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Abstract Background Two million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise the importance of exercise and vocational activity on QoL and therefore will integrate options for physical activity and return to work/vocational support, thus ACT Plus (+). Methods We will conduct a multi-centre, pragmatic, theory driven, randomised controlled trial. We will assess whether ACT+ including usual aftercare (intervention) is more effective and cost-effective than usual aftercare alone (control). The primary outcome is QoL of participants living with or beyond cancer measured using the Functional Assessment of Cancer Therapy: General scale (FACT-G) at 52 weeks. We will recruit 344 participants identified from secondary care sites who have completed hospital-based treatment for cancer with curative intent, with low QoL (determined by the FACT-G) and randomise with an allocation ratio of 1:1 to the intervention or control. The intervention (ACT+) will be delivered by NHS Talking Therapies, specialist services, and cancer charities. The intervention consists of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs, i.e. face-to-face sessions, over the phone or skype. Discussion To date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families. Trial registration ISRCTN: ISRCTN67900293 . Registered on 09 December 2019. All items from the World Health Organization Trial Registration Data Set for this protocol can be found in Additional file 2 Table S1.

Abstract Background Rates of compulsory (also known as involuntary) detention under mental health legislation have been rising over several decades in countries including England. Avoiding such detentions should be a high priority given their potentially traumatic nature and departure from usual ethical principles of consent and collaboration. Those who have been detained previously are at high risk of being detained again, and thus a priority group for preventive interventions. In a very sparse literature, interventions based on crisis planning emerge as having more supporting evidence than other approaches to preventing compulsory detention. Method We have adapted and manualised an intervention previously trialled in Zürich Switzerland, aimed at reducing future compulsory detentions among people being discharged following a psychiatric admission that has included a period of compulsory detention. A co-production group including people with relevant lived and clinical experience has co-designed the adaptations to the intervention, drawing on evidence on crisis planning and self-management and on qualitative interviews with service users and clinicians. We will conduct a randomised controlled feasibility trial of the intervention, randomising 80 participants to either the intervention in addition to usual care, or usual care only. Feasibility and acceptability of the intervention and trial procedures will be assessed through process evaluation (including rates of randomisation, recruitment, and retention) and qualitative interviews. We will also assess and report on planned trial outcomes. The planned primary outcome for a full trial is repeat compulsory detention within one year of randomisation, and secondary outcomes include compulsory detention within 2 years, and symptoms, service satisfaction, self-rated recovery, self-management confidence, and service engagement. A health economic evaluation is also included. Discussion This feasibility study, and any subsequent full trial, will add to a currently limited literature on interventions to prevent involuntary detention, a goal valued highly by service users, carers, clinicians, and policymakers. There are significant potential impediments to recruiting and retaining this group, whose experiences of mental health care have often been negative and traumatising, and who are at high risk of disengagement. Trial registration ISRCTN, ISRCTN11627644. Registered 25th May 2022, https://www.isrctn.com/ISRCTN11627644 .

Background Despite the effectiveness of cognitive remediation, it is not widely implemented because we do not know whether teams will accept it, how much therapist time is needed, whether there are factors which predict lower benefits, whether it is cost-effective and what is required for large-scale roll-out. Objective To understand the factors that will enhance implementation and benefits of cognitive remediation in Early Intervention Services. Design Four work packages: (1) focus groups and interviews exploring the development of satisfaction and preference measures for staff and service users; participant team interviews to collect data, before and after introducing cognitive remediation, to understand team dynamics; (2) an observational study of a newly developed therapist e-training programme; (3) a multiarm multistage four-arm randomised controlled trial comparing different amounts of therapist input with Treatment as Usual; and (4) an analysis of trial data to understand potential mediating and moderating factors that affect treatment benefits. Setting Early Intervention Services in the United Kingdom National Health Service. Participants Staff and service users in touch with Early Intervention Services. Interventions For the e-training, we piloted and then provided an e-learning system for training cognitive remediation therapists. For the randomised trial, we provided a cognitive remediation software programme (CIRCuiTS™,King’s College London, London) that was delivered in three conditions, all offering up to 42 sessions of cognitive remediation. The conditions were: Intensive (one to one with a therapist), Group treatment with a therapist, Independent with drop-in sessions. Main outcome measures Work package 1: We developed two satisfaction measures and tested a team dynamic model. Work package 2: Feasibility and acceptability questionnaire, time to complete e-training modules. Work package 3: The personal recovery measure – Goal Attainment Scale. Results Work package 1: The service user satisfaction with cognitive remediation was reliable and valid. Although it did not show statistically significant differences between the arms of the trial, the most preferred methods (Group and Intensive) had higher associated satisfaction. Team leadership and especially a flattened hierarchy, resources and time were identified as vital for implementation. Our team dynamic model supported the importance of leadership in influencing organisational climate, which then affected staff attitudes. However, this was only significant before staff had any experience of their patients receiving cognitive remediation. Although the sample was much smaller after therapy, this may indicate that experience of the beneficial therapy changes team dynamics. Work package 2: The e-training modules were completed by 43% of the recruited participants. They judged the training to be feasible and acceptable, but it did take longer to complete than expected. COVID-19 with the increased workload may have had some effects, but our data exploration shows that it was individuals who had most recently qualified who had the best outcomes. This may be because of a lighter workload or that they were more used to online training. Adaptations suggested are now being implemented. Work package 3: Following the interim analysis we closed two arms – Independent therapy and Treatment as Usual. Four hundred and forty-eight patients consented and 377 were eligible and completed baseline assessment. They were randomised: Group 134, Independent 65, Intensive 112 and Treatment as Usual 66. At post therapy, there were no differences between Group and Intensive or between Independent and Treatment as Usual, but the combined Group and Intensive versus Treatment as Usual was significant (mean difference: 5.734; standard error = 1.958; p = 0.003; lower confidence interval = 1.898 to upper confidence interval = 9.571). Our economic analysis showed that Group and Intensive cognitive remediation were not different with respect to quality-adjusted life-years (difference £150, 95% confidence interval –£1132 to £1905). Both conferred significant benefit compared with standard care (Group and Treatment as Usual: difference £257, 95% confidence interval –£1694 to £2615; Intensive vs. Treatment as Usual: difference £260, 95% CI –£1654 to £2239). Their cost–benefit for quality-adjusted life-year improvement was well below the National Institute for Health and Care Excellence threshold for adopting the intervention to National Health Service services. Work package 4: Cognition had a small mediation effect, and negative symptoms moderated the transfer of cognitive benefits to goal attainment. Limitations The trial suffered from recruitment difficulties which were overcome when we switched from block to individual randomisation. The final target was large enough to test our main outcomes and moderating and mediating variables. Conclusions Cognitive remediation should be provided in the National Health Service, involving a trained therapist on a Group or Intensive format with team and training support. Future work We have a large database and will continue to investigate factors that affect cognitive remediation benefits. Study registration This study is registered as ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0612-20002) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 4. See the NIHR funding and Awards website for further award information. Plain language summary Cognitive problems in people with schizophrenia predict functional recovery even with the best-possible rehabilitation opportunities. One psychological treatment, cognitive remediation can improve both cognitive and functional recovery, such as in social relationships and occupational achievements. We investigated the optimal way of delivering computerised cognitive remediation in Early Intervention Services by incorporating service user and staff views. Our work involved exploring what treatment factors are important to service users, developing two bespoke cognitive remediation satisfaction measures for service users and service providers. Our investigation of team dynamics suggested that a more flexible leadership style together with increasing resources might be most suited to successful delivery. One challenge for large-scale roll-out of cognitive remediation is therapist training opportunities, so we developed an online programme and then tested it in the United Kingdom and, with a few adaptations, it can be provided to the National Health Service. Although cognitive remediation is effective, we do not know how much therapist time produces therapy benefits, so we conducted a trial comparing three options for cognitive remediation treatment that differed in the amount of the therapist time (Independent, Group and Intensive). We compared these options with a no-treatment group. We investigated benefits of each option in 377 participants from Early Intervention Services. The main benefit assessed was whether participants could achieve their personal goals that were set before therapy began. Although we found no change in a social or occupational functioning scale rated by an observer, the Group and Intensive cognitive remediation produced significant achievements in the participants’ own personal goals compared with those who did not receive therapy or who carried out therapy on their own. We also found that any cognitive remediation therapy option improved thinking skills. Group and Intensive therapy were also cost-effective. Overall, cognitive remediation was acceptable and well liked by service users, so all our data suggest that it should be more easily accessible in the National Health Service. Scientific summary Cognitive remediation (CR) therapy is a psychological intervention targeting cognitive dysfunction associated with psychosis with the goal of improving functional outcomes. Cognitive remediation can improve cognitive and functional recovery, as well as increasing confidence and motivation. Evidence from the largest meta-analysis demonstrated that these effects are durable. National Health Service Early Intervention for psychosis services provide care soon after a diagnosis of psychosis to optimise recovery. Embedding CR in those services may confer long-lasting benefits such as improved social relationships and the opportunity to work or take part in further education. The overarching aim of the Enhancing Cognition and quality of Life in early PSychosiEs (ECLIPSE) research programme was to determine the optimal method of introducing computerised CR therapy (CIRCuiTS™) into NHS Early Intervention Services (EIS) considering improvement in cognitive and social function and cost-effectiveness. The programme was centred on work package 3 (WP3), a randomised, blinded multiarm multisite controlled trial comparing three CR implementation methods with each other and with routine clinical care [Treatment as Usual (TAU)]. To aid the interpretation of WP3 and bolster our recommendations to the NHS, WP1 included a series of studies investigating: patient and staff satisfaction with CR; preference for the methods of CR delivery; and the influence of team organisational climate. Although the CR was computerised and can be completed independently, its effects are boosted via learning, practice and feedback supervised by a therapist. WP2 was a series of studies to design and test an online CR therapist training package to use in their individual teams. Finally, WP4 examined mediators and moderators of the trial results to inform teams about how the clinical features of their individual patients may influence the effect of CR. In WP3, the CR modalities were: Intensive 1 : 1 therapist supervision; Group supervision with one therapist; and Independent (self-determined with infrequent access to therapist supervision). Participants were recruited from EIS in 12 mental health trusts, linked to 6 universities and serving diverse urban/rural populations. They were clinically stable and presented with a non-affective psychotic episode not

