The effectiveness of smoking cessation interventions for socio-economically disadvantaged women: a systematic review and meta-analysis.

INTRODUCTION: This systematic review and meta-analysis assessed the effectiveness of smoking cessation interventions among women smokers in low socio-economic status (SES) groups or women living in disadvantaged areas who are historically underserved by smoking cessation services. METHODS: A systematic literature search was conducted using MEDLINE (OVID), EMBASE, Cochrane, CINAHL, PsychINFO and Web of Science databases. Eligibility criteria included randomised controlled trials of any smoking cessation intervention among women in low SES groups or living in socio-economically disadvantaged areas. A random effects meta-analysis assessed effectiveness of interventions on smoking cessation. Risk of bias was assessed with the Cochrane Risk of Bias tool. The GRADE approach established certainty of evidence. RESULTS: A total of 396 studies were screened for eligibility and 11 (6153 female participants) were included. Seven studies targeted women-only. 5/11 tested a form of face-to-face support. A pooled effect size was estimated in 10/11 studies. At end of treatment, two-thirds more low SES women who received a smoking cessation intervention were more likely to stop smoking than women in control groups (risk ratio (RR) 1.68, 95% CI 1.36-2.08, I2= 34%). The effect was reduced but remained significant when longest available follow-up periods were pooled (RR 1.23, 95% CI 1.04-1.48, I2 = 0%). There was moderate-to-high risk of bias in most studies. Certainty of evidence was low. CONCLUSIONS: Behavioural and behavioural + pharmacotherapy interventions for smoking cessation targeting women in low SES groups or women living in areas of disadvantage were effective in the short term. However, longer follow-up periods indicated reduced effectiveness. Future studies to explore ways to prevent smoking relapse in this population are needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019130160.

The old and familiar meets the new and unknown: patient and clinician perceptions on e-cigarettes for smoking reduction in UK general practice, a qualitative interview study.

BACKGROUND AND AIMS: Clinicians could promote e-cigarettes for harm reduction to people who smoke but cannot stop, but many clinicians feel uneasy doing so. In a randomized controlled trial (RCT), primary care clinicians offered free e-cigarettes and encouraged people with chronic diseases who were unwilling to stop smoking to switch to vaping. We interviewed clinicians and patients to understand how to adopt harm reduction in routine practice. DESIGN: Qualitative analysis nested within an RCT, comprising thematic analysis of semi-structured interviews with primary care clinicians who delivered the trial intervention, and patients who took part. SETTING: Primary care clinics in England. PARTICIPANTS/CASES: Twenty-one patients and 11 clinicians, purposively sampled from an RCT. MEASUREMENTS: We qualitatively explored patients' and clinicians' experiences of: being offered/offering an e-cigarette, past and current perceptions about e-cigarettes and applying a harm reduction approach. FINDINGS: Four themes captured clinicians' and patients' reported perspectives. These were: (1) concepts of safety/risk, with clinicians concerned about recommending a product with unknown long-term risks and patients preferring the known risks of cigarettes; (2) clinicians felt they were going out on a limb by offering these as though they were prescribing them, whereas patients did not share this view; (3) equating quitting with success, as both patients and clinicians conceptualized e-cigarettes as quitting aids; and (4) unchanged views, as clinicians reported that training did not change their existing views about e-cigarettes. These themes were united by the higher-order concept: 'The old and familiar meets the new and unknown', as a contradiction between this new approach and long-established methods underpinned these concerns. CONCLUSIONS: A qualitative analysis found barriers obstructing clinicians and patients from easily accepting e-cigarettes for harm reduction, rather than as aids to support smoking cessation: clinicians had difficulty reconciling harm reduction with their existing ethical models of practice, even following targeted training, and patients saw e-cigarettes as quitting aids.

Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial.

BACKGROUND: Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. METHODS/DESIGN: This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. DISCUSSION: This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. TRIAL REGISTRATION: ISRCTN registry, ISRCTN59404712. Registered 28/11/17.

