Economic evaluation of a trial exploring the effects of a web-based support tool for parents of children with juvenile idiopathic arthritis.

OBJECTIVE: To explore the cost-effectiveness of a web-based support tool for parents of children with Juvenile idiopathic arthritis. METHODS: A multi-centred randomized controlled trial was conducted in paediatric rheumatology centres in England. The WebParC intervention consisted of online information about JIA and its treatment and a toolkit using cognitive-behavioural therapy principles to support parents manage their child's JIA. An economic evaluation was performed alongside the trial involving 220 parents. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress, with two dimensions: difficulty and frequency. These measures along with costs were assessed post intervention at 4 and 12 months. Costs were calculated for healthcare usage using a UK NHS economic perspective. Data was collected and analysed on the impact of caring costs on families. Uncertainty around cost-effectiveness was explored using bootstrapping and cost-effectiveness acceptability curves. RESULTS: The intervention arm showed improved average Pediatric Inventory for Parents scores for the dimensions of frequency and difficulty, of 1.5 and 3.6 respectively at 4 months and 0.35 and 0.39 at 12 months, representing improved PIP scores for the intervention arm. At both 4 and 12 month follow-up, the average total cost per case was higher in the control group when compared with the intervention arm with mean differences of £360 (95% CI £29.6 to £691) at 4 months and £203 (95% CI £16 to £390) at 12 months. The probability of the intervention being cost-effective ranged between 49% and 54%. CONCLUSION: The WebParC intervention led to reductions in primary and secondary healthcare resource use and costs at 4 and 12 months. The intervention demonstrated particular savings for rheumatology services at both follow-ups. Future economies of scale could be realised by health providers with increased opportunities for cost-effectiveness over time. TRIAL REGISTRATION: ISRCTN, ISRCTN13159730.

A patient-initiated treatment model for blepharospasm and hemifacial spasm: a randomized controlled trial.

BACKGROUND: To test, in a two-arm, single center, superiority, randomized controlled trial, the effectiveness of and costs associated with a patient-initiated treatment model for people with hemifacial spasm (HFS) and blepharospasm (BEB) in comparison to usual care. METHODS: One hundred and thirty patients with HFS or BEB, aged 18 years or over, were recruited from a nurse-led botulinum toxin type A clinic at an eye hospital in the United Kingdom (UK), completed baseline measures and were randomized (1:1). The intervention group determined their own botulinum toxin type A (BoNT/A) treatment schedule during the trial period (9 months) and received an information leaflet with a "hotline" number to book an appointment. Usual care appointments were scheduled by treating clinicians. Data analysts were blind to study group. The primary outcomes were disease severity and functional disability, as measured by the Jankovic Rating Scale and Blepharospasm Disability Index, respectively. Secondary outcomes included quality of life, anxiety and depression, satisfaction with care, confidence in the service, economic costs and employment days lost. RESULTS: Sixty-five patients were randomized to each group. The intervention demonstrated no statistically significant difference to usual care for any of primary outcomes. On secondary outcomes the levels of anxiety differed significantly (F2, 142.39 = 1.65, p = 0.02), with the intervention arm exhibiting a decrease and the control arm an increase (Hedges' g = - 0.26 [99% CI -0.83, 0.32]). No other statistically significant differences were found for secondary outcomes. Overall healthcare costs and costs to the patient were on average £198.95 less (95% CI -£256.76, £654.67; p = 0.10) per participant for those in the intervention compared to usual care, although this finding was not significant. CONCLUSIONS: We did not observe differences between the patient-initiated treatment model and usual care for people with BEB or HFS, on any primary outcome measure, quality of life, or depression. The patient-initiated treatment model may, however, have the potential to save healthcare costs and reduce anxiety. Patients using this new model were also equally as satisfied in the service and confident in their care as those receiving treatment as usual. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02577224 , 16th October 2015.

A pilot economic evaluation of a feasibility trial for SUpporting wellbeing through PEeR-Befriending (SUPERB) for post-stroke aphasia.

