title: Usability of the Novel Liraglutide 3.0 mg Pen Injector Among Overweight or Obese Adult Patients With or Without Prior Injection Experience.
abstract: BACKGROUND
  Obesity is associated with multiple comorbidities and increased mortality, making it an important target for treatment. However, achieving and maintaining weight loss by diet and physical activity remains challenging, and may often require pharmacotherapy. Liraglutide 3.0 mg has recently been approved for weight management in the United States, Canada, and EU. The current analysis used a summative usability test to assess safety and effectiveness, ease of use, and training requirements for the novel liraglutide 3.0 mg pen injector.
  
  
  METHODS
  Of the 234 participants, half received instructions for use and video-based training and/or opportunity to handle the device. All participants (excluding pharmacists) performed 6 tasks followed by post- task interviews on task difficulty, device ease of use, and any use errors, close calls, and operational difficulties. Tasks included differentiation of correct box and pen injector, medication clarity assessment, normal, dose reversal, and end-of-content injection. Number/type of use errors, close calls, and operational difficulties were evaluated.
  
  
  RESULTS
  All assessed participants interpreted the instructions for use correctly. No potentially serious use errors, and low numbers of nonserious errors, were reported. Overall, participants committed 105 use errors related to handling, with no potential for harm. A total of 25 close calls and 44 operational difficulties were reported without any pattern indicative of a design flaw. Marked differences in the incidence of events were observed for trained versus untrained participants regardless of prior injection experience. Participants rated ease of use as 6.4/7.
  
  
  CONCLUSIONS
  The liraglutide 3.0 mg pen injector is safe and easy to use for liraglutide administration. New device features allow for safe use after brief training.
authors.affiliation: Scripps Clinic, San Diego, CA, USA fujioka.ken@scrippshealth.org.
authors.forename: Ken
authors.initials: K
authors.lastname: Fujioka
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sparre
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Lily Yong-Hui
authors.initials: LY
authors.lastname: Sun
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Susanne
authors.initials: S
authors.lastname: Krogsgaard
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Kushner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004209:Disposable Equipment; D004501:Education, Medical; D005260:Female; D006282:Health Personnel; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D000069450:Liraglutide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D050177:Overweight / Q000188:drug therapy; D010353:Patient Education as Topic; D012646:Self Administration / Q000295:instrumentation*; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D000069450:Liraglutide
keywords: liraglutide; obesity; pen injector; pharmacotherapy; usability testing