Cited by 889Medication Adherence and CompliancePharmacy and Medical PracticesSurvey Methodology and Nonresponse

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Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice

Farmer, Kevin C.·1999·Clinical Therapeutics

DOI 10.1016/s0149-2918(99)80026-5

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Abstract

Researchers and clinicians have used numerous methods in their attempts to adequately assess patient compliance (adherence) with medication regimens and to identify noncompliant patients. Large variations have been reported in the extent of noncompliance in individual patients and large populations. In addition, nonadherence has often been poorly defined. Direct measures of adherence include drug assays of blood or urine, use of drug markers with the target medication, and direct observation of the patient receiving the medication. Indirect measures of adherence imply that the medication has been used by the patient; these measures include various forms of self-reporting by the patient, medication measurement (pill count), use of electronic monitoring devices, and review of prescription records and claims. Compliance measures should be assessed on the basis of their validity (sensitivity and specificity or statistical correlation) and the reference standard used. Many early studies used pill counts as a reference standard, but electronic monitoring devices such as the Medication Event Monitoring System have replaced pill counts as the reference standard. The choice of a method for measuring adherence to a medication regimen should be based on the usefulness and reliability of the method in light of the researcher's or clinician's goals. Specific methods may be more applicable to certain situations, depending on the type of adherence being assessed, the precision required, and the intended application of the results.

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“Although package inspections and pill counts serve as a gold standard for measuring adherence to treatment of other diseases [54, 65] the heterogeneity of this outcome measure in malaria studies limits comparison of adherence to regimens across studies.”
Background
Study protocol: The Adherence and Intensification of Medications (AIM) study - a cluster randomized controlled effectiveness study
Heisler, M., Hofer, T. P., Klamerus, M. L., Schmittdiel, J. A., Selby, J. V., Hogan, M. M., Bosworth, H. B., Tremblay, A. S., & Kerr, E. A. (2010) · Trials · doi:10.1186/1745-6215-11-95 · Cited by 39
Measures and predictors of varenicline adherence in the treatment of nicotine dependence
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Authors: Farmer, K. C.
Affiliations: University of Oklahoma Health Sciences Center (US)
Corresponding author: Farmer, Kevin C.
Venue: Clinical Therapeutics
Publisher: Elsevier BV
Published: 1999-06
Volume: 21
Issue: 6
Pages: 1074-1090
ISSN: 0149-2918 (ISSN-L)
DOI: 10.1016/s0149-2918(99)80026-5
OpenAlex: W1972110417
Cited by: 889
References: 55
Citations by year: 2026: 10 · 2025: 22 · 2024: 24 · 2023: 29 · 2022: 38 · 2021: 42 · 2020: 35 · 2019: 48 · 2018: 52 · 2017: 44 · 2016: 49 · 2015: 40 · 2014: 62 · 2013: 52 · 2012: 42
FWCI: 7.96
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Clinical Therapeutics (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
Health Sciences › Health Professions › Pharmacy › Pharmacy and Medical Practices
Social Sciences › Sociology and Political Science › Survey Methodology and Nonresponse
Keywords: medication adherence, medication non-adherence, adherence measurement methods, pill count, electronic medication monitoring, medication event monitoring system, self-report, prescription records, clinical trials
MeSH terms: Clinical Trials as Topic, Drug Administration Schedule, Humans, Patient Compliance, Drug Monitoring

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Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice

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