An exploration of the barriers to attendance at the English Stop Smoking Services.

INTRODUCTION: Despite the availability of effective stop smoking assistance, most smokers do not utilise formal cessation programmes such as the English Stop Smoking Services (SSS). We modified the Treatment Barriers Questionnaire (TBQ), developed in the USA, and distributed it to a sample of English smokers to explore the most important barriers to the use of the SSS. METHODS: Participants of Start2quit, a randomised controlled trial aiming to increase attendance at the SSS using tailored risk information and 'taster' sessions, who reported at follow-up that they had not attended the SSS, were asked to complete the TBQ; 672 (76.9% response rate) were retained for analysis. Principal Component Analysis (PCA) was conducted to examine the structure of the data. Multiple linear regressions were used to determine whether any participant characteristics were associated with particular barriers. RESULTS: The most commonly endorsed items related to a lack of information on and a lack of confidence in the efficacy of the SSS. PCA yielded seven factors: Work and time constraints (Factor1); Smokers should quit on their own (Factor2); Nothing can help in quitting smoking(Factor3); Disinterest in quitting (Factor4); Lack of social support to attend (Factor5); Lack of privacy at programmes (Factor6); Lack of information and perceived availability (Factor7). Age was associated with Factors 1, 3 and 4, motivation to quit with Factors 2 and 4, and confidence in quitting with Factors 1, 2, and 3. CONCLUSIONS: The findings suggest that many barriers exist, and they vary according to smoker demographics and characteristics, pointing to the need for tailored recruitment strategies. TRIAL REGISTRATION: ISRCTN76561916.

Smokers' knowledge and perception of electronic cigarettes (e-cigarettes): a qualitative study of non-quitting smokers in a North London general practice.

BACKGROUND: The introduction of electronic cigarettes (e-cigarettes) has provided smokers with an alternative source of nicotine. Interest and use of the device has increased exponentially in the last decade with an estimated 2.9 m adult users in Great Britain. Research so far on the attitudes and perceptions of smokers to this new product has largely focussed on the views of current e-cigarette users, smokers attempting to quit and former cigarette smokers. AIM: This study aimed to explore the views of current tobacco smokers who were not using e-cigarettes and not looking for a cessation method, their understanding and knowledge of e-cigarettes, and their views of e-cigarettes as a smoking cessation aid provided by the National Health Service (NHS). METHODS: Semi-structured in-depth interviews were conducted with 14 patients from a general practice in North London, who smoked conventional tobacco cigarettes on a daily or weekly basis, over 18 years old. An iterative approach allowed for constant data analysis using a thematic approach throughout the data collection stage, and generated four recurring themes. FINDINGS: E-cigarettes were primarily seen as a smoking cessation device, with the supply of nicotine viewed as a benefit helping to reduce withdrawal symptoms, although for some participants this supply could also be a hindrance to dealing with their addiction. Despite uncertainty about the components, e-cigarettes were mostly viewed as healthier due to their lack of carcinogens, tar and smoke inhalation. The lack of reliable information and strong evidence for both the effectiveness and the safety of e-cigarettes led participants to be apprehensive about their provision by the NHS, and acted as a barrier to their use as an aid to quitting. The recurring appeal for more information regarding e-cigarettes make it clear that further high-quality research is urgently needed in this field to provide reliable and accurate information to smokers.

Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: a cluster randomised controlled trial.

