Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn's perianal fistulas

Chitra Karki; Amod Athavale; Vijay Abilash; Gary Hantsbarger; Parnia Geransar; Kate Lee; Slobodan Milicevic; Marko Perovic; Leanne Raven; Magdalena Sajak-Szczerba; Abigail Silber; Annabelle Yoon; Phil Tozer

doi:10.4240/wjgs.v15.i11.2537

Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn's perianal fistulas

World J Gastrointest Surg. 2023 Nov 27;15(11):2537-2552. doi: 10.4240/wjgs.v15.i11.2537.

Authors

Affiliations

¹ Global Evidence and Outcomes-Gastroenterology, Takeda Pharmaceuticals United States, Inc, Cambridge, MA 02139, United States. chitra.karki@takeda.com.
² Trinity Partners, LLC, Waltham, MA 02451-7528, United States.
³ Observational Research, Takeda Pharmaceuticals United States, Inc, Cambridge, MA 02139, United States.
⁴ Medical Affairs, Takeda Pharmaceuticals International Co., Opfikon 8152, Zurich, Switzerland.
⁵ Research and Patient Programs, Crohn's and Colitis Canada, 600-60 St. Clair Avenue East, Toronto M4T 1N5, Ontario, Canada.
⁶ Treasurer, European Federation of Crohn's & Ulcerative Colitis Associations, Brussels B 1000, Belgium.
⁷ Crohn's and Colitis Australia, Camberwell South, VIC 3124, Australia.
⁸ European Federation of Crohn's & Ulcerative Colitis Associations, Brussels B 1000, Belgium.
⁹ Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo 103-8668, Japan.
¹⁰ Department of Colorectal Surgery, St Mark's Hospital and Academic Institute, London HA1 3UJ, United Kingdom.

Abstract

Background: Patients with Crohn's disease (CD) are at risk of developing complications such as perianal fistulas. Patients with Crohn's perianal fistulas (CPF) are affected by fecal incontinence (FI), bleeding, pain, swelling, and purulent perianal discharge, and generally face a higher treatment burden than patients with CD without CPF.

Aim: To gain insights into the burden of illness/quality of life in patients with CPF and their treatment preferences and satisfaction.

Methods: This cross-sectional observational study was conducted in patients with CD aged 21-90 years via a web-enabled questionnaire in seven countries (April-August 2021). Patients were recruited into three cohorts: Cohort 1 included patients without perianal fistulas; cohort 2 included patients with perianal fistulas without fistula-related surgery; and cohort 3 included patients with perianal fistulas and fistula-related surgery. Validated patient-reported outcome measures were used to assess quality of life. Drivers of treatment preferences were measured using a discrete choice experiment (DCE).

Results: In total, 929 patients were recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135). Short Inflammatory Bowel Disease Questionnaire scores were worse for patients with CPF (cohorts 2 and 3) than for those with CD without CPF (cohort 1): Mean score 3.8 and 3.7 vs 4.1, respectively, (P < 0.001). Similarly, mean Revised FI and FI Quality of Life scores were worse for patients with CPF than for those with CD without CPF. Quality of Life with Anal Fistula scores were similar in patients with CPF with or without CPF-related surgery (cohorts 2 and 3): Mean score 41 and 42, respectively. In the DCE, postoperative discomfort and fistula healing rate were the most important treatment attributes influencing treatment choice: Mean relative importance 35.7 and 24.7, respectively.

Conclusion: The burden of illness in CD is significantly higher for patients with CPF and patients rate lower postoperative discomfort and higher healing rates as the most desirable treatment attributes.

Keywords: Burden of illness; Crohn’s disease; Discrete choice experiment; Patient-reported outcomes; Perianal fistulas; Treatment preferences.