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.

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.

Genetic variation in skin traits in New Zealand lambs.

BACKGROUND: This study explored the genetic variability in the New Zealand sheep population for economically important skin traits. Skins were collected at slaughter from two progeny test flocks, resulting in 725 skins evaluated for grain strain, flatness, crust leather strength and overall suitability for shoe leather. DNA profiles collected from skins post-slaughter were matched to individual animals using previously collected high-density genotypes. RESULTS: Considerable phenotypic variation for skin traits was observed, with around 40% of the skins being identified as suitable for high-value shoe leather production. Several key traits associated with leather production, including flatness, tear strength, grain strength and grain strain were found to be moderate to highly heritable (h2 = 0.28-0.82). There were no major significant genome-wide association study (GWAS) peaks associated with many of the traits examined, however, one single-nucleotide polymorphism (SNP) reached significance for the flatness of the skin over the hindquarters. CONCLUSION: This research confirms that suitable lamb skins can be bred for use as high-value shoe leather. While moderately to highly heritable, skin traits in New Zealand lambs appear to be polygenic with no genes of major effect underlaying the traits of interest. Given the complex nature of these traits, the identification and selection of animals with higher-value skins may be enabled by geomic selection. © 2022 The Authors. Journal of The Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Healthcare Professionals' Beliefs, Attitudes, Knowledge, and Behavior Around Vaping in Pregnancy and Postpartum: A Qualitative Study.

INTRODUCTION: Finding effective ways to help pregnant women quit smoking and maintain long-term abstinence is a public health priority. Electronic cigarettes (ie, vaping) could be a suitable cessation tool in pregnancy for those who struggle to quit; however, healthcare professionals (HCP) must be informed about these devices to offer appropriate advice. This study used the Capability, Opportunity, Motivation, and Behavior (COM-B) model and Theoretical Domains Framework (TDF) to explore HCP attitudes towards vaping in pregnancy and postpartum; beliefs about the health risks of vaping; perceived barriers and facilitators of vaping in pregnancy; knowledge of current guidelines and policies; and training needs. METHODS: Interviews (n = 60) were conducted with midwives (n = 17), health visitors (n = 10), general practitioners (n = 15) and stop smoking specialists (n = 18) across the United Kingdom. Interview transcriptions were analyzed thematically using the framework approach and the COM-B. RESULTS: Discussing vaping as a tool for quitting smoking in pregnancy was prevented by a lack of capability (limited knowledge of vaping, lack of training in smoking cessation); lack of opportunity (restricted by organizational policies and guidelines, lack of time and financial issues impacting on training), and negative social influences (sensationalist media and stigma associated with vaping in pregnancy); and lack of motivation (fear of future litigation and comebacks should adverse effects from vaping arise). CONCLUSIONS: Factors related to capability, opportunity, and motivation were identified that influence HCPs attitudes and behaviors towards vaping in pregnancy. Gaps in knowledge and training needs were identified, which could inform the development of targeted vaping training. IMPLICATIONS: Vaping could be suitable in pregnancy for those struggling to quit smoking. However, HCPs must be informed about these devices to offer appropriate advice. These data extend our knowledge of factors influencing HCP attitudes and behaviors towards vaping in pregnancy. Generally, vaping was perceived as safer than cigarettes, but a perceived lack of evidence, health and safety risks, dependency, and regulation issues were concerning. Considering our findings, greater efforts are needed to ensure HCPs are sufficiently informed about vaping and guidelines available. More importance should be placed on training for all HCPs who have contact with pregnant women.

Ideal proportion of the population to be patch tested: How many should we be doing?

BACKGROUND: How many patients should we be patch testing? A previous study suggested that the minimum proportion of a population to be patch tested for allergic contact dermatitis was 1:700 annually. OBJECTIVES: To evaluate if the current minimum rate for patch testing has changed over the 20 years since the previous study in order to maximize the value. METHODS: In cooperation with the British Society for Cutaneous Allergy, a proforma for collation of retrospective data between January 2015 and December 2017 was sent to patch-test centers in the United Kingdom (UK) and the Republic of Ireland (ROI). The number of positive tests was analyzed against the proportion of population tested to see what proportion of the population would yield the greatest number of positive results. RESULTS: Responses from 11 centers showed that the minimum number needed to patch test had increased to 1:550 per head of population per year using the current criteria. CONCLUSIONS: In agreement with previous studies, we should be patch testing more people than we are. We could reduce the threshold for referral of patients we patch test to derive the most benefit from this investigation.

