Wireless Clinical Trial of Data Capture using a Personal Digital Assistant
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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.
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.
참고문헌 (24)
- Welker JA, "Implementation of electronic data capturesystems: barriers and solutions", Contemp Clin Trials, 28(3), pp.329~336 (2007)
- Marks RG, "Validating electronic source data in clinicaltrials", Control Clin Trials, 25(5), pp.437~446 (2004)
- Bunn G, "Scaling up EDC: How to move away frompaper trials", Appl Clin Trials, (1), pp.2~4 (2002)
- Santoro E, "Internetfor clinical trials past, present, and future", Controlled Clinical Trials, 20(2), pp.194~201 (1999)
- Kelly MA, "The Internet and randomisedcontrolled trials", International Journal of Medical Informatics, 47(1), pp.91~99 (1997)
- Schrezenmeir J, "Controlled study on the useof hand-held insulin dosage computers enabling conversionto and optimizing of meal-related insulintherapy regimens", Life Support Syst, 3(1), pp.561~567 (1985)
- Clarke WL, "Gonder-Frederick LA, KovatchevB. Hypoglycemia and the decision to drive a motorvehicle by persons with diabetes", J Am Med Assoc, 282, pp.750~754 (1999)
- Greeno CG, "Binge antecedentsin obese women with and without binge eating disorder", J Consult Clin Psychol, 68(1), pp.95~102 (2000)
- McBride JS, "Using ahand-held computer to collect data in an orthopedicoutpatient clinic: a randomized trial of two survey methods", Medical Care, 37(7), pp.647~ (1999)
- Koop A, "The use of handheld computers inclinical trials", Controlled Clinical Trials, 23(5), pp.469~480 (2002)
- Tsang MW, "Improvement in diabetes control with a monitoringsystem based on a hand-held, touch-screen electronic diary", Journal of Telemedicine and Telecare, 7(1), pp.47~ (2001)
- Duftschmid G, "Management of data from clinical trials using theArchiMed system", Medical Informatics and the Internetin Medicine, 27(2), pp.85~98 (2002)
- Beinlich I, "Pen-based remote dataentry system: a pilot clinical trial", Arzneimittel Forschung, 43(3), pp.399~404 (1993)
- Reilly JC, "Trackingpharmacist interventions with a hand-held computer", American Journal of Health-System Pharmacy, 58(2), pp.158~ (2001)
- Carroll AE, "The effect of point-of-care personal digital assistantuse on resident documentation discrepancies", Pediatrics, 113(3), pp.450~454 (2004)
- Evaluating a DigitalResident Diagnosis Log: Reasons for Limited Acceptanceof a PDA Solution, "Jao C", American Medical Informatics Association, ~ (2003)
- Technology Failure Analysis: Understanding Why A Diabetes Management Tool Developed for A Personal Digital Assistant (PDA) Didn't Work in a Randomized Control Trial, "Keshavjee K", American Medical Informatics Association, ~ (2003)
- Kush RD, "Eclinical trials: planning and implementation.1st ed", pp.15~35 (2003), Centerwatch Inc
- Bang J, "South Korea: The emerging tech notopia. in: M-commerce: global experiences and perspectives. 1st ed", pp.197~219 (2006), Idea Group Pub
- Walker LS, "Brief report: assessment ofchildren's gastrointestinal symptoms for clinical trials", Journal of Pediatric Psychology, 27(3), pp.303~ (2002)
- Matthew AG, "Serial personal digital assistantdata capture of health-related quality of life: a randomizedcontrolled trial in a prostate cancer clinic", Health and Quality of Life Outcomes, 5(1), pp.38~ (2007)
- Lal SO, "Palm computer demonstrates a fastand accurate means of burn data collection", The Journal of Burn Care & Rehabilitation, 21(6), pp.559~561 (2000)
- Hyland ME, "Diary keeping in asthma: comparison of written and electronic methods", BMJ: British Medical Journal, 306(6876), pp.487~ (1993)
- Kos J, "Comparison of an electronic food diarywith a nonquantitative food frequency questionnaire inmale and female smokers and nonsmokers", Journal ofthe American Dietetic Association, 96(3), pp.283~285 (1996)