Validation of claims-based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse events in a commercially-insured population

• Published in: Pharmacoepidemiology and drug safety 2010-06, Vol.19 (6), p.596-603
• Main Authors: Wahl, Peter M., Rodgers, Keith, Schneeweiss, Sebastian, Gage, Brian F., Butler, Javed, Wilmer, Charles, Nash, Marshall, Esper, Gregory, Gitlin, Norman, Osborn, Neal, Short, Louise J., Bohn, Rhonda L.
• Format: Article
• Language: English
• Subjects: Algorithms; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Brain Ischemia - chemically induced; Brain Ischemia - diagnosis; Brain Ischemia - epidemiology; claims data; Cyclooxygenase 2 Inhibitors - adverse effects; Databases, Factual; Epidemiologic Methods; Gastrointestinal Hemorrhage - chemically induced; Gastrointestinal Hemorrhage - diagnosis; Gastrointestinal Hemorrhage - epidemiology; Humans; International Classification of Diseases; ischemic stroke; myocardial infarction; Myocardial Infarction - chemically induced; Myocardial Infarction - diagnosis; Myocardial Infarction - epidemiology; Nonprescription Drugs - adverse effects; Pharmacoepidemiology - methods; positive predictive value; Predictive Value of Tests; Retrospective Studies; Severity of Illness Index; Stroke - chemically induced; Stroke - diagnosis; Stroke - epidemiology; United States - epidemiology; upper GI bleed; validation
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.1924

Purpose To validate administrative claims codes with medical chart review for myocardial infarction (MI), ischemic stroke, and severe upper gastrointestinal (UGI) bleed events in a large, commercially‐insured US population. Methods These validation studies were part of a larger study examining the risk of MI, ischemic stroke, and severe UGI bleeds in patients receiving a new prescription of selective cyclooxygenase (COX)‐2 inhibitors (coxibs) and non‐over‐the‐counter (OTC) non‐steroidal anti‐inflammatory drugs (NSAIDs), between 1 July 2002 and 30 September 2004. Patients from the study cohort and other health plan members from the HealthCore Integrated Research DatabaseSM (HIRD) experiencing these events were selected for these studies. The positive predictive value (PPV) of each of the claims code algorithms, using medical chart review as the gold standard, was calculated. Results Two hundred charts per event were ed. The PPV for MI was 88.4% (177/200; 95%CI, 83.2–92.5%); PPV for ischemic stroke was 87.4% (175/200; 95%CI, 82.0–91.7%); PPV for severe UGI bleed was 56.5% (109/193; 95%CI, 49.2–63.6%). Refining the ischemic stroke claims algorithm resulted in a PPV of 95.5% (95%CI, 91.0–98.2%); refining the claims algorithm for severe UGI bleed resulted in a PPV of 87.8% (95%CI, 78.7–94.0%). Conclusion The results suggest that, for certain adverse events, claims data can serve as the basis for pharmacoepidemiology research and drug safety surveillance in the US. Copyright © 2010 John Wiley & Sons, Ltd.