A national evaluation of Project Cautioning And Relationship Abuse ('CARA') awareness raising workshops for first time offenders of domestic violence and abuse: protocol for a concurrent mixed-methods evaluation design.

Introduction: Interventions related to the perpetration of Domestic Violence and Abuse (DVA) have gained traction over the past several years, in response to dissatisfaction by victims, an inadequate response from the criminal justice system, increased demand on police time and a lack of rehabilitative responses to the perpetration of domestic abuse. The CARA model is a conditional diversionary caution, offered by police for first time offenders of 'standard' or 'medium risk' domestic abuse, that engages perpetrators in awareness raising workshops and signposts them onto further services. Although quasi-experimental studies have indicated that CARA showed promise at reducing reoffending, the CARA model has yet to be evaluated nationally and there is no qualitative evidence related to understanding or learning about the lived experience of perpetrators and victims as they engage with the intervention. Methods: Using a concurrent pragmatic mixed methods design model we will undertake a national evaluation of CARA by triangulating quantitative data from up to nine police forces, and routine data from service providers, with qualitative data from workshop participants, victims and professional stakeholders to: (1) understand the long-term impact of CARA implementation on DVA reoffending and engagement with services and (2) explore perceptions and experiences of both delivery and receipt of CARA. We will use qualitative methodologies that draw on interpretivist and phenomenological perspectives, as well as quantitative methodologies using interrupted time series models, Poisson regression models, Geo mapping and a cost benefits analysis. Ethics and dissemination: Where currently the CARA model is being introduced as a national option for standard risk first-time offending, we will engage with policymakers and academics nationally in the live debate on its effectiveness and suitability during its roll-out. Ethical approval was approved by the University of Southampton on the 1 st June 2022 (Ref: ERGO ID: 71818.A1).

Over 2 million incidents relating to domestic violence and abuse (DVA) were reported to the police in England and Wales in the year leading up to March 2023. DVA leads to poor health and social outcomes for both victims and perpetrators. Consultation suggests that the system is struggling to support victims of domestic abuse and prevent repeat offending. Hampshire were keen to test an intervention that would improve outcomes for victims and their families. They developed a conditional diversionary caution called CARA offered by the police to those who have committed a crime related to domestic violence and abuse for the first time, where the incident was considered as 'standard' according to a domestic abuse risk checklist and professional judgement. Offenders are required to undertake two mandatory workshops that increase awareness of their behaviour and the safety of partners and children. They are further signposted onto services that support improvements in their health and social care needs that may contribute towards their offending behaviour. CARA cautions are now being offered across several regions. However, we don't understand how offenders and victims feel about this intervention and we don't know whether engagement in CARA leads to change in abusive behaviours over a longer period, such as 12 months after the intervention. We will interview offenders, victims and those involved in delivering CARA. We will aim to understand what worked and what didn't work. We will look at what happens to offenders and the costs associated with this and examine whether there may be any differences in outcomes for those of different ethnic backgrounds or from different areas. To develop this plan, we consulted with both victim and offender groups. We will consult with both groups to improve our methodology, data collection and how we share our results with the public.

Making Every Contact Count: health professionals' experiences of integrating conversations about Snacktivity to promote physical activity within routine consultations - a qualitative study.

OBJECTIVE: Helping people to change their health behaviours is becoming a greater feature within the role of health professionals, including through whole system initiatives such as Making Every Contact Count. Health services provide an ideal setting to routinely promote health behaviours, including physical activity. Snacktivity is a novel approach that promotes small bouts of physical activity (activity snacks) throughout the day. This study explored health professionals' initial experiences of delivering a Snacktivity intervention to promote physical activity within routine health consultations. A further aim was to investigate health professionals' ability/fidelity in delivering the Snacktivity intervention to their patients. DESIGN: Semistructured interviews (n=11) and audio recording of consultations (n=46). SETTING AND PARTICIPANTS: Healthcare professionals from a variety of specialisms who delivered the Snacktivity intervention within patient consultations. RESULTS: Analyses revealed two higher-level themes of interest: (1) health professionals' conceptualisation of Snacktivity (subthemes: observations/reflections about patients' understanding, engagement and enthusiasm for delivering the Snacktivity intervention) and (2) health professionals' understanding of Snacktivity and experience in delivering the intervention (subthemes: delivering Snacktivity; limitations, challenges and possible improvements). Consultation audio recordings demonstrated health professionals delivered the Snacktivity intervention with high levels of fidelity. Health professionals were proficient and supportive of delivering the Snacktivity intervention within consultations although practical barriers to implementation such as time constraints were raised, and confidence in doing so was mixed. CONCLUSIONS: Health professionals were proficient and supportive of delivering the Snacktivity intervention within consultations. The primary barrier to implementation was the time to deliver it, however, gaining greater experience in the intervention and improving behaviour change counselling skills may reduce this barrier. TRIAL REGISTRATION NUMBER: ISRCTN64851242.

