Assessment of the minimum clinically important difference in pain, disability, and quality of life after anterior cervical discectomy and fusion Clinical article
Assessment of the minimum clinically important difference in pain, disability, and quality of life after anterior cervical discectomy and fusion Clinical article
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DOI：
10.3171/2012.10.spine12312
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发表时间：
2013-02-01
影响因子：
2.8
通讯作者：
McGirt, Matthew J.
中科院分区：
文献类型：
--
作者：
Parker, Scott L.;Godil, Saniya S.;McGirt, Matthew J.
目的。脊柱手术后的治疗效果通常通过患者报告结果 (PRO) 问卷来衡量。尽管这些调查问卷评估了疼痛、残疾和一般健康状况，但它们的数字分数缺乏直接的、具有临床意义的意义。因此，引入了最小临床重要差异（MCID）的概念，它表明反映对患者有临床意义的改善的结果测量的最小变化。作者着手确定因颈椎神经根病接受 ACDF 治疗的患者的视觉模拟量表 (VAS)、颈部残疾指数 (NDI)、12 项简短健康调查 (SF-12) 和 EQ-5D（EuroQol 健康调查）的颈前路椎间盘切除融合术 (ACDF) 特异性 MCID 值。方法。在研究入组期间，作者在基于网络的前瞻性登记处收集了 69 名因颈神经根病接受 ACDF 的患者的数据。术前和术后 3 个月进行患者报告的结果调查问卷（VAS 颈部疼痛 [NP]）、VAS 手臂疼痛 [AP]、NDI、SF-12 和 EQ-5D），以便计算 3 个月的变化评分。使用北美脊柱协会（NASS）患者满意度量表作为锚点，使用四种已建立的计算方法来计算基于锚点的 MCID 值：1）平均变化，2）最小可检测变化（MDC），3）变化差异，4）受试者工作特征（ROC）曲线分析。结果。 61 名患者 (88%) 可以进行随访。术后 3 个月，以下 PRO 评估有统计学显着改善 (p < 0.001)：VAS-NP (2.7 +/- 3.3)、VAS-AP (3.7 +/- 3.6)、NDI (23.2% +/- 19.7%)、SF-12 身体成分评分 (PCS；10.7 +/- 9.7) 和 EQ-5D (0.20 +/- 9.7) 0.23 质量生命年）。 SF-12 心理成分评分 (MCS) 的改善趋于显着 (3.4 +/- 11.4, p = 0.07)。 4 种 MCID 计算方法为每个 PRO 生成一系列 MCID 值：VAS-NP 2.6-4.0、VAS-AP 2.4-4.2、NDI 16.0%-27.6%、SF-12 PCS 7.0-12.2、SF-12 MCS 0.0-7.2 和 EQ-5D 0.05-0.24 QALY。 NDI (0.80) 观察到最大曲线下面积 (AUC)，SF-12 MCS (0.66) 和 EQ-5D (0.67) 观察到最小 AUC。基于 MDC 方法，VAS-NP 的 MCID 阈值为 2.6 分，VAS-AP 为 4.1 分，NDI 为 17.3%，SF-12 PCS 为 8.1 分，SF-12 MCS 为 4.7 分，EQ-5D QALY 为 0.24 分。 3 个月时患者评分的平均改善超过了 VAS-NP、NDI 和 SF-12 PCS 的 MCID 阈值，但没有超过 VAS-AP、SF-12 MCS 和 EQ-5D 的 MCID 阈值。结论。 ACDF 特定的 MCID 根据所使用的计算技术而变化很大。 MDC 方法似乎最适合 ACDF 人群中的 MCID 计算，因为它提供了高于无应答者 95% 置信区间的阈值（大于测量误差），并且最接近应答者报告的大多数 PRO 的平均变化。当以NASS患者满意度量表为锚定应用MDC方法时，MOD阈值为VAS-NP为2.6分，VAS-AP为4.1分，NDI为17.3%，SF-12 PCS为8.1分，SF-12 MCS为4.7分，EQ-5D为0.24 QALY。 （http://thejns.org/doi/abs/10.3171/2012.10.SPINE12312）
Object. Treatment effectiveness following spine surgery is usually gauged with the help of patient-reported outcome (PRO) questionnaires. Although these questionnaires assess pain, disability, and general health state, their numerical scores lack direct, clinically significant meaning. Thus, the concept of minimum clinically important difference (MCID) has been introduced, which indicates the smallest change in an outcome measure that reflects clinically meaningful improvement to patients. The authors set out to determine anterior cervical discectomy and fusion (ACDF)-specific MCID values for the visual analog scale (VAS), Neck Disability Index (NDI), 12-Item Short-Form Health Survey (SF-12), and EQ-5D (the EuroQol health survey) in patients undergoing ACDF for cervical radiculopathy.Methods. Data on 69 patients who underwent ACDF for cervical radiculopathy were collected in the authors' web-based, prospective registry during the study enrollment period. Patient-reported outcome questionnaires (VAS neck pain [NP]), VAS arm pain [AP], NDI, SF-12, and EQ-5D) were administered preoperatively and 3 months postoperatively, allowing 3-month change scores to be calculated. Four established calculation methods were used to calculate anchor-based MCID values using the North American Spine Society (NASS) patient satisfaction scale as the anchor: 1) average change, 2) minimum detectable change (MDC), 3) change difference, and 4) receiver operating characteristic (ROC) curve analysis.Results. Sixty-one patients (88%) were available at follow-up. At 3 months postoperatively, statistically significant improvement (p < 0.001) was observed for the following PROs assessed: VAS-NP (2.7 +/- 3.3), VAS-AP (3.7 +/- 3.6), NDI (23.2% +/- 19.7%), SF-12 physical component score (PCS; 10.7 +/- 9.7), and EQ-5D (0.20 +/- 0.23 QALY). Improvement on the SF-12 mental component score (MCS) trended toward significance (3.4 +/- 11.4, p = 0.07). The 4 MCID calculation methods generated a range of MCID values for each of the PROs: VAS-NP 2.6-4.0, VAS-AP 2.4-4.2, NDI 16.0%-27.6%, SF-12 PCS 7.0-12.2, SF-12 MCS 0.0-7.2, and EQ-5D 0.05-0.24 QALY. The maximum area under the curve (AUC) was observed for NDI (0.80), and the minimum AUC was observed for SF-12 MCS (0.66) and EQ-5D (0.67). Based on the MDC approach, the MCID threshold was 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D. The mean improvement in patient scores at 3 months surpassed the MCID threshold for VAS-NP, NDI, and SF-12 PCS but not for VAS-AP, SF-12 MCS, and EQ-5D.Conclusions. The ACDF-specific MCID is highly variable depending on the calculation technique used. The MDC approach seems to be most appropriate for MCID calculations in the ACDF population, as it provided a threshold value above the 95% confidence interval of nonresponders (greater than the measurement error) and was closest to the average change of most PROs reported by responders. When the MDC method was applied with the NASS patient satisfaction scale as the anchor, the MOD thresholds were 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D. (http://thejns.org/doi/abs/10.3171/2012.10.SPINE12312)