Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial.

INTRODUCTION: Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes. METHODS AND ANALYSIS: A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention. ETHICS AND DISSEMINATION: The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN68786622. PROTOCOL VERSION: 2.0 (16 May 2023).

Effectiveness and cost-effectiveness of a web-based cardiac rehabilitation programme for people with chronic stable angina: protocol for the ACTIVATE (Angina Controlled Trial Investigating the Value of the 'Activate your heart' Therapeutic E-intervention) randomised controlled trial.

INTRODUCTION: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group. The objectives of this study are to compare the effectiveness and cost-effectiveness of the 'Activate Your Heart' cardiac rehabilitation programme for people with chronic stable angina compared with usual care. METHODS AND ANALYSIS: ACTIVATE is a multicentre, parallel-group, two-arm, superiority, pragmatic randomised controlled trial, with recruitment from primary and secondary care centres in England and Wales and a target sample size of 518 (1:1 allocation; allocation sequence by minimisation programme with built-in random element). The study uses secure web-based allocation concealment. The two treatments will be optimal usual care (control) and optimal usual care plus the 'Activate Your Heart' web-based cardiac rehabilitation programme (intervention). Outcome assessment and statistical analysis will be performed blinded; participants will be unblinded. Outcomes will be measured at baseline and at 6 and 12 months' follow-up. Primary outcome will be the UK version of Seattle Angina Questionnaire (SAQ-UK), physical limitations domain at 12 months' follow-up. Secondary outcomes will be the remaining two domains of SAQ-UK, dyspnoea, anxiety and depression, health utility, self-efficacy, physical activity and the incremental shuttle walk test. All safety events will be recorded, and serious adverse events assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be cost-utility analysis from health service perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme. ETHICS AND DISSEMINATION: North of Scotland National Health Service Research Ethics Committee approval, reference 21/NS/0115. Participants will provide written informed consent. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN10054455.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0).

INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial. METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences. TRIAL REGISTRATION NUMBER: ISRCTN17395671.

A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial.

BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. METHODS/DESIGN: Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4-9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22.

Views of female genital mutilation survivors, men and health-care professionals on timing of deinfibulation surgery and NHS service provision: qualitative FGM Sister Study.

Background: Female genital mutilation is an important UK health-care challenge. There are no health benefits of female genital mutilation, and it is associated with lifelong physical, psychological and sexual impacts. The annual cost to the NHS to care for survivors is £100M. Deinfibulation may improve the health and well-being of some women, but there is no consensus on the optimal timing of surgery for type 3 survivors. UK care provision is reportedly suboptimal. Objectives: We aimed to explore the views of survivors, men and health-care professionals on the timing of deinfibulation surgery and NHS service provision. Methods: This was a qualitative study informed by the Sound of Silence framework. This framework is useful for researching sensitive issues and the health-care needs of marginalised populations. A total of 101 interviews with 44 survivors, 13 men and 44 health-care professionals were conducted, supplemented by two workshops with affected communities (participants, n = 10) and one workshop with stakeholders (participants, n = 30). Data were analysed using a hybrid framework method. Results: There was no clear consensus between groups on the optimal timing of deinfibulation. However, within groups, survivors expressed a preference for deinfibulation pre pregnancy; health-care professionals preferred antenatal deinfibulation, with the caveat that it should be the survivor's choice. There was no consensus among men. There was agreement that deinfibulation should take place in a hospital setting and be undertaken by a suitable health-care professional. Decision-making around deinfibulation was complex. Deficiencies in professionals' awareness, knowledge and understanding resulted in impacts on the provision of appropriate care. Although there were examples of good practice and positive care interactions, in general, service provision was opaque and remains suboptimal, with deficiencies most notable in mental health. Deinfibulation reportedly helps to mitigate some of the impacts of female genital mutilation. Interactions between survivors and health-care professionals were disproportionately framed around the law. The way in which services are planned and provided often silences the perspectives and preferences of survivors and their families. Limitations: Only a minority of the interviews were conducted in a language other than English, and the recruitment of survivors was predominantly through maternity settings, which meant that some voices may not have been heard. The sample of men was relatively small, limiting interpretation. Conclusions: In general, service provision remains suboptimal and can silence the perspectives and preferences of survivors. Deinfibulation services need to be widely advertised and information should highlight that the procedure will be carried out in hospital by suitable health-care professionals and that a range of time points will be offered to facilitate choice. Future services should be developed with survivors to ensure that they are clinically and culturally appropriate. Guidelines should be updated to better reflect the needs of survivors and to ensure consistency in service provision. Future work: Research is needed to (1) map female genital mutilation service provision; (2) develop and test effective education to address deficits in awareness and knowledge for affected communities and health-care professionals; and (3) develop, monitor and evaluate clinically and culturally competent female genital mutilation services. Trial registration: Current Controlled Trials ISRCTN14710507. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 27, No. 3. See the NIHR Journals Library website for further project information.

