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The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV) : Development and Statement
| Reporting guideline provided for? (i.e. exactly what the authors state in the paper) |
Reporting of disproportionality analyses. |
| Full bibliographic reference | Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G, Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M, Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ, Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E, Raschi E, Khouri C. The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement. Drug Saf. 2024;47(6):575-584. |
| Language | English |
| PubMed ID | 38713346 |
| Relevant URLs (full-text if available) |
Access the READUS-PV checklist and the READUS-PV checklist for abstracts. |
| Explanation and elaboration papers | Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G, Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M, Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ, Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E, Raschi E, Khouri C. 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. 2024;47(6):585-599. PMID: 38713347 |
| Reporting guideline website URL | http://www.readus-statement.org/ |
| Reporting guideline acronym | READUS-PV |
| Study design | Observational studies |
| Clinical area | Pharmaceutical medicine, Public health |
| Applies to the whole report or to individual sections of the report? | Abstract, Whole report |
| Record last updated on | June 12, 2024 |