Norwich Medical School, Faculty of Medicine and Health Science, University of East Anglia, Norwich NR4 7TJ, UK.
Trials. 2012 May 30;13:69. doi: 10.1186/1745-6215-13-69.
Most people who stop smoking successfully for a few weeks will return to smoking again in the medium term. There are few effective interventions to prevent this relapse and none used routinely in clinical practice. A previous exploratory meta-analysis suggested that self-help booklets may be effective but requires confirmation. This trial aims to evaluate the effectiveness and cost-effectiveness of a set of self-help educational materials to prevent smoking relapse in the National Health Service (NHS) Stop Smoking Service.
METHODS/DESIGN: This is an open, randomized controlled trial. The target population is carbon monoxide (CO) verified quitters at four weeks in the NHS stop smoking clinic (total sample size N = 1,400). The experimental intervention tested is a set of eight revised Forever Free booklets, including an introduction booklet and more extensive information on all important issues for relapse prevention. The control intervention is a leaflet that has no evidence to suggest it is effective but is currently given to some patients using NHS stop smoking services. Two follow-up telephone interviews will be conducted at three and 12 months after the quit date. The primary outcome will be prolonged abstinence from months four to 12 with no more than five lapses, confirmed by a CO test at the 12-month assessment. The secondary outcomes will be seven-day self-report point prevalence abstinence at three months and seven-day biochemically confirmed point prevalence abstinence at 12 months. To assess cost-effectiveness, costs will be estimated from a health service perspective and the EQ-5D will be used to estimate the QALY (Quality Adjusted Life Year) gain associated with each intervention. The comparison of smoking abstinence rates (and any other binary outcomes) between the two trial arms will be carried out using odds ratio as the outcome statistic and other related statistical tests. Exploratory subgroup analyses, including logistic regression analyses with interaction terms, will be conducted to investigate possible effect-modifying variables.
The possible effect of self-help educational materials for the prevention of smoking relapse has important public health implications.
Current Controlled Trials ISRCTN36980856.
大多数成功戒烟数周的人在中期内会再次复吸。目前几乎没有有效的干预措施来预防这种复发，也没有一种干预措施在临床实践中常规使用。先前的探索性荟萃分析表明，自助手册可能有效，但需要证实。本试验旨在评估一套自助教育材料在英国国民健康服务（NHS）戒烟服务中预防吸烟复发的有效性和成本效益。
方法/设计：这是一项开放、随机对照试验。目标人群是 NHS 戒烟诊所中四周时经一氧化碳（CO）验证的戒烟者（总样本量 N=1400）。测试的实验组干预措施是一套修订后的 8 本《永远自由》手册，包括一本介绍手册和更广泛的关于预防复发的所有重要问题的信息。对照组干预措施是一种目前在使用 NHS 戒烟服务的一些患者中使用的没有证据表明其有效的传单。戒烟日期后三个月和 12 个月将进行两次随访电话访谈。主要结局是在四个月到十二个月期间持续戒烟，没有超过五次复发，在 12 个月评估时通过 CO 测试确认。次要结局是三个月时 7 天自我报告点流行率戒烟和 12 个月时 7 天生物化学确认点流行率戒烟。为了评估成本效益，将从卫生服务角度估算成本，并使用 EQ-5D 估算与每种干预措施相关的 QALY（质量调整生命年）收益。将使用优势比作为结局统计量，对两种试验组的吸烟戒断率（和任何其他二分类结局）进行比较，同时还将进行其他相关统计检验。将进行探索性亚组分析，包括带有交互项的逻辑回归分析，以调查可能的效应修饰变量。
预防吸烟复发的自助教育材料的可能效果对公共卫生具有重要意义。
当前对照试验 ISRCTN36980856。
