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Background There is a need for robust evidence on the effectiveness and cost-effectiveness of domestic abuse perpetrator programmes in reducing abusive behaviour and improving wellbeing for victim/survivors. While any randomised controlled trial can present difficulties in terms of recruitment and retention, conducting such a trial with domestic abuse perpetrators is particularly challenging. This paper reports the pilot and feasibility trial of a voluntary domestic abuse perpetrator group programme in the United Kingdom. Methods This was a pragmatic individually randomised pilot and feasibility trial with an integrated qualitative study in one site (covering three local-authority areas) in England. Male perpetrators were randomised to either the intervention or usual care. The intervention was a 23-week group programme for male perpetrators in heterosexual relationships, with a planned average of three additional one-to-one sessions, and one-to-one support for female current- or ex-partners was delivered by third sector organisations. There was no active control treatment for men, and partners of control men were signposted towards domestic abuse support services. Data were collected at three-monthly intervals for nine months from both male and female participants. The objectives assessed were recruitment, retention, data completeness, fidelity to the intervention model, and acceptability of the trial design. Results This study recruited 36 men (22 randomly allocated to attend the intervention group programme, 14 to usual care), and 15 current- or ex-partners (39% of eligible partners). Retention and completeness of data were high: 67% of male, and 80% of female participants completed the self-reported questionnaire at nine-months. A framework for assessing fidelity to the intervention was developed. In interviews, men who completed all or most of the intervention gave positive feedback and reported changes in their own behaviour. Partners were also largely supportive of the trial and were positive about the intervention. Participants who were not allocated to the intervention group reported feeling disappointed but understood the rationale for the trial. Conclusions It was feasible to recruit, randomise and retain male perpetrators and female victim/survivors of abuse and collect self-reported outcome data. Participants were engaged in the intervention and reported positive benefits. The trial design was seen as acceptable. Trial registration: ISRCTN71797549, registered 27/05/2022

Abstract Background: Incidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia and pre-term delivery. Optimum glycaemic control is associated with reduction in adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention. Randomised Controlled Trials (RCTs) of CGM in pregnant women with Type 1 diabetes mellitus demonstrate effectiveness for improved perinatal outcomes. Few adequately powered RCTs to evaluate CGM for adverse perinatal outcomes in women with GDM have been undertaken. We aim to establish the feasibility of a multi-site RCT to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor (isCGM) compared with self-monitored blood glucose (SMBG) in women with GDM for reducing fetal macrosomia and improving maternal and fetal outcomes. We will evaluate recruitment and retention rates, adherence to device requirements, adequacy of data capture and acceptability of trial design and isCGM devices. Methods: Open-label multicentre randomised controlled feasibility trial. Inclusion criteria: pregnant women, singleton pregnancy, recent diagnosis of GDM (within 14 days of commencing medication, up to 32+0 weeks gestation) prescribed metformin and/or insulin. Women will be consecutively recruited and randomised to isCGM (FreestyleLibre2) or SMBG. At every antenatal visit, glucose measurements will be evaluated. The SMBG group will use blinded isCGM for 14 days at baseline (~12-32 weeks) and ~34-36 weeks. The primary outcome is the recruitment rate and absolute number of women participating. Clinical assessments of maternal and fetal/infant health will be undertaken at baseline, birth, up to ~13 weeks postnatal. Psychological, behavioural and health economic measures will be assessed at baseline and ~34-36 weeks gestation. Qualitative interviews will be undertaken with study decliners, participants and professionals to explore trial acceptability, of using isCGM and SMBG. Discussion: GDM can negatively impact pregnancy outcomes. isCGM could offer a timely, easy-to-engage-with intervention, to improve glycaemic control, potentially reducing adverse pregnancy, birth and long-term health outcomes for mother and child. This study will determine the feasibility of conducting a large-scale multisite RCT of isCGM in women with GDM. Trial registration: This study has been registered with the ISRCTN(reference: ISRCTN42125256, Date registered: 07/11/2022) https://www.isrctn.com/ISRCTN42125256

Background Dental caries in childhood is a burden on the daily lives of children and their families, and associated with poor oral health in adulthood. In England, dental caries is the most common reason for young children to be admitted to hospital. It is believed that most tooth extractions (due to decay) for children aged 10 years and under, could be avoided with improved prevention and early management. National public health policy recommendations in England include specific oral health initiatives to tackle tooth decay. One of these initiatives is delivered as part of the Healthy Child Programme and includes providing workforce training in oral health, integrating oral health advice into home visits, and the timely provision of fluoride toothpaste. This protocol seeks to assess the delivery of the First Dental Steps intervention and uncertainties related to the acceptability, recruitment, and retention of participants. Methods This study seeks to explore the feasibility and acceptability of the First Dental Steps intervention and research methods. First Dental Steps intervention will be delivered in local authority areas in South West England and includes oral health training for health visitors (or community nursery nurses) working with 0–5-year-olds and their families. Further, for vulnerable families, integrating oral health advice and the provision of an oral health pack (including a free flow cup, an age appropriate toothbrush, and 1450 ppm fluoride toothpaste) during a mandated check by a health visitor. In this study five local authority areas will receive the intervention. Interviews with parents receiving the intervention and health visitors delivering the intervention will be undertaken, along with a range of additional interviews with stakeholders from both intervention and comparison sites (four additional local authority areas). Discussion This protocol was written after the start of the COVID-19 pandemic, as a result, some of the original methods were adjusted specifically to account for disruptions caused by the pandemic. Results of this study will primarily provide evidence on the acceptability and feasibility of both the First Dental Steps intervention and the research methods from the perspective of both families and stakeholders.

BACKGROUND Immune thrombocytopenia (ITP) is a rare autoimmune thrombocytopenia with associated bleeding risk and fatigue. Recommended first line ITP treatment is with high dose glucocorticoids but side effects, heterogeneous responses and high relapse rates are significant problems. METHODS In this multicenter, UK based, open label, randomized controlled trial, we randomly assigned adult patients with ITP requiring first line treatment to glucocorticoid alone (standard care) versus combined glucocorticoid and mycophenolate (1:1 ratio). The primary efficacy outcome was time from randomization to treatment failure, defined as platelets 100x109/L vs 63.9%, p

Background Surgery for established cataract is highly cost-effective and uncontroversial, yet uncertainty remains for individuals about when to proceed and when to delay surgery during the earlier stages of cataract. Objective We aimed to improve decision-making for cataract surgery through the development of evidence-based clinical tools that provide general information and personalised risk/benefit information. Design We used a mixed methodology consisting of four work packages. Work package 1 involved the development and psychometric validation of a brief, patient self-reported measure of visual difficulty from cataract and its relief from surgery, named Cataract Patient-Reported Outcome Measure, five items (Cat-PROM5). Work package 2 involved the review and refinement of risk models for adverse surgical events (posterior capsule rupture and visual acuity loss related to cataract surgery). Work package 3 involved the development of prediction models for the Cat-PROM5-based self-reported outcomes from a cohort study of 1500 patients; assessment of the validity of preference-based health economic indices for cataract surgery and the calibration of these to Cat-PROM5; assessment of patients’ and health-care professionals’ views on risk–benefit presentation formats, the perceived usefulness of Cat-PROM5, the value of personalised risk–benefit information, high-value information items and shared decision-making; development of cataract decision aid frequently asked questions, incorporation of personalised estimates of risks and benefits; and development of a cataract decision quality measure to assess the quality of decision-making. Work package 4 involved a mixed-methods feasibility study for a fully powered randomised controlled trial of the use of the cataract decision aid and a qualitative study of discordant or mismatching perceptions of outcome between patients and health-care professionals. Setting Four English NHS recruitment centres were involved: Bristol (lead centre), Brighton, Gloucestershire and Torbay. Multicentre NHS cataract surgery data were obtained from the National Ophthalmology Database. Participants Work package 1 – participants (n = 822) were from all four centres. Work package 2 – electronic medical record data were taken from the National Ophthalmology Database (final set > 1M operations). Work package 3 – cohort study participants were from Bristol (n = 1200) and Gloucestershire (n = 300); qualitative and development work was undertaken with patients and health-care professionals from all four centres. Work package 4 – Bristol, Brighton and Torbay participated in the recruitment of patients (n = 42) for the feasibility trial and recruitment of health-care professionals for the qualitative elements. Interventions For the feasibility trial, the intervention was the use of the cataract decision aid, incorporating frequently asked questions and personalised estimations of both adverse outcomes and self-reported benefit. Main outcome measures There was a range of quantitative and qualitative outcome measures: questionnaire psychometric performance metrics, risk indicators of adverse surgical events and visual outcome, predictors of self-reported outcome following cataract surgery, patient and health-care practitioner views, health economic calibration measures and randomised controlled trial feasibility measures. Data sources The data sources were patient self-reported questionnaire responses, study clinical data collection forms, recorded interviews with patients and health-care professionals, and anonymised National Ophthalmology Database data. Results Work package 1 – Cat-PROM5 was developed and validated with excellent to good psychometric properties (Rasch reliability 0.9, intraclass correlation repeatability 0.9, unidimensionality with residual eigenvalues ≤ 1.5) and excellent responsiveness to surgical intervention (Cohen delta –1.45). Work package 2 – earlier risk models for posterior capsule rupture and visual acuity loss were broadly affirmed (C-statistic for posterior capsule rupture 0.64; visual acuity loss 0.71). Work package 3 – the Cat-PROM5-based self-reported outcome regression models were derived based on 1181 participants with complete data (R 2 ≈ 30% for each). Of the four preference-based health economic indices assessed, two demonstrated reasonable performance. Cat-PROM5 was successfully calibrated to health economic indices; adjusted limited dependent variable mixture models offered good to excellent fit (root-mean-square error 0.10–0.16). The personalised quantitative risk information was generally perceived as beneficial. A cataract decision aid and cataract decision quality measure were successfully developed based on the views of patients and health-care professionals. Work package 4 – data completeness was good for the feasibility study primary and secondary variables both before and after intervention/surgery (data completeness range 100–88%). Considering ability to recruit, the sample size required, instrumentation and availability of necessary health economic data, a fully powered randomised controlled trial (patients, n = 800, effect size 0.2 standard deviations, power 80%; p = 0.05) of the cataract decision aid would be feasible following psychometric refinement of the primary outcome (the cataract decision quality measure). The cataract decision aid was generally well-received by patients and health-care professionals, with cautions raised regarding perceived time and workload barriers. Discordant outcomes mostly related to patient dissatisfaction, with no clinical problem found. Limitations The National Ophthalmology Database data are expected to include some errors (mitigated by large multicentre data aggregations). The feasibility randomised controlled trial primary outcome (the cataract decision quality measure) displayed psychometric imperfections requiring refinement. The clinical occurrence of discordant outcomes is uncommon and the study team experienced difficulty identifying patients in this situation. Future work Future work could include regular review of the risk models for adverse outcomes to ensure currency, and the technical precision of complex-numbers analysis of refractive outcome to invite opportunities to improve post-operative spectacle-free vision. In addition, a fully powered randomised controlled trial of the cataract decision aid would be feasible, following psychometric refinement of the primary outcome (the cataract decision quality measure); this would clarify its potential role in routine service delivery. Conclusions In this research programme, evidence-based clinical tools have been successfully developed to improve pre-operative decision-making in cataract surgery. These include a psychometrically robust, patient-reported outcome measure (Cat-PROM5); prediction models for patient self-reported outcomes using Cat-PROM5; prediction models for clinically adverse surgical events and adverse visual acuity outcomes; and a cataract decision aid with relevant general information and personalised risk/benefit predictions. In addition, the successful mapping of Cat-PROM5 to existing health economic indices was achieved and the performances of indices were assessed in patients undergoing cataract surgery. A future full-powered randomised controlled trial of the cataract decision aid would be feasible (patients, n = 800, effect size 0.2 standard deviations, power 80%; p = 0.05). Trial registration This trial is registered as ISRCTN11309852. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 9. See the NIHR Journals Library website for further project information.

