Improving the Diagnostic Accuracy of RECAM in North American Patients With Suspected Idiosyncratic Drug-Induced Liver Injury

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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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