Clinical Research Directory

Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy

Sponsor: The First Affiliated Hospital with Nanjing Medical University

Summary

This is a prospective, multicenter, randomized crossover diagnostic accuracy study. A total of 80 patients with liver cirrhosis will be enrolled and randomly assigned to two sequence groups at a 1:1 ratio. Participants in Sequence A will complete the paper-based Psychometric Hepatic Encephalopathy Score (PHES) on Day 1 and the electronic PHES on Day 2; participants in Sequence B will receive the tests in reverse order. All tests will be performed at the same time of day with a 1-day washout interval to minimize carryover effect. The primary objective is to verify the equivalence of total scores between electronic and paper-based PHES. Secondary objectives include evaluating the consistency of MHE classification and individual subtest scores, and analyzing the effects of test sequence and time period on results. This study aims to provide evidence for clinical promotion of the electronic PHES tool.

Official title: Evaluation of Diagnostic Performance of Electronic Psychometric Hepatic Encephalopathy Score (PHES): A Randomized Crossover Study

Key Details

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Locations (2)