哮喘联盟

   摘要
   简介：一项最近的关于网络治疗戒烟的荟萃分析表明其疗效证据不一致。一种可能原因是试验过程中不同的“非指定”戒烟治疗措施（包括其它网络干预措施）夸大或掩盖了试验干预效果。本文旨在分析iQUITT研究（一项关于网络和电话治疗戒烟的随机对照研究）中非指定干预措施对戒烟效果的影响。
   方法：受试者被随机分为三组：基础网络对照组（BI组，共675人）、强化网络干预组（EI组，共651人）、EI结合电话咨询组（EI+P组，共679人）。主要的评估指标为3个月及6个月后的30天戒烟率（ppa）。采用自动跟踪数据评估“指定”干预措施的应用情况。“非指定”干预措施的评估包括药物治疗、行为治疗、备选治疗和非研究内的网络治疗。采用单变量和多变量逻辑回归模型分析非指定干预措施是否与30天ppa有关。
   结果：约有70%受试者至少使用了一种非指定干预措施。3个月和6个月时，仅BI组受试者采用非研究内网络治疗的比率更高。用以控制非指定干预措施应用情况和基线预测因素的多变量分析模型结果显示：高强度的非研究内网络治疗与3个月及6个月的30天ppa呈正相关，而药物治疗和行为治疗与6个月的30天ppa呈负相关。
   结论：在评估网络戒烟治疗时，非指定干预措施的使用是需要考虑的一个重要因素。本研究结果强调了临床试验在选择对照组时的方法学问题。除了主要试验结果，研究者还应该报道非指定干预措施的应用情况。
 

（刘国梁 审校）
Nicotine Tob Res. 2014 May 8. [Epub ahead of print]

 

Use of "Non-assigned" Interventions in a Randomized Trial of Internet and Telephone Treatment for Smoking Cessation.
 

Cobb CO1, Graham AL.
 

ABSTRACT
INTRODUCTION:A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness. One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects. We examined the impact of non-assigned treatment use on cessation outcomes in TheiQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation.
METHODS: Participants were randomized to a basic Internet (BI) comparison condition (N = 675), enhanced Internet (EI: N = 651), or EI plus telephone counseling (EI+P: N = 679). The primary outcome was 30-day point prevalence abstinence (ppa) at 3 and 6 months. "Assigned" intervention use was assessed with automated tracking data. Assessment of "non-assigned" treatments included pharmacotherapy, behavioral, alternative, and non-study Internet treatments. Univariate and multivariate logistic regression models examined whether non-assigned treatment use was associated with 30-day ppa.
RESULTS: About 70% of participants used at least one non-assigned treatment. A higher rate of non-study Internet treatment among BI participants was the only treatment group difference at both 3 and 6 months. Multivariate models controlling for condition and baseline predictors of non-assigned treatment use showed that high-intensity non-study Internet treatment was positively associated with 30-day ppa at 3 and 6 months, and pharmacotherapy and behavioral treatment use was negatively associated with 30-day ppa at 6 months.
CONCLUSIONS: Non-assigned treatment use is an important factor to consider in evaluating Internet cessation interventions. Results highlight methodological issues in selecting a comparison condition. Researchers should report non-assigned treatment use alongside main trial outcomes.
 

Nicotine Tob Res. 2014 May 8. [Epub ahead of print]