title: Assessment of low-grade hepatic encephalopathy: a critical analysis.
abstract: OBJECTIVE
  The value of paper-pencil tests and West-Haven-criteria for assessment of low-grade hepatic encephalopathy under conditions of a randomized, double-blind, placebo-controlled, clinical trial was evaluated in a cohort of 217 cirrhotics.
  
  
  METHODS
  Patients were graded at least twice clinically for severity of hepatic encephalopathy and tested concomitantly with a recommended psychometric test battery.
  
  
  RESULTS
  Re-evaluation of the study documentation showed that at study entry 33% and during the study even 50% of the patients were wrongly allocated to minimal or overt hepatic encephalopathy. Despite the participating physicians' training, 31% of the number-connection-tests-A, 20% of the number-connection-tests-B and 28% of the line-tracing-test were in retrospect considered invalid by an independent psychologist. Neither the Portosystemic-Encephalopathy-Syndrome (PSE) test nor the Psychometric-Hepatic-Encephalopathy-Sum (PHES)-score reliably picked up clinical improvement in the individual patient. Although these test scores could statistically differentiate between patients with minimal and overt hepatic encephalopathy, the clinical classification of individual patients into one of the groups will have a high rate of error. The PHES-Score was less balanced than the score derived from the PSE-Syndrome-Test.
  
  
  CONCLUSIONS
  Inaccuracies in conducting paper-pencil tests together with the subjectivity and incorrectness of clinical HE-grading question the usefulness of West-Haven-criteria and paper-pencil tests including related scores for quantification of low-grade HE at least in multicenter approaches.
authors.affiliation: Department of Gastroenterology, Hepatology and Infectiology, Heinrich-Heine-University Düsseldorf, Moorenstrasse 5, 40225 Düsseldorf, Germany. Kircheis@med.uni-duesseldorf.de
authors.forename: Gerald
authors.initials: G
authors.lastname: Kircheis
authors.forename: Wolfgang E
authors.initials: WE
authors.lastname: Fleig
authors.forename: Roman
authors.initials: R
authors.lastname: Görtelmeyer
authors.forename: Susanne
authors.initials: S
authors.lastname: Grafe
authors.forename: Dieter
authors.initials: D
authors.lastname: Häussinger
mesh_terms: D015331:Cohort Studies; D003937:Diagnosis, Differential; D004185:Disability Evaluation; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005355:Fibrosis / Q000150:complications; D006501:Hepatic Encephalopathy / Q000175:diagnosis* / Q000503:physiopathology / Q000523:psychology*; D006801:Humans; D008107:Liver Diseases / Q000150:complications*; D008137:Longitudinal Studies; D009483:Neuropsychological Tests / Q000592:standards*; D010919:Placebos; D011237:Predictive Value of Tests; D011594:Psychometrics / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014145:Trail Making Test
chemical_list: D010919:Placebos