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儿童肾移植后的药物依从性与治疗结果:基于远程医疗的多模式随访方法的结果

Medication adherence and outcomes after paediatric kidney transplantation: results from a telemedicine-based, multimodal aftercare approach.

作者信息

Karaterzi Sinem, Prüfe Jenny, Wolff Julia Katharina, Kanzelmeyer Nele Kirsten, Ahlenstiel-Grunow Thurid, Gertges Raoul, Dehn-Hindenberg Andrea, Nöhre Mariel, De Zwaan Martina, Tegtbur Uwe, Schiffer Mario, Pape Lars

机构信息

Department of Pediatrics II, University Hospital of Essen, Essen, Germany.

IGES Institute, Berlin, Germany.

出版信息

Front Nephrol. 2025 Jun 12;5:1569116. doi: 10.3389/fneph.2025.1569116. eCollection 2025.

Abstract

BACKGROUND

Adolescents and young adults demonstrate the poorest long-term graft survival post-kidney transplantation (KTx) due to a multifactorial aetiology. KTx360° is a multicentre, multimodal, telemedicine-based follow-up care model designed to improve transplant survival in adult and paediatric patients.

METHODS

The paediatric component of the study was conducted at the Hannover study centres from May 2017 to October 2020 and is registered under the ISRCTN29416382 trial code. The post-transplant care model employed a structured approach, incorporating specialized case management, telemedicine support, psychological assessments and exercise assessments, with targeted interventions. The present study adopted a quasi-experimental, prospective, observational design. The primary endpoint was graft failure, defined as death or the initiation of long-term dialysis. The secondary endpoints were appointment and medication adherence, quality of life, and mental health. In the current study endpoints were analysed in a quasi-experimental, prospective, observational study: All secondary endpoints were analysed longitudinally over study duration in the intervention group using study data. Graft failure was investigated using claims data from participating statutory health insurance providers by a comparison of the eligible-to-treat group (patients transplanted after 2017 (after start of KTx360°) in study centres; ETT) to historical data in study centres (patients transplanted between 2012 and 2017 (before start of KTx360°); historical control group) and two external control groups (controls transplanted after 2017 external control group resp. between 2012-2017 in other KTx centres external historical control group). Descriptive analyses were performed reporting 95% confidence intervals.

RESULTS

We recruited 72 children/adolescents of whom 26 were incident (enrolled within the first year after KTx) and 46 prevalent (enrolled >1 year after KTx) participants. For all participants study data was collected on appointment and medication adherence, quality of life, and mental health. Claims data was available of 22 patients in the ETT, 17 patients in the historical control group, 71 patients in the external control group and 68 patients in the external historical control group (availability of data depends on number of participating insurance companies). In the initial years of the aftercare period, the study data revealed complete adherence behaviour among both prevalent and incident participants. However, a trend towards increasing non-adherence among prevalent participants compared to incident participants was observed. During the observation period in the first year following transplantation, no graft failure was observed in any of the study centre groups: the ETT and historical control group. Low levels of graft failure (3-6%) were observed in the external controls (external control group and external historical control group, other KTx centres). Patients were at increased risk for mental health issues with internalizing symptoms being most prevalent. Parents rated their children's mental health worse than the patients themselves. While we saw general improvement over the course of the study, changes were not significant. Similar, quality of life was judged worse by-proxy than by patients. Development of quality of life over the course of study was heterogeneous.

CONCLUSION

The present study observed slight trends of increasing non-adherence among prevalent participants. However, adherence levels remained consistently high across all groups. No graft failures were recorded during the observation period in the study centre Hannover before and after the implementation of KTx360°. Graft survival and adherence were significantly better in the paediatric participants than in adults. The present study suggests that adherence-enhancing and individualized therapies based on telemedicine may potentially be effective over the long term. Assessment of quality of life and mental health revealed an elevated probability of mental health concerns. Evidence from patients and proxies indicated that a combined assessment is an effective method of identifying patients at risk.

摘要

背景

由于多种病因,青少年和青年在肾移植(KTx)后长期移植物存活率最差。KTx360°是一种基于远程医疗的多中心、多模式随访护理模式,旨在提高成人和儿童患者的移植存活率。

方法

该研究的儿科部分于2017年5月至2020年10月在汉诺威研究中心进行,并以ISRCTN29416382试验代码注册。移植后护理模式采用结构化方法,纳入专业病例管理、远程医疗支持、心理评估和运动评估,并进行针对性干预。本研究采用准实验性、前瞻性观察设计。主要终点是移植物失败,定义为死亡或开始长期透析。次要终点是预约和药物依从性、生活质量和心理健康。在本研究中,终点在一项准实验性、前瞻性观察研究中进行分析:所有次要终点在干预组的研究期间通过研究数据进行纵向分析。通过将符合治疗条件的组(2017年后(KTx360°开始后)在研究中心接受移植的患者;ETT)与研究中心的历史数据(2012年至2017年(KTx360°开始前)接受移植的患者;历史对照组)以及两个外部对照组(2017年后接受移植的外部对照组和2012 - 2017年在其他KTx中心接受移植的外部历史对照组)进行比较,利用参与法定健康保险提供者的理赔数据调查移植物失败情况。进行描述性分析并报告95%置信区间。

结果

我们招募了72名儿童/青少年,其中26名是新发病例(在KTx后第一年内入组),46名是现患病例(在KTx后1年以上入组)。对于所有参与者,收集了关于预约和药物依从性、生活质量和心理健康的研究数据。ETT组有22名患者、历史对照组有17名患者、外部对照组有71名患者以及外部历史对照组有68名患者可获得理赔数据(数据可用性取决于参与保险公司的数量)。在随访期的最初几年,研究数据显示现患病例和新发病例参与者的依从行为均良好。然而,观察到现患病例参与者与新发病例参与者相比,不依从趋势有所增加。在移植后第一年的观察期内,研究中心组(ETT和历史对照组)未观察到移植物失败。外部对照组(外部对照组和外部历史对照组,其他KTx中心)观察到低水平的移植物失败(3 - 6%)。患者出现心理健康问题的风险增加,内化症状最为普遍。家长对孩子心理健康的评价比患者自己更差。虽然在研究过程中我们看到了总体改善,但变化并不显著。同样,生活质量由代理人评价比患者本人评价更差。研究过程中生活质量的发展是异质性的。

结论

本研究观察到现患病例参与者中不依从有轻微增加趋势。然而,所有组的依从水平一直保持较高。在实施KTx360°前后,汉诺威研究中心在观察期内未记录到移植物失败。儿科参与者的移植物存活率和依从性明显优于成人。本研究表明,基于远程医疗的增强依从性个体化治疗可能长期有效。生活质量和心理健康评估显示心理健康问题的可能性增加。来自患者和代理人的证据表明,联合评估是识别有风险患者的有效方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb2c/12197946/98ec5ec960b9/fneph-05-1569116-g001.jpg

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