Rationale and design of the chronic GVHD cohort study: improving outcomes assessment in chronic GVHD.

Publication Type:

Journal Article

Source:

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, Volume 17, Issue 8, p.1114-20 (2011)

Keywords:

2011, Adolescent, Adult, Aged, Center-Authored Paper, Child, Child, Preschool, Chronic Disease, Clinical Research Division, Clinical Trials as Topic, Cohort Studies, Consortium Authored Paper, Data Collection, Female, Graft vs Host Disease, Humans, Longitudinal Studies, Male, Middle Aged, Outcome Assessment (Health Care), Prospective Studies, Treatment Outcome, Young Adult

Abstract:

In 2005, the National Institutes of Health sponsored a Consensus Development Project on Criteria for Clinical Trials in chronic graft-versus-host (cGVHD) to achieve consensus about key elements of cGVHD research, including definitions for diagnosis, severity scoring, and response measures. To test these proposed definitions, a multicenter prospective cohort study of people with cGVHD is ongoing. This study will evaluate the performance of proposed prognostic factors, measures of disease activity, and surrogate endpoints for therapeutic response. Data are collected at 6-month intervals in a heterogeneous population of patients reflecting modern transplant techniques and posttransplantation clinical management (target enrollment 672 with cGVHD from 10 transplantation centers). This report describes the rationale, design, and methods of the cGVHD cohort study, and invites other investigators to collaborate with the Consortium to analyze data or specimens.