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Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults with liver cirrhosis. The main questions it aims to answer are: Do the total scores of the electronic and paper tests match for the same patient? Do both tests classify patients as having MHE or not in the same way? Researchers will compare the electronic PHES to the paper PHES to see if they produce equivalent results. Participants will: Be assigned by chance to one of two groups. Group A will take the paper test first, then the electronic test the next day. Group B will take the electronic test first, then the paper test the next day. Complete two cognitive tests (one paper-based and one electronic) on two separate days. Provide information about their medical history and complete routine blood tests as part of their standard care.
Official title: Efficacy Evaluation of Electronic Psychometric Hepatic Encephalopathy Score (PHES) in Diagnosing Hepatic Encephalopathy Based on a Randomized Crossover Design
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-10
Completion Date
2026-12
Last Updated
2026-10-14
Healthy Volunteers
No
Interventions
Paper-based PHES
The paper-based PHES is a standard, validated neuropsychological test administered using paper forms and a pen. It consists of five subtests: Number Connection Test A, Number Connection Test B, Digit Symbol Test, Line-Tracing Test, and Serial Dotting Test. Participants complete the test under the supervision of a trained researcher. The researcher records the completion time and error rates for each subtest, and the total PHES score is calculated manually according to standard guidelines.
Electronic PHES
The electronic PHES is a digital version of the standard PHES administered via a mobile application on a tablet or smartphone. The test content, subtest settings, and scoring criteria are identical to the paper-based version. The application automatically records completion times, errors, and calculates the total score. Researchers provide operational instructions and supervise the participants throughout the test.