Emergency Maternal Hospital Readmissions in the Postnatal Period: A Population-Based Cohort Study.

OBJECTIVE: To determine the change in English emergency postnatal maternal readmissions 2007-2017 (pre-COVID-19) and the association with maternal demographics, obstetric risk factors and postnatal length of stay (LOS). DESIGN: National cohort study. SETTING: All English National Health Service hospitals. POPULATION: A total of 6 192 140 women who gave birth in English NHS hospitals from April 2007 to March 2017. METHODS: Statistical analysis using birth and readmission data from routinely collected National Hospital Episode Statistics (HES) database. MAIN OUTCOME MEASURES: Rate of emergency postnatal maternal hospital readmissions related to pregnancy or giving birth within 42 days postpartum, readmission diagnoses and association with maternal demographic factors, obstetric risk factors and postnatal LOS. RESULTS: A significant increase in the rate of emergency postnatal maternal readmissions from 15 128 (2.5%) in 2008 to 20 734 (3.4%) in 2016 (aOR 1.32, 95% CI 1.28-1.37) was found. Risk factors for readmission included minoritised ethnicity (particularly Black or Black British ethnicity: aOR 1.35, 95% CI 1.31-1.39); age < 20 years (aOR 1.09, 95% CI 1.05-1.12); 40+ years (aOR 1.07, 95% CI 1.03-1.10); primiparity (multiparity: aOR 0.92, 95% CI 0.91-0.93); nonspontaneous vaginal birth modes (emergency caesarean: aOR 1.86, 95% CI 1.82-1.90); longer LOS (4+ vs. 0 days: aOR 1.58, 95% CI 1.53-1.64); and obstetric risk factors including urinary retention (aOR 2.34, 95% CI 2.06-2.53) and postnatal wound breakdown (aOR 2.01, 95% CI 1.83-2.21). CONCLUSIONS: The concerning rise in emergency maternal readmissions should be addressed from a health inequalities perspective focusing on women from minoritised ethnic groups; those <20 and ≥40 years old; primiparous women; and those with specified obstetric risk factors.

Health screening clinic to reduce absenteeism and presenteeism among NHS Staff: eTHOS a pilot RCT.

