In Japan, the National Clinical Database (NCD) was founded in April 2010 as the parent body of the database system linked to the board certification system. Registration began in 2011, and to date, more than 3,300 facilities have enrolled and more than one million cases are expected to enroll each year. Given the broad impact of this database initiative, considering the social implications of their activities is important. In this study, we identified and addressed issues arising from data collection and analysis, with a primary focus on providing high-quality healthcare to patients and the general public. Improvements resulting from NCD initiatives have been implemented in clinical settings throughout Japan. Clinical research using such database as well as evidence-based policy recommendations can impact businesses, the government and insurance companies. The NCD project is realistic in terms of effort and cost, and its activities are conducted lawfully and ethically with due consideration of its effects on society. Continuous evaluation on the whole system is essential. Such evaluation provides the validity of the framework of healthcare standards as well as ensures the reliability of collected data to guarantee the scientific quality in clinical databases.

Background The objective of this study was to validate the board certification system of the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHBPS) using the data of hepatectomy cases from the National Clinical Database (NCD) of Japan. Methods Minimal required annual numbers of high-level hepato-biliary-pancreatic (HBP) surgeries were 50 for a board-certified A training institution and 30 for a board-certified B training institution. Records of 14,970 patients who had undergone hepatectomy of more than one segment (MOS), excluding lateral segmentectomy, during 2011 and 2012 were analyzed according to the category of board-certified institution and with or without participation of board-certified instructors or expert surgeons. Results Thirty-day mortality and operative mortality of 14,970 patients after MOS hepatectomy were 1.9% and 3.8%, respectively. Operative mortality rates after MOS hepatectomies performed at certified A institutions, certified B institutions, and non-certified institutions were 3.1%, 3.8%, and 4.5%, respectively (P < 0.001). The operative mortality rates after MOS hepatectomies performed with participation of certified instructors or expert surgeons were better than those without (3.5% vs. 4.3%, P = 0.012). A multiple logistic regression model showed that the cutoffs of high-level HBP surgeries performed per year at hospitals that predicted operative mortality after MOS hepatectomies were 10 and 50. Conclusions Competences and requirements for board-certified institutions, instructors, and expert surgeons to perform hepatectomy were found to be appropriate.

In this study, we successfully constructed an acceptable risk model using preoperative risk factors to predict eight postoperative morbidities highly associated with mortality in gastric cancer patients. This risk model could help to tailor perioperative management and improve clinical outcomes for patients who undergo distal gastrectomy.

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This study created the world's second risk calculator to predict the complications of low anterior resection as a model based on mass nationwide data. In particular, this model is the first to predict anastomotic leakage.