Female genital mutilation (or cutting) involves changing or removing parts of a girl's or woman's genitalia when there is no medical reason to do so. Many women and girls who have been cut live in the UK, where female genital mutilation is illegal. Some girls and women who have been cut experience problems in getting pregnant and having their baby. There are four types of cutting. Type 3 involves cutting and sewing together the genitalia, leaving only a small hole. Women and girls with type 3 mutilation can have a small operation to open their vagina. We do not know when the best time is to have this operation. We would also like to know more about how NHS female genital mutilation services can best help women. To answer these questions, we talked to 141 people, who were women who have been cut, men and health-care professionals. They told us that there is no ideal time to have the operation. Women who have been cut would like the operation before they get pregnant, but health-care professionals would like women to have it during their pregnancy. Men were not sure when it should happen. They all agreed that the operation should take place in a hospital and be carried out by a skilled professional. The way that we support women and men could be better and we need to improve the help that is offered. Sometimes women and men did not know where to go for help or how to ask for help. Women, men and health-care professionals sometimes found it hard to talk about cutting. Some health professionals did not have the right skills to undertake the operation. They told us that they need more training and clearer guidance to ensure that women feel cared for and safe.

Enhancing the health of NHS staff: eTHOS - protocol for a randomised controlled pilot trial of an employee health screening clinic for NHS staff to reduce absenteeism and presenteeism, compared with usual care.

BACKGROUND: Staff absenteeism and presenteeism incur high costs to the NHS and are associated with adverse health outcomes. The main causes are musculoskeletal complaints and mental ill-health, which are potentially modifiable, and cardiovascular risk factors are also common. We will test the feasibility of an RCT to evaluate the clinical and cost-effectiveness of an employee health screening clinic on reducing sickness absenteeism and presenteeism. METHODS: This is an individually randomised controlled pilot trial aiming to recruit 480 participants. All previously unscreened employees from four hospitals within three UK NHS hospital Trusts will be eligible. Those randomised to the intervention arm will be invited to attend an employee health screening clinic consisting of a screening assessment for musculoskeletal (STarT MSK and STarT Back), mental (PHQ-9 and GAD-7) and cardiovascular (NHS Health Check if aged ≥ 40, lifestyle check if < 40 years) health. Screen positives will be given advice and/or referral to recommended services. Those randomised to the control arm will receive usual care. Participants will complete a questionnaire at baseline and 26 weeks; anonymised absenteeism and staff demographics will also be collected from personnel records. The co-primary outcomes are as follows: recruitment, referrals and uptake of recommended services in the intervention arm. Secondary outcomes include the following: results of screening assessments, uptake of individual referrals, reported changes in health behaviours, acceptability and feasibility of intervention, indication of contamination and costs. Outcomes related to the definitive trial include self-reported and employee records of absenteeism with reasons. Process evaluation to inform a future trial includes interviews with participants, intervention delivery staff and service providers receiving referrals. Analyses will include presentation of descriptive statistics, framework analysis for qualitative data and costs and consequences presented for health economics. DISCUSSION: The study will provide data to inform the design of a definitive RCT which aims to find an effective and cost-effective method of reducing absenteeism and presenteeism amongst NHS staff. The feasibility study will test trial procedures, and process outcomes, including the success of strategies for including underserved groups, and provide information and data to help inform the design and sample size for a definitive trial. TRIAL REGISTRATION: ISRCTN reference number 10237475 .