Background: Staff sickness absenteeism and presenteeism (attending work while unwell) incur high costs to the NHS, are associated with adverse patient outcomes and have been exacerbated by the COVID-19 pandemic. The main causes are mental and musculoskeletal ill health with cardiovascular risk factors common. Objectives: To undertake a feasibility study to inform the design of a definitive randomised controlled trial of the effectiveness and cost effectiveness of a health screening clinic in reducing absenteeism and presenteeism amongst the National Health Service staff. Design: Individually randomised controlled pilot trial of the staff health screening clinic compared with usual care, including qualitative process evaluation. Setting: Four United Kingdom National Health Service hospitals from two urban and one rural Trust. Participants: Hospital employees who had not previously attended a pilot health screening clinic at Queen Elizabeth Hospital Birmingham. Interventions: Nurse-led staff health screening clinic with assessment for musculoskeletal health (STarT musculoskeletal; STarT Back), mental health (patient health questionnaire-9; generalised anxiety disorder questionnaire-7) and cardiovascular health (NHS health check if aged ≥ 40, lifestyle check if < 40 years). Screen positives were given advice and/or referral to services according to UK guidelines. Main outcome measures: The three coprimary outcomes were recruitment, referrals and attendance at referred services. These formed stop/go criteria when considered together. If any of these values fell into the 'amber' zone, then the trial would require modifications to proceed to full trial. If all were 'red', then the trial would be considered unfeasible. Secondary outcomes collected to inform the design of the definitive randomised controlled trial included: generalisability, screening results, individual referrals required/attended, health behaviours, acceptability/feasibility of processes, indication of contamination and costs. Outcomes related to the definitive trial included self-reported and employee records of absenteeism with reasons. Process evaluation included interviews with participants, intervention delivery staff and service providers. Descriptive statistics were presented and framework analysis conducted for qualitative data. Due to the COVID-19 pandemic, outcomes were captured up to 6 months only. Results: Three hundred and fourteen participants were consented (236 randomised), the majority within 4 months. The recruitment rate of 314/3788 (8.3%) invited was lower than anticipated (meeting red for this criteria), but screening identified that 57/118 (48.3%) randomised were eligible for referral to either general practitioner (81%), mental health (18%) and/or physiotherapy services (30%) (green). Early trial closure precluded determination of attendance at referrals, but 31.6% of those eligible reported intending to attend (amber). Fifty-one of the 80 (63.75%) planned qualitative interviews were conducted. Quantitative and qualitative data from the process evaluation indicated that the electronic database-driven screening intervention and data collection were efficient, promoting good fidelity, although needing more personalisation at times. Recruitment and delivery of the full trial would benefit from a longer development period to better understand local context, develop effective strategies for engaging with underserved groups, provide longer training and better integration with referral services. Delivery of the pilot was limited by the impact of COVID-19 with staff redeployment, COVID-research prioritisation and reduced availability of community and in-house referral services. While recruitment was rapid, it did not fully represent ethnic minority groups and truncated follow-up due to funding limitations prevented full assessment of attendance at recommended services and secondary outcomes. Conclusions: There is both a clinical need (evidenced by 48% screened eligible for a referral) and perceived benefit (data from the qualitative interviews) for this National Health Service staff health screening clinic. The three stop/go criteria were red, green and amber; therefore, the Trial Oversight Committee recommended that a full-scale trial should proceed, but with modifications to adapt to local context and adopt processes to engage better with underserved communities. Trial registration: This trial is registered as ISRCTN10237475. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/42/42) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 23. See the NIHR Funding and Awards website for further award information.

Sickness absenteeism and presenteeism (attendance at work while ill, with poor work performance) are major problems in the NHS and associated with worse patient health care. The most common causes of NHS staff sickness absenteeism and presenteeism are muscular complaints and mental ill health. Poor lifestyle and illnesses associated with heart disease are also important factors. Staff health checks might improve the health of NHS staff, but no studies have included screening tests to address the most common causes of poor staff health. This pilot study tested whether it would be possible to deliver a randomised controlled trial of an NHS staff health screening clinic, where some people get the screening check and others do not (chosen at random, like flipping a coin). We used an electronic database to capture all data. Participants completed initial questionnaires either at home or at work, then attended a face-to-face screening clinic using recognised screening questionnaires and tests to detect problems with muscular, mental or heart health. We considered how NHS staff and healthcare organisations would want the screening clinic and trial to run, how a diverse range of NHS staff could best be approached, how many staff might need to be invited and what their healthcare needs would be. The study ran in four UK NHS hospitals during the COVID-19 pandemic. Two hundred and thirty-six NHS staff participated, but early trial closure due to the pandemic meant that some results were unavailable. For the primary feasibility outcomes, although recruitment rates of around 8% were lower than anticipated, half of staff screened needed referral for further health care and one-third reported intending to attend. Staff felt that the clinic addressed an important health need. The Trial Oversight Committee recommended proceeding to a full-scale trial but with modifications to address findings from the process evaluation, including ways to encourage a wider group of NHS staff to take part.

Evidence for exercise-based interventions across 45 different long-term conditions: an overview of systematic reviews.

