Case Definition Companion Guides

Case Definition Companion Guides

The Case Definition Companion Guides (CG) are designed to facilitate harmonized application of a published Brighton Collaboration Case Definitions (CD) by providing:
  • Standard data abstraction forms, specific to the CD level of certainty criteria for use in:

    • Background incidence studies
    • Case-control or cohort studies testing for possible vaccine-event causality
  • A glossary of terms, if relevant to the CD, to ensure a common understanding of key clinical terms that apply to reaching specific levels of certainty
  • An approach to organize and interpret safety data and use them to determine CD level of certainty

The CGs also provide guidance for real-time data collection or investigation that will facilitate the ability to meet the highest possible level of certainty for the case definition.

As well as resources for scientific, epidemiologic and pharmacovigilance studies of a given adverse event including:

  • ICD-9, ICD-10, MedDRA and SNOMEDCT codes for use in database coding or administrative data case finding

  • Data on background incidence in global populations
  • Evidence for known risk factors for the event, including data on possible or proven vaccine-event associations