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.

Introduction Evidence-based smoking cessation and temporary abstinence interventions to address smoking in mental health settings are available, but the impact of these interventions is limited. Therefore, this review aimed to identify and synthesise the perceived barriers and enablers to supporting smoking cessation in mental health settings. Method Six databases were searched for articles reporting the investigation of perceived barriers and enablers to supporting smoking cessation in mental health settings. Data were extracted and coded using a mixed inductive/deductive method to the Theoretical Domains Framework (TDF), Key barriers and enablers were identified through the combining of coding frequency, elaboration, and expressed importance. Results Of thirty-one included articles, 56 barriers/enablers were reported from the perspectives of mental healthcare professionals (MHPs), 48 from patient perspectives, 21 from mixed perspectives, and 0 from relatives/carers. Barriers to supporting smoking cessation or temporary abstinence in mental health settings mainly fell within the domains: environmental context and resources (e.g. MHPs lack of time); knowledge (e.g. interactions around smoking that did occur were ill-informed); social influences (e.g. smoking norms within social network), and intentions (e.g. MHPs lack positive intentions to deliver support). Enablers mainly fell within the domains: environmental context and resources (e.g. use of appropriate support materials) and social influences (e.g. pro-quitting social norms). Conclusion The importance of overcoming competing demands on staff time and resources, the inclusion of tailored, personalised support, the exploitation of patients wider social support networks, and enhancing knowledge and awareness around the benefits smoking cessation is highlighted. Implications Identified barriers and enablers represent targets for future interventions to improve the support of smoking cessation in mental health settings. Future research needs to examine the perceptions of the carers and family/friends of patients in relation to the smoking behaviour change support delivered to patients.

Background Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial. Methods This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates. Results 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption. Conclusions The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service. Trial registration ISRCTN57447996

IntroductionUp to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service.Methods and analysisThis will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews.Ethics and disseminationEthical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins.Trial registration numberISRCTN28090877.

During recruitment, potential trial participants are usually given a written study patient information sheet (PIS). These are often long, complex and visually unappealing documents, which may have a negative impact on recruitment. Improving their readability by employing user testing, and their presentation by using graphic designers may improve patient understanding and aid recruitment.We undertook an embedded randomised controlled trial within the NIHR-funded REFORM study, as part of the MRC START initiative, to evaluate whether enhancing PIS improves trial recruitment and retention. 6,900 patients due to be mailed a REFORM recruitment pack were randomised in a 1:1:1 ratio to receive one of three types of PIS: the original based on the NHS ethics template (n=2,298); an enhanced, user tested PIS (n=2,301); or a 'template' PIS which was developed using an enhanced PIS from another trial in a similar population (n=2,301).193 participants (2.8%) were randomised to the trial: 62 (2.7%) in the control group; 63 (2.7%) in the user tested group; and 68 (3.0%) in the template group (OR: template vs control 1.10 (95% CI 0.77-1.56, p=60); user tested vs control 1.01 (95% CI 0.71-1.45, p=0.94); and user tested vs template 0.92 (95% CI 0.65-1.31, p=0.65)). Logistic regression analysis demonstrated that PIS allocation did not significantly predict recruitment (p= 0.33) or retention in the trial (p=0.83).There was no evidence to suggest that enhanced PIS increased recruitment and retention rates to the REFORM trial. However, the number of patients randomised was low and we may be underpowered to detect a difference.