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Table 1 Characteristics of published instruments assessing causal relationship between medication exposure and adverse events

From: Use of case reports and the Adverse Event Reporting System in systematic reviews: overcoming barriers to assess the link between Crohn’s disease medications and hepatosplenic T-cell lymphoma

 

Naranjo

Kramer

WHO

Numerical range

−4 to +13

−7 to +7

n/a

Format

Ten questions answered ‘yes,’ ‘no,’ or ‘don’t know,’ each with a numerical value; numbers summed for final score. Higher scores indicate greater likelihood of causality.

An algorithm with six separate axes/flowcharts. Each axis contributes points to the final score. Higher scores indicate greater likelihood of causality.

Contains six categories; the user selects the one for which most criteria are met.

Distinguishes irreversible adverse events from other adverse events?

No

Yes

No

Addresses methods used to confirm adverse event?

Yes

No

No

Asks about serum medication levels?

Yes

Yes

No

Considers prior experience with medication?

Yes

Yes

Yes

Considers alternate etiologies?

Yes

Yes

Yes

Questions about rechallenge?

Yes

Yes

Yes

Questions about dechallenge?

Yes

Yes

Yes

  1. n/a, not applicable; WHO, World Health Organization.