A comparative study of mobile electronic data entry systems for clinical trials data collection

Purpose: To determine the speed, accuracy, ease of use, and user satisfaction of various electronic data entry platforms for use in the collection of mammography clinical trials data. Method and materials: Four electronic data entry platforms were tested: standalone personal digital assistant (PDA), Tablet PC, digitizer Tablet/PDA Hybrid (DTP Hybrid), and digital pen (d-pen). Standard paper data entry was used as control. Each of five radiologist readers was assigned to enter interpretations for 20 screening mammograms using three out of the five data entry methods. Assistants recorded both start and stop data entry times of the radiologists and the number of help requests made. Data were checked for handwriting recognition accuracy for the d-pen platform using handwriting verification software. A user satisfaction survey was administered at the end of each platform reading session. Results: Tablet PC and d-pen were statistically equivalent to conventional pen and paper in initial data entry speed. Average verification time for d-pen was significantly less than secondary electronic data entry of paper forms (p-value < 0.001). The number of errors in handwriting recognition for d-pen was less than secondary electronic data entry of the paper forms data. Users were most satisfied with Tablet PC, d-pen, and conventional pen and paper for data entry. Conclusions: Tablet PC and d-pen are equally fast and easy-to-use data entry methods that are well tolerated by radiologist users. Handwriting recognition review and correction for the d-pen is significantly faster and more accurate than secondary manual keyboard and mouse data entry. (c) 2005 Elsevier Ireland Ltd. All rights reserved.