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.

The diversity in tobacco use among women of reproductive age (15-49 years) in Pakistan: A secondary analysis of a Multiple Indicator Cluster Survey (MICS) 2016-2018.

INTRODUCTION: Tobacco use in women of reproductive age group(15-49 years) may contribute to poor maternal and child health outcomes. We estimated the prevalence of smokeless tobacco (ST), cigarette, and waterpipe use among these women in Pakistan and explored associations with socio-economic differences and birthweights after recent childbirths (past 2 years). METHODS: We used the Multiple Indicator Cluster Surveys(MICS) datasets from three provinces in Pakistan. Prevalence was generated for current use of tobacco among women with recent childbirth(WWRC) and without recent childbirth(WWoRC). We further compared socio-economic status and birthweights between tobacco users and non-users. RESULTS: The prevalence of current ST use was 1·4% and 2·5%, and waterpipe smoking was 1·2% and 1·8%, in WWRC and WWoRC, respectively. ST use varied across Pakistan's provinces by 13 percentage points in WWRC and WWoRC while waterpipe smoking by 10 and 15 percentage points, respectively. The odds of using any form of tobacco were significantly lower with higher levels of education or wealth index. Compared to children born to mothers who did not use tobacco, the birthweight of children born to mothers who smoked waterpipe was on average 0.83kg (95%CI -1·6 to -0·1) lower whereas it was 0·33kg (95%CI -0·9 to 0·3) higher for ST users. CONCLUSIONS: Tobacco use among women of reproductive age in Pakistan varied significantly based on province and tobacco type. Waterpipe smoking was associated with a reduction in birth weight. Raising awareness of the harms of tobacco use among women of reproductive age and targeting interventions in high-burden regions of Pakistan should be prioritised. IMPLICATIONS: The prevalence of current smokeless tobacco use and waterpipe smoking varied significantly in Pakistan (~13 and ~15 percentage points, respectively) among women of reproductive age, and there seems to be little change in tobacco use behaviour around pregnancy and early motherhood. The study highlights a need to better understand the prevalence of tobacco use in Pakistan, and further contextual research is warranted to understand the reasons for such high tobacco use in certain areas. This information highlights the need for improving current tobacco control interventions and policies, including measures that could help reduce its use and prevent its uptake. Furthermore, compared to children born to mothers who did not use any form of tobacco, we found a statistically significant difference (830 grams) in birthweight for babies born to mothers who at the time of the interview smoked waterpipe and a non-statistically significant difference of about 330 grams for children born to mothers who at the time of the interview used smokeless tobacco. In addition to our findings, some literature suggests the association of waterpipe smoking with low birth weight. A possible explanation could be the exposure to smoke that contains toxicants from the tobacco product itself in addition to the burning of charcoal, which is required when using waterpipe. Waterpipe smoking also results in high exposures of carbon monoxide and polycyclic aromatic hydrocarbons, which are known to be carcinogenic and teratogenic. In terms of smokeless tobacco use, further research is warranted to understand its impact on birth outcomes through longitudinal studies accounting for diverse products, its constituents and the amount of consumption.

Children Learning About Secondhand Smoke (CLASS III): a protocol for a cluster randomised controlled trial of a school-based smoke-free intervention in Bangladesh and Pakistan.

INTRODUCTION: Secondhand smoke (SHS) exposure is a major cause of premature death and disease, especially among children. Children in economically developing countries are particularly affected as smoke-free laws are typically only partially implemented and private homes and cars remain a key source of SHS exposure. Currently, firm conclusions cannot be drawn from the available evidence on the effectiveness of non-legislative interventions designed to protect children from SHS exposure. Following the success of two feasibility studies and a pilot trial, we plan to evaluate a school-based approach to protect children from SHS exposure in Bangladesh and Pakistan-countries with a strong commitment to smoke-free environments but with high levels of SHS exposure in children. We will conduct a two-arm cluster randomised controlled trial in Bangladesh and Pakistan to assess the effectiveness and cost effectiveness of a school-based smoke-free intervention (SFI) in reducing children's exposure to SHS and the frequency and severity of respiratory symptoms. METHODS AND ANALYSIS: We plan to recruit 68 randomly selected schools from two cities-Dhaka in Bangladesh and Karachi in Pakistan. From each school, we will recruit approximately 40 students in a year (9-12 years old) with a total of 2720 children. Half of the schools will be randomly allocated to the intervention arm receiving SFI and the other half will receive usual education. Salivary cotinine concentration-a highly sensitive and specific biomarker of SHS exposure-is the primary outcome, which will be measured at month 3 post-randomisation. Secondary outcomes will include frequency and severity of respiratory symptoms, healthcare contacts, school absenteeism, smoking uptake and quality of life. Embedded economic and process evaluations will also be conducted. ETHICS AND DISSEMINATION: The trial has received ethics approval from the Research Governance Committee at the University of York. Approvals have also been obtained from Bangladesh Medical Research Council and Pakistan Health Research Council. If SFI is found effective, we will use a variety of channels to share our findings with both academic and non-academic audiences. We will work with the education departments in Bangladesh and Pakistan and advocate for including SFI within the curriculum. TRIAL REGISTRATION NUMBER: ISRCTN28878365.

