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确立全层肩袖撕裂患者的美国肩肘外科医生评分和西部Ontario 肩袖指数的最小临床重要差异。

Establishing minimally important differences for the American Shoulder and Elbow Surgeons score and the Western Ontario Rotator Cuff Index in patients with full-thickness rotator cuff tears.

机构信息

Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, USA.

Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA.

出版信息

J Shoulder Elbow Surg. 2018 May;27(5):e160-e166. doi: 10.1016/j.jse.2017.10.042. Epub 2018 Jan 4.

DOI:10.1016/j.jse.2017.10.042
PMID:29307675
Abstract

BACKGROUND

The American Shoulder and Elbow Surgeons (ASES) score and the Western Ontario Rotator Cuff Index (WORC) are frequently used measures in clinical research for patients with rotator cuff tears (RCTs). The minimally important differences (MIDs) for these measures have not been established in patients with RCTs. The purpose of this study was to establish the MIDs for patients with known RCTs treated both surgically or nonsurgically.

METHODS

We included 222 subjects with full-thickness RCTs. The WORC and ASES were collected at baseline and at 4, 8, 16, 32, 48, and 64 weeks, as was an end of study form with questions about change in the condition after treatment. We calculated anchor-based and distribution-based MIDs. We used regression modeling to determine change in MIDs as predicted by several variables.

RESULTS

For the anchor-based method, we found an MID of 21.9 for the ASES and -282.6 for the WORC. When using the distribution-based method of ½ and ⅓ the standard deviation, we arrived at an MID of 26.9 and 17.9 points for the ASES and -588.7 and -392.5 points for the WORC. No variables predicted MID changes.

CONCLUSION

This is the first study to report MIDs for the ASES and WORC in a population of patients with only full-thickness RCTs. This information will directly improve our ability to determine when patients with RCTs are changing in a meaningful manner and accurately power clinical studies using these outcome measures.

摘要

背景

美国肩肘外科医师学会(ASES)评分和西部安大略省肩肘外科评分(WORC)是常用于肩袖撕裂(RCT)患者的临床研究的指标。尚未在接受 RCT 治疗的患者中确定这些指标的最小临床重要差异(MID)。本研究旨在为接受手术或非手术治疗的已知 RCT 患者建立 MID。

方法

我们纳入了 222 名全层 RCT 患者。WORC 和 ASES 在基线和 4、8、16、32、48 和 64 周时收集,在研究结束时还收集了一份关于治疗后病情变化的问卷。我们计算了基于锚定和基于分布的 MID。我们使用回归建模来确定几种变量预测 MID 变化的情况。

结果

对于基于锚定的方法,我们发现 ASES 的 MID 为 21.9,WORC 的 MID 为-282.6。当使用基于分布的方法,即标准偏差的 1/2 和 1/3 时,我们得出 ASES 的 MID 为 26.9 和 17.9 分,WORC 的 MID 为-588.7 和-392.5 分。没有变量可以预测 MID 变化。

结论

这是第一项在仅患有全层 RCT 的患者人群中报告 ASES 和 WORC 的 MID 的研究。这些信息将直接提高我们确定 RCT 患者何时以有意义的方式发生变化的能力,并准确地为使用这些结局指标的临床研究提供动力。

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