Real-time remote outpatient consultations in secondary and tertiary care: A systematic review of inequalities in invitation and uptake.

BACKGROUND: Health policies in most high income countries increasingly recommend provision of routine outpatient care via remote (video and/or telephone) appointments, especially due to the pandemic. This is thought to improve access to care and promote efficiency within resource-constrained health services. There is limited evidence about the impact on existing inequalities in the invitation and uptake of health services when remote outpatient care is offered. AIM: To systematically review the evidence on the offer and/or uptake of real-time remote outpatient consultations in secondary and tertiary care, assessed according to key sociodemographic characteristics. METHODS: Seven electronic bibliographic databases were searched for studies reporting the proportion of patients with key characteristics (following PROGRESS Plus criteria) who were offered and/or accepted real-time remote outpatient consultation for any chronic condition. Comparison groups included usual care (face-to-face), another intervention, or offer/uptake within a comparable time period. Study processes were undertaken in duplicate. Data are reported narratively. RESULTS: Twenty-nine studies were included. Uptake of video consultations ranged from 5% to 78% and telephone consultations from 12% to 78%. Patients aged over 65, with lower educational attainment, on lower household incomes and without English as a first language were least likely to have a remote consultation. Females were generally more likely to have remote consultations than males. Non-white ethnicities were less likely to use remote consultations but where they did, were significantly more likely to choose telephone over video appointments (p<0.001). CONCLUSIONS: Offering remote consultations may perpetuate or exacerbate existing health inequalities in access to healthcare. More research is needed on current health disparities by sociodemographic characteristics and to explore what works well for different patient groups and why so that processes can be designed to ameliorate these health disparities. TRIAL REGISTRATION: PROSPERO registration no: CRD42021241791.

Hidden healthcare populations: using intersectionality to theorise the experiences of LGBT+ people in Nigeria, Africa.

Minority population groups are often excluded or marginalised within health systems and in health research and policy. This article argues that theories of intersectionality can help us to understand these issues and develops the concept of 'hidden healthcare populations' - using the case of people who identify as Lesbian, Gay, Bisexual, Transgender Plus (LGBT+) in Nigeria, in sub-Saharan Africa. The findings present original qualitative data from a seldom heard population group about instances of abuse, rejection and marginalisation by healthcare providers working in public and private healthcare facilities, and the attempts of LGBT+ people to resist and survive in that context. We extend theoretical understandings of intersectionality in global public health and explore how the concept relates to the social determinants of health. The article has significant implications for policy and healthcare education and responds to a call from the World Health Organisation to generate context-specific data to guide interventions targeted at minority population groups. Additionally, our discussion has wider significance because it highlights the Western-centric nature of much theory in health policy - and offers analysis and reinterpretation that incorporates queer, postcolonial, African perspectives.

Accuracy and cost-effectiveness of different screening strategies for identifying undiagnosed COPD among primary care patients (≥40 years) in China: a cross-sectional screening test accuracy study: findings from the Breathe Well group.

