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

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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.

ABBREVIATIONS CSORN = Canadian Spine Outcomes and Research Network; DS = Disability Scale; LDH = lumbar disc herniation; LDS = lumbar degenerative spondylolisthesis; LSS = lumbar spinal stenosis; MCS = Mental Component Summary; PCS = Physical Component Summary; PRO = patient-reported outcome; QOL = quality of life; VAS = visual analog scale.

Article Information

Correspondence Charles G. Fisher: Vancouver General Hospital/University of British Columbia, Vancouver, BC, Canada. charles.fisher@vch.ca.

INCLUDE WHEN CITING Published online December 21, 2018; DOI: 10.3171/2018.8.SPINE18715.

Disclosures Dr. Fisher has received consultant fees from Medtronic and NuVasive, has received royalties to his institution from a Medtronic research grant, and has received fellowship support to his institution from AOSpine and Medtronic for work outside of the present study. Dr. Johnson has received grant support to his institution from Stryker. Dr. Paquet has received educational grant support to his institution from Medtronic of Canada. Dr. Manson has been a consultant for and received non–study-related support from Medtronic. Dr. Rampersaud has been a consultant for and received royalties from Medtronic.

© AANS, except where prohibited by US copyright law.

Headings

Figures

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    Patient-reported outcomes for physical function over time after surgery for LDH (lumbar disc), LDS (lumbar spond.), and LSS (lumbar stenosis) according to the DS (A–C) and PCS (D–F). Recovery plateau indicated by inverted triangles.

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    Patient-reported outcomes for the pain dimension over time after surgery for LDH, LDS, and LSS according to the VAS leg (A–C) and VAS back (D–F). Recovery plateau indicated by inverted triangles.

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    Patient-reported outcomes for mental QOL over time after surgery for LDH, LDS, and LSS according to the MCS (A–C). Recovery plateau indicated by inverted triangles.

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    Patient-reported outcomes for pain (A and B), physical function (C and D), and mental QOL (E) after fusion (solid line) and nonfusion (dashed line) for LSS. Recovery plateau indicated by inverted triangles for fusion and asterisks for nonfusion.

  • View in gallery

    Patient-reported outcomes for pain (A and B), physical function (C and D), and mental QOL (E) after fusion (solid line) and nonfusion (dashed line) for LDS. Recovery plateau indicated by inverted triangles for fusion and asterisks for nonfusion.

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