Aim In the UK, injectable medicines are often prepared and administered by nurses following the Injectable Medicines Guide (IMG). Our earlier study confirmed a higher frequency of correct administration with user-tested versus standard IMG guidelines. This current study aimed to model the cost-effectiveness of user-testing. Methods The costs and cost-effectiveness of user-testing were explored by modifying an existing probabilistic decision-analytic model. The adapted model considered administration of intravenous voriconazole to hospital inpatients by nurses. It included 11 error types, their probability of detection and level of harm. Model inputs (including costs) were derived from our previous study and other published data. Monte Carlo simulation using 20,000 samples (sufficient for convergence) was performed with a 5-year time horizon from the perspective of the 121 NHS trusts and health boards that use the IMG. Sensitivity analyses were undertaken for the risk of a medication error and other sources of uncertainty. Results The net monetary benefit at £20,000/quality-adjusted life year was £3,190,064 (95% credible interval (CrI): −346,709 to 8,480,665), favouring user-testing with a 96% chance of cost-effectiveness. Incremental cost-savings were £240,943 (95% CrI 43,527–491,576), also favouring user-tested guidelines with a 99% chance of cost-saving. The total user testing cost was £6317 (95% CrI 6012–6627). These findings were robust to assumptions about a range of input parameters, but greater uncertainty was seen with a lower medication error risk. Conclusions User-testing of injectable medicines guidelines is a low-cost intervention that is highly likely to be cost-effective, especially for high-risk medicines.

Purpose The validity and responsiveness of the EQ-5D-3L in visual conditions has been questioned, inspiring development of a vision ‘bolt-on’ domain (EQ-5D-3L + VIS). Developments in preference-based measures (PBM) also includes the EQ-5D-5L and the ICECAP-O capability wellbeing measure. This study aimed to examine the construct validity and responsiveness of the EQ-5D-3L, EQ-5D-5L, EQ-5D-3L + VIS and ICECAP-O in cataract surgery patients for the first time, to inform choice of PBM for economic evaluation in this population. Methods The analyses used data from the UK Predict-CAT cataract surgery cohort study. PBMs and the Cat-PROM5 [a validated measure of cataract quality of life (QOL)] were completed before surgery and 4–8 weeks after. Construct validity was assessed using correlations and known-group differences evaluated using regression. Responsiveness was evaluated using effect sizes and analysis of variance to compare change scores between groups, defined by patient-reported and clinical outcomes. Results The sample comprised 1315 patients at baseline. No PBMs were associated with visual acuity and only the ICECAP-O (Spearman’s rs = − 0.35), EQ-5D-3L + VIS (rs = − 0.42) and EQ-5D-5L (Value Set for England rs = − 0.31) correlated at least moderately with the Cat-PROM5. Effect sizes of change were consistently largest for the EQ-5D-3L + VIS (range 0.34–0.41), followed by the ICECAP-O (range 0.20–0.34). Results indicated no improvement in responsiveness using the EQ-5D-5L (range 0.13–0.16) compared to the EQ-5D-3L (range 0.17–0.20). Conclusions Whilst no PBMs comprehensively demonstrated evidence of construct validity and responsiveness in cataract surgery patients, the ICECAP-O was the most responsive generic PBM to improvements in QOL. Surprisingly the EQ-5D-5L was not more responsive than the EQ-5D-3L in this setting.

Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

Strategies to address declining physical activity levels among children and adolescents have focused on ‘individual-level’ approaches which often fail to demonstrate impact. Recent attention has been on an alternative ‘whole-school’ approach to increasing physical activity that involves promoting physical activity throughout all aspects of the school environment. There is, however, a lack of evidence on how whole-school physical activity approaches could be implemented in the UK. This qualitative study explored perspectives of key stakeholders on potential reasons for the lack of impact of individual-level school-based interventions on children’s physical activity, and key considerations for adopting a whole-school approach. Nineteen semi-structured interviews were conducted with a range of stakeholders involved in the implementation of physical activity programmes in UK schools. Data were analysed using an inductive approach. Respondents suggested that individual-level school-based interventions to increase physical activity often failed to consult end users in the design and were typically implemented in environments unsupportive of long-term change. They subsequently outlined specific barriers and key facilitators for the adoption and implementation of whole-school approaches in UK settings and recommended a shift in research foci towards building an evidence base around educational outcomes and whole-school implementation insights.

Given the growing global increase in harm from alcohol and substance use, and the inadequacy of standard treatment to tackle the challenge, the use of physical activity (PA) interventions has received increased attention. The aim of this review is to identify common and cross cutting themes relating to how and why physical activity may impact on reduction of/abstinence from alcohol and other drug use to support future intervention design (including aspects of physical activity, barriers and facilitators, and elements of support which may have an impact). Twenty papers including qualitative data were included in the synthesis. A deductive coding framework was created and sought to identify biological, environmental and psycho-social barriers, facilitators and mechanisms of participants’ experience of engaging with physical activity interventions. Key themes supported in the evidence included how interventions influence use (e.g. reduced cravings, increases in bodily awareness and health and fitness, the development of positive focus and new identity, and increases in mood and quality of life); the impact of frequency, intensity, type, duration and timing of physical activity; perceived barriers and facilitators to engaging in physical activity (e.g. health and fitness, access and affordability, perceptions of others); and details of how much support and in what form best supports sustained changes in physical activity (e.g. social support and environment). Despite evidence being sparse, key barriers and facilitators pertinent to intervention design were identified. Recommendations for future research are indicated and the evidence promotes the need for individually tailored programmes of support for physical activity.

