People with severe mental illness (SMI) die 10-20 years earlier than the general population, largely due to non-communicable diseases (NCDs) such as hypertension and diabetes and risk factors such as hypercholesterolaemia. This cross-sectional study gathered data from people with SMI from three national mental health institutions in South Asia. Data was collected based on the WHO Stepwise approach to NCD risk factor surveillance and the prevalence of screening, diagnosis and treatment for diabetes, hypertension, and hypercholesterolaemia was assessed. Logistic regression models assessed the associations of sociodemographic characteristics with NCD screening. Three thousand nine hundred and eighty nine participants were recruited. Screening prevalence varied by country and disease, with hypertension being the most commonly screened NCD (Bangladesh = 52.5% [50.0-55.1], India = 43.1% [40.3-45.9], Pakistan = 60.9% [58.2-63.5]), and cholesterol was the least common (Bangladesh = 4.1% [3.2-5.2], India = 14.8% [12.9-17.0], Pakistan = 9.6% [8.1-11.3]). Characteristics such as BMI, age and education level were positively associated with screening, and females were more likely to be screened than males. There are low levels of screening for NCDs among individuals with SMI accessing tertiary institutions in South Asia, with significant sociodemographic disparities. Standardised screening protocols tailored to South Asian populations could mitigate the increased risk of NCDs in this population.

Introduction Diabetic foot ulceration represents a prevalent, persistent and resource-intensive complication of diabetes. These ulcers are slow to heal, prone to recurrence and impose a substantial burden on both patients and healthcare providers. The reducing the impact of diabetic foot ulcers (REDUCE) intervention has been designed as a multifaceted approach targeting psychological and behavioural determinants linked to diabetic foot ulcer (DFU) outcomes. Following a successful pilot trial, the REDUCE trial has been designed as a pragmatic, multicentre randomised trial to compare the effectiveness and cost-effectiveness of the REDUCE intervention plus usual care versus usual care alone in reducing recurrence in people with healed DFUs. Additionally, there is an embedded process evaluation and two sub-studies which will be carried out alongside the main trial.Methods and analysis Adults over 18 years of age, with a recently healed DFU and two lower limbs, will be identified from around 30 specialist multidisciplinary diabetic foot clinics at participating National Health Service Trusts in the UK. Patients with active Charcot neuro-osteoarthropathy, active DFU or ulcers healed for more than 12 weeks will be excluded. We will aim to recruit 544 participants (1:1 randomisation). The primary outcome for this trial will be total ulcer-free days with limbs intact (ie, without amputation) between randomisation and the end of follow-up (18 months post-randomisation). Secondary outcomes include time to re-ulceration, total number of ulcers, amputation, quality of life (EQ-5D-5L), Patient Health Questionnaire-9, Nottingham Assessment of Functional Footcare, ICEpop capability measure for adults and resource use. As part of the process evaluation, up to 20 REDUCE intervention patient-participants will be interviewed, and the healthcare professionals delivering the intervention will also be interviewed. An assessment of intervention fidelity will also be carried out.Ethics and dissemination Ethics approval was granted by Wales 3 Research Ethics Committee (REC reference 22/WA/0053) on 16 March 2022. The findings will be presented at relevant conferences and disseminated via peer-reviewed research publications and to relevant stakeholders.Trial registration number ISRCTN15570706.

Emotional disorders in young people have been increasing, leading to a high demand for support and long waiting times for UK child and adolescent mental health services (CAMHS). Consequently, access to evidence-based psychological therapy is limited; in addition, many young people do not respond to existing treatments. Blended delivery of therapy, which combines face-to-face and digital interventions, offers a promising solution to improve the reach and effectiveness of mental health support. However, the efficacy of blended behavioural activation (BA) for young people with depression is not yet established. This randomised controlled trial will investigate the clinical and cost effectiveness of blended behavioural activation intervention for adolescents aged 11–17 years with moderate to severe depression. We will recruit 446 participants from CAMHS across 6 sites in the UK. Participants will be randomised to receive either BA with psychoeducation (PE) and treatment as usual (TAU) or PE and TAU. The primary outcome measure will be depressive symptoms, assessed using the child-completed Mood and Feelings Questionnaire (MFQ-C) at 6 months. A range of secondary outcome measures will be collected to estimate the clinical and cost effectiveness and acceptability of the intervention. A nested qualitative investigation exploring provider and young people/carer perspectives will be included. The findings from this trial will provide crucial evidence on the effectiveness of blended BA for young people with moderate to severe depression. If effective, this intervention could offer a scalable and accessible treatment option, potentially transforming the delivery of mental health services for adolescents. The large sample size and pragmatic approach will enhance the generalisability of the results, informing future clinical practice and policy. ISCRTN12315118. Registered on August 29, 2023.

Introduction Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.Methods and analysis This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.Ethics and dissemination Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.Trial registration number ISRCTN77855199.

Background People with severe mental illness (SMI) are at higher risk of developing non-communicable diseases, leading to increased comorbidities and elevated mortality rates. Their health often declines due to poor dietary habits, such as low intake of fruits and vegetables (FV), combined with insufficient physical activity (PA). Aims We report the prevalence of low FV intake and PA (as per WHO criteria) and their sociodemographic and clinical risk factors in people with SMI in South Asia. Methods A cross-sectional survey was conducted between June 2019 and January 2022 across tertiary mental health institutions in Bangladesh, India, and Pakistan among adults diagnosed with SMI. We collected data on sociodemographics, body mass index, physical comorbidities, and health behaviours. PA and FV were measured too while logistic regression analysis was used to identify factors associated with low FV intake and PA. Results Among 3989 participants, the prevalence of participants who met the WHO recommendations for FV intake was 4.9% (196/3989), and for PA was 45.6% (1817/3989). Older adults (55 + years) were less likely to meet PA recommendations compared to younger adults (18–24 years) (odds ratio (OR) = 0.56, 95%CI = 0.40–0.80, p = 0.001), and those with higher income levels had higher odds of meeting PA recommendations compared to those with lower income (OR = 2.23, 95%CI = 1.49–3.34, p < 0.001). Additionally, individuals who reported adequate FV intake were significantly more likely to meet PA recommendations (OR = 2.90, 95% CI = 2.02–4.16, p < 0.001). Conclusion A majority of people with SMI did not meet the WHO recommendations for PA and FV intake. The associated factors, including age, income, and dietary habits, emphasise the complexity of addressing health behaviours in this vulnerable population in South Asia.

Peripheral Arterial Disease(PAD) is a prevalent cardiovascular condition affecting millions worldwide, and the advent of machine learning(ML) techniques offers promising opportunities to enhance risk prediction and personalise patient management in this complex disease. This systematic review and meta-analysis aimed to evaluate the performance of ML models in predicting adverse outcomes in PAD patients compared to traditional statistical approaches. A comprehensive search of major databases(MEDLINE,EMBASE,CINAHL,Cochrane CENTRAL) was conducted for studies published between 2000 and 2024. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the PROBAST tool. The quality of included studies was also assessed using criteria outlined by Qiao et al. A modified Hierarchical Summary Receiver Operating Characteristic(HSROC) analysis was performed to compare the predictive performance of various ML models and traditional regression methods. Thirteen studies met the inclusion criteria. Gradient boosted models demonstrated the highest predictive performance with a diagnostic odds ratio(DOR) of 36.593(95% CI:24.44-54.79), sensitivity of 0.853, and specificity of 0.863. The best performing ML models for outcomes within 2 years, showed a DOR of 34.169(95% CI:22.840-51.117). Traditional regression models consistently underperformed compared to ML approaches, with the lowest DOR of 3.326(95% CI:1.814-6.097). The quality assessment revealed a mix of methodological rigor, with 54% of studies rated as low risk of bias and 46% as unclear. Advanced ML techniques demonstrate superior predictive power for adverse outcomes in PAD patients compared to traditional regression methods.

