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

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

A smoking cessation smartphone app that delivers real-time 'context aware' behavioural support: the Quit Sense feasibility RCT.

Background: During a quit attempt, cues from a smoker's environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides 'in the moment' support to help them manage these during a quit attempt. Objective: To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense. Design: A parallel, two-arm randomised controlled trial with a qualitative process evaluation and a 'Study Within A Trial' evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation. Setting: Online with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website. Participants: Smokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram. Interventions: Participants were allocated to 'usual care' arm (n = 105; text message referral to the National Health Service SmokeFree website) or 'usual care' plus Quit Sense (n = 104), via a text message invitation to install the Quit Sense app. Main outcome measures: Follow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: ≥ 70%), including biochemical validation rates (progression criterion #2 threshold: ≥ 70%), recruitment costs, app installation (progression criterion #3 threshold: ≥ 70%) and engagement rates (progression criterion #4 threshold: ≥ 60%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative). Results: Self-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was £19.20, which included advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12/104) in the Quit Sense arm and 2.9% (3/105) in the usual care arm (estimated effect size: adjusted odds ratio = 4.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met. The Study Within A Trial analysis found a £20 versus £10 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions. Limitations: Biochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support. Conclusions: The trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense. Future work: Progression to a definitive trial is warranted providing improved biochemical validation rates. Trial registration: This trial is registered as ISRCTN12326962. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/92/31) and is published in full in Public Health Research; Vol. 12, No. 4. See the NIHR Funding and Awards website for further award information.

Smokers often fail to quit because of urges to smoke triggered by their surroundings (e.g. being around smokers). We developed a smartphone app ('Quit Sense') which learns about an individual's surroundings and locations where they smoke. During a quit attempt, Quit Sense uses in-built sensors to identify when smokers are in those locations and sends 'in the moment' advice to help prevent them from smoking. We ran a feasibility study to help plan for a future large study to see if Quit Sense helps smokers to quit. This feasibility study was designed to tell us how many participants complete study measures; recruitment costs; how many participants install and use Quit Sense; and estimate whether Quit Sense may help smokers to stop and how it might do this. We recruited 209 smokers using online adverts on Google search, Facebook and Instagram, costing £19 per participant. Participants then had an equal chance of receiving a web link to the National Health Service SmokeFree website ('usual care group') or receive that same web link plus a link to the Quit Sense app ('Quit Sense group'). Three-quarters of the Quit Sense group installed the app on their phone and half of these used the app for more than 1 week. We followed up 77% of participants at 6 months to collect study data, though only 39% of quitters returned a saliva sample for abstinence verification. At 6 months, more people in the Quit Sense group had stopped smoking (12%) than the usual care group (3%). It was not clear how the app helped smokers to quit based on study measures, though interviews found that the process of training the app helped people quit through learning about what triggered their smoking behaviour. The findings support undertaking a large study to tell us whether Quit Sense really does help smokers to quit.

Experts' views on translating NHS support to stop smoking in pregnancy into a comprehensive digital intervention.

Many pregnant smokers need support to quit successfully. In the United Kingdom, trained smoking cessation advisors deliver structured behavioural counselling alongside access to free nicotine replacement therapy (NRT); known as the 'Standard Treatment Programme' (STP). Pregnant smokers who access STP support are more likely to quit, but uptake is low. A digital intervention could be offered as an adjunct or alternative to existing STP support to increase cessation rates. However, there are few pregnancy-specific digital options routinely available and, among those that are, there is limited evidence of their effectiveness. This study investigated experts' views on the feasibility of translating the STP into a comprehensive digital intervention. Virtual group and individual interviews were undertaken with 37 experts (11 focus groups, 3 interviews) with a real-time voting activity in the focus groups to prompt discussion. Framework Analysis was applied to the data to examine themes and patterns. Experts were supportive of a digital translation of the STP and considered most behavioural counselling content to be transferable. However, replicating human-to-human accountability, empathy and the ability to go 'off-script' was thought more challenging. Suggestions for how this might be achieved included tailoring and personalisation, use of artificial intelligence tools, peer support and the option to escalate contact to a human advisor. Experts had mixed views on the role that exhaled breath carbon monoxide monitoring might have in a digital cessation intervention for pregnancy. Electronic provision of free NRT, and potentially e-cigarettes, without interpersonal support was generally well received. However, experts had concerns about it exacerbating low NRT adherence, governance issues (e.g. being accountable for the suitability of recommended products), and people's ability to misrepresent their eligibility. The STP was considered largely transferable to a digital intervention and potentially helpful for cessation in pregnancy, so merits further development and evaluation.

