title: Health outcomes of interest for evaluation in the Post-Licensure Rapid Immunization Safety Monitoring Program.
abstract: Active vaccine safety surveillance systems commonly use computerized diagnostic codes to identify potential health outcomes of interest. Evidence concerning the accuracy of these codes is variable, and few systematic reviews are available. This project's aim was to select a list of health outcomes of interest most suitable for evaluation in the Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program. We conducted an expert elicitation process to develop the list. A comprehensive list of potential health outcomes of interest was formed based on input from a wide variety of vaccine safety experts. We then selected five panelists with senior leadership roles in vaccine safety from both within and outside the FDA. We elicited the experts' recommendations via a structured, iterative process that included an Internet-assisted telephone conference call and formal voting procedures. The expert panelists identified several criteria as important in their choices, including clinical severity, public health importance, rare or uncommon incidence, relevance to two or more vaccines, and historical association with vaccines. The list of 24 outcomes chosen by the experts and refined by the FDA included ten neurologic outcomes, two circulatory system outcomes, and two musculoskeletal outcomes. The PRISM program plans to conduct a set of evidence reviews on the positive predictive value and other characteristics of existing computerized codes and algorithms to identify these health outcomes of interest.
authors.affiliation: Center for Child Health Care Studies, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 02215, United States. tracy lieu@harvardpilgrim.org
authors.forename: Tracy A
authors.initials: TA
authors.lastname: Lieu
authors.forename: Michael D
authors.initials: MD
authors.lastname: Nguyen
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: David B
authors.initials: DB
authors.lastname: Martin
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000473:pathology*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D014612:Vaccines