The global impact of tobacco control policies on smokeless tobacco use: a systematic review.

BACKGROUND: Smokeless tobacco, used by more than 300 million people globally, results in substantial morbidity and mortality. For smokeless tobacco control, many countries have adopted policies beyond the WHO Framework Convention on Tobacco Control, which has been instrumental in reducing smoking prevalence. The impact of these policies (within and outside the Framework Convention on Tobacco Control) on smokeless tobacco use remains unclear. We aimed to systematically review policies that are relevant to smokeless tobacco and its context and investigate their impact on smokeless tobacco use. METHODS: In this systematic review, we searched 11 electronic databases and grey literature between Jan 1, 2005, and Sept 20, 2021, in English and key south Asian languages, to summarise smokeless tobacco policies and their impact. Inclusion criteria were all types of studies on smokeless tobacco users that mentioned any smokeless tobacco relevant policies since 2005, except systematic reviews. Policies issued by organisations or private institutions were excluded as well as studies on e-cigarettes and Electronic Nicotine Delivery System except where harm reduction or switching were evaluated as a tobacco cessation strategy. Two reviewers independently screened articles, and data were extracted after standardisation. Quality of studies was appraised using the Effective Public Health Practice Project's Quality Assessment Tool. Outcomes for impact assessment included smokeless tobacco prevalence, uptake, cessation, and health effects. Due to substantial heterogeneity in the descriptions of policies and outcomes, data were descriptively and narratively synthesised. This systematic review was registered in PROSPERO (CRD42020191946). FINDINGS: 14 317 records were identified, of which 252 eligible studies were included as describing smokeless tobacco policies. 57 countries had policies targeting smokeless tobacco, of which 17 had policies outside the Framework Convention on Tobacco Control for smokeless tobacco (eg, spitting bans). 18 studies evaluated the impact, which were of variable quality (six strong, seven moderate, and five weak) and reported mainly on prevalence of smokeless tobacco use. The body of work evaluating policy initiatives based on the Framework Convention on Tobacco Control found that these initiatives were associated with reductions in smokeless tobacco prevalence of between 4·4% and 30·3% for taxation and 22·2% and 70·9% for multifaceted policies. Two studies evaluating the non-Framework policy of sales bans reported significant reductions in smokeless tobacco sale (6·4%) and use (combined sex 17·6%); one study, however, reported an increased trend in smokeless tobacco use in the youth after a total sales ban, likely due to cross-border smuggling. The one study reporting on cessation found a 13·3% increase in quit attempts in individuals exposed (47·5%) to Framework Convention on Tobacco Control policy: education, communication, training, and public awareness, compared with non-exposed (34·2%). INTERPRETATION: Many countries have implemented smokeless tobacco control policies, including those that extend beyond the Framework Convention on Tobacco Control. The available evidence suggests that taxation and multifaceted policy initiatives are associated with meaningful reductions in smokeless tobacco use. FUNDING: UK National Institute for Health Research.

Oral Cancer Risk Assessment for Different Types of Smokeless Tobacco Products Sold Worldwide: A Review of Reviews and Meta-analyses.