Background: Almost half of the global population face significant challenges from long-term conditions (LTCs) resulting in substantive health and socioeconomic burden. Exercise is a potentially key intervention in effective LTC management. Methods: In this overview of systematic reviews (SRs), we searched six electronic databases from January 2000 to October 2023 for SRs assessing health outcomes (mortality, hospitalisation, exercise capacity, disability, frailty, health-related quality of life (HRQoL), and physical activity) related to exercise-based interventions in adults (aged >18 years) diagnosed with one of 45 LTCs. Methodological quality was assessed using AMSTAR-2. International Prospective Resister of Systematic Reviews (PROSPERO) ID: CRD42022319214. Findings: Forty-two SRs plus three supplementary RCTs were included, providing 990 RCTs in 936,825 people across 39 LTCs. No evidence was identified for six LTCs. Predominant outcome domains were HRQoL (82% of SRs/RCTs) and exercise capacity (66%); whereas disability, mortality, physical activity, and hospitalisation were less frequently reported (≤25%). Evidence supporting exercise-based interventions was identified in 25 LTCs, was unclear for 13 LTCs, and for one LTC suggested no effect. No SRs considered multimorbidity in the delivery of exercise. Methodological quality varied: critically-low (33%), low (26%), moderate (26%), and high (12%). Interpretation: Exercise-based interventions improve HRQoL and exercise capacity across numerous LTCs. Key evidence gaps included limited mortality and hospitalisation data and consideration of multimorbidity impact on exercise-based interventions. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).

Association of latent class analysis-derived multimorbidity clusters with adverse health outcomes in patients with multiple long-term conditions: comparative results across three UK cohorts.

Background: It remains unclear how to meaningfully classify people living with multimorbidity (multiple long-term conditions (MLTCs)), beyond counting the number of conditions. This paper aims to identify clusters of MLTCs in different age groups and associated risks of adverse health outcomes and service use. Methods: Latent class analysis was used to identify MLTCs clusters in different age groups in three cohorts: Secure Anonymised Information Linkage Databank (SAIL) (n = 1,825,289), UK Biobank (n = 502,363), and the UK Household Longitudinal Study (UKHLS) (n = 49,186). Incidence rate ratios (IRR) for MLTC clusters were computed for: all-cause mortality, hospitalisations, and general practice (GP) use over 10 years, using <2 MLTCs as reference. Information on health outcomes and service use were extracted for a ten year follow up period (between 01st Jan 2010 and 31st Dec 2019 for UK Biobank and UKHLS, and between 01st Jan 2011 and 31st Dec 2020 for SAIL). Findings: Clustering MLTCs produced largely similar results across different age groups and cohorts. MLTC clusters had distinct associations with health outcomes and service use after accounting for LTC counts, in fully adjusted models. The largest associations with mortality, hospitalisations and GP use in SAIL were observed for the "Pain+" cluster in the age-group 18-36 years (mortality IRR = 4.47, hospitalisation IRR = 1.84; GP use IRR = 2.87) and the "Hypertension, Diabetes & Heart disease" cluster in the age-group 37-54 years (mortality IRR = 4.52, hospitalisation IRR = 1.53, GP use IRR = 2.36). In UK Biobank, the "Cancer, Thyroid disease & Rheumatoid arthritis" cluster in the age group 37-54 years had the largest association with mortality (IRR = 2.47). Cardiometabolic clusters across all age groups, pain/mental health clusters in younger groups, and cancer and pulmonary related clusters in older age groups had higher risk for all outcomes. In UKHLS, MLTC clusters were not significantly associated with higher risk of adverse outcomes, except for the hospitalisation in the age-group 18-36 years. Interpretation: Personalising care around MLTC clusters that have higher risk of adverse outcomes may have important implications for practice (in relation to secondary prevention), policy (with allocation of health care resources), and research (intervention development and targeting), for people living with MLTCs. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).

Mixed-methods evaluation of an enhanced asthma biologics clinical pathway in the West Midlands UK.

