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确定腰椎退行性疾病手术后的最小临床重要差异估计值:加拿大脊柱结局和研究网络(CSORN)注册分析。

Determining minimal clinically important difference estimates following surgery for degenerative conditions of the lumbar spine: analysis of the Canadian Spine Outcomes and Research Network (CSORN) registry.

机构信息

Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, 399 Bathurst St, Toronto, Ontario, M5T 2S8, Canada.

Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, 399 Bathurst St, Toronto, Ontario, M5T 2S8, Canada; Orthopaedics, Department of Surgery, University of Toronto, 149 College St, Toronto, Ontario, M5T 1P5, Canada; Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, 155 College St 4(th) floor, Toronto, Ontario, M5T 3M6, Canada.

出版信息

Spine J. 2023 Sep;23(9):1323-1333. doi: 10.1016/j.spinee.2023.05.001. Epub 2023 May 7.

DOI:10.1016/j.spinee.2023.05.001
PMID:37160168
Abstract

BACKGROUND CONTEXT

There is significant variability in minimal clinically important difference (MCID) criteria for lumbar spine surgery that suggests population and primary pathology specific thresholds may be required to help determine surgical success when using patient reported outcome measures (PROMs).

PURPOSE

The purpose of this study was to estimate MCID thresholds for 3 commonly used PROMs after surgical intervention for each of 4 common lumbar spine pathologies.

STUDY DESIGN/SETTING: Observational longitudinal study of patients from the Canadian Spine Outcomes and Research Network (CSORN) national registry.

PATIENT SAMPLE

Patients undergoing surgery from 2015 to 2018 for lumbar spinal stenosis (LSS; n = 856), degenerative spondylolisthesis (DS; n = 591), disc herniation (DH; n = 520) or degenerative disc disease (DDD n = 185) were included.

OUTCOME MEASURES

PROMs were collected presurgery and 1-year postsurgery: the Oswestry Disability Index (ODI), and back and leg Numeric Pain Rating Scales (NPRS). At 1-year, patients reported whether they were 'Much better'/'Better'/'Same'/'Worse'/'Much worse' compared to before their surgery. Responses to this item were used as the anchor in analyses to determine surgical MCIDs for benefit ('Much better'/'Better') and substantial benefit ('Much better').

METHODS

MCIDs for absolute and percentage change for each of the 3 PROMs were estimated using a receiving operating curve (ROC) approach, with maximization of Youden's index as primary criterion. Area under the curve (AUC) estimates, sensitivity, specificity and correct classification rates were determined. All analyses were conducted separately by pathology group.

RESULTS

MCIDs for ODI change ranged from -10.0 (DDD) to -16.9 (DH) for benefit, and -13.8 (LSS) to -22.0 (DS,DH) for substantial benefit. MCID for back and leg NPRS change were -2 to -3 for each group for benefit and -4.0 for substantial benefit for all groups on back NPRS. MCID estimates for percentage change varied by PROM and pathology group, ranging from -11.1% (ODI for DDD) to -50.0% (leg NPRS for DH) for benefit and from -40.0% (ODI for DDD) to -66.6% (leg NPRS for DH) for substantial benefit. Correct classification rates for all MCID thresholds ranged from 71% to 89% and were relatively lower for absolute vs percent change for those with high or low presurgical scores.

CONCLUSIONS

Our findings suggest that the use of generic MCID thresholds across pathologies in lumbar spine surgery is not recommended. For patients with relatively low or high presurgery PROM scores, MCIDs based on percentage change, rather than absolute change, appear generally preferable. These findings have applicability in clinical and research settings, and are important for future surgical prognostic work.

摘要

背景

腰椎手术的最小临床重要差异(MCID)标准存在显著差异,这表明在使用患者报告的结果测量(PROM)时,可能需要针对特定人群和主要病理情况确定特定的阈值,以帮助确定手术的成功。

目的

本研究旨在为 4 种常见腰椎病变患者接受手术干预后,对 3 种常用 PROM 进行 MCID 阈值估计。

研究设计/设置:来自加拿大脊柱结局和研究网络(CSORN)国家登记处的患者的观察性纵向研究。

患者样本

纳入 2015 年至 2018 年接受手术治疗的腰椎管狭窄症(LSS;n=856)、退行性脊柱滑脱(DS;n=591)、椎间盘突出症(DH;n=520)或退变性椎间盘疾病(DDD;n=185)患者。

研究结果

术前和术后 1 年采集 PROM:Oswestry 残疾指数(ODI)和背部及腿部数字疼痛评分量表(NPRS)。术后 1 年,患者报告与手术前相比“好得多”/“好一些”/“相同”/“差一些”/“差得多”。分析中使用该项目的回答作为锚定,以确定获益(“好得多”/“好一些”)和显著获益(“好得多”)的手术 MCID。

方法

使用接收者操作特征曲线(ROC)方法估计 3 种 PROM 的绝对值和百分比变化的 MCID,最大约登指数为主要标准。确定曲线下面积(AUC)估计值、灵敏度、特异性和正确分类率。根据病变组分别进行所有分析。

结论

本研究结果表明,不建议在腰椎手术中跨病变使用通用 MCID 阈值。对于术前 PROM 评分相对较低或较高的患者,基于百分比变化的 MCID,而不是绝对值变化的 MCID,似乎总体上更可取。这些发现适用于临床和研究环境,对未来的手术预后工作很重要。

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