Background Poor adherence to photoprotection from ultraviolet radiation in the rare disease xeroderma pigmentosum can be life-threatening due to heightened risk of skin cancers. This novel, two-phase research programme used mixed methods to investigate photoprotection in xeroderma pigmentosum, and its psychosocial impact, to develop an intervention to improve photoprotection. Objective(s) Phase I: To identify barriers to optimal photoprotection. Phase II: To design and test a personalised psychological intervention to improve photoprotection. Design Phase I: Interview study; n-of-1 photoprotection study; objective measurement of ultraviolet radiation exposure study; international cross-sectional survey. Phase II: Consensus conference to synthesise findings and determine targets/priorities for intervention; intervention development using Intervention mapping; randomised controlled trial to test efficacy, cost-effectiveness and intervention mechanisms. Settings for Phases I and II National Xeroderma Pigmentosum Service, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom; Specialist xeroderma pigmentosum clinics in Regensburg, Germany, Japan, Tunisia; Patient support organisations in France and USA. Participants Children < 16 (Phase I only) and adults (> 16) diagnosed with xeroderma pigmentosum. Intervention (Phase II) XPAND is a seven-session personalised psychological intervention designed to be facilitated by non-psychologists, delivered in spring to summer 2018 versus wait list control (intervention in spring to summer 2019). Main trial outcome measure (Phase II) Average daily ultraviolet radiation dose to the face calculated by combining objective ultraviolet radiation exposure with self-reported photoprotection. Results Phase I: Varying levels of photoprotection were found, with most participants doing less than clinically recommended. The international survey (N = 156) and estimation of ultraviolet radiation dose-to-face (N = 41) found that adults had worse photoprotection than the ‘cared for’ sample, but that overall the total dose-to-face was similar in the two groups because the ‘cared for’ group were outside more. The n-of-1 study (N = 20) showed that fluctuations in protection were associated with time of day, weekday versus weekend, environmental risk perceptions and symptoms resulting from exposure, self-regulatory and psychological constructs. The qualitative study (N = 25) identified three modes of adaptation to photoprotection: (1) ‘dominated’, (2)‘integrated’ and (3) ‘resistant’. Modifiable drivers of photoprotection behaviour were identified in the survey studies, including belief-based predictors and the important role of habits. These combined findings informed the development and targets of the XPAND intervention. Phase II: The intervention group (n = 6) had significantly lower daily average ultraviolet radiation dose-to-face (primary outcome) compared to control (n = 7) (−0.25 Standard Erythemal Dose, p 16 years with a confirmed diagnosis of XP, sufficient English language comprehension and no cognitive impairment completed the measures themselves. Parents/caregivers of children (

BackgroundInterest in the application of predictive risk models (PRMs) in health care to identify people most likely to experience disease and treatment-related complications is increasing. In cancer care, these techniques are focused primarily on the prediction of survival or life-threatening toxicities (eg, febrile neutropenia). Fewer studies focus on the use of PRMs for symptoms or supportive care needs. The application of PRMs to chemotherapy-related symptoms (CRS) would enable earlier identification and initiation of prompt, personalized, and tailored interventions. While some PRMs exist for CRS, few were translated into clinical practice, and human factors associated with their use were not reported. ObjectiveWe aim to explore patients’ and clinicians’ perspectives of the utility and real-world application of PRMs to improve the management of CRS. MethodsFocus groups (N=10) and interviews (N=5) were conducted with patients (N=28) and clinicians (N=26) across 5 European countries. Interactions were audio-recorded, transcribed verbatim, and analyzed thematically. ResultsBoth clinicians and patients recognized the value of having individualized risk predictions for CRS and appreciated how this type of information would facilitate the provision of tailored preventative treatments or supportive care interactions. However, cautious and skeptical attitudes toward the use of PRMs in clinical care were noted by both groups, particularly in relationship to the uncertainty regarding how the information would be generated. Visualization and presentation of PRM information in a usable and useful format for both patients and clinicians was identified as a challenge to their successful implementation in clinical care. ConclusionsFindings from this study provide information on clinicians’ and patients’ perspectives on the clinical use of PRMs for the management of CRS. These international perspectives are important because they provide insight into the risks and benefits of using PRMs to evaluate CRS. In addition, they highlight the need to find ways to more effectively present and use this information in clinical practice. Further research that explores the best ways to incorporate this type of information while maintaining the human side of care is warranted. Trial RegistrationClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081

Introduction Ethnic minorities (also called racialised groups) are more likely to experience severe mental illness (SMI). People with SMI are more likely to experience multimorbidity (MM), making psychosis among racialised groups more likely to lead to MM, poor outcomes, disability and premature mortality.Methods and analysis This National Institute for Health and Care Research-funded study (151887) seeks to use innovative participatory methods including photovoice and biographical narrative interviews in urban and rural areas of England to assemble experience data. These data will be subjected to polytextual thematic analysis, and alongside pictures and captions, will inform an experienced-based co-design of interventions, the implementation of which will be evaluated. There will be an economic analysis and a process evaluation of the implementation.Ethics and dissemination This programme of work has received ethical (IRAS 322421; Newcastle North Tyneside Research Ethics Committee 23/NE/0143) and sponsor approval. The findings will be disseminated in galleries showing the creative work, as lay and academic summaries and infographics; as practice briefings for practitioners, commissioners and policy makers; peer-reviewed publications.Trial registration number https://www.researchregistry.com/browse-the-registry%23home/registrationdetails/649c08111c037d0027b17d17/

Abstract Cognitive Remediation (CR) improves cognition and functioning but is implemented in a variety of ways (independent, group and one-to-one). There is no information on whether service users find these implementation methods acceptable or if their satisfaction influences CR outcomes. We used mixed participatory methods, including focus groups, to co-develop a CR satisfaction scale. This was refined using three psychometric criteria (Cronbach’s alpha, item discrimination, test-retest agreement) to select items. Factor analysis explored potential substructures. The refined measure was used in structural equation joint modelling to evaluate whether satisfaction with CR is affected by implementation method and treatment engagement or influences recovery outcome, using data from a randomised controlled trial. Four themes (therapy hours, therapist, treatment effects, computer use) generated a 31-item Cognitive Remediation Satisfaction scale (CRS) that reduced to 18 Likert items, 2 binary and 2 open-ended questions following psychometric assessment. CRS had good internal consistency (Alpha = 0.814), test-retest reliability (r= 0.763), and concurrent validity using the Working Alliance Inventory (r = 0.56). A 2-factor solution divided items into therapy engagement and therapy effects. Satisfaction was not related to implementation method but was significantly associated with CR engagement. Therapy hours were significantly associated with recovery, but there was no direct effect of satisfaction on outcome. Although satisfaction is important to therapy engagement, it has no direct effect on outcome. CR therapy hours directly affect outcome irrespective of which implementation model is used, so measuring satisfaction early might help to identify those who are likely to disengage. The study has mixed methods design.

Abstract Experiences of trauma in childhood and adulthood are highly prevalent among service users accessing acute, crisis, emergency, and residential mental health services. These settings, and restraint and seclusion practices used, can be extremely traumatic, leading to a growing awareness for the need for trauma informed care (TIC). The aim of TIC is to acknowledge the prevalence and impact of trauma and create a safe environment to prevent re-traumatisation. This scoping review maps the TIC approaches delivered in these settings and reports related service user and staff experiences and attitudes, staff wellbeing, and service use outcomes. We searched seven databases (EMBASE; PsycINFO; MEDLINE; Web of Science; Social Policy and Practice; Maternity and Infant Care Database; Cochrane Library Trials Register) between 24/02/2022-10/03/2022, used backwards and forwards citation tracking, and consulted academic and lived experience experts, identifying 4244 potentially relevant studies. Thirty-one studies were included. Most studies (n = 23) were conducted in the USA and were based in acute mental health services (n = 16). We identified few trials, limiting inferences that can be drawn from the findings. The Six Core Strategies (n = 7) and the Sanctuary Model (n = 6) were the most commonly reported approaches. Rates of restraint and seclusion reportedly decreased. Some service users reported feeling trusted and cared for, while staff reported feeling empathy for service users and having a greater understanding of trauma. Staff reported needing training to deliver TIC effectively. TIC principles should be at the core of all mental health service delivery. Implementing TIC approaches may integrate best practice into mental health care, although significant time and financial resources are required to implement organisational change at scale. Most evidence is preliminary in nature, and confined to acute and residential services, with little evidence on community crisis or emergency services. Clinical and research developments should prioritise lived experience expertise in addressing these gaps.

Introduction: There is growing evidence that prehabilitation programmes effectively improve the physical and psychological conditions of cancer patients awaiting treatment. During the pandemic, people with cancer were classed as vulnerable. To reduce risk to this population Kent and Medway Prehabilitation service transformed into a TeleHealth format. The aim of this study is to assess the impact on health-related quality of life (HRQoL) and the costs of a digital multimodal prehabilitation programme. Methods: HRQoL was measured with the EQ-5D and quality-adjusted life years (QALYs) were calculated. Costs of the prehabilitation service and inpatient care were calculated. Comparisons were made between different levels of prehabilitation received. Results: A sample of 192 individuals was included in the study Mean HRQoL improved from 69.53 at baseline to 85.71 post-rehabilitation, a 23% increase. For each additional week of prehabilitation care in cancer patients, the model predicts that the total QALYS increase by 0.02, when baseline utility is held constant. Conclusions: Prehabilitation is associated with improved HRQoL and QALYs. Our model of a multimodal digital prehabilitation program can be beneficial for patients and reduce costs for healthcare facilities even when the patients attend only a few sessions.

Background Creative arts practice can enhance the depth and quality of mental health research by capturing and foregrounding participants’ lived experience. Creative methods are emotionally activating and promote multiple perspectives, tolerating ambiguities and uncertainties, which are shared and even celebrated.Key arguments Methods such as photovoice use imagery to elucidate narratives that are not easily captured by more traditional interview-based research techniques. However, the use of creative methods and participatory research remains novel as there is little guidance of how to navigate conceptual, practical, and analytical challenges.Conclusion This paper considers these challenges, and puts forward practical and theory informed recommendations, using as study of photovoice methods for investigating ethnic inequalities in the use of the mental health act (Co-Pact) as a case study.

Summary: Background: 3% of kidney transplant recipients return to dialysis annually upon allograft failure. Development of antibodies (Ab) against human leukocyte antigens (HLA) is a validated prognostic biomarker of allograft failure. We tested whether screening for HLA Ab, combined with an intervention to improve adherence and optimization of immunosuppression could prevent allograft failure. Methods: Prospective, open-labelled randomised biomarker-based strategy (hybrid) trial in 13 UK transplant centres [EudraCT (2012-004308-36) and ISRCTN (46157828)]. Patients were randomly allocated (1:1) to unblinded or double-blinded arms and screened every 8 months. Unblinded HLA Ab+ patients were interviewed to encourage medication adherence and had tailored optimisation of Tacrolimus, Mycophenolate mofetil and Prednisolone. The primary outcome was time to graft failure in an intention to treat analysis. The trial had 80% power to detect a hazard ratio of 0.49 in donor specific antibody (DSA)+ patients. Findings: From 11/9/13 to 27/10/16, 5519 were screened for eligibility and 2037 randomised (1028 to unblinded care and 1009 to double blinded care). We identified 198 with DSA and 818 with non-DSA. Development of DSA, but not non-DSA was predictive of graft failure. HRs for graft failure in unblinded DSA+ and non-DSA+ groups were 1.54 (95% CI: 0.72 to 3.30) and 0.97 (0.54–1.74) respectively, providing no evidence of an intervention effect. Non-inferiority for the overall unblinded versus blinded comparison was not demonstrated as the upper confidence limit of the HR for graft failure exceeded 1.4 (1.02, 95% CI: 0.72 to 1.44). The only secondary endpoint reduced in the unblinded arm was biopsy-proven rejection. Interpretation: Intervention to improve adherence and optimize immunosuppression does not delay failure of renal transplants after development of DSA. Whilst DSA predicts increased risk of allograft failure, novel interventions are needed before screening can be used to direct therapy. Funding: The National Institute for Health Research Efficacy and Mechanism Evaluation programme grant (ref 11/100/34).

Abstract Background Poor social circumstances can induce, exacerbate and prolong symptoms of mental health conditions, while having a mental health condition can also lead to worse social outcomes. Many people with mental health conditions prioritise improvement in social and functional outcomes over reduction in clinical symptoms. Interventions that improve social circumstances in this population should thus be considered a priority for research and policy. Methods This rapid evidence synthesis reports on randomised controlled trials of interventions to improve social circumstances across eight social domains (Housing and homelessness; money and basic needs; work and education; social isolation and connectedness; family, intimate and caring relationships; victimisation and exploitation; offending; and rights, inclusion and citizenship) in people with mental health conditions. Economic evaluations were also identified. A comprehensive, stepped search approach of the Cochrane library, MEDLINE, Embase, PsycINFO, Web of Science and Scopus was conducted. Results One systematic review and 102 randomised controlled trials were included. We did not find RCT evidence for interventions to improve family, intimate and caring relationships and only one or two trials for each of improving money and basic needs, victimisation and exploitation, and rights, inclusion and citizenship. Evidence from successful interventions in improving homelessness (Housing First) and employment (Individual Placement and Support) suggests that high-intensity interventions which focus on the desired social outcome and provide comprehensive multidisciplinary support could influence positive change in social circumstances of people with mental health conditions. Objective social isolation could be improved using a range of approaches such as supported socialisation and social skills training but interventions to reduce offending showed few benefits. Studies with cost and cost-effectiveness components were generally supportive of interventions to improve housing and vocational outcomes. More research is needed to ensure that social circumstances accompanied by high risks of further exacerbation of mental health conditions are adequately addressed. Conclusions Although there is a large body of literature examining how to support some aspects of life for people with mental health conditions, more high-quality evidence is required in other social domains. Integration into mental health services of interventions targeting social circumstances could significantly improve a number of social outcomes.

Background Youth adversity (e.g., abuse and bullying victimisation) is robust risk factor for later mental health problems (e.g., depression and anxiety). Research shows the prevalence of youth adversity and rates of mental health problems vary by individual characteristics, identity or social groups (e.g., gender and ethnicity). However, little is known about whether the impact of youth adversity on mental health problems differ across the intersections of these characteristics (e.g., white females). This paper reports on a component of the ATTUNE research programme (work package 2) which aims to investigate the impact and mechanisms of youth adversity on depressive and anxiety symptoms in young people by intersectionality profiles. Methods The data are from 4 UK adolescent cohorts: HeadStart Cornwall, Oxwell, REACH, and DASH. These cohorts were assembled for adolescents living in distinct geographical locations representing coastal, suburban and urban places in the UK. Youth adversity was assessed using a series of self-report questionnaires and official records. Validated self-report instruments measured depressive and anxiety symptoms. A range of different variables were classified as possible social and cognitive mechanisms. Results and analysis Structural equation modelling (e.g., multiple group models, latent growth models) and multilevel modelling will be used, with adaptation of methods to suit the specific available data, in accord with statistical and epidemiological conventions. Discussion The results from this research programme will broaden our understanding of the association between youth adversity and mental health, including new information about intersectionality and related mechanisms in young people in the UK. The findings will inform future research, clinical guidance, and policy to protect and promote the mental health of those most vulnerable to the negative consequences of youth adversity.

One in eight individuals worldwide lives with a mental health disorder. For many European countries, the prevalence is even higher, with one in four people reporting mental health problems [1]. Three-quarters of all mental health disorders develop before age 25, with many presenting initially in undiagnosed forms already in the mid-teens and eventually manifesting as severe disorders and lasting into old age [2]. There is also growing evidence that mental health disorder symptoms cross diagnoses and people frequently have more than one mental health disorder [3].

Abstract Background Major depressive disorder (MDD) is highly prevalent across Europe. While evidence-based treatments exist, many people with MDD have their condition undetected and/or untreated. This study aimed to assess the cost-effectiveness of reducing treatment gaps using a modeling approach. Methods A decision-tree model covering a 27-month time horizon was used. This followed a care pathway where MDD could be detected or not, and where different forms of treatment could be provided. Expected costs pertaining to Germany, Hungary, Italy, Portugal, Sweden, and the UK were calculated and quality-adjusted life years (QALYs) were estimated. The incremental costs per QALY of reducing detection and treatment gaps were estimated. Results The expected costs with a detection gap of 69% and treatment gap of 50% were €1236 in Germany, €476 in Hungary, €1413 in Italy, €938 in Portugal, €2093 in Sweden, and €1496 in the UK. The incremental costs per QALY of reducing the detection gap to 50% ranged from €2429 in Hungary to €10,686 in Sweden. The figures for reducing the treatment gap to 25% ranged from €3146 in Hungary to €13,843 in Sweden. Conclusions Reducing detection and treatment gaps, and maintaining current patterns of care, is likely to increase healthcare costs in the short term. However, outcomes are improved, and reducing these gaps to 50 and 25%, respectively, appears to be a cost-effective use of resources.

