评估脆弱性测量指标的临床有意义变化。
Evaluation of Clinically Meaningful Changes in Measures of Frailty.
机构信息
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
PyeongChang Health Center and County Hospital, PyeongChang, Gangwon-Do, Republic of Korea.
出版信息
J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1143-1147. doi: 10.1093/gerona/glaa003.
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.
背景
确定广泛使用的虚弱测量指标的临床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，该研究纳入了 1135 名居住在社区的老年人，他们在基线和 1 年后使用 EuroQol-5D 评估了虚弱和与健康相关的生活质量。虚弱测量指标包括缺陷累积虚弱指数（FI）；虚弱表型；疲劳、抵抗、活动能力、疾病和体重减轻量表；以及骨质疏松性骨折研究（SOF）指数。我们通过基于分布的方法和基于锚定的方法，使用 EuroQol-5D 评分和反应性指数来确定临床有意义的变化。
结果
在 1 年后，925 名参与者中有虚弱测量指标（81.5%）。基于分布的方法，FI 的小和大临床有意义的变化分别为 0.019 和 0.057，虚弱表型为 0.249 和 0.623，FRAIL 量表为 0.235 和 0.587，SOF 指数为 0.116 和 0.289。小和大变化的基于锚定的估计分别为 FI 的 0.028 和 0.076，虚弱表型的 0.097 和 0.607，FRAIL 量表的 0.269 和 0.368，SOF 指数的 0.023 和 0.287。基于反应性指数，在临床试验中达到 80%功效的每组样本量，从小变化的 51（FI）到 7272（SOF 指数），大变化的 9（FI）到 133（FRAIL 量表）不等。
结论
虚弱测量指标的临床有意义变化的估计可以为临床试验和社区居住的老年人的临床护理中跟踪虚弱的纵向变化选择虚弱测量指标提供信息。
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