High prevalence of spin was found in pharmacovigilance studies usingdisproportionality analyses todetectsafetysignals: a meta-epidemiologicalstudy: Spin in pharmacovigilance disproportionality analyses
| dc.rights.license | open | en_US |
| dc.contributor.author | MOUFFAK, Amelle | |
| dc.contributor.author | LEPELLEY, Marion | |
| dc.contributor.author | REVOL, Bruno | |
| dc.contributor.author | BERNARDEAU, Claire | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | SALVO, Francesco | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | PARIENTE, Antoine
IDREF: 13395711X | |
| dc.contributor.author | ROUSTIT, Matthieu | |
| dc.contributor.author | CRACOWSKI, Jean-Luc | |
| dc.contributor.author | KHOURI, Charles | |
| dc.date.accessioned | 2021-08-23T08:58:38Z | |
| dc.date.available | 2021-08-23T08:58:38Z | |
| dc.date.issued | 2021-06-26 | |
| dc.identifier.issn | 0895-4356 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/110187 | |
| dc.description.abstractEn | OBJECTIVE: To systematically review and appraise misinterpretation of pharmacovigilance disproportionality analysis results in published studies. STUDY DESIGN AND SETTING: We randomly selected 100 studies that performeddisproportionality analysesand indexed in Medline identified during a systematic literature search. Titles, abstracts and main texts (results, discussion and conclusion) were evaluated for spin independently by 2 reviewers. Spin in pharmacovigilance studies was classified according to 3 main categories: inappropriate interpretation, inappropriate extrapolations and misleading reporting. RESULTS: Of the 100 studies evaluated, we found that 63%, 56% and 51% had at least one type of spin in their abstract, main text or conclusion respectively, and 40%used causal language to interpret their results in the abstract or conclusion.Spin in titles and results were exclusively represented by inappropriate interpretations of findings (12% and 21% respectively), with terms such as "risk of" or "risks associated with" or results erroneously presented as regular Odds Ratios. Spin in discussion sections mostly concernedinappropriate interpretations (38%)and misleading reporting (12%). Misleading reporting, notably failing to acknowledge the limitations of disproportionality analyses, was the most frequent type of spin in abstracts (55%) and conclusion sections (37%). CONCLUSION: We found that spin is frequent in publications of pharmacovigilance disproportionality analyses, notably in abstracts.This consisted notably in an over-interpretation of the results suggesting a proven causative link between a drug use and the risk of an event. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | Pharmacovigilance | |
| dc.subject.en | Disproportionality analyses | |
| dc.subject.en | Signal detection | |
| dc.subject.en | Spin | |
| dc.subject.en | Reporting | |
| dc.title.en | High prevalence of spin was found in pharmacovigilance studies usingdisproportionality analyses todetectsafetysignals: a meta-epidemiologicalstudy: Spin in pharmacovigilance disproportionality analyses | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1016/j.jclinepi.2021.06.022 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 34186195 | en_US |
| bordeaux.journal | Journal of Clinical Epidemiology | en_US |
| bordeaux.page | 73-79 | en_US |
| bordeaux.volume | 138 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | PharmacoEpi-Drugs | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-03323982 | |
| hal.version | 1 | |
| hal.date.transferred | 2021-08-23T08:58:42Z | |
| hal.export | true | |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Journal%20of%20Clinical%20Epidemiology&rft.date=2021-06-26&rft.volume=138&rft.spage=73-79&rft.epage=73-79&rft.eissn=0895-4356&rft.issn=0895-4356&rft.au=MOUFFAK,%20Amelle&LEPELLEY,%20Marion&REVOL,%20Bruno&BERNARDEAU,%20Claire&SALVO,%20Francesco&rft.genre=article |
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