The effectiveness of text support for stopping smoking in pregnancy (MiQuit): multi-trial pooled analysis investigating effect moderators and mechanisms of action.

INTRODUCTION: Digital cessation support appeals to pregnant smokers. In two pooled RCTs, MiQuit, a pregnancy-specific tailored text messaging intervention, did not show effectiveness for validated prolonged abstinence. However, secondary outcomes and potential moderators and mediators have not been investigated. We aimed to determine, using pooled RCT data: 1) MiQuit effectiveness for a range of smoking outcomes; 2) whether baseline tobacco dependence or quit motivation moderate effectiveness; 3) whether hypothesized mechanisms of action (quitting determination, self-efficacy, baby harm beliefs, lapse prevention strategies) mediate effectiveness. METHODS: Pooled data analysis from two procedurally identical RCTs comparing MiQuit (N=704) to usual care (N=705). Participants were smokers, <25 weeks pregnant, recruited from 40 English antenatal clinics. Outcomes included self-reported seven-day abstinence at four weeks post-baseline and late pregnancy, and prolonged abstinence. Late pregnancy outcomes were also biochemically validated. We used hierarchical regression and Structural Equation Modelling. RESULTS: MiQuit increased self-reported, seven-day abstinence at four weeks (OR=1.73 [95% CI 1.10-2.74]) and was borderline significant at late pregnancy (OR=1.34 [0.99-1.82]) but not for prolonged or validated outcomes. Effectiveness was not moderated by baseline dependence (Heaviness of Smoking "low" versus "moderate-high") or motivation (planning to quit ≤30 days [high] versus >30days [low]), but effects on self-reported outcomes were larger for the high motivation sub-group. MiQuit had a small effect on mean lapse prevention strategies (MiQuit 8.6 [SE 0.17], UC 8.1 [SE 0.17]; P=0.030) but not other mechanisms. CONCLUSIONS: MiQuit increased short-term but not prolonged or validated abstinence and may be most effective for those motivated to quit sooner. IMPLICATIONS: Digital cessation support appeals to pregnant smokers. MiQuit, a tailored, theory-guided text messaging program for quitting smoking in pregnancy, has not shown effectiveness for validated prolonged abstinence in two previous RCTs but its impact on other smoking outcomes and potential mechanisms of action are unknown. When pooling trial data, MiQuit increased self-reported short-term abstinence, including making a quit attempt and abstinence at four-week follow-up, but not late pregnancy, sustained or validated abstinence. MiQuit appeared effective at late pregnancy for participants with high quitting motivation, but its mechanisms of action remain uncertain. Additional support components are likely required to enhance effectiveness.

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

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

The Relationship Between Reported Daily Nicotine Dose from NRT and Daily Cigarette Consumption in Pregnant Women Who Smoke in an Observational Cohort Study.