Interest in and Use of Smoking Cessation Support Across Pregnancy and Postpartum.

BACKGROUND: Limited research exists on interest in and use of smoking cessation support in pregnancy and postpartum. METHODS: A longitudinal cohort of pregnant smokers and recent ex-smokers were recruited in Nottinghamshire, United Kingdom (N = 850). Data were collected at 8-26 weeks gestation, 34-36 weeks gestation, and 3 months postpartum and used as three cross-sectional surveys. Interest and use of cessation support and belief and behavior measures were collected at all waves. Key data were adjusted for nonresponse and analyzed descriptively, and multiple regression was used to identify associations. RESULTS: In early and late pregnancy, 44% (95% CI 40% to 48%) and 43% (95% CI 37% to 49%) of smokers, respectively, were interested in cessation support with 33% (95% CI 27% to 39%) interested postpartum. In early pregnancy, 43% of smokers reported discussing cessation with a midwife and, in late pregnancy, 27% did so. Over one-third (38%) did not report discussing quitting with a health professional during pregnancy. Twenty-seven percent of smokers reported using any National Health Service (NHS) cessation support and 12% accessed NHS Stop Smoking Services during pregnancy. Lower quitting confidence (self-efficacy), higher confidence in stopping with support, higher quitting motivation, and higher age were associated with higher interest in support (ps ≤ .001). A recent quit attempt and greater interest in support was associated with speaking to a health professional about quitting and use of NHS cessation support (ps ≤ .001). CONCLUSIONS: When asked in early or late pregnancy, about half of pregnant smokers were interested in cessation support, though most did not engage. Cessation support should be offered throughout pregnancy and after delivery. IMPLICATIONS: There is relatively high interest in cessation support in early and late pregnancy and postpartum among smokers; however, a much smaller proportion of pregnant or postpartum women access any cessation support, highlighting a gap between interest and engagement. Reflecting women's interest, offers of cessation support should be provided throughout pregnancy and after delivery. Increasing motivation to quit and confidence in quitting with assistance may enhance interest in support, and promoting the discussion of stopping smoking between women and health practitioners may contribute to higher support engagement rates.

Factors influencing the uptake and use of nicotine replacement therapy and e-cigarettes in pregnant women who smoke: a qualitative evidence synthesis.

