ABSTRACT
Objectives: Past research has emphasized injection force as a clinically highly relevant technical attribute of pen devices. However, little work has been conducted to relate these results to in-use studies. This article explores whether and how differences in pen injection force profiles influence users’ self-reported perceived ease of injection and preferences.
Methods: Three different pen systems were subjected to measurements of injection force using an automated mechanical set-up followed by a simulated use study where users assessed perceived ease of injection.
Main outcomes measure: Outcomes were measured by fitting data of measured injection force and perceived ease of injection using a linear model.
Results: Although mechanical testing revealed significant differences between the three pen’s measured injection forces these differences were not directly perceived by users in simulated injection studies.
Conclusion: The article bridges literature on injection force measurement and simulated use. It reveals how users’ perceived ease of injection is less sensitive to measured injection forces than prior research has assumed. Thus, future research should holistically integrate patient feedback in new device development. Key limitations of this work are the low number of participants in the simulated use study and the fact that the ease of injection was assessed indirectly.
Declaration of interest
Both authors are employees of Ypsomed. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose
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Notes on contributors
Jakob Lange
J Lange designed and interpreted the injection force measurements. A Schneider designed, conducted and interpreted the usability evaluation. The authors jointly drafted, reviewed and approved the paper and both authors agree to accountable for all aspects of the work.