Table 4.
HDISS-DU score responsiveness
| 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 | ||
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
ANCOVA analysis of covariance, HDISS-DU Hand Disability in Systemic Sclerosis-Digital Ulcers, n number of participants, SE standard error
†A negative mean change in HDISS-DU score indicates an improvement
‡Defined as ≥ 3 point decrease in the score [24]
§Defined as < 3 point decrease in the score [24]