PurposeAccidents are the most common cause of death among UK military personnel. It is a common misconception in the general public that accidental injuries are always the result of random events, however research suggests that mental health problems and the increased levels of risky behaviour in military personnel may play a role. The objective of this study was to further our understanding of injuries and deaths not related to deployment by examining the associations of mental health, alcohol misuse and smoking with inpatient admission to hospital for accidents and injuries, and attendance to accident and emergency (A&E) departments.MethodsData on all hospital admissions for accidents and injuries and A&E attendance at NHS hospitals in England, Scotland and Wales were linked to data on self-reported mental health problems, alcohol misuse and smoking from a large, representative UK military cohort of serving and ex-serving personnel (n = 8,602). Logistic regression was used to examine the associations between having a hospital admission for an accident or injury with self-reported mental health problems, alcohol misuse and smoking. Cox proportional-hazards regression was then conducted to assess the associations of mental health problems, alcohol misuse and smoking with time to hospital admission for an accident or injury. Finally, negative binomial regression was used to examine associations between the number of A&E attendances with mental health problems, alcohol misuse and smoking.ResultsPersonnel reporting symptoms of common mental disorder (CMD) or probable post-traumatic stress disorder (PTSD) were more likely to have an admission to hospital for an accident or injury (fully adjusted odds ratio 1.39, 95% confidence interval [CI] 1.05-1.84), than those who did not report these symptoms, and also had more attendances to A&E (fully adjusted incidence rate ratio [IRR] 1.32, 95% CI 1.16-1.51). A&E attendances were also more common in personnel who were smokers (fully adjusted IRR 1.21, 95% CI 1.09-1.35) following adjustment for demographic, military and health characteristics.ConclusionsThe findings suggest that accidents and injuries among military personnel are not always random events and that there are health and behavioural factors, including poor mental health and smoking, which are associated (with small effect sizes) with an increased risk of being involved in an accident. Clinicians treating individuals attending hospital after an accident should consider their healthcare needs holistically, including issues related to mental health and health damaging behaviours.

Abstract Background Telephone therapist delivered CBT (TCBT) and web-based CBT (WCBT) have been shown to be significantly more clinically effective than treatment as usual (TAU) at reducing IBS symptom severity and impact at 12 months in adults with refractory IBS. In this paper we assess the cost-effectiveness of the interventions. Methods Participants were recruited from 74 general practices and three gastroenterology centres in England. Interventions costs were calculated, and other service use and lost employment measured and costed for one-year post randomisation. Quality-adjusted life years (QALYs) were combined with costs to determine cost-effectiveness of TCBT and WCBT compared to TAU. Results TCBT cost £956 more than TAU (95% CI, £601–£1435) and generated 0.0429 more QALYs. WCBT cost £224 more than TAU (95% CI, − £11 to £448) and produced 0.029 more QALYs. Compared to TAU, TCBT had an incremental cost per QALY of £22,284 while the figure for WCBT was £7724. After multiple imputation these ratios increased to £27,436 and £17,388 respectively. Including lost employment and informal care, TCBT had costs that were on average £866 lower than TAU (95% CI, − £1133 to £2957), and WCBT had costs that were £1028 lower than TAU (95% CI, − £448 to £2580). Conclusions TCBT and WCBT resulted in more QALYs and higher costs than TAU. Complete case analysis suggests both therapies are cost-effective from a healthcare perspective. Imputation for missing data reduces cost-effectiveness but WCTB remained cost-effective. If the reduced societal costs are included both interventions are likely to be more cost-effective. Trial registration ISRCTN44427879 (registered 18.11.13).

Abstract Background AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth ‘voices’). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU). Methods This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued. Discussion This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings. Trial registration ISRCTN registry ISRCTN55682735 . Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).

Abstract Background Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an ‘integrated GP care’ approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit. Methods A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to ‘integrated GP care plus treatment as usual’ or ‘treatment as usual’. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level. Results Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small. Conclusions It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients’/GPs’ utilisation of audio/visual and training resources before proceeding to a full trial evaluation. Trial registration NCT02444520 (ClinicalTrials.gov).

Abstract Background Despite well-established guidelines for managing major depressive disorder, its extensive disability burden persists. This Value of Treatment mission from the European Brain Council aimed to elucidate the nature and extent of “gaps” between best-practice and current-practice care, specifically to: 1. Identify current treatment gaps along the care pathway and determine the extent of these gaps in comparison with the stepped-care model and 2. Recommend policies intending to better meet patient needs (i.e., minimize treatment gaps). Methods After agreement upon a set of relevant treatment gaps, data pertaining to each gap were gathered and synthesized from several sources across six European countries. Subsequently, a modified Delphi approach was undertaken to attain consensus among an expert panel on proposed recommendations for minimizing treatment gaps. Results Four recommendations were made to increase the depression diagnosis rate (from ~50% episodes), aiming to both increase the number of patients seeking help, and the likelihood of a practitioner to correctly detect depression. These should reduce time to treatment (from ~1 to ~8 years after illness onset) and increase rates of treatment; nine further recommendations aimed to increase rates of treatment (from ~25 to ~50% of patients currently treated), mainly focused on targeting the best treatment to each patient. To improve follow-up after treatment initiation (from ~30 to ~65% followed up within 3 months), seven recommendations focused on increasing continuity of care. For those not responding, 10 recommendations focused on ensuring access to more specialist care (currently at rates of ~5–25% of patients). Conclusions The treatment gaps in depression care are substantial and concerning, from the proportion of people not entering care pathways to those stagnating in primary care with impairing and persistent illness. A wide range of recommendations can be made to enhance care throughout the pathway.

Background Diagnoses of personality disorder are prevalent among people using community secondary mental health services. Identifying cost-effective community-based interventions is important when working with finite resources. Aims To assess the cost-effectiveness of primary or secondary care community-based interventions for people with complex emotional needs who meet criteria for a diagnosis of personality disorder to inform healthcare policy-making. Method Systematic review (PROSPERO: CRD42020134068) of databases. We included economic evaluations of interventions for adults with complex emotional needs associated with a diagnosis of personality disorder in community mental health settings published before 18 September 2019. Study quality was assessed using the CHEERS statement. Results Eighteen studies were included. The studies mainly evaluated psychotherapeutic interventions. Studies were also identified that evaluated altering the setting in which care was delivered and joint crisis plans. No strong economic evidence to support a single intervention or model of community-based care was identified. Conclusions Robust economic evidence to support a single intervention or model of community-based care for people with complex emotional needs is lacking. The strongest evidence was for dialectical behaviour therapy, with all three identified studies indicating that it is likely to be cost-effective in community settings compared with treatment as usual. More robust evidence is required on the cost-effectiveness of community-based interventions on which decision makers can confidently base guidelines or allocate resources. The evidence should be based on consistent measures of costs and outcomes with sufficient sample sizes to demonstrate impacts on these.

BackgroundThere is a growing global need for scalable approaches to training and supervising primary care workers (PCWs) to deliver mental health services. Over the past decade, the World Health Organization Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) and associated training and implementation guidance have been disseminated to more than 100 countries. On the basis of the opportunities provided by mobile technology, an updated electronic Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG) is now being developed along with a clinical dashboard and guidance for the use of mobile technology in supervision. ObjectiveThis study aims to assess the feasibility, acceptability, adoption, and other implementation parameters of the e-mhGAP-IG for diagnosis and management of depression in 2 lower-middle-income countries (Nepal and Nigeria) and to conduct a feasibility cluster randomized controlled trial (cRCT) to evaluate trial procedures for a subsequent fully powered trial comparing the clinical effectiveness and cost-effectiveness of the e-mhGAP-IG and remote supervision with standard mhGAP-IG implementation. MethodsA feasibility cRCT will be conducted in Nepal and Nigeria to evaluate the feasibility of the e-mhGAP-IG for use in depression diagnosis and treatment. In each country, an estimated 20 primary health clinics (PHCs) in Nepal and 6 PHCs in Nigeria will be randomized to have their staff trained in e-mhGAP-IG or the paper version of mhGAP-IG v2.0. The PHC will be the unit of clustering. All PCWs within a facility will receive the same training (e-mhGAP-IG vs paper mhGAP-IG). Approximately 2-5 PCWs, depending on staffing, will be recruited per clinic (estimated 20 health workers per arm in Nepal and 15 per arm in Nigeria). The primary outcomes of interest will be the feasibility and acceptability of training, supervision, and care delivery using the e-mhGAP-IG. Secondary implementation outcomes include the adoption of the e-mhGAP-IG and feasibility of trial procedures. The secondary intervention outcome—and the primary outcome for a subsequent fully powered trial—will be the accurate identification of depression by PCWs. Detection rates before and after training will be compared in each arm. ResultsTo date, qualitative formative work has been conducted at both sites to prepare for the pilot feasibility cRCT, and the e-mhGAP-IG and remote supervision guidelines have been developed. ConclusionsThe incorporation of mobile digital technology has the potential to improve the scalability of mental health services in primary care and enhance the quality and accuracy of care. Trial RegistrationClinicalTrials.gov NCT04522453; https://clinicaltrials.gov/ct2/show/NCT04522453. International Registered Report Identifier (IRRID)PRR1-10.2196/24115

