Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation

Table 1 Inclusion and exclusion criteria.¹

Inclusion criteria:
1. Age greater than 18 years (to allow informed consent).
2. Diagnosis is lumbar degenerative disease (disc degeneration, disc herniation, spinal stenosis, spondylolisthesis, or degenerative scoliosis).
3. Surgery involves at least one lumbar vertebra.
4. Surgery at Harborview Medical Center or University of Washington Medical Center.
Exclusion criteria:
1. Inflammatory spondyloarthropathy.
2. Spinal malignancy or infection.
3. Pregnancy.
4. No telephone contact, or planning to move within a year.
5. Unable to complete study questionnaires or follow-up telephone interviews in English.

¹Concurrent with the initiation of this study, we established a spine registry to track safety and outcomes of all spine surgery procedures at the University of Washington (the Spine End Results Registry). Research coordinators attempt to offer most patients scheduled for spine surgery at the University of Washington the opportunity to enroll in the registry, but because of limited staff, only the busiest spine clinics are staffed with research coordinators. The criteria listed here specify the subset of registry patients selected for studying lumbar surgery for degenerative disease.

ISSN: 1471-2474