Perera Subashan, Mody Samir H, Woodman Richard C, Studenski Stephanie A
Division of Geriatric Medicine and Department of Biostatistics, Univeristy of Pittsburgh, 3471 Fifth Avenue, Pittsburgh, PA 15213, USA.
J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x.
To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness.
Secondary data analyses using distribution- and anchor-based methods to determine meaningful change.
Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors.
Older adults with mobility disabilities in a strength training trial (n=100), subacute stroke survivors in an intervention trial (n=100), and a prospective cohort of community-dwelling older people (n=492).
Gait speed, Short Physical Performance Battery (SPPB), 6-minute-walk distance (6MWD), and self-reported mobility.
Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed, 0.27 to 0.55 points for SPPB, and 19 to 22 m for 6MWD. Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed, 0.99 to 1.34 points for SPPB, and 47 to 49 m for 6MWD. Based on responsiveness indices, per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change.
Best initial estimates of small meaningful change are near 0.05 m/s for gait speed, 0.5 points for SPPB, and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed, 1.0 point for SPPB, and 50 m for 6MWD. For clinical use, substantial change in these measures and small change in gait speed and 6MWD, but not SPPB, are detectable. For research use, these measures yield feasible sample sizes for detecting meaningful change.
估计身体机能指标中有意义的微小个体变化及显著个体变化的幅度,并评估其反应性。
采用基于分布和锚定的方法进行二次数据分析以确定有意义的变化。
对社区居住老年人和亚急性中风幸存者的观察性研究及临床试验数据进行二次分析。
力量训练试验中的行动不便老年人(n = 100)、干预试验中的亚急性中风幸存者(n = 100)以及社区居住老年人的前瞻性队列(n = 492)。
步速、简短身体机能量表(SPPB)、6分钟步行距离(6MWD)以及自我报告的行动能力。
大多数有意义的微小变化估计值为步速0.04至0.06米/秒、SPPB 0.27至0.55分、6MWD 19至22米。大多数显著变化估计值为步速0.08至0.14米/秒、SPPB 0.99至1.34分、6MWD 47至49米。根据反应性指标,临床试验中每组样本量对于显著变化为13至42例,对于有意义的微小变化为71至161例。
有意义的微小变化的最佳初始估计值为步速接近0.05米/秒、SPPB为0.5分、6MWD为20米;显著变化的最佳初始估计值为步速接近0.10米/秒、SPPB为1.0分、6MWD为50米。对于临床应用,这些指标中的显著变化以及步速和6MWD的微小变化(但不包括SPPB)是可检测的。对于研究应用,这些指标得出了用于检测有意义变化的可行样本量。