Novel Electronic Data Capture Tool Is More Time Efficient for Adverse Event (AE) Capture and Reporting

BACKGROUND: AE capture and reporting is one of the most time-consuming activities related to the conduct of hematopoietic stem cell transplant (HSCT) clinical trials, with some trials requiring hundreds of AEs to be captured and summarized for reporting. To improve the AE reporting process, our HSCT Program collaborated with the University of Virginia Biomedical Informatics Division of the Public Health Sciences Department to develop a novel electronic data capture tool. The purpose of this study was to evaluate the tool's efficiency and identify areas for improvement. 

METHODS: The electronic tool was designed to be quick, simple to use, and easy to deploy. Microsoft Excel array formulas were used, allowing a calculation to be carried out across multiple input variables to yield a result array without requiring the user to initiate the calculation. As each AE is captured, summary data are updated dynamically with start date, end date, and highest grade (Figure 1). AEs from 5 mock subjects, with 100 data points each, were captured and recorded by 2 separate users by the traditional paper method and the electronic method. The paper method captured AEs upon grade change only, and the electronic tool captured all AEs with and without grade changes. The start date, end date, and highest grade of AEs were reported in a mock database. The time interval for data capture and reporting for each subject was recorded by the user and compared between the 2 modalities. The capture and reporting of events was measured per second. 

RESULTS: The electronic tool captured 446 AEs, and the paper method captured 175 grade change AEs. The time interval of AE capture using the electronic tool was shorter in 1 user, even with the capture of an additional 271 events. The time interval of AE reporting was shorter for both users with the electronic tool. The average time of data capture using the electronic tool was 9.56 sec/event, and 24.46 sec/event using the paper format, making the electronic tool 2.5-fold faster for AE capture. The average time of data reporting using the electronic tool was 2.10 sec/event, and 10.20 sec/event using the paper format, making the electronic tool 4.8-fold faster for data reporting. Overall, the electronic tool was on average 23 seconds faster per event, and 2.9-fold faster per event for AE capture and reporting combined.

CONCLUSIONS: The electronic tool is more time efficient per event for both AE capture and reporting. Use of the electronic tool can be improved by modifying parameters for AE capture to shorten data capture time. The electronic tool can be applied in the clinic setting with an electronic tablet for real-time AE collection. Use of the electronic tool in an investigator-initiated trial was successful. We intend to evaluate accuracy of the electronic versus paper method and to apply the tool in a Sponsored clinical trial.