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Table 6 Change in patient-reported outcome measures and musculoskeletal involvement by the MCID estimates for all participants and for diffuse cutaneous SSc

From: Minimal Clinically Important Differences for the Modified Rodnan Skin Score: Results from the Scleroderma Lung Studies (SLS-I and SLS-II)

 

Overall N

SF-36 PCS

SF-36 MCS

TDI

Joint contracturesb

Tendon friction rubsb

N

Mean difference

p valuea

N

Mean difference

p valuea

N

Mean difference

p valuea

N

N (% improved)

p value

N

N (% improved)

p value

Change in mRSS > 5 improvement in diffuse cutaneous SSc

 12 months

  Change ≥ − 5 (no change/worsening group)

82

62

0.59 (8.35)

Ref.

62

1.79 (11.52)

Ref.

76

0.32 (2.90)

Ref.

53

2 (4%)

0.01

12

9 (75%)

0.99

  Change <− 5 (improvement group)

64

54

3.62 (8.20)

0.05

54

3.05 (9.03)

0.52

59

1.85 (4.03)

0.01

40

9 (23%)

 

12

9 (75%)

 

Change in mRSS > 3 improvement in all participants

 12 months

  Change ≥ − 3 (no change/worsening group)

143

102

−0.01 (8.59)

Ref.

102

0.90 (11.67)

Ref.

132

0.04 (3.53)

Ref.

61

7 (12%)

0.3

8

5 (63%)

0.33

  Change <− 3 (improvement group)

101

101

2.66 (8.11)

0.03

85

3.27 (8.84)

0.12

92

1.34 (3.72)

0.01

56

10 (18%)

 

18

15 (83%)

 

Change in mRSS > 4 improvement in all participants

 12 months

  Change ≥ − 4 (no change/worsening group)

159

115

0.05 (8.41)

Ref.

115

1.37 (11.36)

Ref.

144

0.03 (3.41)

Ref.

68

7 (10%)

0.1

12

9 (75%)

0.99

  Change <− 4 (improvement group)

85

72

3.06 (8.26)

0.02

72

2.93 (9.00)

0.33

80

1.55 (3.90)

0.01

49

10 (20%)

 

14

11 (79%)

 
  1. MCID minimal clinically important difference, mRSS modified Rodnan Skin Score, Ref. reference, SF-36 MCS Short Form-36 Mental Component Summary, SF-36 PCS Short Form-36 Physical Component Summary, SSc systemic sclerosis, TDI Transition Dyspnea Index
  2. at test of whether change is significantly different from “no change” group
  3. bAnalysis set for joint contractures and tendon friction rubs includes only participants with present joint contractures (small or large) or tendon friction rubs at baseline. Only participants with data at both baseline and 12 months are included. Chi-square tests (or Fisher’s exact tests where appropriate) were used to compare percentage of participants who improved by MCID group