Shears Melissa, McGolrick Danielle, Waters Braden, Jakab Marnie, Boyd J Gordon, Muscedere John
School of Medicine, Queen's University, Kingston, Ontario, Canada.
Department of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.
BMJ Open. 2017 Dec 26;7(12):e018872. doi: 10.1136/bmjopen-2017-018872.
Frailty is associated with reduced functional capacity, decreased resistance to stressors and is predictive of a range of adverse health outcomes, including dependency, hospitalisation and mortality. Early identification of frailty may prevent, reduce and postpone adverse health outcomes. However, there is a need for additional evidence to guide decision-making for the care of frail patients since frail persons are frequently excluded from studies, the differential impact of frailty is often not examined in clinical trials and few large-scale clinical trials examining frail cohorts have been conducted. Randomised control trials (RCTs) published to date have used a diverse range of definitions of frailty, as well as a variety of outcome measures. The objective of this systematic review is to comprehensively characterise the frail populations enrolled and the end points reported in frailty RCTs.
We will identify all RCTs reporting on the outcome of interventions in adult (age ≥18 years) frail populations as defined by authors, in all settings of care. Databases will include MEDLINE, CINAHL, EMBASE, PsycInfo, Global Health, the Joanna Briggs database and Cochrane Library. Two reviewers will independently determine trial eligibility. For each included trial, we will conduct duplicate independent data extraction, inter-rater reliability, risk of bias assessment and evaluation of the quality of the evidence using the Grading of Recommendations, Assessment, Development and Evaluations approach.
This systematic review will comprehensively identify RCTs including frail patients to identify how frailty is measured and which outcomes are reported. The results of this systematic review may inform clinicians caring for persons with frailty, facilitate conduct of future RCTs and inform future efforts to develop common data elements and core outcomes for frailty studies. Our findings will be disseminated through conference presentation and publication in peer-reviewed journals.
CRD42017065233.
衰弱与功能能力下降、对应激源的抵抗力降低相关，并且可预测一系列不良健康结局，包括失能、住院和死亡。早期识别衰弱可能预防、减少和推迟不良健康结局。然而，由于衰弱者经常被排除在研究之外，衰弱的差异影响在临床试验中往往未得到检验，并且很少有针对衰弱队列的大规模临床试验，因此需要更多证据来指导衰弱患者护理的决策制定。迄今为止发表的随机对照试验（RCT）使用了多种衰弱定义以及各种结局指标。本系统评价的目的是全面描述纳入的衰弱人群以及衰弱RCT中报告的终点。
我们将识别所有报告针对作者定义的成年（年龄≥18岁）衰弱人群干预结局的RCT，涵盖所有护理环境。数据库将包括MEDLINE、CINAHL、EMBASE、PsycInfo、全球健康、乔安娜·布里格斯数据库和Cochrane图书馆。两名评审员将独立确定试验的合格性。对于每项纳入的试验，我们将进行重复独立的数据提取、评分者间信度、偏倚风险评估，并使用推荐分级、评估、制定与评价方法评估证据质量。
本系统评价将全面识别纳入衰弱患者的RCT，以确定如何测量衰弱以及报告了哪些结局。本系统评价的结果可能为护理衰弱患者的临床医生提供信息，促进未来RCT的开展，并为未来制定衰弱研究的通用数据元素和核心结局提供信息。我们的研究结果将通过会议报告和在同行评审期刊上发表进行传播。
PROSPERO注册号：CRD42017065233。