Smokeless tobacco (SLT) use is a significant cause of lip and oral cavity cancers. Globally, oral cancer prevalence is strongly linked to the types of tobacco products used, their chemical composition, and their pattern of use. Except snus, all SLT products sold in different World Health Organization regions are strongly associated with oral cancer incidence. Shammah showed the highest association OR with 95% confidence intervals (CI; OR, 38.74; 95% CI, 19.50-76.96), followed by oral snuff (OR, 11.80; 95% CI, 8.45-16.49), gutkha (OR, 8.67; 95% CI, 3.59-20.93), tobacco with betel quid (OR, 7.74; 95% CI, 5.38-11.13), toombak (OR, 4.72; 95% CI, 2.88-7.73), and unspecified chewing tobacco (OR, 4.72; 95% CI, 3.13-7.11). Most SLT products containing high levels of carcinogenic tobacco-specific nitrosamines (TSNA) exhibit a high risk of oral cancer. There is an urgent need to frame and implement international policies for oral cancer prevention through legal control of the TSNA levels in all SLT product types. PREVENTION RELEVANCE: Most smokeless tobacco products sold worldwide, mainly shammah, toombak, gutkha, betel quid with tobacco, and dry snuff, are associated with a high risk of oral cancer. A high concentration of tobacco-specific nitrosamines in smokeless tobacco products is the major causative factor for oral cancer development.

Non-compliant packaging and illicit smokeless tobacco in Bangladesh, India and Pakistan: findings of a pack analysis.

INTRODUCTION: Illicit smokeless tobacco (ST) trade has seldom been documented despite ST use in at least 127 countries across the world. Based on non-compliance with packaging regulations, we report the proportion of illicit ST products from samples on sale in Bangladesh, India and Pakistan where 85% of global ST users reside. METHODS: We purchased unique ST products from tobacco sellers in two purposively selected administrative areas (division/district) in each of the three countries. The criteria to determine illicit ST products were based on country-specific legal requirements for ST packaging and labelling. These requirements included: 'market retail price disclosure', 'sale statement disclosure', 'pictorial health warning (PHW) pertinence', 'appropriate textual health warning' and 'using misleading descriptors (MDs)'. Non-compliance with even one of the legal requirements was considered to render the ST product illicit. RESULTS: Almost all ST products bought in Bangladesh and India were non-compliant with the local packaging requirements and hence potentially illicit, all products in Pakistan lacked desirable features. The most common feature missing was health warnings: 84% packs in Bangladesh, 93% in India, and 100% in Pakistan either did not have PHW or their sizes were too small. In Bangladesh, 61% packs carried MDs. In India and Pakistan, the proportions of such packs were 32% and 42%, respectively. CONCLUSIONS: Weak and poorly enforced ST control policies may be slowing the progress of tobacco control in South Asia. Standardised regulations are required for packaging and labelling ST. Improving compliance and reducing sale of cheap illicit products may require business licensing and market surveillance.

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.

Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis: a multicentre, randomised controlled trial of the ProLife programme in South Africa.

OBJECTIVE: To investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking. DESIGN: Multicentre, individual, randomised controlled trial where participants were assigned (1:1) to the ProLife intervention or usual care. SETTING: 27 primary care clinics in South Africa. PARTICIPANTS: 574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use. INTERVENTIONS: The intervention, delivered by lay health workers (LHWs), consisted of three brief motivational interviewing (MI) sessions, augmented with short message service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking. OUTCOME MEASURES: The primary outcome was successful versus unsuccessful TB treatment at 6-9 months, from TB records. Secondary outcomes were biochemically confirmed sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral therapy (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates in patients who had bacteriology-confirmed TB at baseline, from TB records. RESULTS: Between 15 November 2018 and 31 August 2019, 574 participants were randomised to receive either the intervention (n=283) or usual care (n=291). TB treatment success rates did not differ significantly between intervention (67.8%) and control (70.1%; OR 0.9, 95% CI 0.64% to 1.27%). There was no evidence of an effect at 3 and 6 months, respectively, on continuous smoking abstinence (OR 0.65, 95% CI 0.37 to 1.14; OR 0.76, 95% CI 0.35 to 1.63), TB medication adherence (OR 1.22, 95% CI 0.52 to 2.87; OR 0.89, 95% CI 0.26 to 3.07), taking ART (OR 0.79, 95% CI 0.38 to 1.65; OR 2.05, 95% CI 0.80 to 5.27) or AUDIT scores (mean score difference 0.55, 95% CI -1.01 to 2.11; -0.04, 95% CI -2.0 to 1.91) and adjusting for baseline values. Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63). CONCLUSIONS: Simultaneous targeting of multiple health risk behaviours with MI and SMS using LHWs may not be an effective approach to improve TB outcomes. TRIAL REGISTRATION NUMBER: ISRCTN62728852.

Attitudes of smokers towards tobacco control policies: findings from the Studying Tobacco users of Pakistan (STOP) survey.

BACKGROUND: Public attitude is a political driver in successful implementation of tobacco control policies. We assessed support for a range of tobacco control policies among smokers in Pakistan. METHODS: We conducted a household survey among adult smokers in 10 cities of Pakistan, using a two-stage random sampling strategy to select households and Kish grid method to select one smoker per household. Attitudes were measured using a five-point ordinal scale on four policy statements: a complete ban on tobacco sale within 10 years; raising the legal age to buy tobacco from 18 to 21; increasing tobacco taxes to fund healthcare and a ban on smoking in cars with minors. RESULTS: 6014 participants were interviewed between September 2019 and March 2020. Most participants demonstrated strong support for all policy statements: a ban on smoking in cars with minors (86.5%); a complete ban on tobacco sale within 10 years (82.1%); raising the legal age to buy tobacco (77.9%) and increasing tobacco taxes (68.1%). Smokers' support for tobacco control policies increased with age but decreased with higher educational attainment and heaviness of smoking. CONCLUSIONS: There is strong support among smokers in Pakistan to strengthen tobacco control. Given this, policy-makers should strongly consider strengthening existing national policies on tobacco control.

Awareness, perceptions of and compliance with tobacco control policies among naswar vendors in Khyber Pakhtunkhwa Pakistan.

INTRODUCTION: Regulatory compliance in the retail environment is integral to the success of tobacco control. We assessed compliance among naswar (smokeless tobacco product widely used in South Asia) vendors with tobacco control laws. We also assessed their awareness of tobacco-related harms and policies and perceived effect of policies on their sales. METHODS: We surveyed 286 naswar vendors in three districts of the Khyber Pakhtunkhwa province of Pakistan. We recruited general and specialty vendors from urban and rural areas through multistage cluster sampling. Compliance was measured for promotion, sale to/by minors and tax paid on naswar. We used logistic regression analyses for assessing the association between the outcome variables (awareness of tobacco harms and laws, perceptions about the effect of policies on business and compliance with laws) and their predictors. RESULTS: Most vendors (70%) were aware of tobacco-related harms of naswar. Although educated vendors were more aware of tobacco control policies, the greatest awareness was for a ban on sales to/by minors (21% overall). The majority of vendors (76%) violated this policy (measured by self-report), and violations were more common among rural than urban vendors (OR 2.27, 95% CI 1.05 to 4.96). Most vendors (71%) violated a ban on promotion of naswar. Vendors perceived tax increases and sales ban to/by minors as most detrimental for business. CONCLUSIONS: There was poor awareness and compliance among naswar vendors in Pakistan with tobacco control laws. This study finds potential areas for policy interventions that can reduce urban/rural disparities in implementation of and compliance with tobacco control laws.

Illicit cigarette trade in the cities of Pakistan: comparing findings between the consumer and waste recycle store surveys.

BACKGROUND: Concerns about the magnitude of illicit cigarette trade have prevented the Government of Pakistan from increasing tobacco taxes. We estimated the proportion of illicit cigarettes sold in Pakistani cities. Moreover, we compared two methods for collecting cigarette packs and investigated if the illicit cigarette trade equates to tax evasion. METHOD: We analysed cigarette packs collected from 10 cities of Pakistan using two methods: consumer survey based on a two-stage random sampling strategy to recruit adult smokers and photograph their cigarette packs and waste recycle store survey to purchase used cigarette packs. Cigarettes were considered illicit if any one of the following was absent from their packs: text and pictorial health warning, underage sale prohibition warning, retail price and manufacturer's name. From the consumer survey, we also estimated the proportion of smokers who purchased loose cigarettes (illegal) and packs below the minimum retail price. Taxation officers (n=4) were consulted to assess their level of confidence in judging tax evasion using the above criteria. RESULTS: Out of 2416 cigarette packs in the consumer survey, 454 (17.8%; 95% CI 15.4% to 20.2%) were illicit. Similarly, out of 6213 packs from waste recycle shops, 1046 (16.8%; 95% CI 15.9% to 17.7%) were illicit; the difference was not statistically significant (p=0.473). Among consumers, 29.5% bought loose cigarettes and 13.8% paid less than the minimum retail price. The taxation officers considered the manufacturer's name and retail price on cigarette packs as the most relevant criteria to detect tax evasion. CONCLUSIONS: One in six cigarette packs consumed in Pakistan could be illicit. These figures are far less than those propagated by the tobacco industry. Collecting packs from waste recycle stores is an efficient and valid method to estimate illicit cigarette trade.

What Factors are Associated With Waterpipe Smoking Cessation? A Secondary Data Analysis.

