Abstract
Background contextCriteria for success after surgical treatment of lumbar spinal stenosis (LSS) have been defined previously; however, there are no clear criteria for failure and worsening after surgery as assessed by patient-reported outcome measures (PROMs). PurposeWe aimed to quantify changes in standard PROMs that most accurately identified failure and worsening after surgery for LSS. Study design /settingRetrospective analysis of prospective national spine registry data with 12-months follow-up. Patient sampleWe analyzed 10,822 patients aged 50 years and older operated in Norway during a decade, and 8,258 (76%) responded 12 months after surgery. Outcome measures (PROMs)We calculated final scores, absolute changes, and percentage changes for Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for back and leg pain (0-10), and EuroQol-5D (EQ-5D). These 12 PROM derivates were compared to the Global Perceived Effect (GPE), a 7-point Likert scale. MethodsWe used ODI, NRS back and leg pain, and EQ-5D 12 months after surgery to identify patients with failure (no effect) and worsening (clinical deterioration). The corresponding GPE at 12-months was graded as failure (GPE=4-7) and worsening (GPE=6-7) and used as an external criterion. To quantify the most accurate cut-off values corresponding to failure and worsening, we calculated areas under the curves (AUCs) of receiver operating characteristics (ROC) curves for the respective PROM derivates. ResultsMean (95% CI) age was 68.3 (68.1 – 68.5) years, and 52% were females. There were 1,683 (20%) failures, and 476 (6%) patients were worse after surgery. The mean (95% CI) pre- and postoperative ODIs were 39.8 (39.5 – 40.2) and 23.7 (23.3 – 24.1), respectively. At 12 months, the mean difference (95% CI) in ODI was 16.1 (15.7 – 16.4), and the mean (95% CI) percentage improvement 38.8% (37.8 – 38.8).The PROM derivates identified failure and worsening accurately (AUC>0.80), except for the absolute change in EQ-5D. The ODI derivates were most accurate to identify both failure and worsening. We found that less than 20% improvement in ODI most accurately identified failure (AUC=0.89 [95% CI: 0.88 to 0.90]), and an ODI final score of 39 points or more most accurately identified worsening (AUC =0.91 [95% CI: 0.90 – 0.92]). ConclusionsIn this national register study, ODI derivates were most accurate to identify both failure and worsening after surgery for degenerative lumbar spinal stenosis. We recommend use of ODI percentage change and ODI final score for further studies of failure and worsening in elective spine surgery.
Highlights
Patients operated for lumbar spinal stenosis (LSS) are more likely to improve than those treated conservatively [1,2,3]
We found that less than 20% improvement in Oswestry Disability Index (ODI) most accurately identified failure (AUC=0.89 [95% CI: 0.88 to 0.90]), and an ODI final score of 39 points or more most accurately identified worsening (AUC =0.91 [95% CI: 0.90 − 0.92])
Of 10,822 patients enrolled in the registry, 8,311 (77%) responded at 12 months follow-up
Summary
Patients operated for lumbar spinal stenosis (LSS) are more likely to improve than those treated conservatively [1,2,3]. Criteria for success after surgical treatment of lumbar spinal stenosis (LSS) have been defined previously; there are no clear criteria for failure and worsening after surgery as assessed by patient-reported outcome measures (PROMs). OUTCOME MEASURES (PROMS): We calculated final scores, absolute changes, and percentage changes for Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for back and leg pain (0-10), and EuroQol-5D (EQ-5D). These 12 PROM derivates were compared to the Global Perceived Effect (GPE), a 7-point Likert scale. METHODS: We used ODI, NRS back and leg pain, and EQ-5D 12 months after surgery to identify patients with failure (no effect) and worsening (clinical deterioration).
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