BACKGROUND: Nicotine replacement therapy (NRT) delivers nicotine without the toxic chemicals present in tobacco smoke. It is an effective smoking cessation aid in non-pregnant smokers, but there is less evidence of effectiveness in pregnancy. Systematic review evidence suggests that pregnant women do not adhere to NRT as prescribed, which might undermine effectiveness. Electronic cigarettes (e-cigarettes) have grown in popularity, but effectiveness and safety in pregnancy are not yet established. The determinants of uptake and use of NRT and e-cigarettes in pregnancy are unknown. OBJECTIVES: To explore factors affecting uptake and use of NRT and e-cigarettes in pregnancy. SEARCH METHODS: We searched MEDLINE(R), CINAHL and PsycINFO on 1 February 2019. We manually searched OpenGrey database and screened references of included studies and relevant reviews. We also conducted forward citation searches of included studies. SELECTION CRITERIA: We selected studies that used qualitative methods of data collection and analysis, included women who had smoked in pregnancy, and elicited participants' views about using NRT/e-cigarettes for smoking cessation or harm reduction (i.e. to smoke fewer cigarettes) during pregnancy. DATA COLLECTION AND ANALYSIS: We identified determinants of uptake and use of NRT/e-cigarettes in pregnancy using a thematic synthesis approach. Two review authors assessed the quality of included studies with the Wallace tool. Two review authors used the CERQual approach to assess confidence in review findings. The contexts of studies from this review and the relevant Cochrane effectiveness review were not similar enough to fully integrate findings; however, we created a matrix to juxtapose findings from this review with the descriptions of behavioural support from trials in the effectiveness review. MAIN RESULTS: We included 21 studies: 15 focused on NRT, 3 on e-cigarettes, and 3 on both. Studies took place in five high-income countries. Most studies contributed few relevant data; substantially fewer data were available on determinants of e-cigarettes. Many studies focused predominantly on issues relating to smoking cessation, and determinants of NRT/e-cigarette use was often presented as one of the themes. We identified six descriptive themes and 18 findings within those themes; from these we developed three overarching analytical themes representing key determinants of uptake and adherence to NRT and/or e-cigarettes in pregnancy. The analytical themes show that women's desire to protect their unborn babies from harm is one of the main reasons they use these products. Furthermore, women consider advice from health professionals when deciding whether to use NRT or e-cigarettes; when health professionals tell women that NRT or e-cigarettes are safer than smoking and that it is okay for them to use these in pregnancy, women report feeling more confident about using them. Conversely, women who are told that NRT or e-cigarettes are as dangerous or more dangerous than smoking and that they should not use them during pregnancy feel less confident about using them. Women's past experiences with NRT can also affect their willingness to use NRT in pregnancy; women who feel that NRT had worked for them (or someone they know) in the past were more confident about using it again. However, women who had negative experiences were more reluctant to use NRT. No trials on e-cigarette use in pregnancy were included in the Cochrane effectiveness review, so we considered only NRT findings when integrating results from this review and the effectiveness review. No qualitative studies were conducted alongside trials, making full integration of the findings challenging. Women enrolled in trials would have agreed to being allocated to NRT or control group and would have received standardised information on NRT at the start of the trial. Overall, the findings of this synthesis are less relevant to women's decisions about starting NRT in trials and more likely to help explain trial participants' adherence to NRT after starting it. We considered most findings to be of moderate certainty; we assessed findings on NRT use as being of higher certainty than those on e-cigarette use. This was mainly due to the limited data from fewer studies (only in the UK and USA) that contributed to e-cigarette findings. Overall, we judged studies to be of acceptable quality with only minor methodological issues. AUTHORS' CONCLUSIONS: Consistent messages from health professionals, based on high-quality evidence and clearly explaining the safety of NRT and e-cigarettes compared to smoking in pregnancy, could help women use NRT and e-cigarettes more consistently/as recommended. This may improve their attitudes towards NRT or e-cigarettes, increase their willingness to use these in their attempt to quit, and subsequently encourage them to stay smoke-free.

Pharmacological interventions for promoting smoking cessation during pregnancy.

