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 populatio...
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| Format: | Article |
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e035552.full |
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| author | Patrick Doherty David Reeves Gemma E Shields Adrian Wells Lora Capobianco Anthony Heagerty Deborah Buck Linda M Davies |
| author_facet | Patrick Doherty David Reeves Gemma E Shields Adrian Wells Lora Capobianco Anthony Heagerty Deborah Buck Linda M Davies |
| author_sort | Patrick Doherty |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-d04670cb8e9541f6a977d5b712f16e49 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d04670cb8e9541f6a977d5b712f16e492025-01-09T05:05:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-035552Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depressionPatrick Doherty0David Reeves1Gemma E Shields2Adrian Wells3Lora Capobianco4Anthony Heagerty5Deborah Buck6Linda M Davies75Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD, UKNIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, Manchester Academic Health Science Centre (MAHSC), The University of Manchester, Manchester, UKManchester Centre for Health Economics, The University of Manchester, Manchester, UKResearch & Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Manchester, UK4 Greater Manchester Mental Health NHS Foundation Trust, Manchester, UKDivision of Cardiovascular Sciences, The University of Manchester, Manchester, UKManchester Centre for Health Economics, The University of Manchester, Manchester, UKManchester Centre for Health Economics, The University of Manchester, Manchester, UKIntroduction 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.https://bmjopen.bmj.com/content/10/9/e035552.full |
| spellingShingle | Patrick Doherty David Reeves Gemma E Shields Adrian Wells Lora Capobianco Anthony Heagerty Deborah Buck Linda M Davies Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression BMJ Open |
| title | Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression |
| title_full | Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression |
| title_fullStr | Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression |
| title_full_unstemmed | Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression |
| title_short | Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression |
| title_sort | protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and or depression |
| url | https://bmjopen.bmj.com/content/10/9/e035552.full |
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