PDF(Pubmed)
Abstract：
UNASSIGNED: The after-care treatment project KTx360° aimed to reduce graft failure and mortality after kidney transplantation (KTx).
UNASSIGNED: The study was conducted in the study centers Hannover, Erlangen and Hannoversch Muenden from May 2017 to October 2020 under the trial registration ISRCTN29416382. The program provided a multimodal aftercare program including specialized case management, telemedicine support, psychological and exercise assessments, and interventions. For the analysis of graft failure, which was defined as death, re-transplantation or start of long-term dialysis, we used longitudinal claims data from participating statutory health insurances (SHI) which enabled us to compare participants with controls. To balance covariate distributions between these nonrandomized groups we used propensity score methodology, in particular the inverse probability of treatment weighting (IPTW) approach.
UNASSIGNED: In total, 930 adult participants were recruited at three different transplant centres in Germany, of whom 320 were incident (enrolled within the first year after KTx) and 610 prevalent (enrolled >1 year after KTx) patients. Due to differences in the availability of the claims data, the claims data of 411 participants and 418 controls could be used for the analyses. In the prevalent group we detected a significantly lower risk for graft failure in the study participants compared to the matched controls (HR = 0.13, 95% CI = 0.04-0.39, p = 0.005, n = 389 observations), whereas this difference could not be detected in the incident group (HR = 0.92, 95% CI = 0.54-1.56, p = 0.837, n = 440 observations).
UNASSIGNED: Our findings suggest that a multimodal and multidisciplinary aftercare intervention can significantly improve outcome after KTx, specifically in patients later after KTx. For evaluation of effects on these outcome parameters in patients enrolled within the first year after transplantation longer observation times are necessary.
UNASSIGNED: The study was funded by the Global Innovation fund of the Joint Federal Committee of the Federal Republic of Germany, grant number 01NVF16009.
UNASSIGNED: The study was conducted in the study centers Hannover, Erlangen and Hannoversch Muenden from May 2017 to October 2020 under the trial registration ISRCTN29416382. The program provided a multimodal aftercare program including specialized case management, telemedicine support, psychological and exercise assessments, and interventions. For the analysis of graft failure, which was defined as death, re-transplantation or start of long-term dialysis, we used longitudinal claims data from participating statutory health insurances (SHI) which enabled us to compare participants with controls. To balance covariate distributions between these nonrandomized groups we used propensity score methodology, in particular the inverse probability of treatment weighting (IPTW) approach.
UNASSIGNED: In total, 930 adult participants were recruited at three different transplant centres in Germany, of whom 320 were incident (enrolled within the first year after KTx) and 610 prevalent (enrolled >1 year after KTx) patients. Due to differences in the availability of the claims data, the claims data of 411 participants and 418 controls could be used for the analyses. In the prevalent group we detected a significantly lower risk for graft failure in the study participants compared to the matched controls (HR = 0.13, 95% CI = 0.04-0.39, p = 0.005, n = 389 observations), whereas this difference could not be detected in the incident group (HR = 0.92, 95% CI = 0.54-1.56, p = 0.837, n = 440 observations).
UNASSIGNED: Our findings suggest that a multimodal and multidisciplinary aftercare intervention can significantly improve outcome after KTx, specifically in patients later after KTx. For evaluation of effects on these outcome parameters in patients enrolled within the first year after transplantation longer observation times are necessary.
UNASSIGNED: The study was funded by the Global Innovation fund of the Joint Federal Committee of the Federal Republic of Germany, grant number 01NVF16009.
摘要：
■善后治疗项目KTx360°旨在减少肾移植（KTx）后的移植物衰竭和死亡率。
■这项研究是在汉诺威的研究中心进行的，Erlangen和HannoverschMuenden于2017年5月至2020年10月根据ISRCTN29416382的试验注册。该计划提供了一个多模式的护理计划，包括专门的病例管理，远程医疗支持，心理和运动评估，和干预。对于移植物失败的分析，被定义为死亡，重新移植或开始长期透析，我们使用了来自参与法定健康保险(SHI)的纵向索赔数据,这使我们能够将参与者与对照组进行比较.为了平衡这些非随机组之间的协变量分布，我们使用了倾向评分方法，特别是治疗加权逆概率(IPTW)方法。
■总共，德国三个不同的移植中心招募了930名成年参与者，其中320例(在KTx后的第一年内登记)和610例流行(在KTx后>1年登记)患者。由于索赔数据的可用性存在差异，411名参与者和418名对照的索赔数据可用于分析。在流行组中，我们发现与匹配的对照组相比，研究参与者的移植失败风险显着降低（HR=0.13，95％CI=0.04-0.39，p=0.005，n=389观察值）。而在事件组中无法检测到这种差异(HR=0.92,95%CI=0.54~1.56,p=0.837,n=440).
■我们的研究结果表明，多模式和多学科的护理干预可以显着改善KTx后的预后，特别是在KTx后的患者中。为了评估移植后第一年内招募的患者对这些结果参数的影响，需要更长的观察时间。
■该研究由德意志联邦共和国联合联邦委员会全球创新基金资助，授权号01NVF16009。
■这项研究是在汉诺威的研究中心进行的，Erlangen和HannoverschMuenden于2017年5月至2020年10月根据ISRCTN29416382的试验注册。该计划提供了一个多模式的护理计划，包括专门的病例管理，远程医疗支持，心理和运动评估，和干预。对于移植物失败的分析，被定义为死亡，重新移植或开始长期透析，我们使用了来自参与法定健康保险(SHI)的纵向索赔数据,这使我们能够将参与者与对照组进行比较.为了平衡这些非随机组之间的协变量分布，我们使用了倾向评分方法，特别是治疗加权逆概率(IPTW)方法。
■总共，德国三个不同的移植中心招募了930名成年参与者，其中320例(在KTx后的第一年内登记)和610例流行(在KTx后>1年登记)患者。由于索赔数据的可用性存在差异，411名参与者和418名对照的索赔数据可用于分析。在流行组中，我们发现与匹配的对照组相比，研究参与者的移植失败风险显着降低（HR=0.13，95％CI=0.04-0.39，p=0.005，n=389观察值）。而在事件组中无法检测到这种差异(HR=0.92,95%CI=0.54~1.56,p=0.837,n=440).
■我们的研究结果表明，多模式和多学科的护理干预可以显着改善KTx后的预后，特别是在KTx后的患者中。为了评估移植后第一年内招募的患者对这些结果参数的影响，需要更长的观察时间。
■该研究由德意志联邦共和国联合联邦委员会全球创新基金资助，授权号01NVF16009。
