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Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis

Maria, V A, Victorino, R M·1997·Hepatology
DOI 10.1002/hep.510260319
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Abstract

The objective of this study is to present and validate a clinical scale for the diagnosis of drug-induced liver injury (DILI). Five components were selected to be included in the scale: temporal relationship between drug intake and the onset of clinical picture, exclusion of alternative causes, extrahepatic manifestations, rechallenge or accidental re-exposure, and previous report in medical literature. The relative importance of each component was weighed, and arbitrary scores were attributed. The probability of the diagnosis of DILI was expressed as a final score, which could vary from -6 to 20. Content validity, criterion validity, construct validity, and inter-rater reliability were studied. To analyze validity and reliability, a random sample of 50 cases of suspected DILI was drawn from a series of 120 cases reported to our unit. The classification of the 50 cases by three experts in DILI was used as the external standard in the study of criterion validity. Agreement between the scale and the standard, and agreement between two independent raters (inter-rater reliability) was analyzed by weighted κ coefficient. There was agreement between the scale and the standard in 42 cases (84%) with a weighted κ coefficient of 0.90. A good discriminatory capacity of the scale was found when construct validity was studied. Agreement between raters was observed in 86% of the cases, corresponding to the weighted κ of 0.93. In conclusion, the clinical scale was shown to have a high-level of validity and inter-rater reliability as well as a good discriminatory capacity between different levels of probability. These data suggest that the scale is suitable for use in clinical practice and may contribute to overcome the difficulties in the process of causality assessment in DILI.

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  • 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 [35]

  • 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 [35]

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Research works printed but not linked: 13

  1. REFERENCES standard to accurately discriminate between individuals with and without DILI. Second, in all cases of suspected DILI, our 1. Miller RR. Hospital admissions due to adverse drug reactions. A report from the Boston Collaborative Drug Surveillance Program. Arch Intern scale always makes the final probability dependent on the Med 1974;134:219-223. analysis of seven parameters, whereas with the decision tree, 2. Lewis JH, Zimmerman HJ. Drug-induced liver disease. Med Clin North the final classification rests frequently on the analysis of a Am 1989;73:775-792.
  2. single parameter. This may increase significantly the possibil- 3. Døssing M, Andreasen PB. Drug-induced liver disease in Denmark. An analysis of 572 cases of hepatotoxicity reported to the Danish Board of ity of error, particularly in more complex cases. Adverse Reactions to Drugs. Scand J Gastroenterol 1982;17:205-211.
  3. Despite its recognized low sensitivity, immunological tests 4. Friis H, Andreasen PB. Drug-induced hepatic injury: an analysis of 1100 are usually considered as highly specific when positive. 18 cases reported to the Danish Committee of Adverse Drug Reactions They could be used as an additional standard in the process between 1978 and 1987. J Intern Med 1992;232:133-138.
  4. Maddrey WC, Boitnott JR. Drug-induced chronic liver disease. Gastro- enterology 1977;72:1348-1353. between the classification of the scale and the results of im- 6. Sharp JR, Ishak KG, Zimmerman HJ. Chronic active hepatitis and severe munological tests observed in our study represents additional hepatic necrosis associated with nitrofurantoin. Ann Intern Med 1980; evidence in favor of the validity of the instrument. 92:14-19. Our scale has considerable similarities with the one pro- 7. Ransohoff DF, Jacobs G. Terminal hepatic failure following a small dose of sulfametoxazole-trimethoprim. Gastroenterology 1981;80:816-819.
  5. Berg PA, Becker EW. The lymphocyte transformation test a-debated eases of the Gastrointestinal Tract and Liver. London: Churchill Living- method for the evaluation of drug allergic hepatic injury. J Hepatol stone, 1989. 1995;22:115-118.
  6. Davies MH, Harrison RF, Elias E, Hubscher G. Antibiotic-associated 19. Be ´nichou C. Criteria of drug-induced liver disorders: report of an inter- acute vanishing bile duct syndrome: a pattern associated with severe, national consensus meeting. J Hepatol 1990;11:272-276.
  7. prolonged, intrahepatic cholestasis. J Hepatol 1994;20:112-116.
  8. Danan G, Be ´nichou C, Flahault A. Score d'imputation d'une atteinte 10. Calmus Y, Biour M, Poupon R. Les tests in vitro dans le diagnostic des he ´patique aigue a `un me ´dicament. Gastroenterol Clin Biol 1993;17: he ´patites me ´dicamenteuses. Gastroenterol Clin Biol 1987;11:586-598. H22-24.
  9. Steiner DL, Norman GR. Health Measurement Scales. A Practical Guide 12. Gennis MA, Vemmuri R, Burns EA, Hill JV, Miller MA, Spielberg SP. to Their Development and Use. Oxford: Oxford University Press, 1991. Familial occurrence of hypersensitivity to phenitoin. Am J Med 1991;
  10. Victorino RMM, Maria VAJ, Correia AP, de Moura MC. Floxacillin- 91:631-634. induced cholestatic hepatitis with evidence of lymphocyte sensitization. 13. Victorino RMM, Maria VAJ. Modifications of lymphocyte transforma- Arch Intern Med 1987;147:987-989.
  11. tion test in a case of drug-induced cholestatic hepatitis. Diagnostic 24. Maria VAJ, Silva JP, Victorino RMM. Agranulocytosis and liver damage Immunol 1985;3:171-181. associated to pyrazinobutazone with evidence for an immunological 14. Victorino RMM, Maria VAJ, Pinto L. Evidence for prostaglandin produc- mechanism. J Rheumatol 1989;16:1484-1485. ing suppressor cells in drug-induced hepatitis and implications in the 25. Stricker BH. Diagnosis and causality assessment of drug-induced hepatic diagnosis of drug sensitization. Clin Exp Immunol 1992;87:132-137.
  12. injury. In: Dukes MNG, ed. Drug-Induced Hepatic Injury. Amsterdam: 15. Maria VAJ, Pinto L, Victorino RMM. Lymphocyte reactivity to ex-vivo Elsevier, 1992:1-13. drug antigens in drug-induced hepatitis. J Hepatol 1994;21:151-158.
  13. Tsutsui H, Terano Y, Sakagami C, Haseqawa I, Mizoguchi Y, Morisawa 28. Czaja AJ, Carpenter HA. Validation of scoring system for diagnosis of S. Drug specific T cells derived from patients with drug-induced allergic hepatitis. J Immunol 1992;149:706-716. autoimmune hepatitis. Dig Dis Sci 1996;41:305-314.

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Metadata

Authors
Maria, V. A., & Victorino, R. M.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
1997-09
Volume
26
Issue
3
Pages
664-669
ISSN
0270-9139
DOI
10.1002/hep.510260319
Cited by
351
References
3
Language
en
Licence
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 6574 d)

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