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测定融合延伸治疗相邻节段病变后疼痛、残疾和生活质量的最小临床重要差异。

Determination of minimum clinically important difference in pain, disability, and quality of life after extension of fusion for adjacent-segment disease.

机构信息

Departments of Neurosurgery and Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

出版信息

J Neurosurg Spine. 2012 Jan;16(1):61-7. doi: 10.3171/2011.8.SPINE1194. Epub 2011 Sep 30.


DOI:10.3171/2011.8.SPINE1194
PMID:21962034
Abstract

OBJECT: Spinal surgical outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lack a direct clinical meaning. As a result, the concept of minimum clinical important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of adjacent-segment degeneration following index lumbar fusion, which commonly requires revision laminectomy and extension of fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for adjacent-segment disease (ASD). METHODS: In 50 consecutive patients undergoing revision surgery for ASD-associated back and leg pain, PRO measures of back and leg pain on a visual analog scale (BP-VAS and LP-VAS, respectively), Oswestry Disability Index (ODI), 12-Item Short Form Health Survey Physical and Mental Component Summaries (SF-12 PCS and MCS, respectively), and EuroQol-5D health survey (EQ-5D) were assessed preoperatively and 2 years postoperatively. The following 4 well-established anchor-based MCID calculation methods were used to calculate MCID: average change; minimum detectable change (MDC); change difference; and receiver operating characteristic curve (ROC) analysis for the following 2 separate anchors: health transition item (HTI) of the SF-36 and satisfaction index. RESULTS: All patients were available for 2-year PRO assessment. Two years after surgery, a statistically significant improvement was observed for all PROs (mean changes: BP-VAS score [4.80 ± 3.25], LP-VAS score [3.28 ± 3.25], ODI [10.24 ± 13.49], SF-12 PCS [8.69 ± 12.55] and MCS [8.49 ± 11.45] scores, and EQ-5D [0.38 ± 0.45]; all p < 0.001). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS score, 2.3-6.5; LP-VAS score, 1.7-4.3; ODI, 6.8-16.9; SF-12 PCS, 6.1-12.6; SF-12 MCS, 2.4-10.8; and EQ-5D, 0.27-0.54). The area under the ROC curve was consistently greater for the HTI anchor than the satisfaction anchor, suggesting this as a more accurate anchor for MCID. CONCLUSIONS: Adjacent-segment disease revision surgery-specific MCID is highly variable based on calculation technique. The MDC approach with HTI anchor appears to be most appropriate for calculation of MCID after revision lumbar fusion for ASD because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was not significantly affected by choice of anchor. Based on this method, MCID following ASD revision lumbar surgery is 3.8 points for BP-VAS score, 2.4 points for LP-VAS score, 6.8 points for ODI, 8.8 points for SF-12 PCS, 9.3 points for SF-12 MCS, and 0.35 quality-adjusted life-years for EQ-5D.

摘要

目的:脊柱外科手术结果研究依赖于患者报告的结果(PRO)测量来评估治疗效果。这些问卷的一个缺点是,其数值评分的改善程度缺乏直接的临床意义。因此,最小临床重要差异(MCID)的概念被用于衡量达到临床相关治疗效果所需的临界阈值。由于过去十年中脊柱融合的应用增加,索引腰椎融合后相邻节段退变的发生率也增加,这通常需要进行翻修椎板切除术和融合延长。在相邻节段疾病(ASD)的腰椎翻修手术中,任何 PRO 都没有调查过 MCID。

方法:在 50 例因 ASD 相关腰背疼痛而行翻修手术的连续患者中,分别评估术前和术后 2 年的腰背疼痛视觉模拟量表(BP-VAS 和 LP-VAS)、Oswestry 残疾指数(ODI)、12 项简明健康调查量表身体和精神成分摘要(SF-12 PCS 和 MCS)和欧洲五维健康量表(EQ-5D)的 PRO 测量。采用以下 4 种成熟的基于锚定的 MCID 计算方法来计算 MCID:平均变化;最小可检测变化(MDC);变化差异;以及为以下 2 个单独的锚定物(SF-36 的健康转移项目[HTI]和满意度指数)进行的接收器操作特征曲线(ROC)分析。

结果:所有患者均进行了 2 年的 PRO 评估。手术后 2 年,所有 PRO 均有统计学显著改善(平均变化:BP-VAS 评分[4.80±3.25]、LP-VAS 评分[3.28±3.25]、ODI[10.24±13.49]、SF-12 PCS[8.69±12.55]和 MCS[8.49±11.45]评分和 EQ-5D[0.38±0.45];所有 p<0.001)。4 种 MCID 计算方法为每个 PRO 产生了一系列 MCID 值(BP-VAS 评分,2.3-6.5;LP-VAS 评分,1.7-4.3;ODI,6.8-16.9;SF-12 PCS,6.1-12.6;SF-12 MCS,2.4-10.8;和 EQ-5D,0.27-0.54)。HTI 锚定的 ROC 曲线下面积始终大于满意度锚定,这表明 HTI 锚定更适合 MCID。

结论:基于计算技术,相邻节段疾病翻修手术的特定 MCID 变化很大。MDC 方法与 HTI 锚定似乎最适合 ASD 腰椎翻修融合后的 MCID 计算,因为它提供了一个高于未改善队列的 95% CI(大于测量误差)的阈值,与改善和满意患者报告的平均变化得分最接近,并且不受锚定选择的显著影响。根据这种方法,ASD 腰椎翻修术后的 MCID 为 BP-VAS 评分 3.8 分、LP-VAS 评分 2.4 分、ODI 评分 6.8 分、SF-12 PCS 评分 8.8 分、SF-12 MCS 评分 9.3 分和 EQ-5D 的 0.35 质量调整生命年。

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