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Progress and Outcomes
There have been two primary outcomes in the past year, 2003-2004. First, is implementation of a demonstration project regarding the feasibility of large-scale civilian application of one of the products developed in earlier years of this project: the ANAM Sports Medicine Battery (ASMB). Second, many of the data analyses from projects initiated in prior years have been completed this past year and have resulted in a number of significant scientific presentations and publications.
This past year, the ASMB demonstration project cleared its final regulatory hurdle and was approved by the DoD IRB. Subject enrollment commenced in August of 2003, as scheduled. The project will demonstrate the feasibility of using the ASMB as part of concussion surveillance and management for athletes in contact sports at 22 high schools in Fairfax County Virginia. In previous studies, many of them presented or published this past year, we demonstrated the scientific properties of the ASMB as a concussion management and surveillance instrument. These studies, performed in collaboration with the Defense and Veterans Brain Injury Center (DVBIC), were, however, conducted at the US Military Academy at West Point and at Fort Bragg, both of which are highly disciplined and structured environments. In addition, the DVBIC settings incorporated significant numbers of medical and research personnel, and utilized designated spaces and dedicated computer equipment. The purpose of the Fairfax County project is to demonstrate that the current ASMB system is sufficiently robust and user-friendly that it can be incorporated into a civilian public high school setting. This includes demonstrating that ASMB can be administered effectively by certified athletic trainers and team coaches, using primarily pre-existing computer equipment already available in high school classrooms, and that ASMB data can augment traditionally-based clinical decision-making.
The second primary area of progress has been the completion of many of the data analyses which at the time of last year's report were ongoing or planned, and the conversion of these analyses into peer-reviewed scientific presentations and publications. Perhaps the most important of these is the paper scheduled to appear as the lead article in the May 2004 issue of Neurosurgery. This paper represents many years of work on the part of ATRC investigators, as well as collaborating investigators from the DVBIC, Walter Reed Army Medical Center, and U.S. Navy. The paper describes the day by day recovery of one of the largest concussion cohorts (nearly 800 baselines and 64 concussions) ever reported in the scientific literature. As can be seen from the below list of scientific presentations, in addition to the above-described paper, the additional data analyses completed and presented at scientific conferences this past year indicate that approximately six other papers are likely to result from the USMA and Fort Bragg data sets, with data analysis still ongoing and likely to yield additional findings.
Last year's progress report also described NRH's efforts to develop ANAM as a clinical instrument for monitoring cognition in systemic diseases such as lupus and fibromyalgia. The fibromyalgia project, which had just been approved for funding through the Department of Medicine at the Washington Hospital Center at the time of the writing of last year's progress report, has been ongoing since May of 2003. Recruitment for the study continues and is slightly beyond the halfway point; it is on schedule for completion during the NCEP.
The lupus projects, both with NIH and with the Albert Einstein College of Medicine, also are ongoing, and have produced an interim data analysis with significant findings regarding ANAM and its relation to traditional neuropsychological tests as well its relation to immune biomarkers of disease activity. To abstracts based on a portion of these preliminary findings, with NRH's Tresa Roebuck-Spencer as first author, and co-authors from NIH and Albert Einstein, have been submitted, with one accepted for the American Psychological Association meeting thin coming August, and under review for acceptance for the upcoming Rheumatology Society 2004 meeting. We also are participating as co-investigators with Albert Einstein College of Medicine in the preparation of a Dana Foundation grant proposal to expand on pilot efforts this past year to relate changes in cognitive performance as assessed by ANAM with changes in NR2 antibody status. The Dana Foundation proposal will build on this past year's work by adding assessment of intactness of the blood brain barrier, in an attempt to identify whether cognitive impairment occurs as a consequence of the presence of the NR2 antibody, but primarily when NR2 positivity occurs in combination with a breach of the blood-brain barrier.
he above data analyses have produced a useful byproduct which we hope to exploit in future projects: Drs. Bleiberg, Cernich, and Roebuck-Spencer, have had intensive immersion in ANAM and traditional neuropsychological test data from large and diverse populations of healthy and diseased subjects. This has created two forms of tangible knowledge and experience. The first is a much more refined understanding of the database and data analysis approaches useful with ANAM data, as well as ideas for improving automation of all aspects of ANAM data management. The second is accumulation of clinical experience in the use of ANAM data, in combination with traditional neuropsychological test data and other clinical information, to assist clinical decision-making. There is both art and science in clinical decision-making, and the below-listed papers indicate our effort to quantify the scientific part of clinical decision-making, essentially identifying the sensitivity and specificity of ANAM in various situations. |