Author information
1Division of Gastroenterology and Hepatology, University of Michigan.
2Division of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine.
3Division of Gastrointestinal and Liver Diseases, Keck Medicine of University of Southern California.
4Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic.
5NAFLD Research Center, Division of Gastroenterology and Hepatology, University of California San Diego.
6Division of Gastroenterology and Hepatology, University of California-San Francisco.
7Division of Digestive and Liver Diseases, Columbia University.
8Division of Gastroenterology & Hepatology, Weill Cornell Medicine.
9Division of Gastroenterology and hepatology, Virginia Commonwealth University and Richmond VA Medical Center.
10Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center.
11Division of Transplantation, Department of Surgery, Northwestern University.
12Division of Gastroenterology and Hepatology, Duke University School of Medicine.
13Division of Gastroenterology and hepatology, Mayo Clinic Rochester.
Abstract
Background: One of the primary goals of the Liver Cirrhosis Network (LCN) is to develop a cohort study to better understand and predict the risk of hepatic decompensation and other clinical and patient-reported outcomes among patients with Child A cirrhosis.
Methods: The LCN consists of a Scientific Data Coordinating Center (SDCC) and 10 clinical centers whose investigators populate multiple committees. The LCN Definitions and Measurements Committee developed preliminary definitions of cirrhosis and its complications by literature review, expert opinion, and reviewing definition documents developed by other organizations. The Cohort Committee developed the study protocol with the input of the steering committee.
Results: The LCN developed a prospective cohort study to describe and predict the rates of incident clinical events pertaining to first decompensation and patient reported outcomes. The LCN developed a pragmatic definition of compensated cirrhosis incorporating clinical, laboratory, imaging, and histological criteria. Definitions of incident and recompensated ascites, overt hepatic encephalopathy, variceal hemorrhage, bleeding due to portal gastropathy, and hepatocellular carcinoma were also codified.
Conclusion: The LCN Cohort Study design will inform the natural history of cirrhosis in contemporary patients with compensated cirrhosis. The LCN Definitions and Measures Committee developed criteria for the definition of cirrhosis to standardize entry into this multi-center cohort study and standardized criteria for liver-related outcome measures. This effort has produced definitions intended to be both sensitive and specific as well as easily operationalized by study staff such that outcomes critical to the LCN cohort are identified and reported in an accurate and generalizable fashion.