Background: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive–behavioural therapy for adults with dissociative seizures. Design: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial. Setting: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive–behavioural therapy services. Participants: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017. Interventions: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive–behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care. Main outcome measures: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness. Results: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n = 182; and cognitive–behavioural therapy plus standardised medical care, n = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1–35 dissociative seizures); cognitive–behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0–20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive–behavioural therapy at a p-value

Abstract Background Chronic rejection is the single biggest cause of premature kidney graft failure. HLA antibodies (Ab) are an established prognostic biomarker for premature graft failure so there is a need to test whether treatment decisions based on the presence of the biomarker can alter prognosis. The Optimised TacrolimuS and MMF for HLA Antibodies after Renal Transplantation (OuTSMART) trial combines two elements. Firstly, testing whether a routine screening programme for HLA Ab in all kidney transplant recipients is useful by comparing blinding versus unblinding of HLA Ab status. Secondly, for those found to be HLA Ab+, testing whether the introduction of a standard optimisation treatment protocol can reduce graft failure rates. Methods OuTSMART is a prospective, open-labelled, randomised biomarker-based strategy (hybrid) trial, with two arms stratified by biomarker (HLA Ab) status. The primary outcome was amended from graft failure rates at 3 years to time to graft failure to increase power and require fewer participants to be recruited. Length of follow-up subsequently is variable, with all participants followed up for at least 43 months up to a maximum of 89 months. The primary outcome will be analysed using Cox regression adjusting for stratification factors. Analyses will be according to the intention-to-treat using all participants as randomised. Outcomes will be analysed comparing standard care versus biomarker-led care groups within the HLA Ab+ participants (including those who become HLA Ab+ through re-screening) as well as between HLA-Ab-unblinded and HLA-Ab-blinded groups using all participants. Discussion Changes to the primary outcome permit recruitment of fewer participants to achieve the same statistical power. Pre-stating the statistical analysis plan guards against changes to the analysis methods at the point of analysis that might otherwise introduce bias through knowledge of the data. Any deviations from the analysis plan will be justified in the final report. Trial registration ISRCTN registry, ID: ISRCTN46157828. Registered on 26 March 2013; EudraCT 2012–004308-36. Registered on 10 December 2012.

Abstract Background In a randomised controlled trial, contamination is defined as the receipt of active intervention amongst participants in the control arm. This review assessed the processes leading to contamination, its typical quantity, methods used to mitigate it, and impact of use of cluster randomisation to prevent it on study findings in trials of complex interventions in mental health. Methods This is a scoping review of trial design approaches and methods of study conduct to address contamination. Studies included were randomised controlled trials of complex interventions in mental health that described the process leading to, amount of, or solution used to counter contamination. The Medline, Embase, and PsycInfo databases were searched for trials published between 2000 and 2015. Risk of bias was assessed using the Jadad score and domains recommended by Cochrane plus some relevant to cluster randomised trials. Results Two hundred and thirty-four articles were included in the review. The main processes that led to contamination were health professionals delivering both active and comparator treatments and communication among clinicians and participants from the different trial arms. Twenty-three trials (10%) measured binary treatment receipt in the control arm with median 13% of participants found to be contaminated (IQR 5–33%). The most common design approach for dealing with contamination was the use of cluster randomisation (n = 93). In addition, many researchers used simple trial conduct methods to minimise contamination due to suspected contamination processes, such as organising for each clinician to provide only one treatment and separating trial arms spatially or temporally. There was little evidence for a relationship between cluster randomisation to avoid contamination and size of treatment effect estimate. Conclusion There was some evidence of modest levels of treatment contamination with a large range, although a minority of studies reported the amount of contamination. A limitation was that many trials described the problem in little detail. Overall there is a need for greater measurement and reporting of treatment receipt in the control arm of trials. Researchers should be aware of trial conduct methods that can be used to minimise contamination without resorting to cluster randomisation.

Background: The NHS is the biggest employer in the UK. Depression and anxiety are common reasons for sickness absence among staff. Evidence suggests that an intervention based on a case management model using a biopsychosocial approach could be cost-effective and lead to earlier return to work for staff with common mental health disorders. Objective: The objective was to assess the feasibility and acceptability of conducting a trial of the clinical effectiveness and cost-effectiveness of an early occupational health referral and case management intervention to facilitate the return to work of NHS staff on sick leave with any common mental health disorder (e.g. depression or anxiety). Design: A multicentre mixed-methods feasibility study with embedded process evaluation and economic analyses. The study comprised an updated systematic review, survey of care as usual, and development of an intervention in consultation with key stakeholders. Although this was not a randomised controlled trial, the study design comprised two arms where participants received either the intervention or care as usual. Participants: Participants were NHS staff on sick leave for 7 or more consecutive days but less than 90 consecutive days, with a common mental health disorder. Intervention: The intervention involved early referral to occupational health combined with standardised work-focused case management. Control/comparator: Participants in the control arm received care as usual. Primary outcome: The primary outcome was the feasibility and acceptability of the intervention, study processes (including methods of recruiting participants) and data collection tools to measure return to work, episodes of sickness absence, workability (a worker’s functional ability to perform their job), occupational functioning, symptomatology and cost-effectiveness proposed for use in a main trial. Results: Forty articles and two guidelines were included in an updated systematic review. A total of 49 of the 126 (39%) occupational health providers who were approached participated in a national survey of care as usual. Selected multidisciplinary stakeholders contributed to the development of the work-focused case management intervention (including a training workshop). Six NHS trusts (occupational health departments) agreed to take part in the study, although one trust withdrew prior to participant recruitment, citing staff shortages. At mixed intervention sites, participants were sequentially allocated to each arm, where possible. Approximately 1938 (3.9%) NHS staff from the participating sites were on sick leave with a common mental health disorder during the study period. Forty-two sick-listed NHS staff were screened for eligibility on receipt of occupational health management referrals. Twenty-four (57%) participants were consented: 11 (46%) received the case management intervention and 13 (54%) received care as usual. Follow-up data were collected from 11 out of 24 (46%) participants at 3 months and 10 out of 24 (42%) participants at 6 months. The case management intervention and case manager training were found to be acceptable and inexpensive to deliver. Possible contamination issues are likely in a future trial if participants are individually randomised at mixed intervention sites. Harms: No adverse events were reported. Limitations: The method of identification and recruitment of eligible sick-listed staff was ineffective in practice because uptake of referral to occupational health was low, but a new targeted method has been devised. Conclusion: All study questions were addressed. Difficulties raising organisational awareness of the study coupled with a lack of change in occupational health referral practices by line managers affected the identification and recruitment of participants. Strategies to overcome these barriers in a main trial were identified. The case management intervention was fit for purpose and acceptable to deliver in the NHS. Trial registration: Current Controlled Trials ISRCTN14621901. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 12. See the NIHR Journals Library website for further project information.

BACKGROUND: Extensive evidence shows that well over 50% of people prefer to be cared for and to die at home provided circumstances allow choice. Despite best efforts and policies, one-third or less of all deaths take place at home in many countries of the world. OBJECTIVES: 1. to quantify the effect of home palliative care services for adult patients with advanced illness and their family caregivers on patients' odds of dying at home; 2. to examine the clinical effectiveness of home palliative care services on other outcomes for patients and their caregivers such as symptom control, quality of life, caregiver distress and satisfaction with care; 3. to compare the resource use and costs associated with these services; 4. to critically appraise and summarize the current evidence on cost-effectiveness. METHODS: Search methods: We searched 12 electronic databases up to November 2012. We checked the reference lists of all included studies, 49 relevant systematic reviews, four key textbooks and recent conference abstracts. We contacted 17 experts and researchers for unpublished data. Selection criteria: We included randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series (ITSs) evaluating the impact of home palliative care services on outcomes for adults with advanced illness or their family caregivers, or both. Data collection and analysis: One review author assessed the identified titles and abstracts. Two independent reviewers performed assessment of all potentially relevant studies, data extraction and assessment of methodological quality. We carried out meta-analysis where appropriate and calculated numbers needed to treat to benefit (NNTBs) for the primary outcome (death at home). MAIN RESULTS: We identified 23 studies (16 RCTs, 6 of high quality), including 37,561 participants and 4042 family caregivers, largely with advanced cancer but also congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), HIV/AIDS and multiple sclerosis (MS), among other conditions. Meta-analysis showed increased odds of dying at home (odds ratio (OR) 2.21, 95% CI 1.31 to 3.71; Z = 2.98, P value = 0.003; Chi2 = 20.57, degrees of freedom (df) = 6, P value = 0.002; I2 = 71%; NNTB 5, 95% CI 3 to 14 (seven trials with 1222 participants, three of high quality)). In addition, narrative synthesis showed evidence of small but statistically significant beneficial effects of home palliative care services compared to usual care on reducing symptom burden for patients (three trials, two of high quality, and one CBA with 2107 participants) and of no effect on caregiver grief (three RCTs, two of high quality, and one CBA with 2113 caregivers). Evidence on cost-effectiveness (six studies) is inconclusive. AUTHORS' CONCLUSIONS: The results provide clear and reliable evidence that home palliative care increases the chance of dying at home and reduces symptom burden in particular for patients with cancer, without impacting on caregiver grief. This justifies providing home palliative care for patients who wish to die at home. More work is needed to study cost-effectiveness especially for people with non-malignant conditions, assessing place of death and appropriate outcomes that are sensitive to change and valid in these populations, and to compare different models of home palliative care, in powered studies.

