Table 1.
Responsiveness by Retrospective Global Pain of Changea
| CAMEO Trial | SPACE Trial | SSM Trial | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pain change | MeanS RM | Scoreb change | SRMc | (95% CI) | P-valued | Scoreb change | SRMc | (95% CI) | P-valued | Scoreb change | SRMc | (95% CI) | P-valued |
| PROMIS 4a | <.0001 | <.0001 | <.0001 | ||||||||||
| • Better | .63 | 4.52 | .60 | (.40,.81) | .003 | 6.84 | 1.10 | (.93,1.13) | .0002 | 1.92 | .20 | (01,.40) | .94 |
| • Same | .34 | 1.10 | .23 | (−.01,.46) | -- | 3.27 | .62 | (.37,.90) | -- | 1.47 | .17 | (−.03,.36) | -- |
| • Worse | −.30 | −1.52 | −.25 | (−.53,.01) | .066 | 0.21 | .08 | (−.35,.59) | .089 | −6.11 | −.70 | (−.99,−.43) | <.0001 |
| PROMIS 6a | <.0001 | <.0001 | <.0001 | ||||||||||
| • Better | .61 | 4.66 | .60 | (.39,.83) | .003 | 6.92 | 1.06 | (.92,12) | <.0001 | 1.68 | .17 | (−.02,.36) | .99 |
| • Same | .32 | 1.13 | .22 | (−01,.44) | -- | 3.05 | .58 | (.31,.88) | -- | 1.50 | .17 | (−.03,.36) | -- |
| • Worse | −.30 | −1.45 | −.24 | (−.53,.02) | .082 | −0.07 | −.01 | (−.46,.43) | .094 | −5.81 | −.65 | (−.92,−.39) | .0001 |
| PROMIS 8a | <.0001 | <.0001 | <.0001 | ||||||||||
| • Better | .60 | 4.17 | .55 | (.35,.79) | .012 | 6.69 | 1.07 | (.92,1.25) | .0002 | 1.72 | .18 | (−.01,.37) | .98 |
| • Same | .34 | 1.15 | .22 | (−.01,.44) | -- | 3.17 | .63 | (.36,.95) | 1.44 | .16 | (−.03,.36) | -- | |
| • Worse | −.25 | −1.71 | −.28 | (−.57,−.01) | .042 | 0.63 | .16 | (−.27,.65) | .182 | −5.54 | −.63 | (−.87,−.39) | .0002 |
| PROMIS 6b | <.0001 | <.0001 | <.0001 | ||||||||||
| • Better | .62 | 4.45 | .66 | (.46,87) | .0006 | 6.02 | 1.06 | (.92,1.22) | .0002 | 1.36 | .14 | (−.06,.33) | .96 |
| • Same | .30 | 0.88 | .17 | (−.06,.39) | -- | 2.67 | .53 | (.30,.77) | -- | 1.71 | .20 | (−.01,.39) | -- |
| • Worse | −.28 | −1.10 | −.20 | (−.46,.06) | .159 | −0.06 | .01 | (−.40,.53) | .103 | −5.93 | −.66 | (−.91,−.42) | <.0001 |
| PROMIS average | |||||||||||||
| • Better | .62 | .60 | 1.07 | .17 | |||||||||
| • Same | .33 | .21 | .59 | .18 | |||||||||
| • Worse | −.28 | −.24 | .06 | −.66 | |||||||||
| BPI Interference | <.0001 | <.0001 | .024 | ||||||||||
| • Better | .71 | 1.77 | .76 | (.56,.97) | .0003 | 2.51 | 1.20 | (1.02,1.4) | <.0001 | 0.43 | .17 | (−.02,.36) | .999 |
| • Same | .32 | 0.51 | .35 | (.09,.61) | -- | 0.64 | .42 | (.18,.68) | -- | 0.41 | .19 | (−.01,.38) | -- |
| • Worse | −.18 | −0.45 | −.26 | (−.54,.00) | .019 | 0.32 | .23 | (−.21,.69) | .78 | −0.80 | −.25 | (−.56,.06) | .033 |
| PEG | <.0001 | <.0001 | .034 | ||||||||||
| • Better | .79 | 1.67 | .77 | (.57,.99) | .0005 | 2.61 | 1.43 | (1.25,1.6) | <.0001 | 0.46 | .18 | (−.01,.37) | .994 |
| • Same | .36 | 0.53 | .31 | (.08,.54) | -- | 0.86 | .60 | (.35,.87) | -- | 0.42 | .18 | (−.02,.39) | -- |
| • Worse | −.13 | −0.34 | −.22 | (−.49,.04) | .028 | 0.14 | .09 | (−.34,.57) | .203 | −0.73 | −.25 | (−.57,.06) | .048 |
| SF Bodily Paind | <.0001 | ||||||||||||
| • Better | 8.13 | .47 | (.29,.66) | .838 | |||||||||
| • Same | 6.71 | .54 | (.29,.79) | -- | |||||||||
| • Worse | −3.50 | −.20 | (−.45,.04) | .001 | |||||||||
| Roland-Morrisd | <.0001 | ||||||||||||
| • Better | 2.90 | .56 | (.40,.73) | .019 | |||||||||
| • Same | 1.01 | .27 | (.05,.49) | -- | |||||||||
| • Worse | −0.84 | −.23 | (−.49,.02) | .048 | |||||||||
a
Total N (better, same, worse) with baseline and follow-up data in CAMEO = 234 (104, 68, 62); in SPACE = 222 (134, 66, 22); and in SSM = 238 (102, 96, 40)
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 three change groups. Other p values were derived from t-test comparing change scores between_reference (i.e. “same”) and changed (“better” or “worse”) groups and were adjusted for multiple comparison