Non-adherence (NA) to immunosuppressants (IS) among renal transplant recipients (RTRs) is associated with higher risk of allograft rejection, graft loss, and mortality. A precise measurement of NA is indispensable, although its prevalence differs greatly depending on the respective measurement methods. The objective of this study was to assess the accuracy and concordance of different measurement methods of NA in patients after renal transplantation. This was a single-center prospective observational study. At baseline (T0), NA was measured via physicians’ estimates (PE), self-reports (SR), and tacrolimus trough level variability (CV%) in 78 RTRs. A Visual Analogue Scale (VAS, 0–100%) was applied both for SR and PE. In addition, we used BAASIS© for SR and a 5-point Likert scale for PE. NA was measured prospectively via electronic monitoring (EM, VAICA©) during a three month period. Meanwhile, all participants received phone calls in a two week interval (T1-T6) during which SRs were given. Seventy-eight RTRs participated in our study. At t0, NA rates of 6.4%, 28.6%, and 15.4% were found for PE, SR, and CV%, respectively. No correlation was found between these methods. During the study, the percentages of self-reported and electronically monitored adherence remained high, with a minimum mean of 91.2% for the strictest adherence measure (Timing Adherence ±30 min). Our results revealed a moderate to high association between SR and EM. In contrast to PE and CV%, SR significantly predicted electronically monitored adherence. Overall, a decreasing effect of electronically monitored adherence was found for both taking and timing adherence (±2 h, ±30 min) over the course of the study. The moderate to high concordance of SR and EM suggests that both methods measure NA equally accurately. SR seems to be a method that can adequately depict electronically monitored NA and may represent a good and economical instrument to assess NA in clinical practice. The increased adherence at the beginning of the study and its subsequent decrease suggests an intervention effect. Surveillance of IS intake via EM with intermittent phone calls could improve adherence on a short-term basis. To establish long-term effects, further research is necessary.

中文翻译：

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评估肾移植后不依从性的测量方法的准确性和一致性 - 一项前瞻性研究

肾移植受者 (RTR) 对免疫抑制剂 (IS) 的不依从性 (NA) 与更高的同种异体移植排斥、移植物丢失和死亡率风险相关。NA 的精确测量是必不可少的，尽管其流行程度因各自的测量方法而异。本研究的目的是评估肾移植术后患者 NA 不同测量方法的准确性和一致性。这是一项单中心前瞻性观察性研究。在基线 (T0) 时，通过医生估计 (PE)、自我报告 (SR) 和 78 个 RTR 中的他克莫司谷水平变异性 (CV%) 测量 NA。视觉模拟量表（VAS，0-100%）适用于 SR 和 PE。此外，我们对 SR 使用 BAASIS©，对 PE 使用李克特 5 点量表。通过电子监测（EM，VAICA©) 三个月。同时，所有参与者都在两周的时间间隔（T1-T6）内接到电话，在此期间给予 SR。78 个 RTR 参与了我们的研究。在 t0，PE、SR 和 CV% 的 NA 率分别为 6.4%、28.6% 和 15.4%。这些方法之间没有发现相关性。在研究期间，自我报告和电子监控的依从性百分比仍然很高，最严格的依从性措施（时间依从性 ±30 分钟）的最低平均值为 91.2%。我们的结果显示 SR 和 EM 之间存在中度到高度的关联。与 PE 和 CV% 相比，SR 显着预测了电子监测的依从性。总体而言，在研究过程中，电子监测的依从性对服用和定时依从性（±2 小时，±30 分钟）都有降低的影响。SR 和 EM 的中高一致性表明这两种方法都同样准确地测量了 NA。SR 似乎是一种可以充分描述电子监测 NA 的方法，并且可能代表一种在临床实践中评估 NA 的良好且经济的工具。研究开始时依从性的增加及其随后的下降表明存在干预作用。通过 EM 通过间歇性电话监控 IS 摄入量可以在短期内提高依从性。为了建立长期影响，需要进一步研究。研究开始时依从性的增加及其随后的下降表明存在干预作用。通过 EM 通过间歇性电话监控 IS 摄入量可以在短期内提高依从性。为了建立长期影响，需要进一步研究。研究开始时依从性的增加及其随后的下降表明存在干预作用。通过 EM 通过间歇性电话监控 IS 摄入量可以在短期内提高依从性。为了建立长期影响，需要进一步研究。