Experiences and impact of psychiatric inpatient admissions far away from home: a qualitative study with young people, parents/carers and healthcare professionals.

BACKGROUND: There are significant clinical, policy and societal concerns about the impact on young people (YP), from admission to psychiatric wards far from home. However, research evidence is scarce. AIMS: To investigate the impact of at-distance admissions to general adolescent units, from the perspectives of YP, parents/carers and healthcare professionals (HCPs) including service commissioners, to inform clinical practice, service development and policy. METHOD: Semistructured interviews with purposive samples of YP aged 13-17 years (n=28) and parents/carers (n=19) across five large regions in England, and a national sample of HCPs (n=51), were analysed using a framework approach. RESULTS: There was considerable agreement between YP, parents/carers and HCPs on the challenges of at-distance admissions. YP and parents/carers had limited or no involvement in decision-making processes around admission and highlighted a lack of available information about individual units. Being far from home posed challenges with maintaining home contact and practical/financial challenges for families visiting. HCPs struggled with ensuring continuity of care, particularly around maintaining access to local clinical teams and educational support. However, some YP perceived separation from their local environment as beneficial because it removed them from unhelpful environments. At-distance admissions provided respite for some families struggling to support their child. CONCLUSIONS: At-distance admissions lead to additional distress, uncertainty, compromised continuity of care and educational, financial and other practical difficulties, some of which could be better mitigated. For a minority, there are some benefits from such admissions. CLINICAL IMPLICATIONS: Standardised online information, accessible prior to admission, is needed for all Child and Adolescent Mental Health Services units. Additional practical and financial burden placed on families needs greater recognition and consideration of potential sources of support. Policy changes should incorporate findings that at-distance or adult ward admissions may be preferable in certain circumstances.

Whole systems approaches to diet and healthy weight: A scoping review of reviews.

BACKGROUND: Obesity is a global epidemic affecting all age groups, populations, and income levels across continents, though is known to disproportionately affect socioeconomically disadvantaged populations. The causes of obesity are complex, informed by diet and weight practices, but shaped by social, commercial, and environmental factors and government policy. Consequently, a Whole System Approach (WSA)-which considers the many causes of obesity and shifts the focus away from individuals as points of intervention and puts an emphasis on understanding and improving the system in which people live-is required. This scoping review of reviews aims to: determine how WSAs to diet and healthy weight have been implemented and evaluated nationally and internationally; to determine what models or theories have been used to implement WSAs; describe how WSAs have been evaluated; determine if WSAs are effective; and to identify the contribution of the public and/or service users in the development of WSAs. METHOD: Systematic searches were carried out using CINAHL, Scopus, PsycINFO (ProQuest), the Cochrane Library, and MEDLINE. Included review papers were those that focused on the application of a whole system approach to diet and/or healthy weight, and/or reported the theory/model used to implement or simulate this approach. Databases were searched from 1995 to March 2022 using a combination of text and Medical Subject Headings (MeSH terms). In addition, reference sections of identified articles were examined for additional relevant articles. Covidence software was used to screen titles and abstracts from the electronic databases and resolve conflicts. RESULTS: A total of 20,308 articles were initially retrieved; after duplicate removal 7,690 unique title and abstracts were reviewed, and 110 articles were selected for full text review. On completion of full text review, 8 review articles were included for data extraction. These included: one umbrella review, four systematic reviews, a rapid review, and two literature reviews (one of which was on strategic reports written for government and public health policy). Evaluations of WSA were mainly process evaluations although health outcomes were assessed in some studies. Several conceptual frameworks or mathematical modelling approaches have been applied to WSAs for diet, healthy weight, and obesity to inform their planning or delivery, and to understand/map the associated systems. Common mathematical approaches include agent based or System Dynamic Modelling. Underlying both conceptual and mathematical models is an understanding how the elements of the complex systems impact each other to affect diet, healthy weight, and obesity. WSA implementations have reported some success in positively impacting health outcomes including reducing Body Mass Index, reducing sugary food intake, and increasing physical activity. Public and user involvement in WSA was not widely reported. CONCLUSION: The application of WSA to diet and healthy weight shows promise, yet the research is lagging behind their implementation. Further robust evidence for using WSA to address diet and healthy weight are required, including incorporating process and outcome evaluations (perhaps using established approaches such as Systems Dynamic Modelling). Furthermore, the analysis of epidemiological data alongside longitudinal process and outcome evaluation regarding the implementation of a WSA is required.

