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全膝关节置换术后 KOOS-12 的最小有意义变化值和最小临床有意义差异值。

Minimal important change and minimum clinically important difference values of the KOOS-12 after total knee arthroplasty.

机构信息

Department of Orthopaedics and Traumatology, University Medical Center of the Johannes-Gutenberg University, Mainz, Germany; Australian Institute of Musculoskeletal Research, Sydney, Australia.

Australian Institute of Musculoskeletal Research, Sydney, Australia.

出版信息

Knee. 2021 Mar;29:541-546. doi: 10.1016/j.knee.2021.03.005. Epub 2021 Mar 21.

Abstract

PURPOSE

The minimal important change (minimal amount of change vs. baseline that a patient recognizes as a clinical change) and minimum clinically important difference (smallest difference between two measurements that are deemed important by patients) are important values to evaluate the clinical relevance of changes over time and differences between groups. This study aims to establish these values for the KOOS-12 at 1 year postoperatively.

METHODS

KOOS-12 scores were calculated from the full-length KOOS completed by patients undergoing primary TKA preoperatively and at 1 year follow up. Minimal important change (MIC) values were estimated using the anchor-based predictive modeling approach and adjustment for the large proportion of improved patients in the study cohort was performed. The MCID was defined as the difference in the mean change in the KOOS-12 between the 'no improvement' and 'little improvement' groups.

RESULTS

A total of 352 patients (161 male:191 female) with an overall mean age of 67.9 years (standard deviation (SD) 8.2) and a mean body mass index of 31.4 kg/m (SD 6.3) were included: 97.1% of patients reported an important improvement, 1.1% reported being about the same and 1.7% reported being importantly worse. The MIC improvement values were 11.5 for Pain, 13.7 for Function, 5.5 for Quality of Life (QoL) and 14.9 for the total KOOS-12 score. MCID values were 13.5 for Pain, 15.2 for Function, 8.0 for QoL and 11.1 for the total KOOS-12 score.

CONCLUSION

MIC of 14.9 and MCID of 11.1 established in this study can assist clinicians and researchers in the interpretation of within-group changes (MIC) and differences between groups (MCID) at 1 year after TKA.

摘要

目的

最小有意义变化(与基线相比,患者认为临床变化的最小变化量)和最小临床有意义差异(患者认为重要的两个测量值之间的最小差异)是评估随时间变化的临床相关性和组间差异的重要值。本研究旨在确定术后 1 年 KOOS-12 的这些值。

方法

从术前接受初次 TKA 的患者完成的全长 KOOS 中计算 KOOS-12 评分,并在术后 1 年进行随访。使用基于锚定的预测建模方法估计最小有意义变化(MIC)值,并对研究队列中大量改善患者进行调整。MCID 定义为“无改善”和“略有改善”组之间 KOOS-12 平均变化差异。

结果

共纳入 352 名患者(161 名男性:191 名女性),平均年龄 67.9 岁(标准差 8.2),平均 BMI 为 31.4kg/m(标准差 6.3):97.1%的患者报告有重要改善,1.1%报告无变化,1.7%报告明显恶化。MIC 改善值为疼痛 11.5,功能 13.7,生活质量(QoL)5.5,总 KOOS-12 评分 14.9。MCID 值为疼痛 13.5,功能 15.2,QoL 8.0,总 KOOS-12 评分 11.1。

结论

本研究确定的 MIC 为 14.9,MCID 为 11.1,可帮助临床医生和研究人员解释 TKA 后 1 年的组内变化(MIC)和组间差异(MCID)。

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