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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. 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. 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). 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 for this review can be found on Open Science Framework (https://osf.io/ptmzc/).

Objective Smoking during pregnancy poses significant health risks, necessitating accurate continuous monitoring of pregnant women’s smoking behaviours. Existing methods relying on self-reporting lack objectivity, while biochemical measures like exhaled carbon monoxide (CO) provide validation but suffer from low participant engagement. We developed myCOtrak to address these limitations by integrating real-time CO monitoring with self-reported smoking, nicotine replacement therapy (NRT), and e-cigarette use. Results myCOtrak combines automated CO data from the Bedfont iCO monitor with daily surveys. It demonstrated high feasibility and usability in initial testing with 23 participants, with 75% continuing data submission for ≥ 14 days. Key features include seamless CO integration, cloud-based storage, and longitudinal tracking, offering a validated, scalable tool for smoking cessation research.

Initiating a quit attempt and achieving abstinence are distinct behaviors that have distinct correlates in general smokers. Studies predicting prenatal smoking have not addressed this. Pregnant smokers (N = 207), recruited to a cessation intervention trial, were used as an observational cohort. Women completed measures at baseline and 12-week follow-up (mid-late pregnancy). Outcomes were having made at least one quit attempt since baseline, and cotinine-validated 7-day abstinence at follow-up in attempters. Baseline predictors included demographics (age, deprivation, partner's smoking), smoking behaviors (nicotine dependence, quit attempt history, previous prenatal smoking), and smoking beliefs (self-efficacy, determination, intention to quit, nonsmoker identity, social support, pregnancy-outcome beliefs). For each outcome, variables reaching p < .1 in logistic regression analyses were entered into a multivariate model controlling for trial arm. A complete case analysis was undertaken, with missing data assumptions tested in sensitivity analyses. One hundred seventy-five women (85%) completed follow-up. Intention and determination to quit (p < .001), self-efficacy, nonsmoker identity, and not having previously smoked in pregnancy (p < .05) were univariate predictors of making a quit attempt, with stronger intention to quit the only independent predictor (multivariate odds ratio [OR] = 2.41, 95% confidence interval [CI] 1.19-4.87). Only nicotine dependence predicted validated abstinence among those who made a quit attempt (multivariate OR = 0.25, 95% CI 0.10-0.60). Initiating a quit attempt and achieving abstinence during pregnancy were found to have different correlates. For women yet to make a quit attempt in their pregnancy, smoking beliefs may be important intervention targets, but once they are engaged in quitting, nicotine dependence appears of prime importance. This study suggests that cognitive, particularly motivational, variables predict whether pregnant smokers will make a quit attempt, but they do not predict successful abstinence in those who attempt to quit, where nicotine dependence dominates. Interventions should facilitate quit attempts by targeting motivational variables among pregnant women who continue to smoke, but should focus on managing withdrawal once a woman initiates a quit attempt.

Smoking in pregnancy is a major public health concern. Pregnant smokers are particularly difficult to reach, with low uptake of support options and few effective interventions. Text message-based self-help is a promising, low-cost intervention for this population, but its real-world uptake is largely unknown. The objective of this study was to explore the uptake and cost-effectiveness of a tailored, theory-guided, text message intervention for pregnant smokers (\"MiQuit\") when advertised on the internet. Links to a website providing MiQuit initiation information (texting a short code) were advertised on a cost-per-click basis on 2 websites (Google Search and Facebook; £1000 budget each) and free of charge within smoking-in-pregnancy webpages on 2 noncommercial websites (National Childbirth Trust and NHS Choices). Daily budgets were capped to allow the Google and Facebook adverts to run for 1 and 3 months, respectively. We recorded the number of times adverts were shown and clicked on, the number of MiQuit initiations, the characteristics of those initiating MiQuit, and whether support was discontinued prematurely. For the commercial adverts, we calculated the cost per initiation and, using quit rates obtained from an earlier clinical trial, estimated the cost per additional quitter. With equal capped budgets, there were 812 and 1889 advert clicks to the MiQuit website from Google (search-based) and Facebook (banner) adverts, respectively. MiQuit was initiated by 5.2% (42/812) of those clicking via Google (95% CI 3.9%-6.9%) and 2.22% (42/1889) of those clicking via Facebook (95% CI 1.65%-2.99%). Adverts on noncommercial webpages generated 53 clicks over 6 months, with 9 initiations (9/53, 17%; 95% CI 9%-30%). For the commercial websites combined, mean cost per initiation was £24.73; estimated cost per additional quitter, including text delivery costs, was £735.86 (95% CI £227.66-£5223.93). Those initiating MiQuit via Google were typically very early in pregnancy (median gestation 5 weeks, interquartile range 10 weeks); those initiating via Facebook were distributed more evenly across pregnancy (median gestation 16 weeks, interquartile range 14 weeks). Commercial online adverts are a feasible, likely cost-effective method for engaging pregnant smokers in digital cessation support and may generate uptake at a faster rate than noncommercial websites. As a strategy for implementing MiQuit, online advertising has large reach potential and can offer support to a hard-to-reach population of smokers.

