The BRIDGE project: a feasibility randomised controlled trial of brief, intensive assessment and integrated formulation for young people (age 14-24) with features of borderline personality disorder (Protocol).

Background: Borderline personality disorder (BPD) is a severe mental disorder that is characterised by a pervasive pattern of instability of interpersonal relationships, self-image, and mood as well as marked impulsivity. BPD has its peak incidence and prevalence from puberty through to emerging adulthood. BPD is a controversial diagnosis in young people. Commonly, young people with BPD are under-diagnosed, untreated, are not in employment or training and are estranged from their families. Yet, they have complex needs and are at high suicide risk. Aim: To assess the feasibility of conducting a randomised controlled trial (f-RCT) of a BRIDGE, a brief intervention programme for young people (age 14-24) with BPD symptoms (sub-threshold or threshold) in a community sample from Scotland, UK. Method: Forty young people (age 14-24) meeting criteria for BPD symptoms, will be randomised in a 1:1 ratio to receive either a) the BRIDGE intervention plus service-as-usual or b) service-as-usual alone. Follow up will be 12 weeks and 24 weeks post-intervention. The study is carried out between 2021 to 2024. Outcome: The two primary outcomes of the MQ funded, BRIDGE project (f-RCT) are i. recruitment rates and ii. retention rates. The study will present the acceptability and appropriateness of our putative outcome measures for a future definitive randomised controlled trial (d-RCT). Impact: Young people with BPD benefit from good clinical care and targeted intervention, however are regularly missed or mislabelled. The community based feasibility trial would provide initial evidence of variable needs of young people with complex needs, who maybe missed or excluded from services as they don't "fit" a model/diagnosis. Workable multi-agency service model proposed in the trial would be a major advance in understanding care pathways regardless of trial outcome. Clinical Trial Registration: ClinicalTrial.gov, identifier NCT05023447.

Baseline Characteristics in the Remote Diet Intervention to REduce long-COVID Symptoms Trial (ReDIRECT).

Background: The persistence of symptoms for ≥12 weeks after a COVID-19 infection is known as Long COVID (LC), a condition with unclear pathophysiology and no proven treatments to date. Living with obesity is a risk factor for LC and has symptoms which may overlap with and aggravate LC. Methods: ReDIRECT is a remotely delivered trial assessing whether weight management can reduce LC symptoms. We recruited people with LC and BMI >27kg/m 2. The intervention was delivered remotely by dietitians, with online data collection (medical and dietary history, COVID-19 infection and vaccination, body composition, LC history/symptoms, blood pressure, quality of life, sociodemographic data). Participants self-selected the dominant LC symptoms they most wanted to improve from the intervention. Results: Participants (n=234) in England (64%) and Scotland (30%) were mainly women (85%) of white ethnicity (90%), with 13% living in the 20% most deprived areas, a mean age of 46 (SD10) years, and median BMI of 35kg/m 2 (IQR 32-40). Before starting the study, 30% reported more than one COVID-19 infection (82% confirmed with one or more positive tests). LC Diagnosis was mainly by GPs (71%), other healthcare professionals (9%), or self-diagnosed (21%). The median total number of symptoms was 6 (IQR 4-8). Self-selected dominant LC symptoms included fatigue (54%), breathlessness (16%), pain (12%), anxiety/depression (1%) and "other" (17%). At baseline, 82% were taking medication, 57% reported 1+ other medical conditions. Quality of life was poor; 20% were on long-term sick leave or reduced working hours. Most (92%) reported having gained weight since contracting COVID-19 (median weight change +11.5 kg, range -11.5 to +45.3 kg). Conclusions: Symptoms linked to LC and overweight are diverse and complex. Remote trial delivery enabled rapid recruitment across the UK yet certain groups (e.g. men and those from ethnic minority groups) were under-represented. Trial registration: ISRCTN registry ( ISRCTN12595520, 25/11/2021).

