Background Frailty is of increasing interest in trials, either as a target of intervention, as an outcome or as a potential treatment modifier. However, frailty measurement is often highly variable. This scoping review assessed how frailty is quantified in randomised controlled trials (RCTs), in what context and for what purposes. Methods We searched five electronic databases for RCTs in which frailty was measured among trial participants. We extracted data on intervention type, the frailty measure used and the purpose for which frailty was assessed. We then compared these data according to reasons for frailty assessment. Results We identified 415 RCTs assessing frailty across a range of interventions. Frailty was used to define the target population (166 trials), as an outcome (156 trials), as an effect modifier examining interaction of frailty on treatment effect (61 trials), as a purely descriptive characteristic (42 trials) or as a prognostic marker examining the impact of frailty on future health outcome (78 trials). The trials used 28 different measures of frailty (plus 29 additional trial-specific measures). The frailty phenotype model was the most common overall (164 trials), for defining the target population (90/166 trials) and as an outcome (81/156 trials). The cumulative deficit model frailty index was also frequently used (102 trials) and was most common among trials assessing treatment effect modification (21/61 trials). Conclusion Frailty measurement in RCTs is highly variable. Understanding the properties of respective frailty measures and how these relate to frailty as encountered in clinical practice is a priority to ensure that trial findings can inform healthcare delivery for people living with frailty.

中文翻译：

---

随机对照试验中虚弱测量和分析的范围综述


背景 衰弱在试验中越来越受到关注，无论是作为干预的目标、结局还是潜在的治疗调节因素。然而，虚弱的测量通常是高度可变的。本范围综述评估了随机对照试验 （RCT） 中如何量化虚弱、在何种背景下以及出于何种目的。方法 我们在 5 个电子数据库中检索了测量试验参与者虚弱程度的 RCT。我们提取了有关干预类型、使用的衰弱测量方法和评估衰弱目的的资料。然后，我们根据衰弱评估的原因比较了这些数据。结果 我们确定了 415 项 RCTs，评估了一系列干预措施的衰弱性。衰弱被用来定义目标人群（166 项试验）、作为结局（156 项试验）、作为检查衰弱与治疗效果相互作用的效果调节因子（61 项试验）、作为纯粹的描述性特征（42 项试验）或作为检查衰弱对未来健康结局影响的预后标志物（78 项试验）。这些试验使用了 28 种不同的虚弱指标（加上 29 项额外的试验特异性指标）。衰弱表型模型是最常见的总体模型（164 项试验），用于定义目标人群（90/166 项试验）和作为结局（81/156 项试验）。累积缺陷模型虚弱指数也经常使用（102 项试验），在评估治疗效果调整的试验中最为常见（21/61 项试验）。结论 RCT 中的虚弱测量是高度可变的。了解各个衰弱指标的特性以及这些特性与临床实践中遇到的衰弱有何关系是确保试验结果可以为衰弱患者的医疗保健提供信息的首要任务。