BACKGROUND: People with severe mental illnesses, including psychosis, have an increased risk of cardiovascular disease. We aimed to evaluate the effects of a primary care intervention on decreasing total cholesterol concentrations and cardiovascular disease risk in people with severe mental illnesses. METHODS: We did this cluster randomised trial in general practices across England, with general practices as the cluster unit. We randomly assigned general practices (1:1) with 40 or more patients with severe mental illnesses using a computer-generated random sequence with a block size of four. Researchers were masked to allocation, but patients and general practice staff were not. We included participants aged 30-75 years with severe mental illnesses (schizophrenia, bipolar disorder, or psychosis), who had raised cholesterol concentrations (5·0 mmol/L) or a total:HDL cholesterol ratio of 4·0 mmol/L or more and one or more modifiable cardiovascular disease risk factors. Eligible participants were recruited within each practice before randomisation. The Primrose intervention consisted of appointments (≤12) with a trained primary care professional involving manualised interventions for cardiovascular disease prevention (ie, adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking). Treatment as usual involved feedback of screening results only. The primary outcome was total cholesterol at 12 months and the primary economic analysis outcome was health-care costs. We used intention-to-treat analysis. The trial is registered with Current Controlled Trials, number ISRCTN13762819. FINDINGS: Between Dec 10, 2013, and Sept 30, 2015, we recruited general practices and between May 9, 2014, and Feb 10, 2016, we recruited participants and randomly assigned 76 general practices with 327 participants to the Primrose intervention (n=38 with 155 patients) or treatment as usual (n=38 with 172 patients). Total cholesterol concentration data were available at 12 months for 137 (88%) participants in the Primrose intervention group and 152 (88%) participants in the treatment-as-usual group. The mean total cholesterol concentration did not differ at 12 months between the two groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI -0·22 to 0·29; p=0·788). This result was unchanged by pre-agreed supportive analyses. Mean cholesterol decreased over 12 months (-0·22 mmol/L [1·1] for Primrose vs -0·36 mmol/L [1·1] for treatment as usual). Total health-care costs (£1286 [SE 178] in the Primrose intervention group vs £2182 [328] in the treatment-as-usual group; mean difference -£895, 95% CI -1631 to -160; p=0·012) and psychiatric inpatient costs (£157 [135] vs £956 [313]; -£799, -1480 to -117; p=0·018) were lower in the Primrose intervention group than the treatment-as-usual group. Six serious adverse events of hospital admission and one death occurred in the Primrose group (n=7) and 23, including three deaths, occurred in the treatment-as-usual group (n=18). INTERPRETATION: Total cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important. FUNDING: National Institute of Health Research Programme Grants for Applied Research.

Cost-effectiveness of personal tailored risk information and taster sessions to increase the uptake of the NHS stop smoking services: the Start2quit randomized controlled trial.

AIMS: To assess the cost-effectiveness of a two-component intervention designed to increase attendance at the NHS Stop Smoking Services (SSSs) in England. DESIGN: Cost-effectiveness analysis alongside a randomized controlled trial (Start2quit). SETTING: NHS SSS and general practices in England. PARTICIPANTS: The study comprised 4384 smokers aged 16 years or more identified from medical records in 99 participating practices, who were motivated to quit and had not attended the SSS in the previous 12 months. INTERVENTION AND COMPARATOR: Intervention was a personalized and tailored letter sent from the general practitioner (GP) and a personal invitation and appointment to attend a taster session providing information about SSS. Control was a standard generic letter from the GP advertising SSS and asking smokers to contact the service to make an appointment. MEASUREMENTS: Costs measured from an NHS/personal social services perspective, estimated health gains in quality-adjusted life-years (QALYs) measured with EQ-5D and incremental cost per QALY gained during both 6 months and a life-time horizon. FINDINGS: During the trial period, the adjusted mean difference in costs was £92 [95% confidence interval (CI) = -£32 to -£216) and the adjusted mean difference in QALY gains was 0.002 (95% CI = -0.001 to 0.004). This generates an incremental cost per QALY gained of £59 401. The probability that the tailored letter and taster session is more cost-effective than the generic letter at 6 months is never above 50%. In contrast, the discounted life-time health-care cost was lower in the intervention group, while the life-time QALY gains were significantly higher. The probability that the intervention is more cost-effective is more than 83% using a £20 000-30 000 per QALY-gained decision-making threshold. CONCLUSIONS: An intervention designed to increase attendance at the NHS Stop Smoking Services (tailored letter and taster session in the services) appears less likely to be cost-effective than a generic letter in the short term, but is likely to become more cost-effective than the generic letter during the long term.