Biologic treatments can alleviate severe asthma symptoms and reduce health service use. However, service capacity limits and low referral rates from primary care indicate unmet patient need. We report a mixed-methods evaluation of an enhanced severe asthma pathway implemented in Staffordshire and Stoke-on-Trent, UK which aimed to optimise primary care referrals through training/education, and increased capacity in specialist clinics. Quantitative analysis assessed patient wait times between pathway stages, prescribing changes, exacerbations, hospital admissions and asthma control. Interviews with 12 stakeholders evaluated perceptions of the enhanced pathway across settings. In 12 months, 564 patients from 28 general practices were reviewed for biologics eligibility, of whom 125 (22.2%) were referred for specialist assessment. Wait times were significantly lower under the enhanced pathway when compared against historic patients following the standard pathway, and reduced overall from a mean of 76.4 to 26.7 weeks between referral and biologics initiation (p < 0.001). Patients commencing biologics (n = 46) showed significantly reduced reliever inhaler prescribing rates (p = 0.037), 60% lower oral steroid use (p < 0.001), significantly reduced exacerbation rates (p < 0.001) and fewer hospital admissions (p < 0.001) compared with the 12 months pre-treatment. Mean asthma control scores reduced from 3.13 pre-initiation to 1.89 post-initiation (p < 0.001) - a clinically significant improvement. Interviewees viewed the enhanced pathway positively, although ongoing issues related to difficulties engaging primary care amid concerns around increased workloads and pathway capacity. The large number of referrals generated from a comparatively small number of general practices confirms substantial unmet need that an enhanced severe asthma pathway could help address if implemented routinely.

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).

Supporting healthcare professionals to address child weight with parents: a qualitative study.

BACKGROUND: Primary care and community healthcare professionals (HCPs) are well placed to discuss child excess weight with parents and support them to make changes. However, HCPs have concerns about addressing this issue. There is a need to understand the factors that influence HCPs in initiating these conversations to inform strategies to support them. AIM: To explore with HCPs, working in primary care and community settings, their experiences of having conversations about child weight with parents, and the factors that create barriers or facilitate them to have these conversations. DESIGN AND SETTING: A qualitative study with GPs, primary care nurses (PNs), and school nurses (SNs) in England. METHOD: GPs and PNs were recruited to participate in semi-structured interviews. SNs from a community healthcare NHS trust were recruited to participate in focus groups. Vignettes were used to stimulate discussion. Data were analysed guided by the Framework approach. RESULTS: Thirteen GPs, seven PNs, and 20 SNs participated. The following three themes were identified regarding barriers to HCPs having conversations about child excess weight: structural and organisational; HCP related; and parent or family related. The themes identified for the factors that facilitate these conversations were: structural changes (for example, dedicated appointments, access to weight assessment data, joined-up working across agencies); HCP approaches (for example, providing appropriate dietary and physical activity advice); and HCP knowledge and skills (for example, enhancing HCPs' general and weight management-related skills and knowledge of child weight management services). CONCLUSION: A range of barriers exist to HCPs addressing child excess weight with parents in primary care and community settings. Actions to effect structural changes and support HCPs in developing relevant knowledge and skills are required to overcome these barriers.

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.

Engaging stakeholders to level up COPD care in LMICs: lessons learned from the "Breathe Well" programme in Brazil, China, Georgia, and North Macedonia.

BACKGROUND: Effective stakeholder engagement in health research is increasingly being recognised and promoted as an important pathway to closing the gap between knowledge production and its use in health systems. However, little is known about its process and impacts, particularly in low-and middle-income countries. This opinion piece draws on the stakeholder engagement experiences from a global health research programme on Chronic Obstructive Pulmonary Disease (COPD) led by clinician researchers in Brazil, China, Georgia and North Macedonia, and presents the process, outcomes and lessons learned. MAIN BODY: Each country team was supported with an overarching engagement protocol and mentored to develop a tailored plan. Patient involvement in research was previously limited in all countries, requiring intensive efforts through personal communication, meetings, advisory groups and social media. Accredited training programmes were effective incentives for participation from healthcare providers; and aligning research findings with competing policy priorities enabled interest and dialogue with decision-makers. The COVID-19 pandemic severely limited possibilities for planned engagement, although remote methods were used where possible. Planned and persistent engagement contributed to shared knowledge and commitment to change, including raised patient and public awareness about COPD, improved skills and practice of healthcare providers, increased interest and support from clinical leaders, and dialogue for integrating COPD services into national policy and practice. CONCLUSION: Stakeholder engagement enabled relevant local actors to produce and utilise knowledge for small wins such as improving day-to-day practice and for long-term goals of equitable access to COPD care. For it to be successful and sustained, stakeholder engagement needs to be valued and integrated throughout the research and knowledge generation process, complete with dedicated resources, contextualised and flexible planning, and commitment.

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.

Retaining public health volunteers beyond COVID-19.

