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

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

doi:10.1186/1471-2288-12-171

Abstract

BackgroundAdherences 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.MethodsUsing 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.ResultsThe 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.ConclusionsUsing 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 registrationClinicaltrials.gov NCT00396994

Highlights

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
Adherence to treatment is monitored by various methods including self-report, proxy report, observation, and in the case of medication use, by pill counts and more recently by Medication Event Monitoring Systems (MEMS) pill bottle caps [1,2,7]
MEMS caps serve as a form of electronic monitoring by recording when the cap is opened or pill removed, and have emerged as a preferred, objective standard of adherence monitoring in many clinical trials.[1]

Summary

Introduction

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. MEMS caps serve as a form of electronic monitoring by recording when the cap is opened or pill removed, and have emerged as a preferred, objective standard of adherence monitoring in many clinical trials.[1]. Similar to these studies focusing on medication use, electronic monitoring of device adherence could be considered as a gold standard to monitor adherence

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