Factors influencing effective data sharing between health care and social care regarding the care of older people: a qualitative evidence synthesis.

Background: Sharing data about patients between health and social care organisations and professionals, such as details of their medication, is essential to provide co-ordinated and person-centred care. While professionals can share data in a number of ways - for example, through shared electronic record systems or multidisciplinary team meetings - there are many factors that make sharing data across the health and social care boundary difficult. These include professional hierarchies, inaccessible electronic systems and concerns around confidentiality. Data-sharing is particularly important for the care of older people, as they are more likely to have multiple or long-term conditions; understanding is needed on how to enable effective data-sharing. Objectives: To identify factors perceived as influencing effective data-sharing, including the successful adoption of interventions to improve data-sharing, between healthcare and social care organisations and professionals regarding the care of older people. Methods: MEDLINE and seven further databases were searched (in March 2023) for qualitative and mixed-methods studies. Relevant websites were searched and citation-chasing completed on included studies. Studies were included if they focused on older people, as defined by the study, and data-sharing, defined as the transfer of information between healthcare and social care organisations, or care professionals, regarding a patient, and were conducted in the United Kingdom. Purposive sampling was used to obtain a final set of studies which were analysed using framework synthesis. Quality appraisal was conducted using the Wallace checklist. Stakeholder and public and patient involvement groups were consulted throughout the project. Results: Twenty-four studies were included; most scored highly on the quality appraisal checklist. Four main themes were identified. Within Goals, we found five purposes of data-sharing: joint (health and social care) assessment, integrated case management, transitions from hospital to home, for residents of care homes, and for palliative care. In Relationships, building interprofessional relationships, and therefore trust and respect, between professionals supported data-sharing, while the presence of professional prejudices and mistrust hindered it. Interorganisational Processes and procedures, such as a shared vision of care and operationalisation of formal agreements, for example data governance, supported data-sharing. Within Technology and infrastructure, the use of technology as a tool supported data-sharing, as did professionals' awareness of the wider care system. There were also specific factors influencing data-sharing related to its purpose; for example, there was a lack of legal frameworks in the area of palliative care. Limitations: Data-sharing was usually discussed in the context of wider initiatives, for example integrated care, which meant the information provided was often limited. The COVID-19 pandemic has had significant impacts on ways of working; none of our included studies were conducted during or since the pandemic. Conclusions: Our findings indicate the importance of building interprofessional relationships and ensuring that professionals are able to share data in multiple ways. Future work: Exploration of the impact of new technologies and ways of working adopted as a result of the COVID-19 pandemic on data-sharing is needed. Additionally, research should explore patient experience and the prevention of digital exclusion among health and social care professionals. Study registration: The protocol was registered on PROSPERO CRD42023416621. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR135660), as part of a series of evidence syntheses under award NIHR130538, and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 12. See the NIHR Funding and Awards website for further award information.

Health and social care organisations and professionals need to share data about older people. Data ­ for example, details of medication ­ can be shared in different ways, for example electronic records systems, team meetings. Sharing data is important, especially for people with multiple or long-term conditions as they may need co-ordinated help from health and social care services. However, professionals often find it difficult to share data. For example, they may have concerns about confidentiality or may not have access to the same electronic record systems. This review investigated factors that influence data-sharing between health and social care. We found 24 studies that used methods such as focus groups or interviews. We found five main purposes of sharing data in the studies: to assess people's need for health and social care to co-ordinate care for people with existing needs to help people move from hospital to home to care for people living in care homes to support end-of-life care. Factors that help health and social care professionals share data include: having trust and respect for each other having suitable policies and processes in place between their organisations having an awareness of why other professionals need data. New technologies can help professionals share data, but they need to be part of the normal way that people work. These findings could help to improve data-sharing as they show that professionals need multiple ways of sharing data. They also suggest more research is needed so that new technology supports data-sharing. Stakeholders ­ for example, doctors, social workers, and public and patient representatives ­ provided feedback throughout the project. The review contains studies published between 1995 and March 2023.

Remote monitoring for long-term physical health conditions: an evidence and gap map.

Background: Remote monitoring involves the measurement of an aspect of a patient's health without that person being seen face to face. It could benefit the individual and aid the efficient provision of health services. However, remote monitoring can be used to monitor different aspects of health in different ways. This evidence map allows users to find evidence on different forms of remote monitoring for different conditions easily to support the commissioning and implementation of interventions. Objectives: The aim of this map was to provide an overview of the volume, diversity and nature of recent systematic reviews on the effectiveness, acceptability and implementation of remote monitoring for adults with long-term physical health conditions. Data sources: We searched MEDLINE, nine further databases and Epistemonikos for systematic reviews published between 2018 and March 2022, PROSPERO for continuing reviews, and completed citation chasing on included studies. Review methods: (Study selection and Study appraisal): Included systematic reviews focused on adult populations with a long-term physical health condition and reported on the effectiveness, acceptability or implementation of remote monitoring. All forms of remote monitoring where data were passed to a healthcare professional as part of the intervention were included. Data were extracted on the characteristics of the remote monitoring intervention and outcomes assessed in the review. AMSTAR 2 was used to assess quality. Results were presented in an interactive evidence and gap map and summarised narratively. Stakeholder and public and patient involvement groups provided feedback throughout the project. Results: We included 72 systematic reviews. Of these, 61 focus on the effectiveness of remote monitoring and 24 on its acceptability and/or implementation, with some reviews reporting on both. The majority contained studies from North America and Europe (38 included studies from the United Kingdom). Patients with cardiovascular disease, diabetes and respiratory conditions were the most studied populations. Data were collected predominantly using common devices such as blood pressure monitors and transmitted via applications, websites, e-mail or patient portals, feedback provided via telephone call and by nurses. In terms of outcomes, most reviews focused on physical health, mental health and well-being, health service use, acceptability or implementation. Few reviews reported on less common conditions or on the views of carers or healthcare professionals. Most reviews were of low or critically low quality. Limitations: Many terms are used to describe remote monitoring; we searched as widely as possible but may have missed some relevant reviews. Poor reporting of remote monitoring interventions may mean some included reviews contain interventions that do not meet our definition, while relevant reviews might have been excluded. This also made the interpretation of results difficult. Conclusions and future work: The map provides an interactive, visual representation of evidence on the effectiveness of remote monitoring and its acceptability and successful implementation. This evidence could support the commissioning and delivery of remote monitoring interventions, while the limitations and gaps could inform further research and technological development. Future reviews should follow the guidelines for conducting and reporting systematic reviews and investigate the application of remote monitoring in less common conditions. Review registration: A protocol was registered on the OSF registry (https://doi.org/10.17605/OSF.IO/6Q7P4). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Services and Delivery Research programme (NIHR award ref: NIHR135450) as part of a series of evidence syntheses under award NIHR130538. For more information, visit https://fundingawards.nihr.ac.uk/award/NIHR135450 and https://fundingawards.nihr.ac.uk/award/NIHR130538. The report is published in full in Health and Social Care Delivery Research; Vol. 11, No. 22. See the NIHR Funding and Awards website for further project information.

Remote monitoring is when an aspect of a patient's health, such as blood pressure, is measured at home, and this information is passed to a healthcare professional. We created an evidence and gap map for remote monitoring in adults with long-term physical health conditions. The map is presented as an interactive online table, which can be used to find the number and quality of systematic reviews that address specific questions (e.g. remote monitoring in diabetes). The map does not summarise findings from the reviews (e.g. whether remote monitoring works or not). We found 72 reviews investigating whether remote monitoring works and/or how to implement it, including whether it is acceptable to patients, carers and healthcare professionals. Thirty-seven reviews included studies from the United Kingdom. The most common health conditions were heart disease, diabetes and lung conditions. There was little or no evidence for some health conditions (e.g. epilepsy). Data from patients were collected mainly using common devices (e.g. heart rate monitors) and passed to healthcare providers using computer applications, websites and telephone calls. Most feedback received by patients was motivational/educational. There was evidence about the acceptability of remote monitoring for patients, but little for carers and healthcare professionals. Reviews focused on whether remote monitoring affected physical and mental health, health service use, acceptability or implementation. More than half the included reviews were judged to be low quality; however, they may still include high-quality studies. The map could help to design and deliver remote monitoring programmes and guide further research and technology development. Stakeholder and public and patient representatives provided feedback throughout the project. The map contains reviews published between 2018 and March 2022.

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

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

Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Economic evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: a cost-utility and cost-consequences analysis.

BACKGROUND: People in prison experience a range of physical and mental health problems. Evaluating the effectiveness and efficiency of prison-based interventions presents a number of methodological challenges. We present a case study of an economic evaluation of a prison-based intervention ("Engager") to address common mental health problems. METHODS: Two hundred and eighty people were recruited from prisons in England and randomised to Engager plus usual care or usual care. Participants were followed up for 12 months following release from prison. The primary analysis is the cost per quality-adjusted life year (QALY) gained of Engager compared to usual care from a National Health Service (NHS) perspective with QALYs calculated using the CORE 6 Dimension. A cost-consequences analysis evaluated cross-sectoral costs and a range of outcomes. RESULTS: From an NHS perspective, Engager cost an additional £2737 per participant (95% of iterations between £1029 and £4718) with a mean QALY difference of - 0.014 (95% of iterations between - 0.045 and 0.017). For the cost-consequences, there was evidence of improved access to substance misuse services 12 months post-release (odds ratio 2.244, 95% confidence Interval 1.304-3.861). CONCLUSION: Engager provides a rare example of a cost-utility analysis conducted in prisons and the community using patient-completed measures. Although the results from this trial show no evidence that Engager is cost-effective, the results of the cost-consequences analysis suggest that follow-up beyond 12 months post-release using routine data may provide additional insights into the effectiveness of the intervention and the importance of including a wide range of costs and outcomes in prison-based economic evaluations. TRIAL REGISTRATION: (ISRCTN11707331).

What is the volume, diversity and nature of recent, robust evidence for the use of peer support in health and social care? An evidence and gap map.

