Patients with Growth-Related Disorders and Caregivers Prefer the Somapacitan Device to the Somatrogon Device: Results from a Randomized Crossover Study Assessing Device Preference and Ease of Use Following Simulated Injections.

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2024-10-30 eCollection Date: 2024-01-01 DOI:10.2147/MDER.S484354
Shahid Akhtar, Birgitte Berg, Johan Medina, Maya Nicole Gonczi, Sophie Hamilton, Emily Hildebrand, Nicky Kelepouris, Jesper Skov Neergaard, Claus Sværke, Gitte Ter-Borch, Niklas Kahr Rasmussen
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Abstract

Purpose: Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya®, Novo Nordisk A/S) and somatrogon (Ngenla®, Pfizer).

Patients and methods: In a randomized, crossover study conducted between September 20 and November 2, 2023, we recruited 33 adolescents with a growth-related disorder, and 37 caregivers, at six locations in the United States. Each participant was trained in the use of both devices and asked to perform a simulated injection. Device training time, preparation and injection time, and injection completeness were recorded. Participants also completed the Device Handling and Preference Questionnaire (DHPAQ) to indicate their device preference and ease of use opinions. Following conclusion of the "standard" visit, 10 adolescents and 10 caregivers were randomly selected to participate in a sub-study to validate the relevance, comprehensiveness, and comprehension of the DHPAQ.

Results: The majority of participants (84.3%; 95% confidence interval [CI]: 74;92) preferred the somapacitan device to the somatrogon device (p < 0.0001). Almost all (98.6%; 95% CI: 92;100) participants answered that the somapacitan device was easy or very easy to use, while three-quarters (74.3%; 95% CI: 62;84) answered the same for the somatrogon device. Average training and injection times were lower for the somapacitan device than for the somatrogon device. Also, more patients successfully completed the injection with the somapacitan device than with the somatrogon device (97.1% vs 92.9%). Cognitive debriefing interviews indicated the DHPAQ was relevant, comprehensive, and fully comprehended.

Conclusion: The somapacitan device was preferred to the somatrogon device by a majority of participants. More participants considered the somapacitan device to be easy or very easy to use than the somatrogon device.

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与Somatrogon装置相比,生长相关障碍患者和护理人员更喜欢Somapacitan装置:模拟注射后评估设备偏好和易用性的随机交叉研究结果。
目的:众所周知,坚持生长激素治疗会影响生长结果。研究表明,对设备的偏好和易用性都会影响治疗的依从性。在这项研究中,我们对两种长效生长激素--somapacitan(Sogroya®,诺和诺德公司)和somatrogon(Ngenla®,辉瑞公司)--的设备偏好和易用性进行了评估:在 2023 年 9 月 20 日至 11 月 2 日期间进行的一项随机交叉研究中,我们在美国六个地点招募了 33 名患有生长相关障碍的青少年和 37 名护理人员。每位参与者都接受了两种设备的使用培训,并被要求进行模拟注射。对设备培训时间、准备和注射时间以及注射完整性进行了记录。参与者还填写了设备操作和偏好问卷 (DHPAQ),以表明他们对设备的偏好和易用性的看法。在 "标准 "访问结束后,随机抽取 10 名青少年和 10 名护理人员参加一项子研究,以验证 DHPAQ 的相关性、全面性和理解性:大多数参与者(84.3%;95% 置信区间 [CI]:74;92)更喜欢使用 somapacitan 装置而不是 somatrogon 装置(p 结论:大多数参与者(84.3%;95% 置信区间 [CI]:74;92)更喜欢使用 somapacitan 装置而不是 somatrogon 装置:大多数参与者倾向于使用 somapacitan 设备而非 somatrogon 设备。更多的参与者认为 somapacitan 设备比 somatrogon 设备易于使用或非常易于使用。
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来源期刊
Medical Devices-Evidence and Research
Medical Devices-Evidence and Research ENGINEERING, BIOMEDICAL-
CiteScore
2.80
自引率
0.00%
发文量
41
审稿时长
16 weeks
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