INTRODUCTION: Waterpipe smoking is gaining popularity and becoming a major global public health concern. An understanding of factors that predict waterpipe smoking cessation is necessary for targeting tobacco control efforts. METHODS: This is a secondary data analysis of a randomized controlled trial comparing the efficacy of varenicline against placebo in helping waterpipe smokers to quit. A total of 510 adult daily waterpipe smokers were recruited to the trial in 2016. Logistic regression models were applied to assess factors (i.e., demographic, environmental, behavioral, and physiological) associated with primary outcome (waterpipe smoking cessation) and secondary outcomes (waterpipe cessation alongside abstinence from cigarette and short-term and long-term waterpipe smoking cessation). Cessation was defined as 7-day point prevalence abstinence from smoking reported at 5,12, and/or 25 weeks follow-ups. RESULTS: Over a period of six months, 189 (39.2%) participants abstained from waterpipe smoking for at least one week. Being male (adjusted odds ratio (aOR):2.99 (95%CI:1.47-6.08)), dual smoker (waterpipe and cigarettes) (aOR:2.98 (95%CI:1.87-4.74)), more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having a history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation. CONCLUSIONS: In addition to nicotine dependency, social factors such as home restrictions on smoking, and not sharing waterpipe were identified as predictors of waterpipe smoking cessation. To help waterpipe smokers quit, social environment may be just as or even more important than well-known physical and psychological factors. IMPLICATIONS: A range of factors, predominantly social factors play a significant role in facilitating or deterring waterpipe smokers from quitting smoking. Our findings suggest that interventions that focus on social as well as physical/psychological factors may encourage waterpipe smokers in achieving abstinence.

Tobacco Use Among 1 310 716 Women of Reproductive age (15-49 Years) in 42 Low- and Middle-Income Countries: Secondary Data Analysis From the 2010-2016 Demographic and Health Surveys.

INTRODUCTION: Tobacco use among women, especially during pregnancy is a public health concern. There is a need to understand the diverse nature of their tobacco consumption across the globe. METHODS: We used Demographic and Health Surveys (DHS) data collected between 2010 and 2016 from 42 low- and middle-income countries (LMICs) to estimate the prevalence of smoking, smokeless tobacco, and dual use among pregnant and non-pregnant women of reproductive age (15-49 y). We compared tobacco use between both groups adjusted for age, type of residence, education and combined wealth index, and a subgroup analysis for the South-East Asia Region (SEAR) as the tobacco use in SEAR among women is far more diverse than in other regions primarily due to the popularity of smokeless tobacco use in this region. RESULTS: Based on the data of 1 310 716 women in 42 LMICs, the prevalence of smoking was 0.69%(95%CI: 0.51-0.90) among pregnant women and 1.09%(95%CI: 0.81-1.42) among non-pregnant women. The prevalence of smokeless tobacco use was 0.56%(95%CI: 0.33-0.84) among pregnant women and 0.78%(95%CI: 0.35-1.37) among non-pregnant women. The relative risk ratios(RRR) for smoking (0.85; 95%CI: 0.67-1.09) and smokeless tobacco use (0.81; 95%CI:0.67-1.00) were not-significantly lower among pregnant women than non-pregnant women and education and wealth index had an inverse relationship with both forms of tobacco. In SEAR, among pregnant women, the prevalence of smoking and smokeless tobacco use was 1.81% and 0.45%, respectively. However, pregnant women were 7%(RRR 1.07; 95%CI:1.02-1.12) more likely to use smokeless tobacco than non-pregnant women. CONCLUSION: Despite the added risk of foetal harm during pregnancy, there is no evidence that the tobacco consumption between pregnant and non-pregnant women differ in 42 LMICs. A significantly higher use of smokeless tobacco among pregnant women in SEAR is of particular concern and warrants further investigation. IMPLICATIONS: Tobacco use among women in low- and middle-income countries (LMICs) is lower than high-income countries (HICs), but this may be because LMICs are earlier in the epidemiological transition of tobacco use. If ignored as a public health issue and the tobacco industry continues to market its products to women, the level of tobacco use may rise as it did in HICs. Also, despite low prevalence rates and with no evidence that these differ among pregnant and non-pregnant women, is concerning as tobacco consumption in any form during pregnancy is associated with poor birth outcomes. This suggests a need for raising awareness about the harms of tobacco use among women in LMICs, especially during pregnancy. There is a need to develop preventive and cessation interventions to decrease tobacco use (smoking and smokeless) among women who are from low socio-economic status and less educated, as they bear the greatest burden of tobacco use.

