Evolving quality standards for large-scale registries: the GARFIELD-AF experience.

Area of Science:

• Cardiology
• Clinical Research
• Data Science

Background:

• Registries offer valuable insights into real-world treatment practices and outcomes.
• However, the reliability of registry data hinges on stringent quality standards, which are often lacking.
• The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) aimed to address this gap.

Purpose of the Study:

• To outline the quality standards implemented in the GARFIELD-AF registry.
• To demonstrate the effectiveness of these standards in ensuring data accuracy and completeness.
• To establish a potential benchmark for quality in future patient registries.

Main Methods:

• GARFIELD-AF enrolled approximately 57,000 patients across 35 countries over 6.5 years.
• A combination of remote and onsite monitoring was used, with source data verification (SDV) on 20% of cases.
• Four performance measures were developed to rank sites and identify those with suboptimal data quality.

Main Results:

• Partial SDV showed high concordance (94.4%) with full SDV (93.1%), validating the efficiency of targeted checks.
• Performance measures successfully identified sites needing closer monitoring.
• Implementation of quality standards led to improved data concordance in subsequent monitoring phases (95.6%).

Conclusions:

• The quality standards developed for GARFIELD-AF are effective in ensuring high-quality registry data.
• These standards provide a robust framework that can inform and guide future patient registries.
• Establishing and adhering to such standards is crucial for maximizing the value of real-world data.