International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium
Andrew C Harris, Rachel Young, Steven Devine, William J Hogan, Francis Ayuk, Udomsak Bunworasate, Chantiya Chanswangphuwana, Yvonne A Efebera, Ernst Holler, Mark Litzow, Rainer Ordemann, Muna Qayed, Anne S Renteria, Ran Reshef, Matthias Wölfl, Yi-Bin Chen, Steven Goldstein, Madan Jagasia, Franco Locatelli, Stephan Mielke, David Porter, Tal Schechter, Zhanna Shekhovtsova, James L M Ferrara, John E Levine, Andrew C Harris, Rachel Young, Steven Devine, William J Hogan, Francis Ayuk, Udomsak Bunworasate, Chantiya Chanswangphuwana, Yvonne A Efebera, Ernst Holler, Mark Litzow, Rainer Ordemann, Muna Qayed, Anne S Renteria, Ran Reshef, Matthias Wölfl, Yi-Bin Chen, Steven Goldstein, Madan Jagasia, Franco Locatelli, Stephan Mielke, David Porter, Tal Schechter, Zhanna Shekhovtsova, James L M Ferrara, John E Levine
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.
Keywords: BMT; Bone marrow transplant; GVHD; Graft-versus-host disease; Guidance; Guidelines; staging; standardization.
Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
Source: PubMed