Table 8.
Known-groups validity: ANOVA models of SAT scores by global assessment levels at week 12 (pooled dataset; N = 698)1.
| SAT at Week 12 | ||||||||
|---|---|---|---|---|---|---|---|---|
| n | (1) Pain relief | (2) Activity level | (3) Quality of life | (4) Undergo treatment again | (5) Compared to previous treatment | 3-Item SAT treatment effect subscale | 2-Item SAT treatment satisfaction subscale | |
| PGIC, LS mean (SE) | ||||||||
| Very much improved | 103 | 1.9 (0.0) | 1.4 (0.1) | 1.7 (0.1) | 1.7 (0.1) | 1.7 (0.1) | 5.0 (0.1) | 3.5 (0.2) |
| Much improved | 115 | 1.4 (0.0) | 0.8 (0.1) | 1.0 (0.0) | 1.6 (0.1) | 1.1 (0.1) | 3.3 (0.1) | 2.7 (0.1) |
| Slightly improved | 159 | 0.8 (0.0) | 0.3 (0.0) | 0.5 (0.0) | 1.1 (0.1) | 0.5 (0.1) | 1.6 (0.1) | 1.6 (0.1) |
| No change | 275 | 0.0 (0.0) | 0.0 (0.0) | 0.0 (0.0) | 0.6 (0.1) | 0.0 (0.1) | −0.1 (0.1) | 0.6 (0.1) |
| Slightly worse | 31 | −0.7 (0.1) | −0.3 (0.1) | −0.1 (0.1) | 0.0 (0.2) | −0.2 (0.2) | −1.1 (0.2) | −0.2 (0.3) |
| Much worse2 | 14 | −1.2 (0.1) | −0.9 (0.2) | −0.9 (0.1) | −0.9 (0.3) | −1.1 (0.2) | −3.0 (0.3) | −2.0 (0.4) |
| P-value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |
|
| ||||||||
| CGIC3, LS mean (SE) | ||||||||
| Very much improved | 63 | 1.9 (0.1) | 1.4 (0.1) | 1.7 (0.1) | 1.7 (0.1) | 1.7 (0.1) | 5.0 (0.2) | 3.5 (0.2) |
| Much improved | 56 | 1.4 (0.1) | 0.7 (0.1) | 1.0 (0.1) | 1.3 (0.1) | 1.1 (0.1) | 3.0 (0.2) | 2.4 (0.2) |
| Slightly improved | 78 | 0.7 (0.1) | 0.3 (0.1) | 0.5 (0.1) | 0.9 (0.1) | 0.4 (0.1) | 1.5 (0.2) | 1.3 (0.2) |
| No change | 140 | −0.1 (0.0) | −0.1 (0.1) | −0.1 (0.0) | 0.3 (0.1) | −0.2 (0.1) | −0.3 (0.1) | 0.1 (0.1) |
| Slightly worse | 10 | −0.1 (0.2) | 0.1 (0.2) | 0.2 (0.2) | −0.2 (0.3) | −0.1 (0.3) | 0.2 (0.4) | −0.3 (0.5) |
| Much worse2 | 2 | −1.5 (0.4) | −0.5 (0.5) | −0.5 (0.4) | −1.5 (0.7) | −0.5 (0.7) | −2.5 (1.0) | −2.0 (1.1) |
| P-value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |
ANOVA: analysis of variance; CGIC: Clinician Global Impression of Change; LS: least-squares; PGIC: Patient Global Impression of Change; SAT: Self-Assessment of Treatment; SE: standard error.
1Known-groups validity was assessed using ANOVA to evaluate whether SAT items and subscale scores discriminated between patient groups based on different amounts of patient- and clinician-reported change at Week 12. Pooled dataset included data from two clinical trials, Studies C116 (N = 349) and C117 (N = 349).
2PGIC and CGIC responses of “Very much worse” and “Much worse” were combined due to small sample sizes.
3Study C117 only.