Establishment of Definitions and Review Process for Consistent Adjudication of Cause-specific Mortality after Allogeneic Unrelated-donor Hematopoietic Cell Transplantation
Establishment of Definitions and Review Process for Consistent Adjudication of Cause-specific Mortality after Allogeneic Unrelated-donor Hematopoietic Cell Transplantation
复制标题
DOI：
10.1016/j.bbmt.2015.05.019
复制
发表时间：
2015-09-01
影响因子：
4.3
通讯作者：
McCarthy, Philip L.
中科院分区：
文献类型：
--
作者：
Hahn, Theresa;Sucheston-Campbell, Lara E.;McCarthy, Philip L.
临床试验通常使用裁决委员会来完善终点，但观察性研究或全基因组关联研究很少这样做。我们的目标是建立非相关供体异体造血细胞移植（URD-HCT）后死因特异性死亡的定义，评估报告和裁决的死因特异性死亡之间的不一致性，并确定导致死因特异性死亡确定不一致的因素。一个共识小组裁定1484例HCT后1年内死亡的患者，来自2000年至2011年151个美国移植中心向国际血液和骨髓移植研究中心报告的3532例URD-HCT后急性白血病或骨髓异常增生患者。死亡分为疾病相关和移植相关。该小组同意中心报告的99%的死亡与疾病有关，80%的死亡与移植有关。移植年份（队列效应）和疾病状态显著影响专家组和中心之间的一致性。移植后< 100天死亡的敏感性分析显示，骨髓增生异常综合征患者的小组和中心之间的一致性最低。判定死因特异性死亡的标准预定义标准导致了对类似临床情况的一致应用和对死因特异性死亡类别的更清晰描述。其他竞争事件的研究，如癌症特异性与治疗相关的死亡率，将受益于我们的结果。我们详细的算法应该会导致中心对死因特异性死亡的更一致的报告。(C) 2015年美国血液和骨髓移植学会。
Clinical trials commonly use adjudication committees to refine endpoints, but observational research or genome-wide association studies rarely do. Our goals were to establish definitions of cause-specific death after unrelated-donor allogeneic hematopoietic cell transplantation (URD-HCT), to estimate discordance between reported and adjudicated cause-specific death, and to identify factors contributing to inconsistency in cause-specific death determination. A consensus panel adjudicated cause-specific death in 1484 patients who died within 1 year after HCT, derived from 3532 acute leukemia or myelodysplasia patients after URD-HCT from 2000 to 2011 reported by 151 US transplant centers to the Center for International Blood and Marrow Transplant Research. Deaths were classified as disease-related or transplant-related. The panel agreed with >99% of deaths reported by centers as disease-related and 80% reported as transplant-related. Year of transplant (cohort effect) and disease status significantly influenced agreement between the panel and centers. Sensitivity analysis of deaths < 100 days post-transplant yielded the lowest agreement between the panel and centers for myelodysplastic syndrome patients. Standard predefined criteria for adjudicating cause-specific death led to consistent application to similar clinical scenarios and clearer delineation of cause-specific death categories. Other studies of competing events such as cancer-specific versus treatment-related mortality would benefit from our results. Our detailed algorithm should result in more consistent reporting of cause-specific death by centers. (C) 2015 American Society for Blood and Marrow Transplantation.