Zhang Yongni, Ai Dongmei, Gao Yuan, Li Weimin, Yi Yixiong, Xu Xiongwei, Hu Haoyu, Zhang NanNan, Yang Songbin, Lian Xiaowen, Wang YuZhang, Martin Pt RobRoy L, Zhang Xin
Duquesne-China Health Institute, Duquesne University, Pittsburgh, Pennsylvania, USA.
Department of Rehabilitation Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.
Orthop J Sports Med. 2025 Apr 30;13(4):23259671251322906. doi: 10.1177/23259671251322906. eCollection 2025 Apr.
The simplified Chinese Lower Extremity Functional Scale (SC-LEFS) is a patient-reported outcome measure specifically developed for Chinese-speaking patients to assess functional status in those with lower extremity musculoskeletal disorders. However, to date, no studies have specifically examined the reliability and responsiveness of the SC-LEFS in nonarthritic musculoskeletal injuries.
To define the minimal detectable change (MDC) as a measure of test-retest reliability and the substantial clinical benefit (SCB) as a measure of responsiveness for the SC-LEFS in patients with nonarthritic lower extremity musculoskeletal injuries.
Cohort study (diagnosis); Level of evidence, 3.
Patients aged between 18 and 50 years with a lower extremity musculoskeletal injury who were referred for physical therapy visits completed the SC-LEFS at the initial assessment and at the 4-week follow-up. Patients were classified into "stable,""improved," and "not improved" groups based on self-reported changes at the 4-week follow-up. The "stable" group was used to establish the MDC value for test-retest reliability. The "improved" and "not improved" groups were used to determine the SCB value for responsiveness.
A total of 763 patients (44.8% women), with a mean age of 32.9 (SD, 9.4) years, were included. Using the "stable" group (n = 40), excellent test-retest reliability was demonstrated with an intraclass correlation coefficient of 0.98 and an MDC of 5.1 points. To evaluate the responsiveness, the "improved" (n = 497) and "not improved" (n = 266) groups were analyzed. Receiver operator characteristic analysis found an SCB value of 9.5 points on the SC-LEFS. This change score could differentiate those "improved" from those "not improved" with a sensitivity of 0.68, specificity of 0.71, and area under the curve of 0.75 (95% CI, 0.71-0.78).
This study offers evidence of test-retest reliability and responsiveness with MDC and SCB values for the SC-LEFS in Chinese-speaking patients with nonarthritic lower musculoskeletal extremity injuries. Clinicians should consider 5.1 points as the measurement error and 9.5 points as the threshold for clinically meaningful improvement on the SC-LEFS in patients with lower extremity musculoskeletal injuries over a 4-week treatment period.
简化中文版下肢功能量表(SC - LEFS)是一种专门为说中文的患者开发的患者报告结局指标,用于评估下肢肌肉骨骼疾病患者的功能状态。然而,迄今为止,尚无研究专门考察SC - LEFS在非关节炎性肌肉骨骼损伤中的信度和反应度。
确定最小可检测变化(MDC)作为重测信度的指标,以及实质临床获益(SCB)作为SC - LEFS在非关节炎性下肢肌肉骨骼损伤患者中反应度的指标。
队列研究(诊断);证据等级,3级。
年龄在18至50岁之间、因下肢肌肉骨骼损伤前来接受物理治疗的患者在初始评估和4周随访时完成SC - LEFS。根据4周随访时自我报告的变化,将患者分为“稳定”“改善”和“未改善”组。“稳定”组用于确定重测信度的MDC值。“改善”组和“未改善”组用于确定反应度的SCB值。
共纳入763例患者(44.8%为女性),平均年龄32.9(标准差,9.4)岁。使用“稳定”组(n = 40),组内相关系数为0.98,MDC为5.1分,显示出极好的重测信度。为评估反应度,对“改善”组(n = 497)和“未改善”组(n = 266)进行分析。受试者工作特征分析发现,SC - LEFS的SCB值为9.5分。这个变化分数能够区分“改善”和“未改善”的患者,灵敏度为0.68,特异度为0.71,曲线下面积为0.75(95%可信区间,0.71 - 0.78)。
本研究为SC - LEFS在说中文的非关节炎性下肢肌肉骨骼损伤患者中的重测信度和反应度提供了证据,MDC和SCB值可作为参考。临床医生应将5.1分视为测量误差,将9.5分视为下肢肌肉骨骼损伤患者在4周治疗期间SC - LEFS上具有临床意义改善的阈值。