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Background  Leakage is a major concern for people who use a stoma, but people’s experience and its impact is not well understood. This study aimed to establish a definition of leakage through clinical and user input. This information was used to develop and validate a new measurement tool to understand the impact of leakage for people using a stoma appliance, in the UK, US, France, and Denmark.    Methods  Participants were recruited from a panel of users, hosted by Coloplast, that includes people who currently use Coloplast products. Six clinicians and 41 users took part in concept elicitation interviews. The qualitative findings were used to draft items. A panel of clinical experts was organized to develop and validate items ( N  = 6). Cognitive debrief interviews were conducted with five users in each country, which resulted in removing some items and revising the measure. A psychometric validation was conducted with 340 people in four countries whereby participants were asked to complete a series of measures online. Full psychometric analyses including validity and reliability were conducted.    Results  A final tool was established consisting of three domains related to the burden of leakage: “Emotional impact,” “Usual and social activities,” and “Coping and control.” Convergent validity was evaluated by benchmarking to existing health-related quality of life instruments (domains of SF-36 and Ostomy-Q). This showed high correlation between domains of the leakage tool and other measures, in particular for the Emotional impact domain when compared with SF-36 Emotional well-being and Ostomy-Q Confidence domain ( p  < 0.001). Coping and control correlated moderately well with most PROs tested for except the physical functioning domains, which showed only modest correlation ( p  < 0.001). Usual and social activities correlated equally well with all domains. Internal consistency was high for Emotional impact and Usual and social activities (> 0.92).    Conclusion  The study highlights how users define leakage and its impact in a way that is meaningful to them. This information has been used to develop an instrument to measure leakage which can potentially be used by clinicians and researchers. The instrument demonstrated evidence supporting its reliability and validity as an outcome measure to assess the impact of leakage in stoma care.    Electronic supplementary material  The online version of this article (10.1186/s12955-018-1054-0) contains supplementary material, which is available to authorized users.

The ostomy leak impact tool: development and validation of a new patient-reported tool to measure the burden of leakage in ostomy device users