Section of Neurosurgery, The University of Chicago, 5841 South Maryland Ave, MC3026, J341, Chicago, IL, 60637, USA,
Acta Neurochir (Wien). 2013 Dec;155(12):2345-54; discussion 2355. doi: 10.1007/s00701-013-1909-4. Epub 2013 Oct 18.
BACKGROUND: The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes (PROs): Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain, and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary. However, the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear. In this context, the concept of minimum clinically important difference (MCID) is developing into the standard by which to evaluate treatments, patient satisfaction and cost-effectiveness. METHODS: Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospective blinded database. PROs (NDI, PCS, MCS and VAS) were collected preoperatively, and together with blinded Surgeon Ratings (SR) at 3 months and 6 months post-surgery. Four anchor-based approaches were used to calculate different MCIDs. Three anchors (VAS, HTI (Health Transition Item of the SF-36) and SR) were used to evaluate surgery outcome. The best clinically and statistically relevant MCID was chosen. RESULTS: On average, all patients presented with a statistically significant improvement (p < 0.001) postoperatively for NDI (27.42 to 19.42), PCS (33.02 to 42.03), MCS (44 to 50.74) and VAS (2.85 to 1.93). The four MCID anchor-based approaches yielded a range of values for each PRO: 2.23-16.59 for PCS, 0.11-16.27 for MCS and 2.72-12.08 for NDI. When compared to the VAS and HTI anchors, the area under the ROC curve was greater for SR. This finding suggests that SR may be a more reliable anchor for MCID calculation. CONCLUSION: The MDC (minimum detectable change) approach together with the SR anchor appears to be the most appropriate MCID method. It offers the greatest area under the ROC curve (threshold above the 95 % CI), and the choice of the anchor did not significantly affect this result. MCID values for this dataset were 5.6 for PCS, 5.12 for MCS and 2.41 for NDI.
背景：颈椎手术治疗效果的测量通常依赖于四个主要的患者报告结果（PROs）：颈椎残障指数（NDI）、疼痛视觉模拟量表（VAS）和简明 36 健康调查量表（SF-36）的生理（PCS）和心理（MCS）综合评分。然而，这些评分的临床意义以及它们如何有效地衡量治疗效果尚不清楚。在这种情况下，最小临床重要差异（MCID）的概念正在发展成为评估治疗效果、患者满意度和成本效益的标准。
方法：从一个前瞻性盲数据库中选择了 88 例因下颈椎退行性疾病接受手术的连续患者。在术前收集 PROs（NDI、PCS、MCS 和 VAS），并在术后 3 个月和 6 个月时与盲法外科医生评分（SR）一起收集。使用四种基于锚定的方法来计算不同的 MCID。三个锚定（VAS、HTI（SF-36 的健康转移项目）和 SR）用于评估手术效果。选择最具临床和统计学意义的 MCID。
结果：平均而言，所有患者在术后均表现出统计学上显著的改善（p<0.001），NDI（从 27.42 降至 19.42）、PCS（从 33.02 升至 42.03）、MCS（从 44 升至 50.74）和 VAS（从 2.85 降至 1.93）。四种基于锚定的 MCID 方法为每个 PRO 提供了一个范围的数值：PCS 为 2.23-16.59，MCS 为 0.11-16.27，NDI 为 2.72-12.08。与 VAS 和 HTI 锚定相比，SR 的 ROC 曲线下面积更大。这一发现表明，SR 可能是计算 MCID 的更可靠锚定。
结论：MDC（最小可检测变化）方法与 SR 锚定结合似乎是最适合的 MCID 方法。它提供了最大的 ROC 曲线下面积（阈值高于 95%CI），并且锚定的选择并没有显著影响这一结果。该数据集的 MCID 值为 PCS 为 5.6，MCS 为 5.12，NDI 为 2.41。
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