Livingstone-Banks Jonathan, Ordóñez-Mena José M, Hartmann-Boyce Jamie
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Cochrane Database Syst Rev. 2019 Jan 9;1(1):CD001118. doi: 10.1002/14651858.CD001118.pub4.
Many smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully.
The aims of this review were to determine the effectiveness of different forms of print-based self-help materials that provide a structured programme for smokers to follow, compared with no treatment and with other minimal contact strategies, and to determine the comparative effectiveness of different components and characteristics of print-based self-help, such as computer-generated feedback, additional materials, tailoring of materials to individuals, and targeting of materials at specific groups.
We searched the Cochrane Tobacco Addiction Group Trials Register, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The date of the most recent search was March 2018.
We included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested print-based materials providing self-help compared with minimal print-based self-help (such as a short leaflet) or a lower-intensity control. We defined 'self-help' as structured programming for smokers trying to quit without intensive contact with a therapist.
We extracted data in accordance with standard methodological procedures set out by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each study and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a random-effects model.
We identified 75 studies that met our inclusion criteria. Many study reports did not include sufficient detail to allow judgement of risk of bias for some domains. We judged 30 studies (40%) to be at high risk of bias for one or more domains.Thirty-five studies evaluated the effects of standard, non-tailored self-help materials. Eleven studies compared self-help materials alone with no intervention and found a small effect in favour of the intervention (n = 13,241; risk ratio (RR) 1.19, 95% confidence interval (CI) 1.03 to 1.37; I² = 0%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for indirect relevance to populations in low- and middle-income countries because evidence for this comparison came from studies conducted solely in high-income countries and there is reason to believe the intervention might work differently in low- and middle-income countries. This analysis excluded two studies by the same author team with strongly positive outcomes that were clear outliers and introduced significant heterogeneity. Six further studies of structured self-help compared with brief leaflets did not show evidence of an effect of self-help materials on smoking cessation (n = 7023; RR 0.87, 95% CI 0.71 to 1.07; I² = 21%). We found evidence of benefit from standard self-help materials when there was brief contact that did not include smoking cessation advice (4 studies; n = 2822; RR 1.39, 95% CI 1.03 to 1.88; I² = 0%), but not when self-help was provided as an adjunct to face-to-face smoking cessation advice for all participants (11 studies; n = 5365; RR 0.99, 95% CI 0.76 to 1.28; I² = 32%).Thirty-two studies tested materials tailored for the characteristics of individual smokers, with controls receiving no materials, or stage-matched or non-tailored materials. Most of these studies used more than one mailing. Pooling studies that compared tailored self-help with no self-help, either on its own or compared with advice, or as an adjunct to advice, showed a benefit of providing tailored self-help interventions (12 studies; n = 19,190; RR 1.34, 95% CI 1.20 to 1.49; I² = 0%) with little evidence of difference between subgroups (10 studies compared tailored with no materials, n = 14,359; RR 1.34, 95% CI 1.19 to 1.51; I² = 0%; two studies compared tailored materials with brief advice, n = 2992; RR 1.13, 95% CI 0.86 to 1.49; I² = 0%; and two studies evaluated tailored materials as an adjunct to brief advice, n = 1839; RR 1.72, 95% CI 1.17 to 2.53; I² = 10%). When studies compared tailored self-help with non-tailored self-help, results favoured tailored interventions when the tailored interventions involved more mailings than the non-tailored interventions (9 studies; n = 14,166; RR 1.42, 95% CI 1.20 to 1.68; I² = 0%), but not when the two conditions were contact-matched (10 studies; n = 11,024; RR 1.07, 95% CI 0.89 to 1.30; I² = 50%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for risk of bias.Five studies evaluated self-help materials as an adjunct to nicotine replacement therapy; pooling three of these provided no evidence of additional benefit (n = 1769; RR 1.05, 95% CI 0.86 to 1.30; I² = 0%). Four studies evaluating additional written materials favoured the intervention, but the lower confidence interval crossed the line of no effect (RR 1.20, 95% CI 0.91 to 1.58; I² = 73%). A small number of other studies did not detect benefit from using targeted materials, or find differences between different self-help programmes.
AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that when no other support is available, written self-help materials help more people to stop smoking than no intervention. When people receive advice from a health professional or are using nicotine replacement therapy, there is no evidence that self-help materials add to their effect. However, small benefits cannot be excluded. Moderate-certainty evidence shows that self-help materials that use data from participants to tailor the nature of the advice or support given are more effective than no intervention. However, when tailored self-help materials, which typically involve repeated assessment and mailing, were compared with untailored materials delivered similarly, there was no evidence of benefit.Available evidence tested self-help interventions in high-income countries, where more intensive support is often available. Further research is needed to investigate effects of these interventions in low- and middle-income countries, where more intensive support may not be available.