OBJECTIVES: To explore the feasibility of a full economic evaluation of usual care plus peer-befriending versus usual care control, and potential cost-effectiveness of peer-befriending for people with aphasia. To report initial costs, ease of instruments' completion and overall data completeness. DESIGN: Pilot economic evaluation within a feasibility randomised controlled trial. SETTING: Community, England. PARTICIPANTS: People with post-stroke aphasia and low levels of psychological distress. INTERVENTION: All participants received usual care; intervention participants received six peer-befriending visits between randomisation and four months. MAIN MEASURES: Costs were collected on the stroke-adapted Client Service Receipt Inventory (CSRI) for health, social care and personal out-of-pocket expenditure arising from care for participants and carers at 4- and 10-months post-randomisation. Health gains and costs were reported using the General Health Questionnaire-12 and the EQ-5D-5L. Mean (CI) differences for costs and health gains were reported and uncertainty represented using non-parametric bootstrapping and cost-effectiveness acceptability curves. RESULTS: 56 participants were randomised. Mean age was 70.1 (SD 13.4). Most (n = 37, 66%) had mild and many (n = 14; 25%) severe aphasia. There was ≥94% completion of CSRI questions. Peer-befriending was higher in intervention arm (p < 0.01) but there were no significant differences in total costs between trial arms. Peer-befriending visits costed on average £57.24 (including training and supervision costs). The probability of peer-befriending being cost-effective ranged 39% to 66%. CONCLUSIONS: Economic data can be collected from participants with post-stroke aphasia, indicating a full economic evaluation within a definitive trial is feasible. A larger study is needed to demonstrate further cost-effectiveness of peer-befriending.

A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis: a cost-effectiveness analysis.

OBJECTIVE: To determine whether a patient-initiated DMARD self-monitoring service for people on MTX is a cost-effective model of care for patients with RA or PsA. METHODS: An economic evaluation was undertaken alongside a randomized controlled trial involving 100 patients. Outcome measures were quality of life and ESR assessed at baseline and post-intervention. Costs were calculated for healthcare usage using a United Kingdom National Health Service economic perspective. Sensitivity analysis was performed to explore the impact of nurse-led telephone helplines. Uncertainty around the cost-effectiveness ratios was estimated by bootstrapping and analysing the cost-effectiveness planes. RESULTS: Fifty-two patients received the intervention and 48 usual care. The difference in mean cost per case indicated that the intervention was £263 more expensive (P < 0.001; 95% CI: £149.14, £375.86) when the helpline costs were accounted for and £94 cheaper (P = 0.08; 95% CI: -£199.26, £10.41) when these costs were absorbed by the usual service. There were, however, statistically significant savings for the patient (P = 0.02; 95% CI: -£28.98, £3.00). When costs and effectiveness measures of ESR and quality of life measured, using the Short Form-12v1, were combined this did not show the patient-initiated service to be cost-effective at a statistically significant level. CONCLUSION: This patient-initiated service led to reductions in primary and secondary healthcare services that translated into reduced costs, in comparison with usual care, but were not cost-effective. Further work is needed to establish how nurse-led telephone triage services are integrated into rheumatology services and the associated costs of setting up and delivering them. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, ISRCTN21613721.

Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial.

OBJECTIVE: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. DESIGN: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. PARTICIPANTS AND SETTING: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. INTERVENTION: Six 1-hour peer-befriending visits over three months. MAIN MEASURES: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. RESULTS: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, -2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated. CONCLUSIONS: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial.Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke.

'Emotion is of the essence. Number one priority': A nested qualitative study exploring psychosocial adjustment to stroke and aphasia.

