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关节镜肩袖修复术后的最小临床重要差异、显著临床获益和患者可接受的症状状态。

Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State After Arthroscopic Rotator Cuff Repair.

机构信息

Department of Orthopaedic Surgery, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Republic of Korea.

Department of Orthopaedic Surgery, Kangnam Korea Hospital, Seoul, Republic of Korea.

出版信息

Am J Sports Med. 2020 Sep;48(11):2650-2659. doi: 10.1177/0363546520943862. Epub 2020 Aug 19.

DOI:10.1177/0363546520943862
PMID:32813985
Abstract

BACKGROUND

Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) are emerging criteria for patient-based treatment assessments. However, few studies have investigated these measures after rotator cuff repair.

PURPOSE

(1) To determine MCID, SCB, and PASS values for pain visual analog scale (pVAS), Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons (ASES) score, and University of California, Los Angeles (UCLA) score after arthroscopic rotator cuff repair. (2) To determine factors for achieving the MCID, SCB, and PASS.

STUDY DESIGN

Cohort study (diagnosis); Level of evidence, 2.

METHODS

We analyzed prospectively collected data from a rotator cuff surgery registry between March 2018 and February 2019. Eighty-two patients were included, and anchor questions for deriving MCID, SCB, and PASS values were applied at 1-year follow-up after the surgery. The MCID and SCB for the pVAS, ASES, SANE, and UCLA scores were then derived via 2 methods: a sensitivity- and specificity-based approach, which was used alone to derive PASS values, and a between-patients approach. Additionally, univariable and multivariable logistic regression analyses were performed to determine factors for achieving the MCID, SCB, and PASS.

RESULTS

All 4 scores showed acceptable areas under the curve. MCID, SCB, and PASS values for the pVAS were 1.5, 2.5, and 1.7; for ASES scores, 21.0, 26.0, and 78.0; for SANE, 13.0, 20.0, and 71.0; and for UCLA scores, 6.0, 8.0, and 23.0, respectively. Poor preoperative scores demonstrated significantly higher odds ratios (ORs) for achieving the MCID and SCB and lower ORs for achieving the PASS. Retear, large to massive tear, and older age showed lower ORs for achieving the MCID or SCB. For PASS items, male sex and biceps tenodesis had higher ORs, and older age had lower ORs. MCID, SCB, and PASS values per the sensitivity- and specificity-based approach were applied in factor analyses.

CONCLUSION

Reliable MCID, SCB, and PASS values were obtained from patient evaluations 1 year after arthroscopic rotator cuff surgery. Poor preoperative score (MCID and SCB), male sex, and biceps tenodesis showed higher ORs, whereas poor preoperative score (PASS), retear, large to massive tear, and older age demonstrated lower ORs.

摘要

背景

最小临床重要差异(MCID)、显著临床获益(SCB)和患者可接受的症状状态(PASS)是新兴的基于患者的治疗评估标准。然而,很少有研究调查过肩袖修复后的这些指标。

目的

(1)确定关节镜下肩袖修复后疼痛视觉模拟评分(pVAS)、单一评估数字评估(SANE)、美国肩肘外科医生(ASES)评分和加利福尼亚大学洛杉矶分校(UCLA)评分的 MCID、SCB 和 PASS 值。(2)确定达到 MCID、SCB 和 PASS 的因素。

研究设计

队列研究(诊断);证据水平,2 级。

方法

我们分析了 2018 年 3 月至 2019 年 2 月期间肩袖手术登记处前瞻性收集的数据。纳入 82 例患者,在手术后 1 年随访时应用锚定问题来确定 MCID、SCB 和 PASS 值。然后通过 2 种方法得出 pVAS、ASES、SANE 和 UCLA 评分的 MCID 和 SCB:基于敏感性和特异性的方法,单独用于确定 PASS 值,以及基于患者的方法。此外,进行单变量和多变量逻辑回归分析以确定达到 MCID、SCB 和 PASS 的因素。

结果

所有 4 个评分的曲线下面积均具有可接受性。pVAS 的 MCID、SCB 和 PASS 值分别为 1.5、2.5 和 1.7;ASES 评分为 21.0、26.0 和 78.0;SANE 为 13.0、20.0 和 71.0;UCLA 评分为 6.0、8.0 和 23.0。术前评分较差的患者达到 MCID 和 SCB 的优势比(OR)显著更高,而达到 PASS 的 OR 显著更低。再撕裂、大撕裂或巨大撕裂以及年龄较大与达到 MCID 或 SCB 的可能性降低相关。对于 PASS 项目,男性和肱二头肌肌腱固定术的 OR 更高,而年龄较大的 OR 更低。基于敏感性和特异性的方法得出的 MCID、SCB 和 PASS 值在因子分析中进行了应用。

结论

关节镜下肩袖手术后 1 年,患者评估得出可靠的 MCID、SCB 和 PASS 值。术前评分较差(MCID 和 SCB)、男性和肱二头肌肌腱固定术与更高的 OR 相关,而术前评分较差(PASS)、再撕裂、大撕裂或巨大撕裂以及年龄较大与较低的 OR 相关。

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