Engagement With Stop Smoking Services After Referral or Signposting: A Mixed Methods Study.

INTRODUCTION: Screening for smoking when people interact with healthcare services and referral of those who smoke to stop smoking services (SSSs) is a key component of efforts to tackle tobacco use. However, little is known about what happens after someone is referred or signposted to SSSs. METHODS: As part of the Cessation of Smoking Trial in the Emergency Department (NCT04854616), those randomised to intervention (n= 505) were referred to local SSSs (along with receiving brief advice and an e-cigarette starter kit) and those randomised to control (n= 502) were given contact details for the same services (signposted). SSS engagement data was collected: 1) directly from participants and 2) from SSS, additional qualitative data came from 33 participant interviews. RESULTS: Engagement with SSSs was very low. 3.2% (n=16) of those in the intervention group and 2.4% (n=12) in the control group reported attending a one-to-one support session. From SSS data, engagement was also low with 8.9% (n=43) of those referred engaging and 3.1% (n=15) going on to quit with SSS support. The majority of the 24 intervention participants interviewed did not recall being contacted by an SSS. CONCLUSION: Referral or signposting to stop smoking services within an Emergency Department based trial resulted in very low levels of engagement. Barriers to engagement identified included participants not being contacted by SSSs and the support offered not meeting their needs. IMPLICATIONS: Referral or signposting of those who smoke to Stop smoking services from the Emergency Department resulted in low rates of engagement in this large multi-centre randomised controlled trial. In order to better support those who smoke it may be more effective for smoking cessation advice to be offered 'in the moment' within clinical settings, and follow-up to be proactively offered rather than relying on people being motivated to contact the services themselves or engaging when contacted.

The FRESHAIR4Life study: Global implementation research on non-communicable disease prevention targeting adolescents' exposure to tobacco and air pollution in disadvantaged populations.

The FRESHAIR4Life study aims to reduce the non-communicable disease (NCD) burden by implementing preventive interventions targeting adolescents' exposure to tobacco use and air pollution (AP) worldwide. This paper presents the FRESHAIR4Life methodology and initial rapid review results. The rapid review, using various databases and PubMed, aimed to guide decision-making on risk factor focus, target areas, and populations. It showed variable NCD mortality rates related to tobacco use and AP across the participating countries, with tobacco as the main risk factor in the Kyrgyz Republic, Greece, and Romania, and AP prevailing in Pakistan and Uganda. Adolescent exposure levels, sources, and correlates varied. The study will continue with an in-depth situational analysis to guide the selection, adaptation, and integration of evidence-based interventions into the FRESHAIR4Life prevention package. This package will be implemented, evaluated, assessed for cost-effectiveness, and iteratively refined. The research places a strong emphasis on co-creation, capacity building, and comprehensive communication and dissemination.

Nicotine strength of e-liquids used by adult vapers in Great Britain: A population survey 2016 to 2024.

BACKGROUND AND AIMS: In March 2024, the UK government announced plans to introduce a Vaping Products Duty that will tax e-liquids based on their nicotine strength. This study examined trends in the nicotine strength of e-liquids used by adult vapers and differences in those currently used across relevant subgroups. DESIGN: Nationally-representative, cross-sectional household survey, July 2016 to January 2024. SETTING: Great Britain. PARTICIPANTS: 7981 adult vapers. MEASUREMENTS: Participants were asked whether the e-cigarette they mainly use contains nicotine (yes/no) and the e-liquid strength (no nicotine, >0-≤ 6, 7-11, 12-19 or ≥20 mg/ml). We also collected information on the main device type used (disposable/refillable/pod), age, gender, occupational social grade, history of ≥1 mental health conditions, smoking status and (among past-year smokers) level of cigarette addiction. FINDINGS: The proportion of vapers in England using high-strength (≥20 mg/ml) e-liquids increased from an average of 3.8% (95% confidence interval [CI] = 2.9-5.0) up to June 2021 to 32.5% (CI = 27.9-37.4) in January 2024 (the vast majority of whom [93.3% in January 2024] reported using exactly 20 mg/ml; the legal limit). This rise was most pronounced among those using disposable e-cigarettes, those aged 18-24 years and all smoking statuses (including never smokers) except long-term (≥1y) ex-smokers. Of those surveyed in 2022-2024 in Great Britain, overall, 89.5% (CI = 88.1-90.8) said they usually used e-cigarettes containing nicotine, 8.7% (CI = 7.5-10.0) used nicotine-free e-cigarettes, and 1.8% (CI = 1.2-2.4) were unsure. The proportion using ≥20 mg/ml was higher among those mainly using disposable (47.9%) compared with pod (16.3%) or refillable (11.5%) devices; never smokers (36.0%), current smokers (28.8%) or recent (<1y) ex-smokers (27.4%), compared with long-term ex-smokers (13.9%); and younger (16-24y; 44.2%) compared with older (≥25y; range 9.4-25.1%) age groups. There were no notable differences across other subgroups of interest. CONCLUSIONS: Use of high-strength nicotine e-liquids in England appears to have increased sharply in recent years. Most adult vapers in Great Britain appear to use e-cigarettes that contain nicotine but different subgroups use different strengths: nicotine strengths tend to be higher among those who mainly use disposable devices and those aged 16-24y, and lower among long-term ex-smokers.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

