The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial

Background: Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: 'How to stop smoking in pregnancy and following childbirth' (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? <p/>Design and Methods: This study is a phase II exploratory individually randomised controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n=600) will be pregnant smokers identified at maternity booking who when contacted by specialist cessation services agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. Research questions What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomisation an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? <p/>Discussion: This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicentre randomised controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit

Adolescents’ responses to the promotion and flavouring of e-cigarettes

Objectives The purpose of the study is to examine adolescents’ awareness of e-cigarette marketing and investigate the impact of e-cigarette flavour descriptors on perceptions of product harm and user image. Methods Data come from the 2014 Youth Tobacco Policy Survey, a cross-sectional in-home survey conducted with 11–16 year olds across the UK (n = 1205). Adolescents’ awareness of e-cigarette promotion, brands, and flavours was assessed. Perceptions of product harm, and likely user of four examples of e-cigarette flavours was also examined. Results Some participants had tried e-cigarettes (12 %) but regular use was low (2 %) and confined to adolescents who had also smoked tobacco. Most were aware of at least one promotional channel (82 %) and that e-cigarettes came in different flavours (69 %). Brand awareness was low. E-cigarettes were perceived as harmful (M = 3.54, SD = 1.19) but this was moderated by product flavours. Fruit and sweet flavours were perceived as more likely to be tried by young never smokers than adult smokers trying to quit (p < 0.001). Conclusions There is a need to monitor the impact of future market and regulatory change on youth uptake and perceptions of e-cigarettes