BACKGROUND: Stroke and aphasia can have a profound impact on people's lives, and depression is a common, frequently persistent consequence. Social networks also suffer, with poor social support associated with worse recovery. It is essential to support psychosocial well-being post-stroke, and examine which factors facilitate successful adjustment to living with aphasia. AIMS: In the context of a feasibility randomized controlled trial of peer-befriending (SUPERB), this qualitative study explores adjustment for people with aphasia in the post-acute phase of recovery, a phase often neglected in previous research. METHODS & PROCEDURES: Semi-structured interviews were conducted with 20 people with aphasia and 10 significant others, who were purposively sampled from the wider group of 56 people with aphasia and 48 significant others. Interviews took place in participants' homes; they were analysed using framework analysis. OUTCOMES & RESULTS: Participants with aphasia were 10 women and 10 men; their median (interquartile range-IQR) age was 70 (57.5-77.0) years. Twelve participants had mild aphasia, eight moderate-severe aphasia. Significant others were six women and four men with a median (IQR) age of 70.5 (43-79) years. They identified a range of factors that influenced adjustment to aphasia post-stroke. Some were personal resources, including mood and emotions; identity/sense of self; attitude and outlook; faith and spirituality; and moving forward. Significant others also talked about the impact of becoming carers. Other factors were external sources of support, including familial and other relationships; doctors, nurses and hospital communication; life on the ward; therapies and therapists; psychological support, stroke groups; and community and socializing. CONCLUSIONS & IMPLICATIONS: To promote adjustment in the acute phase, hospital staff should prioritize the humanizing aspects of care provision. In the post-acute phase, clinicians play an integral role in supporting adjustment and can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy. What this paper adds What is already known on the subject Anxiety and depression are common consequences of stroke, with depression rates high at 33% at 1 year post-onset. There is evidence that the psychological needs of people with aphasia are even greater than those of the general stroke population. Social support and social networks are also negatively impacted. Few studies have examined adjustment when people are still in hospital or in the early stages of post-stroke life in the community (< 6 months). Further, many stroke studies exclude people with aphasia. What this paper adds to existing knowledge Adjustment to living with stroke and aphasia begins in the early stages of recovery. While this partly depends on personal resources, many factors depend on external sources of help and support. These include doctors, nurses and hospital communication, their experience of life on the ward, and their therapists' person-centred care. What are the potential or actual clinical implications of this work? Clinicians play an integral role in facilitating people with aphasia to utilize their personal resources and support systems to adjust to life after stroke. They can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy.

Barriers to effective diabetes management - a survey of people with severe mental illness.

BACKGROUND: People with severe mental illnesses (SMI) such as schizophrenia and bipolar disorder have an increased risk of developing type 2 diabetes and have poorer health outcomes than those with diabetes alone. To maintain good diabetes control, people with diabetes are advised to engage in several self-management behaviours. The aim of this study was to identify barriers or enablers of diabetes self-management experienced by people with SMI. METHODS: Adults with type 2 diabetes and SMI were recruited through UK National Health Service organisations and mental health and diabetes charities. Participants completed an anonymous survey consisting of: Summary of Diabetes Self-Care Activities (SDSCA); CORE-10 measure of psychological distress; a measure of barriers and enablers of diabetes self-management based on the Theoretical Domains Framework; Diabetes UK care survey on receipt of 14 essential aspects of diabetes healthcare. To identify the strongest explanatory variables of SDSCA outcomes, significant variables (p < .05) identified from univariate analyses were entered into multiple regressions. RESULTS: Most of the 77 participants had bipolar disorder (42%) or schizophrenia (36%). They received a mean of 7.6 (SD 3.0) diabetes healthcare essentials. Only 28.6% had developed a diabetes care plan with their health professional and only 40% reported receiving specialist psychological support. Engagement in self-management activities was variable. Participants reported taking medication on 6.1 (SD 2.0) days in the previous week but other behaviours were less frequent: general diet 4.1 (2.3) days; specific diet 3.6 (1.8) days, taking exercise 2.4 (2.1) days and checking feet on 1.7 (1.8) days. Smoking prevalence was 44%. Participants reported finding regular exercise and following a healthy diet particularly difficult. Factors associated with diabetes self-management included: the level of diabetes healthcare and support received; emotional wellbeing; priority given to diabetes; perceived ability to manage diabetes or establish a routine to do so; and perceived consequences of diabetes self-management. CONCLUSIONS: Several aspects of diabetes healthcare and self-management are suboptimal in people with SMI. There is a need to improve diabetes self-management support for this population by integrating diabetes action plans into care planning and providing adequate psychological support to help people with SMI manage their diabetes.

Evaluation of expressive writing for postpartum health: a randomised controlled trial.

