Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression

INTRODUCTION: Cardiac rehabilitation (CR) is offered to reduce the risk of further cardiac events and to improve patients' health and quality of life following a cardiac event. Psychological care is a common component of CR as symptoms of depression and/or anxiety are more prevalent in this population, however evidence for the cost-effectiveness of current interventions is limited. Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients. This protocol describes the planned approach to the economic evaluation of MCT for CR patients. METHODS AND ANALYSIS: The economic evaluation work will consist of a within-trial analysis and an economic model. The PATHWAY Group MCT study has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomised controlled trial study design (UK Clinical Trials Gateway). A within-trial economic evaluation and economic model will compare the cost-effectiveness of MCT plus usual care (UC) to UC, from a health and social care perspective in the UK. The within-trial analysis will use intention-to-treat and estimate total costs and quality-adjusted life-years (QALYs) for the trial follow-up. Single imputation will be used to impute missing baseline variables. Multiple imputation will be used to impute values missing at follow-up. Items of resource use will be multiplied by published national healthcare costs. Regression analysis will be used to estimate net costs and net QALYs and these estimates will be bootstrapped to generate 10 000 net pairs of costs and QALYs to inform the probability of cost-effectiveness. A decision analytical economic model will be developed to synthesise trial data with the published literature over a longer time frame. Sensitivity analysis will explore uncertainty. Guidance of the methods for economic models will be followed and dissemination will adhere to reporting guidelines. ETHICS AND DISSEMINATION: The economic evaluation includes a within-trial analysis. The trial which included the collection of this data was reviewed and approved by Ethics. Ethics approval was obtained by the Preston Research Ethics Committee (project ID 156862). The modelling analysis is not applicable for Ethics as it will use data from the trial (secondary analysis) and the published literature. Results of the main trial and economic evaluation will be published in the peer-reviewed National Institute for Health Research (NIHR) journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences. TRIAL REGISTRATION NUMBER: ISRCTN74643496; Pre-results

Health State Values of Deaf British Sign Language (BSL) Users in the UK: An Application of the BSL Version of the EQ-5D-5L

Background: Deaf people experience health inequalities compared to hearing populations. The EQ-5D, a widely used, standardised, generic measure of health status, which is available in over 100 languages, was recently translated into British Sign Language (BSL) and initial validation conducted. Using data from this previous study of the EQ-5D-5L BSL we aimed to assess (1) whether responses to the EQ-5D differed between a sample of Deaf BSL users and the general population (2) whether socio-demographic characteristics and clinical measures were associated with EQ-5D index scores in Deaf BSL users and (3) the impact of psychological distress and depression on health status in Deaf BSL users. Methods: Published population tariffs were applied to the EQ-5D-5L BSL, using the crosswalk methodology, to estimate health state values. Descriptive statistics (mean, SD, 95% CIs) compared Deaf BSL signer participants’ (n = 92) responses to data from the general population. Descriptive statistics and linear regression analyses were used to identify associations between Deaf participants’ EQ-5D index scores, socio-demographic characteristics, physical health and depression. Descriptive statistics compared the BSL index scores for people with psychological distress/depression to those from two cross-sectional, population-based surveys. Results: Using the EQ-5D, Deaf participants had lower mean health-state values (0.78; 95% CI 0.72–0.83; n = 89) than people participating in the 2017 Health Survey for England (0.84; 95% CI 0.83–0.84; n = 7169). Unlike larger studies, such as the Health Survey for England sample, there was insufficient evidence to assess whether Deaf participants’ EQ-5D health state values were associated with their demographic characteristics. Nevertheless, analysis of the BSL study data indicated long-standing physical illness was associated with lower health-state values (ordinary least squares coefficient = − 0.354; 95% CI − 0.484, − 0.224; p < 0.01; n = 82). Forty-three percent of our Deaf participants had depression. Participants with depression had reduced health status (0.67; 95% CI 0.58–0.77; n = 36) compared to those with no psychological distress or depression (0.87; 95% CI 0.61–0.67; n = 36). Conclusions: The study highlights reduced health in the Deaf signing population, compared to the general population. Public health initiatives focused on BSL users, aiming to increase physical and mental health, are needed to address this gap

Utilising Patient and Public Involvement in Stated Preference Research in Health: Learning from the Existing Literature and a Case Study