Long COVID (LC, symptoms lasting 12 weeks or more after a COVID-19 infection) is a poorly understood condition, with no proven treatments. Living with obesity increases the risk of developing LC; symptoms of obesity overlap and aggravate those of LC. The ReDIRECT study tests, in people living with both LC and overweight, whether weight management can reduce LC symptoms. The study involves total diet replacement (with porridge, soups and shakes) for 12 weeks and is delivered remotely, with dietitian support via internet and/or phone. Researchers collected all data via online forms (medical and diet history, COVID-19 infection and vaccination, weight, height, LC history and symptoms, blood pressure, quality of life, and other demographic data). Each participant selected the LC symptom they most wanted to see improve. Participants (n=234) lived across the UK, were mainly women (85%) of white ethnicity (90%), with 13% living in the 20% most deprived areas. Their average age was 46 years old with an average body mass index (BMI) of 35kg/m ². Diagnosis of LC was mainly by GPs (71%), other healthcare professionals (9%), or self-diagnosed (21%). Participants reported on average 6 symptoms each, identifying fatigue (54%), breathlessness (16%), pain (12%), anxiety/depression (1%) and "other" (17%) as the symptom they would most like to see improve. At the start of the study, most (82%) were taking medication, half (57%) reported 1+ other medical conditions. Quality of life was poor, and 20% were on long-term sick leave or reduced working hours. Most (92%) reported gaining weight since contracting COVID-19, on average +11.5 kg. The baseline characteristics of ReDIRECT study participants show that symptoms linked to LC and overweight are diverse and complex. The study being "remote" means that recruitment was rapid and across the UK, yet certain groups (e.g. men and those from ethnic minority groups) were under-represented.

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).

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).

Cost-effectiveness of sentinel screening of endemic diseases alongside malaria diagnosis: A case study in schistosomiasis.

BACKGROUND: In countries where malaria is endemic, the use of rapid diagnostic tests(RDTs) has become routine, especially in rural settings. Such regions are characterised by often having other co-endemic infectious diseases, at high levels of prevalence. AIM: To illustrate the potential added-value of "sentinel" screening for patients presenting for a routine diagnostic test for malaria, at healthcare facilities in Uganda. METHODS: We developed an economic model by combining two decision trees, one for malaria and a second for the co-endemic disease schistosomiasis. The integrated model was designed to inform policy strategies for the co-endemic disease in addition to malaria (i.e., whether to test opportunistically for schistosomiasis or use mass drug administration(MDA) as per usual practice).We performed the analysis on three comparators varying testing accuracy and costs. RESULTS: Sentinel screening can provide added value to the testing of patients compared with the status quo: when schistosomiasis prevalence is high then MDA is preferential; if low prevalence, treating no one is preferred. If the disease has average levels of prevalence, then a strategy involving testing is preferred. Prevalence thresholds driving the dominant strategy are dependent upon the model parameters, which are highly context specific. At average levels of prevalence for schistosomiasis and malaria for Uganda, adding a sentinel screening was cost-effective when the accuracy of test was higher than current diagnostics and when economies of scope were generated(Expected value clinical Information = 0.65$ per DALY averted, 137.91$ per correct diagnoses).Protocols using diagnostics with current accuracy levels were preferred only for levels of MDA coverage below 75%. CONCLUSION: The importance of the epidemiological setting is crucial in determining the best cost-effective strategy for detecting endemic disease. Economies of scope can make sentinel screenings cost-effective strategies in specific contexts. Blanket thresholds recommended for MDA may not always be the preferred option for endemic diseases.

A more equitable approach to economic evaluation: Directly developing conceptual capability wellbeing attributes for Tanzania and Malawi.

