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脊髓型颈椎病手术后达到最小临床重要差异的临床预测因素:来自加拿大脊柱结局与研究网络的外部验证研究

Clinical predictors of achieving the minimal clinically important difference after surgery for cervical spondylotic myelopathy: an external validation study from the Canadian Spine Outcomes and Research Network.

作者信息

Evaniew Nathan, Cadotte David W, Dea Nicolas, Bailey Christopher S, Christie Sean D, Fisher Charles G, Paquet Jerome, Soroceanu Alex, Thomas Kenneth C, Rampersaud Y Raja, Manson Neil A, Johnson Michael, Nataraj Andrew, Hall Hamilton, McIntosh Greg, Jacobs W Bradley

机构信息

1University of Calgary Spine Program, University of Calgary, Alberta.

2Vancouver Spine Surgery Institute, University of British Columba, Vancouver, British Columbia.

出版信息

J Neurosurg Spine. 2020 Apr 10;33(2):129-137. doi: 10.3171/2020.2.SPINE191495. Print 2020 Aug 1.

Abstract

OBJECTIVE

Recently identified prognostic variables among patients undergoing surgery for cervical spondylotic myelopathy (CSM) are limited to two large international data sets. To optimally inform shared clinical decision-making, the authors evaluated which preoperative clinical factors are significantly associated with improvement on the modified Japanese Orthopaedic Association (mJOA) scale by at least the minimum clinically important difference (MCID) 12 months after surgery, among patients from the Canadian Spine Outcomes and Research Network (CSORN).

METHODS

The authors performed an observational cohort study with data that were prospectively collected from CSM patients at 7 centers between 2015 and 2017. Candidate variables were tested using univariable and multiple binomial logistic regression, and multiple sensitivity analyses were performed to test assumptions about the nature of the statistical models. Validated mJOA MCIDs were implemented that varied according to baseline CSM severity.

RESULTS

Among 205 patients with CSM, there were 64 (31%) classified as mild, 86 (42%) as moderate, and 55 (27%) as severe. Overall, 52% of patients achieved MCID and the mean change in mJOA score at 12 months after surgery was 1.7 ± 2.6 points (p < 0.01), but the subgroup of patients with mild CSM did not significantly improve (mean change 0.1 ± 1.9 points, p = 0.8). Univariate analyses failed to identify significant associations between achieving MCID and sex, BMI, living status, education, smoking, disability claims, or number of comorbidities. After adjustment for potential confounders, the odds of achieving MCID were significantly reduced with older age (OR 0.7 per decade, 95% CI 0.5-0.9, p < 0.01) and higher baseline mJOA score (OR 0.8 per point, 95% CI 0.7-0.9, p < 0.01). The effects of symptom duration (OR 1.0 per additional month, 95% CI 0.9-1.0, p = 0.2) and smoking (OR 0.4, 95% CI 0.2-1.0, p = 0.06) were not statistically significant.

CONCLUSIONS

Surgery is effective at halting the progression of functional decline with CSM, and approximately half of all patients achieve the MCID. Data from the CSORN confirmed that older age is independently associated with poorer outcomes, but novel findings include that patients with milder CSM did not experience meaningful improvement, and that symptom duration and smoking were not important. These findings support a nuanced approach to shared decision-making that acknowledges some prognostic uncertainty when weighing the various risks, benefits, and alternatives to surgical treatment.

摘要

目的

最近在接受脊髓型颈椎病(CSM)手术的患者中确定的预后变量仅限于两个大型国际数据集。为了优化共享临床决策,作者评估了在加拿大脊柱结局与研究网络(CSORN)的患者中,哪些术前临床因素与术后12个月改良日本骨科协会(mJOA)量表改善至少达到最小临床重要差异(MCID)显著相关。

方法

作者进行了一项观察性队列研究,使用2015年至2017年期间从7个中心的CSM患者前瞻性收集的数据。使用单变量和多变量二项式逻辑回归测试候选变量,并进行多次敏感性分析以检验关于统计模型性质的假设。实施了根据基线CSM严重程度而变化的经过验证的mJOA MCID。

结果

在205例CSM患者中,64例(31%)为轻度,86例(42%)为中度,55例(27%)为重度。总体而言,52%的患者达到MCID,术后12个月mJOA评分的平均变化为1.7±2.6分(p<0.01),但轻度CSM患者亚组没有显著改善(平均变化0.1±1.9分,p = 0.8)。单变量分析未能确定达到MCID与性别、体重指数、生活状况、教育程度、吸烟、残疾索赔或合并症数量之间的显著关联。在对潜在混杂因素进行调整后,年龄较大(每十年OR 0.7,95%CI 0.5 - 0.9,p<0.01)和基线mJOA评分较高(每分OR 0.8,95%CI 0.7 - 0.9,p<0.01)时达到MCID的几率显著降低。症状持续时间(每增加一个月OR 1.0,95%CI

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