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Protocol
Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression
  1. Gemma E Shields1,
  2. Adrian Wells2,3,
  3. Patrick Doherty4,
  4. David Reeves5,
  5. Lora Capobianco3,
  6. Anthony Heagerty6,
  7. Deborah Buck1,
  8. Linda M Davies1
  1. 1Manchester Centre for Health Economics, The University of Manchester, Manchester, UK
  2. 2Faculty of Biology, Medicine and Health, School of Psychological Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, Manchester, UK
  3. 3Research & Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Manchester, UK
  4. 4Department of Health Sciences, University of York, York, North Yorkshire, UK
  5. 5Centre for Primary Care, The University of Manchester, Manchester, Manchester, UK
  6. 6Institute of Cardiovascular Sciences, The University of Manchester, Manchester, Manchester, UK
  1. Correspondence to Gemma E Shields; gemma.shields{at}manchester.ac.uk

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 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.

  • cardiology
  • rehabilitation medicine
  • health economics
  • psychiatry
https://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Twitter @gemmaeshields

  • Contributors GES, AW and LMD formulated the research questions. GES wrote the first draft of the protocol. DB, AW, PJD, TH, LC, DR and LMD contributed to the final writing of the paper, AW is the chief investigator.

  • Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (PGfAR) Programme (Grant Reference Number RP-PG-1211-20011). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.