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dc.contributor.authorPlotkin, Scott Randall
dc.contributor.authorArdern-Holmes, S. L.
dc.contributor.authorBarker, Frederick George
dc.contributor.authorBlakeley, Jaishri O.
dc.contributor.authorEvans, D. G.
dc.contributor.authorFerner, R. E.
dc.contributor.authorHadlock, Theresa A
dc.contributor.authorHalpin, C.
dc.date.accessioned2017-05-19T16:45:11Z
dc.date.issued2013
dc.identifierQuick submit: 2017-04-22T20:25:21-0400
dc.identifier.citationPlotkin, S. R., S. L. Ardern-Holmes, F. G. Barker, J. O. Blakeley, D. G. Evans, R. E. Ferner, T. A. Hadlock, and C. Halpin. 2013. “Hearing and Facial Function Outcomes for Neurofibromatosis 2 Clinical Trials.” Neurology 81 (Issue 21, Supplement 1) (November 18): S25–S32. doi:10.1212/01.wnl.0000435746.02780.f6.en_US
dc.identifier.issn0028-3878en_US
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:32725814
dc.description.abstractObjectives: Vestibular schwannomas are the hallmark of neurofibromatosis 2 (NF2), occurring in >95% of patients. These tumors develop on the vestibulocochlear nerve and are associated with significant morbidity due to hearing loss, tinnitus, imbalance, facial weakness, and risk of early mortality from brainstem compression. Although hearing loss and facial weakness have been identified as important functional outcomes for patients with NF2, there is a lack of consensus regarding appropriate endpoints in clinical trials. Methods: The functional outcomes group reviewed existing endpoints for hearing and facial function and developed consensus recommendations for response evaluation in NF2 clinical trials. Results: For hearing endpoints, the functional group endorsed the use of maximum word recognition score as a primary endpoint, with the 95% critical difference as primary hearing outcomes. The group recommended use of the scaled measurement of improvement in lip excursion (SMILE) system for studies of facial function. Conclusions: These recommendations are intended to provide researchers with a common set of endpoints for use in clinical trials of patients with NF2. The use of common endpoints should improve the quality of clinical trials and foster comparison among studies for hearing loss and facial weakness.en_US
dc.language.isoen_USen_US
dc.publisherOvid Technologies (Wolters Kluwer Health)en_US
dc.relation.isversionof10.1212/01.wnl.0000435746.02780.f6en_US
dc.relation.hasversionhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3908336/en_US
dash.licenseMETA_ONLY
dc.titleHearing and facial function outcomes for neurofibromatosis 2 clinical trialsen_US
dc.typeJournal Articleen_US
dc.date.updated2017-04-23T00:25:09Z
dc.description.versionAccepted Manuscripten_US
dc.relation.journalNeurologyen_US
dash.depositing.authorPlotkin, Scott Randall
dash.embargo.until10000-01-01
dc.date.available2013
dc.identifier.doi10.1212/01.wnl.0000435746.02780.f6*
workflow.legacycommentsPre OA-policyen_US
dash.contributor.affiliatedHadlock, Tessa
dash.contributor.affiliatedBarker, Frederick
dash.contributor.affiliatedPlotkin, Scott


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