Capability wellbeing can potentially provide a holistic outcome for health economic evaluation and the capability approach seems promising for African countries. As yet there is no work that has explored the evaluative space needed for health and care decision making at the whole population level and procedures that merely translate existing measures developed in the global north to contexts in the global south risk embedding structural inequalities. This work seeks to elicit the concepts within the capability wellbeing evaluative space for general adult populations in Tanzania and Malawi. Semi-structured interviews with 68 participants across Tanzania and Malawi were conducted between October 2021 and July 2022. Analysis used thematic coding frames and the writing of analytic accounts. Interview schedules were common across the two country settings, however data collection and analysis were conducted independently by two separate teams and only brought together once it was clear that the data from the two countries was sufficiently aligned for a single analysis. Eight common attributes of capability wellbeing were found across the two countries: financial security; basic needs; achievement and personal development; attachment, love and friendship; participation in community activities; faith and spirituality; health; making decisions without unwanted interference. These attributes can be used to generate outcome measures for use in economic evaluations comparing alternative health interventions. By centring the voices of Tanzanians and Malawians in the construction of attributes that describe a good life, the research can facilitate greater equity within economic evaluations across different global settings.

The short-term impact of Schistosoma mansoni infection on health-related quality of life: implications for current elimination policies.

The WHO aims to eliminate schistosomiasis as a public health problem by 2030. However, standard morbidity measures poorly correlate to infection intensities, hindering disease monitoring and evaluation. This is exacerbated by insufficient evidence on Schistosoma's impact on health-related quality of life (HRQoL). We conducted community-based cross-sectional surveys and parasitological examinations in moderate-to-high Schistosoma mansoni endemic communities in Uganda. We calculated parasitic infections and used EQ-5D instruments to estimate and compare HRQoL utilities in these populations. We further employed Tobit/linear regression models to predict HRQoL determinants. Two-thirds of the 560 participants were diagnosed with parasitic infection(s), 49% having S. mansoni. No significant negative association was observed between HRQoL and S. mansoni infection status/intensity. However, severity of pain urinating (ß = -0.106; s.e. = 0.043) and body swelling (ß = -0.326; s.e. = 0.005), increasing age (ß = -0.016; s.e. = 0.033), reduced socio-economic status (ß = 0.128; s.e. = 0.032), and being unemployed predicted lower HRQoL. Symptom severity and socio-economic status were better predictors of short-term HRQoL than current S. mansoni infection status/intensity. This is key to disentangling the link between infection(s) and short-term health outcomes, and highlights the complexity of correlating current infection(s) with long-term morbidity. Further evidence is needed on long-term schistosomiasis-associated HRQoL, health and economic outcomes to inform the case for upfront investments in schistosomiasis interventions.

The Social and Emotional Education and Development intervention to address wellbeing in primary school age children: the SEED cluster RCT.

Background: Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective: The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils' social and emotional well-being. Design: This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting: The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants: A total of 2639 pupils in Scotland. Intervention: The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure: The primary outcome was pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results: The primary outcome, pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk -1.30 (95% confidence interval -1.87 to -0.73), standardised effect size -0.27 (95% confidence interval -0.39 to -0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk -2.36 (95% confidence interval -3.62 to -1.11), standardised effect size -0.42 (95% confidence interval -0.64 to -0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations: It was a challenge to retain schools over five waves of data collection. Conclusions: This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work: Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration: This trial is registered as ISRCTN51707384. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

