title: A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Research needs to be conducted on designing validation studies to test anaphylaxis algorithms and estimating their predictive power, sensitivity, and specificity.
authors.affiliation: United BioSource Corporation, Lexington, MA 02420, USA. gary.schneider@unitedbiosource.com
authors.forename: Gary
authors.initials: G
authors.lastname: Schneider
authors.forename: Sumesh
authors.initials: S
authors.lastname: Kachroo
authors.forename: Natalie
authors.initials: N
authors.lastname: Jones
authors.forename: Sheila
authors.initials: S
authors.lastname: Crean
authors.forename: Philip
authors.initials: P
authors.lastname: Rotella
authors.forename: Ruzan
authors.initials: R
authors.lastname: Avetisyan
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Reynolds
mesh_terms: D000465:Algorithms; D000707:Anaphylaxis / Q000453:epidemiology*; D000799:Angioedema / Q000453:epidemiology*; D016208:Databases, Factual / Q000706:statistics & numerical data; D006801:Humans; D007345:Insurance Claim Review; D038801:International Classification of Diseases; D017063:Outcome Assessment, Health Care / Q000379:methods; D010865:Pilot Projects; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic