title: A systematic review of validated methods for identifying erythema multiforme major/minor/not otherwise specified, Stevens-Johnson Syndrome, or toxic epidermal necrolysis using administrative and claims data.
abstract: OBJECTIVE
  The Food and Drug Administration's (FDA) Mini-Sentinel pilot program 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 (HOIs) from administrative and claims data. This paper summarizes the process and findings of the algorithm review of erythema multiforme and related conditions.
  
  
  METHODS
  PubMed and Iowa Drug Information Service searches were conducted to identify citations applicable to the erythema multiforme HOI. Level 1 abstract reviews and Level 2 full-text reviews were conducted to find articles that used administrative and claims data to identify erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis and that included validation estimates of the coding algorithms.
  
  
  RESULTS
  Our search revealed limited literature focusing on erythema multiforme and related conditions that provided administrative and claims data-based algorithms and validation estimates. Only four studies provided validated algorithms and all studies used the same International Classification of Diseases code, 695.1. Approximately half of cases subjected to expert review were consistent with erythema multiforme and related conditions.
  
  
  CONCLUSIONS
  Updated research needs to be conducted on designing validation studies that test algorithms for erythema multiforme and related conditions and that take into account recent changes in the diagnostic coding of these diseases.
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; D016208:Databases, Factual / Q000706:statistics & numerical data; D004892:Erythema Multiforme / Q000175:diagnosis / Q000453:epidemiology*; D006801:Humans; D007345:Insurance Claim Review / Q000706:statistics & numerical data; D038801:International Classification of Diseases; D017063:Outcome Assessment, Health Care / Q000379:methods; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods; D013262:Stevens-Johnson Syndrome / Q000175:diagnosis / Q000453:epidemiology*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic