title: International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium.
abstract: Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed on by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multicenter clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance followed discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture, which may improve the reproducibility of GVHD clinical trials after further prospective validation.
authors.affiliation: Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Blood and Marrow Transplantation Program, University of Utah, Salt Lake City, Utah.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Harris
authors.affiliation: Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai Hospital, New York, New York.
authors.forename: Rachel
authors.initials: R
authors.lastname: Young
authors.affiliation: Blood and Marrow Transplantation Program, Ohio State University, Columbus, Ohio.
authors.forename: Steven
authors.initials: S
authors.lastname: Devine
authors.affiliation: Blood and Marrow Transplantation Program, Mayo Clinic, Rochester, Minnesota.
authors.forename: William J
authors.initials: WJ
authors.lastname: Hogan
authors.affiliation: Department of Stem Cell Transplantation, University Medical Center, Hamburg-Eppendorf, Germany.
authors.forename: Francis
authors.initials: F
authors.lastname: Ayuk
authors.affiliation: Blood and Marrow Transplantation Program, Chulalongkorn University, Bangkok, Thailand.
authors.forename: Udomsak
authors.initials: U
authors.lastname: Bunworasate
authors.affiliation: Blood and Marrow Transplantation Program, Chulalongkorn University, Bangkok, Thailand.
authors.forename: Chantiya
authors.initials: C
authors.lastname: Chanswangphuwana
authors.affiliation: Blood and Marrow Transplantation Program, Ohio State University, Columbus, Ohio.
authors.forename: Yvonne A
authors.initials: YA
authors.lastname: Efebera
authors.affiliation: Blood and Marrow Transplantation Program, University of Regensburg, Regensburg, Germany.
authors.forename: Ernst
authors.initials: E
authors.lastname: Holler
authors.affiliation: Blood and Marrow Transplantation Program, Mayo Clinic, Rochester, Minnesota.
authors.forename: Mark
authors.initials: M
authors.lastname: Litzow
authors.affiliation: Blood and Marrow Transplantation Program, University Hospital TU Dresden, Dresden, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Ordemann
authors.affiliation: Pediatric Blood and Marrow Transplantation Program, Aflac Cancer and Blood Disorders Center, Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia.
authors.forename: Muna
authors.initials: M
authors.lastname: Qayed
authors.affiliation: Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai Hospital, New York, New York.
authors.forename: Anne S
authors.initials: AS
authors.lastname: Renteria
authors.affiliation: Blood and Marrow Transplantation Program, Columbia University Medical Center, New York, New York.
authors.forename: Ran
authors.initials: R
authors.lastname: Reshef
authors.affiliation: Pediatric Blood and Marrow Transplantation Program, Children's Hospital, University of Würzburg, Würzburg, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Wölfl
authors.affiliation: Bone Marrow Transplantation Program, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Yi-Bin
authors.initials: YB
authors.lastname: Chen
authors.affiliation: Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan.
authors.forename: Steven
authors.initials: S
authors.lastname: Goldstein
authors.affiliation: Division of Hematology-Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Madan
authors.initials: M
authors.lastname: Jagasia
authors.affiliation: Pediatric Blood and Marrow Transplantation Program, Ospedale Pediatrico Bambino Gesu, Rome, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Locatelli
authors.affiliation: Blood and Marrow Transplantation Program, University of Würzburg, Würzburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Mielke
authors.affiliation: Blood and Marrow Transplantation Program, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: David
authors.initials: D
authors.lastname: Porter
authors.affiliation: Pediatric Blood and Marrow Transplantation Program, The Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Tal
authors.initials: T
authors.lastname: Schechter
authors.affiliation: Federal Clinical Research Center for Children's Hematology, Oncology and Immunology, Moscow, Russian Federation.
authors.forename: Zhanna
authors.initials: Z
authors.lastname: Shekhovtsova
authors.affiliation: Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai Hospital, New York, New York.
authors.forename: James L M
authors.initials: JL
authors.lastname: Ferrara
authors.affiliation: Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai Hospital, New York, New York. Electronic address: john.levine@mssm.edu.
authors.forename: John E
authors.initials: JE
authors.lastname: Levine
mesh_terms: D000208:Acute Disease; D064591:Allografts; D006086:Graft vs Host Disease / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic
keywords: BMT; Bone marrow transplant; GVHD; Graft-versus-host disease; Guidance; Guidelines; staging; standardization