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Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN).

Abstract

BACKGROUND & AIMS

Because of the lack of objective tests to diagnose drug-induced liver injury (DILI), causality assessment is a matter of debate. Expert opinion is often used in research and industry, but its test-retest reliability is unknown. To determine the test-retest reliability of the expert opinion process used by the Drug-Induced Liver Injury Network (DILIN).

METHODS

Three DILIN hepatologists adjudicate suspected hepatotoxicity cases to one of five categories representing levels of likelihood of DILI. Adjudication is based on retrospective assessment of gathered case data that include prospective follow-up information. One hundred randomly selected DILIN cases were re-assessed using the same processes for initial assessment but by three different reviewers in 92% of cases.

RESULTS

The median time between assessments was 938 days (range 140-2352). Thirty-one cases involved >1 agent. Weighted kappa statistics for overall case and individual agent category agreement were 0.60 (95% CI: 0.50-0.71) and 0.60 (0.52-0.68) respectively. Overall case adjudications were within one category of each other 93% of the time, while 5% differed by two categories and 2% differed by three categories. Fourteen per cent crossed the 50% threshold of likelihood owing to competing diagnoses or atypical timing between drug exposure and injury.

CONCLUSIONS

The DILIN expert opinion causality assessment method has moderate interobserver reliability but very good agreement within one category. A small but important proportion of cases could not be reliably diagnosed as ≥50% likely to be DILI.

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  • Authors+Show Affiliations

    ,

    Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.

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    Source

    MeSH

    Adult
    Aged
    Chemical and Drug Induced Liver Injury
    Cohort Studies
    Dietary Supplements
    Female
    Humans
    Male
    Middle Aged
    Plant Preparations
    Reproducibility of Results
    Risk Factors
    Severity of Illness Index

    Pub Type(s)

    Journal Article
    Research Support, N.I.H., Extramural
    Research Support, N.I.H., Intramural
    Validation Studies

    Language

    eng

    PubMed ID

    24661785

    Citation

    Hayashi, Paul H., et al. "Reliability of Causality Assessment for Drug, Herbal and Dietary Supplement Hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN)." Liver International : Official Journal of the International Association for the Study of the Liver, vol. 35, no. 5, 2015, pp. 1623-32.
    Hayashi PH, Barnhart HX, Fontana RJ, et al. Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN). Liver Int. 2015;35(5):1623-32.
    Hayashi, P. H., Barnhart, H. X., Fontana, R. J., Chalasani, N., Davern, T. J., Talwalkar, J. A., ... Rockey, D. C. (2015). Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN). Liver International : Official Journal of the International Association for the Study of the Liver, 35(5), pp. 1623-32. doi:10.1111/liv.12540.
    Hayashi PH, et al. Reliability of Causality Assessment for Drug, Herbal and Dietary Supplement Hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN). Liver Int. 2015;35(5):1623-32. PubMed PMID: 24661785.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN). AU - Hayashi,Paul H, AU - Barnhart,Huiman X, AU - Fontana,Robert J, AU - Chalasani,Naga, AU - Davern,Timothy J, AU - Talwalkar,Jayant A, AU - Reddy,K Rajender, AU - Stolz,Andrew A, AU - Hoofnagle,Jay H, AU - Rockey,Don C, Y1 - 2014/04/16/ PY - 2013/10/25/received PY - 2014/03/13/accepted PY - 2014/3/26/entrez PY - 2014/3/26/pubmed PY - 2016/1/15/medline KW - adverse reaction KW - diagnosis KW - drug-induced liver injury KW - hepatotoxicity KW - toxicity SP - 1623 EP - 32 JF - Liver international : official journal of the International Association for the Study of the Liver JO - Liver Int. VL - 35 IS - 5 N2 - BACKGROUND & AIMS: Because of the lack of objective tests to diagnose drug-induced liver injury (DILI), causality assessment is a matter of debate. Expert opinion is often used in research and industry, but its test-retest reliability is unknown. To determine the test-retest reliability of the expert opinion process used by the Drug-Induced Liver Injury Network (DILIN). METHODS: Three DILIN hepatologists adjudicate suspected hepatotoxicity cases to one of five categories representing levels of likelihood of DILI. Adjudication is based on retrospective assessment of gathered case data that include prospective follow-up information. One hundred randomly selected DILIN cases were re-assessed using the same processes for initial assessment but by three different reviewers in 92% of cases. RESULTS: The median time between assessments was 938 days (range 140-2352). Thirty-one cases involved >1 agent. Weighted kappa statistics for overall case and individual agent category agreement were 0.60 (95% CI: 0.50-0.71) and 0.60 (0.52-0.68) respectively. Overall case adjudications were within one category of each other 93% of the time, while 5% differed by two categories and 2% differed by three categories. Fourteen per cent crossed the 50% threshold of likelihood owing to competing diagnoses or atypical timing between drug exposure and injury. CONCLUSIONS: The DILIN expert opinion causality assessment method has moderate interobserver reliability but very good agreement within one category. A small but important proportion of cases could not be reliably diagnosed as ≥50% likely to be DILI. SN - 1478-3231 UR - https://www.unboundmedicine.com/medline/citation/24661785/Reliability_of_causality_assessment_for_drug_herbal_and_dietary_supplement_hepatotoxicity_in_the_Drug_Induced_Liver_Injury_Network__DILIN__ L2 - https://doi.org/10.1111/liv.12540 DB - PRIME DP - Unbound Medicine ER -