Study design
COMPLICATION
Data for the psychometric validation study was obtained from a randomized controlled, open-label, comparative, cross-over, multicenter investigation (Clinical Trial ID: NCT04101318). This investigation was carried out in four countries including United Kingdom (UK), Germany, Italy, and Norway. Subjects were eligible for enrolment if they had a colostomy or ileostomy for at least three months, were at least 18 years old, were able to use an electronic diary (questionnaire), had liquid fecal output, and an existing skin complication in the peristomal area. A total of 79 subjects were enrolled of which 72 completed the investigation. Of these, 70 subjects were eligible to be part of the psychometric analysis population. A small subset of the participants from UK were asked if they were willing to participate in an exit cognitive debriefing interview. Prior to commencing data collection, the investigation was approved by the local ethics committee in each country (UK: 20/LO/0220, Germany: 19-363 and 00012177, the Netherlands: NL71653.068.19, Italy: NP 3841, and Norway: 65025). All subjects provided written informed consent.