title: Evaluation of Usability and Acceptance of a New Autoinjector Intended for Methotrexate Subcutaneous Self-Administration in the Management of Rheumatoid Arthritis.
abstract: BACKGROUND
  Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease, for which the introduction of injectable treatments has had a major impact on quality of life directly related to the disease. The purpose of this descriptive study was to evaluate the usability of a new autoinjector, intended for methotrexate self-administration, based on the device's design and instructions for use (IFU).
  
  
  METHODS
  This multicenter trial included three user groups: a group of patients with established RA subdivided into two groups according to their hand disability, and a group of caregivers or nurses. Each subject performed three simulated injections with a water-filled device on a foam pad. The first injection was made just after reading the IFU without further instructions (first phase). The second phase consisted of two injections made after explanations provided upon request of the subject in an optimum environment and in a "worst-case" home environment. The usability of the autoinjector was assessed by a questionnaire (success: ≥75% of positive responses) and by a score card reflecting injection performances (success: execution of ≥75% of handling steps).
  
  
  RESULTS
  Forty-two subjects were enrolled in the study. During the first phase, the great majority of subjects succeeded in the usability questionnaire (90.5%) and in the injection performance (95.2%) with no major differences between the user groups. In the Second phase, all subjects from all three user groups succeeded in the usability questionnaire and had a positive rate of device handling, regardless of the environment and of the user group. No safety concerns were raised during the study.
  
  
  CONCLUSIONS
  This study found a very high level of usability and subject acceptance of the autoinjector, intended for methotrexate self-administration, regardless of the hand disability and environmental conditions.
  
  
  BACKGROUND
  Nordic Group.
  
  
  BACKGROUND
  EudraCT reference number: 2014-A0141245.
authors.affiliation: Rheumatology Institute, Paris, France.|Rheumatology Department, Cochin Hospital, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Hudry
authors.affiliation: Rheumatology Institute, Paris, France.|Rheumatology Department, Cochin Hospital, Paris, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Lebrun
authors.affiliation: Rheumatology Institute, Paris, France.|Department of Rheumatology, Ambroise Paré Hospital, Paris, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Moura
authors.affiliation: Medical Department, Nordic Pharma France, Paris, France. elena.zinovieva@nordicpharma.com.
authors.forename: Elena
authors.initials: E
authors.lastname: Zinovieva
authors.affiliation: Disphar International, Nordic Group, Baarn, The Netherlands.
authors.forename: Onne
authors.initials: O
authors.lastname: Backers
authors.affiliation: Medical Department, Nordic Pharma France, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Herman-Demars
keywords: Autoinjector; Device; Methotrexate; Pen; Rheumatoid arthritis; Rheumatology; Subcutaneous; Therapeutic education; Usability