Impact of methodological choices on findings from pharmacoepidemiological studies: Final results of the IMI-protect (pharmacoepidemiological research on outcomes of therapeutics by a European consortium) project
Klungel, Olaf; De Groot, Mark; Gardarsdottir, Helga; Brauer, Ruth; Grimaldi-Bensouda, Lamiae; Kurz, Xavier; Gasse, Christiane; Reynolds, Robert
(2014) Pharmacoepidemiology and Drug Safety, volume 23, issue S1, pp.
(Abstract)
Abstract
Background: Pharmacoepidemiological (PE) research should provide consistent, reliable and reproducible results to contribute to the benefit-risk assessment of medicines. IMI-PROTECT aims to identify sources of methodological variations in PE studies using a common protocol and analysis plan across databases (including independent replication studies). In addition, differences by design, applied to
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a same drug-adverse event (AE) pair in different databases are examined. Results from PE studies will be evaluated on 7 drug-AE pairs (i.e. 1. antibiotics and acute liver injury; 2. antidepressants and hip fracture; 3. benzodiazepines and hip fracture; 4. anticonvulsants and suicide/suicide attempts; 5. calcium channel blockers and malignancies; 6. inhaled longacting β2 agonists and acute myocardial infarction; 7. a negative control study: antibiotics and acute myocardial infarction) conducted in 7 European and 1 US electronic databases. These are: the CPRD and THIN from the UK, the Danish national registries, the Dutch Mondriaan project (NPCRD, AHC), the Spanish BIFAP, the French PGRx and the US InVision Datamart. Objectives: To review and understand the methodological issues encountered in these studies and to draw conclusions about their relevance for future PE research.
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Keywords: antibiotic agent, calcium channel blocking agent, anticonvulsive agent, benzodiazepine derivative, antidepressant agent, pharmacoepidemiology, risk management, therapy, data base, hip fracture, acute heart infarction, agonist, liver injury, replication study, register, United Kingdom, risk assessment
ISSN: 1053-8569
Publisher: John Wiley and Sons Ltd
Note: Abstracts of the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, October 24–27, 2014, Taipei, Taiwan
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