Effectiveness of personalised risk information and taster sessions to increase the uptake of smoking cessation services (Start2quit): a randomised controlled trial.

BACKGROUND: National Health Service Stop Smoking Services (SSSs) offer help to smokers motivated to quit; however, attendance rates are low and recent figures show a downward trend. We aimed to assess the effectiveness of a two-component personalised intervention on attendance at SSSs. METHODS: We did this randomised controlled trial in 18 SSSs in England. Current smokers (aged ≥16 years) were identified from medical records in 99 general practices and invited to participate by their general practitioner. Individuals who gave consent, were motivated to quit, and had not attended the SSS within the past 12 months, were randomly assigned (3:2), via computer-generated randomisation with permuted blocks (block size of five), to receive either an individually tailored risk letter and invitation to attend a no-commitment introductory session run by the local SSS (intervention group) or a standard generic letter advertising the local SSS (control group). Randomisation was stratified by sex. Masking of participants to receipt of a personal letter and invitation to a taster session was not possible. The personal letter was generated by a research assistant, but the remainder of the research team were masked to group allocation. General practitioners, practice staff, and SSS advisers were unaware of their patients' allocation. The primary outcome was attendance at the first session of an SSS course within 6 months from randomisation. We did analysis by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN 76561916. FINDINGS: Recruitment, collection of baseline data, delivery of the intervention, and follow up of participants took place between Jan 31, 2011, and July 12, 2014. We randomly assigned 4384 smokers to the intervention group (n=2636) or the control group (n=1748); 4383 participants comprised the intention-to-treat population. Attendance at the first session of an SSS course was significantly higher in the intervention group than in the control group (458 [17·4%] vs 158 [9·0%] participants; unadjusted odds ratio 2·12 [95% CI 1·75-2·57]; p<0·0001). INTERPRETATION: Delivery of personalised risk information alongside an invitation to an introductory session more than doubled the odds of attending the SSS compared with a standard generic invitation to contact the service. This result suggests that a more proactive approach, combined with an opportunity to experience local services, can reduce patient barriers to receiving treatment and has high potential to increase uptake. FUNDING: National Institutes of Health Research Health Technology Assessment.

Start2quit: a randomised clinical controlled trial to evaluate the effectiveness and cost-effectiveness of using personal tailored risk information and taster sessions to increase the uptake of the NHS Stop Smoking Services.

BACKGROUND: The NHS Stop Smoking Services (SSSs) offer help to smokers who want to quit. However, the proportion of smokers attending the SSSs is low and current figures show a continuing downward trend. This research addressed the problem of how to motivate more smokers to accept help to quit. OBJECTIVES: To assess the relative effectiveness, and cost-effectiveness, of an intervention consisting of proactive recruitment by a brief computer-tailored personal risk letter and an invitation to a 'Come and Try it' taster session to provide information about the SSSs, compared with a standard generic letter advertising the service, in terms of attendance at the SSSs of at least one session and validated 7-day point prevalent abstinence at the 6-month follow-up. DESIGN: Randomised controlled trial of a complex intervention with follow-up 6 months after the date of randomisation. SETTING: SSSs and general practices in England. PARTICIPANTS: All smokers aged ≥ 16 years identified from medical records in participating practices who were motivated to quit and who had not attended the SSS in the previous 12 months. Participants were randomised in the ratio 3 : 2 (intervention to control) by a computer program. INTERVENTIONS: Intervention - brief personalised and tailored letter sent from the general practitioner using information obtained from the screening questionnaire and from medical records, and an invitation to attend a taster session, run by the local SSS. Control - standard generic letter from the general practice advertising the local SSS and the therapies available, and asking the smoker to contact the service to make an appointment. MAIN OUTCOME MEASURES: (1) Proportion of people attending the first session of a 6-week course over a period of 6 months from the receipt of the invitation letter, measured by records of attendance at the SSSs; (2) 7-day point prevalent abstinence at the 6-month follow-up, validated by salivary cotinine analysis; and (3) cost-effectiveness of the intervention. RESULTS: Eighteen SSSs and 99 practices within the SSS areas participated; 4384 participants were randomised to the intervention (n = 2636) or control (n = 1748). One participant withdrew and 4383 were analysed. The proportion of people attending the first session of a SSS course was significantly higher in the intervention group than in the control group [17.4% vs. 9.0%; unadjusted odds ratio (OR) 2.12, 95% confidence interval (CI) 1.75 to 2.57; p < 0.001]. The validated 7-day point prevalent abstinence at the 6-month follow-up was significantly higher in the intervention group than in the control group (9.0% vs. 5.6%; unadjusted OR 1.68, 95% CI 1.32 to 2.15; p < 0.001), as was the validated 3-month prolonged abstinence and all other periods of abstinence measured by self-report. Using the National Institute for Health and Care Excellence decision-making threshold range of £20,000-30,000 per quality-adjusted life-year gained, the probability that the intervention was more cost-effective than the control was up to 27% at 6 months and > 86% over a lifetime horizon. LIMITATIONS: Participating SSSs may not be representative of all SSSs in England. Recruitment was low, at 4%. CONCLUSIONS: The Start2quit trial added to evidence that a proactive approach with an intensive intervention to deliver personalised risk information and offer a no-commitment introductory session can be successful in reaching more smokers and increasing the uptake of the SSS and quit rates. The intervention appears less likely to be cost-effective in the short term, but is highly likely to be cost-effective over a lifetime horizon. FUTURE WORK: Further research could assess the separate effects of these components. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76561916. FUNDING DETAILS: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 3. See the NIHR Journals Library website for further project information.

