ALGORITHMS USED IN ADVERSE DRUG EVENT REPORTS - A COMPARATIVE-STUDY

OBJECTIVE: TO determine if and how the Kramer and Karch algorithms dif fer in assigning a probability that a published case was actually an a dverse drug event (ADE), and to determine if these algorithms could be used to assess published ADEs. DESIGN: Open, single-rater comparison of Karch and Kramer algorithms in 200 published ADE reports. MAIN RESU LTS: The algorithms were not significantly different regarding the pro portion of cases deemed definite (p = 0.5204) or probable (p = 0.2972) ADEs. The Kramer instrument was more likely to assign a possible risk of ADE (p = 0.0001), while the Karch instrument was more likely to as sign a risk of unlikely (p = 0.0001), The algorithms agreed in 41% of the cases and could be used to assess published ADEs. CONCLUSIONS: The Karch and Kramer algorithms may disagree in how they assign a probabi lity of risk to a potential ADE. This may be due to how algorithms are applied as well as to structural differences.