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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