title: Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.
abstract: The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed.
authors.affiliation: Johns Hopkins University, Departments of Neurology, Neurosurgery and Oncology, Baltimore, Maryland (J.O.B.); Critical Path Institute, 1730 E. River Road, Tucson, Arizona (S.J.C.); University of Colorado School of Medicine, Denver Veterans Affairs Medical Center, 12631 East 17th Avenue B185, Aurora, Colorado (J.R.C.); Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, Maryland (N.K.L.); University of Texas MD Anderson Cancer Center, 1515 Holcombe Bld., Houston, Texas (T.R.M., J.S.W.).
authors.forename: Jaishri O
authors.initials: JO
authors.lastname: Blakeley
authors.affiliation: Johns Hopkins University, Departments of Neurology, Neurosurgery and Oncology, Baltimore, Maryland (J.O.B.); Critical Path Institute, 1730 E. River Road, Tucson, Arizona (S.J.C.); University of Colorado School of Medicine, Denver Veterans Affairs Medical Center, 12631 East 17th Avenue B185, Aurora, Colorado (J.R.C.); Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, Maryland (N.K.L.); University of Texas MD Anderson Cancer Center, 1515 Holcombe Bld., Houston, Texas (T.R.M., J.S.W.).
authors.forename: Stephen Joel
authors.initials: SJ
authors.lastname: Coons
authors.affiliation: Johns Hopkins University, Departments of Neurology, Neurosurgery and Oncology, Baltimore, Maryland (J.O.B.); Critical Path Institute, 1730 E. River Road, Tucson, Arizona (S.J.C.); University of Colorado School of Medicine, Denver Veterans Affairs Medical Center, 12631 East 17th Avenue B185, Aurora, Colorado (J.R.C.); Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, Maryland (N.K.L.); University of Texas MD Anderson Cancer Center, 1515 Holcombe Bld., Houston, Texas (T.R.M., J.S.W.).
authors.forename: John R
authors.initials: JR
authors.lastname: Corboy
authors.affiliation: Johns Hopkins University, Departments of Neurology, Neurosurgery and Oncology, Baltimore, Maryland (J.O.B.); Critical Path Institute, 1730 E. River Road, Tucson, Arizona (S.J.C.); University of Colorado School of Medicine, Denver Veterans Affairs Medical Center, 12631 East 17th Avenue B185, Aurora, Colorado (J.R.C.); Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, Maryland (N.K.L.); University of Texas MD Anderson Cancer Center, 1515 Holcombe Bld., Houston, Texas (T.R.M., J.S.W.).
authors.forename: Nancy
authors.initials: N
authors.lastname: Kline Leidy
authors.affiliation: Johns Hopkins University, Departments of Neurology, Neurosurgery and Oncology, Baltimore, Maryland (J.O.B.); Critical Path Institute, 1730 E. River Road, Tucson, Arizona (S.J.C.); University of Colorado School of Medicine, Denver Veterans Affairs Medical Center, 12631 East 17th Avenue B185, Aurora, Colorado (J.R.C.); Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, Maryland (N.K.L.); University of Texas MD Anderson Cancer Center, 1515 Holcombe Bld., Houston, Texas (T.R.M., J.S.W.).
authors.forename: Tito R
authors.initials: TR
authors.lastname: Mendoza
authors.affiliation: Johns Hopkins University, Departments of Neurology, Neurosurgery and Oncology, Baltimore, Maryland (J.O.B.); Critical Path Institute, 1730 E. River Road, Tucson, Arizona (S.J.C.); University of Colorado School of Medicine, Denver Veterans Affairs Medical Center, 12631 East 17th Avenue B185, Aurora, Colorado (J.R.C.); Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, Maryland (N.K.L.); University of Texas MD Anderson Cancer Center, 1515 Holcombe Bld., Houston, Texas (T.R.M., J.S.W.).
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Wefel
mesh_terms: D000818:Animals; D001932:Brain Neoplasms / Q000473:pathology / Q000628:therapy*; D002986:Clinical Trials as Topic; D005910:Glioma / Q000401:mortality / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: clinical outcome assessment; clinical trials; endpoints; malignant glioma