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Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice
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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“Package inspection and pill counts, while more ‘objective’ measures [54, 55], are dependent on the availability of packaging.”
From Adherence to treatment with artemether–lumefantrine or amodiaquine–artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial (2018) · cites this paper as [54]
In the citing paper
“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.”
From Adherence to treatment with artemether–lumefantrine or amodiaquine–artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial (2018) · cites this paper as [54]
In the citing paper
“Although package inspections and pill counts serve as a gold standard for measuring adherence to treatment of other diseases [54, 65]”
From Adherence to treatment with artemether–lumefantrine or amodiaquine–artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial (2018) · cites this paper as [54]
In the citing paper
“Although there is mixed evidence,39, 40 some research suggests that minority groups have lower adjuvant hormonal therapy adherence.8, 10, 29”
From Behavioral interventions to enhance adherence to hormone therapy in breast cancer survivors: a systematic literature review (2016) · cites this paper as [10]
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Metadata
- 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)
- 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
- 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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