Establishment of Definitions and Review Process for Consistent Adjudication of Cause-Specific Mortality After Allogeneic Unrelated Donor Hematopoietic Cell Transplantation.

Publication Type:

Journal Article

Source:

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation (2015)

Abstract:

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), estimate discordance between reported and adjudicated cause-specific death, and identify factors contributing to inconsistency in cause-specific deathdetermination. A consensus panel adjudicated cause-specific deathin 1,484 patients who died within 1 year after HCT, derived from 3,532 acute leukemia or myelodysplasia patients after URD-HCT 2000-2011 reported by 151 U.S. transplant centers to CIBMTR. Deaths were classified as disease-related (DRM) or transplant-related (TRM). The panel agreed with >99% of deaths reported by centers as DRM and 80% reported as TRM. Year of transplant (cohort effect) and disease status significantly influenced agreement between panel and centers. Sensitivity analysis of deaths <100 days post-transplant yielded lowest agreement between the panel and centers for myelodysplastic syndrome patients. Standard pre-defined criteria for adjudicating cause-specific deathled to consistent application to similar clinical scenarios and clearer delineation of cause-specific deathcategories. Other studies of competing events like cancer-specific vs treatment-related mortality would benefit from our results. Our detailed algorithm should result in more consistent reporting of cause-specific deathby centers.