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

Drug Safety Matters

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.

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章

1. #31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori (00:00:00)

2. Intro (00:00:11)

3. Welcome (00:01:26)

4. What is disproportionality analysis? (00:01:57)

5. A reporting problem in PV science (00:03:58)

6. What is the READUS-PV project? (00:09:49)

7. Why the recent spike in disproportionality reporting? (00:15:06)

8. Effects of the reporting spike (00:18:34)

9. Enhancing Pharmacovigilance Reporting Practices (00:19:44)

10. What has prevented a more widespread support of previous guidelines? (00:21:27)

11. Patterns in the publication of disproportionality analyses (00:22:40)

12. What is the Delphi method? (00:24:20)

13. Transparency, replicability and reproducibility in PV research - what impact will the READUS-PV have? (00:31:59)

14. Implementing Pharmacovigilance Reporting Guidelines (00:36:10)

15. What are the next steps to ensure uptake and integration of READUS-PV into the community? (00:36:30)

16. Listener question: How does READUS-PV apply to disproportionality analyses on medication errors? (00:37:39)

17. Final comments (00:39:20)

18. Outro (00:41:32)