Standardizing Data Collection in Traumatic Brain Injury

http://www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA534620&Location=U2&doc=GetTRDoc.pdf


Standardizing Data Collection in Traumatic Brain Injury

Walter Reed Army Institute of Research,Washington,DC,20307

Andrew I.R. Maas M.D., Cynthia L. Harrison-Felix PhD, David Menon, M.D., P. David Adelson,
M.D., Tom Balkin, PhD., Ross Bullock, M.D., Doortje C. Engel, M.D., PhD, Wayne Gordon,
PhD., Jean Langlois-Orman, ScD., Henry L. Lew, M.D., PhD.1, Claudia Robertson, M.D.,
Nancy Temkin,PhD., Alex Valadka M.D., Mieke Verfaellie,PhD., Mark Wainwright, M.D., David W. Wright, M.D. and Karen Schwab, PhD



Collaboration among investigators, centers, countries and disciplines is essential to advancing the care for traumatic brain injury (TBI). It is then important that we ?speak the same language?. Great variability, however exists in data collection and coding of variables in TBI studies, confounding comparisons between and analysis across different studies. Randomized controlled trials can never address the many uncertainties around treatment approaches in TBI. Pooling data from different clinical studies and high-quality observational studies combined with Comparative Effectiveness Research may provide excellent alternatives in a cost-efficient way. Standardization of data collection and coding is essential to this purpose. Common Data Elements are presented for demographics and clinical variables applicable across the broad spectrum of TBI. Most recommendations represent a consensus, derived from clinical practice. Some recommendations concern novel approaches, for example towards assessing the intensity of
therapy in severely injured patients. Up to three levels of detail for coding data elements were developed: basic, intermediate, and advanced, with the greatest level of detail in the advanced version. More detailed codings can be collapsed into the basic version. Templates were produced to summarize coding formats explanation of choices and recommendations for procedures. Endorsement of the recommendations has been obtained from many authoritative organisations. The development of Common Data Elements for TBI should be viewed as a continuing process: As more experience is gained, refinement and amendments will be required. This proposed process of standardization will facilitate Comparative Effectiveness Research and encourage high-quality meta-analysis of individual patient data.