Robert Schnoll1, E Paul Wileyto2, Robert Gross3, Brian Hitsman4, Larry W Hawk5, Paul Cinciripini6, Tony P George7, Neal L Benowitz8, Su Fen Lubitz9, Rebecca Ashare9, Rachel F Tyndale10, Caryn Lerman11. 1. Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104, USA. Electronic address: schnoll@pennmedicine.upenn.edu. 2. Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104, USA. 3. Division of Infectious Diseases and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, 3610 Hamilton Walk, Philadelphia, PA 19104, USA. 4. Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Drive, Chicago, IL 60611, USA. 5. Department of Psychology, State University of New York at Buffalo, 230 Park Hall, The State University of New York, Buffalo, NY 14260, USA. 6. Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Houston, TX 77030, USA. 7. Centre for Addiction and Mental Health and Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, 100 Stokes S., BGB 3288, Toronto, ON M6J 1H4, Canada. 8. Departments of Medicine, and Bioengineering & Therapeutic Sciences, University of California, San Francisco, CA, 94143, USA. 9. Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104, USA. 10. Department of Pharmacology & Toxicology, University of Toronto, 1 King's College Circle, Toronto, ON M5S 1A8, Canada. 11. Department of Psychiatry and Norris Cancer Center, 1441 Eastlake Avenue, Health Sciences Campus, University of Southern California, Los Angeles, CA, 90033, USA.
Abstract
BACKGROUND: Adherence to nicotine patches relates to cessation. This is the first study to examine the validity of self-reported nicotine patch adherence relative to saliva cotinine. METHODS: We used data from 198 clinical trial participants who received 11 weeks of nicotine patches, self-reported patch use, hadsaliva cotinine 1-week after the start of treatment assessed, and were not smoking when saliva was collected (CO < 6). Self-reported patch adherence was defined as: 3-day (before saliva collection), 7-day (before saliva collection), 3-week use (7 days before, and 14 days after, saliva collection), and 11-week use (7 days before, and 10 weeks after, saliva collection). Analyses, including receiver operating characteristic curves, considered differences in nicotine metabolism. Sensitivity, specificity and positive (PPV) and negative predictive value (NPV) assessed optimal cotinine cut-point for adherence. RESULTS:Self-reported 7-day (r = 0.13) and 3-week (r = 0.13) patch use marginally correlated with week 1 cotinine (p's = 0.08) but not 3-day or 11-week. Significant area under the curve (AUC) values of 0.67 (95 %CI: 0.55-0.79) and 0.72 (95 %CI: 0.57-0.88) were found using 7-day self-report for the overall sample and for slow metabolizers (p's<0.01), but not for normal metabolizers. Optimal 1-week cotinine cut-points using 7-day self-report were 170 ng/mL (overall) and 184 ng/mL (slow), with sensitivity = 0.56-0.62, specificity = 0.69-0.78, PPV = 0.96-0.97, and NPV = 0.13-0.14. CONCLUSIONS: Among CO-confirmed abstainers, self-reported patch use and saliva cotinine assessed 1-week into treatment, were modestly correlated and optimal cotinine cut-point differed by rate of nicotine metabolism. Seven-day patch use may be a more valid self-report measure of patch adherence based on cotinine than 3-day, 3-week, or 11-week. Rate of nicotine metabolism may affect this relationship.
RCT Entities:
BACKGROUND: Adherence to nicotine patches relates to cessation. This is the first study to examine the validity of self-reported nicotine patch adherence relative to saliva cotinine. METHODS: We used data from 198 clinical trial participants who received 11 weeks of nicotine patches, self-reported patch use, had saliva cotinine 1-week after the start of treatment assessed, and were not smoking when saliva was collected (CO < 6). Self-reported patch adherence was defined as: 3-day (before saliva collection), 7-day (before saliva collection), 3-week use (7 days before, and 14 days after, saliva collection), and 11-week use (7 days before, and 10 weeks after, saliva collection). Analyses, including receiver operating characteristic curves, considered differences in nicotine metabolism. Sensitivity, specificity and positive (PPV) and negative predictive value (NPV) assessed optimal cotinine cut-point for adherence. RESULTS: Self-reported 7-day (r = 0.13) and 3-week (r = 0.13) patch use marginally correlated with week 1 cotinine (p's = 0.08) but not 3-day or 11-week. Significant area under the curve (AUC) values of 0.67 (95 %CI: 0.55-0.79) and 0.72 (95 %CI: 0.57-0.88) were found using 7-day self-report for the overall sample and for slow metabolizers (p's<0.01), but not for normal metabolizers. Optimal 1-week cotinine cut-points using 7-day self-report were 170 ng/mL (overall) and 184 ng/mL (slow), with sensitivity = 0.56-0.62, specificity = 0.69-0.78, PPV = 0.96-0.97, and NPV = 0.13-0.14. CONCLUSIONS: Among CO-confirmed abstainers, self-reported patch use and saliva cotinine assessed 1-week into treatment, were modestly correlated and optimal cotinine cut-point differed by rate of nicotine metabolism. Seven-day patch use may be a more valid self-report measure of patch adherence based on cotinine than 3-day, 3-week, or 11-week. Rate of nicotine metabolism may affect this relationship.
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