许多吸烟者能够自行戒烟,但为吸烟者提供结构化戒烟计划的材料可能会增加成功戒烟的人数。
本综述旨在确定与无治疗及其他低强度接触策略相比,不同形式的基于印刷品的自助材料(为吸烟者提供结构化戒烟计划)的有效性,并确定基于印刷品的自助材料的不同组成部分和特征(如计算机生成的反馈、额外材料、针对个体的材料定制以及针对特定群体的材料)的相对有效性。
我们检索了Cochrane烟草成瘾小组试验注册库、ClinicalTrials.gov和国际临床试验注册平台(ICTRP)。最近一次检索日期为2018年3月。
我们纳入了随访至少六个月的戒烟随机试验,其中至少有一组测试了基于印刷品的自助材料,并与最低限度的基于印刷品的自助材料(如简短传单)或低强度对照进行比较。我们将“自助”定义为为试图戒烟的吸烟者提供结构化计划,且无需与治疗师进行密集接触。
我们按照Cochrane制定的标准方法程序提取数据。主要结局指标是基线吸烟的人在至少六个月随访后的戒烟情况。我们采用了每项研究中最严格的戒烟定义,并在可行时采用生化验证率。在适当情况下,我们使用随机效应模型进行荟萃分析。
我们确定了75项符合纳入标准的研究。许多研究报告没有包含足够的细节,无法判断某些领域的偏倚风险。我们判定30项研究(40%)在一个或多个领域存在高偏倚风险。35项研究评估了标准的、非定制的自助材料的效果。11项研究将单独的自助材料与无干预进行比较,发现干预有小的效果(n = 13241;风险比(RR)1.19,95%置信区间(CI)1.03至1.37;I² = 0%)。根据GRADE,我们判定该证据为中等确定性,因与低收入和中等收入国家人群的间接相关性而降级,因为该比较的证据仅来自高收入国家进行的研究,且有理由相信该干预在低收入和中等收入国家可能效果不同。该分析排除了同一作者团队的两项结果非常积极的研究,这两项研究明显是异常值并引入了显著的异质性。另外六项将结构化自助与简短传单进行比较的研究未显示自助材料对戒烟有效果的证据(n = 7023;RR 0.87,95% CI 0.71至1.07;I² = 21%)。我们发现当有不包括戒烟建议的简短接触时,标准自助材料有获益证据(4项研究;n = 2822;RR 1.39,95% CI 1.03至1.88;I² = 0%),但当为所有参与者提供自助作为面对面戒烟建议的辅助时则没有(11项研究;n = 5365;RR 0.99,95% CI 0.76至1.28;I² = 32%)。32项研究测试了针对个体吸烟者特征定制的材料,对照组未接受材料,或接受阶段匹配或非定制的材料。这些研究大多使用了不止一次邮寄。汇总比较定制自助与无自助(单独或与建议相比,或作为建议的辅助)的研究表明,提供定制自助干预有获益(12项研究;n = 19190;RR 1.34,95% CI 1.20至1.49;I² = 0%),亚组间差异证据很少(10项研究比较定制与无材料,n = 14359;RR 1.34,95% CI 1.19至1.51;I² = 0%;两项研究比较定制材料与简短建议,n = 2992;RR 1.13,95% CI 0.86至1.49;I² = 0%;两项研究评估定制材料作为简短建议的辅助,n = 1839;RR 1.72,95% CI 1.17至2.53;I² = 10%)。当研究比较定制自助与非定制自助时,当定制干预比非定制干预涉及更多邮寄时,结果有利于定制干预(9项研究;n = 14166;RR 1.42,95% CI 1.20至1.68;I² = 0%),但当两种情况接触匹配时则不然(10项研究;n = 11024;RR 1.07,95% CI 0.89至1.30;I² = 50%)。根据GRADE我们判定该证据为中等确定性,因偏倚风险而降级。5项研究评估了自助材料作为尼古丁替代疗法的辅助;汇总其中3项未提供额外获益的证据(n = 1769;RR 1.05,95% CI 0.86至1.30;I² = 0%)。4项评估额外书面材料的研究支持干预,但较低的置信区间跨越了无效果线(RR 1.20,95% CI 0.91至1.58;I² = 73%)。少数其他研究未检测到使用针对性材料的获益,或未发现不同自助计划之间的差异。
中等确定性证据表明,在没有其他支持的情况下,书面自助材料比无干预能帮助更多人戒烟。当人们从健康专业人员处获得建议或正在使用尼古丁替代疗法时,没有证据表明自助材料会增加其效果。然而,不能排除有小的获益。中等确定性证据表明,利用参与者数据定制所提供建议或支持性质的自助材料比无干预更有效。然而,当将通常涉及重复评估和邮寄的定制自助材料与以类似方式提供的非定制材料进行比较时,没有获益的证据。现有证据在高收入国家测试了自助干预,在这些国家通常可获得更强化的支持。需要进一步研究来调查这些干预在低收入和中等收入国家的效果,在这些国家可能无法获得更强化的支持。