[HTML][HTML] International, multicenter standardization of acute graft-versus-host disease clinical data collection: a report from the Mount Sinai Acute GVHD International …

AC Harris, R Young, S Devine, WJ Hogan… - Biology of Blood and …, 2016 - Elsevier
AC Harris, R Young, S Devine, WJ Hogan, F Ayuk, U Bunworasate, C Chanswangphuwana…
Biology of Blood and Marrow Transplantation, 2016Elsevier
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 …
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.
Elsevier