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. Patient-reported 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-versus-host 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.
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. Patient-reported 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-versus-host 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.
Authors: S Chiodi; S Spinelli; G Ravera; A R Petti; M T Van Lint; T Lamparelli; F Gualandi; D Occhini; N Mordini; G Berisso; S Bregante; F Frassoni; A Bacigalupo Journal: Br J Haematol Date: 2000-09 Impact factor: 6.998
Authors: N Worel; D Biener; P Kalhs; M Mitterbauer; F Keil; A Schulenburg; P Höcker; K Dieckmann; G Fischer; A Rosenmayr; W Linkesch; W Hinterberger; K Lechner; H T Greinix Journal: Bone Marrow Transplant Date: 2002-11 Impact factor: 5.483
Authors: T Duell; M T van Lint; P Ljungman; A Tichelli; G Socié; J F Apperley; M Weiss; A Cohen; E Nekolla; H J Kolb Journal: Ann Intern Med Date: 1997-02-01 Impact factor: 25.391
Authors: Madan H Jagasia; Hildegard T Greinix; Mukta Arora; Kirsten M Williams; Daniel Wolff; Edward W Cowen; Jeanne Palmer; Daniel Weisdorf; Nathaniel S Treister; Guang-Shing Cheng; Holly Kerr; Pamela Stratton; Rafael F Duarte; George B McDonald; Yoshihiro Inamoto; Afonso Vigorito; Sally Arai; Manuel B Datiles; David Jacobsohn; Theo Heller; Carrie L Kitko; Sandra A Mitchell; Paul J Martin; Howard Shulman; Roy S Wu; Corey S Cutler; Georgia B Vogelsang; Stephanie J Lee; Steven Z Pavletic; Mary E D Flowers Journal: Biol Blood Marrow Transplant Date: 2014-12-18 Impact factor: 5.742
Authors: William A Wood; Allison M Deal; Amy Abernethy; Ethan Basch; Claudio Battaglini; Yoon Hie Kim; Julia Whitley; Charlotte Shatten; Jon Serody; Thomas Shea; Bryce B Reeve Journal: Biol Blood Marrow Transplant Date: 2012-12-16 Impact factor: 5.742