Tim Coleman

Environmental tobacco smoke and fetal health: systematic review and meta-analysis

Objective: To determine the effects of environmental tobacco smoke (ETS) exposure on birth outcomes. Design: A systematic review and meta-analysis was performed in accordance with MOOSE guidelines. MEDLINE, EMBASE, CINAHL and LILACS (up to October 2007), were searched and also reviews and reference lists from publications, with no language restrictions. Pooled mean differences and odds ratios (ORs) with 95% confidence intervals were estimated using data extracted from papers, based on random effect models. Setting: Comparative epidemiological studies. Patients: Pregnant women or women who have given birth. Exposures: Maternal exposure to ETS during pregnancy. Main outcome measures: Mean birth weight and proportion of premature infants. Results: 58 studies were included; 53 used cohort designs, 23 ascertaining ETS exposure prospectively and 30 retrospectively; 5 used case–control designs. In prospective studies, ETS exposure was associated with a 33 g (95% CI 16 to 51) reduction in mean birth weight, and in retrospective studies a 40 g (95% CI 26 to 54) reduction. ETS exposure was also associated with an increased risk of low birth weight (birth weight <2500 g; prospective studies: OR 1.32, 95% CI 1.07 to 1.63; retrospective studies: OR 1.22, 95% CI 1.08 to 1.37). The risk of small for gestational age (<10th centile) birth was significantly associated with ETS exposure only in retrospective studies (OR 1.21, 95% CI 1.06 to 1.37). There was no effect of ETS exposure on gestational age. Conclusions: Exposure of non-smoking pregnant women to ETS reduces mean birth weight by 33 g or more, and increases the risk of birth weight below 2500 g by 22%, but has no clear effect on gestation or the risk of being small for gestational age.

A systematic review of the effectiveness of smoking relapse prevention interventions for abstinent smokers

AIMS To carry out a systematic review of the effectiveness of relapse prevention interventions (RPIs) among abstinent smokers who had completed an initial course of treatment or who had abstained unassisted, pooling only outcome data from similar follow-up time points. METHODS We used the same search strategy as was used in Cochrane reviews of RPIs to identify randomized trials of behavioural and pharmacological studies of smoking RPIs published up to July 2008. Abstinence from smoking was defined as either continuous abstinence or point prevalence abstinence, measured at three follow-up time points: short term (1-3 months post randomization), medium term (6-9 months) and long term (12-18 months). Abstinence among pregnant/postpartum women was also measured at delivery or the last follow-up prior to delivery. Random effect meta-analysis was used to estimate pooled odds ratios (OR) with 95% confidence intervals (CI). RESULTS Thirty-six studies randomizing abstainers were included. Self-help materials appeared to be effective in preventing relapse at long-term follow up in initially unaided quitters (pooled OR 1.52; 95% CI 1.15 to 2.01, I2 = 0%, NNT = 11, 3 studies). Other behavioural interventions for relapse prevention appeared effective in the short term only. There were positive results for the use of pharmacotherapies for relapse prevention. Bupropion was effective at long-term follow-up (pooled OR 1.49; 95% CI 1.10 to 2.01; I2 = 0%; NNT = 11; 4 studies). Nicotine replacement therapy (NRT) was effective at medium-term (pooled OR 1.56; 95% CI 1.16 to 2.11; I2 = 37%; NNT = 14; 4 trials) and long-term follow-ups (pooled OR 1.33; 95% CI 1.08 to 1.63; I2 = 0%; NNT = 20; 4 trials). Single trials of extended treatment of Varenicline and rimonabant were also found to be effective at short-term and medium-term follow-ups. CONCLUSIONS Self-help materials appear to prevent relapse in initially unaided quitters. Use of NRT, bupropion and varenicline appears to be effective in preventing relapse following an initial period of abstinence or an acute treatment episode. There is currently no good evidence that behavioural support prevents relapse after initial unaided abstinence or following an acute treatment period.

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.

