Trial reportPloS one2013
NIKEI: a new inexpensive and non-invasive scoring system to exclude advanced fibrosis in patients with NAFLD.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Accuracy of Noninvasive Scoring Systems in Assessing Liver Fibrosis in Patients with Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis.Gut and liver · 2022Pooled it
- Multicentre validation and comparison of 23 noninvasive diagnostic models for liver fibrosis in treatment-naïve Chinese patients with autoimmune hepatitis.BMC gastroenterology · 2026Article
- Sequential Fibrosis-4 Index and Mac-2 Binding Protein Glycosylation Isomer Combination Improve Detection of Advanced Fibrosis in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Multicenter Study.Gastro hep advances · 2026Article
- The Value of TyG-Related Indices in Evaluating MASLD and Significant Liver Fibrosis in MASLD.Canadian journal of gastroenterology & hepatology · 2025Article
- TR score: A noninvasive model to predict histological stages in patients with primary biliary cholangitis.Frontiers in immunology · 2023Article
- Association of Serum Bilirubin and Functional Variants of Heme Oxygenase 1 and Bilirubin UDP-Glucuronosyl Transferase Genes in Czech Adult Patients with Non-Alcoholic Fatty Liver Disease.Antioxidants (Basel, Switzerland) · 2021Article
- Clinical indicators for progression of nonalcoholic steatohepatitis to cirrhosis.World journal of gastroenterology · 2021Review
- Sequential Combination of FIB-4 Followed by M2BPGi Enhanced Diagnostic Performance for Advanced Hepatic Fibrosis in an Average Risk Population.Journal of clinical medicine · 2020Article
- Development and validation of a nomogram for predicting nonalcoholic fatty liver disease in the non-obese Chinese population.American journal of translational research · 2020Article
- Overview of the Pathogenesis, Genetic, and Non-Invasive Clinical, Biochemical, and Scoring Methods in the Assessment of NAFLD.International journal of environmental research and public health · 2019Review
- Non-alcoholic fatty liver disease associated with hepatocellular carcinoma: An increasing concern.The Indian journal of medical research · 2019Review
- Modified thresholds for fibrosis risk scores in nonalcoholic fatty liver disease are necessary in the obese.Obesity surgery · 2017Article
- Article
- Liver fibrosis in non-alcoholic fatty liver disease - diagnostic challenge with prognostic significance.World journal of gastroenterology · 2015Review
- Composite prognostic models across the non-alcoholic fatty liver disease spectrum: Clinical application in developing countries.World journal of hepatology · 2015Review
- Non-invasive methods for the diagnosis of nonalcoholic fatty liver disease.World journal of hepatology · 2015Review
- New discriminant score to predict the fibrotic stage of non-alcoholic steatohepatitis in Japan.Hepatology international · 2015Article
- Bioregulatory systems medicine: an innovative approach to integrating the science of molecular networks, inflammation, and systems biology with the patient's autoregulatory capacity?Frontiers in physiology · 2015Article
- Serum amylase levels are decreased in Chinese non-alcoholic fatty liver disease patients.Lipids in health and disease · 2014Article
- Association between noninvasive fibrosis markers and cardio-vascular organ damage among adults with hepatic steatosis.PloS one · 2014Article
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.