The National Intrepid Center of Excellence (NICoE) and QuesGen Tackle TBI in the Military

Executive Summary

Overview of the Largest Military Neuroimaging Study Ever Conducted

Opening in the fall of 2010 and located on the campus of the Walter Reed National Military Medical Center in Bethesda, MD, the NICoE is the site of the largest study of neuroimaging of TBI in the military.  Studies like CENTER-TBI in Europe and TRACK-TBI in America are probably the civilian studies that come closest in terms of the number of imaging studies conducted.

QuesGen was able to work hand-in-hand with NICoE to build a unique and completely customized system that assessed and recorded the imaging findings — making it all extremely easy to capture, enter, validate, and search the data.

This work forms the foundation of QuesGen Systems’ current neuroimaging platform.

With a study of such magnitude, significance, and expense, it was imperative that everyone involved was speaking the same language and defining their data in the same way. QuesGen developed a specific, easy-to-use system based on an expanded set of common data elements (CDEs).

The CDEs for neuroimaging, defined by the NINDS (National Institute of Neurological Disorders and Stroke), was a great starting point. Initially, there were 24 finding types defined by the CDEs.

“With the NICoE patient population presenting mostly with chronic-mild TBI, we quickly found that we needed additional finding types to accurately record their injuries. Working with the TBI community and the NINDS for more than 10 years to use, promote and improve the CDEs has been a great and iterative process.”

These were mainly geared towards acute, moderate, and severe TBI. Because of the nature of injuries of the military service members at the NICoE, we added another 14 finding types. The Imaging findings ended up being defined by 38 finding types of different gradations and locations in the brain resulting in over 890 data points. The data model developed at the NICoE using the expanded CDEs, forms the basis of QuesGen’s Imaging platform.

With thousands of readings in this study, Dr. Reidy says the common data elements proved to be critical. 

“Because of what QuesGen set up for us, we can really detect patterns and sub-types of TBI and how patients respond to treatment. It affects and informs not only the NICoE patients but 300,000+ service members living with TBI all across the military.”

Building an Advanced Adjudication Model

Because neuroimaging studies face the challenge of obtaining consistent and accurate reads across multiple radiologists, adjudication was a critical component of the study design. QuesGen developed and implemented a system and process that compared radiology readings. Study protocol dictated that each imaging set would be read by two independent radiologists and adjudicated by a third. As it turned out, most of the adjudication through the study was automatic.

Findings from the first two study readers would be visually presented to the third adjudicator in a way that made it easy to confirm the reliability of the results: Green meant the findings matched, red meant they did not match, and yellow meant there was some overlap but also discrepancies among the results.

Dr. Reidy explains it this way:

“One person reads data one way because they were trained in New York and the other reads it another way because they were trained in California. They use different terms, have different ideas, etc. When creating a user-friendly adjudication model, QuesGen helped us define study standards that are critical to research on this scale.”

The QuesGen adjudication system resulted in more accurate study data and more efficient use of radiologists time.

Streamlining for Radiologists

Radiologists like to do things quickly, which posed a challenge as Dr. Riedy and his team of 25 researchers were dealing with a program that collected such vast amounts of images and corresponding data. When looking at and reviewing imaging, radiologists typically record their findings by drafting a write-up (which is usually rather long), meticulously capturing every detail, which is eventually sent to the clinician for review.

The key was making it useful for both the research and the clinical interpretation of the results.

QuesGen was able to completely streamline the process by setting up a system that used only structured data. With the common data elements in place, the data was cleanly presented to researchers, allowing them to quickly compare and assess how many subjects had subarachnoid hemorrhaging, how many had a midline shift, and so on.

Ultimately, QuesGen’s tool expedited the entire process for radiologists, significantly reducing their time in evaluating, capturing, and analyzing data.

Discovering Objectivity from the Data

The traumatic brain injury military patient population is a high-risk group. In fact, more than 60% of active-duty service members diagnosed with a TBI show signs of depression and other behavioral health conditions within a year following their first brain injury. 

The key to the NICoE imaging study lies in its objectivity. 

“With most brain issues, things can be pretty subjective,” explains Dr. Riedy. “’I have a headache… my head’s cloudy…I can’t think straight.’ But with an objective measure of an image with patterns seen in the common data elements, it’s far easier to determine a treatment path — or even develop new treatments.” 

Conclusion

In the end, it’s the advanced imaging done in the NICoE study that will help researchers to objectively determine who has a TBI and who doesn’t. And by understanding what patterns in the imaging lead to what symptoms, the best treatment path for each patient can be determined with far greater efficacy, resulting in the best possible outcomes for TBI patients and their families.

“That in itself is Nobel Prize-winning stuff,” concludes Dr. Riedy. “I believe the answers are in the data, and QuesGen played a big part in allowing us to effectively capture and efficiently analyze this game-changing data.”