Smokeless tobacco products, supply chain and retailers' practices in England: a multimethods study to inform policy.

BACKGROUND: In England, many people of South Asian origin consume smokeless tobacco (ST). ST use can lead to oral cancer, which is disproportionately high in South Asians. Our aims were to assess the compliance of ST product retailers with statutory regulations and to explore the supply chain of ST. METHODS: We undertook a multimethods study between August 2017 and July 2019 in five English boroughs with a high proportion of ethnic South Asians. We purchased ST products and conducted field surveys with ST retailers at point of sale. Qualitative interviews were conducted with ST retailers and suppliers. ST packs were assessed for regulatory compliance, while quantitative and qualitative data triangulated information on retailers' practices and the ST supply chain. RESULTS: We collected 41 unique ST products, which included dry snuff, naswar, gutka, chewing tobacco and zarda. ST products were not registered, and demonstrated low compliance with health warning (14.6%) and packaging (56.1%) requirements. ST availability in surveyed boroughs was high (38.2%-69.7%); dry snuff, naswar and zarda were most commonly available. ST retailers demonstrated limited knowledge of regulations, and one-third were found to advertise ST at point of sale. Qualitative insights revealed illicit supply and distribution networks, as well as ST production in discreet locations. CONCLUSION: ST products are widely available in England, yet non-compliant with statutory regulations. In order to safeguard consumers, in particular ethnic South Asians, stronger efforts are needed to regulate the supply chain of ST at both national and international levels.

Predictors of Cigarette Smoking, Smokeless Tobacco Consumption, and Use of both forms in Adolescents in South Asia: A Secondary Analysis of the Global Youth Tobacco Surveys.

INTRODUCTION: Tobacco uptake in adolescents is associated with a range of predictors. We examined the predictors of cigarette smoking, smokeless tobacco (ST) consumption, and use of both ST and cigarettes among adolescents in four South Asian countries. METHODS: We analyzed the Global Youth Tobacco Surveys (GYTS) data for Bangladesh (2013), India (2009), Pakistan (2013), and Sri Lanka (2015), using multinomial regression to examine associations between several predictors and tobacco use. RESULTS: Data from 23 681 adolescents were analyzed. Overall, 82.8% of the study population were between 13 and 15 years and 52.7% were girls, 2% were cigarette smokers, 6.5% were ST users, and 1.1% used both ST and cigarettes, in the past 30 days. Exposure to smoking in public places was associated with past 30-day smoking (relative risk ratio [RRR] 5.59, 95% confidence intervals [CI] 4.28-7.28), ST use (RRR 2.07, 95% CI 1.84-2.32), and use of both ST and cigarettes (RRR 11.42, 95% CI 7.44-17.54). Exposure to tobacco use in electronic media and being offered free tobacco products were associated with all forms of tobacco use. Shopkeepers' refusal to sell cigarettes protected adolescents from smoking (RRR 0.47, 95% CI 0.36-0.63) and ST use (RRR 0.65, 95% CI 0.45-0.95). However, exposure to antitobacco mass media messages was not protective for any form of tobacco use. Adolescents taught at school about harmful effects of tobacco were less likely to use ST; no evidence of this association was observed for smoking. CONCLUSION: The associations between tobacco use and protobacco factors were strong, but the associations with antitobacco factors lacked strength and consistency in this study population. IMPLICATIONS: The predictors of adolescents using different tobacco products, crucial to inform and evaluate tobacco control efforts, are poorly understood. We investigated the associations between several environmental-level factors and cigarette smoking, ST consumption, and use of both forms among adolescents, whereas most of the previous studies focused on individual-level factors. Our study found strong associations between tobacco use and protobacco factors and lack of strength and consistency in associations between antitobacco factors and tobacco use in the study population. Our results indicate that the current tobacco control policies need strengthening to curb the tobacco epidemic in these countries.

The Impact of COVID-19 on Smoking Patterns in Pakistan: Findings From a Longitudinal Survey of Smokers.

