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. 2020 Sep 29;7(10):62. doi: 10.3390/medicines7100062

Table 6.

Characteristics of RUCAM.

RUCAM Specificities
Basic features

  • Validated method (gold standard) based on cases with positive reexposure test results, providing thereby a robust CAM

  • Worldwide use with 46,266 DILI cases assessed by RUCAM published 2014–2019, outperforming thereby any other CAM in term of number of cases published

  • Assesses causality in DILI and HILI cases validly and reproducibly

  • A typical intelligent diagnostic algorithm in line with artificial intelligence (AI) concepts

  • A diagnostic algorithm for objective, robust causality assessment

  • Assessment is user friendly, cost effective with results available in time and without needing expert rounds that often provide subjective and fragile, arbitrary opinions based on own experience

  • Transparency of case data and clear result presentation

  • Suitable for reevaluation by peers and any of other interested parties such as national regulatory agencies international registries, and pharma companies

  • Mandatory application for DILI cases if to be used for establishing new robust diagnostic biomarkers

  • High causality gradings with complete data

  • With prospective case data collection best results are obtainable

Clearly defined and scored key elements

  • Time frame of latency period

  • Time frame of dechallenge

  • Recurrent ALT or ALP increase

  • Risk factors

  • Individual comedications

  • Exclusion of alternative causes

  • Markers of HAV, HBV, HCV, HEV

  • Markers of CMV, EBV, HSV, VZV

  • Cardiac hepatopathy and other alternative causes

  • Liver and biliary tract imaging

  • Doppler sonography of liver vessels

  • Prior known hepatotoxicity of drug or herb

  • Unintentional reexposure

Other important specificities

  • Laboratory based hepatotoxicity criteria

  • Laboratory based liver injury pattern

  • Hepatotoxicity specific method

  • Structured, liver related method

  • Quantitative, liver related method, based on scored key elements

Abbreviations: AI: Artificial Intelligence; ALT: Alanine aminotransferase; ALP: Alkaline phosphatase; CAM: Causality assessment method; CMV: Cytomegalovirus; DILI: Drug induced liver injury; EBV: Epstein Barr virus; HAV: Hepatitis A virus; HBV: Hepatitis B virus; HCV: Hepatitis C virus; HEV: Hepatitis E virus; HILI: herb induced liver injury; HSV: Herpes simplex virus; RUCAM: Roussel Uclaf Causality Assessment Method; VZV: Varicella zoster virus.