We studied the Social and Emotional Education and Development (SEED) primary school intervention to see if it could improve the social and emotional well-being of pupils in Scotland. The SEED intervention is a process with several elements. We collected information from school pupils, staff and parents, and assessed if the schools involved were happy, safe and caring environments. We sought to highlight any strengths or weaknesses in how each school approaches social and emotional well-being. The SEED intervention also measures the social and emotional well-being of pupils. This includes pupils' strengths and difficulties, confidence, understanding of emotions and quality of relationships. We gave the information back to each school to help them decide what they can do to improve the social and emotional well-being of their pupils. We gave schools a guide to available resources, reviewed according to how well they are known to work elsewhere. The same social and emotional well-being measurements were repeated every 1 or 2 years, to see if any improvements had been made, and to guide any further adaptions of activities. The study ran in 38 schools over 7 years; half of the schools were randomly selected to receive the SEED intervention and half carried on as normal. Two age groups of pupils were recruited; the younger group was aged 4 or 5 years and the older group was aged 8 or 9 years at the start of the study. We found that the SEED intervention did slightly improve social and emotional well-being. Improvements were greater for older pupils, in particular for boys, and lasted beyond their transition from primary to secondary school. We also found that it was cost-effective for schools to run the SEED intervention. Schools valued the structure and shared ownership associated with the process. We concluded that the SEED intervention is an acceptable way to modestly improve pupil well-being and school ethos.

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial.

INTRODUCTION: The reproductive years can increase women's weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development. METHODS AND ANALYSIS: Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost-utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants' experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences. TRIAL REGISTRATION NUMBER: ISRCTN16299220.

Levelling up health in the early years: A cost-analysis of infant feeding and healthcare.

BACKGROUND: Although breastfeeding is recommended as the optimal form of nutrition in the first six months, it is not sustained as the predominant mode of feeding infants in Scotland. This study estimated the impact of infant feeding choices on primary and secondary healthcare service costs in a 13-year birth cohort. METHOD: Using linked administrative datasets, in a retrospective cohort design of 502,948 singletons born in Scotland between 1997 and 2009, we estimated the cost of GP consultations and hospital admissions by area deprivation and mode of infant feeding up to 6-8 weeks for ten common childhood conditions from birth to 27 months. Additionally, we calculated the potential healthcare savings if all infants in the cohort had been exclusively breastfed at 6-8 weeks. Discounting of 1.5% was applied following current health economic conventions and 2009/10 used as the base year. RESULTS: Over the study period, the estimated cost of hospital admissions in the cohort was £111 million and £2 million for the 2% subset of the cohort with primary care records. Within each quintile of deprivation, exclusively breastfed infants used fewer healthcare services and incurred lower costs compared to infants fed (any) formula milk. At least £10 million of healthcare costs may have been avoided if formula-fed infants had been exclusively breastfed within the first 6-8 weeks of birth. CONCLUSIONS: This study using a representative birth cohort demonstrates how breastmilk can promote equitable child health by reducing childhood illness and healthcare utilisation in the early years.

A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.

The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Estimating the prevalence and predictors of musculoskeletal disorders in Tanzania: a cross-sectional pilot study.

Introduction: musculoskeletal (MSK) disorders account for approximately 20% of all years lived with disability worldwide however studies of MSK disorders in Africa are scarce. This pilot study aimed to estimate the community-based prevalence of MSK disorders, identify predictors, and assess the associated disability in a Tanzanian population. Methods: a cross-sectional study was conducted in one village in the Kilimanjaro region from March to June 2019. The Gait, Arms, Legs, Spine (GALS) or paediatric GALS (pGALS) examinations were used during household and school visits. Individuals positive in GALS/pGALS screening were assessed by the regional examination of the musculoskeletal system (REMS) and Modified Health Assessment Questionnaire (MHAQ). Results: among the 1,172 individuals enrolled in households, 95 (8.1%, 95% CI: 6.6 - 9.8) showed signs of MSK disorders using the GALS/pGALS examination and 37 (3.2%, 95% CI: 2.2 - 4.3) using the REMS. Among 682 schools enrolled children, seven showed signs of MSK disorders using the GALS/pGALS examination (1.0%, 95% CI: 0.4 - 2.1) and three using the REMS (0.4%, 95% CI: 0.0 - 1.3). In the household-enrolled adult population, female gender and increasing age were associated with GALS and REMS-positive findings. Among GALS-positive adults, increasing age was associated with REMS-positive status and increasing MHAQ score. Conclusion: this Tanzanian study demonstrates a prevalence of MSK disorders and identifies predictors of MSK disorders comparable to those seen globally. These findings can inform the development of rheumatology services and interventions in Tanzania and the design of future investigations of the determinants of MSK disorders, and their impacts on health, livelihoods, and well-being.