Who We Test For: Aligning Relational and Public Health Responsibilities in COVID-19 Testing in Scotland.

COVID-19 testing programs in the UK often called on people to test to "protect others." In this article we explore motivations to test and the relationships to "others" involved in an asymptomatic testing program at a Scottish university. We show that participants engaged with testing as a relational technology, through which they navigated multiple overlapping responsibilities to kin, colleagues, flatmates, strangers, and to more diffuse publics. We argue that the success of testing as a technique of governance depends not only on the production of disciplined selves, but also on the program's capacity to align interpersonal and public scales of responsibility.

Process evaluation of a pragmatic feasibility trial on smokeless tobacco cessation intervention delivered in dental hospitals.

BACKGROUND: Article 14 of the WHO 'Framework Convention on Tobacco Control' recommends, that all oral healthcare providers provide support for tobacco cessation, to all patients. Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, implementation remains low in most high-burden countries like Pakistan. A pragmatic pilot trial of a dentist-delivered behavioural support intervention for smokeless tobacco (ST) cessation, was conducted in dental hospitals in Pakistan. This paper presents the findings of the process evaluation of the trial. METHODS: A mixed-method process evaluation of a multi-centre randomised control pilot trial of dentist-delivered behavioural support intervention ST cessation was conducted. The intervention included three sessions namely: pre-quit, quit and post-quit sessions. The process evaluation involved: semi-structured interviews with trial participants (n = 26, of which dental patients were n = 13 and participating dentists were n = 13 conducted from June-August 2022); and fidelity assessment of audio recordings of the intervention sessions (n = 29). The framework approach was used to thematically analyse the interview data. RESULTS: Overall the trial procedures were well accepted, however, young patients expressed uneasiness over revealing their ST use status. The intervention was received positively by dentists and patients. Dentists identified some challenges in delivering behavioural support to their patients. Of these, some were related to the contents of the intervention whereas, others were related to the logistics of delivering the intervention in a clinical setting (such as workload and space). Acceptability of the intervention resources was overall low amongst young patients as they did not take the intervention resources home due to fear of their family members finding out about their ST use. The intervention was successful in achieving the intended impact (in those who engaged with the intervention), i.e., change in the patients' ST use behaviour. Giving up ST with the aid of behavioural support also had an unintended negative effect i.e., the use of harmful substances (cannabis, cigarettes) to give up ST use. Patients' satisfaction with their dental treatment seemed to influence the intervention outcome. CONCLUSION: While there are many variables to consider, but for the participants of this study, behavioural support for abstinence delivered through dentists during routine dental care, appears to be an acceptable and practical approach in helping patients give up ST use, in a country like Pakistan, where negligible support is offered to ST users.

Behavioural support and nicotine replacement therapy for smokeless tobacco cessation in Bangladesh, India and Pakistan: A pilot randomized controlled trial.

