Table 2.

The READUS-PV checklist for abstracts for standalone studies

Section and topic	Item #	Checklist item
Background	1a	State the aim/rationale for performing the study.
	1b	Specify the adverse event(s) and/or the drug(s) under study, when applicable.
	1c	Specify the specific population or setting, when applicable.
Methods	2a	Identify the study as a “disproportionality analysis” and specify the type of data used.
	2b	Specify the name of the database(s) used and the type of access.
	2c	Specify the timeframe and geographical region, when applicable.
	2d	Specify the disproportionality measure(s) used and their statistical significance threshold(s).
	2e	Specify if a case-by-case analysis is performed.
Results	3	Report main findings including their precision (e.g., 95% confidence intervals), together with a short summary of the case-by-case analysis.
Conclusion	4a	Clearly report key conclusions.
	4b	Acknowledge that the disproportionality analysis is a hypothesis generating or refinement approach.
	4c	State the implications and clinical relevance of the findings.

READUS-PV REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance