BACKGROUND To determine the clinically meaningful changes and responsiveness of widely used frailty measures. METHODS We analyzed data from a prospective cohort study of 1,135 community-dwelling older adults who underwent assessments of frailty and health-related quality of life using the EuroQol-5D at baseline and 1 year later. Frailty measures included deficit-accumulation frailty index (FI); frailty phenotype; Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale; and the Study of Osteoporotic Fracture (SOF) index. We determined the clinically meaningful changes by the distribution-based method and the anchor-based method using the EuroQol-5D score and responsiveness indices. RESULTS Frailty measures were available in 925 participants at 1 year (81.5%). Based on the distribution-based method, small and large clinically meaningful changes were 0.019 and 0.057 for FI, 0.249 and 0.623 for frailty phenotype, 0.235 and 0.587 for FRAIL scale, and 0.116 and 0.289 for SOF index, respectively. The anchor-based estimates of small and large changes were 0.028 and 0.076 for FI, 0.097 and 0.607 for frailty phenotype, 0.269 and 0.368 for FRAIL scale, and 0.023 and 0.287 for SOF index, respectively. Based on the responsiveness index, per-group sample sizes to achieve 80% power in clinical trials, ranged from 51 (FI) to 7,272 (SOF index) for a small change and 9 (FI) to 133 (FRAIL scale) for a large change. CONCLUSIONS The estimates of clinically meaningful change of frailty measures can inform the choice of frailty measures to track longitudinal changes of frailty in clinical trials and clinical care of community-dwelling older adults.

中文翻译：

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评估脆弱性的临床意义变化。

背景技术为了确定广泛使用的脆弱措施的临床上有意义的变化和反应性。方法我们分析了一项前瞻性队列研究的数据，该研究针对1,135名居住在社区的老年人，他们在基线和1年后使用EuroQol-5D评估了身体虚弱和与健康相关的生活质量。脆弱性措施包括赤字积累脆弱性指数（FI）；脆弱的表型 疲劳，抵抗，行走，疾病和减肥秤；和骨质疏松性骨折（SOF）指数的研究。我们使用EuroQol-5D评分和反应指数通过基于分布的方法和基于锚的方法确定了具有临床意义的变化。结果在1年中，有925位参与者提供了脆弱性测量（81.5％）。基于基于分布的方法，临床上有意义的小变化和大变化分别是：FI为0.019和0.057，脆弱表型为0.249和0.623，FRAIL量表为0.235和0.587，SOF指数为0.116和0.289。基于锚的细微变化和较大变化的估计值分别为：FI为0.028和0.076，脆弱表型为0.097和0.607，FRAIL量表为0.269和0.368，SOF指数为0.023和0.287。根据响应指数，在临床试验中每组样本的数量要达到80％的功效，小变化的范围从51（FI）到7,272（SOF指数），大变化的范围是9（FI）到133（FRAIL量表）更改。结论临床上脆弱性变化的有意义的估计可以指导脆弱性测量的选择，以追踪社区居民老年人的临床试验和临床护理中脆弱性的纵向变化。