Biology of Blood and Marrow Transplantation
Volume 16, Issue 3 , Pages 295-300 , March 2010

Patient-Reported Outcomes for Acute Graft-versus-Host Disease Prevention and Treatment Trials

  • Stephanie J. Lee

      Affiliations

    • Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington
    • Corresponding Author InformationCorrespondence and reprint requests: Stephanie J. Lee, MD, MPH, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, N5-290, Seattle, WA 98109.
    • ,
  • Loretta A. Williams

      Affiliations

    • Department of Symptom Research, The University of Texas M.D. Anderson Cancer Center, Houston, Texas

Received 15 July 2009 ,Accepted 21 August 2009.

References 

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  2. Patient Reported Outcome (PRO-CTCAE). Available at: https://wiki.nci.nih.gov/display/CTMS/Patient+Reported+Outcome+(PRO-CTCAE). Accessed July 3, 2009.
  3. Food and Drug Administration. Draft Guidance for Industry. PRO measures: use in medical product development to support labeling claims. 2006. Available at: http://www.fda.gov/cder/guidance. Accessed May 4, 2009.
  4. Wang XS, Shi Q, Williams LA, et al. Serum interleukin-6 predicts the development of multiple symptoms at nadir of allogeneic hematopoietic stem cell transplantation. Cancer. 2008;113:2102–2109
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  11. Ware JE, Kosinski M, Keller SD. SF-36 Physical and Mental Health Summary Scales: A User's Manual. New England Medical Center. Boston, MA: The Health Institute; 1994;
  12. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: A Manual and Interpretation Guide. New England Medical Center. Boston, MA: The Health Institute; 1993;
  13. McQuellon RP, Russell GB, Cella DF, et al. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997;19:357–368
  14. Cleeland CS, Mendoza TR, Wang XS, et al. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000;89:1634–1646
  15. Altmaier EM, Ewell M, McQuellon R, et al. The effect of unrelated donor marrow transplantation on health-related quality of life: a report of the unrelated donor marrow transplantation trial (T-cell depletion trial). Biol Blood Marrow Transplant. 2006;12:648–655
  16. Wagner JE, Thompson JS, Carter SL, Kernan NA. Effect of graft-versus-host disease prophylaxis on 3-year disease-free survival in recipients of unrelated donor bone marrow (T-cell depletion trial): a multi-centre, randomised phase II-III trial. Lancet. 2005;366:733–741
  17. Lee SJ, Kim HT, Ho VT, et al. Quality of life associated with acute and chronic graft-versus-host disease. Bone Marrow Transplant. 2006;38:305–310
  18. Williams LA, Giralt SA, Wang XS, et al. Measuring the symptom burden of allogeneic hematopoietic stem cell transplantation in patients with and without acute graft-versus-host disease [abstract 49]. Biol Blood Marrow Transplant. 2009;15:20–21

 Financial disclosure: See Acknowledgments on page 299.

PII: S1083-8791(09)00409-1

doi: 10.1016/j.bbmt.2009.08.021

Biology of Blood and Marrow Transplantation
Volume 16, Issue 3 , Pages 295-300 , March 2010

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