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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., (© 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Background : Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods : A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results : A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions : Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration : ISRCTN22202133; SWAT 35., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Cochrane A et al.)