Signal detection on spontaneous reports of adverse events following immunisation: a comparison of the performance of a disproportionality-based algorithm and a time-to-onset-based algorithm.
Bottom Line: The vaccine product labels were used as proxies for true safety signals.A TTO algorithm with roughly the same sensitivity as the highest-ranked MGPS had better specificity but longer time-to-detection.Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
Affiliation: Vaccine Safety Research Group (VSRG), Vaccines Clinical Safety & Pharmacovigilance (VCSP), GlaxoSmithKline Vaccines, Wavre, Belgium.Show MeSH
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Mentions: Receiver operating characteristic plots 12 were generated for the three TTO algorithms (with time windows of 30, 60 and 90 days after immunisation) by varying the p-value threshold from 0 to 1 by 0.01 and for each MGPS set of stratification factors by varying the EB05 threshold from 0 to 10 by 0.1 (Figure 1). The ROC curves associated to TTO algorithms are above all MGPS ROC curves, whatever the choice of stratifications.
Affiliation: Vaccine Safety Research Group (VSRG), Vaccines Clinical Safety & Pharmacovigilance (VCSP), GlaxoSmithKline Vaccines, Wavre, Belgium.