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.

中文翻译：

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在戒烟试验中使用戒酒者的自我报告和唾液可替宁评估尼古丁贴片的粘附性。

背景技术对尼古丁贴剂的坚持涉及戒烟。这是第一个检查自我报告的尼古丁贴片相对于唾液可替宁的有效性的研究。方法我们使用了来自198名临床试验参与者的数据，这些参与者接受了11周的尼古丁贴剂，自我报告的贴剂使用，在开始治疗后1周进行了唾液可替宁评估，并且在收集唾液时不吸烟（CO <6）。自我报告的贴剂依从性定义为：3天（唾液收集之前），7天（唾液收集之前），3周使用（唾液收集之前7天和14天之后）和11周使用（收集唾液之前7天和之后10周）。包括接受者工作特征曲线在内的分析均考虑了尼古丁代谢的差异。灵敏度，特异性和阳性（PPV）和阴性预测值（NPV）评估了最佳可替宁切入点的依从性。结果自我报告的7天（r = 0.13）和3周（r = 0.13）贴剂的使用与第1周可替宁略有相关（p's = 0.08），但与3天或11周无关。使用7天自我报告的总样本和慢代谢者（p's）曲线下（AUC）值分别为0.67（95％CI：0.55-0.79）和0.72（95％CI：0.57-0.88）。 <0.01），但不适用于正常代谢者。使用7天自我报告的最佳1周可替宁切割点为170 ng / mL（总体）和184 ng / mL（缓慢），敏感性= 0.56-0.62，特异性= 0.69-0.78，PPV = 0.96-0.97 ，且NPV = 0.13-0.14。结论在联合确认的戒烟者中，自我报告的贴剂使用和唾液可替宁在治疗1周后进行了评估，两者之间存在适度的相关性，最佳可替宁切割点因尼古丁代谢率而异。相比于3天，3周或11周，基于可替宁的情况，使用7天的贴剂可能是一种更有效的自我报告贴剂依从性的自我衡量指标。尼古丁代谢率可能会影响这种关系。