BACKGROUND: Tobacco smoking in pregnancy causes serious health problems for the developing fetus and mother. When used by non-pregnant smokers, pharmacotherapies (nicotine replacement therapy (NRT), bupropion, and varenicline) are effective for increasing smoking cessation, however their efficacy and safety in pregnancy remains unknown. Electronic cigarettes (ECs) are becoming widely used, but their efficacy and safety when used for smoking cessation in pregnancy are also unknown. OBJECTIVES: To determine the efficacy and safety of smoking cessation pharmacotherapies and ECs used during pregnancy for smoking cessation in later pregnancy and after childbirth, and to determine adherence to smoking cessation pharmacotherapies and ECs for smoking cessation during pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (20 May 2019), trial registers, and grey literature, and checked references of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) conducted in pregnant women, comparing smoking cessation pharmacotherapy or EC use with either placebo or no pharmacotherapy/EC control. We excluded quasi-randomised, cross-over, and within-participant designs, and RCTs with additional intervention components not matched between trial arms. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. The primary efficacy outcome was smoking cessation in later pregnancy; safety was assessed by 11 outcomes (principally birth outcomes) that indicated neonatal and infant well-being. We also collated data on adherence to trial treatments. We calculated the risk ratio (RR) or mean difference (MD) and the 95% confidence intervals (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate. MAIN RESULTS: We included 11 trials that enrolled a total of 2412 pregnant women who smoked at enrolment, nine trials of NRT and two trials of bupropion as adjuncts to behavioural support, with comparable behavioural support provided in the control arms. No trials investigated varenicline or ECs. We assessed four trials as at low risk of bias overall. The overall certainty of the evidence was low across outcomes and comparisons as assessed using GRADE, with reductions in confidence due to risk of bias, imprecision, and inconsistency. Compared to placebo and non-placebo (behavioural support only) controls, there was low-certainty evidence that NRT increased the likelihood of smoking abstinence in later pregnancy (RR 1.37, 95% CI 1.08 to 1.74; I² = 34%, 9 studies, 2336 women). However, in subgroup analysis by comparator type, there was a subgroup difference between placebo-controlled and non-placebo controlled RCTs (test for subgroup differences P = 0.008). There was unclear evidence of an effect in placebo-controlled RCTs (RR 1.21, 95% CI 0.95 to 1.55; I² = 0%, 6 studies, 2063 women), whereas non-placebo-controlled trials showed clearer evidence of a benefit (RR 8.55, 95% CI 2.05 to 35.71; I² = 0%, 3 studies, 273 women). An additional subgroup analysis in which studies were grouped by the type of NRT used found no difference in the effectiveness of NRT in those using patches or fast-acting NRT (test for subgroup differences P = 0.08). There was no evidence of a difference between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities, or neonatal death. In one study infants born to women who had been randomised to NRT had higher rates of 'survival without developmental impairment' at two years of age compared to the placebo group. Non-serious adverse effects observed with NRT included headache, nausea, and local reactions (e.g. skin irritation from patches or foul taste from gum), but data could not be pooled. Adherence to NRT treatment regimens was generally low. We identified low-certainty evidence that there was no difference in smoking abstinence rates observed in later pregnancy in women using bupropion when compared to placebo control (RR 0.74, 95% CI 0.21 to 2.64; I² = 0%, 2 studies, 76 women). Evidence investigating the safety outcomes of bupropion use was sparse, but the existing evidence showed no difference between the bupropion and control group. AUTHORS' CONCLUSIONS: NRT used for smoking cessation in pregnancy may increase smoking cessation rates in late pregnancy. However, this evidence is of low certainty, as the effect was not evident when potentially biased, non-placebo-controlled RCTs were excluded from the analysis. Future studies may therefore change this conclusion. We found no evidence that NRT has either positive or negative impacts on birth outcomes; however, the evidence for some of these outcomes was also judged to be of low certainty due to imprecision and inconsistency. We found no evidence that bupropion may be an effective aid for smoking cessation during pregnancy, and there was little evidence evaluating its safety in this population. Further research evidence on the efficacy and safety of pharmacotherapy and EC use for smoking cessation in pregnancy is needed, ideally from placebo-controlled RCTs that achieve higher adherence rates and that monitor infants' outcomes into childhood. Future RCTs of NRT should investigate higher doses than those tested in the studies included in this review.

Identifying Effective Behavior Change Techniques for Alcohol and Illicit Substance Use During Pregnancy: A Systematic Review.

BACKGROUND: During pregnancy, consuming alcohol and using illicit drugs can have serious health implications for both mother and child. Behavioral change interventions, especially those underpinned by theoretical constructs, can be effective in reducing harmful substance use among pregnant women. PURPOSE: To understand what type of behavior change mechanisms could be useful in reducing alcohol consumption or achieving abstinence from illicit drug use during pregnancy, this review aimed to identify behavior change techniques (BCTs), the smallest, active components of interventions that may be effective. It also aimed to establish the extent that psychosocial-based theories were used to inform intervention design. METHODS: To identify eligible randomized controlled trials (RCTs), five databases were searched electronically from the end search dates of the most recent Cochrane systematic reviews on behavioral interventions for each behavior, until March 2018. Within the RCTs, intervention descriptions were analyzed for BCT content and extent of theory use in the intervention design process and outcome measurements, in each trial, was established. "Effectiveness percentages," the number of times a BCT had been a component of an effective intervention divided by the total number of interventions it had been used in, were calculated for BCTs used in two or more trials. RESULTS: Including all RCTs from the Cochrane reviews, and those published subsequently, nine alcohol and six illicit drug trials were identified. Interventions tested in four alcohol RCTs and no illicit drugs RCTs showed positive results. Subsequent data were extracted for alcohol consumption trials only. Thirteen BCTs showed "potential effectiveness" for alcohol consumption. Six of nine included alcohol trials reported using theory but not extensively. CONCLUSIONS: Action planning, behavioral contract, prompts/cues, self-talk, offer/direct toward written material, problem solving, feedback on behavior, social support (unspecified), information about health consequences, behavior substitution, assess current readiness and ability to reduce excess alcohol consumption, goal setting (behavior), and tailor interactions appropriately are BCTs that could be useful in helping reduce alcohol consumption among pregnant women.