Objectives To evaluate the cost, accessibility and patient satisfaction implications of two clinical pathways used in the management of chronic headache.Intervention Management of chronic headache following referral from Primary Care that differed in the first appointment, either a Neurology appointment or an MRI brain scan.Design and setting A pragmatic, non-randomised, prospective, single-centre study at a Central Hospital in London.Participants Adult patients with chronic headache referred from primary to secondary care.Primary and secondary outcome measures Participants’ use of healthcare services and costs were estimated using primary and secondary care databases and questionnaires quarterly up to 12 months postrecruitment. Cost analyses were compared using generalised linear models. Secondary outcomes assessed: access to care, patient satisfaction, headache burden and self-perceived quality of life using headache-specific (Migraine Disability Assessment Scale and Headache Impact Test) and a generic questionnaire (5-level EQ-5D).Results Mean (SD) cost up to 6 months postrecruitment per participant was £578 (£420) for the Neurology group (n=128) and £245 (£172) for the MRI group (n=95), leading to an estimated mean cost difference of £333 (95% CI £253 to £413, p

Background: The children of parents with severe personality difficulties have greater risk of significant mental health problems. Existing care is poorly co-ordinated, with limited effectiveness. A specialised parenting intervention may improve child and parenting outcomes, reduce family morbidity and lower the service costs. Objectives: To develop a specialised parenting intervention for parents affected by severe personality difficulties who have children with mental health problems and to conduct a feasibility trial. Design: A pragmatic, mixed-methods design to develop and pilot a specialised parenting intervention, Helping Families Programme-Modified, and to conduct a randomised feasibility trial with process evaluation. Initial cost-effectiveness was assessed using UK NHS/Personal Social Services and societal perspectives, generating quality-adjusted life-years. Researchers collecting quantitative data were masked to participant allocation. Setting: Two NHS mental health trusts and concomitant children’s social care services. Participants: Parents who met the following criteria: (1) the primary caregiver of the index child, (2) aged 18–65 years, (3) have severe personality difficulties, (4) proficient in English and (5) capable of providing informed consent. Index children who met the following criteria: (1) aged 3–11 years, (2) living with index parent and (3) have significant emotional/behavioural difficulties. Exclusion criteria were (1) having coexisting psychosis, (2) participating in another parenting intervention, (3) receiving inpatient care, (4) having insufficient language/cognitive abilities, (5) having child developmental disorder, (6) care proceedings and (7) index child not residing with index parent. Intervention: The Helping Families Programme-Modified – a 16-session intervention using structured, goal-orientated strategies and collaborative therapeutic methods to improve parenting, and child and parent functioning. Usual care – standard care augmented by a single psychoeducational session. Main outcome measures: Trial feasibility – rates of recruitment, eligibility, allocation, retention, data completion and experience. Intervention acceptability – rates of acceptance, completion, alliance (Working Alliance Inventory-Short Revised) and experience. Outcomes – child (assessed via Concerns About My Child, Eyberg Child Behaviour Inventory, Child Behaviour Checklist-Internalising Scale), parenting (assessed via the Arnold-O’Leary Parenting Scale, Kansas Parental Satisfaction Scale), parent (assessed via the Symptom Checklist-27), and health economics (assessed via the Client Service Receipt Inventory, EuroQol-5 Dimensions). Results: The findings broadly supported trial feasibility using non-diagnostic screening criteria. Parents were mainly referred from one site (75.0%). Site and participant factors delayed recruitment. An estimate of eligible parents was not obtained. Of the 86 parents referred, 60 (69.7%) completed screening and 48 of these (80.0%) were recruited. Participants experienced significant disadvantage and multiple morbidity. The Helping Families Programme-Modified uptake (87.5%) was higher than usual-care uptake (62.5%). Trial retention (66.7%, 95% confidence interval 51.6% to 79.6%) exceeded the a priori rate. Process findings highlighted the impact of random allocation and the negative effects on retention. The Helping Families Programme-Modified was acceptable, with duration of delivery longer than planned, whereas the usual-care condition was less acceptable. At initial follow-up, effects on child and parenting outcomes were detected across both arms, with a potential outcome advantage for the Helping Families Programme-Modified (effect size range 0.0–1.3). For parental quality-adjusted life-years, the Helping Families Programme-Modified dominated usual care, and child quality-adjusted life-years resulted in higher costs and more quality-adjusted life-years. At second follow-up, the Helping Families Programme-Modified was associated with higher costs and more quality-adjusted life-years than usual care. For child quality-adjusted life-years, when controlled for baseline EuroQol-5 Dimensions, three-level version, usual care dominated the Helping Families Programme-Modified. No serious adverse events were reported. Conclusion: The Helping Families Programme-Modified is an acceptable specialised parenting intervention. Trial methods using non-diagnostic criteria were largely supported. For future work, a definitive efficacy trial should consider site selection, recruitment methods, intervention efficiency and revised comparator condition. Trial registration: Current Controlled Trials ISRCTN14573230. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 14. See the NIHR Journals Library website for further project information.

BackgroundThe density of information in digital health records offers new potential opportunities for automated prediction of cost-relevant outcomes.AimsWe investigated the extent to which routinely recorded data held in the electronic health record (EHR) predict priority service outcomes and whether natural language processing tools enhance the predictions. We evaluated three high priority outcomes: in-patient duration, readmission following in-patient care and high service cost after first presentation.MethodWe used data obtained from a clinical database derived from the EHR of a large mental healthcare provider within the UK. We combined structured data with text-derived data relating to diagnosis statements, medication and psychiatric symptomatology. Predictors of the three different clinical outcomes were modelled using logistic regression with performance evaluated against a validation set to derive areas under receiver operating characteristic curves.ResultsIn validation samples, the full models (using all available data) achieved areas under receiver operating characteristic curves between 0.59 and 0.85 (in-patient duration 0.63, readmission 0.59, high service use 0.85). Adding natural language processing-derived data to the models increased the variance explained across all clinical scenarios (observed increase in r2 = 12–46%).ConclusionsEHR data offer the potential to improve routine clinical predictions by utilising previously inaccessible data. Of our scenarios, prediction of high service use after initial presentation achieved the highest performance.

Abstract Background The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov (NCT02407691) registered on 19 March 2015; Pan African Clinical Trials Registry (201504001078347) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) (DOH-27-0515-5048) NHREC number 4048 issued on 21/04/2015.

Background: Irritable bowel syndrome (IBS) affects 10–22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive–behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited. Objectives: To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS. Design: This was a three-arm randomised controlled trial. Setting: This trial took place in UK primary and secondary care. Participants: Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016. Interventions: TCBT – patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours’ therapist time). WCBT – interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours’ therapist time). Main outcome measures: Primary outcomes – IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs]. Results: In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited – 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8; p

BackgroundAlthough patients value evidence-based therapeutic activities, little is known about nurses' perceptions.AimsTo investigate whether implementing an activities training programme would positively alter staff perceptions of the ward or be detrimental through the increased workload (trial registration: ISRCTN 06545047).MethodWe conducted a stepped wedge cluster randomised trial involving 16 wards with psychology-led nurse training as the intervention. The main outcome was a staff self-report measure of perceptions of the ward (VOTE) and secondary outcomes measuring potential deterioration were the Index of Work Satisfaction (IWS) and the Maslach Burnout Inventory (MBI). Data were analysed using mixed-effects regression models, with repeated assessments from staff over time.ResultsThere were 1075 valid outcome measurements from 539 nursing staff. VOTE scores did not change over time (standardised effect size 0.04, 95% CI –0.09 to 0.18, P = 0.54), neither did IWS or MBI scores (IWS, standardised effect size 0.02, 95% CI –0.11 to 0.16, P = 0.74; MBI standardised effect size –0.09, 95% CI –0.24 to 0.06, P = 0.24). There was a mean increase of 1.5 activities per ward (95% CI –0.4 to 3.4, P = 0.12) and on average 6.3 more patients attended groups (95% CI –4.1 to 16.6, P = 0.23) following training. Staff feedback on training was positive.ConclusionsOur training programme did not change nurses' perceptions of the ward, job satisfaction or burnout. During the study period many service changes occurred, most having a negative impact through increased pressure on staffing, patient mix and management so it is perhaps unsurprising that we found no benefits or reduction in staff skill.Declaration of interestNone.