Background: Peer support interventions involve people drawing on shared personal experience to help one another improve their physical or mental health, or reduce social isolation. If effective, they may also lessen the demand on health and social care services, reducing costs. However, the design and delivery of peer support varies greatly, from the targeted problem or need, the setting and mode of delivery, to the number and content of sessions. Robust evidence is essential for policymakers commissioning peer support and practitioners delivering services in health care and community settings. This map draws together evidence on different types of peer support to support the design and delivery of interventions. Objectives: The aim of this map was to provide an overview of the volume, diversity and nature of recent, high quality evidence on the effectiveness and cost-effectiveness of the use of peer support in health and social care. Search Methods: We searched MEDLINE, seven further bibliographic databases, and Epistemonikos for systematic reviews (in October 2020), randomised controlled trials (in March 2021) and economic evaluations (in May 2021) on the effectiveness of peer support interventions in health and social care. We also conducted searches of Google Scholar, two trial registers, PROSPERO, and completed citation chasing on included studies. Selection Criteria: Systematic reviews, randomised controlled trials and economic evaluations were included in the map. Included studies focused on adult populations with a defined health or social care need, were conducted in high-income countries, and published since 2015. Any measure of effectiveness was included, as was any form of peer support providing the peer had shared experience with the participant and a formalised role. Data Collection and Analysis: Data were extracted on the type of peer support intervention and outcomes assessed in included studies. Standardised tools were used to assess study quality for all studies: assessing the methodological quality of systematic reviews 2 for systematic reviews; Cochrane risk of bias tool for randomised controlled trials; and consensus health economic criteria list for economic evaluations. Main Results: We included 91 studies: 32 systematic reviews; 52 randomised controlled trials; and 7 economic evaluations. Whilst most included systematic reviews and economic evaluations were assessed to be of low or medium quality, the majority of randomised controlled trials were of higher quality. There were concentrations of evidence relating to different types of peer support, including education, psychological support, self-care/self-management and social support. Populations with long-term health conditions were most commonly studied. The majority of studies measured health-related indicators as outcomes; few studies assessed cost-effectiveness. Studies were unevenly distributed geographically, with most being conducted in the USA. Several gaps were evident regarding the delivery of peer support, particularly the integration of peers and professionals in delivering support and interventions of longer duration. Authors' Conclusions: Although there is evidence available to inform the commissioning and delivery of peer support in health and social care, there are also clear gaps that need to be addressed to further support provision, particularly regarding cost-effectiveness. The effectiveness of peer support in different countries, with varying health and social care systems, is a priority for future research, as is the integration of peers with professionals in delivering peer support.

Improving continence in children and young people with neurodisability: a systematic review and survey.

BACKGROUND: Children and young people with neurodisability often need help to achieve socially acceptable bladder and bowel control. Approaches vary depending on whether or not the impairment results from spinal cord pathology that impairs motor control and sensation of the bladder and bowel. Currently, there is uncertainty about which interventions are effective. OBJECTIVE: The objective was to summarise the available evidence on and current practice for improving continence in children and young people with neurodisability. DESIGN: A systematic review of the effectiveness, cost-effectiveness and factors that modify intervention implementation, alongside a cross-sectional, online survey of current practice with health professionals, parent carers, school and care staff and young people with neurodisability. RESULTS: Twelve databases were searched in the review, resulting in 5756 references; 71 studies (72 papers) were included in the analyses. Most of the evidence was for children with spinal cord pathology, which involved evaluations of pharmacological approaches and surgical techniques, whereas the evidence pertaining to those with non-spinal-cord-related pathology tended to be for behavioural interventions. The methodological quality of studies was rated as being moderate to poor. There were three robust qualitative studies about the experience of continence among children with spinal cord pathology. We found substantial heterogeneity across the interventions that we evaluated in terms of quality, study design and outcomes measured. No economic studies were found. The results were synthesised narratively and reported in text and tables. We did not find any eligible studies evaluating interventions using toilet and clothing adaptations in the review, although the survey highlighted that these types of interventions are frequently used and considered. In total, 949 people responded to the survey: 202 health professionals, 605 parent carers, 122 school and social care staff, and 20 young people. The survey results illustrated the different roles that professionals have in improving continence, highlighting the importance of a multidisciplinary approach to supporting children and young people and their families. Clinicians employ a range of assessments and interventions to improve continence or independent toileting, depending on the needs of the child. LIMITATIONS: Quantitative studies in the review were not methodologically robust. The survey had a risk of response bias. CONCLUSIONS: Our research found a dearth of good-quality evidence for many of the interventions currently in use, and no evidence of experiences of implementing interventions for children with non-spinal-cord-related pathology. There was also no evidence of cost-effectiveness of any of the interventions. FUTURE WORK: There is a need to involve young people and families in the design of high-quality evaluative research for interventions that aim to improve continence. This is especially the case for children with autism and learning disability, who have been neglected in previous evaluative and qualitative research. We recommend better training for health, education and care professionals about toileting, informed by evidence and the lived experiences of children and their families. We recommend a joined-up multidisciplinary and holistic approach to improving continence to maximise independence, dignity and comfort. It is vital that children and young people with neurodisability have early access to regular, integrated assessment of their bladder and bowel health, and are fully supported with appropriate personalised treatment. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018100572. 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. 73. See the NIHR Journals Library website for further project information.

