vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Tomas BergvallMarie Lindquist

Abstract

Individual case safety reports of suspected harm from medicines are fundamental to post-marketing surveillance. Their value is directly proportional to the amount of clinically relevant information they include. To improve the quality of the data, communication between stakeholders is essential and can be facilitated by a simple score and visualisation of the results. The objective of this study was to propose a measure of completeness and identify predictors of well-documented reports, globally. The Uppsala Monitoring Centre has developed the vigiGrade completeness score to measure the amount of clinically relevant information in structured format, without reflecting whether the information establishes causality between the drug and adverse event. The vigiGrade completeness score (C) starts at 1 for reports with information on time-to-onset, age, sex, indication, outcome, report type, dose, country, primary reporter and comments. For each missing dimension, a penalty is detracted which varies with clinical relevance. We classified reports with C > 0.8 as well-documented and identified all such reports in the WHO global individual case safety report database, VigiBase, from 2007 to January 2012. We utilised odds ratios with sta...Continue Reading

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Citations

Jul 24, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ola CasterG Niklas Norén
Aug 7, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·G Niklas Norén
Feb 19, 2016·Pharmacoepidemiology and Drug Safety·Sabrina CrépinLouis Merle
Jul 19, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ermelinda ViolaAnita Conforti
Jun 17, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hugo J de BoerSteven G Newmaster
Jun 13, 2015·Indian Journal of Pharmacology·Kalaiselvan VivekanandanG N Singh
Jul 16, 2016·European Journal of Clinical Pharmacology·Monia DonatiDomenico Motola
Oct 1, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Geneviève DurrieuJean-Louis Montastruc
Jun 28, 2017·Pharmacoepidemiology and Drug Safety·Ola CasterG Niklas Norén
Aug 17, 2019·European Journal of Clinical Pharmacology·Pierre SabatierJean-Louis Montastruc
Jul 28, 2017·Expert Opinion on Drug Safety·Marco TuccoriCorrado Blandizzi
Oct 22, 2019·Movement Disorders : Official Journal of the Movement Disorder Society·Tatiana Pacheco-PaezJean-Louis Montastruc
Jan 9, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Monica A MuñozAlmut G Winterstein
Mar 17, 2020·Expert Review of Clinical Pharmacology·Janet Sultana, Gianluca Trifirò
Jan 11, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Abbie BarryEleni Aklillu
Jul 29, 2020·Therapeutic Innovation & Regulatory Science·Inyoung LeeTodd A Lee
Sep 16, 2020·Pharmacology Research & Perspectives·Josiah Tatenda Masuka, Star Khoza
Jan 1, 2017·Therapeutic Innovation & Regulatory Science·Jeremy D JokinenMelissa Truffa
Feb 2, 2019·Pharmacoepidemiology and Drug Safety·Bernhardt SachsJulia Stingl
Dec 12, 2019·Pharmacoepidemiology and Drug Safety·Masami TsuchiyaNariyasu Mano
Feb 8, 2020·Indian Journal of Pharmacology·Kotni MuraliBikash Medhi
Jul 6, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Farid KheloufiJoelle Micallef
Oct 5, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Khac-Dung NguyenSten Olsson
Jul 7, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Alice Capogrosso SansoneMarco Tuccori
Dec 23, 2017·Pharmacoepidemiology and Drug Safety·Joep H G SchollEugène P van Puijenbroek
Jun 27, 2019·International Journal of Environmental Research and Public Health·Francesco De Pretis, Barbara Osimani
May 24, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Jonathan SpikerTaxiarchis Botsis
Apr 22, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Thamir M AlshammariYazed Alsowaida
May 16, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ingrid OosterhuisLinda Härmark
Jul 1, 2016·Therapeutic Innovation & Regulatory Science·Rishi KumarG N Singh

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Software Mentioned

vigiGrade
VigiBase
VigiFlow

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