Smoking cessation advice recorded during pregnancy in United Kingdom primary care

Background: United Kingdom (UK) national guidelines recommend that all pregnant women who smoke should be advised to quit at every available opportunity, and brief cessation advice is an efficient and cost-effective means to increase quit rates. The Quality and Outcomes Framework (QOF) implemented in 2004 requires general practitioners to document their delivery of smoking cessation advice in patient records. However, no specific targets have been set in QOF for the recording of this advice in pregnant women. We used a large electronic primary care database from the UK to quantify the pregnancies in which women who smoked were recorded to have been given smoking cessation advice, and the associated maternal characteristics. Methods: Using The Health Improvement Network database we calculated annual propotions of pregnant smokers between 2000 and 2009 with cessation advice documented in their medical records during pregnancy. Logistic regression was used to assess variation in the recording of cessation advice with maternal characteristics. Results: Among 45,296 pregnancies in women who smoked, recorded cessation advice increased from 7% in 2000 to 37% in 2004 when the QOF was introduced and reduced slightly to 30% in 2009. Pregnant smokers from the youngest age group (15–19) were 21% more likely to have a record of cessation advice compared to pregnant smokers aged 25–29 (OR 1.21, 95% CI 1.10-1.35) and pregnant smokers from the most deprived group were 38% more likely to have a record for cessation advice compared to pregnant smokers from the least deprived group (OR 1.38, 95% CI 1.14-1.68). Pregnant smokers with asthma were twice as likely to have documentation of cessation advice in their primary care records compared to pregnant smokers without asthma (OR 1.97, 95% CI 1.80-2.16). Presence of comorbidities such as diabetes, hypertension and mental illness also increased the likelihood of having smoking cessation advice recorded. No marked variations were observed in the recording of cessation advice with body mass index. Conclusion: Recorded delivery of smoking cessation advice for pregnant smokers in primary care has increased with some fluctuation over the years, especially after the implementation of the QOF, and varies with maternal characteristics

Pharmacological interventions for promoting smoking cessation during pregnancy

Background Smoking in pregnancy is a public health problem. When used by non-pregnant smokers, pharmacotherapies (nicotine replacement therapy (NRT), bupropion and varenicline) are effective for smoking cessation, however, their efficacy and safety in pregnancy remains unknown. Electronic Nicotine Delivery Systems (ENDS), or e-cigarettes, are becoming widely used but their efficacy and safety when used for smoking cessation in pregnancy are also unknown. Objectives To determine the efficacy and safety of smoking cessation pharmacotherapies (including NRT, varenicline and bupropion), other medications, or ENDS when used for smoking cessation in pregnancy. Search methods We searched the Pregnancy and Childbirth Group's Trials Register (11 July 2015), checked references of retrieved studies, and contacted authors. Selection criteria Randomised controlled trials (RCTs) conducted in pregnant women with designs that permit the independent effects of any type of pharmacotherapy or ENDS on smoking cessation to be ascertained were eligible for inclusion. The following RCT designs are included. Placebo-RCTs: any form of NRT, other pharmacotherapy, or ENDS, with or without behavioural support/cognitive behaviour therapy (CBT), or brief advice, compared with an identical placebo and behavioural support of similar intensity. RCTs providing a comparison between i) any form of NRT, other pharmacotherapy, or ENDS added to behavioural support/CBT, or brief advice and ii) behavioural support of similar (ideally identical) intensity. Parallel- or cluster-randomised trials were eligible for inclusion. Quasi-randomised, cross-over and within-participant designs were not, due to the potential biases associated with these designs. Data collection and analysis Two review authors independently assessed trials for inclusion and risk of bias and also independently extracted data and cross checked individual outcomes of this process to ensure accuracy. The primary efficacy outcome was smoking cessation in later pregnancy (in all but one trial, at or around delivery); safety was assessed by 11 outcomes (principally birth outcomes) that indicated neonatal and infant well-being; and we also collated data on adherence with trial treatments. Main results This review includes a total of nine trials which enrolled 2210 pregnant smokers: eight trials of NRT and one trial of bupropion as adjuncts to behavioural support/CBT. The risk of bias was generally low across trials with virtually all domains of the 'Risk of bias' assessment tool being satisfied for the majority of studies. We found no trials investigating varenicline or ENDS. Compared to placebo and non-placebo controls, there was a difference in smoking rates observed in later pregnancy favouring use of NRT (risk ratio (RR) 1.41, 95% confidence interval (CI) 1.03 to 1.93, eight studies, 2199 women). However, subgroup analysis of placebo-RCTs provided a lower RR in favour of NRT (RR 1.28, 95% CI 0.99 to 1.66, five studies, 1926 women), whereas within the two non-placebo RCTs there was a strong positive effect of NRT, (RR 8.51, 95% CI 2.05 to 35.28, three studies, 273 women; P value for random-effects subgroup interaction test = 0.01). There were no differences between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities or neonatal death. Compared to placebo group infants, at two years of age, infants born to women who had been randomised to NRT had higher rates of 'survival without developmental impairment' (one trial). Generally, adherence with trial NRT regimens was low. Non-serious side effects observed with NRT included headache, nausea and local reactions (e.g. skin irritation from patches or foul taste from gum), but these data could not be pooled. Authors' conclusions NRT used in pregnancy for smoking cessation increases smoking cessation rates measured in late pregnancy by approximately 40%. There is evidence, suggesting that when potentially-biased, non-placebo RCTs are excluded from analyses, NRT is no more effective than placebo. There is no evidence that NRT used for smoking cessation in pregnancy has either positive or negative impacts on birth outcomes. However, evidence from the only trial to have followed up infants after birth, suggests use of NRT promotes healthy developmental outcomes in infants. Further research evidence on NRT efficacy and safety is needed, ideally from placebo-controlled RCTs which achieve higher adherence rates and which monitor infants' outcomes into childhood. Accruing data suggests that it would be ethical for future RCTs to investigate higher doses of NRT than those tested in the included studies