Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective? Curr Hematol Malig Rep 2019 Feb;14(1):22-30
Date
01/15/2019Pubmed ID
30637541Pubmed Central ID
PMC6408224DOI
10.1007/s11899-019-0494-xScopus ID
2-s2.0-85060182293 (requires institutional sign-in at Scopus site) 11 CitationsAbstract
PURPOSE OF REVIEW: Graft versus host disease (GVHD) is a common complication following hematopoietic cell transplant and is associated with a high symptom burden, reduced functional status, and impaired quality of life (QOL). QOL is best assessed by patient-reported outcomes (PRO). Numerous clinical trials for the prevention and treatment of GVHD are available. This review aims to understand the landscape of PRO inclusion in clinical trials for GVHD over the last decade.
RECENT FINDINGS: Consensus bodies, including experts in GVHD, PRO, and clinical trials have made recommendations for a standardized approach for the inclusion of PRO in clinical trials including as primary outcomes, however, these have yet to be implemented in a consistent manner in practice. Consistently applying consensus recommendation in chronic GVHD will ensure that PROs are appropriately included in clinical trials. Development of validated measures in acute GVHD and composite outcomes for all GVHD trials are required.
Author List
Shaw BEAuthor
Bronwen E. Shaw MBChB, PhD Center Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Graft vs Host DiseaseHematopoietic Stem Cell Transplantation
Humans
Patient Reported Outcome Measures
Transplantation Conditioning
Treatment Outcome