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

• Main Authors: Jeffrey Brianne A, Hannan Marian T, Quinn Emily K, Zimmerman Sheryl, Barton Bruce A, Rubin Clinton T, Kiel Douglas P
• Format: Article
• Language: English
• Published: BMC 2012-11-01
• Series: BMC Medical Research Methodology
• Online Access: http://www.biomedcentral.com/1471-2288/12/171

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p> <p>Trial registration</p> <p>Clinicaltrials.gov NCT00396994</p>