Discussion of public and patient involvement (PPI) in health economics (HE) research is growing. There is much literature on PPI principles and standards, but little specifically regarding involving patients in HE research. Here, we outline “PACTS”, a set of principles, developed with a PPI group, for considering patient involvement in HE research. Planning: Involvement is best built in to research plans from the outset. This includes setting specific goals for involvement activities, and clearly communicating the background and purpose of involvement. Approach selection: We describe two main approaches to involvement—discussion-based and task-based. Discussion-based approaches are useful for generating broad insights and revealing “unknown unknowns”. Task-based approaches offer a more focused means of shedding light on “known unknowns”. Continuous involvement: Involving patients throughout the research process and across a range of projects helps build expertise for patients and insight for HE researchers. Team building: Meaningful involvement creates a shared sense of ownership of the research and, over time, helps to develop a team ethos, enhancing the positive impacts of involvement. Sensitivity: HE research can be perceived as technical and impersonal. Addressing this requires sensitivity, clarity, and an honest and open approach. There is increased recognition that patient contributors are experts at providing a “lived experience” perspective, in the way that clinicians are experts at providing an overview of conditions and HEs are experts in the methodology of their discipline. We hope these “PACTS Principles” complement existing PPI approaches and provide a useful foundation for health economists considering patient involvement. Electronic supplementary material The online version of this article (10.1007/s40271-020-00461-4) contains supplementary material, which is available to authorized users.

IntroductionLateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker.Methods and analysisThe study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial.Ethics and disseminationEthical approval for the study was given by the South West—Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences.Trial registration numberISRCTN10649958

This paper considers patient and public involvement (PPI) in health economics research and how this might be facilitated. PPI refers to research carried out ‘with’ or ‘by’ members of the public and is now an important aspect of health research policies internationally. Patients and members of the public can be involved in all stages of the research cycle, from establishing whether the topic is important to influencing details of study design, wording of patient-facing documentation and interpretation and dissemination of findings. PPI has become commonplace in health services research. In the context of clinical trials, it has become imperative, with, for example, patients and members of the public informing the selection of outcome measures and recruitment methods, and qualitative research is frequently steered by PPI input regarding the content of interview topic guides and the interpretation of study findings. It is less common for PPI to be explicitly reported in the economic components of health services research. However, we argue that involvement is no less important in this area. The fundamental rationale for involving people in research is that it promotes democratic principles, research quality and relevance to service users. These arguments equally apply to health economics as to other health research disciplines. Our overarching aim in this paper is to show how health economic research might be informed by PPI. We report our experiences of PPI via case studies in child health, reflect on our learnings, and make suggestions for future research practice. Plain Language Summary This paper considers how to involve patients and members of the public in health economics research. Health economists often carry out research into the value for money (sometimes called ‘cost effectiveness’) of new ways of treating people. This can help in decisions about which treatments are publically funded. In an economic evaluation, the economist identifies and values the key things used to treat someone who is unwell. They also have to measure how unwell that person is and whether their health changes with treatment. They do this by asking them questions about how they rate specific aspects of their health. Economists compare costs and health outcomes of different treatments. Patient and public involvement in health research is really important because the public fund health systems (through taxation in the UK) and benefit from healthcare. This paper shares our ideas on and experiences involving the public in health economic research studies. All our examples come from the involvement of children and/or parents. We think our approaches would also apply to adults.

IntroductionLoneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations.Methods and analysisThe PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context.Ethics and disseminationThis study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners.Trial registration numberISRCTN19193075

Background Adolescent girls are less physically active than recommended for health, and levels decline further as they approach adulthood. Peers can influence adolescent girls’ physical activity. Interventions capitalising on peer support could positively impact physical activity behaviour in this group. Building on promising feasibility work, the purpose of this cluster randomised controlled trial is to assess whether the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A) increases adolescent girls’ physical activity and is cost effective. Methods PLAN-A is a two-arm secondary school-based cluster randomised controlled trial, conducted with girls aged 13–14 years from twenty schools in the south west of England. The intervention requires participants to nominate influential girls within their year group to become peer supporters. The top 15% of girls nominated in each school receive three days of training designed to prepare them to support their peers to be more physically active during a ten-week intervention period. Data will be collected at two time points, at baseline (T0) and 5–6 months post-intervention (T1). Schools will be randomly allocated to the intervention (n = 10) or control (n = 10) arm after T0. At each time point, all consenting participants will wear an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity. Multivariable mixed effects linear regression will be used to estimate differences in the primary outcome between the two arms and will be examined on an Intention-to-Treat (ITT) basis. A self-report psychosocial questionnaire will be completed by participants to assess self-esteem and physical activity motivation. Resource use and quality of life will be measured for the purposes of an economic evaluation. A mixed-methods process evaluation will be conducted to explore intervention fidelity, acceptability and sustainability. Analysis of quantitative process evaluation data will be descriptive, and the framework method will be used to analyse qualitative data. Discussion This paper describes the protocol for the PLAN-A cluster randomised controlled trial, a novel approach to increasing adolescent girls’ physical activity levels through peer support. Trial registration ISRCTN14539759–31 May, 2018. Electronic supplementary material The online version of this article (10.1186/s12889-019-7012-x) contains supplementary material, which is available to authorized users.

