Support for primary care prescribing for adult ADHD in England: national survey.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder with effective pharmacological treatments that improve symptoms and reduce complications. NICE guidelines recommend primary care practitioners prescribe medication for adult ADHD under shared care agreements with adult mental health services (AMHS). However, provision remains uneven, with some practitioners reporting a lack of support. AIM: This study aimed to describe supportive elements (prescribing, shared care, AMHS availability) of primary care prescribing for adult ADHD medication in England, to inform service improvement and improve access for this underserved population. DESIGN AND SETTING: Three interlinked cross-sectional surveys asked every integrated care board (ICB) in England (Commissioners), and convenience samples of healthcare professionals (HP) and people with lived experience (LE), about elements supporting pharmacological treatment of ADHD in primary care. METHOD: Descriptive analyses used percentages and confidence intervals to summarise responses by stakeholder group. Variations in reported provision and practice were explored and displayed visually using mapping software. RESULTS: Data from 782 respondents (42 Commissioners; 331 HP; 409 LE) revealed differences in reported provision by stakeholder group, including for prescribing (94.6% of HP vs 62.6% of LE). Over 40% of respondents reported extended AMHS waiting times of two years or more. There was some variability by NHS region, for example London had highest rates of HP reported prescribing (100%), and lowest reported extended waiting times (25.0%). CONCLUSION: Elements supporting appropriate shared care prescribing of ADHD medication via primary care are not universally available in England. Co-ordinated approaches are needed to address these gaps.

Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN.

INTRODUCTION: Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual's overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia. METHOD AND ANALYSIS: This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes. ETHICS AND DISSEMINATION: The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16413728.

Is neighbourhood deprivation in primary school-aged children associated with their mental health and does this association change over 30 months?

As both socioeconomic deprivation and the prevalence of childhood mental health difficulties continue to increase, exploring the relationship between them is important to guide policy. We aimed to replicate the finding of a mental health gap that widened with age between those living in the most and least deprived areas among primary school pupils. We used data from 2075 children aged 4-9 years in the South West of England recruited to the STARS (Supporting Teachers and childRen in Schools) trial, which collected teacher- and parent-reported Strength and Difficulties Questionnaire (SDQ) at baseline, 18-month and 30-month follow-up. We fitted multilevel regression models to explore the relationship between Index of Multiple Deprivation (IMD) quintile and SDQ total difficulties score and an algorithm-generated "probable disorder" variable that combined SDQ data from teachers and parents. Teacher- and parent-reported SDQ total difficulties scores indicated worse mental health in children living in more deprived neighbourhoods, which was attenuated by controlling for special educational needs and disabilities but remained significant by parent report, and there was no interaction year group status (age) at baseline. We did not detect an association between probable disorder and IMD although an interaction with time was evident (p = 0.003). Analysis by study wave revealed associations at baseline (odds ratio 1.94, 95% confidence interval 0.97-3.89) and 18 months (1.96, 1.07-3.59) but not 30 months (0.94, 0.54-1.57). These findings augment the existing, highly compelling evidence demonstrating worse mental health in children exposed to socioeconomic deprivation.

Children and young people's reported contact with professional services for mental health concerns: a secondary data analysis.

Children and young people's mental health services have been under increasing pressure following COVID-19. Understanding, for which channels help is sought from, will highlight services needing support. This study aims to explore the professional services that parents of children, and young people get help from when they have a concern for the child's/their mental health. Secondary analysis of data is taken from Mental Health of Children and Young People in England Survey, 2017. 7608 reports of mental health-related contact with professional services from parents of 5-16 year-olds and self-reports from young people aged 17-19 were available. Service contact was reported by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis, age, gender and ethnicity. Less than two-thirds of children and young people with a DSM-V diagnosis (63.5% (95% CI 58.6-68.1) aged 5-10, and 64.0% (95% CI 59.4-68.4) aged 11-16) reported contact with any professional services. The figure was lower for those aged 17-19; 50.1% (95% CI 42.8-58.2), p = 0.005. Children and young people aged 5-16 from Black (11.7%; 95% CI 2.4-41.4), Asian (55.1%; 95% CI 34.7-73.9) and Mixed (46.0%; 95% CI 32.4-60.3) ethnic groups reported less contact with professional services compared to those from the White group (66.9%; 95% CI 63.5-70.2). Patterns of service access during the three main educational stages aid with understanding service need during childhood. These lower levels of reported service access for young people aged 17-19 with a DSM-V diagnosis and those in ethnic minority groups demand further investigation.

