A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data
Article first published online: 19 JAN 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Volume 21, Issue Supplement S1, pages 240–247, January 2012
How to Cite
Schneider, G., Kachroo, S., Jones, N., Crean, S., Rotella, P., Avetisyan, R. and Reynolds, M. W. (2012), A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data. Pharmacoepidem. Drug Safe., 21: 240–247. doi: 10.1002/pds.2327
- Issue published online: 19 JAN 2012
- Article first published online: 19 JAN 2012
- FDA through the Department of Health and Human Services. Grant Number: HHSF223200910006I
- administrative and claims data;
- coding algorithm
The Food and Drug Administration's Mini-Sentinel pilot program initially aims to conduct active surveillance to refine safety signals that emerge for marketed medical products. A key facet of this surveillance is to develop and understand the validity of algorithms for identifying health outcomes of interest from administrative and claims data. This article summarizes the process and findings of the algorithm review of anaphylaxis.
PubMed and Iowa Drug Information Service searches were conducted to identify citations applicable to the anaphylaxis health outcome of interest. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles using administrative and claims data to identify anaphylaxis and including validation estimates of the coding algorithms.
Our search revealed limited literature focusing on anaphylaxis that provided administrative and claims data–based algorithms and validation estimates. Only four studies identified via literature searches provided validated algorithms; however, two additional studies were identified by Mini-Sentinel collaborators and were incorporated. The International Classification of Diseases, Ninth Revision, codes varied, as did the positive predictive value, depending on the cohort characteristics and the specific codes used to identify anaphylaxis.
Research needs to be conducted on designing validation studies to test anaphylaxis algorithms and estimating their predictive power, sensitivity, and specificity. Copyright © 2012 John Wiley & Sons, Ltd.