TY - JOUR
T1 - Defining clinically meaningful outcomes in the evaluation of new treatments for oral mucositis
T2 - Oral mucositis patient provider advisory board
AU - Bellm, Lisa A.
AU - Cunningham, Gail
AU - Durnell, Laurie
AU - Eilers, June
AU - Epstein, Joel B.
AU - Fleming, Tom
AU - Fuchs, Henry J.
AU - Haskins, Martha Nash
AU - Horowitz, Mary M.
AU - Martin, Paul J.
AU - McGuire, Deborah B.
AU - Mullane, Kevin
AU - Oster, Gerry
PY - 2002
Y1 - 2002
N2 - Oral mucositis (OM)-related outcomes constituting a meaningful clinical advance in bone marrow transplant patients were considered by an interdisciplinary panel. Meaningful outcomes are essential in product development for OM, a condition without effective prevention or treatment. The most important outcomes to measure, the feasibility of measuring these in a clinical trial, and clinically meaningful differences in these outcomes were determined by the panel. Most important are reduction in oral pain and use of opioid analgesics, improvement in oral intake and quality of life, and reduction of hospitalization duration. Reduction in the severity of OM measured by an objective evaluation of oral mucosa could provide insight regarding the biologic activity of an intervention. Further data are required to define the precise relationship between reduction in visible OM and improvement in outcome. Minimally, clinical trials for OM should assess oral pain, opioid use, oral intake, and include objective assessment of OM.
AB - Oral mucositis (OM)-related outcomes constituting a meaningful clinical advance in bone marrow transplant patients were considered by an interdisciplinary panel. Meaningful outcomes are essential in product development for OM, a condition without effective prevention or treatment. The most important outcomes to measure, the feasibility of measuring these in a clinical trial, and clinically meaningful differences in these outcomes were determined by the panel. Most important are reduction in oral pain and use of opioid analgesics, improvement in oral intake and quality of life, and reduction of hospitalization duration. Reduction in the severity of OM measured by an objective evaluation of oral mucosa could provide insight regarding the biologic activity of an intervention. Further data are required to define the precise relationship between reduction in visible OM and improvement in outcome. Minimally, clinical trials for OM should assess oral pain, opioid use, oral intake, and include objective assessment of OM.
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U2 - 10.1081/CNV-120002497
DO - 10.1081/CNV-120002497
M3 - Article
C2 - 12197238
AN - SCOPUS:0036044122
SN - 0735-7907
VL - 20
SP - 793
EP - 800
JO - Cancer Investigation
JF - Cancer Investigation
IS - 5-6
ER -