Background: Many services designed to support victim/survivors of intimate partner violence (IPV) do not have a specific focus on, or understanding of neurodivergence, which may impact autistic access to meaningful support. The aim of this project was to examine the support and recovery needs of autistic adults who have experienced IPV. Method: We recruited 21 autistic adults (mean age = 42) to take part in a semi-structured interview about the experience of IPV. We asked questions about their support seeking, and recommendations for future intervention. We analysed the data using reflexive thematic analysis. One author coded all data, engaging in reflexive discussion with the whole team. They then organised these into themes in collaboration with a second team member. These were circulated to the whole team for discussion and refinement.Results: We identified three themes in the data, which focused on support and recovery: 1) Recovery is a journey (recovery is non-linear, and involves multiple disclosures over time). 2) Building better systems (addressing systemic gaps in knowledge and practice, combatting under-resourcing), and 3) How do we stop this? (recognising potential individual risk factors and increasing relationship education).Conclusions: Our findings suggest that approaches to supporting autistic victim/survivors in recovery needs a nuanced, multi-pronged approach. Intervention should focus on relationship education ensuring access to appropriate therapies and support for individuals and ameliorating systemic issues such as a lack of professional understanding, and lack of practical support for survivors

The efficacy of a smartphone app intervention (BabyMind©) in facilitating mind-mindedness was investigated in a randomized controlled trial, assigning mothers and their 6-month-olds (N = 152; 72 girls, 146 White) to intervention or active control conditions. Mothers who had received the BabyMind© app intervention scored higher for appropriate (d = .61, 95% CI .28, .94) and lower for non-attuned (d = -.55, 95% CI -.92, -.18) mind-related comments at follow-up (age 12 months), compared with their control group counterparts. Adjusting for missing data did not alter this pattern of findings. Mothers' baseline parental reflective functioning did not moderate these relations. Results are discussed in terms of the benefits of early intervention and exploring the efficacy of the app in more diverse populations.

Aims To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS). Methods A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants' EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses. Results The base case analysis found participants in the compression bandage group accrued marginally fewer QALYs, on average, compared with those in the standard bandage group (reduction of 0.0050 QALYs (95% confidence interval (CI) -0.0051 to -0.0049)), and accumulated additional mean costs (incremental cost of 52.68 pound per participant (95% CI 50.56 to 54.80)). Findings remained robust to assumptions tested in sensitivity analyses, although considerable uncertainty surrounded the outcome estimates. Conclusion Use of a two-layer compression bandage is marginally less effective in terms of health-related quality of life, and more expensive when compared with a standard bandage following TKA, so therefore is unlikely to provide a cost-effective option.

This multi-arm, parallel group, single-blinded randomised controlled trial aimed to assess three commercially available mouthwashes effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The manuscript has been written in accordance with the CONSORT statement. Methods Eligible participants were SARS-CoV-2 positive with a positive test in the last 72 hours. All participants had mild to moderate symptoms and could provide 5 saliva samples over a 60-minute period. Participants delivered a baseline saliva sample and then used a mouthwash as per manufacturer’s instructions. They provided further saliva samples at minute 1, 10, 30 and 60. Participants were randomised to one of four groups; OraWise+, Total Care Listerine, Cool Mint Listerine and water (control). The lab-based research team were blind to the intervention. The research question was: Can SARS-CoV-2 be rendered inactive in saliva by using a mouthwash and how long does this effect last? The primary outcome was the amount of viable infectious SARS-CoV-2 virus in the sample, compared to the baseline sample. The secondary outcome measure was the amount of genetic material from the SARS-CoV-2 virus in the sample, measured via PCR testing. Results In total 100 participants were recruited (25 per group). Eight participants did not receive the allocated intervention and did not have saliva samples collected. There were no adverse events. In total 42 of the 92 participants had viable virus which could be cultured at baseline. Statistical analysis of the primary outcome was not advised due to the reduced level of viable virus at baseline and the positive skewness present in the distribution of log10(titre) data. Observational data of the primary outcome measure is presented. Analysis of the secondary outcome PCR measure showed that there was strong evidence for a decrease in SARS-CoV-2 RNA levels compared to water for all mouthwashes after 1 minute, OraWise+ -0.49 (-0.92, -0.05) p-value 0.029, Cool Mint Listerine -0.81 (-1.25, -0.38) p-value <0.001, Total Care Listerine -1.05 (-1.48, -0.62) p-value <0.001. For the remaining timepoints there was generally no evidence of virus level reduction compared to water although there is weak evidence for a decrease at ten minutes using Total Care Listerine -0.44 (-0.88, 0.01), p-value 0.053. Conclusion The three mouthwashes included in this trial observationally demonstrated a reduction in virus titre level 1 minute after use, with virus levels normalising up to 60 minutes compared to the control. Although an interesting observation, this result could not be statistically analysed. Using the secondary outcome PCR measure all three included mouthwashes reduced virus levels compared to water at 1 minute and these results were statistically significant. Clinically this result does not support the use of the included mouthwashes to reduce SARS-CoV-2 levels in saliva.

