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2017. Development and validation of a primary sclerosing cholangitis–specific patient‐reported outcomes instrument: The PSC PRO

Authors: Zobair M. Younossi Arian Afendy Maria Stepanova Andrei Racila Fatema Nader Rachel Gomel Ricky Safer William R. Lenderking Anne Skalicky Leah Kleinman Robert P. Myers G. Mani Subramanian John G. McHutchison Cynthia Levy Christopher L. Bowlus Kris Kowdley Andrew J. Muir

Journal: AASLD Hepatology First published:20 November 2017


"Our objective was to develop and validate a PSC‐specific patient‐reported outcome (PRO) instrument. We developed a 42‐item PSC PRO instrument that contains two modules (Symptoms and Impact of Symptoms) and conducted an external validation."

"Conclusion:  PSC PRO is a self‐administered disease‐specific instrument developed according to U.S. Food and Drug Administration guidelines. This preliminary validation study suggests good psychometric properties. Further validation of the instrument in a larger and more diverse sample of PSC patients is needed."

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