A pilot cluster randomised controlled trial of a peer-delivered outreach community-based smoking cessation intervention for women living in disadvantaged communities in Ireland.

INTRODUCTION: The health of women in rural communities is adversely impacted by increased rates of tobacco use linked to socio-economic disadvantage (SED) and by limited access to services. We Can Quit (WCQ) is a smoking cessation programme delivered by trained lay women (community facilitators) in local communities, which was developed using a Community-based Participatory Research (CBPR) approach and tailored to women living in SED areas of Ireland. METHODS: The We Can Quit2 (WCQ2) pilot cluster randomised controlled trial with an inbuilt process evaluation was conducted in four matched pairs of urban and semi-rural SED districts (8-10,000 women per district) to assess feasibility. Districts were independently randomised to WCQ (group support +/- nicotine replacement therapy), or to individual support delivered by health professionals. RESULTS: Findings showed that that the WCQ outreach programme is acceptable and feasible to implement for smoking women living in disadvantaged neighbourhoods. A secondary outcome of smoking abstinence (self-report + biochemical validation) demonstrated 27% abstinence in the intervention group versus 17% in usual care at end of programme. Low literacy was highlighted as a major barrier to participants' acceptability. DISCUSSION: The design of our project provides an affordable solution for governments in prioritising outreach smoking cessation in vulnerable populations in countries with rising rates of female lung cancer. Our community-based model using a CBPR approach empowers local women to become trained to deliver smoking cessation programmes within their own local communities. This provides a foundation to create a sustainable and equitable way to address tobacco use in rural communities.

A process evaluation of 'We Can Quit': a community-based smoking cessation intervention targeting women from areas of socio-disadvantage in Ireland.

BACKGROUND: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme, 'We Can Quit', was developed in Ireland tailored to SED women. This includes group-based support delivered by trained lay local community facilitators (CFs) and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, 'We Can Quit 2'. This paper reports on the WCQ2 process evaluation which assessed feasibility and acceptability of the programme and trial processes. METHODS: Embedded qualitative design using the UK Medical Research Council's process evaluation framework. Semi-structured interviews with trial participants (N = 21) and CFs (N = 8). Thematic analysis was utilised. RESULTS: Peer-modelling, a non-judgemental environment, CFs facilitation of group support were viewed as acceptable programme related factors. Some participants expressed concerns about NRT side effects. Provision of free NRT was welcomed and accepted by participants, although structural barriers made access challenging. Pharmacists took on a role that became larger than originally envisaged - and the majority provided additional support to women in their quit attempts between group meetings which augmented and supplemented the intervention sessions provided by the CFs. Participants reported good acceptance of repeated measures for data collection, but mixed acceptability of provision of saliva samples. Low literacy affected the feasibility of some women to fully engage with programme and trial-related materials. This was despite efforts made by intervention developers and the trial team to make materials (e.g., participant intervention booklet; consent forms and participant information leaflets) accessible while also meeting requirements under 2018 European General Data Protection Regulation legislation. Hypothetical scenarios of direct (e.g., researcher present during programme delivery) and indirect (e.g., audio recordings of programme sessions) observational fidelity assessments for a future definitive trial (DT) were acceptable. CONCLUSIONS: Intervention and trial-related processes were generally feasible and acceptable to participants and CFs. Any future DT will need to take further steps to mitigate structural barriers to accessing free NRT; and the established problem of low literacy and low educational attainment in SED areas, while continuing to comply within the contemporary legislative research environment. TRIAL REGISTRATION: WCQ2 pilot trial ( ISRCTN74721694 ).

The effectiveness of smoking cessation interventions for socio-economically disadvantaged women: a systematic review and meta-analysis.

INTRODUCTION: This systematic review and meta-analysis assessed the effectiveness of smoking cessation interventions among women smokers in low socio-economic status (SES) groups or women living in disadvantaged areas who are historically underserved by smoking cessation services. METHODS: A systematic literature search was conducted using MEDLINE (OVID), EMBASE, Cochrane, CINAHL, PsychINFO and Web of Science databases. Eligibility criteria included randomised controlled trials of any smoking cessation intervention among women in low SES groups or living in socio-economically disadvantaged areas. A random effects meta-analysis assessed effectiveness of interventions on smoking cessation. Risk of bias was assessed with the Cochrane Risk of Bias tool. The GRADE approach established certainty of evidence. RESULTS: A total of 396 studies were screened for eligibility and 11 (6153 female participants) were included. Seven studies targeted women-only. 5/11 tested a form of face-to-face support. A pooled effect size was estimated in 10/11 studies. At end of treatment, two-thirds more low SES women who received a smoking cessation intervention were more likely to stop smoking than women in control groups (risk ratio (RR) 1.68, 95% CI 1.36-2.08, I2= 34%). The effect was reduced but remained significant when longest available follow-up periods were pooled (RR 1.23, 95% CI 1.04-1.48, I2 = 0%). There was moderate-to-high risk of bias in most studies. Certainty of evidence was low. CONCLUSIONS: Behavioural and behavioural + pharmacotherapy interventions for smoking cessation targeting women in low SES groups or women living in areas of disadvantage were effective in the short term. However, longer follow-up periods indicated reduced effectiveness. Future studies to explore ways to prevent smoking relapse in this population are needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019130160.

