title: vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  The objective of this study was to propose a measure of completeness and identify predictors of well-documented reports, globally.
  
  
  METHODS
  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 statistical shrinkage to identify subgroups with unexpectedly high proportions of well-documented reports.
  
  
  RESULTS
  Altogether, 430,000 (13 %) of the studied reports achieved C > 0.8 in VigiBase. For VigiBase as a whole, the median completeness was 0.41 with an interquartile range of 0.26-0.63. Two out of three well-documented reports come from Europe, and two out of three from physicians. Among the countries with more than 1,000 reports in total, the highest rate of well-documented reports is 65 % in Italy. Tunisia, Spain, Portugal, Croatia and Denmark each have rates above 50 %, and another 20 countries have rates above 30 %. On the whole, 24 % of the reports from physicians are well-documented compared with only 4 % for consumers/non-health professionals. Notably, Denmark and Norway have more than 50 % well-documented reports from consumers/non-health professionals and higher rates than for physicians. The rate of well-documented reports for the E2B format is 11 % compared with 22 % for the older INTDIS (International Drug Information System) format. However, for E2B reports entered via the WHO programme's e-reporting system VigiFlow, the rate is 29 %.
  
  
  CONCLUSIONS
  Overall, only one report in eight provides the desired level of information, but much higher proportions are observed for individual countries. Physicians and e-reporting tools also generate greater proportions of well-documented reports overall. Reports from consumers/non-health professionals in specific regions have excellent quality, which illustrates their potential for the future. vigiGrade has already provided valuable information by highlighting data quality issues both in Italy and the USA.
authors.affiliation: Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden, tomas.bergvall@who-umc.org.
authors.forename: Tomas
authors.initials: T
authors.lastname: Bergvall
authors.forename: G Niklas
authors.initials: GN
authors.lastname: Norén
authors.forename: Marie
authors.initials: M
authors.lastname: Lindquist
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000706:statistics & numerical data*; D003142:Communication; D016208:Databases, Factual / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D007391:International Cooperation; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D011785:Quality Assurance, Health Care; D012107:Research Design; D013548:Sweden; D014944:World Health Organization