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
Date
08/29/2002Pubmed ID
12197238DOI
10.1081/cnv-120002497Scopus ID
2-s2.0-0036044122 (requires institutional sign-in at Scopus site) 53 CitationsAbstract
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 GAuthor
Mary M. Horowitz MD, MS Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Analgesics, OpioidBone Marrow Transplantation
Clinical Trials as Topic
Eating
Endpoint Determination
Hospitalization
Humans
Mouth Mucosa
Pain
Quality of Life
Stomatitis
Treatment Outcome
