Introduction Tobacco smoking remains a leading cause of ill-health, premature mortality and a driver of health inequalities. To support smokers in England, a comprehensive approach to treating tobacco dependence is being implemented. This includes offering support to all people admitted to hospitals, as well as women and pregnant people within NHS settings. We aim to describe the protocol for an evaluation of this tobacco-dependence service.Methods and analysis This is a national evaluation across five regions in England (i.e., South West, West Midlands, Greater Manchester, North East and North Cumbria, Yorkshire and Humber) including 11 NHS Foundation Trusts. It is funded from September 2021 to September 2025. Evaluation settings are acute hospital, maternity and inpatient mental health.Work package (WP) 1 involves qualitative key informant interviews to characterise the policy implementation context. WP 2 involves an online survey to assess the routinisation of the service in practice and staff attitudes regarding tobacco dependence, plus in-depth interviews with relevant practitioners to explore survey findings and interviews with smokers to investigate its usefulness and impact. WP 3 involves descriptive statistical analysis of routinely collected data to assess service uptake and impact on health and care outcomes (e.g., smoking status). WP 4 involves an economic analysis of routinely collected data to determine the financial impact of the service. Qualitative data (WP 1, WP 2) will be analysed using Thematic Analysis and Framework Analysis, respectively. WP 2 survey data will be analysed using descriptive statistics.Ethics and dissemination This evaluation received favourable ethical opinion from Newcastle University (17756/2021) and NHS Wales Research Ethics Committee (22/WA/0203). It has also received Confidentiality Advisory Group support (22CAG0103).

Background High tobacco prices reduce smoking prevalence. Illicit tobacco undermines price policies, particularly among youth, and keeps smokers addicted. Furthermore, tobacco companies have a history of smuggling. A UK anti-tobacco smuggling strategy was launched in 2000. A sub-national plan led by Fresh was launched in 2009. Objectives To reduce supply and demand, Fresh developed a strategic framework within broader tobacco control across North-East England, which included: developing partnerships; engaging frontline staff; gathering/developing intelligence; delivering enforcement; delivering communications; engaging retailers; protecting policies from tobacco companies; and assessing progress. Methods Methods include health and enforcement partnerships, developing insight-led, demand-reduction campaigns; developing key message documents; producing enforcement guidance on Article 5.3; tracking public opinion and market share. See www.keep-it-out.co.uk and www.illicit- tobacco.co.uk. Results North-East England illicit market decreased from 15% (2009) to 10% (2019). Nationally, the market has halved since 2000. Conclusions Reducing demand and supply needs to take a strategic approach and be framed within broader tobacco control.

Background and challenges to implementation The North East of England (pop 2.6m) has significant health challenges, largely resulting from an historic industrial past, and subsequent high rates of tobacco use. The region united in pooling public health budgets in order to deliver key interventions at scale. Eight key strands of tobacco control have been delivered synergistically over the last decade including smoking cessation, advocacy and media, regulation, research, secondhand smoke protection. Intervention or response The overall annual budget of USD 915k is used cost-effectively and funds a small regional multidisciplinary team supporting the work of the localities providing expertise, strategic support, advocacy, mass media campaigns, coordinating practice sharing and industrializing system wide reform, and delivering work at scale on complex issues. The work is guided by international best practise and informed by national tobacco strategies including those from ASH UK, Department of Health and Public Health England. Results and lessons learnt There has been a 41% reduction in the smoker population - the biggest regional decline in the last decade. A social movement has grown with high levels of public support for future regulation. Making tobacco control 'everyone's business' has been important and having a clear vision for the future vital to maintain funding commitment and focus. It is important to constantly reinforce the rationale for this investment from a health inequalities perspective and the strong return on investment tobacco control gives. Conclusions and key recommendations Significant economies of scale have been achieved with high value for money. In the UK there is a need for effective tobacco action from the community grass roots level right up to the national and international stage. A similar approach is in place around alcohol denormalisation now through the regional programme "Balance" and the two programmes are working together with notable success.The North East England provides a useful model for others.

