Abstract
Purpose
Adherence to recombinant human growth hormone (r-hGH) is critical to growth and other outcomes in patients with growth disorders, but the requirement for daily injections means that ease of use is an important factor. This study assessed the perceived ease of use and functionality of the prototype of a reusable pen injector (pen device) for r-hGH that incorporates several advanced features.
Participants and methods
Semi-structured 60-minute qualitative interviews were conducted in 5 countries with 57 health care professionals (HCPs) and 30 patients with GH deficiency/caregivers administering r-hGH to patients, including children. HCPs had to be responsible for training in the use of r-hGH pen devices and to see ≥4 r-hGH patients/caregivers per month. Patients/caregivers had to have experience with r-hGH administration for at least 6 months.
Results
Thirty-seven (65%) of HCPs described the pen device as “simple” or “easy” to use. The aluminum body was generally perceived as attractive, high quality and comfortable to hold and operate. The ease of preparation and use made it suitable for both children and adults. The ability to dial back the r-hGH dose, if entered incorrectly, was mentioned as a major benefit, because other devices need several user steps to reset. Patients/caregivers felt the pen device was easy to use and the injection-feedback features reassured them that the full dose had been given. Overall, 40 (70%) HCPs and 16 (52%) patients/caregivers were likely to recommend or request the pen device. Moreover, patients/caregivers rated the pen device higher than their current reusable pens and almost equal to the leading disposable device for ease of learning, preparation, administration and ease of use.
Conclusion
The prototype pen device successfully met its design objectives and was very well accepted by HCPs and patients/caregivers for its ease of use, appearance and functionality.
Acknowledgments
The authors would like to thank the patients, caregivers and HCPs for their participation. The authors would also like to thank Shazada Ali at Double Helix Discovery, London, UK. This study was sponsored by Merck KGaA, Darmstadt, Germany. Saizen® is manufactured by Merck KGaA, Darmstadt, Germany. Medical writing assistance was provided by David Candlish and Steven Goodrick, inScience Communications, UK, and funded by Merck KGaA, Darmstadt, Germany.
Author contributions
Both authors contributed to the design of the study, data collection and interpretation and the writing and review of the manuscript and agree to be accountable for all aspects of the work.
Disclosure
MS is an employee of Merck KGaA, Darmstadt, Germany. CA is an independent pharmaceutical market research consultant. The authors report no other conflicts of interest in this work.