The Lifetime Health and Economic Burden of Smokeless Tobacco use in Bangladesh, India, and Pakistan: Results From ASTRAMOD.

INTRODUCTION: Under the current policy landscapes, the lifetime health and economic burden of smokeless tobacco (ST) products, consumed by over 297 million ST users in South Asia, is unknown. The aim of this study was to estimate the lifetime health effects and costs attributable to current and future ST use in Bangladesh, India, and Pakistan where the majority of ST users live. AIMS AND METHODS: We developed a Markov-based state-transition model (ASTRAMOD) to predict the lifetime costs of treatment of four diseases (oral, pharyngeal, esophageal cancers, and stroke) and disability-adjusted life years (DALYs), attributable to the current and future use of ST under existing ST policy scenario. Country-specific Global Adult Tobacco Surveys, life tables, and meta-analyses of South Asian and South East Asian studies were used to populate the model. A probabilistic sensitivity analysis evaluated the uncertainty in model predictions. RESULTS: If there were no change in the current ST policies, the lifetime ST-attributable treatment costs would be over US$19 billion in India, over US$1.5 billion in Bangladesh, and over US$3 billion in Pakistan. For all countries, the attributable costs are higher for younger cohorts with costs declining with increasing age for those over 50. The model predicted that a typical 15-year-old male adoloscent would gain 0.07-0.18 life years, avert 0.07-0.19 DALYs, and generate a cost-savings of US$7-21 on healthcare spending if ST policies were changed to eliminate ST use. CONCLUSIONS: Policy interventions aimed at decreasing the uptake of ST and increasing quitting success have the potential to substantially decrease the economic and health burden of ST. IMPLICATIONS: This study provides the most comprehensive estimates of the lifetime health and economic burden of ST by 5-year age and sex cohorts. This is also the first study that highlights the scale of health and economic burden of ST in Bangladesh, India, and Pakistan if there were no changes in the current ST policies. Policymakers and practitioners can use the reported data to justify their decisions to improve current ST policies and practices in their country. Researchers can use the ASTRAMOD methodology to estimate the impact of future ST policy changes.

The economic burden of multimorbidity: Protocol for a systematic review.

Multimorbidity, also known as multiple long-term conditions, leads to higher healthcare utilisation, including hospitalisation, readmission, and polypharmacy, as well as a financial burden to families, society, and nations. Despite some progress, the economic burden of multimorbidity remains poorly understood. This paper outlines a protocol for a systematic review that aims to identify and synthesise comprehensive evidence on the economic burden of multimorbidity, considering various definitions and measurements of multimorbidity, including their implications for future cost-of-illness analyses. The review will include studies involving people of all ages with multimorbidity without any restriction on location and setting. Cost-of-illness studies or studies that examined economic burden including model-based studies will be included, and economic evaluation studies will be excluded. Databases including Scopus (that includes PubMed/MEDLINE), Web of Science, CINAHL Plus, PsycINFO, NHS EED (including the HTA database), and the Cost-Effectiveness Analysis Registry, will be searched until March 2024. The risk of bias within included studies will be independently assessed by two authors using appropriate checklists. A narrative synthesis of the main characteristics and results, by definitions and measurements of multimorbidity, will be conducted. The total economic burden of multimorbidity will be reported as mean annual costs per patient and disaggregated based on counts of diseases, disease clusters, and weighted indices. The results of this review will provide valuable insights for researchers into the key cost components and areas that require further investigation in order to improve the rigour of future studies on the economic burden of multimorbidity. Additionally, these findings will broaden our understanding of the economic impact of multimorbidity, inform us about the costs of inaction, and guide decision-making regarding resource allocation and cost-effective interventions. The systematic review's results will be submitted to a peer-reviewed journal, presented at conferences, and shared via an online webinar for discussion.

Economic evaluations of interventional opportunities for the management of mental-physical multimorbidity: a systematic review.