Pregnancy, birth and adjusting to a new baby is a potentially stressful time that can negatively affect the health of women. There is some evidence that expressive writing can have positive effects on psychological and physical health, particularly during stressful periods. The current study aimed to evaluate whether expressive writing would improve women's postpartum health. A randomized controlled trial was conducted with three conditions: expressive writing (n = 188), a control writing task (n = 213), or normal care (n = 163). Measures of psychological health, physical health and quality of life were measured at baseline (6-12 weeks postpartum), 1 and 6 months later. Ratings of stress were taken before and after the expressive writing task. Intent-to-treat analyses showed no significant differences between women in the expressive writing, control writing and normal care groups on measures of physical health, anxiety, depression, mood or quality of life at 1 and 6 months. Uptake and adherence to the writing tasks was low. However, women in the expressive writing group rated their stress as significantly reduced after completing the task. Cost analysis suggest women who did expressive writing had the lowest costs in terms of healthcare service use and lowest cost per unit of improvement in quality of life. Results suggest expressive writing is not effective as a universal intervention for all women 6-12 weeks postpartum. Future research should examine expressive writing as a targeted intervention for women in high-risk groups, such as those with mild or moderate depression, and further examine cost-effectiveness.Clinical trial registration number ISRCTN58399513 www.isrctn.com.

Barriers and enablers of type 2 diabetes self-management in people with severe mental illness.

BACKGROUND: People with diabetes and severe mental illness (SMI) experience poorer outcomes than those with diabetes alone. To improve outcomes, it is necessary to understand the difficulties that people with SMI experience in managing their diabetes. AIMS: To identify barriers and enablers to effective diabetes self-management experienced by people with SMI and type 2 diabetes. METHOD: Qualitative methodology using semi-structured interviews was employed. Development of the interview topic guide and analysis of the transcripts were informed by the Theoretical Domains Framework for behaviour change, which consists of fourteen theoretical domains that have been found to influence behaviour. RESULTS: Fourteen people with SMI and type 2 diabetes took part in the study. Participants considered diabetes self-management to be important, were aware of the risks of poor diabetes control but struggled to follow recommended advice, particularly if their mental health was poor. Support from family and health professionals was considered an important enabler of diabetes self-management. CONCLUSIONS: New approaches are required to support diabetes self-management in people with SMI. This study identified some of the important domains that may be targeted in new interventions.

Implementation of recommended type 2 diabetes care for people with severe mental illness - a qualitative exploration with healthcare professionals.

BACKGROUND: The purpose of this study was to explore the barriers and facilitators healthcare professionals experience when managing type 2 diabetes in people with severe mental illness (SMI). METHODS: A qualitative semi-structured interview approach was employed. Questions were structured according to the Theoretical Domains Framework (TDF), which outlines 14 domains that can act as barriers and facilitators to changing behaviour. Interviews were audio-recorded and transcribed verbatim. The data were coded according to the 14 domains of the TDF, belief statements were created within each domain and the most relevant belief statements within each domain identified through a consensus approach. Analyses were conducted by two researchers, and discrepancies agreed with a third researcher. RESULTS: Sixteen healthcare professionals, from a range of services, involved in the care of people with type 2 diabetes and SMI took part in an interview. Inter-rater reliability for each of the domains varied (25 %-74 %). All fourteen domains were deemed relevant, with 42 specific beliefs identified as important to the target behaviour. Participants identified having relevant knowledge and skills for diabetes management, prioritising this area of health, and reviewing health behaviours to develop action plans, as particularly important. At an organisational level, integrated care provision and shared information technology (IT) services between mental health and physical services, and clearly defined roles and responsibilities for the different professions, with designated time to undertake the work were identified as crucial. CONCLUSIONS: The findings highlight that healthcare professionals' experience a range of barriers and enablers when attempting to manage type 2 diabetes in people with SMI. These include organisational factors and individual beliefs, suggesting that interventions need to be targeted at both an organisation and individual level in order to change behaviour. Further work is needed to model these relationships in a larger sample of participants in line with the MRC guidance for developing complex interventions.

Self management interventions for type 2 diabetes in adult people with severe mental illness.