Background and challenges to implementation Fresh is an award winning tobacco control programme. One of our roles is the de-normalisation of smoking and advocating policy interventions. Public awareness is fundamental, but advertising budgets are always under pressure and cannot be maintained all year round. "Earned media" is highly cost-effective, reaching thousands and setting agendas among decision makers by presenting tobacco as an serious issue. Earned media can also complement and add depth, believability and impact to paid-for campaigns and the role of real people is an integral part. Intervention or response Fresh runs an "always-on", year-round programme to gain media coverage around the benefits of quitting smoking and to argue for effective regulation. This involves supplying press releases for press, online, radio and TV and increasingly news websites. Through working with partners we have added the voices of doctors and real people sharing both positive experiences of quitting and negative experiences of smoking related diseases, and supporting calls for action. This has including working with a lung cancer patient in her final months. Results and lessons learnt · Relationships need sensitivity and tact to develop, but people will willingly share their stories as a warning to others. · Ex-smokers and doctors as spokespeople enables us to target news media more effectively · The harm of disease can feel remote to smokers: real stories in the media can make these more believable. · Ex-smokers are proud of quitting, and report that positive publicity can provide them with an added incentive to stay quit, and advise others · Ex-smokers can also become champions for legislative change. Conclusions and key recommendations Real people's stories play an important role in communicating the consequences of smoking and there are many opportunities to share these beyond advertising campaigns. While the media is changing away from traditional print, new media brings new channels and new opportunities.

Background and challenges to implementation North East (NE) England has had the fastest drops in smoking prevalence in the country. The UK's illicit tobacco market has almost halved following successful national strategies but still remains a problem in some communities because price and availability increases accessibility for children and reduces smokers' motivation to quit. In 2009, 16% of the NE tobacco market was illicit. Fresh, the NE's comprehensive tobacco control programme, has implemented an innovative and successful strategic framework to reduce the supply and demand. Intervention or response Since 2007, Fresh has worked with health and regulatory partners to reduce the illicit tobacco market. Several waves of quantitative and qualitative research with the public and stakeholders have informed the development of a multi-component strategic framework based on international principles which enhances national strategies and can be implemented locally or sub-nationally. Its eight objectives are to develop partnerships, engage frontline workers, generate intelligence, deliver enforcement, deliver marketing and communications, work with businesses, protect policies from the tobacco industry and assess progress. [Illicit Tobacco Programme Strategic Framework] Results and lessons learnt The illicit tobacco market in the NE has declined from 16% in 2009 to 12% in 2017. The proportion of smokers who buy illicit tobacco has reduced from 24% to 18% over the same timeframe. In-depth qualitative research has supported the development of effective, evidence-based demand reduction campaigns which have led to increases in intelligence and reductions in comfort levels with the illicit tobacco trade. Regulatory partners are prioritising illicit tobacco as part of their broader enforcement policies. Conclusions and key recommendations The success of this strategic framework demonstrates that activity can be co-ordinated locally or sub-nationally to support national strategies to reduce the illicit tobacco market. Activity should always be placed within the broader context of 'all tobacco kills' and should contain measures to reduce both supply and demand. Useful resources for other programmes and settings can be found at www.illicit-tobacco.co.uk.