Assessing the fidelity of delivery of an intervention to increase attendance at the English Stop Smoking Services.

BACKGROUND: Implementation fidelity refers to the extent to which a proposed intervention is enacted as designed and is necessary to determine how much the intervention in question is the primary mechanism in any changes observed. Start2quit was a randomised controlled trial that aimed to improve attendance at the English Stop Smoking Service (SSS). The complex intervention combining computer-tailored personal risk letters and no-commitment ("taster") sessions aimed at encouraging attendance at the SSS doubled attendance at the SSS and significantly increased abstinence rates, although attendance and abstinence varied between participating SSSs. Assessment of the fidelity of the delivery of the taster sessions to the protocol was embedded into the trial and is the focus of this study. METHODS: Eighteen SSSs participated in the study. Taster sessions were delivered by SSS advisors in the area. Of the 131 sessions delivered, 93 (71 %) were recorded and 41 (31.3 %) were selected for transcription and analysis. The taster session protocol contained 73 specified behaviours, which were independently classified into component behaviour change techniques (BCTs) using an established taxonomy for smoking cessation. All transcripts were coded by two authors with 25 % additionally coded by a third. The fidelity of each taster session was expressed as the percentage of overall protocol-specified behaviours that were delivered. Adherence to each BCT was measured as the number of behaviours applied by the advisors within each BCT divided by the total number classified within each. RESULTS: Adherence of protocol-specified behaviours was relatively high (median 71.23 %), though there was considerable variation (28.76 to 95.89 %) in individual sessions. Median fidelity to specific BCTs across sessions also varied from 50 to 100 %. Shorter sessions, sessions run jointly by two advisors, by female advisors, or by advisors aged 45 to 54 were associated with higher levels of adherence. There was no association between adherence and subsequent attendance at the SSS. CONCLUSIONS: These results suggest that the delivery of the intervention of this study is not likely to have been impacted by issues of fidelity. As such, we can have greater confidence that variability in the main outcome is not due to variability in SSS advisor adherence to the protocol of the taster sessions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76561916.

Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial.

BACKGROUND: People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices. METHODS/DESIGN: The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care. DISCUSSION: The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013. Date and Version Number: 27 August 2014 Version 5.

Computer-tailored smoking cessation advice matched to reading ability: Perceptions of participants from the ESCAPE trial.

