Self-reported Adherence with the Use of a Device in a Clinical Trial as Validated by Electronic Monitors: the VIBES Study

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Author
Jeffrey, Brianne A
Quinn, Emily K
Zimmerman, Sheryl
Barton, Bruce A
Rubin, Clinton T
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https://doi.org/10.1186/1471-2288-12-171Metadata
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Jeffrey, Brianne A., Marian T. Hannan, Emily K. Quinn, Sheryl Zimmerman, Bruce A. Barton, Clinton T. Rubin, and Douglas P. Kiel. 2012. Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study. BMC Medical Research Methodology 12: 171.Abstract
Background: Adherences to treatments that require a behavioral action often rely on self-reported recall, yet it is vital to determine whether real time self reporting of adherence using a simple logbook accurately captures adherence. The purpose of this study was to determine whether real time self-reported adherence is an accurate measurement of device usage during a clinical trial by comparing it to electronic recording. Methods: Using data collected from older adult men and women (N=135, mean age 82.3 yrs; range 66 to 98 yrs) participating in a clinical trial evaluating a vibrating platform for the treatment of osteoporosis, daily adherence to platform treatment was monitored using both self-reported written logs and electronically recorded radio-frequency identification card usage, enabling a direct comparison of the two methods over one year. Agreement between methods was also evaluated after stratification by age, gender, time in study, and cognition status. Results: The two methods were in high agreement (overall intraclass correlation coefficient = 0.96). The agreement between the two methods did not differ between age groups, sex, time in study and cognitive function. Conclusions: Using a log book to report adherence to a daily intervention requiring a behavioral action in older adults is an accurate and simple approach to use in clinical trials, as evidenced by the high degree of concordance with an electronic monitor.Other Sources
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3533958/pdf/Terms of Use
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http://nrs.harvard.edu/urn-3:HUL.InstRepos:11181199
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