From Springer Nature via Jisc Publications RouterHistory: registration 2020-07-17, online 2020-08-04, pub-electronic 2020-08-04, pub-print 2021-07Publication status: PublishedFunder: Programme Grants for Applied Research; doi: http://dx.doi.org/10.13039/501100007602; Grant(s): RP-PG-1211-20011Abstract: Publications reporting discrete choice experiments of healthcare interventions rarely discuss whether patient and public involvement (PPI) activities have been conducted. This paper presents examples from the existing literature and a detailed case study from the National Institute for Health Research-funded PATHWAY programme that comprehensively included PPI activities at multiple stages of preference research. Reflecting on these examples, as well as the wider PPI literature, we describe the different stages at which it is possible to effectively incorporate PPI across preference research, including the design, recruitment and dissemination of projects. Benefits of PPI activities include gaining practical insights from a wider perspective, which can positively impact experiment design as well as survey materials. Further benefits included advice around recruitment and reaching a greater audience with dissemination activities, amongst others. There are challenges associated with PPI activities; examples include time, cost and outlining expectations. Overall, although we acknowledge practical difficulties associated with PPI, this work highlights that it is possible for preference researchers to implement PPI across preference research. Further research systematically comparing methods related to PPI in preference research and their associated impact on the methods and results of studies would strengthen the literature

Delivery preferences for psychological intervention in cardiac rehabilitation : a pilot discrete choice experiment

BACKGROUND: Cardiac rehabilitation (CR) is a programme of care offered to people who recently experienced a cardiac event. There is a growing focus on home-based formats of CR and a lack of evidence on preferences for psychological care in CR. This pilot study aimed to investigate preferences for delivery attributes of a psychological therapy intervention in CR patients with symptoms of anxiety and/or depression. METHODS: A discrete choice experiment (DCE) was conducted and recruited participants from a feasibility trial. Participants were asked to choose between two hypothetical interventions, described using five attributes; intervention type (home or centre-based), information provided, therapy manual format, cost to the National Health Service (NHS) and waiting time. A separate opt-out was included. A conditional logit using maximum likelihood estimation was used to analyse preferences. The NHS cost was used to estimate willingness to pay for aspects of the intervention delivery. RESULTS: 35 responses were received (39% response rate). Results indicated that participants would prefer to receive any form of therapy compared with no therapy. Statistically significant results were limited, but included participants being keen to avoid not receiving information prior to therapy (β=-0.270; p=0.03) and preferring a lower cost to the NHS (β=-0.001; p=0.00). No significant results were identified for the type of psychological intervention, format of therapy/exercises and programme start time. Coefficients indicated preferences were stronger for home-based therapy compared with centre-based, but this was not significant. CONCLUSIONS: The pilot study demonstrates the feasibility of a DCE in this group, it identifies potential attributes and levels, and estimates the sample sizes needed for a full study. Preliminary evidence indicated that sampled participants tended to prefer home-based psychological therapy in CR and wanted to receive information before initiating therapy. Results are limited due to the pilot design and further research is needed

Cost-effectiveness of home-based cardiac rehabilitation : a systematic review

OBJECTIVE: Centre-based cardiac rehabilitation (CR) is recognised as cost-effective for individuals following a cardiac event. However, home-based alternatives are becoming increasingly popular, especially since COVID-19, which necessitated alternative modes of care delivery. This review aimed to assess whether home-based CR interventions are cost-effective (vs centre-based CR). METHODS: Using the MEDLINE, Embase and PsycINFO databases, literature searches were conducted in October 2021 to identify full economic evaluations (synthesising costs and effects). Studies were included if they focused on home-based elements of a CR programme or full home-based programmes. Data extraction and critical appraisal were completed using the NHS EED handbook, Consolidated Health Economic Evaluation Reporting Standards and Drummond checklists and were summarised narratively. The protocol was registered on the PROSPERO database (CRD42021286252). RESULTS: Nine studies were included in the review. Interventions were heterogeneous in terms of delivery, components of care and duration. Most studies were economic evaluations within clinical trials (8/9). All studies reported quality-adjusted life years, with the EQ-5D as the most common measure of health status (6/9 studies). Most studies (7/9 studies) concluded that home-based CR (added to or replacing centre-based CR) was cost-effective compared with centre-based options. CONCLUSIONS: Evidence suggests that home-based CR options are cost-effective. The limited size of the evidence base and heterogeneity in methods limits external validity. There were further limitations to the evidence base (eg, limited sample sizes) that increase uncertainty. Future research is needed to cover a greater range of home-based designs, including home-based options for psychological care, with greater sample sizes and the potential to acknowledge patient heterogeneity

