Table 2.
Responsiveness by Prospective Global Pain of Changea
| CAMEO Trial | SPACE Trial | SSSM Trial | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pain change | MeanSRM | Scoreb change | SRMc | (95% CI) | P-valued | Scoreb change | SRMc | (95% CI) | P-valued | Scoreb change | SRMc | (95% CI) | P-valued |
| PROMIS-PI 4a | .0007 | <.0001 | <.0001 | ||||||||||
| • Better | .87 | 5.31 | .80 | (.44,1.2) | .111 | 8.11 | 1.22 | (0.98,1.5) | <.0001 | 5.64 | .60 | (.04,.80) | <.0001 |
| • Same | .40 | 2.57 | .36 | (.15,.57) | -- | 3.45 | .76 | (.59,.95) | -- | 0.47 | .08 | (−.12,.28) | -- |
| • Worse | −.52 | −2.39 | −.53 | (−.98,−.12) | .018 | −0.82 | −.17 | (−.73,.35) | .014 | −7.68 | −.86 | (−1.2,−.59) | <.0001 |
| PROMIS-PI 6a | .004 | <.0001 | <.0001 | ||||||||||
| • Better | .83 | 4.97 | .77 | (.35,1.3) | .277 | 8.06 | 1.15 | (.93,1.4) | <.0001 | 5.47 | .57 | (.38,.76) | .0003 |
| • Same | .39 | 2.83 | .38 | (.16,.60) | -- | 3.33 | .70 | (.52,.89) | -- | 0.61 | .10 | (−.10,.29) | -- |
| • Worse | −.50 | −1.95 | −.51 | (−.11,−.04) | .028 | −0.41 | −.10 | (−.74,.40) | .052 | −7.88 | −.88 | (−1.2,−.62) | <.0001 |
| PROMIS-PI 8a | .001 | <.0001 | <.0001 | ||||||||||
| • Better | .87 | 4.58 | .72 | (.34,1.1) | .287 | 7.81 | 1.19 | (.95,1.5) | <.0001 | 5.68 | .61 | (.43,.80) | <.0001 |
| • Same | .41 | 2.54 | .36 | (.14,.59) | -- | 3.49 | .77 | (.58,.97) | -- | 0.51 | .09 | (−.11,.28) | -- |
| • Worse | −.46 | −1.46 | −.40 | (−.92,.08) | .066 | −0.51 | −.13 | (−.76,.37) | .024 | −7.84 | −.86 | (−1.2,−.59) | <.0001 |
| PROMIS 6b | .006 | <.0001 | <.0001 | ||||||||||
| • Better | .82 | 4.75 | .69 | (.35,1.1) | .053 | 7.04 | 1.18 | (1.00,1.4) | <.0001 | 5.57 | .60 | (.42,.78 | .0003 |
| • Same | .36 | 1.84 | .30 | (.08,.52) | -- | 2.86 | .65 | (.47,.85) | -- | 0.71 | .12 | (−.08,.31) | -- |
| • Worse | −.40 | −0.74 | −.20 | (−.76,.29) | .26 | −0.41 | −.10 | (−.74,.39) | .056 | −8.51 | −.91 | (−1.2, −.66) | <.0001 |
| PROMIS average | |||||||||||||
| • Better | .85 | .75 | 1.19 | .60 | |||||||||
| • Same | .39 | .35 | .72 | .10 | |||||||||
| • Worse | −.47 | −.41 | −.13 | −.88 | |||||||||
| BPI Interference | <.0001 | <.0001 | <.0001 | ||||||||||
| • Better | .87 | 1.66 | .65 | (.35,.97) | .119 | 2.70 | 1.21 | (.99,1.4) | <.0001 | 1.81 | .75 | (.58,.93) | <.0001 |
| • Same | .50 | 0.89 | .58 | (.35,.83) | -- | 1.20 | .78 | (.58,.99) | -- | 0.19 | .13 | (−.07,.33) | -- |
| • Worse | −.50 | −1.06 | −.57 | (−1.2,−.09) | .0007 | −0.13 | −.12 | (−.83,.38) | .027 | −2.13 | −.82 | (−1.1,−.57) | <.0001 |
| PEG | <.0001 | <.0001 | <.0001 | ||||||||||
| • Better | 1.02 | 2.02 | .85 | (.60,1.1) | .0007 | 2.85 | 1.45 | (1.23,1.7) | <.0001 | 1.93 | .77 | (.59,.97) | <.0001 |
| • Same | .50 | 0.67 | .45 | (.24,.67) | -- | 1.30 | .94 | (.73,1.2) | -- | 0.15 | .10 | (−.09,.30) | -- |
| • Worse | −.60 | −1.22 | −.87 | (−1.6,−.34) | .0003 | −0.13 | −.07 | (−.62,.45) | .007 | −2.11 | −.87 | (−1.1,−.64) | <.0001 |
| SF Bodily Pain ∥ | .013 | ||||||||||||
| • Better | 10.18 | .50 | (.20,.80) | .296 | |||||||||
| • Same | 5.14 | .37 | (.12,.63) | -- | |||||||||
| • Worse | −4.44 | −.31 | (−1.1,.20) | .084 | |||||||||
| Roland-Morris∥ | .055 | ||||||||||||
| • Better | 2.18 | .49 | (.18,.83) | .138 | |||||||||
| • Same | 0.62 | .16 | (−.05,.38) | -- | |||||||||
| • Worse | −0.44 | −.10 | (−.59,.40) | .59 | |||||||||
a
Total N (better, same, worse) with baseline and follow-up data in CAMEO = 135 (38, 79, 18); in SPACE = 222 (94, 112, 16); and in SSM = 238 (83, 100, 55)
b
Score change = baseline - follow-up (positive score: improvement, negative score: worsening)
c
SRM = baseline – follow-up/SD change score
d
bolded P-values are from omnibus ANOVA tests comparing changes scores among 3global ratings of change groups. Other P-values are derived from t-test comparing change scores between reference (i.e. “same”) and changed (“better” or “worse”) groups and were adjusted for multiple comparison