Cost and economic evidence for asset-based approaches to health improvement and their evaluation methods: a systematic review.

BACKGROUND: Asset-based approaches (ABAs) tackle health inequalities by empowering people in more disadvantaged communities, or targeted populations, to better utilise pre-existing local community-based resources. Using existing resources supports individuals to better manage their own health and its determinants, potentially at low cost. Targeting individuals disengaged with traditional service delivery methods offers further potential for meaningful cost-savings, since these people often require costly care. Thus, improving prevention, and management, of ill-health in these groups may have considerable cost implications. AIM: To systematically review the extent of current cost and economic evidence on ABAs, and methods used to develop it. METHODS: Search strategy terms encompassed: i) costing; ii) intervention detail; and iii) locality. Databases searched: Medline, CENTRAL and Wed of Science. Researchers screened 9,116 articles. Risk of bias was assessed using the Critical Appraisal Skills Programme (CASP) tool. Narrative synthesis summarised findings. RESULTS: Twelve papers met inclusion criteria, representing eleven different ABAs. Within studies, methods varied widely, not only in design and comparators, but also in terms of included costs and outcome measures. Studies suggested economic efficiency, but lack of suitable comparators made more definitive conclusions difficult. CONCLUSION: Economic evidence around ABAs is limited. ABAs may be a promising way to engage underserved or minority groups, that may have lower net costs compared to alternative health and wellbeing improvement approaches. ABAs, an example of embedded services, suffer in the context of economic evaluation, which typically consider services as mutually exclusive alternatives. Economics of the surrounding services, mechanisms of information sharing, and collaboration underpin the success of assets and ABAs. The economic evidence, and evaluations in general, would benefit from increased context and detail to help ensure more nuanced and sophisticated understanding of the economics of ABAs. Further evidence is needed to reach conclusions about cost-effectiveness of ABAs.

'Far Away from Home': adolescent inpatient admissions far from home, out of area or to adult wards: a national surveillance study.

BACKGROUND: The increasing prevalence and acuity of mental disorders among children and adolescents have placed pressure on services, including inpatient care, and resulted in young people being admitted at-distance or to adult wards. Little empirical research has investigated such admissions. OBJECTIVE: To determine the incidence, clinical characteristics and 6-month outcomes of patients aged 13-17 years old admitted at-distance (>50 miles from home or out of region) to general adolescent psychiatric wards or to adult psychiatric wards. METHODS: Surveillance over 13 months (February 2021-February 2022) using the Child and Adolescent Psychiatry Surveillance System including baseline and 6-month follow-up questionnaires. FINDINGS: Data were collected about 290 admissions (follow-up rate 99% (288 of 290); sample were 73% female, mean age 15.8 years). The estimated adjusted yearly incidence of at-distance admission was 13.7-16.9 per 100 000 young people 13-17 years old. 38% were admitted >100 miles from home and 8% >200 miles. The most common diagnoses at referral were depression (34%) and autism spectrum disorder (20%); other common referral concerns included suicide risk (80%), emotional dysregulation (53%) and psychotic symptoms (22%). Over two-fifths (41%) waited ≥1 week for a bed, with 55% waiting in general hospital settings. At 6-month follow-up, 20% were still in hospital, the majority in at-distance placements. CONCLUSIONS: At-distance and adult ward admissions for patients aged <18 remain an ongoing challenge for healthcare provision and have an impact on acute hospital resource use. CLINICAL IMPLICATIONS: Long waits in non-specialist settings increase pressure across the healthcare system, highlighting the need to improve local service provision and commissioning to reflect identified clinical needs.

Cost-effectiveness of providing university students with a mindfulness-based intervention to reduce psychological distress: economic evaluation of a pragmatic randomised controlled trial.

OBJECTIVE: Increasing numbers of young people attending university has raised concerns about the capacity of student mental health services to support them. We conducted a randomised controlled trial (RCT) to explore whether provision of an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students-MSS), compared with university mental health support as usual (SAU), reduced psychological distress during the examination period. Here, we conduct an economic evaluation of MSS+SAU compared with SAU. DESIGN AND SETTING: Economic evaluation conducted alongside a pragmatic, parallel, single-blinded RCT comparing provision of MSS+SAU to SAU. PARTICIPANTS: 616 university students randomised. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the university counselling service. Costs relate to staff time required to deliver counselling service offerings. QALYs were derived from the Clinical Outcomes in Routine Evaluation Dimension 6 Dimension (CORE-6D) preference based tool, which uses responses to six items of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM; primary clinical outcome measure). Primary follow-up duration was 5 and 7 months for the two recruitment cohorts. RESULTS: It was estimated to cost £1584 (2022 prices) to deliver an MSS course to 30 students, £52.82 per student. Both costs (adjusted mean difference: £48, 95% CI £40-£56) and QALYs (adjusted mean difference: 0.014, 95% CI 0.008 to 0.021) were significantly higher in the MSS arm compared with SAU. The incremental cost-effectiveness ratio (ICER) was £3355, with a very high (99.99%) probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY. CONCLUSIONS: MSS leads to significantly improved outcomes at a moderate additional cost. The ICER of £3355 per QALY suggests that MSS is cost-effective when compared with the UK's National Institute for Health and Care Excellence thresholds of £20 000 per QALY. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry, ACTRN12615001160527.

Protocol of the process evaluation of cluster randomised control trial for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FluCare).

BACKGROUND: Influenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention's mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. METHODS/DESIGN: A mixed method process evaluation to inform the interpretation of trial findings. OBJECTIVES: • Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. • Explore the effects of individual intervention components on primary outcomes. • Investigate the mechanisms of impact. • Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). • Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. DISCUSSION: Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings. TRIAL REGISTRATION: ISRCTN ISRCTN22729870. Registered on 24 August 2022.

Codesigning a systemic discharge intervention for inpatient mental health settings (MINDS): a protocol for integrating realist evaluation and an engineering-based systems approach.

INTRODUCTION: Transition following discharge from mental health hospital is high risk in terms of relapse, readmission and suicide. Discharge planning supports transition and reduces risk. It is a complex activity involving interacting systemic elements. The codesigning a systemic discharge intervention for inpatient mental health settings (MINDS) study aims to improve the process for people being discharged, their carers/supporters and staff who work in mental health services, by understanding, co-designing and evaluating implementation of a systemic approach to discharge planning. METHODS AND ANALYSIS: The MINDS study integrates realist research and an engineering-informed systems approach across three stages. Stage 1 applies realist review and evaluation using a systems approach to develop programme theories of discharge planning. Stage 2 uses an Engineering Better Care framework to codesign a novel systemic discharge intervention, which will be subjected to process and economic evaluation in stage 3. The programme theories and resulting care planning approach will be refined throughout the study ready for a future clinical trial. MINDS is co-led by an expert by experience, with researchers with lived experience co-leading each stage. ETHICS AND DISSEMINATION: MINDS stage 1 has received ethical approval from Yorkshire & The Humber-Bradford Leeds (Research Ethics Committee (22/YH/0122). Findings from MINDS will be disseminated via high-impact journal publications and conference presentations, including those with service user and mental health professional audiences. We will establish routes to engage with public and service user communities and National Health Service professionals including blogs, podcasts and short videos. TRIAL REGISTRATION NUMBER: MINDS is funded by the National Institute of Health Research (NIHR 133013) https://fundingawards.nihr.ac.uk/award/NIHR133013. The realist review protocol is registered on PROSPERO. PROSPERO REGISTRATION NUMBER: CRD42021293255.

