International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium

• Authors: Andrew C. Harris, University of Michigan; Rachel Young, University of Michigan; Steven Devine, Ohio State University; William J. Hogan, Mayo Clinic; Francis Ayuk, University Medical Center, Germany; Udomsak Bunworasate, Chulalongkorn University; Chantiya Chanswangphuwana, Chulalongkorn University; Yvonne A. Efebera, Ohio State University; Ernst Holler, University of Regensburg; Mark Litzow, Mayo Clinic; Rainer Ordemann, University Hospital TU Dresden; Muna Qayed, Emory University; Anne S. Renteria, Mt Sinai Hosp; Ran Reshef, Columbia University; Matthias Woelfl, University of Wurzburg; Yi-Bin Chen, Massachusetts General Hospital; Steven Goldstein, University of Michigan; Madan Jagasia, Vanderbilt University; Franco Locatelli, Ospedale Pediatrico Bambino Gesu, Italy; Stephan Mielke, University of Wurzburg; David Porter, University of Pennsylvania; Tai Schechter, The Hospital for Sick Children, Toronto; Zhanna Shekhovtsova, Federal Center for Pediatric Hematology, Moscow; James L.M. Ferrara, Mount Sinai Hospital, NY; John E. Levine, University of Michigan
• Journal Title: Biology of Blood and Marrow Transplantation
• Volume: Volume 22, Number 1
• Publisher: Elsevier | 2016-01-01, Pages 4-10
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1016/j.bbmt.2015.09.001
• Subjects: Health Sciences, Oncology; Health Sciences, Pathology
• Keywords: Science & Technology; Life Sciences & Biomedicine; Hematology; Immunology; Transplantation; Bone marrow transplant; BMT; Graft-versus-host disease; Guidance; Guidelines; GVHD; staging; standardization; HEMATOPOIETIC-CELL TRANSPLANTATION; BONE-MARROW-TRANSPLANTATION; SURVIVAL; THERAPY; MORTALITY; DIAGNOSIS; CENTERS; SCORE

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.