OBJECTIVES: The COVID-19 pandemic has led to a change in people's volunteering behaviours; participation has increased in informal volunteering (giving unpaid help to those who are not a relative) while decreasing in formal volunteering (unpaid help to groups or clubs). There is an interest from stakeholders who have experienced increased participation in maintaining the positive patterns of volunteering, aligning with National Health Service (NHS) objectives and realising benefits in a wider public health context. This research uses a local COVID-19 public health volunteering programme case study to explore the volunteer's journey and perspective using volunteers' reported experiences to consider the potential for volunteer retention and role expansion into other public health issues beyond the COVID-19 pandemic. METHODS: Recruitment was undertaken by Birmingham City Council Public Health Team via the COVID-19 Community Champions programme mailing list. Semi-structured focus group discussions, one-to-one interviews and email interviews were conducted with volunteers. Data were analysed through directed thematic analysis using an iteratively developed coding frame. RESULTS: Data were collected from three focus group discussions, four interviews, and one email interview involving a total of 16 participants. Six themes were identified: volunteer motivations and expectations; volunteer management; programme organisation; feeling valued; continued need for role, and interest in new responsibilities. CONCLUSION: Our findings indicate that the factors which are conducive to volunteer recruitment, retention and re-purposing were: maintaining the original terms of engaging with the volunteering opportunity (including retaining the original brief and remit), adjusting these through consultative processes with an emphasis on seeking permission from the volunteers already involved and ensuring a reliable and consistent management and support structure. While some of the learning is specific to the local volunteer programme in question and the context of the COVID-19 pandemic, there are lessons that can be generalised to other scenarios and settings.

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.

Identifying and understanding the care pathway of patients with atrial fibrillation in Brazil and the impact of the COVID-19 pandemic: A mixed-methods study.

BACKGROUND: Atrial fibrillation (AF) is a major risk factor for stroke. To enable improvements to AF diagnosis and follow-up care, understanding current patient pathways and barriers to optimal care are essential. We investigated the patient care pathways and their drivers, and the impact of the COVID-19 pandemic on patient pathways in a middle-income country setting, Brazil. METHODS: This mixed-methods study in São Paulo, included adults (≥18y) with AF from 13 primary/secondary healthcare facilities. Surveys using baseline, follow-up (administered ≥two months after baseline) and COVID-19 questionnaires (quantitative), and three focus group discussions (FGDs) were conducted. Minimum sample size for the quantitative component was 236 and we aimed to reach saturation with at least three FGDs for the qualitative component. Descriptive statistics were used for quantitative data and a content analysis was used for qualitative data to identify themes related to AF diagnosis and follow-up care. RESULTS: 267 participants completed the baseline questionnaire: 25% were diagnosed in primary care, 65% in an emergency or inpatient department. At follow-up (n = 259), 31% visited more than one facility for AF care, and 7% had no follow-up. Intervals between international normalised ratio (INR) tests were increased during the pandemic, and the number of healthcare visits and availability of medication were reduced. Seventeen patients participated in three FGDs and revealed that AF diagnosis often occurred following a medical emergency and patients often delay care-seeking due to misconceptions about AF symptoms. Long waiting times, doctor/patient interactions and health system factors, such as doctor availability and the referral system, influence where participants visited for follow-up care. CONCLUSIONS: Lack of public awareness and underdeveloped primary healthcare lead to delayed diagnosis, which impacts clinical outcomes and excess patient and healthcare system costs. Health system, care-provider, and pandemic factors disrupt timely and effective continuity of care.

Text message conversations between peer supporters and women to deliver infant feeding support using behaviour change techniques: A qualitative analysis.

