Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease

Inclusion criteria

• ✓. The subject has voluntarily provided verbal assent or written assent in accordance with the site's Institutional Review Board (IRB) guidelines;
• ✓. The subject's legal guardian has voluntarily provided permission for study participation and authorization for access to personal health information in conjunction with HIPPA;
• ✓. The subject has a diagnosis of ALGS or PFIC;
• ✓. The subject is able to speak and comprehend US English (applicable only for children age 5 and older);
• ✓. The subject is willing and able to participate in the two-week validation study (applicable only for children age 5 and older); and
• ✓. The subject is able to understand the nature, scope, and possible consequences of the study, and/or does not present evidence of an uncooperative attitude (applicable only for children age 5 and older).
• ✓. The caregiver voluntarily provided written informed consent;
• ✓. The caregiver is 18 years of age or older;