OBJECTIVES: Economic evaluations of interventions for people with mental-physical multimorbidity, including a depressive disorder, are sparse. This study examines whether such interventions in adults are cost-effective. DESIGN: A systematic review. DATA SOURCES: MEDLINE, CINAHL Plus, PsycINFO, Cochrane CENTRAL, Scopus, Web of Science and NHS EED databases were searched until 5 March 2022. ELIGIBILITY CRITERIA: We included studies involving people aged ≥18 with two or more chronic conditions (one being a depressive disorder). Economic evaluation studies that compared costs and outcomes of interventions were included, and those that assessed only costs or effects were excluded. DATA EXTRACTION AND SYNTHESIS: Two authors independently assessed risk of bias in included studies using recommended checklists. A narrative analysis of the characteristics and results by type of intervention and levels of healthcare provision was conducted. RESULTS: A total of 19 studies, all undertaken in high-income countries, met inclusion criteria. Four intervention types were reported: collaborative care, self-management, telephone-based and antidepressant treatment. Most (14 of 19) interventions were implemented at the organisational level and were potentially cost-effective, particularly, the collaborative care for people with depressive disorder and diabetes, comorbid major depression and cancer and depression and multiple long-term conditions. Cost-effectiveness ranged from £206 per quality-adjusted life year (QALY) for collaborative care programmes for older adults with diabetes and depression at primary care clinics (USA) to £79 723 per QALY for combining collaborative care with improved opportunistic screening for adults with depressive disorder and diabetes (England). Conclusions on cost-effectiveness were constrained by methodological aspects of the included studies: choice of perspectives, time horizon and costing methods. CONCLUSIONS: Economic evaluations of interventions to manage multimorbidity with a depressive disorder are non-existent in low-income and middle-income countries. The design and reporting of future economic evaluations must improve to provide robust conclusions. PROSPERO REGISTRATION NUMBER: CRD42022302036.

Framework Convention on Tobacco Control 2030-A Program to Accelerate the Implementation of World Health Organization Framework Convention for Tobacco Control in Low- and Middle-Income Countries: A Mixed-Methods Evaluation.

BACKGROUND: Framework Convention on Tobacco Control (FCTC) 2030 Program (2017-2021) was launched to accelerate World Health Organization (WHO) FCTC implementation in 15 low- and middle-income countries (LMICs). We evaluated the Program in six domains: Governance; Smoke-Free Policies; Taxation; Packaging and Health Warnings; Tobacco Advertising, Promotion, and Sponsorship (TAPS) bans; and International and Regional Cooperation. AIMS AND METHODS: Following a mixed-methods design, we surveyed (June-September 2020) FCTC focal persons in 14 of the 15 countries, to understand the Program's financial and technical inputs and progress made in each of the six domains. The data were coded in terms of inputs (financial = 1, technical = 1, or both = 2) and progress (none = 1, some = 2, partial = 3, or strong = 4) and a correlation was computed between the inputs and progress scores for each domain. We conducted semi-structured interviews with key stakeholders in five countries. We triangulated between the survey and interview findings. RESULTS: FCTC 2030 offered substantial financial and technical inputs, responsive to country needs, across all six domains. There was a high positive correlation between technical inputs and progress in five of the six domains, ranging from r = 0.61 for taxation (p < .05) to r = 0.91 and for smoke-free policies (p < .001). The interviews indicated that the Program provided timely and relevant evidence and created opportunities for influencing tobacco control debates. CONCLUSIONS: The FCTC 2030 Program might have led to variable, but significant progress in advancing FCTC implementation in the 15 countries. As expected, much of the progress was in augmenting existing structures and resources for FCTC implementation. The resulting advances are likely to lead to further progress in FCTC policy implementation. IMPLICATIONS: What this study adds: In many LMICs, WHO FCTC policies are not in place; and even when enshrined in law, they are poorly enforced. It is not clear how financial and technical assistance to high tobacco-burden LMICs can most effectively accelerate the implementation of WHO FCTC policies and offer value for money. Bespoke and responsive assistance, both financial and technical, to LMICs aimed at accelerating the implementation of WHO FCTC policies are likely to lead to progress in tobacco control.

Behavioural support and nicotine replacement therapy for smokeless tobacco cessation: protocol for a pilot randomised-controlled multi-country trial.

BACKGROUND: Smokeless tobacco (ST) is consumed globally by more than 350 million people, with approximately 85% of all users based in South and Southeast Asia. In this region, ST products are cheap and easily accessible. Evidence-based interventions to people quit ST use are lacking. This study aims to test the feasibility of conducting a future definitive trial of ST cessation, using a culturally adapted behavioural intervention, and/or nicotine replacement therapy (NRT) in three South Asian countries. METHODS: We will conduct a factorial design, randomised-controlled pilot trial in Bangladesh, India and Pakistan. Daily ST users will be recruited from primary health care settings in Dhaka, Noida and Karachi. Participants will be individually randomised to receive intervention A (4 or 6 mg NRT chewing gum for 8-weeks), intervention B (BISCA: face-to-face behavioural support for ST cessation), a combination of interventions A and B or usual care (Very Brief Advice - VBA). The participants will provide demographic and ST use related data at baseline, and at 6, 12 and 26 weeks of follow-up. Salivary cotinine samples will be collected at baseline and 26 weeks. The analyses will undertake an assessment of the feasibility of recruitment, randomisation, data collection and participant retention, as well as the feasibility of intervention delivery. We will also identify potential cessation outcomes to inform the main trial, understand the implementation, context and mechanisms of impact through a process evaluation and, thirdly, establish health resource use and impact on the quality of life through health economic data. DISCUSSION: The widespread and continued use of ST products in South Asia is consistent with a high rate of associated diseases and negative impact on the quality of life. The identification of feasible, effective and cost-effective interventions for ST is necessary to inform national and regional efforts to reduce ST use at the population level. The findings of this pilot trial will inform the development of larger trials for ST cessation among South Asian users, with relevance to wider regions and populations having high rates of ST use. TRIAL REGISTRATION: ISRCTN identifier 65109397.

Research can be integrated into public health policy-making: global lessons for and from Spanish economic evaluations.

WHO promotes the use of research in policy-making to drive improvements in health, including in achieving Sustainable Development Goals such as tobacco control. The European Union's new €95 billion Horizon Europe research framework programme parallels these aims, and also includes commitments to fund economic evaluations. However, researchers often express frustration at the perceived lack of attention to scientific evidence during policy-making. For example, some researchers claim that evidence regarding the return on investment from optimal implementation of evidence-based policies is frequently overlooked. An increasingly large body of literature acknowledges inevitable barriers to research use, but also analyses facilitators encouraging such use. This opinion piece describes how some research is integrated into policy-making. It highlights two recent reviews. One examines impact assessments of 36 multi-project research programmes and identifies three characteristics of projects more likely to influence policy-making. These include a focus on healthcare system needs, engagement of stakeholders, and research conducted for organizations supported by structures to receive and use evidence. The second review suggests that such characteristics are likely to occur as part of a comprehensive national health research system strategy, especially one integrated into the healthcare system. We also describe two policy-informing economic evaluations conducted in Spain. These examined the most cost-effective package of evidence-based tobacco control interventions and the cost-effectiveness of different strategies to increase screening coverage for cervical cancer. Both projects focused on issues of healthcare concern and involved considerable stakeholder engagement. The Spanish examples reinforce some lessons from the global literature and, therefore, could help demonstrate to authorities in Spain the value of developing comprehensive health research systems, possibly following the interfaces and receptor model. The aim of this would be to integrate needs assessment and stakeholder engagement with structures spanning the research and health systems. In such structures, economic evaluation evidence could be collated, analysed by experts in relation to healthcare needs, and fed into both policy-making as appropriate, and future research calls. The increasingly large local and global evidence base on research utilization could inform detailed implementation of this approach once accepted as politically desirable. Given the COVID-19 pandemic, increasing the cost-effectiveness of healthcare systems and return on investment of public health interventions becomes even more important.

Determinants of Physical Activity and Dietary Habits among Adults in Ghana: A Cross-Sectional Study.

A critical understanding of the interrelationship between two behavioral decisions­participating in physical activity, and eating healthily­is lacking in Ghana. This study aimed to determine which factors affect each of the two behavioral decisions, jointly and separately, among adults aged 18 years or older in three metropolises (Kumasi, Accra, and Tamale) of Ghana. The data from the Ghana Obesity Survey 2021 were used. A bivariate probit model was fitted to estimate nonlinear models that indicate an individual's joint decision to participate in physical activity and consume a healthy diet. A positive correlation (r = 0.085; p < 0.05) was found between these two decisions, indicating a relationship between these two behavioral decisions. The common correlates between these decisions were self-reported good health status, high income, and attitudes toward being overweight. Men were more likely to be physically active but less likely to eat well. Both religion and culture determined participation in physical activity, but not the consumption of a healthy diet. Marital status determined diet, but not physical activity. The new knowledge gained from this analysis around the nature and the extent of the interconnectedness between physical activity and diet is critical to devising targeted interventions for obesity prevention in Ghana.

Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial.

AIM: To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Maori or whanau (extended-family) of Maori, given the high smoking prevalence in this population. DESIGN: Pragmatic, open-label, randomized, community-based non-inferiority trial. SETTING: Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand. PARTICIPANTS: Adult daily smokers who identified as Maori or whanau of Maori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi-media advertising. INTERVENTIONS: A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low-intensity cessation behavioural support from the prescribing doctor and community stop-smoking services or a research assistant. Day 5 of treatment was the designated quit date. MEASUREMENTS: The primary outcome was carbon monoxide-verified continuous abstinence at 6 months, analysed as intention-to-treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post-quit date included: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. FINDINGS: Verified continuous abstinence rates at 6 months post-quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = -0.22 to 8.79; relative risk 1.55; 95% CI = 0.97-2.46]. Sensitivity analyses confirmed that the findings were robust. Self-reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49-0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping. CONCLUSION: A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Maori or whanau (extended-family) of Maori, with significantly fewer adverse events.

Identification of Policy Priorities to Address the Burden of Smokeless Tobacco in Pakistan: A Multimethod Analysis.

INTRODUCTION: We assessed the magnitude of smokeless tobacco (ST) use in Pakistan and identified policy gaps to help ascertain short-, medium-, and long-term priorities. We then elicited stakeholders' views as to which of these identified priorities are most important. METHODS: In a multimethod study, we: analyzed Global Tobacco Surveillance System data sets to estimate ST consumption and disease burden; conducted a documentary review to identify gaps in policies to control ST in comparison with smoking; elicited stakeholders' views in an interactive workshop to identify a set of policy options available to address ST burden in Pakistan; and ranked policy priorities using a postevent survey. RESULTS: Among all tobacco users in Pakistan (n = 24 million), one-third of men and two-thirds of women consume ST. In 2017, its use led to an estimated 18 711 deaths due to cancer and ischemic heart disease. Compared to smoking, policies to control ST lag behind significantly. Priority areas for ST policies included: banning ST sale to and by minors, advocacy campaigns, introduction of licensing, levying taxes on ST, and standardizing ST packaging. A clear commitment to close cooperation between state actors and stakeholder groups is needed to create a climate of support and information for effective policy making. CONCLUSIONS: Smokeless tobacco control in Pakistan should focus on four key policy instruments: legislation, education, fiscal policies, and quit support. More research into the effectiveness of such policies is also needed. IMPLICATIONS: A number of opportunities to improve ST regulation in Pakistan were identified. Among these, immediate priorities include banning ST sale to and by minors, mobilizing advocacy campaign, introduction of licensing through the 1958 Tobacco Vendors Act, levying taxes on ST, and standardizing ST packaging.

Envisioning and shaping translation of knowledge into action: A comparative case-study of stakeholder engagement in the development of a European tobacco control tool.

Stakeholder engagement in health policy research is often said to increase 'research impact', but the active role of stakeholders in creating impact remains underexplored. We explored how stakeholders shaped the translation of health policy research into action. Our comparative case-study tracked a European research project that aimed to transfer an existing tobacco control return on investment tool. That project also aimed to increase its impact by engaging with stakeholders in further developing the tool. We conducted semi-structured interviews, using an actor-scenario mapping approach. Actor-scenarios can be seen as relational descriptions of a future world. We mapped the scenarios by asking stakeholders to describe who and what would play a role in the tool's utilisation. Our results show that stakeholders envisioned disparate futures for the tool. Some scenarios were specific, whereas most were generic projections of abstract potential users and responsibilities. We show how stakeholders mobilised elements of context, such as legislative support and agricultural practice, that would affect the tool's use. We conclude that stakeholders shape knowledge translation processes by continuously putting forth explicit or implicit scenarios about the future. Mapping actor-scenarios may help in aligning knowledge production with utilisation. Insights into potential roles and responsibilities could be fed back in research projects with the aim of increasing the likelihood that the study results may be used.

The Relationship between Lifestyle and Costs Related to Medicine Use in Adults / Relação entre Estilo de Vida e Custos Relacionados ao Uso de Medicamentos em Adultos

Abstract Background: The unhealthy lifestyle is growing and this can have repercussions on health status demanding actions on the occurrence of diseases and leads to increased expenses. Objective: To examine the interrelationship between the costs of medicine use and lifestyle behaviors. Methods: A cohort study with 118 participants, age around 51.7 ± 7.1 years old. It was collected personal and anthropometric data and information about medicine of continuous use to calculate the costs. Lifestyle variables included habitual physical activity (PA) assessed by pedometer, sedentary behavior by Baecke questionnaire, sleep quality by mini sleep questionnaire and self-report of smoke and alcohol consumption. Statistical analyses were performed by BioEstat (version 5.2) and the significance level set at p-value < 0.05. Results: In 12 months, 62 subjects bought 172 medicines, representing an overall cost of US$ 3,087.01. Expenditures with drugs were negatively related to PA (r = -0.194, p-value = 0.035 and r = -0.281, p-value = 0.002), but positively related with sleep quality (r = 0.299, p-value=0.001 and r = 0.315, p-value = 0.001) and age (r = 0.274, p-value = 0.003). Four multivariate models were executed considering lifestyle behaviors in different moments of cohort and medicine costs, and all these models identify important relationship between lifestyle behaviors with expenditures with drugs. Conclusion: Worse sleep quality seems to increase the costs related to medicine use in adults, while obesity and ageing play a relevant role in this phenomenon and alcohol consumption seems a variable with relevant economic impact.

Resumo Fundamento: O estilo de vida pouco saudável está se expandindo e isso pode ter repercussões no estado de saúde, exigindo ações contra a ocorrência de doenças e levando ao aumento de gastos. Objetivo: Examinar a interrelação entre os custos do uso de medicamentos e comportamentos de estilo de vida. Métodos: Estudo de coorte com 118 participantes com idade de 51,7 ± 7,1 anos. Foram coletados dados pessoais e antropométricos e informações sobre medicamentos de uso contínuo para calcular os custos. As variáveis de estilo de vida incluíram: atividade física (AF) habitual, avaliada por pedômetro; comportamento sedentário, pelo questionário de Baecke; qualidade do sono, através do Mini Questionário do Sono, e autorrelato de tabagismo e consumo de álcool. As análises estatísticas foram realizadas no programa BioEstat (versão 5.2), e o nível de significância estabelecido como p < 0,05. Resultados: Em 12 meses, 62 indivíduos compraram 172 medicamentos, representando um custo total de US$ 3.087,01. Gastos com medicamentos foram negativamente relacionados à AF (r = -0,194, p-valor = 0,035 e r = -0,281, p-valor = 0,002), mas relacionaram-se positivamente com a qualidade do sono (r = 0,299, p-valor=0,001 e r=0,315, p-valor = 0,001) e idade (r = 0,274, p-valor = 0,003). Quatro modelos multivariados foram executados, considerando os comportamentos de estilo de vida em diferentes momentos da coorte e custos dos medicamentos, e todos esses modelos identificam relações importantes entre comportamentos de estilo de vida e gastos com medicamentos. Conclusão: A pior qualidade do sono parece aumentar os custos relacionados ao uso de medicamentos em adultos, enquanto a obesidade e o envelhecimento desempenham um papel relevante nesse fenômeno, e o consumo de álcool parece ser uma variável com impacto econômico significativo.

Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial.

BACKGROUND AND AIMS: Cytisine, a nicotinic acetylcholine receptor partial agonist (like varenicline) found in some plants, is a low-cost, effective smoking cessation medication that may appeal to Maori [the indigenous people of New Zealand (NZ)]. The RAUORA trial aims to determine the effectiveness, safety and cost-effectiveness of cytisine (Tabex® ) versus varenicline (Champix® ) for smoking cessation in Maori and the whanau (extended family) of Maori. DESIGN: Pragmatic, community-based, open-label randomized non-inferiority trial. SETTING: Lakes District Health Board region, NZ. PARTICIPANTS: Daily smokers (n = 2140) who self-identify as Maori or whanau of Maori, and are: aged ≥ 18 years, motivated to quit smoking in the next 2 weeks, eligible for subsidized varenicline, able to provide verbal consent and have daily access to a mobile phone/internet. Recruitment uses multi-media advertising. INTERVENTION AND COMPARATOR: Participants are randomized (1 : 1 ratio) to receive a prescription for 12 weeks of cytisine tablets [following the manufacturer's dosing regimen for 25 days, then one 1.5-mg tablet every 6 hours (two per day) until 12 weeks] or varenicline tablets (following the manufacturer's dosing regimen). Both groups receive brief stop-smoking advice from the prescribing doctor and withdrawal-orientated behavioural support via community-based stop-smoking counselling services (frequency, duration and mode of delivery tailored for participants) or a research assistant (six weekly 10-15-minute calls). Participants are advised to reduce their smoking over the first 4 days of treatment, with day 5 as their designated quit-date. MEASUREMENTS: The primary outcome is carbon monoxide-verified continuous abstinence at 6 months post-quit date. Secondary outcomes at 1, 3, 6 and 12 months post-quit date include: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance, treatment acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. COMMENTS: This trial compares cytisine and varenicline when used by the indigenous people of NZ and their extended family for smoking cessation.

Nicotine preloading for smoking cessation: the Preloading RCT.

BACKGROUND: Nicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data. OBJECTIVES: To assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading. DESIGN: Open-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis. SETTING: NHS smoking cessation clinics. PARTICIPANTS: People seeking help to stop smoking. INTERVENTIONS: Nicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators. MAIN OUTCOME MEASURES: The primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix®; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model. RESULTS: In total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) -0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62; p = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73; p = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI -£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving. LIMITATIONS: The open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified. CONCLUSIONS: Use of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33031001. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.

Estimates of costs for modelling return on investment from smoking cessation interventions.

BACKGROUND AND AIMS: Modelling return on investment (ROI) from smoking cessation interventions requires estimates of their costs and benefits. This paper describes a standardized method developed to source both economic costs of tobacco smoking and costs of implementing cessation interventions for a Europe-wide ROI model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)]. DESIGN: Focused search of administrative and published data. A standardized checklist was developed in order to ensure consistency in methods of data collection. SETTING AND PARTICIPANTS: Adult population (15+ years) in Hungary, Netherlands, Germany, Spain and England. For passive smoking-related costs, child population (0-15 years) was also included. MEASUREMENTS: Costs of treating smoking-attributable diseases; productivity losses due to smoking-attributable absenteeism; and costs of implementing smoking cessation interventions. FINDINGS: Annual costs (per case) of treating smoking attributable lung cancer were between €5074 (Hungary) and €52 106 (Germany); coronary heart disease between €1521 (Spain) and €3955 (Netherlands); chronic obstructive pulmonary disease between €1280 (England) and €4199 (Spain); stroke between €1829 (Hungary) and €14 880 (Netherlands). Costs (per recipient) of smoking cessation medications were estimated to be: for standard duration of varenicline between €225 (England) and €465 (Hungary); for bupropion between €25 (Hungary) and €220 (Germany). Costs (per recipient) of providing behavioural support were also wide-ranging: one-to-one behavioural support between €34 (Hungary) and €474 (Netherlands); and group-based behavioural support between €12 (Hungary) and €257 (Germany). The costs (per recipient) of delivering brief physician advice were: €24 (England); €9 (Germany); €4 (Hungary); €33 (Netherlands); and €27 (Spain). CONCLUSIONS: Costs of treating smoking-attributable diseases as well as the costs of implementing smoking cessation interventions vary substantially across Hungary, Netherlands, Germany, Spain and England. Estimates for the costs of these diseases and interventions can contribute to return on investment estimates in support of national or regional policy decisions.

Cost-effectiveness of alternative smoking cessation scenarios in Spain: results from the EQUIPTMOD.