BACKGROUND: People with severe mental illness are twice as likely to develop type 2 diabetes as those without severe mental illness. Treatment guidelines for type 2 diabetes recommend that structured education should be integrated into routine care and should be offered to all. However, for people with severe mental illness, physical health may be a low priority, and motivation to change may be limited. These additional challenges mean that the findings reported in previous systematic reviews of diabetes self management interventions may not be generalised to those with severe mental illness, and that tailored approaches to effective diabetes education may be required for this population. OBJECTIVES: To assess the effects of diabetes self management interventions specifically tailored for people with type 2 diabetes and severe mental illness. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, EMBASE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the International Clinical Trials Registry Platform (ICTRP) Search Portal, ClinicalTrials.gov and grey literature. The date of the last search of all databases was 07 March 2016. SELECTION CRITERIA: Randomised controlled trials of diabetes self management interventions for people with type 2 diabetes and severe mental illness. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts and full-text articles, extracted data and conducted the risk of bias assessment. We used a taxonomy of behaviour change techniques and the framework for behaviour change theory to describe the theoretical basis of the interventions and active ingredients. We used the GRADE method (Grades of Recommendation, Assessment, Development and Evaluation Working Group) to assess trials for overall quality of evidence. MAIN RESULTS: We included one randomised controlled trial involving 64 participants with schizophrenia or schizoaffective disorder. The average age of participants was 54 years; participants had been living with type 2 diabetes for on average nine years, and with their psychiatric diagnosis since they were on average 28 years of age. Investigators evaluated the 24-week Diabetes Awareness and Rehabilitation Training (DART) programme in comparison with usual care plus information (UCI). Follow-up after trial completion was six months. Risk of bias was mostly unclear but was high for selective reporting. Trial authors did not report on diabetes-related complications, all-cause mortality, adverse events, health-related quality of life nor socioeconomic effects. Twelve months of data on self care behaviours as measured by total energy expenditure showed a mean of 2148 kcal for DART and 1496 kcal for UCI (52 participants; very low-quality evidence), indicating no substantial improvement. The intervention did not have a substantial effect on glycosylated haemoglobin A1c (HbA1c) at 6 or 12 months of follow-up (12-month HbA1c data 7.9% for DART vs 6.9% for UCI; 52 participants; very low-quality evidence). Researchers noted small improvements in body mass index immediately after the intervention was provided and at six months, along with improved weight post intervention. Diabetes knowledge and self efficacy improved immediately following receipt of the intervention, and knowledge also at six months. The intervention did not improve blood pressure. AUTHORS' CONCLUSIONS: Evidence is insufficient to show whether type 2 diabetes self management interventions for people with severe mental illness are effective in improving outcomes. Researchers must conduct additional trials to establish efficacy, and to identify the active ingredients in these interventions and the people most likely to benefit from them.

Cross-national comparisons of attitudes towards suicide and suicidal persons in university students from 12 countries.

This paper reports the results of a comparative investigation of attitudes to suicide and suicidal persons in 5,572 university students from 12 countries. Participants filled out two scales measuring attitudes towards suicide and suicidal persons, a measure of psychological distress together with the questions about suicidal behavior. Results showed that the highest suicide acceptance scores were observed in Austrian, UK, Japanese and Saudi Arabian samples and the lowest scores were noted in Tunisian, Turkish, Iranian and Palestinian samples. While the highest social acceptance scores for a suicidal friend were noted in Turkish, US, Italian and Tunisian samples, the lowest scores were seen in Japanese, Saudi Arabian, Palestinian and Jordanian samples. Compared to participants with a suicidal past, those who were never suicidal displayed more internal barriers against suicidal behavior. Men were more accepting of suicide than women but women were more willing to help an imagined suicidal peer. Participants with accepting attitudes towards suicide but rejecting attitudes towards suicidal persons reported more suicidal behavior and psychological distress, and were more often from high suicide rate countries and samples than their counterparts. They are considered to be caught in a fatal trap in which most predominant feelings of suicidality such as hopelessness or helplessness are likely to occur. We conclude that in some societies such as Japan and Saudi Arabia it might be difficult for suicidal individuals to activate and make use of social support systems.

Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK.

