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BMC Med Res Methodol. 2012 Nov 14;12:171. doi: 10.1186/1471-2288-12-171.

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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1
Hebrew SeniorLife Institute for Aging Research, Musculoskeletal Research Center, Boston, MA, USA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00396994.

PMID:
23150931
PMCID:
PMC3533958
DOI:
10.1186/1471-2288-12-171
[Indexed for MEDLINE]
Free PMC Article
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