Development and psychometric testing of the urostomy peristomal skin symptom questionnaire

Objective: While current assessment tools for peristomal skin complications (PSCs) provide valuable assessment of clinician-observed signs, a comprehensive understanding of the condition requires the integration of the patient's perspective on their symptom experience. This study aimed to develop and validate the Urostomy Peristomal Skin Symptom Questionnaire (UPSS), a novel patient-reported outcome measure designed to comprehensively assess the symptom experience in urostomy patients. Methods: Following established methodological standards, this study was conducted in three sequential phases involving 508 urostomy patients: scale development, incorporating a literature review, qualitative interviews, Delphi expert consultation, and cognitive interviewing; initial testing, featuring item analysis and exploratory factor analysis (EFA); and psychometric validation via a cross-sectional survey to assess reliability and validity. Results: The final 29-item UPSS encompasses seven dimensions within two subscales (Symptom Discomfort and Symptom Impact). The scale exhibits strong content validity (S-CVI/Ave = 0.980), good construct validity supported by both exploratory and confirmatory factor analysis, and high reliability (Cronbach's α = 0.881; test-retest intraclass correlation coefficients [ICC] = 0.892). Conclusions: The UPSS is a rigorously developed and psychometrically robust instrument that provides the first comprehensive, patient-centered assessment of peristomal skin symptom burden in urostomy care. By enabling the identification of the "invisible" population burdened by specific symptom clusters and their impacts, the UPSS holds substantial promise for refining clinical practice, guiding personalized interventions, and advancing patient-centered outcomes research.