Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Multi-centre, multi-database studies with common protocols: Lessons learnt from the IMI PROTECT project

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Tramadol use in Norway: A register-based population study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Hypnotics and mortality--partial confounding by disease, substance abuse and socioeconomic factors?

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Use of quinine and mortality-risk in patients with heart failure-a Danish nationwide observational study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Omega-3 fatty acids and risk of cardiovascular disease in Inuit: First prospective cohort study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Components of diabetes prevalence in Denmark 1996-2016 and future trends until 2030

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Prevalence, incidence and mortality of type 1 and type 2 diabetes in Denmark 1996-2016

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Olaf H. Klungel
  • Xavier Kurz
  • Mark C.H. de Groot
  • Raymond G. Schlienger
  • Stephanie Tcherny-Lessenot
  • Lamiae Grimaldi
  • Luisa Ibáñez
  • Rolf H.H. Groenwold
  • Robert F. Reynolds
  • Y. Alvarez
  • G. Candore
  • J. Durand
  • J. Slattery
  • J. Hasford
  • M. Rottenkolber
  • S. Schmiedl
  • F. de Abajo Iglesias
  • M. Gil
  • R. Gonzalez
  • C. Huerta Alvarez
  • E. Martin
  • B. Oliva
  • G. Requena
  • J. Amelio
  • R. Brauer
  • G. Downey
  • M. Feudjo-Tepie
  • M. Schoonen
  • S. Johansson
  • J. Robinson
  • M. Schuerch
  • I. Tatt
  • H. Petri
  • L. A. Garcia
  • A. Ruigomez
  • J. Campbell
  • A. Gallagher
  • E. Ng
  • T. P. van Staa
  • O. Demol
  • N. Boudiaf
  • K. Davis
  • J. Logie
  • J. Pimenta
  • R. Beau-Lejdstrom
  • L. Grimaldi-Bensouda
  • L. Abenhaim
  • L. Grimaldi-Bensouda
  • P. F. Rønn
  • S. Ali
  • On behalf of the members of work-package 2 of PROTECT
Vis graf over relationer

Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases. Methods: The selection of Drug-Adverse Event pairs was based on public health impact, regulatory relevance, and the possibility to study a broad range of methodological issues. Common protocols and data analytical specifications were jointly developed and independently and blindly executed in different databases in Europe with replications in the same and different databases. Results: The association between antibiotics and acute liver injury, benzodiazepines and hip fracture, antidepressants and hip fracture, inhaled long-acting beta2-agonists and acute myocardial infarction was consistent in direction across multiple designs, databases and methods to control for confounding. Some variation in magnitude of the associations was observed depending on design, exposure and outcome definitions, but none of the differences were statistically significant. The association between anti-epileptics and suicidality was inconsistent across the UK CPRD, Danish National registries and the French PGRx system. Calcium channel blockers were not associated with the risk of cancer in the UK CPRD, and this was consistent across different classes of calcium channel blockers, cumulative durations of use up to >10years and different types of cancer. Conclusions: A network for observational drug effect studies allowing the execution of common protocols in multiple databases was created. Increased consistency of findings across multiple designs and databases in different countries will increase confidence in findings from observational drug research and benefit/risk assessment of medicines.

OriginalsprogEngelsk
TidsskriftPharmacoepidemiology and Drug Safety
Vol/bind25
Sider (fra-til)156-165
Antal sider10
ISSN1053-8569
DOI
StatusUdgivet - 1 mar. 2016

ID: 51988978