#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori

Disproportionality analyses are a mainstay of pharmacovigilance
research, but without clear guidelines, they often lead to
confusion and misinterpretation. Enter the READUS-PV statement:
the first-ever guide for reporting disproportionality analyses
that are replicable, reliable, and reproducible.  


Tune in to find out: 


The history of reporting guidelines in pharmacovigilance and
why the READUS-PV guidelines were created 

Why there has been a spike in the publication of
disproportionality analyses in recent years and what this means
for their reliability 

What it means to publish “good” pharmacovigilance science
 






Want to know more? 


Read the READUS-PV guidelines, why they were created, and why
they are important. 

In 2021, Khouri and colleagues showed that current methods
and models used for disproportionality analyses are unreliable,
and Mouffak and colleagues found that there is a tendency to
overstate results in published disproportionality analyses. 

A book on data mining techniques in Pharmacovigilance by
Poluzzi and colleagues delves deeper into this exponential
increase in disproportionality analyses.  

This paper elaborates on the Delphi technique, and how it is
used to gather data from reviewers to achieve scientific
consensus on a problem. 






Join the conversation on social mediaFollow us on
Facebook, LinkedIn, X, or Bluesky and share your thoughts about
the show with the hashtag #DrugSafetyMatters.

Got a story to share?We’re always looking for new
content and interesting people to interview. If you have a great
idea for a show, get in touch!

About UMCRead more about Uppsala Monitoring Centre
and how we work to advance medicines safety.