A Comparison of Adherence Assessment Methods Utilized in the United States: Perspectives of Researchers, HIV-Infected Children, and their Caregivers

National Cancer Institute, Center for Cancer Research, Bethesda, Maryland, USA.
AIDS patient care and STDs (Impact Factor: 3.5). 08/2009; 23(8):593-601. DOI: 10.1089/apc.2009.0021
Source: PubMed


This study sought to elucidate methodological issues in adherence research by comparing multiple methods of assessing adherence to antiretroviral medication. From 2003 to 2004, 24 youths with vertically infected HIV disease (mean age = 14.0 years; range, 8-18) and their caregivers participated in a 6-month study. These children were all on highly active antiretroviral therapy (HAART) and were relatively healthy (mean CD4 absolute count = 711.8 +/- 604.5). Adherence was assessed with the Medication Event Monitoring System (MEMS), pill counts, and interviews. Patients and caregivers completed the Perceptions of Adherence Study Participation (PASP) questionnaire. MEMS provided the most detailed adherence information, and good reliability was indicated by significant correlations with medical markers. Pill counts provided similar adherence rates, while patients and caregivers reported nearly perfect adherence in interviews. Problems were experienced with each method: MEMS were expensive, had cap malfunctions, and lack a consistent guiding principle for data interpretation. With pill counts, families forgot to bring all medication bottles to clinic, and interviews were compromised by social desirability and difficulty reaching families by telephone. Most patients and caregivers believed study participation improved the child's adherence, although PASP ratings were unrelated to adherence at the study endpoint. While MEMS may be most reliable, pill counts offer comparable data and are less costly, while interviews seemed least accurate in this study. Most participants reported positive perceptions of their research experience. A consensus among researchers is needed for defining and measuring adherence, and specific recommendations are offered for achieving this goal.

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Available from: Staci C Martin
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    • "Moreover, patients may not remember to bring their medication to appointments (Mghamba, Minzi, Massawe, & Sasi, 2013). Electronic adherence monitoring (e.g., Medication Event Monitoring System [MEMS]; Haberer, Kahane, et al., 2010; Haberer, Kiwanuka, Nansera, Wilson, & Bangsberg, 2010) is costly, and bottle openings do not always reflect medication ingestion (Martin et al., 2009). Finally, plasma antiretroviral (ARV) drug levels reflect only short-term adherence (1–3 days; Nettles et al., 2006; Wertheimer, Freedberg, Walensky, Yazdanapah, & Losina, 2006), adherence may transiently improve before clinic visits (Cramer, Scheyer, & Mattson, 1990; Podsadecki, Vrijens, Tousset, Rode, & Hanna, 2008), and collection is resourceintensive , requiring cold chain and phlebotomy (ter Heine, "
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    ABSTRACT: Current tools for measuring medication adherence have significant limitations, especially among pediatric populations. We conducted a prospective observational study to assess the use of antiretroviral (ARV) drug levels in hair for evaluating antiretroviral therapy (ART) adherence among HIV-infected children in rural Uganda. Three-day caregiver recall, 30-day visual analog scale (VAS), Medication Event Monitoring System (MEMS), and unannounced pill counts and liquid formulation weights (UPC) were collected monthly over a one-year period. Hair samples were collected quarterly and analyzed for nevirapine (NVP) levels, and plasma HIV RNA levels were collected every six months. Among children with at least one hair sample collected, we used univariable random intercept linear regression models to compare log transformed NVP concentrations with each adherence measure, and the child's age, sex, and CD4 count percentage (CD4%). One hundred and twenty-one children aged 2-10 years were enrolled in the study; 74 (61%) provided at least one hair sample, and the mean number of hair samples collected per child was 1.9 (standard deviation [SD] 1.0). Three-day caregiver recall, VAS, and MEMS were found to be positively associated with increasing NVP concentration in hair, although associations were not statistically significant. UPC was found to have a nonsignificant negative association with increasing hair NVP concentration. In conclusion, NVP drug concentrations in hair were found to have nonsignificant, although generally positive, associations with other adherence measures in a cohort of HIV-infected children in Uganda. Hair collection in this population proved challenging, suggesting the need for community education and buy-in with the introduction of novel methodologies.
    Full-text · Article · Dec 2014 · AIDS Care
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    • "In clinical trials, poor adherence makes it difficult to draw conclusions about the implications of a trial or treatment, as results may be dose-dependent or rely heavily on a strict adherence to a prescribed regimen [1,3-5,8]. Without knowing the optimal way to monitor adherence, one cannot accurately interpret the results of clinical trials or properly treat patients [1,7]. "
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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.
    Full-text · Article · Nov 2012 · BMC Medical Research Methodology
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    • "There are several methods used to evaluate or measure adherence to medications, each with advantages and disadvantages [21,22]. Thus, there is no gold standard in measuring medication adherence [21,23]. The common approach is to use multiple methods to compare or assess the robustness of the estimates of adherence. "
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    ABSTRACT: BackgroundThis trial aims at testing the efficacy of weekly reminder and motivational text messages, compared to usual care in improving adherence to Highly Active Antiretroviral Treatment in patients attending a clinic in Yaoundé, Cameroon.Methods and DesignThis is a single-centered randomized controlled single-blinded trial. A central computer generated randomization list will be generated using random block sizes. Allocation will be determined by sequentially numbered sealed opaque envelopes. 198 participants will either receive the mobile phone text message or usual care. Our hypothesis is that weekly motivational text messages can improve adherence to Highly Active Antiretroviral Treatment and other clinical outcomes in the control group by acting as a reminder, a cue to action and opening communication channels. Data will be collected at baseline, three months and six months. A blinded program secretary will send out text messages and record delivery.Our primary outcomes are adherence measured by the visual analogue scale, self report, and pharmacy refill data. Our secondary outcomes are clinical: weight, body mass index, opportunistic infections, all cause mortality and retention; biological: Cluster Designation 4 count and viral load; and quality of life. Analysis will be by intention-to-treat. Covariates and subgroups will be taken into account.DiscussionThis trial investigates the potential of SMS motivational reminders to improve adherence to Highly Active Antiretroviral Treatment in Cameroon. The intervention targets non-adherence due to forgetfulness and other forms of non-adherence.Trial RegistrationPan-African Clinical Trials Registry PACTR201011000261458 NCT01247181
    Full-text · Article · Jan 2011 · Trials
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