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一项在初级保健中实施的优化戒烟治疗的随机对照试验。

A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care.

机构信息

Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

University of Wisconsin School of Medicine and Public Health, Department of Medicine, Madison, WI, USA.

出版信息

Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.

DOI:10.1093/abm/kax059
PMID:30212849
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6135958/
Abstract

BACKGROUND

The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings.

PURPOSE

To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST).

METHODS

Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence.

RESULTS

A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800.

CONCLUSIONS

A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care.

CLINICAL TRIAL REGISTRATION

NCT02301403.

摘要

背景

戒烟治疗在实际应用中的效果有限,这或许是因为我们没有优化此类治疗的组成部分,也没有为实际临床环境开发和评估过治疗方法。

目的

验证一种经多阶段最优策略(MOST)因素筛查实验确认有效的戒烟治疗方案。

方法

从初级保健诊所招募有戒烟意愿的成年吸烟者(N=623)。参与者被随机分配接受推荐的常规护理(R-UC;10 分钟的面询、8 周尼古丁贴片和戒烟热线服务转诊)或戒烟优化治疗(A-OT;3 周预戒烟迷你锭、26 周尼古丁贴片+迷你锭、3 次面询和 8 次电话咨询以及 7-11 次自动电话提醒用药)。主要结局是自我报告和生物化学确认(一氧化碳,CO<6 ppm)的 7 天点前戒烟率。

结果

A-OT 组参与者的自我报告戒烟率在 4、8、16 和 26 周时显著高于 R-UC 组(OR:1.91-3.05;p<0.001)。生物化学确认的 26 周戒烟率低于自我报告的 26 周率,但显示出相似的治疗效果大小(OR=2.94,p<0.001)。在 26 周的戒烟率上,人口统计学、精神病学或尼古丁依赖变量没有调节治疗效果。A-OT 在 26 周 CO 确认的戒烟方面具有 7800 美元的增量成本效益比。

结论

通过 MOST 开发进行优化的戒烟治疗方案,在初级保健环境中接受治疗的吸烟者中,显著提高了戒烟率,超过了 R-UC 吸烟治疗。

临床试验注册

NCT02301403。

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