Cost-effectiveness of closed incision negative pressure wound therapy in preventing surgical site infection among obese women giving birth by caesarean section: An economic evaluation (DRESSING trial).

BACKGROUND: There is growing evidence regarding the potential of closed incision negative pressure wound therapy (ci-NPWT) to prevent surgical site infections (SSIs) in healing wounds by primary closure following a caesarean section (CS). AIM: To assess the cost-effectiveness of ci-NPWT compared to standard dressings for prevention of SSI in obese women giving birth by CS. MATERIALS AND METHODS: Cost-effectiveness and cost-utility analyses from a health service perspective were undertaken alongside a multicentre pragmatic randomised controlled trial, which recruited women with a pre-pregnancy body mass index ≥30 kg/m2 giving birth by elective/semi-urgent CS who received ci-NPWT (n = 1017) or standard dressings (n = 1018). Resource use and health-related quality of life (SF-12v2) collected during admission and for four weeks post-discharge were used to derive costs and quality-adjusted life years (QALYs). RESULTS: ci-NPWT was associated with AUD$162 (95%CI -$170 to $494) higher cost per person and an additional $12 849 (95%CI -$62 138 to $133 378) per SSI avoided. There was no detectable difference in QALYs between groups; however, there are high levels of uncertainty around both cost and QALY estimates. There is a 20% likelihood that ci-NPWT would be considered cost-effective at a willingness-to-pay threshold of $50 000 per QALY. Per protocol and complete case analyses gave similar results, suggesting that findings are robust to protocol deviators and adjustments for missing data. CONCLUSIONS: ci-NPWT for the prevention of SSI in obese women undergoing CS is unlikely to be cost-effective in terms of health service resources and is currently unjustified for routine use for this purpose.

Stratification of adolescents across mental phenomena emphasizes the importance of transdiagnostic distress: a replication in two general population cohorts.

Characterizing patterns of mental phenomena in epidemiological studies of adolescents can provide insight into the latent organization of psychiatric disorders. This avoids the biases of chronicity and selection inherent in clinical samples, guides models of shared aetiology within psychiatric disorders and informs the development and implementation of interventions. We applied Gaussian mixture modelling to measures of mental phenomena from two general population cohorts: the Avon Longitudinal Study of Parents and Children (ALSPAC, n = 3018) and the Neuroscience in Psychiatry Network (NSPN, n = 2023). We defined classes according to their patterns of both positive (e.g. wellbeing and self-esteem) and negative (e.g. depression, anxiety, and psychotic experiences) phenomena. Subsequently, we characterized classes by considering the distribution of diagnoses and sex split across classes. Four well-separated classes were identified within each cohort. Classes primarily differed by overall severity of transdiagnostic distress rather than particular patterns of phenomena akin to diagnoses. Further, as overall severity of distress increased, so did within-class variability, the proportion of individuals with operational psychiatric diagnoses. These results suggest that classes of mental phenomena in the general population of adolescents may not be the same as those found in clinical samples. Classes differentiated only by overall severity support the existence of a general, transdiagnostic mental distress factor and have important implications for intervention.

Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FLUCARE).

The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice.Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent.The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality.Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm.Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit.The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data.Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level.This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination.Trial registration: ISRCTN ISRCTN22729870 . Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.

PHOENIX (Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays): protocol for a randomised, multicentre feasibility study.