Learning to go to the toilet is an important skill. Becoming continent involves knowing when you need to go, holding on until you find the right place, going to the toilet, cleaning and getting dressed again. Many children and young people with special educational needs or disability can learn to become clean and dry, sometimes with help or equipment. Advice is not consistent about the best ways to assess and treat continence problems for children and young people with neurodisability. This research aimed to find out how families and professionals measure and improve continence, and if there was evidence about which treatments are useful. We brought together the results of studies that have tested ways of assessing and improving toilet training for children and young people with special educational needs or disability. We carried out four online surveys with health professionals, education and care staff, parent carers, and disabled young people. We brought together and explained the findings from the surveys and the studies with help from parent carers and professionals. Approaches to improving continence vary depending on whether or not the child or young person's nerves and muscles that control their bladder and bowel work properly. Children and young people with conditions affecting the nerves and muscles of their bladder and bowel are often helped by medical or surgical treatments. Children and young people with conditions such as learning disability or autism may benefit from behavioural therapies to help them learn to use the toilet. There is poor evidence for how well treatments work and whether or not they are value for money. More and better research is needed to make sure that children and young people are able to be clean and dry without pads, maximising their independence, dignity and comfort. This also requires an adequate number of fully accessible toilets in the community.

Economic Aspects of Delivering Primary Care Services: An Evidence Synthesis to Inform Policy and Research Priorities.

Policy Points The 2018 Declaration of Astana reemphasized the importance of primary health care and its role in achieving universal health coverage. While there is a large amount of literature on the economic aspects of delivering primary care services, there is a need for more comprehensive overviews of this evidence. In this article, we offer such an overview. Evidence suggests that there are several strategies involving coverage, financing, service delivery, and governance arrangements which can, if implemented, have positive economic impacts on the delivery of primary care services. These include arrangements such as worker task-shifting and telemedicine. The implementation of any such arrangements, based on positive economic evidence, should carefully account for potential impacts on overall health care access and quality. There are many opportunities for further research, with notable gaps in evidence on the impacts of increasing primary care funding or the overall supply of primary care services. CONTEXT: The 2018 Declaration of Astana reemphasized the importance of primary health care and its role in achieving universal health coverage. To strengthen primary health care, policymakers need guidance on how to allocate resources in a manner that maximizes its economic benefits. METHODS: We collated and synthesized published systematic reviews of evidence on the economic aspects of different models of delivering primary care services. Building on previous efforts, we adapted existing taxonomies of primary care components to classify our results according to four categories: coverage, financing, service delivery, and governance. FINDINGS: We identified and classified 109 reviews that met our inclusion criteria according to our taxonomy of primary care components: coverage, financing, service delivery, and governance arrangements. A significant body of evidence suggests that several specific primary care arrangements, such as health workers' task shifting and telemedicine, can have positive economic impacts (such as lower overall health care costs). Notably absent were reviews on the impact of increasing primary care funding or the overall supply of primary care services. CONCLUSIONS: There is a great opportunity for further research to systematically examine the broader economic impacts of investing in primary care services. Despite progress over the last decade, significant evidence gaps on the economic implications of different models of primary care services remain, which could help inform the basis of future research efforts.

Strategies to identify individuals with monogenic diabetes: results of an economic evaluation.

OBJECTIVES: To evaluate and compare the lifetime costs associated with strategies to identify individuals with monogenic diabetes and change their treatment to more appropriate therapy. DESIGN: A decision analytical model from the perspective of the National Health Service (NHS) in England and Wales was developed and analysed. The model was informed by the literature, routinely collected data and a clinical study conducted in parallel with the modelling. SETTING: Secondary care in the UK. PARTICIPANTS: Simulations based on characteristics of patients diagnosed with diabetes <30 years old. INTERVENTIONS: Four test-treatment strategies to identify individuals with monogenic diabetes in a prevalent cohort of diabetics diagnosed under the age of 30 years were modelled: clinician-based genetic test referral, targeted genetic testing based on clinical prediction models, targeted genetic testing based on biomarkers, and blanket genetic testing. The results of the test-treatment strategies were compared with a strategy of no genetic testing. PRIMARY AND SECONDARY OUTCOME MEASURES: Discounted lifetime costs, proportion of cases of monogenic diabetes identified. RESULTS: Based on current evidence, strategies using clinical characteristics or biomarkers were estimated to save approximately £100-£200 per person with diabetes over a lifetime compared with no testing. Sensitivity analyses indicated that the prevalence of monogenic diabetes, the uptake of testing, and the frequency of home blood glucose monitoring had the largest impact on the results (ranging from savings of £400-£50 per person), but did not change the overall findings. The model is limited by many model inputs being based on very few individuals, and some long-term data informed by clinical opinion. CONCLUSIONS: Costs to the NHS could be saved with targeted genetic testing based on clinical characteristics or biomarkers. More research should focus on the economic case for the use of such strategies closer to the time of diabetes diagnosis. TRIAL REGISTRATION NUMBER: NCT01238380.

Interventions to improve the mental health of children and young people with long-term physical conditions: linked evidence syntheses.

