title: NIKEI: a new inexpensive and non-invasive scoring system to exclude advanced fibrosis in patients with NAFLD.
abstract: OBJECTIVE
  To develop, validate and compare a non-invasive fibrosis scoring system for non-alcoholic fatty liver disease (NAFLD) derived from routinely obtained clinical and biochemical parameters.
  
  
  METHODS
  267 consecutive patients with biopsy proven fatty liver or non-alcoholic steatohepatitis were randomly assigned to the estimation (2/3) or validation (1/3) group to develop a model for the prediction of advanced fibrosis. Univariate statistics were performed to compare patients with and without advanced fibrosis, and following a multivariate logistic regression analysis a new scoring system was constructed. This non-invasive Koeln-Essen-index (NIKEI) was validated and compared to the FIB-4 index by calculating the area under the receiver operating characteristic curve (AUC). We evaluated a stepwise combination of both scoring systems for the precise prediction of advanced fibrosis. To set in contrast, we additionally tested the diagnostic accuracy of the AST/ALT ratio, BARD score and the NAFLD fibrosis score in our cohort.
  
  
  RESULTS
  Age, AST, AST/ALT ratio, and total bilirubin were identified as significant predictors of advanced fibrosis and used to construct the NIKEI with an AUC of 0.968 [0.937; 0.998] compared to 0.929 [0.869; 0.989] for the FIB-4 index. The absence of advanced fibrosis could be confirmed with excellent accuracy (99-100%). The positive predictive value of the FIB-4 index was higher (100% vs. 60%), however, the false negative rate was also high (33%). With a stepwise combination of both indices 82%-84% of biopsies would have been avoidable without a single misclassification. The AUROC for AST/ALT ratio, the NAFLD fibrosis score, and the BARD score were 0.81 (95% CI, 0.72-0.90), 0.96 (95% CI 0.92-0.99), and 0.67 (95% CI 0.55-0.78), respectively.
  
  
  CONCLUSIONS
  The NIKEI can reliably exclude advanced fibrosis in subjects with NAFLD. In combination with the FIB-4 index misclassification with inadequate clinical management can be avoided while the need for liver biopsies can be reduced.
authors.affiliation: Clinic for Gastroenterology and Hepatology, University Hospital of Cologne, Cologne, Germany. muenevver.demir@uk-koeln.de
authors.forename: Münevver
authors.initials: M
authors.lastname: Demir
authors.forename: Sonja
authors.initials: S
authors.lastname: Lang
authors.forename: Martin
authors.initials: M
authors.lastname: Schlattjan
authors.forename: Uta
authors.initials: U
authors.lastname: Drebber
authors.forename: Inga
authors.initials: I
authors.lastname: Wedemeyer
authors.forename: Dirk
authors.initials: D
authors.lastname: Nierhoff
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kaul
authors.forename: Jan
authors.initials: J
authors.lastname: Sowa
authors.forename: Ali
authors.initials: A
authors.lastname: Canbay
authors.forename: Ulrich
authors.initials: U
authors.lastname: Töx
authors.forename: Hans-Michael
authors.initials: HM
authors.lastname: Steffen
mesh_terms: D000328:Adult; D005234:Fatty Liver / Q000175:diagnosis / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D065626:Non-alcoholic Fatty Liver Disease; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D012720:Severity of Illness Index
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