title: Establishment of Definitions and Review Process for Consistent Adjudication of Cause-specific Mortality after Allogeneic Unrelated-donor Hematopoietic Cell Transplantation.
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), 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.
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Theresa
authors.initials: T
authors.lastname: Hahn
authors.affiliation: Department of Cancer Prevention and Control, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Lara E
authors.initials: LE
authors.lastname: Sucheston-Campbell
authors.affiliation: Department of Cancer Prevention and Control, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Leah
authors.initials: L
authors.lastname: Preus
authors.affiliation: Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.
authors.forename: Xiaochun
authors.initials: X
authors.lastname: Zhu
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA.
authors.forename: John A
authors.initials: JA
authors.lastname: Hansen
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Martin
authors.affiliation: Department of Biostatistics and Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Li
authors.initials: L
authors.lastname: Yan
authors.affiliation: Department of Biostatistics and Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Song
authors.initials: S
authors.lastname: Liu
authors.affiliation: Center for International Blood and Marrow Transplant Research, Minneapolis Campus, Minneapolis, MN.
authors.forename: Stephen
authors.initials: S
authors.lastname: Spellman
authors.affiliation: Department of Biostatistics, State University of New York at Buffalo, Buffalo, NY and Dalla Lana School of Public Health, University of Toronto, Toronto, ONT, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Tritchler
authors.affiliation: Department of Cancer Prevention and Control, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Alyssa
authors.initials: A
authors.lastname: Clay
authors.affiliation: Department of Pediatrics, The University of Chicago, Chicago, IL.
authors.forename: Kenan
authors.initials: K
authors.lastname: Onel
authors.affiliation: Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Pasquini
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Philip L
authors.initials: PL
authors.lastname: McCarthy
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D064591:Allografts; D005260:Female; D005500:Follow-Up Studies; D019337:Hematologic Neoplasms / Q000401:mortality / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061349:Unrelated Donors
keywords: Acute leukemia; Adjudication; Allogeneic HCT; Cause-specific mortality