Safety of Electronic Cigarette Use During Breastfeeding: Qualitative Study Using Online Forum Discussions.

BACKGROUND: Electronic cigarettes (e-cigs) are an increasingly popular alternative to smoking, helping to prevent relapse in those trying to quit and with the potential to reduce harm as they are likely to be safer than standard cigarettes. Many women return to smoking in the postpartum period having stopped during pregnancy, and while this can affect their decisions about breastfeeding, little is known about women's opinions on using e-cigs during this period. OBJECTIVE: The aim of this study is to explore online forum users' current attitudes, motivations, and barriers to postpartum e-cig use, particularly as a breastfeeding mother. METHODS: Data were collected via publicly accessible (identified by Google search) online forum discussions, and a priori codes identified. All transcripts were entered into NVivo for analysis, with a template approach to thematic analysis being used to code all transcripts from which themes were derived. RESULTS: Four themes were identified: use, perceived risk, social support and evidence, with a number of subthemes identified within these. Women were using e-cigs to prevent postpartum return to smoking, but opinions on their safety were conflicting. They were concerned about possible transfer of harmful products from e-cigs via breastmilk and secondhand exposure, so they were actively seeking and sharing information on e-cigs from a variety of sources. Although some women were supportive of e-cig use, others provided harsh judgement for mothers who used them. CONCLUSIONS: E-cigs have the potential to reduce the number of women who return to smoking in the postpartum period and potentially improve breastfeeding rates, if breastfeeding mothers have access to relevant and reliable information. Health care providers should consider discussing e-cigs with mothers at risk of returning to smoking in the postpartum period.

Views on and experiences of electronic cigarettes: a qualitative study of women who are pregnant or have recently given birth.

BACKGROUND: Electronic cigarettes (ECs) are increasingly used for reducing or stopping smoking, with some studies showing positive outcomes. However, little is known about views on ECs during pregnancy or postpartum and previous studies have nearly all been conducted in the US and have methodological limitations, such as not distinguishing between smokers and ex/non-smokers. A greater understanding of this topic will help to inform both clinicians and EC interventions. We elicited views and experiences of ECs among UK pregnant or recently pregnant women. METHODS: We conducted semi-structured telephone interviews, using topic guides, with pregnant or recently pregnant women, who were current or recent ex-smokers. To ensure broad views of ECs were obtained, recruitment was from several geographical locations and via various avenues of recruitment. This included stop smoking services, antenatal and health visitor clinics, a pregnancy website and an informal network. Participants were 15 pregnant and 15 postpartum women, including nine current EC users, 11 ex-users, and 10 never-users. Five women who were interviewed in pregnancy were later interviewed in postpartum to explore if their views had changed. Audio data was transcribed verbatim and framework analysis was applied. RESULTS: Five main themes emerged: motivations for use (e.g., for stopping or reducing smoking), social stigma (e.g., avoiding use in public, preferring 'discrete' NRT), using the EC (e.g., mostly used at home); consumer aspects (e.g., limited advice available), and harm perceptions (e.g., viewed as less harmful than smoking; concerns about safety and addiction). CONCLUSIONS: ECs were viewed positively by some pregnant and postpartum women and seen as less harmful than smoking and useful as aids for reducing and stopping smoking. However, due to perceived social stigma, some women feel uncomfortable using ECs in public, especially during pregnancy, and had concerns about safety and nicotine dependence. Health professionals and designers of EC interventions need to provide women with up-to-date and consistent information and advice about safety and dependence, as well as considering the influence of social stigma.

Uptake of Tailored Text Message Smoking Cessation Support in Pregnancy When Advertised on the Internet (MiQuit): Observational Study.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Smoking Cessation Support by Text Message During Pregnancy: A Qualitative Study of Views and Experiences of the MiQuit Intervention.

