Double–blind control of the data manager doesn't have any impact on data entry reliability and should be considered as an avoidable cost

BACKGROUND: Database systems have been developed to store data from large medical trials and survey studies. However, a reliable data storage system does not guarantee data entering reliability. We aimed to evaluate if double-blind control of the data manager might have any effect on data-reliability. Our secondary aim was to assess the influence of the inserting position in the insertion-sheet on data-entry accuracy and the effectiveness of electronic controls in identifying data-entering mistakes. METHODS: A cross-sectional survey and single data-manager data entry. Data from PACMeR_02 survey, which had been conducted within a framework of the SESy-Europe project (PACMeR_01.4), were used as substrate for this study. We analyzed the electronic storage of 6446 medical charts. We structured data insertion in four sequential phases. After each phase, the data stored in the database were tested in order to detect unreliable entries through both computerized and manual random control. Control was provided in a double blind fashion. RESULTS: Double-blind control of the data manager didn't improve data entry reliability. Entries near the end of the insertion sheet were correlated with a larger number of mistakes. Data entry monitoring by electronic-control was statistically more effective than hand-searching of randomly selected medical records. CONCLUSION: Double-blind control of the data manager should be considered an avoidable cost. Electronic-control for monitoring of data-entry reliability is suggested.