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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 categoryResponse typeNumberLS mean change in HDISS-DU score (SE)Overall F test valuep valueEffect size
Patient-reported severity score18.04< 0.0001 
 − 6Improvement1− 1.86 (0.72)  N/A
 − 5Improvement5− 1.41 (0.32)  − 1.3
 − 4Improvement14− 0.94 (0.19)  − 0.9
 − 3Improvement52− 0.66 (0.10)  − 0.6
 − 2Improvement73− 0.59 (0.08)  − 0.5
 − 1Improvement114− 0.22 (0.07)  − 0.2
 0No change107− 0.03 (0.07)  0.0
 1Deterioration410.33 (0.11)  0.3
 2Deterioration70.36 (0.27)  0.5
 3Deterioration30.87 (0.42)  0.7
 4Deterioration20.59 (0.51)  5.1
 5DeteriorationN/AN/A  N/A
Physician-reported severity score13.99< 0.0001 
 − 6Improvement2− 0.66 (0.53)  − 2.2
 − 5Improvement10.18 (0.75)  N/A
 − 4Improvement9− 0.99 (0.25)  − 1.1
 − 3Improvement46− 0.56 (0.11)  − 0.5
 − 2Improvement90− 0.47 (0.08)  − 0.4
 − 1Improvement124− 0.30 (0.07)  − 0.3
 0No change129− 0.02 (0.07)  − 0.0
 1Deterioration250.11 (0.15)  0.2
 2Deterioration71.09 (0.28)  0.8
 3Deterioration20.63 (0.53)  0.6
 4DeteriorationN/AN/A  N/A
 5Deterioration10.29 (0.75)  N/A
Patient-reported global change score28.25< 0.0001 
 1Deterioration70.58 (0.27)  0.4
 2Deterioration180.72 (0.17)  0.6
 3Deterioration330.18 (0.13)  0.2
 4No change780.02 (0.08)  0.0
 5Improvement111− 0.25 (0.07)  − 0.3
 6Improvement132− 0.53 (0.06)  − 0.5
 7Improvement40− 0.86 (0.11)  − 0.8
Physician-reported global change score23.56< 0.0001 
 1Deterioration31.18 (0.43)  6.3
 2Deterioration210.55 (0.16)  0.4
 3Deterioration400.10 (0.12)  0.2
 4No change65− 0.08 (0.09)  − 0.0
 5Improvement122− 0.17 (0.07)  − 0.2
 6Improvement13− 0.49 (0.07)  − 0.4
 7Improvement55− 0.63 (0.10)  − 0.7
Responder status79.22< 0.0001 
 ResponderImprovement169− 0.65 (0.06)  − 0.6
 Non-responder§No change2510.01 (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]