NT Medical School, The University of Notre Dame Australia Melbourne Clinical School, Werribee, Victoria, Australia.
Health and Education, Torrens University Australia, Melbourne, Victoria, Australia.
BMJ Open. 2024 Jun 5;14(6):e079830. doi: 10.1136/bmjopen-2023-079830.
Chronic disease self-management (CDSM) is a vital component of congestive heart failure (CHF) programmes. Recent CHF guidelines have downgraded CDSM programmes citing a lack of gold-standard evidence. This protocol describes the aims and methods of a systematic review to collate and synthesise the published research evidence to determine the effectiveness of CDSM programmes and interventions for patients treated for CHF.
Medline, PubMed, Embase, CENTRAL, CINAHL, Cochrane Central Register of Controlled Trials, PsycINFO, SCOPUS, Web of Science, the Science Citation Index and registers of clinical trials will be searched from 1966 to 2024. In addition, the reference lists of shortlisted articles will be reviewed. Randomised controlled trials, with case management interventions of CDSM and CHF with reported major adverse cardiovascular events (MACEs), will be extracted and analysed. There is no restriction on language. Study protocol template developed from Cochrane Collaboration and Reporting adheres to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines for systematic review and meta-analyses 2020. Two independent authors will apply inclusions and exclusion criteria to limit article search and assess bias and certainty of evidence rating. Data extraction and study description of included studies will include quality appraisal of studies and quantitative synthesis of data will then be undertaken to ascertain evidence for the study aims. Subgroup analyses will be conducted for different CDSM programmes. The primary outcome will be a significant change in MACE parameters between intervention and control arms. Meta-analysis will be conducted using statistical software, if feasible.
Ethics approval is not sought as the study is not collecting primary patient data. The results of this study will be disseminated through peer-reviewed scientific journals and also presented to audiences through meetings and scientific conferences.
CRD42023431539.
慢性病自我管理(CDSM)是充血性心力衰竭(CHF)计划的重要组成部分。最近的 CHF 指南降低了 CDSM 计划的地位,理由是缺乏黄金标准证据。本方案描述了一项系统评价的目的和方法,以整理和综合已发表的研究证据,确定针对 CHF 治疗患者的 CDSM 计划和干预措施的有效性。
将从 1966 年至 2024 年在 Medline、PubMed、Embase、CENTRAL、CINAHL、Cochrane 中央对照试验注册中心、PsycINFO、SCOPUS、Web of Science、科学引文索引和临床试验注册处搜索 Medline、PubMed、Embase、CENTRAL、CINAHL、Cochrane 中央对照试验注册中心、PsycINFO、SCOPUS、Web of Science、科学引文索引和临床试验注册处。此外,还将审查入选文章的参考文献列表。将提取和分析具有 CDSM 和 CHF 病例管理干预措施且报告有重大心血管不良事件(MACE)的随机对照试验。不限制语言。研究方案模板源自 Cochrane 协作组织,报告符合 2020 年系统评价和荟萃分析的首选报告项目的系统评价和荟萃分析方案指南。两名独立作者将应用纳入和排除标准来限制文章搜索,并评估偏倚和证据质量评级的确定性。将对纳入研究进行数据提取和研究描述,包括对研究质量的评估,并对数据进行定量综合,以确定研究目的的证据。将对不同的 CDSM 计划进行亚组分析。主要结局指标为干预组和对照组之间 MACE 参数的显著变化。如果可行,将使用统计软件进行荟萃分析。
由于本研究不收集原始患者数据,因此不寻求伦理批准。该研究的结果将通过同行评议的科学期刊传播,并通过会议和科学会议向受众展示。
PROSPERO 注册号:CRD42023431539。