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

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.

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.

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).

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.