INTRODUCTION: For nonpregnant people unable to quit smoking, the NHS recommends nicotine replacement therapy (NRT) for smoking reduction. This is not recommended during pregnancy due to concerns about higher nicotine intake than smoking alone. We investigated the relationship between daily nicotine dose from NRT and cigarette consumption reported by pregnant women receiving smoking cessation support. METHODS: We conducted secondary analysis of data from currently smoking pregnant women, recruited from antenatal clinics (Nottingham University Hospitals, UK) or online between June 2019-September 2020. Participants set a quit date, received a prototype NRT adherence intervention, and reported cigarettes per day (CPD) and daily NRT dose (mg) via smartphone app for 28 days. RESULTS: 388 women were screened, 32 (8%) were eligible and joined the study. 24 (75%) submitted 510 app reports in total. 17 (71%) reported smoking and using NRT concurrently on at least one day, with concurrent use reported on 109 (21%) of app reports.The relationship between daily NRT dose and CPD followed an exponential decay curve of approximately 7%. In multilevel repeated measures modelling using 4 linear splines (knots 17, 40, and 85 mg/NRT), significant fixed effects of daily NRT dose on CPD were observed for splines 1, 3, and 4. The strongest association was spline 1 (0-17 mg/NRT), where each 10 mg NRT increase was associated with a 0.6 CPD reduction (24% on average). CONCLUSIONS: Among women in a cessation study, many smoked and used NRT concurrently; within these women, daily nicotine dose and heaviness of smoking were inversely related. IMPLICATIONS: Findings have implications for the design of future interventions intended to reduce harm associated with smoking in pregnancy. They suggest using NRT alongside smoking in pregnancy could help some women reduce the number of cigarettes they smoke per day.

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

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

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

Systematic review and meta-analysis investigating nicotine, cotinine and carbon monoxide exposures in people who both smoke and use nicotine replacement therapy.

AIMS: To determine effects of concurrent smoking and nicotine replacement therapy (NRT) use on reported heaviness of smoking, nicotine (cotinine) body fluid and exhaled air carbon monoxide (CO) concentrations. METHODS: Systematic review and meta-analysis of RCTs, which test interventions permitting concurrent NRT use and smoking and comparing, within participants, outcomes when smoking with those when smoking and using NRT concurrently. Measurements included reported number of cigarettes smoked per day (CPD), body fluid cotinine and expired air CO concentrations. RESULTS: Twenty-nine studies were included in the review. Meta-analysis of nine showed that, compared with when solely smoking, fewer cigarettes were smoked daily when NRT was used (mean difference during concurrent smoking and NRT use, -2.06 CPD [95% CI = -3.06 to -1.07, P < 0.0001]). Meta-analysis of seven studies revealed a non-significant reduction in exhaled CO during concurrent smoking and NRT use (mean difference, -0.58 ppm [95% CI = -2.18 to 1.03, P = 0.48]), but in the three studies that tested NRT used in the lead-up to quitting (i.e. as preloading), a similar reduction in exhaled CO was statistically significant (mean difference, -2.54 ppm CO [95% CI = -4.14 to -0.95, P = 0.002]). Eleven studies reported cotinine concentrations, but meta-analysis was not possible because of data reporting heterogeneity; of these, seven reported lower cotinine concentrations with concurrent NRT use and smoking, four reported no differences, and none reported higher concentrations. CONCLUSIONS: People who smoke and also use nicotine replacement therapy report smoking less heavily than people who solely smoke. When nicotine replacement therapy is used in the lead-up to quitting (preloading), this reported smoking reduction has been biochemically confirmed. There is no evidence that concurrent smoking and nicotine replacement therapy use result in greater nicotine exposure than solely smoking.

Development of "Baby, Me, & NRT": A Behavioral Intervention to Improve the Effectiveness of Nicotine Replacement Therapy in Pregnancy.

