Validation of data quality in a nationwide gastroenterological surgical database: The National Clinical Database site-visit and remote audits, 2016-2018

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.