Aims :

Our aim is to develop a reporting guideline for studies using disproportionality analyses in databases of spontaneously reported adverse events. 

Methods :

The development of the READUS-PV statement follow the process proposed by the EQUATOR network.

1 – Recruitment of the Delphi expert panel

We will recruit editors, stakeholders and researchers representative of the community of scientists engaged in analysis and publication of disproportionality analyses.  

2 – Open-text survey

We will use an open-text survey to ask the steering and working committees to suggest items that they believe should be included in the guideline under each sub-section of the RECORD-PE guideline.

3 – The Delphi process

Panel members will be asked to rank how strongly they believe the proposed theme should be incorporated into the READUS-PV reporting guideline.

4 – Draft reporting items

Items which will be ranked highest in each sub-section will then be considered during regular teleconferences and electronic communication among the working and steering committees. Items will be included in the checklist if more than 80% of participants agreed on the concept, wording, and message of the item.