Discrete choice experiment to investigate preferences for psychological intervention in cardiac rehabilitation

OBJECTIVE: Cardiac rehabilitation (CR) is offered to people who recently experienced a cardiac event, and often comprises of exercise, education and psychological care. This stated preference study aimed to investigate preferences for attributes of a psychological therapy intervention in CR. METHODS: A discrete choice experiment (DCE) was conducted and recruited a general population sample and a trial sample. DCE attributes included the modality (group or individual), healthcare professional providing care, information provided prior to therapy, location and the cost to the National Health Service (NHS). Participants were asked to choose between two hypothetical designs of therapy, with a separate opt-out included. A mixed logit model was used to analyse preferences. Cost to the NHS was used to estimate willingness to pay (WTP) for aspects of the intervention design. RESULTS: Three hundred and four participants completed the DCE (general public sample (n=262, mean age 47, 48% female) and trial sample (n=42, mean age 66, 45% female)). A preference for receiving psychological therapy was demonstrated by both samples (general population WTP £1081; 95% CI £957 to £1206). The general population appeared to favour individual therapy (WTP £213; 95% CI £160 to £266), delivered by a CR professional (WTP £48; 9% % CI £4 to £93) and with a lower cost (β=-0.002; p<0.001). Participants preferred to avoid options where no information was received prior to starting therapy (WTP -£106; 95% CI -£153 to -£59). Results for the location attribute were variable and challenging to interpret. CONCLUSIONS: The study demonstrates a preference for psychological therapy as part of a programme of CR, as participants were more likely to opt-in to therapy. Results indicate that some aspects of the delivery which may be important to participants can be tailored to design a psychological therapy. Preference heterogeneity is an issue which may prevent a 'one-size-fits-all' approach to psychological therapy in CR

Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme

BackgroundAnxiety and depression contribute to poorer physical and mental health outcomes in cardiac patients. Psychological treatments are not routinely offered in cardiac care and have mixed and small effects. We conducted a series of studies under the PATHWAY research programme aimed at understanding and improving mental health outcomes for patients undergoing cardiac rehabilitation (CR) through provision of metacognitive therapy (MCT).MethodsPATHWAY was a series of feasibility trials, single-blind, multicenter, randomized controlled trials (RCTs), qualitative, stated preferences for therapy and health economics studies.FindingsPatients felt their psychological needs were not met in CR and their narratives of distress could be parsimoniously explained by the metacognitive model. Patients reported they would prefer therapy over no therapy as part of CR, which included delivery by a cardiac professional. Two feasibility studies demonstrated that RCTs of group-based and self-help MCT were acceptable, could be embedded in CR services, and that RCTs of these interventions were feasible. A definitive RCT of group-MCT within CR (n = 332) demonstrated significantly greater reductions in the severity of anxiety and depression, exceeding CR alone, with gains maintained at 12 month follow-up (SMD HADS total score = 0.52 at 4 months and 0.33 at 12 months). A definitive trial of self-help MCT is ongoing.ConclusionThere is a need to better meet the psychological needs of CR patients. Embedding MCT into CR demonstrated high acceptability and improved efficacy on psychological outcomes. Results support roll-out of MCT in CR with evaluation of national implementation.RegistrationURL: NCT02420431; ISRCTN74643496; NCT03129282.</jats:sec

Protocol of a feasibility randomised controlled trial of Empowered Conversations: training family carers to enhance their relationships and communication with people living with dementia. [version 1; peer review: 3 approved]

Background: Communication difficulties can cause frustration, low mood, and stress for people living with dementia and their carer. Carers should be offered training on adapting their communication skills. However, it is not common for skills-based education to examine emotional aspects of care and the effect of dementia on relationships. The Empowered Conversations (EC) training course was developed in response to a gap in service provision and has been adapted to a virtual format (Zoom). It addresses the specific psychological, relationship, and communication needs of informal and family dementia carers. The primary aim of the study is to investigate the feasibility of conducting a multi-centre randomised controlled evaluation trial of EC.  Secondary aims include exploring the acceptability of delivering the intervention online and examining the optimum way of establishing cost-effectiveness. Methods: The feasibility trial uses a pragmatic data-collector blind parallel two-group RCT design with two arms (EC intervention plus treatment as usual, and treatment as usual waitlist control). There will be a 2:1 allocation in favour of the EC-training intervention arm. 75 participants will complete baseline outcome measures exploring their role as a carer, including their physical and mental health, attitudes to caring, quality of life, and use of health and social care services. These will be repeated after six-months. Participants allocated to the treatment group who complete the course will be invited to participate in a qualitative interview discussing their experience of EC. Discussion: The study will investigate recruitment pathways (including facilitators and barriers to recruitment), estimate retention levels and response rates to questionnaires, obtain additional evidence regarding proof of concept, and consider the most appropriate primary outcome measures and methods for evaluating cost-effectiveness. The results of the feasibility study will be used to inform the development of a multicentre randomised controlled trial in the United Kingdom. Registration: ISRCTN15261686 (02/03/2022

An economic evaluation of targeted case-finding strategies for identifying postnatal depression: A model-based analysis comparing common case-finding instruments

BackgroundHalf of women with postnatal depression (PND) are not identified in routine care. We aimed to estimate the cost-effectiveness of PND case-finding in women with risk factors for PND.MethodsA decision tree was developed to represent the one-year costs and health outcomes associated with case-finding and treatment for PND. The sensitivity and specificity of case-finding instruments, and prevalence and severity of PND, for women with ≥1 PND risk factor were estimated from a cohort of postnatal women. Risk factors were history of anxiety/depression, age ResultsMore than half of the cohort had one or more PND risk factor (57.8 %; 95 % CI 52.7 %-62.7 %). The most cost-effective case-finding strategy was the Edinburgh Postnatal Depression Scale with a cut-off of ≥10 (EPDS-10). Among high-risk women, there is a high probability that EPDS-10 case-finding for PND is cost-effective compared to no case-finding (78.5 % at a threshold of £20,000/QALY), with an ICER of £8146/QALY gained. Universal case-finding is even more cost-effective at £2945/QALY gained (versus no case-finding). There is a greater health improvement with universal rather than targeted case-finding.LimitationsThe model includes costs and health benefits for mothers in the first year postpartum, the broader (e.g. families, societal) and long-term impacts are also important.ConclusionsUniversal PND case-finding is more cost-effective than targeted case-finding which itself is more cost-effective than not case-finding

A service mapping exercise of four health and social care staff mental health and wellbeing services, Resilience Hubs, to describe health service provision and interventions

Background: NHS England funded 40 Mental Health and Wellbeing Hubs to support health and social care staff affected by the COVID-19 pandemic. We aimed to document variations in how national guidance was adapted to the local contexts of four Hubs in the North of England.Methods: We used a modified version of Price’s (2019) service mapping methodology. Service level data were used to inform the analysis. A mapping template was adapted from a range of tools, including the European Service Mapping Schedule, and reviewed by Hub leads. Key data included service model; staffing; and interventions. Data were collected between March 2021 – March 2022 by site research assistants. Findings were accuracy-checked by Hub leads, and a logic model developed to theorise how the Hubs may effect change.Results: Hub goals and service models closely reflected guidance; offering: proactive outreach; team-based support; clinical assessment; onward referral, and rapid access to mental health support (in-house and external). Implementation reflected a service context of a client group with high mental health need, and high waiting times at external mental health services. Hubs were predominantly staffed by experienced clinicians, to manage these mental health presentations and organisational working. Formulation-based psychological assessment and the provision of direct therapy were not core functions of the NHS England model, however all Hubs incorporated these adaptations into their service models in response to local contexts, such as extensive waiting lists within external services, and/or client presentations falling between gaps in existing service provision. Finally, a standalone clinical records system was seen as important to reassure Hub users of confidentiality. Other more nuanced variation depended on localised contexts.Conclusion: This study provides a map for setting up services, emphasising early understandings of how new services will integrate within existing systems. Local and regional contexts led to variation in service configuration. Whilst additional Hub functions are supported by available literature, further research is needed to determine whether these functions should comprise essential components of staff wellbeing services moving forward. Future research should also determine the comparative effectiveness of service components, and the limits of permissible variation.Study registration: researchregistry6303.</p