BACKGROUND AND AIMS: Smokeless tobacco (ST) use in South Asia is high, yet interventions to support its cessation are lacking. We tested the feasibility of delivering interventions for ST cessation in South Asia. DESIGN: We used a 2 × 2 factorial design, pilot randomized controlled trial with a duration of 26 weeks, including baseline and follow-up (6, 12 and 26 weeks) assessments. SETTING: Two primary health-care facilities each in Dhaka (Bangladesh) and Karachi (Pakistan) and a walk-in cancer screening clinic in Noida (India) took part. PARTICIPANTS: Adult daily ST users willing to make a quit attempt within 30 days. Of 392 screened, 264 participants [mean age: 35 years, standard deviation = 12.5, 140 (53%) male] were recruited between December 2020 and December 2021; 132 from Bangladesh, 44 from India and 88 from Pakistan. INTERVENTIONS: Participants were randomized to one of three treatment options [8-week support through nicotine replacement therapy (NRT, n = 66), a behavioural intervention for smokeless tobacco cessation in adults (BISCA, n = 66) or their combination (n = 66)] or the control condition of very brief advice (VBA) to quit (n = 66). MEASUREMENTS: Recruitment and retention, data completeness and feasibility of intervention delivery were evaluated. Biochemically verified abstinence from tobacco, using salivary cotinine, was measured at 26 weeks. FINDINGS: Retention rates were 94.7% at 6 weeks, dropping to 89.4% at 26 weeks. Attendance in BISCA pre-quit (100%) and quit sessions (86.3%) was high, but lower in post-quit sessions (65.9%), with variability among countries. Adherence to NRT also varied (45.5% Bangladesh, 90% India). Data completion for key variables exceeded 93% among time-points, except at 26 weeks for questions on nicotine dependence (90%), urges (89%) and saliva samples (62.7%). Among follow-up time-points, self-reported abstinence was generally higher among participants receiving BISCA and/or NRT. At 26 weeks, biochemically verified abstinence was observed among 16 (12.1%) participants receiving BISCA and 13 (9.8%) participants receiving NRT. CONCLUSIONS: This multi-country pilot randomized controlled trial of tobacco cessation among adult smokeless tobacco users in South Asia demonstrated the ability to recruit and retain participants and report abstinence, suggesting that a future definitive smokeless tobacco cessation trial is viable.

A qualitative study of using nicotine products for smoking cessation after discharge from residential drug and alcohol treatment in Australia.

INTRODUCTION: Tobacco smoking is highly prevalent among alcohol and other drugs (AOD) service clients and, despite interest in quitting, abstinence is rarely sustained. Nicotine products may assist after discharge from residential treatment services, but little is known about client receptivity to them. This study examined AOD withdrawal service clients' experiences of two types of nicotine products for smoking cessation post-discharge, combination nicotine replacement therapy (cNRT) and nicotine vaping products (NVP). METHODS: We held semi-structured telephone interviews with 31 Australian AOD service clients in a clinical trial of a 12-week smoking cessation intervention using Quitline support plus cNRT or NVP delivered post-discharge from a smoke-free residential service. We asked about health and social factors, nicotine cravings, Quitline experience, and barriers and facilitators to cNRT or NVP, then thematically analysed data. RESULTS: cNRT and NVP were described by participants as feasible and acceptable for smoking cessation. For most participants, cost limited cNRT access post study, as did difficulty navigating NVP prescription access. Quitline support was valued, but not consistently used, with participants noting low assistance with NVP-facilitated cessation. Participants considered both cessation methods acceptable and socially supported, and sought information on decreasing nicotine use via NVP. DISCUSSION AND CONCLUSIONS: AOD service clients highly valued receiving cNRT or NVP with behavioural support for smoking reduction or abstinence. Both interventions were acceptable to service clients. Findings suggest a potential need to examine both whether NVP use should be permitted in this context, and guidance on the individual suitability of cNRT or NVP.

Effect of 3 months and 12 months of financial incentives on 12-month postpartum smoking cessation maintenance: A randomized controlled trial.

BACKGROUND AND AIMS: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). DESIGN, SETTING AND PARTICIPANTS: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. INTERVENTIONS: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). MEASUREMENTS: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. SECONDARY OUTCOMES: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. FINDINGS: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12-month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. CONCLUSIONS: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care.

'Stopping the start': support for proposed tobacco control policies - a population-based survey in Great Britain 2021-2023.

OBJECTIVES: This study assessed public support for four proposed tobacco control policies in Great Britain: (1) Raising the sales age of tobacco by 1 year every year (Smokefree Generation); (2) Raising the sales age of tobacco from 18 years to 21 years; (3) Providing prescription e-cigarettes as smoking cessation aids to adults who smoke; (4) Restricting e-cigarette advertising to prevent youth uptake. DESIGN: Repeat cross-sectional population-based survey weighted to match the population of Great Britain. SETTING: The survey was conducted in England, Scotland and Wales in September 2021, October 2022 and October 2023. PARTICIPANTS: 6541 adults living in Great Britain. MAIN OUTCOME MEASURES: Support for each policy and year and prevalence ratios (PRs) comparing support between years and subgroups. RESULTS: The most popular policy each year was restricting e-cigarette advertising (74%/79%/85%), followed by raising the sales age to 21 years (50%/58%/64%), providing prescription e-cigarettes (45%/44%/47%) and Smokefree Generation (34%/44%/49%). The largest increases were for policies about the age of sale (Smokefree Generation: 2021/2022 PR=1.28, 95% CI 1.18 to 1.40, 2022/2023 PR=1.12, 95% CI 1.04 to 1.20; raising the age to 21 years: 2021/2022 PR=1.16, 95% CI 1.09 to 1.23, 2022/2023 PR=1.11, 95% CI 1.05 to 1.17). Only 30% opposed Smokefree Generation in 2023 down from 41% in 2021. CONCLUSIONS: Support for each policy increased each year, except for providing prescription e-cigarettes. Restricting e-cigarette advertising was the most popular policy, while support for age of sale policies, in particular for a Smokefree Generation, grew most. TRIAL REGISTRATION: The study protocol was published on the Open Science Framework (https://osf.io/46z2c/) prior to starting the analysis.

