The Clinical Outcomes Assessment (COA) Expert Working Group (EWG) is charged with a multidimensional set of aims and deliverables relevant to the identification, study and validation of outcome measures appropriate for use in applied clinical trials of therapeutic interventions for traumatic brain injury (TBI). Based on the functional domains affected by TBI and the need for validated measures to examine change over time in response to therapeutic interventions, the COA EWG concentrates efforts toward identification and validation of measures in several targeted areas, including:

• Global Outcome
• Cognitive Functioning
• Psychological Health
• Quality of Life
• Physical Function

Lead: Michael McCrea, PhD | Dr. McCrea is is Professor of Neurosurgery and Neurology and Director of Brain Injury Research at the Medical College of Wisconsin, and a research neuropsychologist at the Clement Zablocki VA Medical Center in Milwaukee, Wisconsin. He is ABCN board-certified in clinical neuropsychology and is the immediate past President of the American Academy of Clinical Neuropsychology. Dr. McCrea has led several large, multi-center studies on the effects of traumatic brain injury and sport-related concussion. He has experience in utilizing DoD-affiliated databases to conduct epidemiological and prospective research on the effects of mTBI in OEF/OIF service members. He currently serves on the National Football League Head, Neck and Spine Committee. Dr. McCrea serves on the TED Executive Committee and its Outcomes Core.

Co-lead: Sureyya S. Dikmen, PhD | Dr. Dikmen is a Professor in the Department of Rehabilitation Medicine, and Adjunct Professor in the Departments of Neurological Surgery and Psychiatry and Behavioral Sciences at University of Washington. Dr. Dikmen is one of the founding members of the UW TBI Model System, and is very active on the Research and Data Collection teams of TBIMS. Her research interests include the natural history of neuropsychological and psychosocial outcomes and the recovery and prediction of these functions after TBI.

Co-lead: Joseph Giacino, PhD | Dr. Giacino is the Director of Rehabilitation Neuropsychology at Spaulding Rehabilitation Hospital, Consulting Neuropsychologist in the Department of Psychiatry at Massachusetts General Hospital and Associate Professor in the Department of Physical Medicine and Rehabilitation at Harvard Medical School. Dr. Giacino's clinical and research activities are centered on the development and application of novel assessment and treatment methods for individuals with severe acquired brain injury (ABI) and disorders of consciousness (DOC). He serves as co-investigator on the TED Initiative providing expertise on outcome assessment methods for TBI patients.

Co-lead: Harvey Levin, PhD | Dr. Levin is Scientific Director, Neurorehabilitation: Neurons to Networks Traumatic Brain Injury Center of Excellence, Michael E. De Bakey Veterans Affairs Medical Center, in Houston, Texas. He is a neuropsychologist with extensive experience in conducting funded research on multiple domains of recovery from TBI, including multimodality brain imaging, cognition, motor, and sensory capacities in civilians, service members, and Veterans. Additionally, Dr. Levin is Professor of Physical Medicine and Rehabilitation at Baylor College of Medicine, where he has organized the outcome assessment of NINDS clinical trials and directed projects on mild TBI supported by CDMRP and NINDS. Dr. Levin serves on the TED Executive Committee and its Outcomes Core.

Co-lead: Murray Stein, MD MPH | Dr. Stein is Distinguished Professor of Psychiatry and Family & Preventive Medicine and Vice Chair for Clinical Research in Psychiatry at the University of California, San Diego, where he directs the Anxiety & Traumatic Stress Disorders Program. Dr. Stein’s research interests include the epidemiology, neurobiology, and treatment of anxiety and trauma and stress-related disorders especially social anxiety disorder, panic disorder, and posttraumatic stress disorder. He has written or co-written over 500 peer-reviewed scientific articles on these topics. He serves on the TED Executive and Steering Committees and Outcomes Core providing expertise in psychiatry and PTS.

Co-lead: John Whyte, MD PhD | Dr. Whyte is Director of The Moss Rehabilitation Research Institute at Albert Einstein Healthcare Network with expertise in assessment and treatment of cognitive and functional deficits related to brain injury. He was involved in the development of the initial round of “Common Data Elements” for TBI, and was the co-editor of the special issue of the Archives of Physical Medicine and Rehabilitation that disseminated those efforts. He is currently co-Principal Investigator of a NIDRR-funded Module project within the TBI Model System to combine outcome measurement items from several scales into a single measurement tool that can be used for long-term treatment studies. He plays a principal role in the TED Outcomes Core.