Developing logic models to inform public health policy outcome evaluation: an example from tobacco control.

BACKGROUND: The evaluation of large-scale public health policy interventions often relies on observational designs where attributing causality is challenging. Logic models-visual representations of an intervention's anticipated causal pathway-facilitate the analysis of the most relevant outcomes. We aimed to develop a set of logic models that could be widely used in tobacco policy evaluation. METHODS: We developed an overarching logic model that reflected the broad categories of outcomes that would be expected following the implementation of tobacco control policies. We subsequently reviewed policy documents to identify the outcomes expected to result from the implementation of each policy and conducted a literature review of existing evaluations to identify further outcomes. The models were revised according to feedbacks from a range of stakeholders. RESULTS: The final models represented expected causal pathways for each policy. The models included short-term outcomes (such as policy awareness, compliance and social cognitive outcomes), intermediate outcomes (such as changes in smoking behaviour) and long-term outcomes (such as mortality, morbidity and health service usage). CONCLUSIONS: The use of logic models enables transparent and theory-based planning of evaluation analyses and should be encouraged in the evaluation of tobacco control policy, as well as other areas of public health.

Do cravings predict smoking cessation in smokers calling a national quit line: secondary analyses from a randomised trial for the utility of 'urges to smoke' measures.

BACKGROUND: Single-item urges to smoke measures have been contemplated as important measures of nicotine dependence This study aimed to prospectively determine the relationships between measures of craving to smoke and smoking cessation, and compare their ability to predict cessation with the Heaviness of Smoking Index, an established measure of nicotine dependence. METHODS: We conducted a secondary analysis of data from the randomised controlled PORTSSS trial. Measures of nicotine dependence, ascertained before making a quit attempt, were the HSI, frequency of urges to smoke (FUTS) and strength of urges to smoke (SUTS). Self-reported abstinence at six months after quitting was the primary outcome measure. Multivariate logistic regression and Receiver Operating Characteristic (ROC) analysis were used to assess associations and abilities of the nicotine dependence measures to predict smoking cessation. RESULTS: Of 2,535 participants, 53.5% were female; the median (Interquartile range) age was 38 (28-50) years. Both FUTS and HSI were inversely associated with abstinence six months after quitting; for each point increase in HSI score, participants were 16% less likely to have stopped smoking (OR 0.84, 95% C.I 0.78-0.89, p < 0.0001). Compared to participants with the lowest possible FUTS scores, those with greater scores had generally lower odds of cessation (p across frequency of urges categories=0.0026). SUTS was not associated with smoking cessation. ROC analysis suggested the HSI and FUTS had similar predictive validity for cessation. CONCLUSIONS: Higher FUTS and HSI scores were inversely associated with successful smoking cessation six months after quit attempts began and both had similar validity for predicting cessation.

Did hardening occur among smokers in England from 2000 to 2010?

AIMS: To assess trends in the prevalence of 'hardcore' smoking in England between 2000 and 2010, and to examine associations between hardcore smoking and socio-demographic variables. DESIGN: Secondary analysis of data from the United Kingdom's General Lifestyle Survey (GLF) and the Health Survey for England (HSE). SETTING: Households in England. PARTICIPANTS: Self-reported adult current smokers resident in England aged 26 years and over. MEASUREMENTS: Hardcore smokers were defined in three ways: smokers who do not want to quit (D1), those who 'usually' smoke their first cigarette of the day within 30 minutes of waking (D2) and a combination of D1 and D2, termed D3. Multivariable logistic regression was used to explore associations between these variables and calendar year, age, sex and socio-economic status, and P-values for trends in odds were calculated. FINDINGS: The odds of smokers being defined as hardcore according to D3 increased over time in both the GLF (P < 0.001) and HSE (P = 0.04), even after adjusting for risk factors. Higher dependence (D2) was noted in men [odds ratio (OR): 1.19, 95% confidence interval (CI): 1.13-1.24], those of 50-59 years (OR: 1.94, 95% CI: 1.80-2.09) and smokers in lower occupational groups (OR: 2.11, 95% CI: (1.97-2.26). Lack of motivation to quit (D1) increased with age and was more likely in men. CONCLUSIONS: The proportion of smokers in England with both low motivation to quit and high dependence appears to have increased between 2000 and 2010, independently of risk factors, suggesting that 'hardening' may be occurring in this smoker population.

Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial.

BACKGROUND: The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. METHODS/DESIGN: This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. DISCUSSION: This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

Smoking, self-regulation and moral positioning: a focus group study with British smokers from a disadvantaged community.

Smoking in many Western societies has become a both moral aand health issue in recent years, but little is known about how smokers position themselves and regulate their behaviour in this context. In this article, we report the findings from a study investigating how smokers from an economically disadvantaged community in the East Midlands (UK) respond to concerns about the health impact of smoking on others. We conducted ten focus group (FG) discussions with mixed groups (by smoking status and gender; N = 58 participants) covering a range of topics, including smoking norms, self-regulation, and smoking in diverse contexts. We transcribed all FG discussions before analysing the data using techniques from discourse analysis. Smokers in general positioned themselves as socially responsible smokers and morally upstanding citizens. This position was bolstered in two main ways: 'everyday accommodation', whereby everyday efforts to accommodate the needs of non-smokers were referenced, and 'taking a stand', whereby proactive interventions to prevent smoking in (young) others were cited. We suggest that smoking cessation campaigns could usefully be informed by this ethic of care for others.

'No-one actually goes to a shop and buys them do they?': attitudes and behaviours regarding illicit tobacco in a multiply disadvantaged community in England.

AIMS: To explore attitudes towards, and experience of, illicit tobacco usage in a disadvantaged community against a backdrop of austerity and declining national trends in illicit tobacco use. DESIGN: Qualitative study using 10 focus groups. SETTING: Multiply disadvantaged community in Nottingham, United Kingdom. PARTICIPANTS: Fifty-eight smokers, ex- and non-smokers aged 15-60 years. MEASUREMENTS: Focus group topic guides. FINDINGS: There was high awareness and use of illegal tobacco sources, with 'fag houses' (individuals selling cigarettes from their own homes) being particularly widespread. Rather than being regarded as marginal behaviour, buying illicit tobacco was perceived as commonplace, even where products were known to be counterfeit. Smokers' willingness to smoke inferior 'nasty' counterfeit products may be testament to their need for cheap nicotine. Illicit tobacco was seen to be of mutual benefit to both user (because of its low cost) and seller (because it provided income and support for the local economy). Illicit tobacco sellers were generally condoned, in contrast with the government, which was blamed for unfair tobacco taxation, attitudes possibly heightened by the recession. Easy access to illicit tobacco was seen to facilitate and sustain smoking, with the main concern being around underage smokers who were perceived to be able to buy cheap cigarettes without challenge. CONCLUSIONS: National strategies to reduce illicit tobacco may have limited impact in communities during a recession and where illicit trade is part of the local culture and economy. There may be potential to influence illicit tobacco use by building on the ambivalence and unease expressed around selling to children.

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.