The National Institutes of Health (NIH) has created a new global clinical and behavioral assessment toolbox — the NIH Toolbox for Assessment of Neurological and Behavioral Function — that combines older and newly developed measurement tools into a shorter and more reliable test. It's been years in the making and hundreds of scientists have been part of its development. The new toolbox was officially rolled out to the research community in early September.
“Everyone tends to measure aspects of cognitive, behavioral, and emotional health in a different way,” said Molly V. Wagster, PhD, chief of the behavioral and systems neuroscience branch at the National Institute on Aging. “There was little uniformity,” she said, noting that the lack of standardized measures made it difficult to compare and interpret findings across studies and populations.
Claudia Moy, PhD, a Project Team member from the National Institute of Neurological Disorders and Stroke (NINDS), said that clinical neuroscience research would benefit from this set of instruments. “It's an advantage to have standardized tools to do large clinical trials and meta-analyses to compare study results,” she said.
Dr. Moy added that researchers who study neurological disorders also would have access to the NINDS-developed Neuro-QOL assessment, which provides standardized measures of quality of life for neurological conditions and in many ways complements the measures in the NIH Toolbox. Both the NIH Toolbox and Neuro-QOL will be built into the NINDS Common Data Elements project, which provides researchers with a common set of questions and methodology to collect and record medical information. The NIH Toolbox can be used independently or together with these other tools.
The NIH Toolbox is designed in four independent modules — cognition, emotion, motor, and sensation — that in total should take no longer than two hours to administer, Dr. Wagster said. It has been designed with an eye toward measuring outcomes in clinical trials and large epidemiological and longitudinal studies. The massive initiative was funded under the NIH Blueprint for Neuroscience Research program.
Dr. Wagster is the NIH Project Officer for the development of the toolbox and worked closely with a team from twelve different institutes, centers, and offices at the NIH to provide oversight to the design, research and development of the measures. The tools are based on data collected and analyzed from across the lifespan, ages three to 85. There are versions in English and Spanish and the toolbox will be royalty free to scientists.
The NIH Toolbox contains measures developed from a normative sample, Dr. Wagster explained. The next step is for researchers to validate the measures in patient populations to see what works and what doesn't.
HISTORY OF PROJECT
Richard Gershon, PhD, associate professor and vice chair for research at the Northwestern University Feinberg School of Medicine, is the principal investigator on the project. He and colleagues identified more than half a dozen experts in cognition, motor function, emotion and sensory research and they led teams that recruited over 200 scientists to assess roughly 2000 measures and determine which ones met criteria for use in the NIH Toolbox. In addition to the existing instruments, the teams developed new measures for adults and children. Each module was reduced to 30 minutes and the scales were validated in a series of studies.
Investigators who received federal grants to test the NIH Toolbox will be sharing their data and pointing out the importance of having one set of tools to conduct cognitive, behavioral, emotional, and sensorimotor research.
TESTING THE MEASURES
For example, Mustafa M. Husain, MD, professor of psychiatry and internal medicine, head of ECT Service, director of the Neuro Stimulation Research Lab and chief of the Geriatric Psychiatry Division at the University of Texas Southwestern Medical Center, has been using the NIH Toolbox to study depression in Parkinson's (PD) patients, and received a Challenge Grant from the NINDS to pilot the Toolbox for the first time in patients with PD. Dr. Husain and his colleagues want to evaluate which components patients with PD can or cannot complete. The Toolbox's motor domain comprises multiple tasks that may be easy for healthy individuals but may prove difficult for those with movement disorders, he noted. Dr. Husain's team has also evaluated the Toolbox's cognitive domain; these measures may prove helpful in light of new evidence emerging on PD-related cognitive difficulties.
Victor Mark, MD, an associate professor of physical medicine and rehabilitation, neurology and psychology at the University of Alabama at Birmingham (UAB) and director of the Spain Rehabilitation Center, received a Challenge Grant to test whether the Toolbox was sensitive enough to identify problems in patients with neurological injuries. He is interested in how cognitive disorders impact functional recovery.
“The NIH toolbox might actually be too sensitive,” said Dr. Mark. “It might require fine-tuning.” In an early-release version, there were a few tests, for instance, the Dimensional Change Card Sort test and Flanker that required touch screen interactions and automatically stopped the assessment if a person did not respond within a certain amount of time. Half of the brain-damaged patients could not meet that criterion. They were too slow, said Dr. Mark, who suspects that the September 2012 Toolbox release, changing from a touch screen — where a person has to move his hand from the table to the screen — to a keyboard, might solve the problem.
“It will be interesting to see whether revisions in the final toolbox design will address this,” he said. “Still, I think it is gratifying that there is now one kind of assessment that can transcend and cut across different types of brain illnesses and injuries.”
The NIH Toolbox is designed in four independent modules — cognition, emotion, motor, and sensation — that in total should take no longer than two hours to administer. Watch here for a sample of the newly developed tests in each category: http://bit.ly/aNQ4KB.