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Table 4 HDISS-DU score responsiveness

From: Psychometric validation of the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU®) patient-reported outcome instrument

Response category

Response type

Number

LS mean change in HDISS-DU score (SE)

Overall F test value

p value

Effect size

Patient-reported severity score

18.04

< 0.0001

 

 − 6

Improvement

1

− 1.86 (0.72)

  

N/A

 − 5

Improvement

5

− 1.41 (0.32)

  

− 1.3

 − 4

Improvement

14

− 0.94 (0.19)

  

− 0.9

 − 3

Improvement

52

− 0.66 (0.10)

  

− 0.6

 − 2

Improvement

73

− 0.59 (0.08)

  

− 0.5

 − 1

Improvement

114

− 0.22 (0.07)

  

− 0.2

 0

No change

107

− 0.03 (0.07)

  

0.0

 1

Deterioration

41

0.33 (0.11)

  

0.3

 2

Deterioration

7

0.36 (0.27)

  

0.5

 3

Deterioration

3

0.87 (0.42)

  

0.7

 4

Deterioration

2

0.59 (0.51)

  

5.1

 5

Deterioration

N/A

N/A

  

N/A

Physician-reported severity score

13.99

< 0.0001

 

 − 6

Improvement

2

− 0.66 (0.53)

  

− 2.2

 − 5

Improvement

1

0.18 (0.75)

  

N/A

 − 4

Improvement

9

− 0.99 (0.25)

  

− 1.1

 − 3

Improvement

46

− 0.56 (0.11)

  

− 0.5

 − 2

Improvement

90

− 0.47 (0.08)

  

− 0.4

 − 1

Improvement

124

− 0.30 (0.07)

  

− 0.3

 0

No change

129

− 0.02 (0.07)

  

− 0.0

 1

Deterioration

25

0.11 (0.15)

  

0.2

 2

Deterioration

7

1.09 (0.28)

  

0.8

 3

Deterioration

2

0.63 (0.53)

  

0.6

 4

Deterioration

N/A

N/A

  

N/A

 5

Deterioration

1

0.29 (0.75)

  

N/A

Patient-reported global change score

28.25

< 0.0001

 

 1

Deterioration

7

0.58 (0.27)

  

0.4

 2

Deterioration

18

0.72 (0.17)

  

0.6

 3

Deterioration

33

0.18 (0.13)

  

0.2

 4

No change

78

0.02 (0.08)

  

0.0

 5

Improvement

111

− 0.25 (0.07)

  

− 0.3

 6

Improvement

132

− 0.53 (0.06)

  

− 0.5

 7

Improvement

40

− 0.86 (0.11)

  

− 0.8

Physician-reported global change score

23.56

< 0.0001

 

 1

Deterioration

3

1.18 (0.43)

  

6.3

 2

Deterioration

21

0.55 (0.16)

  

0.4

 3

Deterioration

40

0.10 (0.12)

  

0.2

 4

No change

65

− 0.08 (0.09)

  

− 0.0

 5

Improvement

122

− 0.17 (0.07)

  

− 0.2

 6

Improvement

13

− 0.49 (0.07)

  

− 0.4

 7

Improvement

55

− 0.63 (0.10)

  

− 0.7

Responder status

79.22

< 0.0001

 

 Responder

Improvement

169

− 0.65 (0.06)

  

− 0.6

 Non-responder§

No change

251

0.01 (0.05)

  

0.0

  1. Change from baseline to week 16 in HDISS-DU score was assessed by ANCOVA, controlling for baseline HDISS-DU score, by week 16 response for the global assessments and responder status (based on the 16-week change on the global pain scale). The effect size was calculated by subtracting the baseline scores from week 16 scores and dividing by the baseline score standard deviation
  2. ANCOVA analysis of covariance, HDISS-DU Hand Disability in Systemic Sclerosis-Digital Ulcers, n number of participants, SE standard error
  3. A negative mean change in HDISS-DU score indicates an improvement
  4. Defined as ≥ 3 point decrease in the score [24]
  5. §Defined as < 3 point decrease in the score [24]