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).

Rapid ethnographic appraisal of community concepts of and responses to joint pain in Kilimanjaro, Tanzania.

INTRODUCTION: Musculoskeletal disorders, experienced as joint pain, are a significant global health problem, but little is known about how joint pain is categorised and understood in Tanzania. Understanding existing conceptualisations of and responses to joint pain is important to ensure both research and interventions are equitable and avoid biomedical imposition. METHODS: Rapid ethnographic appraisal was conducted in a periurban and rural community in Kilimanjaro, documenting language used to describe joint pain, ideas about causes, understandings of who experiences such pain, the impacts pain has and how people respond to it. We conducted 66 interviews with community leaders, traditional healers, community members and pharmacists.Photographs were taken and included in fieldnotes to supplement the interview data and develop thick descriptions. Data were analysed by constant comparison using QDA Miner software. RESULTS: Across the sample, dominant concepts of joint pain were named ugonjwa wa baridi, cold disease; ugonjwa wa uzee, old age disease; rimatizim, disease of the joints; and gauti, gout. Causes mentioned included exposure to the cold, old age, alcohol and red meat consumption, witchcraft, demons and injuries/falls. Age, gender and occupation were seen as important factors for developing joint pain. Perceived impacts of joint pain included loss of mobility, economic and family problems, developing new health conditions, death, reduction in sexual functioning and negative self-perceptions. Responses to joint pain blended biomedical treatments, herbal remedies, consultations with traditional healers and religious rituals. CONCLUSIONS: Conceptualisations of and responses to joint pain in the two communities were syncretic, mixing folk and biomedical practices. Narratives about who is affected by joint pain mirror emerging epidemiological findings, suggesting a strong 'lay epidemiology' in these communities. Anthropological methods can support the decolonisation of global health by decentring the imposition of English language biomedicine and pursuing synthetic, dignified languages of care.

Testing the feasibility of a co-designed intervention, comprising self-managed, home-based, exercise training with embedded behavioural support and compression therapy for people with venous leg ulcers receiving treatment at home (FISCU-II).

BACKGROUND: Venous leg ulcers (VLUs) heal slowly, are painful for patients and are costly for healthcare systems; they also affect patients' quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However, a large population of people with VLUs are unable to access such an intervention due to frailty and age. OBJECTIVES: To assess the feasibility of 'FISCU Home' (a co-designed, 12-week home-based self-managed lifestyle programme based on exercise and behaviour support) as an adjunct therapy to compression in people with VLUs. METHODS: Forty people with VLUs, receiving treatment at home, were recruited from community nursing and tissue viability teams, and via a newspaper advertisement. Participants were randomized 1 : 1 either to exercise with behaviour support (three times per week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events (AEs). Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e. ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated. RESULTS: The study recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed compression therapy. No serious AEs or exercise-related AEs were reported. Median (interquartile range) ulcer healing time was shorter in the exercise group [29 (7-108) vs. 42 (6-116) weeks]. CONCLUSIONS: The feasibility and acceptability of both a home- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported.

Evaluation of the Healthy Start voucher scheme on maternal vitamin use and child breastfeeding: a natural experiment using data linkage.

Background: Having a good start in life during pregnancy and infancy has been shown to be important for living both a healthy life and a longer life. Despite the introduction of many policies for the early-years age group, including voucher schemes, with the aim of improving nutrition, there is limited evidence of their impact on health. Objectives: To assess the effectiveness of the Healthy Start voucher scheme on infant, child and maternal outcomes, and to capture the lived experiences of the Healthy Start voucher scheme for low-income women. Design: This was a natural experiment study using existing data sets, linked to routinely collected health data sets, with a nested qualitative study of low-income women and an assessment of the health economics. Setting: Representative sample of Scottish children and UK children. Participants: Growing Up in Scotland cohort 2 (n = 2240), respondents to the 2015 Infant Feeding Study (n = 8067) and a sample of 40 participants in the qualitative study. Interventions: The Health Start voucher, a means-tested scheme that provides vouchers worth £3.10 per week to spend on liquid milk, formula milk, fruit and vegetables. Main outcome measures: Infant and child outcomes - breastfeeding initiation and duration; maternal outcomes - vitamin use pre and during pregnancy. Results: The exposed group were women receiving the Healthy Start voucher (R), with two control groups: eligible and not claiming the Healthy Start voucher (E) and nearly eligible. There was no difference in vitamin use during pregnancy for either comparison (receiving the Healthy Start voucher, 82%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.10 vs. receiving the Healthy Start voucher, 87%; nearly eligible, 88%; p = 0.43) in the Growing Up in Scotland cohort. Proportions were similar for the Infant Feeding Study cohort (receiving the Healthy Start voucher, 89%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.01 vs. receiving the Healthy Start voucher, 89%; nearly eligible, 87%; p = 0.01); although results were statistically significantly different, these were small effect sizes. There was no difference for either comparison in breastfeeding initiation or breastfeeding duration in months in Growing Up in Scotland, but there was a negative effect of the Healthy Start voucher in the Infant Feeding Survey. This contrast between data sets indicates that results are inconclusive for breastfeeding. The qualitative study found that despite the low monetary value the women valued the Healthy Start voucher scheme. However, the broader lives of low-income women are crucial to understand the constraints to offer a healthy diet. Limitations: Owing to the policy being in place, it was difficult to identify appropriate control groups using existing data sources, especially in the Infant Feeding Study. Conclusions: As the Healthy Start voucher scheme attempts to influence health behaviour, this evaluation can inform other policies aiming to change behaviour and use voucher incentives. The null effect of Healthy Start vouchers on the primary outcomes may be due to the value of the vouchers being insufficient to change the broader lives of low-income women to offer a healthy diet. Future work: The methods developed to undertake an economic evaluation alongside a natural experiment using existing data can be used to explore the cost-effectiveness of the Healthy Start voucher scheme. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 11. See the NIHR Journals Library website for further project information.

United Kingdom governments have introduced many policies to support infants and their families. Most of these policies have not been evaluated in terms of health outcomes. Therefore, there is limited evidence for policy-makers about whether or not the right policies are in place to make a difference to the health of young children and their families. We investigated the impact of the Healthy Start voucher scheme (worth £3.10 per week to spend on milk, fruit and vegetables) on the health of low-income mothers, and their infants and young children, in particular vitamin use of mothers and breastfeeding of infants. Using survey data, there were high rates of vitamin use during pregnancy, but fewer women taking vitamins before pregnancy. There was no effect of Healthy Start vouchers on taking vitamins before or during pregnancy. There was inconclusive evidence of the effect of Healthy Start vouchers on breastfeeding, indicating that use of the vouchers does not discourage breastfeeding in women with low incomes. From interviews with mothers, we found that they valued the Healthy Start vouchers and understood the aims of the policy. Healthy Start vouchers were not mentioned in decision-making around breastfeeding. Women's choice to breast or formula feed was based on a range of other factors, such as support to breastfeed. They wanted to provide a healthy diet for their families, but owing to living on low incomes did not always manage it. Policy-makers still need more evidence about the effects of voucher schemes to improve the health of low-income mothers, and their infants and young children. The decision-makers require evidence to determine where to allocate limited resources. There is a need to improve support for low-income families to provide their families with a healthy diet.

Relationship of the SITLESS intervention on medication use in community-dwelling older adults: an exploratory study.