BACKGROUND: Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. METHODS: This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. RESULTS: A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. CONCLUSIONS: The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to support the cost effectiveness of providing peer support, but neither was it proven a costly intervention to deliver. The findings support an argument for a larger scale trial of peer support as an adjunct to existing services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74852771.

Evaluating artificial intelligence-driven stress echocardiography analysis system (EASE study): A mixed method study.

INTRODUCTION: The use and value of artificial intelligence (AI)-driven tools and techniques are under investigation in detecting coronary artery disease (CAD). EchoGo Pro is a patented AI-driven stress echocardiography analysis system produced by Ultromics Ltd. (henceforth Ultromics) to support clinicians in detecting cardiac ischaemia and potential CAD. This manuscript presents the research protocol for a field study to independently evaluate the accuracy, acceptability, implementation barriers, users' experience and willingness to pay, cost-effectiveness and value of EchoGo Pro. METHODS AND ANALYSIS: The 'Evaluating AI-driven stress echocardiography analysis system' (EASE) study is a mixed-method evaluation, which will be conducted in five work packages (WPs). In WP1, we will examine the diagnostic accuracy by comparing test reports generated by EchoGo Pro and three manual raters. In WP2, we will focus on interviewing clinicians, innovation/transformation staff, and patients within the National Health Service (NHS), and staff within Ultromics, to assess the acceptability of this technology. In this WP, we will determine convergence and divergence between EchoGo Pro recommendations and cardiologists' interpretations and will assess what profile of cases is linked with convergence and divergence between EchoGo Pro recommendations and cardiologists' interpretations and how these link to outcomes. In WP4, we will conduct a quantitative cross-sectional survey of trust in AI tools applied to cardiac care settings among clinicians, healthcare commissioners and the general public. Lastly, in WP5, we will estimate the cost of deploying the EchoGo Pro technology, cost-effectiveness and willingness to pay cardiologists, healthcare commissioners and the general public. The results of this evaluation will support evidence-informed decision-making around the widespread adoption of EchoGo Pro and similar technologies in the NHS and other health systems. ETHICS APPROVAL AND DISSEMINATION: This research has been approved by the NHS Health Research Authority (IRAS No: 315284) and the London South Bank University Ethics Panel (ETH2223-0164). Alongside journal publications, we will disseminate study methods and findings in conferences, seminars and social media. We will produce additional outputs in appropriate forms, for example, research summaries and policy briefs, for diverse audiences in NHS.

SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia.

OBJECTIVE: To evaluate systematically the fidelity of a peer-befriending intervention for people with aphasia. DESIGN: SUpporting wellbeing through Peer-befriending (SUPERB) was a feasibility randomised controlled trial comparing usual care to usual care +peer-befriending. This paper reports on the fidelity of all intervention aspects (training and supervision of providers/befrienders; intervention visits) which was evaluated across all areas of the Behaviour Change Consortium framework. SETTING: Community. PARTICIPANTS: People with aphasia early poststroke and low levels of distress, randomised to the intervention arm of the trial (n=28); 10 peer-befrienders at least 1-year poststroke. INTERVENTION: Peer-befrienders were trained (4-6 hours); and received regular supervision (monthly group while actively befriending, and one-to-one as and when needed) in order to provide six 1-hour peer-befriending visits over 3 months. MAIN MEASURES: Metrics included number and length of training, supervision sessions and visits. All training and supervision sessions and one (of six) visits per pair were rated against fidelity checklists and evaluated for inter-rater and intrarater reliability (Gwets AC1 agreement coefficient). Per-cent adherence to protocol was evaluated. RESULTS: All peer-befrienders received 4-6 hours training over 2-3 days as intended. There were 25 group supervision sessions with a median number attended of 14 (IQR=8-18). Twenty-six participants agreed (92.8%) to the intervention and 21 (80.8%) received all six visits (median visit length 60 min). Adherence was high for training (91.7%-100%) and supervision (83%-100%) and moderate-to-high for befriending visits (66.7%-100%). Where calculable, inter-rater and intrarater reliability was high for training and supervision (Gwets AC1 >0.90) and moderate-to-high for intervention visits (Gwets AC1 0.44-1.0). CONCLUSION: Planning of fidelity processes at the outset of the trial and monitoring throughout was feasible and ensured good-to-high fidelity for this peer-befriending intervention. The results permit confidence in other findings from the SUPERB trial. TRIAL REGISTRATION NUMBER: NCT02947776.

