Utilities associated with stoma-related complications: peristomal skin complications and leakages

Abstract

Aim

Peristomal skin complications (PSCs) and leakages are major issues for people living with a stoma. The purpose of this study is to understand how these stoma-linked complications impact health-related quality of life (HRQoL) in a UK population.

Materials and methods

The study used time trade-off (TTO) methodology to quantify health state utilities associated with two stoma-related complications: PSC and leakages. Respondents assessed 10 different health states with different PSC severity levels (no, mild, moderate or severe PSC) and frequencies of leakage events (2, 12 or 48 leakages onto clothes per year, and no leakage due to a digital solution). The average disutility value for each health state was also assessed. The study was conducted via a web-based survey in the UK adult general population.

Results and limitations

The analysis included 758 respondents. Respondents considered living with a stoma with no PSC to be more favorable than the other health states. Severe pain, itching and/or burning (PIB) was associated with the largest disutility compared to no PSC. The disutility (0–1 scale) compared to no PSC was 0.287 (p < .0001), 0.106 (p < .0001) and 0.025 (p=.0005) for PIB scores of 8, 5 and 2, respectively, on a 1–10 scale. More frequent leakage events were associated with lower utility. The utility decreases compared to no PSC were 0.114 (p < .0001), 0.057 (p < .0001) and 0.022 (p < .0001) for 48, 12 and 2 leakage events per year, respectively. The health state with a digital notification solution that notifies the user before a leakage event happens was considered as good as no PSC.

Conclusions

Experiencing mild, moderate, and severe levels of PSC or leakage onto clothes is associated with a significant reduction in HRQoL compared to no PSC and/or no leakage. Stoma appliances that reduce the skin complications or keep leakage from reaching the clothes are likely to improve HRQoL.

Keywords:

• Ostomy
• health-related quality of life
• HRQoL
• time trade-off
• cost–utility analysis
• disutility

JEL CLASSIFICATION CODES:

• I10
• I1
• I
• I12

Transparency

Declaration of funding

This research was funded by Coloplast A/S, Humlebaek, Denmark.

Declaration of financial/other relationships

Authors JHB and LFJ were employed by Coloplast A/S during the study period and the preparation of this manuscript. NR was a member of the Coloplast Ostomy Forum Advisory board and has been compensated for her contribution according to fair market value. CY and MB are employed at Incentive Denmark, which is a paid vendor of Coloplast A/S, Denmark.

Author contributions

JHB and LFJ conceived the original idea that was discussed and further developed by all authors. CY and MB performed the data collection and statistical analysis. All authors contributed to the interpretation of results and critically reviewed and approved the final manuscript. All authors are accountable for all aspects of the work.

Acknowledgements

The authors thank Brian Devin for his valuable input toward the accuracy of the health state descriptions and Professor John Brazier for his contribution to both the health state definitions and the interpretation of results.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have received research, speaking and/or consulting support from Eli Lilly and Company, GlaxoSmithKline/Stiefel, AbbVie, Janssen, Alovtech, vTv Therapeutics, Bristol-Myers Squibb, Samsung, Pfizer, Boehringer Ingelheim, Amgen, Dermavant, Arcutis, Novartis, Novan, UCB, Helsinn, Sun Pharma, Almirall, Galderma, Leo Pharma, Mylan, Celgene, Ortho Dermatology, Menlo, Merck & Co, Qurient, Forte, Arena, Biocon, Accordant, Argenx, Sanofi, Regeneron, the National Biological Corporation, Caremark, Teladoc, Eurofins, Informa, UpToDate and the National Psoriasis Foundation. He is founder and part owner of Causa Research and holds stock in Sensal Health. The other peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.