P. Tubertbitter et al., COMPARING THE TOXICITY OF 2 DRUGS IN THE FRAMEWORK OF SPONTANEOUS REPORTING - A CONFIDENCE-INTERVAL APPROACH, Journal of clinical epidemiology, 49(1), 1996, pp. 121-123
Citations number
15
Categorie Soggetti
Public, Environmental & Occupation Heath","Medicine, General & Internal
Spontaneous reporting remains the most frequently used technique in po
st-marketing surveillance. Decision making usually depends on comparis
ons between the number of adverse drug reactions (ADRs) reported for t
wo drugs on the basis of an equivalent number of prescriptions. The va
lidity of such comparisons is expected to be jeopardized by probable u
nderreporting of ADR cases. This problem is accentuated when it cannot
be assumed that the magnitude of underreporting is the same for the b
oth drugs. Differences in reporting ratios can overemphasize, cancel,
or reverse the conclusions of a statistical comparison based on the nu
mber of reports. We propose a single method for (1) calculating confid
ence intervals for relative risks estimated in the context of spontane
ous reporting and (2) deriving the range of reporting ratios for which
the conclusion of the statistical comparison remains statistically va
lid.