An amendment to this paper has been published and can be accessed via the original article.

Background: Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord that affects adults and children and that causes motor, sensory and autonomic dysfunction. There is a prolonged recovery phase, which may continue for many years. Neuromyelitis optica (NMO) is an uncommon relapsing inflammatory central nervous system condition in which TM can be the first presenting symptom. As TM and NMO affect many patients in the prime of their working life, the disorder can impose a significant demand on health resources. There are currently no robust controlled trials in children or adults to inform the optimal treatment of TM. However, treatment with intravenous immunoglobulin (IVIG) is being effectively used in the management of a range of neurological conditions. Although other interventions such as plasma exchange (PLEX) in addition to intravenous (IV) methylprednisolone therapy can be beneficial in TM, PLEX is costly and technically challenging to deliver in the acute setting. IVIG is more readily accessible and less costly. Objective: To evaluate whether additional and early treatment with IVIG is of extra benefit in TM compared with standard therapy with IV steroids. Design: A multicentre, single-blind, parallel-group randomised controlled trial of IVIG compared with standard therapy for the treatment of TM in adults and children. Participants: Patients aged ≥ 1 year diagnosed with either acute first-onset TM or first presentation of NMO. Target recruitment was 170 participants (85 participants per arm). Interventions: Participants were randomised 1 : 1 to treatment with IV methylprednisolone only or treatment with IV methylprednisolone plus 2 g/kg of IVIG in divided doses within 5 days of the first commencement of steroid therapy. Main outcome measures: Primary outcome measure – American Spinal Injury Association (ASIA) Impairment Scale at 6 months post randomisation, with a good outcome defined by a two-grade change. Secondary and tertiary outcome measures – ASIA motor and sensory scales, Expanded Disability Status Scale, health outcome, quality of life, Client Service Receipt Inventory and International Spinal Cord Injury Pain, Bladder and Bowel Basic Data Sets. Results: In total, 26 participants were screened and two were randomised into the study. With the limited sample size, treatment effect could not be determined. However, we identified barriers to accrual that included strict inclusion criteria, the short enrolment window, challenges associated with the use of the ASIA Impairment Scale as an outcome measure and estimation of the incidence of TM. Conclusions: The study did not reach the end point and the effect of IVIG in TM/NMO could not be determined. Investigators should be aware of the potential challenges associated with carrying out a rare disease trial with a short enrolment window. The study question is one that still necessitates investigation. Preliminary work to ameliorate the effect of the barriers encountered in this study is vital. Trial registration: EudraCT 2014-002335-34, ClinicalTrials.gov NCT02398994 and Current Controlled Trials ISRCTN12127581. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 31. See the NIHR Journals Library website for further project information. Funding was also received from Biotest AG, Germany (supply of IVIG) and the Transverse Myelitis Society (excess research cost to facilitate study initiation).

Background: Depression is common in patients with coronary heart disease (CHD) but the relationship is uncertain. In the UK, general practitioners (GPs) have been remunerated for finding depression in CHD patients; however, it is unclear how to manage these patients. Objectives: Our aim was to explore the relationship between CHD and depression in a GP population and to develop nurse-led personalised care (PC) for patients with CHD and depression. Design: The UPBEAT-UK study consisted of four related studies. A cohort study of patients from CHD registers to explore the relationship between CHD and depression. A metasynthesis of relevant literature and two qualitative studies [patients’ perspectives and GP/practice nurse (PN) views on management of CHD and depression] helped develop an intervention. A pilot randomised controlled trial (RCT) of PC was conducted. Setting: Thirty-three GP surgeries in south London. Participants: Adult patients on GP CHD registers. Interventions: From the qualitative studies, we developed nurse-led PC, combining case management and self-management theory. Following biopsychosocial assessment, a PC plan was devised for each patient with chest pain and depressive symptoms. Nurses helped patients address their most important related problems. Use of existing resources was promoted. Nurse time was conserved through telephone follow-up. Main outcome measures: The main outcome of the pilot study of our newly developed PC for people with depression and CHD was to assess the acceptability and feasibility of the intervention and to decide on the best outcome measures. Depression, measured by the Hospital Anxiety and Depression Scale – depression subscale, and chest pain, measured by the Rose angina questionnaire, were the main outcome measures for the feasibility and cohort studies. Cardiac outcomes in the cohort study included: attendance at rapid access chest pain clinics, stent insertion, bypass graft surgery, myocardial infarction and cardiovascular death. Service use and costs were measured and linked to quality-adjusted life-years (QALYs). Data for the pilot RCT were obtained by research assistants from patient interviews at baseline, 1, 6 and 12 months for the pilot RCT and at baseline and 6-monthly interviews for up to 36 months for the cohort study, using standard questionnaires. Results: Personalised care was acceptable to patients and proved feasible. The reporting of chest pain in the intervention group was half that of the control group at 6 months, and this reduction was maintained at 1 year. There was also a small improvement in self-efficacy measures in the intervention group at 12 months. Anxiety was more prevalent than depression in our CHD cohort over the 3 years. Nearly half of the cohort complained of chest pain at outset, with two-thirds of these being suggestive of angina. Baseline exertional chest pain (suggestive of angina), anxiety and depression were independent predictors of adverse cardiac outcome. Psychosocial factors predicted the continued reporting of exertional chest pain across the 3 years of follow-up. Costs were slightly lower for the PC group but QALYs were also lower. Neither difference was statistically significant. Conclusions: Chest pain, anxiety, depression and social problems are common in patients on CHD registers in primary care and predict adverse cardiac outcomes. Together they pose a complex management problem for GPs and PNs. Our pilot trial of PC suggests a promising approach for treatment of these patients. Generalisation is limited because of the selection bias in recruitment of the practices and the subsequent participation rate of the CHD register patients, and the fact that the research took place in south London boroughs. Future work should explicitly explore methods for effective implementation of the intervention, including staff training needs and changes to practice. Trial registration: Current Controlled Trials ISRCTN21615909. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 4, No. 8. See the NIHR Journals Library website for further project information.

Introduction Psychological distress is common in end-stage kidney disease (ESKD) and is associated with poorer health outcomes. Cognitive behavioural therapy (CBT) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions. Access to skilled therapists competent in managing the competing mental and physical health demands of ESKD is limited. Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-resourced services. This study examines the feasibility and acceptability of implementing a two-arm parallel randomised controlled trial of online CBT with (intervention arm) and without (control arm) therapist support to improve psychological distress in patients undergoing haemodialysis.Methods Patients will be screened for depression and anxiety while attending for their haemodialysis treatments. We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and/or anxiety. Patients will be randomised individually (using a 1:1 computerised sequence ratio) to either online CBT with therapist telephone support (intervention arm), or online CBT with no therapist (control arm). Outcomes include feasibility and acceptability descriptive data on rates of recruitment, randomisation, retention and treatment adherence. Self-report outcomes include measures of depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), quality of life (Euro-QoL), service use (client service receipt inventory) and illness cognitions (brief illness perception questionnaire). A qualitative process evaluation will also be conducted. The statistician will be blinded to treatment allocation.Ethics and dissemination A National Health Service (NHS) research ethics committee approved the study. Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis. Any amendments to the protocol will be submitted to the NHS committee and study sponsor.Trial registration number NCT023528702; Pre-results.

BackgroundKnowledge of the configuration and costs of community rehabilitation and support for people with long-term neurological conditions (LTNCs) is needed to inform future service development and resource allocation. In a multicentre prospective cohort study evaluating community service delivery during the year post-discharge from in-patient neuro-rehabilitation, a key objective was to determine service use, costs, and predictors of these costs.MethodsPatients consecutively admitted over one year to all nine London specialised (Level 1) in-patient neuro-rehabilitation units were recruited on discharge. They or their carers completed postal/web-based questionnaires at discharge and six and twelve months later, providing demographic data and measures of impairment, disability, service needs and provision. This paper describes health and social care service use, informal care and associated costs. Regression models using non-parametric boot-strapping identified predictors of costs over time.ResultsOverall, 152 patients provided consistent data. Mean formal service costs fell significantly from £13,290 (sd £19,369) during the first six months to £9,335 (sd £19,036) from six-twelve months, (t = 2.35, PConclusionCommunity services for people with LTNCs carry substantial costs that shift from health to social care over time, increasing the burden on families. Prioritising rehabilitation services towards those in greatest need could limit access to others needing on-going support to promote their independence and reduce their reliance on families. This argues for greater investment in future rehabilitation services.

