Pre-notification and personalisation of text messages to increase questionnaire completion in a smoking cessation pregnancy RCT: An embedded randomised factorial trial

Background: Low completion rates of questionnaires in randomised controlled trials can compromise the reliability of the results, so ways to boost questionnaire completion are often implemented. Although there is evidence to suggest that sending a text message to participants increases completion, there is little evidence around the timing or personalisation of these text messages. Methods: A two-by-two factorial SWAT (study within a trial) was embedded within the MiQuit-3 trial, looking at smoking cessation within pregnant smokers. Participants who reached their 36-week gestational follow-up were randomised to receive a personalised or non-personalised text message, either one week or one day prior to their follow-up. Primary outcomes were completion rate of questionnaire via telephone. Secondary outcomes included: completion rate via any method, time to completion, and number of attempts to contact required. Results In total 194 participants were randomised into the SWAT to receive a text message that was personalised early(n=50), personalised late (n=47), non-personalised early(n=50), or non-personalised late(n=47). There was no evidence that timing of the text message (early: one week before; or late: one day before) had an effect on any of the outcomes. There was evidence that a personalised text message would result in fewer completions compared with a non-personalised text message when data was collected only via the telephone(adjusted OR 0.44, 95% CI 0.22-0.87, p=0.02). However, these results were not significant when looking at completion via any method (adjusted OR 0.61, 95% CI 0.30-1.24, p=0.17). There was no evidence to show that personalisation or not was better for any of the secondary outcomes. Conclusion Timing of the text message does not appear to influence the completion of questionnaires. Personalisation of a text message may be detrimental to questionnaire completion, if data is only collected via the telephone - however, more SWATs should be undertaken in this field

Attitudes to E-Cigarettes and Cessation Support for Pregnant Women from English Stop Smoking Services: A Mixed Methods Study

Smoking in pregnancy remains a public health problem. In the UK e-cigarettes are the most popular aid to quitting smoking outside of pregnancy, but we don’t know the extent of e-cigarette use in pregnancy or how English Stop Smoking Services (SSS) respond to pregnant women who vape. In 2015 we surveyed SSS managers about cessation support for pregnant women and responses to clients who vaped. Subsequently we interviewed a sub-sample of managers to seek explanations for the SSS’ position on e-cigarettes; interviews were thematically analysed. Survey response rate was 67.8% (72/106); overall managers reported 2.2% (range 1.4–4.3%) of pregnant clients were using e-cigarettes. Most SSS reported supporting pregnant women who already vaped, but would not recommend e-cigarette use; for women that were still smoking and not using e-cigarettes, 8.3% of SSS were likely/very likely to advise using e-cigarettes, with 56.9% of SSS unlikely/very unlikely to advise using them. Fifteen respondents were interviewed; interviewees were generally positive about the potential of e-cigarettes for cessation in pregnancy although concerns about perceived lack of evidence for safety were expressed and most wanted research on this. Clear guidance on e-cigarette use informed by pregnancy specific research will assist SSS to provide consistent evidence-based support

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis.

BACKGROUND: Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called 'MiQuit' to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit's evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy. METHODS/DESIGN: This is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks' gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks' gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate. DISCUSSION: If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017

Large multicentre pilot randomised controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit)

Aims: To estimate the effectiveness of pregnancy smoking cessation support delivered by SMS text message and key parameters needed to plan a definitive trial. Design: Multicentre, parallel-group, single-blinded, individual randomised controlled trial Setting: 16 antenatal clinics in England. Participants: 407 participants were randomised to the intervention (n=203) or usual care (n=204). Eligible women were 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. Intervention: All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually-tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Outcome Measurements: Seven smoking outcomes including validated continuous abstinence from 4 weeks post-randomisation until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Findings: Using the validated, continuous abstinence outcome, 5.4% (11/203) of MiQuit participants were abstinent versus 2.0% (4/204) of usual care participants (odds ratio [OR] 2.7, 95% confidence interval [CI] 0.93 to 9.35). The Bayes Factor for this outcome was 2.23. Completeness of follow up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI -£395.78 to £843.62). Conclusions: There was some evidence, though not conclusive, that a text messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care

Multicentre, randomised controlled trial of a low-cost smoking cessation text message intervention for pregnant smokers (MiQuit)