Smoking prevalence and purchasing of menthol cigarettes since the menthol flavour ban in Great Britain: a population-based survey between 2020 and 2023.

BACKGROUND: Menthol cigarettes have been banned in Great Britain (GB) since May 2020. Still, menthol accessories and unlabelled cigarettes perceived as mentholated are available, and people can buy menthol cigarettes overseas or illicitly. This study assessed: trends in smoking menthol cigarettes among all adults and 18-24-year-olds in GB between October 2020 and March 2023; trends in and differences between England, Scotland and Wales during the same period and purchase sources among people smoking menthol versus non-flavoured cigarettes. METHODS: Population-weighted data were from a monthly cross-sectional survey of adults in GB. Among people smoking cigarettes, we calculated the proportion smoking menthol cigarettes across all adults and 18-24-year-olds, and prevalence ratios (PR) between the first and last quarter. We also calculated the proportions of people smoking menthol/non-flavoured cigarettes by purchase source (including illicit sources). RESULTS: In the first quarter, 16.2% of adults smoking cigarettes reported menthol cigarette smoking with little to no decline throughout the study (PR 0.85, 95% CI 0.71 to 1.01), while it declined among 18-24-year-olds (PR 0.75, 95% CI 0.63 to 0.89). The prevalence of menthol cigarette smoking fell by two-thirds in Wales (PR 0.36, 95% CI 0.19 to 0.62) but remained relatively stable in England (PR 0.88, 95% CI 0.72 to 1.06) and Scotland (PR 0.94, 95% CI 0.59 to 1.53). The main purchasing sources were licit (93.9%), 14.8% reported illicit sources and 11.5% cross-border purchases, without notable differences from people smoking non-flavoured cigarettes. CONCLUSIONS: Roughly one million adults in GB still smoke menthol cigarettes and, with the exception of Wales and young people, there were no noteworthy changes in the post-ban period. There was no indication that the overall persistence of menthol smoking was driven by illicit purchases.

Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial.

BACKGROUND: Supporting people to quit smoking is one of the most powerful interventions to improve health. The Emergency Department (ED) represents a potentially valuable opportunity to deliver a smoking cessation intervention if it is sufficiently resourced. The objective of this trial was to determine whether an opportunistic ED-based smoking cessation intervention can help people to quit smoking. METHODS: In this multicentre, parallel-group, randomised controlled superiority trial conducted between January and August 2022, adults who smoked daily and attended one of six UK EDs were randomised to intervention (brief advice, e-cigarette starter kit and referral to stop smoking services) or control (written information on stop smoking services). The primary outcome was biochemically validated abstinence at 6 months. RESULTS: An intention-to-treat analysis included 972 of 1443 people screened for inclusion (484 in the intervention group, 488 in the control group). Of 975 participants randomised, 3 were subsequently excluded, 17 withdrew and 287 were lost to follow-up. The 6-month biochemically-verified abstinence rate was 7.2% in the intervention group and 4.1% in the control group (relative risk 1.76; 95% CI 1.03 to 3.01; p=0.038). Self-reported 7-day abstinence at 6 months was 23.3% in the intervention group and 12.9% in the control group (relative risk 1.80; 95% CI 1.36 to 2.38; p<0.001). No serious adverse events related to taking part in the trial were reported. CONCLUSIONS: An opportunistic smoking cessation intervention comprising brief advice, an e-cigarette starter kit and referral to stop smoking services is effective for sustained smoking abstinence with few reported adverse events. TRIAL REGISTRATION NUMBER: NCT04854616.

Public health engagement in alcohol licensing in England and Scotland: the ExILEnS mixed-method, natural experiment evaluation.