OBJECTIVES: To examine the accuracy and cost-effectiveness of various chronic obstructive pulmonary disease (COPD) screening tests and combinations within a Chinese primary care population. DESIGN: Screening test accuracy study. SETTING: Urban and rural community health centres in four municipalities of China: Beijing (north), Chengdu (southwest), Guangzhou (south) and Shenyang (northeast). PARTICIPANTS: Community residents aged 40 years and above who attended community health centres for any reason were invited to participate. 2445 participants (mean age 59.8 (SD 9.6) years, 39.1% (n=956) male) completed the study (February-December 2019), 68.9% (n=1684) were never-smokers and 3.6% (n=88) had an existing COPD diagnosis. 13.7% (n=333) of participants had spirometry-confirmed airflow obstruction. INTERVENTIONS: Participants completed six index tests (screening questionnaires (COPD Diagnostic Questionnaire, COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE), Chinese Symptom-Based Questionnaire (C-SBQ), COPD-SQ), microspirometry (COPD-6), peak flow (model of peak flow meters used in the study (USPE)) and the reference test (ndd Easy On-PC). PRIMARY AND SECONDARY OUTCOMES: Cases were defined as those with forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) below the lower limit of normal (LLN-GLI) on the reference test. Performance of individual screening tests and their combinations was evaluated, with cost-effectiveness analyses providing cost per additional true case detected. RESULTS: Airflow measurement devices (sensitivities 64.9% (95% CI 59.5% to 70.0%) and 67.3% (95% CI 61.9% to 72.3%), specificities 89.7% (95% CI 88.4% to 91.0%) and 82.6% (95% CI 80.9% to 84.2%) for microspirometry and peak flow, respectively) generally performed better than questionnaires, the most accurate of which was C-SBQ (sensitivity 63.1% (95% CI 57.6% to 68.3%) specificity 74.2% (95% CI 72.3% to 76.1%)). The combination of C-SBQ and microspirometry used in parallel maximised sensitivity (81.4%) (95% CI 76.8% to 85.4%) and had specificity of 68.0% (95% CI 66.0% to 70.0%), with an incremental cost-effectiveness ratio of £64.20 (CNY385) per additional case detected compared with peak flow. CONCLUSIONS: Simple screening tests to identify undiagnosed COPD within the primary care setting in China is possible, and a combination of C-SBQ and microspirometry is the most sensitive and cost-effective. Further work is required to explore optimal cut-points and effectiveness of programme implementation. TRIAL REGISTRATION NUMBER: ISRCTN13357135.

Practice nurse-supported weight self-management delivered within the national child immunisation programme for postnatal women: a feasibility cluster RCT.

BACKGROUND: Pregnancy is a high-risk time for excessive weight gain. The rising prevalence of obesity in women, combined with excess weight gain during pregnancy, means that there are more women with obesity in the postnatal period. This can have adverse health consequences for women in later life and increases the health risks during subsequent pregnancies. OBJECTIVE: The primary aim was to produce evidence of whether or not a Phase III trial of a brief weight management intervention, in which postnatal women are encouraged by practice nurses as part of the national child immunisation programme to self-monitor their weight and use an online weight management programme, is feasible and acceptable. DESIGN: The research involved a cluster randomised controlled feasibility trial and two semistructured interview studies with intervention participants and practice nurses who delivered the intervention. Trial data were collected at baseline and 3 months later. The interview studies took place after trial follow-up. SETTING: The trial took place in Birmingham, UK. PARTICIPANTS: Twenty-eight postnatal women who were overweight/obese were recruited via Birmingham Women's Hospital or general practices. Nine intervention participants and seven nurses were interviewed. INTERVENTIONS: The intervention was delivered in the context of the national child immunisation programme. The intervention group were offered brief support that encouraged self-management of weight when they attended their practice to have their child immunised at 2, 3 and 4 months of age. The intervention involved the provision of motivation and support by nurses to encourage participants to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. The role of the nurse was to provide regular external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a record card in their child's health record ('red book') or using the online programme. The behavioural goal was for women to lose 0.5-1 kg per week. The usual-care group received a healthy lifestyle leaflet. MAIN OUTCOME MEASURES: The primary outcome was the feasibility of a Phase III trial to test the effectiveness of the intervention, as assessed against three traffic-light stop-go criteria (recruitment, adherence to regular self-weighing and registration with an online weight management programme). RESULTS: The traffic-light criteria results were red for recruitment (28/80, 35% of target), amber for registration with the online weight loss programme (9/16, 56%) and green for adherence to weekly self-weighing (10/16, 63%). Nurses delivered the intervention with high fidelity. In the qualitative studies, participants indicated that the intervention was acceptable to them and they welcomed receiving support to lose weight at their child immunisation appointments. Although nurses raised some caveats to implementation, they felt that the intervention was easy to deliver and that it would motivate postnatal women to lose weight. LIMITATIONS: Fewer participants were recruited than planned. CONCLUSIONS: Although women and practice nurses responded well to the intervention and adherence to self-weighing was high, recruitment was challenging and there is scope to improve engagement with the intervention. FUTURE WORK: Future research should focus on investigating other methods of recruitment and, thereafter, testing the effectiveness of the intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12209332. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 49. See the NIHR Journals Library website for further project information.