The We Can Quit2 Smoking Cessation Trial: Knowledge Exchange and Dissemination Following a Community-Based Participatory Research Approach.

BACKGROUND: 'We Can Quit2' pilot randomised controlled trial determined the feasibility [of conducting a community-based trial of We Can Quit, a peer-delivered stop-smoking programme (group support, combination nicotine replacement therapy (NRT), and tailored individual support) for women living in socioeconomically disadvantaged areas in Ireland. Lessons from a knowledge exchange (KE) workshop that reengaged trial stakeholders are presented. METHODS: The trial dissemination plan included invitation of community, regional and national stakeholders (n = 176) to a KE interactive workshop, who received an accessible brief beforehand. Trial findings were presented. Enhancements to community engagement, participants' recruitment and retention, and policy priorities arising from the research were discussed. Field notes and responses to a post-event anonymous questionnaire were analysed using thematic content analysis. RESULTS: Workshop attendees (41/176, 23%) recommended: dedicated additional time to engage community stakeholders; social prescribing pathways to enhance recruitment; more adaptation of trial-related information and assistance in completion of data forms for low literacy individuals; encouraging women to join healthy community programmes to facilitate retention and sustainability; removal of barriers to access NRT; and ongoing provision of cessation services tailored to disadvantaged groups. CONCLUSIONS: The findings are relevant to the implementation of other community-based health interventions for disadvantaged groups, to policy makers and to service providers.

An application of PRECIS-2 to evaluate trial design in a pilot cluster randomised controlled trial of a community-based smoking cessation intervention for women living in disadvantaged areas of Ireland.

BACKGROUND: "We Can Quit2" (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of 'We Can Quit' (WCQ, a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised 'enhanced usual care' offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under 'real-world' conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT). METHODS: The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: eligibility, recruitment, setting, organisation, flexibility-delivery, flexibility-adherence, follow-up and primary outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. RESULTS: Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Trial recruitment was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. CONCLUSIONS: PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry ( No. 74721694 ).

Peer-Delivery of a Gender-Specific Smoking Cessation Intervention for Women Living in Disadvantaged Communities in Ireland We Can Quit2 (WCQ2)-A Pilot Cluster Randomized Controlled Trial.

INTRODUCTION: We Can Quit" (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland. AIMS AND METHODS: The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8-10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking. RESULTS: Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants' acceptability. CONCLUSIONS: WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design. IMPLICATIONS: This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.

We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland-study protocol for a pilot cluster randomised controlled trial.

BACKGROUND: Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The 'We Can Quit2' (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. METHODS/DESIGN: Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland's national health service, the Health Service Executive (HSE). Within each cluster, 24-25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. DISCUSSION: Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. TRIAL REGISTRATION: Concurrent to publication. Controlled trials ISRCTN74721694.

Smoking cessation programmes for women living in disadvantaged communities, "We Can Quit 2": A systematic review protocol.

Tobacco use is the leading cause of preventable death in Ireland with almost 6,000 smokers dying each year from smoking-related diseases. Amongst younger Irish women, smoking rates are considerably higher in those from socially disadvantaged areas compared to women from affluent areas. Women from poorer areas also experience higher rates of lung cancer. To our knowledge, there are no peer reviewed published systematic reviews on the effectiveness of interventions tailored to reduce smoking rates in women from disadvantaged areas. This systematic review protocol will aim to examine the effectiveness of such interventions and to describe trial processes such as recruitment, follow-up and dropout prevention strategies, as well as barriers and enablers of successful implementation.    A systematic review will be conducted of peer-reviewed randomised controlled trials and associated process evaluations of smoking cessation interventions designed for women living in socially disadvantaged areas. If the search returns, less than five studies are review criteria will expand to include quasi-experimental studies. A number of databases of scholarly literature will be searched from inception using a detailed search strategy. Two independent reviewers will screen titles, abstracts and full-text articles to identify relevant studies using a pre-defined checklist based on PICOS. In the case of disagreement, a third reviewer will be consulted. The quality of included studies will be assessed using the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE) criteria. Quantitative data will be extracted and, if comparable, will be assessed using meta-analysis. A narrative meta-synthesis of qualitative data will be conducted.   This review aims to synthesise information from relevant studies on smoking cessation interventions tailored for women from socially disadvantaged areas. The evidence obtained from studies and presented in this review will help guide future research in this area. Registration: This review will be registered with International Prospective Register of Systematic Reviews (PROSPERO).