The Symptom Assessment Project (SAP) developed the first PSC-specific symptom measures for fatigue, brain fog, and liver pain using a rigorous, stepwise approach. Each tool was designed to capture the real experiences of PSC patients with scientific precision.
Fatigue and brain fog measures were adapted from NIH PROMIS, a set of standardized tools for reliably assessing patient symptoms, while liver pain required a new measure developed entirely from patient interviews.
How the Tools Were Developed
- Grounded in real patient experiences: Every concept came from in-depth interviews with 126 symptomatic PSC patients.
- Tested for clarity and relevance: Structured feedback sessions with additional patients ensured instructions, wording, and response options were clear and reflected real-world PSC experiences.
- Validated through survey data: From August to December 2025, the PSC Partners Patient Registry collected 280 responses using the new PRO measures, supporting their validity.
Key Findings
- Over 80% of PSC patients experience five or more symptoms simultaneously.
- Liver pain is a real symptom and closely correlates with nerve innervation in the liver capsule.
- Fatigue and brain fog significantly reduce functional capacity and daily functioning.
Practical Tools for Patients, Clinicians & Researchers
- Facilitate patient-provider communication: Printable measures let patients share their symptom experiences directly with providers.
- Ensure symptoms are documented: The tools ensure that symptoms are formally recorded in medical records, supporting informed care.
- Support clinical trial endpoints: The measures provide standardized, validated data that can be used to evaluate whether treatments meaningfully improve how patients feel and function.
Impact
- Strengthen patient agency: Provides patients with clear tools to communicate symptoms and advocate for appropriate care.
- Counter symptom normalization: Helps patients and caregivers recognize and report symptoms often minimized or accepted as a new baseline.
- Turn lived experience into evidence: Transforms patient-reported symptoms into validated measures that inform both clinical care and research.
References
PSC Partners Patient Registry. (2024). 2024 AASLD Liver Meeting abstract and poster: “Understanding fatigue experiences through qualitative interviews with adults living with primary sclerosing cholangitis (PSC): An essential first step toward customizing a PSC-specific PROMIS measure.”
PSC Partners Seeking a Cure. (2025). Communicating patient experiences with fatigue, brain fog, and liver pain.
