期刊
JOURNAL OF HEPATOLOGY
卷 50, 期 1, 页码 36-41出版社
ELSEVIER
DOI: 10.1016/j.jhep.2008.07.039
关键词
Liver disease; Biopsy; Hepatitis C virus; Validity; Surrogate markers
资金
- NIH [R01 DA12568, R01 DA04334, R01 DA13806]
- NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES [K01AI071754] Funding Source: NIH RePORTER
- NATIONAL INSTITUTE ON DRUG ABUSE [R56DA004334, R01DA013806, R01DA012568, R01DA004334] Funding Source: NIH RePORTER
Background/Aims: Alternatives to liver biopsy for staging liver disease caused by hepatitis C virus (HCV) have not appeared accurate enough for widespread clinical use. We characterized the magnitude of the impact of error in the gold standard on the observed diagnostic accuracy of surrogate markers. Methods:We calculated the area under the receiver operating characteristic curve (AUROC) for a surrogate marker against the gold standard (biopsy) for a range of possible performances of each test (biopsy and marker) against truth and a gradient of clinically significant disease prevalence. Results: In the 'best' scenario where liver biopsy accuracy is highest (sensitivity and specificity of biopsy are 90%) and the prevalence of significant disease 40%, the calculated AUROC would be 0.90 for a perfect marker (99% actual accuracy) which is within the range of what has already been observed. With lower biopsy sensitivity and specificity, AUROC determinations >0.90 could not be achieved even for a marker that perfectly measured disease. Conclusions: We demonstrate that error in the liver biopsy result itself makes it impossible to distinguish a perfect surrogate from ones that are now judged by some as clinically unacceptable. An alternative gold standard is needed to assess the accuracy of tests used to stage HCV-related liver disease. (C) 2008 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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