After giving birth, many women find it hard to lose the weight that they gained during pregnancy. Research so far has focused on testing intensive weight loss programmes that cannot be given to all women who give birth because it would be too expensive. Instead, we tested a brief intervention delivered by practice nurses to mothers when they attended their practice to have their child immunised. We completed a study to test how well our recruitment methods worked, how well the intervention could be delivered by nurses during immunisation appointments and whether or not women followed the intervention. Women who were overweight/obese and had given birth at least 4 weeks previously were invited to participate. Women interested in participating were visited at home at the start and end of the study to measure their weight and to collect information about them. Participants were allocated to the intervention group or to a comparison group based on which practice they attended. For the intervention group, nurses encouraged women to monitor their weight weekly and record this on a record card in their child's health record (the 'red book') when they attended the practice to have their child immunised when their child was 2, 3 and 4 months old. Women were encouraged to use an online weight loss programme to help them lose weight and were advised to aim to lose 0.5­1 kg per week. Those in the comparison group were given a healthy living leaflet. Women and nurses were interviewed about their experiences of the study. Recruiting women to the study was difficult; however, women who did participate mostly followed the intervention well and weighed themselves weekly. Nurses liked the intervention; they felt that it could be incorporated into immunisation appointments and suggested some ideas for improvement. The study appeared feasible and acceptable, but better ways of recruiting women are needed.

The experiences of postnatal women and healthcare professionals of a brief weight management intervention embedded within the national child immunisation programme.

BACKGROUND: After childbirth, most women do not lose the extra weight gained during pregnancy. This is important because postnatal weight retention contributes to the development of obesity in later life. Research shows that postnatal women living with overweight would prefer to weigh less, are interested in implementing weight loss strategies, and would like support. Without evidence for the benefit of weight management interventions during pregnancy, postnatal interventions are increasingly important. Research has focused on intensive weight loss programmes, which cannot be offered to all postnatal women. Instead, we investigated the feasibility of a brief intervention delivered to postnatal women at child immunisation appointments. This qualitative study explored the views of women who received the intervention and healthcare professionals who delivered it. METHODS: The intervention was delivered within the context of the national child immunisation programme. The intervention group were offered brief support encouraging self-management of weight when attending general practices to have their child immunised at two, three and four months of age. The intervention involved motivation and support from practice nurses to encourage women to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. Nurses provided external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a weight record card. Nested within this trial, semi-structured interviews explored the experiences of postnatal women who received the intervention and nurses who delivered it. RESULTS: The intervention was generally acceptable to participants and child immunisation appointments considered a suitable intervention setting. Nurses were hesitant to discuss maternal weight, viewing the postnatal period as a vulnerable time. Whilst some caveats to implementation were discussed by nurses, they felt the intervention was easy to deliver and would motivate postnatal women to lose weight. CONCLUSIONS: Participants were keen to lose weight after childbirth. Overall, they reported that the intervention was acceptable, convenient, and, appreciated support to lose weight after childbirth. Although nurses, expressed concerns about raising the topic of weight in the early postnatal period, they felt the intervention was easy to deliver and would help to motivate women to lose weight.

Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT.

BACKGROUND: There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. OBJECTIVES: To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. DESIGN: A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). SETTING: Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. PARTICIPANTS: There were 450 participants aged 16-74 years, with a body mass index of 30-40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. INTERVENTION: e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven 'steps to health'. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. PRIMARY OUTCOME MEASURE: Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. SECONDARY OUTCOMES: Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. RESULTS: Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval -2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval -£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. LIMITATIONS: A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. FUTURE WORK: The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. CONCLUSIONS: Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15644451. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.

