International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium
By Andrew C. Harris, R. Young, S. Devine, W. Hogan, F. Ayuk, U. Bunworasate, C. Chanswangphuwana, Y. Efebera, E. Holler, M. Litzow and 15 more. Biology of Blood and Marrow Transplantation, 2015
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Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon 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 multi-center 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 was following 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.
Subfields: Genetics, Hematology, Pediatrics, Perinatology and Child Health
View Paper: https://www.semanticscholar.org/paper/fbe3a66b00fe46caa83c1842abdc29e0424780fb