Medical College of Wisconsin
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Defining clinically meaningful outcomes in the evaluation of new treatments for oral mucositis: oral mucositis patient provider advisory board. Cancer Invest 2002;20(5-6):793-800 PMID: 12197238

Pubmed ID

12197238

Abstract

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.

Author List

Bellm LA, Cunningham G, Durnell L, Eilers J, Epstein JB, Fleming T, Fuchs HJ, Haskins MN, Horowitz MM, Martin PJ, McGuire DB, Mullane K, Oster G

Author

Mary M. Horowitz MD, MS Center Director, Professor in the Medicine department at Medical College of Wisconsin




Scopus

2-s2.0-0036044122   41 Citations

MESH terms used to index this publication - Major topics in bold

Analgesics, Opioid
Bone Marrow Transplantation
Clinical Trials as Topic
Eating
Endpoint Determination
Hospitalization
Humans
Mouth Mucosa
Pain
Quality of Life
Stomatitis
Treatment Outcome
jenkins-FCD Prod-296 4db9d02597e0a2e889e230f853b641c12f1c3ee3