Outcomes Module

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

This is a "modular" project in which many Model Systems hospitals collaborate. Dr. John Whyte, MD, PhD, from Moss Rehabilitation Research Institute and Dr. Joseph Giacino, PhD, from the Spaulding/Harvard Model System are the Co-Principal Investigators for this project.

The specific aims of the Module project 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.
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.