Background:Young adults represent a third of the United Kingdom prison population and are at risk of poor health outcomes, including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce the negative consequences of criminal sanctions and address the root causes of offending. However, evidence of their effectiveness has not yet been established. The Gateway programme, issued as a conditional caution, aimed to improve the life chances of young adults committing low-level offences. Participants agreed not to reoffend during the 16-week caution and, following a needs assessment, received individual support from a Gateway navigator and attended two workshops encouraging analysis of own behaviour and its consequences. Objective:To evaluate the effectiveness and cost-effectiveness of Gateway in relation to health and well-being of participants compared to usual process (court summons or a different conditional caution). Design, setting and participants:Pragmatic, multisite, parallel-group, superiority randomised controlled trial with two 6-month internal pilots and a target sample size of 334. Randomisation between Gateway and usual process was on a 1 : 1 basis. Four Hampshire Constabulary sites recruited 18- to 24-year-old residents of Hampshire and Isle of Wight who were questioned for an eligible low-level offence. Semistructured interviews were also held with a sample of Gateway programme participants, staff and police study recruiters. Main outcome measures:Primary outcome was the Warwick-Edinburgh Mental Wellbeing Scale score at 12 months. Secondary outcomes included health status, alcohol and drug use, recidivism and resource use. Results:Recruitment commenced in October 2019 and the trial stopped in April 2021. A total of 191 participants were recruited, with 109 randomised to Gateway and 82 to usual process. Due to an initial overestimation of potentially eligible young people and low retention rates, recruitment targets were adjusted, and a range of mitigating measures introduced. Although recruitment broadly met study progression criteria [35/50 (70%) Pilot 1: 64/74 (86%) Pilot 2], retention was low throughout (overall: data collected at week 4 was 50%: at week 16 it was 50%: 1-year 37%). Low retention was multifactorial, with one of the main barriers being difficulties contacting participants. It was therefore not possible to complete the randomised controlled trial or the health economics analyses. Qualitative interviews held with 58 individuals yielded rare insights into the benefits and limitations of this type of intervention, as well as barriers and facilitators in relation to recruitment in this setting. Limitations:Despite close collaboration with the police to address recruitment and consent issues, expansion of the inclusion criteria and recruitment area and introducing other measures, the researchers were unable to collect sufficient data within an acceptable timeframe. Conclusions:The Gateway study was a unique endeavour to gather evidence for a potentially life-changing intervention for an underserved population. The experience gained indicates that randomised controlled trials of interventions, with a health-related outcome, are possible in this setting but point towards the need for conservative recruitment and retention estimates in this target population. Other study designs should be considered. The qualitative evaluation provided a range of valuable lessons for those seeking to design similar interventions or conduct research in similar settings. Study registration:This study is registered as ISRCTN11888938. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 16/122/20) and is published in full in Public Health Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information.

