Bilgasem Ahmed, Vivekanantha Prushoth, Gyemi Lauren, Hassan Zackariyah, Slawaska-Eng David, Meena Amit, Malik Shahbaz, de Sa Darren
Northern Ontario School of Medicine, Sudbury, Ontario, Canada.
Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Knee Surg Sports Traumatol Arthrosc. 2025 May 6. doi: 10.1002/ksa.12684.
To investigate minimal clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS) values for patient-reported outcome measures (PROMs) after patellar stabilization surgery for patellar instability. Secondary outcomes included to describe methods to calculate clinically significant outcomes (CSOs), and to report on the achievement of these metrics.
On 31 July 2024, three databases were searched. Information on whether studies calculated MCID, SCB or PASS values or used previously established values was recorded. Data on study characteristics, CSO values, and the method of MCID quantification (e.g., distribution vs. anchor) were extracted.
A total of 17 articles with 1447 patients (1462 knees) were included. A total of 18 unique outcome measures were reported. Six out of 15 (40%), 2 out of 5 (40%), and zero studies used prior established values for MCID, SCB and PASS, respectively. MCID ranged widely (e.g., International Knee Documentation Committee [IKDC]: 5.6-20.5; Kujala Anterior Knee Pain Scale: 5.38-11.9 and Lysholm: 5.6-11.1). Fourteen out of 15 utilized a distribution-based method to calculate MCID, with only one study using an anchor-based method. SCB values ranged widely as well (e.g.
, IKDC: 14.5-23.6; Knee Osteoarthritis and Outcome Score [KOOS] symptoms: 4.2-14.2 and KOOS activities of daily living [ADLs]: 6.5-25.7). Large variability was found among percentages of patients that achieved MCID values (e.g.
, IKDC: 28%-98.6%, Kujala: 38%-100%, Lysholm: 44%-98.4% and Tegner: 84%-95%).
The significant heterogeneity in reported thresholds for MCID, SCB and PASS across studies highlights critical challenges in interpreting results after patellar stabilization surgery, specifically regarding what constitutes a clinically relevant outcome. MCID was the most commonly reported metric and calculated predominantly with distribution-based methods, with over half of the studies using previously established thresholds. PASS and SCB were widely underreported as well, suggesting a need for studies investigating patellar stabilization to prioritize the calculation of all three metrics, using anchor-based techniques.
Level IV.
探讨髌骨不稳定患者行髌骨稳定手术后患者报告结局量表（PROMs）的最小临床重要差异（MCID）、显著临床获益（SCB）、患者可接受症状状态（PASS）值。次要结局包括描述计算临床显著结局（CSO）的方法，并报告这些指标的达成情况。
2024年7月31日，检索了三个数据库。记录有关研究是否计算了MCID、SCB或PASS值或使用先前确定的值的信息。提取有关研究特征、CSO值和MCID量化方法（例如，分布法与锚定法）的数据。
共纳入17篇文章，涉及1447例患者（1462个膝关节）。共报告了18种独特的结局指标。15项研究中有6项（40%）、5项研究中有2项（40%）以及0项研究分别使用了先前确定的MCID、SCB和PASS值。MCID范围广泛（例如，国际膝关节文献委员会[IKDC]：5.6 - 20.5；库贾拉前膝痛量表：5.38 - 11.9；以及Lysholm量表：5.6 - 11.1）。15项研究中有14项采用基于分布的方法计算MCID，只有1项研究使用基于锚定的方法。SCB值范围也很广（例如，IKDC：14.5 - 23.6；膝关节骨关节炎与结局评分[KOOS]症状：4.2 - 14.2；以及KOOS日常生活活动[ADLs]：6.5 - 25.7）。在达到MCID值的患者百分比中发现了很大的变异性（例如，IKDC：28% - 98.6%，库贾拉：38% - 100%，Lysholm：44% - 98.4%，以及特格纳：84% - 95%）。
各研究报告的MCID、SCB和PASS阈值存在显著异质性，突出了髌骨稳定手术后结果解读中的关键挑战，特别是在确定什么构成临床相关结局方面。MCID是最常报告的指标，主要通过基于分布的方法计算，超过一半 的研究使用先前确定的阈值。PASS和SCB的报告也普遍不足，这表明需要进行研究来调查髌骨稳定手术，优先使用基于锚定的技术计算所有这三个指标。
四级。
