关节镜下前交叉韧带重建临床显著结局测量阈值的报告存在很大差异：一项系统评价。

Substantial Variability Exists in Reporting Clinically Significant Outcome Measure Thresholds for Arthroscopic Anterior Cruciate Ligament Reconstruction: A Systematic Review.

作者信息

Childers Justin T, Lack Benjamin T, Mowers Colton C, Haff Christopher W, Berreta Rodrigo S, Jackson Garrett R, Knapik Derrick M, Nuelle Clayton W, DeFroda Steven F

机构信息

Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida, U.S.A.

Rush University Medical Center, Chicago, Illinois, U.S.A.

出版信息

Arthroscopy. 2025 Jan 30. doi: 10.1016/j.arthro.2025.01.023.

DOI:10.1016/j.arthro.2025.01.023

PMID:39892434

Abstract

PURPOSE

To systematically review the reporting of clinically significant outcome measure (CSO) thresholds and methods for calculating thresholds after anterior cruciate ligament (ACL) reconstruction.

METHODS

A systematic review of PubMed, Embase, and Web of Science databases was conducted to identify articles that met inclusion criteria from January 1, 2015, to July 7, 2024. Inclusion criteria included studies reporting CSO thresholds including minimal clinically important difference (MCID), substantial clinical benefit (SCB), or patient acceptable symptomatic state (PASS) for patients after ACL reconstruction with minimum 12-month follow-up. The Methodological Index for Non-Randomized Studies criteria were used to assess study quality. Study demographics, patient-reported outcome measures (PROMs), CSO thresholds, and method of CSO calculation were collected.

RESULTS

A total of 56 studies (n = 52,292 patients) met the final inclusion criteria. Reported PROMs included International Knee Documentation Committee (n = 35 studies), Knee Injury and Osteoarthritis Outcome score (n = 33 studies), Tegner (n = 20 studies), and Lysholm (n = 19 studies) scores. The PASS was reported in 35 studies, MCID in 30, and SCB in 4. Among the studies that reported PASS, the most used threshold calculation was the ROC-Youden index (71.4%, n = 25/35). In the studies reporting MCID, the most used threshold calculation was the 0.5 standard deviation of mean change method (36.7%, n = 11/30). The most-reported threshold calculation among the SCB studies was the ROC curve analysis (75%, n = 3/4). In studies independently calculating CSOs, the most common methods were 0.5 standard deviations of mean change for MCID (50%, n = 10/20), the ROC-Youden index for PASS (73.3%, n = 11/15), and ROC curve analysis (75.0%, n = 3/4) for SCB. Descriptions of anchor questions were reported in 22 studies (39.3%).

CONCLUSIONS

Substantial variability exists in the reporting and calculation of MCID, SCB, and PASS for various PROMs after ACL reconstruction.

LEVEL OF EVIDENCE

Level IV, systematic review of Level II-IV studies.

摘要

目的

系统回顾前交叉韧带（ACL）重建术后临床显著结局指标（CSO）阈值及阈值计算方法的报告情况。

方法

对PubMed、Embase和Web of Science数据库进行系统回顾，以识别2015年1月1日至2024年7月7日符合纳入标准的文章。纳入标准包括报告CSO阈值的研究，这些阈值包括最小临床重要差异（MCID）、实质性临床获益（SCB）或患者可接受症状状态（PASS），研究对象为ACL重建术后至少随访12个月的患者。采用非随机研究方法学指标标准评估研究质量。收集研究的人口统计学数据、患者报告结局指标（PROMs）、CSO阈值及CSO计算方法。

结果

共有56项研究（n = 52,292例患者）符合最终纳入标准。报告的PROMs包括国际膝关节文献委员会评分（n = 35项研究）、膝关节损伤和骨关节炎结局评分（n = 33项研究）、Tegner评分（n = 20项研究）和Lysholm评分（n = 19项研究）。35项研究报告了PASS，30项报告了MCID，4项报告了SCB。在报告PASS的研究中，最常用的阈值计算方法是ROC-Youden指数（71.4%，n = 25/35）。在报告MCID的研究中，最常用的阈值计算方法是平均变化的0.5个标准差法（36.7%，n = 11/30）。SCB研究中报告最多的阈值计算方法是ROC曲线分析（75%，n = 3/4）。在独立计算CSO的研究中，MCID最常用的方法是平均变化的0.5个标准差（50%，n = 10/20），PASS是ROC-Youden指数（73.3%，n = 11/15），SCB是ROC曲线分析（75.0%，n = 3/4）。22项研究（39.3%）报告了锚定问题的描述。