NIKEI: A New Inexpensive and Non-Invasive Scoring System to Exclude Advanced Fibrosis in Patients with NAFLD

Abstract

AimsTo 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.Methods267 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.ResultsAge, 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.ConclusionThe 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.

Development of Serum Marker Models to Increase Diagnostic Accuracy of Advanced Fibrosis in Nonalcoholic Fatty Liver Disease: The New LINKI Algorithm Compared with Established Algorithms

“…Our results are in accordance with those of Boursier et al [24], who showed moderate diagnostic performance for BARD (AUROC 0.70). NIKEI is a newly developed NAFLD specific fibrosis score [9]. In its original publication, a very high diagnostic accuracy was reported with an AUROC of 0.97 and an NPV of 0.99.…”

“…Several algorithms including a combination of indirect markers have been developed in NAFLD patients (BARD [8], NIKEI [9], NAFLD fibrosis score [10], NASH-CRN regression score [11]) as well as in patients with chronic hepatitis C virus (HCV) infection (GUCI [12], APRI [13], FIB-4 [14], King´s score [15], Forns score [16], Lok index [17]) (S1 Table). It is unclear whether the algorithms that were developed in NAFLD patients provide a better diagnostic accuracy.…”

Composite prognostic models across the non-alcoholic fatty liver disease spectrum: Clinical application in developing countries

“…Age, platelet count and/or INR are also included in several other predictive models which have not yet been validated in adult patients with NAFLD. These scoring panels incorporate a number of components known to independently predict fibrosis severity in NAFLD, including bilirubin [123] , GGT [124] and albumin [106] .…”

Розробка Неінвазивної Моделі Для Підвищення Точності Діагностики Стадії Фіброзу Печінки При Неалкогольній Жировій Хворобі Печінки

“…Using a combination of these indicators can greatly improve the diagnosis of NAFLD. Thus, according to data of Indian researchers, [36] it was found the presence of strong positive correlation between the platelet count, gamma-glutamyltranspeptidase and apolipoprotein A and the absence of liver fibrosis in patients with NAFLD (negative predictive value -94.3 %). The results of study Sakugawa and coauthors, showed that level of hyaluronic acid can be used to reliably distinguish the initial (F0-2) and severe fibrosis (F3-4) (AUC = 0.97) [37].…”