INTRODUCTION: We investigated the influence of COVID-19 on smoking patterns in Pakistan. METHODS: In a longitudinal survey, we asked cigarette smokers in Pakistan about their smoking behaviors before and since COVID-19. Smokers were recruited before COVID-19 using two-stage random probability sampling. Since COVID-19, three subsequent waves were conducted over the telephone, asking additional questions on social determinants, mental health, and well-being. Based on the first two waves, we estimated the proportion of smokers who stopped, decreased, maintained, or increased smoking. We also explored any factors associated with the change in smoking patterns. In those who stopped smoking soon after COVID-19, we estimated the proportion relapsed in subsequent waves. We estimated all proportions based on complete-case analysis. RESULTS: We recruited 6014 smokers between September 2019 and February 2020; of these, 2087 (2062 reported smoking outcomes) were followed up in May 2020 after COVID-19. Since COVID-19, 14% (290/2062) smokers reported quitting. Among those who continued smoking: 68% (1210/1772) reduced, 14% (239/1772) maintained, and 18% (323/1772) increased cigarette consumption; 37% (351/938) reported at least one quit attempt; 41% (669/1619) were more motivated; while 21% (333/1619) were less motivated to quit. Changes in smoking patterns varied with nicotine dependence, motivation to quit, and financial stability since COVID-19. Among those reporting quitting soon after COVID-19, 39% (81/206) relapsed in the subsequent months (June-July 2020). CONCLUSIONS: There have been significant bidirectional changes in smoking patterns since COVID-19 in Pakistan. Although many people stopped, reduced, or tried quitting smoking, some increased smoking and some relapsed after quitting. IMPLICATIONS: We observed significant and complex changes in people's smoking patterns, which are likely to be attributable to the COVID-19 pandemic and replicated in similar events in the future. Assessing these changes is essential for most low- and middle-income countries like Pakistan, where the vast majority of tobacco users live, but cessation support is still rudimentary. If provided routinely, smoking cessation interventions can potentially support millions of highly motivated individuals in quitting successfully both in general and in global events like COVID-19, in particular.

Global impact of tobacco control policies on smokeless tobacco use: a systematic review protocol.

INTRODUCTION: Smokeless tobacco (ST) was consumed by 356 million people globally in 2017. Recent evidence shows that ST consumption is responsible for an estimated 652 494 all-cause deaths across the globe annually. The WHO Framework Convention on Tobacco Control (FCTC) was negotiated in 2003 and ratified in 2005 to implement effective tobacco control measures. While the policy measures enacted through various tobacco control laws have been effective in reducing the incidence and prevalence of smoking, the impact of ST-related policies (within WHO FCTC and beyond) on ST use is under-researched and not collated. METHODS AND ANALYSIS: A systematic review will be conducted to collate all available ST-related policies implemented across various countries and assess their impact on ST use. The following databases will be searched: Medline, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Scopus, EconLit, ISI Web of Science, Cochrane Library (CENTRAL), African Index Medicus, LILACS, Scientific Electronic Library Online, Index Medicus for the Eastern Mediterranean Region, Index Medicus for South-East Asia Region, Western Pacific Region Index Medicus and WHO Library Database, as well as Google search engine and country-specific government websites. All ST-related policy documents (FCTC and non-FCTC) will be included. Results will be limited to literature published since 2005 in English and regional languages (Bengali, Hindi and Urdu). Two reviewers will independently employ two-stage screening to determine inclusion. The Effective Public Health Practice Project's 'Quality Assessment Tool for Quantitative Studies' will be used to record ratings of quality and risk of bias among studies selected for inclusion. Data will be extracted using a standardised form. Meta-analysis and narrative synthesis will be used. ETHICS AND DISSEMINATION: Permission for ethics exemption of the review was obtained from the Centre for Chronic Disease Control's Institutional Ethics Committee, India (CCDC_IEC_06_2020; dated 16 April 2020). The results will be disseminated through publications in a peer-reviewed journal and will be presented in national and international conferences. PROSPERO REGISTRATION NUMBER: CRD42020191946.

Compliance of smokeless tobacco supply chain actors and products with tobacco control laws in Bangladesh, India and Pakistan: protocol for a multicentre sequential mixed-methods study.

INTRODUCTION: South Asia is home to more than 300 million smokeless tobacco (ST) users. Bangladesh, India and Pakistan as signatories to the Framework Convention for Tobacco Control (FCTC) have developed policies aimed at curbing the use of tobacco. The objective of this study is to assess the compliance of ST point-of-sale (POS) vendors and the supply chain with the articles of the FCTC and specifically with national tobacco control laws. We also aim to assess disparities in compliance with tobacco control laws between ST and smoked tobacco products. METHODS AND ANALYSIS: The study will be carried out at two sites each in Bangladesh, India and Pakistan. We will conduct a sequential mixed-methods study with five components: (1) mapping of ST POS, (2) analyses of ST samples packaging, (3) observation, (4) survey interviews of POS and (5) in-depth interviews with wholesale dealers/suppliers/manufacturers of ST. We aim to conduct at least 300 POS survey interviews and observations, and 6-10 in-depth interviews in each of the three countries. Data collection will be done by trained data collectors. The main statistical analysis will report the frequencies and proportions of shops that comply with the FCTC and local tobacco control policies, and provide a 95% CI of these estimates. The qualitative in-depth interview data will be analysed using the framework approach. The findings will be connected, each component informing the focus and/or design of the next component. ETHICS AND DISSEMINATION: Ethical approvals for the study have been received from the Health Sciences Research Governance Committee at the University of York, UK. In-country approvals were taken from the National Bioethics Committee in Pakistan, the Bangladesh Medical Research Council and the Indian Medical Research Council. Our results will be disseminated via scientific conferences, peer-reviewed research publications and press releases.

Openness Personality Trait Associated With Benefit From a Nonpharmacological Breathlessness Intervention in People With Intrathoracic Cancer: An Exploratory Analysis.

CONTEXT: Breathlessness is common in people with lung cancer. Nonpharmacological breathlessness interventions reduce distress because of and increase mastery over breathlessness. OBJECTIVES: Identify patient characteristics associated with response to breathlessness interventions. METHODS: Exploratory secondary trial data analysis. Response defined as a one-point improvement in 0-10 Numerical Rating Scale of worst breathlessness/last 24 hours (response-worst) or a 0.5-point improvement in the Chronic Respiratory Questionnaire (CRQ) mastery (response-mastery) at four weeks. Univariable regression explored relationships with plausible demographic, clinical, and psychological variables followed by multivariable regression for associated (P < 0.05) variables. RESULTS: About 158 participants with intrathoracic cancer (mean age 69.4 [SD 9.35] years; 40% women) were randomized to one or three breathlessness training sessions. About 91 participants had evaluable data for response-worst and 107 for response-mastery. In the univariable analyses, the personality trait openness was associated with response-worst (odds ratio [OR] 1.99 [95% CI 1.08-3.67]; P = 0.028) and response-mastery (OR 1.84 [95% CI 1.04-3.23]; P = 0.035). Higher CRQ-fatigue (OR 0.61 [95% CI 0.41-0.91]; P = 0.015), CRQ-emotion (OR 0.68 [95% CI 0.47-0.96]; P = 0.030), and worse CRQ-mastery (OR 0.61 [95% CI 0.42-0.88]; P = 0.008), and the presence of metastases and fatigue were associated with reduced odds of response-mastery. In the adjusted response-mastery model, only openness remained (OR 1.73 [95% CI 0.95-3.15]; P = 0.072). CONCLUSION: Worse baseline health, worse breathlessness mastery, but not severity, and openness were associated with a better odds of response. Breathlessness services must be easy to access, and patients should be encouraged and supported to attend.

Factors associated with dual use of waterpipe tobacco and cigarettes among adults in Pakistan.

BACKGROUND: Little is known about dual use of waterpipe tobacco and cigarettes, especially in countries where both are prevalent. AIMS: This study aimed to assess demographic correlates, patterns of use and quit behaviours of waterpipe users in Pakistan who also smoke cigarettes. METHODS: Data were taken from a randomized controlled trial in Pakistan that assessed smoking cessation in 510 adult waterpipe users, stratified on concurrent cigarette use. Logistic regression analysis was done to assess the association between waterpipe tobacco users who also smoke cigarettes (dual use) and their demographic characteristics, smoking history and quit behaviour. Unadjusted odds ratios (OR) and adjusted OR (ORa) and 95% confidence intervals (CI) were determined. RESULTS: Dual use was significantly associated with younger age (ORa = 0.36, 95% CI: 0.19-0.70) and middle-school educational level (11-15 years), versus no formal education, (ORa = 2.01, 95% CI: 1.15-3.50). Dual use was also associated with smoking less than all day versus all day (defined as continuously for several hours) (ORa = 2.71, 95%: CI 1.73-4.25) and younger age at starting smoking (ORa = 0.95, 95% CI: 0.93-0.98). No association was found between dual use and sex, marital status, duration of smoking, nicotine dependence or quit history. CONCLUSION: Waterpipe tobacco users who also smoke cigarettes differ from waterpipe-only users, particularly in demographic characteristics. More research is needed to explore the interaction between these two smoking behaviours. Health promotion and cessation interventions in Pakistan should consider tailoring their approach to account for the unique characteristics of dual waterpipe and cigarette users.