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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: Time-to-onset (TTO) methods measure how unexpected the TTO distribution of a vaccine-event pair is compared with what is expected from other vaccines and events.Our purpose is to compare the performance associated with each method.The vaccine product labels were used as proxies for true safety signals.

View Article: PubMed Central - PubMed

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

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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: Time-to-onset (TTO) methods measure how unexpected the TTO distribution of a vaccine-event pair is compared with what is expected from other vaccines and events.Our purpose is to compare the performance associated with each method.The vaccine product labels were used as proxies for true safety signals.

View Article: PubMed Central - PubMed

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

Show MeSH