Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.
Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Eur Spine J. 2024 Nov;33(11):4270-4280. doi: 10.1007/s00586-024-08440-1. Epub 2024 Aug 13.
To evaluate the responsiveness of the original low back pain specific Oswestry Disability Index (ODI) and the spinal stenosis specific Zürich Claudication Questionnaire (ZCQ), and to investigate cut-off values for clinical "success" for ODI and ZCQ in surgically treated patients with lumbar spinal stenosis (LSS).
We included 601 LSS patients (218 with, 383 without degenerative spondylolisthesis) from the NORDSTEN trials. Outcome measures included ODI and ZCQ (symptom severity and physical function scales) with three alternative response parameters: scores at follow-up, absolute and relative changes from baseline to two-year follow-up. Effect size and standardised response mean evaluated internal responsiveness. External responsiveness was assessed by the Spearman rank correlation between patient-reported global perceived effect scale (GPE) and ODI and ZCQ, and receiver operating characteristics (ROC). We evaluated which cut-off values could maximise the percentage of correctly classified patients according to the GPE-anchor "completely recovered" / "much improved" for each parameter.
Internal and external responsiveness were high for all three indices with effect sizes, standardized response means, ROC and corresponding area under the curve > 0.8. Correlations with GPE responses were moderate (> 0.50) for absolute change and strong (> 0.67) for relative change and follow-up scores. The 30% ODI relative change cut-off correctly classified 81% of patients to "success", within a range of accurate cut-offs according to the GPE-anchor.
ODI and ZCQ demonstrate comparable responsiveness in evaluating outcomes for surgically treated LSS patients. The 30% ODI threshold was consistent with treatment "success" in NORDSTEN trials.
ClinicalTrials.gov; NCT02007083 10/12/2013, NCT02051374 31/01/2014 and NCT03562936 20/06/2018.
评估原始腰痛专用 Oswestry 功能障碍指数（ODI）和脊柱狭窄专用苏黎世跛行问卷（ZCQ）的反应能力，并为接受手术治疗的腰椎管狭窄症（LSS）患者的 ODI 和 ZCQ 确定临床“成功”的截断值。
我们纳入了来自 NORDSTEN 试验的 601 例 LSS 患者（218 例伴退行性腰椎滑脱，383 例不伴退行性腰椎滑脱）。结局测量包括 ODI 和 ZCQ（症状严重程度和身体功能量表），采用三种替代反应参数：随访时的评分、从基线到两年随访的绝对和相对变化。效应量和标准化反应均值评估内部反应能力。通过患者报告的总体感觉效果量表（GPE）与 ODI 和 ZCQ 之间的 Spearman 秩相关关系以及接受者操作特征（ROC）评估外部反应能力。我们评估了每个参数的截断值可以根据 GPE 锚定“完全恢复”/“明显改善”使根据 GPE 锚定“完全恢复”/“明显改善”分类的患者比例最大化。
所有三个指标的内部和外部反应能力均较高，效应量、标准化反应均值、ROC 和相应的曲线下面积均大于 0.8。与 GPE 反应的相关性为中度（>0.50），绝对变化和强（>0.67），相对变化和随访评分。30%ODI 相对变化的截断值可正确分类 81%的患者为“成功”，根据 GPE 锚定，这一范围的截断值是准确的。
ODI 和 ZCQ 在评估接受手术治疗的 LSS 患者的结局方面具有相似的反应能力。NORDSTEN 试验中，30%ODI 阈值与治疗“成功”一致。
ClinicalTrials.gov；NCT02007083 于 2013 年 12 月 10 日，NCT02051374 于 2014 年 1 月 31 日，NCT03562936 于 2018 年 6 月 20 日。
