Validation of AGA clinical care pathway and AASLD practice guidance for nonalcoholic fatty liver disease in a prospective cohort of patients with type 2 diabetes

Background and Aims: Recently, the American Gastroenterological Association (AGA) and American Association for the Study of Liver Diseases (AASLD) developed clinical pathways to evaluate populations at high-risk for nonalcoholic fatty liver disease (NAFLD). We assessed the diagnostic performance of the new guidance in a well-phenotyped cohort of patients with Type 2 diabetes mellitus (T2DM).Approach and Results: This prospective study enrolled adults age >= 50 years with T2DM. Participants underwent a standardized clinical research visit with magnetic resonance imaging (MRI) and ultrasound-based assessment of liver fat and stiffness and ELF testing. Of 417 participants (36% men) with T2DM with FIB-4 and MRE data, the prevalence of NAFLD was 64% and 12% had advanced fibrosis (MRE >= 3.63 kPa). Applying the AGA pathway of FIB-4 and vibration controlled transient elastography (VCTE) the false negative rate was 3.3% and 18% would qualify for specialty referral. Applying FIB-4 + ELF AASLD pathway the false negative rate was 4.5% but 50% would qualify specialty referral. Applying higher ELF cut points improved the pathway yielding a similar false negative rate of 4.9% but decreased specialty referral to 27%.Conclusion: Validation of the AGA clinical pathway in a prospectively recruited cohort with T2DM revealed a low false negative rate and avoided specialty referral in a large percentage of patients. The AASLD pathway with FIB-4 + ELF resulted in a high rate of specialty referral, which improved with utilization of higher ELF cut-points and may serve as an alternative for primary care and endocrinology clinics without access to VCTE.