Development and Clinical Evaluation of the Modified Hepatic Encephalopathy Staging Tool
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Published on: July 21, 2023
Annarein J C Kerbert1, Caterina Chesta2, Pooja Balachandran2
1Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands; Division of Medicine, Liver Failure Group, Institute for Liver and Digestive Health, University College London, London, United Kingdom.
Background & Aims:
Hepatic encephalopathy (HE) is a serious complication of advanced cirrhosis, requiring accurate and consistent diagnosis and staging. The commonly used West Haven criteria have substantial interobserver variability. This study aimed to develop the modified Hepatic Encephalopathy Staging Tool (mHEST) as a more objective and reproducible HE assessment method for regulated clinical trials.
Methods:
This study consisted of 2 parts. In part 1, 49 health care professionals from 6 countries evaluated 6 video vignettes depicting different HE stages. After viewing a mHEST training video, participants assessed the vignettes twice (5-10 days apart). Inter- and intrarater agreement were analyzed. In Part 2, a prospective single-center study enrolled 128 hospitalized patients with decompensated cirrhosis. Trained professionals independently assessed HE using both West Haven criteria and mHEST. Diagnostic consistency, prognostic performance, and impact on established scoring systems were compared.
Results:
In part 1, inter-rater concordance ranged from 83.3% to 100%, and intrarater agreement from 81.0% to 100%. In part 2, inter-rater reliability was significantly higher for mHEST than West Haven (κ = 0.934 vs 0.367). mHEST improved the performance of HE-containing scores, including Child-Pugh and CLIF-C Organ Failure. Plasma ammonia levels increased stepwise with mHEST grades, but not with West Haven. mHEST grades correlated with 1-year mortality, and low mHEST grades (0-1) independently predicted improved 1-year survival.
Conclusions:
MHEST is a user-friendly, reliable, and prognostically accurate HE assessment tool that outperforms West Haven criteria and has been accepted by the United States Food and Drug Administration as a clinical trial endpoint.