Nicotine replacement therapy in pregnancy

Is probably safer than smoking Smoking harms unborn children. It increases the risk of growth restriction, preterm birth, miscarriage, and perinatal death,1 2 but despite this over a quarter of pregnant women in the United Kingdom smoke.3 Pregnancy motivates a minority to stop for at least part of the pregnancy, but most start again after giving birth.3 Compared with women who manage to stop, those who continue are younger and less educated; more likely to be single and in manual occupations;4 and much less likely to perceive smoking as a risk to their baby.3 Reducing smoking in pregnancy is an obvious health priority, but progress has been slow.3 Non-pregnant smokers are most likely to quit if offered a combination of behavioural support and pharmacotherapy with either nicotine replacement therapy5 or bupropion.6 The addition of pharmacotherapy increases quit rates obtained with behavioural support by 1.5-fold to 2-fold. Behavioural support is also effective in pregnancy,7 but is usually provided alone because of concerns that drugs may harm the fetus.8 This is understandable for bupropion, which is an avoidable drug, …

Impact of UK National Health Service smoking cessation services: variations in outcomes in England

Objectives: To determine the extent to which UK National Health Service (NHS) smoking cessation services in England reach smokers and support them to quit at four weeks, and to identify which service and area characteristics contribute to observed outcomes. Design: Ordinary least squares regression was used to investigate local smoking outcomes in relation to characteristics of health authorities and their smoking cessation services. Setting: 76 health authorities (from a total of 99) in England from April 2000 to March 2001. Main outcome measures:Reach—number of smokers attending cessation services and setting a quit date as a percentage of the adult smoking population in each health authority. Absolute success—number of smokers setting a quit date who subsequently reported quitting at four weeks (not having smoked between two and four weeks after quit date). Cessation rate—number of smokers who reported quitting at four weeks as a percentage of those setting a quit date. Loss—percentage lost to follow up. Results: A range of service and area characteristics was associated with each outcome. For example, group support proved more effective than one to one interventions in helping a greater proportion of smokers to quit at four weeks. Services based in health action zones were reaching larger numbers of smokers. However, services operating in deprived communities achieved lower cessation rates than those in more prosperous areas. Conclusions: Well developed, evidence based NHS smoking cessation services, reflecting good practice, are yielding positive outcomes in England. However, most of the data are based on self reported smoking status at four weeks. It will be important to obtain validated data about continuous cessation over one year or more in order to assess longer term impact.

Can data from primary care medical records be used to monitor national smoking prevalence

Background Data from primary care records could potentially provide more comprehensive population-level information on smoking prevalence at lower cost and in a more timely fashion than commissioned national surveys. Therefore, we compared smoking prevalence calculated from a database of primary care electronic medical records with that from a ‘gold standard’ national survey to determine whether or not medical records can provide accurate population-level data on smoking. Methods For each year from 2000 to 2008, the annual recorded prevalence of current smoking among patients in The Health Improvement Network (THIN) Database was compared with the ‘General Household Survey (GHS)-predicted prevalence’ of smoking in the THIN population, calculated through indirect standardisation by applying age-, sex- and region-specific smoking rates from the corresponding GHS to the THIN population. Results Completeness of smoking data recording in THIN improved steadily in the study period. By 2008, there was good agreement between recorded smoking prevalence in THIN and the GHS-predicted prevalence; the GHS-predicted prevalence of current smoking in the THIN population was 21.8% for men and 20.2% for women, and the recorded prevalence was 22.4% and 18.9%, respectively. Conclusions The prevalence of current smoking recorded within THIN has converged towards that which would be expected if GHS smoking rates are applied to the THIN population. Data from electronic primary care databases such as THIN may provide an alternative means of monitoring national smoking prevalence.

Unplanned attempts to quit smoking: missed opportunities for health promotion?

OBJECTIVES To investigate the occurrence, determinants and reported success of unplanned and planned attempts to quit smoking, and sources of support used in these attempts. DESIGN Cross-sectional questionnaire survey of 3512 current and ex-smokers. SETTING Twenty-four general practices in Nottinghamshire, UK. PARTICIPANTS Individuals who reported making a quit attempt within the last 6 months. MEASUREMENTS Occurrence, triggers for, support used and success of planned and unplanned quit attempts. RESULTS A total of 1805 (51.4%) participants returned completed questionnaires, reporting 394 quit attempts made within the previous 6 months of which 37% were unplanned. Males were significantly more likely to make an unplanned quit attempt [adjusted odds ratio (OR) 1.60, 95% confidence interval (CI) 1.04-2.46], but the occurrence of unplanned quit attempts did not differ significantly by socio-economic group or amount smoked. The most common triggers for unplanned quit attempts were advice from a general practitioner or health professional (27.9%) and health problems (24.5%). 5.4% and 4.1% of unplanned quit attempts used National Health Service cessation services on a one to one and group basis, respectively, and more than half (51.7%) were made without any support. Nevertheless, unplanned attempts were more likely to be reported to be successful (adjusted OR 2.01, 95% CI 1.23-3.27, P < 0.01). CONCLUSIONS Unplanned quit attempts are common among smokers in all socio-demographic groups, are triggered commonly by advice from a health professional and are more likely to succeed; however, the majority of these unplanned attempts are unsupported. It is important to develop methods of providing behavioural and/or pharmacological support for these attempts, and determine whether these increase cessation rates still further.

The impact of the Quality and Outcomes Framework (QOF) on the recording of smoking targets in primary care medical records: cross-sectional analyses from The Health Improvement Network (THIN) database

BackgroundSmoking is a UK public health threat but GPs can be effective in helping patients to quit; consequently, the Quality and Outcomes Framework (QOF) incentivises the recording of smoking status and delivery of cessation advice in patients’ medical records. This study investigates the association between smoking-related QOF targets and such recording, and the factors which influence these clinical activities.MethodsFor 2000 to 2008, using medical records in The Health Improvement Network (THIN) database, the annual proportions of i) patients who had a record of smoking status made in the previous 27 months and ii) current smokers recorded as receiving cessation advice in the previous 15 months were calculated. Then, for all patients at selected points before and after the QOF’s implementation, data on gender, age, Townsend score, and smoking-related morbidity were extracted. Multivariate logistic regression was used to investigate individual-level characteristics associated with the recording of smoking status and cessation advice.ResultsRapid increases in recording smoking status and advice occurred around the QOF’s introduction in April 2004. Subsequently, compliance to targets has been sustained, although rates of increase have slowed. By 2008 64.5% of patients aged 15+ had smoking status documented in the previous 27 months and 50.5% of current smokers had cessation advice recorded in the last 15 months. Adjusted odds ratios show that, both before and after the introduction of the QOF, those with chronic medical conditions, greater social deprivation and women were more likely to have a recent recording of smoking status or cessation advice. Since the QOF’s introduction, the strongest characteristic associated with recording activities was the presence of co-morbidity. An example of this was patients with COPD, who in 2008, were 15.38 (95% CI 13.70-17.27) times and 11.72 (95% CI 10.41-13.21) times more likely to have a record of smoking status and cessation advice, respectively.ConclusionsRates of recording smoking status and cessation advice plateaued after large increases during the QOF’s introduction; however, recording remains most strongly associated with the presence of chronic disease as specified by the QOF, and suggests that incentivised targets have a direct effect on clinical behaviour.

Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy

BackgroundSmoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA)-funded smoking, nicotine and pregnancy (SNAP) trial will investigate whether or not nicotine replacement therapy (NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women.Methods/DesignOver two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within two weeks of this) and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups.DiscussionThis trial is designed to ascertain whether or not standard doses of NRT (as transdermal patches) are effective and safe when used for smoking cessation during pregnancy.

Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: Randomised controlled trial

Objective To compare the effects of free nicotine replacement therapy or proactive telephone counselling in addition to standard smoking cessation support offered through a telephone quitline. Design Parallel group, 2×2 factorial, randomised controlled trial. Setting National quitline, England. Participants 2591 non-pregnant smokers aged 16 or more residing in England who called the quitline between February 2009 and February 2010 and agreed to set a quit date: 648 were each randomised to standard support, proactive support, or proactive support with nicotine replacement therapy, and 647 were randomised to standard support with nicotine replacement therapy. Interventions Two interventions were offered in addition to standard support: six weeks’ nicotine replacement therapy, provided free, and proactive counselling sessions (repeat telephone calls from, and interaction with, cessation advisors). Main outcome measures The primary outcome was self reported smoking cessation for six or more months after the quit date. The secondary outcome was cessation validated by exhaled carbon monoxide measured at six or more months. Results At six months, 17.7% (n=229) of those offered nicotine replacement therapy reported smoking cessation compared with 20.1% (n=261) not offered such therapy (odds ratio 0.85, 95% confidence interval 0.70 to 1.04), and 18.2% (n=236) offered proactive counselling reported smoking cessation compared with 19.6% (n=254) offered standard support (0.91, 0.75 to 1.11). Data validated by carbon monoxide readings changed the findings for nicotine replacement therapy only, with smoking cessation validated in 6.6% (85/1295) of those offered nicotine replacement therapy compared with 9.4% (122/1296) not offered such therapy (0.67, 0.50 to 0.90). Conclusions Offering free nicotine replacement therapy or additional (proactive) counselling to standard helpline support had no additional effect on smoking cessation. Trial registration ClinicalTrials.gov NCT00775944.