Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project

Victoria Abbing-Karahagopian; Xavier Kurz; Frank de Vries; Tjeerd P van Staa; Yolanda Alvarez; Ulrik Hesse; Joerg Hasford; Liset van Dijk; Francisco J de Abajo; John G Weil; Lamiae Grimaldi-Bensouda; Antoine C G Egberts; Robert F Reynolds; Olaf H Klungel

doi:10.2174/1574884708666131111211802

Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project

Victoria Abbing-Karahagopian, Xavier Kurz, Frank de Vries, Tjeerd P van Staa, Yolanda Alvarez, Ulrik Hesse, Joerg Hasford, Liset van Dijk, Francisco J de Abajo, John G Weil, Lamiae Grimaldi-Bensouda, Antoine C G Egberts, Robert F Reynolds, Olaf H Klungel^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: Observational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis.

PURPOSE: The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied.

METHODS: Based on two consensus meetings and a literature search, we selected five drug-adverse event (AE) pairs to be evaluated in different databases. This selection was done according to pre-defined criteria such as regulatory and public health impact, and the potential to investigate a broad range of methodological issues.

RESULTS: The selected drug-AE pairs are: 1) inhaled long-acting beta-2 agonists and acute myocardial infarction; 2) antimicrobials and acute liver injury; 3) antidepressants and/or benzodiazepines and hip fracture; 4) anticonvulsants and suicide/suicide attempts; and 5) calcium channel blockers and malignancies. Six European databases, that will be used to evaluate the drug-AE pairs retrospectively, are also described.

CONCLUSION: The selected drug-AE pairs will be evaluated in PE studies using common protocols. Based on consistencies and discrepancies of these studies, a framework for guiding methodological choices will be developed. This will increase the usefulness and reliability of PE studies for benefit-risk assessment and decision-making.

Original language	English
Pages (from-to)	130-138
Number of pages	9
Journal	Current Clinical Pharmacology
Volume	9
Issue number	2
DOIs	https://doi.org/10.2174/1574884708666131111211802
Publication status	Published - May 2014
Externally published	Yes

Keywords

Adverse Drug Reaction Reporting Systems/statistics & numerical data
Databases, Factual/statistics & numerical data
Drug-Related Side Effects and Adverse Reactions/epidemiology
Europe/epidemiology
Humans
Pharmacoepidemiology/methods
Reproducibility of Results
Retrospective Studies
Risk Assessment/methods

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10.2174/1574884708666131111211802Licence: CC BY

Cite this

Abbing-Karahagopian, V., Kurz, X., de Vries, F., van Staa, T. P., Alvarez, Y., Hesse, U., Hasford, J., Dijk, L. V., de Abajo, F. J., Weil, J. G., Grimaldi-Bensouda, L., Egberts, A. C. G., Reynolds, R. F., & Klungel, O. H. (2014). Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project. Current Clinical Pharmacology, 9(2), 130-138. https://doi.org/10.2174/1574884708666131111211802

@article{df3d9af7f5d546358affe0ce2dab422b,

title = "Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project",

abstract = "BACKGROUND: Observational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis.PURPOSE: The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied.METHODS: Based on two consensus meetings and a literature search, we selected five drug-adverse event (AE) pairs to be evaluated in different databases. This selection was done according to pre-defined criteria such as regulatory and public health impact, and the potential to investigate a broad range of methodological issues.RESULTS: The selected drug-AE pairs are: 1) inhaled long-acting beta-2 agonists and acute myocardial infarction; 2) antimicrobials and acute liver injury; 3) antidepressants and/or benzodiazepines and hip fracture; 4) anticonvulsants and suicide/suicide attempts; and 5) calcium channel blockers and malignancies. Six European databases, that will be used to evaluate the drug-AE pairs retrospectively, are also described.CONCLUSION: The selected drug-AE pairs will be evaluated in PE studies using common protocols. Based on consistencies and discrepancies of these studies, a framework for guiding methodological choices will be developed. This will increase the usefulness and reliability of PE studies for benefit-risk assessment and decision-making.",

keywords = "Adverse Drug Reaction Reporting Systems/statistics & numerical data, Databases, Factual/statistics & numerical data, Drug-Related Side Effects and Adverse Reactions/epidemiology, Europe/epidemiology, Humans, Pharmacoepidemiology/methods, Reproducibility of Results, Retrospective Studies, Risk Assessment/methods",

