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Development of an Extended Measure of Global Function to Support Clinical Trials Originating in Acute Care

PI(s): Lead – John Whyte, MD and Joseph Giacino, PhD (Spaulding-Harvard Traumatic Brain Injury Model System, Boston, MA); Site – Gale Whiteneck, PhD

Funded by: National Institute on Disability and Rehabilitation Research

Dates: 2013 - 2017

Contact(s): Gale Whiteneck email gale@craighospital.org

The specific aims of this Module are: 1) to identify a combination of a small number of outcome measures (or items therefrom) whose items span a range suitable for clinical trials originating in acute rehabilitation (i.e., including patients with disorders of consciousness), and continuing to at least 1 year post-injury (i.e., capable of measuring neuro-cognitive functioning beyond the range of the FIM and with greater precision than the GOS-E or DRS); 2) to gather preliminary data on longitudinal recovery over the first year, using this derived outcome measure, in order to assess its performance and predictive validity; and 3) to identify multiple alternative behaviors of comparable difficulty level that mark the boundary between the minimally conscious state (MCS) and higher levels of functioning. Phase 1 of the module will analyze existing datasets containing pairs of candidate measures to identify their degree of overlap; to select a small number of specific measures covering a broad range of global functioning for further study; and to establish rules for administering the specific measures so that only measures which are appropriate for a particular patient’s functional abilities are administered. Phase 2 will collect pilot data on items or measures intended to fill in missing measurement gaps in the broad continuum of global functioning. Phase 3 will administer the selected instrument/item battery using the established rules to efficiently administer only appropriate measures to each of 80 cases at admission, discharge, or follow-up. Rasch (or other IRT) analysis of the data will be used to identify a psychometrically sound item set that adequately covers and precisely measures the broadest range of a unidimensional construct of global function. The results of the analysis will also determine if alternative behavioral indictors also fall on the same dimension of global function and can be used to mark the boundary between the MCC and higher levels of functioning.