What is endorsement?

Endorsement of a reporting guideline by journals is typically exemplified by a statement in the journal’s Instructions to Authors, typically in the form of a recommendation to authors to adhere to the checklist.

Why Endorse READUS-PV?

Meta-epidemiological studies have shown that published disproportionality analyses are often poorly reported and interpreted hampering the use and the ability to assess research findings, and contributing to research waste (i.e. avoidable inappropriate conduct and dissemination of research) [1,2].

Endorsement of READUS-PV reporting guideline is an efficient way to improve the reporting completeness of disproportionality analyses in your journal and to promote adequate interpretation of the findings.

How to endorse READUS-PV

     Step 1 :

Include mention of the READUS statement and reference the READUS-PV website in your journal’s instructions to authors for reporting disproportionality analyses.

Our suggested text to include in journal’s instructions for authors is as follows:

« [journal name] requires a completed READUS-PV checklist as a condition of submission when reporting findings from a disproportionality analysis in an individual case safety reports database. Templates for these can be found on the READUS-PV website. At minimum, your article should report the content addressed by each item of the checklist »

     Step 2 :

Contact us through the contact form and we will add you to our endorsers list

Additional resources to help journals develop editorial policies around reporting guidelines can be found on the EQUATOR Network website

References

[1]  Khouri C, Revol B, Lepelley M, Mouffak A, Bernardeau C, Salvo F, et al. A meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases. J Clin Epidemiol 2021;139:191–8. https://doi.org/10.1016/j.jclinepi.2021.07.014.

[2]  Mouffak A, Lepelley M, Revol B, Bernardeau C, Salvo F, Pariente A, et al. High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study. J Clin Epidemiol 2021;138:73–9. https://doi.org/10.1016/j.jclinepi.2021.06.022.

They endorse READUS-PV