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Agenda. Hearing Walking Facial strength Bowel/bladder function Pulmonary outcomes. Example of audiogram. Gardner-Robertson Hearing Classification Scheme. American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Hearing response criteria: 95% critical difference threshold.
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Agenda • Hearing • Walking • Facial strength • Bowel/bladder function • Pulmonary outcomes
American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
Hearing response criteria: 95% critical difference threshold Baseline score 95% critical difference threshold Floor effect Ceiling effect Rauch and Halpin, 2006
Walking (from approval of ampyra) • Inclusion criteria included the ability to walk 25 feet in 8–45 seconds • The primary measure of efficacy in both trials was walking speed (in feet per second) as measured by the Timed 25-foot Walk (T25W), using a responder analysis. • A responder was defined as a patient who showed faster walking speed for a least three visits out of a possible four during the double-blind period than the maximum value achieved in the five non-double-blind no treatment visits (four before the double-blind period and one after).
Other endpoints • Walking • Bowel/bladder function • Respiratory function