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. However, patients with RA may suffer from reduced manual dexterity, meaning that administering self-injections can be physically problematic.
Objectives The primary objective of this French multicenter study was to evaluate the usability of a new auto-injector, based on the device design and instructions for use (IFU).
Methods Three groups of subjects were enrolled in the trial: i/ professional nurses or caregivers; ii/ patients with established RA diagnosis with moderate to severe and iii/ from mild hand disability to normal hand function (assessed by Cochin scale above or fewer than 20, respectively). Injections (inj.) were performed with a water-filled device on a foam pad mimicking skin behavior. Each subject performed three inj. in different conditions (first phase (one inj.): just after reading the IFU without further instructions; second phase after explanations upon user's request (two inj.): first in an optimum environment then in a “worst case” environment (noise, dimmed light etc.)). The usability of the auto-injector was assessed by a questionnaire (success: ≥75% of positive responses) and by a score card reflecting injection performances, assessed by an independent observer (success: execution of ≥75% of handling steps).
Results 42 subjects were enrolled in the study between November 2014 and March 2015. There were no major differences in subject profiles (group size, age, sex) between the 3 user groups. During the first phase, the great majority of subjects succeeded in the usability questionnaire (90.5%) and in the inj. performance (95.2%) with no major differences between the user groups. In the second phase, all subjects from all 3 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 auto-injector, regardless of the hand disability. The high performance rate in the first phase showed an intuitive device handling. The study also emphasized the importance of instructions provided to the patient for a 100% understanding and handling success.
Disclosure of Interest C. Hudry Consultant for: Nordic Pharma, A. Lebrun Consultant for: Nordic Pharma, B. Moura Consultant for: Nordic Pharma, O. Backers Employee of: Disphar international, H. Herman-Demars Employee of: Nordic Pharma