Table 1 Characteristics of participants in the STOP GAP trial
From: Investigating the effect of independent, blinded digital image assessment on the STOP GAP trial
Blinded measurements useda | Unblinded measurements used | |||
|---|---|---|---|---|
Characteristic | Ciclosporin (n = 45) | Prednisolone (n = 41) | Ciclosporin (n = 12) | Prednisolone (n = 10) |
Age at randomisation (years) | ||||
Mean [SD] | 57.4 [16.5] | 52.6 [14.6] | 55.4 [20.0] | 47.7 [16.4] |
Gender | ||||
Male | 14 (31%) | 18 (44%) | 3 (25%) | 3 (30%) |
Female | 31 (69%) | 23 (56%) | 9 (75%) | 7 (70%) |
Ethnicity | ||||
White | 42 (93%) | 41 (100%) | 11 (92%) | 10 (100%) |
Non-White | 3 (7%) | 0 (0%) | 1 (8%) | 0 (0%) |
Type of pyoderma gangrenosum | ||||
Classical | 40 (89%) | 35 (85%) | 8 (67%) | 10 (100%) |
Cribriform | 2 (4%) | 2 (5%) | 2 (17%) | 0 (0%) |
Peristomal | 2 (4%) | 2 (5%) | 0 (0%) | 0 (0%) |
Bullous | 0 (0%) | 1 (2%) | 0 (0%) | 0 (0%) |
Unsure | 1 (2%) | 1 (2%) | 2 (17%) | 0 (0%) |
Location of lesion | ||||
Arm | 2 (4%) | 1 (2%) | 0 (0%) | 0 (0%) |
Leg | 31 (69%) | 24 (59%) | 8 (67%) | 8 (80%) |
Other | 12 (27%) | 16 (39%) | 4 (33%) | 2 (20%) |
Blinded measurements available at baseline | ||||
One assessor’s measurement available | 20 (44%) | 18 (44%) | 0 (0%) | 2 (20%) |
Both assessors’ measurements available | 25 (56%) | 23 (56%) | 1 (8%) | 2 (20%) |
Neither assessors’ measurements available | – | – | 11 (92%) | 6 (60%) |
Blinded measurements available at 6 weeks | ||||
One assessor’s measurement available | 28 (62%) | 19 (46%) | 2 (17%) | 1 (10%) |
Both assessors’ measurements available | 17 (38%) | 22 (54%) | 1 (8%) | 0 (0%) |
Neither assessors’ measurements available | – | – | 9 (75%) | 9 (90%) |
Time from baseline visit to ‘6-week’b follow-up visit (days) | ||||
Median (IQR) | 46 (42, 49) | 42 (42, 47) | 49 (44, 51) | 44 (41, 49) |
(Min, Max) | (23, 59) | (19, 54) | (42, 80) | (40, 71) |