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Healthc Inform Res > Volume 15(2); 2009 > Article
Journal of Korean Society of Medical Informatics 2009;15(2):235-244.
DOI: https://doi.org/10.4258/jksmi.2009.15.2.235    Published online June 30, 2009.
Wireless Clinical Trial of Data Capture using a Personal Digital Assistant
Sook Kyoung Park1, Soo Heon Park2, Min Goo Kang3, Young Moon Chae4, Sukil Kim5, Soon Choy5, Inyoung Choi6
1Division of Vaccine Preventable Disease Control & National Immunization Program, Department of Infectious Disease Control, Korea.
2Department of Internal Medicine, St. Mary Hospital, The Catholic University of Korea, Korea.
3College of Information Sciences, Hansin University, Korea.
4Graduate School of Public Health, Yonsei University, Korea.
5Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Korea.
6Catholic Medical Center, Clinical Research Coordinating Center, The Catholic University of Korea, Korea.
Correspondence:  Inyoung Choi,
Received: 22 September 2008
Abstract

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.

Key Words: Clinical Trials, Electronic Data Capture System, Handheld Computers, PDA (Personal Digital Assistants) Computer, Mobile Phone
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