Background: International systematic reviews suggest an association between alcohol availability and increased alcohol-related harms. Alcohol availability is regulated through separate locally administered licensing systems in England and Scotland, in which local public health teams have a statutory role. The system in Scotland includes a public health objective for licensing. Public health teams engage to varying degrees in licensing matters but no previous study has sought to objectively characterise and measure their activity, examine their effectiveness, or compare practices between Scotland and England. Aim: To critically assess the impact and mechanisms of impact of public health team engagement in alcohol premises licensing on alcohol-related harms in England and Scotland. Methods: We recruited 39 diverse public health teams in England (n = 27) and Scotland (n = 12). Public health teams more active in licensing were recruited first and then matched to lower-activity public health teams. Using structured interviews (n = 66), documentation analysis, and expert consultation, we developed and applied the Public Health Engagement In Alcohol Licensing (PHIAL) measure to quantify six-monthly activity levels from 2012 to 2019. Time series of PHIAL scores, and health and crime outcomes for each area, were analysed using multivariable negative binomial mixed-effects models to assess correlations between outcome and exposure, with 18-month average PHIAL score as the primary exposure metric. In-depth interviews (n = 53) and a workshop (n = 10) explored public health team approaches and potential mechanisms of impact of alcohol availability interventions with public health team members and licensing stakeholders (local authority licensing officers, managers and lawyers/clerks, police staff with a licensing remit, local elected representatives). Findings: Nineteen public health team activity types were assessed in six categories: (1) staffing; (2) reviewing and (3) responding to licence applications; (4) data usage; (5) influencing licensing stakeholders/policy; and (6) public involvement. Usage and intensity of activities and overall approaches varied within and between areas over time, including between Scotland and England. The latter variation could be explained by legal, structural and philosophical differences, including Scotland's public health objective. This objective was felt to legitimise public health considerations and the use of public health data within licensing. Quantitative analysis showed no clear evidence of association between level of public health team activity and the health or crime outcomes examined, using the primary exposure or other metrics (neither change in, nor cumulative, PHIAL scores). Qualitative data suggested that public health team input was valued by many licensing stakeholders, and that alcohol availability may lead to harms by affecting the accessibility, visibility and norms of alcohol consumption, but that the licensing systems have limited power to act in the interests of public health. Conclusions: This study provides no evidence that public health team engagement in local licensing matters was associated with measurable downstream reductions in crime or health harms, in the short term, or over a 7-year follow-up period. The extensive qualitative data suggest that public health team engagement is valued and appears to be slowly reorienting the licensing system to better address health (and other) harms, especially in Scotland, but this will take time. A rise in home drinking, alcohol deliveries, and the inherent inability of the licensing system to reduce - or in the case of online sales, to contain - availability, may explain the null findings and will continue to limit the potential of these licensing systems to address alcohol-related harms. Future work: Further analysis could consider the relative success of different public health team approaches in terms of changing alcohol availability and retailing. A key gap relates to the nature and impact of online availability on alcohol consumption, harms and inequalities, alongside development and study of relevant policy options. A national approach to licensing data and oversight would greatly facilitate future studies and public health input to licensing. Limitations: Our interview data and therefore PHIAL scores may be limited by recall bias where documentary evidence of public health activity was not available, and by possible variability in grading of such activity, though steps were taken to minimise both. The analyses would have benefited from additional data on licensing policies and environmental changes that might have affected availability or harms in the study areas. Study registration: The study was registered with the Research Registry (researchregistry6162) on 26 October 2020. The study protocol was published in BMC Medical Research Methodology on 6 November 2018. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number 15/129/11.

Research finds that when alcohol is more easily available, because more places sell alcohol or have longer opening hours, people tend to drink more and harms tend to increase. In England and Scotland, 'Licensing Committees' in local governments have power over which venues are given a licence to sell alcohol legally. They make decisions based on local policy and on licensing goals set out in law. Licensing laws are slightly different in both nations, and health representatives are often involved in trying to influence local licensing decisions and policies, to reduce alcohol-related harms. We aimed to find out what public health teams have done to influence alcohol licensing and whether their actions have affected alcohol-related harms. We recruited 39 public health teams (Scotland: 12; England: 27) and measured how active they were on licensing matters. We gathered detailed information (from interviews and papers) about their actions from 2012 to 2019, and asked them and others involved in licensing (including police, and local authority licensing teams and lawyers) about how their efforts might make a difference to harms. We gathered local data on alcohol-related health harms and crimes during 2009­19. We analysed whether any changes in these harms were related to the level of public health team activity, and explored differences between Scotland and England. Public health teams across Scotland and England took varied approaches to engaging in alcohol licensing, and their work was often welcomed by others working in the licensing system. However, we found no clear relationship between the level of licensing-related activity that public health teams engaged in and the levels of alcohol-related health harms or crime. This may be because their actions make only a modest difference to licensing decisions, or because it may take longer than the study period for them to have a sizeable impact. Reducing alcohol-related harms through licensing may require strengthening national licensing laws and the powers of public health teams, including by addressing online sales and home deliveries.

Safety of e-cigarettes and nicotine patches as stop-smoking aids in pregnancy: Secondary analysis of the Pregnancy Trial of E-cigarettes and Patches (PREP) randomized controlled trial.

