The importance of adherence in tuberculosis treatment clinical trials and its relevance in explanatory and pragmatic trials
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Points• Adherence to prescribed treatment remains a critical component of clinical trials in tuberculosis (TB) treatment.Recent evidence indicates that adherence strongly influences the outcome of therapy; attention to its quantification and measures to assure its implementation should increase.• In the context of a World Health Organization (WHO) Technical Consultation on "Advances in Clinical Trial Design for Development of New TB Treatments," we reviewed the challenges related to adherence confronting the trials community.• We discuss the importance of adherence to therapy in TB clinical trials, consider several definitions and measures of adherence, comment on the standard provided by directly observed therapy (DOT), and briefly review evolving electronic methods for the assessment of adherence.• Adherence affects both the outcome of therapy and the risk of acquired drug resistance.Assessment of adherence should consider not only overall adherence but also the timing and intensity of nonadherence.• Appropriate methods for pooling and analyzing electronic data on adherence are needed.• Better methods are needed for linking information on adherence to individual pharmacokinetics and pharmacodynamics and to individual patient outcomes.
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Treatment adherence is related to drug pharmacokinetics that causes a lower peak drug concentration than normal; additional doses may result in a higher risk of toxicity than usual peak concentrations.
“Treatment adherence is related to drug pharmacokinetics that causes a lower peak drug concentration than normal; in contrast, additional doses may result in a higher risk of toxicity than usual peak concentrations.30”
From The effects of acceptance and commitment therapy on psychosocial impact and adherence of multidrug-resistant tuberculosis patients (2022) · cites this paper as [30]
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- Authors
- Vernon, A., Fielding, K., Savic, R., Dodd, L., & Nahid, P.
- Affiliations
- Centers for Disease Control and Prevention (US)
- University of the Witwatersrand (ZA)
- National Institutes of Health (US)
- San Francisco General Hospital (US)
- Corresponding author
- Vernon, Andrew
- Venue
- PLOS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2019-12-10
- Volume
- 16
- Issue
- 12
- Pages
- e1002884
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC6903706
- OpenAlex
- W2994185183
- Cited by
- 104
- References
- 35
- Citations by year
- 2026: 6 · 2025: 15 · 2024: 19 · 2023: 23 · 2022: 11 · 2021: 21 · 2020: 9
- FWCI
- 7.86
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Informationszentrum Lebenswissenschaften (ZB MED) (submittedVersion, cc-by)
- Funders
- Centers for Disease Control and Prevention
- Medical Research Council (MR/R010161/1)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- tuberculosis, medication adherence, clinical trial design, explanatory trials, pragmatic trials, directly observed therapy, electronic adherence monitoring, drug resistance, pharmacokinetics/pharmacodynamics
- MeSH terms
- Clinical Trials as Topic, Humans, Research Design, Tuberculosis
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