BACKGROUND Immune thrombocytopenia (ITP) is a rare autoimmune condition associated with bleeding risk and fatigue. Current first line ITP treatment is with high dose corticosteroids but frequent side effects, heterogeneous responses and high relapse rates are significant problems, with only 20% remaining in sustained long-term remission. In the UK, mycophenolate (MMF) is frequently used as second line treatment, with retrospective data in ITP suggesting efficacy in 50-80% of patients with good tolerability, although responses are often delayed. The FLIGHT trial aimed to test the hypothesis that MMF combined with corticosteroid is a more effective first line ITP treatment than current standard of care, corticosteroid alone. METHODS In this multicentre, UK based, open label, randomised controlled trial, we randomly assigned 120 patients with ITP requiring first line treatment, to corticosteroid alone (standard care) versus combined corticosteroid and MMF (1:1 ratio). Patients >16 years old, with baseline platelet count RESULTS Of the 120 ITP patients consented, recruited and randomised (52.4% male, mean age 54 years, range 17-87), mean baseline platelet count was 7 x109/L and mean follow up was for 18 months (maximum follow up 24 months, minimum follow up of 12 months). Patient demographics and baseline values are shown in table 1. Significantly fewer treatment failures occurred in patients randomised to MMF as shown in figure 1 (22% [n=13 of 59] vs 44% [n=27 of 61], aHR=0.41 [0.21, 0.80], p=0.0064, and when secondary ITP patients were excluded, aHR 0.37 [0.19, 0.71] p=0.0029). There were similar rates between the groups of significant adverse events, bleeding events, rescue treatments, hospital admissions and treatment side effects including infection (n=14 in each group), neutropenia (4 patients in corticosteroid group), and gastrointestinal side effects (table 2). However, some aspects of quality of life (QoL) were worse in those patients assigned to the MMF group including physical role, physical function and fatigue. CONCLUSIONS This is the first randomised trial using MMF to treat ITP, demonstrating good efficacy and tolerability, even with the inclusion of elderly patients (27.5% were >70 years, 15.8% >75 years). Therefore, MMF may be considered an effective, well tolerated first line treatment option, alongside a short course of steroids, for some patients with ITP, approximately halving the risk of refractory or relapsed ITP. At final follow up, 56% of patients treated with corticosteroid alone had not required 2nd line treatment, which is higher than previous reports. It is unclear why some aspects of QoL were worse in the MMF group. This is an important reminder that disease response and patient experience may not correlate and emphasises the importance of including PROM outcomes within trials. For ITP, to date, PROMs have only been systematically evaluated in the TPO-RA randomised controlled trials. The FLIGHT trial received ethical approval from NRES Committee South West and is registered, (EudraCT Number: 2017-001171-23. ClinicalTrials.gov number: NCT03156452). This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0815-20016). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Mycophenolate is unlicensed for ITP treatment

PLAN-A is a cluster randomised controlled trial of a peer-led physical activity intervention which uses peer supporters to increase the physical activity of 13&ndash, 14-year-old girls in the UK. This paper uses latent class analysis to identify classes in the whole study population and investigate how those selected as peer supporters in PLAN-A were drawn from different social groups. We identified five classes of girls, based on psychosocial variables (self-esteem, physical activity self-efficacy, motivation, physical activity values among friends and peer support for physical activity (PA) and physical activity behaviour variables (average minutes of weekday MVPA, sedentary time and screen viewing). Peer supporters were similar to the whole study population in terms of overall demographics, but were drawn unequally from the five classes. In addition, there was considerable variation in the distribution of peer supporters between schools. The selection of peer supporters is an integral component of peer-led interventions and should be explored and linked to underlying theory to understand the characteristics of those recruited. However, demographic representativeness is not necessarily the aim, and simple reporting of overall demographic comparisons may mask important differences within subgroups.

The aim of this review is to systematically describe and quantify the effects of PA interventions on alcohol and other drug use outcomes, and to identify any apparent effect of PA dose and type, possible mechanisms of effect, and any other aspect of intervention delivery (e.g. key behaviour change processes), within a framework to inform the design and evaluation of future interventions. Systematic searches were designed to identify published and grey literature on the role of PA for reducing the risk of progression to alcohol and other drug use (PREVENTION), supporting individuals to reduce alcohol and other drug use for harm reduction (REDUCTION), and promote abstinence and relapse prevention during and after treatment of alcohol and other drug use (TREATMENT). Searches identified 49,518 records, with 49,342 excluded on title and abstract. We screened 176 full text articles from which we included 32 studies in 32 papers with quantitative results of relevance to this review. Meta-analysis of two studies showed a significant effect of PA on prevention of alcohol initiation (risk ratio [RR]: 0.72, 95%CI: 0.61 to 0.85). Meta-analysis of four studies showed no clear evidence for an effect of PA on alcohol consumption (Standardised Mean Difference [SMD]: 0.19, 95%, Confidence Interval −0.57 to 0.18). We were unable to quantitatively examine the effects of PA interventions on other drug use alone, or in combination with alcohol use, for prevention, reduction or treatment. Among the 19 treatment studies with an alcohol and other drug use outcome, there was a trend for promising short-term effect but with limited information about intervention fidelity and exercise dose, there was a moderate to high risk of bias. We identified no studies reporting the cost-effectiveness of interventions. More rigorous and well-designed research is needed. Our novel approach to the review provides a clearer guide to achieve this in future research questions addressed to inform policy and practice for different populations and settings., Highlights • A comprehensive systematic review of physical activity and alcohol and/or substance use. • Looks at the prevention, reduction, and treatment of alcohol and/or substance use. • Highlights what may be most effective and gaps in knowledge. • Considers different elements of physical activity interventions for best practice.

IntroductionObservational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.Methods and analysisThis is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.Ethics and disseminationThe study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients.Trial registration numberISRCTN86184521; Pre-results.

