Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40202, USA.
Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.
BACKGROUND CONTEXT: The Neck Disability Index (NDI), the short form-36 (SF-36) physical component summary (PCS), and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery. The minimum clinically important difference (MCID) is a threshold of improvement that is clinically relevant to the patient. However, the true goal is to provide the patient with a substantial clinical benefit (SCB). PURPOSE: This study determines the MCID and SCB using common anchor-based methods for NDI, PCS, and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders. STUDY DESIGN/SETTING: The study setting is a longitudinal cohort in a multisurgeon spine specialty clinic. PATIENT SAMPLE: The sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospectively collected outcome scores with a minimum 1-year follow-up. OUTCOME MEASURES: The outcome measures of the study were NDI, SF-36, and numeric rating scales for arm and neck pain. METHODS: The MCID and SCB values for NDI, PCS, and pain scales for arm and neck pain were determined using receiver operating characteristic (ROC) curve analysis with the Health Transition Item of the SF-36 as an anchor. The Health Transition Item asks a patient "Compared to one year ago, how would you rate your health in general now?" with answers ranging from "Much Better," "Somewhat Better," "About the Same," "Somewhat Worse," to "Much Worse." An ROC curve was constructed for each measure. The ROC curve-derived MCID was the change score with equal sensitivity and specificity to distinguish the "Somewhat Better" from the "About the Same" patients. The ROC curve-derived SCB was the change score with equal sensitivity and specificity to distinguish the "Much Better" from the "Somewhat Better" patients. Distribution-based methods including the standard error of the mean and the minimum detectable change were also used to calculate MCID. RESULTS: The calculated MCID is 7.5 for the NDI, 4.1 for SF-36 PCS, and 2.5 for arm and neck pain. The calculated SCB is 9.5 for the NDI, 6.5 for SF-36 PCS, and 3.5 for arm and neck pain. CONCLUSIONS: Patients with an eight-point decrease in NDI, a 4.1-point increase in PCS, and a three-point decrease in arm or neck pain can detect a minimally clinically important change. Patients with a 10-point decrease in NDI, a 6.5-point increase in PCS, and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion.
背景：颈痛残疾指数（NDI）、简明 36 健康调查量表（SF-36）生理成分概要（PCS）和手臂及颈部疼痛量表，这些常用于评估颈椎术后治疗效果的工具，目前其最小临床重要差异（MCID）已被认为是一个具有临床意义的改善阈值。然而，真正的目标是为患者提供实质性的临床获益（SCB）。
目的：本研究旨在通过常见的基于锚定的方法，确定接受颈椎融合术治疗退行性疾病的患者的 NDI、PCS 和手臂及颈部疼痛量表的 MCID 和 SCB。
研究设计/环境：本研究是一项在多外科医生脊柱专科诊所进行的纵向队列研究。
患者样本：该样本包括 505 名接受颈椎融合术治疗退行性脊柱疾病的患者，他们前瞻性地收集了至少 1 年随访的结果评分。
结局测量：研究的结局测量包括 NDI、SF-36 和手臂及颈部疼痛的数字评分量表。
方法：使用简明 36 健康调查量表的健康转变项目作为锚定，通过接受者操作特征（ROC）曲线分析确定 NDI、PCS 和手臂及颈部疼痛量表的 MCID 和 SCB 值。健康转变项目询问患者“与一年前相比，您现在的整体健康状况如何？”，答案从“好得多”“好一些”“大致相同”“差一些”到“差得多”。为每个指标构建了一个 ROC 曲线。ROC 曲线衍生的 MCID 是改变评分，具有相等的敏感性和特异性，以区分“好一些”和“大致相同”的患者。ROC 曲线衍生的 SCB 是改变评分，具有相等的敏感性和特异性，以区分“好得多”和“好一些”的患者。基于分布的方法，包括均数的标准误差和最小可检测变化，也被用于计算 MCID。
结果：NDI 的计算 MCID 为 7.5，SF-36 PCS 的计算 MCID 为 4.1，手臂和颈部疼痛的计算 MCID 为 2.5。NDI 的计算 SCB 为 9.5，SF-36 PCS 的计算 SCB 为 6.5，手臂和颈部疼痛的计算 SCB 为 3.5。
结论：NDI 下降 8 分、PCS 增加 4.1 分、手臂或颈部疼痛减少 3 分的患者可检测到最小临床重要变化。NDI 下降 10 分、PCS 增加 6.5 分、手臂或颈部疼痛减少 4 分的患者可在颈椎融合术后检测到 SCB。
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