Tobacco packaging design for reducing tobacco use

Background&nbsp; Tobacco use is the largest single preventable cause of death and disease worldwide. Standardised tobacco packaging is an intervention intended to reduce the promotional appeal of packs and can be defined as packaging with a uniform colour (and in some cases shape and size) with no logos or branding, apart from health warnings and other government-mandated information, and the brand name in a prescribed uniform font, colour and size. Australia was the first country to implement standardised tobacco packaging between October and December 2012, France implemented standardised tobacco packaging on 1 January 2017 and several other countries are implementing, or intending to implement, standardised tobacco packaging.&nbsp; Objectives&nbsp; To assess the effect of standardised tobacco packaging on tobacco use uptake, cessation and reduction.&nbsp; Search methods&nbsp; We searched MEDLINE, Embase, PsycINFO and six other databases from 1980 to January 2016. We checked bibliographies and contacted study authors to identify additional peer-reviewed studies.&nbsp; Selection criteria&nbsp; Primary outcomes included changes in tobacco use prevalence incorporating tobacco use uptake, cessation, consumption and relapse prevention. Secondary outcomes covered intermediate outcomes that can be measured and are relevant to tobacco use uptake, cessation or reduction. We considered multiple study designs: randomised controlled trials, quasi-experimental and experimental studies, observational cross-sectional and cohort studies. The review focused on all populations and people of any age; to be included, studies had to be published in peer-reviewed journals. We examined studies that assessed the impact of changes in tobacco packaging such as colour, design, size and type of health warnings on the packs in relation to branded packaging. In experiments, the control condition was branded tobacco packaging but could include variations of standardised packaging.&nbsp; Data collection and analysis&nbsp; Screening and data extraction followed standard Cochrane methods. We used different 'Risk of bias' domains for different study types. We have summarised findings narratively.&nbsp; Main results&nbsp; Fifty-one studies met our inclusion criteria, involving approximately 800,000 participants. The studies included were diverse, including observational studies, between- and within-participant experimental studies, cohort and cross-sectional studies, and time-series analyses. Few studies assessed behavioural outcomes in youth and non-smokers. Five studies assessed the primary outcomes: one observational study assessed smoking prevalence among 700,000 participants until one year after standardised packaging in Australia; four studies assessed consumption in 9394 participants, including a series of Australian national cross-sectional surveys of 8811 current smokers, in addition to three smaller studies. No studies assessed uptake, cessation, or relapse prevention. Two studies assessed quit attempts. Twenty studies examined other behavioural outcomes and 45 studies examined non-behavioural outcomes (e.g. appeal, perceptions of harm). In line with the challenges inherent in evaluating standardised tobacco packaging, a number of methodological imitations were apparent in the included studies and overall we judged most studies to be at high or unclear risk of bias in at least one domain. The one included study assessing the impact of standardised tobacco packaging on smoking prevalence in Australia found a 3.7% reduction in odds when comparing before to after the packaging change, or a 0.5 percentage point drop in smoking prevalence, when adjusting for confounders. Confidence in this finding is limited, due to the nature of the evidence available, and is therefore rated low by GRADE standards. Findings were mixed amongst the four studies assessing consumption, with some studies finding no difference and some studies finding evidence of a decrease; certainty in this outcome was rated very low by GRADE standards due to the limitations in study design. One national study of Australian adult smoker cohorts (5441 participants) found that quit attempts increased from 20.2% prior to the introduction of standardised packaging to 26.6% one year post-implementation. A second study of calls to quitlines provides indirect support for this finding, with a 78% increase observed in the number of calls after the implementation of standardised packaging. Here again, certainty is low. Studies of other behavioural outcomes found evidence of increased avoidance behaviours when using standardised packs, reduced demand for standardised packs and reduced craving. Evidence from studies measuring eye-tracking showed increased visual attention to health warnings on standardised compared to branded packs. Corroborative evidence for the latter finding came from studies assessing non-behavioural outcomes, which in general found greater warning salience when viewing standardised, than branded packs. There was mixed evidence for quitting cognitions, whereas findings with youth generally pointed towards standardised packs being less likely to motivate smoking initiation than branded packs. We found the most consistent evidence for appeal, with standardised packs rating lower than branded packs. Tobacco in standardised packs was also generally perceived as worse-tasting and lower quality than tobacco in branded packs. Standardised packaging also appeared to reduce misperceptions that some cigarettes are less harmful than others, but only when dark colours were used for the uniform colour of the pack.&nbsp; Authors' conclusions&nbsp; The available evidence suggests that standardised packaging may reduce smoking prevalence. Only one country had implemented standardised packaging at the time of this review, so evidence comes from one large observational study that provides evidence for this effect. A reduction in smoking behaviour is supported by routinely collected data by the Australian government. Data on the effects of standardised packaging on non-behavioural outcomes (e.g. appeal) are clearer and provide plausible mechanisms of effect consistent with the observed decline in prevalence. As standardised packaging is implemented in different countries, research programmes should be initiated to capture long term effects on tobacco use prevalence, behaviour, and uptake. We did not find any evidence suggesting standardised packaging may increase tobacco use

Bereavement through substance use: findings from an interview study with adults in England and Scotland

Background Deaths associated with alcohol and/or drugs belong to a category of ‘special’ deaths due to three characteristics: traumatic circumstances of the death, stigma directed to both the bereaved and the deceased, and resulting disenfranchised grief experienced by the bereaved. These factors can impede those who are bereaved in this way from both grieving and accessing support. In response to a lack of research in this area this paper reports on an interview study that has aimed to better understand the experiences and needs of this neglected group of bereaved people. Method Interviews with 106 adults (parents, children, spouses, siblings, nieces and friends) bereaved through substance use in Scotland and England. Results Five themes describe interviewee experiences: possibility of death, official processes, stigma, grief and support. These findings suggest what is dominant or unique in this group of bereaved people; namely, that living with substance use (including anticipatory grief), experiencing the subsequent death (often traumatic and stigmatised) and the responses of professionals and others (more likely negative than positive) can disenfranchise grief and negatively impact bereavement and seeking support. Conclusions This article describes a large and unique sample, the largest in the world to be recruited from this population. Our study raises awareness of a hitherto largely ignored and marginalised group of bereaved people, highlighting what might be particular to their bereavement experience and how this may differ from other bereavements, thereby providing an evidence base for improving the availability, level and quality of support. © 2016 Taylor & Franci

Recommended core items to assess e-cigarette use in population-based surveys

A consistent approach using standardised items to assess e-cigarette use in both youth and adult populations will aid cross-survey and cross-national comparisons of the effect of e-cigarette (and tobacco) policies and improve our understanding of the population health impact of e-cigarette use. Focusing on adult behaviour, we propose a set of e-cigarette use items, discuss their utility and potential adaptation, and highlight e-cigarette constructs that researchers should avoid without further item development. Reliable and valid items will strengthen the emerging science and inform knowledge synthesis for policy-making. Building on informal discussions at a series of international meetings of 65 experts from 15 countries, the authors provide recommendations for assessing e-cigarette use behaviour, relative perceived harm, device type, presence of nicotine, flavours and reasons for use. We recommend items assessing eight core constructs: e-cigarette ever use, frequency of use and former daily use; relative perceived harm; device type; primary flavour preference; presence of nicotine; and primary reason for use. These items should be standardised or minimally adapted for the policy context and target population. Researchers should be prepared to update items as e-cigarette device characteristics change. A minimum set of e-cigarette items is proposed to encourage consensus around items to allow for cross-survey and cross-jurisdictional comparisons of e-cigarette use behaviour. These proposed items are a starting point. We recognise room for continued improvement, and welcome input from e-cigarette users and scientific colleagues

Exploring the uptake and use of electronic cigarettes provided to smokers accessing homeless centres: a four-centre cluster feasibility trial

Background: Smoking prevalence is extremely high in adults experiencing homelessness, and there is little evidence regarding which cessation interventions work best. This study explored the feasibility of providing free electronic cigarette starter kits to smokers accessing homeless centres in the UK. / Objectives: Seven key objectives were examined to inform a future trial: (1) assess willingness of smokers to participate in the study to estimate recruitment rates; (2) assess participant retention in the intervention and control arms; (3) examine the perceived value of the intervention, facilitators of and barriers to engagement, and influence of local context; (4) assess service providers’ capacity to support the study and the type of information and training required; (5) assess the potential efficacy of supplying free electronic cigarette starter kits; (6) explore the feasibility of collecting data on contacts with health-care services as an input to a main economic evaluation; and (7) estimate the cost of providing the intervention and usual care. / Design: A prospective cohort four-centre pragmatic cluster feasibility study with embedded qualitative process evaluation. / Setting: Four homeless centres. Two residential units in London, England. One day centre in Northampton, England. One day centre in Edinburgh, Scotland. / Intervention: In the intervention arm, a single refillable electronic cigarette was provided together with e-liquid, which was provided once per week for 4 weeks (choice of three flavours: fruit, menthol or tobacco; two nicotine strengths: 12 or 18 mg/ml). There was written information on electronic cigarette use and support. In the usual-care arm, written information on quitting smoking (adapted from NHS Choices) and signposting to the local stop smoking service were provided. / Results: Fifty-two per cent of eligible participants invited to take part in the study were successfully recruited (56% in the electronic cigarette arm; 50.5% in the usual-care arm; total n = 80). Retention rates were 75%, 63% and 59% at 4, 12 and 24 weeks, respectively. The qualitative component found that perceived value of the intervention was high. Barriers were participants’ personal difficulties and cannabis use. Facilitators were participants’ desire to change, free electronic cigarettes and social dynamics. Staff capacity to support the study was generally good. Carbon monoxide-validated sustained abstinence rates at 24 weeks were 6.25% (3/48) in the electronic cigarette arm compared with 0% (0/32) in the usual-care arm (intention to treat). Almost all participants present at follow-up visits completed measures needed for input into an economic evaluation, although information about staff time to support usual care could not be gathered. The cost of providing the electronic cigarette intervention was estimated at £114.42 per person. An estimated cost could not be calculated for usual care. / Limitations: Clusters could not be fully randomised because of a lack of centre readiness. The originally specified recruitment target was not achieved and recruitment was particularly difficult in residential centres. Blinding was not possible for the measurement of outcomes. Staff time supporting usual care could not be collected. / Conclusions: The study was associated with reasonable recruitment and retention rates and promising acceptability in the electronic cigarette arm. Data required for full cost-effectiveness evaluation in the electronic cigarette arm could be collected, but some data were not available in the usual-care arm. / Future work: Future research should focus on several key issues to help design optimal studies and interventions with this population, including which types of centres the intervention works best in, how best to retain participants in the study, how to help staff to deliver the intervention, and how best to record staff treatment time given the demands on their time. / Trial registration: Current Controlled Trials ISRCTN14140672; the protocol was registered as researchregistry4346. / Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 7. See the NIHR Journals Library website for further project information

