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Wireless Clinical Trial of Data Capture using a Personal Digital Assistant

 Sook-Kyoung Park  ;  Soo-Heon Park  ;  Min-Goo Kang  ;  Young Moon Chae  ;  Sukil Kim  ;  Soon Choy  ;  Inyoung Choi 
 Journal of Korean Society of Medical Informatics (대한의료정보학회지), Vol.15(2) : 235-244, 2009 
Journal Title
Journal of Korean Society of Medical Informatics(대한의료정보학회지)
Issue Date
Clinical Trials ; Electronic Data Capture System ; Handheld Computers ; PDA (Personal Digital Assistants) Computer ; Mobile Phone
Objective: Personal Digital Assistants (PDAs) have the potential to improve clinical trial data collection; however, most current PDA-based clinical data collection systems typically collect and store data in the offline mode, and then transfer the data to an operational database. The purpose of this study was to explore the usefulness of a wireless clinical data collection system for an irritable bowel syndrome trial compared with the traditional paper based data collection. Methods: We have developed a PDA-based data capture system for clinical trials, and tested it in a double-blind trial. Sixty four patients with irritable bowel syndrome were randomly selected and divided into a control group that used the standard paper report forms (CRF) and an intervention group that used the electronic report forms (e-CRF), daily for five weeks. There were 630 data sets consisting of six questions each, and thus 3,570 data points total were collected. Results: The response rate of the control group was significantly higher than that of the intervention group. However, the completeness of the response in the intervention group was higher and the number of input errors per person for the PDA group was lower than in the paper group. Conclusion: A PDA based electronic diary improved the response rate and decreased input errors in an IBS trial. We conclude that mobile devices can be very useful, especially when the proposed design and connectivity aspects have been taken into account.
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4. Graduate School of Public Health (보건대학원) > Graduate School of Public Health (보건대학원) > 1. Journal Papers
Yonsei Authors
Chae, Young Moon(채영문)
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