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患有生长相关疾病的患者及其护理人员相较于索马促生长素装置更喜欢索马帕西坦装置:一项评估模拟注射后装置偏好和易用性的随机交叉研究结果。

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.

作者信息

Akhtar Shahid, Berg Birgitte, Medina Johan, Gonczi Maya Nicole, Hamilton Sophie, Hildebrand Emily, Kelepouris Nicky, Neergaard Jesper Skov, Sværke Claus, Ter-Borch Gitte, Rasmussen Niklas Kahr

机构信息

Devices & Digital Health, Novo Nordisk A/S, Søborg, Denmark.

Clinical Operations, Obesity, Liver Diseases & Devices, Novo Nordisk A/S, Søborg, Denmark.

出版信息

Med Devices (Auckl). 2024 Oct 30;17:427-439. doi: 10.2147/MDER.S484354. eCollection 2024.

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.

摘要

目的

已知生长激素治疗的依从性会影响生长结果。已证明设备偏好和易用性都会影响治疗依从性。在本研究中,我们评估了两种长效生长激素索马帕西坦(Sogroya,诺和诺德公司)和索马促生长素(Ngenla,辉瑞公司)的设备偏好和易用性。

患者与方法

在2023年9月20日至11月2日进行的一项随机交叉研究中,我们在美国的六个地点招募了33名患有生长相关疾病的青少年和37名护理人员。每位参与者都接受了两种设备使用的培训,并被要求进行模拟注射。记录设备培训时间、准备和注射时间以及注射完成情况。参与者还完成了设备操作与偏好问卷(DHPAQ),以表明他们对设备的偏好和易用性看法。在“标准”访视结束后,随机选择10名青少年和10名护理人员参与一项子研究,以验证DHPAQ的相关性、全面性和可理解性。

结果

大多数参与者(84.3%;95%置信区间[CI]:74;92)更喜欢索马帕西坦设备而非索马促生长素设备(p < 0.0001)。几乎所有(98.6%;95% CI:92;100)参与者回答索马帕西坦设备易于或非常易于使用,而四分之三(74.3%;95% CI:62;84)的参与者对索马促生长素设备给出了相同回答。索马帕西坦设备的平均培训和注射时间低于索马促生长素设备。此外,使用索马帕西坦设备成功完成注射的患者比使用索马促生长素设备的更多(97.1%对92.9%)。认知汇报访谈表明DHPAQ具有相关性、全面性且易于理解。

结论

大多数参与者更喜欢索马帕西坦设备而非索马促生长素设备。与索马促生长素设备相比,更多参与者认为索马帕西坦设备易于或非常易于使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cb5/11531717/6b295ffdb265/MDER-17-427-g0001.jpg

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