Sarah Byford

Background: Early intervention increases the likelihood of eating disorder recovery but many young people delay help-seeking. We developed a smartphone-friendly, online decision-making tool to address this gap (FREED-Mobile (FREED-M)). Aims: To conduct a randomised controlled feasibility trial of the FREED-M decision-making tool with 16- to 25-year-olds with a suspected eating disorder and no previous treatment for this. Method: Participants were randomly allocated to FREED-M or an active control in a parallel group, two-arm trial. Outcomes were measured at weeks 0 (baseline), 4 (post-intervention) and 12 (follow-up). The primary feasibility outcome was attrition at follow-up. Other outcomes included motivational, clinical and economic measures. Results: We over-recruited with 204 randomised participants (including 20 fraudulent participants). Main analyses were conducted with 184 genuine responders (FREED-M: n = 91, control: n = 93). At baseline, participants’ mean age was 21.0 (s.d. 2.0) years, 89% identified as female and 64% as White. Mean body mass index was 23.1 kg/m ² (6.3). N = 83 participants had an anorexia nervosa-like disorder, 101 had another eating disorder or high eating disorder risk. Attrition at week 12 was n = 112 (61%). Of the n = 42 FREED-M participants who provided acceptability ratings, 79% liked the intervention and 66% found it useful. Between-group effect sizes for motivation and readiness to change were small to medium at 4 weeks ( d = 0.27 and d = 0.15, respectively) favouring FREED-M, but differences were not sustained at follow-up ( d = −0.02 and d = −0.12, respectively). Discussions: Although the attrition rate was high, recruitment exceeded expectations. Acceptability of FREED-M was high among participants who provided acceptability ratings. Motivation/readiness to change and help-seeking are candidates for primary outcomes in a future randomised controlled trial.

Background Health services face difficult choices regarding how to allocate scarce health and social care resources. Economic evaluation can aid this process of decision making by allowing competing healthcare interventions or services to be compared in terms of their costs and consequences. However, existing use of economic evaluation of health services largely focuses on comparing interventions in terms of their impact on health only, missing factors potentially important to broader wellbeing. The capability approach measures outcomes in terms of what people are able to do and be. It provides an alternative evaluative space for economic evaluation, which may be especially beneficial for populations such as children and young people, for whom health might not be the only outcome of importance to their wellbeing. Study aims This study aims to develop conceptual attributes and descriptive systems for capability wellbeing measures for children and young people to be used in economic evaluation. Methods Qualitative interviews will be used with children, young people and parents/guardians in the UK to develop the conceptual attributes (items) and wording for the capability wellbeing measures. Recruitment will be undertaken through organisations such as schools and charities and online using Facebook. In-depth interviews will be face-to-face or online and will focus on identifying factors important to children and young people’s wellbeing to generate attributes for the capability wellbeing measures. Subsequent semi-structured interviews will focus on refining the wording used in the measures. Interviews will be analysed using methods of constant comparison, to explore similarities and differences in what participants considered important to children and young people’s wellbeing and to develop appropriate wording for the measures based on participant responses. Ethics The study received approval from the University of Bristol Faculty of Health Sciences Research Ethics Committee (reference 77121).