INTRODUCTION: SMS text messaging is increasingly used for delivering smoking cessation support and pilot studies suggest this may also be useful in pregnancy. This study explores the views of women who received a tailored text messaging cessation intervention (MiQuit) during pregnancy, focusing on acceptability, perceived impact, and suggestions for improvements. METHODS: Semi-structured interviews were undertaken with 15 purposively sampled women who had received the MiQuit intervention during pregnancy as part of a randomized controlled trial. Data were analyzed thematically. RESULTS: Three main themes were identified: "impact", "approach," and "optimization." Participants described an immediate, yet often short-lived, impact from the texts that distracted and delayed them from smoking and they perceived that texts focusing on the development of and risk to the baby generated more enduring emotional impacts. Most women found receiving support by text preferable to face-to-face cessation support, with participants citing the greater regularity, convenience, and non-judgmental style as particular advantages. Participants would have preferred a longer support program with increased tailoring, greater customization of text timings and consideration of cutting down as an alternative/precursor to quitting. CONCLUSION: Pregnancy-specific cessation support by text message was well received and participants considered the support increased their motivation to stop smoking. The focus on the developing baby, the regularity of contact and the provision of gentle, encouraging messages were highlighted as particularly important elements of the program. IMPLICATIONS: This study adds further evidence to the acceptability and perceived positive impact of text-messaging programs in aiding smoking cessation in pregnancy. The findings indicate that for some women, this type of support is preferable to face-to-face methods and could be utilized by health professionals, either in addition to current methods or as an alternative. This study is also relevant to researchers developing health-related text programs to consider participants' desire for greater tailoring. Further research is required into adapting and continuing text support for women postpartum.

'Opt-out' referrals after identifying pregnant smokers using exhaled air carbon monoxide: impact on engagement with smoking cessation support.

BACKGROUND: In the UK, free smoking cessation support is available to pregnant women; only a minority accesses this. 'Opt-out' referrals to stop smoking services (SSS) are recommended by UK guidelines. These involve identifying pregnant smokers using exhaled carbon monoxide (CO) and referring them for support unless they object. METHODS: To assess the impact of 'opt-out' referrals for pregnant smokers on SSS uptake and effectiveness, we conducted a 'before-after' service development evaluation. In the 6-month 'before' period, there was a routine 'opt-in' referral system for self-reported smokers at antenatal 'booking' appointments. In the 6-month 'after' period, additional 'opt-out' referrals were introduced at the 12-week ultrasound appointments; women with CO≥4 ppm were referred to, and outcome data were collected from, local SSS. RESULTS: Approximately 2300 women attended antenatal care in each period. Before the implementation, 536 (23.4%) women reported smoking at 'booking' and 290 (12.7%) were referred to SSS. After the implementation, 524 (22.9%) women reported smoking at 'booking', an additional 156 smokers (6.8%) were identified via the 'opt-out' referrals and, in total, 421 (18.4%) were referred to SSS. Over twice as many women set a quit date with the SSS after 'opt-out' referrals were implemented (121 (5.3%, 95% CI 4.4% to 6.3%) compared to 57 (2.5%, 95% CI 1.9% to 3.2%) before implementation) and reported being abstinent 4 weeks later (93 (4.1%, 95% CI 3.3% to 4.9%) compared to 46 (2.0%, 1.5% to 2.7%) before implementation). CONCLUSIONS: In a hospital with an 'opt-in' referral system, adding CO screening with 'opt-out' referrals as women attended ultrasound examinations doubled the numbers of pregnant smokers setting quit dates and reporting smoking cessation.

Lessons learned from the London Exercise and Pregnant (LEAP) Smokers randomised controlled trial process evaluation: implications for the design of physical activity for smoking cessation interventions during pregnancy.