AIMS: To assess the cost-effectiveness of alternative smoking cessation scenarios from the perspective of the Spanish National Health Service (NHS). DESIGN: We used the European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD), a Markov-based state transition economic model, to estimate the return on investment (ROI) of: (a) the current provision of smoking cessation services (brief physician advice and printed self-helped material + smoking ban and tobacco duty at current levels); and (b) four alternative scenarios to complement the current provision: coverage of proactive telephone calls; nicotine replacement therapy (mono and combo) [prescription nicotine replacement therapy (Rx NRT)]; varenicline (standard duration); or bupropion. A rate of 3% was used to discount life-time costs and benefits. SETTING: Spain. PARTICIPANTS: Adult smoking population (16+ years). MEASUREMENTS: Health-care costs associated with treatment of smoking attributable diseases (lung cancer, coronary heart disease, chronic obstructive pulmonary infection and stroke); intervention costs; quality-adjusted life years (QALYs). Costs and outcomes were summarized using various ROI estimates. FINDINGS: The cost of implementing the current provision of smoking cessation services is approximately €61 million in the current year. This translates to 18 quitters per 1000 smokers and a life-time benefit-cost ratio of 5, compared with no such provision. All alternative scenarios were dominant (cost-saving: less expensive to run and generated more QALYs) from the life-time perspective, compared with the current provision. The life-time benefit-cost ratios were: 1.87 (proactive telephone calls); 1.17 (Rx NRT); 2.40 (varenicline-standard duration); and bupropion (2.18). The results remained robust in the sensitivity analysis. CONCLUSIONS: According to the EQUIPTMOD modelling tool it would be cost-effective for the Spanish authorities to expand the reach of existing GP brief interventions for smoking cessation, provide pro-active telephone support, and reimburse smoking cessation medication to smokers trying to stop. Such policies would more than pay for themselves in the long run.

An examination of user costs in relation to smokers using a cessation service based in the UK.

BACKGROUND: Smoking cessation services provide support to smokers who desire to quit. Published studies to date have looked at the cost and benefit of service provision but typically focus on clinical trial data. Using routinely collected observational data, this study examined the costs involved in providing a service in terms of average health care expenditure per successful quit attempt in addition to population - level cost-effectiveness measures. METHODS: Data were analysed from Quit-51 smoking cessation service across five English regions between March 2013 and March 2016 (n = 9116). For each user, costs were estimated in relation to: (i) time spent with advisers; (ii) prescription of pharmacotherapy. The total costs compared against self-reported quit at 12 weeks, which represents the time period for which the service is offered. Cost per quit (CPQ), with 95% confidence interval (CI), was calculated by relating total expenditure to the number of quitters, firstly for the whole dataset and then by subgroups of key categorical variables, namely; gender, age group, the Fagerstrom test for nicotine dependence (FTND) and Index of Multiple Deprivation (IMD). Confidence intervals (CIs) for the mean estimates were derived using a non-parametric bootstrap procedure. Parameters derived from the calculation in relation to treatment were used to estimate potential long-term population outcomes under a scenario where the Quit 51 prescription was rolled out nationally. RESULTS: The overall mean CPQ for this sample as estimated at 12 weeks was £403.51 (95% CI = £393.36 to £413.76). The estimated CPQs at this time point were comparable for those aged 12-19 (£423.56, 95% CI = £369.45 to £492.60) and those aged 20-29 (£430.76, 95% CI = £395.95 to £470.56). Differences were also seen in relation to other subgroups considered. The treatment parameters translated to a projected increase of 1.5 quality-adjusted life years (QALYs) per 1000 smokers in the short-term and 23.4 QALYS per 1000 smokers based on a lifetime horizon. CONCLUSIONS: These figures throw light on service expenditure for each successful quit over the timeframe for which the service is offered in addition to highlighting variability in these costs across different subgroups of the user population.

Assessment of cost-effective changes to the current and potential provision of smoking cessation services: an analysis based on the EQUIPTMOD.

BACKGROUND AND AIMS: Increasing the reach of smoking cessation services and/or including new but effective medications to the current provision may provide significant health and economic benefits; the scale of such benefits is currently unknown. The aim of this study was to estimate the cost-effectiveness from a health-care perspective of viable national level changes in smoking cessation provision in the Netherlands and England. METHODS: A Markov-based state transition model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)] was used to estimate costs and benefits [expressed in quality-adjusted life years (QALY)] of changing the current provision of smoking cessation programmes in the Netherlands and England. The changes included: (a) increasing the reach of top-level services to increase potential quitters (e.g. brief physician advice); (b) increasing the reach of behavioural support (group-based therapy and SMS text-messaging support) to increase the success rates; (c) including a new but effective medication (cytisine); and (d) all changes implemented together (combined change). The costs and QALYs generated by those changes over 2, 5, 10 years and a life-time were compared with that of the current practice in each country. Results were expressed as incremental net benefit (INB) and incremental cost-effectiveness ratio (ICER). A sequential analysis from a life-time perspective was conducted to identify the optimal change. RESULTS: The combined change was dominant (cost-saving) over all alternative changes and over the current practice, in both countries. The combined change would generate an incremental net benefit of €11.47 (2 years) to €56.16 (life-time) per smoker in the Netherlands and €9.96 (2 years) to €60.72 (life-time) per smoker in England. The current practice was dominated by all alternative changes. CONCLUSION: Current provision of smoking cessation services in the Netherlands and England can benefit economically from the inclusion of cytisine and increasing the reach of brief physician advice, text-messaging support and group-based therapy.

