Sierevelt I N, van Eekeren I C M, Haverkamp D, Reilingh M L, Terwee C B, Kerkhoffs G M M J
Department of Orthopedics, MC Slotervaart, Louwesweg 6, 1066 EC, Amsterdam, The Netherlands.
Department of Orthopaedic Surgery, Orthopaedic Research Center Amsterdam, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1339-47. doi: 10.1007/s00167-015-3941-9. Epub 2015 Dec 24.
The aim of this study was to evaluate the responsiveness of the Foot and Ankle Outcome Score (FAOS) and provide data on the Minimally Important Change (MIC) in patients 1 year after hindfoot and ankle surgery.
Prospective pre-operative and 1 year post-operative FAOS scores were collected from 145 patients. A patient's global assessment and a longitudinal derived Function Change Score were used as external anchors. To assess responsiveness, effect sizes (ES) and Standardized Response Means (SRM) were calculated and hypotheses on their magnitudes were formulated. Additional ROC curve analysis was performed, and the Area Under the Curve (AUC) was calculated as a measure of responsiveness. MIC values were estimated using two different methods: (1) the mean change method and (2) the optimal cut-off point of the ROC curve.
Responsiveness was supported by confirmation of 84% of the hypothesized ES and SRM and almost all AUCs exceeding 0.70. MIC values ranged from 7 (symptoms) to 38 (sport) points. They varied between calculation methods and were negatively associated with baseline values. A considerable amount of MIC values did not exceed the smallest detectable change limit, indicating that the FAOS is more suitable at group level than for longitudinally following individual patients.
The FAOS demonstrated good responsiveness in patients 1 year after hindfoot and ankle surgery. Due to their wide variation, MIC estimates derived in this study should be interpreted with caution. However, these estimates can be of value to facilitate sample size calculation in future studies.
Diagnostic study, Level I.
本研究旨在评估足踝结局评分(FAOS)的反应性,并提供后足和踝关节手术后1年患者的最小重要变化(MIC)数据。
收集了145例患者术前和术后1年的前瞻性FAOS评分。将患者的整体评估和纵向得出的功能变化评分用作外部对照。为了评估反应性,计算了效应量(ES)和标准化反应均值(SRM),并对其大小提出了假设。进行了额外的ROC曲线分析,并计算曲线下面积(AUC)作为反应性的指标。使用两种不同方法估计MIC值:(1)平均变化法和(2)ROC曲线的最佳切点。
84%的假设ES和SRM得到证实,几乎所有AUC均超过0.70,支持了反应性。MIC值范围为7(症状)至38(运动)分。它们在计算方法之间有所不同,并且与基线值呈负相关。相当数量的MIC值未超过最小可检测变化限度,表明FAOS在组水平上比纵向跟踪个体患者更合适。
FAOS在足后和踝关节手术后1年的患者中显示出良好的反应性。由于其变化范围广泛,本研究得出的MIC估计值应谨慎解释。然而,这些估计值对于未来研究中样本量的计算可能有价值。
诊断性研究,I级。