Comparative usability study for a certolizumab pegol autoinjection device in patients with rheumatoid arthritis

Abstract

Objectives: To compare the usability of a new certolizumab pegol (CZP) autoinjector with the adalimumab, etanercept, and golimumab devices in patients with rheumatoid arthritis. Methods: Two identical studies were performed in 2013 and 2016; patients performed a simulated selfinjection with the CZP autoinjector and the most up-to-date device versions at the time in a randomized, consecutive sequence. The primary end point was the ranking of the four autoinjectors in order of preference. Device usability and intuitiveness were assessed across a range of secondary and exploratory end points. Results: The 2013 and 2016 study populations included 76 patients each; a significant majority (2013: 67%; 2016: 59%) ranked the CZP autoinjector as their most preferred device (p < 0.001). Most patients agreed that the CZP autoinjector was easier to use, start, and manipulate, and were more willing to use it than the comparator devices (p < 0.001 for all pairwise comparisons with CZP). Likert score differences also favored the CZP autoinjector regarding how easy it was to determine injection completion. The CZP autoinjector was associated with a low rate of use error. Conclusions: In both studies, the CZP autoinjector was the preferred choice compared to the alternative devices and was associated with a high level of patient satisfaction. ARTICLE HISTORY

Improving the safety of disposable auto-injection devices: a systematic review of use errors

“…Knowledge about use errors of existing, similar equipment is an important source of information on the design and development of new medical devices. A proper analysis of known problems is essential for ensuring that (Jeannerot et al, 2016) Buttons (Fujioka et al, 2015;Rohrer et al, 2013) Feedback -audible (Lange et al, 2015;Varunok et al, 2011) Feedback -visible (Lange et al, 2015;Lange et al, 2014) Packaging (Guerlain et al, 2010b) Safety cap (Lange et al, 2015;Pachon et al, 2014;Demary et al, 2014;Domańska et al, 2017;Guerlain et al, 2010b) Site disinfection (Jeannerot et al, 2016) Washing hands (Jeannerot et al, 2016) these issues will not occur with a newly developed device. One of the strengths of the present study is its systematic analysis of all use errors reported in the literature.…”

“…"Incorrect handling" refers to errors where users did not perform actions with the correct finger (Salter et al, 2014) or the correct hand (Hudry et al, 2017). The "incorrect storage" subcategory is related to cases in which users could not state the correct storage conditions for the auto-injection device (Sicherer et al, 2000;Domańska et al, 2017) or did not take the device out of the refrigerator long enough before the injection to reach room temperature (Schiff et al, 2016). With regard to post-injection tasks, three publications mentioned failure to massage the injection site after the injection (Salter et al, 2014;Brown et al, 2013;Saleh-Langenberg et al, 2017).…”

“…Subcategory References Device orientation a) device held upside-down (Lange et al, 2015;Sicherer et al, 2000;Robinson et al, 2014;Matfin et al, 2015;Salter et al, 2014;Umasunthar et al, 2015;Mehr et al, 2007;Arga et al, 2011;Topal et al, 2013;Schmid et al, 2013;Hudry et al, 2017;Domańska et al, 2017;Guerlain et al, 2010b;Saleh-Langenberg et al, 2017;Hanna et al, 2016;Andre et al, 2017) b) device held at the wrong angle (Phillips et al, 2011) Preparation a) incorrect needle attachment (Stauder et al, 2014;Fujioka et al, 2015;Phillips et al, 2011;Lange et al, 2014;Schertz et al, 2011;Pfützner et al, 2012;Pfützner et al, 2010) b) incorrect priming (flow and air bubble checking/removal) (Stauder et al, 2014;Fujioka et al, 2015;Jeannerot et al, 2016;Lange et al, 2014;Schertz et al, 2011) c) incorrect device selection (Fujioka et al, 2015;Raffa et al, 2017) d) failure to check device integrity (Hudry et al, 2017;Schiff et al, 2016;Schertz et al, 2011;Saunders et al, 2012) e) failure to check product validity (Sicherer et al, 2000;Schmid et al, 2013;Hudry et al, 2017;Schiff et al, 2016) f) tampering with the device (Andre et al, 2017) Protective/safety cap a) inco...…”

“…With regard to the "hygiene" category, three types of use error were identified. Four publications reported that the injection site was not disinfected (Schiff et al, 2016;Domańska et al, 2017;Jeannerot et al, 2016;Pfützner et al, 2012). One of these also mentioned that users did not wash their hands before using the device (Schiff et al, 2016).…”

“…The "device orientation" category refers to errors related to not holding a device in the correct way. The great majority of errors in this category concern holding a device upside down (Lange et al, 2015;Sicherer et al, 2000;Robinson et al, 2014;Matfin et al, 2015;Salter et al, 2014;Umasunthar et al, 2015;Mehr et al, 2007;Arga et al, 2011;Topal et al, 2013;Saleh-Langenberg et al, 2017;Hanna et al, 2016;Schmid et al, 2013;Hudry et al, 2017;Domańska et al, 2017;Guerlain et al, 2010b;Andre et al, 2017). In conjunction with the "wrong angle" subcategory, one study reported that users did not place the device perpendicular to the thigh for the injection or did not withdraw the device straight out after the injection (Phillips et al, 2011).…”