Sensitivity of changes in chronic graft-versus-host disease activity to changes in patient-reported quality of life: Results from the chronic graft-versus-host disease consortium

Joseph Pidala, Brenda F. Kurland, Xiaoyu Chai, Georgia Vogelsang, Daniel J. Weisdorf, Steven Pavletic, Corey Cutler, Navneet Majhail, Stephanie J. Lee

Research output: Contribution to journalArticle

Abstract

Background The 2005 National Institute of Health Chronic Graft-versus-Host Disease Consensus Conference recommended collection of patient-reported outcomes in clinical trials on chronic graft-versus-host disease. We assessed whether changes in chronic graft-versus-host disease severity, determined using National Institute of Health criteria, clinicians' assessment or patients' self-evaluation, correlated with patient-reported quality of life as measured by the Short Form-36 and Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) instruments. Design and Methods Three-hundred and thirty-six adult patients (median age 52 years; range, 19 - 79) with chronic graft-versus-host disease from six transplant centers contributed baseline and follow-up data (from 936 visits overall). Results While the majority of the patients had stable chronic graft-versus-host disease, improvement or worsening was noted in approximately 40% of follow-up visits. Multivariable analysis demonstrated no association between change in chronic graft-versus-host disease severity evaluated by National Institute of Health criteria and change in quality of life, while clinician-reported changes in severity were associated with changes in some quality of life measures. Patientreported changes in the severity of chronic graft-versus-host disease were associated with changes in all quality of life measures. Comparison of the Short Form-36 and the FACT-BMT suggested that the data collected in the Functional Assessment of Cancer Therapy - General (FACT-G) core survey are sufficient without the need for the Short Form-36 or the FACT-BMT subscale. Conclusions We conclude that serial National Institute of Health and clinician-reported chronic graft-versushost disease severity assessments cannot substitute for patient-reported outcomes in clinical trials. Collection of just the FACT-G instead of the Short Form-36 and the full FACT-BMT will decrease respondent burden without compromising quality of life assessment.

Original languageEnglish (US)
Pages (from-to)1528-1535
Number of pages8
JournalHaematologica
Volume96
Issue number10
DOIs
StatePublished - Oct 1 2011

Keywords

  • Chronic graft versus host disease
  • Quality of life
  • Sensitivity to change

ASJC Scopus subject areas

  • Hematology

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