The Spine Journal
Volume 16, Issue 4, Supplement, April 2016, Pages S12–S18
Proceedings of the 2016 BritSpine Biennial Scientific Congress of the United Kingdom Spine Societies
Tamas F. Fekete, MD, Daniel Haschtmann, MD, Frank S. Kleinstück, MD, François Porchet, MD, Dezsö Jeszenszky, MD, PhD, Anne F. Mannion, PhD
Abstract
Background Context
A new approach to the interpretation of treatment success comprises the reporting of the proportion of patients whose symptoms have reduced to an acceptable level, ie, who have reached a satisfactory state.
Purpose
We sought to evaluate the acceptable level of pain in patients after surgery for painful degenerative lumbar disorders.
Design
This is a cross-sectional study of outcome data, 12 months postoperatively.
Patient Sample
The sample includes 6,943 patients registered in our in-house Spine Outcomes Registry, nested within the EUROSPINE “Spine Tango” registry, undergoing surgery for degenerative disorders of the lumbar spine (disc herniation [DH; N=1,608], spinal stenosis [SS; N=1,782], degenerative spondylolisthesis [DS; N=1,000], degenerative deformity [DegDef; N=612], and degenerative disc or segment disease [DegSeg; N=473], and 1,468 degenerative but no specific category).
Outcome Measures
The Core Outcome Measures Index (COMI) was the outcome measure. The specific items used for this analysis were the two 0 to 10 graphic rating scales for back and leg pain and the symptom-specific well-being (SSWB) item “if you had to spend the rest of your life with the symptoms you have now, how would you feel about it?”, with a 5-point response scale from “very satisfied” to “very dissatisfied.”
Methods
The COMI was completed before and at 3, 12, and 24 months after surgery. Answers on the SSWB were dichotomized and used as the external criterion in receiver operating characteristics (ROC) analysis to derive the cutoff score for pain (the higher of back and leg pain) indicating being at least “somewhat satisfied” with the symptom state 12 months postoperatively. Sensitivity analyses were carried out for various subgroups (sex, age, pathology, comorbidity status, smoking status, preoperative pain level, previous surgery, type of health insurance, and time of follow-up [3 and 24 months]). The study was funded by the Schulthess Klinik Research Funds; there were no potential conflict of interest-associated biases for any of the authors.
Results
Of 6,943 patients, 6,248 (90%) returned a 12-month questionnaire, of which 47% reported being at least somewhat satisfied with their symptom state (52% [DH], 45% [SS], 53% [DS], 44% [DegDef], 45% [DegSeg], and 44% [others]). The areas under the curve for the ROCs were 0.89 to 0.91 for the different pathologies, indicating a good ability of the pain score to discriminate between being in a satisfactory state or not. The cutoff indicating a satisfactory symptom state was ≤2 points for DH (sensitivity: 76%; specificity: 88%) and ≤3 points for all other pathologies (sensitivity: 79%–84%; specificity 81%–85%). The sensitivity analyses revealed ≤3 points to be the most common cutoff for the various subgroups.
Conclusions
Most spine interventions decrease pain but rarely do they totally eliminate it. Reporting of the percent of patients achieving a pain score equivalent to the “acceptable symptom state” may represent a more stringent target for denoting surgical success in the treatment of painful spinal disorders. For DH, this is ≤2, and for other degenerative pathologies it is ≤3.