Usual care in a multicentre randomised controlled trial of financial incentives for smoking cessation in pregnancy: qualitative findings from a mixed-methods process evaluation.

OBJECTIVES: Financial incentives are recommended by the UK's National Institute for Health and Care Excellence to aid smoking cessation in pregnancy. However, little is known about how implementation contexts might impact on their effectiveness. Variations in smoking cessation support (usual care) for pregnant women who smoke were examined qualitatively as part of a prospective process evaluation of the Cessation in Pregnancy Incentives Trial (CPIT III). DESIGN: Longitudinal case studies of five CPIT III trial sites informed by realist evaluation. SETTING: A stop smoking service (SSS) serving a maternity hospital constituted each case study, located in three UK countries. PARTICIPANTS: Data collection included semistructured interviews with trial participants (n=22), maternity (n=12) and SSS staff (n=17); and site observations and perspectives recorded in fieldnotes (n=85). RESULTS: Cessation support (usual care) for pregnant women varied in amount, location, staff capacity, flexibility and content across sites. SSS staff capacity was important to avoid gaps in support. Colocation and good working relationships between maternity and SSS professionals enabled prioritisation and reinforced the importance of smoking cessation. Sites with limited use of carbon monoxide (CO) monitoring reduced opportunities to identify smokers while inconsistency around automatic referral processes prevented the offer of cessation support. SSS professionals colocated within antenatal clinics were available to women they could not otherwise reach. Flexibility around location, timing and tailoring of approaches for support, facilitated initial and sustained engagement and reduced the burden on women. CONCLUSIONS: Trial sites faced varied barriers and facilitators to delivering cessation support, reflecting heterogeneity in usual care. If financial incentives are more effective with concurrent smoking cessation support, sites with fewer barriers and more facilitators regarding this support would be expected to have more promising trial outcomes. Future reporting of trial outcomes will assist in understanding incentives' generalisability across a wide range of usual care settings. TRIAL REGISTRATION NUMBER: ISRCTN15236311.

A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

INTRODUCTION: Smoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%-23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to sudden infant death syndrome, respiratory diseases and increased likelihood of taking up smoking. These risks impact the long-term health of the child with associated increase in health costs. Emerging evidence suggests that offering financial incentives to pregnant women to quit is highly cost effective.This protocol describes the economic evaluation of a multi-centre randomised controlled trial (Cessation in Pregnancy Incentives Trial III, CPIT III) designed to establish whether offering financial incentives, in addition to usual care, is effective and cost effective in helping pregnant women to quit. METHODS AND ANALYSIS: The economic evaluation will identify, measure and value resource use and outcomes from CPIT III, comparing participants randomised to either usual care or usual care plus up to £400 financial incentives. Within-trial and long-term analyses will be conducted from a National Health Service and Personal Social Services perspective; the outcome for both analyses will be quality adjusted life-years measured using EQ-5D-5L. Patient level data collected during the trial will be used for the within-trial analysis, with an additional outcome of cotinine validated quit rates at 34-38 weeks gestation and 6 months postpartum. The long-term model will be informed by data from the trial and published literature. ETHICS AND DISSEMINATION: TRIAL REGISTRATION NUMBER: ISRCTN15236311; Pre-results (https://doi.org/10.1186/ISRCTN15236311).

Impact of maternal smoking on early childhood health: a retrospective cohort linked dataset analysis of 697 003 children born in Scotland 1997-2009.

OBJECTIVE: Smoking during pregnancy is associated with adverse health impacts on mother and child. We used a large linked Scottish dataset to produce contemporary estimates of the impact on child health, particularly hospitalisation. DESIGN: Retrospective cohort study linking birth, death, maternity, infant health, child health surveillance and admission records. We examined the association between smoking status at maternity booking and pregnancy outcomes, hospital admission and death during the first 5 years of life. Models were adjusted for maternal age, socioeconomic status, infant feeding, country of birth, sex, parity and delivery mode. We calculated population attributable fraction (PAF) for each outcome. SETTING: Scotland, UK. PARTICIPANTS: Singleton births between 1997 and 2009 (n=697 003) followed to March 2012. RESULTS: 332 386 children had at least one admission by 31 March 2012. There were 56 588 born small for gestational age, 40 492 prematurely and 1074 postneonatal deaths. Within the first 5 years of life, 56 615 children had at least one admission for acute respiratory infections, 24 088 for bronchiolitis and 7549 for asthma. Maternal smoking significantly increased admission for acute respiratory infections (adjusted HR 1.29, 95% CI 1.25 to 1.34, PAF 6.7%) and bronchiolitis (HR 1.43, 95% CI 1.38 to 1.48 under 1 year, PAF 10.1%), asthma (HR 1.29, 95% CI 1.22 to 1.37 age 1-5 years, PAF 7.1%) and bacterial meningitis (HR 1.49, 95% CI 1.30 to 1.71, PAF 11.8%) age 0-5 years. Neonatal mortality (adjusted OR 1.32, 95% CI 1.17 to 1.49, PAF 6.7%), postneonatal mortality (OR 2.18, 95% CI 1.87 to 2.53, PAF 22.3%), small for gestational age (OR 2.67, 95% CI 2.62 to 2.73, PAF 27.5%) and prematurity (OR 1.41, 95% CI 1.37 to 1.44, PAF 8.8%) were higher among the offspring of smokers. CONCLUSION: Smoking during pregnancy causes significant ill health and death among children born in Scotland. These findings support continued investment to reduce smoking among women before, during and after pregnancy as 50% of women will go on to have further children.