Background: Text message cessation programmes have potential to change smoking behaviour during pregnancy but their effectiveness is unknown. This study aimed to estimate key parameters, including effectiveness and cost-effectiveness, for delivering a definitive effectiveness trial of a pregnancy specific, theory-guided, tailored text message cessation intervention. Methods: Multicentre, single-blinded, randomised controlled trial. Pregnant smokers (<25 weeks gestation) were recruited from 16 antenatal screening clinics in England. Control participants received usual care and a smoking cessation leaflet. Intervention participants received the control components plus 12 weeks of individually-tailored, automated, interactive, cessation text messages (MiQuit). Key parameters to inform a full trial were recruitment and outcome ascertainment rates. 7 smoking outcomes were assessed; the planned primary outcome for the full trial was continuous abstinence from 4 weeks post-randomisation until 36 weeks gestation, validated biochemically. Estimated costs were modelled per quitter and per QALY. Findings: 407 participants (203 MiQuit, 204 control) were randomised, 39% of those eligible. At follow-up, similar proportions per group provided self-report smoking status and a validation sample. More MiQuit participants achieved validated continuous abstinence relative to controls (5.4% vs. 2.0%; odds ratio [adjusted for site and gestation] 2.7, 95% CI 0.93 to 9.35). Adjusted odds ratios on other smoking outcomes ranged from 1.03 to 3.28 in favour of MiQuit. Incremental costs per quitter/QALY were £140.91 (95% CI -£192.87 to £617.96)/£3,623.09 (-£4,926.56 to £16,197.20), respectively, at the end of pregnancy. Discussion: Findings imply that this low-cost text message intervention is likely to be effective and cost-effective. A full trial is warranted

Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial and meta-analysis.

AIMS: To test the efficacy of 'MiQuit', a tailored, self-help, text message stop smoking programme for pregnancy, as an adjunct to usual care (UC) for smoking cessation in pregnancy. DESIGN: Multicentre, open, two-arm, parallel-group, superiority randomised controlled trial (RCT) and a trial sequential analysis (TSA) meta-analysis combining trial findings with two previous ones. SETTING: Twenty-four English hospital antenatal clinics. PARTICIPANTS: A total of 1002 pregnant women who were ≥16 years old, were ≤25 weeks gestation and smoked ≥1 daily cigarette and accepted information on cessation with no requirement to set quit dates. INTERVENTIONS: UC or UC plus 'MiQuit': 12 weeks of tailored, smoking cessation text messages focussed on inducing and aiding cessation. MEASUREMENTS: Primary outcome: biochemically validated cessation between 4 weeks after randomisation and late pregnancy. SECONDARY OUTCOMES: shorter and non-validated abstinence periods, pregnancy outcomes and incremental cost-effectiveness ratios. FINDINGS: RCT: cessation was 5.19% (26/501) and 4.59% (23/501) in MiQuit and UC groups (adjusted odds ratio [adj OR] for quitting with MiQuit versus UC, 95% CI = 1.15 [0.65-2.04]); other abstinence findings were similar, with higher point estimates. Primary outcome ascertainment was 61.7% (309) and 67.3% (337) in MiQuit and UC groups with 71.1% (54/76) and 69.5% (41/59) abstinence validation rates, respectively. Pregnancy outcomes were similar and the incremental cost per quality-adjusted life year was -£1118 (95% CI = -£4806-£1911). More MiQuit group women reported making at least one quit attempt (adj OR [95% CI]) for making an attempt, 1.50 (1.07-2.09). TSA meta-analysis: this found no significant difference in prolonged abstinence between MiQuit and UC (pooled OR = 1.49, adjusted 95% CI = 0.62-3.60). CONCLUSIONS: Irrespective of whether they want to try quitting, when offered a tailored, self-help, text message stop smoking programme for pregnancy (MiQuit) as an adjunct to usual care, pregnant women are not more likely to stop smoking until childbirth but they report more attempts at stopping smoking

‘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 access 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 impact of ‘opt-out’ referrals for pregnant smokers on SSS uptake and effectiveness, we conducted a ‘before-after’ service development evaluation. In a six-month ‘before’ period there was a routine ‘opt-in’ referral system for self-reported smokers at antenatal ‘booking’ appointments. In a six-month ‘after’ period, additional ‘opt-out’ referrals were introduced at 12 weeks ultrasound appointments; women with CO≥4ppm 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%-6.3%) compared to 57 (2.5%, 95%CI: 1.9%-3.2%) before implementation) and reported being abstinent four weeks later (93 (4.1%, 95%CI: 3.3%-4.9%) compared to 46 (2.0%, 1.5%-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 numbers of pregnant smokers setting quit dates and reporting smoking cessation

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 (Additional co-authors: Felix Naughton, Peter Sasieni, Isaac Manyonda & Katie Myers Smit

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