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Causality Assessment in Drug-Induced Liver Injury Using A Structured Expert Opinion Process: Comparison to the Roussel-Uclaf Causality Assessment Method

Rockey, Don C., Seeff, Leonard B., Rochon, James, Freston, James, Chalasani, Naga, Bonacini, Maurizio, Fontana, Robert J., Hayashi, Paul H.·2010·Hepatology
DOI 10.1002/hep.23577PMC PMC3249230
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Abstract

Drug-induced liver injury (DILI) is largely a diagnosis of exclusion and is therefore challenging. The US Drug-Induced Liver Injury Network (DILIN) prospective study used two methods to assess DILI causality: a structured expert opinion process and the Roussel-Uclaf Causality Assessment Method (RUCAM). Causality assessment focused on detailed clinical and laboratory data from patients with suspected DILI. The adjudication process used standardized numerical and descriptive definitions and scored cases as definite, highly likely, probable, possible, or unlikely. Results of the structured expert opinion procedure were compared with those derived by the RUCAM approach. Among 250 patients with suspected DILI, the expert opinion adjudication process scored 78 patients (31%) as definite, 102 (41%) as highly likely, 37 (15%) as probable, 25 (10%) as possible, and 8 (3%) as unlikely. Among 187 enrollees who had received a single implicated drug, initial complete agreement was reached for 50 (27%) with the expert opinion process and for 34 (19%) with a five-category RUCAM scale ( P = 0.08), and the two methods demonstrated a modest correlation with each other (Spearman's r = 0.42, P = 0.0001). Importantly, the RUCAM approach substantially shifted the causality likelihood toward lower probabilities in comparison with the DILIN expert opinion process. Conclusion : The structured DILIN expert opinion process produced higher agreement rates and likelihood scores than RUCAM in assessing causality, but there was still considerable interobserver variability in both. Accordingly, a more objective, reliable, and reproducible means of assessing DILI causality is still needed. Hepatology 2010

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  • The likelihood of DILI can be divided into five probability groups: definite >95%, highly likely 75-95%, probable 50-74%, possible 25-49%, unlikely <25%.

    “The likelihood of DILI can be divided into five probability groups: definite, > 95% likelihood; highly likely, 75-95% likelihood; probable, 50-74% likelihood; possible, 25-49% likelihood; and unlikely, < 25% likelihood [62].”

    From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [62]

  • Prospective research conducted in the DILIN used a structured expert opinion process (SEOP) for causality assessment.

    “Prospective research conducted in the DILIN used a structured expert opinion process (SEOP) for causality assessment [62].”

    From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [62]

  • Despite inter-observer variability with both instruments, the expert opinion approach resulted in superior inter-rater agreement and improved likelihood score compared with RUCAM.

    “Despite the demonstration of inter‐observer variability with both instruments, the expert opinion approach resulted in superior inter‐rater agreement and improved the likelihood score.”

    From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [40]

  • When compared with RUCAM, concordance between expert opinion and RUCAM yielded a correlation coefficient of .42 and low complete inter-rater agreement.

    “When compared with RUCAM, the concordance between the two methods yielded a correlation coefficient of .42 and a low complete inter‐rater agreement.”

    From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [40]

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Citations

Cites

  • Statistical Methods for Rates and Proportions

    Fleiss, J. L., Levin, B., & Paik, M. C. (2003) · Wiley Series in Probability and Statistics · doi:10.1002/0471445428 · Cited by 18,646

  • A method for estimating the probability of adverse drug reactions

    Naranjo, C. A., Busto, U., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., Janecek, E., Domecq, C., & Greenblatt, D. J. (1981) · Clinical Pharmacology and Therapeutics · doi:10.1038/clpt.1981.154 · Cited by 11,914 · cited 1×

    “Efforts have therefore turned toward developing more objective diagnostic strategies through the creation of specific instruments such as the Roussel-Uclaf Causality Assessment Method (RUCAM), the Maria and Victorino method, and the Naranjo scale, the last designed to assess all forms of adverse drug reactions.(9-13)…”
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Research works printed but not linked: 26

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Metadata

Authors
Rockey, D. C., Seeff, L. B., Rochon, J., Freston, J., Chalasani, N., Bonacini, M., Fontana, R. J., & Hayashi, P. H.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2010-06
Volume
51
Issue
6
Pages
2117-2126
ISSN
0270-9139
DOI
10.1002/hep.23577
PMC
PMC3249230
Cited by
313
References
2
Language
en
Licence
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 1918 d)

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