Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation.
Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation.
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在互联网和电话戒烟治疗随机试验中使用非指定干预措施。
DOI：
10.1093/ntr/ntu066
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发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Graham,AmandaL
中科院分区：
文献类型：
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作者：
Cobb,CarolineO;Graham,AmandaL
前言最近一项关于互联网戒烟干预措施的荟萃分析发现了关于有效性的混合证据。一种解释可能是不同地使用非指定的戒烟治疗-包括其他互联网程序-放大或掩盖研究干预效果。我们在iQUITT研究中检验了非指定治疗使用对戒烟结果的影响。iQUITT研究是一项关于互联网和电话戒烟治疗的随机试验。方法参与者被随机分为基本互联网(BI)比较条件(N=675)、增强互联网(EI：651)或EI+电话咨询(EI+P：N=679)。主要结果是在3个月和6个月时30天的时点戒断(PPA)。使用自动跟踪数据评估分配的干预使用。对非指定治疗的评估包括药物治疗、行为治疗、替代治疗和非研究互联网治疗。单变量和多变量Logistic回归模型检验了非指定治疗使用是否与30天PAA相关。结果约70%的参与者使用了至少一种非指定治疗。在BI参与者中，非研究性互联网治疗的比率较高是治疗组在3个月和6个月时唯一的差异。控制条件和非指定治疗使用的基线预测因素的多变量模型显示，高强度非研究互联网治疗与3个月和6个月的30天PPA呈正相关，药物治疗和行为治疗的使用与6个月的30天PPA呈负相关。结论非指定治疗使用是评估互联网戒断干预的一个重要因素。结果突出了在选择比较条件时的方法学问题。研究人员应在报告主要试验结果的同时报告非分配治疗的使用情况。
IntroductionA 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 The iQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation.MethodsParticipants 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.ResultsAbout 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.ConclusionsNon-assigned treatment use is an important factor to consider when evaluating Internet cessation interventions. Results highlight methodological issues in selecting a comparison condition. Researchers should report non-assigned treatment use alongside main trial outcomes.