电子尼古丁递送系统随机对照试验中,对减少吸烟感兴趣的人的减员预测因素。

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Caroline O. Cobb , Serenity Budd , Gabrielle Maldonado , Rabia Imran , Jonathan Foulds , Jessica Yingst , Miao-Shan Yen , Le Kang , Shumei Sun , Phoebe Brosnan Hall , Nadia Chowdhury , Joanna E. Cohen
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引用次数: 0

摘要

背景:减少自然减员是纵向随机对照试验(RCT)中减少选择偏差的关键环节。很少有关于电子尼古丁给药系统(ENDS)的研究能够对长期保留率进行检查。本分析探讨了在为期24周的干预期间,在尼古丁给药方式不同的ENDS中,自然减员、基线测量和分配条件之间的关系:每天吸烟≥10支[CPD]且吸烟时间≥1年并表示有兴趣减少吸烟但不戒烟的参与者(N = 520)被随机分配到4种条件中的一种:含有0、8或36毫克/毫升液态尼古丁的ENDS(双盲给药)或香烟形状的塑料管。通过拟合 Cox 比例危险回归模型,研究了随时间推移的自然减员情况以及自然减员的预测因素,包括基线特征和条件。采用逐步法确定最终模型;α设为 0.05:不同情况下的自然减员差异不大(223/520),大多数(69%)患者都失去了随访机会。只有年龄、教育水平和家庭收入对自然减员有明显的预测作用。年龄每增加一岁,流失风险就会降低 3%。拥有学士学位或更高学历与降低流失风险有关。收入最低的人群(结论:ENDS尼古丁含量并没有降低流失风险:在这项试验中,ENDS尼古丁含量并没有导致不同的流失率,因此需要针对特定亚群开展有针对性的保留工作。试验注册号:NCT02342795。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction

Background

Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention period.

Methods

Participants (N = 520) who smoked ≥10 cigarettes per day [CPD] for ≥1 year and reported interest in reducing but not quitting were randomized to 1 of 4 conditions: an ENDS containing 0, 8, or 36 mg/ml liquid nicotine (administered double-blind) or a cigarette-shaped plastic tube. Cox proportional hazards regression models were fit to examine attrition over time and predictors of attrition including baseline characteristics and condition. A stepwise approach was used to determine the final model; alpha was set at 0.05.

Results

Attrition did not differ significantly by condition (223/520), and most (69%) were lost-to-follow-up. Only age, education level, and household income were significantly predictive of attrition. For every additional year of age, attrition risk fell by 3%. Holding a bachelor's degree or higher was associated with reduced attrition risk. Those with the lowest income (<$10 K) were more likely to be withdrawn compared to those earning $10 K–39 K, and those with the highest income ($100 K+) were more likely to be withdrawn compared with the latter bracket and those earning $70-99 K.

Conclusion

ENDS nicotine content did not drive differential attrition in this trial, and targeted retention efforts are needed for specific subgroups.

Trial Registration #: NCT02342795

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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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