Table 11.

Concurrent validity: ANOVA models of BPI change scores by SAT scores at Week 12 (pooled dataset; N = 698)¹.

SAT		BPI change scores at Week 12
		Pain at its worst in last 24 hours			Pain at its least in the last 24 hours
		N	LS mean (SE)	P-value	N	LS mean (SE)	P-value
(1) How do you assess your pain level after treatment in this study?	Better	340	−3.6 (0.1)	<0.0001	340	−1.3 (0.1)	<0.0001
	No change	309	−0.8 (0.1)	309	0.7 (0.1)
	Worse	47	0.5 (0.3)	47	1.3 (0.3)
(2) How do you assess your activity level after treatment in this study?	Better	210	−4.1 (0.2)	<0.0001	210	−1.5 (0.1)	<0.0001
	No change	451	−1.3 (0.1)	451	0.3 (0.1)
	Worse	35	0.2 (0.4)	35	(0.4)
(3) How has your quality of life changed after treatment in this study?	Better	266	−3.8 (0.1)	<0.0001	266	−1.4 (0.1)	<0.0001
	No change	408	−1.1 (0.1)	408	0.5 (0.1)
	Worse	22	0.3 (0.5)	22	(0.4)
(4) Would you undergo this treatment again?	Better	450	−2.6 (0.1)	<0.0001	450	−0.6 (0.1)	<0.0001
	No change	173	−1.1 (0.2)	173	0.5 (0.2)
	Worse	73	−0.9 (0.3)	73	(0.3)
(5) How do you compare the treatment you received in this study to previous medication or therapies for your pain?	Better	295	−3.3 (0.1)	<0.0001	295	−1.1 (0.1)	<0.0001
	No change	312	−1.3 (0.1)	312	0.4 (0.1)
	Worse	89	−1.0 (0.3)	89	0.3 (0.2)
SAT treatment effect subscale (Items 1, 2, and 3)	Better	358	−3.5 (0.1)	<0.0001	358	−1.2 (0.1)	<0.0001
	No change	279	−0.8 (0.1)	279	0.7 (0.1)
	Worse	59	0.4 (0.3)	59	1.2 (0.3)
SAT treatment satisfaction subscale (Items 4 and 5)	Better	447	−2.7 (0.1)	<0.0001	447	−0.6 (0.1)	<0.0001
	No change	141	−1.0 (0.2)	141	0.6 (0.2)
	Worse	108	−0.9 (0.3)	108	0.5 (0.2)

ANOVA: analysis of variance; BPI: Brief Pain Inventory; LS: least-squares; SAT: Self-Assessment of Treatment; SE: standard error.

¹Concurrent validity was evaluated using ANOVA to compare BPI changes in pain by SAT response levels (patients improved; no change; worsened). Pooled dataset included data from two clinical trials, Studies C116 (N = 349) and C117 (N = 349).