Manchester Centre for Health Economics, The University of Manchester, Manchester, UK
Faculty of Biology, Medicine and Health, School of Psychological Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, Manchester, UK.
BMJ Open. 2020 Sep 10;10(9):e035552. doi: 10.1136/bmjopen-2019-035552.
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.
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.
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.
ISRCTN74643496; Pre-results.
心脏康复（CR）旨在降低进一步发生心脏事件的风险，并改善心脏事件后患者的健康和生活质量。心理护理是 CR 的常见组成部分，因为患有抑郁和/或焦虑症的患者在这一人群中更为普遍，但是，目前干预措施的成本效益证据有限。元认知疗法（MCT）是一种新的治疗方法，在心理健康环境中对治疗焦虑和抑郁非常有效，并且正在 CR 患者中进行评估。本方案描述了针对 CR 患者的 MCT 进行经济评估的计划方法。
经济评估工作将包括试验内分析和经济模型。PATHWAY 小组 MCT 研究已预先设计，以便在随机对照试验研究设计（英国临床试验门户）中收集全面的自我报告资源使用和健康结果数据，包括 EQ-5D。从英国卫生和社会保健的角度来看，将在试验内经济评估和经济模型中比较 MCT 加常规护理（UC）与 UC 的成本效益。试验内分析将使用意向治疗，估算试验随访的总费用和质量调整生命年（QALY）。单值插补将用于插补基线变量的缺失值。多重插补将用于插补随访时缺失的值。资源使用项将乘以公布的国家医疗保健费用。回归分析将用于估计净费用和净 QALY，这些估计值将通过自举生成 10000 对成本和 QALY 来估算成本效益的概率。将开发决策分析经济模型以在更长的时间范围内综合试验数据和已发表的文献。敏感性分析将探索不确定性。将遵循经济模型方法指南，并按照报告指南进行传播。
经济评估包括试验内分析。该试验包括这项数据的收集，已由伦理审查并批准。普雷斯顿研究伦理委员会（项目 ID 156862）已获得伦理批准。建模分析不适用于伦理，因为它将使用来自试验（二次分析）和已发表文献的数据。主要试验和经济评估的结果将在同行评议的英国国家卫生研究所（NIHR）期刊库（应用研究计划拨款）中发表，提交给同行评议的期刊，并在适当的会议上展示。
ISRCTN74643496；预结果。