BACKGROUND: The challenges of delivering interventions for pregnant smokers have been poorly documented. Also, the process of promoting a physical activity intervention for pregnant smokers has not been previously recorded. This study describes the experiences of researchers conducting a randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy and explores how the effectiveness of future interventions could be improved. METHODS: Two focus groups, with independent facilitators, were conducted with six researchers who had enrolled pregnant smokers in the LEAP trial, provided the interventions, and administered the research measures. Topics included recruitment, retention and how the physical activity intervention for pregnant smokers was delivered and how it was adapted when necessary to suit the women. The focus groups were audio-recorded, transcribed verbatim and subjected to thematic analysis. RESULTS: Five themes emerged related to barriers or enablers to intervention delivery: (1) nature of the intervention; (2) personal characteristics of trial participants; (3) practical issues; (4) researchers' engagement with participants; (5) training and support needs. Researchers perceived that participants may have been deterred by the intensive and generic nature of the intervention and the need to simultaneously quit smoking and increase physical activity. Women also appeared hampered by pregnancy ailments, social deprivation, and poor mental health. Researchers observed that their status as health professionals was valued by participants but it was challenging to maintain contact with participants. Training and support needs were identified for dealing with pregnant teenagers, participants' friends and family, and post-natal return to smoking. CONCLUSIONS: Future exercise interventions for smoking cessation in pregnancy may benefit by increased tailoring of the intervention to the characteristics of the women, including their psychological profile, socio-economic background, pregnancy ailments and exercise preferences. Delivering an effective physical activity intervention for smoking cessation in pregnancy may require more comprehensive training for those delivering the intervention, particularly with regard to dealing with teenage smokers and smokers' friends and family, as well as for avoiding post-natal return to smoking. TRIAL REGISTRATION: ISRCTN48600346 , date of registration: 21/07/2008.

Deer leather: analysis of the microstructure affecting pebble.

BACKGROUND: Deer leather has a characteristic pattern, referred to as 'pebble', which is accorded such importance that a lack of it renders a leather defective. Synchrotron-based small-angle X-ray scattering (SAXS), ultrasonic imaging, scanning electron microscopy, and tear tests were used to investigate the structural characteristics of well-pebbled and poorly pebbled cervine leathers. RESULTS: Poorly pebbled leather has a less open structure in the upper grain region than well-pebbled leather. The orientation index (OI) of leather with a poor pebble is less than that of the well-pebbled leather, particularly in the corium. The tear strength is also less for the poorly pebbled leather. CONCLUSIONS: The differences in structure between well- and poorly pebbled cervine leathers are not the same as the structural differences between tight and loose bovine leathers, to which they are sometimes compared. On the contrary, good pebble may reflect an internal structure similar to that of looseness. It is hoped that methods to prevent a reduction in pebbling during the processing of cervine leather may be developed by applying this knowledge of cervine leather's structural characteristics. © 2017 Society of Chemical Industry.

Understanding Pregnant Smokers' Adherence to Nicotine Replacement Therapy During a Quit Attempt: A Qualitative Study.

BACKGROUND: Pregnant smokers may be offered nicotine replacement therapy (NRT) alongside behavioral support to assist with a quit attempt. Yet trials of NRT have found adherence to be low among pregnant women, and this has made it difficult to determine the efficacy of NRT. The aim of this study is to understand the experience of pregnant women who use NRT but discontinue this early or do not use the medication as recommended. METHODS: Semi-structured telephone interviews were conducted with 14 pregnant smokers who had recently been prescribed NRT, but self-reported poor NRT adherence or discontinuing treatment prematurely. Data were transcribed and analyzed using inductive thematic analysis RESULTS: There were four main themes identified; expectations of NRT, experience of using NRT, safety concerns and experience of using e-cigarettes. Some women intentionally used NRT to substitute a proportion of their cigarette intake and smoked alongside. Most women smoked while using NRT. Women who underutilized NRT did so as they experienced side effects, or were concerned that using NRT instead of smoking could actually increase their nicotine exposure and potential for increased nicotine dependence or fetal harm. Most women spoke about the use of e-cigarettes as a smoking cessation method but only a few had actually experienced using them during pregnancy. CONCLUSION: Many women underused NRT but simultaneously smoked. Challenging negative perceptions about NRT and educating women further about the risks of smoking may encourage them to use NRT products as recommended. IMPLICATIONS: These findings add to the research surrounding the efficacy of NRT during pregnancy by providing insight into how pregnant women use NRT during a quit attempt and how this may influence adherence. It may assist health professionals to support pregnant smokers by increasing their understanding about the differing ways in which women use NRT and help them address concerns women may have about the safety of NRT.

The Association Between Treatment Adherence to Nicotine Patches and Smoking Cessation in Pregnancy: A Secondary Analysis of a Randomized Controlled Trial.

INTRODUCTION: In nonpregnant "quitters," adherence to nicotine replacement therapy (NRT) increases smoking cessation. We investigated relationships between adherence to placebo or NRT patches and cessation in pregnancy, including an assessment of reverse causation and whether any adherence: cessation relationship is moderated when using nicotine or placebo patches. METHODS: Using data from 1050 pregnant trial participants, regression models investigated associations between maternal characteristics, adherence and smoking cessation. RESULTS: Adherence during the first month was associated with lower baseline cotinine concentrations (ß -0.08, 95% confidence interval [CI] -0.15 to -0.01) and randomization to NRT (ß 2.59, 95% CI 1.50 to 3.68). Adherence during both treatment months was associated with being randomized to NRT (ß 0.51, 95% CI 0.29 to 0.72) and inversely associated with higher nicotine dependence. Adherence with either NRT or placebo was associated with cessation at 1 month (odds ratio [OR] 1.11, 95% CI 1.08 to 1.13) and delivery (OR 1.06, 95% CI 1.03 to 1.09), but no such association was observed in the subgroup where reverse causation was not possible. Amongst all women, greater adherence to nicotine patches was associated with increased cessation (OR 2.47, 95% CI 1.32 to 4.63) but greater adherence to placebo was not (OR 0.98, 95% CI: 0.44 to 2.18). CONCLUSION: Women who were more adherent to NRT were more likely to achieve abstinence; more nicotine dependent women probably showed lower adherence to NRT because they relapsed to smoking more quickly. The interaction between nicotine-containing patches and adherence for cessation suggests that the association between adherence with nicotine patches and cessation may be partly causal. IMPLICATIONS: This study used placebo randomized controlled trial data to investigate both associations between women's characteristics and adherence to NRT patch treatment, and the relationship between adherence to NRT patch treatment and odds of cessation in pregnant quitters. Greater adherence was seen with NRT patches, and greater adherence with NRT patches increased the odds of smoking cessation. A likely explanation for findings is that NRT patches, if used sufficiently, may be effective for at least some pregnant women who try to stop smoking. Trials testing interventions which encourage women's adherence to higher dose NRT are indicated.

Pregnant Women's Experiences and Views on an "Opt-Out" Referral Pathway to Specialist Smoking Cessation Support: A Qualitative Evaluation.

INTRODUCTION: Smoking in pregnancy remains an important and costly public health concern with policy makers worldwide researching methods to aid cessation. UK government guidelines recommend implementation of an "opt-out" (ie, whether requested or not) referral pathway for pregnant smokers to specialist smoking cessation support using carbon monoxide (CO) screening. This study explores the views of pregnant smokers who experienced this new pathway in one UK hospital trust. METHODS: Eighteen semi-structured telephone interviews with women who experienced the opt-out pathway were undertaken. Data were analyzed thematically. RESULTS: Three themes were identified relating to expectations, acceptability and impact of the pathway. Women were generally very accepting of the CO testing especially when it met their prior expectations and was perceived as being a routine component of antenatal care. They considered the visual feedback from the CO monitoring improved their motivation to quit. Views on the automatic referral for cessation support were divided with questions raised as to the removal of choice, with many women also expressing dissatisfaction about perceived lack of contact by Stop Smoking Services (SSS) following referral. CONCLUSION: The opt-out pathway is potentially an acceptable addition to current practice. The women considered CO monitoring to be the most valuable element of the pathway. Women keen to engage with SSS desired a more efficient system of contact. IMPLICATIONS: This study presents a unique insight into pregnant women's views on the implementation of opt-out referrals for smoking cessation. Introducing CO testing and opt-out referrals at the time of antenatal ultrasound examination can potentially increase motivation to stop smoking in pregnancy. The findings demonstrate that facilitating access to SSS was not always achieved, and further refinement is needed to ensure more effective contact procedures. Ensuring all women are fully informed prior to the CO testing may further improve both the impact of the opt-out referral pathway and the chance of successfully engaging with SSS.

A randomized trial of nicotine-replacement therapy patches in pregnancy.

BACKGROUND: Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy. METHODS: We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes. RESULTS: Of 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups. CONCLUSIONS: Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.).