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Background: Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date., Methods/design: The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome., Discussion: This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy., Trial Registration: ISRCTN48600346.

Background: Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services., Methods: A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed., Results: We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR) 1.32 (95%CI: 1.03-1.69). There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06). The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY) gained of £8,500., Conclusions: The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery., Trial Registration: Current Controlled Trials ISRCTN82127540.

Aim: School-based smoking prevention programmes may delay the age of smoking initiation, but do not appear to achieve lasting reductions in smoking prevalence beyond school-leaving age. We explored whether delaying the age at which someone initiates smoking may have life-time benefits by increasing the likelihood of quitting in later life., Design and Setting: Data from the General Household Survey of Great Britain were used in a logistic regression model to examine the association between age at which someone initiates regular smoking and the probability that the person will quit smoking later in life. The effect of confounding variables (sex, ethnicity, socio-economic class, education and geographical location) was taken into account. The predicted relationship was used in a cohort model to estimate the life-time reduction in smoking prevalence and all-cause mortality of a school-based smoking prevention programme., Results: Age of regular smoking initiation was associated strongly with the probability of quitting later in life (coefficient -0.103, P < 0.001). The strength of the association was slightly reduced but still significant when confounding variables were included (coefficient -0.075, P < 0.001). An intervention that delays smoking initiation without decreasing smoking prevalence at age 18 may reduce adult smoking prevalence by 0.13-0.32% (depending on age) and all-cause mortality by 0.09% over the life-time of the sample., Conclusion: School-based smoking prevention programmes have potential for a beneficial effect over the life-time of the participants even if they have no apparent effect at school-leaving age.

Introduction: A Society for Research on Nicotine and Tobacco working group recommended outcome measures for cessation-induction trials and aid-to-cessation trials. Cessation-induction trials aim to motivate unwilling quitters to make a quit attempt. Aid-to-cessation trials give either medication or behavioral interventions to increase the rate at which willing quitters succeed in their attempts. Nicotine-assisted reduction programs combine features of both types of interventions by giving nicotine replacement to unwilling quitters. Treatment can be prolonged more than a year, quit attempts can occur and succeed early or late in the program, and renewed quit attempts are an inherent part of the program. Conventional outcome measures are tied to a fixed but arbitrary point in follow-up and cannot capture the true outcome: Prolonged cessation anchored to the point at which a person makes a successful quit attempt., Discussion: We propose that the outcome should be counted from the successful quit attempt that began during the treatment period and continues for a defined period, ideally 6 months. In particular, if a trial compared a short reduction program with a long reduction program, it would not be possible to obtain an unbiased assessment of the outcome of such a trial using a measure tied to a fixed point in follow-up. Floating prolonged abstinence could provide such an assessment and is suitable for either prolonged cessation-induction trial or combined cessation-induction and aid-to-cessation trials.

To evaluate the relative cost-effectiveness of nicotine replacement therapy (NRT) and bupropion SR for smoking cessation, the authors reviewed published studies and developed a decision analytic model from the UK National Health Services perspective. Irrespective of the methods or assumptions involved, the results of published studies consistently indicated that NRT for smoking cessation is cost-effective. No published studies have evaluated the relative cost-effectiveness of bupropion SR for smoking cessation. The results of the decision analyses indicated that, as compared with advice or counseling alone, the incremental cost per life-years saved is about $1,441-$3,455 for NRT, $920-$2,150 for bupropion SR, and $1,282-$2,836 for NRT plus bupropion SR. The cost-effectiveness of adding NRT and bupropion SR to advice or counseling for smoking cessation is better than many other accepted health care interventions.

Background and Aims: Previous economic evaluations of smoking cessation interventions for pregnant women are limited to single components, which do not in isolation offer sufficient potential impact to address smoking cessation targets. To inform the development of more appropriate complex interventions, we (1) describe the development of the Economics of Smoking in Pregnancy: Household (ESIP.H) model for estimating the life‐time cost‐effectiveness of smoking cessation interventions aimed at pregnant women and (2) use a hypothetical case study to demonstrate how ESIP.H can be used to identify the characteristics of optimum smoking cessation interventions. Methods: The hypothetical intervention was based on current evidence relating to component elements, including financial incentives, partner smoking, intensive behaviour change support, cigarettes consumption and duration of support to 12 months post‐partum. ESIP.H was developed to assess the life‐time health and cost impacts of multi‐component interventions compared with standard National Health Service (NHS) care in England. ESIP.H considers cigarette consumption, partner smoking and some health conditions (e.g. obesity) that were not included in previous models. The Markov model's parameters were estimated based on published literature, expert judgement and evidence‐based assumptions. The hypothetical intervention was evaluated from an NHS perspective. Results: The hypothetical intervention was associated with an incremental gain in quitters (mother and partner) at 12 months postpartum of 249 [95% confidence interval (CI) = 195–304] per 1000 pregnant smokers. Over the long‐term, it had an incremental negative cost of £193 (CI = –£779 to 344) and it improved health, with a 0.50 (CI = 0.36–0.69) increase in quality‐adjusted life years (QALYs) for mothers, partners and offspring, with a 100% probability of being cost‐effective. Conclusions: The Economics of Smoking in Pregnancy: Household model for estimating cost‐effectiveness of smoking cessation interventions aimed at pregnant women found that a hypothetical smoking cessation intervention would greatly extend reach, reduce smoking and be cost‐effective. [ABSTRACT FROM AUTHOR]