Abstract
BACKGROUND: Peristomal skin complications (PSCs) pose a major challenge for people living with an ostomy. To avoid severe PSCs, it is important that people with an ostomy check their peristomal skin condition on a regular basis and seek professional help when needed. AIM: To validate a new ostomy skin tool (OST 2.0) that will make regular assessment of the peristomal skin easier. METHODS: Seventy subjects participating in a clinical trial were eligible for the analysis and data used for the validation. Item-level correlation with anchors, inter-item correlations, convergent validity of domains, test-retest reliability, anchor- and distribution-based methods for assessment of meaningful change were all part of the psychometric validation of the tool. RESULTS: A final tool was established including six patient reported outcome items and automatic assessment of the discolored peristomal area. Follow-up with cognitive debriefing interviews assured that the concepts were considered relevant for people with an ostomy. CONCLUSION: The OST 2.0 demonstrated evidence supporting its reliability and validity as an outcome measure to capture both visible and non-visible peristomal skin complications.