How did smokers respond to standardised cigarette packaging with new, larger health warnings in the United Kingdom during the transition period? A cross-sectional online survey

Introduction: In the United Kingdom, standardised packaging for cigarettes was phased in between May 2016 and May 2017. We assessed whether there was an association between using standardised packs and warning salience, thoughts about the risks of smoking, thoughts about quitting, and awareness and use of stop-smoking websites. Methods: We conducted a cross-sectional online survey with current smokers aged 16 and over (N = 1865) recruited in two regions of England between February-April 2017, when both standardised and fully-branded packs were on the market. Participants were asked about use of standardised packs, warning salience (noticing, reading closely), and whether the packs they were using increased thoughts of the risks of smoking and quitting. They were also asked about awareness of stop-smoking websites, source of awareness (including warnings on packs), and whether they had visited a stop-smoking website. Results: Most participants reported currently using standardised packs (76.4%), 9.3% were not currently using them but had previously used them, and 14.3% had never used them. Compared with never users, current users were more likely to have noticed the warnings on packs often/very often (AOR (95%CI) = 2.76 (2.10, 3.63)), read them closely often/very often (AOR(95%CI) = 2.16 (1.51, 3.10)), thought somewhat/a lot about the health risks of smoking (AOR(95%CI) = 1.92 (1.38, 2.68)), and thought somewhat/a lot about quitting (AOR(95%CI) = 1.90 (1.30, 2.77)). They were also more likely to have noticed a stop-smoking website on packs. Conclusions: Consistent with the broad objectives of standardised packaging, we found that it was associated with increased warning salience and thoughts about risks and quittingOutput Status: Forthcoming/Available Onlin

The UK's Global Health Respiratory Network: Improving respiratory health of the world's poorest through research collaborations.

Respiratory disorders are responsible for considerable morbidity, health care utilisation, societal costs and approximately one in five deaths worldwide [1-4]. Yet, despite this substantial health and societal burden – which particularly affects the world’s poorest populations and as such is a major contributor to global health inequalities – respiratory disorders have historically not received the policy priority they warrant. For example, despite causing an estimated 1000 deaths per day, less than half of the world’s countries collect data on asthma prevalence (http://www.globalasthmareport.org/). This is true for both communicable and non-communicable respiratory disorders, many of which are either amenable to treatment or preventable

Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

&lt;p&gt;&lt;b&gt;Background:&lt;/b&gt; Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation.&lt;/p&gt; &lt;p&gt;&lt;b&gt;Methods:&lt;/b&gt; Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received "usual care".&lt;/p&gt; &lt;p&gt;&lt;b&gt;Results:&lt;/b&gt; Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1) vs. 2.7 (SD 3.7) kg). Between group differences were not significant (p=0.23, 95% CI -0.9 to 3.5). In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%).&lt;/p&gt; &lt;p&gt;&lt;b&gt;Conclusions:&lt;/b&gt; The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence.&lt;/p&gt