BACKGROUND: The effectiveness of Nicotine Replacement Therapy (NRT) for smoking cessation in pregnancy is limited by inconsistent and incorrect use. This paper describes the development process for "Baby, Me, & NRT", a novel pregnancy-specific intervention aimed at enhancing adherence to NRT. METHODS: An integrated approach to intervention development was used, combining evidence, theory, stakeholders' feedback, and tailoring principles. The process involved six iterative steps: (1) synthesizing relevant published evidence and guidance, (2) collecting primary qualitative data on barriers and facilitators to NRT adherence along with potential intervention design features, (3) identifying relevant behavioral theories and mapping the evidence against these, (4) prioritizing behavioral determinants identified in steps 1 and 2, generating intervention objectives, and identifying behavior change techniques which target the prioritized determinants, (5) consulting with stakeholders on intervention components, key content and tailoring features, and (6) producing a prototype intervention along with implementation guidance. RESULTS: The prototype intervention comprises of a multi-component, 1-month cessation programme, which includes six enhanced behavioral support sessions delivered by a trained advisor, tailored text messages, a website, and an illustrated booklet. It promotes the uptake of high-dose and combination NRT, emphasizes the importance of adherence, addresses motivation to use NRT, proactively helps problem solve NRT use issues, and provides guidance on preventing and managing smoking lapses. CONCLUSION: The development process generated an evidence- and theory-guided intervention, designed with stakeholder input, aimed at improving NRT effectiveness for smoking cessation in pregnancy. The prototype intervention has since been optimized and is being evaluated in a randomized controlled trial.

An Automated, Online Feasibility Randomized Controlled Trial of a Just-In-Time Adaptive Intervention for Smoking Cessation (Quit Sense).

INTRODUCTION: Learned smoking cues from a smoker's environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting. METHODS: A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation. Smoker's willing to make a quit attempt were recruited using online paid-for adverts and randomized to "usual care" (text message referral to NHS SmokeFree website) or "usual care" plus a text message invitation to install Quit Sense. Procedures, excluding manual follow-up for nonresponders, were automated. Follow-up at 6 weeks and 6 months included feasibility, intervention engagement, smoking-related, and economic outcomes. Abstinence was verified using cotinine assessment from posted saliva samples. RESULTS: Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found. CONCLUSIONS: Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense. IMPLICATIONS: Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sense, an estimated one-half will engage with it for more than 1 week. Evidence that Quit Sense may increase verified abstinence at 6-month follow-up, relative to usual care, was generated, although low saliva return rates to verify smoking status contributed to considerable imprecision in the effect size estimate.

Comparison of a Daily Smartphone App and Retrospective Questionnaire Measures of Adherence to Nicotine Replacement Therapy Among Pregnant Women: Observational Study.

BACKGROUND: Few studies have investigated how to best measure adherence to smoking cessation medications, but continuous usage measures are recommended. OBJECTIVE: In this first study of its kind, we compared methods for measuring adherence to nicotine replacement therapy (NRT) among pregnant women, investigating the completeness and validity of data collected from daily assessments using a smartphone app versus data collected from retrospective questionnaires. METHODS: Women aged ≥16 years who were daily smokers and <25 weeks pregnant were offered smoking-cessation counseling and encouraged to use NRT. For 28 days after setting a quit date (QD), women were asked to report NRT use daily to a smartphone app and to questionnaires administered in person or remotely at 7 and 28 days. For both data collection methods, we provided up to £25 (~US $30) as compensation for the time taken providing research data. Data completeness and NRT use reported to the app and in questionnaires were compared. For each method, we also correlated mean daily nicotine doses reported within 7 days of the QD with Day 7 saliva cotinine concentrations. RESULTS: Of the 438 women assessed for eligibility, 40 participated and 35 accepted NRT. More participants (31/35) submitted NRT usage data to the app by Day 28 (median 25, IQR 11 days) than completed the Day 28 questionnaire (24/35) or either of the two questionnaires (27/35). Data submitted to the app showed a lower reported duration of NRT use compared to that indicated in the questionnaire (median for app 24 days, IQR 10.25; median for questionnaire 28 days, IQR 4.75; P=.007), and there appeared to be specific cases of overreporting to the questionnaire. Mean daily nicotine doses between the QD and Day 7 were lower when calculated using app data (median for app 40 mg, IQR 52.1; median for questionnaire 40 mg, IQR 63.1; P=.001), and some large outliers were evident for the questionnaire. Mean daily nicotine doses, adjusted for cigarettes smoked, were not associated with cotinine concentrations for either method (app rs=0.184, P=.55; questionnaire rs=0.031, P=.92), but the small sample size meant that the analysis was likely underpowered. CONCLUSIONS: Daily assessment of NRT use via a smartphone app facilitated more complete data (a higher response rate) than questionnaires, and reporting rates over 28 days were encouraging among pregnant women. App data had better face validity; retrospective questionnaires appeared to overestimate NRT use for some participants.