INTRODUCTION: Two million out of the UK's 5 million routine diagnostic CT scans performed each year incorporate the thoracolumbar spine or pelvic region. Up to one-third reveal undiagnosed osteoporosis or vertebral fractures. We developed an intervention, Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays ('PHOENIX'), to facilitate early detection and management of osteoporosis in people attending hospitals for CT scans. METHODS AND ANALYSIS: A multicentre, randomised, pragmatic feasibility study. From the general CT-attending population, women aged ≥65 years and men aged ≥75 years attending for CT scans are invited to participate, via a novel consent form incorporating Fracture Risk Assessment (FRAX) questions. Those at increased 10-year risk (within the amber or red zones of the UK FRAX graphical outputs for further action) are block randomised (1:1:1) to (1) PHOENIX intervention, (2) active control or (3) usual care. The PHOENIX intervention comprises (i) retrieving the CT scans using the NHS Image Exchange Portal, (ii) Mindways QCT Pro software analysis of CT hip and spine none density with CT vertebral fracture assessment, (iii) sending the participants' general practitioner (GP) a clinical report including diagnosis, necessary investigations and recommended treatment. Baseline CT scans from groups 2 and 3 are assessed with the PHOENIX intervention only at study end. Assuming 25% attrition, the study is powered to find a predicted superior osteoporosis treatment rate with PHOENIX (20%) vs 16% among patients whose GPs were sent the FRAX questionnaire only (active control) and 5% in the usual care group. Five hospitals are participating to determine feasibility. The co-primary feasibility outcome measures are (a) ability to randomise 375 patients within 10 months and (b) retention of 75% of survivors, completing their 1-year bone health outcome questionnaire. Secondary 1-year outcomes include osteoporosis/vertebral fracture identification rates and osteoporosis treatment rates. Stakeholder acceptability and economic aspects are evaluated. ETHICS AND DISSEMINATION: Approved by committee (National Research Ethics Service) East of England (EE) as REF/19/EE/0176. Dissemination will be through the Royal Osteoporosis Society (to patients and public) as well as to clinician peers via national and international bone/rheumatology scientific and clinical meetings. TRIAL REGISTRATION NUMBER: ISRCTN14722819.

Evaluation of a whole system approach to diet and healthy weight in the east of Scotland: Study protocol.

Obesity is a global epidemic affecting all age groups, populations and income levels across continents. The causes of obesity are complex and are routed in health behaviours, environmental factors, government policy and the cultural and built environment. Consequently, a Whole System Approach (WSA) which considers the many causes of obesity and shifts the focus away from individuals as points of intervention and puts an emphasis on understanding and improving the system in which people live in is required. This protocol describes a programme of research that will: critically evaluate the evidence for WSAs; assess longitudinally the implementation of a WSA to diet and healthy weight to explore the range of levers (drivers) and opportunities to influence relevant partnerships and interventions to target obesity in East Scotland. The programme consists of four workstreams within a mixed methods framework: 1) Systematic review of reviews of WSAs to diet and healthy weight; 2) Longitudinal qualitative process evaluation of implementing two WSAs in Scotland; 3) Quantitative and Qualitative momentary analysis evaluation of a WSA; and 4) the application of System Dynamics Modelling (SDM) methodology to two council areas in Scotland. A Public Involvement in Research group (PIRg) have informed each stage of the research process. The research programme's breadth and its novel nature, mean that it will provide valuable findings for the increasing numbers who commission, deliver, support and evaluate WSAs to diet and healthy weight nationally and internationally.

The Peterborough Exemplar: a protocol to evaluate the impact and implementation of a new patient-centred, system-wide community mental healthcare model in England.

