Table 3.
Time-weighted average of treatment effects at 2 years (AUC) from adjusted* as-treated randomized and observational cohorts combined primary outcome analysis, according to treatment received and patient follow-up status.
DS | Patient follow-up status | Surgical | Non- operative |
Treatment Effect† (95% CI) |
---|---|---|---|---|
SF-36 Bodily Pain (BP) (SE)†† | Currently in study | 30.8 (1) | 13.1 (1.2) | 17.7 (15.1, 20.3) |
Lost to follow-up | 25.1 (1.3) | 14.1 (1.4) | 11.1 (7.8, 14.4) | |
p-value | <0.001 | 0.60 | 0.002 | |
| ||||
SF-36 Physical Function (PF) (SE)†† | Currently in study | 24.8 (1) | 10.4 (1.2) | 14.4 (11.9, 16.9) |
Lost to follow-up | 20.6 (1.3) | 9.7 (1.4) | 10.8 (7.7, 14) | |
p-value | 0.01 | 0.71 | 0.074 | |
| ||||
Oswestry Disability Index (ODI) (SE)‡ | Currently in study | −22.4 (0.8) | −7.8 (1) | −14.6 (−16.5, −12.6) |
Lost to follow-up | −20.1 (1) | −7.9 (1.1) | −12.2 (−14.7, −9.7) | |
p-value | 0.082 | 0.96 | 0.13 | |
| ||||
Stenosis Bothersomeness Index (SE)§ | Currently in study | −8 (0.3) | −2.8 (0.3) | −5.2 (−5.9, −4.5) |
Lost to follow-up | −6.9 (0.4) | −3.5 (0.4) | −3.4 (−4.3, −2.5) | |
p-value | 0.008 | 0.19 | 0.002 |
Adjusted for age, gender, race, work status, depression, BMI, any neurofroamen L or R, joint problem, stomach problem, reflex deficit, number of moderate/severe stenotic levels, other** comorbidity, baseline stenosis bothersomeness, baseline score (for SF-36 and ODI), and center.
Treatment effect is the difference between the surgical and non-operative mean change from baseline.
The SF-36 scores range from 0 to 100, with higher score indicating less severe symptoms.
The Oswestry Disability Index ranges from 0 to 100, with lower scores indicating less severe symptoms.
The Stenosis Bothersomeness index range from 0 to 24, with lower scores indicating less severe symptoms.
Other comorbidities include: stroke, cancer, fibromyalgia, chronic fatigue syndrome (CFS), post-traumatic stress disorder (PTSD), alcohol, drug dependency, lung, liver, kidney, blood vessel, nervous system, migraine, anxiety.