Journal of hepatology
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Journal of hepatology · Apr 2007
ReviewHepatology may have problems with putative surrogate outcome measures.
A surrogate outcome measure is a laboratory measurement, a physical sign, or another intermediate substitute that is able to predict an intervention's effect on a clinically meaningful outcome. A clinical outcome detects how a patient feels, functions, or survives. Surrogate outcome measures occur faster or more often, are cheaper, and/or are less invasively achieved than the clinical outcome. ⋯ In hepatology a number of putative surrogate outcomes are used both in clinical research and in clinical practice without having been properly validated. Sustained virological response to interferons and ribavirin in patients with chronic hepatitis C, serum bilirubin concentration following ursodeoxycholic acid or immunosuppressants for patients with primary biliary cirrhosis, and nutritional outcomes following artificial nutrition for liver patients may not be valid surrogates for morbidity or mortality. The challenge is to develop reliable surrogates, both to facilitate the development of new interventions and to ensure our patients and us that these interventions are effective clinically.