Development and Content Validation of a Questionnaire for Measuring Beliefs About Using Nicotine Replacement Therapy for Smoking Cessation in Pregnancy.

INTRODUCTION: Improving adherence to nicotine replacement therapy (NRT) in pregnancy may result in higher smoking cessation rates. Informed by the Necessities and Concerns Framework, we developed an intervention targeting pregnancy NRT adherence. To evaluate this, we derived the NRT in pregnancy necessities and concerns questionnaire (NiP-NCQ), which measures perceived need for NRT and concerns about potential consequences. AIMS AND METHODS: Here we describe the development and content validation of NiP-NCQ. From qualitative work, we identified potentially modifiable determinants of pregnancy NRT adherence and classed these as necessity beliefs or concerns. We translated these into draft self-report items and piloted items on 39 pregnant women offered NRT and a prototype NRT adherence intervention, assessing distributions and sensitivity to change. After removing poorly performing items, smoking cessation experts (N = 16) completed an online discriminant content validation (DCV) task to determine whether retained items measure a necessity belief, concern, both, or neither construct. RESULTS: Draft NRT concern items encompassed safety for the baby, side effects, too much or insufficient nicotine, and addictiveness. Draft necessity belief items included perceived need for NRT for short- and longer-term abstinence, and desire to minimize or cope without NRT. Of 22 out of 29 items retained after piloting, four were removed following the DCV task: three were judged to measure neither construct and one possibly both. The final NiP-NCQ comprised nine items per construct (18 total). CONCLUSIONS: The NiP-NCQ measures potentially modifiable determinants of pregnancy NRT adherence within two distinct constructs and may have research and clinical utility for evaluating interventions targeting these. IMPLICATIONS: Poor adherence to NRT in pregnancy may result from low perceived need and concerns about consequences; interventions challenging these beliefs may yield higher smoking cessation rates. To evaluate an NRT adherence intervention informed by the Necessities and Concerns Framework, we developed the NiP-NCQ. Through the content development and refinement processes described in this paper, we derived an evidence-based, 18-item questionnaire measuring two distinct constructs within two nine-item subscales. Higher concerns and lower necessity beliefs indicate more negative NRT beliefs; NiP-NCQ may have research and clinical utility for interventions targeting these.

Developing a taxonomy to describe offspring outcomes in studies involving pregnant mammals' exposure to non-tobacco nicotine: A systematic scoping review.

INTRODUCTION: Many countries recommend Nicotine Replacement Therapy (NRT) for smoking cessation in pregnancy. Preclinical studies of nicotine exposure to pregnant mammals could indicate how nicotine may adversely affect the developing fetus. As a first step towards summarising this literature, we undertook a systematic scoping review to determine the number and nature of offspring outcomes studied. METHODS: We searched MEDLINE and EMBASE databases for papers reporting empirical data on offspring outcomes following nicotine exposure to pregnant non-human mammals. We excluded studies that investigated exposure to only smoking, e-cigarettes, nicotine vaccines, or studies with no 'nicotine only' group. We developed a draft taxonomy and using this, described and quantified outcomes reported. RESULTS: We identified 476 studies, which reported 729 offspring outcomes. The draft taxonomy classified outcomes as being measured in i) whole animals, ii) body systems and iii) 'other'. Body system outcomes were further categorised as being functional changes, or changes at macroscopic or cellular levels. The most frequently used outcomes were those detecting changes in the brain (n = 265), physical parameters measured in whole animals (n = 122) and any respiratory system changes (n = 97). CONCLUSIONS: This scoping review quantifies the nature and frequency of outcomes used in preclinical studies investigating the potential impacts of nicotine administration in pregnancy on offspring. Systematic reviews of studies investigating outcomes involving animal brains, respiratory system, or 'whole animal' outcomes may have greatest potential for further advancing knowledge regarding impacts of gestational nicotine exposure on offspring. PROTOCOL AND REGISTRATION: Protocol for this review can be found on Open Science Framework (https://osf.io/ptmzc/).

Promoting and Maintaining Changes in Smoking Behavior for Patients Following Discharge from a Smoke-free Mental Health Inpatient Stay: Development of a Complex Intervention Using the Behavior Change Wheel.

INTRODUCTION: Evidence suggests that smokers can successfully quit, remain abstinent or reduce smoking during a smoke-free mental health inpatient stay, provided behavioral/pharmacological support are offered. However, few evidence-based strategies to prevent the return to prehospital smoking behaviors post-discharge exist. AIMS AND METHODS: We report the development of an intervention designed to support smoking-related behavior change following discharge from a smoke-free mental health stay. We followed the Behavior Change Wheel (BCW) intervention development process. The target behavior was supporting patients to change their smoking behaviors following discharge from a smoke-free mental health stay. Using systematic reviews, we identified the barriers and enablers, classified according to the Theoretical Domains Framework (TDF). Potential intervention functions to address key influences were identified by consulting the BCW and Behavior Change Technique (BCT) taxonomy. Another systematic review identified effectiveness of BCTs in this context. Stakeholder consultations were conducted to prioritize and refine intervention content. RESULTS: Barriers and enablers to supporting smoking cessation were identified within the domains of environmental context and resources (lack of staff time); knowledge (ill-informed interactions about smoking); social influences, and intentions (lack of intention to deliver support). Potential strategies to address these influences included goal setting, problem-solving, feedback, social support, and information on health consequences. A strategy for operationalizing these techniques into intervention components was agreed upon: Pre-discharge evaluation sessions, a personalized resource folder, tailored behavioral and text message support post-discharge, and a peer interaction group, delivered by a trained mental health worker. CONCLUSIONS: The intervention includes targeted resources to support smoking-related behavior change in patients following discharge from a smoke-free mental health setting. IMPLICATIONS: Using the BCW and TDF supported a theoretically and empirically informed process to define and develop a tailored intervention that acknowledges barriers and enablers to supporting smoking cessation in mental health settings. The result is a novel complex theory- and evidence-based intervention that will be formally tested in a randomized controlled feasibility study.

Investigating the cost-effectiveness of three cessation interventions on a national scale using the Economics of Smoking in Pregnancy (ESIP) decision analytical model.

AIM: To measure the cost-effectiveness of adding text message (TMB), exercise (EB) and abstinent-contingent financial incentive-based (CFIB) stop smoking interventions to standard smoking cessation support for pregnant women in England. DESIGN: Modelling cost-effectiveness outcomes by separately adding three cessation interventions to standard cessation care offered to pregnant women in England. English National Health Service Stop Smoking Services (NHS SSS) statistics from 2019 to 2020 were used for estimating the base quit rate. Intervention effectiveness and cost data for interventions were taken from trial reports. Cost-effectiveness was derived using the economics of smoking in pregnancy (ESIP) model from a health service and personal social services perspective. Interventions were compared with each other as well as against standard cessation care. SETTING: English NHS SSS. PARTICIPANTS/CASES: A total of 13 799 pregnant women who accessed NHS SSS. Interventions and comparator; comparator: standard stop smoking support comprising behavioural intervention and an offer of nicotine replacement therapy (NRT). Three additive interventions were TMB, EB and CFIB. MEASUREMENTS: Incremental cost-effectiveness ratios per quality-adjusted life-years gained for both mothers and offspring over their life-times; return on investment (ROI); and cost-effectiveness acceptability curves (CEACs). FINDINGS: The addition of any of the interventions compared with standard care alone was preferred, but only significant for the addition of CFIB, with the CEAC suggesting an at least 90% chance of being favoured to standard care alone. When compared against each other CFIB appeared to yield the largest returns, but this was not significant. The estimated ROI for CFIB was £2 [95% confidence interval (CI) = £1-3] in health-care savings for every £1 spent by the NHS on the cessation intervention. CONCLUSIONS: For a health system which currently provides behavioural support and an offer of nicotine replacement therapy as standard stop smoking support for pregnant women, the greatest economic gains would be provided by operating an abstinent-contingent financial incentives scheme alongside this.

Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial.

Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95-2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14-3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47-0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.

Are E-cigarettes associated with postpartum return to smoking? Secondary analyses of a UK pregnancy longitudinal cohort.

OBJECTIVES: Postpartum return to smoking (PPRS) is an important public health problem. E-cigarette (EC) use has increased in recent years, and in a contemporary UK pregnancy cohort, we investigated factors, including ECs use, associated with PPRS. DESIGN: Secondary analyses of a longitudinal cohort survey with questionnaires at baseline (8-26 weeks' gestation), late pregnancy (34-36 weeks) and 3 months after delivery. SETTING: 17 hospitals in England and Scotland in 2017. PARTICIPANTS: The cohort recruited 750 women who were current or recent ex-smokers and/or EC users. A subgroup of women reported being abstinent from smoking in late pregnancy (n=162, 21.6%), and of these 137 (84.6%) completed the postpartum questionnaire and were included in analyses. OUTCOME MEASURES: Demographics, smoking behaviours and beliefs, views and experience of ECs and infant feeding. RESULTS: 35.8% (95% CI 28% to 44%) of women reported PPRS. EC use in pregnancy (adjusted OR 0.34, 95% CI 0.13 to 0.85) and breast feeding (adjusted OR 0.06, 95% CI 0.02 to 0.24) were inversely associated with PPRS, while household member smoking at 3 months post partum was positively associated with PPRS (adjusted OR 11.1, 95% CI 2.47 to 50.2). CONCLUSION: EC use in pregnancy could influence PPRS. Further research is needed to confirm this and investigate whether ECs could be used to prevent PPRS.

The development and acceptability testing of an app-based smart survey system to record smoking behaviour, use of nicotine replacement therapy (NRT) and e-cigarettes.

OBJECTIVE: Nicotine replacement therapy (NRT) helps people stop smoking. Monitoring treatment adherence is important as poor adherence to NRT limits its effectiveness. As e-cigarettes contain nicotine, their use ('vaping') is likely to affect both NRT use and smoking. We wished to measure adherence to NRT, and to investigate relationships between NRT, vaping and smoking so we developed 'NicUse', a smartphone App linked to a cloud database for collecting data relevant to NRT adherence. We report user-acceptability and investigate data validity among pregnant people by comparing heaviness of smoking reported to NicUse surveys with contemporaneous exhaled carbon monoxide readings. RESULTS: Thirty five pregnant women participating in a pilot study were asked to install and use NicUse on their smartphones. 32/35 (91%) logged into NicUse, 31 (89%) completed one or more surveys, and 22 (63%) completed these on ≥ 20 of 28 study days. Twenty-four gave end-of-study user acceptability ratings; 23 (96%) agreed or strongly agreed NicUse was 'Easy to use' and 'Instructions were clear'. There was a strong correlation between the number of daily cigarettes reported on NicUse and exhaled CO readings taken on study Day 7 (Pearson's r = 0.95, p < 0.001). NicUse appears highly acceptable, and smoking data reported to it shows validity.