Background and challenges to implementation An intervention to encourage and support pregnant women to stop smoking by implementing National Institute of Health and Clinical Excellence guidance (2010) was introduced across north east England, a region with almost 30 000 births per year. Intervention or response Comprised provision of equipment for universal, routine carbon monoxide (CO) monitoring, opt-out referral and enhanced follow-up. Positive impact was reported in Bell et al (2017). The current paper reports findings from qualitative interviews with pregnant smokers which aimed to ascertain the acceptability of the intervention. Women from the four areas where full implementation had taken place were interviewed individually face-to-face, initially at around 16 weeks of pregnancy (n=17) and again 4-10 weeks later (n=8) or postpartum (n=3). Interviews were recorded, transcribed then analysed thematically. Results and lessons learnt Universal CO monitoring and opt-out referral appeared acceptable and the former motivated women to quit. When linked to a professional discourse of caring and concern, the intervention prompted women to take action. Where women continued to smoke or failed to attend smoking cessation services (SCS) appointments, they received a risk perception intervention (RPI), visually demonstrating the immediate, negative effects of CO on the foetus. Most women accepted the need for this hard-hitting approach, and although distressing, they expressed gratitude for it. Having this risk message personalised raised awareness and sometimes led to setting a quit date; however some resented the approach. Women generally found the RPI and enhanced follow up supportive and also benefited from greater family inclusion. Where maternity services were either less focused on prioritising the smoking cessation message, or less well integrated with SCS or where maternity staff were not as adept at delivering the RPI women found the intervention less acceptable. Conclusions and key recommendations The intervention proved to be acceptable to pregnant women smokers interviewed during and shortly after pregnancy. Wider application is recommended.

Background and challenges to implementation The evidence for mass media to raise awareness about the harm of smoking and benefits of quitting remains strong. However, pressures on budgets means TV is not always seen as an affordable option, while the emergence of digital media presents an attractive option to funders as a way of saving costs while maintaining responses. Digital and social media has provided us with learnings about the role of “push” (broadcast) and “pull” (direct responses) within campaigns and the balance of positive and negative messages. Intervention or response Fresh (a subnational tobacco control programme) has ran three hard hitting health campaigns on regional TV while using digital media including advertising and boosted Facebook posts as a supporting channel to prompt discussion and to generate responses to a campaign website. Content online has included real people's stories, including emotionally engaging videos of former smokers with COPD or cancer. Results and lessons learnt Our experience has found that as well as generating thousands of responses: Social media is a new platform to share hard hitting real people's stories which convey the shock, emotion and life-limiting reality of smoking. The public are keen to engage on a discourse around how smoking has devastated families. People tag friends, share posts and tell their own stories about loved ones affected. This challenges assumptions by some that social media needs to be constantly positive to compete with commercial brands for attention and doubtless provides opportunities on other tobacco control topics. Conclusions and key recommendations Digital media plays an important role in driving direct responses to campaign websites that offer support, and in generating discussion. However, it is still TV that drives the conversation and response rates online; digital display performs best if it features campaign visuals, while TV advertising is often discussed in Facebook responses. We continue to make the case to fund TV advertising.

Background and challenges to implementation England's comprehensive smokefree law (workplaces and enclosed public places), introduced in 2007, has been effective in protecting public health and has enjoyed increasing public support (86% in the NE in 2017) and consistent high compliance. The decade since has seen continued focus in the North East of England around protection from secondhand smoke, normalising smokefree spaces and building public support through a social movement around 'Making Smoking History'. Intervention or response Working with partners in local government and the health service, Fresh - the NE's regional comprehensive tobacco control programme - has delivered sustained activity to reinforce the importance of protection from secondhand smoke including training of front line staff and also voluntary policies around smokefree outdoor areas frequented by children, lobbied for further evidence based legislation whilst highlighting the ultimate aim of encouraging smokers to quit. Results and lessons learnt New regulations were introduced in 2015 to extend the smokefree law to cover private vehicles carrying children under 18 (91% NE public support). With 40% of NE smokers reporting they still smoke in the home, the need for ongoing education is clear and in 2017 Fresh ran a “secondhand smoke is poison” campaign with a hard hitting message around taking smoking right outside the home and the importance of protecting children from exposure. Conclusions and key recommendations The success of the smokefree law has led the way in increasing public support for existing and potential tobacco control measures. It has provided the opportunity to go beyond the scope of the law by introducing new smokefree areas. Further legislation to make all private vehicles smokefree would be welcome. It has been important to place this work within an overall programme where quitting tobacco remains the goal. Overall smoking in the NE has declined by 41% in this decade.