When health-care professionals refer patients with chronic conditions to an exercise referral scheme, the effects on long-term increases in physical activity are limited. We therefore developed the e-coachER support package to add to usual exercise referral schemes and to prompt the use of skills such as self-monitoring and goal-setting. This package was also intended to empower patients to increase their levels of physical activity long term. The seven-step programme was delivered online (via an interactive website). As part of the package, we mailed participants a guide for accessing the online programme, a pedometer and a fridge magnet with a notepad to record physical activity. We aimed to determine whether or not adding the e-coachER support to usual exercise referral schemes resulted in lasting changes in moderate and vigorous physical activity and whether or not it offers good value for money compared with exercise referral schemes alone. A total of 450 inactive individuals were recruited across Plymouth, Birmingham and Glasgow and were referred to an exercise referral scheme for the following participant-reported main reasons: weight loss (50%), low mood (19%), osteoarthritis (12%), type 2 diabetes (10%) and high blood pressure (8%). Half of the individuals were given access to the e-coachER support and the other half were not. All individuals were mailed a wrist-worn movement sensor (accelerometer) to wear for 1 week and a survey to assess other outcomes at the start of the study as well as at 4 and 12 months post randomisation. At the start of the study, the participants were inactive and most had multiple health conditions. The participants had an average body mass index of 33 kg/m² and an average age of 50 years. Most (83%) were white. Participants with access to e-coachER support were only slightly more active at 12 months than those who did not have access, but we cannot be confident in the findings because we had data from fewer participants than planned. The lack of a clear effect may have been as a result of around one-third of participants not accessing the website, but otherwise there was reasonable engagement. The provision of the e-coachER support package led to an additional cost of £439 per participant over a 12-month period.

The ABA intervention for improving breastfeeding initiation and continuation: Feasibility study results.

The UK has low breastfeeding rates, with socioeconomic disparities. The Assets-based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours. ABA is underpinned by the behaviour change wheel and offers an assets-based approach focusing on positive capabilities of individuals and communities, including use of a Genogram. This study aimed to investigate feasibility of intervention delivery within a randomised controlled trial (RCT). Nulliparous women ≥16 years, (n = 103) from two English sites were recruited and randomised to either intervention or usual care. The intervention - delivered through face-to-face, telephone and text message by trained Infant Feeding Helpers (IFHs) - ran from 30-weeks' gestation until 5-months postnatal. Outcomes included recruitment rates and follow-up at 3-days, 8-weeks and 6-months postnatal, with collection of future full trial outcomes via questionnaires. A mixed-methods process evaluation included qualitative interviews with 30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings. This study successfully recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3-days, 8-weeks and 6-months respectively. Breastfeeding at 8-weeks was obtained for 95.1% using routine data for non-responders. It was possible to recruit and train peer supporters to deliver the intervention with adequate fidelity. The ABA intervention was acceptable to women, IFHs and maternity services. There was minimal contamination and no evidence of intervention-related harm. In conclusion, the intervention is feasible to deliver within an RCT, and a definitive trial required.

Cultural adaptation of an existing children's weight management programme: the CHANGE intervention and feasibility RCT.