Background: Individuals with Down syndrome (DS) require specialized medical follow‐up and services more frequently than the general population, resulting in substantial healthcare costs for families and health systems. This systematic review aimed to synthesize evidence on the magnitude and determinants of direct healthcare and indirect costs associated with DS. Methods: We searched Web of Science, PubMed, and Scopus for observational and experimental studies published in English between January 1, 2000, and December 31, 2022 (updated June 15, 2024), that reported healthcare costs or cost determinants for individuals with DS. Reference lists were also screened. We excluded non‐English papers, qualitative studies, reviews, protocols, editorials, and gray literature. Results: The search identified 625 unique citations, of which 14 matched the inclusion criteria. Half were conducted in the USA. Inpatient services constituted the largest share of direct healthcare costs in 58% of studies. Indirect costs, mainly productivity losses among families, were reported in 25% of studies. Healthcare costs were highest during infancy (driven primarily by congenital heart defects and early hospitalizations), decreased throughout childhood and adolescence, and increased again in adulthood, particularly after age 40, due to age‐related comorbidities such as dementia and multimorbidity. Associated morbidities, greater functional limitations, and lower socioeconomic status were consistently associated with higher costs. Conclusions: Age, comorbidities, functional ability, and socioeconomic factors are key drivers of healthcare costs in DS. Long‐term, comprehensive policies integrating medical, social, and educational support are needed. Priority should be given to early cardiac surgery coverage, multidisciplinary adult transition clinics, subsidized respite care, and financial assistance schemes to reduce both inpatient utilization and family productivity losses.

Background: In clinical practice, olanzapine is commonly used in young people with anorexia nervosa, although the underpinning evidence-base is limited. However, its efficacy, tolerability, acceptability and adherence rate, and the patients’, carers’ and clinicians’ views of olanzapine treatment are unclear. This synopsis article summarises the methods and results of the OPEN feasibility study, overarching the findings and drawing comprehensive conclusions from a quantitative feasibility outcome paper and two qualitative research papers. Methods: The OPEN study assessed the feasibility of a future randomised controlled trial on olanzapine in young people with anorexia nervosa in an open-label, one-armed feasibility study. In this study, we aimed to include 55 patients with anorexia nervosa or atypical anorexia nervosa aged 12–24 who gained < 2 kg within at least 1 month of treatment as usual. Time points for assessments were at baseline, 8 weeks, 16 weeks, and 6 or 12 months. We estimated recruitment, adherence and attrition rates and mean changes in body weight, body mass index and eating disorder psychopathology. In addition, we explored the views on and experiences with olanzapine treatment within a clinical trial setting using qualitative interviews with young people with anorexia nervosa, their families and clinicians. Results: Fifty-two people were pre-screened, 35 were eligible and 20 participants were recruited and started olanzapine. Of these, 15 continued olanzapine for ≥ 16 weeks. Participants experienced, on average, a decrease in their eating disorder psychopathology, and body weight and body mass index increased during treatment with olanzapine as an adjunct to treatment as usual. Important themes derived from semi-structured qualitative interviews with young people and their parents were: moving away from the illness towards recovery, evaluating information on olanzapine, consent and trust in shared decision-making and the ambivalence around recovery. The main themes expressed by clinicians included: acknowledging the concerns of young people with anorexia nervosa and their families, prioritising person-centred care, the limited service capacity and strict study eligibility criteria. Limitations: The study failed to meet the recruitment target and showed low adherence rates for treatment with olanzapine. Possible reasons for the recruitment difficulties and the low adherence rate include the high clinical workload of eating disorder services during and after the COVID-19 pandemic, the heterogeneity of eating disorder service setup across the country, and the reluctance of patients to agree to take olanzapine under the relatively restricted conditions of a clinical study. Conclusions: A realistic time schedule for site-preparation, recruitment, treatment and follow-up, realistic recruitment targets and easy access to medical and laboratory examinations may improve the success of future feasibility studies and randomised controlled trials in this patient group. Future work: The difficulties in conducting the OPEN study will inform the planning for future pharmacological and non-pharmacological studies in anorexia nervosa. Therefore, we developed a checklist with action points for the planning of pharmacological trials in eating disorders. Furthermore, novel pharmacological options such as typical and atypical psychedelic drugs (e.g. psilocybin and ketamine) might be more acceptable for people with anorexia nervosa as they do not have the side effect of immediate weight gain. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR130780.

Purpose: Despite increased calls for greater health and wellbeing promotion in workplaces and schools, little is known about how these organisations make use of evidence to support health and wellbeing investment decisions. Design/methodology/approach: A scoping review was conducted to explore how workplaces and schools use evidence in their health and wellbeing investments decisions and to synthesise findings across a range of OECD countries. Findings: A total of 27 studies from nine countries met inclusion criteria. Included studies were analysed thematically. Both studies of schools and workplaces faced challenges in identifying and using a variety of forms of evidence, due to insufficient time and human resources. We generated three themes based on the data extracted to explain how schools and workplaces used evidence to invest in health and wellbeing. These were ‘Evidence-based provision adapted to context’ which looks at how evidence is used or not used in tandem with context of the decision; ‘Having expertise’, which reports decision-makers seeking expertise in their selection of evidence or reliance on their experiences to make a decision related to health and wellbeing; and ‘Challenging the status quo’ which shows instances where evidence could be used to challenge decision-making and current wellbeing practice or prioritise different wellbeing areas. These findings highlight how organisational politics shapes which health and wellbeing evidence decision-makers choose to use-or ignore. Originality/value: This review highlights how and why schools and workplaces choose to invest in health and wellbeing initiatives and how evidence use affects their selection. It shows how resources and power dynamics shape evidence use in decision-making processes about wellbeing and goes beyond seeing evidence as solely helping organisations to solve a specific problem.

Background: Mental health issues are prevalent among children and young people (CYP) with chronic conditions like epilepsy, yet few access evidence-based psychological therapies. Evidence from the Mental Health Intervention for Children with Epilepsy (MICE) trial supports the effectiveness of a personalised modular psychological intervention, but cost-effectiveness is unknown. Aims: To assess the cost-effectiveness of the MICE intervention compared with assessment-enhanced usual care at 12-months follow-up, taking a health and social care perspective. Method: We conducted a within-trial economic evaluation. Outcomes were the Strengths and Difficulties Questionnaire (SDQ; primary) and quality-adjusted life years (QALYs; secondary) for CYP, caregivers, and CYP and caregivers combined. Sensitivity analyses examined missing data and intervention-costing assumptions. Results: Cost-effectiveness results for the SDQ indicated that MICE had a higher probability of being cost-effective compared with control at a willingness to pay ≥£368 per unit improvement. For QALYs, MICE had a lower probability of being cost-effective for CYP compared with control (35 to 42%) across the £20 000–£30 000 per QALY threshold range. However, at the upper threshold this finding was reversed in sensitivity analyses with missing data imputed (45 to 58%) and with MICE costed at 75%, assuming the intervention partly substituted standard services (46 to 55%). Furthermore, MICE had a higher probability of being cost-effective for caregiver QALYs (52 to 63%) and combined CYP and caregiver QALYs (62 to 75%). Conclusions: MICE appears to be cost-effective compared with assessment-enhanced usual care when considering QALYs for CYP and caregivers combined, though uncertainty exists across willingness-to-pay thresholds.

Background: Perinatal mental health disorders affect one in five mothers during pregnancy or within 2 years post childbirth. These disorders can lead to poor pregnancy and childbirth outcomes and maternal deaths. Additionally, they negatively affect a child’s cognitive, social and emotional development. Stigma and a lack of specialised services have limited access to mental health care. National Health Service England invested £365M in community perinatal mental health teams, but their impact on women and infants’ outcomes are not known. Objectives: Develop a taxonomy of community perinatal mental health teams (work package 1). Compare and validate two assessments of quality of mother–infant interaction for use by community perinatal mental health teams (work package 2). Evaluate the effectiveness and cost-effectiveness of community perinatal mental health teams (work packages 3 and 4). Design: Mixed-methods study. Setting: Community perinatal mental health teams in England. Participants: Women who were pregnant or within 2 years postnatal. Methods and outcome measures: Work package 1: Typology of community perinatal mental health teams in England. Work package 2: Reliability and validity of two observational assessments of parent–infant interaction. Work package 3: Realist evaluation interviews with women, partners/close others, and staff to determine effective community perinatal mental health team components. Work package 4: Analysis of linked data: Association of community perinatal mental health teams with access to secondary care mental health services. Risk of acute relapse and improved obstetric and neonate outcomes for women with pre-existing severe disorders in areas with community perinatal mental health teams compared to generic services. Economic analysis of cost of community perinatal mental health teams. Results: Objective 1: Community perinatal mental health team typologies revealed in 2020, 84% had basic staffing levels and 63% had more multi-professionals. Objective 2: The ‘Parent Infant Interaction Observation Scale’ and ‘National Institute of Child Health and Human Development’ assessments of mother–infant interaction were reliable and valid; the National Institute of Child Health and Human Development is more suitable for community perinatal mental health teams. Objective 3: Work package 3: Interviews with 139 women, 55 partners/close others and 80 health workers highlighted the importance of specialist perinatal knowledge, responding in a warm and non-judgemental way, working closely with other healthcare providers, optimising medication, supporting mothers to reduce conflict and improve social support, helping mother–infant bonding, and teaching emotional management. Work package 4: Analysis of linked health data revealed higher risks for obstetric and neonate problems in women with severe mental health disorders, particularly recent or very serious episodes. Work package 4: Areas with community perinatal mental health teams saw increased mental health access among perinatal women and reduced need for acute care, albeit at a higher cost and with greater neonatal risks. Limitations: High levels of missing data on diagnosis and mental health outcomes in existing health and service data. Lack of data on child outcomes. Evaluation occurred during community perinatal mental health team changes and the coronavirus disease discovered in 2019 pandemic limiting a full assessment of the impact of community perinatal mental health teams on maternal and child outcomes. Conclusions: Community perinatal mental health teams can support perinatal women with complex, moderate/severe mental health disorders, but further attention to women’s physical needs is essential. The use of observational assessments of parent–infant relationships will enhance the evaluation of community perinatal mental health teams’ impact on infant outcomes. Future work: Research should focus on prospective studies that gather mental health and child outcomes from community perinatal mental health teams and primary care mental health, to assess broader impacts of perinatal-specific treatment across care pathways. Study registration: This study is registered on Research Registry as researchregistry5463. 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: 17/49/38) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 38. See the NIHR Funding and Awards website for further award information.

Background: Childhood trauma is a public health challenge, and there is currently a service/needs gap. Low-intensive treatments where the task of leading the treatment is partially shifted to a caregiver can help bridge this gap by freeing therapist resources. Stepping Together for Children after Trauma (ST-CT), is a novel parent-led, therapist-assisted treatment with promising results in the U.S. Also, it has shown to be feasible as a first-line intervention in Norwegian municipal services and ST-CT is well accepted by children, caregivers, and therapists.Objective: This study is the first randomized controlled trial of ST-CT by independent researchers. The study consists of three work-packages: WP1: Investigates (a) the effectiveness of ST-CT compared to therapy as usual (TAU) in reducing post-traumatic stress symptoms (PTSS), related mental health symptoms, sleep problems and increasing daily functioning; (b) the cost-effectiveness of ST-CT compared to TAU in terms of quality adjusted life years; (c) future health care utilization. WP2: Looks at change processes in ST-CT, with changes in sleep, post-traumatic cognitions and child-parent relationship as potential mediators of reductions in child PTSS. WP3: Investigates keys to implementation into regular first-line mental health services.Methods: The study has a type 1 hybrid effectiveness-implementation design. Children between 7-12 years of age with symptoms of PTSS and their caregivers are randomized to either ST-CT or TAU and participants are assessed at five time points during the first year. Sleep quality is measured with a non-contact radar 1 week pre- and post-treatment and registry data of use of prescribed medications and mental health service utilization will be collected 3 years post-inclusion. The study aims to include 160 child-parent dyads from 30 municipalities.Conclusion: Results can help gain a better understanding of the effectiveness and change processes of ST-CT and may provide important knowledge for a future dissemination and implementation.Trial registration: ClinicalTrials.gov identifier: NCT05734547.