Fatigue and Cognitive Impairment in Adults With Primary Sclerosing Cholangitis: Results From Concept Elicitation Interviews

BACKGROUND AND AIMS: To understand the experience of fatigue and cognitive impairment in adults with symptomatic primary sclerosing cholangitis (PSC) as an essential first step towards developing PSC-specific symptom measures. METHODS: Purposeful sampling was used to identify 17 symptomatic adults from the PSC Symptom Assessment Project who met general trial eligibility criteria for in-depth concept elicitation interviews focused on key PSC symptoms. Of these, twelve were interviewed in-depth about fatigue and eleven about cognitive impairment. Interviews were conducted virtually, audio-recorded, transcribed and analysed. The Theory of Unpleasant Symptoms guided the development of a PSC symptom conceptual framework. RESULTS: Participants were on average 42 years old, 57% male, 71% White and 57% had inflammatory bowel disease. Half experienced fatigue and cognitive impairment daily, while others described varying frequencies of these symptoms. Most participants described fatigue getting progressively worse throughout the day, often requiring naps. Fatigue interfered with domestic duties, job responsibilities and family/social activities. Fatigue impacted mental health with frustration, sadness and guilt. Participants with cognitive impairment reported it ranged from mild to severe, with some unable to live independently or maintain employment. Working memory, verbal fluency, attention and processing speed were impacted. Fatigue and cognitive impairment frequently co-occurred but could occur separately. CONCLUSIONS: PSC-related fatigue and cognitive impairment impact daily, work-related, emotional and social functioning in symptomatic adults. These qualitative findings inform the customization of PSC-specific fatigue and cognitive function measures with strong content validity that is necessary for use in PSC research and clinical trials.