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

Area of Science:

• Pharmacovigilance and Drug Safety
• Health Informatics
• Data Quality Assessment

Background:

• Individual case safety reports (ICSRs) are crucial for post-marketing drug surveillance.
• The clinical value of ICSRs is directly linked to the completeness of information provided.
• Improving data quality through enhanced communication and standardized metrics is essential.

Purpose of the Study:

• To introduce the vigiGrade completeness score for evaluating ICSR data quality.
• To identify predictors associated with well-documented safety reports on a global scale.

Main Methods:

• Developed the vigiGrade completeness score (C) to quantify clinically relevant information in structured ICSRs.
• Defined 'well-documented' reports as those with a C score > 0.8.
• Analyzed data from the WHO global ICSR database (VigiBase) from 2007 to January 2012.
• Utilized odds ratios to identify subgroups with a high proportion of well-documented reports.

Main Results:

• 13% (430,000) of analyzed reports in VigiBase were classified as well-documented (C > 0.8).
• Well-documented reports predominantly originated from Europe (2/3) and physicians (2/3).
• Italy reported the highest rate (65%) of well-documented reports among countries with over 1,000 reports; several European nations also showed high rates (>30%).
• Physician-submitted reports had a 24% well-documented rate versus 4% for consumers; however, Denmark and Norway showed high consumer report quality.
• Reports in the older INTDIS format (22%) were more complete than E2B format (11%), except for E2B reports via VigiFlow (29%).

Conclusions:

• Globally, only one in eight safety reports meets the desired information completeness standard.
• Significant variations in data quality exist across countries, with some demonstrating much higher proportions of well-documented reports.
• Physicians and e-reporting systems (like VigiFlow) contribute to higher quality reports.
• Consumer reports from specific regions show high quality, indicating future potential.
• The vigiGrade score has successfully identified data quality issues in regions like Italy and the USA.