Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

OBJECTIVE: To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. DESIGN: Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. SETTING: One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. PARTICIPANTS: 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. INTERVENTIONS: The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. MAIN OUTCOME MEASURE: The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (<14.2 ng/mL) or urine (<44.7 ng/mL). Secondary outcomes included birth weight, engagement, and self reported quit at four weeks. RESULTS: Recruitment was extended from 12 to 15 months to achieve the target sample size. Follow-up continued until September 2013. Of the 306 women randomised, three controls opted out soon after enrolment; these women did not want their data to be used, leaving 306 intervention and 303 control group participants in the intention to treat analysis. No harms of financial incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) P<0.001. The absolute risk difference was 14.0% (95% confidence interval 8.2% to 19.7%). The number needed to treat (where financial incentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group and 3120 (SD 590) g in the control group (P=0.67). CONCLUSION: This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy; as this was only a single centre trial, incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom. TRIAL REGISTRATION: Current Controlled Trials ISRCTN87508788.

The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial.

BACKGROUND: Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: 'How to stop smoking in pregnancy and following childbirth' (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? DESIGN AND METHODS: This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy.Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? DISCUSSION: This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit. TRIAL REGISTRATION: Current Controlled Trials ISRCTN87508788.

Professional training to reduce children's exposure to second-hand smoke in the home: evidence-based considerations on targeting and content.

AIMS: Proponents of theory-based evaluations argue that the type of evidence needed by public health decision-makers is not simply whether interventions work or not. A more fruitful approach is to understand the contexts and circumstances associated with effectiveness. This article aims: to firstly understand factors influencing professionals' practice following their participation in training that aimed to reduce children's exposure to second-hand smoke (SHS) in the home via increased usage of brief interventions; and secondly to consider the implications of these factors for improving the skills of a diverse workforce. METHODS: Questionnaires were issued to the 231 participants pre- and post-training and at three-month follow-up. Four focus groups and four interviews were run with 16 people who had attended the training in the previous four to eight months and who performed a wide range of professional roles, reflecting the diversity of those trained. RESULTS: The three-month follow-up data indicated that some, but not all, participants had engaged in components of the brief intervention and changed their practice. This difference was largely explained by professional role. Those working in a health-visiting role or team were considered better placed to support families through a process of restricting SHS exposure in the home. Triangulated data also indicated that these professionals more often practised elements of the brief intervention. There was also some evidence that the training did not equip participants with the full range of information they wanted, or with the skills that they felt that they needed. CONCLUSIONS: Decisions on who to target for training need to be informed by an understanding of the contexts in which professionals work and the opportunities and constraints within these. Those working in a health-visiting team are credible message carriers, have opportunities to develop a relationship with families, and can be well placed to provide families with sustained support. To do so, they need clear messages on precisely how to reduce exposure. In addition, they need the skills to support families through a process of change.

Secondhand smoke in cars: assessing children's potential exposure during typical journey conditions.

OBJECTIVE: To measure levels of fine particulate matter in the rear passenger area of cars where smoking does and does not take place during typical real-life car journeys. METHODS: Fine particulate matter (PM(2.5)) was used as a marker of secondhand smoke and was measured and logged every minute of each car journey undertaken by smoking and non-smoking study participants. The monitoring instrument was located at breathing zone height in the rear seating area of each car. Participants were asked to carry out their normal driving and smoking behaviours over a 3-day period. RESULTS: 17 subjects (14 smokers) completed a total of 104 journeys (63 smoking journeys). Journeys averaged 27 min (range 5-70 min). PM(2.5) levels averaged 85 and 7.4 µg/m(3) during smoking and non-smoking car journeys, respectively. During smoking journeys, peak PM(2.5) concentrations averaged 385 µg/m(3), with one journey measuring over 880 µg/m(3). PM(2.5) concentrations were strongly linked to rate of smoking (cigarettes per minute). Use of forced ventilation and opening of car windows were very common during smoking journeys, but PM(2.5) concentrations were still found to exceed WHO indoor air quality guidance (25 µg/m(3)) at some point in the measurement period during all smoking journeys. CONCLUSIONS: PM(2.5) concentrations in cars where smoking takes place are high and greatly exceed international indoor air quality guidance values. Children exposed to these levels of fine particulate are likely to suffer ill-health effects. There are increasing numbers of countries legislating against smoking in cars and such measures may be appropriate to prevent the exposure of children to these high levels of secondhand smoke.