Objectives To evaluate the impact of low-friction (LF) bedding on graft loss in an acute burn care setting, and to examine the feasibility and costs of using LF bedding compared with standard care. Design Proof of concept before and after study with feasibility of delivering the intervention. Setting Three burns services within two UK hospital trusts. Participants Inclusion criteria were patients older than 4 weeks, who received a skin graft after burn injury and were admitted overnight. The comparator cohort were eligible patients admitted in a 12-month period before the intervention. Intervention Introduction of LF sheets and pillowcases during a 15-month period. Outcome measures For proof of concept, the LF and comparator cohorts were compared in terms of number of regrafting operations (primary), percentage graft loss, hospital length of stay (LoS) and LoS cost (secondary). Feasibility outcomes were practicality and safety of using LF bedding. Results 131 patients were eligible for the LF cohort and 90 patients for the comparator cohort. Although the primary outcome of the proportion needing regrafting was halved in the LF cohort, the confidence interval (CI) crossed 1 (OR (95% CI): 0.56 (0.16 to 1.88)). Partial graft loss (any loss) was significantly reduced in the LF cohort (OR (95% CI): 0.27 (0.14, 0.51)). Inpatient LoS was no different between the two cohorts (difference in median days (95% CI): 0 (−2 to 1)), and the estimated difference in LoS cost was £−1139 (−4829 to 2551). Practical issues were easily resolved, and no safety incidents occurred while patients were nursed on LF bedding. Conclusions LF bedding is safe to use in burned patients with skin grafts and we have shown proof of concept for the intervention. Further economic modelling is required to see if an appropriately powered randomised control trial would be worthwhile or if roll out across the National Health Service is justified. Trial registration number ISRCTN82599687.

Background Alcohol and substance use results in significant human and economic cost globally and is associated with economic costs of £21 billion and £15billion within the UK, respectively, and trends for use are not improving. Pharmacological interventions are well researched, but relapse rates across interventions for substance and alcohol use disorders are as high as 60–90%. Physical activity may offer an alternative or adjunct approach to reducing rates of alcohol and substance use that is associated with few adverse side effects, is easily accessible, and is potentially cost-effective. Through psychological, behavioural, and physiological mechanisms, physical activity may offer benefits in the prevention, reduction, and treatment of alcohol and substance use across the lifespan. Whilst physical activity is widely advocated as offering benefit, no systematic review exists of physical activity (in all forms) and its effects on all levels of alcohol and substance use across all ages to help inform policymakers, service providers, and commissioners. Methods The objectives of this mixed methods systematic review are to describe and evaluate the quantitative and qualitative research obtained by a diverse search strategy on the impact of physical activity and its potential to:Reduce the risk of progression to alcohol and/or substance use (PREVENTION)Support individuals to reduce alcohol and/or substance use for harm reduction (REDUCTION), andPromote abstinence and relapse prevention during and after treatment for an alcohol and/or substance use disorder (TREATMENT). With the input of key stakeholders, we aim to assess how what we know can be translated into policy and practice. Quantitative, qualitative, service evaluations, and economic analyses will be brought together in a final narrative synthesis that will describe the potential benefits of physical activity for whom, in what conditions, and in what form. Discussion This review will provide details of what is known about physical activity and the prevention, reduction, and treatment of alcohol and/or substance use. The synthesised findings will be disseminated to policymakers, service providers, and commissioners in the UK. Systematic review registration PROSPERO number: CRD42017079322. Electronic supplementary material The online version of this article (10.1186/s13643-018-0674-0) contains supplementary material, which is available to authorized users.

BackgroundOver 150 000 cases of suspected transient ischaemic attack (TIA) are referred to outpatient clinics in England each year. The majority of referrals are made by GPs.AimThis study aimed to identify how many patients referred to a TIA clinic actually have TIA (that is, calculate the positive predictive value [PPV] of first-contact healthcare referral) and to record the alternative diagnoses in patients without TIA, in order to determine the optimal service model for patients with suspected TIA.Design and settingA systematic review of TIA clinic referrals from first-contact health professionals (GPs and emergency department [ED] doctors) was undertaken.MethodFour databases were searched using terms for TIA and diagnostic accuracy. Data on the number of patients referred to a TIA clinic who actually had a TIA (PPVs) were extracted. Frequencies of differential diagnoses were recorded, where reported. Study quality was assessed using the QUADAS-2 tool.ResultsNineteen studies were included and reported sufficient information on referrals from GPs and ED doctors to derive PPVs (n = 15 935 referrals). PPVs for TIA ranged from 12.9% to 72.5%. A formal meta-analysis was not conducted due to heterogeneity across studies. Of those not diagnosed with TIA, approximately half of the final diagnoses were of neurological or cardiovascular conditions.ConclusionThis study highlights the variation in prevalence of true vascular events in patients referred to TIA clinics. For patients without a cerebrovascular diagnosis, the high prevalence of conditions that also require specialist investigations and management are an additional burden on a care pathway that is primarily designed to prevent recurrent stroke. Service commissioners need to assess whether the existing outpatient provision is optimal for people with pathologies other than cerebrovascular disease.

The objective of this economic study was to evaluate the resource use and cost associated with the management of small area burns, including the additional costs associated with unexpected illness after burn in children of less than five years of age. This study was conducted as a secondary analysis of a multi-centre prospective observational cohort study investigating the physiological response to burns in children. 452 children were included in the economic analysis (median age = 1.60 years, 61.3% boys, median total burn surface area [TBSA] = 1.00%) with a mean length of stay of 0.69 days. Of these children, 21.5% re-presented to medical care with an unexpected illness within fourteen days of injury. The cost of managing a burn of less than 10% TBSA in a child less than five years of age was £785. The additional cost associated with the management of illness after burn was £1381. A generalised linear regression model was used to determine the association between an unexpected illness after burn, presenting child characteristics and NHS cost. Our findings may be of value to those planning economic evaluations of novel technologies in burn care.

