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评价肾移植后每年监测免疫抑制药物依从性的工具 - 一项单中心开放前瞻性试验。

Evaluation of tools for annual capture of adherence to immunosuppressive medications after renal transplantation - a single-centre open prospective trial.

机构信息

Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.

School of Pharmacy, University of Oslo, Oslo, Norway.

出版信息

Transpl Int. 2019 Jun;32(6):614-625. doi: 10.1111/tri.13412. Epub 2019 Mar 6.

Abstract

Annual assessment of adherence would strengthen long-term outcome assessments from registry data. The objective of this study was to evaluate tools suitable for annual routine capture of adherence data in renal transplant recipients. A single-centre open prospective trial included 295 renal transplant recipients on tacrolimus. Two-thirds of the patients were included 4 weeks post-transplant, randomized 1:1 to intensive or single-point adherence assessment in the early phase and 1-year post-transplant. One-third were included 1-year post-transplant during a cross-sectional investigation. Adherence was assessed using multiple methods: The "Basel Assessment of Adherence to Immunosuppressive Medication Scale" (BAASIS ) questionnaire was used to assess self-reported adherence. The treating clinician scored patient's adherence and tacrolimus trough-concentration variability was calculated. In the analyses, the data from the different tools were dichotomized (adherent/nonadherent). The BAASIS overall response rate was over 80%. Intensive BAASIS assessment early after transplantation increased the chance of capturing a nonadherence event, but did not influence the 1-year adherence prevalence. The adherence tools generally captured different populations. Combining the tools, the nonadherence prevalence at 1 year was 38%. The different tools identified to a large degree different patients as nonadherent. Combining these tools is feasible for annual capture of adherence status.

摘要

年度依从性评估将加强从注册数据得出的长期结果评估。本研究的目的是评估适合在肾移植受者中常规年度采集依从性数据的工具。一项单中心开放前瞻性试验纳入了 295 例接受他克莫司治疗的肾移植受者。三分之二的患者在移植后 4 周内入组,随机分为强化组和单点评估组(1:1),分别在早期和移植后 1 年进行评估。三分之一的患者在横断面调查中于移植后 1 年入组。使用多种方法评估依从性:使用“巴塞尔免疫抑制药物依从性评估量表”(BAASIS)问卷评估自我报告的依从性。治疗医生对患者的依从性进行评分,并计算他克莫司谷浓度变异性。在分析中,不同工具的数据被分为(依从/不依从)。BAASIS 的总体响应率超过 80%。移植后早期进行强化 BAASIS 评估增加了捕捉不依从事件的机会,但不影响 1 年的依从率。这些依从性工具通常捕捉到不同的人群。联合使用这些工具,1 年时的不依从率为 38%。不同的工具在很大程度上识别出了不同的不依从患者。联合使用这些工具可以实现每年依从性状态的采集。

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