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Table 2 Responsiveness of depression measures by prospective global rating of change for mood

From: Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials

Depression change

Mean SRM

CAMEO

SPACE

SSM

Score change*

SRM†

(95% CI)

P‡

Score change*

SRM†

(95% CI)

P‡

Score change*

SRM†

(95% CI)

P‡

PROMIS 4-item

    

.008

   

 < .0001

   

 < .0001

 Better

.54

3.58

.48

(.23, .75)

.019

5.12

.59

(.38, .81)

 < .0001

4.81

.56

(.32, .82)

.005

 Same

.10

− 0.17

− .02

(− .27, .25)

–

 − 0.14

− .02

(− .21, .17)

–

1.41

.27

(.10, .44)

–

 Worse

− .27

− 1.09

− .12

(− .55, .32)

.87

 − 3.38

− .55

(− .95, − .19)

.122

− 1.55

− .16

 

.072

PROMIS 6-item

    

.008

   

 < .0001

   

 < .0001

 Better

.58

4.13

.54

(.29, .80)

.039

5.85

.64

(.42, .87)

 < .0001

5.17

.55

(.33, .79)

.003

 Same

.13

0.72

.13

(− .14, .41)

–

0.16

.03

(− .16, .21)

–

1.35

.23

(.06, .41)

–

 Worse

− .28

− 1.03

− .11

(− .54, .33)

.61

 − 2.95

− .52

(− .94, − .12)

.186

− 1.94

− .21

(− .53, .12)

.055

PROMIS 8-item

    

.007

   

< .0001

   

< .0001

 Better

.59

4.22

.56

(.31, .83)

.037

5.93

.65

(.43, .88)

< .0001

5.16

.55

(.33, .79)

.002

 Same

.14

0.76

.13

(− .13, .39)

–

0.19

.03

(− .15, .21)

–

1.39

.26

(.09, .44)

–

 Worse

− .27

− 1.00

− .11

(− .54, .34)

.61

− 3.12

− .53

(− .95, − .14)

.141

− 1.56

− .17

(− .48, .16)

.082

PROMIS SF

    

.009

   

< .0001

   

< .0001

 Better

.60

4.22

.56

(.31, .84)

.077

6.51

.70

(.47, .95)

< .0001

5.26

.54

(.31, .79)

.003

 Same

.16

1.10

.17

(− .09, .44)

–

0.45

.08

(− .11, .26)

–

1.33

.22

(.05, .39)

–

 Worse

− .33

− 1.35

− .14

(− .58, .30)

.40

− 3.57

− .65

(− 1.2, − .19)

.060

− 1.94

− .20

(− .51, .12)

.068

PROMIS average

             

 Better

.58

 

.54

   

.65

   

.55

  

 Same

.13

 

.10

   

.03

   

.25

  

 Worse

− .29

 

− .12

   

− .56

   

− .19

  

PHQ-9

    

.002

   

< .0001

   

.001

 Better

.63

3.56

.71

(.43, 1.0)

.026

2.52

.67

(.48, .87)

.002

3.23

.51

(.27, .76)

.014

 Same

.24

1.07

.25

(− .02, .56)

–

0.69

.20

(.02, .40)

–

1.13

.26

(.09, .43)

–

 Worse

− .18

− 0.73

− .13

(− .60, .31)

.34

− 1.45

− .33

(− .84, .10)

.039

− 0.30

− .07

(− .42, .26)

.28

PHQ-2

    

.163

   

 < .0001

   

.007

 Better

.53

0.78

.50

(.25, .75)

.44

0.93

.71

(.53, .89)

 < .0001

0.81

.39

(.14, .66)

.045

 Same

.16

0.39

.25

(.− .01, .51)

–

0.12

.11

(− .08, .33)

–

0.19

.13

(− .04, .30)

–

 Worse

− .24

0.00

− .01

(− .49, .41)

.63

− 0.48

− .33

(− .97, .14)

.143

− 0.24

− .12

(− .42, .22)

.38

SF-36 Mental

    

 < .0001

        

 Better

 

15.18

.71

(.50, .94)

 < .0001

        

 Same

 

− 0.22

− .02

(− .28, .25)

–

        

 Worse

 

 − 9.55

− .69

(− 1.5, − .17)

.076

        
  1. Total N (better, same, worse) with baseline and follow-up data in CAMEO = 135 (55, 58, 22); in SPACE = 223 (87, 114, 22); and in SSM = 239 (70, 131, 38)
  2. *Score change = baseline—follow-up (positive score indicates improvement, and negative score indicates worsening)
  3. †SRM = (baseline − follow-up)/SD change score;
  4. ‡Bolded p-values are from omnibus ANOVA tests comparing change scores among the three groups. Other p values were derived from pairwise comparisons of change scores between better vs. same, same vs. worse, and better vs. worse, and were adjusted for multiple comparisons using the Tukey–Kramer procedure. Since all better vs. worse pairwise comparisons were significant when the omnibus test was significant, only better vs. same and same vs. worse p-values are reported in this table
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