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Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

机译：一项先行临床试验中未宣布的电话药计数可评估伐尼克兰依从性

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Background: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials.Objectives: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy.Research design: Secondary data analysis of a randomized pilot study.Participants: 46 moderate-to-heavy (>10 cigarettes per day) African-American smokers.Main measures: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded.Results: Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% < $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004) than participants with matching phone and in-person counts (n = 39).Conclusion: Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy.
机译：背景：尽管有一致的证据将戒烟药物治疗依从性与更好的结局联系起来，但缺乏客观的依从性措施的知识，并且很少关注在戒烟临床试验中监测药物治疗的使用。目的：研究未宣布的电话药计数作为评估依从性的方法研究设计：一项随机先导研究的二次数据分析参与者：46名中度至重度（每天> 10支香烟）非洲裔美国吸烟者主要措施：吸烟者接受了1个月的伐尼克兰（Pfizer Global Pharmaceuticals （纽约州纽约市）在基线处的药丸盒中。在第1个月进行面对面的药片计数之前4天，通过电话完成了未宣布的药片计数。在这两个计数中，打开了药丸盒的每个隔室，并记录了剩余药丸的数量。结果：参与者的平均年龄48岁（SD = 13），女性（59％），低收入（60％<家庭月收入$ 1800）和每天平均抽17支香烟（SD = 7）。通过电话和面对面的药物计数之间高度一致（rs = 0.94，P <0.001）。计数不一致的参与者（n = 7）的伐尼克兰依从性较低（平均[SD] = 77％[18％]对95％[9％]，P <0.0005），但过去的药物依从性更好（1.0 [0.8] ]与2.8 [1.0]，P <0.0004）相比，电话和面对面计数相匹配（n = 39）。结论：未宣布的电话药计数似乎是衡量戒烟依从性的可靠且实用的方法。

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