Abstract
I'm excited to present this issue of Journal of Neurotrauma, which includes a fantastic collection of articles on hot topics in traumatic brain injury research.
I'd like to draw special attention to two articles from the TRACK-TBI group regarding the most common primary outcome measure used in clinical trials of acute traumatic brain injury: the Glasgow Outcome Scale-Extended (GOSE). The first article is entitled “Central Curation of Glasgow Outcome Scale-Extended Data: Lessons Learned from TRACK-TBI.” In it, Boase et al. report that in an initial phase of the TRACK-TBI effort, 24% of GOSEs had errors identified by central review. With standardization and further training of site assessors, the error rate was reduced to 10% in a later phase of the TRACK-TBI project. The second article is entitled “A Manual for the Glasgow Outcome Scale-Extended Interview.” In it, Wilson et al. provide the information needed to standardize and train assessors. Their manual includes the principles of assessment, advice on administering each section of the GOSE interview, and guidance on “borderline” and “difficult” cases. These articles provide important information about an unglamorous but critically important part of multi-center clinical studies.
While there is considerable controversy about whether the GOSE is the “right” outcome measure to use for clinical trials in TBI, the fact remains that the US Food and Drug Administration and other regulatory agencies still consider the GOSE to be the most appropriate primary outcome measure at this time. Thus, it would be wise for us all to pull together and work from the same standardized cornerstones as we build our knowledge structures.