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Abstract
Objectives The burden of cardiovascular disease (CVD) is increasing. Cardiac rehabilitation (CR) is a complex intervention offered to patients with CVD, following a heart event, diagnosis or intervention, and it aims to reduce mortality and morbidity. The objective of this within-trial economic evaluation was to compare the cost-effectiveness of metacognitive therapy (MCT) plus usual care (UC) to UC, from a health and social care perspective in the UK.
Methods A multicentre, single-blind, randomised controlled trial (ISRCTN74643496) was conducted in the UK involving 332 patients with CR with elevated symptoms of anxiety and/or depression and compared group-based MCT with UC. The primary outcome of the cost-effectiveness analysis was quality-adjusted life-years (QALYs). The time horizon of the primary analysis was a 12-month follow-up. Missing data were imputed using multiple imputation. Uncertainty was explored by probabilistic bootstrapping. Sensitivity analyses tested the impact of the study design and assumptions on the incremental cost-effectiveness ratio.
Results In the primary cost-effectiveness analysis, MCT intervention was dominant, with a cost-saving (net cost −£219; 95% CI −£1446, £1007) and QALY gains (net QALY 0.015; 95% CI −0.015, 0.045). However, there is a high level of uncertainty in the estimates. At a threshold of £30 000 per QALY, MCT intervention of around 76% was likely to be cost-effective.
Conclusions Results suggest that intervention may be cost-saving and health-increasing; however, findings are uncertain and subject to limitations. Further research should aim to reduce the uncertainty in the findings (eg, with larger sample sizes) and explore potential longer-term economic benefits associated with MCT in this setting.
- REHABILITATION MEDICINE
- CARDIOLOGY
- HEALTH ECONOMICS
- Anxiety disorders
- Depression & mood disorders
Data availability statement
Data are available upon reasonable request. Anonymised data are available upon reasonable request from the corresponding author.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Data availability statement
Data are available upon reasonable request. Anonymised data are available upon reasonable request from the corresponding author.
Footnotes
Contributors AW is the chief investigator in the PATHWAY project. AW, LMD, DR, PJD and AH conceived the idea for the research project. AW, LMD and GES designed tools for economic data collection. GES drafted the first version of the manuscript, and all authors contributed to the subsequent versions. LMD, GES, DB, EC and CH cleaned the data and contributed to the analysis. LC contributed to the trial management, including the collection of economic data and solving inconsistencies during data cleaning. All authors helped to interpret the analysis and results. All authors read and approved the final manuscript. GES is the guarantor who takes primary responsibility for the paper.
Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (grant No. 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 All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest. AW is the developer of MCT and co-director of the Metacognitive Therapy Institute. He has received funding as Chief Investigator (CI) for the studies 'Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services' (PATHWAY-Beacons; NIHR202956) and 'Mechanisms of Change in Metacognitive Therapy for Depression and Anxiety in Cardiac Rehabilitation Patients' (PATHWAY-Mechanisms; NIHR205669). He is also CI for the following projects: NIHR201495; and co-CI on NIHR203634. LC, DB, GES, LMD and DR report funding from the NIHR. AH reports lecturing for a related pharmaceutical company.
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.
Provenance and peer review Not commissioned; externally peer reviewed.
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