OBJECTIVE: To analyse text message conversations between peer supporters (called Infant Feeding Helpers - IFHs) and new mothers using qualitative methods to understand how peer support can influence and support women's feeding experiences. DESIGN: Qualitative analysis of text messages conversations using both inductive thematic and deductive content approaches to coding. Thematic analysis of the text message transcripts and deductive content analysis was used to code if Behaviour Change Techniques (BCTs) were employed by IFHs in their interactions with women. BCTs coded in text messages were then compared with those tabulated from antenatal meeting recordings and documented in interview transcripts. PARTICIPANTS AND SETTING: 18 primiparous women and 7 Infant Feeding Helpers from one community site in South-West England. FINDINGS: Three key themes were identified in the18 text message conversations (1679 texts): 'breastfeeding challenges', 'mother-centred conversations', and 'emotional and practical support'. The core BCTs of 'social support' and 'changing the social environment' were found at least once in 17 (94 %) and 18 (100 %) text message conversations respectively. Meanwhile, 'instruction to perform the behaviour' was used at least once in over 50 % of conversations. Generally, the use of BCTs was greatest between birth and two weeks during a period of daily texts when women reported many feeding challenges. The number and range of BCTs used in text messages were similar to those documented in audio-recorded meetings and interview accounts. CONCLUSION AND IMPLICATIONS: Infant Feeding Helpers were able to provide engaging and successful breastfeeding peer support through text messages. Messaging was shown to be an appropriate and accessible method of delivering BCTs focussing on 'social support' and 'changing the social environment'. Peer supporters delivering BCTs via text messages is acceptable and appropriate to use if in-person support is limited due to unforeseen circumstances such as the COVID-19 pandemic.

Home-based versus centre-based cardiac rehabilitation.

BACKGROUND: Cardiovascular disease is the most common cause of death globally. Traditionally, centre-based cardiac rehabilitation programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based and technology-supported cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation, especially during the SARS-CoV-2 pandemic. This is an update of a review previously published in 2009, 2015, and 2017. OBJECTIVES: To compare the effect of home-based (which may include digital/telehealth interventions) and supervised centre-based cardiac rehabilitation on mortality and morbidity, exercise-capacity, health-related quality of life, and modifiable cardiac risk factors in patients with heart disease SEARCH METHODS: We updated searches from the previous Cochrane Review by searching the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid) and CINAHL (EBSCO) on 16 September 2022. We also searched two clinical trials registers as well as previous systematic reviews and reference lists of included studies. No language restrictions were applied. SELECTION CRITERIA: We included randomised controlled trials that compared centre-based cardiac rehabilitation (e.g. hospital, sports/community centre) with home-based programmes (± digital/telehealth platforms) in adults with myocardial infarction, angina, heart failure, or who had undergone revascularisation. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all identified references for inclusion based on predefined inclusion criteria. Disagreements were resolved through discussion or by involving a third review author. Two authors independently extracted outcome data and study characteristics and assessed risk of bias. Certainty of evidence was assessed using GRADE. MAIN RESULTS: We included three new trials in this update, bringing a total of 24 trials that have randomised a total of 3046 participants undergoing cardiac rehabilitation. A further nine studies were identified and are awaiting classification. Manual searching of trial registers until 16 September 2022 revealed a further 14 clinical trial registrations - these are ongoing. Participants had a history of acute myocardial infarction, revascularisation, or heart failure. Although there was little evidence of high risk of bias, a number of studies provided insufficient detail to enable assessment of potential risk of bias; in particular, details of generation and concealment of random allocation sequencing and blinding of outcome assessment were poorly reported. No evidence of a difference was seen between home- and centre-based cardiac rehabilitation in our primary outcomes up to 12 months of follow-up: total mortality (risk ratio [RR] = 1.19, 95% confidence interval [CI] 0.65 to 2.16; participants = 1647; studies = 12/comparisons = 14; low-certainty evidence) or exercise capacity (standardised mean difference (SMD) = -0.10, 95% CI -0.24 to 0.04; participants = 2343; studies = 24/comparisons = 28; low-certainty evidence). The majority of evidence (N=71 / 77 comparisons of either total or domain scores) showed no significant difference in health-related quality of life up to 24 months follow-up between home- and centre-based cardiac rehabilitation. Trials were generally of short duration, with only three studies reporting outcomes beyond 12 months (exercise capacity: SMD 0.11, 95% CI -0.01 to 0.23; participants = 1074; studies = 3; moderate-certainty evidence). There was a similar level of trial completion (RR 1.03, 95% CI 0.99 to 1.08; participants = 2638; studies = 22/comparisons = 26; low-certainty evidence) between home-based and centre-based participants. The cost per patient of centre- and home-based programmes was similar. AUTHORS' CONCLUSIONS: This update supports previous conclusions that home- (± digital/telehealth platforms) and centre-based forms of cardiac rehabilitation formally supported by healthcare staff seem to be similarly effective in improving clinical and health-related quality of life outcomes in patients after myocardial infarction, or revascularisation, or with heart failure. This finding supports the continued expansion of healthcare professional supervised home-based cardiac rehabilitation programmes (± digital/telehealth platforms), especially important in the context of the ongoing global SARS-CoV-2 pandemic that has much limited patients in face-to-face access of hospital and community health services. Where settings are able to provide both supervised centre- and home-based programmes, consideration of the preference of the individual patient would seem appropriate. Although not included in the scope of this review, there is an increasing evidence base supporting the use of hybrid models that combine elements of both centre-based and home-based cardiac rehabilitation delivery. Further data are needed to determine: (1) whether the short-term effects of home/digital-telehealth and centre-based cardiac rehabilitation models of delivery can be confirmed in the longer term; (2) the relative clinical effectiveness and safety of home-based programmes for other heart patients, e.g. post-valve surgery and atrial fibrillation.