AIMS: The aim of this study was to examine the safety of e-cigarettes (EC) and nicotine patches (NRT) when used to help pregnant smokers quit. DESIGN: A recent trial of EC versus NRT reported safety outcomes in the randomized arms. We conducted a further analysis based on product use. SETTING: Twenty-three hospitals in England and a stop-smoking service in Scotland took part. PARTICIPANTS: The participants comprised 1140 pregnant smokers. INTERVENTIONS: We compared women using and not using EC and NRT regularly during pregnancy. MEASUREMENTS: Measurements included nicotine intake compared with baseline, birth weight, other pregnancy outcomes, adverse events, maternal respiratory symptoms and relapse in early abstainers. FINDINGS: Use of EC was more common than use of NRT (47.3% vs 21.6%, P < 0.001). Women who stopped smoking (abstainers) and used EC at the end-of-pregnancy (EOP) reduced their salivary cotinine by 45% [49.3 ng/ml, 95% confidence interval (CI) = -79.8 to -10]. Only one abstainer used NRT at EOP. In dual users, cotinine increased by 19% (24 ng/ml, 95% CI = 3.5-68). In women reporting a reduction of at least 50% in cigarette consumption, cotinine levels increased by 10% in those using nicotine products and by 9% in those who did not. Birth weights in dual users and exclusive smokers were the same (3.1 kg). Birth weight in abstainers using either nicotine product was higher than in smokers [3.3 kg, standard deviation (SD) = 0.7] versus 3.1 kg, SD = 0.6; difference = 0.15 kg, 95% CI = 0.05-0.25) and not different from abstainers not using nicotine products (3.1 kg, SD = 0.8). Abstainers and smokers using nicotine products had no worse pregnancy outcomes or more adverse events than abstainers and smokers not using them. EC users reported more improvements than non-users in cough [adjusted relative risk (aRR) = 0.59, 95% CI = 0.37-0.93] and phlegm (aRR = 0.53, 95% CI = 0.31-0.92), controlling for smoking status. EC or NRT use had no association with relapse. CONCLUSIONS: Regular use of e-cigarettes or nicotine patches by pregnant smokers does not appear to be associated with any adverse outcomes.

Smokeless Tobacco Cessation Support in Dental Hospitals in Pakistan: Dentists and Dental Patients' Perspectives on Current Practices, Support Needed, and Opportunities Available.

INTRODUCTION: Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, the implementation remains low, especially for smokeless tobacco (ST). The purpose of this study was to develop an understanding of the influences governing the implementation of ST cessation support in dental hospitals. AIMS AND METHODS: A multicenter qualitative study was conducted at two tertiary-care dental hospitals, in Pakistan. Semi-structured interview guide, guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model, were used to capture the views of dentists (n = 12) and dental patients (n = 12), regarding ST cessation support in dental hospitals. Framework approach was used to thematically analyze the data. RESULTS: Screening of ST users in routine dental practice was seldom practiced and the cessation support offered was brief advice. Barriers identified by dentists included: Fear of offending and stereotyping patients; lack of knowledge and skills; lack of privacy; lack of belief in the effectiveness of behavioral support; lack of time and workload pressure; ST use amongst dentists; lack of referral systems and; the absence of a mandatory requirement of offering ST cessation support. Facilitators included: Delivering support through junior dentists and the length of interaction between the dentist and the patient. Naswar was the most common ST product used by dental patients. Patients reported receiving negligible cessation support from any healthcare provider. CONCLUSIONS: A range of influences governing the implementation of ST cessation support in dental hospitals were identified. These findings can inform the implementation of behavioral interventions for ST cessation in dental and other clinical settings, in low and middle-income countries. IMPLICATIONS: Smokeless tobacco control considerably lags, in comparison to the control of combustible tobacco. This is the first study that qualitatively explores the implementation of ST cessation support in dental settings in Pakistan. Utilizing the "Capability-Opportunity-Motivation-Behavior" model, it provides an in-depth understanding of the inability of dentists in implementing effective behavioral interventions for ST cessation support in routine dental practice. Highlighting the striking discrepancy between the patient's need for and receptivity towards cessation support and the dentists' concerns over their patients' receptivity towards cessation support, it calls for the need for effective implementation strategies to optimize dentist-led tobacco cessation interventions in low-resource settings.

Behaviour Change Intervention for Smokeless Tobacco (ST) Cessation Delivered through Dentists in Dental Settings: A pragmatic pilot trial.

