TABLE 5. Data fields in the RUCAM, CDS, and RECAM causality assessment instruments.
Data field | Updated RUCAM108 score | CDS109 score | RECAM113 score |
---|---|---|---|
1. Chronology (latency) | |||
1a. Drug start to liver injury onseta | +1 to +2 | +1 to +3 | −6 to +4 |
1b. Drug discontinuation to liver injury onseta | +1 | −3 to +3 | −6 to 0 |
2. Dechallengeb | −2 to +3 hepatocellular; 0 to +2 cholestatic/mixed | 0 to +3 | −6 to +4 |
3. Competing causes of liver injury | −3 to +2 | −3 to +3 | −6 to 0 |
4. Rechallenge | 0 to +3 | +3 | 0 or + 6 |
5. Track record of drug/HDS hepatotoxicity | 0 to +2 | −3 to +2 | 0 to +3 |
Risk factors | 0 to +1 | N/A | N/Ac |
6. Concomitant medication | −3 to 0 | N/A | N/Ad |
7. Extrahepatic manifestations | – | 0 to +3 | – |
Range of scores | −9 to +14 | −6 to 17 | −6 to +20 |
DILI likelihood categories | |||
Definite | ≥ 9 | > 17 | Highly likely/high probable ≥ 8 |
Probable | 6–8 | 14–17 | 4–7 |
Possible | 3–5 | 10–13 | −3 to +3 |
Unlikely | 1–2 | 6–9 | Unlikely/excluded, < −4 |
Excluded | ≤ 0 | ≤ 6 |
Note: Only scores from the updated RUCAM are shown and are composites derived from hepatocellular and mixed/cholestatic categories.110
Abbreviations: CDS, clinical diagnostic scale; NA, not applicable; RECAM, Revised Electronic Causality Assessment Method; RUCAM, Roussel‐Uclaf Causality Assessment Method.
Only 1 of those 2 (i.e., only 1a or 1b) is counted.
Stratified by hepatocellular versus mixed/cholestatic in early version.
In RECAM, risk factors were not assigned scores.
RECAM was developed only for single drug cases and does not account for concomitant medications.