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颈椎手术后的临床有意义改善:30%减少与绝对点变化 MCID 值。

Clinically Meaningful Improvement Following Cervical Spine Surgery: 30% Reduction Versus Absolute Point-change MCID Values.

机构信息

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN.

Steamboat Orthopaedic and Spine Institute, Steamboat Springs, CO.

出版信息

Spine (Phila Pa 1976). 2021 Jun 1;46(11):717-725. doi: 10.1097/BRS.0000000000003887.

DOI:10.1097/BRS.0000000000003887
PMID:33337676
Abstract

STUDY DESIGN

Retrospective analysis of prospectively collected registry data.

OBJECTIVE

The aim of this study was to compare the performance of 30% reduction to established absolute point-change values for measures of disability and pain in patients undergoing elective cervical spine surgery.

SUMMARY OF BACKGROUND DATA

Recent studies recommend using a proportional change from baseline instead of an absolute point-change value to define minimum clinically important difference (MCID).

METHODS

Analyses included 13,179 patients who underwent cervical spine surgery for degenerative disease between April 2013 and February 2018. Participants completed a baseline and 12-month follow-up assessment that included questionnaires to assess disability (Neck Disability Index [NDI]), neck and arm pain (Numeric Rating Scale [NRS-NP/AP], and satisfaction [NASS scale]). Participants were classified as met or not met 30% reduction from baseline in each of the respective measures. The 30% reduction in scores at 12 months was compared to a wide range of established absolute point-change MCID values using receiver-operating characteristic curves, area under the receiver-operating characteristic curve (AUROC), and logistic regression analyses. These analyses were conducted for the entire patient cohort, as well as for subgroups based on baseline severity and surgical approach.

RESULTS

Thirty percent reduction in NDI and NRS-NP/AP scores predicted satisfaction with more accuracy than absolute point-change values for the total population and ACDF and posterior fusion procedures (P < 0.05). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0-20%: 16.8%) and bed-bound disability (ODI 81%-100%: 16.6%) categories. For pain, there was a 1.9% to 11% and 1.6% to 9.6% AUROC difference for no/mild neck and arm pain (NRS 0-4), respectively, in favor of a 30% reduction threshold.

CONCLUSION

A 30% reduction from baseline is a valid method for determining MCID in disability and pain for patients undergoing cervical spine surgery.Level of Evidence: 3.

摘要

研究设计

前瞻性收集的注册数据的回顾性分析。

目的

本研究旨在比较 30%的减少幅度与接受择期颈椎手术的患者的残疾和疼痛测量的既定绝对变化值之间的关系。

背景数据概要

最近的研究建议使用与基线相比的比例变化,而不是绝对变化值来定义最小临床重要差异(MCID)。

方法

分析包括 2013 年 4 月至 2018 年 2 月期间接受颈椎退行性疾病手术的 13179 名患者。参与者完成了基线和 12 个月的随访评估,包括评估残疾(颈部残疾指数[NDI])、颈部和手臂疼痛(数字评分量表[NRS-NP/AP])和满意度(NASS 量表)的问卷。参与者根据各自测量的基线的 30%减少幅度被分为达到或未达到标准。12 个月时的 30%的评分减少与广泛的既定绝对变化 MCID 值进行比较,使用接受者操作特征曲线、接受者操作特征曲线下面积(AUROC)和逻辑回归分析。这些分析是针对整个患者队列进行的,以及根据基线严重程度和手术方法进行的亚组分析。

结果

NDI 和 NRS-NP/AP 评分的 30%减少幅度比总人群和 ACDF 和后路融合术的绝对变化值更准确地预测满意度(P<0.05)。30%减少幅度最有利于 AUROC 差异的是最低残疾(ODI 0-20%:16.8%)和卧床残疾(ODI 81%-100%:16.6%)类别。对于疼痛,对于无/轻度颈部和手臂疼痛(NRS 0-4),30%减少幅度的 AUROC 差异分别为 1.9%至 11%和 1.6%至 9.6%,有利于 30%减少幅度。

结论

基线减少 30%是确定接受颈椎手术的患者残疾和疼痛的 MCID 的有效方法。

证据水平

3 级。

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