Nonalcoholic Fatty Liver Disease Adult Database 2

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions that can progress to significant fibrosis and cirrhosis. There are an estimated 40-90 million individuals within the United States with NAFLD, 10- 30% of whom have NASH and may develop NASH-related cirrhosis. Identifying through non- invasive means those individuals who are at risk for progressive liver disease remains challenging.

The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications and treatment of NASH.

The NAFLD Adult Database 2 continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies. Comprehensive data, including demographics, medical history, symptoms, medication use, alcohol use and routine laboratory studies were collected on all participants at entry and at annual visits for up to 10 years after enrollment. A liver biopsy was collected at baseline if not collected in a prior NASH CRN study. Study questionnaires administered at enrollment included Skinner Lifetime Drinking history, Alcohol Use Disorders Identification Test (AUDIT) and Beverage Questionnaire (BEVQ-15).

Specimens were collected every 48 weeks during follow-up. If liver biopsies were obtained as part of routine patient care, they were scored using the NASH CRN NAFLD Activity Score (NAS) and fibrosis score. The Interim drinking history (AUDIT-C) and BEVQ-15 were collected at follow-up visits.