title: Design validation and labeling comprehension study for a new epinephrine autoinjector.
abstract: BACKGROUND
  To facilitate the correct use of epinephrine autoinjectors (EAIs) by patients and caregivers, a novel EAI (Auvi-Q) was designed to help minimize use-related hazards.
  
  
  OBJECTIVE
  To support validation of Auvi-Q final design and assess whether the instructions for use in the patient information leaflet (PIL) are effective in training participants on proper use of Auvi-Q.
  
  
  METHODS
  Healthy participants, 20 adult and 20 pediatric, were assessed for their ability to complete a simulated injection by following the Auvi-Q instructions for use. Participants relied only on the contents of the PIL and other labeling features (device labeling and its instructions for use, electronic voice instructions and visual prompts).
  
  
  RESULTS
  The mean ± SD age of the adult and pediatric participants was 39.4 ± 11.6 and 10.9 ± 2.3 years, respectively. In total, 80% of adult and 35% of pediatric participants had prior experience with EAIs. All adults and 95% of pediatric participants completed a simulated injection on the first attempt; 1 pediatric participant required parental training and a second attempt. Three adult and 4 pediatric participants exhibited a noncritical issue while successfully completing the simulated injection. Most participants agreed that the injection steps were easy to follow and the PIL facilitated understanding on using Auvi-Q safely and effectively.
  
  
  CONCLUSIONS
  The PIL and other labeling features were effective in communicating instructions for successful use of Auvi-Q. This study provided validation support for the final design and anticipated instructions for use of Auvi-Q.
authors.affiliation: Intelliject Inc, Richmond, VA, USA. eric.edwards@intelliject.com
authors.forename: Eric S
authors.initials: ES
authors.lastname: Edwards
authors.forename: Evan T
authors.initials: ET
authors.lastname: Edwards
authors.forename: Ronald
authors.initials: R
authors.lastname: Gunn
authors.forename: Patricia
authors.initials: P
authors.lastname: Patterson
authors.forename: Robert
authors.initials: R
authors.lastname: North
mesh_terms: D000293:Adolescent; D000328:Adult; D000707:Anaphylaxis / Q000188:drug therapy*; D017028:Caregivers; D002648:Child; D032882:Comprehension; D004348:Drug Labeling; D004837:Epinephrine / Q000627:therapeutic use*; D004864:Equipment and Supplies; D006801:Humans; D008297:Male; D008875:Middle Aged; D063046:Patient Medication Knowledge; D012646:Self Administration / Q000295:instrumentation*
chemical_list: D004837:Epinephrine