Should "standard gamble" and "'time trade off" utility measurement be used more in mental health research?

BACKGROUND: This review and discussion paper demonstrates that utility and preference measurement in mental health research is increasing. However there is still a general reluctance around using the methods due to methodological challenges and concerns around the capacity of users to understand utility methods during the research process. AIMS OF THE STUDY: This paper sets out to describe and review some of the previously documented difficulties of using utility measurements in mental health services research and to highlight where they have been used successfully as measures. Additionally the paper aims to discuss a means of improving the methods used to capture service user utility and preference measurement and why decision making would be better informed as a result. METHODS: International literature on utility measurement is reviewed, specifically examining the use of standard gamble and time trade off methods in mental health. RESULTS: Utility measurement in mental health is increasing though as the review demonstrates, concerns still exist over its application. A number of methods can be used to improve the approach overall and these are discussed as well as specific areas worthy of utility measurement including 'disutility' of admission, medication and medication side effects. DISCUSSION AND LIMITATIONS: Overall this paper argues that it is necessary to persist with efforts to conduct utility measurement calculation albeit with a critical eye on the methods in an attempt to ensure improvements are continually made. Utility and preference scores may be limited in that they only provide a rough score but they are defended as a means of providing some form of strength of preference for health states. The review is limited to English only texts. IMPLICATIONS FOR HEALTH CARE PROVISION: The debate on whether to use standard gamble and time trade off has implications for health services resource allocations, decision making, health economics research, policy making and health services research generally involving psychiatric service users. The paper argues that the absence of utility measurement in mental health runs the risk of mental health being disadvantaged in decisions around resource allocation. IMPLICATIONS FOR HEALTH POLICIES: Institutions involved in decision making like the United Kingdom's National Institute for Health and Clinical Excellence, would be better served in their decision making and calculation of Quality Adjusted Life Years if more utility measurement in psychiatric research was carried out. Other arguments for using utility measurement include the desirability of using utility measurement to elicit a patient dimension of risk. IMPLICATIONS FOR FURTHER RESEARCH: Future utility research should aim for better involvement of service users in the design stage, the changing of time frames offered to users in health state scenarios used, a greater need for comparative work of utilities scoring across illness and between standard gamble and time trade off and more staff training in the use of utility methodology with mental health service users.

Antipsychotic medication side effects knowledge amongst registered mental health nurses in England: A national survey.

WHAT IS KNOWN ON THE SUBJECT?: Research findings indicate the percentage of knowledge-related errors in medicines management is high, accounting for approximately 75% of all errors, with insufficient knowledge levels one of the most significant contributors of medication errors. Patients should be able to trust nurses to engage therapeutically and actively listen to their needs and concerns, responding using skills that are helpful, providing information that is clear, accurate, meaningful and free from jargon. However, without knowledge of pharmacology, it is impossible for nurses to be able to provide adequate advice. WHAT THE PAPER ADDS TO THE EXISTING KNOWLEDGE?: This study has examined an area that had not yet been systematically examined previously, which draws together previous research findings on mental health nurses' knowledge of adverse events, including side effects and medication errors, related to antipsychotic medication within NHS inpatient settings. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: A recent study has found that almost three-quarters (73%) of patients taking antipsychotic medication reported side effects to some degree. This high number of people experiencing antipsychotic medication side effects is likely to compromise care, especially in situations where nurses have inadequate knowledge of side effects and are unable to provide effective advice to patients. The findings from this study allow the mental health nursing profession an opportunity to reflect on the best means to increase knowledge and increase patient safety awareness and benefits for mental health service users. ABSTRACT: Introduction Antipsychotic medications play a significant role in the treatment and recovery of people with several psychiatric disorders. However, research findings indicate mental health nurses are insufficiently knowledgeable about antipsychotic medication side effects. Aim To assess practising mental health nurses' knowledge of antipsychotic medication side effects using a Multiple-Choice Questionnaire (MCQ) across National Health Service (NHS) Trusts in England. Hypothesis Knowledge of antipsychotic medication side effects amongst registered mental health nurses is related to their academic qualification, clinical banding and length of experience. Method A national survey of registered mental health nurses was carried out using an online questionnaire which was disseminated by Research and Development departments. Results A total of 504 questionnaires were returned, 245 of which had full data and further analysed. The mean score for the sample was 14.4 and only 21 participants attained a mark of >80%. Implications for Practice Two out of three of our hypotheses (that length of experience and clinical banding are directly related to knowledge of antipsychotic medication side effects) were supported. Our study found many nurses have a suboptimal working knowledge of antipsychotic medication side effects which has the potential to compromise care. Strategies need to be put in place to enhance pharmacology knowledge.