Background Treatment to suppress or lessen effects of puberty are outlined in clinical guidelines for adolescents experiencing gender dysphoria/incongruence. Robust evidence concerning risks and benefits is lacking and there is a need to aggregate evidence as new studies are published.Aim To identify and synthesise studies assessing the outcomes of puberty suppression in adolescents experiencing gender dysphoria/incongruence.Methods A systematic review and narrative synthesis. Database searches (Medline, Embase, CINAHL, PsycINFO, Web of Science) were performed in April 2022, with results assessed independently by two reviewers. An adapted version of the Newcastle-Ottawa Scale for cohort studies was used to appraise study quality. Only moderate-quality and high-quality studies were synthesised. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines were used.Results 11 cohort, 8 cross-sectional and 31 pre-post studies were included (n=50). One cross-sectional study was high quality, 25 studies were moderate quality (including 5 cohort studies) and 24 were low quality. Synthesis of moderate-quality and high-quality studies showed consistent evidence demonstrating efficacy for suppressing puberty. Height increased in multiple studies, although not in line with expected growth. Multiple studies reported reductions in bone density during treatment. Limited and/or inconsistent evidence was found in relation to gender dysphoria, psychological and psychosocial health, body satisfaction, cardiometabolic risk, cognitive development and fertility.Conclusions There is a lack of high-quality research assessing puberty suppression in adolescents experiencing gender dysphoria/incongruence. No conclusions can be drawn about the impact on gender dysphoria, mental and psychosocial health or cognitive development. Bone health and height may be compromised during treatment. More recent studies published since April 2022 until January 2024 also support the conclusions of this review.PROSPERO registration number CRD42021289659.

Background: Autistic people are more likely to experience intimate partner violence (IPV) than non-autistic peers, but our knowledge about how they recognise abuse and make sense of what has happened to them is sparse. The aim of this study was to explore how autistic people recognise and make meaning after experiencing IPV.Method: We recruited 21 autistic adults to take part in a semi-structured interview about the experience of IPV. We asked questions about how they had made sense of their experiences, and how it had impacted them. We analysed the data using reflexive thematic analysis. One author coded all data, engaging in reflexive discussion with the whole team. They organised codes into themes in collaboration with a second team member. Results: We identified three themes in the data, which focussed on understanding and sense-making after intimate violence. Theme 1) 'Power' focussed on the role that power dynamics had played in sense-making. Theme 2 'Disruptions of self' explored feeling of dehumanisation, objectification and stigmatisation among participants that led to them feeling like they were worth less than others, and that they had to mould themselves to fit perpetrator expectations. Theme 3 'Now, with hindsight' focussed on how survivors had struggled to recognise the violence, with a sense that it could 'always be worse', and that they needed clearer understanding of what 'red flags' look like in a relationship. Conclusions: Our findings suggest that making sense of the experience of intimate violence among autistic adults is shaped by both individual, interpersonal, and societal factors which normalise violence against autistic people, making it difficult to leave abusive relationships. By highlighting the factors that shape understanding, we can explore how to prevent these occurrences in future (e.g. better early education about neurodiversity, and relationships).

BackgroundClinical guidelines outline the use of hormones for masculinisation/feminisation in adolescents experiencing gender dysphoria or incongruence. Robust evidence concerning risks and benefits is lacking. There is a need to aggregate evidence as research becomes available.AimIdentify and synthesise studies assessing the outcomes of hormones for masculinisation/feminisation in adolescents experiencing gender dysphoria/incongruence.MethodsSystematic review and narrative synthesis. Database searches (MEDLINE, Embase, CINAHL, PsycINFO, Web of Science) were performed in April 2022, with results assessed independently by two reviewers. An adapted version of the Newcastle-Ottawa Scale for Cohort Studies was used to assess study quality. Moderate- and high-quality studies were synthesised.Results12 cohort, 9 cross-sectional and 32 pre–post studies were included (n=53). One cohort study was high-quality. Other studies were moderate (n=33) and low-quality (n=19). Synthesis of high and moderate-quality studies showed consistent evidence demonstrating induction of puberty, although with varying feminising/masculinising effects. There was limited evidence regarding gender dysphoria, body satisfaction, psychosocial and cognitive outcomes, and fertility. Evidence from mainly pre–post studies with 12-month follow-up showed improvements in psychological outcomes. Inconsistent results were observed for height/growth, bone health and cardiometabolic effects. Most studies included adolescents who received puberty suppression, making it difficult to determine the effects of hormones alone.ConclusionsThere is a lack of high-quality research assessing the use of hormones in adolescents experiencing gender dysphoria/incongruence. Moderate-quality evidence suggests mental health may be improved during treatment, but robust study is still required. For other outcomes, no conclusions can be drawn. More recent studies published since April 2022 until January 2024 also support the conclusions of this review.PROSPERO registration number:CRD42021289659.

