Anchor measures
stoma, ’
EROSION, COMPLICATIONS
For the psychometric evaluation, five anchor measures were included. After review of the literature for gold standard measures to use as anchor measures, it was deemed there were none that were appropriate for use. As such, new items were developed in line with US FDA guidance (For the PGIS anchor, subjects were initially asked whether they had “any skin complications around your stoma today” (Yes/No). If patients answered ‘Yes’, they were then asked to “describe the skin complications around your stoma today”, using a five-point Likert-type scale, with options of ‘very mild’, ‘mild’, ‘moderate’, ‘severe’, and ‘very severe’. These responses were coded from ‘1- very mild’ to ‘5- very severe’ (0 if ‘No’ to the first question). This was asked at both visits.For the PGIC anchor, subjects were asked “Compared to the beginning of this test period, how have any skin complications around your stoma changed”. Response options used a seven-point Likert-type scale ranging from ‘1 = very much improved, 2 = much improved, 3 = a little improved, 4 = no change, 5 = a little worse, 6 = much worse, 7 = very much worse’. This question was completed at Visit 2 only.For the CGIS anchor, three versions of the anchor were included. These questions asked about the subject’s overall PSCs, erosion, and discoloration. Firstly, “Does the subject have any PSCs on the peristomal skin today?” (Yes/No). Secondly, “If yes, overall, how would you describe the severity of the subject’s PSCs on the peristomal skin today?” (very severe, severe, moderate, mild, very mild). The responses were coded from ‘1- very mild’ to ‘5- very severe’ (0 if ‘No’ to the first question). This was asked at both visits.Similarly, there were three CGIC questions asking about changes in the subject’s PSCs. Response options used a seven-point Likert scale ranging from ‘1 = very much improved, 2 = much improved, 3 = a little improved, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse’. This was asked at Visit 2 only.The DET score as an anchor measure was calculated by summing all scores given, which resulted in a range of scores from 0 to 15, where higher scores represented more severe symptoms.