Progressive supranuclear palsy (PSP) and multiple system atrophy (MSA) are progressive disabling neurological conditions usually fatal within 10 years of onset. Little is known about the economic costs of these conditions. This paper reports service use and costs from France, Germany and the UK and identifies patient characteristics that are associated with cost. 767 patients were recruited, and 760 included in the study, from 44 centres as part of the NNIPPS trial. Service use during the previous six months was measured at entry to the study and costs calculated. Mean six-month costs were calculated for 742 patients. Data on patient sociodemographic and clinical characteristics were recorded and used in regression models to identify predictors of service costs and unpaid care costs (i.e., care from family and friends). The mean six-month service costs of PSP were €24,491 in France, €30,643 in Germany and €25,655 in the UK. The costs for MSA were €28,924, €25,645 and €19,103 respectively. Unpaid care accounted for 68-76%. Formal and unpaid costs were significantly higher the more severe the illness, as indicated by the Parkinson's Plus Symptom scale. There was a significant inverse relationship between service and unpaid care costs.

Aims and method We aimed to estimate the costs of care for people with a personality disorder diagnosis and compare service use and costs for those receiving specialist input and those receiving generic care. Service use data were obtained from records and costs calculated. Comparisons were made between those who received care from specialist personality disorder teams and those who did not. Demographic and clinical predictors of costs were identified with regression modelling. Results Mean total costs before diagnosis were £10 156 for the specialist group and £11 531 for the non-specialist group. Post-diagnosis costs were £24 017 and £22 266 respectively. Costs were associated with specialist care, comorbid conditions and living outside of London. Clinical implications Receiving increased support from a specialist service may reduce the need for in-patient care. This may be clinically appropriate and results in a distribution of costs.

SUMMARY: PURPOSE OF REVIEW In an effort to maximize the benefits gained from limited health care resources, economic evaluation is becoming an increasingly common feature of clinical trials. This paper explores growth in the quantity and quality of economic evaluations in the mental health field through a systematic review of all such evaluations published over a 12-month period.RECENT FINDINGS Twenty-eight economic evaluations met the inclusion criteria for the review. Cost-effectiveness and cost-consequences analyses were the most commonly employed methods of economic evaluation. Only two cost-utility analyses were located, involving the calculation of cost per quality adjusted life year gained. Thus comparison of resource implications across broad areas of mental health are not possible. Only 11 randomized controlled trials were located, although strong economic evaluations employing other designs were found. Only six studies took a cost perspective that came close to being societal. Narrow perspectives were common, with few studies including assessment of patient and family costs, nonhealth care costs or productivity losses. Small and unjustified sample sizes and short follow-up periods were not uncommon, although there have been improvements in these areas of study design in comparison to earlier reviews.SUMMARY Economic evaluations in mental health are more commonly undertaken and the methods employed are improving with time. However, there are still inadequate numbers of such evaluations to inform resource allocation decisions and poor methods are still common. Careful examination of the few good quality economic evaluations in existence may help to improve this situation in the future. [ABSTRACT FROM AUTHOR]

Abstract Early psychosis is characterised by heterogeneity in illness trajectories, where outcomes remain poor for many. Understanding psychosis symptoms and their relation to illness outcomes, from a novel network perspective, may help to delineate psychopathology within early psychosis and identify pivotal targets for intervention. Using network modelling in first episode psychosis (FEP), this study aimed to identify: (a) key central and bridge symptoms most influential in symptom networks, and (b) examine the structure and stability of the networks at baseline and 12-month follow-up. Data on 1027 participants with FEP were taken from the National EDEN longitudinal study and used to create regularised partial correlation networks using the ‘EBICglasso’ algorithm for positive, negative, and depressive symptoms at baseline and at 12-months. Centrality and bridge estimations were computed using a permutation-based network comparison test. Depression featured as a central symptom in both the baseline and 12-month networks. Conceptual disorganisation, stereotyped thinking, along with hallucinations and suspiciousness featured as key bridge symptoms across the networks. The network comparison test revealed that the strength and bridge centralities did not differ significantly between the two networks (C = 0.096153; p = 0.22297). However, the network structure and connectedness differed significantly from baseline to follow-up (M = 0.16405, p =

Abstract Background Inpatient psychiatric care is unpopular and expensive, and development and evaluation of alternatives is a long-standing policy and research priority around the world. In England, the three main models documented over the past fifty years (teams offering crisis assessment and treatment at home; acute day units; and residential crisis services in the community) have recently been augmented by several new service models. These are intended to enhance choice and flexibility within catchment area acute care systems, but remain largely undocumented in the research literature. We therefore aimed to describe the types and distribution of crisis care models across England through a national survey. Methods We carried out comprehensive mapping of crisis resolution teams (CRTs) using previous surveys, websites and multiple official data sources. Managers of CRTs were invited to participate as key informants who were familiar with the provision and organisation of crisis care services within their catchment area. The survey could be completed online or via telephone interview with a researcher, and elicited details about types of crisis care delivered in the local catchment area. Results We mapped a total of 200 adult CRTs and completed the survey with 184 (92%). Of the 200 mapped adult CRTs, there was a local (i.e., within the adult CRT catchment area) children and young persons CRT for 84 (42%), and an older adults CRT for 73 (37%). While all but one health region in England provided CRTs for working age adults, there was high variability regarding provision of all other community crisis service models and system configurations. Crisis cafes, street triage teams and separate crisis assessment services have all proliferated since a similar survey in 2016, while provision of acute day units has reduced. Conclusions The composition of catchment area crisis systems varies greatly across England and popularity of models seems unrelated to strength of evidence. A group of emerging crisis care models with varying functions within service systems are increasingly prevalent: they have potential to offer greater choice and flexibility in managing crises, but an evidence base regarding impact on service user experiences and outcomes is yet to be established.

Abstract Background Persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS. Methods A randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20 weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52 weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52 weeks. Discussion This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS). Trial registration ClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.

Abstract Background Cannabis is the most commonly used illicit substance amongst people with psychosis. Continued cannabis use following the onset of psychosis is associated with poorer functional and clinical outcomes. However, finding effective ways of intervening has been very challenging. We examined the clinical and cost-effectiveness of adjunctive contingency management (CM), which involves incentives for abstinence from cannabis use, in people with a recent diagnosis of psychosis. Methods CIRCLE was a pragmatic multi-centre randomised controlled trial. Participants were recruited via Early Intervention in Psychosis (EIP) services across the Midlands and South East of England. They had had at least one episode of clinically diagnosed psychosis (affective or non-affective); were aged 18 to 36; reported cannabis use in at least 12 out of the previous 24 weeks; and were not currently receiving treatment for cannabis misuse, or subject to a legal requirement for cannabis testing. Participants were randomised via a secure web-based service 1:1 to either an experimental arm, involving 12 weeks of CM plus a six-session psychoeducation package, or a control arm receiving the psychoeducation package only. The total potential voucher reward in the CM intervention was £240. The primary outcome was time to acute psychiatric care, operationalised as admission to an acute mental health service (including community alternatives to admission). Primary outcome data were collected from patient records at 18 months post-consent by assessors masked to allocation. The trial was registered with the ISRCTN registry, number ISRCTN33576045. Results Five hundred fifty-one participants were recruited between June 2012 and April 2016. Primary outcome data were obtained for 272 (98%) in the CM (experimental) group and 259 (95%) in the control group. There was no statistically significant difference in time to acute psychiatric care (the primary outcome) (HR 1.03, 95% CI 0.76, 1.40) between groups. By 18 months, 90 (33%) of participants in the CM group, and 85 (30%) of the control groups had been admitted at least once to an acute psychiatric service. Amongst those who had experienced an acute psychiatric admission, the median time to admission was 196 days (IQR 82, 364) in the CM group and 245 days (IQR 99, 382) in the control group. Cost-effectiveness analyses suggest that there is an 81% likelihood that the intervention was cost-effective, mainly resulting from higher mean inpatient costs for the control group compared with the CM group; however, the cost difference between groups was not statistically significant. There were 58 adverse events, 27 in the CM group and 31 in the control group. Conclusions Overall, these results suggest that CM is not an effective intervention for improving the time to acute psychiatric admission or reducing cannabis use in psychosis, at least at the level of voucher reward offered.

Background: Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. Objectives: The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. Design: This was a three-arm, single-blind, parallel randomised controlled trial. Setting: A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. Participants: A total of 1742 participants aged 40–74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. Interventions: The intervention was designed to integrate MI and cognitive–behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. Randomisation: Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. Main outcome measures: The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Results: The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) –288 to 147.9 steps, and mean 7.24 steps, 95% CI –224.01 to 238.5 steps, respectively] or in reducing weight (mean –0.03 kg, 95% CI –0.49 to 0.44 kg, and mean –0.42 kg, 95% CI –0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI –85.28 to 347.48 steps, and mean 210.22 steps, 95% CI –19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean –0.52 kg, 95% CI –0.90 to –0.13 kg, and mean –0.55 kg, 95% CI –0.95 to –0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. Conclusions: Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. Trial registration: Current Controlled Trials ISRCTN84864870. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.