SF-36 评分用于退行性颈脊髓病的最小临床重要差异。
Minimum Clinically Important Difference in SF-36 Scores for Use in Degenerative Cervical Myelopathy.
机构信息
Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
出版信息
Spine (Phila Pa 1976). 2018 Nov 1;43(21):E1260-E1266. doi: 10.1097/BRS.0000000000002684.
STUDY DESIGN
Post-hoc analysis of 606 patients enrolled in the AOSpine CSM-NA or CSM-I prospective, multicenter cohort studies.
OBJECTIVE
The aim of this study was to determine the minimum clinically important difference (MCID) in SF-36v2 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores in patients undergoing surgery for degenerative cervical myelopathy (DCM).
SUMMARY OF BACKGROUND DATA
There has been a shift toward focus on patient-reported outcomes (PROs) in spine surgery. However, the numerical scores of PROs lack immediate clinical meaning. The MCID adds a dimension of interpretability to PRO scales; by defining the smallest change, a patient would consider meaningful.
METHODS
The MCID of the SF-36v2 PCS and MCS were determined by distribution- and anchor-based methods comparing preoperative to 12-month scores. Distribution-based approaches included calculation of the half standard deviation and standard error of measurement (SEM). Change in Neck Disability Index (NDI) served as the anchor: "worse" (ΔNDI>7.5); "unchanged" (7.5≥ΔNDI>-7.5); "slightly improved" (-7.5≥ΔNDI>-15); and "markedly improved" (ΔNDI ≤-15). Receiver operating characteristic (ROC) analysis was performed to determine the change score for the MCID with even sensitivity and specificity to distinguish patients who were "slightly improved" versus "unchanged" on the NDI.
RESULTS
The MCID for the SF-36v2 PCS and MCS were 4.6 and 6.8 by half standard deviation and 2.9 and 4.3 by SEM, respectively. By ROC analysis, the MCID was 3.9 for the SF-36v2 PCS score and 3.2 for the SF-36v2 MCS score. Using a cutoff of 4 points, the SF-36v2 PCS had a sensitivity of 72.2% and specificity of 68.1%, and MCS 61.9% and 64.6%, respectively, in separating patients who were "markedly improved" or "slightly improved" from those who were "unchanged" or "worse."
CONCLUSION
We found the MCID of the SF-36v2 PCS and MCS to be 4 points. This will facilitate use of the SF-36v2 as an outcome in future studies of DCM.
LEVEL OF EVIDENCE
研究设计
对纳入 AOSpine CSM-NA 或 CSM-I 前瞻性、多中心队列研究的 606 例患者进行了回顾性分析。
目的
本研究旨在确定退行性颈椎脊髓病（DCM）患者接受手术治疗后 SF-36v2 生理成分综合评分（PCS）和心理成分综合评分（MCS）的最小临床重要差异（MCID）。
背景资料概要
脊柱外科手术的关注点已逐渐转向患者报告的结局（PROs）。然而，PRO 的数值评分缺乏直接的临床意义。MCID 为 PRO 量表增加了可解释性维度；通过定义最小变化，患者会认为这是有意义的。
方法
通过术前与 12 个月时评分的分布和锚定方法来确定 SF-36v2 PCS 和 MCS 的 MCID。分布方法包括计算半标准差和测量标准误差（SEM）。颈痛残疾指数（NDI）的变化作为锚定标准：“更差”（ΔNDI＞7.5）；“不变”（7.5≥ΔNDI＞-7.5）；“略有改善”（-7.5≥ΔNDI＞-15）；“明显改善”（ΔNDI≤-15）。进行接收者操作特征（ROC）分析，以确定 MCID 的变化评分，使 NDI 上的“略有改善”和“不变”的患者具有相同的敏感性和特异性。
结果
SF-36v2 PCS 和 MCS 的 MCID 分别为半标准差的 4.6 和 6.8，SEM 的 2.9 和 4.3。通过 ROC 分析，SF-36v2 PCS 的 MCID 为 3.9，SF-36v2 MCS 的 MCID 为 3.2。使用 4 分的截断值，SF-36v2 PCS 的敏感性为 72.2%，特异性为 68.1%，MCS 的敏感性为 61.9%，特异性为 64.6%，分别用于区分“明显改善”或“略有改善”与“不变”或“更差”的患者。
结论
我们发现 SF-36v2 PCS 和 MCS 的 MCID 为 4 分。这将促进 SF-36v2 在未来 DCM 研究中的应用。
证据水平
3 级。
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