Background: Sedentary behavior (SB) and physical activity (PA) interventions in older adults can improve health outcomes. Problems related with aging include prevalent comorbidity, multiple non-communicable diseases, complaints, and resulting polypharmacy. This manuscript examines the relationship between an intervention aiming at reducing SB on medication patterns. Method: This manuscript presents a local sub-analysis of the SITLESS trial data on medication use. SITLESS was an exercise referral scheme (ERS) enhanced by self-management strategies (SMS) to reduce SB in community-dwelling older adults. We analyzed data from the ERS + SMS, ERS and usual care (UC) groups. Patient medication records were available at baseline and at the end of the intervention (4-month period) and were analyzed to explore the effect of SITLESS on medication patterns of use. Result: A sample of 75 participants was analyzed, mostly older overweight women with poor body composition scores and mobility limitations. There was a significant reduction of 1.6 medicines (SD = 2.7) in the ERS group (p < 0.01), but not in the UC or ERS + SMS groups. Differences were more evident in medicines used for short periods of time. Conclusion: The findings suggest that an exercise-based program enhanced by SMS to reduce SB might influence medication use for acute conditions but there is a need to further investigate effects on long-term medicine use in older adults.

Pilot study of a ketogenic diet in bipolar disorder.

BACKGROUND: Recent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder. However, no clinical trials have been conducted to date. AIMS: To assess the recruitment and feasibility of a ketogenic diet intervention in bipolar disorder. METHOD: Euthymic individuals with bipolar disorder were recruited to a 6-8 week trial of a modified ketogenic diet, and a range of clinical, economic and functional outcome measures were assessed. Study registration number: ISRCTN61613198. RESULTS: Of 27 recruited participants, 26 commenced and 20 completed the modified ketogenic diet for 6-8 weeks. The outcomes data-set was 95% complete for daily ketone measures, 95% complete for daily glucose measures and 95% complete for daily ecological momentary assessment of symptoms during the intervention period. Mean daily blood ketone readings were 1.3 mmol/L (s.d. = 0.77, median = 1.1) during the intervention period, and 91% of all readings indicated ketosis, suggesting a high degree of adherence to the diet. Over 91% of daily blood glucose readings were within normal range, with 9% indicating mild hypoglycaemia. Eleven minor adverse events were recorded, including fatigue, constipation, drowsiness and hunger. One serious adverse event was reported (euglycemic ketoacidosis in a participant taking SGLT2-inhibitor medication). CONCLUSIONS: The recruitment and retention of euthymic individuals with bipolar disorder to a 6-8 week ketogenic diet intervention was feasible, with high completion rates for outcome measures. The majority of participants reached and maintained ketosis, and adverse events were generally mild and modifiable. A future randomised controlled trial is now warranted.

Benefits, risks, barriers, and facilitators to cycling: a narrative review.

There is large potential to increase cycling participation worldwide. Participation in cycling is associated with lower risk of mortality from any cause, and incidence of cardiovascular disease and type 2 diabetes, as well as positive mental health and well-being. The largest potential for health gains likely to come from increasing participation amongst those who do not currently cycle regularly, rather than encouraging those who already cycle regularly to cycle more. Replacing car journeys with cycling can lead to reductions in air pollution emissions and lower pollutant exposure to the general population. Important gaps and uncertainties in the existing evidence base include: the extent to which the health benefits associated with cycling participation are fully causal due to the observational nature of much of the existing evidence base; the real-world economic cost-benefits of pragmatic interventions to increase cycling participation; and the most effective (combination of) approaches to increase cycling participation. To address these uncertainties, large-scale, long-term randomised controlled trials are needed to: evaluate the effectiveness, and cost-effectiveness, of (combinations of) intervention approaches to induce sustained long-term increases in cycling participation in terms of increases in numbers of people cycling regularly and number of cycling journeys undertaken, across a range of population demographic groups; establish the effects of such interventions on relevant outcomes related to health and wellbeing, economic productivity and wider societal impacts; and provide more robust quantification of potential harms of increasing cycling participation, such as collision risks.