Introduction: FlexPro® PenMate® (PenMate®) (Novo Nordisk A/S, Denmark) aims to reduce needle anxiety by hiding the needle during injection. This usability test validated the safe and effective use of PenMate® and the instructions for use (IFU) in patients with growth hormone (GH) deficiency (GHD), Turner syndrome (TS), Noonan syndrome (NS) and children born small for gestational age (SGA).
Methods: Participants were selected according to FDA Human Factors Engineering (HFE) guidelines: children/adolescents (1017 years) with GHD/SGA (n=16), TS/NS (n=15), adult patients/caregivers of patients with GHD/SGA/TS/NS (≥18 years) (n=19), and HCPs (n=15) managing patients with GHD/SGA/TS/NS. All performed four scenarios after training: first-time use of PenMate®; replace a depleted FlexPro® pen in PenMate®; check GH and wipe the front stopper; and one IFU comprehension scenario. Participants completed post-test questionnaires on PenMate® use, training and IFU. Questionnaires used a seven-point scoring scale: 1=strongly disagree, 7=strongly agree. Task failures, use errors, close calls and operational difficulties were recorded by observers. Root causes of all observations were evaluated by subjective feedback from participants.
Results: Participant demographics (mean [range]) were: GHD/SGA (88% male; age 14 years ), TS/NS (100% female; age 14 years ), adult patients/caregivers (58% female; age 44 years ), HCPs (80% female; age 44 years ). No task failures, potential serious or non-serious errors were recorded. Eighteen handling-use errors (committed by 14 participants) (no potential for harm), 11 close calls (committed by 11 participants) and 19 operational difficulties (committed by 17 participants) were recorded. Participants provided positive ratings for PenMate® use, training and IFU (mean ratings, 67). Participants correctly interpreted five out of six IFU excerpts.
Conclusions: PenMate® was considered easy to use and the IFU was considered helpful. No potentially serious or non-serious user errors were recorded. Handling use errors were not related to PenMate®.
18 Sep 2014 - 20 Sep 2014