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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.

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.

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  • Authors+Show Affiliations

    ,

    Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX 75390-8887, USA. don.rockey@utsouthwestern.edu

    , , , , , , ,

    Source

    Hepatology (Baltimore, Md.) 51:6 2010 Jun pg 2117-26

    MeSH

    Adult
    Aged
    Chemical and Drug Induced Liver Injury
    Expert Testimony
    Female
    Humans
    Male
    Middle Aged
    Prospective Studies

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    20512999

    Citation

    Rockey, Don C., et al. "Causality Assessment in Drug-induced Liver Injury Using a Structured Expert Opinion Process: Comparison to the Roussel-Uclaf Causality Assessment Method." Hepatology (Baltimore, Md.), vol. 51, no. 6, 2010, pp. 2117-26.
    Rockey DC, Seeff LB, Rochon J, et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method. Hepatology. 2010;51(6):2117-26.
    Rockey, D. C., Seeff, L. B., Rochon, J., Freston, J., Chalasani, N., Bonacini, M., ... Hayashi, P. H. (2010). Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method. Hepatology (Baltimore, Md.), 51(6), pp. 2117-26. doi:10.1002/hep.23577.
    Rockey DC, et al. Causality Assessment in Drug-induced Liver Injury Using a Structured Expert Opinion Process: Comparison to the Roussel-Uclaf Causality Assessment Method. Hepatology. 2010;51(6):2117-26. PubMed PMID: 20512999.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method. AU - Rockey,Don C, AU - Seeff,Leonard B, AU - Rochon,James, AU - Freston,James, AU - Chalasani,Naga, AU - Bonacini,Maurizio, AU - Fontana,Robert J, AU - Hayashi,Paul H, AU - ,, PY - 2010/6/1/entrez PY - 2010/6/1/pubmed PY - 2010/6/18/medline SP - 2117 EP - 26 JF - Hepatology (Baltimore, Md.) JO - Hepatology VL - 51 IS - 6 N2 - UNLABELLED: 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. SN - 1527-3350 UR - https://www.unboundmedicine.com/medline/citation/20512999/Causality_assessment_in_drug_induced_liver_injury_using_a_structured_expert_opinion_process:_comparison_to_the_Roussel_Uclaf_causality_assessment_method_ L2 - https://doi.org/10.1002/hep.23577 DB - PRIME DP - Unbound Medicine ER -