INTRODUCTION: Evidence on smokeless tobacco (ST) cessation interventions is scarce. The South Asian (SA) region which shares more than 90% of the burden of ST use, is grossly underrepresented in research on ST cessation. This study aimed to assess the feasibility of delivering and investigating a behavioural support intervention for ST cessation in dental settings in Pakistan. METHODS: A multi-centre, pilot, 2-armed parallel group, individually randomised control trial, with a 1:1 allocation ratio, was conducted at two dental hospitals. Eligibility criteria included: being a ST user; seeking dental treatment and; not currently accessing cessation support. All participants were provided written self-help, ST cessation material. The intervention group also received a dentist-delivered, bespoke behavioural support intervention for ST cessation developed for users of SA origin. Participants were followed up telephonically at three and six months. Self-reported six month abstinence was verified by salivary cotinine. Analysis was descriptive, with 95% confidence intervals presented where appropriate. RESULTS: 100 participants were successfully recruited from the selected hospitals. Of these 78% continued to engage throughout the study duration and provided primary outcome data, whereas, 63% completed all hospital visits. The outcome measures were successfully collected. Biochemically verified six-month abstinence in the intervention and control group was 10% and 4%. CONCLUSIONS: It was feasible to deliver and evaluate a dentist-delivered behavioural support intervention for ST cessation in Pakistan. The data suggested that the intervention may improve ST quit rates. The findings of this study will be useful in informing the design of future definitive studies. IMPLICATIONS: To our knowledge this is the first pragmatic pilot trial on ST cessation in dental settings in Pakistan and the first trial on dentist-delivered structured behavioural support intervention for ST cessation. It adds to the scarce, trial evidence base on ST cessation interventions. Findings suggest behavioural support intervention for ST cessation may improve quit rates. The trial was conducted in a country with poor ST control measures, where ST products are not taxed, the products are sold openly to and by minors and the users are offered negligible cessation support. The findings may therefore be generalisable to LMICs and particularly South Asian countries, with similar policy backgrounds.

Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy.

Background: Some pregnant smokers try e-cigarettes, but effectiveness and safety of such use are unknown. Objectives: To compare effectiveness and safety of nicotine patches and e-cigarettes in pregnancy. Design: A pragmatic multi-centre randomised controlled trial. Setting: Twenty-three hospitals across England, and a Stop Smoking Service in Scotland. Participants: One thousand one hundred and forty pregnant daily smokers (12-24 weeks' gestation) motivated to stop smoking, with no strong preference for using nicotine patches or e-cigarettes. Interventions: Participants in the e-cigarette arm were posted a refillable e-cigarette device with two 10 ml bottles of tobacco-flavoured e-liquid (18 mg nicotine). Participants in the nicotine patches arm were posted a 2-week supply of 15 mg/16-hour nicotine patches. Supplies were provided for up to 8 weeks. Participants sourced further supplies themselves as needed. Participants in both arms received support calls prior to their target quit date, on the quit date, and weekly for the next 4 weeks. Outcome measures: The primary outcome was validated prolonged abstinence at the end of pregnancy. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included self-reported abstinence at different time points, treatment adherence and safety outcomes. Results: Only 55% of self-reported abstainers mailed back useable saliva samples. Due to this, validated sustained abstinence rates were low (6.8% vs. 4.4% in the e-cigarettes and nicotine patches arms, respectively, risk ratio = 1.55, 95% confidence interval 0.95 to 2.53; Bayes factor = 2.7). In a pre-specified sensitivity analysis that excluded abstainers using non-allocated products, the difference became significant (6.8% vs. 3.6%, risk ratio = 1.93, 95% confidence interval 1.14 to 3.26; Bayes factor = 10). Almost a third of the sample did not set a target quit date and the uptake of support calls was low, as was the initial product use. At end of pregnancy, 33.8% versus 5.6% of participants were using their allocated product in the e-cigarettes versus nicotine patches arm (risk ratio = 6.01, 95% confidence interval 4.21 to 8.58). Regular use of e-cigarettes in the nicotine patches arm was more common than use of nicotine replacement products in the e-cigarette arm (17.8% vs. 2.8%). Rates of adverse events and adverse birth outcomes were similar in the two study arms, apart from participants in the e-cigarette arm having fewer infants with low birthweight (<2500 g) (9.6% vs. 14.8%, risk ratio = 0.65, 95% confidence interval 0.47 to 0.90; Bayes factor = 10.3). Limitations: Low rates of validation reduced the study power. A substantial proportion of participants did not use the support on offer sufficiently to test its benefits. Sample size may have been too small to detect differences in less frequent adverse effects. Conclusions: E-cigarettes were not significantly more effective than nicotine patches in the primary analysis, but when e-cigarettes use in the nicotine patches arm was accounted for, e-cigarettes were almost twice as effective as patches in all abstinence outcomes. In pregnant smokers seeking help, compared to nicotine patches, e-cigarettes are probably more effective, do not pose more risks to birth outcomes assessed in this study and may reduce the incidence of low birthweight. Future work: Routine monitoring of smoking cessation and birth outcomes in pregnant women using nicotine patches and e-cigarettes and further studies are needed to confirm these results. Trial registration: This trial is registered as ISRCTN62025374 and Eudract 2017-001237-65. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 13. See the NIHR Journals Library website for further project information.

Like many other smokers in the UK, some pregnant smokers try to limit or stop smoking with the help of e-cigarettes. It is not known whether this helps with stopping smoking and whether using e-cigarettes has any bad effects on the baby. We recruited 1140 pregnant smokers who wanted to quit. A random half were given nicotine patches, which are commonly used to help smokers quit. The other half were given an e-cigarette. They also received six weekly phone calls to support them in stopping smoking. We then looked at how many in each group stopped smoking by the end of pregnancy. More women stopped smoking in the group that was given an e-cigarette, but the difference was small and could be due to chance. However, some of the women in the nicotine patch group who had successfully stopped smoking were using e-cigarettes rather than patches. When these (and women in the e-cigarette group who used patches) were not counted, e-cigarettes helped almost twice as many women stop smoking than patches. E-cigarettes were better than patches in preventing low birthweight (having babies who weigh less than 2.5 kg). Otherwise, women given patches and those given e-cigarettes (and their babies) had similar numbers of medical complications. For pregnant women who smoke and need help to quit, e-cigarettes are probably more helpful than nicotine patches, and do not pose any additional risks to women or their babies.

BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking.

INTRODUCTION: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse. This trial aims to determine whether an intervention to prevent postpartum relapse is effective and cost-effective. METHODS AND ANALYSIS: A randomised controlled trial of a complex intervention to prevent postpartum smoking relapse (BabyBreathe), with internal pilot, economic and process evaluations. Participants are adults who are pregnant and who report having quit smoking in the 12 months before, or during pregnancy. Participants are eligible if they read and understand English, and provide informed consent. Following consent and biochemical validation of smoking abstinence, participants are randomised to intervention or usual care/control (no specific relapse prevention support). The BabyBreathe intervention consists of manualised advice from a trained member of the health visiting service, health information leaflets for participants and partners, access to the BabyBreathe website and app. At the time of birth, participants are posted the BabyBreathe box and support is provided by text message for up to 12 months postpartum. Target sample size is 880, recruiting across midwifery services at four hubs in England and Scotland and through remote advertising in England, Scotland, Wales and Northern Ireland. Outcomes are collected at 6 and 12 months. The primary outcome is self-reported sustained smoking abstinence at 12 months, carbon monoxide verified. Secondary outcomes include self-reported abstinence, time to relapse, partner smoking status and quality of life. ETHICS AND DISSEMINATION: The trial was approved by the North West Preston Research Ethics committee (21/NW/0017). Dissemination will include publication in peer-reviewed journals, presentation at academic and public conferences including patient and public involvement and to policymakers and practitioners. TRIAL REGISTRATION NUMBER: ISRCTN70307341.

How Do Adolescent Smoking Prevention Interventions Work in Different Contextual Settings? A Qualitative Comparative Study Between the UK and Colombia.

BACKGROUND: Adolescent smoking is associated with significant health and social risks. Previous research has demonstrated the effectiveness of interventions based on behavior change theories in preventing adolescent smoking uptake. However, evidence from the theory-based perspective of evaluation is limited, especially for how such complex interventions work, and how they work when implemented in different contextual settings. METHOD: A comparative qualitative analysis was conducted to explore various influences on behavior change among participants taking part in two smoking prevention interventions in Northern Ireland and Bogotá. Twenty-seven focus groups were conducted in 12 schools (6 in Northern Ireland and 6 in Bogota, n = 195 pupils participated; aged 11-15 years). The Theoretical Domains Framework guided a content analysis of the data. RESULTS: We found similarities across settings in terms of knowledge, skills, and beliefs related to smoking or vaping behavior change, as well as differences in contextual resources and social influence. Different environmental resources included availability to purchase tobacco products in the neighborhoods and previous information about tobacco risk. Participants in both interventions perceived behavioral change outcomes related to personal skills and intention to not smoke or vape. CONCLUSION: These findings have highlighted how both individual factors and contextual resources influence behavior change for smoking prevention in practice. Local contextual factors and social influences affecting pupils should be taken into account in the implementation and evaluation of health behavior change interventions. In particular, this study supports using social and contextual influence strategies in interventions to reduce the onset of adolescent smoking and vaping.