BACKGROUND: Excess weight in children is a continuing health issue. Community-based children's weight management programmes have had some effect in promoting weight loss. Families from minority ethnic communities are less likely to complete these programmes but, to date, no programmes have been culturally adapted to address this. OBJECTIVES: We aimed to (1) culturally adapt an existing weight management programme for children aged 4-11 years and their families to make it more suited to Pakistani and Bangladeshi communities but inclusive of all families and (2) evaluate the adapted programme to assess its feasibility and acceptability, as well as the feasibility of methods, for a future full-scale trial. DESIGN: In phase I, a cultural adaptation of a programme that was informed by formative research and guided by two theoretical frameworks was undertaken and in phase II this adapted programme was delivered in a cluster-randomised feasibility study (for which the clusters were the standard and adapted children's weight management programmes). SETTING: Birmingham: a large, ethnically diverse UK city. PARTICIPANTS: In phase I, Pakistani and Bangladeshi parents of children with excess weight, and, in phase II, children aged 4-11 years who have excess weight and their families. INTERVENTIONS: A culturally adapted children's weight management programme, comprising six sessions, which was delivered to children and parents, targeting diet and physical activity and incorporating behaviour change techniques, was developed in phase I and delivered in the intervention arm to 16 groups in phase II. The eight groups in the comparator arm received the standard (unadapted) children's weight management programme. MAIN OUTCOME MEASURES: The primary outcome was the proportion of Pakistani and Bangladeshi families completing (attending ≥ 60% of) the adapted programme. Secondary outcomes included the proportion of all families completing the adapted programme, the feasibility of delivery of the programme, the programme's acceptability to participants, the feasibility of trial processes and the feasibility of collection of outcome and cost data. RESULTS: The proportion of Pakistani and Bangladeshi families and all families completing the adapted programme was 78.8% [95% confidence interval (CI) 64.8% to 88.2%] and 76.3% (95% CI 67.0% to 83.6%), respectively. The programme was feasible to deliver with some refinements and was well received. Ninety-two families participated in outcome data collection. Data collection was mostly feasible, but participant burden was high. Data collection on the cost of programme delivery was feasible, but costs to families were more challenging to capture. There was high attrition over the 6-month follow-up period (35%) and differential attrition in the two study arms (29% and 52% in the intervention and comparator arms, respectively). LIMITATIONS: The study was not designed to address the issue of low participant uptake of children's weight management programmes. The design of a future trial may include individual randomisation and a 'minimal intervention' arm, the acceptability of which has not been evaluated in this study. CONCLUSIONS: The theoretically informed, culturally adapted children's weight management programme was highly acceptable to children and families of all ethnicities. Consideration should be given to a future trial to evaluate clinical effectiveness and cost-effectiveness of the adapted programme, but the design of a future trial would need to address the logistics of data collection, participant burden and study attrition. TRIAL REGISTRATION: Current Controlled Trials ISRCTN81798055. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 33. See the NIHR Journals Library website for further project information. Kate Jolly is part-funded by the Collaboration for Leadership in Applied Health Research and Care West Midlands.

Many programmes have been designed for children with excess weight and their families to help them try and lose weight. Often families start going to these programmes but do not complete them. This has been noted to be an issue in families from ethnic minority communities. We aimed to adapt an existing programme for families of primary school children with excess weight to make it more suitable for Pakistani and Bangladeshi families. We asked parents from these communities who had experience of the existing programme what they thought about it and what they would like to change. We used this information to help us adapt the existing programme. We also aimed to make the programme acceptable to families of all ethnicities. We then aimed to (1) test delivery of the adapted programme, (2) see whether or not it was acceptable to Pakistani and Bangladeshi families and families of other ethnicities and (3) test methods to be used in a future research study to determine whether or not the adapted programme helps children to lose weight and provides value for money. We asked parents and children who attended and the staff delivering the new programme for their views. A panel of Pakistani and Bangladeshi parents helped us to plan our study methods. The programme was successfully delivered and the parents, children and staff all enjoyed it. Overall, 76% of families from all ethnic backgrounds who started attending the programme completed it. This was substantially higher than the 58% of families who completed the standard (unadapted) programme. We identified several issues that we would need to take into account when designing a future study. These include making sure that the families taking part are not overburdened and that we take steps to make sure that as many families as possible are followed up until the end of the study.

Model-based evaluation of the long-term cost-effectiveness of systematic case-finding for COPD in primary care.

INTRODUCTION: 'One-off' systematic case-finding for COPD using a respiratory screening questionnaire is more effective and cost-effective than routine care at identifying new cases. However, it is not known whether early diagnosis and treatment is beneficial in the longer term. We estimated the long-term cost-effectiveness of a regular case-finding programme in primary care. METHODS: A Markov decision analytic model was developed to compare the cost-effectiveness of a 3-yearly systematic case-finding programme targeted to ever smokers aged ≥50 years with the current routine diagnostic process in UK primary care. Patient-level data on case-finding pathways was obtained from a large randomised controlled trial. Information on the natural history of COPD and treatment effects was obtained from a linked COPD cohort, UK primary care database and published literature. The discounted lifetime cost per quality-adjusted life-year (QALY) gained was calculated from a health service perspective. RESULTS: The incremental cost-effectiveness ratio of systematic case-finding versus current care was £16 596 per additional QALY gained, with a 78% probability of cost-effectiveness at a £20 000 per QALY willingness-to-pay threshold. The base case result was robust to multiple one-way sensitivity analyses. The main drivers were response rate to the initial screening questionnaire and attendance rate for the confirmatory spirometry test. DISCUSSION: Regular systematic case-finding for COPD using a screening questionnaire in primary care is likely to be cost-effective in the long-term despite uncertainties in treatment effectiveness. Further knowledge of the natural history of case-found patients and the effectiveness of their management will improve confidence to implement such an approach.