BACKGROUND: Community mental healthcare has significantly grown since de-institutionalization. Despite progress, service fragmentation and gaps in service provision remain key barriers to effective community care in England. Recent mental healthcare policies highlighted the need to transform service provision by developing patient-centred, joined-up community mental healthcare. In response to policy guidance, a system-wide community mental healthcare model was developed in Peterborough (England). The "Peterborough Exemplar" is based on two main pillars: (1) the creation of knowledge exchange pathways to strengthen interorganizational relationships, and (2) the development of new, accessible community services addressing existing service gaps. This paper presents the protocol developed to evaluate the Peterborough Exemplar. METHODS: A quasi-experimental design with an intervention group and a nonequivalent comparator group has been developed to compare service provision provided in Peterborough pre- and post-intervention with services provided in Fenland, a neighbouring area where service users access usual care. Two evaluation methods will be employed to compare service provision between the two groups: (1) outcome measures completed by service users and carers will be analysed to assess quality of life and service satisfaction, and (2) service activity data will be analysed to assess service usage. In addition, qualitative interviews will be conducted with staff members of participating organizations to explore the implementation of the Exemplar in Peterborough and evaluate knowledge exchange processes among local service providers. A matched control approach will be used to compare outcome measures between the two areas. Descriptive and inferential statistics, including chi-square tests, will be used to analyse service activity data and examine differences between the two areas. A thematic analysis will be adopted to analyse qualitative data. DISCUSSION: Outcomes of the evaluation will contribute to understanding the contribution of the Peterborough Exemplar on mental health service provision locally. Evaluation findings and intermediate reporting will be shared with organizations involved in the implementation of the Peterborough Exemplar and with local decision-makers to inform the Exemplar delivery. As the Peterborough Exemplar is an Early Implementer (EI) site funded by NHS England, findings will be shared with policy-makers to inform national policy on community mental healthcare and integrated care.

INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care-study protocol for a multicentre randomised controlled trial.

BACKGROUND: Hospital-acquired and ventilator-associated pneumonias (HAP and VAP) are common in critical care and can be life-threatening. Rapid microbiological diagnostics, linked to an algorithm to translate their results into antibiotic choices, could simultaneously improve patient outcomes and antimicrobial stewardship. METHODS: The INHALE Randomised Controlled Trial is a multi-centre, parallel study exploring the potential of the BioFire FilmArray molecular diagnostic to guide antibiotic treatment of HAP/VAP in intensive care units (ICU); it identifies pathogens and key antibiotic resistance in around 90 min. The comparator is standard care whereby the patient receives empirical antibiotics until microbiological culture results become available, typically after 48-72 h. Adult and paediatric ICU patients are eligible if they are about to receive antibiotics for a suspected lower respiratory infection (including HAP/VAP) for the first time or a change in antibiotic because of a deteriorating clinical condition. Breathing spontaneously or intubated, they must have been hospitalised for 48 h or more. Patients are randomised 1:1 to receive either antibiotics guided by the FilmArray molecular diagnostic and its trial-based prescribing algorithm or standard care, meaning empirical antibiotics based on local policy, adapted subsequently based upon local microbiology culture results. Co-primary outcomes are (i) non-inferiority in clinical cure of pneumonia at 14 days post-randomisation and (ii) superiority in antimicrobial stewardship at 24 h post-randomisation (defined as % of patients on active and proportionate antibiotics). Secondary outcomes include further stewardship reviews; length of ICU stay; co-morbidity indicators, including septic shock, change in sequential organ failure assessment scores, and secondary pneumonias; ventilator-free days; adverse events over 21 days; all-cause mortality; and total antibiotic usage. Both cost-effectiveness of the molecular diagnostic-guided therapy and behavioural aspects determining antibiotic prescribing are being explored. A sample size of 552 will be required to detect clinically significant results with 90% power and 5% significance for the co-primary outcomes. DISCUSSION: This trial will test whether the potential merits of rapid molecular diagnostics for pathogen and resistance detection in HAP/VAP are realised in patient outcomes and/or improved antibiotic stewardship. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16483855 . Retrospectively registered on 15 July 2019.

Adding a Dimension to the Dichotomy: Affective Processes Are Implicated in the Relationship Between Autistic and Schizotypal Traits.

INTRODUCTION: There is a recognized increase in vulnerability to psychosis in autistic people (AP). However, the construct of psychosis (particularly schizophrenia) contains several distinct factors, making understanding the relationship between autism and psychosis complex. Previous research has suggested that affective lability may be particularly related to psychotic experiences for AP who have experienced psychosis (AP-P). There is also a suggestion that psychosis might be a state of extreme (over)empathizing, perhaps related to emotional processes. METHOD: We recruited three groups: AP-P (N = 23), a group of AP who had not experienced psychosis (AP-NP; N = 59) and a neurotypical control group (NC, N = 41). Participants completed measures of autistic traits, schizotypal traits (as a proxy for psychosis-proneness), emotional processes, and perspective taking (as a proxy for the type of empathizing most theoretically likely to be linked to psychosis). As well as comparisons between groups, regression analyses were used to understand the influence of dependent variables on schizotypal traits. RESULTS: We found that AP-P had significantly higher rates of schizotypy (positive and disorganized), as well as higher rates of emotional difficulties. Across all groups, affective lability had a positive and significant association with positive and disorganized schizotypal traits. Differences in perspective taking between groups were small and generally non-significant, particularly in adjusted comparisons; additionally, its impact on schizotypy was small and non-significant. DISCUSSION: Our findings suggest that positive and disorganized schizotypy, in particular, have a relationship with affective lability. This, in turn, supports the idea of emotional processes as related to the development of schizotypal traits and psychosis across all individuals, regardless of autism diagnostic status. We found no evidence of empathy relating to any subscale of schizotypy, or the total schizotypy score. We contend that emotional processes should be considered in exploration of the relationship between autism and schizotypy in future. This may help to explain some of the findings of overlap between these constructs in previous research. Factors known to affect neurodevelopment of emotion systems such as history of early trauma, challenges during pregnancy and birth, and early childhood experiences of adversity during critical windows of development need further consideration in future research.

Long-term cognitive outcome in adult survivors of an early childhood posterior fossa brain tumour.

PURPOSE: Posterior fossa brain tumours (PFT) and their treatment in young children are often associated with subsequent cognitive impairment. However, reported follow-up periods rarely exceed 10 years. This study reports very long-term cognitive consequences of surviving an early childhood PFT. METHODS: 62 adult survivors of a PFT, ascertained from a national register, diagnosed before 5 years of age, and a sibling control, received a single IQ assessment an average of 32 years (range 18-53) after initial diagnosis, using the Weschler Abbreviated Scale of Intelligence. Regression models were fitted to survivor-sibling pair differences on verbal and performance IQ (VIQ and PIQ) scores to investigate whether increasing time between PFT diagnosis and follow-up IQ assessment contributed to survivor-sibling IQ differences. RESULTS: At follow-up, survivors had, on average, VIQ 15 points and PIQ 19 points lower than their siblings. There was no significant effect of time since diagnosis on survivor-sibling VIQ difference. Survivors who received radiotherapy showed no significant effect of time since diagnosis on survivor-sibling PIQ difference. Survivors who did not receive radiotherapy demonstrated a trend for it to reduce. CONCLUSIONS: VIQ and PIQ deficits persist in adulthood, suggesting the effect of a fixed injury imposing on cognitive development, rather than an ongoing pathological process. IMPLICATIONS FOR CANCER SURVIVORS: The findings will help parents and others supporting survivors of an early life PFT to identify and plan for possible cognitive outcomes, and highlight the importance of early interventions to optimize cognitive function during the developmental period.

Association between developmental milestones and age of schizophrenia onset: Results from the Northern Finland Birth Cohort 1966.