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i).

BACKGROUND: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. METHODS AND DESIGN: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.

Family Functioning in Children With ADHD and Subthreshold ADHD: A 3-Year Longitudinal Study.

OBJECTIVE: To compare family functioning over time for elementary school children with Attention-Deficit/Hyperactivity Disorder (ADHD; N = 179) and subthreshold ADHD (ST-ADHD; N = 86), to children without ADHD (Control; N = 212). METHOD: ADHD was assessed using the Conners 3 ADHD Index and Diagnostic Interview Schedule for Children IV. At baseline, 18-month follow-up and 36-month follow-up, parents completed measures assessing a range of family functioning domains. RESULTS: At baseline, the ADHD group reported higher psychological distress, less parenting self-efficacy, less parenting consistency, and more stressful life events; and both groups reported poorer family quality of life (QoL) and greater parenting anger. Trajectories were largely similar to controls (i.e., stable over time), but unlike controls, ADHD and ST-ADHD groups showed lessening parent-partner support and parenting warmth, respectively; and both groups showed worsening aspects of family QoL. CONCLUSION: Families of children with ADHD and ST-ADHD report persistently poor or worsening family functioning; highlighting a need for tailored psycho-social supports.

Student- and School-Level Factors Associated With Mental Health and Well-Being in Early Adolescence.

OBJECTIVE: Adolescence is a key developmental window that may determine long-term mental health. As schools may influence mental health of students, this study aimed to examine the association of school-level characteristics with students' mental health over time. METHOD: Longitudinal data from a cluster randomized controlled trial comprising 8,376 students (55% female; aged 11-14 years at baseline) across 84 schools in the United Kingdom were analyzed. Data collection started in the academic years 2016/2017 (cohort 1) and 2017/2018 (cohort 2), with follow-up at 1, 1.5, and 2 years. Students' mental health (risk for depression [Center for Epidemiologic Studies Depression Scale], social-emotional-behavioral difficulties [Strength and Difficulties Questionnaire]) and well-being (Warwick-Edinburgh Mental Well-Being Scale) and relationships with student- and school-level characteristics were explored using multilevel regression models. RESULTS: Mental health difficulties and poorer well-being increased over time, particularly in girls. Differences among schools represented a small but statistically significant proportion of variation (95% CI) in students' mental health at each time point: depression, 1.7% (0.9%-2.5%) to 2.5% (1.6%-3.4%); social-emotional-behavioral difficulties, 1.9% (1.1%-2.7%) to 2.8% (2.1%-3.5%); and well-being, 1.8% (0.9%-2.7%) to 2.2% (1.4%-3.0%). Better student-rated school climate analyzed as a time-varying factor at the student and school level was associated with lower risk of depression (regression coefficient [95%CI] student level: -4.25 [-4.48, -4.01]; school level: -4.28 [-5.81, -2.75]), fewer social-emotional-behavioral difficulties (student level: -2.46 [-2.57, -2.35]; school level: -2.36 [-3.08, -1.63]), and higher well-being (student level: 3.88 [3.70, 4.05]; school-level: 4.28 [3.17, 5.38]), which was a stable relationship. CONCLUSION: Student-rated school climate predicted mental health in early adolescence. Policy and system interventions that focus on school climate may promote students' mental health.

Efficacy and moderators of efficacy of cognitive behavioural therapies with a trauma focus in children and adolescents: an individual participant data meta-analysis of randomised trials.

BACKGROUND: Existing clinical trials of cognitive behavioural therapies with a trauma focus (CBTs-TF) are underpowered to examine key variables that might moderate treatment effects. We aimed to determine the efficacy of CBTs-TF for young people, relative to passive and active control conditions, and elucidate putative individual-level and treatment-level moderators. METHODS: This was an individual participant data meta-analysis of published and unpublished randomised studies in young people aged 6-18 years exposed to trauma. We included studies identified by the latest UK National Institute of Health and Care Excellence guidelines (completed on Jan 29, 2018) and updated their search. The search strategy included database searches restricted to publications between Jan 1, 2018, and Nov 12, 2019; grey literature search of trial registries ClinicalTrials.gov and ISRCTN; preprint archives PsyArXiv and bioRxiv; and use of social media and emails to key authors to identify any unpublished datasets. The primary outcome was post-traumatic stress symptoms after treatment (<1 month after the final session). Predominantly, one-stage random-effects models were fitted. This study is registered with PROSPERO, CRD42019151954. FINDINGS: We identified 38 studies; 25 studies provided individual participant data, comprising 1686 young people (mean age 13·65 years [SD 3·01]), with 802 receiving CBTs-TF and 884 a control condition. The risk-of-bias assessment indicated five studies as low risk and 20 studies with some concerns. Participants who received CBTs-TF had lower mean post-traumatic stress symptoms after treatment than those who received the control conditions, after adjusting for post-traumatic stress symptoms before treatment (b=-13·17, 95% CI -17·84 to -8·50, p<0·001, τ2=103·72). Moderation analysis indicated that this effect of CBTs-TF on post-traumatic stress symptoms post-treatment increased by 0·15 units (b=-0·15, 95% CI -0·29 to -0·01, p=0·041, τ2=0·03) for each unit increase in pre-treatment post-traumatic stress symptoms. INTERPRETATION: This is the first individual participant data meta-analysis of young people exposed to trauma. Our findings support CBTs-TF as the first-line treatment, irrespective of age, gender, trauma characteristics, or carer involvement in treatment, with particular benefits for those with higher initial distress. FUNDING: Swiss National Science Foundation.

Survival of revision ankle arthroplasty.

Aims: The number of revision total ankle arthroplasties (TAAs) which are undertaken is increasing. Few studies have reported the survival after this procedure. The primary aim of this study was to analyze the survival of revision ankle arthroplasties using large datasets. Secondary aims were to summarize the demographics of the patients, the indications for revision TAA, further operations, and predictors of survival. Methods: The study combined data from the National Joint Registry and NHS Digital to report the survival of revision TAA. We have previously reported the failure rates and risk factors for failure after TAA, and the outcome of fusion after a failed TAA, using the same methodology. Survival was assessed using life tables and Kaplan Meier graphs. Cox proportional hazards regression models were fitted to compare failure rates. Results: A total of 228 patients underwent revision TAA. The mean follow-up was 2.6 years (SD 2.0). The mean time between the initial procedure and revision was 2.3 years (SD 1.8). The most commonly used implant was the Inbone which was used in 81 patients. A total of 29 (12.7%) failed; nine (3.9%) patients underwent a further revision, 19 (8.3%) underwent a fusion, and one (0.4%) had an amputation. The rate of survival was 95.4% (95% confidence interval (CI) 91.6 to 97.5) at one year, 87.7% (95% CI 81.9 to 91.7; n = 124) at three years and 77.5% (95% CI 66.9 to 85.0; n = 57) at five years. Revision-specific implants had a better survival than when primary implants were used at revision. A total of 50 patients (21.9%) had further surgery; 19 (8.3%) underwent reoperation in the first 12 months. Cox regression models were prepared. In crude analysis the only significant risk factors for failure were the use of cement (hazard ratio (HR) 3.02 (95% CI 1.13 to 8.09)) and the time since the primary procedure (HR 0.67 (95% CI 0.47 to 0.97)). No risk factors for failure were identified in multivariable Cox regression modelling. Conclusion: Revision TAAs have good medium term survival and low rates of further surgery. New modular revision implants appear to have improved the survival compared with the use of traditional primary implants at revision.

Missing the context: The challenge of social inequalities to school-based mental health interventions.

Given well-established links between socio-economic adversity and mental health, it is unsurprising that young people's mental health is deteriorating amidst economic crises. The World Health Organisation (WHO) recognises mental health as "crucial to personal, community, and socio-economic development" and outlines goals to reshape environments such as schools to protect mental health. Schools offer an ideal setting to promote wellbeing and prevent mental ill-health during a key developmental window. We describe how social inequalities present a challenge to designing school-based interventions for prevention and promotion for mental health and wellbeing, and suggest priorities to aid and evaluate their effectiveness.

Fusion after a failed primary total ankle arthroplasty.

Aims: When a total ankle arthroplasty (TAA) fails, it can be converted to a fusion or a revision arthroplasty. Despite the increasing numbers of TAAs being undertaken, there is little information in the literature about the management of patients undergoing fusion following a failed TAA. The primary aim of this study was to analyze the survival of fusions following a failed TAA using a large dataset from the National Joint Registry (NJR). Methods: A data linkage study combined NJR and NHS Digital data. Failure of a TAA was defined as a fusion, revision to a further TAA, or amputation. Life tables and Kaplan-Meier graphs were used to record survival. Cox proportional hazards regression models were fitted to compare the rates of failure. Results: A total of 131 patients underwent fusion as a salvage procedure following TAA. Their mean age was 65.7 years (SD 10.6) and 73 (55.7%) were male. The mean follow-up was 47.5 months (SD 27.2). The mean time between TAA and fusion was 5.3 years (SD 2.7). Overall, 32 (24.4%) underwent reoperations other than revision and 29 (22.1%) failed. Of these 24 (18.3%) underwent revision of the fusion and five (3.8%) had a below-knee amputation. No patients underwent conversion to a further TAA. Failure usually occurred in the first three postoperative years with one-year survival of fusion being 96.0% (95% confidence interval (CI) 90.7 to 98.3) and three-year survival in 69 patients being 77.5% (95% CI 68.3 to 84.4). Conclusion: Salvage fusion after a failed TAA shows moderate rates of failure and reoperations. Nearly 25% of patients required revision within three years. This study is an extension of studies using the same methodology reporting the failure rates and risk factors for failure, which have recently been published, and also one reporting the outcome of revision TAA for a failed primary TAA, using the same methodology, which will shortly be published.

The multifaceted consequences and economic costs of child anxiety problems: A systematic review and meta-analysis.

Background: Over a quarter of people have an anxiety disorder at some point in their life, with many first experiencing difficulties during childhood or adolescence. Despite this, gaps still exist in the current evidence base of the multiple consequences of childhood anxiety problems and their costs. Methods: A systematic review of Medline, PsycINFO, EconLit and the National Health Service Economic Evaluation Database was conducted for longitudinal and economic studies reporting on the association between childhood anxiety problems and at least one individual-, family- or societal-level outcome or cost. All studies were synthesised narratively. For longitudinal studies, 'effect direction' was used as a common metric, with random effects meta-analysis undertaken where possible. Results: Eighty-three studies met inclusion criteria and were synthesised narratively. We identified 788 separate analyses from the longitudinal studies, which we grouped into 15 overarching outcome domains. Thirteen of the studies were incorporated into 13 meta-analyses, which indicated that childhood anxiety disorders were associated with future anxiety, mood, behaviour and substance disorders. Narrative synthesis also suggested associations between anxiety problems and worse physical health, behaviour, self-harm, eating, relationship, educational, health care, employment, and financial outcomes. 'Effect direction' was conflicting in some domains due to a sparse evidence base. Higher economic costs were identified for the child, their families, healthcare providers and wider society, although evidence was limited and only covered short follow-up periods, up to a maximum of 2 years. Total annual societal costs per anxious child were up to £4040 (2021 GBP). Conclusions: Childhood anxiety problems are associated with impaired outcomes in numerous domains, and considerable economic costs, which highlight the need for cost-effective interventions and policies to tackle them. More economic evidence is needed to inform models of the long-term, economic-related, consequences of childhood anxiety problems.

A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study.

BACKGROUND: Delirium affects over 20% of all hospitalised older adults. Delirium is associated with a number of adverse outcomes following hospital admission including cognitive decline, anxiety and depression, increased mortality and care needs. Previous research has addressed prevention of delirium in hospitals and care homes, and there are guidelines on short-term treatment of delirium during admission. However, no studies have addressed the problem of longer-term recovery after delirium and it is currently unknown whether interventions to improve recovery after delirium are effective and cost-effective. The primary objective of this feasibility study is to test a new, theory-informed rehabilitation intervention (RecoverED) in older adults delivered following a hospital admission complicated by delirium to determine whether (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible. METHODS: The study is a multi-centre, single-arm feasibility study of a rehabilitation intervention with an embedded process evaluation. Sixty participants with delirium (aged > 65 years old) and carer pairs will be recruited from six NHS acute hospitals across the UK. All pairs will be offered the intervention, with follow-up assessments conducted at 3 months and 6 months post-discharge home. The intervention will be delivered in participants' own homes by therapists and rehabilitation support workers for up to 10 intervention sessions over 12 weeks. The intervention will be tailored to individual needs, and the chosen intervention plan and goals will be discussed and agreed with participants and carers. Quantitative data on reach, retention, fidelity and dose will be collected and summarised using descriptive statistics. The feasibility outcomes that will be used to determine whether the study meets the criteria for progression to a definitive randomised controlled trial (RCT) include recruitment, delivery of the intervention, retention, data collection and acceptability of outcome measures. Acceptability of the intervention will be assessed using in-depth, semi-structured qualitative interviews with participants and healthcare professionals. DISCUSSION: Findings will inform the design of a pragmatic multi-centre RCT of the effectiveness and cost-effectiveness of the RecoverED intervention for helping the longer-term recovery of people with delirium compared to usual care. TRIAL REGISTRATION: The feasibility study was registered: ISRCTN15676570.

Young People's Mental Health Changes, Risk, and Resilience During the COVID-19 Pandemic.

Importance: As young people's mental health difficulties increase, understanding risk and resilience factors under challenging circumstances becomes critical. Objective: To explore the outcomes of the COVID-19 pandemic on secondary school students' mental health difficulties, as well as the associations with individual, family, friendship, and school characteristics. Design, Setting, and Participants: For this cohort study, follow-up data from the My Resilience in Adolescence (MYRIAD) cluster randomized clinical trial were collected across 2 representative UK cohorts. Mainstream UK secondary schools with a strategy and structure to deliver social-emotional learning, with an appointed head teacher, and that were not rated "inadequate" in their latest official inspection were recruited. A total of 5663 schools were approached, 532 showed interest, and 84 consented. Cohort 1 included 12 schools and 864 students, and cohort 2 included 72 schools and 6386 students. COVID-19 was declared a pandemic after cohort 1 had completed all assessments (September 2018 to January 2020), but cohort 2 had not (September 2019 to June 2021). Exposures: Cohort 2 was exposed to the COVID-19 pandemic, including 3 national lockdowns. Associations of individual, family, friendship, and school characteristics with students' mental health were explored. Main Outcomes and Measures: Changes in students' risk for depression (Center for Epidemiological Studies-Depression scale); social, emotional, and behavioral difficulties (Strengths and Difficulties Questionnaire); and mental well-being (Warwick-Edinburgh Mental Well-Being Scale). Results: Of the 7250 participants included, the mean (SD) age was 13.7 (0.6) years, 3947 (55.4%) identified as female, and 5378 (73.1%) self-reported their race as White. Twelve schools and 769 of the 864 students (89.0%) in cohort 1 and 54 schools and 2958 of the 6386 students (46.3%) in cohort 2 provided data and were analyzed. Mental health difficulties increased in both cohorts but to a greater extent among students exposed to the pandemic, including for risk of depression (adjusted mean difference [AMD], 1.91; 95% CI, 1.07-2.76); social, emotional, and behavioral difficulties (AMD, 0.76; 95% CI, 0.33-1.18); and mental well-being (AMD, -2.08; 95% CI, -2.80 to -1.36). Positive school climate, high home connectedness, and having a friend during lockdown were protective factors during the pandemic. Female gender and initial low risk for mental health difficulties were associated with greater mental health deteriorations. Partial school attendance during lockdown was associated with better adjustment than no attendance when returning to school. Conclusions and Relevance: This cohort study of secondary school students demonstrated that to promote mental health and adjustment, policy interventions should foster home connectedness, peer friendship, and school climate; avoid full school closures; and consider individual differences.

Evaluation of the prehospital use of a Valsalva assist device in the emergency treatment of supraventricular tachycardia (EVADE SVT): study protocol for a stepped wedge cluster randomised controlled trial.

INTRODUCTION: Patients with episodes of supraventricular tachycardia (SVT), a common heart arrhythmia, are often attended by ambulance services. International guidelines advocate treatment with the Valsalva manoeuvre (VM), but this simple physical treatment has a low success rate, with most patients requiring conveyance to hospital. The Valsalva Assist Device (VAD) is a simple device that might help practitioners and patients perform a more effective VM and reduce the need for patients to be taken to hospital. METHODS AND ANALYSIS: This stepped wedge cluster randomised controlled trial, conducted within a UK ambulance service, compares the current standard VM with a VAD-delivered VM in stable adult patients presenting to the ambulance service with SVT. The primary outcome is conveyance to hospital; secondary outcomes measures include cardioversion rates, duration of ambulance care and number of subsequent episodes of SVT requiring ambulance service care. We plan to recruit approximately 800 patients, to have 90% power to detect an absolute reduction in conveyance rate of 10% (from 90% to 80%) between the standard VM (control) and VAD-delivered VM (intervention). Such a reduction in conveyance would benefit patients, the ambulance service and receiving emergency departments. It is estimated potential savings would pay for devices for the entire ambulance trust within 7 months. ETHICS AND DISSEMINATION: The study has been approved by the Oxford Research Ethics Committee (reference 22/SC/0032). Dissemination will be through peer-reviewed journal publication, presentation at national and international conferences and by the Arrhythmia Alliance, a patient support charity. TRIAL REGISTRATION NUMBER: ISRCTN16145266.

Are There Ethnic Differences in Recorded Features among Patients Subsequently Diagnosed with Cancer? An English Longitudinal Data-Linked Study.

We investigated ethnic differences in the presenting features recorded in primary care before cancer diagnosis. METHODS: English population-based cancer-registry-linked primary care data were analysed. We identified the coded features of six cancers (breast, lung, prostate, colorectal, oesophagogastric, and myeloma) in the year pre-diagnosis. Logistic regression models investigated ethnic differences in first-incident cancer features, adjusted for age, sex, smoking status, deprivation, and comorbidity. RESULTS: Of 130,944 patients, 92% were White. In total, 188,487 incident features were recorded in the year pre-diagnosis, with 48% (89,531) as sole features. Compared with White patients, Asian and Black patients with breast, colorectal, and prostate cancer were more likely than White patients to have multiple features; the opposite was seen for the Black and Other ethnic groups with lung or prostate cancer. The proportion with relevant recorded features was broadly similar by ethnicity, with notable cancer-specific exceptions. Asian and Black patients were more likely to have low-risk features (e.g., cough, upper abdominal pain) recorded. Non-White patients were less likely to have alarm features. CONCLUSION: The degree to which these differences reflect disease, patient or healthcare factors is unclear. Further research examining the predictive value of cancer features in ethnic minority groups and their association with cancer outcomes is needed.

Risk Factors for Failure of Total Ankle Replacements: A Data Linkage Study Using the National Joint Registry and NHS Digital.

BACKGROUND: Despite the increasing numbers of ankle replacements, there remains debate about which patients should undergo an ankle replacement, and there are limited studies analyzing risk factors for failure of an ankle replacement. The primary aim of this study is to analyze the risk factors for failure of total ankle replacements. METHODS: A data linkage study combining the National Joint Registry (NJR) Data and NHS (National Health Service) Digital data was performed. The primary outcome of failure is defined as the removal or exchange of any components of the implanted device. Kaplan-Meier survival charts were used to illustrate survivorship. Multivariable Cox proportional hazards regression models were fitted to analyze potential risk factors for failures or ankle replacements. RESULTS: The overall 5-year survival was 90.2% (95% CI 89.2%-91.1%). In multivariable (adjusted) Cox regression models, only age (hazard ratio [HR] 0.96, 95% CI 0.94-0.97), body mass index (BMI; HR 1.03, 95% CI 1.01-1.06), and underlying etiology (HR 0.88, 95% CI 0.80-0.97) were associated with an increased risk of failure. CONCLUSION: This study demonstrates that younger patients and those with an increased BMI have an increased risk of failure of a primary ankle replacement. We also show that rheumatoid patients have higher survivorship than those with osteoarthritis. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.

Do Adolescents Like School-Based Mindfulness Training? Predictors of Mindfulness Practice and Responsiveness in the MYRIAD Trial.

OBJECTIVE: We explored what predicts secondary school students' mindfulness practice and responsiveness to universal school-based mindfulness training (SBMT), and how students experience SBMT. METHOD: A mixed-methods design was used. Participants were 4,232 students (11-13 years of age), in 43 UK secondary schools, who received universal SBMT (ie, ".b" program), within the MYRIAD trial (ISRCTN86619085). Following previous research, student, teacher, school, and implementation factors were evaluated as potential predictors of students' out-of-school mindfulness practice and responsiveness (ie, interest in and attitudes toward SBMT), using mixed-effects linear regression. We explored pupils' SBMT experiences using thematic content analysis of their answers to 2 free-response questions, 1 question focused on positive experiences and 1 question on difficulties/challenges. RESULTS: Students reported practicing out-of-school mindfulness exercises on average once during the intervention (mean [SD] = 1.16 [1.07]; range, 0-5). Students' average ratings of responsiveness were intermediate (mean [SD] = 4.72 [2.88]; range, 0-10). Girls reported more responsiveness. High risk of mental health problems was associated with lower responsiveness. Asian ethnicity and higher school-level economic deprivation were related to greater responsiveness. More SBMT sessions and better quality of delivery were associated with both greater mindfulness practice and responsiveness. In terms of students' experiences of SBMT, the most frequent themes (60% of the minimally elaborated responses) were an increased awareness of bodily feelings/sensations and increased ability to regulate emotions. CONCLUSION: Most students did not engage with mindfulness practice. Although responsiveness to the SMBT was intermediate on average, there was substantial variation, with some youth rating it negatively and others rating it positively. Future SBMT developers should consider co-designing curricula with students, carefully assessing the student characteristics, aspects of the school environment, and implementation factors associated with mindfulness practice and responsiveness. SBMT teacher training is key, as more observed proficiency in SBMT teaching is associated with greater student mindfulness practice and responsiveness to SBMT.