Conceptual framework for outcomes research studies of hepatitis C: an analytical review

Conceptual framework for outcomes research studies of hepatitis C: an analytical review Urbano Sbarigia,1 Tom R Denee,1 Norris G Turner,2 George J Wan,3 Alan Morrison,4 Anna S Kaufman,4 Gary Rice,5 Geoffrey M Dusheiko6,7 1Janssen Pharmaceutica, Beerse, Belgium; 2Johnson & Johnson Health Care Systems, Inc., Titusville, NJ, 3Mallinckrodt Pharmaceuticals, St. Louis, MO, USA; 4ScribCo, Effort, PA, USA, 5Diplomat Specialty Pharmacy, Flint, MI, USA, 6The University College London Medical Institute for Liver and Digestive Health, London, UK; 7Kings College Hospital, London, UK Abstract: Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs have shown great efficacy in clinical trials, observational studies are needed to determine their effectiveness in clinical practice. Previous observational studies have shown that multiple factors, besides the drug regimen, affect patient outcomes in clinical practice. Here, we provide an analytical review of published outcomes studies of the management of hepatitis C virus infection. A conceptual framework defines the relationships between four categories of variables: health care system structure, patient characteristics, process-of-care, and patient outcomes. This framework can provide a starting point for outcomes studies addressing the use and effectiveness of new antiviral drug treatments. Keywords: chronic hepatitis C, humans, treatment outcome, combination drug therapy, antiviral agents