Background The North East of England (population 2.6 million) has a notable track record in tobacco control, and local government organisations have a vision to "Make Smoking History", with all 12 localities agreeing in 2014 to work towards 5% adult smoking by 2025. The target seems ambitious but a comprehensive sub-national programme is in place to achieve it. With a baseline smoking prevalence of 18.7% in 2015, work was undertaken in 2017 to model current trends in smoking prevalence, uptake and quitting in the North East, and identify key targets and policies for further improvements and to assess how realistic the goal is. Methods Data from the Smoking Toolkit Study (www.smokinginengland.info - annual sample size national of >20,000) and the UK's Annual Population Survey (annual national samnple size 300,000) were used to model trends in key parameters (cigarette smoking prevalence; ever-smoking prevalence in young people; quit attempt prevalence; quit success rate; overall quit rate) and make forecasts under a range of different assumptions. Results Smoking prevalence has declined in the North East slightly faster than the national average and this appears to be because of higher quit success rates. Increasing quit attempt rate to 45% per year, maintaining a quit success rate at 20%, and reducing uptake to 0.3% per year could put the North East on a path to 5% adult smoking prevalence within 10 years. These are all realistic targets but will require the implementation of a package of policies and a sustained commitment to investment. Conclusions Modelling has shown that a bold ambition of all but eliminating smoking by 2025 can be achieved in an English region without unrealistic assumptions about the changes that need to be made in uptake, quit attempts and quit success rates. This modelling work has galvanised further action especially within the health system.

Background and challenges to implementation In 2011/12, more pregnant women smoked at delivery in North East England (population 2.6 million) than the national average (21% vs 13%). Work with midwives across the region identified barriers to implementing national guidance for universal carbon monoxide (CO) screening and referral for smoking cessation (SC) support. These included lack of equipment, and midwives' concerns that quit advice was not worthwhile and might undermine relationships with women. Intervention or response A system wide approach, babyClear©, was commissioned across 12 local government areas involving eight NHS hospital maternity services and associated smoking cessation services. The intervention provided equipment and training for universal CO monitoring, opt-out referral to SC services and enhanced support to quit. Independent evaluation assessed effectiveness and implementation. Service data for more than 37,000 deliveries in 2013-14, including 10,500 smokers, was analysed for impact on quit rates. Interviews with more than 90 healthcare staff were conducted. Routine smoking at delivery data for local commissioning areas was monitored 2012-2017. Results and lessons learnt Quit rates nearly doubled (aOR 1.8, 95% CI 1.5-2.2) and referrals for SC support increased by 2.5 fold (95% CI 2.2-2.8) after initial implementation (Bell et al, 2017). There was variation in effectiveness between maternity services. Process evaluation indicated that effective SC advice was deliverable within routine maternity care and acceptable to women and maternity staff. Diversity of SC service delivery models, variable resourcing and organisational stability influenced implementation. Regional smoking at delivery rates declined steadily from 21% to 16% 2012-2017, but some localities experienced recent increases, suggesting variable sustainability. Conclusions and key recommendations The intervention improved quit rates through system wide training and action to improve identification and referral of pregnant smokers. Local contexts have a critical role to play in both implementing and sustaining such initiatives into practice. Identifying core intervention ingredients and potential for flexibility and tailoring is recommended.

