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Improving the Diagnostic Accuracy of RECAM in North American Patients With Suspected Idiosyncratic Drug-Induced Liver Injury
Abstract
INTRODUCTION: The Revised Electronic Causality Assessment Method (RECAM) is an updated, electronic version of the Roussel Uclaf Causality Assessment Method (RUCAM) to diagnose drug-induced liver injury (DILI). The primary aim of this study was to compare RECAM vs RUCAM in patients with suspected DILI. METHODS: Patient encounters from October 1, 2015, to September 30, 2019, were searched for suspected DILI using ICD-10 K71 codes for toxic liver disease. DILI Network (DILIN) expert opinion scores were assigned to each case (1/2/3 = probable DILI, 4/5 = non-DILI). RECAM and RUCAM scores were compared with DILIN expert opinion scores. RESULTS: Among 766,930 encounters searched, 120 unique patients met inclusion criteria with 72 (60%) adjudicated as probable-DILI. The most frequent suspect drugs were antimicrobials (38.3%), antineoplastics (8.3%), and antirheumatic drugs (8.3%). The mean age was 49.2 + 15.6 years, and 50% were female with 45.8% having hepatocellular injury. RUCAM had better agreement with DILIN expert opinion for probable-DILI vs RECAM (66.7% vs 44.4%, P = 0.018). Both had 100% agreement with DILIN expert opinion for non-DILI. Frequently missing laboratory data included hepatitis C virus (HCV) RNA (64.3%) and antihepatitis E virus (HEV) immunoglobulin M (IgM) testing (70%), leading to loss of up to 6 points in RECAM scoring but not affecting RUCAM scores. A modified RECAM that made HCV RNA and anti-HEV IgM optional had better agreement with DILIN expert opinion compared with RUCAM (79.2% vs 66.7%, P = 0.09). DISCUSSION: Among 120 suspected DILI cases, RUCAM had better agreement with DILIN expert opinion scores vs RECAM. Making HCV RNA and anti-HEV IgM testing optional significantly improved agreement between RECAM and DILIN expert opinion. Future modifications to RECAM are needed to improve causality assessment in North American patients with suspected DILI.
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“The group from Cincinnati reported 123 suspected DILI cases and found that removal of the requirement for HCV-RNA and HEV testing would improve the scoring system compared with expert opinion. 25”
From The contemporary epidemiology, causes, and management of drug-induced liver injury (2026) · cites this paper as [25]
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Cites
EASL Clinical Practice Guidelines: Drug-induced liver injury
Andrade, R. J., Aithal, G. P., Björnsson, E. S., Kaplowitz, N., Kullak-Ublick, G. A., Larrey, D., & Karlsen, T. H. (2019) · Journal of Hepatology · doi:10.1016/j.jhep.2019.02.014 · Cited by 1,276
ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury
Chalasani, N. P., Maddur, H., Russo, M. W., Wong, R. J., Reddy, K. R., & on behalf of the Practice Parameters Committee of the American College of Gastroenterology (2021) · American Journal of Gastroenterology · doi:10.14309/ajg.0000000000001259 · Cited by 430
AASLD practice guidance on drug, herbal, and dietary supplement–induced liver injury
Fontana, R. J., Liou, I., Reuben, A., Suzuki, A., Fiel, M. I., Lee, W., & Navarro, V. (2023) · Hepatology · doi:10.1002/hep.32689 · Cited by 340
Self-citationA revised electronic version of RUCAM for the diagnosis of DILI
Hayashi, P. H., Lucena, M. I., Fontana, R. J., Bjornsson, E. S., Aithal, G. P., Barnhart, H., Gonzalez‐Jimenez, A., Yang, Q., Gu, J., Andrade, R. J., et al. (2022) · Hepatology · doi:10.1002/hep.32327 · Cited by 160
Self-citationYeboah-Korang, A., Louissaint, J., Tsung, I., Prabhu, S., & Fontana, R. J. (2020) · Drug Safety · doi:10.1007/s40264-019-00903-5 · Cited by 15
Self-citationValidation of the revised electronic version of RUCAM for diagnosis of DILI in Chinese patients
Zhao, X., Wang, Y., Lai, R., Wang, X., Yu, Y., Li, M., Zhao, H., Ma, Z., Li, M., Guo, T., et al. (2024) · Hepatology Communications · doi:10.1097/hc9.0000000000000235 · Cited by 12
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Cited by
The contemporary epidemiology, causes, and management of drug-induced liver injury
Swanson, L., & Fontana, R. J. (2026) · Hepatology Communications · doi:10.1097/hc9.0000000000001011
Self-citation
Metadata
- Authors
- Ciricillo, J., Myer, A., Yeboah-Korang, A., Osman, A., Rahim, F., Goldfarb, D. G., Sharma, Y., Louissaint, J., Sherman, K. E., & Fontana, R. J.
- Affiliations
- Division of Digestive Diseases, University of Cincinnati Medical Center, Cincinnati, Ohio, USA;
- Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Brooklyn, New York, USA;
- Division of Gastroenterology and Hepatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA;
- Division of Gastroenterology and Hepatology, University of Michigan Health System, Ann Arbor, Michigan, USA.
- ORCID
- Venue
- American Journal of Gastroenterology
- Published
- 2024-10-18
- Volume
- 120
- Issue
- 6
- Pages
- 1325-1333
- ISSN
- 0002-9270
- 1572-0241
- Cited by
- 6
- References
- 6
- Language
- en
- Funders
- American Association for the Study of Liver Diseases (2018 AASLD Foundation Advanced/Transplant Hepatology Grant)
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- Ciricillo, J., Myer, A., Yeboah-Korang, A., Osman, A., Rahim, F., Goldfarb, D. G., Sharma, Y., Louissaint, J., Sherman, K. E., & Fontana, R. J. (2025). Improving the Diagnostic Accuracy of RECAM in North American Patients With Suspected Idiosyncratic Drug-Induced Liver Injury. American Journal of Gastroenterology. https://doi.org/10.14309/ajg.0000000000003147
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