OBJECTIVE: To explore perceptions of computer-tailored advice reports for smoking cessation matched to the recipient's reading level. METHODS: Current cigarette smokers in the UK aged 18-65 who completed a Smoking Behavior Questionnaire (n=6911) were randomized to receive standard generic materials or standard materials plus computer-tailored reports adapted to the recipient's reading level. Smoking status and perception of the reports was assessed at a 6-month follow-up. 4677 participants were included in the analysis. RESULTS: 53.3% were categorized into the easy reading group (ERG). The relative benefit of the intervention for prolonged 3-month abstinence was more marked in the ERG (2.6%/1.9%, OR=1.50) than in the standard reading group (SRG) (4.0%/3.8%, OR=1.05), although the interaction was not statistically significant. Participants in the Intervention group perceived the standard materials more positively than did those in the Control group, and participants in the ERG perceived both the generic material and the tailored report more positively. CONCLUSIONS: The easy reading version of this brief self-help intervention was better perceived than the standard version, and appeared to have a small, but promising effect in smokers with a lower literacy level. PRACTICE IMPLICATIONS: An association between reading level and deprivation emphasizes the need to adapt smoking cessation materials to address the needs of smokers with lower literacy.

Are predictors of making a quit attempt the same as predictors of 3-month abstinence from smoking? Findings from a sample of smokers recruited for a study of computer-tailored smoking cessation advice in primary care.

AIMS: To identify predictors of quit attempts and of 3-month abstinence from cigarette smoking. DESIGN: Secondary analysis of data gathered for a two-armed randomized controlled trial with 6-month follow-up. SETTING: A total of 123 general practices across the United Kingdom. PARTICIPANTS: A total of 4397 participants who completed the 6-month follow-up. Participants were categorized on self-reported smoking behaviour at 6-month follow-up as non-attempters (n = 2664), attempted quitters (n = 1548) and successful quitters (n = 185). MEASURES: Demographic characteristics, smoking history and nicotine dependence, cognitive and social-environmental factors measured at baseline were examined as potential predictors of quit attempts and 3-month abstinence. FINDINGS: Univariate predictors of quit attempts included commitment [odds ratio (OR) = 11.64, 95% confidence interval (CI) = 8.30-16.32], motivation (OR = 2.10, 95% CI = 1.98-2.22) and determination to quit (OR = 1.94, 95% CI = 1.83-2.05). Successful quitting was associated with being married (OR = 1.51, 95% CI = 1.11-2.05), lower social deprivation (OR = 0.47, 95% CI = 0.30-0.74), higher reading level (OR = 1.62, 95% CI = 1.19-2.21) and lower nicotine dependence (OR = 0.42, 95% CI = 0.29-0.62). Health problems related to smoking and previous quit attempts for 3 months or longer predicted both. In the multivariate analysis, the significant predictors of making a quit attempt were; later stage of readiness to quit (OR = 5.38, 95% CI = 3.67-7.89), motivation (OR = 1.48, 95% CI = 1.34-1.62) and determination to quit (OR = 1.16, 95% CI = 1.05-1.29) and health problems related to smoking (OR = 1.44, 95% CI = 1.18-1.75). For 3-month abstinence, the only significant predictor was not having health problems related to smoking (OR = 0.50, 95% CI = 0.29-0.83). CONCLUSIONS: While high motivation and determination to quit is necessary to prompt an attempt to quit smoking, demographic factors and level of nicotine dependence are more important for maintaining abstinence.

Randomized controlled trial to assess the short-term effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care (iQuit in practice).