Background: Chewing gum may stimulate gastrointestinal motility with beneficial effects on postoperative ileus suggested in small studies. The primary aim of this trial was to determine whether chewing gum reduces length of hospital stay (LOS) after colorectal resection. Secondary aims included examining bowel habit symptoms, complications and healthcare costs. Method: This clinical trial randomly allocated postoperative patients to standard care with or without chewing gum (sugar-free gum for at least ten minutes, four times/day on days 1-5) in 5 UK hospitals. The primary outcome was LOS. Cox regression was used to calculate hazard ratios (HR) for LOS. Differences between groups for the selected secondary outcomes were assessed using Student’s t-test, χ2 and Mann-Whitney tests as appropriate. Results: Data from 402 of 412 patients, of whom 199 (49.5%) were allocated to chewing gum, were available for analysis. 40% of patients in both groups had laparoscopic surgery, and all study sites used enhanced recovery after surgery programmes. Median (IQR) LOS was not different between groups with both 7 (5-11) days (p=0.962) showing a HR for gum at 0.94 (95% CI=0.77-1.15, p=0.557). Compared to controls, participants allocated to gum had worse quality of life (EQ-5D-3L) at 6 and 12 weeks post-operation (but not day 4), and more Dindo-Demartines-Clavien complications graded 3 and above and deaths (6 vs. 16 and 0 vs. 11, respectively, but none were classed as related to gum). No other differences were observed. Conclusion: Chewing gum did not alter the return of bowel function or LOS. Trial registration: ISRCTN55784442

BackgroundTelephone triage is proposed as a method of managing increasing demand for primary care. Previous studies have involved small samples in limited settings, and focused on nurse roles. Evidence is limited regarding the impact on primary care workload, costs, and patient safety and experience when triage is used to manage patients requesting same-day consultations in general practice.ObjectivesIn comparison with usual care (UC), to assess the impact of GP-led telephone triage (GPT) and nurse-led computer-supported telephone triage (NT) on primary care workload and cost, patient experience of care, and patient safety and health status for patients requesting same-day consultations in general practice.DesignPragmatic cluster randomised controlled trial, incorporating economic evaluation and qualitative process evaluation.SettingGeneral practices (n = 42) in four regions of England, UK (Devon, Bristol/Somerset, Warwickshire/Coventry, Norfolk/Suffolk).ParticipantsPatients requesting same-day consultations.InterventionsPractices were randomised to GPT, NT or UC. Data collection was not blinded; however, analysis was conducted by a statistician blinded to practice allocation.Main outcome measuresPrimary – primary care contacts [general practice, out-of-hours primary care, accident and emergency (A&E) and walk-in centre attendances] in the 28 days following the index consultation request. Secondary – resource use and costs, patient safety (deaths and emergency hospital admissions within 7 days of index request, and A&E attendance within 28 days), health status and experience of care.ResultsOf 20,990 eligible randomised patients (UCn = 7283; GPTn = 6695; NTn = 7012), primary outcome data were analysed for 16,211 patients (UCn = 5572; GPTn = 5171; NTn = 5468). Compared with UC, GPT and NT increased primary outcome contacts (over 28-day follow-up) by 33% [rate ratio (RR) 1.33, 95% confidence interval (CI) 1.30 to 1.36] and 48% (RR 1.48, 95% CI 1.44 to 1.52), respectively. Compared with GPT, NT was associated with a marginal increase in primary outcome contacts by 4% (RR 1.04, 95% CI 1.01 to 1.08). Triage was associated with a redistribution of primary care contacts. Although GPT, compared with UC, increased the rate of overall GP contacts (face to face and telephone) over the 28 days by 38% (RR 1.38, 95% CI 1.28 to 1.50), GP face-to-face contacts were reduced by 39% (RR 0.61, 95% CI 0.54 to 0.69). NT reduced the rate of overall GP contacts by 16% (RR 0.84, 95% CI 0.78 to 0.91) and GP face-to-face contacts by 20% (RR 0.80, 95% CI 0.71 to 0.90), whereas nurse contacts increased. The increased rate of primary care contacts in triage arms is largely attributable to increased telephone contacts. Estimated overall patient–clinician contact time on the index day increased in triage (GPT = 10.3 minutes; NT = 14.8 minutes; UC = 9.6 minutes), although patterns of clinician use varied between arms. Taking account of both the pattern and duration of primary outcome contacts, overall costs over the 28-day follow-up were similar in all three arms (approximately £75 per patient). Triage appeared safe, and no differences in patient health status were observed. NT was somewhat less acceptable to patients than GPT or UC. The process evaluation identified the complexity associated with introducing triage but found no consistency across practices about what works and what does not work when implementing it.ConclusionsIntroducing GPT or NT was associated with a redistribution of primary care workload for patients requesting same-day consultations, and at similar cost to UC. Although triage seemed to be safe, investigation of the circumstances of a larger number of deaths or admissions after triage might be warranted, and monitoring of these events is necessary as triage is implemented.Trial registrationCurrent Controlled Trials ISRCTN20687662.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 13. See the NIHR Journals Library website for further project information.

