AbstractBackground: The aim of the study is to develop a specific patient-reported scale of liver cirrhosis according to thePatient Reported Outcome guidelines of the Food and Drug Administration (FDA), and to examine its capacity tofill gaps in this field.Methods: A conceptual framework was developed and a preliminary item pool developed through literature reviewand interviews of 10 patients with liver cirrhosis. With the preliminary items, we performed a pilot survey that includeda cognitive test with patients and interviews with experts; the focus was on content and language of the scale. In theitem selection stage, seven statistical methods including discrete trends method, discrimination analysis, exploratoryfactor analysis, Cronbach’s α coefficient, correlation coefficient, test-retest reliability, Item-Response Theory were appliedto survey data from 200 subjects (150 liver cirrhosis patients and 50 controls). This produced the preliminary LiverCirrhosis Patient-reported Outcome Measure (LC-PROM). In the next stage, we conducted the survey