Table 2.
Area under curve subgroup results from the adjusted* as-treated Oswestry Disability Index (ODI) outcome analysis for the six significant treatment effect predictors (time weighted average 4 year treatment effects).
SPS Predictors | N |
Surgical (n = 413) |
Non-operative (n = 221) |
Treatment Effect
(95% CI) † |
---|---|---|---|---|
| ||||
Baseline ODI ≤ 56 | 482 | −18.9 (0.8) | −3.9 (0.9) | −15 (−17, −13) |
Baseline ODI > 56 | 150 | −28.3 (1.5) | −23.9 (2.2) | −4.4 (−8.7, −0.1) |
p-value | <0.001 | <0.001 | <0.001 | |
| ||||
Smoker | 62 | −8.9 (2.2) | −7.4 (2.4) | −1.6 (−6.6, 3.5) |
Non-Smoker | 566 | −20.7 (0.7) | −9 (0.9) | −11.7 (−13.6, −9.9) |
p-value | <0.001 | 0.53 | <0.001 | |
| ||||
No Neuroforaminal Stenosis | 427 | −19.6 (0.8) | −10.9 (1) | −8.7 (−10.8, −6.5) |
Neuroforaminal Stenosis | 207 | −20 (1.2) | −5.8 (1.3) | −14.2 (−17, −11.3) |
p-value | 0.80 | 0.003 | 0.002 | |
| ||||
Predominant Back Pain | 159 | −16.3 (1.4) | −9.1 (1.6) | −7.3 (−10.8, −3.7) |
Predominant Leg Pain | 456 | −20.6 (0.8) | −9.1 (0.9) | −11.5 (−13.5, −9.5) |
p-value | 0.008 | 0.97 | 0.035 | |
| ||||
No Lifting at Work | 324 | −20.9 (0.9) | −8.3 (1.1) | −12.5 (−14.9, −10.1) |
Lifting at Work | 307 | −18.1 (1) | −9.5 (1.1) | −8.5 (−11, −6) |
p-value | 0.039 | 0.46 | 0.017 | |
| ||||
Any Neurological Deficit | 349 | −21 (0.9) | −7.7 (1.1) | −13.3 (−15.5, −11) |
No Neurological Deficit | 285 | −18 (1) | −10.8 (1.2) | −7.2 (−9.8, −4.6) |
p-value | 0.037 | 0.058 | <0.001 |
Adjusted for center, age, gender, baseline ODI score, income, treatment preference, duration of symptoms, compensation, smoking status, BMI, baseline Stenosis Bothersomeness, joint, stomach and bowel problems.
Treatment effect is the difference between the surgical and non-operative mean change from baseline. Analysis is done using a mixed model with a random subject intercept term. Treatment is a time-varying covariate where a patients’ experience prior to surgery is attributed to the non-operative arm and time is measured from enrollment and his/her post-surgery outcomes are attributed to the surgical arm and time is measured from time of surgery.