Validation of claims-based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse...

Area of Science:

• Pharmacoepidemiology
• Health Outcomes Research
• Biostatistics

Background:

• Administrative claims data are increasingly used for health outcomes research.
• Validating these data against medical chart review is crucial for ensuring accuracy in studies.
• This study focuses on adverse events associated with selective cyclooxygenase-2 inhibitors and non-steroidal anti-inflammatory drugs.

Purpose of the Study:

• To validate administrative claims codes against medical chart review for myocardial infarction (MI), ischemic stroke, and severe upper gastrointestinal (UGI) bleed events.
• To assess the accuracy of claims data for identifying specific adverse events in a large, commercially-insured US population.
• To inform the use of claims data in pharmacoepidemiology and drug safety surveillance.

Main Methods:

• Utilized a large, commercially-insured US population database (HealthCore Integrated Research DatabaseSM).
• Selected patients experiencing MI, ischemic stroke, or severe UGI bleeds between July 2002 and September 2004.
• Calculated the positive predictive value (PPV) of claims code algorithms using medical chart review as the gold standard.

Main Results:

• Initial PPV for MI was 88.4% and for ischemic stroke was 87.4%.
• Initial PPV for severe UGI bleed was 56.5%.
• Refined algorithms improved PPV for ischemic stroke to 95.5% and for severe UGI bleed to 87.8%.

Conclusions:

• Administrative claims data demonstrate good validity for identifying MI and ischemic stroke.
• Claims data show potential for tracking severe UGI bleeds, especially after algorithm refinement.
• Claims data can serve as a basis for pharmacoepidemiology research and drug safety surveillance in the US.