Logical checking function increases the accuracy of data entry in the patterns of care study.

Abstract

BACKGROUND: For clinical studies, the use of a databases combined with a computer is becoming popular for data capturing. Commercially available database software has a logical checking function, which can restrict the type of data and their range. The study presented here quantitatively and prospectively evaluated the effectiveness for data management with this function using the database of Patterns of Care Study (PCS) in Japan. PATIENTS AND METHODS: The first external audit was performed from September 1998 to March 1999 using the PCS database without the function, and the second from April to September 1999 with the function. We analyzed the numbers and patterns of erroneous data for these two periods obtained with and without the function. RESULTS: In the database without the function, the number of incorrect data was 2,812 out of 596,186 (0.47%), while the corresponding number with the function was significantly reduced to 161 out of 533,656 (0.03%, p < 0.0001). CONCLUSIONS: The data accuracy was improved by using the computer database more extensively than the conventional case report form. By adding the logical checking function to the PCS database, significant improvement in the accuracy of data entry was accomplished. This indicates the potential for increasing the accuracy of data capturing with the aid of a computer.