BACKGROUND: Although mental health difficulties can severely complicate the lives of children and young people (CYP) with long-term physical conditions (LTCs), there is a lack of evidence about the effectiveness of interventions to treat them. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of interventions aiming to improve the mental health of CYP with LTCs (review 1) and explore the factors that may enhance or limit their delivery (review 2). DATA SOURCES: For review 1, 13 electronic databases were searched, including MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Science Citation Index. For review 2, MEDLINE, PsycINFO and CINAHL were searched. Supplementary searches, author contact and grey literature searches were also conducted. REVIEW METHODS: The first systematic review sought randomised controlled trials (RCTs) and economic evaluations of interventions to improve elevated symptoms of mental ill health in CYP with LTCs. Effect sizes for each outcome were calculated post intervention (Cohen's d). When appropriate, random-effects meta-analyses produced pooled effect sizes (d). Review 2 located primary qualitative studies exploring experiences of CYP with LTCs, their families and/or practitioners, regarding interventions aiming to improve the mental health and well-being of CYP with LTCs. Synthesis followed the principles of metaethnography. An overarching synthesis integrated the findings from review 1 and review 2 using a deductive approach. End-user involvement, including topic experts and CYP with LTCs and their parents, was a feature throughout the project. RESULTS: Review 1 synthesised 25 RCTs evaluating 11 types of intervention, sampling 12 different LTCs. Tentative evidence from seven studies suggests that cognitive-behavioural therapy interventions could improve the mental health of CYP with certain LTCs. Intervention-LTC dyads were diverse, with few opportunities to meta-analyse. No economic evaluations were located. Review 2 synthesised 57 studies evaluating 21 types of intervention. Most studies were of individuals with cancer, a human immunodeficiency virus (HIV) infection or mixed LTCs. Interventions often aimed to improve broader mental health and well-being, rather than symptoms of mental health disorder. The metaethnography identified five main constructs, described in an explanatory line of argument model of the experience of interventions. Nine overarching synthesis categories emerged from the integrated evidence, raising implications for future research. LIMITATIONS: Review 1 conclusions were limited by the lack of evidence about intervention effectiveness. No relevant economic evaluations were located. There were no UK studies included in review 1, limiting the applicability of findings. The mental health status of participants in review 2 was usually unknown, limiting comparability with review 1. The different evidence identified by the two systematic reviews challenged the overarching synthesis. CONCLUSIONS: There is a relatively small amount of comparable evidence for the effectiveness of interventions for the mental health of CYP with LTCs. Qualitative evidence provided insight into the experiences that intervention deliverers and recipients valued. Future research should evaluate potentially effective intervention components in high-quality RCTs integrating process evaluations. End-user involvement enriched the project. STUDY REGISTRATION: This study is registered as PROSPERO CRD42011001716. FUNDING: The National Institute for Health Research (NIHR) Health Technology Assessment programme and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

Many children and young people with a long-term physical health condition also experience feelings of depression, anxiety and other mental health issues that affect their day-to-day life, their family and others around them. This review investigates whether or not interventions (treatments, strategies and resources) can help children and young people with their mental health. The study also reviewed studies that explored the attitudes and experiences of those involved in receiving or delivering similar interventions. The study found 25 publications that evaluated 11 different types of interventions, including cognitive­behavioural therapy (seven studies) and music therapy (one study). There were some positive effects for the strategies tested on both mental health and other outcomes, but, because the studies were often small, exact effects were uncertain. Many of the studies were not very well designed or carried out and differences between research designs meant that it was hard to compare different studies. The study found 57 publications that explored experiences of interventions. Analysis suggested that it is important that strategies involve building good relationships and are delivered in what feels like a safe space. Participants in studies tended to like interventions that provided social support and helped them feel better about living with a long-term physical condition. Successful interventions were viewed as accessible and engaging. These studies were often conducted well, but they focused on the range of interventions rather than the review evaluating how well interventions work. There are many gaps in the research carried out so far. Some long-term conditions affecting children and young people have not been the subject of studies of mental health interventions, and some important outcomes, such as school attendance and self-care, have not been assessed. More carefully designed UK research consulting children and young people, parents and practitioners is needed before it can be clear what works for children with particular physical conditions to help their mental health, and why.

Cost-effectiveness of diagnostic and therapeutic interventions for chronic hepatitis C: a systematic review of model-based analyses.