Is Individualism Suicidogenic? Findings From a Multinational Study of Young Adults From 12 Countries.

The associations of individualistic versus collectivistic value orientations with suicidal ideation and attempts, attitudes towards suicide and towards suicidal individuals, and psychological distress were investigated across 12 nations (N = 5572 university students). We expected differential associations of value orientations with suicidal behavior and moderating effects of the prevailing value orientations in the various countries. Findings showed that intermediate levels of individualism appeared protective against suicide attempts across all investigated nations, but that, otherwise, there seemingly are no universal associations of individualism and collectivism with suicidal behaviors. High collectivism was associated with less suicidal ideation only in individualistic countries. Low individualism appeared to be a risk factor for suicidal ideation specifically in Muslim collectivistic cultures, whereas high individualism in Asian collectivistic cultures. Collectivistic values are uniformly associated with less permissive attitudes to suicide, whereas individualistic values with a more stigmatized view of suicidal behavior. Both individualistic and collectivistic values were associated with socially accepting attitudes to a suicidal peer, helping a suicidal friend, and emotional involvement. The associations of individualistic and collectivistic values with disapproving attitudes to suicidal disclosure were complex. Beliefs in punishment after death for suicide, seeing suicide as mental illness, and emotional involvement with a suicidal friend were lower in high-suicide-rate countries. These evidence patterns are discussed in the light of related research evidence, along with directions for future research in this area.

Views of service users and providers on joint crisis plans: single blind randomized controlled trial.

INTRODUCTION: We report participants' and case managers' use of and views on the value of Joint Crisis Plans (JCPs), shown to reduce compulsory hospitalisation and violence. METHOD: One hundred sixty people with psychosis or bipolar disorder participated in a randomized controlled trial. Intervention group participants were interviewed on receipt of the JCP, on hospitalisation, and at 15 month follow-ups; case managers were interviewed at 15 months. RESULTS: Sixty-two of the 65 people who received a JCP (95%) were interviewed at least once. Depending on the question, 46-96% of JCP holders (N = 44) responded positively to questions concerning the value of the JCP at immediate follow up. At 15 months the proportions of positive responses to the different questions was 14-82% (N = 50). Thirty-nine to eighty-five per cent of case managers (N = 28) responded positively at 15 months. Comparing the total scores of participants who had completed both the initial and follow up questionnaires showed a shift in responses, from positive to no change, from the immediate follow up to 15 months (means 6.1 vs. 8.3, difference 2.2, 95% CI 0.8, 3.7, P = 0.003) where a higher score indicates less positive views. The two items that received highest endorsement also showed least shift over time, i.e. whether the participant would recommend the JCP to others (90% initial vs. 82% at 15 months) and whether they felt more in control of their mental health problem as a result (71% at initial vs. 56% at 15 months). Case managers at 15 months were more positive than service users, with total score means of 5 vs. 7.8 (difference -2.8, 95% CI -4.5, -1.2, P = 0.002). CONCLUSIONS: The best supported hypothesis was that participants felt more in control of their mental health problem. Together with the previously reported outcomes, this suggests JCPs empower their holders to obtain their preferred care and treatment in a crisis. Further research is needed to more clearly identify the mechanisms of action of JCPs and how their initial positive impact can be sustained.

Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB).

BACKGROUND: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. METHODS/DESIGN: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). DISCUSSION: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016.