Understanding perceived availability and importance of tobacco control interventions to inform European adoption of a UK economic model: a cross-sectional study.

BACKGROUND: The evidence on the extent to which stakeholders in different European countries agree with availability and importance of tobacco-control interventions is limited. This study assessed and compared stakeholders' views from five European countries and compared the perceived ranking of interventions with evidence-based ranking using cost-effectiveness data. METHODS: An interview survey (face-to-face, by phone or Skype) was conducted between April and July 2014 with five categories of stakeholders - decision makers, service purchasers, service providers, evidence generators and health promotion advocates - from Germany, Hungary, the Netherlands, Spain, and the United Kingdom. A list of potential stakeholders drawn from the research team's contacts and snowballing served as the sampling frame. An email invitation was sent to all stakeholders in this list and recruitment was based on positive replies. Respondents were asked to rate availability and importance of 30 tobacco control interventions. Kappa coefficients assessed agreement of stakeholders' views. A mean importance score for each intervention was used to rank the interventions. This ranking was compared with the ranking based on cost-effectiveness data from a published review. RESULTS: Ninety-three stakeholders (55.7% response rate) completed the survey: 18.3% were from Germany, 17.2% from Hungary, 30.1% from the Netherlands, 19.4% from Spain, and 15.1% from the UK. Of those, 31.2% were decision makers, 26.9% evidence generators, 19.4% service providers, 15.1% health-promotion advocates, and 7.5% purchasers of services/pharmaceutical products. Smoking restrictions in public areas were rated as the most important intervention (mean score = 1.89). The agreement on availability of interventions between the stakeholders was very low (kappa = 0.098; 95% CI = [0.085, 0.111] but the agreement on the importance of the interventions was fair (kappa = 0.239; 95% CI = [0.208, 0.253]). A correlation was found between availability and importance rankings for stage-based interventions. The importance ranking was not statistically concordant with the ranking based on published cost-effectiveness data (Kendall rank correlation coefficient = 0.40; p-value = 0.11; 95% CI = [- 0.09, 0.89]). CONCLUSIONS: The intrinsic differences in stakeholder views must be addressed while transferring economic evidence Europe-wide. Strong engagement with stakeholders, focussing on better communication, has a potential to mitigate this challenge.

OPTIMIZING USABILITY OF AN ECONOMIC DECISION SUPPORT TOOL: PROTOTYPE OF THE EQUIPT TOOL.

OBJECTIVES: Economic decision-support tools can provide valuable information for tobacco control stakeholders, but their usability may impact the adoption of such tools. This study aims to illustrate a mixed-method usability evaluation of an economic decision-support tool for tobacco control, using the EQUIPT ROI tool prototype as a case study. METHODS: A cross-sectional mixed methods design was used, including a heuristic evaluation, a thinking aloud approach, and a questionnaire testing and exploring the usability of the Return of Investment tool. RESULTS: A total of sixty-six users evaluated the tool (thinking aloud) and completed the questionnaire. For the heuristic evaluation, four experts evaluated the interface. In total twenty-one percent of the respondents perceived good usability. A total of 118 usability problems were identified, from which twenty-six problems were categorized as most severe, indicating high priority to fix them before implementation. CONCLUSIONS: Combining user-based and expert-based evaluation methods is recommended as these were shown to identify unique usability problems. The evaluation provides input to optimize usability of a decision-support tool, and may serve as a vantage point for other developers to conduct usability evaluations to refine similar tools before wide-scale implementation. Such studies could reduce implementation gaps by optimizing usability, enhancing in turn the research impact of such interventions.