Obesity is one of the major contributors to the excess mortality seen in people with severe mental illness (SMI) and in low- and middle-income countries people with SMI may be at an even greater risk. In this study, we aimed to determine the prevalence of obesity and overweight in people with SMI and investigate the association of obesity and overweight with sociodemographic variables, other physical comorbidities, and health-risk behaviours. This was a multi-country cross-sectional survey study where data were collected from 3989 adults with SMI from three specialist mental health institutions in Bangladesh, India, and Pakistan. The prevalence of overweight and obesity was estimated using Asian BMI thresholds. Multinomial regression models were then used to explore associations between overweight and obesity with various potential determinants. There was a high prevalence of overweight (17·3 %) and obesity (46·2 %). The relative risk of having obesity (compared to normal weight) was double in women (RRR = 2·04) compared with men. Participants who met the WHO recommendations for fruit and vegetable intake had 2·53 (95 % CI: 1·65-3·88) times greater risk of having obesity compared to those not meeting them. Also, the relative risk of having obesity in people with hypertension is 69 % higher than in people without hypertension (RRR = 1·69). In conclusion, obesity is highly prevalent in SMI and associated with chronic disease. The complex relationship between diet and risk of obesity was also highlighted. People with SMI and obesity could benefit from screening for non-communicable diseases, better nutritional education, and context-appropriate lifestyle interventions.

ABSTRACTAimsTo evaluate whether adding financial incentives to usual care is cost-effective in encouraging pregnant women to quit tobacco smoking, compared to usual care alone.DesignCost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a healthcare provider’s perspective, embedded in the Smoking Cessation in Pregnancy Incentives Trial (CPIT III). Long-term analyses were conducted from the same perspective, using an existing Markov model over a lifetime horizon.SettingSeven maternity smoking cessation sites in Scotland, England and Northern Ireland in the United Kingdom.ParticipantsIn the short-term analysis CPIT III participants were assessed: women 16 years or older, self-reporting as smokers, less than 24 weeks pregnant and English speaking (n=944). The same population was used for the lifetime analysis, plus their infants.MeasurementsCosts include financial incentive vouchers and postage, cessation support and nicotine replacement therapy and neonatal stays. The outcome measure was biochemically verified quit rate for the CEA and quality adjusted life-years (QALY) for CUA. Costs are presented in 2020 GBP sterling (£).Data for the lifetime analysis came from the trial and was combined with data from published literature embedded in the model, reporting incremental cost per quitter and QALY. A 3.5% discount rate was applied.FindingsThe short-term incremental cost per quitter was £4,400, uncertainty in QALY gains resulted in a cost per QALY of £150,000. Results of sensitivity analyses confirm these results. The long-term analysis combined costs and outcomes for mother and infants, results show a cost saving of £37 (-£35 to £106) and increase in QALYs of 0.171 (0.124 to 0.229). These findings indicate that, over a lifetime, financial incentives are cost saving and improve health outcomes.ConclusionsOffering up to £400 financial incentives, in addition to usual care, to support pregnant women to stop smoking is cost-effective over a lifetime for mother and infants.EthicsEthics approval received from NHS West of Scotland Research Ethics Committee-2, August 2017.Registration detailsTrial registration number: ISRCTN15236311, date registered 09/10/2017 https://doi.org/10.1186/ISRCTN15236311