N001 Developing a quality of life score for Crohn’s anal fistula (CAF-QoL)

Abstract

Background: Crohn's perianal fistulas are challenging for clinicians and patients. Many do not respond to available treatments, and despite recommendations by a recent global consensus,1 there are currently no specific patient-derived quality of life (QoL) tools to measure outcomes including response to treatment, in patients with perianal Crohn's fistulas (pCF). Early explorative qualitative work2 has demonstrated that pCF impact QoL far beyond restricting daily and sexual activities, and a patient-centred, patient derived tool is needed. We aimed to provide a patient reported outcomes measure (PROM) for this complicated disease phenotype; preliminary development of the PROM by a multidisciplinary clinical, research and patient study team is reported here. Methods: Following recognised PROM development procedures,3 we (a) conducted unstructured qualitative interviews (n = 12; median duration 43 min, range: 18-145 min) to explore the experience of living with pCF; (b) completed a pragmatic thematic analysis of transcribed interviews to identify the 'long list' of issues of importance/concern to patients; (c) incorporated outcomes from a pre-existing multidisciplinary systematic review/consensus exercise assessing outcomes in patients undergoing interventions for pCF; (d) refined the number of items at a further team meeting by eliminating repetition and overlap. Results: From the original long list (45 items), 35 items were retained under three broad categories. (1) Fistula symptoms; (2) fistula treatment; (3) impact of fistulae on quality of life. The list was reviewed by the study team and converted into questions (Category 1) and statements (Categories 2 and 3). The team also agreed to adopt scales measuring frequency (1-5) in the symptom category, and degree of agreement (1-5) in treatment/quality of life categories. Conclusions: The PROM to assess clinical outcome and QoL in patients with Crohn's anal fistula-the CAF-QoL-is ready for refinement and testing. Planned cognitive semi-structured interviews with patients will inform further item reduction, followed by validation (test-retest) of the questionnaire to confirm the final version of the Crohn's Anal Fistula Quality of Life (CAF-QoL) tool.