A Multicenter Pilot Evaluation of the National Institutes of Health Chronic Graft-versus- Host Disease (cGVHD) Therapeutic Response Measures: Feasibility,

Slides:



Advertisements
Similar presentations
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis.
Advertisements

Overview of Chronic GVHD Response Assessment
Stephanie J. Lee, Loretta A. Williams 
Sirolimus in Combination with Cyclosporine or Tacrolimus Plus Methotrexate for Prevention of Graft-versus-Host Disease following Hematopoietic Cell Transplantation.
A Multicenter Pilot Evaluation of the National Institutes of Health Chronic Graft-versus- Host Disease (cGVHD) Therapeutic Response Measures: Feasibility,
Measuring Therapeutic Response in Chronic Graft-versus-Host Disease: National Institutes of Health Consensus Development Project on Criteria for Clinical.
Center for International Blood and Marrow Transplant Research Chronic Graft-versus- Host Disease Risk Score Predicts Mortality in an Independent Validation.
Clinical Evaluation of Oral Chronic Graft-Versus-Host Disease
Incidence and Prognostic Value of Eosinophilia in Chronic Graft-versus-Host Disease after Nonmyeloablative Hematopoietic Cell Transplantation  Imran Ahmad,
Pharmacokinetics of Ganciclovir after Oral Valganciclovir versus Intravenous Ganciclovir in Allogeneic Stem Cell Transplant Patients with Graft-versus-Host.
Validation of National Institutes of Health Global Scoring System for Chronic Graft- Versus-Host Disease (GVHD) According to Overall and GVHD-Specific.
Prognostic Factors of Chronic Graft-versus-Host Disease Following Allogeneic Peripheral Blood Stem Cell Transplantation: The National Institutes Health.
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging.
David Myerson, Gideon Steinbach, Ted A. Gooley, Howard M. Shulman 
Voriconazole-Induced Phototoxicity Masquerading as Chronic Graft-versus-Host Disease of the Skin in Allogeneic Hematopoietic Cell Transplant Recipients 
Unique Abnormalities of CD4+ and CD8+ Central Memory Cells Associated with Chronic Graft-versus-Host Disease Improve after Extracorporeal Photopheresis 
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis.
Salivary Gland Involvement in Chronic Graft-Versus-Host Disease: Prevalence, Clinical Significance, and Recommendations for Evaluation  Matin M. Imanguli,
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: III. The 2014 Biomarker.
Imatinib Mesylate for the Treatment of Steroid-Refractory Sclerotic-Type Cutaneous Chronic Graft-versus-Host Disease  Kristin Baird, Leora E. Comis, Galen.
Implementation of Post-Transplant Assessment Tools for Improved Accuracy of Graft- Versus-Host Disease Reporting  Madhu Ragupathi, Jaskiran Kaur, Luda.
Oral Manifestations Compatible with Chronic Graft-versus-Host Disease in Patients with Fanconi Anemia  Laura Grein Cavalcanti, Renata L. Fuentes Araújo,
Mark Pines, David Snyder, Shai Yarkoni, Arnon Nagler 
Characterization and Risk Factor Analysis of Osteoporosis in a Large Cohort of Patients with Chronic Graft-versus-Host Disease  Filip Pirsl, Lauren M.
Bisphosphonate Therapy for Reduced Bone Mineral Density in Children with Chronic Graft-versus-Host Disease  Paul A. Carpenter, Paul Hoffmeister, Charles.
Do Patients and Physicians Agree When They Assess Quality of Life?
Peripheral Blood Grafts from Unrelated Donors Are Associated with Increased Acute and Chronic Graft-versus-Host Disease without Improved Survival  Mary.
Fluticasone, Azithromycin, and Montelukast Treatment for New-Onset Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation  Kirsten.
National Institutes of Health Chronic Graft-versus-Host Disease Staging in Severely Affected Patients: Organ and Global Scoring Correlate with Established.
Extracorporeal Photopheresis in Steroid-Refractory Acute or Chronic Graft-versus-Host Disease: Results of a Systematic Review of Prospective Studies 
Stephanie J. Lee, Loretta A. Williams 
Chronic graft-versus-host disease
Symptom Distress Predicts Long-Term Health and Well-Being in Allogeneic Stem Cell Transplantation Survivors  Margaret F. Bevans, Sandra A. Mitchell, John.
