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膝关节骨软骨同种异体移植术后患者报告结局测量的最小临床重要差异和实质性临床获益。

The Minimal Clinically Important Difference and Substantial Clinical Benefit in the Patient-Reported Outcome Measures of Patients Undergoing Osteochondral Allograft Transplantation in the Knee.

机构信息

Sports Medicine Center, Funabashi Orthopedic Hospital, Funabashi, Chiba, Japan.

Cartilage Repair Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

出版信息

Cartilage. 2021 Jan;12(1):42-50. doi: 10.1177/1947603518812552. Epub 2018 Nov 22.

Abstract

OBJECTIVE

Little is known regarding the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) with regard to the Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Lysholm score, and Short Form 12 (SF-12) score of patients who undergo osteochondral allograft transplantation (OCA). We aimed to determine the MCID and SCB associated with those patient-reported outcome measures (PROMs) after OCA.

DESIGN

We analyzed the data of 86 consecutive patients who underwent OCA and who completed satisfaction surveys at a minimum of 1 year postoperatively and had at least one repeated PROM. MCID was determined using an anchor-based method: the optimal cutoff point for receiver operative characteristic (ROC) curves. If an anchor-based method was inapplicable, distribution-based methods were employed. SCB was determined using ROC curve analysis.

RESULTS

Based on the ROC curve analysis, MCID was 16.7 for KOOS pain, 25 for KOOS sports/recreation, and 9.8 for IKDC. SCB was 27.7 for KOOS pain, 10.7 for KOOS symptom, 30 for KOOS sports/recreation, 31.3 for KOOS quality of life, 26.9 for IKDC, 25 for Lysholm, and 12.1 for SF-12 physical component summary. No significant association was noted between SCB achievement and the baseline patient factors and baseline PROMs.

CONCLUSION

We demonstrated the MCIDs and SCBs of several PROMs in patients undergoing OCA. These results will aid the interpretation of the effect of treatment and clinical trial settings. Moreover, the SCBs will help surgeons in the counseling of patients, where patients expect optimal results rather than minimal improvement.

摘要

目的

对于接受软骨下骨异体骨移植(OCA)的患者,我们对于 Knee injury and Osteoarthritis Outcome Score(KOOS)、国际膝关节文献委员会(IKDC)主观膝关节评估表、Lysholm 评分和 Short Form 12(SF-12)评分的最小临床重要差异(MCID)和显著临床获益(SCB)知之甚少。我们旨在确定与这些患者报告的结果测量(PROM)相关的 MCID 和 SCB。

设计

我们分析了 86 例连续接受 OCA 并在术后至少 1 年完成满意度调查且至少重复一次 PROM 的患者的数据。MCID 采用基于锚的方法确定:最佳截断点为接收器工作特征(ROC)曲线。如果基于锚的方法不适用,则使用基于分布的方法。SCB 通过 ROC 曲线分析确定。

结果

基于 ROC 曲线分析,KOOS 疼痛的 MCID 为 16.7,KOOS 运动/娱乐的 MCID 为 25,IKDC 的 MCID 为 9.8。SCB 为 KOOS 疼痛的 27.7,KOOS 症状的 10.7,KOOS 运动/娱乐的 30,KOOS 生活质量的 31.3,IKDC 的 26.9,Lysholm 的 25,SF-12 生理成分综合评分的 12.1。未发现 SCB 实现与基线患者因素和基线 PROM 之间存在显著关联。

结论

我们在接受 OCA 的患者中证明了几种 PROM 的 MCID 和 SCB。这些结果将有助于解释治疗效果和临床试验设置。此外,SCB 将帮助外科医生对患者进行咨询,患者期望的是最佳结果,而不是最小程度的改善。

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