Discussion
bleeding, itching, pain
BLEEDING
The OST 2.0 was designed to evaluate the severity of PSCs within the ostomy population, and the Decision Tree score offers a simple and evidence-based categorization of PSC severity (Despite the continuous development of improved ostomy devices, people living with an ostomy continue to experience challenges with PSCs (A review by To be fit for purpose, an instrument should demonstrate psychometric properties including validity, reliability, and responsiveness to change (Overall, the OST 2.0 instrument demonstrated good correlations with the anchor measures at item level, and inter-item correlations were therefore subsequently evaluated; revealing that pain, itching, and burning severity items could be mapped together. Thus, generating the possibility of using the PIB score as a second composite score in addition to the Decision Tree score, which currently is the outcome score of the OST 2.0.Concept elicitation work performed during development of the OST 2.0 (When evaluating convergent validity of the PIB domain, a moderate correlation with the PGIS anchor was found, while its correlation with the DET score was weak. These data underlined that there was conformity in what the PIB score measures and what people with an ostomy were experiencing. The weak correlation with the DET score was expected as it further supports the difference between what the DET score measures and how people with an ostomy experience sensation symptoms in the peristomal area. The Decision Tree score demonstrated a strong correlation with the DET score, which could partially be due to the incorporation of peristomal image analysis and subsequent quantification of the discolored area in this domain. Moreover, this correlation could also reflect that the visible signs of PSCs (weeping, bleeding, and ulcer/sores) are an integrated part of the Decision Tree score. As the discoloration domain is strongly impacting the outcome of the DET score (The OST 2.0 demonstrated good stability based on the test-retest reliability assessment. This evaluation was conducted to evaluate the degree to which the PIB (weekly mean) score and the Decision Tree score were similar over time in a subset of subjects (defined as having stable peristomal skin according to anchor points). In general, test-retest reliability findings should be interpreted in consideration of the ability to detect change findings, as good test-retest reliability can be the artefact of a score being unable to detect change. If an instrument like the OST 2.0 is intended to measure a change in patients over time, it is crucial that the tool is responsive to change (The ability to detect change is an inevitable prerequisite to subsequently determine the meaningful change of a score. Positioning the magnitude of a given clinical change into a meaningful context can often be challenging and a statistical analysis for interpreting the outcome of a clinical score should not stand alone (