Cellular Therapy and Transfusion Medicine Unit, Careggi University Hospital, Florence, Italy.
Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.
Bone Marrow Transplant. 2023 Jun;58(6):659-666. doi: 10.1038/s41409-023-01924-6. Epub 2023 Mar 9.
From 2016 EBMT and JACIE developed an international risk-adapted benchmarking program of haematopoietic stem cell transplant (HSCT) outcome to provide individual EBMT Centers with a means of quality-assuring the HSCT process and meeting FACT-JACIE accreditation requirements relating to 1-year survival outcomes. Informed by previous experience from Europe, North America and Australasia, the Clinical Outcomes Group (COG) established criteria for patient and Center selection, and a set of key clinical variables within a dedicated statistical model adapted to the capabilities of the EBMT Registry. The first phase of the project was launched in 2019 to test the acceptability of the benchmarking model through assessment of Centers' performance for 1-year data completeness and survival outcomes of autologous and allogeneic HSCT covering 2013-2016. A second phase was delivered in July 2021 covering 2015-2019 and including survival outcomes. Reports of individual Center performance were shared directly with local principal investigators and their responses were assimilated. The experience thus far has supported the feasibility, acceptability and reliability of the system as well as identifying its limitations. We provide a summary of experience and learning so far in this 'work in progress', as well as highlighting future challenges of delivering a modern, robust, data-complete, risk-adapted benchmarking program across new EBMT Registry systems.
从 2016 年起,EBMT 和 JACIE 制定了一个国际风险适应的造血干细胞移植(HSCT)结果基准测试计划,为各个 EBMT 中心提供了一种确保 HSCT 过程质量并满足 FACT-JACIE 认证要求的方法,该认证要求与 1 年生存率结果有关。在欧洲、北美和澳大拉西亚的先前经验的基础上,临床结果组(COG)为患者和中心的选择制定了标准,并在专门的统计模型中建立了一套关键临床变量,该模型适用于 EBMT 注册中心的能力。该项目的第一阶段于 2019 年启动,通过评估中心在 2013-2016 年期间的 1 年数据完整性和自体及异基因 HSCT 的生存率方面的表现,来测试基准测试模型的可接受性。第二阶段于 2021 年 7 月完成,涵盖了 2015-2019 年的数据,并包括了生存率结果。个别中心表现的报告直接与当地主要研究者分享,他们的反馈被整合。到目前为止,该经验支持了该系统的可行性、可接受性和可靠性,同时也确定了其局限性。我们在这份“进展中的工作”中总结了迄今为止的经验和学习,并强调了在新的 EBMT 注册系统中提供现代、稳健、数据完整、风险适应的基准测试计划的未来挑战。