Background: Telephone triage is increasingly used to manage workload in primary care; however, supporting evidence for this approach is scarce. We aimed to assess the effectiveness and cost consequences of general practitioner-(GP)-led and nurse-led telephone triage compared with usual care for patients seeking same-day consultations in primary care. Methods: We did a pragmatic, cluster-randomised controlled trial and economic evaluation between March 1, 2011, and March 31, 2013, at 42 practices in four centres in the UK. Practices were randomly assigned (1:1:1), via a computer-generated randomisation sequence minimised for geographical location, practice deprivation, and practice list size, to either GP-led triage, nurse-led computer-supported triage, or usual care. We included patients who telephoned the practice seeking a same-day face-to-face consultation with a GP. Allocations were concealed from practices until after they had agreed to participate and a stochastic element was included within the minimisation algorithm to maintain concealment. Patients, clinicians, and researchers were not masked to allocation, but practice assignment was concealed from the trial statistician. The primary outcome was primary care workload (patient contacts, including those attending accident and emergency departments) in the 28 days after the first same-day request. Analyses were by intention to treat and per protocol. This trial was registered with the ISRCTN register, number ISRCTN20687662. Findings: We randomly assigned 42 practices to GP triage (n=13), nurse triage (n=15), or usual care (n=14), and 20 990 patients (n=6695 vs 7012 vs 7283) were randomly assigned, of whom 16 211 (77%) patients provided primary outcome data (n=5171 vs 5468 vs 5572). GP triage was associated with a 33% increase in the mean number of contacts per person over 28 days compared with usual care (2·65 [SD 1·74] vs 1·91 [1·43]; rate ratio [RR] 1·33, 95% CI 1·30-1·36), and nurse triage with a 48% increase (2·81 [SD 1·68]; RR 1·48, 95% CI 1·44-1·52). Eight patients died within 7 days of the index request: five in the GP-triage group, two in the nurse-triage group, and one in the usual-care group; however, these deaths were not associated with the trial group or procedures. Although triage interventions were associated with increased contacts, estimated costs over 28 days were similar between all three groups (roughly £75 per patient). Interpretation: Introduction of telephone triage delivered by a GP or nurse was associated with an increase in the number of primary care contacts in the 28 days after a patient's request for a same-day GP consultation, with similar costs to those of usual care. Telephone triage might be useful in aiding the delivery of primary care. The whole-system implications should be assessed when introduction of such a system is considered. Funding: Health Technology Assessment Programme UK National Institute for Health Research. © 2014 Campbell et al. Open Access article distributed under the terms of CC BY-NC-ND.

BACKGROUND: There have been few rigorous studies on the effects of behavioural support for helping smokers to reduce who do not immediately wish to quit. While reduction may not have the health benefits of quitting, it may lead smokers to want to quit. Physical activity (PA) helps to reduce cravings and withdrawal symptoms, and also reduces weight gain after quitting, but smokers may be less inclined to exercise. There is scope to develop and determine the effectiveness of interventions to support smoking reduction and increase physical activity, for those not ready to quit. OBJECTIVE: To conduct a pilot randomised controlled trial (RCT) [Exercise Assisted Reduction then Stop (EARS) smoking study] to (1) design and evaluate the feasibility and acceptability of a PA and smoking-reduction counselling intervention [for disadvantaged smokers who do not wish to quit but do want to reduce their smoking (to increase the likelihood of quitting)], and (2) to inform the design of a large RCT to determine the clinical effectiveness and cost-effectiveness of the intervention. DESIGN: A single-centre, pragmatic, pilot trial with follow-up up to 16 weeks. A mixed methods approach assessed the acceptability and feasibility of the intervention and trial methods. Smokers were individually randomised to intervention or control arms. SETTING: General practices, NHS buildings, community venues, and the Stop Smoking Service (SSS) within Plymouth, UK. PARTICIPANTS: Aged > 18 years, smoking ≥ 10 cigarettes per day (for ≥ 2 years) who wished to cut down. We excluded individuals who were contraindicated for moderate PA, posed a safety risk to the research team, wished to quit immediately or use Nicotine Replacement Therapy, not registered with a general practitioner, or did not converse in English. INTERVENTION: We designed a client-centred, counselling-based intervention designed to support smoking reduction and increases in PA. Support sessions were delivered by trained counsellors either face to face or by telephone. Both intervention and control arms were given information at baseline on specialist SSS support available should they have wished to quit. MAIN OUTCOME MEASURES: The primary outcome was 4-week post-quit expired air carbon monoxide (CO)-confirmed abstinence from smoking. Secondary outcomes included validated behavioural, cognitive and emotional/affective and health-related quality of life measures and treatment costs. RESULTS: The study randomised 99 participants, 49 to the intervention arm and 50 to the control arm, with a 62% follow-up rate at 16 weeks. In the intervention and control arms, 14% versus 4%, respectively [relative risk = 3.57; 95% confidence interval (CI) 0.78 to 16.35], had expired CO-confirmed abstinence at least 4 and up to 8 weeks after quit day; 22% versus 6% (relative risk = 3.74; 95% CI 1.11 to 12.60) made a quit attempt; 10% versus 4% (relative risk = 92.55; 95% CI 0.52 to 12.53) achieved point-prevalent abstinence at 16 weeks; and 39% versus 20% (relative risk = 1.94; 95% CI 1.01 to 3.74) achieved at least a 50% reduction in the number of cigarettes smoked daily. The percentage reporting using PA for controlling smoking in the intervention versus control arms was 55% versus 22%, respectively at 8 weeks and 37% versus 16%, respectively, at 16 weeks. The counsellors generally delivered the intervention as planned and participants responded with a variety of smoking reduction strategies, sometimes supported by changes in PA. The intervention costs were approximately £192 per participant. Exploratory cost-effectiveness modelling indicates that the intervention may be cost-effective. CONCLUSIONS: The study provided valuable information on the resources needed to improve study recruitment and retention. Offering support for smoking reduction and PA appears to have value in promoting reduction and cessation in disadvantaged smokers not currently motivated to quit. A large RCT is needed to assess the clinical effectiveness and cost-effectiveness of the intervention in this population. TRIAL REGISTRATION: ISRCTN 13837944. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 18, No. 4. See the NIHR Journals Library website for further project information.