Rapaport Robert, Saenger Paul, Schmidt Heinrich, Hasegawa Yukihiro, Colle Michel, Loche Sandro, Marcantonio Sandra, Bonfig Walter, Zabransky Markus, Lifshitz Fima
Division of Pediatric Endocrinology and Diabetes, Mount Sinai School of Medicine, Mineola, NY, USA.
Med Devices (Auckl). 2013 Sep 2;6:141-6. doi: 10.2147/MDER.S50088. eCollection 2013.
Close adherence to the recommended treatment regimen is important for the success of recombinant human growth hormone therapy, although nonadherence can be common. Ease of use and safety during use/storage are among several important factors in the design of a growth hormone injection device intended for long-term use. This study was performed to validate the usability and assess the ease of use of a new pen device (SurePal™) that has been developed to support daily administration of the recombinant human growth hormone product, Omnitrope® (somatropin). The primary objectives of the study were to assess if study participants, representing intended users of the pen in clinical practice, were able to perform an injection procedure into an injection pad effectively and safely and disassemble the pen without receiving a needlestick injury. A total of 106 participants (61 adults and 45 children/adolescents) were enrolled at two study centers (one in the US, one in Germany). Results for both primary usability tasks met the predefined acceptance criteria, with >85% of participants successfully performing each task. All of the other tasks/handling steps assessed were also successfully performed by most participants, with high success rates reflected in the high proportion of participants who classified each task as "very easy" or "easy". After a second use of the device, 87%-97% of participants rated it as "very easy" or "easy" to use. In summary, the new pen device is safe and easy to use for both adults and children, and will help to support effective, long-term daily administration of the recombinant human growth hormone product, Omnitrope®.
严格遵循推荐的治疗方案对于重组人生长激素治疗的成功至关重要，尽管不依从情况可能很常见。在设计用于长期使用的生长激素注射装置时，使用方便性和使用/储存期间的安全性是几个重要因素。本研究旨在验证一种新的笔式装置（SurePal™）的可用性，并评估其使用方便性，该装置是为支持重组人生长激素产品奥曲肽（生长激素）的每日给药而开发的。该研究的主要目的是评估代表临床实践中笔式装置预期使用者的研究参与者是否能够有效地、安全地将药物注射到注射垫中，并拆卸笔式装置而不受到针刺伤。在两个研究中心（一个在美国，一个在德国）共招募了106名参与者（61名成年人和45名儿童/青少年）。两项主要可用性任务的结果均符合预先定义的接受标准，超过85%的参与者成功完成了每项任务。大多数参与者也成功完成了评估的所有其他任务/操作步骤，高成功率体现在将每项任务归类为“非常容易”或“容易”的参与者比例很高。在第二次使用该装置后，87%-97%的参与者将其评为使用“非常容易”或“容易”。总之，这种新的笔式装置对成人和儿童来说都是安全且易于使用的，将有助于支持重组人生长激素产品奥曲肽的有效长期每日给药。