We investigated relationships between early developmental milestones, schizophrenia incidence and variability in its age at onset. We hypothesized that the period of risk for schizophrenia would be longer for those with later development. The Northern Finland Birth Cohort 1966 was followed until 47 years of age, and those members diagnosed with schizophrenia or any other non-affective psychoses identified. Latent profile analysis was used to classify people into homogenous classes with respect to developmental milestones, and subsequently survival analysis explored relationship between classes and age of schizophrenia onset. Results suggest that 4-classes (early, regular, late, and extra late developers) can be identified, but due to few cases in one class (n = 93, <0.01% of 10,501), only 3 classes (early, regular, late) could be meaningfully compared. Schizophrenia incidence until 47 years of age differed systematically between classes: late developers had the highest cumulative incidence (2.39%); regular were intermediate (1.25%); and early developers had the lowest incidence (0.99%). However, age at onset and its variability was similar across classes, suggesting that our hypothesis of a wider 'window' for schizophrenia onset in late developers was not supported.

PROGRESS: the PROMISE governance framework to decrease coercion in mental healthcare.

Reducing physical intervention in mental health inpatient care is a global priority. It is extremely distressing both to patients and staff. PROactive Management of Integrated Services and Environments (PROMISE) was developed within Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) to bring about culture change to decrease coercion in care. This study evaluates the changes in physical intervention numbers and patient experience metrics and proposes an easy-to-adopt and adapt governance framework for complex interventions. PROMISE was based on three core values of: providing a caring response to all distress; courage to challenge the status quo; and coproduction of novel solutions. It sought to transform daily front-line interactions related to risk-based restrictive practice that often leads to physical interventions. PROactive Governance of Recovery Settings and Services, a five-step governance framework (Report, Reflect, Review, Rethink and Refresh), was developed in an iterative and organic fashion to oversee the improvement journey and effectively translate information into knowledge, learning and actions. Overall physical interventions reduced from 328 to 241and210 across consecutive years (2014, 2015-2016 and 2016-2017, respectively). Indeed, the 2016-2017 total would have been further reduced to 126 were it not for the perceived substantial care needs of one patient. Prone restraints reduced from 82 to 32 (2015-2016 and 2016-2017, respectively). During 2016-2017, each ward had a continuous 3-month period of no restraints and 4 months without prone restrains. Patient experience surveys (n=4591) for 2014-2017 rated overall satisfaction with care at 87%. CPFT reported fewer physical interventions and maintained high patient experience scores when using a five-pronged governance approach. It has a summative function to define where a team or an organisation is relative to goals and is formative in setting up the next steps relating to action, learning and future planning.

A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.

BACKGROUND: The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. METHODS: We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. FINDINGS: Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (ß -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. INTERPRETATION: Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. FUNDING: University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England.

Clinical services for adults with an intellectual disability and epilepsy: A comparison of management alternatives.

BACKGROUND: Intellectual disability (ID) is relatively common in people with epilepsy, with prevalence estimated to be around 25%. Surprisingly, given this relatively high frequency, along with higher rates of refractory epilepsy than in those without ID, little is known about outcomes of different management approaches/clinical services treating epilepsy in adults with ID-we investigate this area. MATERIALS & METHODS: We undertook a naturalistic observational cohort study measuring outcomes in n = 91 adults with ID over a 7-month period (recruited within the period March 2008 to April 2010). Participants were receiving treatment for refractory epilepsy (primarily) in one of two clinical service settings: community ID teams (CIDTs) or hospital Neurology services. RESULTS: The pattern of comorbidities appeared important in predicting clinical service, with Neurologists managing the epilepsy of relatively more of those with neurological comorbidities whilst CIDTs managed the epilepsy of relatively more of those with psychiatric comorbidities. Epilepsy-related outcomes, as measured by the Glasgow Epilepsy Outcome Scale 35 (GEOS-35) and the Epilepsy and Learning Disabilities Quality of Life Scale (ELDQoL) did not differ significantly between Neurology services and CIDTs. DISCUSSION: In the context of this study, the absence of evidence for differences in epilepsy-related outcomes amongst adults with ID and refractory epilepsy between mainstream neurology and specialist ID clinical services is considered. Determining the selection of the service managing the epilepsy of adults with an ID on the basis of the skill sets also required to treat associated comorbidities may hence be a reasonable heuristic.