Document Detail

A proposed objective way to assess results of randomized prospective clinical trials with acute graft-versus-host disease as an outcome of interest.
MedLine Citation:
PMID:  11380417     Owner:  NLM     Status:  MEDLINE    
The assessment of graft-versus-host disease (GVHD) as an end-point in clinical trials requires subjective judgement to distinguish morbidity caused by GVHD from morbidity caused by other complications. We developed a method based on ordinal regression for longitudinal assessment of morbidity involving the skin, liver and gut, regardless of cause as an objective end-point in randomized prospective phase III treatment or prevention trials for which GVHD is an outcome of interest. This method was validated for treatment studies by showing that morbidity was more severe among patients with grade II-IV GVHD than among those who did not have GVHD. We found no differences in morbidity involving the skin, liver and gut after the diagnosis of GVHD in a group of 30 patients who received peripheral blood stem cells and a group of 37 who received marrow in a randomized phase III clinical trial. These preliminary results suggest that objective end-points could be used in randomized clinical trials for treatment of GVHD. Further studies will be needed to determine if similar methods could be used in randomized clinical trials for prevention of GVHD.
H Al-Ghamdi; W Leisenring; W I Bensinger; R A Nash; R Storb; F R Appelbaum; P J Martin
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  British journal of haematology     Volume:  113     ISSN:  0007-1048     ISO Abbreviation:  Br. J. Haematol.     Publication Date:  2001 May 
Date Detail:
Created Date:  2001-05-30     Completed Date:  2001-07-05     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0372544     Medline TA:  Br J Haematol     Country:  England    
Other Details:
Languages:  eng     Pagination:  461-9     Citation Subset:  IM    
Division of Clinical Research, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA.
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MeSH Terms
Acute Disease
Bone Marrow Transplantation*
Chi-Square Distribution
Graft vs Host Disease / complications*,  mortality
Hematopoietic Stem Cell Transplantation / adverse effects*,  mortality
Intestinal Diseases / etiology
Leukemia / mortality,  therapy*
Liver Diseases / etiology
Middle Aged
Prospective Studies
Regression Analysis
Skin Diseases / etiology
Transplantation Conditioning
Treatment Outcome
Grant Support

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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