Table 3

Multivariable linear mixed models to predict changes in skin severity according to 9 different measures

Sequential change of skin severity measures/Contrast in clinician or patient perception of skin changeClinician
Patient
Estimate (95% CI)PEstimate (95% CI)P
NIH response erythema*scale     
    Improve vs stable −10.49 (−14 ∼ −6.97) < .001 −5.58 (−9.81 ∼ −1.36) .01 
    Worsen vs stable 6.42 (0.48 ∼ 12.36) .03 6.17 (−2.26 ∼ 14.59) .15 
NIH response movable sclerosis scale     
    Improve vs stable −2.07 (−3.82 ∼ −0.31) .02 −0.8 (−2.72 ∼ 1.12) .41 
    Worsen vs stable 1.35 (−1.62 ∼ 4.32) .37 −1.36 (−5.18 ∼ 2.47) .49 
NIH response nonmovable sclerosis scale     
    Improve vs stable −0.44 (−1.62 ∼ 0.74) .47 0.05 (−1.2 ∼ 1.31) .93 
    Worsen vs stable 5.13 (3.14 ∼ 7.12) < .001 1.95 (−0.56 ∼ 4.46) .13 
Vienna Total Score15      
    Improve vs stable −1.63 (−2.21 ∼ −1.05) < .001 −0.55 (−1.24 ∼ 0.13) .11 
    Worsen vs stable 1.8 (0.82 ∼ 2.78) < .001 1.16 (−0.21 ∼ 2.53) .10 
Hopkins sclerotic scale     
    Improve vs stable −0.14 (−0.29 ∼ 0.01) .07 −0.09 (−0.26 ∼ 0.07) .27 
    Worsen vs stable 0.4 (0.15 ∼ 0.65) .002 0.26 (−0.08 ∼ 0.59) .13 
Hopkins fascia scale     
    Improve vs stable −0.15 (−0.26 ∼ −0.03) .01 −0.1 (−0.22 ∼ 0.02) .09 
    Worsen vs stable 0.09 (−0.1 ∼ 0.27) .36 0.04 (−0.2 ∼ 0.28) .73 
Skin itching     
    Improve vs stable −0.3 (−0.85 ∼ 0.25) .28 −0.53 (−1.06 ∼ −0.01) .05 
    Worsen vs stable 0.81 (−0.11 ∼ 1.73) .08 2.88 (1.82 ∼ 3.94) < .001 
NIH composite 0-3 score     
    Improve vs stable −0.74 (−0.93 ∼ −0.56) < .001 −0.36 (−0.58 ∼ −0.14) .002 
    Worsen vs stable 0.78 (0.46 ∼ 1.09) < .001 0.79 (0.35 ∼ 1.24) < .001 
Skin subscale, Lee Symptom Scale16      
    Improve vs stable −11.9 (−16.05 ∼ −7.76) < .001 −8.75 (−12.7 ∼ −4.79) < .001 
    Worsen vs stable 9.89 (2.84 ∼ 16.93) .006 28.91 (20.64 ∼ 37.18) < .001 
Sequential change of skin severity measures/Contrast in clinician or patient perception of skin changeClinician
Patient
Estimate (95% CI)PEstimate (95% CI)P
NIH response erythema*scale     
    Improve vs stable −10.49 (−14 ∼ −6.97) < .001 −5.58 (−9.81 ∼ −1.36) .01 
    Worsen vs stable 6.42 (0.48 ∼ 12.36) .03 6.17 (−2.26 ∼ 14.59) .15 
NIH response movable sclerosis scale     
    Improve vs stable −2.07 (−3.82 ∼ −0.31) .02 −0.8 (−2.72 ∼ 1.12) .41 
    Worsen vs stable 1.35 (−1.62 ∼ 4.32) .37 −1.36 (−5.18 ∼ 2.47) .49 
NIH response nonmovable sclerosis scale     
    Improve vs stable −0.44 (−1.62 ∼ 0.74) .47 0.05 (−1.2 ∼ 1.31) .93 
    Worsen vs stable 5.13 (3.14 ∼ 7.12) < .001 1.95 (−0.56 ∼ 4.46) .13 
Vienna Total Score15      
    Improve vs stable −1.63 (−2.21 ∼ −1.05) < .001 −0.55 (−1.24 ∼ 0.13) .11 
    Worsen vs stable 1.8 (0.82 ∼ 2.78) < .001 1.16 (−0.21 ∼ 2.53) .10 
Hopkins sclerotic scale     
    Improve vs stable −0.14 (−0.29 ∼ 0.01) .07 −0.09 (−0.26 ∼ 0.07) .27 
    Worsen vs stable 0.4 (0.15 ∼ 0.65) .002 0.26 (−0.08 ∼ 0.59) .13 
Hopkins fascia scale     
    Improve vs stable −0.15 (−0.26 ∼ −0.03) .01 −0.1 (−0.22 ∼ 0.02) .09 
    Worsen vs stable 0.09 (−0.1 ∼ 0.27) .36 0.04 (−0.2 ∼ 0.28) .73 
Skin itching     
    Improve vs stable −0.3 (−0.85 ∼ 0.25) .28 −0.53 (−1.06 ∼ −0.01) .05 
    Worsen vs stable 0.81 (−0.11 ∼ 1.73) .08 2.88 (1.82 ∼ 3.94) < .001 
NIH composite 0-3 score     
    Improve vs stable −0.74 (−0.93 ∼ −0.56) < .001 −0.36 (−0.58 ∼ −0.14) .002 
    Worsen vs stable 0.78 (0.46 ∼ 1.09) < .001 0.79 (0.35 ∼ 1.24) < .001 
Skin subscale, Lee Symptom Scale16      
    Improve vs stable −11.9 (−16.05 ∼ −7.76) < .001 −8.75 (−12.7 ∼ −4.79) < .001 
    Worsen vs stable 9.89 (2.84 ∼ 16.93) .006 28.91 (20.64 ∼ 37.18) < .001 

The linear mixed models were used to predict clinician or patient-reported change in skin involvement according to sequential changes in skin severity by 9 different measures (P ≤ .01 in bold). Each model includes one sequential change measure as the outcome, one perceived change measure as the covariate of interest, and controls for study site and for factors related to perceived change (Karnofsky performance status, case type, and months from HCT to enrollment).

NIH indicates National Institutes of Health; CI, confidence interval; and HCT, hematopoietic cell transplantation.

*

Includes any cutaneous manifestations other than sclerosis and fasciitis.

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