Incorporating Household Spillovers in Cost Utility Analysis: A Case Study Using Behavior Change in COPD.

OBJECTIVES: It is important to capture all health effects of interventions in cost-utility analyses conducted under a societal or healthcare perspective. However, this is rarely done. Household spillovers (health effects on patients' other household members) may be particularly likely in the context of technologies and interventions to change behaviors that are interdependent in the household. Our objective was to prospectively collect outcome data from household members and illustrate how these can be included in a cost-utility analysis of a behavior change intervention in chronic obstructive pulmonary disease (COPD). METHODS: Data were collected from patients' household members (n = 153) alongside a randomized controlled trial of a COPD self-management intervention. The impact of the intervention on household members' EQ-5D-5L scores (primary outcome), was evaluated. Analyses were then carried out to estimate household members' quality-adjusted life-years (QALYs) and assess the impact of including these QALYs on cost-effectiveness. RESULTS: The intervention had a negligible spillover on household members' EQ-5D-5L scores (-0.007; p = .75). There were also no statistically significant spillovers at the 5 percent level in household member secondary outcomes. In the base-case model, the inclusion of household member QALYs in the incremental cost-effectiveness ratio (ICER) denominator marginally increased the ICER from GBP 10,271 (EUR 13,146) to GBP 10,991 (EUR 14,068) per QALY gained. CONCLUSIONS: This study demonstrates it is feasible to prospectively collect and include household members' outcome data in cost utility analysis, although the study highlighted several methodological issues. In this case, the intervention did not impact significantly on household members' health or health behaviors, but inclusion of household spillovers may make a difference in other contexts.

The cost effectiveness of REACH-HF and home-based cardiac rehabilitation compared with the usual medical care for heart failure with reduced ejection fraction: A decision model-based analysis.

BACKGROUND: The REACH-HF (Rehabilitation EnAblement in CHronic Heart Failure) trial found that the REACH-HF home-based cardiac rehabilitation intervention resulted in a clinically meaningful improvement in disease-specific health-related quality of life in patients with reduced ejection fraction heart failure (HFrEF). The aims of this study were to assess the long-term cost-effectiveness of the addition of REACH-HF intervention or home-based cardiac rehabilitation to usual care compared with usual care alone in patients with HFrEF. DESIGN AND METHODS: A Markov model was developed using a patient lifetime horizon and integrating evidence from the REACH-HF trial, a systematic review/meta-analysis of randomised trials, estimates of mortality and hospital admission and UK costs at 2015/2016 prices. Taking a UK National Health and Personal Social Services perspective we report the incremental cost per quality-adjusted life-year (QALY) gained, assessing uncertainty using probabilistic and deterministic sensitivity analyses. RESULTS: In base case analysis, the REACH-HF intervention was associated with per patient mean QALY gain of 0.23 and an increased mean cost of £400 compared with usual care, resulting in a cost per QALY gained of £1720. Probabilistic sensitivity analysis indicated a 78% probability that REACH-HF is cost effective versus usual care at a threshold of £20,000 per QALY gained. Results were similar for home-based cardiac rehabilitation versus usual care. Sensitivity analyses indicate the findings to be robust to changes in model assumptions and parameters. CONCLUSIONS: Our cost-utility analyses indicate that the addition of the REACH-HF intervention and home-based cardiac rehabilitation programmes are likely to be cost-effective treatment options versus usual care alone in patients with HFrEF.

Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.

BACKGROUND: The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years. METHODS: Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years. RESULTS: Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice. CONCLUSIONS: A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m2 reduces healthcare costs and improves health more than advising weight loss.

The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial.

BACKGROUND: Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low. DESIGN AND METHODS: The aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone. RESULTS: The study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of -5.7 points (95% confidence interval -10.6 to -0.7) in favour of the REACH-HF intervention group ( p = 0.025). With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant. CONCLUSIONS: The novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.