Background and challenges to implementation With tobacco advertising, sponsorship and promotion (2003) and point of sale displays (2015) prohibited, tobacco packaging had become the main source of promotion in the UK. Evidence shows that branding helps to recruit young people to a lifetime of addiction. A concerted national advocacy campaign on standardised packaging was undertaken from 2011 through the Smokefree Action Coalition (SFAC) with strong support by Fresh (North East England) and local authorities in the region. Intervention or response Fresh, along with colleagues in the NE, supported the campaign from its inception and responded in force to two governmental consultations with submissions from local authorities and in particular regulatory teams, the health service, the police and the voluntary sector. All NE authorities had robust policies in place to counter the efforts by the tobacco industry to derail progress towards implementation of the measure. Results and lessons learnt In 2015, the UK became the second country in the world to pass legislation on standardised packs with full compliance achieved by May 2017. The tobacco industry issued legal challenges and appeals to both the UK and the European Union, but they lost. Public support for the measure was 60% by February 2017. Early results from NE research shows that the measure is having an impact on smokers who had seen the packs, with 60% thinking they looked less attractive and 51% noticing the health warnings more. There is also no evidence to suggest that standard packs will lead to an increase in the illicit tobacco market. Conclusions and key recommendations Working through the SFAC ensured that there was a huge ground swell of support in the NE and scores of organisations were able to unite around an effective campaign. Collaboration internationally was also pivotal including the leadership from Australia. The introduction of standardised packaging is another key milestone in the NE ambition to Make Smoking History.

INTRODUCTION:To systematically review the evidence regarding the effect of standardized packaging on illicit tobacco use. METHODS:Data sources were EMBASE, Web of Knowledge, Scopus, PsycInfo, Medline, and the British Library catalogue, from 01/01/1987 to 28/11/2016. Reference lists of included studies were hand searched for additional papers. Search strategies were based on the terms 'tobacco', 'packaging' and 'illicit'. The search was restricted to English language references. Two reviewers screened titles and abstracts for empirical studies that addressed the topic of standardized packaging and illicit tobacco use. This resulted in 153 full text papers retrieved for screening. Following exclusions, ten papers were included in the review. Two reviewers' extracted data using piloted standardized data extraction forms. Studies were assessed for quality and relevance using CASP. RESULTS:There was little homogeneity between included studies, so a narrative synthesis was employed. Of the relevant studies five reported smokers did not intend to or actually purchase further illicit tobacco following standardized packaging, although one suggested a small number of responders to online news felt smokers would be more inclined to purchase illicit tobacco, following standardized packaging. Two studies reported retailers did not intend to or actually increase sales of illicit tobacco following standardized packaging. Finally, two studies reported industry data on illicit tobacco were of poor quality and not supported by independent data. CONCLUSIONS:There were few studies examining tobacco standardized packaging and illicit trade, however those available showed no evidence that standardized packaging could lead to increases in illicit trade.

INTRODUCTION:Tobacco smoking claims 700,000 lives every year in Europe and the cost of tobacco smoking in the EU is estimated between €98 and €130 billion annually; direct medical care costs and indirect costs such as workday losses each represent half of this amount. Policymakers all across Europe are in need of bespoke information on the economic and wider returns of investing in evidence-based tobacco control, including smoking cessation agendas. EQUIPT is designed to test the transferability of one such economic evidence base-the English Tobacco Return on Investment (ROI) tool-to other EU member states. METHODS AND ANALYSIS:EQUIPT is a multicentre, interdisciplinary comparative effectiveness research study in public health. The Tobacco ROI tool already developed in England by the National Institute for Health and Care Excellence (NICE) will be adapted to meet the needs of European decision-makers, following transferability criteria. Stakeholders' needs and intention to use ROI tools in sample countries (Germany, Hungary, Spain and the Netherlands) will be analysed through interviews and surveys and complemented by secondary analysis of the contextual and other factors. Informed by this contextual analysis, the next phase will develop country-specific ROI tools in sample countries using a mix of economic modelling and Visual Basic programming. The results from the country-specific ROI models will then be compared to derive policy proposals that are transferable to other EU states, from which a centralised web tool will be developed. This will then be made available to stakeholders to cater for different decision-making contexts across Europe. ETHICS AND DISSEMINATION:The Brunel University Ethics Committee and relevant authorities in each of the participating countries approved the protocol. EQUIPT has a dedicated work package on dissemination, focusing on stakeholders' communication needs. Results will be disseminated via peer-reviewed publications, e-learning resources and policy briefs.

‘Fresh’ was the UK’s first dedicated regional programme to tackle smoking-related illness and death. Established in the north east of England in 2005, the region has since seen adult smoking rates fall at twice the national average.