The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration.
Drug Saf
; 47(6): 585-599, 2024 Jun.
Article
en En
| MEDLINE
| ID: mdl-38713347
ABSTRACT
In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect conclusions when data are not placed in the correct context. The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) statement was developed to address this issue by promoting transparent and comprehensive reporting of disproportionality studies. While the statement paper explains in greater detail the procedure followed to develop these guidelines, with this explanation paper we present the 14 items retained for READUS-PV guidelines, together with an in-depth explanation of their rationale and bullet points to illustrate their practical implementation. Our primary objective is to foster the adoption of the READUS-PV guidelines among authors, editors, peer reviewers, and readers of disproportionality analyses. Enhancing transparency, completeness, and accuracy of reporting, as well as proper interpretation of their results, READUS-PV guidelines will ultimately facilitate evidence-based decision making in pharmacovigilance.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Sistemas de Registro de Reacción Adversa a Medicamentos
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
/
Farmacovigilancia
Límite:
Humans
Idioma:
En
Revista:
Drug Saf
Asunto de la revista:
TERAPIA POR MEDICAMENTOS
/
TOXICOLOGIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Italia