are reported. (This is a translation of Jpn J Vasc Surg 2016;25:293-310.).