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Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study

Jeffrey, Brianne A.
Hannan, Marian T.
Quinn, Emily K.
Zimmerman, Sheryl
Barton, Bruce A
Rubin, Clinton T.
Kiel, Douglas P.
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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.

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BMC Med Res Methodol. 2012 Nov 14;12:171. doi: 10.1186/1471-2288-12-171. Link to article on publisher's site

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DOI
10.1186/1471-2288-12-171
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23150931
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<p>© 2012 Jeffrey et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p>
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