Randomised controlled trial testing effectiveness of feedback about lung age or exhaled CO combined with very brief advice for smoking cessation compared to very brief advice alone in North Macedonia: findings from the Breathe Well group.

INTRODUCTION: In 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care. METHODS: We conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia. All participants who decided to attempt to quit smoking were advised about accessing smoking cessation medications and were also offered behavioural support as part of the "ACT" component of VBA. Participants were aged ≥ 35 years, smoked ≥ 10 cigarettes per day, were recruited from 31 GP practices regardless of motivation to quit and were randomised (1:1:1) using a sequence generated before the start of recruitment. The primary outcome was biochemically validated 7-day point prevalence abstinence at 4 weeks (wks). Participants and GPs were not blinded to allocation after randomisation, however outcome assessors were blind to treatment allocation. RESULTS: There was no evidence of a difference in biochemically confirmed quitting between intervention and control at 4wks (VBA + LA RR 0.90 (97.5%CI: 0.35, 2.27); VBA + CO RR 1.04 (97.5%CI: 0.44, 2.44)), however the absolute number of quitters was small (VBA + LA 1.6%, VBA + CO 1.8%, VBA 1.8%). A similar lack of effect was observed at 12 and 26wks, apart from in the VBA + LA arm where the point estimate was significant but the confidence intervals were very wide. In both treatment arms, a larger proportion reported a reduction in cigarettes smoked per day at 4wks (VBA + LA 1.30 (1.10, 1.54); VBA + CO 1.23 (1.03, 1.49)) compared with VBA. The point estimates indicated a similar direction of effect at 12wks and 26wks, but differences were not statistically significant. Quantitative process measures indicated high fidelity to the intervention delivery protocols, but low uptake of behavioural and pharmacological support. VBA was the dominant intervention in the health economic analyses. CONCLUSION: Overall, there was no evidence that adding LA or CO to VBA increased quit rates. However, a small effect cannot be ruled out as the proportion quitting was low and therefore estimates were imprecise. There was some evidence that participants in the intervention arms were more likely to reduce the amount smoked, at least in the short term. More research is needed to find effective ways to support quitting in settings like North Macedonia where a strong smoking culture persists. TRIAL REGISTRATION: The trial was registered at http://www.isrctn.com (ISRCTN54228638) on the 07/09/2018.

Protocol for a cluster randomised waitlist-controlled trial of a goal-based behaviour change intervention for employees in workplaces enrolled in health and wellbeing initiatives.

Many workplaces offer health and wellbeing initiatives to their staff as recommended by international and national health organisations. Despite their potential, the influence of these initiatives on health behaviour appears limited and evaluations of their effectiveness are rare. In this research, we propose evaluating the effectiveness of an established behaviour change intervention in a new workplace context. The intervention, 'mental contrasting plus implementation intentions', supports staff in achieving their health and wellbeing goals by encouraging them to compare the future with the present and to develop a plan for overcoming anticipated obstacles. We conducted a systematic review that identified only three trials of this intervention in workplaces and all of them were conducted within healthcare organisations. Our research will be the first to evaluate the effectiveness of mental contrasting outside a solely healthcare context. We propose including staff from 60 organisations, 30 in the intervention and 30 in a waitlisted control group. The findings will contribute to a better understanding of how to empower and support staff to improve their health and wellbeing. Trial registration: ISRCTN17828539.