OBJECTIVES: Peristomal skin complications (PSCs) and leakages onto clothes (LOCs) are major issues for people living with a stoma. The purpose of this study was to understand how these stoma complications impact health-related quality of life (HRQoL) in a Swedish ostomy population.

METHODS: In this study, the time trade-off (TTO) methodology was used to estimate utilities associated with two stoma-related complications: PSCs and LOCs. The health states represented PSC severity levels (mild, moderate or severe) and frequencies of LOC events (1 per month, 4 per month, 2 per year, or no LOC due to a digital solution). The average utility and decrements of the health state was assessed. The study was conducted via a web-based survey in a population of people living with a stoma in Sweden, as is required by the Swedish HTA body.

RESULTS: The analysis included 54 persons with stoma in Sweden. The disutility compared to no PSC was 0.027 (p<0.001), 0.040-0.060 (p<0.001), and 0.124-0.244 (p<0.001) for mild, moderate and severe PSC respectively. Severe pain, itching and/or burning (PIB) and bleeding skin resulted in significantly lower utilities compared to the base case with no PSC. A significant disutility of 0.053-0.101 (p<0.008) associated with frequent leakage onto clothes (1 or more leakage event per month) was found. The health state with a digital notification solution that notifies the user before a leakage event happens was associated with a significant utility gain of 0.018 (p=0.004) when compared to the health state with no PSC.

CONCLUSIONS: Peristomal skin complications and leakages onto clothes are associated with significant disutility. Ostomy care solutions that could reduce skin complications or keep leakage from reaching the clothes could increase the HRQoL of people living with a stoma.