University of Toronto Orthopaedic Sports Medicine Program, Women's College Hospital, Toronto, Ontario, Canada.
Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, California, USA.
Am J Sports Med. 2021 Jan;49(1):193-199. doi: 10.1177/0363546520969883. Epub 2020 Nov 23.
In patients undergoing cartilage restoration of the knee, limited information is available regarding clinically important difference (CID) and Patient Acceptable Symptomatic State (PASS) estimates for commonly used patient-reported outcome measures (PROMs).
The objective of this study was to determine the CID and PASS in the population with knee cartilage restoration for the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee Subjective Knee Form (IKDC) score, and the Lysholm score.
Cohort study (Diagnosis); Level of evidence, 2.
Between 2012 and 2017, patients who underwent a cartilage restoration procedure were prospectively enrolled. Patients completed the KOOS, IKDC, and Lysholm, all of which were scored from 0 to 100, and completed relevant anchor questions at baseline and 1 year postoperatively. Receiver operating characteristic curve analyses were conducted to determine CID and PASS cutoff points. Multivariable regression analyses were performed to determine the effect of age, sex, and baseline score on likelihood of achieving CID and PASS.
Of the 113 patients enrolled, 53 (47%) were male, and the mean age was 36 years. The CID values for the PROMs were 10.7 for KOOS Symptoms, 8.3 for KOOS Pain, 8.8 for KOOS Activities of Daily Living (ADL), 30.0 for KOOS Sports and Recreation, 18.8 for KOOS Quality of Life (QOL), 9.2 for IKDC, and 13.0 for Lysholm. The PASS values were 71.5 for KOOS Symptoms, 72.2 for KOOS Pain, 86.8 for KOOS ADL, 43.8 for KOOS Sports and Recreation, 50.0 for KOOS QOL, 62.1 for IKDC, and 70.0 for Lysholm. Patients with higher baseline scores were more likely to achieve PASS for the IKDC (odds ratio, 2.28; = .03). Baseline score did not have an effect on the likelihood of achieving CID. Younger age was an independent predictor of achieving PASS and CID across all outcomes ( < .05), but sex did not have such an effect.
This study determined CID and PASS values for the KOOS, IKDC, and Lysholm scores among patients treated with knee cartilage restoration. Younger age was a positive prognostic variable, and higher baseline scores implied achieving PASS for the IKDC. The information in this study can be used in designing randomized controlled trials, counseling individual patients as to anticipated outcomes, and conducting responder analyses when evaluating new cartilage technology from a regulatory perspective.
在接受膝关节软骨修复的患者中，关于常用患者报告结局测量（PROM）的临床重要差异（CID）和患者可接受的症状状态（PASS）估计值的信息有限。
本研究旨在确定膝关节软骨修复患者的膝关节损伤和骨关节炎结局评分（KOOS）、国际膝关节文献委员会主观膝关节评分（IKDC）和 Lysholm 评分的 CID 和 PASS。
队列研究（诊断）；证据水平，2 级。
2012 年至 2017 年期间，前瞻性纳入接受软骨修复手术的患者。患者在基线和术后 1 年完成 KOOS、IKDC 和 Lysholm 评分，所有评分均从 0 到 100 分，且均完成相关锚定问题。通过受试者工作特征曲线分析确定 CID 和 PASS 截断点。进行多变量回归分析，以确定年龄、性别和基线评分对达到 CID 和 PASS 的可能性的影响。
在纳入的 113 名患者中，53 名（47%）为男性，平均年龄为 36 岁。PROM 的 CID 值为：KOOS 症状 10.7，KOOS 疼痛 8.3，KOOS 日常生活活动（ADL）8.8，KOOS 运动和娱乐 30.0，KOOS 生活质量（QOL）18.8，IKDC 9.2，Lysholm 13.0。PASS 值为：KOOS 症状 71.5，KOOS 疼痛 72.2，KOOS ADL 86.8，KOOS 运动和娱乐 43.8，KOOS QOL 50.0，IKDC 62.1，Lysholm 70.0。基线评分较高的患者更有可能通过 IKDC 达到 PASS（优势比，2.28；P =.03）。基线评分对达到 CID 的可能性没有影响。年龄较小是所有结局达到 PASS 和 CID 的独立预测因素（P <.05），但性别没有这种影响。
本研究确定了膝关节软骨修复患者的 KOOS、IKDC 和 Lysholm 评分的 CID 和 PASS 值。年龄较小是一个积极的预后变量，而较高的基线评分意味着通过 IKDC 达到 PASS。本研究中的信息可用于设计随机对照试验，为个体患者提供预期结果的咨询，并从监管角度评估新的软骨技术时进行应答者分析。
