Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07852416, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT07852416
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
Evaluation of Diagnostic Performance of Electronic Psychometric Hepatic Encephalopathy Score (PHES): A Randomized Crossover Study
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.
Inclusion: Aged 18 to 75 years; Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, or liver biopsy evidence; Intact cognitive function, no overt hepatic encephalopathy (West-Haven grade ≥ II), and able to cooperate with neuropsychological tests; Voluntarily signed written informed consent with good compliance and full understanding of the study.
Exclusion: Concomitant uncontrolled neuropsychiatric diseases affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, post-stroke sequelae, severe depression/anxiety, schizophrenia); Use of hypnotics, sedatives, or psychotropic drugs within the past 1 month; Severe alcohol dependence or substance abuse, unable to maintain abstinence; Current use of lactulose at screening.