AIMS: To estimate the short-term effectiveness, feasibility and acceptability of a smoking cessation intervention (the iQuit system) that consists of tailored printed and Short Message Service (SMS) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial. DESIGN: A stratified two parallel-group randomized controlled trial comparing usual care (control) with usual care plus the iQuit system (intervention), delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence. SETTING: Thirty-two general practice (GP) surgeries in England, UK. PARTICIPANTS: A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized (control n = 303, intervention n = 299). MEASUREMENTS: Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up. Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date, 8 weeks and 6 months follow-up. FINDINGS: There were no significant between-group differences in the primary outcome [control 40.3%, iQuit 45.2%; odds ratio (OR) = 1.22, 95% confidence interval (CI) = 0.88-1.69] or in secondary short-term smoking outcomes. Six-month prolonged abstinence was significantly higher in the iQuit arm (control 8.9%, iQuit 15.1%; OR = 1.81, 95% CI = 1.09-3.01). iQuit support took on average 7.7 minutes (standard deviation = 4.0) to deliver and 18.9% (95% CI = 14.8-23.7%) of intervention participants discontinued the text message support during the programme. CONCLUSIONS: Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence, but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone.

Cost-effectiveness of computer-tailored smoking cessation advice in primary care: a randomized trial (ESCAPE).

INTRODUCTION: Smoking remains a significant public health problem and is a leading cause of preventable morbidity and mortality around the world. By combining the behavioral intervention principles used in specialist services with the high reach rates of public health interventions, personal tailored self-help cessation intervention provides a potential economical method for improving reach and effectiveness. METHODS: Cost-effectiveness analysis is performed alongside a randomized controlled trial to compare the computer-tailored self-help intervention with a generic self-help intervention in smoking cessation. A Markov model was developed to extrapolate lifetime cost-effectiveness by combining trial data with estimates from the literature. FINDINGS: In the short term, smokers in the intervention group gained 0.0006 (95% CI = -0.0024 to 0.0036) quality-adjusted life years (QALYs) more than those in the control group at an increased cost of about £9 per person (95% CI = £5-£12). This yielded an incremental cost-effectiveness ratio (ICER) of £14,432/QALY. Precision of the ICER estimates was assessed by 5,000 bootstrapping replications. The probability that the intervention was cost effective was 54% (58%) at a cost-effectiveness threshold of £20,000(£30,000) per QALY. The Markov model showed that simulating lifetime outcomes improved the cost-effectiveness ratio (£9,700/QALY) in favor of the tailored intervention. The intervention would have a 55%-57% chance of being more cost effective than nontailored intervention at the willingness-to-pay threshold of £20,000-30,000/QALY. CONCLUSIONS: The computer-tailored intervention appears slightly more likely to be cost effective than the generic self-help intervention in smoking cessation, in both the short term and the long term, but caution is required given the considerable uncertainty surrounding the estimates.

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care.

BACKGROUND: Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. METHODS/DESIGN: The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. DISCUSSION: This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. TRIAL REGISTRATION: ISRCTN56702353.

ESCAPE: a randomised controlled trial of computer-tailored smoking cessation advice in primary care.

AIMS: To evaluate the effectiveness of tailored cessation advice reports, including levels of reading ability, compared with a generic self-help booklet. DESIGN: Participants were randomised to receive standard non-tailored information or to receive standard information plus a cessation advice report and a progress report, both tailored to individual characteristics. SETTING: One hundred and twenty-three general practices located throughout the UK. PARTICIPANTS: Questionnaires were mailed to 58 660 current cigarette smokers aged 18-65 years, identified from general practitioner records. Of the 6911 (11.8%) who completed the questionnaire, provided consent and were enrolled into the study, 6697 (11.4%) were included in the analysis. MEASUREMENTS: Follow-up was by postal questionnaire sent six months after randomisation, or by telephone interview for participants failing to return the questionnaire. The primary outcome was self-reported prolonged abstinence for at least three months at the six-month follow-up. FINDINGS: Quit rates on the primary outcome were not significantly different (3.2% versus 2.7%) (OR = 1.20, 95% CI [0.94, 1.54], P = 0.15). A significantly higher proportion of intervention group participants made a quit attempt during the follow-up period (32.3% versus 29.6%; OR = 1.13, 95% CI [1.01, 1.26], P = 0.026). CONCLUSION: ESCAPE, a brief tailored smoking cessation intervention delivered by post and designed to reach a wide population of smokers, appears to increase the rate at which smokers try to stop, but if there is an effect on prolonged abstinence it is small.

Evaluating the effectiveness of using personal tailored risk information and taster sessions to increase the uptake of smoking cessation services: study protocol for a randomised controlled trial.

BACKGROUND: Although government-funded specialist smoking cessation services in England offer advice and support to smokers motivated to quit, only a small proportion of smokers make use of this service. Evidence suggests that if smokers are proactively and personally invited to use services, use will be higher than with a standard referral made by health professionals. Computer-based systems generating personalised tailored communications also have the potential to engage with a larger proportion of the smoking population. In this study smokers are proactively invited to use the NHS Stop Smoking Service (SSS), with a personal computer-tailored letter and the offer of a no-commitment introductory session designed to give more information about the service. The primary objective is to assess the relative effectiveness on attendance at the NHS SSS, of proactive recruitment by a brief personal letter, tailored to individual characteristics, and invitation to a taster session, over a standard generic letter advertising the service. METHOD/DESIGN: This randomised controlled trial will recruit smokers from general practice who are motivated to quit and have not recently attended the NHS SSS. Smokers aged 16 years and over, identified from medical records in participating practices, are sent a brief screening questionnaire and cover letter from their GP. Smokers giving consent are randomised to the Control group to receive a standard generic letter advertising the local service, or to the Intervention group to receive a brief personal, tailored letter with risk information and an invitation to attend a 'Come and Try it' taster session. The primary outcome, assessed 6 months after the date of randomisation, is the proportion of people attending the NHS SSS for at least one session. Planned recruitment is to secure 4,500 participants, from 18 regions in England served by an NHS SSS. DISCUSSION: Personal risk information generated by computer, with the addition of taster sessions, could be widely replicated and delivered cost effectively to a large proportion of the smoking population. The results of this trial will inform the potential of this method to increase referrals to specialised smoking cessation services and prompt more quit attempts. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76561916.

Effectiveness of web-based tailored smoking cessation advice reports (iQuit): a randomized trial.

AIMS: To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. DESIGN: Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. SETTING: Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. PARTICIPANTS: Participants (n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. MEASUREMENTS: Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. FINDINGS: The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. CONCLUSIONS: A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information.

Randomized controlled trial evaluation of a tailored leaflet and SMS text message self-help intervention for pregnant smokers (MiQuit).

INTRODUCTION: Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers (MiQuit). Secondary aims were to assess whether MiQuit affected cognitive determinants of quitting and to provide a range of potential effect sizes of the intervention effect on smoking abstinence. METHODS: A randomized controlled trial was undertaken in which pregnant smokers were allocated to either receive MiQuit, a tailored self-help leaflet followed by an 11-week program of tailored text messages, or to a control group, receiving a nontailored self-help leaflet. Participants were 207 pregnant smokers identified by community midwives across 7 NHS Trusts (United Kingdom). At 3-month follow-up, intervention acceptability, cognitive determinants of quitting, and smoking outcomes (self-reported and cotinine-validated 7-day point prevalence abstinence) were assessed. RESULTS: Feasibility: 94% (95% CI 89%-99%) of MiQuit participants reported receiving both intervention components. Acceptability: 9% (95% CI 4%-15%) of MiQuit participants opted to discontinue the text messages. Mechanism: compared with controls, MiQuit participants were more likely to set a quit date (p = .049) and reported higher levels of self-efficacy (p = .024), harm beliefs (p = .052), and determination to quit (p = .019). Potential efficacy: self-reported abstinence-MiQuit 22.9%, control 19.6%; odds ratio (OR) = 1.22, 95% CI 0.62-2.41; cotinine-validated abstinence-MiQuit 12.5%, control 7.8%; OR = 1.68, 95% CI 0.66-4.31. CONCLUSIONS: Delivering tailored smoking cessation support to pregnant smokers via leaflet and text message is feasible and acceptable. The positive effects of MiQuit on cognitive determinants and the likelihood of setting a quit date are encouraging. A larger efficacy trial is warranted.