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Classification Accuracy of Biomarkers of Compliance

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Objectives: In this study, we evaluated the classification accuracy of biomarkers of nicotine exposure for identifying noncompliance in randomized controlled trials (RCTs) of very low nicotine content (VLNC) cigarettes. Methods: We combined data from 2 studies to evaluate the classification accuracy of biomarkers of nicotine exposure for identifying noncompliance in RCTs of VLNC cigarettes. Using a novel approach that did not require knowledge of each participant's compliance status, we modeled the distributions of total nicotine equivalents (TNE), total cotinine, and anatabine in compliant and noncompliant participants using a mixture model. Estimates of the classification accuracy were derived from the estimated densities. Results: TNE and total cotinine had near-perfect classification accuracy, but TNE had better classification accuracy than total cotinine (p = .03) and anatabine (p = .014). The classification accuracy of TNE and total cotinine decreased as self-reported study cigarettes increased; anatabine was similar, but the results were more statistically variable. Conclusions: TNE and total cotinine are better classifiers of compliance than anatabine. These results will be useful in determining biomarker thresholds for identifying noncompliance and will aid in the interpretation of future RCTs of VLNC cigarettes.
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Document Type: Research Article

Publication date: May 1, 2019

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  • Tobacco Regulatory Science (Electronic ISSN 2333-9748) is a rigorously peer-reviewed online scientific journal for the dissemination of research relevant to the regulation of tobacco products. The journal content includes a broad array of research domains, including chemistry, biology, behavior, community, and population-level surveillance and epidemiology, as well as knowledge syntheses (eg, meta-analyses or state-of-the-art reviews) and analytic modeling. All articles describe the policy relevance of the research outcomes. Given the global nature of tobacco regulation, particularly as a result of international and national policies, Tobacco Regulatory Science publishes high quality research that is relevant to global regulatory needs and requirements. Tobacco Regulatory Science is published electronically 6 times per year.
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