Dijkstra-et-al_2020_Adverse drug reaction or innocent bystander_A systematic comparison of statistical discovery methods for spontaneous reporting systems.pdf 768,49KB
1000 Titel
  • Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems
1000 Autor/in
  1. Dijkstra, Louis |
  2. Garling, Marco |
  3. Foraita, Ronja |
  4. Pigeot, Iris |
1000 Erscheinungsjahr 2020
1000 LeibnizOpen
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-02-24
1000 Erschienen in
1000 Quellenangabe
  • 29(4):396-403
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • |
1000 Ergänzendes Material
  • |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • PURPOSE: Spontaneous reporting systems (SRSs) are used to discover previously unknown relationships between drugs and adverse drug reactions (ADRs). A plethora of statistical methods have been proposed over the years to identify these drug‐ADR pairs. The objective of this study is to compare a wide variety of methods in their ability to detect these signals, especially when their detection is complicated by the presence of innocent bystanders (drugs that are mistaken to be associated with the ADR, since they are prescribed together with the drug that is the ADR's actual cause). METHODS: Twelve methods, 24 measures in total, ranging from simple disproportionality measures (eg, the reporting odds ratio), hypothesis tests (eg, test of the Poisson mean), Bayesian shrinkage estimates (eg, the Bayesian confidence propagation neural network, BCPNN) to sparse regression (LASSO), are compared in their ability to detect drug‐ADR pairs in a large number of simulated SRSs with varying numbers of innocent bystanders and effect sizes. The area under the precision‐recall curve is used to assess the measures' performance. RESULTS: Hypothesis tests (especially the test of the Poisson mean) perform best when the associations are weak and there is little to no confounding by other drugs. When the level of confounding increases and/or the effect sizes become larger, Bayesian shrinkage methods should be preferred. The LASSO proves to be the most robust against the innocent bystander effect. CONCLUSIONS: There is no absolute “winner”. Which method to use for a particular SRS depends on the effect sizes and the level of confounding present in the data.
1000 Sacherschließung
lokal Pharmacovigilance
lokal Pharmacoepidemiology
lokal Side effect
lokal Surveillance
lokal Innocent bystander effect
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
1000 Label
1000 Förderer
  1. Gemeinsamer Bundesausschuss |
1000 Fördernummer
  1. 01VSF16020
1000 Förderprogramm
  1. Innovationsfonds
1000 Dateien
  1. Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Gemeinsamer Bundesausschuss |
    1000 Förderprogramm Innovationsfonds
    1000 Fördernummer 01VSF16020
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6420648.rdf
1000 Erstellt am 2020-05-07T12:02:42.626+0200
1000 Erstellt von 266
1000 beschreibt frl:6420648
1000 Bearbeitet von 266
1000 Zuletzt bearbeitet Mon Sep 28 15:13:38 CEST 2020
1000 Objekt bearb. Mon Sep 28 15:13:37 CEST 2020
1000 Vgl. frl:6420648
1000 Oai Id
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1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
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