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Comparison of Two Clinical Scales for Causality Assessment in Hepatotoxicity

Lucena, Ma Isabel, Camargo, Raquel, Andrade, Raúl J., Perez-Sanchez, Carlos J., De La Cuesta, Felipe Sanchez·2001·Hepatology
DOI 10.1053/jhep.2001.20645
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Abstract

This study was performed to compare the assessments of drug–induced liver injury obtained with 2 methods, the Council for International Organizations of Medical Sciences (CIOMS) scale and the recently validated Maria & Victorino (M&V) clinical scale, in cases submitted to a registry of hepatotoxicity. A total of 215 cases of hepatotoxicity reported with a structured reporting form were evaluated by 3 independent experts. Because of the use of multiple drugs, 228 ratings were generated. The probability of the diagnosis was classified as definitive, probable, possible, unlikely, or excluded, and evaluated for consistency with a weighted κ statistical test. Absolute agreement between the 2 scales was observed in 42 cases (18%, weighted κ 0.28) with disagreement of 1 level in 108 cases (47%), and of 2 levels in 70 cases (31%). The best correlation between the 2 scales was obtained for drug–induced liver injury involving a suggested immunoallergic mechanism: the disagreement was 1 level or less in 72% of the cases (34 of 48), compared with 60% of the cases (85 of 141) that involved a presumed idiosyncratic metabolic mechanism. The lowest agreement (6%) was observed in cases with evidence of cholestasis. No agreement was found in cases of fulminant hepatitis or death. The CIOMS scale showed better discriminative power and produced assessments closer to those of specialists. The performance of the M&V scale was poor in reactions with long latency periods (i.e., amoxycillin/clavulanic acid), evolution to chronicity after withdrawal (cholestatic pattern), or death.

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  • The Clinical Diagnostic Scale has simplified criteria, but excessive weighting of extrahepatic or hypersensitivity features makes it less valid than RUCAM in DILI assessment.

    “The immunologists Maria and Victorino developed the CDS or Maria and Victorino Scale 34 and although the criteria have been simplified, the excessive weighting of extrahepatic or hypersensitivity features makes it less valid than RUCAM in DILI assessment.”

    From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [42]

  • The CDS is not used widely in clinical practice because it was shown to be inferior to RUCAM.

    “The CDS is not used widely in clinical practice because it was shown to be inferior to the RUCAM [35, 36].”

    From Drug-induced liver injury. Part I: Classification, diagnosis and treatment (2025) · cites this paper as [36]

  • The Maria-Victorino Clinical Diagnostic Scale (CDS) uses similar variables to RUCAM but excludes concomitant medications and includes points for extrahepatic manifestations.

    “The Maria-Victorino Clinical Diagnostic Scale (CDS) uses similar variables to the RUCAM but excludes concomitant medications and includes points for extrahepatic manifestations.”

    From Drug-induced liver injury. Part I: Classification, diagnosis and treatment (2025) · cites this paper as [36]

  • The value of non-liver-specific methods for assessing causality in DILI is limited.

    “Although some methods have been reported to assess causality in adverse drug reactions, including DILI, the value of non-liver-specific methods are limited [55,56].”

    From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [56]

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Metadata

Authors
Lucena, M. I., Camargo, R., Andrade, R. J., Perez-Sanchez, C. J., & De La Cuesta, F. S.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2001-01
Volume
33
Issue
1
Pages
123-130
ISSN
0270-9139
DOI
10.1053/jhep.2001.20645
Cited by
212
References
0
Language
en
Licence
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 5356 d)

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