Impact of Age on Quality of Life, Functional Status, and Survival in Patients with Chronic Graft-versus-Host Disease  Areej El-Jawahri, Joseph Pidala,
Impact of Ocular Chronic Graft-versus-Host Disease on Quality of Life
Clinical Benefit of Response in Chronic Graft-versus-Host Disease
Comparison of Short-Term Response and Long-Term Outcomes after Initial Systemic Treatment of Chronic Graft-Versus-Host Disease  Paul J. Martin, Barry.
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. The 2014 Ancillary.
Lymphocyte Phenotype during Therapy for Acute Graft-versus-Host Disease: A Brief Report from BMT-CTN 0302  Javier Bolaños-Meade, Juan Wu, Brent R. Logan,
Prednisone (PDN)/Sirolimus (SRL) Compared to PDN/SRL/Calcineurin Inhibitor (CNI) as Treatment for Chronic Graft-Versus-Host-Disease (cGVHD): A Randomized.
Risk Factors and Outcome of Chronic Graft-versus-Host Disease after Allogeneic Stem Cell Transplantation—Results from a Single-Center Observational Study 
Oral Chronic Graft-versus-Host Disease Scoring Using the NIH Consensus Criteria  Nathaniel S. Treister, Kristen Stevenson, MS, Haesook Kim, Sook-Bin Woo,
Measuring Therapeutic Response in Chronic Graft-versus-Host Disease
A Novel Strategy in Managing Post-Liver Transplant Acute Graft-Versus-Host-Disease: The New Era (T)Rojan Horse  Zeyad Kanaan, MD, William Tse, MD, FACP 
National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Research Methodology and Study Design Working Group Report 
Betty K. Hamilton, Lisa Rybicki, Sally Arai, Mukta Arora, Corey S
Paul J. Martin, Terry Furlong, Scott D. Rowley, Steven A
Graft-versus-Host Disease Induced Graft-versus-Leukemia Effect: Greater Impact on Relapse and Disease-Free Survival after Reduced Intensity Conditioning 
Randomized Double-Blind Clinical Trial Comparing Clobetasol and Dexamethasone for the Topical Treatment of Symptomatic Oral Chronic Graft-Versus-Host.
Ancillary Therapy and Supportive Care of Chronic Graft-versus-Host Disease: National Institutes of Health Consensus Development Project on Criteria for.
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. The 2014 Clinical.
Myeloablative Transplantation using either Cord Blood or Bone Marrow leads to Immune Recovery, High Long-Term Donor Chimerism and Excellent Survival in.
Eric J. Chow, Kenneth Wong, Stephanie J. Lee, Kara L
Trajectories of Quality of Life after Hematopoietic Cell Transplantation: Secondary Analysis of Blood and Marrow Transplant Clinical Trials Network 0902.
Analysis of Gastrointestinal and Hepatic Chronic Grant-versus-Host Disease Manifestations on Major Outcomes: A Chronic Grant-versus-Host Disease Consortium.
Mohammad Alhyari, M. D. , Aymen Bukannan, M. D. , Kimberly Brown, M. D
Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews  Emily C. Merkel, Sandra A. Mitchell,
John E. Levine, Sophie Paczesny, Stefanie Sarantopoulos 
Biology of Blood and Marrow Transplantation
A Randomized Double-Blind Trial of Hydroxychloroquine for the Prevention of Chronic Graft-versus-Host Disease after Allogeneic Peripheral Blood Stem Cell.
A Refined Risk Score for Acute Graft-versus-Host Disease that Predicts Response to Initial Therapy, Survival, and Transplant-Related Mortality  Margaret.
Young Female Donors Do Not Increase the Risk of Graft-versus-Host Disease or Impact Overall Outcomes in Pediatric HLA-Matched Sibling Hematopoietic Stem.
Preengraftment Syndrome after Unrelated Cord Blood Transplant Is a Strong Predictor of Acute and Chronic Graft-versus-Host Disease  Haydar Frangoul, Li.
Oral Symptom Intensity, Health-Related Quality of Life, and Correlative Salivary Cytokines in Adult Survivors of Hematopoietic Stem Cell Transplantation.
Pulmonary Symptoms Measured by the National Institutes of Health Lung Score Predict Overall Survival, Nonrelapse Mortality, and Patient-Reported Outcomes.
Adult Recipients of Matched Related Donor Blood Cell Transplants Given Myeloablative Regimens Including Pretransplant Antithymocyte Globulin Have Lower.
Mary Eapen  Biology of Blood and Marrow Transplantation 
In Memoriam: E. Donnall Thomas
Graft-versus-Host Disease: State of the Science
Biology of Blood and Marrow Transplantation
Presentation transcript:

A Multicenter Pilot Evaluation of the National Institutes of Health Chronic Graft-versus- Host Disease (cGVHD) Therapeutic Response Measures: Feasibility, Interrater Reliability, and Minimum Detectable Change  Sandra A. Mitchell, David Jacobsohn, Kimberly E. Thormann Powers, Paul A. Carpenter, Mary E.D. Flowers, Edward W. Cowen, Mark Schubert, Maria L. Turner, Stephanie J. Lee, Paul Martin, Michael R. Bishop, Kristin Baird, Javier Bolaños-Meade, Kevin Boyd, Jane M. Fall-Dickson, Lynn H. Gerber, Jean-Pierre Guadagnini, Matin Imanguli, Michael C. Krumlauf, Leslie Lawley, Li Li, Bryce B. Reeve, Janine Austin Clayton, Georgia B. Vogelsang, Steven Z. Pavletic  Biology of Blood and Marrow Transplantation  Volume 17, Issue 11, Pages 1619-1629 (November 2011) DOI: 10.1016/j.bbmt.2011.04.002 Copyright © 2011 Terms and Conditions

Figure 1 Bland-Altman plots, comparing differences (Trial 4) between clinician and expert scoring of cutaneous and oral cGVHD manifestations (difference = clinician score minus expert score) plotted against expert scores. Negative differences reflect clinician underestimation of the extent of involvement, whereas positive differences reflect clinician overestimation of the extent of involvement, relative to the expert’s assessment. A change in the magnitude of the difference between clinician and expert assessments with increasing extent of cGVHD involvement, as assessed by the expert, is determined by looking for patterns along the x-axis. Biology of Blood and Marrow Transplantation 2011 17, 1619-1629DOI: (10.1016/j.bbmt.2011.04.002) Copyright © 2011 Terms and Conditions

Figure 2 Interrater agreement between clinicians and experts for evaluation of gastrointestinal symptoms, functional performance, and cGVHD global scores. In the final 2 trials, substantial interrater agreement was observed in evaluating gastrointestinal symptoms (68% to 94% of pairwise comparisons in perfect agreement), whereas moderate to substantial agreement was noted in evaluating the 2-minute walk (75% to 80% of pairwise assessments were concordant), grip strength (60% to 77% of pairwise assessments were concordant), cGVHD global severity (clinician-expert pairs in perfect agreement 50% to 75% of the time), and cGVHD evolution over the past month (clinician-expert pairs in perfect agreement 40% to 63% of the time). Note: Numbers were rounded so that values add to 100%. Biology of Blood and Marrow Transplantation 2011 17, 1619-1629DOI: (10.1016/j.bbmt.2011.04.002) Copyright © 2011 Terms and Conditions