Table 6.
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.
| IDH | Patient follow-up status | Surgical | Non-operative | Treatment Effect† (95% CI) |
|---|---|---|---|---|
| SF-36 Bodily Pain (BP) (SE)†† | Currently in study | 43.8 (0.7) | 31.2 (0.9) | 12.6 (10.4, 14.8) |
| Lost to follow-up | 38.8 (1.2) | 27.4 (1.6) | 11.4 (7.7, 15.1) | |
|
| ||||
| p-value | <0.001 | 0.036 | 0.55 | |
|
| ||||
| SF-36 Physical Function (PF) (SE)†† | Currently in study | 40.9 (0.7) | 28.1 (0.9) | 12.8 (10.8, 14.9) |
| Lost to follow-up | 37 (1.1) | 25 (1.5) | 12 (8.6, 15.4) | |
|
| ||||
| p-value | 0.003 | 0.071 | 0.65 | |
|
| ||||
| Oswestry Disability Index (ODI) (SE)‡ | Currently in study | −35.7 (0.6) | −23.1 (0.7) | −12.7 (−14.3, −11) |
| Lost to follow-up | −31 (1) | −20.9 (1.3) | −10.1 (−13, −7.3) | |
|
| ||||
| p-value | <0.001 | 0.13 | 0.11 | |
|
| ||||
| Sciatica Bothersomeness Index (SE)§ | Currently in study | −8.8 (0.2) | −6.6 (0.2) | −2.2 (−2.7, −1.6) |
| Lost to follow-up | −8.4 (0.3) | −5.5 (0.4) | −3 (−3.8, −2.1) | |
|
| ||||
| p-value | 0.24 | 0.004 | 0.10 | |
Adjusted for age, gender, race, marital status, compensation, smoking status, herniation location, working status, stomach comorbidity, depression, diabetes, other** comorbidity, self-rated health trend, duration of most recent episode, treatment preference, baseline score (for SF-36, ODI, and Sciatica Bothersomeness Index), 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 Sciatica Bothersomeness index range from 0 to 24, with lower scores indicating less severe symptoms.