BACKGROUND: Decisions about which subgroup of chronic hepatitis C (CHC) patients should be treated with direct acting anti-viral agents (DAAs) have economic importance due to high drug prices. Treat-all DAA strategies for CHC have gained acceptance despite high drug acquisition costs. However, there are also costs associated with the surveillance of CHC to determine a subgroup of patients with significant impairment. The aim of this systematic review was to describe the modelling methods used and summarise results in cost-effectiveness analyses (CEAs) of both CHC treatment with DAAs and surveillance of liver disease. METHODS: Electronic databases including Embase and Medline were searched from inception to May 2015. Eligible studies included models predicting costs and/or outcomes for interventions, surveillance, or management of people with CHC. Narrative and quantitative synthesis were conducted. Quality appraisal was conducted using validated checklists. The review was conducted following principles published by NHS Centre for Research and Dissemination. RESULTS: Forty-one CEAs met the eligibility criteria for the review; 37 evaluated an intervention and four evaluated surveillance strategies for targeting DAA treatment to those likely to gain most benefit. Included studies were of variable quality mostly due to reporting omissions. Of the 37 CEAs, eight models that enabled comparative analysis were fully appraised and synthesized. These models provided non-unique cost-effectiveness estimates in a specific DAA comparison in a specific population defined in terms of genotype, prior treatment status, and presence or absence of cirrhosis. Marked heterogeneity in cost-effectiveness estimates was observed despite this stratification. Approximately half of the estimates suggested that DAAs were cost-effective considering a threshold of US$30,000 and 73% with threshold of US$50,000. Two models evaluating surveillance strategies suggested that treating all CHC patients regardless of the staging of liver disease could be cost-effective. CONCLUSIONS: CEAs of CHC treatments need to better account for variability in their estimates. This analysis suggested that there are still circumstances where DAAs are not cost-effective. Surveillance in place of a treat-all strategy may still need to be considered as an option for deploying DAAs, particularly where acquisition cost is at the limit of affordability for a given health system.

Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT.

BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): To examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation. DESIGN: A two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study. SETTING: UK comprehensive cardiac rehabilitation teams. PARTICIPANTS: Adults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded. INTERVENTIONS: The EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care. MAIN OUTCOME MEASURES: Measures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses' views and experiences. RESULTS: Between September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. Of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. Of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care. LIMITATIONS: Both the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses. CONCLUSIONS: Cardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection. FUTURE RESEARCH: Consideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34701576. 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. 22, No. 30. See the NIHR Journals Library website for further project information.

Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial.

BACKGROUND: Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation. METHODS: An external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed. RESULTS: Eight out of twenty teams were recruited and randomised. Of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months. DISCUSSION: While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions. TRIAL REGISTRATION: ISRCTN34701576 . Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.

Micro-costing analysis of guideline-based treatment by direct-acting agents: the real-life case of hepatitis C management in Brazil.

BACKGROUND: Eradication of hepatitis C virus (HCV) using direct-acting agents (DAA) has been associated with a financial burden to health authorities worldwide. We aimed to evaluate the guideline-based treatment costs by DAAs from the perspective of the Brazilian Ministry of Health (BMoH). METHODS: The activity based costing method was used to estimate the cost for monitoring/treatment of genotype-1 (GT1) HCV patients by the following strategies: peg-interferon (PEG-IFN)/ribavirin (RBV) for 48 weeks, PEG-IFN/RBV plus boceprevir (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (SIM) for 12 weeks. Costs were reported in United States Dollars without (US$) and with adjustment for purchasing power parity (PPP$). Drug costs were collected at the National Database of Health Prices and an overview of the literature was performed to assess effectiveness of SOF/DCV and SOF/SIM regimens in real-world cohorts. RESULTS: Treatment costs of GT1-HCV patients were PPP$ 43,176.28 (US$ 24,020.16) for PEG-IFN/RBV, PPP$ 71,196.03 (US$ 39,578.23) for PEG-IFN/RBV/BOC and PPP$ 86,250.33 (US$ 47,946.92) for PEG-IFN/RBV/TEL. Treatment by all-oral interferon-free regimens were the less expensive approach: PPP$ 19,761.72 (US$ 10,985.90) for SOF/DCV and PPP$ 21,590.91 (US$ 12,002.75) for SOF/SIM. The overview reported HCV eradication in up to 98% for SOF/DCV and 96% for SOF/SIM. CONCLUSION: Strategies with all oral interferon-free might lead to lower costs for management of GT1-HCV patients compared to IFN-based regimens in Brazil. This occurred mainly because of high discounts over international DAA prices due to negotiation between BMoH and pharmaceutical industries.

Immunosuppressive agents in adult kidney transplantation in the National Health Service: a model-based economic evaluation.

BACKGROUND: Immunosuppression is required in kidney transplantation to prevent rejection and prolong graft survival. We conducted an economic evaluation to support England's National Institute for Health and Care Excellence in developing updated guidance on the use of immunosuppression, incorporating new immunosuppressive agents, and addressing changes in pricing and the evidence base. METHODS: A discrete-time state transition model was developed to simulate adult kidney transplant patients over their lifetime. A total of 16 different regimens were modelled to assess the cost-effectiveness of basiliximab and rabbit anti-thymocyte globulin (rabbit ATG) as induction agents (with no antibody induction as a comparator) and immediate-release tacrolimus, prolonged-release tacrolimus, mycophenolate mofetil, mycophenolate sodium, sirolimus, everolimus and belatacept as maintenance agents (with ciclosporin and azathioprine as comparators). Graft survival was extrapolated from acute rejection rates, graft function and post-transplant diabetes rates, all estimated at 12 months post-transplantation. National Health Service (NHS) and personal social services costs were included. Cost-effectiveness thresholds of £20 000 and £30 000 per quality-adjusted life year were used. RESULTS: Basiliximab was predicted to be more effective and less costly than rabbit ATG and induction without antibodies. Immediate-release tacrolimus and mycophenolate mofetil were cost-effective as maintenance therapies. Other therapies were either more expensive and less effective or would only be cost-effective if a threshold in excess of £100 000 per quality-adjusted life year were used. CONCLUSIONS: A regimen comprising induction with basiliximab, followed by maintenance therapy with immediate-release tacrolimus and mycophenolate mofetil, is likely to be effective for uncomplicated adult kidney transplant patients and a cost-effective use of NHS resources.

