(018) Guidelines for the Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance (READUS-PV)

Background: Disproportionality analyses based on individual case safety reports are widely used in pharmacovigilance to detect safety signals. Unfortunately, the reporting of these analyses lacks specific guidelines, leading to incomplete and ambiguous reporting, which may result in incorrect conclusions when data are not placed in the correct context. To address this issue, we developed the REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) guidelines.

Objectives: To describe the development process of READUS-PV and the resulting recommendations.

Methods: We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. Following a 3-step process, including an open-text survey, an online Delphi method (items were retained if more than 80% of participants agreed), and a final online consensus meeting, we developed a checklist for reporting disproportionality analyses.

Results: The open-text survey allowed to gather an initial list of 97 items, and through two rounds of Delphi we retained 60 recommendations for the manuscript and 13 for the abstracts. After merging related items and redescussing them in the consensus meeting, READUS-PV guidelines included 14 recommendations for the manuscript and four more for the abstract to promote transparent and comprehensive reporting of disproportionality studies.

Conclusions: The READUS-PV guidelines provide a structured framework for reporting disproportionality analyses, addressing the current inadequacies in reporting practices. By enhancing transparency, completeness, and accuracy of reporting and facilitating a proper interpretation of results, the adoption of these guidelines will support authors, editors, peer-reviewers, and readers of disproportionality analyses. Ultimately, this will facilitate evidence-based decision-making in pharmacovigilance.