author = "Victoria Abbing-Karahagopian and Xavier Kurz and {de Vries}, Frank and {van Staa}, {Tjeerd P} and Yolanda Alvarez and Ulrik Hesse and Joerg Hasford and Dijk, {Liset van} and {de Abajo}, {Francisco J} and Weil, {John G} and Lamiae Grimaldi-Bensouda and Egberts, {Antoine C G} and Reynolds, {Robert F} and Klungel, {Olaf H}",

year = "2014",

month = may,

doi = "10.2174/1574884708666131111211802",

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pages = "130--138",

journal = "Current Clinical Pharmacology",

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Abbing-Karahagopian, V, Kurz, X, de Vries, F, van Staa, TP, Alvarez, Y, Hesse, U, Hasford, J, Dijk, LV, de Abajo, FJ, Weil, JG, Grimaldi-Bensouda, L, Egberts, ACG, Reynolds, RF & Klungel, OH 2014, 'Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project', Current Clinical Pharmacology, vol. 9, no. 2, pp. 130-138. https://doi.org/10.2174/1574884708666131111211802

TY - JOUR

T1 - Bridging differences in outcomes of pharmacoepidemiological studies

T2 - design and first results of the PROTECT project

AU - Abbing-Karahagopian, Victoria

AU - Kurz, Xavier

AU - de Vries, Frank

AU - van Staa, Tjeerd P

AU - Alvarez, Yolanda

AU - Hesse, Ulrik

AU - Hasford, Joerg

AU - Dijk, Liset van

AU - de Abajo, Francisco J

AU - Weil, John G

AU - Grimaldi-Bensouda, Lamiae

AU - Egberts, Antoine C G

AU - Reynolds, Robert F

AU - Klungel, Olaf H

PY - 2014/5

Y1 - 2014/5

N2 - BACKGROUND: Observational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis.PURPOSE: The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied.METHODS: Based on two consensus meetings and a literature search, we selected five drug-adverse event (AE) pairs to be evaluated in different databases. This selection was done according to pre-defined criteria such as regulatory and public health impact, and the potential to investigate a broad range of methodological issues.RESULTS: The selected drug-AE pairs are: 1) inhaled long-acting beta-2 agonists and acute myocardial infarction; 2) antimicrobials and acute liver injury; 3) antidepressants and/or benzodiazepines and hip fracture; 4) anticonvulsants and suicide/suicide attempts; and 5) calcium channel blockers and malignancies. Six European databases, that will be used to evaluate the drug-AE pairs retrospectively, are also described.CONCLUSION: The selected drug-AE pairs will be evaluated in PE studies using common protocols. Based on consistencies and discrepancies of these studies, a framework for guiding methodological choices will be developed. This will increase the usefulness and reliability of PE studies for benefit-risk assessment and decision-making.

AB - BACKGROUND: Observational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis.PURPOSE: The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied.METHODS: Based on two consensus meetings and a literature search, we selected five drug-adverse event (AE) pairs to be evaluated in different databases. This selection was done according to pre-defined criteria such as regulatory and public health impact, and the potential to investigate a broad range of methodological issues.RESULTS: The selected drug-AE pairs are: 1) inhaled long-acting beta-2 agonists and acute myocardial infarction; 2) antimicrobials and acute liver injury; 3) antidepressants and/or benzodiazepines and hip fracture; 4) anticonvulsants and suicide/suicide attempts; and 5) calcium channel blockers and malignancies. Six European databases, that will be used to evaluate the drug-AE pairs retrospectively, are also described.CONCLUSION: The selected drug-AE pairs will be evaluated in PE studies using common protocols. Based on consistencies and discrepancies of these studies, a framework for guiding methodological choices will be developed. This will increase the usefulness and reliability of PE studies for benefit-risk assessment and decision-making.

KW - Adverse Drug Reaction Reporting Systems/statistics & numerical data

KW - Databases, Factual/statistics & numerical data

KW - Drug-Related Side Effects and Adverse Reactions/epidemiology

KW - Europe/epidemiology

KW - Humans

KW - Pharmacoepidemiology/methods

KW - Reproducibility of Results

KW - Retrospective Studies

KW - Risk Assessment/methods

U2 - 10.2174/1574884708666131111211802

DO - 10.2174/1574884708666131111211802

M3 - Article

C2 - 24218995

SN - 1574-8847

VL - 9

SP - 130

EP - 138

JO - Current Clinical Pharmacology

JF - Current Clinical Pharmacology

IS - 2

ER -