Immunosuppressive therapy for kidney transplantation in adults: a systematic review and economic model.

BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring renal replacement therapy: kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation, followed by immunosuppressive therapy (induction and maintenance therapy) to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect(®), Novartis Pharmaceuticals UK Ltd) and rabbit anti-human thymocyte immunoglobulin (rATG) (Thymoglobulin(®), Sanofi) as induction therapy, and immediate-release tacrolimus (TAC) (Adoport(®), Sandoz; Capexion(®), Mylan; Modigraf(®), Astellas Pharma; Perixis(®), Accord Healthcare; Prograf(®), Astellas Pharma; Tacni(®), Teva; Vivadex(®), Dexcel Pharma), prolonged-release tacrolimus (Advagraf(®) Astellas Pharma), belatacept (BEL) (Nulojix(®), Bristol-Myers Squibb), mycophenolate mofetil (MMF) (Arzip(®), Zentiva; CellCept(®), Roche Products; Myfenax(®), Teva), mycophenolate sodium (MPS) (Myfortic(®), Novartis Pharmaceuticals UK Ltd), sirolimus (SRL) (Rapamune(®), Pfizer) and everolimus (EVL) (Certican(®), Novartis) as maintenance therapy in adult renal transplantation. METHODS: Clinical effectiveness searches were conducted until 18 November 2014 in MEDLINE (via Ovid), EMBASE (via Ovid), Cochrane Central Register of Controlled Trials (via Wiley Online Library) and Web of Science (via ISI), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment (The Cochrane Library via Wiley Online Library) and Health Management Information Consortium (via Ovid). Cost-effectiveness searches were conducted until 18 November 2014 using a costs or economic literature search filter in MEDLINE (via Ovid), EMBASE (via Ovid), NHS Economic Evaluation Database (via Wiley Online Library), Web of Science (via ISI), Health Economic Evaluations Database (via Wiley Online Library) and the American Economic Association's electronic bibliography (via EconLit, EBSCOhost). Included studies were selected according to predefined methods and criteria. A random-effects model was used to analyse clinical effectiveness data (odds ratios for binary data and mean differences for continuous data). Network meta-analyses were undertaken within a Bayesian framework. A new discrete time-state transition economic model (semi-Markov) was developed, with acute rejection, graft function (GRF) and new-onset diabetes mellitus used to extrapolate graft survival. Recipients were assumed to be in one of three health states: functioning graft, graft loss or death. RESULTS: Eighty-nine randomised controlled trials (RCTs), of variable quality, were included. For induction therapy, no treatment appeared more effective than another in reducing graft loss or mortality. Compared with placebo/no induction, rATG and BAS appeared more effective in reducing biopsy-proven acute rejection (BPAR) and BAS appeared more effective at improving GRF. For maintenance therapy, no treatment was better for all outcomes and no treatment appeared most effective at reducing graft loss. BEL + MMF appeared more effective than TAC + MMF and SRL + MMF at reducing mortality. MMF + CSA (ciclosporin), TAC + MMF, SRL + TAC, TAC + AZA (azathioprine) and EVL + CSA appeared more effective than CSA + AZA and EVL + MPS at reducing BPAR. SRL + AZA, TAC + AZA, TAC + MMF and BEL + MMF appeared to improve GRF compared with CSA + AZA and MMF + CSA. In the base-case deterministic and probabilistic analyses, BAS, MMF and TAC were predicted to be cost-effective at £20,000 and £30,000 per quality-adjusted life-year (QALY). When comparing all regimens, only BAS + TAC + MMF was cost-effective at £20,000 and £30,000 per QALY. LIMITATIONS: For included trials, there was substantial methodological heterogeneity, few trials reported follow-up beyond 1 year, and there were insufficient data to perform subgroup analysis. Treatment discontinuation and switching were not modelled. FUTURE WORK: High-quality, better-reported, longer-term RCTs are needed. Ideally, these would be sufficiently powered for subgroup analysis and include health-related quality of life as an outcome. CONCLUSION: Only a regimen of BAS induction followed by maintenance with TAC and MMF is likely to be cost-effective at £20,000-30,000 per QALY. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014013189. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation.

BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation followed by induction and maintenance immunosuppressive therapy to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To systematically review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect,(®) Novartis Pharmaceuticals) and rabbit antihuman thymocyte immunoglobulin (Thymoglobuline,(®) Sanofi) as induction therapy and immediate-release tacrolimus [Adoport(®) (Sandoz); Capexion(®) (Mylan); Modigraf(®) (Astellas Pharma); Perixis(®) (Accord Healthcare); Prograf(®) (Astellas Pharma); Tacni(®) (Teva); Vivadex(®) (Dexcel Pharma)], prolonged-release tacrolimus (Advagraf,(®) Astellas Pharma); belatacept (BEL) (Nulojix,(®) Bristol-Myers Squibb), mycophenolate mofetil (MMF) [Arzip(®) (Zentiva), CellCept(®) (Roche Products), Myfenax(®) (Teva), generic MMF is manufactured by Accord Healthcare, Actavis, Arrow Pharmaceuticals, Dr Reddy's Laboratories, Mylan, Sandoz and Wockhardt], mycophenolate sodium, sirolimus (Rapamune,(®) Pfizer) and everolimus (Certican,(®) Novartis Pharmaceuticals) as maintenance therapy in children and adolescents undergoing renal transplantation. DATA SOURCES: Clinical effectiveness searches were conducted to 7 January 2015 in MEDLINE (via Ovid), EMBASE (via Ovid), Cochrane Central Register of Controlled Trials (via Wiley Online Library) and Web of Science [via Institute for Scientific Information (ISI)], Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment (HTA) (The Cochrane Library via Wiley Online Library) and Health Management Information Consortium (via Ovid). Cost-effectiveness searches were conducted to 15 January 2015 using a costs or economic literature search filter in MEDLINE (via Ovid), EMBASE (via Ovid), NHS Economic Evaluation Databases (via Wiley Online Library), Web of Science (via ISI), Health Economic Evaluations Database (via Wiley Online Library) and EconLit (via EBSCOhost). REVIEW METHODS: Titles and abstracts were screened according to predefined inclusion criteria, as were full texts of identified studies. Included studies were extracted and quality appraised. Data were meta-analysed when appropriate. A new discrete time state transition economic model (semi-Markov) was developed; graft function, and incidences of acute rejection and new-onset diabetes mellitus were used to extrapolate graft survival. Recipients were assumed to be in one of three health states: functioning graft, graft loss or death. RESULTS: Three randomised controlled trials (RCTs) and four non-RCTs were included. The RCTs only evaluated BAS and tacrolimus (TAC). No statistically significant differences in key outcomes were found between BAS and placebo/no induction. Statistically significantly higher graft function (p < 0.01) and less biopsy-proven acute rejection (odds ratio 0.29, 95% confidence interval 0.15 to 0.57) was found between TAC and ciclosporin (CSA). Only one cost-effectiveness study was identified, which informed NICE guidance TA99. BAS [with TAC and azathioprine (AZA)] was predicted to be cost-effective at £20,000-30,000 per quality-adjusted life year (QALY) versus no induction (BAS was dominant). BAS (with CSA and MMF) was not predicted to be cost-effective at £20,000-30,000 per QALY versus no induction (BAS was dominated). TAC (with AZA) was predicted to be cost-effective at £20,000-30,000 per QALY versus CSA (TAC was dominant). A model based on adult evidence suggests that at a cost-effectiveness threshold of £20,000-30,000 per QALY, BAS and TAC are cost-effective in all considered combinations; MMF was also cost-effective with CSA but not TAC. LIMITATIONS: The RCT evidence is very limited; analyses comparing all interventions need to rely on adult evidence. CONCLUSIONS: TAC is likely to be cost-effective (vs. CSA, in combination with AZA) at £20,000-30,000 per QALY. Analysis based on one RCT found BAS to be dominant, but analysis based on another RCT found BAS to be dominated. BAS plus TAC and AZA was predicted to be cost-effective at £20,000-30,000 per QALY when all regimens were compared using extrapolated adult evidence. High-quality primary effectiveness research is needed. The UK Renal Registry could form the basis for a prospective primary study. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014013544. FUNDING: The National Institute for Health Research HTA programme.

Realism and resources: Towards more explanatory economic evaluation.

To be successfully and sustainably adopted, policy-makers, service managers and practitioners want public programmes to be affordable and cost-effective, as well as effective. While the realist evaluation question is often summarised as what works for whom, under what circumstances, we believe the approach can be as salient to answering questions about resource use, costs and cost-effectiveness - the traditional domain of economic evaluation methods. This paper first describes the key similarities and differences between economic evaluation and realist evaluation. It summarises what health economists see as the challenges of evaluating complex interventions, and their suggested solutions. We then use examples of programme theory from a recent realist review of shared care for chronic conditions to illustrate two ways in which realist evaluations might better capture the resource requirements and resource consequences of programmes, and thereby produce explanations of how they are linked to outcomes (i.e. explanations of cost-effectiveness).

Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial.

BACKGROUND: Around 17% of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway. METHODS/DESIGN: This study tests the uncertainties associated with a large-scale evaluation by conducting an external pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac rehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac rehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients (eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team will be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months and 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the retention and flow of patients through treatment will be used to assess intervention feasibility and acceptability. Qualitative interviews will be undertaken to explore trial participants' and cardiac rehabilitation nurses' views and experiences of the trial methods and intervention, and to identify reasons why patients declined to take part in the trial. Outcome data will inform a sample size calculation for a definitive trial. DISCUSSION: The pilot trial and qualitative study will inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological care within cardiac rehabilitation programmes. TRIAL REGISTRATION: ISRCTN34701576 (Registered 29 May 2014).