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

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.

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Clinical outcomes research in spine surgery: what are appropriate follow-up times?

Presented at the 2018 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Oliver G. S. Ayling, Tamir Ailon, Greg McIntosh, Alex Soroceanu, Hamilton Hall, Andrew Nataraj, Christopher S. Bailey, Sean Christie, Alexandra Stratton, Henry Ahn, Michael Johnson, Jerome Paquet, Kenneth Thomas, Neil Manson, Y. Raja Rampersaud and Charles G. Fisher

OBJECTIVE

There has been a generic dictum in spine and musculoskeletal clinical research that a minimum 2-year follow-up is necessary for patient-reported outcomes (PROs) to adequately assess the therapeutic effect of surgery; however, the rationale for this duration is not evidence based. The purpose of this study was to determine the follow-up time necessary to ensure that the effectiveness of a lumbar surgical intervention is adequately captured for three lumbar pathologies and three common PROs.

METHODS

Using the different PROs of pain, physical function, and mental quality of life from the Canadian Spine Outcomes and Research Network (CSORN) prospective database, the authors assessed the time course to the recovery plateau following lumbar spine surgery for lumbar disc herniation, degenerative spondylolisthesis, and spinal stenosis. One-way ANOVA with post hoc testing was used to compare scores on the following standardized PRO measures at baseline and 3, 12, and 24 months postoperatively: Disability Scale (DS), visual analog scale (VAS) for leg and back pain, and SF-12 Mental Component Summary (MCS) and Physical Component Summary (PCS).

RESULTS

Significant differences for all spine pathologies and specific PROs were found with one-way ANOVA (p < 0.0001). The time to plateaued recovery after surgery for lumbar disc herniation (661 patients), lumbar stenosis (913 patients), and lumbar spondylolisthesis (563 patients) followed the same course for the following PRO measures: VAS for back and leg pain, 3 months; DS, 12 months; PCS, 12 months; and MCS, 3 months. Beyond these time points, no further significant improvements in PROs were seen. Patients with degenerative spondylolisthesis or spinal stenosis who had undergone fusion surgery plateaued at 12 months on the DS and PCS, compared to 3 months in those who had not undergone fusion.

CONCLUSIONS

Specific health dimensions follow distinctly different recovery plateaus, indicating that a 2-year postoperative follow-up is not required for all PROs to accurately assess the treatment effect of lumbar spinal surgery. Ultimately, the clinical research question should dictate the follow-up time and the outcome measure utilized; however, there is now evidence to guide the specific duration of follow-up for pain, physical function, and mental quality of life dimensions.