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使用连接式注射装置对生长激素治疗依从性的真实世界数据进行分析。

Analysis of real-world data on growth hormone therapy adherence using a connected injection device.

机构信息

Endocrinology Global Medical, Safety and CMO, Merck KGaA, 64293, Darmstadt, Germany.

Merck Connected Health and Devices, Ares Trading S.A., an affiliate of Merck KGaA, 1262, Eysins, Switzerland.

出版信息

BMC Med Inform Decis Mak. 2020 Jul 29;20(1):176. doi: 10.1186/s12911-020-01183-1.

Abstract

BACKGROUND

Poor adherence to long-term recombinant human growth hormone (r-hGH) treatment can lead to suboptimal clinical outcomes; consequently, supporting and monitoring adherence is a crucial part of patient management. We assessed adherence to r-hGH treatment in children with growth disorders over 48 months using a connected monitoring device (easypod™), which automatically transmits adherence data via an online portal (easypod™ connect); both sit within an adherence decision support system (ADSS). We also investigated the effect of age and sex on adherence.

METHODS

Data from children transmitting over 10 injections between January 2007 and February 2019 were analyzed. Adherence (mg injected/mg prescribed) was categorized as high (≥85%), intermediate (> 56-84%) or low (≤56%) and assessed at seven time points from the start of treatment up to 48 months. Adherence was investigated over time and stratified by puberty status and sex. Mean transmission rate in each adherence category (total number of transmissions/total number of children) at each time point was calculated as a proxy measure of engagement in disease and treatment management. Descriptive analyses were performed.

RESULTS

Longitudinal records were available for 13,553 children. Overall, 71% (n = 9578) had high adherence, 22% (n = 2989) intermediate and 7% (n = 986) low. The proportion of children with high adherence decreased over time from 87% (n = 12,964) to 65% (n = 957) and was higher in pre-pubertal than pubertal children (girls: 80% [n = 1270] vs 70% [n = 4496]; boys 79% [n = 2573] vs 65% [n = 5214]). Children with high adherence had a higher mean number of transmissions (12.5 [SD 24.9]) than children with intermediate (7.2 [SD 15.3]) or low (3.5 [SD 5.7]) adherence.

CONCLUSIONS

High adherence was seen in patients administering r-hGH using the connected device. Children with high adherence were most likely to regularly transmit data. Pubertal children showed lower adherence. We show the potential to develop an ADSS to analyze trends in real-world adherence data. This may prove useful to direct interventions to improve adherence while the ability to readily share data with healthcare professionals may itself improve adherence.

摘要

背景

长期接受重组人生长激素(r-hGH)治疗依从性差可能导致临床结局不理想;因此,支持和监测依从性是患者管理的重要组成部分。我们使用连接监测设备(easypod™)评估了 48 个月内患有生长障碍的儿童接受 r-hGH 治疗的依从性,该设备通过在线门户(easypod™connect)自动传输依从性数据;两者都包含在依从性决策支持系统(ADSS)中。我们还研究了年龄和性别对依从性的影响。

方法

分析了 2007 年 1 月至 2019 年 2 月期间传输超过 10 次注射的儿童数据。依从性(mg 注射/mg 规定)分为高(≥85%)、中(>56-84%)和低(≤56%),并在治疗开始后 7 个时间点进行评估,直至 48 个月。根据青春期状态和性别对依从性进行了随时间的调查。在每个时间点,每个依从性类别(总传输次数/总儿童人数)的平均传输率被计算为疾病和治疗管理参与度的代理指标。进行了描述性分析。

结果

13553 名儿童的纵向记录可用。总体而言,71%(n=9578)的儿童具有高依从性,22%(n=2989)的儿童具有中依从性,7%(n=986)的儿童具有低依从性。高依从性儿童的比例随时间从 87%(n=12,964)下降到 65%(n=957),且青春期前儿童的比例高于青春期儿童(女孩:80%[n=1270] vs 70%[n=4496];男孩:79%[n=2573] vs 65%[n=5214])。高依从性儿童的平均传输次数(12.5[24.9])高于中依从性(7.2[15.3])或低依从性(3.5[5.7])儿童。

结论

使用连接设备接受 r-hGH 治疗的患者中,高依从性较为常见。高依从性儿童更有可能定期传输数据。青春期儿童的依从性较低。我们展示了分析真实世界依从性数据趋势的 ADSS 的潜力。这可能有助于指导改善依从性的干预措施,而能够方便地与医疗保健专业人员共享数据本身可能会提高依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adda/7389874/71d4eda7deda/12911_2020_1183_Fig1_HTML.jpg

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