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.

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.

IntroductionSmoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation.Methods and analysisA two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called ‘Baby, Me and NRT’ (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness.Ethics and disseminationEthics approval was granted by Bloomsbury National Health Service’s Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants.Trial registration number ISRCTN16830506.Protocol version5.0, 10 Oct 2023.

Few studies have investigated how to best measure adherence to smoking cessation medications, but continuous usage measures are recommended. 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. 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. 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 r =0.184, P=.55; questionnaire r =0.031, P=.92), but the small sample size meant that the analysis was likely underpowered. 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.

A disturbance in the perception of personal body size and shape is a key feature of both anorexia and bulimia nervosa, but it has proved difficult to quantify. Previous attempts have used methods like the distorting video technique (DVT), which alters an image by stretching the figure in either the X‐ or Y‐axis. This is a poor representation of the way fat is added to or lost from the body, and the pattern of distortion provides a host of cues to the degree to which the image has been altered. To overcome these problems we have used a specially designed software system that uses biometric data based on real body shapes, instead of simply stretching or compressing images of bodies. This technique also allows individual body parts to be altered separately, so we can determine whether a specific body part is overestimated relative to others. We can also calculate the apparent body mass index (BMI) of our modified pictures, using the perimeter‐area ratio (PAR). This allows us to compare an observer's actual BMI with that calculated for their estimated and ideal bodies. We tested 30 anorexic, 30 bulimic and 137 control observers. Our results show that all three observer groups tend to overestimate their body size, but not significantly so. Both the control and bulimic observers prefer an ideal body with a BMI of 20, which is at the lower end of the ‘normal’ BMI range. However, the anorexics ideal BMI is 15, which is on the border between the emaciated and underweight BMI categories.

Reducing smoking rates in pregnancy continues to be a public health priority. Given a recent UK government policy change resulting in The National Health Service (NHS) making a significant new contribution to cessation support in pregnancy in England, in addition to that of Local Authorities (LA), an up-to-date assessment of national support offered to pregnant women is needed. LA Stop Smoking Service (SSS) managers and representatives from maternity services in NHS Trusts were invited to participate in an online survey in autumn 2020. Topics included service configuration, staffing, practitioner consultations and treatments offered. The survey response rate was 66% (99/151) of LAs and 68% (95/140) of Trusts. Most LAs provided smoking support for pregnant smokers (78%), whereas under half (43%) of NHS Trusts did. Combination nicotine replacement therapy, i.e., a combination of a patch and short-acting product, was offered by LAs (92%) and Trusts (95%) and most commonly for 12 weeks duration, at 53% and 50%, respectively. Similar national online training was undertaken by those supporting women, with the majority undertaking the specialist pregnancy-specific module: LAs 60% and Trusts 79%. However, clinicians were reported to deliver specialist stop smoking support in over 50% of Trusts, whereas this was reported in only 16% of LAs. In England, both LA and NHS Trusts are currently delivering similar stop smoking support to pregnant women. Having nationally recognised treatment programmes and training allows for the delivery of consistent, evidence-based smoking cessation to pregnant women in different healthcare settings.