Development of a Novel Tool to Assess the Impact of Itching in Pediatric Cholestasis.

ABSTRACT:

Objectives

The aim was to develop a clinical outcome assessment (COA) for itching in children with cholestatic pruritus.

Methods

This prospective study aimed to enroll patients aged 4-30 years with Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis type 1 and caregivers of patients aged 5 months to 14 years. Eligible patients experienced itching during ≥3 of the 7 days before enrollment and had not undergone liver transplant or surgical interruption of the enterohepatic circulation. Open-ended qualitative interviews confirmed that itching was a primary concern for patients and caregivers. Diaries were modified and then evaluated by participants during cognitive debriefing. Interview results were reviewed by clinical, COA and statistical experts. Diary

SUBMITTER: Kamath BM 

PROVIDER: S-EPMC5766715 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature