Validation of claims-based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse events in a commercially-insured population.
OBJECTIVE
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 Database(SM) (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 abstracted. 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%).


CONCLUSIONS
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.
HealthCore, Inc., Wilmington, DE 19801, USA. pwahl@healthcore.com
Peter M
PM
Wahl
Keith
K
Rodgers
Sebastian
S
Schneeweiss
Brian F
BF
Gage
Javed
J
Butler
Charles
C
Wilmer
Marshall
M
Nash
Gregory
G
Esper
Norman
N
Gitlin
Neal
N
Osborn
Louise J
LJ
Short
Rhonda L
RL
Bohn
D000465:Algorithms; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D002545:Brain Ischemia / Q000139:chemically induced / Q000175:diagnosis* / Q000453:epidemiology; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects; D016208:Databases, Factual; D004812:Epidemiologic Methods; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D038801:International Classification of Diseases; D009203:Myocardial Infarction / Q000139:chemically induced / Q000175:diagnosis* / Q000453:epidemiology; D004366:Nonprescription Drugs / Q000009:adverse effects; D017891:Pharmacoepidemiology / Q000379:methods; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D012720:Severity of Illness Index; D020521:Stroke / Q000139:chemically induced / Q000175:diagnosis* / Q000453:epidemiology; D014481:United States / Q000453:epidemiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D004366:Nonprescription Drugs