Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan; Medical Technology Innovation Center, Juntendo University, Tokyo, Japan; Clinical Research and Trial Center, Juntendo University, Tokyo, Japan; Graduate School of Health and Sports Science, Juntendo University, Chiba, Japan.
J Orthop Sci. 2021 Jan;26(1):149-155. doi: 10.1016/j.jos.2020.02.010. Epub 2020 Apr 24.
This study aimed to validate and determine the minimal clinically important difference (MCID) in the Japanese version of the International Knee Documentation Committee Subjective Knee Form (Japanese IKDC-SKF) for patients with anterior cruciate ligament (ACL) injuries.
This prospective study was performed using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guideline to assess the measurement properties of reliability, responsiveness, validity, and interpretability of the Japanese IKDC-SKF.
A total of 152 patients were enrolled in the study. The Japanese IKDC-SKF had excellent internal consistency [Cronbach's alpha (95% confidence interval, CI) was 0.90 (0.88-0.92), and the test-retest reliability [intraclass correlation coefficient, ICC (95% CI)] was 0.97 (0.94-0.98). The content validity (r), which was interpretable between the Japanese IKDC-SKF and the Japanese Anterior Cruciate Ligament questionnaire 25 was -0.87 (P < 0.001). The construct validity for the IKDC-SKF was 86% (six of seven hypotheses were consistent with the results), also indicating high validity. Responsiveness of the Japanese IKDC-SKF was confirmed, with an acceptable area under the curve of 0.81 and a large effect size (Cohen's d of 0.8). There were no floor or ceiling effects. The MCID for the Japanese IKDC-SKF for ACL injury was 10.7.
Our results indicate that the Japanese version of the IKDC-SKF is a reliable, valid, and responsive measurement instrument with which to evaluate the physical function of patients with ACL injuries.
本研究旨在验证和确定日本版国际膝关节文献委员会主观膝关节评分（Japanese IKDC-SKF）在前交叉韧带（ACL）损伤患者中的最小临床重要差异（MCID）。
本前瞻性研究采用共识基础的健康状况测量工具选择标准（COSMIN）指南评估 Japanese IKDC-SKF 的可靠性、反应度、有效性和可解释性的测量特性。
共有 152 名患者入组本研究。Japanese IKDC-SKF 具有极好的内部一致性[克朗巴赫系数（95%置信区间，CI）为 0.90（0.88-0.92）]和重测信度[组内相关系数，ICC（95%CI）为 0.97（0.94-0.98）]。Japanese IKDC-SKF 与 Japanese Anterior Cruciate Ligament questionnaire 25 之间的内容效度（r）为-0.87（P<0.001），可解释性强。IKDC-SKF 的结构效度为 86%（7 个假设中的 6 个与结果一致），也表明效度较高。Japanese IKDC-SKF 的反应度得到确认，曲线下面积为 0.81，效应量较大（Cohen's d 为 0.8），不存在地板效应或天花板效应。ACL 损伤的 Japanese IKDC-SKF 的 MCID 为 10.7。
本研究结果表明，日本版 IKDC-SKF 是一种可靠、有效且敏感的测量工具，可用于评估 ACL 损伤患者的身体功能。
