New approaches to fill the methods gap in pharmacovigilance
New approaches to fill the methods gap in pharmacovigilance
New approaches to fill the methods gap in pharmacovigilance
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Study<strong>in</strong>g long-term effects <strong>in</strong> databasesmethodological challenges Selection bias Who are long-term users? Health-seek<strong>in</strong>g behavior Well-controlled Co-medicationIf selection <strong>to</strong> rema<strong>in</strong> <strong>in</strong> <strong>the</strong> cohort is based on fac<strong>to</strong>rsrelated <strong>to</strong> outcome, <strong>the</strong>n results will be biased Some analytic options Comparison of <strong>in</strong>itia<strong>to</strong>rs vs. <strong>in</strong>itia<strong>to</strong>rs and model time-vary<strong>in</strong>ghazards Comparison of switchers vs. switchers consider<strong>in</strong>g cumulativemedication his<strong>to</strong>ry from <strong>in</strong>itiation until switch (dose, duration,etc).19