Department of Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
J Neurosurg Spine. 2011 May;14(5):598-604. doi: 10.3171/2010.12.SPINE10472. Epub 2011 Feb 18.
OBJECT: Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice. METHODS: In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index). RESULTS: All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1-5.3; LP-VAS, 2.1-4.7; ODI, 11-22.9; and EQ-5D, 0.15-0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor. CONCLUSIONS: The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID 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 least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.
目的:脊柱外科的疗效研究依赖于患者报告的结果(PROs)来评估治疗效果。常用的健康相关生活质量问卷包括以下量表:腰背疼痛视觉模拟量表(BP-VAS 和 LP-VAS);Oswestry 功能障碍指数(ODI);以及 EuroQol-5D 健康调查(EQ-5D)。这些问卷的一个缺点是它们的数值评分缺乏直接的意义或临床意义。正因为如此,最小临床重要差异(MCID)的概念已经被提出,作为衡量达到治疗效果所需的临界阈值的一种方法。通过这种方法,达到 MCID 阈值的治疗效果意味着具有临床意义,并证明其在临床实践中的实施是合理的。
方法:在 45 例连续接受经椎间孔腰椎体间融合术(TLIF)治疗低度退行性腰椎滑脱相关腰背疼痛和下肢疼痛的患者中,在术前和术后 2 年分别进行 PRO 问卷测量,包括 BP-VAS、LPVAS、ODI 和 EQ-5D,并计算 2 年的变化评分。使用 4 种已建立的基于锚定的 MCID 计算方法来计算 MCID,具体如下:1)平均变化;2)最小可检测变化(MDC);3)变化差值;4)对于两个单独的锚定(36 项简短健康调查问卷 [SF-36] 的健康转移指数 [HTI] 和满意度指数)进行的接收者操作特征曲线分析。
结果:所有患者均在 2 年随访时可获得。BP-VAS、LP-VAS、ODI 和 EQ-5D 评分在 2 年内的改善分别为 4.3 ± 2.9、3.8 ± 3.4、19.5 ± 11.3 和 0.43 ± 0.44(平均值 ± 标准差)。4 种 MCID 计算方法为每个 PRO 产生了不同的 MCID 值(BP-VAS,2.1-5.3;LP-VAS,2.1-4.7;ODI,11-22.9;和 EQ-5D,0.15-0.54)。4 种 PRO 特异性计算的受试者工作特征曲线的平均曲线下面积(AUC),HTI 锚定优于满意度锚定(HTI [AUC 0.73] vs 满意度 [AUC 0.69]),这表明 HTI 作为一个更准确的锚定。
结论:TLIF 特定的 MCID 具有高度的计算方法依赖性。使用 SF-36 HTI 锚定的 MDC 方法似乎最适合计算 MCID,因为它提供了一个高于未改善队列 95%CI 的阈值(大于测量误差),与改善和满意患者报告的平均变化得分最接近,并且最不受锚定选择的影响。根据 MDC 方法和 HTI 锚定,TLIF 后 MCID 评分分别为:BP-VAS 2.1 分,LP-VAS 2.8 分,ODI 14.9 分,EQ-5D 0.46 个质量调整生命年。
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