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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.

van Holle L, Bauchau V - Pharmacoepidemiol Drug Saf (2013)

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.

View Article: PubMed Central - PubMed

Affiliation: Vaccine Safety Research Group (VSRG), Vaccines Clinical Safety & Pharmacovigilance (VCSP), GlaxoSmithKline Vaccines, Wavre, Belgium.

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Related in: MedlinePlus

Receiver operating characteristic curves associated to the three time-to-onset algorithms based on time window length of 30, 60 and 90 days after immunisation (red dotted line) and the 16 choices of stratification of the multi-item gamma Poisson shrinker (blue solid line)
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fig01: Receiver operating characteristic curves associated to the three time-to-onset algorithms based on time window length of 30, 60 and 90 days after immunisation (red dotted line) and the 16 choices of stratification of the multi-item gamma Poisson shrinker (blue solid line)

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.


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.

van Holle L, Bauchau V - Pharmacoepidemiol Drug Saf (2013)

Receiver operating characteristic curves associated to the three time-to-onset algorithms based on time window length of 30, 60 and 90 days after immunisation (red dotted line) and the 16 choices of stratification of the multi-item gamma Poisson shrinker (blue solid line)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4265288&req=5

fig01: Receiver operating characteristic curves associated to the three time-to-onset algorithms based on time window length of 30, 60 and 90 days after immunisation (red dotted line) and the 16 choices of stratification of the multi-item gamma Poisson shrinker (blue solid line)
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.

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.

View Article: PubMed Central - PubMed

Affiliation: Vaccine Safety Research Group (VSRG), Vaccines Clinical Safety & Pharmacovigilance (VCSP), GlaxoSmithKline Vaccines, Wavre, Belgium.

Show MeSH
Related in: MedlinePlus