Electronic Diaries: Exploring Cross-Cultural Preferences and Acceptability
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Lucy Abraham, MSc, CPsychol Manager, WW Outcomes Research, Pfizer Ltd., Sandwich, Kent, UK Belinda Field, BSc Associate Director, Clinical Research Data Management, Pfizer lnc., New London, Connecticut. USA
Jon Svihro, MD, PhD Associate Professor, Dept of Uroloa, Jessenius Faculty of Medicine. Comenius University, Martin, Slovak Republic Asha Hareendran, PhD Director. WW Outcomes Research. Pfizer Ltd., Sandwich, Kent, UK
Mona 1. Martin, RN, MPA Director, Health Research Associates, Seattle, Washington. USA Donald M. Bushnell, MA Associate Director, Health Research Associates, Seattle, Washington, USA
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Electronic Diaries: Exploring Cross-Cultural Preferences and Acceptability Introduction: The literature supports the use of electronic diaries (e-diaries) in a variety of populations, including diferent disease and age groups. Howevq there has been little discussion of cross-cultural preferences. The aim of this study was to compare acceptability of paper and electronic diaries to collect symptom data from patients with benign prostatic hyperplasia (BPH) in the United States and Slovakia. Methods: Participants were 28 US and 20 Slovak men aged 49-83 years with moderate-to-severe BPH. All were randomly assigned to complete a paper or electronic urinary symptom diary for 7 consecutive days, then complete the alternate version for another 7 days. Participants' experiences with the diaries were assessed via ease of use and preference questions and patient interview. Site issues
were assessed via tracking of technical problems and investigator feedback. Results: The US men preferred the electronic version, whereas men in Slovakia had equal preference between the formats. Most men in both countries felt they could continue using the e-diary for another 2 weeks and still provide accurate information. Technical issues at the Slovakian site included incompatibility with power supplies, loss of battery pow^ and problems downloading data. Conclusion: The use of ediaries is feasible with BPH populations, although this may vary by country When including in clinical trials patients who are less familiar with technofogy careful consideration should be given to diary design, training, and technical issues in that country that may have an impact on the data collection process.
Quai Jason Gong, MD Director, Worldwide Medical, Pfizer lnc., New London, Connecticut, USA Ivan Levinson, MD Director, Worldwide Medical, Pfizer lnc., New London, Connecticut, USA James 5. Streeter, BSCS Senior Director, Clinical Research Data Management, Pfizer lnc., New London, Connecticut. USA
Key Words Electronic diary: BPH; LUTS; Electronic data capture Correspondence Address Lucy Abraham, Outcomes Research. Pfizer Ltd., Ramsgate Road, Sandwich CT13 9NJ, United Kingdom (e-mail: 1ucy.abrahamOpfizer.com). Some ofthis study was presented at the DlA Workshop Benefits and Challenges With ePRO, April 2005. This research was funded by Pfizer Ltd., Sandwich, UK.
INTRODUCTION Benign prostatic hyperplasia (BPH) may result in a complex of obstructive or irr
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