J Korean Soc Med Inform.  2009 Jun;15(2):235-244. 10.4258/jksmi.2009.15.2.235.

Wireless Clinical Trial of Data Capture using a Personal Digital Assistant

• Park SK
• Park SH
• Kang MG
• Chae YM
• Kim S
• Choy S
• Choi I

• KMID: 2211393
• DOI: http://doi.org/10.4258/jksmi.2009.15.2.235

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.

Keyword

Clinical Trials; Electronic Data Capture System; Handheld Computers; PDA (Personal Digital Assistants) Computer; Mobile Phone

MeSH Terms

Cellular Phone
Computers, Handheld
Data Collection
Electronics
Electrons
Humans
Irritable Bowel Syndrome

Figure

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  Figure 1 Study design for paper and PDA

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  Figure 2 Data flow for PDA clinical data collection system *DB: Database †MHS: Message handling system ‡ASP: Active server page

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  Figure 3 Log-in screen and questionnaire screen for PDA

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