title: Biologically plausible and evidence-based risk intervals in immunization safety research.
abstract: In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety. To date, little work has been done to formally assess and determine biologically plausible and evidence-based risk intervals in immunization safety research. In this report, we present a systematic process to define biologically plausible and evidence-based risk interval estimates for two specific AEFIs, febrile seizures and acute disseminated encephalomyelitis. In addition, we review methodologic issues related to the determination of risk intervals for consideration in future studies of immunization safety.
authors: Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, United States. ali.x.rowhani-rahbar@kp.org
authors: Ali
authors: A
authors: Rowhani-Rahbar
authors: Nicola P
authors: NP
authors: Klein
authors: Cornelia L
authors: CL
authors: Dekker
authors: Kathryn M
authors: KM
authors: Edwards
authors: Colin D
authors: CD
authors: Marchant
authors: Claudia
authors: C
authors: Vellozzi
authors: Bruce
authors: B
authors: Fireman
authors: James J
authors: JJ
authors: Sejvar
authors: Neal A
authors: NA
authors: Halsey
authors: Roger
authors: R
authors: Baxter
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D013997:Time Factors; D014611:Vaccination / Q000009:adverse effects*; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines