The NASH Clinical Research Network (NASH CRN) was formed to conduct multi-center studies on the etiology, contributing factors, natural history, and treatment of nonalcoholic steatohepatitis (NASH). The aim of this study was to determine the associations of readily available demographic, clinical and laboratory variables with the diagnosis of NASH and its key histological features, and determine the ability of these variables to predict the severity of nonalcoholic fatty live disease (NAFLD). A total of 1,266 adults were enrolled in NASH CRN studies between October 2004 and February 2008 of whom 1,101 had available liver histology. The median age was 50 years; 82% were white and 12% Hispanic. The median BMI was 33 kg/m2; 49% had hypertension and 31% type 2 diabetes. On liver biopsy, 57% were judged to have definite NASH and 31% bridging fibrosis or cirrhosis. Using data from the 698 patients with liver biopsies within 6 months of clinical data, patients with definite NASH were more likely to be female and have diabetes, higher levels of AST, ALT, alkaline phosphatase, GGT and HOMA-IR. Progressive models for predicting histological diagnoses performed modestly for predicting steatohepatitis or ballooning (area under receiver operating characteristic curves ranged from 0.71 to 0.79), and better for advanced fibrosis (AUC 0.73–0.85).
Readily available clinical and laboratory variables can predict advanced fibrosis in adults with NAFLD but additional information is needed to reliably predict the presence and severity of NASH. Prospective studies of this well-characterized population and associated tissue bank samples offer a unique opportunity to better understand the cause and natural history of NAFLD and develop more precise means for noninvasive diagnosis.
Keywords: nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alanine aminotransferase, biological markers