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慢性心力衰竭运动训练(ExTraMATCH II):个体参与者数据荟萃分析方案

Exercise training for chronic heart failure (ExTraMATCH II): protocol for an individual participant data meta-analysis.

作者信息

Taylor Rod S, Piepoli Massimo F, Smart Neil, Coats Andrew J S, Ellis Stephen, Dalal Hayes, O'Connor Christopher M, Warren Fiona C, Whellan David, Ciani Oriana

机构信息

Institute of Health Research, Exeter Medical School, University of Exeter, UK.

Heart Failure Unit, Guglielmo da Saliceto Hospital, Piacenza, Italy.

出版信息

Int J Cardiol. 2014 Jul 1;174(3):683-7. doi: 10.1016/j.ijcard.2014.04.203. Epub 2014 Apr 26.

DOI:10.1016/j.ijcard.2014.04.203
PMID:24804902
Abstract

BACKGROUND

Patients with chronic heart failure (HF) experience a marked reduction in their exercise capacity, health-related quality of life, and life expectancy. Despite substantive evidence supporting exercise training in HF, uncertainties remain in the interpretation and understanding of this evidence base. Clinicians and healthcare providers seek definitive estimates of impact on mortality, hospitalisation and health-related quality of life, and which HF patient subgroups are likely to most benefit. The original Exercise Training Meta-Analysis for Chronic Heart Failure (ExTraMATCH) individual participant data (IPD) meta-analysis conducted in 2004 will be updated by the current collaboration (ExTraMATCH II), to investigate the effects of exercise training in HF.

METHODS

Randomised controlled trials have been identified from the updated 2014 Cochrane systematic review and the original ExTraMATCH IPD meta-analysis with exercise training of 3 weeks' duration or more compared with a non-exercise control and a minimum follow-up of 6 months. Particular outcomes of interest are mortality, hospitalisation and health-related quality of life plus key baseline patient demographic and clinical data. Original IPD will be requested from the authors of all eligible trials; we will check original data and compile a master dataset. IPD meta-analyses will be conducted using a one-step approach where the IPD from all studies are modelled simultaneously whilst accounting for the clustering of participants with studies.

DISCUSSION

The information from ExTraMATCH II will help inform future national and international clinical and policy decision-making on the use of exercise-based interventions in HF and improve the quality, design and reporting of future trials in this field.

摘要

背景

慢性心力衰竭(HF)患者的运动能力、健康相关生活质量和预期寿命显著降低。尽管有大量证据支持对心力衰竭患者进行运动训练,但在对这一证据基础的解释和理解方面仍存在不确定性。临床医生和医疗服务提供者寻求对死亡率、住院率和健康相关生活质量影响的明确估计,以及哪些心力衰竭患者亚组可能最受益。当前的合作项目(ExTraMATCH II)将对2004年进行的原始慢性心力衰竭运动训练荟萃分析(ExTraMATCH)个体参与者数据(IPD)荟萃分析进行更新,以研究运动训练对心力衰竭的影响。

方法

从2014年更新的Cochrane系统评价和原始ExTraMATCH IPD荟萃分析中识别出随机对照试验,这些试验的运动训练持续时间为3周或更长时间,与非运动对照组相比,最小随访时间为6个月。特别关注的结果是死亡率、住院率和健康相关生活质量,以及关键的基线患者人口统计学和临床数据。将向所有符合条件的试验的作者索取原始IPD;我们将检查原始数据并编制一个主数据集。IPD荟萃分析将采用一步法进行,即对所有研究的IPD同时进行建模,同时考虑参与者与研究的聚类情况。

讨论

ExTraMATCH II提供的信息将有助于为未来国家和国际上关于在心力衰竭中使用基于运动的干预措施的临床和政策决策提供参考,并提高该领域未来试验的质量、设计和报告水平。

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