Abstract
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 has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomized controlled trial study design. 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 analytic 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 NIHR journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences.
Strengths and limitations of this study
· A prospectively designed within-trial economic evaluation alongside a randomised controlled trial, with comprehensive data collection.
· Supplemented by an exploratory decision analytic model to assess cost-effectiveness over a longer-time horizon.
· Comprehensive sensitivity analysis will be used to explore a range of alternative measures of health benefits, impact of assumptions and time horizons.
· Data limitations, such as the trial timeframe, are likely to affect the plausibility of long-term results.
· Issues with generalisability due to variations across cardiac services and populations entering cardiac rehabilitation.
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 NIHR journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences.
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 has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomized controlled trial study design. 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 analytic 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 NIHR journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences.
Strengths and limitations of this study
· A prospectively designed within-trial economic evaluation alongside a randomised controlled trial, with comprehensive data collection.
· Supplemented by an exploratory decision analytic model to assess cost-effectiveness over a longer-time horizon.
· Comprehensive sensitivity analysis will be used to explore a range of alternative measures of health benefits, impact of assumptions and time horizons.
· Data limitations, such as the trial timeframe, are likely to affect the plausibility of long-term results.
· Issues with generalisability due to variations across cardiac services and populations entering cardiac rehabilitation.
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 NIHR journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences.
| Original language | English |
|---|---|
| Journal | BMJ Open |
| Publication status | Accepted/In press - 21 Jul 2020 |